1. Introduction

The picture of a Trojan horse, wrapped in banners reading STOP CETA, best portrays the fears underpinning the public opposition to the Comprehensive Economic and Trade Agreement with Canada (CETA). The main suspicion is that the technical jargon of the economic transatlantic deal, hailed as beneficial for EU consumers, could insidiously be used to attack public policy, health, safety, and environment regulation. Just like the horse used by the Greeks to destroy the city of Troy, CETA could be used to unleash a new wave of neoliberal policies that would erode environmental and social regulation. Next to the widely publicized issues related to the adoption of an Investment Court (which is perceived as a risk to democracy), other parts of CETA have been stigmatized for being perilous. CETA provisions explicitly relating to the field of biotechnology have generated these concerns. Critics have read into these provisions an attempt to upset the precautionary European regulatory choices in this field, which – it is worth recalling – has always been a highly divisive issue in transatlantic relations.

CETA establishes a number of provisions concerning the cooperation in the field of biotechnology. In this context, CETA refers to ‘the importance of following shared objectives’ in the context of the cooperation. These shared objectives include the promotion of ‘efficient science-based approval processes for biotechnology products’; the cooperation on issues related to biotechnology, ‘such as low level presence of genetically modified organisms’; and ‘regulatory cooperation to minimize adverse trade impacts of regulatory practices related to biotechnology products.’ The inclusion of these objectives has raised worries that CETA could erode the EU and Member State precautionary policies in the field of biotechnology. The official position of the European Commission, in its own right, should be reinsuring to these constituencies: ‘So CETA won’t change how the EU regulates food safety, including on GMO products.’[1] This line of reasoning has been echoed by EU parliamentarians supporting CETA.[2]

The cacophony of voices pro and against CETA and the relatively technical issues related to the field of biotechnology warrant some scrutiny of both arguments. This article aims at clarifying the implications of CETA for the regulation of biotechnology, and more particularly sheds light on the question of whether the concerns that CETA will lead to a lowering of the European standards are justified. The international rules on treaty interpretation are used as the main analytical lenses to critically analyse and decipher the CETA text and, accordingly, to answer the central research question.

In order to engage in such analysis, few preliminary words are spent on the current EU regulatory regime for GMOs (section 2). The article will then illustrate the ambiguities in the CETA text, which could be the grounds of the fears of environmental groups and other CETA sceptics (section 3). In this context, particular attention will be devoted to the possible meanings that can be attributed to terms like ‘science-based.’ Against this background, the legal framework for interpreting salient CETA provisions in the field of biotechnology will be presented and applied so as to clarify how certain provisions should be interpreted. Critics may be surprised of the progressive potential of the rules on treaty interpretation.


2. The EU GMO regulatory mess

The commercialization and cultivation of GMOs in the European Union is strictly regulated. To enter the European market, any GMO product needs to be authorized.[3] The main legal framework for the commercialization of GMOs is based on a series of Directives and Regulations, the most important being Directive 2001/18/EC dealing with the deliberate release of GMOs into the environment[4] and Regulation (EC) 1829/2003 concerning the authorization of GMOs for human food and animal feed products.[5] Next to the authorization, any product containing more than 0.9% GMOs should be labelled.[6] The GMO regulatory regime is informed by the precautionary principle.[7]

As of today, 58 GMOs have been approved to enter the European market for food and feed. Most of these are used for animal feed. By contrast, GMOs are seldom used in food products and only one GMO variety – MON 810 – has been approved for cultivation.[8] Thus, while less than 0.1% of EU soil is grown with GMOs and only negligible amounts of GM food are placed in the market, more than 60% of animal feed in Europe is genetically modified. According to some, these differences are due to the fact that the food industry has to label food that contains even minimal amount of GMOs, but does not have labelling obligations for food products derived from animals fed with GMOs: ‘the food industry does not have the same requirements for feed as for food, and consumers are kept in the dark about it due to this lack of labelling.’[9]

While the European regulatory framework is presented as monolithic in the context of CETA, the reality is more complex. Members have different positions, which surface in the bumpy decision-making process. In short, the process of authorization starts when the applicant submits a request to the competent authority of the Members State. In the case of cultivation, the domestic competent body will evaluate the safety of the GMO and then transmit its evaluation to the European Food Safety Authority (‘EFSA’).[10] The request for an authorization for food or feed is initiated at the level of the Member State, but the domestic body forwards the request directly to the EFSA, without a preliminary evaluation.[11] After EFSA has conducted its own risk assessment – which so far has invariably resulted in favourable reviews – the file is passed on to the Commission that prepares a draft decision. At this point, the Standing Committee on the Food Chain and Animal Health (‘SCFCAH’), composed by representatives of all Member States, is called upon to adopt or reject the draft decision. When no opinion is adopted, an Appeal Committee, equally composed by representatives of all Member States, will have to decide. The decision rule is qualified majority in both instances.[12] Thus far, none of these fora were able to reach a decision by qualified majority, a pattern that reflects the divisiveness of the GMO politics in Europe. In the absence of such decisions, it is the Commission that has to approve the product, at least this was the case under the old comitology procedure.[13] This procedure may lead to the odd result that, although a majority of Members oppose authorization, the Commission is legally obliged to authorize the GMOs. In practice, the most divisive issues have been in the area of cultivation of GMOs. The process to approve Maize 1570 for cultivation is a case in point, and one that may have accelerated the reform.[14]

Member States opposed to the authorization of the cultivation of GMOs have often adopted safeguards measures, grounding these measures on allegedly new/different scientific evidence.[15] When confronted with the evidence produced by domestic authorities to justify the safeguard measure, EFSA has systematically confirmed its original assessment. Upon EFSA findings, the Commission asked to repeal these safeguard measures and the Council has consistently opposed the proposals by the Commission. Confronted with this impasse, 13 EU Member States (led by Austria) put forward a request to re-gain autonomy on decisions concerning the cultivation of GMOs, grounding their request on the principle of subsidiarity.[16] In 2015, Directive 2001/18/EC was amended to allow European Member States to introduce cultivation bans or restrictions.[17] The new Article 26b establishes a wide variety of grounds that can be invoked by European Member States to introduce restrictions or prohibitions of GMOs, including environmental policy objectives, town and country planning, land use, and socioeconomic impacts.[18] This shift in policy gives more space to EU Member States and allows a de facto dual (or decentralized) regime for GMOs. [19] At the time of writing, 19 Members have already asked for partial or total prohibition of the cultivation of certain GMOs in their territory.

While this reform could provide a solution to the EU regulatory impasse, it is not free from problems. The 2015 Directive establishes that the grounds to be invoked by the Member States to prohibit cultivation ‘shall, in no case, conflict with the environmental risk assessment carried out pursuant to this Directive or to Regulation (EC) No 1829/2003.’ Members justifying their restrictive measures on ‘environmental policy objectives’ may have difficult time in complying with the latter requirement. In this regard, it is to be noted that many reasons adduced by Member States against the cultivation of GMOs in the past have been based on scientific evidence in apparent contrast with the EFSA conclusions.[20] Article 26b may be read as aiming at silencing these different visions, entrusting EFSA with ‘super-scientific powers.’ At a minimum, it is plausible to expect confusion and controversies when this ‘no-EFSA-ERA-conflict’ provision would be applied in practice. At its face, this provision may be the offspring of a reductivist vision of science, a point further discussed in the next section.

Before turning to the analysis of the possible implications of CETA for the EU regulatory environment, it is worth mentioning another aspect of the GMO regulatory framework of relevance for trade relations. The European Union has a zero-tolerance policy for the contamination of seeds and food, with unauthorized GMOs. In short, if traces of GM products, which have not been authorized in the EU, are found in seeds or other food products, emergency measures can be enacted.[21] The most egregious case of contamination has occurred in 2009, when GM flax (commonly known as Triffid),[22] authorized in Canada but not in Europe, was found in flax imports from Canada. Triffid was first detected in a shipment from Canada to the EU in July 2009, and upon further tests it was found in numerous bakery products and cereals produced in the EU. The discovery of the contamination has been followed by an import restriction of flax originating from Canada and the adoption of new testing requirements.[23]

The EU zero-tolerance policy has been partly revised with the adoption of Regulation 619/2011, which introduces a so-called ‘technical solution.’[24] This Regulation applies to feed only and establishes a ‘technical zero’ when feed is contaminated at less than 0.1% by GM events not yet authorized (but for which an authorization is pending or an authorization has expired).[25] This means that minimum contamination of seed with unauthorized material is now possible in the EU. The zero-tolerance policy for contamination, even if mitigated by the technical solution, remains of great concerns for exporters of agricultural goods to the EU.[26] Article 25.2(c) CETA may have been drafted to respond to these concerns, as it emphasizes the importance of cooperation ‘on issues related to biotechnology, such as low level presence of genetically modified organisms.’ For some, this type of provision evidences the fact that CETA may lead to a relaxation of EU standards in the field of biotechnology.


3. CETA and the new shared objectives for cooperation: Is peace war?

Having offered a brief overview of the EU regulatory regime for GMOs, this section will assess whether CETA is likely to bring some changes and whether the fear that CETA will be a Trojan horse, enabling a dismantling of the GMO policy in the Union is somewhat justified. On a first reading, the part of CETA addressing cooperation in the field of biotechnology may not be considered particularly revolutionary. In fact, it builds on and partly embeds what was agreed between the EU[27] and Canada in the aftermath of the EC – Biotech case.[28] The thorny case was launched by the US, Canada, and Argentina to challenge the inaction on the part of the EU to approve GMOs (the so-called moratorium), as well as certain specific European restrictive measures in the field of the marketing of GMOs (the product-specific measures) and restrictive trade measures of some European Member States (so-called EC Member State safeguard measures). The Panel Report concluded that the EU and the EC Member State measures violated a number of provisions of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (‘SPS Agreement’). The EU decided not to appeal, and a Mutually Agreed Solution was agreed upon between Canada and the EU.[29] This agreement established ‘a bilateral dialogue on agricultural biotech market access issues of mutual interest.’ The dialogue was institutionalized in the form of bi-annual meetings to be held on a set of agreed issues, including ‘GM product approvals in the territory of Canada or the EC; Any trade impact related to asynchronous approvals of genetically modified products or the accidental release of unauthorised products and any new legislation in the field of agriculture biotechnology.’[30] CETA crystallizes the bilateral dialogue by virtually reproducing the text of the Mutually Agreed Solution in Article 25.2(1), arguably strengthening its normative value.

Next to this, Article 25.2(2) sets out some shared objectives ‘with respect to cooperation in the field of biotechnology.’ As mentioned in the Introduction the shared objectives include the promotion of ‘efficient science-based approval processes for biotechnology products’ and the cooperation on issues related to biotechnology, ‘such as low level presence of genetically modified organisms.’ Despite the hortatory language (‘The Parties also note the importance of the following shared objectives’), this provision in CETA has generated concerns.

One key terminology that has alarmed critics, is the text of letter (b), concerning the promotion of ‘efficient science-based approval processes for biotechnology products.’ This wording should be of concern to no one; who could possibly oppose ‘efficiency’ and ‘science-based decision-making’ in the 21st century? Yet, representatives of the civil societies have taken issue at this wording, contrasting it with the precautionary principle.[31] However few have taken the time to elaborate on what ‘efficient science-based decision-making’ really means. Two considerations need to be made on this. First, the phrasing is highly indeterminate. Second, this expression is oft misused and evolved into a somewhat politically charged statement.

Let us start by spending few words on the meaning of the term ‘efficiency,’ one of the most used words in contemporary politics, and arguably one of the emptiest. It is beyond the scope of this article to provide an exposé of the concept of efficiency. A brief introduction to the concept will suffice to illustrate the enormous ambiguities the term brings about. Efficiency is normally related to economics. In this field at least two definitions can be given. The first is referred to as the ‘Pareto efficiency’ and the second as ‘Kaldor-Hicks’ (both deriving their names by the economists who elaborated these concepts). As explained elsewhere ‘a state of the world is Pareto superior to another if at least one person can be made better off without anybody being made worse off; Pareto optimality is reached when it is not possible to move to another state of the world without making at least one person worse off.’[32] The problem with this criterion is that, as a normative criterion, it is hard to use, as changes in rules to the satisfaction of everybody are highly implausible (not to mention that they are unconceivable in the context of GMO politics). It is quite unlikely that the CETA negotiators were thinking of Pareto optimality when using the term efficiency, as this in practice would mean no change in policy at all. The Kaldor-Hicks criterion, by contrast, may appear more apt for decision-making. An allocation of resources is Kaldor-Hicks efficient if following a change in the status quo the gainers benefit more than the losers do; gainers should be able to compensate the losers and still find the change desirable, although the compensation is only potential in nature. In other words, Kaldor-Hicks efficiency is a form of wealth maximization. Kaldor-Hicks, however, has been criticized on various grounds.[33] Here it suffices to mention that such a criterion may be impractical for ‘the substantial information requirements that must be satisfied in order to identify efficient legal rules.’[34]

If we try to apply Kaldor-Hicks efficiency to ‘the approval processes for biotechnology products’, what would it mean in practice? Which costs and benefits should be considered? Costs and benefits for whom? Should the potential costs of contamination be computed in such approval processes? What would be the timeframe for analysis? An overwhelming number of political questions would have to be resolved before such an exercise could be done with some intellectual integrity. The problem, in fact, is that much contestation surrounds the ‘externalities’ posed by biotechnologies. Finally, it goes without saying that if the negotiators were thinking of institutionalizing a practice such as cost-benefit analysis, they could have used this wording.[35] But they did not. So, we are left with a particularly ambiguous term. If ‘efficiency’ is murky at best, what about ‘science-based’?

The term science-based appears to be clearer. Approval processes should be based on ‘science’. But what does it mean that decisions should be based on science in practice? Besides the uncertainties that almost invariably characterize any scientific study, scientific questions do not coincide with political questions and plausible scientific studies can differ in their methodology and thus deliver different results.[36] Choosing between different scientific methodologies is eventually a value choice, as assumptions and models could be more or less conservative and could take into account different variables.[37] When it comes to testing the safety of GMOs, for example, there are different views of what constitute good testing practices. Some toxicologists have criticized the standardized ninety-day rat-feeding tests for the risk assessment and have defended alternative methods, such as chronic two-year studies or toxicogenomic techniques.[38] Despite authoritative claims that scientific consensus has been achieved over the safety of GMOs,[39] the debate is far from settled among scientists.[40] Dividing issues remain in relation to the health effects of GMOs, where to one count at least 26 studies have found adverse or uncertain health effects of GMOs, as well as environmental consequences of GM crops. In relation to the latter, it has been noted that, the use of herbicides has increased with the use of GM crops.[41] On a different note, the question of the potential conflict of interests underpinning scientific studies in the area of GMOs is a cause of concern for the reliability of existing studies.[42] Given that different positions by various scientists often remain all in the realm of scientific plausibility, the question that is left unanswered by the locution ‘science-based’ is ‘whose science’ is to count.

One problem is that at the international level, the term ‘science-based’ has been used to assert authority and to silence controversy in science. The process by which the standards on ractopamine have been adopted at the Codex Alimentarius Commission is a vivid illustration of this issue. In this case, two well-recognized scientific bodies, the Joint WHO/FAO Expert Committee on Food Additives (JECFA) and the EFSA, reached different conclusions on the safety of the substance (which is a beta-agonist administered to animals to accelerate animal growth and the leanness of the meat).[43] In an unusual vote at the Codex Commission, a thin majority (69 in favour vs 67 opposing and 7 abstentions) approved the standard.[44] Notwithstanding the fact that Codex Members were very divided and that there was a negative risk assessment by an established scientific body (ie EFSA), the process was hailed by its proponent as ‘science-based.’[45] The use of the term ‘science-based’ to essentially discredit alternative, plausible scientific opinions is a phenomenon that deserves more attention in the current international legal scenario.

From these brief notes, the dangers entrenched in the apparently innocuous jargon ‘efficiency’ and ‘science-based’ should become apparent. The risk is that the ambiguity of this wording is exploited so as to attribute meanings that favour certain agendas and interests, possibly opening up the way to an Orwellian doublethink. This risk, however, can be mitigated, given that law is endowed with a normative framework for interpretation. As legal scholars, we can address these legitimate fears by asking, how should these terms be interpreted in the CETA context?

Before turning to this question let us also consider another shared objective that has caused concerns among critics: the objective to cooperate internationally on issues related to biotechnology, such as low-level presence of genetically modified organisms.[46] At first, this provision should not be of particular concern. A shared objective of cooperation does not suggest that a particular outcome from the cooperation is preferred to others. In other words, the shared objective of cooperating on this issue should not entail an erosion of the zero-tolerance policy, as some fear. At a second reading, however, some of the concerns voiced by NGOs[47] may be justified. First of all, it is to be noted that the text refers to ‘international cooperation. An international network on low-level presence of GMOs, called the Global Low Level Presence Initiative (GLI), already exists.[48] Most State members of this network are producers of GMOs and have a clear interest to lower the standards regarding adventitious contamination on low-level presence. The existing work done within this network may suggest that the direction of ‘the international cooperation’ is towards increasing the acceptance of contaminated GMO products. This reading may be reinforced by looking at Canadian policy on low-level presence of GM crops, which aims at increasing the thresholds at which contamination could trigger restrictive measures.[49] Given that contamination can be widespread and that a politics of containment is rather costly, the EU zero-tolerance policy remains framed as a serious trade irritant. The CETA text in this respect can be seen as ambiguous; on the one hand, it only aims at facilitating cooperation; on the other hand, in light of the already ongoing international cooperation in this area, it may suggest a certain direction of the cooperation. Against this background, it is important to reflect on how Article 25.2.2(c) should be understood, or in legal jargon, how it should be interpreted.


 4. CETA and Biotech: It’s just a matter of treaty interpretation, stupid!

‘Whenever a subject of international law invokes, applies or goes about implementing a treaty, it can only do so on the basis of a certain understanding of its terms, ergo on the basis of an interpretation.’[50]

As is well known, Article 31-33 of the Vienna Convention on the Law of Treaties (VCLT), reflecting customary international law, constitute the cornerstone for treaty interpretation.[51]  These rules are also referred to by Article 29.17 first sentence of CETA, titled ‘General rule of interpretation.’[52] Article 31 VCLT establishes several canons to be followed when interpreting treaty norms.[53] First, interpretation should be in good faith; second, recourse ought to be made to the ordinary meaning of the words; and third, the context, the object and purpose of the treaty should be taken into account, including those instruments made in connexion with the conclusion of the treaty or subsequent to it. These canons are to be followed simultaneously and no special hierarchy shapes their interrelation. In the words of the WTO Appellate Body, ‘the process of treaty interpretation is an integrated operation, where interpretative rules and principles must be understood and applied as connected and mutually reinforcing components of a holistic exercise.’[54] Moreover, by virtue of Article 29.17 second sentence of CETA, ‘the arbitration panel shall also take into account relevant interpretations in reports of Panels and the Appellate Body adopted by the WTO Dispute Settlement Body.’ From this article, it can be safely inferred that the WTO acquis is of relevance to understand (thus interpreting) the meaning of ambiguous provisions in CETA.

This means that textual, contextual and teleological interpretations are complementary. International tribunals have also clarified that an evolutionary interpretation of the treaty is also compatible with the canons of treaty interpretation.

Against this background, let us now turn to the analysis of how the wording of the provisions concerning the cooperation on biotechnologies should be interpreted in light of Article 31 VCLT and of the WTO acquis. Given the limited scope of this article, only some salient jargon will be analysed. However, the analysis could be easily extended to the rest of Article 25.2 and to other CETA provisions of relevance for the field of biotechnologies.

As mentioned above, one of the biggest fears is that terms like ‘efficient science-based’ will lead towards laxer GMO standards in Europe and will somehow erode the applicability of the precautionary principle.[55] Such a view, however, rests on the dangerous myth that ‘science-based’ is juxtaposed to the precautionary principle and/or to stringent health/safety/environmental regulation. Let me try to dispel this myth, by applying the rules of treaty interpretation, together with the WTO acquis.

A place to start this analysis is to examine the context and the purpose of the treaty, as per Article 31(2). It is undisputable that the Joint Interpretative Instrument on the Comprehensive Economic and Trade Agreement (‘CETA’) between Canada and the European Union and its Member States (hereinafter, ‘the Interpretative Instrument’) constitutes the context of the treaty.[56] Letter (e) of its Preamble clarifies that the Interpretative Instrument ‘provides an agreed interpretation’ of ‘a number of CETA provisions’ in the sense of Article 31 VCLT.[57] While unspecified in the text, it seems plausible to argue that the Interpretative Instrument qualifies as an ‘agreement relating to the treaty which was made between all the parties in connexion with the conclusion of the treaty’, as per Article 31.2(a). As noted by Dörr the term ‘agreement’ is broader than the term treaty. What is essential is the joint initiative and consensus of the parties, as well as the temporal proximity with the conclusion of the treaty. All these elements can be attributed unequivocally to the Interpretative Instrument.

It could be counter-argued that the Interpretative Instrument cannot be used to interpret Article 25.2. The Interpretative Instrument, in fact, includes a Concordance Table ‘relating the statement of the intention.’ In this Table, Article 25.2 does not figure; however, the list in the Table has been defined as non-exhaustive in the Interpretative Instrument. Moreover, it would be contrary to the goal of the Instrument to exclude the field of biotechnology from its scope. The provisions targeted by the Interpretative Instrument are, in fact, those ‘provisions that have been the object of public debate and concerns.’ As mentioned at the outset of this article, the regulation of biotechnologies figured prominently among the public concerns relating to the conclusion of CETA.

Before speculating on how certain terms should be interpreted contextually in light of the Interpretative Instrument, it is worth understanding how, in practice, terms like ‘science-based’ could entail a lowering of the standards in the field of biotechnology. One way by which the standards could be lowered is by attributing almost legally binding value to scientific opinions of bodies like EFSA. In other words by considering a certain policy as science-based only if it directly follows from an EFSA opinion. As explained above, EFSA has adopted almost invariably favorable opinions to GMOs, whereas the EU Member States (and some of their scientific bodies) emphasized the uncertainties surrounding the science, weighed the evidence differently, and in consideration of a number of factors reached a negative assessment of the safety of several GMOs. If the term ‘science-based’ would be taken to mean that the decision should follow the opinions of one scientific panel (say EFSA), the fear of lowering the standards could easily materialize.

However, by taking into consideration the Preamble of the Interpretative Instrument, we can come to the conclusion that the term ‘science-based’ should be interpreted in such a way that does not lead to lowering the standards or to the violation of existing regulation: ‘CETA will also not lower our respective standards and regulations related to food safety, product safety, consumer protection, health, environment … . Imported goods, service suppliers and investors must continue to respect domestic requirements, including rules and regulations.’ This is all the more evident, when we think of the regulatory reform adopted in Europe, according to which Member States are allowed to depart from the opinions of EFSA on a number of grounds. The text of the Preamble is further reinforced by point 2 of the Interpretative Instrument concerning the right to regulate. Such contextual interpretation entails a pluralist conception of science, according to which not only the opinions of scientific bodies like EFSA count, but also the opinions of other scientists.

In letter (d) of the Preamble of the Interpretative Instrument, we can find another clear indication that the term ‘science-based’ should not be interpreted as a rigid criterion to be juxtaposed to the precautionary principle: ‘The European Union and its Member States and Canada reaffirm the commitments with respect to precaution that they have undertaken in international agreements.’ The European Union is a Party to the Cartagena Protocol on Biosafety, which assert ‘adherence to the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development.’ It follows that committing to science-based procedures should not entail the abandonment of commitments in respect to precaution. This reading should not be surprising (though it may go against the grain of mainstream commentaries). Particularly in that, two of the most authoritative international sets of principles on Risk Analysis (the Working Principles for Risk Analysis for Food Safety for Application by Governments[58] (Working Principles for Governments) and the ‘Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius’ (Working Principles for Codex)),[59] recognize that ‘Precaution is an inherent element of risk analysis.’[60]

A nuanced vision of science, which rests on value judgements and that can be compatible with the precautionary principle is also in line with much writing of Science and Technology Studies (STS) scholars. The main insights of this scholarship have penetrated the legal field through the amicus curiae brief submitted by five influential STS scholars[61] in the transatlantic dispute on GMOs (EC – Biotech).[62] The brief articulates the thesis that risk assessment is entrenched with value judgements and contingent on political, social and regulatory contexts. More particularly, risk assessment is presented as ‘conducted within specific national or institutional settings’ and, as such ‘necessarily limited and partial’ and ‘constrained by the decision-making cultures within which such assessments are produced.’[63] The signatories of the brief further argued that when scientific knowledge is characterized by low certainty and low consensus (as is the case for GMOs), the process of public participations should be central to risk analysis. Such sophisticated vision of science lends analytical support to the contextual interpretation of the term ‘science-based,’ as enunciated above.

To round everything out, let us now look into the WTO acquis. It may be intuitive to look at the Panel Report in EC – Biotech to find hints about where WTO law stands in relation to biotechnologies. However, a subsequent Appellate Body Report has interpreted important questions in this ambit. More specifically, the Appellate Body Report in Continued Suspension[64] has further clarified the meaning of the term risk assessment, taking a significantly different approach from the Panel in EC – Biotech. The understanding of this concept is highly pertinent to the interpretation of the term ‘science-based’ because risk assessment is the first step in the risk analysis process[65] and a policy based on risk assessment can be safely considered as science-based.[66]

In the context of WTO law, the EC has argued several times in favour of a ‘relational’ conceptualisation of risk assessment, in the sense that the level of protection that a Member has chosen can legitimately influence the type of scientific assessment conducted. In practice, this entails that two different scientific assessments may reflect different values and can be both valid. The Panel in EC – Biotech and a subsequent Panel in Continued Suspension have rejected such a ‘relational’ conceptualisation of risk assessment. However, the Appellate Body has endorsed the relational interpretation of risk assessment:

‘The risk assessment cannot be entirely isolated from the appropriate level of protection.  There may be circumstances in which the appropriate level of protection chosen by a Member affects the scope or method of the risk assessment.  This may be the case where a WTO Member decides not to adopt an SPS measure based on an international standard because it seeks to achieve a higher level of protection.  In such a situation, the fact that the WTO Member has chosen to set a higher level of protection may require it to perform certain research as part of its risk assessment that is different from the parameters considered and the research carried out in the risk assessment underlying the international standard.’[67]

Following a similar reasoning, the Appellate Body went on, arguing also that the concept of scientific uncertainty is relational; scientific evidence could be sufficient for one Member, but not for another.[68] Most significantly, this interpretation of the terms ‘risk assessment’ and ‘(in)sufficiency of scientific evidence’ lends support to the thesis that terms like ‘science-based’ should not be interpreted in a narrow way that would entrust one scientific body (like EFSA) with super-powers. More concretely stated, under this manner of interpreting the text, an EU Member State could legitimately rely on a different risk assessment than the one conducted by EFSA, given its policy objective. More generally, this reading of the text suggests that in their cooperation on biotechnologies, the EU and Canada should be respectful of the controversies in science, and terms like ‘science-based’ should not be exploited to push for a deregulatory agenda.

The interpretative grid outlined in this section is not only valid for the interpretation of the term ‘science-based.’ The contextual interpretation of CETA and the WTO acquis converge in indicating that all the terms relevant to the field of GMOs policy should be interpreted so as to preserve the stringent regulatory standards of parties; the reform of EU Law was already adopted at the moment when CETA had been signed and, accordingly, this status quo should be considered as accepted by the parties. Most crucially, genuine scientific controversies should be more easily acknowledged and respected. As discussed in the previous section, the science of GMOs is still rather mixed.[69] Environmental concerns over the use of GMOs (eg the risk that the use of herbicides increases with the cultivation of certain GM crops, given that they are developed to be herbicide-resistant)[70] should be considered as pertinent issues for risk assessment. Alternatively, let us think of the shared objective to cooperate internationally on issues related to biotechnology, such as low-level presence of GMOs; in practice, this wording may have to be interpreted so as to allow a cooperation genuinely open to different views. The reference to issues, such as low-level presence of GMOs, should not be taken to imply a certain direction towards which the cooperation should go (eg the erosion of the EU zero-tolerance policy). Such a reading would contravene a contextual interpretation of the agreement (‘CETA will also not lower our respective standards’). Given the reform of the EU regulatory landscape on GMOs, which shifted back powers to the Member States, it would also be desirable that in the process of cooperation, representatives of all Member States are involved, so that different scientific issues underpinning the policy of GMOs could be equally represented. The same should be said for the participation of private actors; not only industry stakeholders should be invited to the table, but also truly independent scientists[71] and representatives of the civil society.

Given the limited scope of this article, the focus has been only on the provisions explicitly addressing biotechnologies (Article 25.2). It goes without saying that a number of other provisions are likely to be relevant in this field. The provisions of Chapter V, on Sanitary and Phytosanitary Measures will undoubtedly play a role, as well as some of the provisions in Chapter XXIV, on Trade and Environment.[72] Let me reiterate that what argued above will be relevant for the interpretation of these provisions as well.

Finally, two caveats are in order. First, while the context of the treaty unambiguously demands a reading of the provisions that is respectful of stringent regulatory standards and of the precautionary principle, the text of the treaty has been drafted in a manner that could easily place these values under stress. Article 25.2 lists as examples for issues of cooperation only issues of interest to Canada, ie a major producer of GMOs. It is unfortunate that the EU negotiators failed to include more powerful language in this text to clarify their attachment to the European values in the field of biotechnology. Reforming the Treaty text, so as to include such language, may be a desirable development.[73] Second, EU Member States, which aim to implement a conservative policy in the field of GMOs will be in a difficult position. On the one hand, CETA (but also WTO law) demands that there is some articulation of the scientific basis of their measures. As aforementioned, this does not mean adherence to the opinions of EFSA; but serious efforts should be made in showing how and what science played a role in their decisions. On the other hand, the new EU reform contains a provision prohibiting ‘conflicts’ with EFSA. As previously stated, this provision is unfortunate and at odds with the more sophisticated vision of science endorsed by the WTO Appellate Body.


6. Conclusions

Many have voiced fears that CETA will lower the regulatory standards in the biotechnology arenas. This article has shown that by following the rules on treaty interpretation, some mild optimism can be displayed in this respect. At the same time, it is plausible to expect that CETA will put pressure on the EU GMO politics. A reductivist vision of science, which has still some currency in trade-policy circles, may open-up the way to a strategic exploitation of some ambiguous terms, favouring de-regulation and anti-precautionary measures. Putting science on a procrustean bed is not only a disservice to science, but also to contemporary democracies and, even if only indirectly, also to international economic regimes. A trade regime, which would further undemocratic reforms (under a reductivist vision of science) is likely to fuel the ongoing backlash against globalization. If trade liberalization has to flourish again, it is high time to ‘re-embed’ it in the social values that many deem essential for achieving more wellbeing for all. The field of biotechnology, with its underpinning scientific controversies and with widespread opposition among citizens, will be an important test-case to observe in which direction the new generation of trade and investment agreements are going. Much will depend on how the treaty text will be interpreted. This article has demonstrated that rules on treaty interpretation offer ample margin to apply the treaty in a way respectful of stringent regulatory standards and of the precautionary principle. It remains to be seen whether this path will be followed in practice.



* Associate Professor, Erasmus School of Law, Erasmus University Rotterdam. I would like to thank Federica Violi, Jennifer Riter and the editors of the journal for insightful comments. The usual disclaimer applies.

[1] European Commission, ‘CETA Explained’ (24 January 2017) <http://ec.europa.eu/trade/policy/in-focus/ceta/ceta-explained/>.

[2] See eg M Schaake, ‘Ten Questions on CETA’ (08 February 2017) <https://marietjeschaake.eu/en/ten-questions-on-ceta>.

[3] Stacked events (or stacks), that is ‘GMOs with multiple events which have been combined by conventional crossing of GM plants with single events’, are subjected to independent approval procedures, even if the single events have been previously approved. Cf J Roïz, ‘Limits of the Current EU Regulatory Framework on GMOs: Risk of Not Authorized GM Event-Traces in Imports’ (November-December 2014) 21(6) Oilseeds & Fats Crops and Lipids 4 <www.ocl-journal.org/articles/ocl/pdf/2014/06/ ocl140037-s.pdf>.

[4] Cf Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration [2001] OJ L 106/1 (Deliberate Release).

[5] Regulation (EC) 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [2003] OJ L 268/1 (GMO Food and Feed).

[6] Cf Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ L 268/1.

[7] Cf Deliberate Release (n 4) recital 8, arts 1, 4.

[8] European Commission, ‘Fact Sheet: Questions and Answers on EU’s Policies on GMOs’ (22 April 2015) <http://europa.eu/rapid/press-release_MEMO-15-4778_ en.htm>.

[9] A Apoteker, ‘GMOs Stalled in Europe: The Strength of Citizens’ Involvement’ in S Krimskey, J Gruber (eds), The GMO Deception: What You Need to Know about the Food, Corporations, and Government Agencies Putting Our Families and Our Environment at Risk (Skyhorse 2014) 188.

[10] Cf Deliberate Release (n 4) art 5.

[11] See European Commission, ‘GMOs: EU Decision-Making Process Explained (19 July 2017) <https://ec.europa.eu/food/plant/gmo/authorisation/decision_making_ process_en> for a clear overview of the decision-making process.

[12] The Appeal Committee was preceded by the Council. For a detailed analysis of the implications of the new comitolgy rule on the EU GMO regulatory framework see C Klika, J Kim, E Versluis, ‘Why Science Cannot Tame Politics: The New EU Comitology Rules and the Centralised Authorisation Procedure of GMOs’ (2013) 4 European Journal of Risk Regulation 327.

[13] Under the new comitology rules, in case of no opinion, the Commission is not obliged to adopt the draft decision. Cf Regulation (EU) 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers [2011] OJ L 55/13, art 6(3). Regulation 182/2011 reads: ‘Where no opinion is delivered, the Commission may adopt the draft implementing act’ (emphasis added). Comitology rules have been revised with the entry into force of the Treaty on the Functioning of the European Union (TFEU) in December 2009.

[14] For an analysis of the process see M Weimer, G Pisani ‘The EU Adventures of “Herculex”: Report on the EU Authorization of the Genetically Modified Maize 1507’ (2014) 5 Eur J of Risk Regulation 208, 208-112.

[15] Safeguard measures are regulated by Direct Release (n 4) art 23, which reads: ‘Where a Member State, as a result of new or additional information made available since the date of the consent and affecting the environmental risk assessment or reassessment of existing information on the basis of new or additional scientific knowledge, has detailed grounds for considering that a GMO as or in a product which has been properly notified and has received written consent under this Directive constitutes a risk to human health or the environment, that Member State may provisionally restrict or prohibit the use and/or sale of that GMO as or in a product on its territory.’ Emergency measures are regulated by GMO Food and Feed (n 5) art 34.

[16] For a more detailed account of this process, see S Poli ‘The Reform of the EU Legislation on GMOs: A Journey to an Unknown Destination?’ (2015) 6 Eur J of Risk Regulation 559.

[17] Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards to the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory [2015] OJ L 68/1. A similar proposal for reform concerning the authorization procedure for the marketing of GMOs in food and feed has not been successful, meaning that there is a split system between cultivation and marketing.

[18] Cf ibid art 26b(3)(a-g); it is to be noted that this list is not exhaustive, but only indicative.

[19] Poli (n 16) 559 ff.

[20] See for instance the discussion by Weimer, Pisani (n 14), on how, in the assessment of Maize 1570 (also called Herculex), Member States questioned the conclusions of EFSA, by arguing that Herculex poses risk both to target and non-target species.

[21] Next to the low-level presence (LLP), contamination may occur through adventitious presence (AP). The latter case is said to happen when the GMO is not approved in any market.

[22] The formal name of Triffid is FP967. This GM variety was developed by Crop Development Centre at the University of Saskatchewan in Canada. See C Viju, M Yeung and W Kerr, ‘Zero Tolerance for GM Flax and the Rules of Trade’ (2014) 37 The World Economy (2014) 137, 143.

[23] ibid 144.

[24] Commission Regulation (EU) 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired [2011] OJ L 166/9.

[25] Cf ibid art 2. 0.1% would be ‘the mass fraction of GM material in the tested material’, see Roïz (n 3) 6.

[26] Roïz (n 3) 5-6.

[27] For a matter of stylistic readability, this article always refers to the EU, even when the correct reference would have been the ‘European Communities’.

[28] WTO, Panel Report, European Communities—Measures Affecting the Approval and Marketing of Biotech Products—Panel Report (21 November 2006) WT/DS291/R, WT/DS292/R, WT/DS293/R (EU—Biotech). Corr 1 and Add 1, 2, 3, 4, 5, 6, 7, 8 and 9, adopted 21 November 2006

[29] WTO, European Communities – Measures Affecting the Approval and Marketing of Biotech Products—Mutually Agreed Solution between Canada and the European Communities (Mutually Agreed Solution) (15 July 2009) WT/DS292/40, G/L/628/Add.1.

[30] For a complete list of issues, see Mutually Agreed Solution (n 4) 29.

[31] See eg K Bär, ‘CETA and Genetic Engineering’ in H Mertins-Kirkwood and others (eds), Making Sense of CETA: An Analysis of the Final Text of the Canada – European Union Comprehensive Economic and Trade Agreement (2nd edn, PowerShift, 2016) 55 <https://www.policyalternatives.ca/sites/default/files/uploads/publications/National%20Office/2016/09/Making_Sense_of_CETA_2016.pdf>.

[32] For a more detailed discussion of the concept of efficiency and the problems it entails as a decision-making criterion see A Arcuri, ‘Eclectism in Law and Economics’ (2008) 1 Erasmus L Rev 59 2008; this paragraph heavily draws on 76-77 of my article. (Parts of) sentences taken from this article are not in quotation marks.

[33] For a discussion of these grounds see ibid.

[34] MJ Rizzo, ‘The Mirage of Efficiency’ (1980) 8 Hofstra L Rev  641, 658.

[35] For a discussion of cost-benefit analysis in the context of risk regulation see A Arcuri, ‘Risk Regulation’ in RJ van den Bergh, A Pacces (eds) Regulation and Economics (2nd edn, Edward Elgar Publishing 2012) 303-338.

[36] Cf A Rosenthal, GM Gray and JD Graham ‘Legislating Acceptable Cancer Risk from Exposure to Toxic Chemicals’ (1992) 19 Ecology L Quarterly 269.

[37] For an early work on this issue see DG Mayo, RD Hollander (eds), Acceptable Evidence: Science and Value in Risk Management (OUP 1991).

[38] For an insightful analysis of the struggles over maintaining the ninety-day rat-feeding tests as the international standards see D Demortain, ‘Regulatory Toxicology’ (2013) 38 Controversy, Science, Technology, & Human Values 727.

[39] A Nicolia, A Manzo, F Veronesi, D Roselini,  ‘An Overview of the Last 10 Years of Genetically Engineered Crop Safety Research’ (2014) 34 Critical Reviews in Biotechnology 77; R Roberts, ‘GMOs Are a Key to Addressing Global Hunger’ Boston Globe (23 May 2004) <www.bostonglobe.com/opinion/2014/05/23/gmos-are-key-tool-addressing-global-hunger/SPlNunvLl5WjovCpXvsihJ/story.html>.

[40] S Krimsky, ‘An Illusory Consensus behind GMO Health Assessment’ (2015) 6 Show all authorsScience, Technology, & Human Values 883; A Hilbeck and others, ‘No Scientific Consensus on GMO Safety’ (2015) 27(4) Environmental Sciences Eur <https://link.springer.com/content/pdf/10.1186%2Fs12302-014-0034-1.pdf>; T Phillips, ‘Genetically Modified Organisms (GMOs): Transgenic Crops and Recombinant DNA Technology’ (2008) 1 Nature Education 213. For a journalistic overview of the scientific debate see N Abou-Gabal ‘Understanding the Controversy and Science of GMOs’ (28 July 2015) <www.huffingtonpost.com/sonimacom/gmos_b_ 7880026.html>.

[41] D Hakim, ‘Doubts About the Promised Bounty of Genetically Modified Crops’ (29 October 2016) <www.nytimes.com/2016/10/30/business/gmo-promise-falls-short.html?smid=tw-nytimes&smtyp=cur>.

[42] See, for example (Editors) ‘Do Seed Companies Control GM Crop Research? Scientists must ask corporations for permission before publishing independent research on genetically modified crops. That restriction must end’ Scientific American (August 1, 2009) <www.scientificamerican.com/article/do-seed-companies-control-gm-crop-research/>.

[43] For a more in-depth analysis of this case see A Arcuri ‘Global Food Safety Standards: The Evolving Regulatory Epistemology at the Intersection of the SPS Agreement and the Codex Alimentarius Commission’ in P Delimatsis (ed), The Law, Economics and Politics of International Standardisation (CUP 2015).

[44] For early comments on the ractopamine case see C-F Lin, ‘Scientification of  Politics or  Politicization  of  Science:  Reassessing the Limits of the  Codex Alimentarius Commission’ (2013) 15 Columbia Science and Tech L Rev 1.

[45] See Arcuri ‘Global Food’ (n 43) 90-91.

[46] See Comprehensive Economic and Trade Agreement (CETA) Between Canada, of the one part, and the European Union and its Member States, of the other part (30 October 2016) art 25.2.2(c) <http://data.consilium.europa.eu/doc/document/ST-10973-2016-INIT/en/pdf>.

[47] See Canadian Biotechnology Network, ‘From Zero-Tolerance to “Low Level Presence” Legalizing GM Contamination in International Trade’ (April 2015) <www.gmo-free-europe.org/fileadmin/files/gmo-free-europe/CBAN_International_Briefing_LLP_2015.pdf>.

[48] The partners in this initiative are the following governments:  Australia, Argentina, Brazil, Canada, Costa Rica, Indonesia, Mexico, Paraguay, Philippines, Russia, South Africa, United States of America, Uruguay and Vietnam, as reported in Government of Canada, ‘International Statement on Low Level Presence’ (7 July 2017) annex <www.agr.gc.ca/ eng/international-statement-on-low-level-presence/?id=1422037306229>. Next to States also private actors have been involved in the initiative, such as the International Grain Trade Coalition (IGTC) (<http://igtcglobal.org/index.php?id=34>).

[49] See Government of Canada, ‘Policy Model – Managing Low Level Presence of Genetically Modified Crops in Imported Grain, Food and Feed’ (7 July 2017) <www.agr.gc.ca/eng/industry-markets-and-trade/agri-food-trade-issues/technical-trade-issues-in-agriculture/low-level-presence/policy-model-managing-low-level-presence-of-genetically-modified-crops-in-imported-grain-food-and-feed/?id=1472836695032>.

[50] O Dörr, ‘Art. 31 General Rule of Interpretation’ in O Dörr, K Schmalenbach (eds), Vienna Convention on the Law of Treaties: A Commentary (Springer 2012) 529.

[51] Vienna Convention on the Law of Treaties (adopted 23 May 1969, entered into force 27 January 1980) 1155 UNTS 331 (VCLT). Several international courts, from the ICJ to ITLOS and the WTO Appellate Body have reiterated the rules of the VCLT reflect customary rules of international law; for an overview of courts and cases where this point has been reiterated see Dörr (n 50) 524.

[52] CETA (n 46) art 29.17. The first sentence reads: ‘The arbitration panel shall interpret the provisions of this Agreement in accordance with customary rules of interpretation of public international law, including those set out in the Vienna Convention on the Law of Treaties.’

[53] Article 31 VCLT (General rule of interpretation) reads as follows:

‘1. A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.

2. The context for the purpose of the interpretation of a treaty shall comprise, in addition to the text, including its preamble and annexes: (a) any agreement relating to the treaty which was made between all the parties in connexion with the conclusion of the treaty; (b) any instrument which was made by one or more parties in connexion with the conclusion of the treaty and accepted by the other parties as an instrument related to the treaty.

3. There shall be taken into account, together with the context: (a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions; (b) any subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its interpretation; (c) any relevant rules of international law applicable in the relations between the parties.

4. A special meaning shall be given to a term if it is established that the parties so intended.’

[54] WTO, Appellate Body China – Measures Affecting Trading Rights, para 399 (as quoted in Dörr (n 50) 541.

[55] P-T Stoll and others, ‘CETA, TTIP and the EU Precautionary Principle: Legal analysis of Selected Parts of the Draft CETA Agreement and the EU TTIP Proposals’ (June 2016) Study – commissioned by Foodwatch, 16 <www.foodwatch.org/fileadmin/ Themen/TTIP_Freihandel/Dokumente/2016-06-21_foodwatch-study_precautionary-principle.pdf>.

[56] G Van Harten, The EU-Canada Joint Interpretive Declaration/Instrument on the CETA (October 8, 2016). Osgoode Legal Studies Research Paper No 6/2017, available at SSRN <https://ssrn.com/abstract=2850281> or <http://dx.doi.org/10.2139/ssrn.2850281>.

[57] Letter e) of the interpretative instrument reads as following: ‘this interpretative instrument, provides, in the sense of Article 31 of the Vienna Convention on the Law of Treaties, a clear and unambiguous statement of what Canada and the European Union and its Member States agreed in a number of CETA provisions that have been the object of public debate and concerns and provides an agreed interpretation thereof. This includes, in particular, the impact of CETA on the ability of governments to regulate in the public interest, as well as the provisions on investment protection and dispute resolution, and on sustainable development, labour rights and environmental protection.’

[58] These principles are the result of seventeen years of negotiations and were finally adopted in 2007, cf Codex Alimentarius Commission, ‘Working Principles for Risk Analysis for Food Safety for Application by Governments’ (2007) CAC/GL 62-2007.

[59] These principles were agreed upon in 2003 and are now included in the Procedural Manual, Codex Alimentarius Commission, Procedural Manual (21st edn, 2013) 107.

[60] Working Principles for Governments (n 58) para 12 and Working Principles for Codex (n 59) para 11. In spite of the general recognition of the role of precaution in risk analysis, no consensus was found on including a reference to the precautionary principle in the section of risk management of the Working Principles (eg cf para 8, ALINORM01-33). For a discussion of the negotiating history of the Working Principles for Codex and questions related to the precautionary principle see C Gerstetter and M-L Maier, ‘Risk regulation, trade and international law: Debating the precautionary principle in and around the WTO’ (2005) TranState Working Paper, 018/2005, <www.sfb597.uni-bremen.de/pages/pubApBeschreibung.php?SPRACHE=de&ID=20>.

[61] L Busch, R Grove-White, S Jasanoff, D Winickoff, B Wynne, ‘Amicus Curiae Brief Submitted to the Dispute Settlement Panel of the WTO in the case of EC-Biotech’ (WT/DS291, 292 and 293) (2004) 15.

[62] Panel Report, EC—Biotech (n 28).

[63] Cf Amicus Brief (n 61) 6.

[64] WTO, Appellate Body Reports, United States – Continued Suspension of Obligations in the EC – Hormones Dispute, WT/DS320/AB/R and Canada – Continued Suspension of Obligations in the EC – Hormones Dispute, WT/DS321/AB/R (16 October 2008 – both adopted 14 November 2008) (Continued Suspension).

[65] It is beyond the scope of this article to present how the practice of risk assessment is embedded into the regulatory process. For an explanation of the origin of risk assessment see B Israel, ‘An Environmental Justice Critique of Risk Assessment’ (1995) 3 New York U Environmental L J 469.

[66] It could be argued that science-based is a concept more encompassing than risk assessment. This is because, if the negotiators would have wanted to focus on the specific practices of risk assessment, they could have used this jargon.

[67] AB Report, Continued Suspension (n 64) para 534 (emphasis added).

[68] ibid paras 685–86.

[69] See multiple references (n 40) above.

[70] For data suggesting that in the US herbicides use has increased in contrast with decreased use in herbicides in the EU see Hakim (n 41).

[71] For the problems related to the independence of scientists assessing the safety of GMOs see Scientific American (n 42).

[72] Notably, Article 24.8(2) is an expression of the precautionary principle.

[73] For techniques by which the Treaty text can be amended see F Violi in this issue.