Introduction to Global Food-Safety Law and Regulation 9789089521705, 9789089521699

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Introduction to Global Food-Safety Law and Regulation Dario Bevilacqua

Introduction to Global Food-Safety Law and Regulation

Europa Law Publishing, Groningen 2015

Introduction to Global Food-Safety Law and Regulation Dario Bevilacqua

Europa Law Publishing is a publishing company specializing in European Union law, international trade law, public international law, environmental law and comparative national law. For further information please contact Europa Law Publishing via email: [email protected] or visit our website at: www.europalawpublishing.com. All rights reserved. No part of this publication may be reproduced or transmitted, in any form or by any means, or stored in any retrieval system of any nature, without the written permission of the publisher. Application for permission for use of copyright material shall be made to the publishers. Full acknowledgement of author, publisher and source must be given. Voor zover het maken van kopieën uit deze uitgave is toegestaan op grond van artikel 16h t/m 16m Auteurswet 1912 juncto het Besluit van 27 november 2002, Stb. 575, dient men de daarvoor wettelijk verschuldigde vergoedingen te voldoen aan de Stichting Reprorecht (Postbus 3060, 2130 KB Hoofddorp). Voor het overnemen van (een) gedeelte(n) uit deze uitgave in bloemlezingen, readers en andere compilatiewerken (artikel 16 Auteurswet 1912) dient men zich tot de uitgever te wenden. © Europa Law Publishing, Dario Bevilacqua, 2015 Typeset in Scala and Scala Sans, Graphic design by G2K Designers, Groningen/Amsterdam NUR 828 ISBN 978-90-8952-169-9 (print) ISBN 978-90-8952-170-5 (ebook)

Preface The following book concerns a new, evolving and still not definite subject: global food safety law and regulation. The subject is new at least under two perspectives. On one side, it concerns a particular specific sector that, despite being connected to several issues and social interests, still presents its own specific and original features, as a sectorial system of public governance. As it is shown in the book, one of the peculiarities of food safety relies on the fact that its specificity is not exclusive or mono-dimensional, while being instead saddled between consumers’ health protection and other economic factors and stakes, such as the free trade of goods. The regulation aimed to guarantee the salubriousness of food has necessarily to consider, as part of the subject, food access and food security, the methods of food production and the various agricultural practices, and food quality. At the same time, rules concerning food safety are characterized by further peculiarities: regarding the dialectic between producers and consumers’ interests, being based on scientific findings, implying cultural and traditional insights. This makes food safety a crucial issue in public regulation, as it shows – better than other subjects do – how interests balancing works, the weight of technical and scientific evaluations in public decisions, the level of impartiality and efficiency granted to the citizens and the quality of democratic mechanisms ensured in the decision-making. Finally, as food is – as widely known – a key issue in the development and the well-being of every society, the quality of its regulation is always strategic and functional to the welfare of the people. That is why issues of jurisdiction and competence or of interests balancing are, in such a field, always complex and controversial. On the other side, global food safety law and regulation is new because it does not regard only a single, closed and united legal order. It is not simply national or European, and it is not even merely international. It is something more. Due to the phenomenon of globalization and to the interconnectedness of economies and societies – particularly evident in the food sector for the spread of the world trade of agricultural goods – also the legal system becomes global. It assumes thus a transnational impact and a universal validity or efficacy. Global law is something different from international law. It coexists with it, but it does not occur merely among States: it is above the States and through them. Notably, it has a particular reflection for national public authorities regulating socio-economic sectors in accordance to common principles and rules coming from a new global legal space. While global law presents as a very interconnected and composite discipline, entailing national laws and various branches of the legal discipline (international law, administrative law, constitutional law and so on), it is at the same time very fragmented, being constituted of several sectorial systems, sometimes communicating among one other. This makes global food safety a fundamental

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sector to be investigated. And that is why it needs to be studied as one specific subject: for its peculiarities and uniqueness, which make it an autonomous field, with a proper set of principles, rules and institutions; for being paradigmatic for other sectors, as it is one of the most developed if seen under the perspective of global governance; for the connections, which are several and deep, with other systems, suggesting possible institutional and regulatory developments in the future. For its features of novelty, the following book will be presented through an inductive method. After a brief introductory chapter indicating the main peculiar topics of food safety law and regulation, I will start the analysis, beginning with the “particular” to arrive at the “general”. Namely, I will show the main features of the subject at stake through the study of and comment on three significant study-cases, all concerning food and trade. This method will help us to find out immediately the problems and to imagine possible solutions or future perspectives. In describing and assessing thus the positive legal prescriptions, I will not proceed through systematic constructions, but through problematic expositions. Even if at the beginning the reader will find it more difficult to follow the decisions taken into account, then it will be much easier to understand the rationale, the spirit and the main features of the analysed regulatory frameworks. The empirical data are thus fundamental in order to understand the abstractions and the theories behind them. In addition, starting from the problems will help us to memorize the concepts and the definitions: the “law in action” will help us to go through the “law on books”.1 Another warning: In the following, I will dedicate a good quantity of pages and reflections to procedural and formal aspects of food safety law and regulation. In that the system is not yet complete and definite, but just an evolving, plural and disordered regime, it is mainly developing through a formal and procedural model. Nonetheless, this is all but irrelevant for the substance of food safety discipline, as the procedural and formal issues have a decisive influence on the content of the decisions on the subject at stake. Rather than studying and learning by heart all the substantive provisions about food safety, it is more useful to understand how such discipline is developed, agreed upon and implemented and who is making those decisions, as this will be common features of all the regulations at the different levels: global, regional, national or local. For this reason, I will also focus on aspects of administrative law, as food safety – being a general interest issue – necessitates a public administration to shape its content.

1

The expression is due to Roscoe Pound, who presented it – taking Tom Sawyer and Huck Finn as example – in his Law in Books and Law in Action, 44 in AM. L. REV. 12 (1910). The idea of distinguishing the two mentioned concepts makes reference to the importance of considering not only the law as it is positivized in legal texts, but also the way it is interpreted by courts and changed through its practical application.

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The book will be divided in five sections: the first one is introductory and gives a descriptive definition of the subject; the second one illustrates its main problems and characters through the study of three legal cases; the third one is a general and articulated analysis of the legal framework of food safety law and regulation, comprising the general principles, the positive prescriptions, the institutional actors and the informal bodies composing such legal architecture; the fourth chapter is dedicated to the main body of global food safety law – the Codex Alimentarius Commission – and, after the general reconstruction of chapter three, it goes back again to considering particular aspects, by deepening the analysis of the main subject of this socio-economic field of regulation; the final chapter presents some conclusion and a summary of the findings of the book. At the end of every chapter, there will be a list of recommended books and articles, which may not be mentioned in the body or the footnotes of the book: the aim is to suggest further reading for a deeper study of the subject, without making the book and its quotations too heavy and long. Acknowledgements. The idea of writing this book started with the occasion to teach at the Universitat Oberta de Catalunya (UOC). In order to prepare an on-line course on food safety I was asked by Professor Jessica Duncan to prepare the materials that I would have delivered to the students for the lessons. During all these years, since 2009, I have had the chance to work on these “lessons”, updating, refining and expanding them for the publication. This book would have never been possible, without the help, the support and the advice of few persons. First, I have to thank Jessica Duncan, who involved me in the UOC project and gave me the chance and the encouragement to do all this. Of course, I have to thank my masters, Professor Sabino Cassese and Professor Marco D’Alberti: it is more than ten years I have been working with both of them and during all this time I have been learning a lot, improving my abilities in research and writing. Finally, I have to thank my family, notably my parents, always supportive, generous and encouraging, and my beloved Tania, who is always helping me, with everything I do. This book is dedicated to her and to my mum Eugenia, for their love and their generosity. Dario Bevilacqua, July 2015

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contents

Preface Contents chapter 1

v ix

What is Global Food-Safety Law?

1 Introduction 2 The scope of food safety law in the global legal space 2.1 Food safety and its multidimensional nature: towards a general and multi-comprehensive regulation 2.2 Food safety and its extra-national nature: towards a global – as well as plural – regulation 2.3 Food safety and its interdisciplinary nature: towards a science-based and multi-disciplinary approach, performed into a public-oriented regulation 3 Conclusions

3 10 12 15

18 20

chapter 2 Global Food-Safety Law ‘in Action’: Characters, Problems,

and Future Perspectives

1 Introduction 2 The EC-Hormones case 2.1 The Case 2.2 “Based on” and “conform to” 2.3 Scientific justification 2.4 The precautionary principle 2.5 Conclusions: the effect and implementation of the DSB decision 2.6 Open questions raised by the Hormones case 3 The EC-Biotech case 3.1 The GMOs and their legal and regulatory framework 3.2 The case 3.3 The inclusion of the EU moratoria under the scope of the SPS Agreement 3.4 The interpretation of the procedural requirement of the SPS Agreement demanding avoidance of undue delay in the national authorization procedures 3.5 The interpretation of Article 5.7 and the exclusion of the precautionary principle from the SPS Agreement 3.6 The exclusion of the Cartagena Biosafety protocol to integrate or interpret WTO law 3.7 Conclusions 4 United States – Certain Measures Affecting Imports of Poultry from China 4.1 The case 4.2 The conclusions of the Panel

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29 29 33 36 38 42 44 47 48 49 58 61

64 66 73 79 80 82 84

introduction to global food-safety law and regulation

4.3 Conclusions 5 Final remarks: positive and negative elements of the global food safety system

88 89

chapter 3 The Global Legal Framework of Food-Safety

Law and Regulation and its Actors

1 Introduction 97 2 The legal framework of global food safety law and regulation 98 2.1 Principles and rationale governing food safety law 98 2.1.1 The risk analysis procedure 98 2.1.2 The precautionary principle. 104 2.1.3 Proportionality and reasonability 112 2.2 The “Joint Food Standards Programme” and the objectives of the Codex Alimentarius Commission 116 2.3 The SPS and the TBT Agreement 121 2.3.1 The SPS Agreement 121 2.3.2 TBT Agreement 129 2.4 The Cartagena Biosafety Protocol 132 3 The institutional framework 138 3.1 The Food and Agriculture Organization of the United Nations (FAO) 138 3.1.1 The Global Forums of Food Safety Regulators 144 3.2 The World Health Organization (WHO) 146 3.2.1 The International Food Safety Authority Network 151 3.3 The International Office of Epizootics and the International Plant Protection Convention 152 3.3.1 The OIE 152 3.3.2 The IPPC 155 4 Conclusions 158 chapter 4

The Codex Alimentarius Commission

1 Introduction 2 Two study cases of Codex standards: The international standard on irradiated foods and the international standard on corn 2.1 The organizational structure of the Codex Alimentarius Commission 2.1.1 The Commission and the other main bodies 2.1.2 The subordinate committees 2.1.3 The Joint FAO-WHO scientific committees 2.1.4 The National Codex Contact Points 2.2 The standard-setting activity of the Codex Alimentarius Commission

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163 167 167 169 171 178 180

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2.2.1 A global administrative procedure: features, positive issues and pitfalls 3 The legitimacy of the Codex Alimentarius Commission: values and drawbacks

chapter 5

Concluding Remarks

187 189 195

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what is global food-safety law?

1 Introduction

On April 24, 2001, a multinational corporation, having its main legal basis in the United States of America, presented a request in accordance with Article 4 Regulation 1997/258/EC to the administrative authorities of The Netherlands. It sought to have the authorization to sell in the territory of the Country – and thus also in the common market of the European Union1 – food products obtained by a genetically modified variety of corn named NK 603. The Dutch administration started an investigation on the product and informed the relevant authorities of the other Member States and of the Community, in order to make a common decision on the authorization, referring – inter alia – to the safety of the products at issue. After a cooperative administrative procedure, the European Commission finally authorized the product to enter the European market (Decision of the Commission of 3 March 2005 (2005/448/EC)). On December 10, 2003 the Appellate Body (AB) of the Dispute Settlement Body (DSB) of the World Trade Organization (WTO) issued a Report 2 requiring Japan to remove a measure against a certain kind of apple coming from the United States. Although the Japanese government based the measure on the fear of the entry, establishment or spread of fire-blight in Japan due to the treatment reserved to those kinds of apples, it was not able to justify its ban by demonstrating the likelihood of the occurrence of the alleged risk. The contested measure was considered illegitimate as it restricted the market without fulfilling the criteria required by the Article 5.7 of the WTO Agreement on the application of sanitary and phytosanitary measures (SPS Agreement), and it was resultingly inconsistent with several other provisions of the same treaty, among which were Articles 2.2 and 5.1. At its Thirty-first Session, from June 30, to July 4, 2008, The Codex Alimentarius Commission agreed upon standard n. 292/2008, approved and published in the same year.3 This applies to live bivalve molluscs and raw bivalve molluscs that have been shucked and/or frozen, and/or processed to reduce or limit target organisms, while essentially retaining their sensory characteristics. The standard gives a definition of the product, of its process and presentation. In addition, it prohibits the use of additives and regulates the use of contaminants, the hygiene practices and the labelling of the food at issue. The standard approved by the CAC is voluntary (soft law), but every member Country of the 188 composing the Organization can adopt the rules it contains and apply them – without any specific modification – inside their legal orders, so to guarantee the safety of the foods produced or imported in their territory. 1

See Articles 28-37 of the Treaty on the Functioning of the European Union (TFEU) (Consolidated version 2012): http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:12012E/TXT.

2

 Japan – Measures affecting the Importation of Apples, WT/DS45/AB/R, http://wto.org/english/tratop_e/ dispu_e/cases_e/ds245_e.htm.

3

http://www.codexalimentarius.org/standards/list-of-standards/.

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The three examples will only give a limited idea of the huge and complex framework of global food safety law and regulation. I presented different scenarios, all involving several regulatory actors and various disciplines, and all concerning – directly or indirectly – the matter of food safety: • A multinational private actor seeking administrative authorization from a national authority in cooperation with the competent institutions of a regional supranational organization in order to put on the European market a food produced with a new technology; • An international adjudicatory body deciding a dispute involving the trade interests of one Country opposed to the health protection interests of another one, and in relation to a potentially risky food product; • An international organization issuing a specific and detailed voluntary norm establishing harmonized criteria to produce conserve and sell certain kinds of food, including the parameters to perform public controls over these activities. The mentioned cases pertain to various legal insights, all constitutive features of food safety governance. We can mention the following four. First, the relation among private and public actors, therefore the dialectic between individual freedom and administrative authority: food producers are requested to respect certain norms in the production, commercialization and transportation of products, while public authorities are called to perform inspections and controls and to issue authorizations or sanctions. In this case, we have a dialectical relationship: on one side, the individual freedom of producers and operators in general, on the other the general interest of ensuring safety, actually carried out by public authorities. However, such a dichotomy is not always that clear and definite, or easy to solve; for instance when individual freedom coincides with free trade protection, which is also a general interest aimed to increase general welfare. In addition, as it will be shown later in the book, this becomes more complicated when such interests balancing involves several legal orders (national, regional, global). Second, we are witnessing the regulatory intervention of national and supranational administrative bodies, of international organizations and of international adjudicatory institutions: public authorities limiting individual economic freedom to protect safety are not only national or local, as in the process of decision the intervention of foreign, supranational or international bodies is determinant in conditioning not only the form of the proceeding, but also the content of the final act (e.g. if prohibiting or not the use of certain substances). Third, food safety governance is featured by the application of general principles of law as well as of technical and specific regulatory acts. Any kind of administrative body involved in a decision about food safety is called to respect certain legal principles: transparency, impartiality, the duty to give reason, due process, and so on. This still happens in a heterogeneous way, but, as we will see, there is a convergence in this sense. Another common feature of decision-

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making in food safety regulation is the adoption of technical specific acts: food regulation is necessarily composed of standards, technical requisites and specific limitations based on scientific demonstrations. This contributes to make public regulation more neutral and objective; at the same time, it also becomes detailed and intrusive, as discretional choices are diminished by the soundness of scientific findings. Fourth, one key element of the subject at stake is the interests balancing between the protection of health and the consumers together with the interests of free global trade and economic development. This means that the competent authorities called to make decisions in this field cannot be blind when protecting health: they need to consider competent interests, they need to make and adopt adequate, reasonable and coherent decisions, and they need to act in a proportionate way. What is, then, food safety? Can we just reduce it to the salubriousness of food products or should we consider it together with other issues? Should the competent policy-makers only aim at health protection or balance it also with other secondary interests? Are such interests always considered secondary or do they prevail – de facto – over health protection? In order to define “food safety”, it is to bear in mind that, at present, the only legal official definition of such a phrase is to be found in a Code of practice issued by the Codex Alimentarius Commission (CAC). 4 However, this is quite general and is thus not of much help. The provision reads: “Food safety – assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use”.5

The quoted definition refers then to the process of production (“when it is prepared”) and to the final act of food that is its consumption (“eaten”). In both moments it must be assured (i.e. the law and the authorities competent of its enforcement must intervene in order to guarantee such task) that no harm is caused to the consumer in accordance to the intended use of the food. In order to formulate a more detailed definition of food safety, such expression is to be further analysed both in its single terms, and in its general complexity. 4

The CAC, established in 1962, is a joint FAO and WHO Expert Advisory Committee that, under the rules of the WTO, sets global safety standards for internationally traded food products. The CAC administers the Codex Alimentarius (Latin term for “food law”), a collection of uniform and coded standards. The standards are based on reports from joint FAO and WHO bodies, for example, the Joint Meeting on Pesticide Residues. They are detailed and specific regulatory measures, with a quasi-binding force, that have a significant impact on legislation and administrations of member countries. More on Codex later on in several sections of the text and in Chapter 4.

5

Codex Alimentarius Commission, Recommended International Code of Practice General Principles of Food Hygiene, CAC/RCP 1-1969, rev. 4 (2003), p. 7.

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introduction to global food-safety law and regulation

A complete and frequently shared legal definition of the term “food” can be found in the “Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety”. Article 2 of such legal text describes “food” as: “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment”.

Similarly, Section I of the Codex Alimentarius Commission Procedural Manual defines food as: “any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs”.6

If the concept of food is linear, shared by both European and international law, and adherent to an empirical view of the matter, the term “safety”, above all in combination with food, needs more explanation. It is to note that such term – even for its etymology (from Latin, salvitas = “safety” and salvus = “safe”) – implies an idea of salvation, the protection from something harmful. This is strongly related to the concept of law, which, by establishing and structuring a social organization – a predetermined order (from which the phrase “legal order”, or “legal system”) – systematizes and describes the rights and duties of people and gives an organization to society, saving it from the unpredictable uncertainty of human passions. It is acknowledged that law is conceived to express the values of a society (“ubi societas ibi ius”) and, by ordering it – to save it – allowing all those values to find a proper, peaceful and secure combination.7 The law is thus something more than just a command, an order from an authority followed by a sanction. It actually stays in the combination of four fundamental elements: humanity, sociality, organization and compliance. Firstly, the law belongs to humans, as self-conscious and self-aware creatures, endowed with intelligence and skill to establish relations of acknowledgement with other humans. Secondly, the law always regards a plurality of individuals, as it is always born in a space signed by 6

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission Procedural Manual – Eighteenth edition, Rome, 2008, p. 18.

7

The idea of the law as a salvific order for society has been deeply studied by an Italian author named Paolo Grossi. See, in particular, L’Europa del diritto, Roma-Bari, Laterza, 2007, p. 14 and Prima lezione di diritto, Roma-Bari, Laterza, 2007, p. 8 et seq.

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pluralism and sociality. Thirdly, in order to have law, such plurality must be also organized in accordance to a predetermined and agreed upon scheme. Finally, the law is an observed order, in which compliance is not mere obedience, but conformity to shared values, to those common principles, which are the basements of society (and which in modern legal systems are normally indicated in the Constitution). Because of the mentioned plurality of values, the guarantees of safety cannot be simply implemented into authoritative rules, commands, prohibitions and interventions coming from the institutional power. Otherwise, legal protection might become arbitrariness or even tyranny. Such guarantees of safety are indeed the result of different values interpretations, of a compromise between freedom and security, of interests balancing, of cost-benefits analysis and of elaborations of scientific conquests. They also derive from programs and plans, from political commitments and public choices, and often they do not have an unambiguous application, as safety in a sector might imply risk or even damage in another. Safety implies thus a complex legal administrative intervention by public authorities, which, according to the situation and stakes involved, might be more or less intrusive, more or less protectionist, more or less free or prudent-oriented. What just mentioned about safety, as you will see, is strikingly evident for what concerns “food safety”, which does not entail only protection from harmful food but also a proportionate balance of all the issues related to its production, transportation, trade and consumption. Safety, in addition, is not to be limited to emergency interventions or to controls over hygienic standards. It should also include proactive regulation, authorization procedures and general criteria for food process. Moreover, health protection is to be reached not only by ensuring the harmlessness of food, but also if such food is wholesome and nutritious as well; not only by checking if its biological properties are altered, but also preventing and controlling it so that no potentially harmful artificial substance enters the food chain. As many other matters, which undergo public regulation, food safety implies a reasonable, fair, impartial and efficient administration. This is based on legal principles, procedural guarantees, effective mechanisms of decision, knowledge of the state of the art and public/accountable discretion in controversial choices, which the authorities are called to make in order to reach their final objective to secure the harmlessness of food. Food safety administration, however, is not simple or mono-dimensional. An interesting example to note the different forms in which food safety presents itself is the regulation of nutrition. Technical nutrition and food composition issues consist of identification, denomination and specification of: food identities; food ingredients and processes; nutrients and other components; methods of analysis and nutrient definitions; units of measures, nutrient expressions and serving sizes; nutrient labels, nutrition and health claims; and compositional standards.

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“The science and practice of nutrition depend substantially and unavoidably on good food composition data. Knowledge of the quantities of nutrients and other components in foods is essential for estimating nutrient intakes, for dietetic advice of all kinds, for all judgments about the relative healthfulness of foods, and for epidemiological research that relates indices of disease to intakes of food components”.8

Such information is also determinant for complete and fair international food safety legislation: food composition tables (FCTs) or nutrient databases (NDBs), which keep up with the concepts of modern nutritional science and with the proliferation of foods and processing techniques, are fundamental to establish regulations in order to protect the consumers’ health and information, and to avoid unfair practices in trade or technical protectionist barriers. We see thus that food safety is not simply controlling the hygienic conditions of a product, but also involves its naming, its ingredients, and the process through which it was made and the way this is all presented to consumers. As said, despite the previously reported definition of the CAC, the phrase “food safety” can assume different meanings and specifications. In addition to all the specifications we made – both concerning food and safety – it must also be distinguished from the concept of food security. The latter refers to the availability of food and one’s access to it, which is, legally speaking, all those norms facilitating, increasing and developing the right to access to food: “Food insecurity arises when people do not have physical and economic access to sufficient safe, nutritious and culturally acceptable food to meet their dietary needs”.9 Food safety concerns instead the non-harmfulness and the salubriousness of foods, with reference to methods of production, hygiene conditions and nutritional properties, and all the related interests surrounding these practices. Nonetheless, although food safety and food security relate to different aims and might produce different and even alternative policies, they often appear connected and intertwined together. A confirmation is found in the words “safe, nutritious and culturally acceptable” used in the sentence quoted right above, from IAASTD, and in the phrase “right to adequate food”,10 which both exemplify and imply that access to food must regard proper and safe food, and that a safer food may favour an easier access to it. 8

A.S. Truswell, D.J. Bateson, K.C. Madafiglio, J.A.T. Pennington, W. M. Rand, J.C. Klensin (1991), INFOODS Guidelines for Describing Foods: A Systematic Approach to Describing Foods to Facilitate International Exchange of Food Composition Data, Academic Press, 1991, Available at http://www.fao.org/ wairdocs/AD069E/AD069E00.HTM.

9

International Assessment of Agricultural Knowledge, Science and Technology for Development (IAASTD), Human Health and Nutrition. Issues in Brief, unpaged, 2009.

10

 http://www.fao.org/righttofood/about-right-to-food/en/. See also Economic and Social Council of the UN, COMMITTEE ON ECONOMIC, SOCIAL AND CULTURAL RIGHTS, Twentieth session, GENERAL COMMENT 12 (Twentieth session, 1999), The right to adequate food (Article 11) Geneva, E/C.12/1999/5, 12 May 1999, http://www.unhchr.ch/tbs/doc.nsf/0/3d02758c707031d58025677f003b73b9.

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In the following, the focus will be on food safety and the global legal institutes concerning it, namely food safety law and regulation. We can thus try to give a definition of the phrase at stake, with the warning that the following definition is to have only a clarifying meaning: A set of principles, rules, procedures and organizations aimed at protecting the consumers’ health from foodborne risks, considering all the food chain, and derivable by a chemical, physical or biological agent, while having regard also of the effects that such activity of protection may have on food-related issues, as food-trade, agriculture, the environment and culture. The matter of such regulation, however, does not present itself in an unambiguous and definite form. On the contrary, food safety can be notably described in accordance to a threefold definition: as a multidimensional, extra-national and interdisciplinary social sector. Firstly, as we have seen in the examples mentioned at the beginning of this section, food safety involves a complex, multi-sectoral and multi-dimensional nature. Its regulation does not regard only the protection of health and the salubriousness of food, food products and feed, but also concerns and influences the administration of other fields of society, such as trade, protection of consumers’ information and expectations, protection of the environment, and the development of agriculture and of food security. Coherently, the International Assessment of Agricultural Knowledge Science and Technology for Development defines agriculture – that is evidently strongly connected to food production – as a multifunctional sector: “Agriculture operates within complex systems and is multifunctional in its nature (…). Multifunctionality recognizes the inescapable interconnectedness of agriculture’s different roles and functions, i.e. agriculture is a multi-output activity producing not only commodities, but also non commodity outputs such as environmental services, landscapes amenities and cultural heritages”.11

Secondly, food safety has reached a strongly developed extra-national character: The mentioned cases showed how the policies determining what we eat are not established only at the national level. On the contrary, they are the result of a global institutional dialectic involving legislative, administrative and adjudicatory domestic and ultra-state authorities, with a significant participation of private bodies. With the globalization of trade and the European common market, rules concerning food must be common and shared in a legal space that goes beyond the State. 11

International Assessment of Agricultural Knowledge, Science and Technology for development (IAASTD), Towards Multifunctional Agriculture for Social Environmental and Economic Sustainability. Issues in Brief, unpaged, 2009.

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Thirdly, the sector of food safety cannot be regulated by private law only or simply left to the forces of the market. There is a need of norms establishing limits in the name of public interests, as well as principles and regulations determining how, when and by whom these limits can be implemented. If the matter cannot be left to the will of private subjects, it cannot also be regulated merely by authoritative decisions either. Food safety law foresees civil law limitations, prescriptions of a penal-law nature, administrative regulations, guarantees of constitutional principles, the application of international rules and a determinant contribution from social and natural sciences. Therefore, it is not only multi-sectorial and extra national, but also interdisciplinary, as it needs to rely on the contribution of several scientific disciplines. Finally, for what concerns the relevance of food safety and therefore the need for a proper regulation of such a field, some statistical and empirical data are of certain interests. A Report issued by the World Health Organization reveals that food safety problems contribute to 1.5 billion cases of diarrhea in children12 and over two million deaths every year, from contaminated food or drinking water, both in developed and developing countries. The United States Centers for Disease Control and Prevention estimates that 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths result from foodborne diseases each year in the United States.13 In addition, as anticipated, food safety is a worldwide issue: contaminated food outbreaks do not respect national boundaries and unilateral measures adopted by national governments, even with a certain level of extraterritorial effects, are insufficient to provide an effective approach to addressing the global food safety problem.



2 The scope of food safety law in the global legal space

Food safety must be identified and articulated as a matter falling under the scope of regulatory policies extended to the global legal space. Such a matter of regulation must be explained and described with reference to all the characters composing its nature: multidimensionality, extra-nationality and interdisciplinarity. The tripartition is significant in order to understand the way food safety regulation started and developed as well as to show why such a sector is strategic and paradigmatic during an historic phase that is strongly characterized by the globalization of economies and societies. The administrative regulation of economic phenomena has recently exceeded State borders in a significant way. Public law is no more only national or international – i.e. between sovereign states – but also transnational and global: “we are 12

World Health Organization [hereinafter WHO], Food Safety Programme, Food Safety: An Essential Public Health Issue for the New Millennium, 9, WHO/SDE/PHE/FOS/99.4 (1999). Interestingly, the same data are confirmed in a much more recent document: “10 facts on food safety”; http://www.who.int/features/ factfiles/food_safety/facts/en/.

13

 See CDC Estimates of Foodborne Illness in the United States, at http://www.cdc.gov/foodborneburden/.

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witnessing the emergence of a ‘global administrative space’: a space in which the strict dichotomy between domestic and international has largely broken down, in which administrative functions are performed in often complex interplays between officials and institutions on different levels, and in which regulation may be highly effective despite its predominantly non-binding form”.14 During the last years, international law faced several considerable changes. To say it better, a new extra-national law juxtaposed to the one regulating the relationships amongst national States and between these and the International Organizations. As said, such development of domestic legal institutes is strongly connected to the phenomenon of globalization and to the interdependency of the economies, for which a socio-economic globalization has been followed also by a legal one. This new legal order, however, is far from being unique, definite and positively determined; while being sectorial, fragmented and open to the interpretation and the implementation of various and heterogeneous bodies. Therefore, the global law shows in several different forms and evolves in different degrees in accordance with the worldwide development of the social sectors it regulates. For instance, we assist to two parallel phenomena: 1) The enactment of “globalized” national administrative policies, as, due to the interconnectedness of economies, more and more domestic market regulations and administrative activities have an increasing transnational impact, affecting the interests of other Countries’ citizens (e.g. of foreign companies trading in the territories of other States). 2) Consequently, such provisions need to respect common principles and not violate the main rules of other legal orders, so that also a new common global normative system tends to affirm, regulating and limiting – with internal effectiveness – determinate activities performed by national administrations. In addition, global administrative law is visible in different forms of multilevel constitutionalism, implying dialectic or dialoguing tensions between principles of different legal orders; in the development of a world ius commune in relation with many iura particularia. 15 In the consolidation of a global arena, 14

N. Krisch and B. Kingsbury, Introduction: Global Governance and Global Administrative Law in the International Legal Order, in EJIL, 17, 1, 2006, p. 1.

15

The phrase “ius commune” recalls a body of law, which formed and developed in continental Europe since the X century and until the codification of the XIX century. Such definition concerns a common law of the people, in opposition with the law(s) of the land(s), typical of the territorialization of law and connected to the birth of the national States. In a global legal space, national legal orders are to be seen as the “iura particularia”, as the local bodies of law, insisting on a particular territory and applying within its borders. At the same time and like in medieval times – although with different connotations –, a new common law is developing around the world, featured by no territorial belonging: global law. At the same time, national legal systems still persist and are connected with the former. This relation – similar to the one occurring in Medieval Europe, where local legal systems interacted with a common body of law derived from the Roman tradition – can produce a dialogue, an activity of exchange (of legal institutes, principles and rules), a dialectic or even an imposition of the ius commune over the iura particularia.

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where many actors besides States and International Organizations bargain and negotiate, thus participating to the policy-making and contributing to shape new regulatory disciplines. Food safety is the perfect paradigm of the described trend: food trade is developed at a global scale and health risks and epidemics may travel with increasing rapidity. It stems clear thus why both aspects of food production need to be regulated at a global scale or at least to be subordinated to common principles: there is the necessity of authorities ensuring the salubriousness of food products and preventing epidemics; while at the same time preserving food quality, and avoiding undue trade restrictions. The importance of food safety law has been noted by several authors dealing with the subject, among which Karin Goodburn stated: “The regulation of food safety represents a particularly important dimension of public policy for four reasons: First, few areas of public policy so directly, personally and continually affect the well-being of every citizen (…). Second, the regulation of food safety has important economic dimensions (…). Third, the Regulation of food safety has an important international dimension (…). Finally, few areas of government regulation of business have such an important cultural dimension”.16

This shows the need of a common regulation of the sector. Nonetheless, without a common world Constitution, common world Parliament and Government, and a common world Judge, and considering the cultural, political and traditional differences concerning food and its origins, the establishment of a common set of rules agreed by all the involved actors seems not feasible. Such a regulation thus cannot be centralized over only one authority and neither be crystallized into one single compulsory legal text. On the contrary, it develops as a fluid, dynamic and evolving discipline emerging from the dialogue and the bargaining among all the actors and the stakes involved in the global arena. And this is why administrative law – disciplining the use of authoritative powers in order to pursue the public’s interest – is the lens through which to analyse this subject, focusing on the methods, the principles and the organization of the policymaking procedures and measuring the impacts of such policies on individuals; and their legitimacy and fairness with reference to fundamental rights and general principles affirming in the world society.



2.1 Food safety and its multidimensional nature: towards a general and multi-comprehensive regulation

Article 1 of the European Regulation on food safety (Reg. n. 178/2002/EC) reads: “This Regulation provides the basis for the assurance of a high level of protection of human health and consumers’ interest in relation to food, taking into account in particular the diversity in the supply of food includ16

K. Goodburn, EU Food Law. A Practical Guide, Cambridge, CRC press, 2001, p. 3-4.

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ing traditional products, whilst ensuring the effective functioning of the internal market”. The Preamble of the SPS Agreement affirms “that no Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health”. Article 1 of the same treaty states: “This Agreement applies to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade. Such measures shall be developed and applied in accordance with the provisions of this Agreement”. Finally, Article 1, letter a) of the Statutes of the Codex Alimentarius Commission (adopted in 1961 by the 11th Session of the FAO Conference and in 1963 by the 16th Session of the World Health Assembly. Revised in 1966 and 2006) provides that the purpose of the Food Standard Programme is “protecting the health of the consumers and ensuring fair practices in the food trade”. As it is easily evident from the reading of the main extra-national norms concerning food safety, the regulation of this subject always appears as a combination and a balancing of various and potentially conflicting interests. The European regulation requires a “high level of protection of human health” and, at the same time, of “consumers’ interest”. The latter is indeed often implied by the former, although this is not so obvious: Inside the category “consumers’ interest” there is not only salubriousness, but also the right to be informed, the right to have personal choices, free from authority’s paternalism and the interest to accessible prices. It is intuitive that administrations empowered to make decisions over product safety are called to consider not only the need to avoid harm, but also the proportionality of any intervention in this sense, in order to avoid unduly price effects or excessive paternalism in consumer protection. In addition, such a measure should take into account the quality of the food and its origin-related characteristics (“the diversity in the supply of food including traditional products”), which might be compromised, for instance, by demanding excessive hygiene requirements to some traditionally prepared foods. In the end, it has to “ensur[e] the functioning of the internal market”, which means avoiding protectionism and undue trade restrictions, and thus encouraging free trade in the European legal space. The provisions of the SPS Agreement are similar to the European ones, although more simplified and more trade-oriented. While recognizing the right of every member state to adopt the measure it considers more appropriate in order to protect health – therefore maintaining states’ autonomy in determining the content of health policies – the treaty establishes rules applying to all those measures which may, “directly or indirectly, affect international trade”, demanding the member countries to offer a proper justification and to respect procedural guarantees for their trade-restricting acts. Here the national authorities can exercise their discretion in enacting their health regulations directed to ensure food safety, but these – in order not to affect international trade – have to be justified through consistency with established international principles and rules, as provided by the SPS Agreement itself.

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Finally, also the Codex Alimentarius presents more than one objective: it limits its main purposes to the two issues of consumers’ health and fair practices in the food trade, which – following the letter of Article 1 of the Statutes17 – appear to be put on the same level and considered in an equal fashion. However, the phrase “fair practice in the food trade” may have an ambiguous result. The term “fair” can exemplify different legal concepts. As it will be demonstrated further, here it is to be intended as legitimate, i.e. conform to the main positive international legislation regulating trade in order to avoid any unfair behaviour in the field. Moreover, this means, above all, acting in conformity with WTO law. The Codex Commission will thus issue voluntary world-wide food standards following the main task to provide the member states with legal tools to enable them to reach a high level of health protection, while, at the same time producing a harmonized regulation of specific issues aimed at avoiding unfair – i.e. discriminatory and protectionist – trade practices. The way such norm is conceived – and its importance, considering it sets the main objectives of the Organization – shows the discretion on behalf of the decision-makers agreeing to the standards, which will be called to balance, case by case, the interests of health and free trade. The main purposes pertaining to food safety are at least five and only sometimes, they appear in a harmonic combination, while often offering the occasion for interest- and norm-conflicts, which have to be solved on a case-by-case basis by the deciding authorities. The main goals can be summed up as the following: • Ensure a high level of human, animal, and plant health protection; • Protect the consumers’ interests; • Guarantee the free circulation of food and feed products and the proper functioning of the market and the economic development; • Guarantee a proper functioning and development of agriculture; • Develop and enhance legal and administrative harmonization in the field. With reference to the food safety legislation, we can affirm that on one side all the food chain is important; on the other, all the relevant factors having a direct effect on food and feed safety are also relevant. Such factors must be located in the harmonization of the legislation, in the development of free trade, in the protection of consumers’ interests and so on. Such multiplicity of purposes is to be found in the main legal source of the EU as well, the EU Treaty (TEU) and the Treaty on the Functioning of the European Union (TFEU), acting as constitutional basis for EU law and regulation. 17

“The Codex Alimentarius Commission shall, subject to Article 5 below, be responsible for making proposals to, and shall be consulted by, the Directors-General of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme, the purpose of which is: (a) protecting the health of the consumers and ensuring fair practices in the food trade”, Article 1, Statutes of the Codex Alimentarius Commission, CAC, Procedural Manual, 21st ed., Rome-Geneve, 2013, p. 4, available at ftp://ftp.fao. org/codex/Publications/ProcManuals/Manual_21e.pdf.

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Such treaties are based on the internal market, they enhance harmonization of legislation among the members and encourages free economy, as Articles 26 TFEU and 114 TFEU – among others – exemplify. At the same time, they require a proportionate balance with other social interests and civil-society rights, as shown by Articles 11, 36 and 191 TFEU, among others. The need to achieve a balance among cohabitant interests is also evident in the vertical and specific regulation of the EU law, as can be seen in the directive and regulations regarding genetically modified foods (Directive 2001/18/EC; Regulations 258/97/EC; 1829/2003; and 1830/2003), which admit the market entrance of such products but only after complex and shared preventive authorization procedures, and admitting a safeguard clause for all those States willing to enact a stricter regulation than the one adopted by the EU. Finally, similar considerations can be made with reference to the main international treaties earlier considered: the SPS Agreement is a trade agreement, with the aim to avoid protectionism. However, it also contains guarantees – though quite limited – for the States to maintain a high level of health protection. The Statutes of the CAC also provide a twofold rationale, coping with the purposes of the organization to be found in an adequate balance between consumers’ health and free trade. The relevant normative authorities and the competent executive administrations face the need to embrace a composite discipline, that is a mixed, integrated and plural regulation, involving more interests and without a clear hierarchy of the latter. This poses several problems, heightened in the global legal space, which will be treated in the following chapters: Which authority has the power to decide which interest is to prevail in uncertain cases? How is it going to decide? According to which criteria? And to whom will it respond of its decisions?



2.2 Food safety and its extra-national nature: towards a global – as well as plural – regulation

Since ancient times one of the primary needs of human beings was to guarantee safety and salubriousness of food products: “Assyrian tablets described the method to be used in determining the correct weights and measures for food grains, and Egyptian scrolls prescribed the labelling to be applied to certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine and bread”.18 With the passage of time, these norms increased, regulating production, commerce and consumption of food products. The first general law of Modern ages, adopted in Great Britain in 1860, con18

Joint FAO/WHO Food Standards Programme, Understanding the Codex Alimentarius, 3rd ed., Rome, 2006, p. 5, ftp://ftp.fao.org/codex/Publications/understanding/Understanding_EN.pdf.

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cerned the prevention from frauds related to food and drinks. Coming closer to the present time, it is notable that the development of the European Community [now European Union] law during the last fifty years has been significantly concerned with food law, above all with reference to food products’ circulation in the common market (as Dassonville19 and Cassis De Dijon20 cases exemplify). Finally, from the half of the XX century, with the creation of the Food and Agricultural Organization (FAO) and of the World Health Organization (WHO) – and afterwards of the Codex Alimentarius Commission – the issue gained an international status. At present, the food chain does not originate and end inside the national borders. On the contrary, it can be present in a disaggregated form, with a multinational development: food products can be produced in one country, transformed in another one and distributed in many others more. This finds confirmation in the increasing use of conservants, of frozen products and of processes guaranteeing a long-time expiration date and has the consequence of favouring the birth and the development of a multiplicity of food chains. Finally, the food sector is one of the most developed all over the world, above all for its economic implications, and one of the most regulated: It is “in size the first production sector in the European Union. […] According to the EU’s directorate general for Enterprise and Industry, the food industry is the third most regulated industrial sector following automobiles and chemicals”.21 Food safety is thus no more just a domestic issue, but it is rather extranational. It is to note that the regulation of such a sector is not simply or solely international, meaning it does not only refer to the relationships and the agreements among sovereign states. The evident interconnectedness of the economies and of economic regulations reveals also a transnational and a global character of the matter. Let us consider all those national administrative measures regulating the import, but also the production or the labelling, of globally traded food. For instance, there is a national proscription prohibiting the use of certain contaminants for reasons of health protection. This measure, although formally approved exclusively for that national legal order and that territory, might have a considerable effect also on the expectations of those individuals living in a Country that allows the use of those contaminants (namely the producers of that type of food, willing to import it into other Countries). At the same time, it might indirectly affect as well the rules and the criteria adopted by the regulatory agencies of that foreign nation: the competition between the two 19

Court of Justice of the European Communities (CJEC), Judgment of 11 July 1974, Procureur du Roi v Benoît and Gustave Dassonville, Case 8/74, ECLI:EU:C:1974:82.

20

Court of Justice of the European Communities (CJEC), Judgment of 20 February 1979, Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein, Case 120/78, ECLI:EU:C:1979:42.

21

B. van der Meulen – M. Van der Velde, European Food Law Handbook, Wageningen, Wageningen Academic Publishers 2008, p. 41.

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systems can be at the origin of the so-called forum shopping22 and may produce legal transplants or public reforms of the regulatory sector. It is what I call the “butterfly effect” of the law, because, due to the globalization of markets and to the interdependencies of national economies, a local or national provision in one country can generate unexpected consequences in another one.23 In addition, food safety regulation is gaining an increasing extra-national character, to be considered as part of a global legal system. Not only the globalization of local and national regulations assuming a (indirect) worldwide effect, but also common worldwide norms and regulations to be applied by domestic authorities. I already mentioned the principles of the SPS Agreement, requiring a proper demonstration and an adequate motivation of the necessity of any health-protective measure restricting the market, as well as the specific criteria contained in the standards of the Codex Alimentarius Commission. Both these types of norms can apply and be implemented by the national and local authorities of the Member Countries, producing the same effect of common and general sources of law provided at the world level. National States maintain their sovereignty, and are still free to opt out from the WTO or to refuse to abide by Codex’ voluntary standards. Nonetheless, as said, the interdependence of the economies and the advantages of developing a common global market force national authorities to observe – and sometimes slavishly reproduce – international rules, with a significant decrement in their administrative discretion. This is quite evident in food safety law, above all when the discipline of free trade enters into conflict with the national approach to protect health. In all such forms of governance, it is to be considered the resistance of national or regional authorities willing to maintain their sovereignty over the matter of food safety. That is why the regulation of this subject can present also in a fragmented way, differentiated if considered with reference to the national, regional or global level. Indeed, there is a tension among the three levels, sometimes one absorbs the other; sometimes there is a dialogue and integration; and some other times – actually rarer and rarer – there is a neat separation and distinction. The word “governance” is to be intended as an activity having the form of government, integrating acts and procedures producing an executive, administrative and regulating effect. Such governance can be then Global, Regional (supranational), national or mixed. This form of regulation is peculiar – in 22

“Forum-shopping is a specific concept of private international law. A person who takes the initiative of bringing a court action may be tempted to choose his court on the basis of the law applied there. A person starting an action might be tempted to choose a forum not because it is the most appropriate forum but because the conflict of laws rules that it applies will prompt the application of the law that he or she prefers”, http://ec.europa.eu/civiljustice/glossary/glossary_en.htm#ForumShop. The same phenomenon can occur as well as for administrative authorities, in which a company can choose to have its activity regulated by a certain administration and not by another one.

23

D. Bevilacqua, The Codex Alimentarius Commission: increasing accountability through transparency. http:// www.iilj.org/GAL/documents/BevilacquaCodex.doc.

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respect to traditional government – because it does not reproduce the classical domestic architecture founded on the tripartition of powers as illuminated by Montesquieu: it does not have a Parliament to which to give account and neither has it developed into a form of hierarchic control. It is characterized instead by a high level of cooperation, bargaining among actors, horizontal and procedural interaction between states and non-state bodies, all occurring inside decisional private-public networks. The administration of food safety appears as a form of governance that does not concern only the national Government and the local authorities, but implies the intervention of several administrative powers, that are national, global or regional. These share and exercise in a cooperative fashion the typical functions of public regulation of a sector: normative and political guidance, administrative execution, authoritative inspection and authorization procedures, discretional interests balancing and controls. The regulation of such a sector is thus no more left to the discretion of domestic authorities. However, despite the developing of common global policies on the issue, food safety still presents several problems concerning jurisdiction, competencies and discretion over a field that has strong ethno-geographical, traditional and political implications. It is thus a matter that is, at the same time, global and transnational, as well as local and connected to the territory; it is centralized and pluralistic, shared and exclusive.



2.3 Food safety and its interdisciplinary nature: towards a science-based and multi-disciplinary approach, performed into a public-oriented regulation

The discipline regulating production, trade and consumption of food has been and still is studied and informed by civil law, specifically agrarian and commercial law. Until few years ago, it was mainly (and partially still is) private autonomy and market negotiation that conditioned the offer and the consumption of agro-alimentary goods. The main guarantees and prohibitions in this field concerned the rights of the contractors and aimed to allow fair conditions and avoid abuses, fraud or damages, to regulate the farmers’ activity and to ensure good faith and fairness in the negotiations. In parallel, administrative and mainly criminal laws offered (and still offer) protection from the deviations from the main discipline, by punishing fraud, adulteration or neglectful attitudes in food conservation. It is agreeable then that for a long period “food safety has traditionally focused on enforcement mechanisms to remove unsafe food from the market after the fact, instead of a more pronounced mandate for the prevention of food safety problems”.24 With the passage of time and the development of the technological innovations in the field, however, the hygienic-sanitary norms and the civil legislation 24

FAO, Committee on agriculture, FAO’s strategy for a Food Chain Approach to Food Safety and Quality: A framework document for the development of future strategic direction, Rome, 31 March-4 April 2003, p. 2.

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revealed to be insufficient and with limited ability to enforce a proper guarantee of food safety, namely for what concerns enterprises’ responsibility and proactive consumers’ protection. New legislation was enacted and, above all in the European Union, it mainly aimed to regulate the relationship between the producers and the consumers. A new actor thus came on the scene of food safety law in addition to producers and consumers: public administrations. The codification of principles, rights, limits and guarantees was not enough to ensure a proper regulation of the matter of food safety and thus administrative authorities were called to intervene in the actual implementation of such regulatory norms; not only in case of violations, but also performing a proactive regulation of such social sector. Therefore, the matter of food safety has become a complex interdisciplinary issue, as several legal disciplines must be now considered to perform regulation over such a field. It is a “functional part of law that combines parts of several branches of law in a coherent body of law to serve its goals”.25 In the global legal space, such coherence is not to be found and the model still appears fragmented and disordered. However, the plurality of legal branches and their interaction are undeniable. This is evident both in the legal orders of national Countries and in international law. In the European system of controls on food hygiene, private operators are charged to perform and bear the responsibility for monitoring the activity of food production in their field of operation (See Articles 1, 2 and 3 of EC Regulation of the European Parliament and of the Council n. 852/2004). In parallel, the Common Agricultural Policy establishes several provisions of agrarian and civil law, which affect also food safety.26 In the United States, consumers or other individuals can use the private law remedial instrument of “class action” against harmful food producers or even against the public authorities.27 In addition, authorities’ intervention is no more only remedial (ex post), but it is required since the beginning of the food chain with a significant risk-preventive approach (ex ante): Protection of consumers’ health is to be ensured not only by sanctioning fraud, but also through agricultural plans, through authorization procedures, through support to traditional or organic agriculture, through the establishment of criteria and good practices for food production, and so on. At the same time, public authorities, when performing such proactive regulation, cannot ignore or disproportionately compress economic interests and individual freedom, but should aim to ensure a balance between market and health protection. Public intervention in food safety issues assumes relevance as a “protection of the third”, meaning that in front of a legal regime that cannot be limited only to the negotiations between the private actors of a contract, public administrations are called upon to offer general protection also of those, which are not parts of a transaction. In such protection of the third, there is a complex and 25

B. van der Meulen – M. Van der Velde, European Food Law Handbook, cit., p. 75.

26 27

For an overview, see http://ec.europa.eu/agriculture/cap-post-2013/.

An interesting case of class action against the FDA is reported by N.D. Fortin, Food Regulation. Law, Science, Policy, and Practice, Wiley, New Jersey, 2009, p. 216 et seq.

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multidimensional intervention of public bodies, which have to consider all the stakes affected, all the costs and benefits produced by their activity or inactivity, and all the knowledge and acquaintance of the matter. The new food safety law is thus distinguished from the old one, as it focuses more on risk prevention, although with different relevance if we look at the global, regional or state level of governance. And, it relies on the contribution of several scientific disciplines not only belonging to the legal sphere, but also to the social and natural sciences. As said, the public relevance of such regulation, transposed in administrative authorities’ intervention in the name of public good, has significantly increased. In order to be impartial and effective, this administrative activity must take into account common constitutional principles and the political addresses indicated by representative bodies; it must be based on sound and independent scientific consultative contributions; it must pay attention to socio-economic consequences; and it must ensure guarantees of reasonable, fair and accountable decision-making, so that the scientific disciplines involved in the regulation are not only legal, but also belong to economic and sociological considerations, and, specifically, also to the field of natural sciences. It is to note that multidimensionality and interdisciplinarity appear interwoven: to regulate such a complex matter requires not only a general, pluralistic and multi-purposed approach, but also the interaction among several scientific disciplines: administrative, constitutional, private and criminal law; socioeconomics studies; and natural sciences. Coherently, the regulation is devolved upon several actors, exemplified by the categories of producers (among which are small and big farmers as well as small and huge corporations), consumers, and administrative regulators (also composed of a multiplicity of heterogeneous subjects: state authorities, representative bodies, private actors with public functions, international organizations, independent agencies, scientific laboratories, and so on). The rest of this book will be dedicated to the study of this activity and of its actors, intervening, cooperating and agreeing on food safety laws and policies in the global legal space. As noted, the interdisciplinarity of the matter implies other problematic insights, pertaining to the administrative tools used to regulate it. Namely, as we will see, a peculiar and significant conflict concerns the tension between policies based on sound natural sciences – i.e. on scientific/ neutral conclusions – and policies informed by representative/political orientation – i.e. by precautionary/discretional approach – as alternative ways in regulating uncertain risk-taking issues.



3 Conclusions

To summarize the previous analysis, we can state that there is no legal and official definition of food safety. However, with this expression it is meant, as a significant and paradigmatic matter, the object of public global 20

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regulation. The transnational character of food and the highly developed trade of food products make it a truly globalized issue and less and less a purely national one. In addition, new scientific discoveries, innovative mechanisms of food production and the need to have laws able to follow a fragmented and complex worldwide food chain impose to have a global regulation structured as an administrative discipline of a public-relevant social sector, and involving many other legal, social and scientific sciences, useful to administer such a matter. We can thus present a functional definition of food safety law and regulation, with the warning that this does not originate in any legal text, that it is far from being sufficient to cover unambiguously such a complex sector and that in some of the legal orders involved in food safety regulation (be them statal, international or supranational), it will be declined in a different way or in a reduced version: Food safety law and regulation are composed of a set of principles, rules and procedures, applying in the global legal space and involving several different actors, aimed at protecting both consumers’ health from foodborne risks (caused by a biological, chemical or physical agent), considering all the food chain, and all food-related issues, potentially affected by such protective regulation, such as food-trade, agriculture, the environment and culture. Notably, such legal and regulatory framework can be specified and is characterized by three main features: - It involves several social sectors and responds to various purposes and stakes, which have to find integration and balanced composition. Therefore, it can be called a multidimensional or multifunctional subject. - It is extra-national: international, trans-national, supranational and global. Due to the globalization of trade and to the interdependency of societies, the sector of food safety requires a common worldwide regulation. However, this needs to respect local peculiarities – mainly connected to the origins and traditions of foods – and needs to be highly inclusive, open, impartial and democratic. By losing the traditional power balance of national States, the global legal space faces a problem of democratic deficit, as, for instance, there is no common Parliament entitled to issue global food laws. Therefore, such an extra-national matter poses problems concerning pluralistic guarantees, impartiality and democratic methods of decision-making. - Finally, food safety is a complex interdisciplinary matter. For its regulation, a heterogeneous group of scientific disciplines is involved. These form the main tools of procedural and bargain-based public regulation performed by different actors and integrated by the contribution of several legal, social and natural sciences. Such introductory presentation is useful to show the main problematic insights of global food safety law and regulation, which can be now listed as the promises for the development of this book, as the questions to be answered in the following pages. First, and concerning the substantial respect of the regulation, the main problematic questions are:

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• Which are the actually dominant purposes inspiring global food safety regulation? • Assessing the present food safety regulation and its development, what kind of substantial consequences does it have on health protection, trade, agriculture and the other issues forming it? • How fragmented and heterogeneous is the matter of food safety? That is, how much does it change depending on the actor interpreting, on the context of implementation and on the dominant culture of the place where it is regulated? Secondly, in relation to the formal and procedural aspect of the regulation at issue, the questions are: • Who and what kinds of authorities make decisions over food safety? • At which level of governance does it happen? Do the common formal requirements affect also the substance of the regulation? • How does decision-making over food safety work at the global level? Is it fragmented or united? Centralized or delegated? • What kind of principles, criteria and rules apply to establish when a food can be considered safe? How does the policy-making procedure work? • Which guarantees of democracy, fairness and impartiality are ensured in the enactment, interpretation and implementation of food safety law and regulation? • What are the advantages, drawbacks and perspectives of the present global food safety framework? In the following chapters, answers to these questions will be sought. Sometimes they will be found, some other times they will lead to other questions.

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Extra reading: On the concept of Law: R. Dworkin, Taking Rights Seriously Cambridge, MA: Harvard University Press, 1977. J. Habermas, Faktizität und Geltung. Beiträge zur Diskurstheorie des Rechts und des demokratischen Rechtsstaats (1992), translated into English by W. Rehg with the title Between Facts and Norms. Contribution to a Discourse Theory of Law and Democracy, Massachusetts, 1996. H.L.A. Hart, The Concept of Law Oxford: Oxford University Press: 1961. H. Kelsen, Pure Theory of Law (1960; Knight trans.), Berkeley 1967, Union (N.J.) 2002. J. Rawls, A Theory of Justice. Cambridge, Massachusetts: Belknap Press of Harvard University Press, 1971. On global administrative law: A.C. Aman, Administrative Law in a Global Era, in Administrative Law Review, 2002, 54, 409. J.-B. Auby, La globalisation, le droit et l’Etat, Montchrestien, 2003. S. Cassese, The Global Polity. Global Dimensions of Democracy and the Rule of Law, Sevilla, Global Law Press, 2012. J. Charney, Universal International Law, in American Journal of International Law, 87, 529, 1993. D. Esty, Good Governance at the Supranational Scale: Globalizing Administrative Law, in Yale Law Journal, 115, 2006. C. Joerges & E.-U. Petersmann, Constitutionalism, Multilevel Trade Governance And Social Regulation, Oxford/Portland, Hart, 2006. N. Krisch and B. Kingsbury, Introduction: Global Governance and Global Administrative Law in the International Legal Order, in EJIL, 17, 1, 2006; Any IILJ Working Paper of the Global Administrative Law series, at http://www.iilj.org. R. B. Stewart, B. Kingsbury, N. Krisch, The emergence of Global Administrative Law, in Law and contemporary problems, 68, 2005. J.H.H. Weiler, The Geology of International Law–Governance, Democracy and Legitimacy, in Zeitschrift für Ausländisches Recht und Völkerrecht, 64, 2004, n. 3, p. 547 ss. On food safety law: K. Goodburn, EU Food Law. A practical Guide, Cambridge, CRC press, 2001. J. Cromer, Recent Developments: Sanitary and Phytosanitary Measures: What they could mean for Health and Safety Regulations under GATT, in Harvard International Law Journal, Spring, 1995. S. Pardo Quintillàn, Free Trade, Public Health Protection and Consumer Information in the European and WTO Context, in Journal of World Trade, 33(6), 1999. R.L. Buchanan, The Development of Science-Based Food Safety Regulations in the United States, in Irish Journal of Agricultural and Food Research, Vol. 39, No. 2, Special Issue on Food Safety (2000). L.M. Wallach, Accountable Governance in the Era of Globalization: the WTO, NAFTA and International Harmonization of Standards, in University of Kansas Law Review, 2002. S. Krapohl, Risk Regulation in the EU between Interests and Expertise: The Case of BSE, in Journal of European Public Policy, 10:2, April 2003. 23

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I. Scoones, Regulatory Manoeuvres: The Bt Cotton Controversy in India, n. 1, U. of Sussex Inst. of Dev. Studies, Working Paper No. 197, 2003. T. Christoforou, The Regulation of genetically modified organisms in the European Union: The Interplay of science, law and politics, in Common Market Law Review, 2004. A.T. Guzman, Food Fears: Health And Safety At The WTO, in Virginia Journal of International Law, Fall 2004. C. Joerges, Transnational Governance and its Legitimacy Problematics: The Examples of Standardization and Food Safety, NYU, 02 February 2004, http://www.law.nyu.edu/ kingsburyb/spring04/globalization/index.html. K. Kanska, Wolves in the Clothing of Sheep? The Case of the European Food Safety Authority, in European Law Review, 2004, n. 29(5). K. Vincent, ‘Mad Cows’ and Eurocrats – Community Response to the BSE crisis, in European Law Journal, 2004, 10. D.L. Pelletier, Nutrition science and policy. Science, law, and politics in the Food and Drug Administration’s genetically engineered foods policy: FDA’s 1992 policy statement, in Nutrition Reviews, 2005 May; 63 (5). H. Rothstein, Escaping the Regulatory Net: Why Regulatory Reform Can Fail Consumers, in Law & Policy, Oct2005, Vol. 27 Issue 4. K.M. Bessel, J.E. Hobbs, W.A. Kerr, Food Safety and Private International Law Liability, Traceability and Transboundary Marketing, in Journal of International Food & Agribusiness Marketing, 2006, Vol. 18 Issue 1/2. L. Caduff & T. Bernauer, Managing Risk and Regulation in European Food Safety Governance in Review of Policy Research, 2006, N. 1, vol. 23. P. Coppens, M.F. da Silva, S. Pettman, European regulations on nutraceuticals, dietary supplements and functional foods: A framework based on safety, in Nutraceuticals and Functional Foods Regulations in the United States and Around The World Toxicology, 3 April 2006 221 (1): p. 59-74. M.A. Recuerda Girela, Food Safety: Science, Politics and the Law, in European Food and Feed Law Review, n. 1/2006. M.A. Recuerda Girela, Risk and Reason in European Food Law, in European Food and Feed law Review, n. 4/2006. J. Felce, European Union Law: packing it in, in European Food and Feed Law Review, 6/2007. S. Gabbi, The Interaction between Risk Assessors and Risk Managers, in European Food and Feed Law Review, 3/2007. A. Garde, The Contribution of Food Labelling to the EU’s Obesity Prevention Strategy, in European Food and Feed Law Review, 6/2007. A. Meisterernst and B. Haber, The Silent Revolution – Legal Overview on Regulation (EC) 1924/2006 on Nutrition and Health Claims, in European Food and Feed Law Review, 6/2007. R. O’ Rourke, Scientific Conflict, the EFSA and a Common Risk Assessment, in European Food and Feed Law Review, 4/2007. M. Rosso Grossman, Genetically Modified Food and Feed and the US National Environmental Policy Act, in European Food and Feed Law Review, 6/2007. A. Alemanno, The European Food Safety Authority at Five, in European Food and Feed Law Review, 1/2008.

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A. Alemanno and S. Mahi, The European Food Safety Authority before European Courts, in European Food and Feed Law Review, 5/2008. C. Chiarolla, Plant Patenting, Benefit Sharing and the Law Applicable to the Food and Agriculture Organisation Standard Material Transfer Agreement, in Journal of World Intellectual Property, January 2008, Vol. 11 Issue 1, p. 1-28. P.M. Desmarchelier, E.A. Szabo, Innovation, Food Safety and Regulation in Innovation: Management, Policy & Practice, July 2008, Vol. 10 Issue 1, p. 121-131. M. Ollinger, D.L. Moore, The Economic Forces Driving Food Safety Quality in Meat and Poultry, in Review of Agricultural Economics, Summer 2008, Vol. 30 Issue 2, p. 289-310. L. Rutkow, J.S. Vernick, J.G. Jr. Hodge.; S.P. Teret, Preemption and the obesity epidemic: state and local menu labeling laws and the nutrition labeling and education act, in Journal of Law, Medicine & Ethics, 2008 Winter; 36 (4): 772-89. A.F. Tagliagambe, Food for Thought: Defending the Food Purveyor When the Meal Turns Bad, FDCC Quarterly, Fall 2008, Vol. 59 Issue 1, p. 45-61. G. Winter, Nature Protection and the Introduction into the Environment of Genetically Modified Organisms: Risk Analysis in EC Multilevel Governance, in Review of European Community & International Environmental Law, 2008, Vol. 17 Issue 2, p. 205-220. A. Alemanno, The European Reform of Organic Farming – Balancing Consumer Preferences and Free Movement Imperatives, in European Food and Feed Law Review, 6/2009. A. Brack, A Disadvantageous Dichotomy in Product Safety Law -- Some Reflections on Sense and Nonsense of the Distinction Food-Nonfood in European Product Safety Law, in European Business Law Review, February 2009, Vol. 20 Issue 1, p. 173-198. M. Chilton & D. Rose D, A rights-based approach to food insecurity in the United States, in American Journal of Public Health, July 1, 2009, Vol. 99, Issue 7. F. González Botija, M.Á. Recuerda, P. Díaz Peralta, A. Martínez Cañellas, L. Roda Ghisleri, A. Lago Candeira, E. Alonso García, M.R. Martínez-Larrañaga, and A. Anadón, Legal Regulation of Risk Analysis and Genetically Modified Foods, in European Food and Feed Law Review, 4/2009. H. Haugen, M. Hans, Food Sovereignty – An Appropriate Approach to Ensure the Right to Food? in Nordic Journal of International Law, 2009, Vol. 78 Issue 3, p. 263-292. T.A. Hemphill, Globalization of the U.S. Food Supply: Reconciling Product Safety Regulation with Free Trade, in Business Economics, July 2009, Vol. 44 Issue 3, p. 154-168. T.A. Melkonyan, J. Schubert, Food Safety Regulations under Ambiguity, in American Journal of Agricultural Economics, December 2009, Vol. 91 Issue 5, p. 1389-1396. S. Negri, Food Safety and Global Health: An International Law Perspective, in Global Health Governance, vol. 3, n. 1 (FALL 2009) http://www.ghgj.org; S. Pape, “May Contain” Labelling: Adequate Consumer Warning or Unnecessarily Defensive Manufacturer Behaviour?, in Journal of Consumer Policy, June 2009, Vol. 32 Issue 2, p. 165-188. D. Pisanello, What do Food Safety and Fair Trade Stand for? Reconciling the Twofold Objective of EU Food Law, in European Food & Feed Law Review, 2009, Vol. 4 Issue 5, p. 320-328. C. Shumei, Sham or shame: Rethinking the China’s milk powder scandal from a legal perspective, in Journal of Risk Research, Sep. 2009, Vol. 12 Issue 6, p. 725-747. B.M.J. van der Meulen, Science based Food Law, in European Food and Feed Law Review, 1/2009.

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B.M.J. Van der Meulen, The System of Food Law in the European Union, in Deakin Law Review, 2009, Vol. 14 Issue 2, p. 305-339. P. Wilde, Self-regulation and the response to concerns about food and beverage marketing to children in the United States in Nutrition Reviews, 2009 Mar; 67 (3): 155-66. D. Bevilacqua and J. Duncan (2010) Towards a New Cosmopolitanism: Global Reflexive Interactive Democracy as a New Mechanism for Civil Society Participation in Agri-food Governance, in Global Jurist: Vol. 10: Iss. 1 (Advances), Article 2. L. Bracht Andersen, The EU Rules on Labelling of Genetically Modified Foods: Mission accomplished?, in European Food and Feed Law Review, 3/2010. D. Fuchs, A. Kalfagianni, The Causes and Consequences of Private Food Governance, in Business & Politics, 2010, Vol. 12 Issue 3, preceding p. 1-34. M. Gallagher and I. Thomas, Food Fraud: The deliberate Adulteration and Misdescription of Foodstuffs in European Food and Feed Law Review, 6/2010: pp. 347-35. M. Hagenmeyer and A. Hahn, Surprisingly “cheap” Health Claims for Food Supplements – By Courtesy of EFSA in European Food and Feed Law Review, 6/2010: pp. 325-340. C. Herody, Y. Soyeux, E. Bech Hansen and K. Gillies The Legal Status of Microbial Food Cultures in the European Union: An Overview in European Food and Feed Law Review, 5/2010: p. 258-269. K. Krell Zbinden, F(G)ood Advertising Practice in Switzerland, in European Food and Feed Law Review, 6/2010: p. 341-346. M. Korzycka-Iwanow and M. Zboralska, Never-ending Debate on Food Supplements: Harmonisation or Disharmonisation of the Law? In European Food and Feed Law Review, 3/2010. S. Leible, Consumer Information beyond Food Law, in European Food and Feed Law Review 6/2010, p. 316-324. B. Mayfield, Reclaiming the Rural Artefact: The Role of Aesthetics, Environmentalism and Food Security in the Emergence of the Law on Open Access, in Ben. Law & Humanities, 2010, Vol. 4 Issue 2, p. 251-273. A.L. Neacsu, M. Tofana, Food Safety Procedures and Food Law Principles in European Union, in Bulletin of the University of Agricultural Sciences & Veterinary Medicine Cluj-Napoca. Agriculture, 2010, Vol. 67 Issue 2, p. 346-351. M. Poto, Food Law under the Rising Sun – The Japanese Perspective, in European Food & Feed Law Review, 5/2010, p. 227-234. V. Rodríguez Fuentes, The Regulation of Food Risk Communication in Spain and the EU, in European Food and Feed Law Review, 4/2010: pp. 204-215. D. Sperling, Food Law, Ethics, and Food Safety Regulation: Roles, Justifications, and Expected Limits, in Journal of Agricultural & Environmental Ethics, Jun2010, Vol. 23 Issue 3, p. 267-278. B. van der Meulen, The Function of Food Law, in European Food and Feed Law Review, 2010, Vol. 5 Issue 2, p. 83-90. B. van der Meulen, The Function of Food Law. On the objectives of food law, legitimate factors and interests taken into account, in European Food and Feed Law Review, 3/2010. A. Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO, Cambridge, Cameron May 2007. B. van der Meulen – M. Van der Velde, European Food Law Handbook, Wageningen, Wageningen Academic Publishers 2008. 26

chapter 2

Global Food-Safety Law ‘in Action’: Characters, Problems, and Future Perspectives

chapter 2



global food-safety law ‘in action’

1 Introduction

In the preceding chapter, I presented the main characters composing and defining food safety law and regulation. As anticipated, the matter poses more than one problem, both for what concerns the object and the subjects of the regulation and for what regards the methods and the forms of the intervention of public bodies in this sector. Global food safety law implies administrative discretional choices concerning a twofold problematic issue: deciding what is safe to eat and to what degree it can be considered so; and establishing how to make these decisions and which actors are empowered to make them. For what concerns the way the discipline is formed, developed and implemented, the main questions are the following: Which are the objects of the regulation? Who is competent to decide on such issues? Which decisional criteria and general principles are to be applied? Which guarantees of impartiality, openness, and accountability – in one word “democracy” – are ensured in this regulatory field? With the foreword that these questions might remain open and that the matter is still evolving and highly debated, in the following paragraphs, I will deepen the aforementioned problematic issues, through a case-study approach, analysing and commenting on food safety law “in action”. This will allow a better explication and description of all the problematic insights of the matter at issue and a presentation in detail of some of its most relevant provisions.



2 The EC-Hormones case

The EC-Hormones case1 was decided by the dispute settlement body of the World Trade Organization, according to some relevant principles and rules of the SPS Agreement. In order to understand food safety law, we need to focus on the legal system of the WTO. At the beginning of XIX century, the economist David Ricardo elaborated on the “comparative advantages” theory.2 This, revised and refined through the decades, is at the origin of the world trade regulatory discipline.3 Based on the immobility of work between Countries and the perfect internal mobility, such theory affirms that the States’ work and production have a different productivity in different situations. Exemplifying: if two countries, let us take Spain and 1

 EC – Measures Concerning Meat and Meat Products, WTO Appellate Body Report 1998, WT/DS 48/AB/R (hereinafter EC-Hormones).

2 3

See D. Ricardo, On the Principles of Political Economy and Taxation (1 ed.), London, 1817.

For a deeper analysis see Chang, Ha-Joon. Bad Samaritans: The Myth of Free Trade and the Secret History of Capitalism, Bloomsbury Press, 2008; R. Findlay, The New Palgrave: A Dictionary of Economics, v. 1, p. 514-517, 1987; Hardwick, Khan and Langmead, An Introduction to Modern Economics – 3rd Edn, 1990; A. O’Sullivan & S.M. Sheffrin, Economics. Principles & Tools, 2003.

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the USA, produce two goods, for instance food and computers, with different levels of effectiveness, and they open to trade, each will specialize in producing the good it produces more efficiently and both the Countries will benefit, in the sense that they will be able to consume both goods at lower prices than those they would find in a situation of autarchy. The reasons for which the two Countries have different efficiencies in producing their goods can be various, but what counts is that whatever is the cause of such different relative efficiencies, both the Countries will have benefits from the commerce between them. Therefore, on one side, the consumers will be allowed access to a bigger variety of goods at a lower cost; on the other, the enterprises will be exposed to competition and thus encouraged to increase their efficiency. In addition, we have to consider other advantages. On one side, the role of the worldwide diffusion of ideas and technology (through commerce and foreign investments) becomes a motor for the growth of recently developed Countries. On the other, the access to foreign markets for goods produced in Countries whose economic growth is determined by exportations has often generated a rapid industrialization and gains in productivity thanks to the economies of scale. Here we just listed a few advantages, foreseen by the comparative advantages theory. Nonetheless, as it will be noted in the following, the creation of the WTO also produced drawbacks and uncertainties, either as failures of economic growth, or in terms of unbalanced conflicts between different public interests, such as the ones involving the environment or the social rights on one side and the market on the other, with the former often sacrificed to the stake of the latter, and with considerable limitations for democratic choices and social protection policies. With regard to food safety, and so health and consumers’ protection, what kind of advantages, risks, pitfalls or losses can be derived by such a trade-oriented model? The question will be addressed in what follows. The World Trade Organization was born on the aforementioned basis and philosophy, as the perfect continuation and evolution of the General Agreement on Tariffs and Trade, born years before – in 1947 – and consisting of a system of agreements aimed at the progressive elimination of custom duties, tariffs on trade and any other trade barriers. However, with the Agreements instituting the WTO, approved in 1994 and entered into force in 1995, the system, mainly for its legal insights, changed in a significant way, showing unprecedented progress and fundamental developments above all concerning the structural organization of such regulation and its coercive effectiveness inside national States. The main objective of the WTO is to “Expand the production of and trade in goods and services with the objective of sustainable development” (Preamble of the Agreement instituting the WTO, ratified at Marrakech and entered into force on the 1st of January 1995). Through the activity of the Organization and, on the basis of the Marrakech Agreements, which, besides instituting the WTO, also foresee a series of principles and common rules pertaining to different sectors of trade for the Member 30

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global food-safety law ‘in action’

States, a worldwide trade regulation was implemented. The latter is characterized by having as its main direct addressees, not the private individuals, but the public authorities. The WTO regulation is above all a regulation for the regulators, establishing limits, principles and rules for the authorities dealing with trade and its exceptions. As the controls and the limits to the enterprises trading in goods and services are concretely performed by the national authorities, WTO law provides common principles, common procedures and common rules for those authorities: requiring them to treat in an equivalent and fair fashion both the national operators and the foreign ones; demanding that if a State operates a certain tariff for goods coming from another State then it will have to recognize the same treatment to all the others; requesting that any exception to the provisions entailing the WTO discipline is equal and adequately justified and motivated. In addition to the substantial functions of the WTO – ensuring a fair, formally egalitarian and harmonized free global trade – the main, instrumental functions of the Organization consist of: guaranteeing a common consultative and deliberative forum for the Governments’ delegates of the Member Countries in order to favour the approbation of multilateral Agreements aimed at developing free global trade (Article II, Agreement Establishing the World Trade Organization); and instituting and managing a stable body to adjudicate and decide all the disputes concerning the subjects covered by the WTO Agreements (Article III, Agreement Establishing the World Trade Organization). For what concerns the first respect, the organizational structure of the World Trade Organization is quite small: the deliberative body is the General Council, which constitutes also the place hosting the ministerial meetings through which the Member States agree on norms to be adopted and on international treaties and conventions in agenda; it does not have an executive body, as the principles and norms are targeted towards States’ executive authorities; the Secretariat, empowered with administrative functions, is composed of a limited number of officer units (500). The WTO thus acts as a forum and as a deliberative body, establishing general norms in order to favour the drafting and the ratification of international treaties related to trade in goods and services on the world scale, (Articles IV – X, WTO Agreement), and contributing to the enhancement of legal harmonization of such a sector. The second instrumental function performed by the WTO concerns the adjudication of inter-state disputes related to measures and activity allegedly violating the world trade agreements in goods and services. With the “Understanding on Rules and Procedures Governing the Settlement of Disputes”, also known as the Dispute Settlement Understanding (DSU), the Member States established all the procedural norms governing dispute adjudication and instituted the Dispute Settlement Body – DSB. This is a permanent body, with functions that can be defined as quasi-judicial: they concern controversies between States with reference to the application and the interpretation of the Treaties composing the general normative body of the WTO. However, the

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formal mechanism of approval (which needs a confirmation of the decision by the General Council, through negative consensus)4 and the wide amount of discretion possessed by the bodies of the DSB in interpreting WTO law make it an ambiguous figure: partially an international court, partially a global policymaking agency. Therefore, the DSB controls and monitors the Member States, preventing them from adopting measures against the freedom of commercial transactions on a global scale. In doing so, it also gives explanations and interpretations of WTO normative provisions, often expanding and specifying their effect and the way of their implementation, thus performing also an indirect policy-making activity. The SPS Agreement, under which scope the Hormones case was decided, concerns the discipline of health protection-oriented exceptions to world trade. More precisely, the mentioned Agreement, as part of the Marrakech set of trade treaties, aims to allow every Member State to enact all the necessary measures directed to protect human, animal or plant health in a way that they would not constitute an unnecessary barrier to global free trade. The Preamble of the Agreement reads: “Reaffirming that no Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade”.

Then it continues, specifying the concept of health protection. Here, at par. 2 of the Preamble, the drafters used the word “desiring” (“Desiring to improve the human health, animal health and phytosanitary situation in all Members”). Nonetheless, with reference to health protection, the Agreement indeed provides a series of procedural and substantial norms aimed to limit and regulate national health protection policies in order to avoid any unduly negative effect on world trade. This finds confirmation in par. 4: “The establishment of a multilateral framework of rules and disciplines to guide the development, adoption and enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade” (Preamble, par. 4). 4

“When the DSB establishes panels, when it adopts panel and Appellate Body reports and when it authorizes retaliation, the DSB must approve the decision unless there is a consensus against it (Articles 6.1, 16.4, 17.14 and 22.6 of the DSU). This special decision-making procedure is commonly referred to as “negative” or “reverse” consensus. At the three mentioned important stages of the dispute settlement process (establishment, adoption and retaliation), the DSB must automatically decide to take the action ahead, unless there is a consensus not to do so. This means that one sole Member can always prevent this reverse consensus, i.e. it can avoid the blocking of the decision (being taken). To do so that Member merely needs to insist on the decision to be approved”, http://www.wto.org/english/tratop_e/dispu_e/ disp_settlement_cbt_e/c3s1p1_e.htm.

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The provisions of the Treaty thus, having as primary task the protection of commercial transactions, impose on Member States the duty to justify and demonstrate any national measure alleged as necessary to protect health. In addition, they also provide principles concerning the way such norms are implemented into the territories of the States.



2.1 The Case

At the beginning of the Nineties, the European Communities [now European Union] enacted a series of Directives against the production and import of meat treated with growth-promoting hormones, which were believed to be dangerous for human health.5 In this way, they restricted their market to goods legally produced in other Countries admitting the use of hormones (Canada and United States). The Panel and then the Appellate Body (AB) of the DSB deciding the case have focused on the criteria through which the EU restricted the free world trade for health protection reasons. The Report, issued by the AB and then adopted by the DSB, required the EU to remove their ban against hormones-treated cattle. Such measure prohibited the use of hormones and the entrance of meat so treated in the territory of the Union and, as it was not adequately justified by a scientific demonstration of the risk, it was found inconsistent with the parameters of the SPS Agreement. The latter requires the Member States intending to limit trade for health protection reasons to provide an appropriate justification based on scientific findings of a probability of risk, on which the measure is founded (Articles 2.2 & 5.1, SPS Agreement). Member States can free themselves from such a demonstration if they prove that the contested measure conforms to or is based on an international standard that is officially recognized. These are, among others, those issued by the Codex Alimentarius Commission. If the State’s SPS measure entails more restrictive criteria than the ones approved in the Codex’ standard, it should be justified through the demonstration of a risk, spotted at least in terms of statistical probability of risk (Article 3, paragraphs 1, 2 & 3). In the case at stake, the EU did not conform its measure to the standard on hormones adopted by the CAC.6 5

The first legislative act (Directive of the Council 81/602/EEC of 31 July 1981) banned the use of hormones in cattle meat breeding. The content of such Directive was then confirmed in other two legislative acts of the Council (88/146/EEC – OJ L 70 of 16 March 1988, Bull. 3-1988 & 88/299/EEC – OJ L 128 of 21 May 1988) which presented a list of the banned hormones and prohibited their use (only admitted for therapeutic or zoological use and under certain conditions) and forbade the trade of cattle meat treated with such hormones inside the Community and coming from abroad. The discipline is thus confirmed in Directive of the Council 96/22/CE of 29 April 1996 – OJ L 125 of 23 May 1996. Today, such veterinary treatment is still prohibited by Directive 2003/74/CE of the European Parliament and of the Council of 22 September 2003 – OJ L 262 of 14 October 2003.

6

Codex Alimentarius Commission, Report of the 21st Session, List of Standards and Related Texts Adopted by the 21st Session of the Codex Alimentarius Commission, ALINORM 95/37 (July 8, 1995).

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Norms of reference for the EC-Hormones case SPS Agreement, Article 3.1: “To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3”. SPS Agreement, Article 3.2: “Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994”. SPS Agreement, Article 3.3: “Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary and phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5”. SPS Agreement, Article 5.1: “Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations”. A chronological analysis of EC-Hormones At its Twenty-First Session, in July 1995, the Codex Alimentarius Commission (CAC) approved a standard concerning the maximum levels of residue for five growth promoting hormones. The decision was made after a secret majority vote and the standard was approved with 33 delegates in favor, 29 opposing and 7 abstaining.7 The European Communities opposed that standard but lost their battle. The EC considered hormones dangerous for human health,8 tackled the standard and, in the same year, enacted a restrictive regulation prohibiting the use of hormones in cattle-meat (Directive of the Council 96/22/EC 29 April 1996) for health protection reasons. This was just the beginning of a long “foodtrade war”. In 1996, the USA and Canada contested, in front of a Panel of the Dispute Settlement Body of the WTO, the European ban towards meat treated with 7

 Ibid.

8

In support of this contention, the European Union relied on the reports of both Dr. Lucier and Dr. André. According to the European Union, the evidence provided to the Panel by the majority of its own scientific experts indicated that there was a real risk of adverse effects arising from the use of the hormones at issue. On this, see EC – Measures Concerning Meat and Meat Products (further on EC-Hormones), WTO Appellate Body Report 1998, WT/DS 48/AB/R, www.wto.org, § 4.17.

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hormones.9 The Panel circulated its Reports to the Members of the WTO on 18 August 1997. The US Panel Report and the Canada Panel Report reached the same conclusions in paragraph 9.1: “(i) The European Communities, by maintaining sanitary measures which are not based on a risk assessment, has acted inconsistently with the requirements contained in Article 5.1 of the Agreement on the Application of Sanitary and Phytosanitary Measures; (…) (iii) The European Communities, by maintaining sanitary measures which are not based on existing international standards without justification under Article 3.3 of the Agreement on the Application of Sanitary and Phytosanitary Measures, has acted inconsistently with the requirements of Article 3.1 of that Agreement. In both Reports, the Panel recommended in paragraph 9.2: ... that the Dispute Settlement Body requests the European Communities to bring its measures in dispute into conformity with its obligations under the Agreement on the Application of Sanitary and Phytosanitary Measures”.10 On 24 September 1997, the European Communities notified the DSB of its decision to appeal certain issues of law covered in the Panel Reports and certain legal interpretations developed by the Panel, pursuant to paragraph 4 of Article 16 of the DSU. The Appellate Body – despite the fact that the dispute would have found a definitive diplomatic solution in 200911 – issued its final decision in 1998, ordering the EU to lift the mentioned ban on the basis that the Communities did not provide adequate scientific evidence that the hormones were actually risky for human health, as is required by the SPS Agreement (Articles 3.3 and 5.1). The latter, as noted, directly relies on CAC standards, which it considers to be sufficient to justify national trade-restrictive measures as far as they conform to or are based on them (Article 3.1 and 3.2). In the case at issue, the Codex standard, although approved only by a small majority, admitted the use of the contested hormones, so that it became particularly difficult, for the European 9

 EC – Measures Concerning Meat and Meat Products (hereinafter EC-Hormones), WTO Appellate Body Report 1998, WT/DS 48/AB/R, www.wto.org.

10 11

 Ibid., par. 6.

After several years, the creation of a new Panel and then of another appeal – concerning, inter alia, the new legislation of the EU, the new scientific findings on the effects of hormones in meat and the retaliatory measures applied by Canada and the US – a diplomatic solution was finally found. “Under the terms of the agreement, the US would agree not to impose new so-called “Carousel” sanctions, which were due to come into force this week and would affect a range of EU products including Italian mineral water, Roquefort cheese and a number of other food products. The US would maintain the currently reduced level of existing sanctions against EU products (68% or $79 million lower), and would eliminate all sanctions beginning in the fourth year of the agreement. In return, the agreement would provide additional duty-free access to the EU market for the type of high quality beef traditionally exported by the US and produced from cattle that have not been treated with growth-promoting hormones. The agreement would provide additional duty-free access for 20,000 tons of beef in the first three years, increasing to 45,000 tons beginning in the fourth year. Before the end of the four-year period, the two sides will seek to agree on the conditions for the settlement applicable beyond that period”: http://europa.eu/rapid/press-release_IP-09-707_en.htm?locale=en.

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Communities, to justify their measure, and the evidence of a generic and possible risk to contract cancer was not enough to maintain the ban.



2.2 “Based on” and “conform to”

The focus of analysis of the reasoning performed by the AB must concern the interpretation of the two phrases characterizing Article 3.1 and 3.2 of the SPS Agreement. The Panel’s interpretation, which equated the expressions “based on” and “conform to”, has been denied by the AB.12 Nonetheless, in giving a new interpretation of the phrase “based on”, the AB adopted a textual and strictly literal approach of such expression, as it finds justification only by comparing the conclusions of the Codex standards and the national measures, without stressing the legitimacy and procedural fairness of the methods to reach those conclusions. For instance, a national SPS measure may be based on the conclusions of a Codex standard, but, after a legitimate, fair and complete procedure, the competent authority may reach a different conclusion. This is what happened in the case at issue, where the EU performed an analogous evaluation on the hormones but reached a precautionary conclusion instead of a risk-taking one. This is a procedural comparative model: in the objective of enhancing harmonization, a significant range of discretion is left to Member States, whereas they are able to prove they act consistently with certain formal requirements. They have to act in transparency, they need to allow public participation, and they have to give reasons for their different decision, which has to be reasonable and proportionate. In such a way, the discretion about the content of a regulatory decision is left to national regulators, while the norms and the procedures to adopt it, as well as a preliminary phase of investigation on behalf of the CAC, are put in common and harmonized at the international level. In the European Union – as in the Codex Alimentarius Commission – the regulation of risk is based on the Risk Analysis procedure. This can be divided into three phases,13 as follows. The risk assessment is the investigative part of 12

“In the first place, the ordinary meaning of ‘based on’ is quite different from the plain or natural import of ‘conform to’. A thing is commonly said to be “based on” another thing when the former ‘stands’ or is ‘founded’ or ‘built’ upon or ‘is supported by’ the latter. In contrast, much more is required before one thing may be regarded as ‘conform[ing] to’ another; the former must ‘comply with’, ‘yield or show compliance’ with the latter. The reference of ‘conform to’ is to ‘correspondence in form or manner’, to ‘compliance with’ or ‘acquiescence’, to ‘follow[ing] in form or nature’. A measure that ‘conforms to’ and incorporates a Codex standard is, of course, “based on” that standard. A measure, however, based on the same standard might not conform to that standard, as where only some, not all, of the elements of the standard are incorporated into the measure”, EC-Hormones, par. 163.

13

Later in this text, we will notice that the phases can be extended to four. Before the risk assessment a significant stage occurs, named risk policy: through this the administrative authorities can formulate guidance for the scientific technical authorities in order to direct the scientific analysis of the risk assessment and, eventually, subordinate it to certain finalities. The matter will be deeply dealt infra, chapter 3, Section 3.1.

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the proceeding and it is normally characterized by a scientific approach in order to ascertain the risk and to calculate its entity. Afterwards, there is the phase of risk management, in which the relevant authorities have to make a decision based on the preceding risk assessment. This moment implies a discretionary power of the authorities, as well as their accountability. In this step, the administration decides which policy is to be adopted and the scientific results are only one of the aspects influencing the decision. In addition, public authorities may be entitled (as happens in the EU law) to adopt the precautionary principle – if all the conditions for its application occur. The final step concerns risk communication, when the entity and the probability of the risk – together with the measure adopted to face it – are explained to the public. In the case at stake then we have two administrative measures, one regional/ supranational, one international, both based on analogous scientific risk assessments. What made the difference, as noted, is the management phase: the Codex one followed a risk taking approach, while the EU followed a precautionary one. The AB, by requiring a strong identity between the concluding acts and by not limiting the evaluation at the formal procedure to perform the final measure,14 retains a notable strength in the standard of review on such issues: Here an adjudicative body, by comparing two administrative-like measures, performs an assessment of the substance and the content of those measures, which are acts reserved to an executive body, in this case also belonging to a different legal order. Although the evaluation referred to scientific justification, it compared two different measures, which, in front of scientific uncertainty and debate, were only based on science, while being instead both discretionary, and directed to different conclusions. As noted, the definition provided by Article 3.1 can receive a more deferent approach, essentially procedural. For instance, the DSB could require that the national measure follows an analogous approach rather than the one adopted by the CAC, basing its proceeding on the results reached by the latter, ensuring all formal and procedural guarantees and the adoption of a proper sciencebased method of investigation. In such a way, an alternative conclusion might be considered legitimate, independently by any substantial or value-related consideration. In order to justify the adopted measure as “based on” an international standard, the State would have to prove that the adopted measure is not in contradiction with the compared one, for instance, providing three preliminary steps: 1. There has been input, like a proposal, coming from the Codex standard; 14

The determinant weight given to the scientific results in order to establish if a measure is legitimate switched the review on substantial, rather than procedural, mechanisms of decision-making. Here the AB did not question if the EU based its measure on scientific studies, but they contested the quality of those studies, allegedly not being able to determine a probability of risk. Formally, the EU performed the required scientific investigations but due to the uncertainty of those studies, opted for a precautionary decision. Therefore, the procedure under which the measure was adopted is not in question, while the substance of it has been considered unjustified as not sufficiently scientifically grounded.

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2. All the relevant aspects of that promise have been analysed and scrutinized in depth; 3. A different provision has been reached through an alternative interpretative process, but following all the criteria of a common procedural decisionmaking form and with due motivation. This would render a national measure that does not show legitimacy or reasonability flaws consistent with the standard and, thereby, also to the SPS Agreement. However, the AB chose a different approach and considered the EU measure inconsistent with the CAC’s standard. It demanded the EU to justify it under the provisions contained in Articles 3.3 and 5.1, that is by giving a scientific justification to the necessity of the more restrictive measure. Following such logic, the regulatory measures that are more restrictive than international standards are only justifiable by reference to objective findings about risk. This, as evident, may cause several difficulties in uncertain cases, when it is not possible to offer objective findings or a reasonable forecast about risk, like for hormones in cattle meat, where the CAC issued a standard that was merely based on science, but which was approved after a long negotiation, and considering political implications. In addition, it empowers a legal adjudicative body to pronounce on scientific or political questions (if hormones are dangerous or if it is worth running the risk); however, it should only dedicate itself to interpreting the correct application of the norms, without interfering with the substance of national decisions.



2.3 Scientific justification

As the EU could not rely on the CAC’s standard to justify its measure, it had to conform to Article 5.1 of the SPS Agreement and thus provide an adequate risk assessment sufficient to demonstrate the necessity of their measure through the identification and evaluation of a risk, at least determined in terms of probability. In order to perform such a demonstration, under WTO law, the trade-restricting Parties are required to give a scientific demonstration of the probability of risk occurrence and so also of the necessity of their intervention. The scientific demonstration of risk as the base and rationale of neutral and sound administrative decisions is one of the main and most peculiar features of the SPS Agreement. The requirement is evident by the reading of Article 2.2: “Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence (…)”.

Such a strict requirement can be avoided, as seen, by the conformity to an international standard. Notwithstanding, whereas a standard is lacking or a Country wants to adopt a more restrictive measure, the scientific justification

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is a necessary element of any justificatory motivation. States can adopt their restrictive measures, even with a stricter approach than the one chosen by the related International Organizations, but they must justify them through the risk assessment procedure provided by Article 5.1. This, however, necessitates that it be based on scientific principles and scientific evidence, in order to conform to Article 2.2 and to undergo an objective and neutral scrutiny by the DSB in case of complaints. Thus, by giving an evaluation and a judgment of such scientific justification, the adjudicative bodies of the WTO can be called to check the reasonability and the necessity of the measure, in accordance with a scientific and probabilistic discourse. The described mechanism of review can be defined as a reasonability test, as it measures the rationale and reasonableness of the SPS measures. However, it is mainly based on scientific evaluations. The logic of the requirement foreseen by Articles 2.2 and 5.1 of the SPS Agreement is quite evident: as health measures concern the risk of harm to human beings, animals or plants, these cannot be simply conjecturized; they need to be proven. In order to perform such a demonstrative task, scientific principles and study results must be particularly feasible and reliable. Above all because, supposing the neutrality of science, they allow decision-making based on objective findings and not on an arbitrary or capricious orientation. Nonetheless, the solution found in the SPS Agreement raised several criticisms, for two main aspects: first, the scientific evaluation severely restricts the discretional and political policy-making of national authorities, undermining the will of representative bodies; second, scientific studies are, above all at present, less and less sound and objective in determining and predicting consequences or justifying policies. Notably, the mechanism can be evaluated under two perspectives: 1) On one side, if scientific data are sound and objective, the adjudicatory body is called merely to evaluate the legitimacy of the scientific methods and to scientifically test if they are reliable enough to justify the measure. This allows enough deference to the discretion of national authorities, as their administrative/political decisions are not under scrutiny. The judicial evaluation, instead, is merely formal. 2) On the other side, when scientific information and knowledge are uncertain or inadequate, they cannot be strictly separated from the administrative/ political choice, which indeed entails a discretional and interest/balancing approach and the will to take or avoid risks. In this way, the scrutiny becomes quite invasive as it extends also to the discretion of national authorities. In addition, it is notable that the SPS Agreement is the only treaty of the ones composing the WTO legal framework which requires such a demonstration even for non-discriminatory and logically coherent national measures.15 15

“The SPS Agreement is the only WTO instrument that imposes on WTO Members the obligation to base their measures on scientific evidence, regardless of whether the measures are discriminatory or viola-

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The role of science has been particularly significant in EC-Hormones as well as in other SPS disputes such as the Appellate Body’s decision in the case “Australia – Measures Affecting Importation of Salmon”.16 In EC-Hormones the AB, while stressing the interpretation of the risk assessment required by Article 5.1 of the SPS Agreement in order to justify the hormones ban of the EU, gave a clear indication of the risk to be proven, demanding “an ascertainable risk: if a risk is not ascertainable, how does a Member ever know or demonstrate that it exists?”. Later it added: “theoretical uncertainty is not the kind of risk which, under Article 5.1, is to be assessed”.17 As it was also specified in the “Australia-Salmon” case, the risk assessment procedure must consist of the following three steps: (1) identification of the diseases and possible biological and economic consequences of their entry or spread; (2) evaluation of the likelihood of entry, establishment, or spread; (3) evaluation of the impact of SPS measures on the likelihood of entry, establishment, or spread of the diseases.18 What is important to note is that there must be a “rational relation” between the assessment of the risk and the adopted measure: this means that the scientific demonstration of the risk and its relative evaluation are decisive for the justification of the measure, more than any other relevant factors not directly related to the probability that the risk occurs. The moment of risk assessment must thus consist in an evaluation of an ascertainable risk, at least in terms of probability. Coherently with this reading, the Annex A 4 of the SPS Agreement uses the word “likelihood”, defining Risk assessment as: “The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences”.

In EC-Hormones, the rigid scientific requirements, demanded by the SPS Agreement in order to justify health-related trade barriers, have proven to be unsatisfying. In the examined case (as well as in the others ruled under that treaty) the DSB did not consider the reasonability and the formal legitimacy of the EU decision, but mainly the scientific reports it provided. So far, science has seemed to be the most effective instrument to ensure objective control by global bodies and tions of other basic provisions of GATT. This extra obligation in fact imposes a higher justificatory burden on all WTO Member States wishing to protect themselves (…) and at the same time makes it easier for potential complaining parties to challenge them”, R. Howse and P. Mavroidis, Europe’s evolving regulatory strategy for GMOs – The issue of consistency with WTO Law: of Kine and Brine, in Fordham International Law Journal, 2000, p. 4-5. 16

Report of the Appellate Body, Australia – Measures Affecting Importation of Salmon (hereinafter “Australia-Salmon”), WTO Doc. WT/DS18/AB/R (October 20, 1998), available at: https://www.wto.org/ english/tratop_e/dispu_e/cases_e/ds18_e.htm.

17

 EC-Hormones, par. 186.

18

 Australia-Salmon, par. 121.

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to justify national regulations. Moreover, this is confirmed by a significant part of the legal narrative, for which technical evaluations have always been considered as neutral judgements, free from outside interests’ influence. However, it is to consider that science has its limits: 1) First, it can be uncertain, as many sectors are still unexplored, unknown and debated. Several times scientific studies were not able to give objective answers; 2) Second, science can be wrong, as many scientists can make mistakes, evaluate partially a phenomenon and forget to consider variables. Also in such cases, scientific studies may not be able to give objective answers; 3) Third, it can be “myopist”, as scientists can make predictions for a short period but are often not able to see in the long run. In those cases, scientific studies may not be able to give definitive answers; 4) Finally, science can be biased: the huge financial and organizational resources necessary in scientific research can have the effect of encouraging outside pressure or corporate influence, so making scientists lose their research objectivity. In many fields of regulation science has often demonstrated that it is unable to assure an objective and univocal response to legitimize a common uniform policy, and to solve the doubts between safety and risk: “A risk assessment is conclusive proof that the risk will be x, and only x, when the study is designed in a specific manner, but it is not irrefutable proof that other scientific theories leading to different assumptions about risk are wrong”.19 In such a way we thus assist the formation of a science policy, i.e. a mechanism of decision performed by experts, who, facing uncertain solutions are required to discretionally choose among more than one possible solution: “The state of knowledge in a given area is often so limited that risk assessors are forced to choose among alternative models or inputs by following rules that take into account considerations other than science. These rules are science policy”.20 19

A. Herwig, The Precautionary Principle in Support of Practical Reason. An Argument Against Formalistic Interpretations of the Precautionary Principle, in C. Joerges & E.-U. Petersmann (eds.), Constitutionalism, Multilevel Trade Governance And Social Regulation, Hart Publishing, Oxford, 2006, p. 318.

20

D. Milijkovic, Sanitary and Phytosanitary Measures in International Trade: Policy Considerations vs. Economic Reasoning, in International Journal of Consumer Studies, 29, 2005, p. 285. On this, see also J. Tickner, C. Raffensperger, N. Myers, The precautionary principle in Action: A Handbook. 1st edition. Science and the Environment Health Network, p. 14-15: “Risk assessments are susceptible to model uncertainty. Current risk assessment is based on at least 50 different assumptions about exposure, dose-response, and extrapolation from animals to humans. All of these have subjective and arbitrary elements. As a result, the quantitative results of risk assessments are highly variable. The European Union recognized the limitations to risk assessment assumptions in its European Benchmark exercise in hazard analysis. (M. Contini, et al., Benchmark Exercise on Major Hazard Analysis, EUR 13386 EN Commission of the European Communities, Luxembourg, 1991). At the same time, current risk assessment leaves out many variables, especially multiple exposures, sensitive populations, or results other

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By requiring a science-based burden of proof to the importing Country, the SPS Agreement underestimates the effect of scientific uncertainty and the incapability of science to give objective answers to new problems. This has also the effect of decreasing national authorities’ discretion and people’s sovereignty in their national territory: The described interpretation also exemplifies the intrusiveness of the DSB decisions into national health measures. Also for sensitive issues such as the environment and health, where certain countries traditionally endorse a precautionary approach, trade-restrictive measures must be justified according to a highly demanding, reasoned motivation, based on scientific objective findings, even when the latter are unreliable for science’s inadequacy.



2.4 The precautionary principle

In the decision of the EC-Hormones case, the AB also refused the justification of the European Communities relying on the precautionary principle. This is to be defined as that principle of action by which public authorities can justify prudential measures relying on scientific uncertainty and on the possibility that a risk occurs.21 The Appellate Body did not deny – in abstract – the inclusion of the precautionary principle into the SPS Agreement, although not explicitly recalled by the Treaty. Moreover, it stated that the principle is not only embodied by Article 5.7 – which was not invoked by the EU in the case at issue and admits prudent temporary measures, when the scientific findings are insufficient to perform a risk assessment – but it is also reflected in Article 3.3, as every member state can decide its own level of health protection, even if more trade restricting than what has already been established in an international standard. As it was stated, Article 3.3 “defines ‘scientific justification’ as being based on ‘an examination and evaluation of available scientific information’. This definition seemingly endorses an implied precautionary approach as it does not require ‘conclusive’ scientific justification for a particular measure, but only a risk assessment based upon current science”.22 The AB, however, excluded the application of the principle in the case at issue, stating that it could not override the science-based risk assessment of Article 5.1. The judges declared:

than cancer. It does not adequately take into account sensitive populations, such as the elderly, children, or those already suffering from environmentally induced diseases. It rarely looks at effects other than cancer, although many environmental health problems involve respiratory disease, birth defects, and nervous system disorders. Risk assessment is designed to analyze linear response (more exposure leads to more harm) and is stymied if this is not the case”. 21

A better detailed definition of the principle will be given later on in Chapter 3.

22

R.D. Thomas, Where’s the Beef? Mad Cows and the Blight of the SPS Agreement, in Vanderbilt Journal of Transnational Law, March 1999, p. 4.

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“The precautionary principle indeed finds reflection in Article 5.7 of the SPS Agreement. We agree, at the same time, with the European Communities, that there is no need to assume that Article 5.7 exhausts the relevance of a precautionary principle. It is also reflected in the sixth paragraph of the preamble and in Article 3.3. These explicitly recognize the right of Members to establish their own appropriate level of sanitary protection, which level may be higher (i.e. more cautious) than that implied in existing international standards, guidelines and recommendations. Thirdly, a panel charged with determining, for instance, whether “sufficient scientific evidence” exists to warrant the maintenance by a Member of a particular SPS measure may, of course, and should, bear in mind that responsible, representative governments commonly act from perspectives of prudence and precaution where risks of irreversible, e.g. life-terminating, damage to human health are concerned. Lastly, however, the precautionary principle does not, by itself, and without a clear textual directive to that effect, relieve a panel from the duty of applying the normal (i.e. customary international law) principles of treaty interpretation in reading the provisions of the SPS Agreement. We accordingly agree with the finding of the Panel that the precautionary principle does not override the provisions of Articles 5.1 and 5.2 of the SPS Agreement”.23

The Member States’ discretion is to be always justified by a scientific and specific demonstration of the likelihood of an ascertainable risk. With this reasoning, the Appellate Body excluded the application of the principle as an exception or integration to the risk assessment phase, implying the necessity, for the importing party, to demonstrate scientifically the likelihood of a risk and a rational relation between this one and the contested national measure. The AB thus excluded the possibility of endorsing a precautionary approach in the phase of risk management (not sufficiently objective to justify trade restrictions). The AB required a rational relation demonstrated in the risk assessment, denying discretion to the risk-managers and unifying the two phases: when it stated that “it is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the actual potential for adverse effects on human health in the real world where people live and work and die” (par. 187). This is so that, in front of the Court, the discretional phase of management could not be used to justify a measure, being absorbed by the scientific evaluation of risk. Finally, the adjudicatory body stated that in theory the precautionary principle could have been considered as customary international law or as a general principle of international law. This argument was strongly sustained by the EU, but the AB denied such status to the principle at issue: “The status of the precautionary principle in international law continues to be the subject of debate among academics, law practitioners, regulators and judges. The precautionary principle is regarded by some as having crystallized into a general principle of customary international environmental law. Whether it has been widely 23

 EC-Hormones, paras. 124-125.

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accepted by Members as a principle of general or customary international law appears less than clear. We consider, however, that it is unnecessary, and probably imprudent, for the Appellate Body in this appeal to take a position on this important, but abstract, question”.24

The requirement of a causality link between an ascertainable risk and the SPS measure implies a preventive approach, rather than a precautious one. The preventive principle allows public authorities to adopt prudent measures to prevent dangers and it relies on the demonstration of a probability of a risk, assuming the availability of a sufficient amount of science to identify and evaluate a risk. This shows that although national states are free to adopt a prudent approach towards the protection of health, they are not entitled to adopt a precautionary one, as they are still required to provide a scientific demonstration based on a probable risk with the prevalence of science over discretion, even in cases of scientific uncertainty and risk possibility.



2.5 Conclusions: the effect and implementation of the DSB decision

Despite being condemned by the AB, the EU did not remove its ban on hormones, refusing to comply with the final decision of the DSB. Notwithstanding, the Report of the DSB obtained indirect enforcement through retaliatory measures by the USA and Canada, consented to by the DSB itself, namely, by the application of Articles 21 and 22 of the DSU. Article 21.1 reads: “Prompt compliance with recommendations or rulings of the DSB is essential in order to ensure effective resolution of disputes to the benefit of all Members”.

Article 22.2 states: “(…) If no satisfactory compensation has been agreed within 20 days after the date of expiry of the reasonable period of time, any party having invoked the dispute settlement procedures may request authorization from the DSB to suspend the application to the Member concerned of concessions or other obligations under the covered agreements”.

International adjudicatory bodies, as the one settling the disputes at the WTO, have always had the problem of sanctioning and enforcing their decisions. The DSB’s reports, however, concerning economic damages affecting member countries (Canada and the USA complained that the EU measure damaged their meat exports) can be enforced through the application of (normally forbidden) tariffs or duties for the amount of the estimated damage. The loss suffered by a protectionist measure can be quantified by a Panel and then compensated for 24

 Ibid., par. 123.

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by extraordinary and retaliatory protectionist measures against the condemned Country. This form of sanction – that grounds on authorized and embedded retaliatory measures – is a strong deterrent for Member States, as the latter joined the Organization in order to enjoy the economic advantages of the free market and in this way they would lose any eventual advantage derived from protectionist derogations. This mechanism of sanction proves to be a significant compulsory system to force members to abide by DSB decisions and WTO norms. This is why WTO law is not only formally binding over sovereign Member States, but it is also enforceable in their territories and protected by sanctions in case it is violated. In the EC-Hormones case the European Communities and their Member States did not modify their legislation, which forbade and still forbid hormones, but they had to pay sanctions for this decision. Their decision not to respect the DSB decision, using their sovereign force, was punished by a specific Panel, which allowed the States that won the dispute to adopt retaliatory measures to compensate for their loss. Although the question is still debated in jurisprudential literature, it may be stated that in order to have law, there is no need of a sanction, as this only concerns a hypothetical moment, related to its violation (there can be law, even without and even before the sanction). Nonetheless, the disposal of effective legal tools for enforcing decisions and prescriptions (besides being a significant deterrent for States failing to conform to international law and using their sovereignty as a shield not to put in conformity their regulations) gives them effectiveness also inside States’ territories and reflects a new feature of extra-national law. This is not merely a law for and between sovereign and independent States, as it is able to penetrate them, forcing national authorities to adapt their regulatory measures to WTO law, even when their internal measures should have only domestic effectiveness. And, this consequently has a quasi-direct effect for the individuals. The described punishable mechanism gives a new force to an international law that is not only and no more formally binding as well as not only directed to national governments, but it is also able to penetrate and condition national sovereignty and to impose upon domestic authorities. In addition, the mere fact that a Country can agree to pay – compensating the losses of the sanctions with the gains of the violation, or simply because it can afford it – does not deny the effectiveness of the norms at stake and of the sanctionatory mechanism applying in case of their violations. The examined decision helps to focus on three relevant insights concerning global food safety law and regulation. Firstly, the executory force of DSB decisions and of WTO law in order to implement common rules for globalized phenomena. This shows how certain domestic regulatory policies no longer are exclusively left to the authority of national States. The latter are legally bound as they ratified an international treaty and have to abide by the decisions of an international adjudicatory body, which interprets and applies legitimate principles and rules affecting also

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internal administrative activity. However, extra-national decisions inevitably affect also the political orientation of sovereign Countries in that field, as well as the substance of all the related executive policies. Nonetheless, at the same time, national measures also have a relevant impact on foreign legal orders: the EU ban affects the economic expectations of North American meat producers – and indirectly also of their consumers – suffering higher prices for the alleged undue competition of EU meat producers; and this might also imply significant pressure over the North American domestic administrative regulations. On the other side, also the lasseiz faire-oriented regulation of Canada and the USA might affect both the EU producers, suffering alleged undue competition by producers using hormones, and the EU consumers, running an alleged risk in having in their food market products treated with potentially dangerous substances. Secondly, the DSB presents as a sectoral adjudicatory body relying on a sectoral treaty. EC-Hormones is the typical food-safety case as it relates to a multidimensional and complex matter. Such a dispute has not been solved by a generalscope world court, but by a “trade dispute settler”. This results in a significant prevalence of trade interests and rationale over any other connected issue, such as protection of health or the environment. Here we have not only a conflict between States but also between social sectors, between different competing public interests. And the composition and the balancing of such stakes involved is not performed following the democratic will of a world demos (made impossible by the lack of a world Parliament and by the fragmentation of the global society), neither following a teleological hierarchy, nor predefined constitutional rationale (both impossible by the lack of a world Constitution), but mainly through the rules of a trade agreement interpreted by a trade adjudicative body. For the way the global legal space is conceived, the factually strongest interests tend to prevail. This regards globalized public interests, national States’ interests, and corporate and private ones. For what concerns the Hormones case and the WTO, we witnessed the so-called “spill-over effect”, a typical phenomenon of global law. With the fragmentation of global law in the regulation of a multidimensional sector, we see that one interest, system or policy tends to prevail over other competing values and interests, compromising the impartiality, as well as the legitimacy, of such regulation: “Legitimacy may be derived from consent (…). However, consent is a problematic source of legitimacy for the WTO. In particular, it does not adequately address critics who fear that when states have consented to delegate some of their sovereign power to the WTO to act in the domain of international trade, the consent has, in fact, spilled over to a far wider range of social concerns, such as health and safety issues”.25 25

P.M. Gerhart, The two constitutional visions of the World Trade Organization, in University of Pennsylvania Journal of International Economic Law, Spring 2003, p. 3 et seq.

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However, this seems to be a structural problem of global regulation: “The paradox of modern societies is that most interests, values, and systems are irreducibly opposed to each other: economy versus society, capital versus labour, France versus Germany. They cannot be integrated into some synthetic unity”.26 Finally, the scope of the DSB decisions. We noted the legal force of DSB decisions but their scope has a considerable relevance as well. Through the recall of international standards and through a review, which embraces the substance of national measures, WTO law affects not only the legitimacy and fairness of States’ regulatory policies but also the political, technical and cultural insights they imply. This, as seen, constitutes a controversial issue for the interpretation and application of substantial international standards (like the ones of the Codex), and for the allocation of the burden of proof when scientific knowledge is insufficient to neutralize food safety policies. The decisive role played by global adjudicative bodies, despite the necessity to interpret and develop the evolving common global law, also risks entailing a significant imbalance among institutional powers, evident in the trespassing of the executive’s competences by the judiciary, and in the general weakness of the legislative. All three issues are then significant for national substantial food safety laws and regulations: these are influenced and shaped by global laws, either general principles of the SPS, or concrete standards of the CAC. The role of science is determinant in orienting the policies, which, because of a factual prevalence and of a spill over effect, tend to follow a trade-oriented policy.



2.6 Open questions raised by the Hormones case

In addition to the analysis of the case, EC-Hormones is useful to raise some further questions, which can have more than a legitimate answer and are going to be left open. 1) We noted that the quasi-judicial interpretation of the DSB has a strong and significant impact over domestic regulations and in general over institutional choices. The main point is: who decides? The decision pertains to the DSB, which, as noted, followed the texts of an international legitimate Agreement. However, some of its provisions can be subject to different interpretations. International customary law might overcome other ones. Therefore, the discretion of the DSB is very important for the allocation of institutional and regulatory powers. From this, we can derive some possible questions: Should choices over the regulation of food-safety be left to democratic political processes, technocratic ones, or market forces? If the choice is to be left to democratic processes, which ones should they be? Instead, if the decision were left to the DSB, would it be reliable and accountable? Should it be accountable or independent? How much can the DSB decide with reference to the substance of the regulation? 26

D. Chalmers, Deliberative Supranationalism and the Reterritorialisation of Authority, comment to C. Joerges, Rethinking European Law’s Supremacy, EUI Working Paper, no. 2005/12, p. 39.

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If the choice were to be left to science or the market, would they be sound and equal? What would be the best choice? 2) The spill-over effect. If on one side the necessity of having a global court, deciding global disputes in accordance with legitimate worldwide norms is evident; on the other, the sectorality of the DSB is striking. Considering how many social sectors, values and interests are connected, involved and affected by global trade, the DSB is often called to pronounce on issues of general scope, on cases with a multidimensional content, on conflicts, which imply a complex and multilevel balancing of interests. The DSB is called to act as a world court, without possessing the features to perform this task. It is not completely a court and, as we saw, it entails wide interpretative powers. Moreover, it is a body of a sectoral organization. Nonetheless, it has a strong impact over national administrative regulations and over their discretionary powers; and not only for trade issues, but also for other social ones, so that international trade adjudications become a sort of indirect regulation. Finally, the DSB is a trade-oriented body, as this is the way it was conceived. Its jurisdiction relates to trade matters and its legal scope concerns the Marrakech Agreements, which are trade treaties. Where is the solution of such imbalance to be found? Should WTO law incorporate social and human rights? Should a new international global court be created? Could these matters be dealt with by the already existing International Court of Justice at the UN? 3) Finally, the effectiveness of the DSB decisions: how far can an international adjudicative body go? Should it consider only the formal legitimacy or the logical coherence of administrative decisions or involve also the substance of such decisions? Is it legally (and politically) justifiable that a judicial body deals with matters which should be left to the executives and which belong to different legal orders? How should we consider a judicial legally oriented decision on scientific issues? Should it go deep for the soundness of science or refrain as scientific investigation pertains to specialized administrative authorities? And, what about uncertain science?



3 The EC-Biotech case

Before analysing the DSB Panel’s decision on the EC-Biotech case, adopted without appeal by the WTO Dispute Settlement Body on November 21, 2006,27 I need to spend some time on Genetically Modified Organisms (GMOs) and on their complex regulatory framework.

27

Panel Report, European Communities–Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R (Sept. 29, 2006) [hereinafter EC-Biotech].

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3.1 The GMOs and their legal and regulatory framework

A legal definition of a genetically modified organism is to be found in the Cartagena Bio-safety Protocol (CBP), which, by referring only to living GMOs, at Article 3(g) describes them as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology”.28 More generally, a GMO is a product of the combination of genes from different organisms, through the recombinant DNA technology. The result of the combination is said to be “genetically modified”, “genetically engineered” or “transgenic”. However, the three denominations may imply different kinds of genetic intervention. For instance, “although in popular parlance the term genetically modified (GM) often is used interchangeably with genetically engineered (GE) and biotechnology, (…) genetic modification refers to a range of methods used to alter the genetic composition of a plant or animal, including traditional hybridization and breeding. Genetic engineering is one type of genetic modification that involves making an intentional targeted change in a plant or animal gene sequence to effect a specific result through the use of recombinant deoxyribonucleic acid (rDNA) technology. Biotechnology refers to methods (including genetic engineering) other than conventional breeding used to produce new plants, animals, and microbes. Conventional breeding is used to describe traditional methods of breeding, or crossing, plants, animals, or microbes with certain desired characteristics for the purpose of generating offspring that express those characteristics”.29

The development of science and biotechnology has reached impressive results in the last twenty years: one of the main and most controversial one concerns genetic modification and all the modern bio-techniques. What has arisen in most discussions is the so-called trans-species genetic modification, which involves violating the inter-specific barrier. This means modifying cell information by artificially transferring the genes between genetically distant organisms, as from a bacterium to a plant (typical of most GM products now in commerce). Several questions rise upon this issue, among which: Do transgenic products present health and social risks? Are they useful? And, for whom? Does present society need such a form of biotechnology or can it be renounced without negative consequences? How much can be left to market norms and how much should be publicly regulated? 28

Cartagena Protocol on Bio-safety, signed at Montreal on 29th of January 2000, entered into force on the 11th of December 2003, available at https://bch.cbd.int/protocol/text/.

29

Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, Safety of Genetically Engineered Foods Approaches to Assessing Unintended Health Effects, The National Academies Press, 2004, p. 17, available at http://www.nap.edu/openbook.php?record_ id=10977&page=17.

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According to the present available scientific information, it is not yet possible to provide absolute and clear answers to these questions: Either for what concerns safety, or for what relates to all the socio-economic implications of such a radical transformation of agricultural processes. At the 27th Session of the Codex Alimentarius Commission, an ad hoc “Intergovernmental Task Force on Foods Derived from Modern Biotechnology” was established, with the mandate to elaborate standards, guidelines or recommendations, as appropriate, for foods derived from modern biotechnology. The Task Force ended its work during 2009, submitting a full report but, at present, a proper standard is not yet available, although the Task Force has actually produced some partial guidelines. Nonetheless, there is still no complete official and legally approved statement to rely on concerning GM foods.30 According to the data produced by the International Service for the Acquisition of Agri-biotechnology Applications (ISAAA) the first significant sowing of transgenic seeds was made in the United States in 1996.31 Since then about 170 million hectares32 have been cultivated using GM seeds, among which are 62.5 in the US, 21.0 in Argentina, 15.8 in Brazil, 7.6 in Canada and in India, 3.8 in China, 2.7 in Paraguay, and 1.8 in South Africa. The GM crops concern mainly soybean, corn, cotton and canola. For instance, in the USA, around 90% of soybeans and 80% of cotton are from GM varieties, as are around 75% of processed foods.33 The genetic traits that have been modified are above all of five kinds: herbicides-resistant, insecticide-resistant, virus resistance, delayed ripening, stacked traits.34 For what concerns the economic aspect, “global R&D investment in GM crops has been estimated to range from $2.05 billion to $2.75 billion annually, most of it in developed countries”.35 30

See Codex Alimentarius Commission, Principles for the Risk Analysis of Foods derived from modern Biotechnology, Rome, CAC/GL 44-2003, 2, available at http://www.codexalimentarius.net/download/ standards/10007/CXG_044e.pdf and Codex Alimentarius Commission, Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-dna Animals, CAC/GL 68-2008, available at http:// www.codexalimentarius.net/download/standards/11023/CXG_068e.pdf.

31

“Chymosin”, an enzyme used to make cheese is the first commercially approved (in 1990) genetically engineered food product. While “Flavr Savr” tomato is the first commercially approved (in 1994) genetically engineered food crop.

32

ISAAA Brief 44-2012: Executive Summary, Global Status of Commercialized Biotech/GM Crops, 2012, available at: http://www.isaaa.org/resources/publications/briefs/44/executivesummary/.

33

On this Animal & Plant Health Inspection Service (APHIS), U.S. DEP’T OF AGRICULTURE, Factsheet: Low-Level Presence (March 2007), available at http://www.aphis.usda.gov/publications/biotechnology/ content/printable_version/fs_llppolicy3-2007.pdf. See also Questions and Answers: Biotechnology and the USDA, Semptember 2012, available at http://www.aphis.usda.gov/publications/biotechnology/content/ printable_version/BRS_QA_biotechandusda.pdf.

34

See The Global Status of Commercialized Biotech/GM Crops: 2008, at http://www.isaaa.org/resources/publications/briefs/39/pptslides/Global-Status-Map-2008.pdf.

35

Richard B. Stewart, The GMO Challenge to International Environmental Trade Regulation: Developing Country Perspectives (New York: unpublished, 2006), p. 5. See also ISAAA Brief 44-2012: Executive Summary, Global Status of Commercialized Biotech/GM Crops, 2012, cit.

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Regarding the described uncertainty over GMOs, many competent subjects – producing companies, institutional authorities, private non-governmental associations and independent science panels – have conducted studies and research. The scientific data provided on GMOs are still considered inadequate, for instance regarding their long-period effect on humans, their impact on biodiversity and on traditional agriculture, or their socio-economic consequences.36 In a precedent work,37 I prepared a short list of hypothetical benefits and drawbacks from an extended use of genetically modified products. Here is an updated version of that list: Benefits.38 The advantages that genetic modification may produce are: an increased agricultural output;39 a more nutritious food;40 general environmental benefits (e.g. “biotech products that are resistant to insect pests require less 36

To have a confirmation of the uncertainty surrounding the scientific reports on GMOs, see G.-E. Séralini, E. Clair, R. Mesnage, S. Gress, N. Defarge, M. Malatestab, D. Hennequin, J. Spiroux de Vendômois, Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize, in Food and Chemical Toxicology, Volume 50, Issue 11, November 2012, Pages 4221–4231 and the available comments at http://www.sciencedirect.com/science/article/pii/S0278691512005637. On the same issue, check as well the opposite answer given by the European Food Safety Authority, Communication of 4 October 2012, available at http://www.efsa.europa.eu/en/press/news/121004.htm, and the Review of the Séralini et al. (2012) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603 as published online on 19 September 2012 in Food and Chemical Toxicology, in EFSA Journal 2012;10 (10): 2910 [9 p.].

37

D. Bevilacqua, The International Regulation of Genetically Modified Organisms: Uncertainty, Fragmentation, and Precaution, in European Environmental Law Review, December 2007, p. 316-318.

38

As a term of reference is useful to check EC-Biotech, First Submission of the US, April 21, 2004, 4-9, available at https://ustr.gov/archive/assets/Trade_Agreements/Monitoring_Enforcement/Dispute_Settlement/WTO/Dispute_Settlement_Listings/asset_upload_file720_5542.pdf and R.B. Stewart, The GMO Challenge, cit., p. 8 et seq. See also Biotechnology Industry Organization (BIO), Guide to Biotechnology (2007); Graham Brookes & Peter Barfoot, GM Crops: The First Ten Years – Global Socio-Economic and Environmental Impacts (ISAAA Brief No. 36, 2006).

39

“Modern biotechnology can significantly increase agricultural output by protecting plants from factors that reduce yields, such pests, diseases”, Report of the National Academy of Medicine and National Academy of Pharmacology, How can genetic engineering contribute to the improvement of human health and food, and what are the obstacles to its application in this area?, November 26, 2002, 1.

40

“The power of genetic engineering to improve the nutritional quality of our food crop species is (…) immense”, N.E. Bourlang, ‘Ending World Hunger. The Promise of Biotechnology and the Threat of Antiscience’ (2000) Zealotry, Plant Physiology, 487; see also the “Golden Rice” case at M. McGloughlin, Why Safe and Effective Food Biotechnology is in the Public Interest, The Washington Legal Foundation Critical Legal Issues, Working Paper Series No. 99. Washington, D.C., USA: The Washington Legal Foundation, 2000; G. Lacy, Deploying the Full Arsenal: Fighting Hunger with Biotechnology, SAIS REVIEW 23(1): 181-202 (2003). Against this view, on the same issue, see V. Shiva, Stolen Harvest: the Hijacking of the Global Food Supply (Research Foundation for Science, Technology and Ecology, 2000); Id, Patents, Myths and Reality, Penguin India, 2001; and Id, Manifestos on the Future of Food and Seed, editor, South End Press, 2007.

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insecticide”);41 disease and cold resistance organisms;42 general health benefits (transplant surgery and creation of low cost medicines)43 and a wide range of social benefits. 44 Drawbacks/Risks. 45 The use of GMOs could also produce damages and risks regarding health and the environment. As concerns health, they consist of toxicity;46 allergenicity;47 damages to the immune system;48 horizontal gene

41

National Academy of Sciences, Transgenic Plants and World Agriculture, July 2000, 487.

42

D.B. Whitman, ‘Genetically Modified Foods: Harmful or Helpful?’ (CSA, April 2000, unpaged), at http://biomed.brown.edu/arise/resources/docs/GM%20foods%20review.pdf.

43

 Ibid.

44

“Champions of GMO technologies claim that, in addition to economic benefits, GMO technologies can provide a range of important social and health, environmental, and social benefits: boosting the ability of developing countries to feed undernourished and growing populations; enhancing small farmer incomes and rural economic development; providing consumers with more nutritious and safer foods (for example, by developing non-allergenic peanuts); preserving forests and biodiversity by enhancing agricultural productivity and thereby reducing the need for agricultural clearing” (see Reports by Council for Biotechnology Information; AgBio World, available at: www.agbioworld.com, (last visited March 28, 2007)); reducing the need for chemical pesticides and the associated risks to agricultural workers and non-target species; reducing fertilize use (for example, by enhancing more rapid crop rotation) and the ecological problems associated with nitrogen and phosphate runoff; and, enhancing carbon sequestration in soils by engineering crop varieties adapted to low-till farming”, R.B. Stewart, The GMO Challenge, cit., 9.

45

Some of the references hereinafter reported are also cited in EC-Biotech, First Submission of the European Communities, Geneva, 17 May 2004, p. 14-24, available at http://www.trade-environment.org/page/ theme/tewto/biotechcase.htm. As a term of reference see also R.B. Stewart, The GMO Challenge, cit., 10 et seq. and A. Bakshi, Potential Adverse Health Effects of Genetically Modified Crops, J. Toxicology & Envtl Health 6(3): 211-226 (May 2003).

46

“Through genetic manipulation, plants which do not naturally contain toxins may become toxic or capable of inherent toxin production”, R.M. Russel, ‘The vitamine A spectrum: from deficiency to toxicity’ (2000) 71 American Journal of Clinical Nutrition, 878. For instance, in herbicides-resistant plants the new gene allows the plant to absorb more herbicide than a sensitive one, so that the residues of chemical products might be found in big quantities in food.

47

S. L. Hefle, J.A. Nordlee and S.L. Taylor, ‘Allergenic Foods’ (1996) 36 Critical Review of Food Science and Nutrition. “More than 90% of food allergies occur in response to specific proteins in milk, eggs, wheat, fish, tree nuts, peanuts, soybeans, and shellfish (3). The risk for allergic reaction stems from a protein from one of these foods incorporated into a food that does not cause a known allergic reaction”, S.H. Dresbach, H. Flax, A. Sokolowski, J. Allred, ‘The Impact of Genetically Modified Organisms on Human Health’ (2001) Family and Consumer Sciences, Ohio University 1, at http://ohioline.osu.edu.

48

For instance, in 1998 the Rowett Institute of Aberdeen, Scotland, (...). On this, see the detailed reconstruction contained in J. M. Smith, Seeds of Deception. Exposing Industry and Government Lies about the Safety of the Genetically Engineered Foods You’re Eating, Paperback 2003.

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transfer and, consequently, antibiotic resistance, 49 plus a wide range of unexpected damage in the long period.50 As far as environment concerns, risks relate to: non-target effects;51 invasiveness and development of resistance;52 unintended effects arising through GMO related management practices;53 damages to biodiversity – preservation of the centre of origin.54 With regard to the regulation of genetically modified organisms, considerable economic, social, political and ethical issues are also to be mentioned.55 Any 49

“Foreign and transgenic DNA has been shown to persist in the stomach and intestine of animals after ingestion of GM products and can be taken up into the cells and nuclei of the receiving organism”, R. Schubbert, U. Hohlweb, D. Renz, and W. Doerfler, ‘On the fate of food ingested foreign DNA in mice: chromosomical associations and placental transmission to the fetus’ (1998) 259 Molecular and General Genetics. In addition, anybody who eats the modified plant also eats the antibiotic-resistant DNA, which is the marker, used to check the result of the genetic modification. This new DNA is not absorbed by man, but can be incorporated by bacteria present in our organism, which might become resistant to antibiotics, on this see M. Buiatti, Le biotechnologie (Bologna: Il Mulino, 2001), 81 et seq. Another example can be seen in the Glyphosate-tolerant soybeans quoted supra: although the plant does not absorb the herbicide, it goes into the soil, contaminating it. This might affect other plants, or find other vehicles to be absorbed by man.

50

“The critics argue that GMOs pose great uncertainties and potential for harm, because the expression of the inserted transgene may result in unexpected characteristics in the modified organism, and those characteristics in turn may interact in unexpected ways with the surrounding environment or consumer”, R.B. Stewart, The GMO Challenge, cit., 10. In general, on the consequences of GMOs consumption on health see Jeffrey M. Smith, Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods, Yes! Books, 4th ed., 2007.

51

The inserted toxins could harm and kill insects which are not pests, damaging biodiversity. See A. Hillbeck et al., ‘Toxicity of Bacillus thuringiensis Cry 1 Ab Toxin to the Predator Chrysoperla carnea’ (1998) 27 Environmental Entomology, 1255.

52

“The resistance-gene may outcross into other plants”, FDA Talk Paper, FDA Action on Corn Bioengineered to Produce Pharmaceutical Material, U.S. Food and Drug Administration, T02-46, 19 Nov. 2002.

53

“The use of GM crops as opposed to conventional crops may lead to a change in agricultural and management practices. Such changes, based on the specific GM crop in question, may have adverse effects on the agro-ecological environment and biodiversity” EC-Biotech, First Submission of the European Communities, cit., 21.

54

The centre of origin of a species is an invaluable and irreplaceable source of genetic material for plant breeding and the genetic modification could harm it, Ibid., 23-24.

55

“The principal contemporary concerns (regarding GMOs) may be placed in six general categories: (…) A) equitable concerns regarding the patenting of GM products (…); B) the level of transparency for exports of GM products (…); C) import bans on GM products (…); D) liability for damage by GM products (…); E) liability for damage for extraterritorial damage by GM products (…); F) long-term decline in global biological diversity”, S.D. Murphy, ‘Biotechnology and International Law’, (2001) Harvard International Law Journal, 6-17; According to some, the market restriction to GM products, while being a trade barrier potentially decreasing consumers’ choices, might, on the contrary, increase their protection from the risk of a biotechnological monopoly, which would as well affect their freedom of choice. On the opposite, “critics argue that a widespread LMO technology in agriculture will benefit a few large multinational

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regulatory system would have significant effects on producers and traders operating in the agricultural sector, a field that is still one of the most important for the economy of most of the States.56 Moreover, the possibility – granted by the present international legal framework – to obtain royalties on modified seeds, plants or foods and the high level of technology required to produce such goods, would be an incredible advantages for big companies from developed States, while it could diminish the interests of traditional or organic production, above all in developing Countries. In addition, it has been held that the transgenic crops would be effective only in an industrial-type and intensive agricultural system, so that if they are profitable in huge fields, they might be less effective in small ones, or in farms lacking the support of appropriate laboratories.57 On the other side, such a new mechanism of production may increase food and social security, by providing a more effective method of cultivation. As noted, the matter is highly debated. In India, for instance, according to some scholars, “biotechnology products are (…) instruments for achieving food security and addressing the prevalent productivity stagnation in the green revolution varieties”.58 However, it has been held that GMOs may have the opposite effect. They might be more expensive to purchase and maintain, and would thus be unlikely to solve the problem of food security since “poverty, rather than inadequate agriculture (…) remains the basis for hunger among the people of developing countries”.59 This interpretation is coherent to the doctrine affirming companies and allow them to establish a global cartel to the detriment of the world’s consumers and farmers. An antitrust suit has already been filed on this ground in the US (B. Picket, et al. v. Monsanto Co., Case No 1:99)”, T.J. Schoenbaum, ‘International Trade in LMOs: The New Regimes’ (2000) International and comparative law quarterly, 857. 56

Agriculture represents “a major source of income for the estimated 2.6 billion people who depend on agriculture for their livelihoods (FAOSTAT 2004)”, World Resource Institute, ‘Millennium Ecosystem Assessment’ (Washington D.C., 2005, 749) at http://www.millenniumassessment.org/documents/document.295.aspx.pdf.

57

In the biotech agriculture, few species occupy most of the cultivated fields of the world’s surface. That is because they are so intensive that they need several thousands of hectares to be productive. In the developing Countries, instead, the agricultural system is mainly based on families, which dispose of small land, and on the diversity of the cultivations. In the latter, the main problem is in lack of cultivable land, which is always in the hands of few people. Introducing GM crops in those systems would thus not solve the problem of starvation and poverty, as it would not redistribute the land and it would deprive people of the advantages of biodiversity. For what concerns in general the impact of GMOs on food supply, see Mohammad B. Habibi-Najafi, Food Biotechnology and Its Impact on Our Food Supply, Global J. Biotechnology & Biochemistry 1(1): 22-27, 24 (2006). For a divergent approach, citing the cultivation of GMOs in small farms and for the debate over the advantages or damages of GMOs for the developing countries see R.B. Stewart, The GMO Challenge, cit., p. 8 ff, p. 16 et seq. and p. 73 et seq.

58

S. Chaturvedi – L. Chawii, Biosafety Protocol, International Trade and Agricultural Biotechnology: Policy Inferences for India, RIS working paper, RIS-DP # 99, New Delhi, September 2005, 18.

59

M. K. McDonald, ‘International Trade Law and the U.S.-EU GMO Debate: Can Africa Weather This Storm?’ (2004) 32 Georgia Journal of International & Comparative Law 501, 504, p. 522.

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that the problem of the world’s hunger concerns distribution, not production.60 The multinational corporations leading this sector of the market might take advantage of their position, also due to their technical feasibility, and they might establish an oligopolistic control of food and seeds market, which would damage the development of these nations, as “agricultural products constitute developing countries’ principal exports to Europe and the United States”.61 The Indian government, indeed, adopted a prudent and cautious approach concerning the regulation of this field, above all for socio-economic concerns.62 Nonetheless, it is to say that the use of biotechnology in Indian agriculture is slightly increasing, particularly for what concerns cotton.63 As already said, the way national States regulate GM production implies, in addition to scientific and environmental issues, several decisive socio-economic and political insights. Such complexity is peculiarly paradigmatic to represent food-safety multidimensionality and means that GMOs regulation needs an omni-comprehensive sort of governance, implying the consideration for coexistence of several concerns and expectations with a high degree of scientific uncertainty. This means that competent rule- and policy-making authorities need to make political-oriented decisions over GMOs; they need to be account60

See, R.W. Herdt, ‘Biotechnology in Agriculture’, (2006) 7 Annual Review of the Environment 18, p. 266 et seq.

61

J.M. Migai Akech, ‘Developing Countries at Crossroads: Aid, Public Participation, and the Regulation of Trade in Genetically Modified Foods’, (2006) Fordham International Law Journal, 270. On the relationship between agricultural economy and environmental degradation in India, see R.N. Chakraborty, ‘Linkages between Income Distribution and Environmental Degradation in Rural India, in S.T. Madsen (ed.), State, Society and the Environment in South Asia, (New Delhi: Nordic Institute of Asian Studies, 1999), p. 165 et seq.

62

On these see A. Gupta, Governing Biosafety in India: The Relevance of the Cartagena Protocol, Belfer Center for Science and International Affairs (BCSIA), Discussion Paper 2000-24, Environment and Natural Resources Program, Kennedy School of Government, Harvard University, 2000, available at http://www.ksg.harvard.edu/gea/pubs/2000-24.pdf, p. 18-19 and 27 and D. Bevilacqua, ‘The Precautionary Principle in GMO Regulations: a vertical and horizontal comparison’, (2006) Poros project 2005-2007: Eu-India Economic Cross Cultural Programme, European Public Law Series, Vol. LXXXIV, p. 132 et seq.

63

“The agricultural biotechnology industry has expanded in India in a major way. The number of agricultural firms engaged in the agricultural biotechnology sector has gone up from 85 in 2001 to 132 in 2003. There were in total 176 biotechnology firms in India, of which almost 48 per cent were agriculturebased companies, 24 per cent with an interest in health related medical activities and 28 per cent were with varied interests, including in environmental biotechnology. In 2003, the number of biotechnology firms was 401, with healthcare firms showing the largest increase, overtaking the number of agricultural biotechnology companies”, S. Chaturvedi – L. Chawii, Biosafety Protocol, cit., 13; “Though India established the bio safety guidelines way back in 1989, till now no commercial trials of GM crops have been allowed”, S. Chaturvedi, Status and Development of Biotechnology in India: An Analytical Overview, RIS working paper, RIS-DP # 28, New Delhi, September 2002, 31. See also A. Gupta, Governing Biosafety, cit., 13-14. Check also also ISAAA Brief 44-2012: Executive Summary, Global Status of Commercialized Biotech/GM Crops, 2012, cit.

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able to the people and to justify them in a reasonable way, either at the national or at the supranational level. However, as already seen, in the global legal space it is not easy to ensure effective representative mechanisms and to put in place a complete multidimensional regulation of such a complex issue. In addition, due to all the uncertainty and to all the cultural and historical perspectives on the field, domestic GM regulations around the world are still quite different one from the other. All this, as we will see in the following, poses several legal and administrative problems. As will be exemplified by the analysis of the EC-Biotech case, the present regulatory framework of GMOs can be summed up with reference to two polar approaches. One, ascribable to the EU, is process-oriented (the regulation focuses on the process through which the GM products are obtained, rather than on the final product and on its physical analogies with traditional ones), based on preliminary authorization, severe controls, compulsory labelling and the precautionary principle. The other, mainly referable to USA and Canada, is product-oriented (“The focus is exclusively on the end product of GM technology, rather than on the fact that the process of genetic modification is used”),64 featured by substantial equivalence to ordinary products, voluntary labelling and the burden to prove the risk is on the administration. In addition to the different domestic legislation, also the international sphere fragmentation seems to confirm the patchwork-like structure of GMOs’ regulation. There is no single treaty regime addressing the discipline of such products, but, rather, “a segmented and at times conflicting network of intellectual property, trade and environment treaties, accompanied by ambiguous customary law or legal principles”.65 This mix of legal disciplines is composed of the SPS Agreement, the Technical Barriers to Trade Agreement, the Trade-related Intellectual Properties Rights Agreement, the World Trade Organization Agreement, the guidelines of the Codex Alimentarius Commission and the Cartagena Bio-safety Protocol (CBP), plus all the regional and national legislations on GMOs, with a transnational impact. As will be seen in the analysis of the EC-Biotech case, the applicability of these conventions to the regulation of GM products is openly debated. According to the European Communities, for instance, SPS provisions should have not been used to assess the actuation of GMOs European legislation, because the latter does not fall within the scope of the agreement.66 On the other hand, some countries, parties of the dispute (namely, Argentina, Canada and USA) have not ratified the CBP, so it cannot apply to them and cannot be 64

E. Marden, Risk and Regulation: U.S. Regulatory Policy on Genetically Modified Food and Agriculture, (2003) 44 Boston College Law Review, p. 734.

65

S. D. Murphy, Biotechnology and International Law, (2001) Harvard International Law Journal, p. 2.

66

EC-Biotech, paras. 4.748 et seq. and 7.147 et seq. According to S. Zarrilli, ‘International Trade in GMOs and Multilateral Negotiations: A New Dilemma for Developing Countries’, in (2000) 5 UNCTAD/DITC/ TNCD/1, 71 et seq., “GMOs are not covered by the SPS if we consider the text of the Agreement, but they fall within its ‘spirit’”. However the Panel excluded the defensive argument of the EU, holding that the European measures fell under the regulation of the SPS Agreement, see EC-Biotech, § 7.147 et seq.

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recalled by the DSB. Moreover, the guidelines of the CAC do not yet provide a common solution to the debate. Norms of reference for the EC-Biotech case SPS Agreement, Article 2.1 and 2.2: “1. Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement. 2. Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5”; SPS Agreement, Article 5.1: “Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations”; SPS Agreement, Article 5.7: “In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time”; SPS Agreement, Article 8: “Members shall observe the provisions of Annex C in the operation of control, inspection and approval procedures, including national systems for approving the use of additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise ensure that their procedures are not inconsistent with the provisions of this Agreement”. SPS Agreement, ANNEX C: “1. Members shall ensure, with respect to any procedure to check and ensure the fulfilment of sanitary or phytosanitary measures, that: (a) such procedures are undertaken and completed without undue delay and in no less favourable manner for imported products than for like domestic products”. Cartagena Biosafety Protocol, Article 10.6: “Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects”.

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3.2 The case

From 1998 to 2004 the European Communities did not approve any import of genetically modified organisms. According to the complex approval procedure, regulated before by the Directive 90/220/EC and now by the Directive 2001/18/EC (together with Regulations 258/97/EC; 1829/2003; and 1830/2003 specifically referring to GM foods), no GM product (imported or produced in the EU) had been authorized to be placed in the European market during that time. This is what has been called the EU “moratoria” against biotechnological products. On May 19, 2004, the European Union authorized the commercialization of “Mais Bt-11”,67 breaking the moratoria. In addition, during the same period, six Member States of the EU explicitly prohibited the marketing and the import inside their territories of GM products approved in the first instance by the European institutions. They relied on Article 16 of Directive n. 90/220/EC and on Article 12 of Regulation no. 97/258/EC, claiming the insufficiency of the investigation provided and the need of more appropriate scientific studies before delivering the authorization. On August 7, 2003, Argentina, Canada and USA challenged the moratoria and the national marketing and import bans issued by the six Member States of the EU before the WTO Dispute Settlement Body, requesting the establishment of a panel to examine the matter, whose decision was delivered in September 2006. It is important to underline that the complainants did not contest the European legislation, but its execution, its concrete application: namely, the moratoria produced, in their view, a de facto unlawful restriction of trade.68 The challenged mechanism of authorization, issued by the EU institutions, involves the participation of all the competent authorities of the Member States and demands the fulfillment of numerous strict environmental requirements (risk assessment against the exporter/producer; approval of the scientific and ethical committees; compulsory labeling; etc.) before placing GM products in the market. The rationale of this procedure is to improve harmonization among the members, 67

This kind of genetic modified variety of corn is one of the most significant approbations of GMO in Europe. “B.t., or Bacillus thuringiensis, is a naturally occurring bacterium that produces crystal proteins that are lethal to insect larvae. B.t. crystal protein genes have been transferred into corn, enabling the corn to produce its own pesticides against insects such as the European corn borer”. For two informative overviews of some of the techniques involved in creating GM foods, visit Biotech Basics (sponsored by Monsanto) http://www.biotechknowledge.monsanto.com/biotech/bbasics.nsf/index or Techniques of Plant Biotechnology from the National Center for Biotechnology Education http://www.ncbe.reading.ac.uk/ NCBE/GMFOOD/techniques”, D.B. Whitman, Genetically Modified, cit. unpaged.

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“The US submits that the EU’s adoption of the moratorium is inconsistent under the WTO Agreement (…). While members are allowed to maintain approval systems, the procedures under that system must be undertaken and completed without undue delay” EC-Biotech, First written submission by the USA, Geneva, April 21, 2004, p. 1; “Argentina is consistently not questioning the Community directives and regulations per se”, EC-Biotech, First written submission of Argentina, Geneva, April 2004, par. 195.

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and, at the same time, ensure an appropriate level of protection of health and the environment69 in a field that still presents considerable scientific uncertainty. However, the strictness and the complexity of this regulation and the extraordinary length of its implementation turned into a de facto denial of the presented requests. This had the effect of producing a strong restriction of international trade and a negative impact over GM producers’ economic expectations. It is also notable that the complainants of the Biotech case have contested the EU and Member States’ measures because they were pressed by agricultural trade associations and by the corporations involved:70 these multinational corporations used the institute of “diplomatic protection”71 to encourage their governments to start an international dispute mainly affecting their interests: the case is still formally an inter-state one, but it substantially involves strong private actors “using their states” to complain against an alleged illegitimate provision issued by other states’ administrative authorities.72 In more detail the contested measures are: 1. A general moratoria against new GM products put in place by the EU; 2. A product specific moratoria against certain specific GM products, whose application was still pending; 3. Nine national imports bans on GM products issued by six EU members. 1. The general moratoria consist of “a de facto measure, i.e. a measure which was not adopted through a formal EU rule – or decision-making process – as it is the result of the application of separate decisions by the group of five (member 69

“Protect human health and the environment” and “to approximate the laws of the member states”, Preamble, recitals 5 and 7 and Article 1, 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.

70

“Agricultural trade associations within the United States, led by the American Soybean Association, pressed the USTR to initiate a WTO challenge against the E.U.’s labeling and traceability rules”, G. Shaffer, A Structural Theory of WTO Dispute Settlement: Why Institutional Choice Lies at the Center of the GMO Case, NYU Journal of International Law and Politics, vol. 41:1, 2008, p. 23. See also ASA Takes Lead in Pushing for New WTO GMO Case Against EU, INSIDE U.S. TRADE, March 12, 2004, at 25.

71

“In international law, diplomatic protection (or diplomatic espousal) is a means for a State to take diplomatic and other action against another State on behalf of its national whose rights and interests have been injured by the other State. Diplomatic protection, which has been confirmed in different cases of the Permanent Court of International Justice and the International Court of Justice, is a discretionary right of a State and may take any form that is not prohibited by international law. It can include consular action, negotiations with the other State, political and economic pressure, judicial or arbitral proceedings or other forms of peaceful dispute settlement. In 2006, the International Law Commission has adopted the Draft Articles on Diplomatic Protection, regulating the entitlement and the exercise of Diplomatic Protection”, http://en.wikipedia.org/wiki/Diplomatic_protection.

72

On this see G. SHAFFER, Defending Interests: Public-Private Partnerships in WTO Litigation, Brookings Institution Press, 2003, who examines the use of formal and informal mechanisms through which “private firms and governmental authorities collaborate to challenge foreign trade barriers within the context of the WTO system”, creating “public-private partnerships to advance their complementary aims”.

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states) and the Commission”.73 This produced a deliberate and general denial of entrance towards GM products. It can also be defined as “the suspension of consideration of applications for, or granting of, approval of biotech products”.74 So, according to the complainants, all the mechanism of approval of the GMOs is part of a general strategy to close EU market to all these products. 2. The product specific moratoria regards all the single applications and namely refers to 24 of 27 GM products, which, according to the complainants, have been deliberately failed or unduly delayed in order to avoid the entrance of those products into the European market. 3. The third contested measure refers to nine bans taken by six EU Member States upon Article 16, Directive n. 90/220/CE and Article 12, Regulation n. 97/258/CE against products approved by the European institutions. By admitting derogation from the EU policy and the approval of safeguard measures, the mentioned provisions allowed the Member States to explicitly deny – where there were new justifiable reasons – the access to their market despite the formal approval of the EU institutions. In order to support their arguments, the complainants alleged the violations of several measures of the SPS Agreement and, with the exclusion of the USA, Canada and Argentina also claimed the breach of the TBT Agreement and the GATT. In September 2006, the competent Dispute Settlement Panel of the World Trade Organization issued its final report on the EC-Biotech dispute. The decision of the panel condemned the European Union, stating that the administrative implementation of the EU regulation concerning genetically modified organisms was not in compliance with WTO law and that the EU had to bring the measures “into conformity with its obligations under the SPS Agreement”.75 The rationale of the panel’s decision related to the necessity to guarantee free global trade and not to allow any unjustified restriction in the Member States of the WTO. The European moratoria was not found in violation of substantive norms, namely Articles 2.2, 2.3, 5.1, 5.2, 5.5, and 5.6,76 but it was considered unlawful under the procedural norms of Article 8 and Annex C(1)(a), requiring completion of the operational and approval procedures “without unduly delay”.77 The Panel analysed the behaviour of the European institutions and of the Member States, and it found them to be exceeding their powers, integrating a de facto violation of WTO law, through inaction and omission. The Panel condemned the behaviour of the European Community, i.e. the material execution of that regulation which integrated a violation of a procedural provision of 73

 EC – Measures Affecting the Approval and Marketing of Biotech Products (WT/DS/291, 292, and 293), Interim Report of the Panel, Geneva, 7 February 2006, § 7.1282.

74 75

 Ibid.

 EC-Biotech, Final Report, paras. 7.1302-7.1305.

76 77

 Ibid., paras. 7.1319 et seq.

 Ibid., paras. 7.1466 et seq.

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the WTO demanding national administrative authorities to act in a tempestive and effective way. Finally, the nine safeguard measures also failed, according to the Panel, to meet some substantial requirements of the SPS Agreement related to risk assessment, being not justifiable under Article 5.7 and resulting in violation of Articles 2.2 and 5.1.78 For these violations, the DSB required the EU and the Member States to put their measures into conformity with the SPS Agreement’s provisions. In the case at stake, a regional administrative procedure enacted upon European legislation, and in conformity with the law of the Treaty establishing the European Community, was found to be illegitimate under international law and to damage the economic interests of American, Argentinean and Canadian companies (and indirectly of the respective States). The contested regulation and the bans issued by the Member States restricted market access as both the EU and its members did not provide sufficient scientific justifications for their market limitations and because an undue delay occurred in several authorization procedures. The EC-Biotech is notably long (more than 1.000 pages, which become 2.400 with annexes) and complicated. The following analysis of the case will stress the most important treated issues, namely focusing on the inclusion of the EU moratoria under the scope of the SPS Agreement; on the interpretation of the procedural requirement of the SPS demanding the avoidance of undue delay in the national authorization procedures; on the interpretation of Article 5.7 and the exclusion of the precautionary principle from the SPS Agreement; on the exclusion of the Cartagena Biosafety protocol in order to integrate or interpret WTO law.



3.3 The inclusion of the EU moratoria under the scope of the SPS Agreement

The first issue concerns a matter that is strictly related to international law and its principles and important to understand how the SPS Agreement applies to national measures and to investigate the features of food safety regulation. The Complaining Parties of the Biotech case all alleged that the EU approval procedures, concerning the deliberate release of biotech products into the environment and concerning novel foods and novel food ingredients, are SPS measures within the scope of the SPS Agreement. The European Union maintain that the EU approval procedures fall in part within the scope of the SPS Agreement, and in part outside the scope of it. Such issue is critical to the case because of the different legal requirements contained in WTO agreements. As noted before, the SPS Agreement contains more stringent provisions than the 78

 Ibid., paras. 8.9-8.10.

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other potentially applicable WTO agreements as it is the only one requiring that trade-restricting measures be based on a scientific “risk assessment”. For instance, GATT requirements focus primarily on whether a measure is discriminatory. In the case at stake, the EU would not have engaged in any discrimination in violation of GATT Article III so long as GM and conventional varieties are found not to be “like products”. This means that the European Community could have maintained its measure by demonstrating – under a number of criteria, including consumer perceptions – that the GM varieties are considered different from conventional varieties. The AB specified the criteria in the so-called Asbestos case: “This approach has, in the main, consisted of employing four general criteria in analyzing ‘likeness’: (i) the properties, nature and quality of the products; (ii) the end-uses of the products; (iii) consumers’ tastes and habits – more comprehensively termed consumers’ perceptions and behaviour – in respect of the products; and (iv) the tariff classification of the products”.79

Namely, in such a case the main differences remain in the unknown properties and effects of the GM products and the different consumers’ perceptions, so that despite all the common elements, GMOs are (or can be considered) substantially different. The Panel, in any case, agreed with the European Union by considering the GMOs non-equivalent to traditional products. Finally, even if they might be found as “like-products”, the restricting measure could have been justified under Article XX of the GATT, as “necessary to protect human, animal or plant life of health”. Another Treaty, under which scope the European moratoria might have fallen, is the Agreement on Technical Barriers to Trade (TBT Agreement). This treaty, disciplining trade restrictions regarding technical characters and external presentation of goods, does not apply to all the measures that fall under the SPS Agreement and thus is quite important to determine which law is relevant between the two, and thus applicable to the contested measure. As for the GATT, the TBT imposes a softer requirement to the Member States in order to justify their measures. Namely, it states that national measures “Shall not be more trade-restrictive than necessary to fulfil a legitimate objective, taking account of the risks non-fulfilment would create. Such legitimate objectives are, inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information, related processing technology or intended end-uses of products.” (Article 2.2, TBT Agreement). 79

 Appellate Body Report, 12 March 2001, European Communities – Measures Affecting Asbestos and Asbestos-Containing Products, WT/DS135/AB/R (AB-2000-11) (hereinafter ‘the Asbestos case’), paras. 101-103.

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As evident, the requirements are more general than the scientific ones demanded by the SPS Agreement and the reported list of criteria is an open one, in which scientific information is only one of the elements to consider. The Panel excluded the application of the GATT and the TBT Agreement80 and found the EU measure to fall under the scope of the SPS Agreement. By quoting Annex A of the SPS Agreement, it stressed the official definition of a SPS measure: “Sanitary or phytosanitary measure – Any measure applied: (a) to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms; (b) to protect human or animal life or health within the territory of the Member from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs; (c) to protect human life or health within the territory of the Member from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or (d) to prevent or limit other damage within the territory of the Member from the entry, establishment or spread of pests. Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety”.

The EU maintained that its regulation did not concern only health protection but also other relevant issues, such as the protection of the environment and the ecosystems.81 This perfectly matches what we already said, regarding food safety in general, and GMOs in particular: The multidimensionality of the matter is striking and the relative regulation is supposed to refer to a multiplicity of purposes. On this, it is notable that the Preamble, which embodies the rationale of the EU Directive n. 18/2001 refers to Article 95 (now Article 114) of the Treaty – concerning the harmonization of national legislations inside the Union and the functioning of the internal market – to the protection of human health and the environment, and to the ethical concerns of the States. This is a key issue in 80

For what concerns the TBT Agreement, the implicit moratoria of the EU and the Member States’ bans did not regard technical barriers, such as, for instance, compulsory labelling. That is why they could not be considered as measures applied to regulate some technical issue concerning production, presentation or commerce of GMOs.

81

 EC-Biotech, Final Report, par. 7.368.

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the international regulation of GMOs as the SPS provisions – mainly concerning free trade restrictions for health reasons – seem to be quite limited in covering in a satisfying and appropriate way such a complex field. However, despite the intrinsic multidimensionality of the European GMOs regulation and despite the defensive argument of the EU, the Panel found that the SPS Agreement has a very expansive scope of coverage and, by analysing all the potential adverse effects alleged by the EU concerning GMOs, it declared the measure to fall within the SPS Agreement scope as it may “directly or indirectly, affect international trade” (Article 1.1, SPS Agreement) and it is directed to ensure the protection from potential adverse effects (such as pests, diseases, disease-carrying organisms, additives, contaminants and toxins), arising from the release of GMOs into the environment, which all fall within the SPS Agreement’s scope.82



3.4 The interpretation of the procedural requirement of the SPS Agreement demanding avoidance of undue delay in the national authorization procedures

Having established that the EU moratoria fell under the scope of the SPS Agreement, the Panel had to check if it violated any of its provisions. The adjudicative body excluded the violation of any substantial requirement, as the contested measure was indeed a procedural behaviour integrating a de facto restriction of trade. With the exclusion of the national bans (which will be dealt infra, para. 3.5), it was not possible to treat the moratoria like a definitive SPS measure and to assess its consistency with Articles 2.2 and 5.1. On the contrary, it could have been assessed with regards to its conformity to the procedural Articles of the SPS Agreement, namely to Article 8 in combination with Annex C(1) (a). In interpreting the words of Annex C(1)(a), the Panel states: “We consider that if approval procedures serve to check and ensure the fulfilment of SPS requirements, then Members applying such procedures must in principle be allowed to take the time that is reasonably needed to determine with adequate confidence whether their relevant SPS requirements are fulfilled, at least if these requirements are WTO-consistent. Put another way, we view Annex C(1)(a), first clause, essentially as a good faith obligation requiring Members to proceed with their approval procedures as promptly as possible, taking account of the need to check and ensure the fulfilment of their relevant SPS requirements. Consequently, delays which are justified in their entirety by the need to check and ensure the fulfilment of a Member’s WTO-consistent SPS requirements should not, in our view, be considered ‘undue’.”.83

82 83

 Ibid., paras. 7.285-7.286; paras. 7.343-7.344; paras. 7.361-362; paras. 7.379-380.

 Ibid. par. 7.1491.

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The Panel also stressed that all the procedural steps adopted to implement a measure must still respect the fourth preambular paragraph of the SPS Agreement stating that one particular object and purpose of the SPS Agreement is “the establishment of a multilateral framework of rules and disciplines to guide the […] enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade”.84 The European Communities defended by stressing the significant changes produced by the entrance into force of the new normative texts (Directive 18/2001/EC and Regulation 29/2003/EC) and on the uncertainty and the scientific complexity of GMOs. On the latter, they observed that “in view of the fact that the underlying science is still in a great state of flux, it has chosen to apply a prudent and precautionary approach to identifying, assessing and managing risks to human health and the environment arising from GMOs and GMO-derived products for which marketing approval has been sought”.85

The Panel replied that: “It is apparent from the foregoing observations that we perceive no inherent tension between the obligation set out in Annex C(1)(a), first clause, to complete approval procedures without undue delay and the application of a prudent and precautionary approach to assessing and approving GMOs or GMO-derived products. Nevertheless, it is clear that application of a prudent and precautionary approach is, and must be, subject to reasonable limits, lest the precautionary approach swallow the discipline imposed by Annex C(1)(a), first clause”.

In addition, the Panel stated: “We note in this regard that if relevant scientific evidence were insufficient to perform a risk assessment as defined in Annex A(1) of the SPS Agreement and as required by Article 5.1 of the SPS Agreement, pursuant to Article 5.7 of the SPS Agreement, a Member may provisionally adopt an SPS measure on the basis of available pertinent information”.86

Finally, the Panel concluded that neither the inadequacy of the existing EU approval legislation, nor the evolving science and the application of a prudent and precautionary approach would provide a justification for delays, which might have occurred because of the application of the general EU moratorium on final approvals.87 84 85

 Ibid. par. 7.1492.

 Ibid. par. 7.1514.

86 87

 Ibid. paras. 7.1516 and 7.1518.

 Ibid. par. 7.1523.

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For what relates to the issue of delay, it is notable that the Panel decided to rely on a general administrative law principle: the promptness and conclusiveness of the authorities’ decisions. The latter are generally required replying to the petitions of private parties and the “silence” of the administration, if not adequately motivated and reasonably justified, can be equivalent to an illegitimate or arbitrary denial. This is significant for a matter of efficiency and effectiveness, requiring public administrations to ensure as well an impartial and formally fair regulation. We can thus see how global law demands formal and procedural limits to national authorities, in order and with the effect to increase their efficiency and reduce their arbitrariness. This is of help for individuals affected by authoritative decisions – although through the necessary activity of national States, as in the case at issue – guaranteed by another source of law besides the national ones and by another body (the DSB), with adjudicatory powers, which vigilate the respect for such principles. In addition, this might also affect the substantial regulation of food safety, as public authorities are required to activate and be efficient in order to justify and show the reasonableness of their decisions affecting food consumption, demonstrating they make them in the name of the general interest.



3.5 The interpretation of Article 5.7 and the exclusion of the precautionary principle from the SPS Agreement

The nine bans of the EU Member States were also judged to be illegitimate under the provisions of the SPS Agreement. The condemned parties failed to justify their measures with reference to Article 5.7 of the Treaty at stake and to the precautionary principle. For what concerns the latter, in particular, the Panel provided its interpretation to the precautionary approach and to its eventual presence in the SPS Agreement, opting for the exclusion of the debated principle and in favour of a preventive approach. Article 5.7 foresees that when “relevant scientific evidence is insufficient”, a Member State may “provisionally adopt” a restricting-trade provision “on the basis of the available pertinent information”. In doing so, it commits to “seek to obtain the additional information” needed to produce “a more objective assessment of risk” and to “review the sanitary or phytosanitary measure accordingly within a reasonable period of time”. This provision loosens the strict requisite imposed by Article 5.1; however, it is not pacific if it implies a precautionary principle or approach or if it excludes it, admitting only a preventive one. The precautionary principle is a very controversial one, still void of an official and shared definition. As already stated (supra § 2.4), it can be described as that procedural principle that can be invoked and applied in cases of scientific uncertainty regarding a possible occurring risk. Such criterion allows administrative authorities to adopt a prudential measure based on a theoretic possibility of risk occurrence and with respect to the proportionality and reasonability principles.

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In Europe, the precautionary approach has reached the highest level of implementation and has a presence in the Treaty on the Functioning of the European Union (at Article 191; formerly Article 174 EC Treaty). It is interpreted as a principle of action, which entitles competent authorities to act prudently only after the scientific test has proven unsatisfying and in conformity with the principles of proportionality and reasonability. This is visible in the words used in the mentioned norm, which reads: “2. Community policy on the environment shall aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at the source and that the polluter should pay. In this context, harmonisation measures answering environmental protection requirements shall include, where appropriate, a safeguard clause allowing Member States to take provisional measures, for non-economic environmental reasons, subject to a Community inspection procedure. 3. In preparing its policy on the environment, the Community shall take account of: – available scientific and technical data, – environmental conditions in the various regions of the Community, – the potential benefits and costs of action or lack of action, – the economic and social development of the Community as a whole and the balanced development of its regions”.

While the second paragraph of the Article is quite generic and only mentions the principle at stake, together with the preventive principle, the third paragraph specifies its procedural application as a principle of action. The quoted provision indeed does not say what precaution consists of, when it is to apply, or which limits not to cross in order to avoid transforming prudence into paralysis or arbitrariness. The norm gives only some rules, which public authorities need to abide by if they want to apply the precautionary principle. The latter, when deciding to act prudently, have to take into account: “available scientific and technical data”, so that precaution is not an alternative to science, but it is logically subsequent to it, when science is uncertain; “environmental conditions in the various regions”, so that they need to consider the physical conditions in which the precautionary principle is adopted; “the potential benefits and costs of action or lack of action”, which means considering taking or not taking action in that field and with what measure; “the economic and social development of the Community”, that is taking into account also social and economic issues and not only the ones concerning health or the environment. Such interpretation seems to be confirmed into institutional Reports: “The decision to act or not to act, based on the precautionary principle, is essentially

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a problem of political interpretation”.88 In addition, a significant part of the legal doctrine followed such approach: “The precautionary principle represents…a principle of action in cases where a risk may eventually emerge”.89

Finally, also part of legal science convened on such conception of the principle: “The principle’s essential purpose is to scientifically frame a decision-making procedure. In no instance does it determine the decision itself. (…). Advocate General Mischo makes clear (…) that the distinction made between evaluation of and dealing with risk fulfils a double requirement: ‘on one hand to introduce science into the policy, and on the other, that of maintaining the autonomy of the policy with regard to the science’”90

By excluding the application of the precautionary principle, the Panel opted for the preventive principle and judged the nine bans inadequately justified, as they did not meet the requisites for the application of such principle, allowing a prudent measure on a basis of a risk determined at least in terms of probability. The preventive principle concerns, as already seen, the possibility for an administrative authority to adopt a prudent approach in order to avoid a future risk, which can be reasonably foreseen at least in terms of probability. Before the Biotech case, the DSB already pronounced on the interpretation and the application of Article 5.7 of the SPS Agreement and on the invocation of the precautionary principle as a justification for an SPS measure for the solution of another dispute under the provisions of the mentioned agreement: “Japan – Measures affecting the Importation of Apples”.91 88

European Parliament Resolution on the Communication on the precautionary principle, A5-0352/2000.

89

Case C-236/01, Monsanto, Opinion of AG S. Alber, 2003, pt. 108. See also Case 174/82, Sandoz BV [1983] ECR I-2211, par. 16: “In so far as there are uncertainties in the present state of scientific research with regard to the harmfulness of a certain additive, it is for the Member States, in the absence of full harmonisation, to decide what degree of protection of the health and life of humans they intend to assure, in light of the specific eating habits of their own population”.

90

J. Cazala, ‘Food Safety and the Precautionary Principle: The Legitimate Moderation of Community Courts’, (2004) 5 European Law Journal 10, p. 545. Check also J. L. da Cruz Vilaça, ‘The Precautionary Principle in EC Law’, (2004) 2 European Public Law 10, p. 387: “the decision about whether matters have gone beyond the acceptable level of risk must be based on as thorough a scientific risk assessment as possible. It is on that same basis that the competent authority must also decide, as part of ‘risk management’, whether preventive measures are called for and which measures appear to be necessary and appropriate to prevent the risk from materializing”.

91

Appellate Body Report, Japan – Measures affecting the Importation of Apples, WT/DS45/AB/R, 10 December 2003 (hereinafter Japan-Apples).

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Namely, in Japan-Apples the AB established that the contested Japanese measure did not comply with the provision of Article 5.7 stating, in order to justify the provisional adoption of a phytosanitary measure, that the relevant scientific evidence was insufficient. To maintain this statement it clarified that: “relevant scientific evidence (…) will be ‘insufficient’ within the meaning of Article 5.7 if the body of scientific evidence does not allow, in quantitative or qualitative terms, the performance of an adequate assessment of risks as required under Article 5.1. Thus (…) the question is whether the relevant evidence, be it ‘general’ or ‘specific’, (…) is sufficient to permit the evaluation of the likelihood of entry, establishment or spread of, in this case, fire-blight in Japan”.92

The AB continued by stating that: “the application of Article 5.7 is triggered not by the existence of scientific uncertainty, but rather by the insufficiency of scientific evidence. The text of Article 5.7 is clear: it refers to ‘cases where relevant scientific evidence is insufficient’, not to ‘scientific uncertainty’. The two concepts are not interchangeable”.93

The AB linked the application of Article 5.7 to the insufficiency of science, in order to assess an alleged risk and not simply to its uncertainty. Nonetheless, by endorsing a too narrow interpretation of the phrase “insufficient evidence” and by factually denying the quality aspect of the word “insufficient” (an uncertain scientific demonstration might be considered qualitatively insufficient), the AB excluded the logical link between the availability of science and its actual capacity to solve uncertainty. On the contrary, the letter of the first part of Article 5.7 – “in cases where relevant scientific evidence is insufficient a member may adopt…on the basis of the available pertinent information” – could receive an alternative interpretation: when a member wants to issue a SPS measure, and the available scientific data are quantitatively or qualitatively insufficient to allow a satisfying evaluation of a risk, because that insufficiency generated uncertainty about the risk itself and its consequences, it is legitimate to issue a SPS measure without a risk assessment. The trade-restrictive decision would thus be based on the judgment of the available scientific methods and data: if they are adequate to produce an appropriate and univocal risk assessment, a sufficient amount of certainty about the matter is also implied; if, on the contrary, the available scientific findings generate uncertainty on the contested substance or product, and a risk cannot be determined, although neither excluded, the risk assessment will be only partially reliable, so that the measure, if it also fulfils the other requirements, could be justified under Article 5.7. 92 93

 Japan-Apples, § 179.

 Ibid., § 184.

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The concept of uncertainty, as related to a potential risk, is central to the question at stake, mainly because the precautionary principle is essentially based on this idea.94 The judges of the DSB, however, denied that a State could justify a trade-restrictive measure only on the base of scientific uncertainty. Indeed, they required a deeper justification: the total insufficiency of the actual scientific evidence, meaning the impossibility to perform an assessment on an identified and likeable risk. In doing so, they excluded all the cases in which the uncertainty about the identification and the likelihood of the risk itself are related to the inadequacy of science to provide enough knowledge to guarantee a minimum amount of safety or to accept the risk. The criteria required by the AB imply an ascertainable determination of a risk (likelihood), and exclude the requirement of uncertainty of scientific information. In such a way, even though the AB might guarantee objectivity in the justification of a national measure, it would embody in Article 5.7 the concept of prevention only – where a risk is at least probable – and not of precaution – where a risk can also be possible. Following the interpretations given by the Dispute Settlement bodies before the Biotech decision, the precautionary principle – or to say better the preventive principle – can only be used after having demonstrated: either the likelihood of a risk, on which a cautious approach is assumed based on the risk’s evaluation; or the insufficiency of scientific demonstration to evaluate the risk, already identified as probable, but not the uncertain results of the scientific findings, in addition to the other three requisites provided by Article 5.7. We already noted the controversies concerning the rigid scientific requirements in order to justify health-related trade barriers under the SPS Agreement. When national measures do not rely on an international standard, these can be accepted only if based on scientific justification. In Japan-Apples (as well as in EC-Hormones) the DSB did not consider the reasonability and the internal legitimacy of Countries’ decisions, but only the scientific reports they provided, regardless of the considerable amount of scientific uncertainty over the contested issues. In the Biotech case, the Panel reasserted that the restriction of the market of GM products for health concerns reasons could be admitted either relying on 94

“The core purpose of the precautionary principle is the management of uncertainty” J. Applegate, The Prometheus, cit., p. 20; check also European Commission, Communication, Commission of the European Union, Communication on the precautionary principle, Brussels, 02.02.2000, COM 2000, p. 3 and so forth; “Uncertainty is an essential component of the precautionary principle”, in EC-Biotech, Amicus Curiae Brief, Geneva, June 1st, 2004, p. 18. In the Environmental Declaration of Rio de Janeiro, at Article 15, there is a clear phrase: “lack of certainty”. Par. 9 Cartagena Convention on Biosafety states: “…where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty…” and this view has been kept also for the CBP: “Lack of scientific certainty…”, Article 10. On the issue check also J. Tickner, C. Raffensperger, and N. Myers, The precautionary principle, cit., p. 2 et seq.; P. Harremoes & oth., The Precautionary principle in the 20th Century. Late lessons from Early Warnings, London, Earthscan, 2002, p. 3 et seq.; T. O’Riordan, J. Cameron, A. Jordan, Reinterpreting, cit., p. 10 et seq.

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international standards, or through scientific evidence. In such a way, it required the demonstration of the likelihood (and not the theoretical possibility) of risk, and in interpreting Article 5.7 it went further in respect to the precedent rulings. The Panel of the Biotech case defined the content of Article 5.7 as an autonomous right of the Member States to adopt the measures they consider more appropriate to protect their citizens from health-related risks.95 However, the adjudicative body of the WTO also added that Article 5.7 is a qualified right, as, for a national SPS measure to be consistent, it needs to satisfy all the requirements of the provision.96 Among the latter, the cornerstone is, as in JapanApples, the first requisite, regarding scientific sufficiency to produce a risk assessment. In order to interpret such requirement, the Panel established an interlink between the provisions of Article 5.7 and Article 5.1, asserting that “scientific evidence is ‘insufficient’ within the meaning of the first sentence of Article 5.7 only if it does not allow the performance of an assessment of risk as defined in Annex A”.97 In addition, the Panel stated that “even if a Member follows a precautionary approach, its SPS measures need to be ‘based on’ (i.e., ‘sufficiently warranted’ or ‘reasonably supported’ by) a risk assessment. Or, to put it another way, such an approach needs to be applied in a manner consistent with the requirements of Article 5.1”.98 Precaution is generally admitted only after and upon the study of a risk. Or, we could say, after an attempted risk assessment. The application of a precautionary approach logically pertains to the second phase of the risk analysis procedure: risk management.99 However, even when risk assessments are characterized by undeniable uncertainty (which leaves the same possibilities to the chances that risk occurs or not), the Dispute Settlement Bodies have repeatedly 95

“Thus, we find the general test provided by the Appellate Body in EC – Tariff Preferences to be applicable, and application of that test leads us to the conclusion that Article 5.7 should be characterized as a right and not an exception from a general obligation under Article 2.2. In other words, we consider that in the same way that ‘Article 3.1 of the SPS Agreement [...] excludes from its scope of application the kinds of situations covered by Article 3.3 of that Agreement’, Article 2.2 excludes from its scope of application the kinds of situations covered by Article 5.7. As we will explain further below, characterizing Article 5.7 as a right rather than as an exception has implications for the allocation of the burden of proof”, EC-Biotech, § 7.2960 (footnotes omitted).

96 97

Ibid., § 7.2989.

 Ibid., § 7.2986. Annex A defines the procedure of risk assessment as “the evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of a Member State”. The mentioned interpretation of Article 5.7 follows the previous ruling of the AB in Japan-Apples and, as noted before, it takes for granted the likelihood of risk as a base for precaution, while excluding its possibility due to scientific uncertainty.

98

 EC-Biotech, § 7.3056.

99

As noted before, “Risk analysis” is a procedural mechanism to regulate risk adopted by the European and International legislation. For what regards the latter, it is to mention the Procedural Manual of the Codex Alimentarius Commission. The risk analysis procedure is composed of three phases: risk assessment, risk management and risk communication.

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affirmed the insufficiency of a precautious risk management action to justify a SPS measure as the managing decision cannot be considered sufficiently objective to exclude disguised protectionism. So that, despite a theoretical open space for the national authorities, suggested by the phrases “based on” and “reasonably supported”, these are still limited and conditioned by the determination of an ascertainable risk. Combining the two interpretations, the DSB has then confirmed the exclusion of precaution both from the phase of risk assessment and from that of risk management, as the latter can be used as justification only upon an appropriate risk assessment, which entails prevention rather than precaution. A prudent approach is thus admitted, but always on the basis of a risk assessment, or, at least, a risk as certainty. The Panel finally observed that “the adequate risk assessment”100 cannot be left to the prudent evaluation of the national governors, but must be determined in an objective way. To do so, it again recalled the definition of Annex A of the SPS Agreement: “a risk assessment would be ‘adequate’ if it meets the standard and definition provided in Annex A”.101 This interpretation absorbs – even in case of scientific uncertainties on the risk itself and on its consequences – the domestic authorities’ discretion of the phase of risk management into the narrow scientific requirements of the one of risk assessment. The prerequisites to apply Article 5.7 are then the identification at least in terms of probability of a risk and the impossibility to perform an assessment of such risk for insufficiency of scientific data. Only when the Member States can establish that the available science does not allow a risk assessment over a likeable risk can Article 5.7 apply; while, if an assessment is possible but its results are considered inadequate or scientific uncertainty does not allow the quantification of the probability of risk, national States are not free to determine their appropriate levels of protection, as foreseen by the Preamble and by Article 4102 of the SPS Agreement. All the described hermeneutical orientations considerably reduce the application of the qualified right embodied in Article 5.7, above all when risk assessment’s results are so ambiguous as to require a discretional decision among more options in the management phase. On the other side, however, the Panel tried to show coherence with Article 5.7, which does not refer to the concepts of uncertainty or precaution, and to require a mechanism of justification aimed at 100 101

Japan-Apples, § 182.

EC-Biotech, cit., § 7.3226.

102

“Further the use of harmonized sanitary and phytosanitary measures between Members, (…), without requiring Members to change their appropriate level of protection of human, animal or plant life or health” (Preamble); “Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitary protection” (emphasis added) (Article 4, Equivalence).

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excluding any kind of potentially arbitrary justification. Nonetheless, by reducing the right entitled in Article 5.7 only to the cases in which there is an impossibility to evaluate an already ascertained risk, the Panel’s interpretation has the effect of impairing the rationale of such provision. As, despite the orientation of the adjudicatory body, it is notable that theoretically, when science is uncertain and inadequate on the risk itself but there are still high possibilities that a risk (maybe a serious one) might still occur, the situation could be viewed as insufficient scientific evidence and therefore justify a temporary measure not based on a scientific risk assessment. In conclusion, it might be held that by the DSB interpretation of the SPS provisions concerning justification of national health measures, member States’ freedom of establishing their appropriate level of discretion is reduced by the necessity of a strict scientific risk assessment and by a limited and sciencerelated risk management, which cannot be based on uncertainty and risk possibility. Namely, the Panel excluded the possibility to apply the precautionary principle based on Article 5.7: According to the judge’s view, the latter embodies at most a preventive principle – i.e. a cautious approach based on the probability of risk – and not a precautionary one.



3.6 The exclusion of the Cartagena Biosafety protocol to integrate or interpret WTO law

In EC-Biotech the Panel also excluded the possibility of justifying the EU measures through the application of the precautionary principle as a principle of (customary103 or treaty) international law. In order to justify its measures, the European Community claimed104 the application of conventional international norms – namely of the rules of international law reflected in the Cartagena Protocol on Biosafety (CBP) – on the precautionary principle and on risk assessment. The Parties which signed the Convention on Biological Diversity in 1993 (among which all the three complaining Parties of the Biotech dispute) adopted, after long and difficult negotiations, the Cartagena Protocol on Bio-safety in 2000 (103 signatories including Canada and Argentina. To date, 156 instruments of ratification or accession have been 103

A s concerns customary law, the Panel refused the European reasoning, noting the lack of demonstration of such assertion and motivating its reasoning by affirming that there was no evidence of a common opinio juris and of a common legal practice of the principle at stake: “the European Communities has not explained exactly what it means by the term ‘general principle of international law’. We note that this term may be understood as encompassing either rules of customary law or the recognized general principles of law or both. Given this, we are prepared to consider whether the precautionary principle fits within either of these categories. This approach is consistent with the position taken by the European Communities in EC-Hormones where the European Communities contended on appeal that the precautionary principle was a general customary rule of international law or at least a general principle of law”, EC-Biotech, Final Report, par. 7.86 et seq.

104

EC-Biotech, First written submission of the European Communities, cit., par. 457.

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deposited with the UN Secretary-General). The Protocol, which entered into force on 11 September 2003, without the ratifications of Canada, Argentina and the USA, addresses the safe transfer, handling and use of living modified organisms that may have adverse effects on biodiversity. Article 1 of the CBP states, as its objective, that: “in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on trans-boundary movements”.

The reported provision implies a precautionary approach to adopt in the regulation concerning the safe transfer, handling and use of living modified organisms. According to the EU, the combination of the CBP with the SPS Agreement had the aim of informing the meaning and clarifying the interpretation of the debated provisions of the latter, notably at Article 5.7. The EU maintained that its behaviour was in conformity with the dispositions of the Protocol, to which the EU legislation and implementation were conforming.105 The recall of the CBP has been considered pertinent for what concerns the application of the precautionary principle and as a source of interpretation of the WTO provisions.106 This issue namely consists of the possibility to use other international provisions to integrate WTO law, through the combination of Article 3.2 of the DSU (DSB has “to clarify the existing provisions of those agreements in accordance with customary rules of interpretation of public international law”) and Article 31(3)(c) of the Vienna Convention on the Law of Treaties107 (in the interpretation of international law “there shall be taken into 105

EC-Biotech, § 4.330 et seq.

106

“ The European Communities would like to stress the importance of international regulatory acts in the field, in particular the Cartagena Biosafety Protocol. According to the Appellate Body, the rules of customary law ‘call for an examination of the ordinary meaning of the words of a treaty, read in their context, and in the light of the object and purpose of the treaty involved’. The Biosafety Protocol can assist the Panel in the process of interpreting WTO rules, in accordance with the Appellate Body findings in US – Shrimp”, Ibid., § 4.358.

107

T he Convention was adopted on 22 May 1969 and opened for signature on 23 May 1969 by the United Nations Conference on the Law of Treaties. The Conference was convened pursuant to General Assembly resolutions 2166 (XXI) of 5 December 1966 and 2287 (XXII) of 6 December 1967. The Conference held two sessions, both at the Neue Hof burg in Vienna, the first session from 26 March to 24 May 1968 and the second session from 9 April to 22 May 1969. In addition to the Convention, the Conference adopted the Final Act and certain declarations and resolutions, which were annexed to that Act. Entry into force on 27 January 1980, in accordance with Article 84(1).Official Publication in United Nations, Treaty Series, vol. 1155, 331.

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account (…) any relevant rules of international law applicable in the relations between the parties”). The AB confirmed this approach in “United States – Standards for Reformulated and Conventional Gasoline”, by saying: “the WTO law must not be read in clinical isolation from international law”.108 What was of main relevance in the Biotech case was the mechanism of application of the precautionary principle as foreseen in the Cartagena Protocol on Bio-safety, which, as already noted, concerns the regulation of living GMOs. The introduction of the principle into the protocol origins in the Convention on Biological Diversity,109 whereas par. 9 of the Preamble states: “where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat” (emphasis added). The word connected to harm (which must be a “significant” one) is not “likelihood”, but “threat”. The latter, indeed, although requiring a good amount of proof, still admits theoretical risk, sufficient to satisfy the “risk requirement” criterion as far it is credibly menacing the occurrence of harm. The phrase “lack of full scientific certainty”, then, also confirms the possibility to apply the precautionary approach. The concept of “uncertainty” is clearly distinguishable from the more demanding “insufficiency” of the SPS Agreement. Notwithstanding, the use of the word “full” implies that the lack of scientific certainty must be considerable in order to adopt a precautionary approach, which cannot simply rely on a minimum amount of scientific doubts. Therefore, there must be a minimum basis – although not a complete and conclusive assessment – of scientific demonstration, which is indeed a proper requisite of the most common form of the precautionary approach, which relies on an inadequate (in this case not fully certain) scientific risk assessment. Following the approach of the Convention, the Protocol has also included a precautionary approach which coincides with the one adopted in the EU. The principle is embodied by Article 10(6) of the CBP, stating: “lack of scientific certainty due to insufficient relevant scientific information and knowledge shall not prevent the Parties of the Protocol from taking all the appropriate decisions to avoid or minimize potential adverse effects from living GMOs”. According to the Protocol, scientific uncertainty over possible risks concerning GMOs is considered sufficient to trigger the application of the precautionary principle, as far as the party shows the inadequacy of the performed risk assessment. On the contrary, the Dispute Settlement Bodies’ interpretation of the SPS Agreement’s provisions requires at least insufficient scientific demonstration, that is an ascertainable risk on which it is impossible to make an evaluation. However, as seen, this conclusion was highly debated. The possibility to 108

United States – Standards for Reformulated and Conventional Gasoline, Appellate Body Report, WT/ DS2/AB/R, 1996, available at https://www.wto.org/english/tratop_e/dispu_e/2-9.pdf, 621.

109

T he Convention is an international Agreement, which was signed in June 1992, and entered into force in December 1993. It counts 188 members, and established and prepared the preparation and ratification of the CBP.

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recall the CBP, combining it with Article 5.7 of the SPS Agreement, would have moved the interpretation and the application of the latter towards a precautionary approach: It would have modified the interpretation of Article 5.7 of the SPS Agreement and, as far as for the Biotech case, theoretically justified the EU Member States’ bans, which were adopted in accordance with the same precautionary approach as the one provided by the CBP. For what concerns such a case of treaty interaction, it is to consider – in addition to the substantial compatibility of the confronted norms – if all the parties of the dispute can be subjected to both the agreements. Argentina, Canada and the European Communities have ratified the Convention on Biological Diversity and are parties to it. On the contrary, the United States has signed it without since ratifying it. Thus, it is not a party to the Convention on Biological Diversity, so for the United States the Convention is not in force. Moreover, only the EU ratified the Protocol, while Argentina, Canada and the USA did not. Therefore, only the EU is part of the CBP. The Panel of the EC-Biotech dispute thus excluded the application of the Convention in accordance with Article 18 of the Vienna Convention: “The mere fact that the United States has signed the Convention on Biological Diversity does not mean that the Convention is applicable to it. (…) [I]f a rule of international law is not applicable to one of the Parties to this dispute, it is not applicable in the relations between all WTO Members”.110 Having excluded application of the criteria indicated by Article 18 of the Vienna Convention, the Panel also neglected the possibility of following Article 31(3)(c)’s hermeneutical criterion (“there shall be taken into account (…) any relevant rules of international law applicable in the relations between the parties”), in order to interpret the SPS Agreement in accordance with the Protocol. For the adjudicative body “Article 31(3)(c) indicates that it is only those rules of international law which are ‘applicable in the relations between the parties’ that are to be taken into account in interpreting a treaty. (...) we note that Article 31(3) (c) does not refer to ‘one or more parties’. Nor does it refer to ‘the parties to a dispute’. We further note that Article 2.1(g) of the Vienna Convention defines the meaning of the term ‘party’ for the purposes of the Vienna Convention. Thus, ‘party’ means ‘a State which has consented to be bound by the treaty and for which the treaty is in force’”.111 Following the reasoning of the Panel, it seems 110

EC-Biotech, Final Report, cit., par. 7.74. To support this reasoning the Panel added: “pursuant to Article 18 of the Vienna Convention a State which has signed a treaty must refrain from acts which would defeat the object and purpose of that treaty, at least until it has made its intention clear not to become a party. (…) we note that Article 18 refers to ‘acts’ which rise to the level of ‘defeat[ing] the object and purpose’ of a treaty, not to acts which are inconsistent with specific terms of that treaty. It does not follow from Article 18 that a State which has signed a treaty has obligations pursuant to the specific terms of that treaty and that the treaty is applicable to it as such. In any event, Article 3(3)(c) refers to applicable ‘rules’ of international law. We think the ‘object and purpose’ of a treaty cannot be reasonably considered to constitute a ‘rule’ of international law”, Ibid., § 7.74.

111

 Ibid., §§ 7.67-7.68.

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clear that the Cartagena Bio-safety Protocol cannot be used in a dispute before the DSB of the WTO if the latter involves Countries that are not Parties to that Protocol. The CBP is not in force for Argentina, Canada and USA and therefore it cannot integrate the compatible SPS provisions. Despite the quoted ruling, the Panel also stated: “the mere fact that one or more disputing parties are not parties to a convention does not necessarily mean that a convention cannot shed light on the meaning and scope of a treaty term to be interpreted”.112 However, it then added: “In the present case, in response to a question from the Panel, the European Communities has identified a number of provisions of the Convention on Biological Diversity and of the Bio-safety Protocol which it considers must be taken into account by the Panel.113 The European Communities has not explained how these provisions are relevant to the interpretation of the WTO agreements at issue in this dispute. We have carefully considered the provisions referred to by the European Communities. Ultimately, however, we did not find it necessary or appropriate to rely on these particular provisions in interpreting the WTO agreements at issue in this dispute”.114

The mentioned finding of the Panel, concerning the conflict of norms, was firmly criticized in a recent Report of the International Law Commission, as it tended to further isolate the WTO legal system from other (factually intertwined) general norms and, relying on the “improbable precise congruence in the membership of most important multilateral conventions”, precluded reference to widely accepted or specialist subject matter treaties: “Bearing in mind the unlikeliness of a precise congruence in the membership of most important multilateral conventions, it would become unlikely that any use of conventional international law could be made in the interpretation of such conventions. This would have the ironic effect that the more the membership of a multilateral treaty such as the WTO covered agreements expanded, the more those treaties would be cut off from the rest of international law. (…). This approach would maintain the “generality” of at least some multilateral treaties. But it would have an inappropriately restrictive effect in two situations: (a) It could preclude reference to treaties which have very wide acceptance in the international community (including by the disputing States) but which are nevertheless not universally ratified and which are not accepted in all respects as stating customary international law (such as UNCLOS); (b) It could also preclude reference to treaties which represent the most important elaboration of the content of international law on 112 113

Ibid., § 7.94.

The European Communities refers to the Preamble and Article 8(g) of the Convention on Biological Diversity and Articles 1, 8, 10, 11, 15, 23, 26 and Annex III of the Biosafety Protocol.

114

EC-Biotech, § 7.95.

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a specialist subject matter, on the basis that they have not been ratified by all the parties to the treaty under interpretation”.115

The use of the CBP in a co-operative way, in order to interpret Article 5.7 of the SPS Agreement, would imply a broad and deep discretion for the competent adjudicating body, which would extend WTO law also to other legal sources. Nevertheless, the judicial authority is often supposed to do so, and in many legal systems, the development of public law has constantly been conditioned by judges’ interpretations. Although the question is all but pacific, using more recent and specific treaties related to these interests to interpret WTO law does not seem in conflict with the WTO Preamble or with the aim of the WTO itself and neither with the function of an adjudicative body. The Preamble of WTO includes, among the general objectives of the organization, the “optimal use of the world’s resources in accordance with the objective of sustainable development” and “to protect and preserve the environment”. Besides that, the general purpose of WTO law is to spread and develop economic welfare around the world, not to protect trade per se: “Trade is not a value, it is only an instrument… to increase the economic welfare of all states”.116 The aim and the rationale to have the WTO are to find a balance between the different interests at stake and even if the law of the organization is above all trade-related and -oriented it must aim at a fair and balanced trade. In order to reach this last objective in particular, the WTO institutions should take in consideration the evolution of general international law, its environmental and social limits, and the effects they could have on trade. Finally, if we consider the DSB in its adjudicative function and the Marrakech Agreements as the (world trade) constitutional-like text of reference, it is to stress how the former should use its interpretative powers about the latter, after more than ten years and with so many factual and legal evolutions surrounding it. In the legal sciences there are at least two literatures concerning constitutional judicial interpretation. One states that a constitutional text should be interpreted in accordance to the original meaning at the moment of entry into force. In this perspective, it is denied that the interpretation of the Constitution by lawyers and legal scientists should follow the evolution of society, a duty which should be left, instead, to the legislature, also in regard of the constitutional reforms. A different doctrine recognizes, particularly to the constitutional court, an active role of constitutional and systemic revision and reinterpretation, based on its technical and cultural legitimacy and on its function of the guaranty of 115

M. Koskenniemi, Fragmentation Of International Law: Difficulties Arising From The Diversification And Expansion Of International Law. Report of the Study Group of the International Law Commission (Geneva: International Law Commission, Fifty-eighth session, 1 May-9 June and 3 July-11 August 2006), available at http://www.un.org/law/ilc/, p. 237-238.

116

J. Pauwelyn, ‘Conflict of Norms in Public International Law’ (2004) 3 Nordic Journal of International Law 73, p. 88.

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pluralism. Therefore, such doctrine emphasizes the evolutionary character of constitutional interpretation, in virtue of the continuous change of society. As evident, for the case at stake, the dichotomy remains as the Dispute Settlement Panel of the WTO might have adopted either one or the other interpretative approaches, in both cases discontenting one of the two parties of the dispute. It is to be remembered, however, that the rationale of the first theory, requiring a textual interpretation coherent with the original meaning of the norms, does rely on the activity of a representative legislature. In the global legal space, however, the latter is lacking, or it is sectoral or scarcely accountable. Finally, we can conclude by saying that the Panel adopted a prudent and formally correct approach: the complaining parties did not ratify the CBP or the Convention on Biodiversity and they could not be affected by its regulations or by its rationale. However, this fact shows another controversial aspect of global food safety law: considering the impact of DSB decisions over national regulations, the refusal of ratification given by the complainants frustrated the application of a legitimate and legally binding international agreement. We may thus ask: What if the EU put its regulation in conformity with WTO law disregarding its obligations towards the other parties of the CBP? Which law is to be applied then to regulate transportation and authorization of genetically modified organisms? And, does the mere fact that some Countries did not ratify such agreement make it invalid all the time it is in contrast with WTO law, approved almost 10 years before? Again we see how certain sectors are more effectively regulated than others are, so that food law is, for certain provisions, a global matter, while being at the same time national for others. The applicable law can sometimes trespass (and affect) national sovereignty, while in other cases be stopped by the free will of the States.



3.7 Conclusions

To sum up, the EC-Biotech case concerns three trade-restrictive measures of the EU: two indirectly implemented through a de facto denial of market authorization of GMOs, and considered illegitimate under Article 8 and Annex C(1)(a) of the SPS Agreement by the Panel ruling the case; the third one consisting of nine bans of GM products issued by six Member States of the EU, also judged inconsistent with the SPS Agreement as, without providing an adequate justification, violated Articles 2.2 and 5.1 of the Agreement. Moreover, the Panel excluded the application of Article 5.7 to justify the EU measures, as the latter and its Members could not demonstrate the impossibility of performing a risk assessment due to the insufficiency of scientific information. Finally, the adjudicatory body also denied the application of the CBP to interpret – following a precautionary orientation – the provisions indicated in Article 5.7 in their most doubtful respects. The exclusion of the CBP was mainly based on the fact that three Countries of the dispute did not ratify that agreement.

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The dispute raises some problematic questions: If on one side the procedural approach of the Panel adopted to evaluate the moratoria seems fair and correct, and easy to harmonize, as it relates to a general and common administrative principle for which administrative authorities are required to reply to the public’s requests with appropriate answers in a reasonable amount of time, the issues concerning the dilemma between risk-taking or precaution are more controversial, as they affect the substance of public decisions. So they raise questions, which are still open: Is the preventive approach enough to ensure health protection in situations of scientific uncertainty? How does such requirement affect national authorities’ discretion? Can the precautionary principle be implied by WTO law? What kind of impact does its exclusion have on constitutional law and democratic policies of the EU? How is the conflict in international laws going to be solved?



4 United States – Certain Measures Affecting Imports of Poultry from China

The analysis of the two preceding decisions focused on two paradigmatic cases, useful to illustrate the characters, the problematic issues and the possible future developments of food safety law and regulation, particularly with reference to the WTO system. Notably, the EC-Hormones case, being the first decision ruled upon under the scope of the SPS Agreement, is particularly important as it is very often used by DSB judges as the main precedent to use to interpret the norms of the Treaty and to solve new disputes. However, it is to stress as well another case, more recent, and useful to have a more complete picture of the system, while updating our study on food safetyrelated decisions at the global level: United States – Certain Measures Affecting Imports of Poultry from China (US-China Poultry).117 In the case at stake, following a complaint of China, the Panel found that an SPS measure adopted by the US Congress – Section 727 of the Omnibus Appropriations Act 2009 – affecting poultry coming from China, was inconsistent with: (a) Articles 5.1 and 5.2 of the SPS Agreement because it was not based on a risk assessment which took into account the factors set forth in Article 5.2; (b) Article 2.2 of the SPS Agreement because it was maintained without sufficient scientific evidence; (c) Article 5.5 of the SPS Agreement because the distinction in ALOPs for poultry products from China and for poultry products from other WTO Members is arbitrary or unjustifiable and that this arbitrary or unjustifiable distinction in ALOPs results in discrimination against China; (d) Article 2.3 of the SPS Agreement, first sentence, because the inconsistency of Section 727 with Article 5.5 of the SPS Agreement necessarily implies that Section 727 is 117

WTO, United States – Certain Measures Affecting Imports of Poultry from China, WT/DS392/R, Report of the Panel 29 September 2010, adopted by the DSB on 25 October 2010, http://wto.org/english/tratop_e/ dispu_e/cases_e/ds392_e.htm#top.

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also inconsistent with Article 2.3 of the SPS Agreement; (e) Article 8 of the SPS Agreement because Section 727 has caused an undue delay in the Food Safety and Inspection Service (“FSIS”) approval procedures and thus the United States failed to observe the provisions of Annex C(1)(a) of the SPS Agreement. The Panel declined to rule on China’s claim that Section 727 was inconsistent with Article 5.6 of the SPS Agreement and found that Section 727 was also inconsistent with: (a) Article I:1 of the GATT 1994 because the United States was not extending an advantage immediately or unconditionally to the like products originating from China, an advantage that it has extended to all other WTO Members; (b) Article XI:1 of the GATT 1994, because during the time it was in operation, Section 727 imposed a prohibition on the importation of poultry products from China. Finally, the Panel found Section 727 not to be justified under Article XX(b) of the GATT 1994 because it was inconsistent with Articles 2.2, 2.3, 5.1, 5.2 and 5.5 of the SPS Agreement and declined to rule on China’s claim that Section 727 was inconsistent with Article 4.2 of the Agreement on Agriculture. On this ground, as the Panel stated that the United States had acted inconsistently with the specified provisions of the SPS Agreement and the GATT 1994, it had nullified or impaired benefits accruing to China under those agreements. However, given that the measure at issue has now expired, they did not recommend that the DSB request the United States to bring the relevant measure into conformity with its obligations under the SPS Agreement and the GATT 1994.118 Besides the ones already mentioned for the previous cases, the norms of reference for the “U.S. – China Poultry” case are: SPS Agreement, Article 2.3: “Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade”. SPS Agreement, Article 5.2: “In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment”. SPS Agreement, Article 5.5:“With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. 118

Ibid., paras. 8.1-8.7.

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Members shall cooperate in the Committee, in accordance with paragraphs 1, 2 and 3 of Article 12, to develop guidelines to further the practical implementation of this provision. In developing the guidelines, the Committee shall take into account all relevant factors, including the exceptional character of human health risks to which people voluntarily expose themselves”. GATT I:1: “With respect to customs duties and charges of any kind imposed on or in connection with importation or exportation or imposed on the international transfer of payments for imports or exports, and with respect to the method of levying such duties and charges, and with respect to all rules and formalities in connection with importation and exportation, and with respect to all matters referred to in paragraphs 2 and 4 of Article III, any advantage, favour, privilege or immunity granted by any contracting party to any product originating in or destined for any other country shall be accorded immediately and unconditionally to the like product originating in or destined for the territories of all other contracting parties.”



4.1 The case

The U.S. House of Representative, on 25 February, and the U.S. Senate, on 10 March 2009, approved a provision in the US Spending bill – Section 727 of the Omnibus Appropriations Act 2009 – stating that “none of the funds made available in this Act may be used to establish or implement a rule allowing poultry products to be imported into the US from the People’s Republic of China”. Section 727 was accompanied by a Joint Explanatory Statement (“JES”), which provided the following “There remain very serious concerns about contaminated foods from China and therefore the bill retains language prohibiting FSIS from using funds to move forward with rules that would allow for the importation of poultry products from China into the U.S. It is noted that China has enacted revisions to its food safety laws. USDA is urged to submit a report to the Committees on the implications of those changes on the safety of imported poultry products from China within one year. The Department is also directed to submit a plan for action to the Committees to guarantee the safety of poultry products from China. Such plan should include the systematic audit of inspection systems, and audits of all poultry and slaughter facilities that China would certify to export to the U.S. The plan also should include the systemic audit of laboratories and other control operations, expanded port-of-entry inspection, and creation of an information sharing program with other major countries importing poultry products from China that have conducted audits and plant inspections among other actions. This plan should be made public on the Food Safety and Inspection Service web site upon its completion”.119 119

JES, Division A of AAA of 2009, p. 82.

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According to China, the possibility for poultry products to access the US market had been cut off by the mentioned legislation passed by the United States Congress, as it restricted the ability of the United States Department of Agriculture (“USDA”) and its agency, the Food Safety and Inspection Service (“FSIS”), to use funds allocated by the US Congress for the purpose of establishing or implementing a rule permitting the importation of poultry products from China into the United States. For these reasons, on 17 April 2009, China requested consultations with the United States concerning certain measures taken by the United States affecting the import of poultry products from China. Then, after the failure of the consultation, on 23 June 2009, China requested the establishment of a panel that the DSB established on 20 July 2009. China claimed that Section 727 was inconsistent with Articles I:1 and XI:1 of the GATT 1994; Article 4.2 of the Agreement on Agriculture; and, under the SPS Agreement, with Article 2.3, because it arbitrarily and unjustifiably discriminates against China; Article 5.5, because the higher level of sanitary protection applied to China is arbitrary and unjustifiable, resulting in discrimination; Article 5.1 and 5.2, because it is not based on a risk assessment within the meaning of Article 5.1 that takes into account the factors in Article 5.2; Article 2.2, because it is not maintained nor based on scientific evidence; Article 5.6, because it is inconsistent with the obligation that SPS measures not be unduly trade-restrictive; and Article 8, because the delay resulting from its application is unjustifiable, or undue.120 Indeed, the contested measure can be seen as a properly internal provision that prohibits appropriated funds from being used to establish or implement a rule allowing poultry products to be imported from China: Using its political and regulatory discretion and exercising its oversight power over the executive branch, the US Congress decides how to allocate the money it disposes, cutting funds for what concerns the implementation of a rule allowing the import of goods not considered safe. Nonetheless, it is clear how such a measure would affect China’s economic interests in exporting poultry to the United States. As Section 727 means that no funds can be expended by the sole executive branch department responsible for creating and implementing these rules on poultry imports from China, it thus limits the competitive opportunities for Chinese poultry products and effectively restricts imports of Chinese poultry products to zero. The measure is therefore trade-restrictive. The problem, which the Panel was called to solve, is if such measure can be considered justified by reason of health protection. According to the USA, the funding restriction of Section 727 was a reaction to China’s major problems of food safety enforcement: interestingly, the United States contested the effectiveness of the food safety system of regulation adopted

120

US-China Poultry, para. 3.1.

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in China, assessing it as incapable of preventing certain risks.121 In order to confirm this belief, they reported that: “In 2007, adulterants added to pet food ingredients by Chinese producers led to the deaths of thousands of US domestic animals. In 2008, adulterants added to milk by Chinese processors sickened hundreds of thousands of persons, and led to the deaths of over a dozen children. The contamination of these products was not allowed under China’s food safety laws. Rather, these food safety crises arose from massive failures in China’s system of food safety enforcement”.122

The Panel made its decision on 29 September 2010, and declared the US SPS measure inconsistent with WTO Law and unduly restrictive of international trade. The Panel’s decision relied mainly on the violations of Articles 2.2, 2.3, 5.5, 5.1 and 5.2: being Section 727 based on the idea that the Chinese food safety regulatory system was not effective, the US did not identify on which grounds it reached such a conclusion and, therefore, rendered discriminatory treatment, if compared with other Countries.



4.2 The conclusions of the Panel

One of the main issues involved in the case is discipline of the equivalence regime of Article 4 of the SPS Agreement. This has been partially dealt with by the competent Panel that, disappointingly, lost an occasion to shed light on a significant and delicate disposition of the SPS Agreement. Article 4 provides that: “Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member’s appropriate level of sanitary or phytosanitary protection. For 121

T he legislative basis for the import and inspection procedures relating to the import of poultry products into the United States is the Poultry Products Inspection Act (PPIA). In order to implement the latter, the Secretary of Agriculture is authorized to make rules, which are detailed in section 381.196 of Title 9 of the Code of Federal Regulations (CFR), and are enforced by FSIS. In accordance with 9 CFR § 381.196, eligibility to export poultry products to the United States requires completing three sequential steps. In the first one, a 3-5 year procedure known as an “initial equivalence determination”, the FSIS investigates whether the food safety measures of the exporting country are equivalent to those employed by the United States. The FSIS investigation includes a document review stage and on-site audits. If equivalence is confirmed, this step culminates in the establishment of a rule in the CFR stating that the country is eligible to export poultry products to the United States. In the case at issue, China’s poultry failed in this first step.

122

US-China Poultry, para.4.38.

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this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures”.

The norm foresees certain discretion upon member states in deciding their own level of SPS protection. This must be respected by the exporting Country, which bears the burden to prove its products are safe and comport to the standards of the importing Country. If such requisite is satisfied, then the product is to be allowed to enter the market of the receiving State. However, rather for this reason, the exporting Country must give access, upon request, to the importing one, in order to perform inspection, testing and other procedures. The effects of such provision are that in the field of food safety, certain typical domestic activities, consisting of performing inspections, controls, sanctions and so on, are no more exclusively national, but also open to foreign authorities, as they need to satisfy the criteria requested by the other Member States of the WTO. This means also that a Country can perform activities of surveillance and control over public authorities of other member States, monitoring if the latter act consistently with the required standards. As the description of the case shows, Section 727 concerned this issue. Nonetheless, in order to refuse the import of certain goods on the ground that the exporting Member does not have an appropriate level of sanitary or phytosanitary protection, implies a proper justification on behalf of the importing State. In the case at stake, the parties disputed two main issues: first, whether Section 727 was part of an equivalence regime, and second, whether it was the type of SPS measure subject to the obligations embodied in Articles 2 and 5 of the SPS Agreement or rather only subject to Article 4 of the SPS Agreement. At the first, the Panel recognized that China had made no claim with respect to the consistency of Section 727 with Article 4 and thus Article 4 was outside its terms of reference. Therefore, they did not go into an analysis of what is required to comply with the obligations in Article 4. And, as there is no SPS adjudicatory decision ruling on Article 4, this was a lost opportunity to shed more light on such provision. Nonetheless, the Panel decided to spend some words on the norm at stake and they did it by referring to a decision from the SPS Committee, entitled “Decision on the Implementation of Article 4 of the Agreement on the Application of Sanitary and Phytosanitary Measures (the Decision)”.123 Its preamble provides 123

Committee on Sanitary and Phytosanitary Measures, Decision on the Implementation of Article 4 of the Agreement on the Application of Sanitary and Phytosanitary Measures, document G/SPS/19/rev. 2, dated 23 July 2004. This Decision was adopted under the authority of the SPS Committee to carry out the functions necessary to implement and further the objectives of the SPS Agreement under Article 12.1, stating “A Committee on Sanitary and Phytosanitary Measures is hereby established to provide a regular forum for consultations. It shall carry out the functions necessary to implement the provisions of this Agreement and the furtherance of its objectives, in particular with respect to harmonization. The Committee shall reach its decisions by consensus”.

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that the Decision was adopted “[d]esiring to make operational the provisions of Article 4” of the SPS Agreement. As reported by the Panel at paragraph 7.135, “the Decision sets out guidelines for any Member who requests the recognition of equivalence of their SPS measures and for the importing Member who is the addressee of such request. As contemplated in the Decision, upon a request for equivalence, the importing Member should explain the objective and rationale of the SPS measure and identify clearly the risks that the relevant measure is intended to address.124 The Decision further explains that the importing Member should indicate the ALOP [appropriate level of sanitary or phytosanitary protection] which its SPS measure is designed to achieve.125 Such an explanation should be accompanied by a copy of the risk assessment on which the SPS measure is based or a technical justification based on a relevant international standard, guideline or recommendation.126 The exporting Member should then provide appropriate science-based and technical information to support its objective”.

As it is immediately clear, and as the Panel noted in paragraph 7.136 and ff., Article 4 cannot be applied in a vacuum, isolated from the other provisions of the SPS Agreement. This means that the rationale and the philosophy of the Agreement cannot be compromised by arbitrary decisions regarding national food safety systems. Also in this case, as for other kinds of SPS measures, there is the need to justify as neutral and objectively necessary any trade-restrictive measure based on the ground of Article 4, thus, by recalling the application of Articles 2 and 5. On such an issue, the following questions arise: without standardization, how would an importing state establish a necessary limit to consider the exporting member’s food safety system satisfying its level of protection? How much discretion would have the adjudicatory body in establishing if the level of efficiency requested by the importing Country is arbitrary or reasonable? Can we require, also in this case, a strict scientific demonstration or can we allow decisions based on statistics and empirical data? Having established that Section 727 had to be justified under all the applicable provisions of the SPS Agreement, the Panel ruling US-China’s Poultry developed its analysis on scientific justification and, through the analysis of Articles 5.1, 5.2 and 2.2 of the Agreement, it confirmed the previous orientation on such matter. The Panel held: “Having examined the evidence presented by the parties, the Panel thus concludes that China has made a prima facie case that the United States has not conducted a risk assessment in respect of Section 727, within the terms of Articles 124 125

Committee on Sanitary and Phytosanitary Measures, Decision on the Implementation of Article 4, para. 2.

Footnote 3 of the Decision states that “[i]n doing so, Members should take into account the Guidelines to Further the Practical Implementation of Article 5.5 adopted by the Committee on Sanitary and Phytosanitary Measures at its meeting of 21-22 June 2000, Ibid.

126

Ibid., para. 2.

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5.1, 5.2 and Annex A(4) of the SPS Agreement. The Panel further concludes that the United States has not rebutted the presumption of inconsistency. Therefore, the Panel finds that Section 727 is not based on a risk assessment and is therefore inconsistent with the obligations in Article 5.1 and 5.2 of the SPS Agreement”.127

Once again, we had the confirmation of the necessity to have a legal justification for the adoption of SPS measures and that this is based on a scientific evaluation of probable risks. Whereas an SPS measure is not based on a risk assessment as required in Articles 5.1 and 5.2 of the SPS Agreement, this measure is presumed not to be based on scientific principles and to be maintained without sufficient scientific evidence, so it is also illegitimate under Article 2.2 of the Agreement at stake. As ruled in the past by the Appellate Body, Articles 2.2 and 5.1 of the SPS Agreement should “constantly be read together”,128 because Article 5.1 of the SPS Agreement may be viewed as a specific application of the basic obligations contained in Article 2.2 of the SPS Agreement. This confirms the interconnectedness of all the provisions of the SPS Agreement and the centrality of science as a criterion of justification for SPS measures. This should work as well in the evaluation of foreign regulatory systems: it seems quite clear as one Member State cannot arbitrarily establish that another one does not comply with the basic standards of safety, and therefore there is the need to justify such a conclusion. In addition, without an official standardization of principles, rules and institutions integrating national food safety systems, also the diversity between two States can ingenerate problems. On one side, the more prudent one may use its health protective approach to discriminate against a competing foreign market. On the other, the necessity to avoid hidden protectionism and to harmonize the standards reduces the level of protection to a minimum, and causes a race to the bottom as a Country with a high level of health protection will have to accept goods from another one, with a less effective one, if a probable risk is not demonstrated. And, for the latter, the scientific – as well as the empirical – proof that a food safety system is not effective, i.e. risky, in protecting food safety is not an easy task to perform in front of a dispute settlement body, which will often lead both to further open the market and reduce the food safety standards. Another relevant reasoning performed by the Panel concerns discrimination and the application of Article 5.5 of the SPS Agreement, which embodies a nondiscrimination principle in respect of the application of the appropriate level of sanitary or phytosanitary protection (“ALOP”). This provision reads as follows: “With the objective of achieving consistency in the application of the concept of appropriate level of sanitary and phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate 127

US-China Poultry, para. 7.192.

128

Appellate Body Report, EC-Hormones, para. 180.

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in different situations, if such distinctions result in discrimination or a disguised restriction on international trade”.

Annex A(5) further defines the concept of ALOP as “the level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory”. The findings of the Panel, in continuum with precedent decisions, are that despite the autonomy of each member to determine its ALOP, this must not be arbitrary and vague, so that it also has to be motivated, and it must not be discriminatory, so that its ALOP cannot be different for different Countries for the same goods in the same conditions or towards like products coming from the same State. The first issue brings us back to scientific demonstrations of a specific risk (“the United States would have to demonstrate that poultry products from China presented a greater risk than poultry products from other WTO Members”);129 the second one is a significant provision to avoid discrimination for comparable situations. For what concerns discrimination, the Panel held that: “Having found that the importation of poultry products from China and that of poultry products from other WTO Members are different yet comparable situations and that the United States is applying different ALOPs to such situations; that the distinction in ALOPs for poultry products from China and for poultry products from other WTO Members is “arbitrary or unjustifiable”; and that this arbitrary or unjustifiable distinction in ALOPs results in “discrimination “ against China, we conclude that the three elements of Article 5.5 of the SPS Agreement are present. Accordingly, the Panel finds that Section 727 is inconsistent with Article 5.5 of the SPS Agreement”.130

Also for what concerns discrimination, the capacity of a member State to provide the evidence that justifies its measure is necessary. It is rather peculiar and significant that such a delicate issue as health protection, being used to easily protect internal markets or discriminate, ends up to be connected to such a rigid system of justification. No matter that health protection can be a sensitive issue for a Country; if a trade-restrictive measure is applied, this is to be justified, either if it is non-discriminatory, or even more, if it treats differently goods coming from different countries.



4.3 Conclusions

The decision on US-China Poultry gives a confirmation of the trends of the previous disputes under the SPS Agreement. We can define at least five relevant insights, coming out of the analysis of the case. 129 130

US-China Poultry, para. 7.250.

Ibid., para. 7.294.

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First, the Panel used the same hermeneutical criteria and logical approach that was used by the precedent Panels and by the Appellate Body in the previous cases. In addition, it frequently recalled the EC-Hormones case – besides EC-Biotech and Japan-Apples, among the others – in order to clarify the interpretation of the SPS provisions and to solve the dispute. Secondly, the decision confirms that any trade restrictive measure for reason of health protection cannot be arbitrary and needs to have a solid justification, under the procedural principles and the rules of the SPS Agreement. More precisely, national SPS measures result in much reduced discretion, as Member States are called upon to give a sound demonstration of risk probability. This reduces the teleological and political moment of health protection policies. Sometimes it neutralizes them, avoiding arbitrariness; some other times, it comprises them under a trade-oriented system, which does not allow precautionary derogations. Thirdly, once again the results of scientific studies are determinant in the decision-making under the SPS Agreement, as they satisfy the requisite of scientific evidence required by Article 2.2 and are thus reliable to demonstrate the necessity of a national SPS measure. This happens as well when a Country wants to contest the efficiency and the effectiveness of a foreign food safety system. As all the SPS provisions are connected together and cannot be considered in isolated way, also the right of the States – to adopt their own ALOP and to check foreign systems of food safety regulation – must be grounded on a proper justification based on science. Fourth, the Panel underlines how the importance of scientific justification is even higher when the trade restriction implies as well discrimination towards a specific Country. If the latter is treated worse than the other ones, then the importing State is required to justify this different treatment, demonstrating its necessity. Finally, the Panel’s decision demonstrates that the activity of food safety regulation is no more exclusively national, as even the internal system of inspection, controls and administration can be the object of judgment by another member State, which can contest – if there is justification for such a decision – the system and refuse to import food products from there.



5 Final remarks: positive and negative elements of the global food safety system

The study of the presented cases is useful to develop some problematic insights of food safety law and regulation. First, national administrative regulations of food safety are no longer independent and exclusive. Prohibiting the use of certain substances in one Country, enacting a too severe mechanism of authorization or contesting the administrative system of food safety of another Country have consequences and a concrete

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impact also on foreign citizens and on their interests and expectations. Emblematically, this happens also for the inaction of the administrations, as for “laisseiz faire” regulations, which rely on the balance created by the play of the actors in the market arena: as the interdependency of the global markets gives a regulatory relevance also to private activities, these are able to condition the activity of the administrations in other territories. For instance, by following the doctrine of the “race to the bottom”, we see that loosening a regulation for a transnational good can influence also the regulators of other countries, leading them to apply the same approach, as far as they are not able to find an ascertainable risk in the contested regulatory method. This produces the need for common principles and norms, although the matter of food and of its safety does still not present global common values and policies, and is shown to be at the same time global, regional, national and local. Second, the centre of the food safety legal framework is trade. More precisely: food trade. Dealing with a global regulation means focusing on a matter that developed more than other ones in the global sphere of law, such as the worldwide movement of goods, which requires worldwide norms, principles and rules in order to regulate it and to regulate the activity of national or local regulators. As any economic activity does, and more than other ones, food production and trade of food products necessitate policies, directives, limits, authorizations and controls. However, these are different in each Country and such differences have a considerable effect on international free trade. Guaranteeing the safety of our food might become a way to enforce protectionist measures, to produce unequal or discriminatory treatments and to allow privileges to certain actors to the detriment of others. As in national legal orders, also in the global legal space, the law and its actors have as their main purpose to strike a balance among competing interests, to create an order aimed to guarantee stability and affordability, to establish common rules, which everyone is required to respect (“everyone is equal before the law”) and to ensure a fair and impartial implementation of the latter. However, and this is the third point, the actual legal framework presents at least three main criticisms: • It is sectoral and fragmented, as the rationale of trade regulation tends to prevail and spill over into other fields, as all the international laws covering the matter are in a disharmonious relationship and not being applied or observed in the same way; • It is too strongly based on scientific results, while the latter seems not always able to ensure soundness and objectivity; • It is too centralized, as national democracies and local policies are diminished by decisions coming from extra-national organizations, which – being very far away in a long chain of government entities – are unable to guarantee the same level of transparency, accountability and people empowerment. Third, the science-based mechanism of decision appears to be too rigid and controversial. The criticism stems from the fact that the scientific result of an 90

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experiment may be often open to several possibilities – due to lack of enough time to see effects in the long run, to the lack of developed scientific tools to make the experiments with new technologies, and so on. That is why it is still a scientific method to end and conclude an experiment affirming that there is the need to continue experimenting, with the implication of a precautionary stop. However, here the problem is the need of a final decision, which regards applying or not applying a trade restrictive SPS measure. The effectiveness of the scientific results are the only way to admit decisions about SPS measures: if a Country demonstrates – scientifically – that there is a risk, at least in terms of probability, then it can adopt an SPS measure restricting the market; if not, it has to open its market to those goods. This “black-and-white” approach does not allow discretion based on scientific uncertainty, even if that is also a scientific approach. The need to have a final decision, based on the idea of maintaining interconnected markets avoiding all unnecessary barriers, leads to this decisional mechanism, grounded on the final result of scientific studies. Fourth, the actors of global food safety law and regulations are several. national authorities still play a significant role, above all in the implementation and execution of the policies, but also in the application of the general norms. This, however, occurs in a heterogeneous way: while trade rules are more generally spread and more effectively applied through their materially binding force, environmental and health norms still have a fragmented or less effective implementation. International organizations also play a strategic role in issuing common worldwide standards, as the CAC does. National States, acting in the international community also participate in the game, by negotiating and ratifying international treaties and by starting international disputes with notable effects on domestic regulations. Finally, the adjudicatory bodies of the WTO bear great responsibility in clarifying, interpreting and applying WTO law and in particular the SPS Agreement. Fifth, the described form of governance does not happen all at the same level. It not only involves different actors from various legal orders, but also entails different legal frameworks in an indefinite and non-institutional global arena. Here, the decision-making is case-by-case oriented, fluid and highly proceduralized. It is centralized and local at the same time. These extra-national decision-making procedures can have the effect of increasing fairness and formal guarantees, for instance requiring and ensuring that administrative authorities make decisions promptly and effectively. Nonetheless, they can reduce other guarantees, as policies are no longer determined by the local authorities – closer to the citizens – but by global ones, less transparent and less accountable than the former. Moreover, formal equality is enhanced by common rules for all the members of the global community, but substantial equality might be impaired as unrepresented and social interests – like the ones related to health, the environment and consumers protection – have weaker rights to be claimed and indefinite and fragile principles to be invoked.

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In this chapter, I showed the main problems of food safety law and regulation illustrating also the legal basis on which the entire substantial norms are framed. In the next one, I will go deep into the substance of food safety law and regulation, by analysing both the legal texts and both the actors of such a sector of regulation.

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Extra reading: On the EC-Hormones case: V.R. Walter, Keeping the WTO from becoming the World Trans-Science Organisation: Scientific Uncertainty, Science Policy and Factfinding in the Growth Hormones Dispute, in Cornell International Law Journal, vol. 31, n. 2, 1998. G.H. Rountree, Raging Hormones: A Discussion of the World Trade Organization’s Decision in the European Union-United States Beef Dispute, in The Georgia Journal of International and Comparative Law, Summer 1999. R.D. Thomas, Where’s the Beef? Mad Cows and the Blight of the SPS Agreement, in Vanderbilt Journal of Transnational Law, March 1999. R.L. Buchanan, The Development of Science-Based Food Safety Regulations in the United States, in Irish Journal of Agricultural and Food Research, Vol. 39, No. 2, Special Issue on Food Safety (2000). R. Howse, Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organization, in Michigan Law review, June 2000. R. Neugebauer, Fine-Tuning WTO Jurisprudence and the SPS Agreement: Lessons from the Beef Hormone Case, in Law and Policy in International Business, 2000. On the EC-Biotech case and on GMOs Regulation: R. Howse and P. C. Mavroidis, Europe’s evolving regulatory strategy for GMOs – The issue of consistency with WTO law: of Kine and Brine, in Fordham International Law Journal, 2000. T.J. Schoenbaum, International Trade in LMOs: The New Regimes, in International and Comparative Law Quarterly, 2000. J.S. Applegate, The Proemetheus Principle: Using the Precautionary Principle to Harmonize the Regulation of Genetically Modified Organism, in Indiana Journal of Global Legal Studies, Indiana University School of Law, 2001. S.D. Murphy, Biotechnology and International Law, in Harward International Law Journal, 2001. I. Scoones, Science, Policy and Regulation: Challenges for Agricultural Biotechnology in Developing Countries, in U. of Sussex Inst. of Dev. Studies, Working Paper No. 147. F.W.A. Brom, WTO, Public Reason and Food Public Reasoning in the ‘Trade Conflict’ on GM-Food, in Ethical Theory and Moral Practice, Vol. 7, No. 4, August, 2004. L. Boisson de Chazournes and M. M. Mbengue, GMOs and Trade: Issues at Stake in the EC Biotech Dispute, in RECIEL 13(3), 2004. T. Christoforou, The Regulation of genetically modified organisms in the European Union: The Interplay of science, law and politics, in Common Market Law Review, 2004. A.T. Guzman, Food Fears: Health And Safety At The WTO, in Virginia Journal of International Law, Fall 2004. J. Cazale, Food Safety and the Precautionary Principle: The Legitimate Moderation of Community Courts, in European Law Journal, 2004, n. 5, vol. 10. D. Bevilacqua, The EC-Biotech Case. Global v. Domestic Procedural Rules in Risk Regulation: The Precautionary Principle, in European Food and Feed Law Review, 6/2006. D. Bevilacqua, The Precautionary Principle in GMO Regulations: a vertical and horizontal comparison, in Poros project 2005-2007: Eu-India Economic Cross Cultural Programme, European Public Law Series, Vol. LXXXIV, December 2006.

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J.M. Migai Akech, Developing Countries at Crossroads: Aid, Public Participation, and the Regulation of Trade in Genetically Modified Foods, in Fordham International Law Journal, January 2006. D. Prévost, Opening Pandora’s Box: The Panel’s Findings in the EC-Biotech Products Dispute, in Legal Issues of Economic Integration, 2007, n. 34(1). M. Rosso Grossman, Genetically Modified Food and Feed and the US National Environmental Policy Act, in European Food and Feed Law Review, 6/2007. G. Winter, Nature Protection and the Introduction into the Environment of Genetically Modified Organisms: Risk Analysis in EC Multilevel Governance, in Review of European Community & International Environmental Law, 2008, Vol. 17 Issue 2, p. 205-220. F. González Botija, M.Á. Recuerda, P. Díaz Peralta, A. Martínez Cañellas, L. Roda Ghisleri, A. Lago Candeira, E. Alonso García, M.R. Martínez-Larrañaga, and A. Anadón, Legal Regulation of Risk Analysis and Genetically Modified Foods, in European Food and Feed Law Review, 4/2009. A. Lago Canderia, A. Martínez Cañellas, M.Á. Recuerda, E. Alonso García, F. González Botija, P. Díaz Peralta, L. Roda Ghisleri, M.R. Martínez-Larrañaga and A. Anadón, GMOs and Resolution of Conflicts Under the WTO, in European Food and Feed Law Review, 4/2009. A. Martínez Cañellas, M.Á. Recuerda, P. Díaz Peralta, F. González Botija, L. Roda Ghisleri, A. Lago Canderia, E. Alonso García, M.R. Martínez-Larrañaga and A. Anadón, How GMO Administrative Regulations Affect the Private Balance between Seller and Buyer, in European Food and Feed Law Review, 4/2009. M.Á. Recuerda, E. Alonso García, F. González Botija, P. Díaz Peralta, A. Martínez Cañellas, A. Lago Candeira, L. Roda Ghisleri, M.R. Martínez-Larrañaga and A. Anadón, Administrative Authorizations, Risk and Biotechnology, in European Food and Feed Law Review, 4/2009. L. Roda Ghisleri, A. Anadón, M.Á. Recuerda, P. Díaz Peralta, F. González Botija, A. Martínez Cañellas, A. Lago Candeira, E. Alonso García, and M.R. Martínez-Larrañaga, Risk Analysis and GM Foods: Scientific Risk Assessment, in European Food and Feed Law Review, 4/2009. G. Schaffer, A Structural Theory of WTO Dispute Settlement: Why Institutional Choice lies at the centre of the GMO case, in NYU Journal of International Law and Politics, vol. 41:1, 2009. On other SPS-related cases: J. Atik, The Weakest Link: Demonstrating the Inconsistency of “Appropriate Levels of Protection in Australia – Salmon, in Risk Analysis, 2004. L.A. Gruszczynski, United States: Certain Measures Affecting Imports of Poultry from China – Just Another SPS Case?, in European Journal of Risk Regulation 3 (2011): 432-437. Available at: http://works.bepress.com/lukasz_gruszczynski/9. D.H. Regan, United States – Certain Measures Affecting Imports of Poultry from China: the fascinating case that wasn’t, in World Trade Review, Volume 11, Special Issue 02, April 2012, pp. 273-305. C. Herrmann, J.P. Terhechte (eds), European Yearbook of International Economic Law (EYIEL), Vol. 3, Springer, London, 2012, p. 595 ff.

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1 Introduction

In the previous chapters, I have introduced some problematic insights of food safety law and regulation, illustrating how the latter works in its actual application. I will now try to draw a map of the legal framework disciplining food safety in the world legal space. Therefore, stress will be given both to the legal texts applicable to the matter at stake and to the most important subjects operating in the field and their acts. The analysis will start with the study of the main principles governing food safety regulation. We noted that too detailed regulations have the consequence of being excessively narrow in indicating the worldwide common provisions over food safety and so they produce notable limitations in national authorities’ discretion in the administration of this field. On the contrary, the application of general and formal principles, in combination with procedural guarantees of fair action, may have a more definite impact on local differences, realizing unity without compromising diversity and producing common formal rules shared by all the legal orders acting in the community, without imposing the same regulation to all. The global food safety regulation is following both paths in parallel: on one side, through the application of common general principles for the competent authorities; on the other, providing specific and detailed acts regulating single products and/or methods. In the last sense, are to be mentioned the standards issued by the CAC, by the International Office of Epizootics (OIE) and the by the Commission of International Plant Convention (IPPC), which, as will be shown in this Chapter and in the following one, operate as concrete and detailed substantial legal requirements for national food safety regulations. Notably, the chapter is divided in five parts, articulated as follows. First, we consider the general principles and criteria governing global food safety law: the risk analysis procedure, the precautionary principle, and the principles of proportionality and reasonableness. Secondly, the focus is given to the “Joint Food Standards Programme” and the objectives of the Codex Alimentarius Commission. We thus see the purposes and the rationale of the international food standardization, introducing the CAC, which will be treated in more detail in chapter 4. Thirdly, we go through the SPS Agreement and then refer to the TBT Agreement, where it marginally covers the issue of food safety. Fourthly, the analysis regards The Cartagena Biosafety Protocol and its impact on global food safety regulation. Finally, we move to the organizational respect of the regulation, focusing on the main subjects operating in the field at the global level, on their objectives and scope and on their projects and actions. We already noted the role of the WTO and of its adjudicating body. In this chapter, the focus is on the Food and Agricultural Organization (FAO), the World Health Organization (WHO) and some informal bodies connected to these two, and on the International Office (OIE) of Epizootics and the International Plant Protection Convention (IPPC) – for their function as standard setters, analogous to the one performed by the CAC –, as they all operate in the field of food safety.

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2 The legal framework of global food safety law and regulation

In the following paragraphs the analysis will consider the main legal institutes composing global food safety law, including: principles, procedures and decisional criteria, general and specific provisions of international treaties, objectives and rationales of standard setting bodies. The aim is to draw a picture of the existing legal system, showing its functions and its logic, focusing on its critical and controversial issues and seeing possible developments for future regulations.



2.1 Principles and rationale governing food safety law

There are some general principles and procedural schemes covering food safety regulation. Most important, for the substance and the content of the regulation are the risk analysis procedure and the precautionary principle. Considerations will also be made for what concerns the principles of proportionality and reasonability, decisive in governing the procedural aspects of the application of food safety regulation.



2.1.1 The risk analysis procedure As Mr. Bob Griffin, Coordinator of the IPPC Secretariat at FAO,

noted, “the discipline of risk analysis was not a new concept introduced in 1995 with the SPS Agreement. It had existed for over a century and was widely used in such diverse fields as insurance, investment and engineering. He described the broad concept of risk analysis as a systematic way of gathering, evaluating and recording information which would lead to recommendations, positions or actions in response to an identified hazard”.1

In the SPS Agreement the discipline of risk analysis is indirectly recalled in the provisions requiring the Member States to base their measure on risk assessment, reducing the relevance of risk management and risk communication – the other two phases of the analysis – in the justification of the national measures under the scope of the Treaty. In addition, the Agreement at issue provides a definition of “risk assessment”, frequently used in legal disputes to test if States have adopted necessary measures to restrict trade under the dispositions provided by Article 2.2 and, above all, Article 5.1. (as in EC-Hormones and EC-Biotech). As we already saw supra, in Chapter 2, at para. 2.1.3, Annex A of the SPS Agreement defines “risk assessment” as: 1

WTO, Committee on Sanitary and Phitosanitary Measure, Summary Report on the Sps Risk Analysis Workshop, G/SPS/GEN/209, 3 November 2000, para. 11.

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“The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs”.

This definition, as we had the chance to note, can be articulated in four points: • Risk assessment is an evaluation, it can be done in a laboratory or using empirical data but, as its name reveals, it consists of assessing the likelihood of a pest, its consequences, and its effects on humans or animals in consideration of quantity and combinations; • It concerns at least the “likelihood”, meaning it cannot conclude as a generic evaluation of potential risks, but it needs to refer to a certain amount, even extremely reduced, of probabilities of “entry, establishment or spread of a pest or a disease”; • It relates to a specific territory, so it must be specific and localized, it must consider not only the potential biological consequences, but also the economic ones, which, as imagined, imply a different and more discretional evaluation, if we assume economics is not a hard science; • The evaluation is limited to certain products that are “food, beverages or feedstuffs”, so it is sectoral-oriented. Once a risk assessment is performed and in accordance with its results, the discovered risks and their evaluation can be communicated to the public authorities and to the citizens, following the criteria of the risk communication. In addition, the competent administrative body will make decisions on how to manage those risks (accepting them, preventing them, reducing them, and so on), according to the phase of risk management. One important principle governing such procedure is the separation of management from the assessment. The rationale follows the idea that a technical and expert-based body deals with the assessment of the risks, while an administrative, democratic and accountable body makes decisions on how to deal with them. Such a philosophy can be explained by three main reasons: • Guaranteeing neutrality and independence of assessors, not influenced by the need to adopt a decision agreed to by public opinion; • Ensuring better knowledge and information for the managers, who will be able to rely on scientific findings and to justify their measure through the recall of those technical conclusions; • Developing a two-fold mechanism of decision-making, which implies expertise and neutrality, and, at the same time, political or administrative discretion, and accountability.

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In order to analyse and clarify the rationale of food safety risk analysis – in that the phases are not three, but indeed four (as also “risk policy” is included) – other two legal sources are of main importance: “The Working Principles For Risk Analysis for Application in the Framework of the Codex Alimentarius”2 and the “Food safety risk analysis”3 guide of the Food and Agricultural Organization for national food safety regulators. The study here only focuses on the first document. However, insights of the food safety risk analysis guide of the FAO will be provided infra, in the section dedicated to FAO. The first document has the objective of providing guidance to the Codex Alimentarius Commission and the joint FAO/WHO expert bodies and consultations. Here, we are presenting all the requisites and the definition of the Risk Analysis procedure. In the next chapter, dedicated to CAC and to its activity, we will evaluate if these are effectively respected and implemented. Section V provides the principles to be applied to risk analysis for its application in the framework of the Codex Alimentarius. In particular, for what concerns the crucial separation between the technical and scientific findings and the discretional and political decisions on risk, Article 3 establishes that “the responsibility for providing advice on risk management lies with the Commission and its subsidiary bodies (risk managers), while the responsibility for risk assessment lies primarily with the joint FAO/WHO expert bodies and consultations (risk assessors)”. Such procedure should be: • applied consistently; • open, transparent and documented; • conducted in accordance with both the Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to Which Other Factors are Taken into Account and the Statements of Principle Relating to the Role of Food Safety Risk Assessment;4 and • evaluated and reviewed as appropriate in the light of newly generated scientific data” (Section V, Article 4). In addition, “the risk analysis should follow a structured approach comprising the four distinct but closely linked components of risk analysis (risk policy, risk assessment, risk management and risk communication) as defined by the Codex Alimentarius Commission,5 each component being integral to the overall risk analysis” (Section V, Article 5). Here the Codex Manual only specifies the formal and procedural guarantees concerning risk analysis, requiring thus consistency, transparency, scientific 2

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission Procedural Manual, cit., p. 75 et seq.

3

FAO, Food safety risk analysis. A guide for food safety authorities, FAO Food and Nutrition Paper no. 87, Rome, 2006, ftp://ftp.fao.org/docrep/fao/009/a0822e/a0822e00.pdf.

4

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission Procedural Manual, cit. Appendix, p. 185 et seq.

5

 Ibid., Definitions of Risk Analysis Terms Related to Food Safety, p. 81 et seq.

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basis and coherence with other related norms. Moreover, it indicates the structure of the procedure, composed of four stages. 1) Risk policy (RP). Article 9 of Section V specifies that “there should be a functional separation of risk assessment and risk management, in order to ensure the scientific integrity of the risk assessment, to avoid confusion over the functions to be performed by risk assessors and risk managers and to reduce any conflict of interest”. However, as we also saw for national authorities enacting SPS measures, such separation is almost impossible in front of scientific uncertainty and it is not strictly respected whereas policy guidance is often provided for the risk assessors. The idea of separating risk assessment from risk management belongs also to European food safety law, and it responds to a widely shared logic of neutrality and discretion, combined in the same decisionmaking but attributed to different subjects. Nonetheless, such separation risks being merely a formal statement as, with the increment of cases where an uncertain scientific activity is to be combined with a highly political regulatory one, it is more and more difficult to keep the two phases separated. In conformity with this observation and despite that some literature depicts risk analysis as a three-fold procedure, excluding “risk policy”, Articles 13-16 give a clear definition of such stage of the proceeding. They provide that: “determination of risk assessment policy should be included as a specific component of risk management. Risk assessment policy should be established by risk managers in advance of risk assessment, in consultation with risk assessors and all other interested parties. This procedure aims at ensuring that the risk assessment is systematic, complete, unbiased and transparent. The mandate given by risk managers to risk assessors should be as clear as possible. Where necessary, risk managers should ask risk assessors to evaluate the potential changes in risk resulting from different risk management options”.

The rationale of the cited provision entails a reasonable logic: there are many different tests, which can be applied in the risk assessment phase; therefore, they need to be led towards determined aims and framed in order to obtain a coherent and sound assessment of risk. Nonetheless, this provides evidence of the fact that scientific evaluations preceding risk management are not purely neutral and objectively performed. On the contrary, they are the output of a predetermined policy, which embeds risk assessment into specific studies and analysis. We can thus assume that the phases are indeed four and that they are far from being separated. Moreover, if the procedure is not covered by proper guarantees of impartiality, transparency and accountability, conflicts of interest or unfair political influence can easily occur at every step of the procedure. 2) Risk assessment (RA). As already indicated, Risk assessment is “a scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk

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characterization”.6 In addition, this phase should follow specific procedural criteria in order to ensure enough guarantees of legitimacy, independency and fairness. Namely, “experts responsible for risk assessment should be selected in a transparent manner on the basis of their expertise, experience, and their independence with regard to the interests involved”. In addition, expert bodies and consultations should ensure effective participation of experts from different parts of the world, including developing countries. Moreover, “risk assessment should be based on all available scientific data. (…). Risk assessment may also take into account qualitative information. Constraints, uncertainties and assumptions having an impact on the risk assessment should be explicitly considered at each step in the risk assessment and documented in a transparent manner”. Finally, “minority opinions should also be recorded. The responsibility for resolving the impact of uncertainty on the risk management decision lies with the risk manager, not the risk assessors” (Section V, Articles 18-25).

It seems clear that the Codex’ definition of risk assessment is more vague than the one provided by the SPS Agreement. The first difference between the two is that the former is directed to international scientific committees, while the latter refers to the national States. The Codex definition does not refer to the “likelihood” of risk and concentrates on information about the hazard; while the SPS definition requires a more conclusive assessment. That is, as we will see better later on, because for the former the RA is a mere base on which to open a discussion for the elaboration of international standards. While, for the latter, RA is the necessary moment on which to base and justify a national policy with trade-restrictive effects. 3) Risk management (RM). Risk management is “the process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options”.7 It is interesting to note that Article 27 specifies that: “while recognizing the dual purposes of the Codex Alimentarius are protecting the health of consumers and ensuring fair practices in the food trade, Codex decisions and recommendations on risk management should have as their primary objective the protection of the health of consumers. Unjustified differences in the level of consumer health protection to address similar risks in different situations should be avoided”.

Such a statement results as a significant integration of the main twofold purpose of the CAC. Nonetheless, it is pretty difficult to evaluate its actual application as 6 7

 Ibid., p. 81.

 Ibid., p. 81.

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every single standard has its different story and rationale, and as the provision of the Procedural Manual applies as a guideline for standard setters and not as a proper binding principle to be observed and guaranteed by an external control. The phase of RM is to be based on risk assessment but considerable discretion is left on behalf of the managers: “The decisions should be based on risk assessment, and taking into account, where appropriate, other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade” (Section V, Article 28). As noted, despite the previous reference to the prevalence of health protection, here a specific provision explicitly foresees taking into account also the fair practices in food trade. CAC’s risk managers are required to include both the scientific results of risk assessment and all the other relevant factors to be considered for the decision. Such factors, however, can assume the status of relevance if they enter the scope of the purposes of the CAC, meaning that risk managers must evaluate and balance the impacts of the standard on consumers’ health and on trade practices. Finally, formal guarantees are also required, as risk management is to “be transparent, consistent and fully documented” (Section V, Article 31). 4) Risk communication (RC). RC is “the interactive exchange of information and opinions throughout the risk analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions”. What is interesting to note is the great relevance given to transparency and information sharing through such a phase of risk communication. This is conceived as something further than the simple exchange of data and reports between risk assessors and risk managers, including also “reciprocal communication with member countries and all interested parties in all aspects of the process” (Section V, Article 38). In addition and coherently, it is explicitly indicated that “Risk communication should be more than the dissemination of information. Its major function should be to ensure that all information and opinion required for effective risk management is incorporated into the decision making process” (Section V, Article 39). As reported, any regulatory decision on food safety must follow the scheme pictured by the risk analysis procedure. This is valid for national authorities, as well as for the CAC. Namely, the latter must issue standards after a discussed and agreed upon risk analysis. This is oriented to a precise risk policy, based on scientific reports on which elaborating on and discussing the draft are done, which implies considerations about risk and ways to deal with it, as well as all relevant factors potentially affected by the standard, and put in place through a transparent and open proceeding. The described procedure, as noted, presents several advantages and follows a logical approach for a subject, which is strongly connected to scientific results and findings, and at the same time is political, for being conditioned by tradition, culture and teleological approaches. Nonetheless, as the previously

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analysed cases show, its application is often not so effective, as it is not always clear when RA ends and when RM begins.



2.1.2 The precautionary principle.

In order to illustrate the precautionary principle as applied to the issue of food safety, it is useful to start the analysis on the European legal system. Article 7 of Regulation 178/2002/EC foresees the use of the precautionary principle inside the risk analysis procedure to regulate food safety. The mentioned norm entails the most recent and detailed description of the precautionary principle inside the EU legislation and it presents as the sum of four cumulative requirements on which the principle at issue may be validly adopted. This would happen: Firstly, “in specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified”; Secondly, and with reference to what was just stated, when “scientific uncertainty persists”; Thirdly, when the risk management measures are “provisional” and “necessary to ensure the high level of health protection chosen in the Community”; Fourthly, when there is “pending further scientific information for a more comprehensive risk assessment”. In addition, the second paragraph of the same Article provides that “measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration”. Therefore, the application of the precautionary principle is not imposed in all cases of uncertainty on risk, giving preference to the so-called “worst case scenario”, nor left to the arbitrary will of national authorities as a tool to apply protectionist policies inside the European Common market. On the contrary, it is conditioned to the presence of several requisites, which, nonetheless, still leave the door open for a more discretional approach in the moment of risk administration. The application of the principle of precaution is thus the result of a discretional choice by the competent authorities, which choose if and how adopt a measure (“may be adopted”) in case all the precedent requirements occur. These, as seen, can be identified as the following: the reasonable possibility of risk’s occurrence following scientific evaluations on the available data not producing definite, certain and sound results; the temporality and the necessity of the measure; the need to seek for further scientific information on the subject. In addition, the norm explicitly requires the respect of other fundamental principles of the EU Law, such as proportionality (“proportionate and no more restrictive of trade than is required”) and the application of a fair proce-

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dure. For instance, the latter occurs when administrations are acting after a cost/benefits analysis and considering any other relevant factor (“regard being had to technical and economic feasibility and other factors”). This implicitly prescribes to provide a proper motivation (the duty to give reason is compulsory for every act of the European Union, as Article 263 TFEU foresees, and it is also a typical general principle of administrative law), indicating also the rationale and the purposes of the precautionary decision. When it leads to controversial cases, the mentioned discretion, or, to say better, the conformity of the discretional activity to the requirements listed above, is checked and controlled by a judge. Namely, it is the Court of Justice of the European Union(CJEU) and the General Court (GC), which play a significant role either in interpreting the precautionary principle or in evaluating the legitimacy of its application. It is notable that in such cases the judiciary has a broad power, similar to the one noted for the DSB of the WTO, as it is required to determine if there is an abuse of precaution used as disguised protectionism. However, the CJEU is required to limit its evaluation to respect predetermined principles and decisional criteria, not to evaluate the substantial decisions of the Member States’ authorities. In front of a precautionary decision issued by a domestic administration, the Court will not demand to scientifically demonstrate the presence of a risk – admittedly impossible – but to show the reasonability of fearing a possible risk and to justify the relative measure in accordance with proportionality and fairness. However, the risk of an intrusive judgement, extended to the substance of the decision, is still possible: having to deal with the reasonability, the proportionality and the logical coherence of administrative decisions on scientifically uncertain phenomena may imply an evaluation of the appropriateness of the substantial decisions of the authorities and an implicit teleological judgement. The CJEU and the GC thus present an analogous feature of the DSB, entailing a deep decisional power. Nonetheless, an important difference between the European Courts and the DSB stays in the scope of their jurisdiction: even if the CJEU may also exercise a quasi-normative role, as in reinterpreting and deciding the application of general principles, it conforms and reinvents EU law through its pronouncements; still, it operates as a general-scope court. When it is involved in forms of judiciary activism, the CJEU is entitled to evaluate all the issues and the constitutional values of the European legal order and therefore to make multidimensional decisions for multidimensional problems. While, as noted, the DSB is merely a sectoral (trade) body. Article 7 of Reg. 178/2002/EC reported above does not enter the details of the definition of the precautionary principle. To be precise, it does not define it per se, but indicates the requirements that must be fulfilled in order for the principle to be invoked and so applied. Such vagueness is the result of a deliberate choice, that is to maintain a good amount of discretion on relevant authorities deciding if to apply or not the principle: “The indeterminacy of the precautionary principle is an advantage, because it invites decision makers to search for

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better round for justifying regulatory responses to hazard”.8 This is relevant mainly in three aspects: 1) Firstly, the substantial content of the precautionary principle is open and flexible and it is not for general law to define it in detail; 2) Secondly, and with reference to the precedent point, the precautionary approach is a principle of action, i.e. a meta-procedural criterion indicating to the relevant authorities when and with which requirements they may act prudently in front of scientific uncertainties about possible risks. There is no imposition to act prudently, but a finalization of the regulatory activity on risk towards precaution; 3) Thirdly, the Article provides an interpretative guide and a legal frame for the competent judge to evaluate and eventually sanction the precautionary activity. When the latter does not fulfil one of the requirements of Article 7 or is illogical or disproportionate, it entails an excess of the use of power and can be questioned by an adjudicative body with reference to its formal legitimacy. On the other side of the coin, it is notable that such a lack of clarity could undermine the individuals’ expectations of legal certainty. This is indeed a typical issue of the post-modernity era, also visible in the legal field. Laws are becoming more and more “fluid”, dynamic and flexible, as well as not easily frameable into rigid and stable normative or institutional borders. And that is why, as noted, at the global level so much power is given to the judiciary or to adjudicating bodies: general principles and open rules are determined, then they are to be interpreted and applied case by case in accordance with the factual and legal issues affecting that particular situation. The same happens with the precautionary principle: being related to scientific uncertainty, it is not easy to predict when it is going to be applied and when not, and it is difficult as well to judge when it is applied correctly and when not. As a term of guarantee, as noted, stays the judge with its wide interpretative powers. In addition, in front of a diminution of the “rule of law”,9 as law is no more stable, rigid and affordable as before, the European legislator insisted on the increment of the “rule of reason”,10 leading to procedural and flexible regulation of precautionary activity. It is possible to distinguish two kinds of principles applying to administrative authorities (so to public powers): 8

A. Herwig, The Precautionary Principle in Support of Practical Reason. An Argument Against Formalistic Interpretations of the Precautionary Principle, in C. Joerges and E.-U. Petersmann (eds), Constitutionalism, Multilevel Trade Governance and Social Regulation, Oxford, Oxford University Press, 2006, p. 305.

9

For “rule of law”, or “regle de droit”, is to be intended to be the subordination of administrative authorities to the law, to its principles and to the positive norms entailed by a legal order.

10

With the expression “rule of reason” is to be intended the tendency of public administrations to act in response to logical and reasonable criteria, where positive legislation is not able to produce stable and detailed rules to set the discipline social phenomenon. Reasonability is still coherent with the principles informing a legal system, but implies a wider power on behalf of the authorities, and eventually of the judges, to interpret and elaborate on the general principles and opinions leading into a socio-legal space.

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1. Procedural or formal and 2. Substantial. 1. Procedural ones only concern procedures, formalities and guarantees that agencies have to ensure when they act. For instance: an authority denies an authorization, or performs an expropriation (a compulsory purchase of a good), or imposes a sanction. This authority needs to respect certain formalities. It needs to give a reasonable justification, to respect higher law; it must give rights to the individual to participate or to addressees (recipients) to intervene or to check the documents of the case. This is all that can be connected to the so-called “due process clause”, although it is more than that. Interestingly, this principle is becoming universal. Most of the countries apply it or announce it as a general principle. In the Biotech case, for instance, the delay of the EU was a violation of a typical formal requirement: giving a proper answer on time. Of course, these procedural principles have a big impact also on substantial rights. That is why they are so important. 2. Substantial principles refer instead to all those limits and obligations, which may affect the discretion or even the content of public powers. So, not that they have to decide in a transparent fashion, but that they do have to decide in one sense or in another. For instance, when there is a requirement that a restrictive measure is justified only if based on science: this is not limited on how administrations decide, but also concerns the content and the discretion of authorities, which are considerably reduced. These kinds of norms have a stronger impact on administrative discretion and are rarer. Think about the standards of the Codex. In being administrative-like acts, they apply to national measure as a substantial limit, not as a formal procedural one. As anticipated, this may happen with technical requirements: demanding a conclusive scientific report to a public authority means reducing a lot its discretion in the decision-making; if science says something then it is in a way; if science says another thing then also the decision will change. Thus, we come to some principles/norms, which are on the border, like reasonability and precaution. What does it mean the administration must act reasonably? Who is establishing reasonability? Usually it is the ordinary laws issued by the Parliament and in international law are the bilateral or multilateral treaties. Nevertheless, this reasonability may change and become less or more influential. Then, precaution. In some way, it has a substantial nature by telling administrations to act prudently. However, it does not force them to do so. For the way it is conceived in Europe, it allows authorities to act prudently without the need to justify that measure only on science, which also requires highly formal justifications, like proportionality, transparency, duty to give reasons and so on. If we look at the precautionary principle as a substantial one imposing prudent action then it is quite unreasonable. However, if applied as a procedural principle, saying that if administrative agencies want to act prudently they need certain justifications but they can rely on precaution in case of uncertainty,

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then we see how useful this principle/approach can be, above all, in global risk regulation. What is said about precaution as an approach or a procedural principle is visible as well in Article 191 (former 174) of the EU Treaty. This foresees the precautionary principle at paragraph 2, although it does not give a definition of it. However, at paragraph 3 it reveals its procedural nature requiring that in the risk administration: “the Community (indeed its institutions) shall take into account available scientific and technical data, (…); the environment conditions (…); the potential benefits and costs of action or lack of action (…); the socio-economic development”. The precautionary decision must thus rely on a complete analysis, not only concerning environmental interests, but also including costs/benefits analyses, evaluation of scientific data available and of socioeconomic consequences of action or inaction in front of risk, and it is to be aimed at pursuing general interests. It must be noted that increasing authorities’ discretion in the use of precaution might imply negative effects, as the abuse of such powers for reasons of protectionism, an excessively intrusive administration of certain social sectors that might comprise individual freedoms above all in the economic field, and disharmonious risk approaches all around the European legal order in accordance with different sensibilities. In response to these legitimate doubts on the utility of the principle, it might be said that authorities’ discretion should be embedded in procedural principles and submitted to judicial control that is supposed to ensure enough guarantees of fair regulation; that the intrusive administration of an economic sector – in fields like the environment and health protection – responds to a precise political choice of maintaining a stronger administrative control over the economic activity and the market in order to pursue the general interest (confirmed by the logic of burden of proof inversion: it is the operator/exporter/producer that needs to demonstrate its product is not harmful and not the importer/administration to prove it is dangerous); finally, that the disharmonic shape of the regulation coincides with a multilevel approach to risk, aiming at unity, but also allowing diversity, maintaining a central administration but also foreseeing national and local institutions to respond to their constituencies bearing the responsibility of a risk-taking or of a prudent activity. In global food safety law, a precautionary approach appears in several forms, some similar to the European model, others more distant. According to the interpretation of the SPS Agreement, as seen in the above legal doctrine analysis, the precautionary principle is to be excluded from the scope of that treaty. What is interesting to note is that Article 5.7 of the SPS Agreement presents a prescription related to prudent action in front of risk very similar to the European model: it indicates four requisites to be fulfilled to justify a trade-restrictive measure without a proper scientific justification. Two of those four requisites coincide with the one indicated at Article 7 of the EU food regulation: the temporariness of the measure and the commitment of the authority to seek more

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scientific information. The main difference stays in the first two lines of the Article, or better, in their official interpretation: as previously observed (supra, Chapter 2, para. 3.5), the insufficiency of scientific data on which rely is viewed as the impossibility to perform an assessment on a risk already identified in terms of probability in the DSB, while the EU regulation admits action in front of uncertainty on a merely possible risk. If in the EU the precautionary principle can be invoked to regulate traderelated issues, in WTO law only prevention is admitted. The principle of prevention aims to avoid unfair trade practice and justifies trade-restrictive policies in the identification of a risk, at least in terms of probability, on which a prudent approach is admitted. The precautionary principle, instead, does not concern the final moment of the decision, which could also be a preventive/prudent one, but the procedural phase of the act; it offers a further mechanism than science to justify a prudent approach about a possible risk. In the Cartagena Biosafety Protocol and in the Convention on Biological Diversity, which preceded and led to the former, the principle of precaution is analogous to the one adopted in the EU. Paragraph 9 of the Convention’s Preamble states: “Noting also that where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat”.

We already had the chance to focus on the interpretation of the wording of the quoted provision, where the reference to threat, to the gravity of the risk (the “significant reduction or loss of biological diversity” requirement implies a qualitative analysis of the situation and entails a discretionary approach of the competent authority); and to the lack of scientific certainty approximate such definition of precaution to the one embodied in the European legislation. For what concerns the Protocol, Article 1 of the CBP, states: “In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.

In addition to explicit reference to the principle, Article 1 makes a direct recall of another international provision enhancing precaution in environmental regulation. Principle 15 of the Rio Declaration on Environment and Development states:

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“In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”.11

As evident, such definition (which does not have any binding force and is specifically related to environment protection policies) is very similar to the one in the Convention on Biological Diversity and entails the same rationale as the EU regulation. It encourages wide application of the precautionary principle, which is here defined as an approach that technically implies less binding force than a principle. The latter is a norm, even if general and abstract, while the approach is only a decisional criterion, which may or may not be used. In addition to the reference to threats, to the gravity of the possible damage and to the lack of scientific certainty, it is interesting to stress the last line of the provision, that indicates the convenience of the intervention and its effectiveness in preventing environmental degradation. This is similar to what Article 191(3) TFEU, which, as noted, requires: a cost/benefits analysis of the necessity and utility of the precautionary approach. Finally, Article 10(6) of the Protocol, which was treated above, follows the same rationale and approach embodied by the Convention and by the Rio Declaration and also presents the requirements to invoke a precautionary approach in front of uncertainty regarding the possibility of occurrence of a risk. For what concerns the CAC, Paragraphs 10 and 11 of the “Working principles for risk analysis for application in the framework of the Codex Alimentarius” of the Procedural Manual read: “10. When there is evidence that a risk to human health exists but scientific data are insufficient or incomplete, the Codex Alimentarius Commission should not proceed to elaborate a standard but should consider elaborating a related text, such as a code of practice, provided that such a text would be supported by the available scientific evidence. 11. Precaution is an inherent element of risk analysis. Many sources of uncertainty exist in the process of risk assessment and risk management of food related hazards to human health. The degree of uncertainty and variability in the available scientific information should be explicitly considered in the risk analysis. Where there is sufficient scientific evidence to allow Codex to proceed to elaborate a standard or related text, the assumptions used for the risk assessment and the risk management options selected should reflect the degree of uncertainty and the characteristics of the hazard”.12

The two mentioned provisions entail two different approaches to precaution. 11

 http://www.unep.org/Documents.Multilingual/Default.asp?documentid=78&articleid=1163.

12

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission Procedural Manual, cit. p. 76.

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In the first one, the core of the guideline stays in the demonstrated existence of a risk: once there is evidence that a risk is present but the available data and the predictions on its effects are insufficient or incomplete, the CAC will have to adopt a prudent approach. It is evident that such a formulation coheres with Article 5.7 of the SPS Agreement and is inspired by a preventive approach, rather than by a precautionary one. Here the drafters of the Procedural Manual went even further, as they indicated the existence, instead of the mere probability, of risk to be determined in order to act prudently. In the second provision, there is an explicit reference to precaution and to scientific uncertainty. However, the vagueness of the text, not indicating the requisites for precaution, nor explaining what uncertainty is, does not help in clarifying its effect on the standard-setting procedure. In addition, in the second part of the provision, the phrase “sufficient scientific evidence” is once again central, as there must already be a minimum of scientific findings: only upon this result can a decision that takes into account uncertainty or unpredictability of those scientific results be made. The dispositions of the CAC’s Procedural Manual do not help in defining the precautionary principle in global law and they seem to propend more for a preventive approach, which might take into consideration scientific uncertainty and the necessity of prudence in front of it. It is interesting to mention also a specific guideline of the Codex, related to GMOs: it is the Guideline indicating the “Principles for the Risk Analysis of Foods derived from modern Biotechnology” issued by the ad hoc task force on biotechnology of the Codex Alimentarius Commission. This states that “risk managers should take into account the uncertainties identified in the risk assessment and implement appropriate measures to manage these uncertainties”.13 The mentioned formulation is quite generic, but the reference to the risk managers and to uncertainty is notable. The approach provided by the guideline appears to follow more the spirit of the European conception of precaution than the preventive approach of the SPS Agreement, as it mainly relies on risk managers’ opinions: in the phase of risk management the competent authorities decide upon the risk assessment as well as on their legitimate discretion; in this discretionary power, as the guideline states, uncertainty must be included and considered, in order to apply the most appropriate measures to face it. As it is written, just as a general principle, the quoted guideline is open to different interpretations. Nonetheless, it seems to leave the door open to a more discretionary approach in regulating uncertainties on GMOs, thus implying a precautious attitude. In conclusion, we can assume that the precautionary principle, as conceived in the European legal order, is to be found in the Convention on bio-safety and 13

Codex Alimentarius Commission, Principles for the Risk Analysis of Foods derived from modern Biotechnology, Rome, CAC/GL 44-2003, 2, available at http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf.

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in the CBP, also recalling the Rio Declaration on Environment and Development. The latter, as we saw in the Biotech case, have a partial and specific scope and/or a reduced binding force. On the opposite, relying on the official interpretation of the DSB and on the vagueness of the provisions of the Procedural Manual of the CAC, precaution is at present excluded both in the latter and in the SPS Agreement, which instead follow a preventive approach. At the same time, considering all this fragmentation and conflict concerning risk regulation, the precautionary principle cannot yet be considered international customary law. It is enforced by many states (“at the domestic level it informs environmental policy and law in Australia, Germany, the UK, the USA, the EU and certain other states”14) and it is included in a large number of international agreements.15 In addition, some legal scientists encouraged the acquaintance of such status, e.g.: “There is certainly sufficient evidence of state practice to support the conclusion that the principle (...) has now received sufficiently broad support to allow a strong argument to be made that it reflects a principle of customary law, and that within the context of the European Union it has now achieved customary status, without prejudice to the precise consequences of its application in any given case”.16

Notwithstanding, the discrepancies among various international conventions and among national states, with reference to its interpretation and implementation, make the precautionary principle only an evolving one and not yet a consolidated source as customary law. Therefore, in the global governance of food safety precaution, it is only partially applied and has not yet reached the nature of a binding norm.



2.1.3 Proportionality and reasonability

The proportionality principle, often combined and fused together with the reasonability principle, is one of the most important principles of global public law, notably, for food safety-related issues. In a fragmented composition of several sectoral regulatory regimes, linked together and characterized by proceduralization and judicial activism, it is crucial to require that decision-making be coherent with the purposes, adequate to reach its tasks, rationally motivated and directed to cause the least harm to conflicting interests. 14

P. Byrnie – A. Boyle, International Law and the Environment, II Ed. (Oxford: Oxford University Press, 2002), p. 118.

15

Preamble to the 1985 Vienna Convention; Preamble to the 1987 Montreal Protocol; Preamble to the Ministerial Declaration of the International Conference on the Protection of the North Sea; Article 4 (3) (f) of the Bamako Convention; Article 2 (5) (a) of the 1992 Biodiversity Convention; The 2000 Biosafety Protocol.

16

P. Sands, Principles of International Environmental Law, II Ed. (Cambridge: Cambridge university press, 2003), p. 279.

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As the rule of law is not as reliable as it was about twenty years ago and legal prescriptions tend to be fluid, flexible and left to the interpretation of the judges, it is the rule of reason that prevails, especially in the global legal sphere.17 Public administrations are asked to act not only in accordance with the law, but also and mainly in accordance with their objectives and functions, and to justify this action with a public-interest reason. Reasonability and proportionality are the criteria to respond to such expectation. The rule of reason and the proportionality principle have known, in the last years, a significant and peculiar development, due to several causes: an increment of politicization of administrative or even judicial decision-making; an increment of the use of technical and scientific knowledge, in order to reach neutrality and objectivity; and an increment of guarantees and procedural mechanisms to open up and make the decisions of the authorities fairer. In such a way, principles and criteria like reasonability, necessity and proportionality, assume a greater weight in public decision-making, above all if the latter is not entirely or satisfyingly subordinated to the rule of law: judges and administrators are called upon to be logic, proportionate, fair, transparent, coherent, above all when they depart from a legal prescription or are interpreting a general principle of law. Reasonability can be meant in several ways, namely, as adequacy between the legislative prescriptions and the administrative decision. However, in the global legal space the legislative is quite multidimensional and the relation is not dual, but plural: national administration must correspond their measures to the principles and rules of international treaties, but also to technical standards or guidelines, as well as to scientific demonstrations, which prove their necessity, all interpreted by the international adjudicatory bodies. Reasonability can also mean coherence between the evaluation and the final decision. This relation is also formed by extra-national law, for instance requiring rational relationship between the decision and sound scientific findings, or between the former and an international standard. Finally, reasonability can be seen as coherence with other comparable decisions. This can be seen in the prohibition to put in place discriminatory measures. The criterion of reasonability in global food safety law and regulation is thus quite decisive, but it is mainly absorbed by the concept of necessity of a measure, that is identified with the scientific demonstration 17

There is a crisis of the rule of law in the sense that in many socio-economic sectors we are experiencing a diminution or even the disappearance of legal certainty. In many situations the legal dispositions ruling a matter are too vague, too open to interpretation, in the hands of judges or executive agencies implementing them. This happens, among other things, because the world has become fluid, “liquid”, to quote a Zygmunt Bauman (Liquid Modernity, Cambridge University Press, Cambridge, 2000), extremely dynamic and interconnected. Therefore, it is not effective to rely on rigid, long-lasting norms that immediately become obsolete or inadequate for the discipline of a sector. As a paradox of this phenomenon, the quantity of positive legal provisions is increasing, but these are the results of the affirmation of the contingent power of the moment. That is why the law in general is in crisis, and most of the decisions, even when they are presented as legal, neutral or technical, are indeed political as an expression of a specific and orientated view.

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required by Articles 2 and 5 of the SPS Agreement and by the adequacy of national authorities’ activity to extra-national law. The proportionality principle relates to the discretionary moment of the decision and to the effect of the latter on the governed ones. As noted before, such principle is also strongly connected to the precautionary one and therefore coherent with its function: whereas wider discretion is granted to executive authorities, the latter are required not to exceed their powers in using it. This occurs through the application of a principle requiring – under the control of a judge – that those powers be used in a reasonable, logic and proportionate way. The proportionality principle was born in the German legal order, and entered other European legal systems through the activity of the CJEU, which imposed it on the domestic courts as a parameter to judge national measures diverging from EU law. It should be described for its three-fold application: In order to be proportionate, a measure should be appropriate, that is suitable for pursuing a predetermined general objective (appropriateness criterion); necessary, in the sense that it should be the only applicable measure to reach that particular objective (necessity criterion); adequate – or proportionate in strict sense – meaning that among all the available measures, it is the one producing the least damage or sacrifice to the objective of the measure (adequacy criterion). For what concerns global food safety law, the principles of proportionality and reasonability are fundamental to cope with such a multidimensional and fluid matter. In addition, they are quite central in the SPS Agreement. Namely, it refers to the “suitability”, “necessity” and “proportionality test”.18 The first two principles, notably referred to as “tests” due to their role of parameters to evaluate the conformity of a SPS measure, can be found in Article 2 of the Agreement. Here it is required that the measure is adequate, effective and necessary to the purpose for which it was adopted so as to exclude alternative options. As already noted in the case studies of Chapter 2, national SPS measures must be justified for their necessity to face a particular risk and for their exclusiveness compared to other solutions. What makes the necessity or reasonability test peculiar are the scientific requirements on which to base the measure. In the case at stake, the reasonability of the measure is not assessed through the mere criteria of logic, coherence and general interests, but it must be found in scientific evidence, objectively demonstrating the necessity of that particular measure. We already noted that this criterion serves to maintain a high level of soundness and neutrality in the justification of the SPS measures and to avoid any disguised discrimination or restriction of international trade. Nonetheless, it also has, at the same time, the effect of strongly reducing national authorities’ discretion. The principle of necessity and reasonability maintains its traditional features, which characterize it as a general and commonly used principle of 18

On this specification see F. Ortino, From ‘‘non-discrimination” to “reasonableness”: a paradigm shift in international economic law?, Jean Monnet Working Papers, no. 1/2005, available at http://papers.ssrn.com/ sol3/papers.cfm?abstract_id=922524, p. 34-35.

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administrative law, but its specification and justification in the field at issue must be based on scientific principles and evidence. For what concerns the proportionality test, mention must be made of Article 5.6 of the SPS Agreement. It is notable that often, namely in common law systems, reasonability and proportionality principles appear combined together, for instance under the threefold specification of the principle of proportionality. In the SPS Agreement they are separated: Article 2 refers to necessity and adequacy, summarized in the concept of reasonability or in the first two categories of proportion mentioned above; Article 5.6 concerns instead proportionality in a strict sense; it coincides with the third category of the general principle of proportionality and is aimed to cause the least negative effect to the objective of the measure and to all those public interests affected by the decision of the authority. Article 5.6 reads: “Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility”.

For what concerns a measure “not more trade-restrictive than required”, note 3 specifies that this occurs in the absence of another measure, that is reasonably available as it takes into account technical and economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is significantly less restrictive to trade. The mentioned provision requires thus that when Member States want to issue a SPS measure based on an identified risk and on scientific evidence, even if they are entitled to achieve their appropriate level of protection, they also must be submitted to the strict limits of proportionality as foreseen by Article 5.6. This means they might be required to prove that the measure adopted has no less harmful alternative solutions. The presence of the last criterion of proportion is significant: it specifies that even if the Member States have the right to pursue the level of health protection they deem most appropriate and even if they justify their restrictive measure by scientific demonstrations, they still cannot abuse of such power, through the enactment of a too restricting measure in front of a small risk, faceable with a less harmful restriction. The typical example in the food safety sector concerns general bans and labelling requirements: in front of a small risk, avoidable with a correct information for the consumers, imposing a ban on that substance might be disproportionate whereas a label prescription could still obtain the intended objective, with a reduced compromise for free trade and for the individual producer. The proportionality and reasonableness principles are thus procedural and formal criteria applying to the decision-making. Their relevance for food safety is high as global and national regulations are actually intertwined and combined

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together, and as the intervention of public administration is quite significant in the direction of food policies. Therefore, the actual legal framework requires the respect of determinate formal guarantees and principles. Among these also to be mentioned are the principles of effectiveness, promptness and transparency, as well as the duty to give reasons. In addition, proportionality and reasonability gained a particularly significant role as they shape the attitude and the effectiveness of global food safety regulators, implicitly requiring a balanced composition of the involved interests and a significant amount of reasonableness and coherence in the choice of intervention.



2.2 The “Joint Food Standards Programme” and the objectives of the Codex Alimentarius Commission

FAO and WHO approved the Joint FAO/WHO Food Standards Programme and the Statutes of the Codex Alimentarius Commission in 1963. The purpose was to institute an international body – the Commission – able to produce a reliable code consisting of specific standards, general guidelines and good practices concerning food and food products. Such normative production had to be based on scientific knowledge and Member States’ agreement, and it was aimed at avoiding fragmentation and heterogeneity in the regulation of a fundamental sector either for health protection or for fair and free world trade. Regulating food safety and quality in accordance to a harmonized approach has always been strategic in the international community, whose cohesion for long time appeared diminished in such field: “Food regulations in different countries are often conflicting and contradictory. Legislation governing preservation, nomenclature and acceptable food standards often varies widely from country to country. New legislation not based on scientific knowledge is often introduced, and little account may be taken of nutritional principles in formulating regulations”.19

The CAC was born under a common programme established by two resolutions (Resolution n. 12/61, approved by the General Conference of FAO on the 5th of October 1962 and Resolution n. 16/42 of the Assembly of the WHO of the 1st of May 1963) of the so-called “parental organizations”, i.e. FAO and WHO. Under a formal profile, the CAC presents as an executive body of FAO and WHO, adopting standards with external relevance. The parental organizations administer the budget of the Commission (Article 9, Statutes of the Codex Alimentarius Commission), they regulate the membership access of the States (Articles 2 and 3, Statutes) and they evaluate periodical reports that the Commission must submit (Article 5, Statutes). Notwithstanding, the activity of the CAC is highly autonomous from FAO and WHO: the contribution and the interven19

 R eport of the First Meeting of the Joint FAO/WHO Expert Committee on Nutrition, 1950, in Joint FAO/ WHO Food Standards Programme, Understanding the Codex, cit., p. 6.

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tion of the parental organizations is foreseen, for instance, in the administration of the expert committees submitting scientific reports to the Commission. However, what is most relevant is the contribution of the Member States. The delegates appointed from the latter are coordinated and guided by the Commission but they bear the responsibility and the power to draft, discuss and then approve the standards, which will be finally published in a world food codex: the Codex Alimentarius. The organism is then an inter-state organization, but it issues supranational 20 standards, which can (they are soft laws, i.e. voluntary norms) be used and adopted, without modification through a mere formal acknowledgement, inside all the States with a significant harmonization effect. Since the Commission was born, it has published around 339 alimentary norms, including, among others, specific standards (related to commodities, labelling, contaminants, inspections procedures and so forth); guidelines (concerning food hygiene, risk management, and so forth); maximum limits (regarding pesticides, hormones and other veterinary drugs) and analytical methods (about different patterns of study and scientific study and analysis of determinate substances used in food production and elaboration). One relevant aspect of the norms composing the Codex is their new status in international law. In the Hormones case, we noted the relevance of a standard in providing a presumption of consistency with WTO law. This happened for those States conforming their measures to or basing them on international standards like those issued by the CAC. We also noted the peculiar legal strength of WTO law and of the decisions provided by the DSB. With the recall of the CAC’s standards by the SPS Agreement, the former was incorporated into the latter and gained an indirect binding force. This mainly happens thanks to the strict scientific mechanism of justification required by the combination of Articles 2.2, 3.3 and 5.1 of the Agreement. On one side, the binding norms of the SPS Agreement, by recalling such standards as a criterion to justify national measures, give strength to the soft (voluntary) acts composing the Codex, so that the latter becomes semi-binding as derogation from them may imply a violation of WTO norms, which would be very difficult to justify (through scientific demonstration). On the other side, the detailed and substantial norms composing the Codex are incorporated into the procedural and formal ones of the SPS Agreement. So that when the latter prescribe necessity and rational justification of national measures, these are indeed informed by specific and agreed standards for any kind of food. It is extremely difficult, inconvenient and seldom successful for a State to justify under WTO law a measure stricter than a Codex standard and this is why, despite not being formally binding, CAC’s prescriptions are still universally obeyed by the Member States of the organization. The described mechanism 20

The term “supranational” implies a condition of hierarchy on behalf of the CAC. This is because, even if its standards are not binding and even if they are discussed and approved by national states’ delegates, they affect domestic regulation from above, gaining force by the SPS Agreement recall and becoming internal norms by a simple translation of their content in national legislations.

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has been called “borrowing regimes”, as two regulatory orders, that reciprocally link together, gain a peculiar legal force that they normally would not have:21 the SPS Agreement entailing specific and detailed norms, the CAC gaining a binding force for its formally voluntary standards. As noted, “the most significant implication for the CAC is that its decisions have a semi-binding effect on governments. This means that the Commission is no longer a ‘gentlemen’s club’ and that negotiations within the CAC are more intense than previously was the case”.22 The rationale, the purposes and the rules governing the functions of the CAC are in the Procedural Manual, which has now come in its 23rd edition. The purposes of the Commission are indicated in Article 1 of the Statutes: “(a) protecting the health of the consumers and ensuring fair practices in the food trade; (b) promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations; (c) determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations; (d) finalizing standards elaborated under (c) above and publishing them in a Codex Alimentarius either as regional or worldwide standards, together with international standards already finalized by other bodies under (b) above, wherever this is practicable; (e) amending published standards, as appropriate, in the light of developments”.23

We already had the occasion to consider the ambivalence of the first letter of the reported list. Here, however, it is important to look at it in connection with the other purposes of the Organization. It is to note that, while under letter (a) the Statutes indicate the main or final objectives of the standardization ensured by the CAC, under the other letters they present the secondary and instrumental (to reach the first ones) tasks towards which the CAC activity is directed. For what concerns the first part, I should recall what has been already said about the fact that the activity of the Commission aims to strike a balance between the protection of consumers’ health and the fairness of food trade. Here I intend to spend some words dedicated to the meanings of the phrases “consumers’ health” and “fair practices in the food trade”. 1. By categorizing health, the constituents of the CAC intended to specify and embed the objective of health protection. This does not refer to health in 21

On this see D.W. Leebron, Linkages, open discourse at the conference “The Boundaries of the WTO”, whose proceedings are in American Journal of International Law, 2002, p. 14.

22

WTO, Statement Made by the FAO/WHO Codex Alimentarius Commission at the Meeting of November, 1516, 1995, Committee on Sanitary and Phytosanitary Measures, G/SPS/W/42.

23

Article 1, Statutes of the Codex Alimentarius Commission, in Codex Alimentarius Commission, Procedural Manual, cit., p. 4.

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general, which is a fundamental right of international law and an absolute value to be guaranteed to the citizens24 and has a multi-comprehensive scope and regulatory impact, but goes beyond the competences and the functions entailed by CAC. The reference is instead to food consumption and, therefore, health protection regards only the substances or the final products that might eventually affect food consumers. For instance, this means that if the final product is not directly dangerous for human health but is produced through a very high polluting mechanism (this is what happens for the swine intensive breeding, not only because it favours disease contractions and diffusion, but also because the excrement has the effect of polluting the air and the water used in the agricultural process), the environmental issue could be neglected by the Codex Commission. Even if this approach might underestimate practices that could be dangerous to human health in the long period and does not have a global vision of many possible consequences of food productions, it is coherent to the functions of the CAC. This is not a health protection organization (“Codex has no public health mandate to which it must conform its decisions”25), but a standardsetter with the minimum requirement of establishing limits, characteristics, methods and rules over food products, ensuring these are not dangerous for the ones consuming them. 2. As noted, the CAC also needs to pay attention to avoid unfair trade practices. In giving an interpretation of the expression “fair practices in food trade”, two are the possible alternatives. a) Firstly, the word “fair” might refer to the social consequences of trade practices. Such a purpose, however, does not match with the powers and the legal tools provided to the Codex Commission: it does not have the discretion and the authority to evaluate the social consequences of food trade practices and approve relative standards to fix the principles, the limits and the rules applying to them. Following this approach would mean assigning to the CAC the possibility to shape private trade activity, orientating it to reach fair results, for instance by issuing standards concerning the environment or the conditions of workers, as many food products are obtained through trade practices that unfairly exploit the advantages of social or environmental dumping. This, however, is to be excluded by the other norms of the Procedural Manual and by 24

See, for instance, “The Universal Declaration on Human Rights”, stating that “1) Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control”, available at http://www.un.org/Overview/rights.html#a25.

25

L.M. Wallach, Accountable Governance in the Era of Globalization: the WTO, NAFTA and International Harmonization of Standards, in University of Kansas Law Review, 2002, p. 7; “At the moment Codex does not have a formal mandate. Rather, the Codex Alimentarius Commission and its subsidiary bodies (the Codex committees, task forces, etc.) are by statute purely advisory”, in Joint FAO/WHO, Report of the Evaluation of the Codex Alimentarius and Other FAO and WHO Food Standards Work, Rome – Geneva, 15th November 2002, p. 28.

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the main task of the Food standard programme, simply directed to harmonize food safety law to avoid protectionism, discriminations and trade barriers. b) Secondly, the aforementioned expression might be clarified as “legitimate practice in food trade”. The word legitimate stays consistent with actual trade law, which is WTO law. The recall of the Codex by the SPS Agreement is a confirmation that the CAC acts coherently with the purposes and the rationale of WTO law, which is mainly ensuring free trade, avoiding undue restrictions, discrimination and protectionism. This means that Codex standards must be drafted and approved in order to give objective and neutral parameters finalized both to set a level of salubriousness of foods and to avoid privileges, abuses of power, trade restrictions and discrimination disguised under the purpose of protecting health. This is coherent with the rationale of the two-fold purpose of the Codex, which is not merely protecting health, but rather providing harmonization to avoid illegitimate trade restrictions, although maintaining a considerable level of consumer protection. For what regards the second part (letters (b) – (e)) of Article 1 of the CAC’s Statutes, these indicate the activities and the functions involving the standardsetting procedure and the main tasks of the Commission, later on specified in the following Articles of the Procedural Manual. The Commission thus has a role of promotion and world-wide coordination for food standards (“promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations”); it determines the shape, the drafting and also the rationale of the standards for the Codex, even though the activity of other organizations – such as the experts committees, which submit scientific reports on which the Commission bases the standards themselves – and guaranteeing wide participation (“determining priorities and initiating and guiding the preparation of draft standards through and with the aid of appropriate organizations”); it finalizes the standards, which, as said, are discussed and prepared by national States’ delegates and then provides for their publication giving them the official status of international laws (“finalizing standards elaborated under (c) above and publishing them in a Codex Alimentarius” ); and it amends, or better, starts and takes care of the amending procedure of the published standards (“amending published standards, as appropriate, in the light of developments”). Article 1 of the CAC Statutes also foresees that the Commission is “responsible for making proposals to, and shall be consulted by, (…) on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme”. This means that the CAC is the body charged by the parental organizations with the responsibility to implement the Joint FAO/WHO Food Standards Programme, but not the one to elaborate materially the standards. The two-fold purpose of such activity is guaranteeing consumers’ health protection and ensuring fair practices in trade. In addition, all the relevant functions for the standard-setting procedure involve the significant presence and active contribution of several actors other than the Commission, such as the States – through their delegates – and other international organizations or extra-national

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subjects. Although the Commission is the organization that formally issues the standards, it mainly acts as the administrative body provided with the responsibility to take care of the procedure, including starting, elaborating, coordinating the drafting, approving and publishing food standards. All this activity is to be taken in conformity with the requirements and the purposes of the Procedural Manual and of the Food Standards Programme.26 In order to pursue its goal the CAC also enjoys organizational functions. For instance it establishes the Executive Committee (Article 6, Statutes), with managerial tasks during all the iter for the formation of the food norms, subsidiary bodies (Article 7, Statutes), such as the Committees, which are the legal entities where the standards are discussed and drafted. Finally, it can also modify its procedural norms, submitting the new version for the Directors-General of FAO and WHO (Article 8, Statutes).



2.3 The SPS and the TBT Agreement

We already had the chance to note how trade law, and WTO law in particular, is part of global food safety law. The provisions concerning the safety of foods as an exception to free trade were to be found, before 1995, in Article XX, lett. b) of the General Agreement on Tariffs and Trade, indicating the measures necessary to protect human, animal or plant life or health. As observed in the analysis of the Biotech case, the application of the SPS Agreement has the effect of excluding the use of other Agreements, when they overlap on the same scope of the former. This is thus the central treaty applying to national food safety measures, bearing some fundamental principles and rules of global food safety law and regulation. Finally, a partial and residual role is left to the TBT Agreement, applying more in case of food quality and food presentation and only if the invocation of the SPS Agreement is to be excluded. The following analysis will be dedicated to the SPS and the TBT Agreements.



2.3.1 The SPS Agreement

We already analysed the SPS Agreement and considered its purposes, the most significant prescriptions it embodies and the way it is applied and interpreted. As noted, the Agreement at issue is an international treaty on trade, included in Annex 1 A of the Marrakech Agreements, which follows the rationale that no Member should be “prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health”. Moreover, it serves to ensure that “these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade”. In order to reach this goal, and “desiring to improve the human health, animal health and phytosanitary situation in all Members”, the Agreement was 26

See supra, Chapter 4.

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conceived to enhance “the establishment of a multilateral framework of rules and disciplines to guide the development, adoption and enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade” (Preamble, SPS Agreement). As already observed, the Agreement at issue is essentially a trade one, having a significant effect on health policies – and thus covering also food safety – as it establishes principles, disciplines, and rules directed to national authorities with jurisdiction in this field, and finalized to guarantee the adoption and the enforcement of Sanitary or Phytosanitary measures without causing a negative impact on trade. Namely, it aims to avoid arbitrary or unjustifiable discrimination between members – for instance by claiming different risk assessments for identical products – or disguised restrictions on trade – for instance by banning a product or by imposing a detailed labelling of goods, which would not require such treatments. The main provisions can be summed up in the following topics: • Scope of the Agreement (Article 1 and Annex A); • Necessity and reasonability test of the SPS measures: scientific evidence (Article 2.2); • Harmonization and reference to linked international organizations (Article 3); • Appropriate level of sanitary or phytosanitary protection (Article 4); • Risk assessment, risk management, non-discrimination and preventive approach (Article 5); • Transparency (Article 7 and Annex B); • Promptness, effectiveness and efficiency of the approval procedures (Article 8 and Annex C); • Consultation of experts (Article 11); • Administration: the Committee on Sanitary and Phytosanitary Measures (Article 12). 1. As we previously noted in the analysis of the Biotech case, in accordance with Article 1 as combined with Annex A, the Sanitary or phytosanitary measures are all relevant laws, decrees, regulations, requirements and procedures aimed at the protection of human, animal or plant health, which may, directly or indirectly, affect international trade. Such measures – put in place by national States or regional organizations – shall be developed and applied in accordance with the provisions of the SPS Agreement. Therefore, a ban, a maximum level of substance limitation, or any other requirement contained in any form of legal act, rather than produced through a particular behaviour performed by an authority, issued in order to protect health and with the effect of restricting or limiting trade, can be defined as a SPS measure and falls under the discipline of the Agreement at issue. 2. The necessity and reasonability tests, as already explained, are required by Article 2.2 of the SPS Agreement and are ruled by scientific principles and

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scientific evidence. Any SPS measure thus cannot be simply justified by its conformity to national legislation, by logic coherence or by discretional reasoning related to a determined social policy: On the opposite, it needs to be based on determinant circumstances proven through the application of scientific knowledge and scientific tests. Only such measures will be deemed necessary and reasonable, and so justifiable even if they restrict or diminish world trade. 3. In order to avoid the demonstration required by the precedent provision, national States can adopt measures conformed to or based on relevant international standards. In such cases, domestic SPS measures are presumed to be in conformity with the Agreement. These standards are the ones recalled by Article 3.4 and by Annex A(3) that are issued by the Codex Alimentarius Commission, by the International Office of Epizootics, and by the international and regional organizations operating within the framework of the International Plant Protection Convention. While the phrase “conform to” can be interpreted as significant adherence to the results and the prescriptions contained in international standards, the interpretation of “based on”, as observed, is not pacific. This might be seen under a procedural perspective, adhering to mechanisms, proceedings, investigation and premises indicated in international standards, on which a national act that reaches alternative conclusions is based; or under a substantial perspective, according to which domestic measures must be based on the results, the conclusions and the rationale of those standards. 4. Article 4.1 of the SPS Agreement, by providing equivalence between Members’ sanitary or phytosanitary measures establishes the right of States to adopt their own appropriate level of sanitary or phytosanitary protection.27 However, these need to be justified under the other provisions of the Agreement. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures. Here two important regulatory principles are established: first, the duty to objectively demonstrate that the measures applied internally in the exporting State reach the same level of health protection of the ones of the importing Country, mirrored by the right for the latter to establish the most appropriate level of health protection; second, the transnationality of typical domestic administrative acts, such as inspection, testing and other relevant procedures, which are no longer limited to national territories while extending to foreign ones as well. For what concerns the first issue, it is notable that while Articles 2, 3 and 5 of the Agreement require a demonstration against the importing Country limiting the entrance and the marketing of foreign products for health protection reasons, Article 4 switches the burden of proof on the exporting one and implicitly embodies a right, for the importing Countries, to establish the level 27

On Article 4 see WTO, Committee on Sanitary and Phytosanitary Measures, Decision on the Implementation of Article 4 of the Agreement on the Application of Sanitary and Phytosanitary Measures, G/ SPS/19/Rev.2, 23 July 2004, available at http://wto.org/english/tratop_e/sps_e/decisions06_e.htm and Codex Alimentarius Commission, Guidelines for the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems, 26th Session, Rome, Italy, 7 July 2003.

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of health protection they deem more appropriate. However, this is only a prima facie burden of proof, as the Article must be read in conjunction with the other ones in a logical sequence. At first, it is recognized that every Member State must foresee the regulation it considers most appropriate to protect health. If another Country wants to export a food product, it bears a prima facie burden of proof to demonstrate that such product does not affect in any way health, as conceived by the importing Country regulation. Once such a demonstration is made, if the latter denies the entrance and the marketing or limits them, performing thus a restriction of world trade, the burden of proof is switched against it and it will have to demonstrate (conforming to the requirements of Articles 2, 3 and 5) the necessity, reasonability, proportionality and appropriateness of its measure. This is logical with the premise that no national SPS measure can be “applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail” (SPS Agreement, Preamble). Moreover, it also finds its confirmation in the adjudicatory phase, where the complaining parties bear a prima facie onus to prove the inconsistency of the contested measure, and then the member imposing that measure is asked to prove its consistency with the Agreement. On such issue, the AB of the DSB in EC-Hormones stated that: “the Panel should have begun the analysis of each legal provision by examining whether the United States and Canada had presented evidence and legal arguments sufficient to demonstrate that the EC measures were inconsistent with the obligations assumed by the European Communities under each Article of the SPS Agreement addressed by the Panel, i.e., Articles 3.1, 3.3, 5.1 and 5.5. Only after such a prima facie determination had been made by the Panel may the onus be shifted to the European Communities to bring forward evidence and arguments to disprove the complaining party’s claim”.28

Therefore, as already seen in the analysis of the cases ruled by the DSB, also this demonstration must be based on a proper risk assessment on behalf of the importing State, which, in case of a market restriction based on Article 4, will have to demonstrate and make clear the risks on which it has grounded its measure. About this issue, namely concerning a request of recognition of equivalence from the exporting Country, a Decision of the SPS Committee – “on the Implementation of Article 4 of the Agreement on the Application of Sanitary and Phytosanitary Measures” – specified that: “An importing Member should consider the relevant information and experience that the sanitary and phytosanitary services have on the measure(s) for which recognition of equivalence is requested as applied to the product for which that request relates. 28

 EC-Hormones, cit., par. 109.

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This information and experience refers to: (i) The historic knowledge and confidence that the competent authority of the importing Member has of the competent authority of the exporting Member. (ii) The existence of an evaluation and recognition of the products-related system of inspection and certification of the exporting Member by the importing Member. (iii) The available scientific information supporting the request for the recognition of equivalence”.29

The provision quoted from the SPS Committee Decision shows that scientific information is only one of the criteria to evaluate the food safety systems of other Members and thus agree or not on the request of equivalence. However, besides historic knowledge and other empirical tools, the scientific method is still the prevailing one. Having regard to the second regulatory issue contained in Article 4, it is notable to stress on the transnational character of food safety regulation. Foreseeing open procedures, in which the exporting countries allow the importing ones to perform inspections or testing on the trading goods even before they ship, means opening internal administrative procedures (of the exporting Country) to foreign actors and, conversely, extending the national administrative procedures of the importing Country to a foreign territory. The SPS Agreement, as noted, follows the needs of the interdependent societies of the globalized world: food safety regulation is not only inside the territories of the States and does not pertain only to the relations among the latter, but also implies composite and coordinated procedures, involving at the same time foreign and domestic authorities. 5. We already noted that the risk assessment phase is quite central in the SPS Agreement and becomes the key demonstration in order to justify a SPS measure that does not find justification through an international standard to show the rational relation between such measure and the alleged risk. It must consist of a reliable demonstration of the likelihood of an ascertained risk performed on the basis of “available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment” (Article 5.2). In addition, the Country required to perform a risk assessment must “take into account the objective of minimizing negative trade effects” (Article 5.4) and “avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade” (Article 5.5). Risk assessment can be avoided – basing the measure on the available data – only in cases of scientific 29

WTO, Committee on Sanitary and Phytosanitary Measures, Decision on the Implementation of Article 4, cit., para. 5.

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insufficiency, i.e. the impossibility of evaluating an identified risk, and only for provisional measures to be revised in accordance to new scientific knowledge (Article 5.7). For what concerns Article 5.5, it is to stress the “Guidelines to Further the Practical Implementation of Article 5.5”.30 In particular, para. A.1. reads: “A Member should indicate the level of protection which it considers to be appropriate with respect to risks to human life or health, to animal life or health or to plant life or health in a sufficiently clear manner so as to permit examination of the extent to which any sanitary or phytosanitary measure achieves that level. Such an indication may be contained in a published statement or other text generally available to interested parties. The statement of the appropriate level of protection may be qualitative or quantitative, and should serve to guide its consistent implementation over time, and also to increase the transparency of the sanitary or phytosanitary regime. Examples might include government policy statements with regard to appropriate levels of protection in response to certain risks, or documents on animal health protection objectives or with respect to plant protection. The use of quantitative terms, where feasible, to describe the appropriate level of protection can facilitate the identification of arbitrary or unjustified distinctions in levels deemed appropriate in different situations”.

Such provision is important, as it requires a particular publicity in the procedure. The quoted guideline foresees that when a Member establishes its own ALOP, it makes it public through an open statement, in order to make it visible to the other States. Once again, the SPS Agreement does not establish what kind of protection may be adopted by the Member States, but it sets how to do it, through a procedural requirement of transparency.31 This does not avoid the duty to justify that policy but it simplifies harmonization and integration by enhancing the share of such policy, allowing other Member States to have access to it. 6. Article 7 embodies a procedural principle, directed to the national authorities issuing SPS measures. It requires that “Members shall notify changes in their sanitary or phytosanitary measures and shall provide information on their sanitary or phytosanitary measures in accordance with the provisions of Annex B”. The latter establishes detailed rules ensuring several formal guar30

WTO, Committee on Sanitary and Phytosanitary Measures, Guidelines to Further the Practical Implementation of Article 5.5, G/SPS/15, 18 July 2000, available at http://wto.org/english/tratop_e/sps_e/ decisions06_e.htm.

31

In this sense, see also A.3.: “A Member should establish clear and effective communication and information flows within and between the authorities responsible for the determination of appropriate levels of protection. An important element in seeking to ensure that decisions on an appropriate level of protection meet the provisions of Article 5.5 is information and communication. The authorities responsible for the preparation and implementation of such decisions should be aware of relevant decisions taken by that Member in other cases, and particularly in situations comparable to the one at hand”, Ibid.

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antees among members: the duty to promptly publish SPS measures “in such a manner as to enable interested Members to become acquainted with them” (Annex B(1)); the duty to lead enquiry points, “responsible for the provision of answers to all reasonable questions from interested Members as well as for the provision of relevant documents” on all the phases and the procedures related to the formulation and the adoption of the SPS measure (Annex B(3)); the duty to publish a notice and “notify other Members, through the Secretariat, of the products to be covered by [a new SPS] regulation together with a brief indication of the objective and rationale of the proposed regulation” (Annex B(5)). On transparency another two implementing documents are to be quoted: the “Recommended Procedures for Implementing the Transparency Obligations of the SPS Agreement (Article 7)’32 and “How to Apply the Transparency Provisions of the SPS Agreement”.33 The two documents consist of a practical guide and procedural mechanisms provided to assist Members in fulfilling their transparency obligations under Article 7 and Annex B of the SPS Agreement regarding the notification of SPS regulations, answering information requests under the national enquiry point system and publishing regulations. For instance, they foresee the establishment of an SPS notification authority and of an SPS enquiry point and the resources needed. In addition, they describe the differences between the roles of the two offices; how these should operate; what kind of information should be notified, the procedures to follow in order to reply to requests and comments from other members; the format to adopt for equivalence notifications; and how to publish national regulations. The described procedural guarantees are significant in food safety law and regulation, as they define – specifying their features – common administrative principles in order to harmonize the proceedings leading to health protection measures with the effect of restricting trade. In such a way, every national policy can follow its appropriate substantial rationale and purpose, but – since it has transnational effect – it must primarily conform to determined procedural requirements, which can be used by the DSB to evaluate the consistency of the national measures to WTO law. In this case, the WTO provisions are not limited to a mere requirement of transparency, as they extend to the determination of specific procedural and institutional recommendations, in order to harmonize principles and rules to apply them. 7. Another procedural guarantee is required by Article 8 in combination with Annex C. In addition to the requirement of avoiding “undue delay” in the procedures leading to the adoption of national SPS measures, the latter indicates several criteria and procedural guarantees to observe in the activities of control and inspection of goods and of approval of SPS measures. In all such moments, 32

WTO, Committee on Sanitary and Phytosanitary Measures, Recommended Procedures for Implementing the Transparency Obligations of the SPS Agreement (Article 7), G/SPS/7/Rev.2, 2 April 2002, available at http://www.wto.org/english/tratop_e/sps_e/decisions06_e.htm.

33

WTO Secretariat , How to Apply the Transparency Provisions of the SPS Agreement, September 2002, available at https://www.wto.org/english/tratop_e/sps_e/spshand_e.pdf.

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national authorities are asked to act promptly and without delay, to ensure the access to all non-reserved information and without discrimination towards national like products, to act in conformity with the reasonability, the necessity and the equitable principles. Also, for what regards such formal guarantees, the “meta-regulatory” character of the SPS Agreement is notable, indicating the criteria, the forms and the mechanism through which Member States can adopt and implement legitimate SPS measures. 8. Article 11.2 of the Agreement at issue reads: “In a dispute under this Agreement involving scientific or technical issues, a panel should seek advice from experts chosen by the panel in consultation with the parties to the dispute. To this end, the panel may, when it deems it appropriate, establish an advisory technical experts group, or consult the relevant international organizations, at the request of either party to the dispute or on its own initiative”.

As evident, the Treaty admits on behalf of the judge a standard of review including technical assessments concerning scientific issues. In order to perform such evaluation the Panel is required (“should”) to seek advice from experts and has the possibility (“may”) to establish an advisory technical group or consult the relevant international organizations. The described provision is coherent with the centrality given to scientific knowledge by the SPS Agreement. In order to perform a correct and objective evaluation of domestic SPS measures based on scientific evidence, the adjudicatory bodies must also rely on scientific knowledge, sought from apposite experts. As noted before, it is to insist on the importance of the separation of powers principle as the judge cannot trespass upon the competences of the executive bodies and thus must refrain from substituting the decisions made by national authorities. Through scientific assessment, the evaluation is indeed also extended to the substantial matter of national regulations. However, in this case, it concerns a neutral aspect consisting of the scientific investigation on which the discretional measure is performed. Through the judgement of the scientific basis of national decisions, the adjudicatory bodies of the WTO can perform incisive and effective control over national measures without questioning their discretionary powers. However, as noted, the complex evolutions of technical knowledge and its intimate connection with discretionary policies are not always a proper guarantee of a neutral and sound judgement of a pure non-discretional moment of the national administrative procedure to enact the SPS measures. 9. The Committee on Sanitary and Phytosanitary Measures (SPS Committee) foreseen by Article 12 aims at establishing a consultative and executive forum for the hearing of the relevant health regulatory authorities and at enhancing the implementation of the dispositions and the objectives of the Agreement, namely with respect to harmonization. More in particular, the tasks of the SPS Committee can be described in a two-fold specification: on one side,

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it ensures information exchange and a de facto peer-review among member States checking and evaluating the SPS procedures and final acts; on the other, it also performs a function of norm-elaboration by offering a legal space to discuss, negotiate and agree on new international laws in the field of health protection and trade.34 As established in the inaugural meeting of 19-20 March, the Committee agreed that the “Rules of Procedure for meetings of the General Council (WT/L/161) shall apply mutatis mutandis for meetings of the Committee on Sanitary and Phytosanitary Measures except as otherwise provided in the Working Procedures (G/SPS/1) as established or as subsequently amended by the Committee on Sanitary and Phytosanitary Measures and except as provided below”.35

Therefore, the Committee presents further characteristics than a simple consultative forum: despite not being a formal regulatory authority, it is configured as a preparatory body functional both to the negotiation, the agreement and the approval of international, bilateral or multilateral treaties, both to the implementation of the SPS norms into the territories of the members. It is notable that in its activity of consultation and negotiation, the SPS Committee is coordinated with the international institutions (FAO, WHO, CAC, and so forth), which intervene as observers with consultative functions and with the objective of securing the best available scientific and technical advice for the administration of this Agreement (Article 12.2 – 12.3). In this way, the Committee is conceived as a global public arena, where all the actors involved participate in the discussion of common themes. These can regard, for instance, the composition between conflicting interests, the exchange or the clarification of determinate scientific information, the discussion and the negotiation on new measures or on the interpretation of international norms. Through an informal structure, the Committee enhances more integration and harmonization in the field of food safety without imposing any prescription over member States, but rather offering them a neutral arena for legal discussion and dialogues.



2.3.2 TBT Agreement

The Agreement on technical barriers to trade (TBT) only indirectly concerns the issue of food safety, as it more generally relates to all the technical barriers – such as “packaging, marking and labelling requirements, and procedures for assessment of conformity with technical regulations and 34

On this J. Scott, Cooperative Regulation in the WTO: The SPS Committee, in Global Law Working Paper, no. 03/06, New York City, 2006, p. 14.

35

WTO, Rules of procedures for meetings of the committee on sanitary and phytosanitary measures, G/L/170, 20 June 1997.

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standards” (Preamble) – which may affect trade in goods (among which is also food products). The TBT Agreement follows the rationale of avoiding that any Country is prevented “from taking measures necessary to ensure the quality of its exports, or for the protection of human, animal or plant life or health, of the environment, or for the prevention of deceptive practices, at the levels it considers appropriate” (TBT Agreement, Preamble). Contemporarily, it aims to prevent that these measures are “applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail or a disguised restriction on international trade, and are otherwise in accordance with the provisions of this Agreement” (TBT Agreement, Preamble). In order to face such a task, it provides a legal framework, indicating the principles, the disciplines and all the necessary legal requirements to apply to the matter of the technical features of traded goods. As noted in the study of the Biotech case, the TBT Agreement is alternative to the SPS, meaning that its provisions “do not apply to sanitary and phytosanitary measures as defined in Annex A of the Agreement on the Application of Sanitary and Phytosanitary Measures” (Article 1.5). As the two agreements could cover the same issues, the constituents foresaw a mechanism to prevent them from overlapping, providing that when a Country adopts a measure, which falls under the scope of the SPS Agreement, the application of the TBT norms is excluded. This means that a Country, which issues a measure covered by the SPS Agreement, cannot justify it under the provisions of the Treaty on technical barriers. When the matter is contested, the decision is attributed to the judges of the Dispute Settlement Panels or of the Appellate Body. A typical example of a debatable issue concerning food safety is to be found in labelling. A Country may adopt a norm foreseeing compulsory labelling for a determinate food product in order to protect the health of specific categories of consumers (for instance, from risks of food allergies) and with the effect of restricting trade. Labelling concerns the external packaging of food and might be considered as a TBT measure. However, as evident, the domestic provision could also fall under the scope of the SPS Agreement, as it presents all the features required by Article 1 and Annex A of the latter. Again, it is possible to notice how global law, especially in the field of food safety, entails a fluid and evolving nature, characterized by a case-by-case approach and by a significant discretionary power assigned to the adjudicatory bodies in determining and clarifying the applicable law. For our analysis, the attention is to focus on Articles 2.2, 2.4 and 5.5 of the TBT Agreement. The former states: “Members shall ensure that technical regulations are not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade. For this purpose, technical regulations shall not be more traderestrictive than necessary to fulfil a legitimate objective, taking account of the risks

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non-fulfilment would create. Such legitimate objectives are, inter alia: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment. In assessing such risks, relevant elements of consideration are, inter alia: available scientific and technical information related processing technology or intended end-uses of products”.

Article 2.2 embodies the principles of necessity and proportionality in strict sense. The first line of the Article implies that only the obstacles to trade caused by technical regulations that can be deemed necessary are to be considered consistent with such agreement. In addition, these technical regulations “shall not be more trade-restrictive than necessary”. With this apparently tautological expression, the constituents of the TBT Agreement intended to require demonstration of both the necessity of the technical measure itself – which can put obstacles to international trade, but occurs to be unavoidable in order to protect legitimate interests – both the proportionality of the chosen measure – which cannot be disproportionate for the task it aims to accomplish and restricts trade only whereas and to the amount it is necessary. In order to perform such a technical regulation, Article 2.2 indicates both the objectives for which a Country may issue a trade-restrictive measure and both the relevant elements on which basing risk assessment to justify it. For the first ones, the norm presents a wide range of alternatives including the protection of health, environment and national security. A TBT measure can be thus directed to several aims, all ascribable to the general interest. The relevant elements of consideration to use, in order to establish the risk that one of the previous objectives could be compromised, include either the available scientific and technical information or related processing technology, or, finally, the enduses of the products. This means that national States are not obliged to justify their technical measures only on scientific evidence, as this is only one of the elements used for risk assessment, but can also motivate it through technical feasibility and even on the basis of the task for which the product is conceived. Articles 2.4 and 5.4 are to be treated together. The first reads: “Where technical regulations are required and relevant international standards exist or their completion is imminent, Members shall use them, or the relevant parts of them, as a basis for their technical regulations except when such international standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems”.

The second one reads:

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“In cases where a positive assurance is required that products conform with technical regulations or standards, and relevant guides or recommendations issued by international standardizing bodies exist or their completion is imminent, Members shall ensure that central government bodies use them, or the relevant parts of them, as a basis for their conformity assessment procedures, except where, as duly explained upon request, such guides or recommendations or relevant parts are inappropriate for the Members concerned, for, inter alia, such reasons as: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment; fundamental climatic or other geographical factors; fundamental technological or infrastructural problems”.

As in the SPS Agreement, also the TBT disposes provisions directed towards harmonization, requiring member States to use international standards on which to base their technical regulations. Different from the treaty on sanitary and phytosanitary measures, the TBT Agreement does not require conformity to international standards, but only their use “as a basis” – that is as a starting point, as a premise – for the technical regulations. Nonetheless, the quoted Articles also foresee the possibility not to use the international standards if they are “ineffective or inappropriate for the fulfilment of the legitimate objectives pursued”. And, the demonstration of such qualities is not to be based on scientific evidence, but must be “duly explained upon request” and motivated on reasons concerning, inter alia: national security requirements; health protection; the environment; fundamental climatic or other geographical factors; and so on. The TBT Agreement only marginally relates to food safety, as national provisions aimed at regulating such an issue often fall under the scope of the SPS Agreement. With reference to the latter, however, the TBT Agreement presents more deference towards the authority of national administrations. These are entitled to restrict trade with technical regulations aiming at objectives other than health; they need to demonstrate the necessity and proportionality of such measures, but when they do not rely on international standards, they are not obliged to use exclusively scientific evidence to justify the measures.



2.4 The Cartagena Biosafety Protocol

The Convention on Biological Diversity, finalized in Nairobi in May 1992 and opened for signature at the United Nations Conference on Environment and Development (UNCED) in Rio de Janeiro on the 5th June 1992, entered into force on the 29th December 1993. The Convention is aimed at the conservation of biological diversity, the sustainable use of natural resources and the fair and equitable sharing of benefits deriving from the use of genetic resources. With decision II/5 of the 17th November 1995 of the Conference of the Parties to the Convention, the latter was established to develop a protocol on

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biosafety, adopted in Montreal on 29 January 2000 at an extraordinary meeting of the Conference of the Parties. The protocol focuses specifically on transboundary movements of any living modified organism resulting from modern biotechnology that may have adverse effects on health and on the conservation and sustainable use of biological diversity.36 It reaffirms the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development and has the objective: “to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements” (Preamble and Article 1).

Unlike the already mentioned treaties, the CBP is not a trade agreement: even if its provisions involve and affect trade and transboundary movement of commercial goods, its content is dedicated to the objective of protecting biological diversity and human health from the possible harmful effects derived by modern biotechnology. The scope of its application is limited to a specific sector, the one of living modified organisms obtained through modern biotechnology, and its objective is twofold: protection of health and of the environment. Differently from the CAC, here the duplicity of the aims of the Protocol are conceived in coherent fashion, as both concerns the possible adverse effects deriving from biotechnology and directed to nature biodiversity and/or human health. It is not a treaty against biotechnology, but about its regulation: as the Preamble reads, “modern biotechnology has great potential for human wellbeing if developed and used with adequate safety measures for the environment and human health, trade”. Moreover, it is not a treaty which ignores or counteracts trade, as another line of the Preamble declares that “trade and environment agreements should be mutually supportive with a view to achieving sustainable 36

As indicated in the introduction of the Cartagena Biosafety Protocol “biosafety is one of the issues addressed by the Convention. This concept refers to the need to protect human health and the environment from the possible adverse effects of the products of modern biotechnology. At the same time, modern biotechnology is recognized as having a great potential for the promotion of human well-being, particularly in meeting critical needs for food, agriculture and health care. The Convention clearly recognizes these twin aspects of modern biotechnology. On the one hand, it provides for the access to and transfer of technologies, including biotechnology, that are relevant to the conservation and sustainable use of biological diversity (for example, in Article 16, paragraph 1, and Article 19, paragraphs 1 and 2). On the other hand, Articles 8(g) and 19, paragraph 3, seek to ensure the development of appropriate procedures to enhance the safety of biotechnology in the context of the Convention’s overall goal of reducing all potential threats to biological diversity, taking also into account the risks to human health. Article 8(g) deals with measures that Parties should take at national level, while Article 19, paragraph 3, sets the stage for the development of an international legally binding instrument to address the issue of biosafety”.

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development”. In addition, in case of conflicts between environment and health protection – e.g., imagining a modified organism with great curative powers but harmful for biodiversity – a balancing between the two interests is more coherent and affordable through compromises; moreover, it can be framed into the reasonability limits of the precautionary principle It is also notable that while the SPS and the TBT Agreement have a general and horizontal scope, referring to all traded goods suffering restrictions from national health or technical regulations, the CBP has a specific/vertical one, as it refers only to living modified organisms and to the effect of the use, handling and trade of such goods on biodiversity and health. The protection of bio-diversity is also reflected in the principles and the prescriptions featuring the protocol: the application of the precautionary principle; the inversion of the burden of proof from the importer/regulator to the exporter/producer; and the application of the Advanced Informed Agreement (AIA) procedure (regulated by Articles 7-10 and 12 of the CBP). The AIA procedure consists of an authorization procedure related to “intentional trans-boundary movement” of LMOs (Article 7). Article 8, together with Annex I, provide a duty for the exporter to send a written notification to the Country of import. This document must contain all the information about the product, including a risk assessment as required by Article 15 and described by Annex III of the Protocol. Then, the Party of import has to make a decision (Articles 9-10), for which it has four options: 1) approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same LMOs, 2) prohibiting the import, 3) requesting additional relevant information in accordance with its domestic regulatory framework or Annex I, or 4) extending the period for decision-making (Article 10(3) (a-d)). This decision can be taken in accordance with the precautionary principle.37 Finally, Article 12 foresees the possibility for a Party of import to review and change a decision regarding an intentional transboundary movement at any time, “in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health. In such case, the Party shall, within thirty days, inform any notifier that has previously notified movements of the living modified organism referred to in such decision (…) and shall set out the reasons for its decision”.

The norm thus provides a safeguard clause also in case of approval of the authorization to the import of LMOs. Such a clause can be adopted with the 37

Articles 10(6) and 11(8): “Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that living modified organism intended for direct use as food or feed, or for processing, in order to avoid or minimize such potential adverse effects”.

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respect of predetermined conditions that are: new scientific information on potential adverse effects; a time limit (30 days); and the duty to give reasons for the change of approach. Admittedly, the AIA procedure might turn into a trade restrictive tool in the hands of national member countries as it directly impacts trade by giving to the importing Country a significant tool to close its market and thus has a significant effect in shaping national food safety policies on GMOs. However, this seems to follow the logic of precaution inspiring the treaty and is necessarily connected to the issue of modern biotechnology: when LMOs trade is at issue, the importing State can require a risk assessment from the exporter; if the latter does not prove the safety of his products (which includes also harm to biodiversity), the former can refuse them. If compared with the burden of proof requested to the importer by the SPS Agreement, the AIA procedure entails the opposite view, as it switches the burden of proof on behalf of the exporter, which has not a mere prima facie burden of proof on the safety of the products coming from its territory, but is also required to produce a proper demonstration of the harmlessness of the trading good. Moreover, the CBP allows Parties to use the precautionary principle, in the evaluation of risk assessment presented by the importer, while the SPS Agreement excludes its application to this phase, leaving a limited possibility only if the risk assessment is impossible, as required by Article 5.7. Article 17 foresees a transnational system of alert and emergency measures in front of unintentional transboundary movements of LMOs, which are “likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”. As soon as a member Country knows of an occurrence under its jurisdiction resulting in a release that leads, or may lead, to an unintentional transboundary movement of a potentially harmful living modified organism, it is required to “take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations”. Such notification should include: “available relevant information on the estimated quantities and relevant characteristics and/or traits of the living modified organism; Information on the circumstances and estimated date of the release, and on the use of the living modified organism in the originating Party; Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures; Any other relevant information; and a point of contact for further information” (Article 17.3). The described mechanism has the purpose of sharing data among the parties, allowing and encouraging a proper transnational and cooperative reaction to potential harms derived from unintended transboundary movements of LMOs. Such a system is quite similar to the one foreseen by the WHO to face worldwide outbreaks of disease (which will be studied further, at par. 3.7) and is

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characterized by a globalized procedure. In an interconnected world, the potentially harmful effects in one Country derived from LMOs might have a considerable effect also in other territories: therefore, the administrative procedure to face them cannot be limited only to the authorities of that Country but has to involve, at least as interested participating actors, also other Countries and the relevant international organizations. Article 18 sets limits and prescriptions for what concerns the handling, transport, packaging and identification of LMOs, always directed to ensure a high level of health and environment protection. Articles 19 and 20 concern cooperation, integration under the Agreement and information sharing. The former requires that: “Each Party shall designate one national focal point to be responsible on its behalf for liaison with the Secretariat. Each Party shall also designate one or more competent national authorities, which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions”.

The second establishes a Biosafety Clearing-House in order to: “(a) facilitate the exchange of scientific, technical, environmental and legal information, and experience with, living modifies organisms; (b) Assist Parties to implement the Protocol, taking into account the special needs of developing country Parties (…)”.

In these two provisions, the administrative nature of the regulation is quite evident. The Protocol does not only set rules and principles to respect, at the international level, when LMOs movements are involved, but establishes also a framework of regulation which coordinates specific national authorities, and institutes a central global point of reference charged with tasks of information exchange and assistance. Here we can see that Member States’ regulatory decisions over LMOs are not only made at the national level pursuant to domestic legislation, but they need to respect the principles of the CBP conforming to its procedural formalities and to facilitate the exchange of information. In addition, they may also involve the active participation of an external body, such as the Biosafety Clearing-House. In connection to what was just noted, Article 23 provides that the Parties shall, inter alia: “Promote and facilitate public awareness, education and participation concerning the safe transfer, handling and use of living modified organisms (…). In doing so, the Parties shall cooperate, as appropriate, with other States and international bodies”. In addition, they shall, “in accordance with their respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public, while respecting confidential information”.

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Once again, the traditional principles of administrative law govern and harmonize a transnational regulation. As noted for the previously examined Agreement, the CBP also requires each Member State to ensure certain formal guarantees of transparency, public participation and impartiality. Such guarantees are not only ensured towards the public – consulted in the decision-making in accordance with national laws – but also on behalf of other member States. As seen, the regulation of food safety is transnational, interdisciplinary and multidimensional: national measures concerning this issue (and other related ones, such as the environment), must conform to common procedural and formal requirements, which, without harmonizing the substance of the regulation that is left to the discretion of the national relevant authorities, at least realize an integration for what concerns the procedural aspects and the guarantees of such activity. Finally, Article 26 requires that, in reaching a decision regarding import under the Protocol or under the domestic measures implementing the Protocol, the Parties “may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities”. This provision is quite significant for our consideration of the multi-dimensionality of food safety and of genetically modified organisms. It confirms that the CBP does not limit its attention only to the protection of bio-diversity and to the mere demonstration of the safety/risk of a product, but it also allows Members to exercise their discretionary powers by making a multicomprehensive decision, which takes into account other socio-economic facts relevant for the decision. The CBP is, as seen, mainly a health/environment-oriented treaty. However, involving the transboundary trade and movement of LMOs, it also comprehends food safety and its related issues. The main features of such Agreement are: the application of the precautionary principle and the prioritization of safety over trade; the inversion of the burden of proof from the importer to the exporter; the institutions of significant mechanisms for the coordination, cooperation and dialogue of global and national administrative authorities coping with the regulation of LMOs; the requirement of respecting certain general and procedural administrative principles contemporaneous with wide discretion left to the national competent authorities. With regards to the nature and provisions of the CBP, as for the SPS Agreement, in this case there is a problem of norms and interests dialectic: here the objective to protect biosafety might be harmful to trade, as the contemporaneous presence of the precautionary principle, of the AIA procedure and of a wide discretion given to national authorities regulating LMOs’ trade, could encourage the latter to adopt disguised protectionist measures under the motivation of protection. At the same time, it is mindful that the specificity of the CBP has a particular relevance in the issue, as the big amount of uncertainty over GMOs may justify a slower harmonization in the

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field and a favour for local regulations inspired by the defense of biodiversity. This, under a legal perspective, would lead to an inverted application, at the global scale, of the subsidiarity approach: the regulation of a subject should be general and attributed to common global bodies, but, if a better regulation – for instance when shared harmonization is impossible – can be reached at the local level, the jurisdiction should be left to the local authorities.



3 The institutional framework

In this second part of the chapter, attention will be drawn to the institutional system of global food safety law. The analysis will thus focus on the bodies with regulatory competencies and powers in this field, and acting in the global legal sphere. As it will be noted, the heterogeneity of the framework is striking, either for what concerns the kinds and the characters of the considered subjects, or for what regards their functions and objectives. The next paragraphs are dedicated to the Food and Agriculture Organization (FAO), to the World Health Organization (WHO), to informal networks of food-safety regulators, to the International Food Safety Network, to the International Office of Epizootics (OIE) and the International Plant Protection Convention (IPPC), as food safety-related standard-setter bodies. For what concerns the Codex Alimentarius Commission, a more detailed analysis will be provided in Chapter 4.



3.1 The Food and Agriculture Organization of the United Nations (FAO)

The Food and Agriculture Organization (FAO) was instituted in 1945, it has its headquarters in Rome, Italy, and presently includes 194 Members, comprising States and a Regional supranational organization (the EU). The objectives of the Organization are: • “raising levels of nutrition and standards of living of the peoples under their respective jurisdictions; • securing improvements in the efficiency of the production and distribution of all food and agricultural products; • bettering the condition of rural populations; • and thus contributing towards an expanding world economy and ensuring humanity’s freedom from hunger” (Preamble of FAO Statute, Quebec, 16 October 1945). In order to reach these objectives, FAO acts as an impartial International body, it is autonomous from its Members, both for what concerns its organization, both for what relates to its activity, and it exercises a proactive role by enhanc-

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ing information and knowledge sharing and encouraging harmonization and cooperative policy directed to tackle food insecurity. Although food safety is not explicitly mentioned in the Preamble, we already noted its intimate interconnection with food security (supra, Chapter 1). In addition, the first point of the provisions listed above refers to an improvement of the levels of nutrition and standards of living: This implicitly entails an approach directed to ensuring food safety and security as well. Moreover, FAO is charged with several specific instrumental functions, which directly or indirectly affect food safety. Namely, these are: 1) Legal, financial and technical assistance to the Countries requiring it, applying either in the legislative or in the executive phase of the implementation of food safety regulations; 2) Institution of global forums and International conferences of food safety regulators realizing informal networks aimed at favouring harmonization, at improving the information sharing, and at developing common approaches in global regulation; 3) Approval and issuance of soft law – including guidelines, opinions and recommendations – directed to the development of a common food safety law; 4) Assistance to the Codex Alimentarius Commission, by the management of joint FAO/WHO expert committees entitled to provide scientific reports during the food standard setting activity in the CAC and by coordinating, assisting and funding the CAC’s activity in the implementation of the Joint FAO/ WHO International Food Standard Programme. The tasks listed above have two common elements: 1. They do not constitute legally binding provisions, as all configure as soft laws or informal guidelines; 2. They all aim at the harmonization of Member States’ disciplines on food and agriculture either for what relates to legal and regulatory aspects, or for what concerns technical and scientific approaches, and with the effect to influence also the policies adopted by the domestic authorities. For the first respect, it is notable that FAO has always had a limited legal force concerning its acts, which have been described as “quasi-normative and operational activities”.38 The specification of such activities is to be found in Article I of FAO Constitution, named “Functions of the Organization”.39 These functions require the Organization to: “Collect, analyse, interpret and disseminate information relating to nutrition, food and agriculture (…); promote and, where appropriate, recommend national and international action with respect to scientific, technological, social and economic 38

S. Marchisio & A. Di Blase, The Food and Agricultural Organization (FAO), Geneva – Rome, Martinus Nijhaff Publishers, 1991, p. 22.

39

FAO, Basic Texts of the Food and Agriculture Organization of the United Nations (hereinafter Basic texts), Volumes I and II – 2008 Edition, Rome, 2008, available in the Internet at http://www.fao.org/docrep/010/ k1713e/k1713e01.htm#P8_10.

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research relating to nutrition, food and agriculture; (…) the conservation of natural resources and the adoption of improved methods of agricultural production; the improvement of the processing, marketing and distribution of food and agricultural products; (…); to furnish such technical assistance as governments may request; to organize, in cooperation with the governments concerned, such missions as may be needed to assist them to fulfil the obligation arising from their acceptance of the recommendations of the United Nations Conference on Food and Agriculture and of this Constitution; and generally to take all necessary and appropriate action to implement the purposes of the Organization as set forth in the Preamble”.

In all the three functions listed above, FAO implements indirect forms of regulation. As said, they are not legally binding for their formal nature (soft law, recommendations); for the substance of the activity (information sharing and exchange); or for the barrier of national sovereignty (technical and legal assistance can be provided only upon request of a Member Country). Nonetheless, they still present a significant impact in shaping global food safety law and in influencing the internal normative and regulatory frameworks of national States. For instance, when FAO provides for technical and legal assistance, it also performs a funding of the following activity (through the institution of trust funds), consisting – among others – of teaching courses and drafting of legal acts in order to develop the capacity building in all the phases of the regulation inside national States. Therefore, it is evident that FAO has a non-binding, while effective, power to influence the decisions of States and to shape and frame the internal implementation of such activity by simply directing the money and the technical support to make it real. It is a de facto influence, still relying on national States will, but made stronger by its effectiveness and by the facilities deriving from the conformity of FAO’s policies with all other provisions of international law. In addition, the recommendations and the interventions of legal and technical assistance gain an indirect capacity to convey and embed the decisions of national authorities: despite being soft laws, they are not weak laws. Moreover, the activities of the international organizations give a pressing contribution to national administrations through a factual influence, due to the development of technical and scientific limits and criteria. This means national authorities are required to guarantee conformity to determinate scientific or technical studies and not to international legal acts, which would not have the force of binding norms. Finally, it is notable that also with the assistance activity the FAO puts in place by supporting States in implementing international standards, its contribution in determining the food safety policy of the Country of intervention is considerable: if the State does not want to conform to the international standard, it will lose FAO’s assistance; this, as evident, strongly pushes domestic institutions to conform to international standards, above all if they do not have

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the legal or the factual means to elaborate an alternative approach that does not violate international laws, such as the ones under the WTO. For what concerns the FAO’s recommendation, the Food safety risk analysis guide40 for national food safety regulators, already referred to above, in Section 3.1.1, should be mentioned. This is a practical guide made for national regulators to help them perform an effective, science-based, cost-effective and international law-consistent regulation of food safety. The content of the document at issue presents a detailed description and explanation of all the phases of the Risk Analysis, which coincides with the one contained in the Procedural Manual of the CAC and that the Member States can follow to adopt the risk analysis procedure inside their territories. The organizational structure of the FAO is composed of the Conference, the Secretariat, the Council, several sectoral committees and the Office of the director-general. 41 The latter coordinates eight departments attributed to various functions, among which is the Agriculture and Consumer Protection Department. This in turn consists of different divisions, among which, the most relevant for food safety regulation, is the Nutrition and Consumer Protection Division. This is aimed to: “create sustainable improvements in nutrition, especially among nutritionally vulnerable households and population groups; provide information, assessments and analysis to combat hunger and reduce all forms of malnutrition; assist countries in identifying people who are food insecure and vulnerable to nutritional problems; promote food safety and quality, and prevent food-borne diseases; focus on consumer protection and fair practices in food trade”. 42

The FAO “Nutrition and Consumer Protection Division” is then divided in three services: Human Nutrition, Food Safety and Quality, and Codex Alimentarius. 1) The first one aims to achieve a sustainable improvement in nutritional well-being through a combination of evidence-based and community-based actions to address local causes of malnutrition; improvements in national and sectoral policies and programmes; support to civil society institutions to enable poor households to acquire sufficient food and utilise it most effectively; and enhancement of education and public information for dietary improvement. 2) The Food Quality and Standards Service (AGNS) “is committed to the enhancement of food safety and quality along the food chain at international, regional and national levels, with the aim of protecting consumers and promoting the production and trade of safe, quality food. We achieve this by: • Establishing and improving national regulatory frameworks for food control 40 41

FAO, Food safety risk analysis. A guide for food safety authorities, op. cit.

For functions, dimensions and activities of the mentioned bodies see http://www.fao.org/unfao/govbodies/en/.

42

http://www.fao.org/ag/AGN/index_en.stm.

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and quality assurance compatible with international requirements, in particular those of the Codex Alimentarius; • Supplying technical advice and expertise for the development of integrated food control systems, thus building capacity in food safety and quality throughout the food chain; • Providing independent scientific advice, risk assessments and related guidance concerning food safety to the Codex Alimentarius and Governments, including the assessment of food additives, chemical and microbiological contaminants, naturally occurring toxicants, and foods derived from modern biotechnology; • Developing guidelines and tools on food safety risk assessment and its use in food safety risk management, and on capacity building in various aspects of food safety and quality; • Assisting in emergency or crisis situations through the provision of food safety guidance”. 43 3) Finally, the Codex Secretariat Service deals with the relations with the CAC and the technical-scientific support on its behalf. As evident, the activities that the three services composing the “Nutrition and Consumer Protection Division” perform all relate to different aspects of food safety (nutrition, consumer protection, scientific opinions for standardization and so on) and all concern mechanisms of legal and administrative harmonization, sharing and diffusion of information, technical and legal assistance, issuance of soft laws and management of scientific research on the field. For what specifically concerns the issue of nutrition, which aims to ensure consumer information and health, it is to say that there is a significant need of technical and legal harmonization in such field at the global level: “the science and practice of nutrition depend substantially and unavoidably on good food composition data. Knowledge of the quantities of nutrients and other components in foods is essential for estimating nutrient intakes, for dietetic advice of all kinds, for all judgments about the relative healthfulness of foods, and for epidemiological research that relates indices of disease to intakes of food components”. 44

Such information is also determinant for a complete and fair international food legislation: food composition tables (FCTs) or nutrient databases (NDBs), which keep up with the concepts of modern nutritional science and with the proliferation of foods and processing techniques, are fundamental to establish regula43

 http://www.fao.org/food/food-safety-quality/home-page/en/.

44

A.S. Truswell, D.J. Bateson, K.C. Madafiglio, J.A.T. Pennington, W. M. Rand, J.C. Klensin (1991), INFOODS Guidelines for Describing Foods: A Systematic Approach to Describing Foods to Facilitate International Exchange of Food Composition Data, Academic Press, Available at http://www.fao.org/wairdocs/ AD069E/AD069E00.HTM.

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tions to protect consumers’ health and information, and to avoid unfair practices in trade or technical protectionist barriers. At present, very few countries possess good systems of FCTs or NDBs and also these, such as the United States and the European Union, have missing foods and missing components in their NDBs, or present discrepancies with the standards adopted in other countries. Although the path to integration has accomplished some significant results in the last decades, largely thanks to the work of the International Network of Food Data Systems (INFOODS), 45 legally speaking the goals are still far from reach, as such common frameworks have not yet reached the status of world-wide standards. INFOODS was established in 1984, based on the recommendations of an international group convened under the auspices of the United Nations University. Acting in collaboration with FAO and with regional mirror organizations (such as EUROFOODS), it presents as an international technical network, with the aim to issue specific voluntary standards to develop international participation and cooperation in the acquisition and exchange of data on the nutrient composition of foods, and to assist, encourage and control national States and regional organization to follow a common scheme and approach. Such international body had, and still has, an organizational framework and an international management structure that include a global secretariat and regional datacenters. Its mandate is “to improve data on the nutrient composition of foods from all parts of the world, with the goal of ensuring that eventually adequate and reliable data can be obtained and interpreted properly worldwide”. 46 INFOODS is a strategic international structure supported and participated in by FAO, with highly relevant influence on global harmonization of data, information and technical standards concerning nutrition, food composition and food labeling. Since its establishment, significant progress has been achieved in improving the quality and availability of food composition data worldwide. 47 However, such structure does not possess a self-executing regulatory force, as the standards it produces are not binding and the activity is limited to providing technical assistance and sharing information: the scientific harmonization still lacks a parallel legal and administrative harmonization to implement it. Therefore, the harmonization of food nutrition issues still faces both technical drawbacks, for the difficulty to create scientific agreement, and legal ones, as a regulation with such scope should not be only national or regional, but extended at the international level. This, however, would still imply some dilemmas to solve: food trade, as well as consumers’ rights, is a present and vivid reality of global relevance, which claims for a stronger and stronger legal harmonization in order to foster equality and ensure economic freedom. Nonetheless, the differences among all the food cultures and perceptions around the world are 45

 http://www.fao.org/infoods/infoods/en/.

46

INFOODS (2003). The International Network of Food Data Systems; available at http://www.fao.org/ infoods/.

47

FAO/WHO (2007), Food composition study guide, Rome-Geneva, 18 October 2007.

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an issue to bear in mind when considering regulating and harmonizing food legislation for what concerns names, nutritive characters, ingredients, information labeling, food composition, and so forth. .



3.1.1 The Global Forums of Food Safety Regulators

Among the activities performed by FAO in the field of food safety, the creation of the two sessions of the Global Forum of Food Safety Regulators – GFFSR is worth mentioning. 48 These were coordinated by FAO and WHO, which, by determining the functional objectives of the network and by managing its activity, performed a role of political coordination and soft administrative harmonization. These global forums were multinational – as composed of national food safety-related administrations – and with the legal nature of informal conferences. The aim was to develop common approaches, exchanges of information and uniformity of regulations through an informal and nonbinding cooperative activity. Both conferences led to reports and guidelines for food safety regulators. In 2004, for instance, the conference approved a document indicating the requisites that the national systems should possess for what concerns controls on food products and processes: a food safety legislation conforming to the standard of the CAC; an administrative structure to manage the inspecting and controlling activity of foods (including strategies, programmes, procedures and funds); laboratories for scientific analysis; performance of activity to inform the citizens; and so on. 49 The document indicates also the ways to harmonize the procedures, the programs and the vigilance over the food sector.50 The rationale of such a network is evident if we think about the US – China Poultry case, where the US contested the food safety system of China. By relying on such informal networks, it is much easier for national States to check other Countries’ food safety systems and to cooperate in order to improve them. This informal and organizational mechanism of integration and mutual exchange of best practices may have a significant impact on global harmonization of food safety systems, through the share of common methods, information and legal institutes. Although without any binding force and mainly through moral suasion, such networks can have a positive impact on trade transactions and prevent cases of trade restriction based on the alleged inefficiency of national food safety systems. The two forums were born after the Communiqué of the Okinawa G-8 Summit. In that occasion, it was asked to FAO and WHO “to organize periodic international meetings of food safety regulators to advance the process 48

The first one, held in Morocco, January 2002 and the second one, held in Bangkok, October 2004. More at http://www.fao.org/docrep/meeting/004/y3680e/y3680e00.HTM.

49

FAO/WHO, Second Global Forum of Food Safety Regulators. Strengthening Official Food Safety Control Services, Bangkok, Thailand, 12-14 October 2004, p. 1-3.

50

 Ibidem, p. 7-11.

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of science-based public consultations”. Each forum lasted only for three or four days they were hosted by a specific Country (Morocco in 2002, Thailand in 2004) and the discussion pertained to a single subject,51 divided in several detailed topics. Finally, the participants had formally to adhere (e.g., in 2004 there were 394 participants diversified in 90 Countries and several IGOs and INGOs. The latter as partners with consultative functions (such as FAO, WHO, OECD, OIE, UNEP, UNICEF, UNIDO, WTO, World Bank)), by presenting and discussing their respective contributions and by approving the final documents, to be then published on the website of the conference. To sum up the functions performed by FAO for what relates to food safety law and regulation, we can say it bears a peculiar role, articulated in the following activities. 1) Providing financial, legal and technical assistance to the Countries requiring it, fostering normative harmonization, executive implementation of international standards (like the ones approved by the CAC) and technical feasibility. Such activity concerns several issues under the field of food safety, relating to agricultural process, safe packing, handling and transport of food, nutrition, consumer protection, and so on. The bodies empowered to perform the mentioned activities are: the legal office, the committees for agriculture, and the two services Human Nutrition and Food Safety and Quality. 2) Approving and issuing soft laws – including guidelines, scientific opinions and recommendations – also directed to the development of a food safety ius commune. Among these, for instance, some documents are mentionable: the “Risk Analysis guidelines”; the “Strategy for a Food Chain Approach to Food Safety and Quality”52 issued by the Committee on agriculture; and the legal papers on line performed by the legal office.53 3) Ensuring scientific assistance to the Codex Alimentarius Commission during its standard-setting activity and enhancing the technical harmonization of food composition data through INFOODS. Namely, for what concerns scientific assistance, the Food Quality and Standards Service and the Codex Secretariat Service, together with the WHO, assist the CAC by instituting and managing expert committees, which will provide scientific reports about standard-related substances. These are the Joint FAO/WHO Expert Committee on Food Additives (JECFA); the Joint FAO/WHO Meeting on Pesticides Residues (JMPR); the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA); The Joint FAO/WHO Expert Meetings on Pesticide Specifications (JMPS); The Joint FAO/WHO Expert Committee on Nutrition (JECN), and I will analyse them in depth in the last chapter. 4) Instituting global forums and International conferences (such as the mentioned ones involving the food safety regulators and the pan-European con51

In the first meeting, the topic was: “Improving Efficiency and Transparency in Food Safety Systems”; while in the second one it was: “Building effective food safety systems”.

52 53

 http://www.fao.org/DOCREP/MEETING/006/Y8350e.HTM.

http://www.fao.org/legal/publications/legislative-studies/en/.

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ference on food safety and quality54). This is mainly a political and cooperativeoriented role performed by FAO. The creation of common global conferences, participated by national authorities, international organizations and stakeholders aim at favouring and improving harmonization, interests balancing and information sharing and at developing common approaches in global regulation. Such activity is dealt by the Agriculture and Consumer Protection Department. The activity of FAO, as well as of the international food safety regulators network, is not translatable into legally binding norms. However, as seen, its contribution is still significant in the evolution and development of global food safety law, above all with the perspective of legislative and executive harmonization and of knowledge and information sharing.



3.2 The World Health Organization (WHO)

In order to describe and focus on WHO, it is useful to start with a specific case. After the outbreak and the spread in 2003 of a highly pathogenic H5N1 avian influenza in poultry, with sporadic, frequently fatal cases in humans, a new influenza virus with great pandemic potential, the new influenza A (H1N1) strain, emerged in Mexico, in April 2009. This consists of a virus affecting pork, transmissible to humans and between humans like a normal flu.55 The transnational character of the H1N1 virus created great pressure on governments, ministries of health and WHO, to make the right decisions and take the right actions at a time of great scientific uncertainty. On 29 April 2009, the WHO raised the level of pandemic influenza alert from phase 4 to 5. In May, it reached phase 6. These WHO pandemic phases are applied in order to perform a proper reaction to different stages of an epidemic. The move to phase 6 activated a number of stepped up preparedness measures, such as the implementation of contingency plans for all the national health systems and at all levels.56 Public health services, laboratories, WHO staff, and industry dedicated to the issue and in many Countries the activity for producing appropriate vaccines was incremented. Nonetheless, manufacturing capacity for antiviral drugs and influenza vaccines is finite and insufficient for a world with 6.8 54 55

 http://www.fao.org/3/a-y3696e.pdf.

“Reassortment of genes from swine, avian, and human viruses have occurred periodically, and triple swine, avian, and human H1N1, H1N2, and H3N2 reassortant viruses have been circulating in swine since at least 1998, especially in North America. (…) The currently circulating A/California/4/2009-like H1N1 virus appears to be a further reassortant of the triple-reassortant swine viruses”, WHO-OFFLU, Joint WHOOFFLU technical teleconference to discuss human–animal interface aspects of the current influenza A (H1N1) situation Meeting Summary, Geneva, 4 May 2009, p. 1, available at http://www.who.int/ csr/resources/publications/swineflu/WHO_OFFLU2009_05_15.pdf, p. 1-2. On 19 May 2009 – As of 06:00 GMT, 19 May 2009, 40 countries have officially reported 9830 cases of influenza A (H1N1) infection, including 79 deaths, http://www.who.int/csr/don/2009_05_19/en/index.html.

56

 http://www.who.int/csr/disease/swineflu/frequently_asked_questions/levels_pandemic_alert/en/index.html.

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billion inhabitants. This is just one of the several reasons for which it is essential to arrange a proactive and preventive approach to avoid the outbreak of such pandemic diseases. All the competent institutions promptly reacted to the described phenomenon,57 among others, with a rapid alert alarm system communicating the outbreak to all national competent authorities and with the development of remedies to prevent the transmission of the influenza to humans: “Industry plans to produce approximately 480 million doses of trivalent seasonal vaccine in 2009. Of this, 350 and 430 million doses will be available by 30 June and 31 July 2009, respectively. For influenza A (H1N1), it is estimated that up to 4.9 billion doses could be produced over a 12-month period after the initiation of full-scale production if 1) There is a vaccine yield equivalent to that routinely obtained for seasonal vaccine and 2) There is use of the most dose-sparing formulations. In this situation, there is a potential access for the UN of supplies of up to 400 million doses”.58 Most of the discussion that rose after the outbreak of the Swine influenza focused on human–animal and human-human interface aspects of the virus, and on the remedies to avoid the contagion. Whilst, it is much more difficult to find official data and reports about the original causes of the disease, and on the remedies to prevent it at an earlier stage, at the level of animal contagion. On this, for instance, an editorial of the Director General of the OIE reads: “intensifying livestock production (…) will lead to increased sanitary and environmental risks, which cannot be effectively controlled without increasingly strict regulations and Veterinary Services that have the power to enforce them within their field of competencies”.59 While we cannot systematically relate the intensive breeding and the outbreak of the virus, it is intuitive that the highly intensive breeding of animals (for instance in batteries) – frequently met in modern agro-industry as a method to increase the productions – can constitute a reason for the incremental increase of the possibility of diseases spreading 57

For instance, “The OIE–FAO Network of Expertise on Animal Influenza (OFFLU), which is sponsored jointly by the World Organisation for Animal Health (OIE) and the Food and Agriculture Organization (FAO), has responded quickly to the current global situation by expanding to include swine influenza expertise. They have posted on their website (http://www.offlu.net/OFFLU%20Site/offlu-29Apr.pdf ) a request to laboratories around the world that may be holding information on swine influenza to share that information with the international scientific community, especially in light of the current public health concerns. WHO and OFFLU have been collaborating on avian influenza H5N1 for several years, and have now expanded their collaboration to address this new event”, WHO-OFFLU, Joint WHOOFFLU technical teleconference to discuss human–animal interface aspects of the current influenza A (H1N1), cit., p. 1. See also the WHO Pandemic Influenza Preparedness and Response, World Health Organization, Geneva 2009, available at http://www.who.int/influenza/resources/documents/pandemic_guidance_04_2009/en/.

58

WHO, Ad hoc Policy Advisory Working Group on Influenza A (H1N1) vaccines, Geneva, 18 May 2009, p. 2.

59

OIE, Feeding the world better by controlling animal diseases, 29 January 2009, unpaged, available at http:// www.oie.int/doc/ged/D5738.PDF.

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among the animals of a farm.60 The swine influenza does not concern eating pork. However, it is certainly a food-borne disease, as it attacked animals under breeding. This is thus a proper issue of food safety, as the breeding method is potentially and significantly dangerous in influencing our food habits and in affecting our health, in general and as food consumers. We already noted how food safety regulation necessarily implies both a proactive approach – including authorization procedures, inspections, consultations, controls and so on – both a remedial one – with systems of rapid alert, confiscations, sanctions or vaccinations. At the global level, the WHO mainly embodies the latter. It is to remind that most of the executive and practical activity to put in place food safety remedial measures is still performed by national health authorities. Nonetheless, the WHO maintains a significant role as coordinator and common referent for what concerns the principles and the approaches to the application and the sharing of information and remedies in cases of foodborne emergencies. The World Health Organization was created in 1948 with the aim to advance all of the peoples to the highest possible level of health (Article 1, Constitution of the World Health Organization). Presently it is composed by 192 members and has its headquarters in Geneva. Article 2 of the WHO constitution foresees the objectives of the Organization, among which some relates to food safety. Namely, these are: “(c) to assist governments in strengthening health services relating to food safety; (…) (f) to promote, in cooperation with other specialized agencies where necessary, the improvement of nutrition…; (…) (r) to assist in developing informed public opinion among all peoples on matters of health and food safety; (…) (u) to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”.

Most of the mentioned objectives are general functions of cooperation, harmonization and worldwide guarantees dedicated to the safety of food. The WHO thus performs similar tasks to the one accorded to FAO, although in a parallel, and sometimes overlapping, sector. 60

On this, see a reconstruction that appeared on the guardian.co.uk: http://www.guardian.co.uk/ world/2009/may/02/swine-flu-pandemic-mexico-pig-farming. On the effects of intensive breeding, the scientific literature is increasing, both on the side of intensive breeding supporters and on the side of the critics. See for instance G.F. Filson (ed.), Intensive Agriculture and Sustainability. A Farming Systems Analysis, Vancouver, UBC Press 2004; OECD, The Environmental Effects of Reforming Agricultural Policies, OECD, Paris, 1998, p. 80 et seq.; various releases of the EU Institutions, such as EC Commission, Intensive Farming and the Impact on the Environment and the Rural Economy of Restrictions on the Use of Chemical and Animal Fertilizers, Brussel-Luxembourg, 1989 and http://ec.europa.eu/environment/integration/research/newsalert/pdf/291na4_en.pdf. On this issue, it is also interesting to see the short film at this website: http://www.themeatrix.com/.

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For instance, it provides technical and legal assistance for the Countries requiring it (this happened, for instance, with the Healthy Food Market Project61 and the Joint FAO/OIE/WHO Consultation on Avian Influenza62), namely intervening in case of emergency, where crisis management is dealt with by local administration in agreement and cooperation with the FAO and with other States’ authorities. Moreover, the WHO entails tasks of creation and coordination of networks of authorities with health competence: it joins FAO in the institution and management of the Global forums of food safety regulators, and to other many horizontal meetings, such as the International Food Safety Authority Network – INFOSAN, described more in detail infra, in section 3.2.1. Finally, the WHO entails a twofold normative power: on one side it issues non-binding guidelines in order to spread and share information and knowledge in health protection sector63 and to coordinate national and regional authorities; on the other side, it is empowered to enact binding regulations – the International Health Regulations (IHR) – with the aim to harmonize national health systems for what concerns certain transfrontal epidemics. The latter only marginally pertains to food safety, as the IHR were originally conceived (in 1969) to face in a coordinated and shared fashion four transnational diseases considered of particular danger: cholera, plague, yellow fever and smallpox.64 The IHR have been finally modified by an intergovernmental working group inside the WHO in 2005 and more kinds of diseases were included, compris61

The activity develops through food inspections, or through knowledge and information sharing for sellers and consumers. On this see G.G. Moy, Healthy marketplaces: an approach for ensuring food safety and environmental health, in Food Control, Vol. 12, Issue 8, December 2001, p. 499-504 and WHO, A guide to healthy food markets, I. World Health Organization, NLM classification: WA 695, Geneva, World Health Organization, 2006.

62

 Joint FAO/OIE/WHO Consultation on Avian Influenza and Human Health: Risk Reduction Measures in Producing, Marketing, and Living with Animals in Asia, Renaissance Hotel, Kuala Lumpur, Malaysia, 4-6 July 2005. http://www.fao.org/docs/eims/upload/246975/aj123e00.pdf: “The Consultation was attended by 29 temporary advisers who were drawn from nine countries and areas of Asia, as well as a temporary adviser from the Netherlands, 12 observers and representatives from Malaysia, Japan International Cooperation Agency (JICA) and the United States Department of Agriculture (USDA); and 23 members of the joint Food and Agriculture Organization of the United Nations (FAO), World Organisation for Animal Health (OIE) and WHO secretariat”, FAO/OIE/WHO, Consultation on avian influenza and human health: Risk reduction measures in producing, marketing, and living with animals in Asia, Report. (WP)NUT/ICP/HSE/4.4/001-E – RS/2005/GE/28(MAA), Kuala Lumpur, Malaysia, World Health Organization Regional Office for the Western Pacific, January 2006, p. 1.

63

On this, see WHO, WHO Global Strategy for Food Safety. Safer Food for Better Health, Food Safety Issues, WA 695, Geneva, WHO, 2002, p. 13 et seq.

64

WHO, International Health Regulations (1969), adopted by the Twenty-second World Health Assembly in 1969 and amended by the Twenty-sixth World Health Assembly in 1973, and the Thirty-fourth World Health Assembly in 1981, Third annotated edition 1983, Geneva, World Health Organization 1983, updated and reprinted in 1992 and in 1995, Articles 2-19.

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ing food-borne ones, so that the new version has reached full legal force in the territories of the Member States in 2007. The new provisions concern a much more open range of emergencies related to public health, including surveillance and management of food products and food-borne epidemics. Their objectives are: enhancing the exchange of information and the management of emergencies;65 impeding the diffusion of diseases without damaging the movement of goods and the commercial transactions; adapting the sanitary control to the need of a highly interconnected world.66 The IHR are legally binding for all those Member States that did not explicitly refuse them, or, if they are not members, which explicitly required to ratify them. The text of the norms is approved after a series of negotiations and under unanimity agreement. However, the regulations become nationally effective only after a procedure of negative consensus: WHO members must formally express their intention not to sign the agreements. Once approved, the IHR require that Member States modify their internal systems for surveillance, management and control of diseases. In addition to the levels of health protection, the IHR also establish procedural norms and criteria in order to harmonize the functioning and the activities of relevant national authorities (for instance with analogous control inspections, vaccinations, and so on). For what concerns the organizational structure of the WHO, attention is to be focused on the Department of Food Safety, Zoonoses and Foodborne Diseases (FOS). This is the body of the organization dealing with the issues involved by food safety and aimed to contrast and reduce the negative impact of foodborne diseases worldwide. Namely, “FOS works with other WHO departments, Regional Offices and WHO collaborating centres as well as other international and national agencies. In particular, WHO works closely with the FAO to address food safety issues along the entire food production chain--from production to consumption--using new methods of risk analysis. These methods provide efficient, science-based tools to improve food safety, thereby benefiting both public health and economic development. FOS endeavours to help all WHO Member States, both developing and developed, through the approaches outlined in the WHO Global Strategy for Food Safety.”67/68

65

“The establishment at WHO and in Member States of real time event management systems for addressing public health risks and emergencies of international concern”, WHO, Revision process of the International Health Regulations (IHR), http://www.who.int/csr/ihr/revision/en/index.html.

66

“The purpose and scope of the IHR (2005) is no longer limited to the notification of specific diseases. States are now required to notify WHO of all events that may constitute public health emergencies of international concern”, Ibid.

67

 http://apps.who.int/iris/bitstream/10665/42559/1/9241545747.pdf?ua=1.

68

 http://www.afro.who.int/fr/groupes-organiques-et-programmes/dnc/securite-alimentaire-et-nutrition/apercugeneral.html.

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The described body thus assist the World Health Assembly and the Executive Board in performing their activity for what concerns food safety and related issues. Therefore, for instance, it is competent in preparing and drafting recommendations, in providing organizational and scientific assistance to the CAC, in coordinating and managing the activities put in place together with the FAO.



3.2.1 The International Food Safety Authority Network

The International Food Safety Authority Network – INFOSAN is a non-institutional body of cooperation among national food safety authorities. It does not possess normative or executive powers, but entails functions related to the exchange, sharing and diffusion of information and to enhance the connections among food safety administrations. INFOSAN was created in March 2004 through an informal mechanism: the WHO required that complying States (at present 145) institute one or more “INFOSAN Focal Points” and one “INFOSAN Emergency Contact Point” in every Country. The management and the activity of INFOSAN have a top-down direction but involve both the WHO and the national authorities. The WHO coordinates and manages the network, activating the procedures of interchange of information, indicating the crucial sectors of intervention, (as happened for GMOs,69 avian influenza70 and zoonoses71) and carrying the responsibility to maintain the guidance and to finalize the activities to the general interests of health protections. The national focal points are periodically in contact among one other, exchanging information and techniques and giving executions to the directives of the WHO. For what concerns the management of emergencies, INFOSAN Emergency and the WHO Global Outbreak Alert & Response Network – GOARN72 are to be mentioned. These start the procedure only in case of outbreaks or incidents of particular gravity that are globally dangerous. If in one State an epidemiologic event breaks, when the national authority gets acquainted with the danger and realizes its transnational effect, it has to alert the other Countries and it can do it through its national INFOSAN Emergency Contact Point, immediately reaching the INFOSAN Emergency Network, which will share this information in real time. 69

WHO/FAO, INFOSAN Information Note No. 4/2005 – Biotechnology, Biotechnology, Geneva, 21 June 2005, http://www.who.int/foodsafety/fs_management/No_04_Biotech_Jun05_en.pdf.

70

WHO/FAO, INFOSAN Information Note No. 7/2005 (Rev 1. 5 Dec) – Avian Influenza (Update of INFOSAN Information Note No. 2/04 – Avian Influenza, 17 Dec. 2004), Highly pathogenic H5N1 avian influenza outbreaks in poultry and in humans: Food safety implications, Geneva, 4 November 2005, http:// www.who.int/foodsafety/fs_management/No_07_AI_Nov05_en.pdf.

71

WHO/FAO, INFOSAN Information Note No. 1/2006 – Zoonotic Diseases Control of neglected zoonotic diseases: challenges and the way forward, Geneva, 17 February 2006, http://www.who.int/foodsafety/ fs_management/No_01_Zoonoses_Feb06_en.pdf.

72

 http://www.who.int/csr/outbreaknetwork/en/.

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To sum up the functions performed by WHO for what relates to food safety law and regulation, we can say it bears a peculiar role, articulated in the following activities. 1) The WHO performs significant activities in the remedial phase of food safety. For instance, this happens through the issuance of world-wide guidelines and advice to face global epidemics; through intervention upon request of the national States in case of emergency, in order to deal with crisis management; through INFOSAN Emergency and the GOARN, when the activation of such mechanisms is required; and through the provisions contained in the IHR, dealing with remedies to emergency outbreaks. 2) Together with FAO, WHO gives its contribution to global harmonization of food safety principles, rules and procedures, as it happens with the international conferences of food regulators, with the assisting activity to the CAC and with the issuance of the IHR. 3) In addition, the WHO provides scientific and legal assistance, in matters strictly related to health protection and hygiene requirements in the field of food production and consumption and coordinates global networks to share information and knowledge and to face emergencies in real time. 4) Finally, through the establishment of a legally binding framework of horizontal regulations (the IHR), the WHO provides common procedural and substantial requirements and methods of approach to face significant worldwide diseases and to reach a more harmonized status of health regulation.



3.3 The International Office of Epizootics and the International Plant Protection Convention

The Annex A of the SPS Agreement, which recalls the international organizations that issue standards able to justify Member States’ measures under Article 3 of the same Agreement, refers, in addition to the CAC, also to the International Office of Epizootics (OIE) and to the International Plant Protection Convention (IPPC). The first one sets standards for animal health and zoonoses; the second one, for plant health.



3.3.1 The OIE

The OIE was established in January 1924 with an international agreement 73 and has its headquarters in Paris. Article 2 of the instituting agreement – lastly updated in July 201174 – foresees that the office “is subject to the authority and control of a Committee composed of Delegates of the contracting Governments”. The body that manages and controls the office and its standard 73

International Agreement for the Creation of an Office International Des Epizooties in Paris, http://www. oie.int/about-us/key-texts/basic-texts/international-agreement-for-the-creation-of-an-office-international-desepizooties/.

74

 http://www.oie.int/fileadmin/Home/eng/About_us/docs/pdf/basic_text/A_BasicTexts_part_1.pdf.

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setting activity is thus an intergovernmental Committee composed of delegates nominated by the national State members. The Appendix to the International Agreement, consisting of the Organic Statutes of the OIE, disciplines the activities and the organization of the Office. Article 2, second par. provides that the Office should be independent from States’ authorities and from the influence of the hosting State, while it should only “correspond directly with the higher authorities or departments responsible for the animal sanitary policy of the various countries”. This means that the office is conceived as an inter-bureaucratic and technical body, with a direct connection with mirror national bodies and ruled by a Committee composed of national delegates, but, at the same time, distinct from the executive of the Member States and so acting autonomously and independently in the global legal space. Such characters are confirmed by Article 4 of the Organic Statutes, which, by indicating the main objects of the office, qualifies it as a technical-bureaucratic body with functions of harmonization and cooperation. Namely these are: “a. To promote and co-ordinate all experimental and other research work concerning the pathology or prophylaxis of contagious diseases of livestock for which international collaboration is deemed desirable. b. To collect and bring to the attention of the Governments or their sanitary services, all facts and documents of general interest concerning the spread of epizootic diseases and the means used to control them. c. To examine international draft agreements regarding animal sanitary measures and to provide signatory Governments with the means of supervising their enforcement”.

The first activity consists of promotion and coordination of research with the objective of fostering international collaboration and administrative harmonization. The second one serves to create a contextual sharing of information and interests’ evaluation among the Governments and their sanitary services. The third one features consultative and supervising performances on behalf of national Governments implementing epizootics-related measures. On the other hand, national members’ governments are required to ensure collaboration by forwarding notification of cases of disease or infection and a periodical bulletin “prepared according to a model adopted by the Committee, giving information on the presence and distribution” of determined diseases, such as Rinderpest, Foot and Mouth disease, Rabies and Swine fever (Article 5, Statutes). The work of the Office is carried out by a Director, a technical staff and employees required for the day-to-day running of the Office (Article 8, Statutes). Article 6 confirms the technical nature of the latter by providing that it “shall be under the authority and control of an International Committee, composed of technical representatives appointed by the participating States, on the basis of one representative for each State”. National States can only appoint one representative each and they will have to share their governing power inside the OIE.

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And, last but not least, these are required to be technical delegates, selected on the basis of their expertise – rather than for their political orientation or for their bureaucratic career. Such composition has been chosen in order to characterize OIE as a technical body, rather than as a political or administrative one. Nonetheless, the membership does not follow an extra-national system of recruitment as the delegates are chosen and sent to the Organization by the Member States. The Committee of delegates is disciplined by Articles 4-6 of the Organic rules of the OIE. Namely, Article 6 establishes that the Committee has the power: “to determine the scientific and technical policy of the Office; to study and vote on Proposals and Recommendations to Member Countries on the problems of the moment concerning the prophylaxis of epizootic diseases”. In addition, it contributes to the internal organization of the Office and to its functioning (with competences regarding the election of the President and of the Administrative Commission, the appointment of the Director General, the budget and the relationship with other international organisations). More generally, the Committee has the right to “discuss all problems, which concern the Office” (Article 1, General Rules of the OIE75), it meets in general session once a year (Article 2, General Rules) and, whenever it reaches the established quorum (it can “proceed with voting only if more than half the Delegates representing Member Countries of the Office are present” Article 6, General Rules) it can pass resolutions which will be notified to the Member States and then published on the Bulletin (Article 7, General Rules). According to Article 10 of the Statutes, the Bulletin “shall contain, in particular: 1. Laws and general or local regulations promulgated in various countries concerning contagious diseases of livestock; 2. Information concerning the spread of contagious diseases of animals; 3. Statistics concerning animal health status worldwide. 4. Bibliographical references”. This act provides thus an important service of information sharing, as it diffuses legal, scientific and statistical information among the parties. The OIE is the world organization for animal health. It is thus a technical inter-governmental body empowered to “develop[s] and publish[es] two types of international health standards for animals and animal products – trade standards and biological standards. These standards are developed through elected Specialist Commissions and are adopted by OIE Members during the annual OIE General Session”.76 In performing its standard setting activity, the OIE follows a precise administrative procedure, maintains a high level of autonomy and relies on scientific principles and approaches. With its activity, it also contributes to the diffusion and share of scientific, legal and factual information as well as knowledge concerning animal health.

75

Decided by the International Committee, 24 May 1973 and updated in June 2006.

76

OIE, The OIE International Standards, Paris, p. 1, available at the health standards section of http://www. oie.int/eng/en_index.htm.

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3.3.2 The IPPC

The IPPC is an international convention – finalised in Rome under the legal framework of the FAO in December 1951 and lastly updated in 1997 77 – aimed at the protection of plant health, with functions concerning the adoption of phytosanitary measures, the establishment of common rules for national Member States, and the increment of international cooperation under the field of its jurisdiction. It is governed by the “Commission on Phytosanitary Measures” (CPM), which is empowered to adopt International Standards for Phytosanitary Measures (ISPMs). By the reading of its preamble, the IPPC’s rationale can be identified in three main objectives: 1) Plant health protection (“controlling pests of plants and plant products and in preventing their international spread”); 2) Ensurance of a fair and open plant trade (“phytosanitary measures should be technically justified, transparent and should not be applied in such a way as to constitute either a means of arbitrary or unjustified discrimination or a disguised restriction, particularly on international trade”): 3) Legal and administrative harmonization in the field at issue (“provide a framework for the development and application of harmonized phytosanitary measures and the elaboration of international standards to that effect”). The Convention – like the CAC and the OIE – is thus conceived as a legal text adopted to enhance and harmonize global health protection with a balanced approach regarding trade priorities. Article I.1 of the Convention specifies the purpose of the IPPC stating that this consists of: “securing common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control, the contracting parties undertake to adopt the legislative, technical and administrative measures specified in this Convention and in supplementary agreements”.

The objective of the Convention is thus to create a common and effective legal, technical and administrative framework, which, by harmonizing the regulation of the field, promotes the adoption of appropriate measures aimed at protecting plant health. The framework established with the IPPC foresees the creation by each contracting Party of a national organization, a contact point to communicate with the CPM and with the objectives of: issuing certificates “relating to the phytosanitary regulations of the importing contracting party for consignments of plants, plant products and other regulated articles”, in order to ensure formal justification of national health measures; harmonizing the surveillance and the 77

Annex 1, IPPC, Procedural Manual, Rome 2008, FAO, p. 134 et seq.

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management of the emergency related to plant health; performing inspection and activities related to hygiene of the plants; protecting endangered species; conducting risk analysis; guaranteeing fair procedures for what concerns plant trade (Article. IV.2, IPPC). In addition, each contracting party commits to foster and develop harmonization, collaboration and information sharing, through: “a) the distribution of information within the territory of the contracting party regarding regulated pests and the means of their prevention and control; b) research and investigation in the field of plant protection; c) the issuance of phytosanitary regulations; and d) the performance of such other functions as may be required for the implementation of this Convention” (Article. IV.3, IPPC).

One important function concerning harmonization is the procedure through which the IPPC Commission supervises the issuance of national phytosanitary certificates concerning trade of plants with the aim to convey this activity under principles, formal guarantees and general criteria established by the IPPC (Article V, IPPC). Consistent with such provision, Article VII disciplines the regulation of the entry of plants and plant products on behalf of the Member States. In order to minimize its negative effect on trade, it requires the latter to undertake their acts in conformity with ten requisites indicated by Article VII.2 (a-j), among which, necessity, reasonableness and technical justifications are to be mentioned as criteria to enact legitimate trade restricting national measures. Article X of the Convention explicitly indicates the standard setting activity performed by the Commission, which adopts international standards and sets the procedures ruling such activity. The process for the development of international standards for phytosanitary measures (ISPMs) is disciplined by Section III of the IPPC Procedural Manual78 and it is divided into four stages: developing the IPPC standard setting work programme, drafting, consulting members, adopting and publishing. The Commission is established within the framework of the FAO and it is an intergovernmental body, entitled – inter alia – to perform a standard setting activity, to adopt guidelines, recommendations and rules of procedures for the resolution of disputes (Article XI.2, IPPC). For what concerns membership and voting, Article XI.4-5 of the Convention provides that: “each contracting party may be represented at sessions of the Commission by a single delegate who may be accompanied by an alternate, and by experts and advisers. Alternates, experts and advisers may take part in the proceedings of the Commission but may not vote, except in the case of an alternate who is duly authorized to substitute for the delegate. The contracting parties shall make every effort to reach agreement on all matters by consensus. If all efforts to reach consensus have been exhausted and no agreement is reached, the decision 78

 Ibid., p. 39 et seq.

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shall, as a last resort, be taken by a two-thirds majority of the contracting parties present and voting”.

As noted, the Commission has an egalitarian intergovernmental composition; national delegates are bureaucrats appointed by national Governments but are supported by scientific experts, and the system of voting is primarily consensus, or in case of failure, a qualified majority of two-thirds. Finally, also the dispute settlement mechanism deserves a mention. The IPPC, differently from the CAC and the OIE, foresees a mechanism to resolve any conflict concerning the interpretation and the application of the Convention or the adoption of national measures that are allegedly inconsistent with the Convention’s rules. If a consultative solution is not found between the Countries involved in the disputes, any of the parties may: “request the Director-General of FAO to appoint a committee of experts to consider the question in dispute, in accordance with rules and procedures that may be established by the Commission. This Committee shall include representatives designated by each contracting party concerned. The Committee shall consider the question in dispute, taking into account all documents and other forms of evidence submitted by the contracting parties concerned” (Article XIII.23, IPPC).

The decision of the Committee is not legally binding and, being composed by representatives of the States, the Committee cannot properly be defined as a judiciary body. However, “the contracting parties agree that the recommendations of such a committee, while not binding in character, will become the basis for renewed consideration by the contracting parties concerned of the matter out of which the disagreement arose” (Article XIII.4, IPPC). The system of dispute settlement thus relies on a technical and intergovernmental (as it includes representatives from each State) committee composed of experts, which issues reports on technical issues, without the legal force of a judiciary decision. The decisions of the Committee resemble neutral and scientific opinions over a debated issue, rather than proper judicial resolutions, and they are taken in order to favour friendly resolutions of the occurred disputes. The IPPC is an international treaty aimed at creating a common and effective legal, technical and administrative framework in order to harmonize the regulation of plant health and related issues, so to minimize the negative effect on trade. The Commission that rules and coordinates the activity under the IPPC performs this task through a standard setting activity, through the application and the diffusion of common legal principles and procedural mechanisms for the contracting parties, through a permanent exchange of information, knowledge and technical expertise among the participants and through the coordination and supervision of national phytosanitary certificates concerning trade of plants or plant-products.

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4 Conclusions

The synthesis of the described legal framework can be done through an example. Let us say that there is one Country that wants to issue a new regulation on a specific commodity, which has health implications and is deemed to be strategic also for economic development. Then the State could require assistance to the FAO for the elaboration of the legislation and for the material implementation of the measure. The Organization can refer to a guideline or to a code of practices agreed upon in a global forum of food safety regulators. Alternatively, a Codex standard may exist on the matter. Then the FAO would require (and help) the Country to conform the domestic measure to the standard and to prepare its regulation following the risk analysis procedure and in accordance with the conclusions of the CAC. Let us say that the corporation producing that commodity wants to export its product to another State and that the latter closes its market for an alleged risk, but justifying this choice with a SPS measure more restricting than the Codex standard. Then the exporting Country – the first one – will be entitled to complain to the DSB of the WTO and eventually require the settlement of a Panel for the adjudication of the dispute. Once this is settled, it should exclude the application of the precautionary principle, evaluating if the restricting measure of the importing Country is to be justified through a scientific demonstration proving its necessity. Nonetheless, if the commodity is a living modified organism and both countries ratified the CBP, the restriction of the market may be justified under the provisions of the latter agreement, also on precautionary bases. Finally, in case a pandemic outbreak occurs from that particular product, through INFOSAN Emergency and the activity of the WHO, all the countries where that food was traded will be alerted and provided with the information and knowledge to face the epidemics. One aspect is of particular relevance in the previous analysis on the legal framework of food safety: its complexity. As said at the beginning of this chapter, we are drawing a map of global food safety norms and bodies, as there is not a common single legislation on it and not a single institution competent for such issues. This relates to the mentioned characters of food safety itself. Multi-dimensionality, extra-nationality and inter-disciplinarity require a complex regulation composed of several general and specific principles and criteria, of different legal texts belonging to different sectors (trade, the environment, agriculture, health), and of several actors (international organizations, informal networks or forums, and national authorities participating to the former). The common aims of the described framework are the harmonization of national regulatory disciplines through the share of agreed to principles, rules and methods, as well as of information, knowledge and technical facilities, and the maintenance of a balance among the plurality of the interests involved, as they enter in conflict. Such a balance concerns both the controversies among free trade, the environment, health and agriculture, both the ones between the needs of the global space and those of the national legal constituencies. All the

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mentioned legal texts and active actors concur to the creation of a framework, either fostering integration, or allowing differences; either developing trade of goods, or enhancing health protection; either fostering a proactive and precautious approach, or making ready emergency remedies. The system is still incomplete and fragmented and some drawbacks are evident in the imbalance between certain conflicting interests or in the decrease of transparency and accountability of the decision-making. Nonetheless, the present system is quite striking in the way it works for an integrated model, confirming how food safety law and regulation is more and more globalized, multi-functional and interdisciplinary. In order to have a complete picture of global food safety law and regulation, it is of crucial importance to focus on the Codex Alimentarius Commission. Distinctly from the previous framework, the Codex appears as a single – although continuously evolving – text of food safety norms, with its own principles, aims and procedures. In addition, it is also the main actor of the system, although it involves the contribution of other relevant subjects. For all these reasons, the CAC will be treated in the following chapter.

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Extra reading On principles of food safety J.S. Applegate, The Proemetheus Principle: Using the Precautionary Principle to Harmonize the Regulation of Genetically Modified Organism, in Indian Journal of Global Legal Studies, Indiana University School of Law, 2001. G.G. Moy, Healthy marketplaces: an approach for ensuring food safety and environmental health, in Food Control, Vol. 12, Issue 8, December 2001. E. Fisher, Precaution, Precaution Everywhere: Developing a ‘Common Understanding’ of the Precautionary Principle in the European Community, in Maastricht Journal of European and Comparative Law, 2002/9. J. Cazale, Food Safety and the Precautionary Principle: The Legitimate Moderation of Community Courts, in European Law Journal, 2004, n. 5, vol. 10. M.A. Recuerda, Dangerous Interpretations of the Precautionary Principle and the Foundational Values of European Union Food Law: Risk versus Risk, in Journal of Food Law and Policy, vol. 4:1, 2008. A. Szajkowska, From mutual recognition to mutual scientific opinion? Constitutional framework for risk analysis in EU food safety law, in Food Policy, December 2009 34 (6): 529-538. A. Szajkowska, The Impact of the Definition of the Precautionary Principle in EU Food Law, in Common Market Law Review, February 2010, Vol. 47 Issue 1, p. 173-196. On the food safety legal framework D. Milijkovic, Sanitary and Phytosanitary Measures in International Trade: Policy Considerations vs. Economic Reasoning, in International Journal of Consumer Studies, 29, 2005. J. Scott, Cooperative Regulation in the WTO: The SPS Committee, in Global Law Working Paper, n. 03/06, New York City, 2006. On food safety institutions E. Millstone & P. van Zwanenberg, The Evolution of Food Safety Policy-making Institutions in the UK, EU and Codex Alimentarius, in Social Policy and Administration, 2002, 36:6.

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The Codex Alimentarius Commission

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the codex alimentarius commission

1 Introduction

We already had the chance to expend some words on the Codex Alimentarius Commission. Through the study of some DSB case law, consideration was given to the way CAC’s standards become quasi-binding norms through the recall of the SPS Agreement. At the same time, the analysis of the legal framework, conducted in the last chapter, focused on CAC’s rationale and on the ambiguity of its dual purpose, on the relationship with FAO and WHO (its parental organization) and on the risk analysis procedure governing the standard-setting procedure. The present chapter consists of a detailed analysis of CAC’s organizational structure and its standard-setting activity. By starting with two study cases concerning two kinds of Codex standard, we will firstly focus on the way CAC is organized, describing the Commission and the Executive Committee, the subordinate committees, the external expert committees charged with the risk assessment phase, and the national contact points through which Member States give their contribution to the Organization. Secondly, we will describe all the eight phases of the standard setting procedure, evaluating – with the perspective of administrative law – the positive issues and the pitfalls of such proceeding. Finally, the conclusions will deal with a general assessment of the CAC, trying to show also its future perspectives.



2 Two study cases of Codex standards: The international standard on irradiated foods and the international standard on corn

As previously noted, the CAC issues plenty of standards, of different kinds. In order to exemplify their description, we can stress the attention on two types of standard: a general or horizontal one, setting principles, limits and criteria for a particular method of food process applicable to all kind of commodities; and a specific, vertical or commodity-related one, indicating exactly the inner characters that a particular food must possess to be correctly produced, traded and consumed. The first one is Codex standard n. 106-1983, reviewed in 2003 (n. 1-2003) on irradiated foods; the second one is Codex standard n. 153-1985 and concerns corn (maize). A general, horizontal, standard: n. 106-1983, on irradiated foods The general standard for irradiated foods “applies to foods processed by ionizing radiation that is used in conjunction with applicable hygienic codes, food standards and transportation codes. It does not apply to foods exposed to doses imparted by measuring instruments used for inspection purposes” (Section 1, Scope). In order to specify what radiation is, Section 2 of the stan-

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dard provides the “general requirements for the process”, indicating the types of ionizing radiation that may be used; the minimum and the maximum absorbed dose derived from the process; and the facilities and control for the process. The latter recommendation should follow the indications of Section 2.3, specifying all the methods that the national authorities must use in controlling such process: “Radiation treatment of foods should be carried out in facilities licensed and registered for this purpose by the competent authority. The facilities shall be designed to meet the requirements of safety, efficacy and good hygienic practices of food processing. The facilities should be staffed by adequate, trained and competent personnel. Control of the process within the facility should include the keeping of adequate records including quantitative dosimetry. Facilities and records should be open to inspection by appropriate authorities. Control should be carried out in accordance with the Recommended International Code of Practice for Radiation Processing of Foods (CAC/RCP 19-1979, Rev.1-2003)”.

These prescriptions thus concern the activity of national administrations, which must conform to the mentioned requisites and to a code issued by CAC itself with another standard: the International Code of Practice for Radiation Processing of Foods. For what concerns the absorbed dose, Section 2.2 establishes that: “the minimum absorbed dose should be sufficient to achieve the technological purpose and the maximum absorbed dose should be less than that which would compromise consumer safety, wholesomeness or would adversely affect structural integrity, functional properties, or sensory attributes. The maximum absorbed dose delivered to a food should not exceed 10kGy, except when necessary to achieve a legitimate technological purpose”.

The prescriptions are directed to food producers and indirectly to food safety regulators and they contain both a general recommendation, without specifying any limit, and a specific one indicating that the maximum absorbed dose should not exceed 10kGy. This implies that producers and national authorities are asked to guarantee that foods produced in their territories with such method present the indicated safety features in order to be traded in any of the member States. The only exception concerns a legitimate technological purpose and note 1 specifies that this must be in conformity with other sources of international regulations: “Report of a Joint FAO/IAEA/WHO Study Group, Technical Report Series 890 WHO. Geneva, 1999; Safety and Nutritional Adequacy of Irradiated Foods, WHO, Geneva, 1994; and Wholesomeness of Irradiated Food, Report of Joint FAO/IAEA WHO Expert Committee, Technical Report Series 659, WHO, Geneva, 1981”. Section 3 provides for the hygiene recommendation requiring that

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“the irradiated food should be prepared, processed, and transported hygienically in accordance with the provisions of the Recommended International Code of Practice – General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997), including the application of the seven principles of Hazard Analysis and Critical Control Point (HACCP) system where applicable for food safety purposes. Where appropriate, the technical requirements for the raw materials and end product should comply with applicable hygienic codes, food standards, and transportation codes”.

Here the standard refers to hygienic requisites, which apply as general criteria to the different moments of preparation, procession and transport and to the technical requirements. Section 4 – concerning technical requirements – foresees, inter alia, that “The irradiation of food is justified only when it fulfils a technological requirement and/or is beneficial for the protection of consumer health”. With this provision, the Codex standard sets a general duty on national food safety authorities, implicitly requiring justifying the process of irradiation, which has to fulfil the technological requirements and have a positive impact on the protection of consumers’ health. Finally, Section 7 provides prescriptions related to the labelling of food produced in such manner, like, for instance, for inventory control: “For irradiated foods, whether prepackaged or not, the relevant shipping documents shall give appropriate information to identify the registered facility which has irradiated the food, the date(s) of treatment, irradiation dose and lot identification” (Section 7.1). Again, the Codex standard poses a general requirement by demanding appropriate information to the other food safety authorities, for them to identify the irradiated food in international transport. A specific, vertical, standard: n. 153-1985, on corn The vertical Codex standard n. 153-1985, related to corn for human consumption, indicates the scope of its application, that is, corn “ready for its intended use as human food, presented in packaged form or sold loose from the package directly to the consumer. This standard specifies requirements for whole grain shelled dent maize, Zea mays indentata L., and/or shelled flint maize, Zea mays indurata L., or their hybrids. It does not apply to processed maize” (Section 1). The first section is thus dedicated to define the product it applies to and it already has a prescriptive rationale, as it indicates which products fall under the scope of the standard and which not. Then it specifies the “essential composition and quality factors” (Section 3). Among the latter, for instance, it requires that “Maize shall be safe and suitable for human consumption. (…) Free from abnormal flavours, odours and living insects. (…) Free from filth in amounts which may represent a hazard to human health.” (Section 3.1). In addition, it should have a maximum moisture content of 15.5% m/m. Lower moisture limits should be required in certain conditions “for certain destinations in relation to

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the climate, duration of transport and storage”, but “governments accepting the Standard are requested to indicate and justify the requirements in force in their country” (Section 3.2.1). Then Section 3.2.2.2 foresees that “the products covered by the provisions of this standard shall be free from the following toxic or noxious seeds in amounts which may represent a hazard to human health. – Crotolaria (Crotalaria spp.), Corn cockle (Agrostemma githago L.), Castor bean (Ricinus communis L.), Jimson weed (Datura ssp.), and other seeds are commonly recognized as harmful to health”. The prescriptions of Section 3 are thus either of general nature (e.g. “suitable for human consumption”) or of specific one (e.g. “maximum moisture content of 15.5% m/m), setting precise limits and excluding the presence of determinate substances. When the requirement of the Codex standard is of general nature this works as a recommendation for national authorities, which will put into practice and specify the content of that general provision. In this case, as noted, the limits concern the purposes and the results, leaving discretion for what concerns the methods and the process. For instance, the sentence of section 3.1 – “Free from filth in amounts which may represent a hazard to human health” – establishes that the domestic administrations are responsible for determining and controlling the level and the hazardness of the amounts of filth. On the contrary, when standards set precise and detailed quantitative limits, the States acting consistently merely have to respect and reproduce those limits inside their territories and exercise a much-reduced discretion on the matter. Section 4 deals with contaminants, excluding the presence of “heavy metals in amounts which may represent a hazard to human health” (Section 4.1) and requiring the compliance with maximum residue limits of pesticide residues and with mycotoxin limits established by the Codex Alimentarius Commission for this commodity (Sections 4.2 and 4.3). Section 5 and 6 refer to hygiene and packaging, while Section 7 concerns labelling requirements, pertaining to the name of the product and to the labelling of non-retail containers. Both the analyzed standards contain prescriptions directed to producers and to the administrative authorities empowered to set the specific limits (if not already established by the standard itself), to perform inspections and to ensure controls. In addition, the two texts provide both general recommendations and principles of action, both specific and detailed requirements. This means that national members are invited to conform their internal measures to the prescriptions of these standards. If they deviate from them, for instance allowing a higher level of the maximum moisture content in corn or the shipping of irradiated foods without appropriate labelling, and the products are traded outside their territories, they will have to justify their divergences. Notably, if Member States adopt national measures with stricter provisions than the ones contained in a Codex standard, the former might be contested under the SPS Agreement as trade-restricting measures. Therefore, the importing Coun-

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try might be asked to offer a scientific justification for its acts. Curiously, no mechanism of judicial review is foreseen in cases where a national State adopts a measure with lower requirements than a Codex standard. In such a case, the importing Country has a twofold way to respond to the inconformity: either acting diplomatically by negotiating with the other countries to put the standard in conformity, or refusing the import of the goods that are inconsistent with the standard’s requisites. Now that we have an idea of what the Codex standards are, we have to look at the bodies producing them and at the way in which they perform this function.



2.1 The organizational structure of the Codex Alimentarius Commission

The organizational structure instituted to give actuation to the Joint FAO/WHO Food Standards Programme presents as the following: • The Codex Alimentarius Commission; • The Executive Committee; • The Secretariat; • The subsidiary committees: - The General Subject Committees, in number of 10, entailing general/ horizontal competences, - The Commodity Committees, in number of 11, divided for any commodity, - The Ad Hoc Intergovernmental Task Forces, on specific delicate issues (such as GMOs), - The regional committee of coordination (Africa, Asia, Europe, and so on); • The scientific and expert external committees (JECFA; JEMRA; JMPR; JMPS; JECN); • The National Codex Contact Points.



2.1.1 The Commission and the other main bodies

The Commission is the main body of the Codex system and it has functions of direction, coordination and officialization of the standard-setting activity and an assembly-like structure. Its organizational apparatus and its personnel are quite small. The officers of the Commission are national delegates appointed by Member States’ governments and, since November 2003, also by the EU.1 They nominate – by election – a Chairperson and three Vice-Chairper1

Decision no. 822 of the EU Council, November 17 2003, 2003/822/CE. The CAC modified the procedural rules, admitting the membership of a regional organization, at: http://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX:32003D0822&from=EN. Then Directors General of FAO and WHO gave their formal approval (Rules of Procedures of the CAC, Rule II n. 3, Proc. Man., p. 6). On this, see http://www.codexalimentarius.org/members-observers/en/.

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sons from among the representatives, alternates and advisers of the Members of the Commission. The Chairperson, or in his/her absence a Vice-Chairperson, shall preside at meetings of the Commission and exercise such other function as may be required to facilitate the work of the Commission. Moreover, the Chairperson and his/her vices, in addition to seven added members resembling a specific geographic area and with the coordinators appointed by the Commission with functions of assistance, will compose the Executive Committee (Rules III, IV and V, Rules of procedures2). The Executive Committee works on behalf and in the name of the Commission. Its functions consist of the following: It “may make proposals to the Commission regarding general orientation, strategic planning, and programming of the work of the Commission, study special problems and shall assist in the management of the Commission’s programme of standards development, namely by conducting a critical review of proposals to undertake work and monitoring the progress of standards development” (Rule V n. 2, Rules of procedures3).

As said, the Commission can also institute new subsidiary bodies to actuate its tasks and can appoint the “coordinators” (Rule IV, Rules of procedures4), which have duties relating to the coordination of regional committees and to the connection between them and the Executive Committee and the Commission. They also “assist the Executive Committee and the Commission, as required, by advising them of the views of countries and recognized regional intergovernmental and non-government organizations in their respective regions on matters under discussion or of interest” (Rule IV.3 (c), Rules of procedure5) and “assist and coordinate the work of the Codex Committees set up under XI.1(b)(i) in their region or group of countries in the preparation of draft standards, guidelines and other recommendations for submission to the Commission”, Rule IV.3 (b), Rules of procedure). The Executive Committee, as said, has the operational and executive functions of the Commission’s decisions.6 Namely, it follows the procedural iter for the standard-setting and it guarantees its fair development: by receiving comments, opinions and proposals from the participants; by coordinating the activity of the subordinate committees and the national delegates; by performing the critical review of the draft standard after the amendments proposed by the Member States and before the final approbation; finally, by analysing the 2 3

 P roc. Man., cit., p. 7-9.

 Ibid., p. 9.

4 5

 Ibid., p. 7-8.

 Ibid., p. 8.

6

“The executive organ of the Commission and the body responsible for managing the standards development process”, FAO/WHO, Enhancing participation in Codex activities, Rome – Geneva, 2005, p. 31, www.codexalimentarius.net.

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development of the draft standard during all the steps of its approval procedure and by producing a report for the Commission. The Secretariat is responsible for the material actuation of the Food standards programme. It is the administrative body of the CAC: it organizes the meetings of the Commission and of the Executive Committee; it fills in the informative documents for the discussion under agenda; it helps the functioning of the Committees with a role of connection with the secretariats of every national Codex committee in the Member States;7 it fosters the diffusion and the circulation of the draft standard among the Member Parties and the relevant international organizations; it materially deals with the final publication of the standards; it reports to the parental organization, namely to the directors of the competent departments (the Food and Nutrition Division and the Department of Food Safety, Zoonoses and Foodborne Diseases).



2.1.2 The subordinate committees

The Procedural Manual disciplines8 the subsidiary bodies of the CAC. These are the subordinate committees and consist of four different kinds. The General Subject Committees9 (so-called horizontal committees) belong to the first one: preparing and drafting standards, guidelines concepts and principles applicable to foods in general or applicable to specific foods or groups of foods, reviewing provisions in Codex commodity standards and developing recommendations pertaining to consumer health and safety that are also recalled by the specialized committees as general norms applicable to regulate specific foods. The second kind of subordinate committees consists of the Commodity Committees,10 preparing and drafting standards, guidelines 7

“A member country to which a Codex Committee has been assigned is responsible for providing all conferences services including the secretariat. (…). The Committee secretariat and the Joint FAO/WHO (Codex) Secretariat are charged with the preparation of the draft report in consultation with the rapporteurs, if any”. Codex Alimentarius Commission, Guidelines to Host Governments of Codex Committees and Ad Hoc Intergovernmental Task Forces, in Proc. Man., cit., p. 65.

8

Rule XI, “Subsidiary Bodies”, Rules of Procedures, p. 13 et seq. and Guidelines to Host Governments of Codex Committees, cit., p. 64 et seq.

9

Food Additives & Contaminants, host country: Netherlands; Food Hygiene, host country: United States; Food Import & Export Certification & Inspection Systems, host country: Australia; Food Labelling, host country: Canada; General Principles, host country: France; Methods of Analysis & Sampling, host country: Hungary; Nutrition & Foods for Special Dietary Uses, host country: Germany; Pesticide Residues, host country: Netherlands; Residues of Veterinary Drugs in Foods, host country: United States, in Codex Alimentarius Commission, Subsidiary Bodies of the Codex Alimentarius Commission, in Ibid., p. 138 et seq.

10

Cereals, Pulses & Legumes, host country: United States; Cocoa Products & Chocolate, host country: Switzerland; Fats & Oils, host country: United Kingdom; Fish & Fishery Products, host country: Norway; Fresh Fruits & Vegetables, host country: Mexico; Meat Hygiene, host country: New Zealand; Milk & Milk Products, host country: New Zealand; Natural Mineral Waters, host country: Switzerland;

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and principles relating to aspects of specific foods or classes of food. The third one is represented by the Task Forces, temporary bodies instituted ad hoc by the Commission to discuss, prepare and draft standards concerning new products with peculiar features (as, for instance, GMOs11). Finally, there are the Joint FAO/WHO Coordinating Committees,12 through which regions or groups of Countries coordinate their activities for the elaboration of standards (these do not participate directly in the standard-setting activity but can adopt regional standards). The membership to the Committees resembles the one of the Commission and it is therefore open to all the Member States. Nonetheless, considering the great number of committees and their distribution all over the world (they are normally hosted by some member States affording the expenses of the management), not all the Countries are able to appoint and fund so many delegations: “The cost of regional, commodity and general committees is met in whole or in part by host countries, but also supported administratively by the Codex secretariat. Member States fund their own participation in meetings. However, bilateral assistance is sometimes provided by developed countries for a developing country to attend a particular Codex meeting, although experienced observers acknowledge that this may be used as a method of garnering support for the sponsor country’s position on issues before such meetings”.13

This has a significant relevance as well on the legal perspective because it subordinates the possibility to have a voice in the negotiations to the economic capacities of the States. On this, it has been pointed out that the “host country principle for Codex committees” presents a significant drawback: “host country agendas tend to dominate and Codex has in general less control over the committees including the selection of chairs. A further consequence is that the committees are skewed towards a limited number of developed country hosts and thus developed country influence”.14 Processed Fruits & Vegetables, host country: United States; Sugars, host country: United Kingdom; Vegetable Proteins, host country: Canada, in Ibid., p. 138 et seq. 11

Codex Alimentarius Commission, Ad hoc intergovernmental Task Force on Foods derived from Biotechnology, 1999-2003 and 2005-2009, CX/FBT, www.codexalimentarius.net.

12

Codex Alimentarius Commission, Subsidiary Bodies under Rule X.1 (b)(ii), in Proc. Man., cit., p. 165 et seq.

13

D. Barling, Food safety norms, public health and consumers: international governance challenges, Centre for Food Policy, Institute of Health Sciences, City University London, Report for the Steering Committee Technology Assessment of the Ministry of Agriculture, Nature and Food Quality, The Netherlands, 16 February 2005, Revised 25 January 2008, p. 12.

14

 Ibid., p. 12, reporting the statements of the CAC (2002), Conclusions and recommendations of the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO work on Food Standards, Alinorm 03/25/3, Rome: Codex Alimentarius Commission, December 2002, para. 149.

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The subsidiary committees have a non-plenary composition, they have an intergovernmental and transnational character, are participated in by national delegates – bureaucrats and experts – and by representatives of IGOs and INGOs (as observers) and they present the structure of mini-councils where the standards are discussed, prepared and drafted.



2.1.3 The Joint FAO-WHO scientific committees

The expert committees are, as said, the Joint FAO/WHO Expert Committee on Food Additives (JECFA); the Joint FAO/WHO Meeting on Pesticides Residues (JMPR); the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA); The Joint FAO/WHO Expert Meetings on Pesticide Specifications (JMPS); The Joint FAO/WHO Expert Committee on Nutrition (JECN). These are five independent organisms connected but external to the CAC – which is not, in fact, a scientific organization – and they are instituted, coordinated and managed by FAO and WHO.15 As previously noted in the focus on the risk analysis procedure, risk assessment occupies a decisive role in food safety regulation: it has technical and neutral features and aims at the identification and evaluation of risks in order to provide scientific advice to the risk managers (as for the Codex: the delegates working in the committees and in the Commission). Scientific advice, as defined by FAO and WHO, is “the conclusion of a skilled evaluation taking account of the scientific evidence, including uncertainties”.16 As noted in a recent FAO/ WHO paper on scientific advice on food safety and nutrition, risk assessment comprises different specifications: “for chemicals, in most cases, the product is a risk assessment leading to the establishment of an Acceptable Daily Intake (ADI) or Acute Reference Dose (ARfD), and the elaboration of Maximum Residue Levels (MRLs) for veterinary drugs or pesticide residues and Maximum Limits (MLs) in relevant commodities. Advice is also provided on exposure assessment methodology at both national and international levels. Risks associated with food-borne pathogens are addressed through risk assessments of specific pathogen-commodity combinations such as Salmonella spp. in eggs and broiler chickens”.17

15

See Article VI of FAO Constitution, Section 31 of the Regulations for Expert Advisory Panels and Committees, Basic Texts of the WHO and Rule no. XXXV of General Rule of the Organization (WHO).

16

FAO/WHO. 2004. Provision of Scientific Advice to Codex and Member Countries. Report of Joint FAO/ WHO Workshop. WHO Headquarters, Geneva, Switzerland. 27-29 January 2004. Page v (available at: ftp://ftp.fao.org/docrep/fao/007/y5388e/y5388e00.pdf ).

17

FAO/WHO, FAO/WHO Framework for the Provision of Scientific Advice on Food Safety and Nutrition (to Codex and member countries), FAO and WHO, Rome-Geneva, 2007, p. 5.

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In accordance with the standard to be elaborated on and with the science policy, which the risk managers decided to adopt, one of the five risk assessors is called to produce a scientific report for the elaboration of the final text. Although some of them possess different legal status, the expert meetings apply the same general principles and have the same mechanisms of consultation. Taking the JECFA as a paradigm, we can present the main traits of the expert committees. JECFA was created in 196518 with the aim to provide to FAO, WHO, CAC and requesting States assessments on food additives safety. Notably, “Its work now also includes the evaluation of contaminants, naturally occurring toxicants and residues of veterinary drugs in food. To date, JECFA has evaluated more than 1,500 food additives, approximately 40 contaminants and naturally occurring toxicants, and residues of approximately 90 veterinary drugs. The Committee has also developed principles for the safety assessment of chemicals in food that are consistent with current thinking on risk assessment and take account of recent developments in toxicology and other relevant sciences”.19

At the end of the scientific investigation, the Committee agrees – through consensus or majority vote (but indicating the results of the minority) – a final scientific report, available on the web after the publication on behalf of the FAO/ WHO Joint Secretariat.20 JECFA is composed of experts selected for their expertise by the two parental organizations. In their activity of recruitment, the latter follow predetermined criteria:21 scientific expertise; diversity and complementarity of the specializations and of the interests; formal equality (concerning gender, nationality and so on). Namely, according to the procedures agreed by FAO and WHO, “All experts selected (…) are required to be recognised in their area of specialization, highly respected by their scientific peers, and impartial and objective in their judgement. Applications are welcomed from all experts irrespective of their affiliation (e.g. government agency, national or regional institute, non-government organizations, industry groups, independent consultants). Efforts are made to promote inclusiveness (in terms of scientific opinion and geographic balance) and enable the involvement of experts from different schools of thought. All experts selected are appointed to function in their personal capacity and not as representatives of any government, industry or other group”.22 18

 http://www.who.int/ipcs/food/jecfa/about/en/index.html.

19

FAO/WHO, FAO/WHO Framework for the Provision of Scientific Advice, cit., p. 29.

20 21

FAO/WHO, Fact Sheet – What is JECFA?, Rome, 9 February 2006, p. 3.

See, for instance: FAO, Food additives and food contaminants, FAO procedural guidelines for the Joint FAO/WHO Expert Committee on Food Additives, Rome, February 2003, p. 2-3, ftp://ftp.fao.org/es/esn/ jecfa/2003-02-24_Food_Add_Cont_Guidelines.pdf.

22

FAO/WHO, FAO/WHO Framework for the Provision of Scientific Advice, cit., p. 16.

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The experts’ selection occurs through public calls, in which the parental organizations indicate the requirements the candidate must meet and the selection criteria. This, however, does not comprise a public context or exam, as the effective choice depends on the evaluation of a selection panel composed of by representatives of FAO and WHO and then is left to the discretionary opinion of the Secretariats and the Director-Generals of parental organizations. This means that the experts are chosen for their skill, but they are not formally tested on their skill, as the selectors are FAO and WHO officers and not other scientists. The experts are then incorporated into five-year lasting “rosters”, from which they are going under another selection in accordance with their specific competences, to give their actual contribution to the activity of scientific advice of one of the committees under the supervision of the FAO/WHO Joint Secretariat.23 “Experts from these rosters are subsequently appointed to serve as members of expert bodies, and FAO experts or WHO temporary advisers for specific meetings. The curricula vitae and evaluation records of experts on the roster are kept on file so that experts can be assigned to particular activities based on their specific knowledge and expertise”.24 The parental organizations organize the meetings through the regular programme budget and with extra-budgetary resources. They invite the participants, prepare the working papers and take care of the publications of the reports. They pay travel and subsistence expenses of the experts, who are not remunerated for their work.25 The lack of honoraria, as evident, is a significant flaw for the neutrality of the model, as it might be an incentive for experts to seek compensatory incomes, which may condition their independence from corporate interests. The other expert committees present a similar model to the one of JECFA, sharing analogous – but not identical – selection criteria of the personnel, the general aims and the organizational structure. Moreover, they all activate with a call for data, giving start to the scientific investigation that will produce final advice, while, on the opposite, they have different scope and scientific objectives. The “JMPR is the Joint FAO/WHO Meetings on Pesticide Residues which provide independent scientific expert advice to the Codex Alimentarius Commission and its specialist Committee on Pesticide Residues as well as to FAO, WHO and member countries. It has been meeting since 1963”.26 The JEMRA was created in 2000, with the following purposes and tasks: “In response to requests from the CAC, and FAO and WHO member countries and the increasing need for risk based scientific advice, JEMRA aims to optimise the utility of MRA as a useful tool to inform actions and decisions aimed 23

FAO/WHO, Preparatory Meeting on the Elaboration of a Common Framework for the Functioning of Joint FAO/WHO Expert Bodies and Consultations, FAO/WHO, Rome, Italy 3-4 September, 2001, p. 7-8.

24 25

FAO/WHO, FAO/WHO Framework for the Provision of Scientific Advice, cit., p. 17.

 Ibid., p. 9.

26

 Ibid., p. 33. See also http://www.fao.org/ag/agp/agpp/Pesticid/Default.htm.

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at improving food safety and to make it equally available to both developing and developed countries. The terms of reference of JEMRA are to: i. provide expert advice on risk assessment of microbiological hazards in foods to FAO and WHO Member countries and the Codex Alimentarius Commission; and evaluate the likely impact of different risk management options in the reduction or control of specific microbiological risk in food”.27

The “JMPS” is composed of scientists collectively possessing expert knowledge for the development of pesticide quality criteria, called “pesticide specifications”. Their opinions and recommendations to FAO/WHO are provided in their individual expert capacities, not as representatives of their countries or organizations. The JMPS is a statutory body of FAO whose panel members are appointed by the Director-General”.28 Finally, the Joint FAO/WHO Expert Committee on Nutrition was established as a FAO Standing Advisory Committee in 1948. In 1952, the Executive Board of WHO was established and the Joint FAO/WHO Expert Committee was formally endorsed. Its purpose is “to advise the Directors-General on scientific issues related to calorie and nutrient requirements so that appropriate recommendations for action can be formulated. The various expert groups have contributed principles for determining and applying general requirements which have been adopted worldwide. The global scientific community has embraced the advice on requirements published first by FAO and later in collaboration with WHO. These “FAO/WHO recommendations” are utilized in virtually all countries. Not only have the FAO/WHO recommendations reflected the state of knowledge at particular points in time, but they have also influenced research agendas and methodologies over the years. The nutrition requirement reports rank among the best-selling and most sought-after publications of both FAO and WHO”.29 In its 24th session, held in July 2001, the CAC recommended that FAO and WHO carry out “a review of the status and procedures of the expert bodies in order to improve the quality, quantity and timeliness of scientific advice”.30 The review was agreed to in the following 25th session and after a number of technical meetings a general updated guide was finally provided in 2007.31 Since then, the system of scientific assistance improved on several issues, above all for what concerns: the high level of scientific expertise, the independency of the experts and the transparency of the Committees. Nonetheless, three problematic insights can still be noted with reference to the scientific committees. Namely, they are: 1. the impartiality and efficiency guarantees in 27

 Ibid., p. 36.

28

 Ibid., p. 38.

29 30

 http://www.fao.org/docrep/v7700t/v7700t06.htm#TopOfPage.

Codex Alimentarius Commission, ALINORM 01/41, Geneva 2-7 July 2001, p. 4 et seq. http://www. codexalimentarius.org/input/download/report/519/Al01_ 41e.pdf.

31

FAP and WHO, FAO/WHO Framework for the Provision of Scientific Advice on Food Safety and Nutrition, Rome, 2007, available at ftp://ftp.fao.org/docrep/fao/010/a1296e/a1296e00.pdf.

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the selection criteria; 2. the absence of honorariums for the experts; and 3. the reduced mechanisms of control and accountability to ensure the neutrality and the fairness of the experts’ activity. 1. For the first issue, it is to note that even if the criteria are specified before the selection, they are still too generic and, by not specifying in detail all the elements for the selection, leave a considerable discretion on behalf of the parental organizations. In addition, they differ from one Committee to another one, and not only for what regards the scientific requisites of the experts.32 In the case of JMPR, for instance, the selection occurs through the evaluation of the curriculum vitae and is notably left to the discretion of the Secretariat of the parental organizations. The Secretariats are administrative bodies of international organizations, which may base their selection not only on pure scientific and meritocratic reasons, or which may not have enough scientific knowledge to evaluate the skill of the candidates. On the other side, it is notable that this might be also positive for guaranteeing an impartial selection, as the selectors could consider also other relevant factors than only the scientific ones, so as to avoid biased scientists. However, the fairness of the selection might be exposed to criticism if we consider that the expert bodies also have a very reduced accountability, as they are not required to give account to any representative bodies for their scientific choices, which, far from being sound and unique, might have – as noted – a significant relevance in the policies on food safety. If we look at the relevance of risk assessment and scientific advice in the whole procedure of risk analysis in food safety regulation, we have to notice the importance of such a moment in the decision-making. Here, however, because of the technical feature of the process, the expert bodies cannot be required to give account for their choices. As they are not politicians and neither bureaucrats, they do not have to be representative or accountable. In addition, they need to be protected from any kind of political or factual influence due to partisan interests. Nevertheless, considering the quasi-regulatory power of their scientific reports, if they are conceived to occupy an “untouchable” position, they need to offer alternative forms of guarantees. One of these concerns the selection methods, which need to be highly 32

“Select experts not only on the basis of their scientific achievements, but also to consider experience in risk assessment (national, international) and knowledge of food safety issues. In addition, proven effectiveness in work with expert bodies and ability to contribute effectively to group work are required, and in order to achieve a balanced representation in the expert body, a broad range of expertise and perspectives. The omission of these elements might compromise quality and acceptance of the expert body’s analysis and advice even if the expert body is composed of distinguished scientists”, FAO/WHO, Provision of Scientific Advice to Codex and Member Countries. Report of a Joint FAO/WHO Workshop, WHO Headquarters, Geneva, Switzerland, 27 –29 January 2004, ftp://ftp.fao.org/docrep/fao/007/y5388e/ y5388e00.pdf., p. 16. On this issue, the same document further recommends: “FAO and WHO should harmonize procedures for the selection of experts across the expert bodies by the establishment of a set of clear, publicly available criteria, as appropriate. The selection process should be transparent, including dealing adequately with conflicts of interest and ensuring balance on expert panels”, Ibid., p 18.

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transparent, motivated in a satisfying manner and structured on a highly open and influence-free mechanism of recruitment. 2. For what concerns the second issue, relating to the lack of remuneration of the experts, it is deducible why this aspect may have a significant influence on the neutrality of the experts. Any stakeholder wanting to orientate the content of an international standard has a considerable “economic weapon” in order to convince scientists to direct their research towards certain results. As it was held in several institutional reports33 and by legal science as well,34 the issue is quite decisive if the independence to the experts is to be reached. In addition to a special fund to provide a salary for the selected experts, the parental organizations should also institute mechanisms of protection for the latter through inspections, controls and incompatibilities both during the service both afterwards.35 To date, the parental organizations faced the issue through an interesting mechanism of “declaration of interests”: “To ensure the objectivity and independence of the scientific advice developed, all experts involved in expert bodies and meetings are required to declare any interests that could constitute a real, potential or apparent conflict of interest with respect to his/her involvement. (…). This “Declaration of Interests” addresses the various financial or other interests (including intellectual) of experts or his/her partner on a personal basis as well as in relation to their employment that could unduly influence the expert’s position with respect to the subject-matter being considered. This covers both relationships that may exist between: i) commercial entities and the expert personally; and ii) commercial entities and the administrative unit with which the expert has an employment relationship”.36

The mechanism is quite important as it provides publicity to the activities and interests of the selected experts and responsibilizes them when accepting a new task. In addition, all the possible conflicts of interest are scrutinized and judged by the joint secretariats, and “The person who disclosed such a conflict (i) may be asked not to take part in the portion of the discussion or work relevant to that interest (ii) may be asked not to take part in the meeting or work altogether, or (iii) if deemed by FAO/WHO to be 33

FAO/WHO, Report of the Evaluation of the Codex, cit., p. 50; FAO/WHO, Framework for the Provision of Scientific Advice to Codex and Member Countries, cit., p. vii.

34

N. Rees & D. Watson (eds), International Standards for Food Safety, Aspen Publications, Gaithersburg, Maryland, 2000, p. 161-162; “FAO and WHO do not pay honoraria, thus giving experts an incentive to accept industry contributions”, A. Herwig, Transnational Governance, cit., in C. Joerges, I. J. Sand & G. Teubner (a cura di), Transnational Governance and Constitutionalism, Hart Publishing, Oxford and Portland Oregon, 2004, p. 220.

35

On this, think, for instance, about the case of an expert at the end of his/her mandate and with the promise to start working for a big food corporation immediately after the experience in the committee: it is intuitive that his/her neutrality might be compromised.

36

FAO/WHO, Framework for the Provision of Scientific Advice to Codex and Member Countries, cit., p. 18-19.

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appropriate under particular circumstances may be asked to take part in the meeting or work provided that the interest of the expert, is publicly disclosed”.37

Again, the discretional power of the secretariats is evident, above all when the contribution is admitted upon the disclosure of the conflict. Here, the officers of the secretariats can evaluate if despite a conflict of interests the expert can still serve its duty. This raises questions of accountability towards the decisionmakers (the officers of the secretariats), as they should be exposed to questions and asked for motivation in front of such kind of choice. However, the declaration of interests is still a significant soft-law mechanism to enhance more independency in the expert bodies, as it increases publicity on possible bias of the scientists involved, offering the risk managers a further criterion to consider in the evaluation of the risk assessment and in the choice of risk policy. Nonetheless, it remains voluntary and cannot be considered as a proper command and control mechanism. 3. Finally, systems to verify and evaluate the scientific results are lacking. These are normally considered and interpreted by risk managers; for instance, the subsidiary committees and the Commission of the Codex. Such evaluation, however, concerns issues like the social, political or economic impact of the standard, while there is no exam of the scientific soundness of the report. This has a precise rationale, as it aims to protect the experts from any kind of judgement or influence, which may compromise their independence and their function of advisors. Nonetheless, if we consider the weight of the scientific advice in the economy of the decision-making and the increasing uncertainties and conflicting doctrines in natural sciences, the lack of a scientific review or responsibility may cause questions about the objectivity of the scientific committees. An interesting mechanism of procedural legitimacy and formal accountability has been provided by FAO and WHO that, in the cited “Framework for the Provision of Scientific Advice on Food Safety and Nutrition”, foresee responsibility as one of the core principles for scientific advice, requiring: “the responsibility of participants to justify their views by adequate citation of reputable sources, the application of a suitable level of caution in data interpretation, timeliness, compliance with agreed task description, efficiency in conducting the assessment, cost-effectiveness of the process and maintenance of confidentiality as mandated and updating scientific advice on the basis of new knowledge (i.e. review of conclusions). (…). In addition, the process is well defined to ensure that the opinions and advice of the experts withstand scrutiny by peers and the current scientific knowledge is applied in reaching a conclusion”.

Despite possible scrutiny by peers, it is not clear to whom experts would be responsible and what kind of sanctions account holders have in case of violation. Even if the model is quite advanced and reasonable in requesting motivation, sources, timeliness and so on, it might raises doubts about the accountability of 37

Ibid., p. 19.

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the account holders as, if the experts are responsible to the joint secretariats of the parental organizations, who controls the latter? What powers do they have to punish the experts? Is their independence at risk under this review?



2.1.4 The National Codex Contact Points

The organizational structure of the CAC is inseparably linked to the National Codex Contact Points (NCCPs). These are organisms of connection and communication created inside the Member States in order to keep the relations between national governments and the Commission. The NCCPs work in cooperation with the National Internal Committees (NICs), which are national bodies mirroring the Codex Committees: they are organized in several working groups analogous to the subsidiary committees of the CAC and composed by experts and bureaucrats; they are open to stakeholders – domestic non-governmental organizations and external experts – and they have functions of discussion and investigation concerning the draft standards. The NICs are disciplined by and apply domestic law, operating under the mandate of the relevant ministries and developing the national strategies on the standards, while they mirror the organization of the Codex structure. The National Codex Contact Points, instead, embody a linking function and have a different legal nature as they connect the NIC and the Governments with the Commission and the subsidiary committees of the Codex: they exercise functions of international relevance. These can be summarized as follows: • Acting as the link between the Codex Secretariat and the member country. • Coordinating all relevant Codex activities within the country. • Receiving all Codex final texts (standards, codes of practice, guidelines and other advisory texts) and working documents of Codex sessions and ensuring that they are circulated to those concerned within the country. • Sending comments on Codex documents or proposals to the Codex Alimentarius Commission, or its subsidiary bodies, and/or the Codex Secretariat. • Acting as a channel for the exchange of information and coordination of activities with other Codex Members. • Working in close cooperation with the National Codex Committee, where such a committee has been established, and acting as liaison point with all national stakeholders to ensure an appropriate balance of policy and technical advice upon which to base decisions relating to issues raised in the context of the Codex work. • Receiving the invitations to Codex sessions and informing the relevant chairpersons and the Codex Secretariat of the members of the national delegation to attend the meeting. • Maintaining a library of Codex final texts. • Promoting Codex activities throughout the Country.38 38

FAO/WHO, Enhancing participation in Codex Activity, Section 3.1. Basics of national Codex activities – Lesson 1. Functions of a national Codex Contact Point, p. 109, available at ftp://ftp.fao.org/docrep/ fao/008/y5884e/y5884e03.pdf.

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Nonetheless, although all the National Contact Points share the purposes and the general activity, they are determined and managed by national governments and in accordance with national legislations. Thus, they differ from one Country to another. This happens also for public participation of stakeholders: “Some countries now hold tripartite national pre-meetings with industry, consumers and government officials before going to Codex, and where consumer organisations can gain access some influence has been experienced. However, such practice is distinctly patchy across different countries. A survey of member organisations by Consumers International (CI) found that 48% of the responding consumer groups are regularly invited to attend or submit written views to government consultations about Codex. Of this number just one-third (12 out of 37) had attended a Codex meeting as a member of a national delegation. Practice at the Codex meetings themselves remains largely unchanged – there is rhetoric about transparency and some improvement, but not much”.39

Here is thus important to stress the public participation to Codex activity. Stakeholders’ participation is foreseen either for the global, or for the national moment of the standard-setting procedure. For what concerns the former – as will be seen infra, at para. 2.2 – an intervention as observers is reserved to all the requesting GMOs. As instead, for the latter, public participation of stakeholders and civil society happens to the National Contact Points and the National Committees. The intervention, however, varies from Country to Country, and this entails a significant influence on States’ strategy in the discussion of standards: each State will decide how much weight to give to national food champions or, for instance, to consumers or small producers’ organizations. In addition, if in some States conflicting interests – such as consumers and industry – are equally represented and can produce a balanced contribution to the national delegation’s orientation, in others they may be represented in a disproportionate way. This reproduces an impaired orientation among the delegates, which, as members of an international organization, are called to represent and act on behalf of the general interests. If a delegation is instead dominated by a corporate interest, the contribution given to the standard-setting may be heavily biased. Moreover, the power of control established in this phase of the standard-setting is quite reduced, as no supranational body is appointed to monitor and assess the impartiality of national Codex Committees; there is no general control over the national delegations and their inner orientation. While, as seen, they are supposed to discuss, bargain and approve standards in the name of the general good, to protect consumers’ health and fair practices in trade. The NCCP are thus a key body inside the Codex organizational architecture, as they entail the national will and orientation over certain food issues and link them to the activity inside the Codex Commission or Committees. On this, it is 39

D. Barling, Food safety norms, public health and consumers, cit., p. 14.

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to note that their activity and teleological approach varies from Country to Country and their reduced accountability may produce a parallel-reduced representation of the general interests at the global level.



2.2 The standard-setting activity of the Codex Alimentarius Commission

The Codex Alimentarius Commission has the organizational apparatus of a network. Although this includes a main body acting as the central reference of the institution, and with powers of coordination and management – the Commission – the organization follows a horizontal development, comprising the participation of several national delegates, dividing the moment of decision in several phases, involving several bodies of the organization, as well as other external authorities, with the aim to produce common decisions. Some of these procedural steps occur at the same time; others are consequent. As it will be noted, the standard-setting procedure reveals important features of a global composite administrative process. Therefore, the organizational structure of the Organization is functional and in charge of such procedural model: the network allows the contemporaneous involvement of all the connected authorities and fosters the effective development of all the phases of the procedure. In this way, the decision-making does not pertain only to one body and does not happen at the same time, but it is composed of all the moments of the procedures and entails the contribution of all the admitted actors. Through the horizontal structure, authorities get closer to the individuals affected by the standards and private parties have a closer institution to demand hearing. Nonetheless, the “atomization” of the decision-maker blurs its activity and visibility, so that it is not always manageable to understand where and how the policy-making is occurring and when and how to intervene, control or contest it. In addition, the complexity of the structure favours the intervention of stronger subjects, while it might be an obstacle for weak actors, i.e. for underrepresented interests or for developing Countries. On one side, the structure of the CAC enhances its accountability better than a vertical and centralized one. On the other, it renders it more complicated and unbalanced, as the Organization’s complexity and fragmentation may reduce the space of intervention and the transparency of its activity. In brief, the procedure can be described as follow. The Commission or the Member States formulate a standard proposal; the competent committees elaborate a request to the scientific committees, indicating a science policy to follow. Then the expert bodies provide scientific advice, on which the Codex Secretariat prepares the scheme for the standard draft that is discussed and finalised in a subordinate committee by national delegates coming from competent national authorities. In the committees, also private parties (such as NGOs and stakeholders) and international organizations intervene as observers. Through the

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National Contact Points, then, the draft is discussed at the national level and eventually amendments are suggested. The final discussion then occurs inside the Commission and involves again national representatives. Here the standard is finally approved and the definitive version of the standard gains its officiality through the publication by the Commission in the Codex. The Codex standards are issued through a procedural mechanism, which resembles the structure of a domestic administrative process of law and has proven to be quite lengthy and complex. It can be divided in eight connected phases, as follows: 1. Initiative and preparation of the standard proposal; 2. Scientific investigation; 3. Administrative investigation and draft preparation; 4. Consultation of the Member States and of the other intervening international organizations; 5. First agreement by the Commission and revision by the Executive Committee; 6. Notice and comment on behalf of Member States; 7. New discussion and eventual amendment of the standard, and, 8. Final discussion and approbation inside the Commission and publication. 40 1. The Commission has the jurisdiction for initiating the procedure, which gives the start to the iter. The Commission makes the decision ex-officio or after a motivated proposal coming from a Member or from a subordinate committee. Such proposal goes under the review of the Executive committee: “An on-going critical review shall ensure that proposals for new work and draft standards submitted to the Commission for adoption continue to meet the strategic priorities of the Commission and can be developed within a reasonable period of time, taking into account the requirements and availability of scientific expert advice”. 41 Then “the Commission decides, taking into account the outcome of the on-going critical review conducted by the Executive Committee, that a standard should be elaborated and also which subsidiary body or other body should undertake the work”. 42 As evident, the procedure starts through an activity, which may involve different subjects belonging to different legal orders: it can come from a national authority as well as from a Codex body, be it the Commission or a subsidiary committee. In this sense, we already noted its global nature, as the procedure can have a national as well as an extra-national start. In addition, it implies the intervention of the Commission as well as that of the Executive Committee. After having reviewed the standard proposal, the latter follows its iter, taking care of the regularity and fairness of the procedure and embodying the role of an interface organism for participation at the decision-making by private parties 40 41

Joint FAO/WHO Food Standards Programme, CAC, Procedural Manual, cit., p. 31 et seq.

 Ibid., p. 32, par. 2.

42

 Ibid., p. 32, par. 3.

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and international organizations. Then, “the Secretariat arranges for the preparation of a proposed draft standard”. 43 2. Once the proceeding started, the CAC can activate, whereas it deems necessary, a sub-proceeding for the risk assessment. In this way, it issues a call for scientific data towards the expert committees44 that are the ones presented supra, at para. 2.1.3. 45 The latter, as seen embodying the function of external independent risk assessors, perform their studies and provide scientific nonbinding opinions for the risk managers. Such scientific reports are public and available on the web, but the same guarantees of transparency are lacking in two other moments of the procedure. Firstly, the selection of the experts on behalf of the parental organizations is not completely transparent. As noted, the guidelines for the selection merely consist of a general list of requisites and the choice is left to the discretion of FAO and WHO Secretariats, and often based on the curriculum of the candidates and not on public and open contexts. Secondly, not all the phases leading to the final scientific report are accessible, while only the conclusion is indeed public. Here the issues of uncertainty and science policy are particularly significant, as greater transparency and clarity in the procedures would help the understanding of the rationale and the scientific approaches used to elaborate a determined report, above all when this is inconclusive. For scientific committees there is a need of an increment of legitimate guarantees: they should use a full transparent organizational pattern being structured as “houses of glass”, i.e. open to a knowledge-control made by stake-holders and civil society and providing complete reports indicating not only the results, but also the methods through which they have reached conclusions, the internal debates and the minority reports. In this way, even not responding for their decisions to a political body, they would at least satisfy a requisite of “reputational accountability”. 46 There is thus a problem of balancing independency and accountability, as the expert bodies should be required not to give account to politically oriented bodies of their technical and sound opinions. At the same time, however, they need to justify and motivate any decision implying a certain amount of discre43

 Ibid., p. 35, par. 2.

44 45

 Ibid., p. 35, par. 2 and 76 et seq.

They are five independent organisms connected but external to the CAC and instituted, coordinated and managed by FAO and WHO: the Joint FAO/WHO Expert Committee on Food Additives (JECFA); the Joint FAO/WHO Meeting on Pesticides Residues (JMPR); the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA); The Joint FAO/WHO Expert Meetings on Pesticide Specifications (JMPS); The Joint FAO/WHO Expert Committee on Nutrition (JECN).

46

“The category of public reputational accountability is meant to apply to situations in which reputation, widely and publicly known, provides a mechanism for accountability even in the absence of other mechanisms as well as in conjunction with them”, R.W. Grant and R.O. Keohane (2004), Accountability and Abuses of Power in World Politics, in “IILJ Working Paper”, 7, p. 17-18. Available at: http://iilj.org/ publications/documents/2004.7%20Grant%20Keohane.pdf.

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tion and offer a proper explanation of the methods and the rationale used in their studies and analyses. In this way, they can maintain their autonomy and independence, offering appropriate guarantees of transparency and legitimacy. This finds a confirmation in paras 17 and ff. of the “Working principles for risk analysis for application in the framework of the Codex Alimentarius”, 47 indicating procedural criteria and guidelines for the risk analysis procedure, included the stage of the assessment and stressing the issue of transparency and openness (see supra, Chapter 3, section 3.1). 3-4. In the subsequent phases, the Secretariat prepares a draft standard and sends it to the Member States and to the relevant International organizations for comments, observations and amendment proposals. 48 The review draft is thus assigned to the competent subordinate committee, where it will be discussed, negotiated and materially written. This phase relies on the scientific report provided by the expert committee and on other relevant factors of a political nature, such as the “economic interests”49 of the States. Therefore, as said, it is open to the discretion of the drafters, who follow the advice of the risk assessors only as a start and then can discuss and elaborate on the standard in accordance with several aspects of a political and social nature. The phase of investigation is thus dual. The first part consists of the technical and scientific evaluations. The second one, although based on the former, contains a general analysis of all legal and factual assumptions involved, and implies a discretional administrative activity. This coincides with the risk management phase and consists of “the process of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options”.50 As said, this moment entails several political implications. It is here that the balance between health and fair practices in trade is arranged, above all in consideration of the linkage between the CAC and the WTO: “Codex’s work remains highly technical and science based but, given its enhanced role under the WTO process, its decisions can have important political ramifications and so the potential to impact within the high politics of trade. Hitherto, the politics of Codex and its processes were more implicit, now the politics of Codex and processes has become more explicit”.51 The draft standard agreed upon at this 47

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Procedural Manual, cit., p. 76 et seq.

48

 Ibid., cit., p. 32.

49

The proposed draft standard is sent to Members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests. Ibid., p. 32.

50

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Procedural Manual, cit., p. 44.

51

D. Barling, Food safety norms, public health and consumers, cit., p. 12.

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step of the procedure is not conclusive though, as the final word is given to the Commission, where it will be then voted and approved. During the described phase, the observers’ participation at the activity of the Codex should be stressed. As stated by the IX Rule of procedure of the CAC, “any Member Nation and any Associate Member of FAO or WHO which is not a Member of the Commission but has a special interest in the work of the Commission, may, upon request communicated to the Director-General of FAO or WHO, attend sessions of the Commission and of its subsidiary bodies as an observer. It may submit memoranda and participate without vote in the discussion”.52

Despite having only observer status, external governmental or non-governmental organizations can influence Codex decision about the standards. In addition, they could also increase transparency and consumers/citizens information enhancing general consent and representation. It is difficult for civil society to monitor Codex activities, either because decisions are made at an extra-national level, or due to the required technical knowledge on which standards are based; and NGOs could inform citizens and explain Codex decisions, acting as a link between decision-makers and decision-recipients and providing a form of mediated political accountability: “Organized civil society may play a key role by ensuring a broader public discussion of policy alternative and by bringing the concerns of citizens into the decision-making process. (…). First, civil society organizations can give a voice to the concerns of citizens, and channel them into the deliberative process of international organizations. Second, they can make internal decision-making processes of international organizations more transparent to the wider public and formulate technical issues in accessible terms”.53

However, if interests’ representation is not equally balanced – as we saw both for Codex committees and national delegations (supra, para. 2.1.4) – the accountability of the global regulators would be impaired and partial, with the effect of decreasing efficiency, equality and impartiality. This is an evident critical issue for what concerns public participation in the Codex. Considering that the intervention is foreseen only in the subordinate committees, a problem of lack of resources for a complete participation is strikingly evident: only a few actors can afford to participate in the sessions of all the committees and these are Business non-governmental organizations – BINGOs, that are mainly multinational corporations.54 In addition, if impartiality and transparency are not 52 53

 Ibid., p. 11.

P. Nanz, Legitimation of Transnational Governance Regimes and Foodstuff Regulation at the WTO: Comments on Alexia Herwig, in C. Joerges, I. J. Sand and G. Teubner (ed.), Transnational Governance and Constitutionalism, Oxford and Portland Oregon, Hart, 2004, p. 230.

54

At the moment, the NGOs participating in Codex activity are 156, among which only 9 do not belong to the industry sector, see International Non-governmental Organisations in Observer Status with the Codex

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already ensured in NGOs themselves and if their members are not accountable as well to the people they represent, their work might have the opposite effect of providing wrong information, misleading public opinion and diminishing civil society participation. Nonetheless, this is an interesting aspect related to CAC’s legitimacy, as it shows the attempt to guarantee some form of transparency and public participation to a body, which has no direct representative mandate, in order to provide a procedural legitimacy. 5. The deliberative-decisional phase is articulated in more steps. After a first discussion inside the Commission, a provisory version of the standard is distributed to the Member States through the National Codex Contact Points. Here there is a domestic discussion of the standards, which are examined, assessed and evaluated. Governments can propose changes, revisions and amendments. 6. In accordance with the requests and the proposals from Member Parties, the Secretariat can propose a modified version of the draft and submit it to critical review by the Executive Committee. If the standard is approved by the Commission, it can be already issued in this phase with an accelerated procedure. Otherwise, the last two steps (5 and 6) are repeated, until the standard is finally approved in the Commission. 7. The final approbation occurs through consensus 55 or, if this is not possible, through simple majority. In this phase, private parties or international organizations cannot intervene as observers and the decision-making procedure is covered by secrecy. This is an evident drawback concerning the legitimacy of the standard setting, as such phase is not sufficiently monitored and the national delegates are repaired from political control of all the constituencies involved by their decisions. 8. The Secretariat has the material power to provide for the publication of the standard. Thus, this is “published and issued to all Member States and Associate Members of FAO and/or WHO and to the international organizations concerned. The above mentioned publications will constitute the Codex Alimentarius”.56 The mechanism to approve the standards reproduces the archetype of: “a global-transnational administrative process. Indeed, as an administrative process, it entails an initiative that through a series of linked acts directed to acquire knowledge, evaluate facts and balance interests, arrives at a final decision, carried out into a standard, applicable to States and ready for implementation at a national level. The process is global and transnational because the decisionmaking procedure involves national governments, national or regional authorities Alimentarius Commission, Report by the Secretariat (CAC/28 INF/1), Annex I. 55

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Procedural Manual, cit., Rules of procedure, Rule XII.2, p. 14. On the issue of consensus in international law, see A. Cassese, International Law, International Organizations: A Comparative Approach, Westport, Praeger, 1994.

56

Joint FAO/WHO Food Standards Programme, Codex Alimentarius Commission, Procedural Manual, cit., p. 34.

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(agencies, committees, etc.), private multinational subjects, inter-state organizations and so forth. In addition, it responds to a multi-layer logic, foreseeing phases that are handled at the national level and phases that are dealt with at the global level, although it finally explicates its effects on the territories of national states”.57

What is interesting concerns the contribution given by all the competent actors of the procedure. Here, in particular, administrative and institutional bodies taking part in the decision making are mainly the national delegates. As they represent domestic administrative authorities, the latter figure as standardsetters, as standard-recipients and as standard-executers. In the first moment, however, they share their power among them and with other subjects, and they follow principles and procedures established at the international level; in the second and the third ones, they see their interpretative and executive power notably reduced as the standards are detailed, specific and de facto binding. In order to justify the latter and grant more legitimacy to the standard setting procedure, CAC’s Procedural Manual ensures certain formal guarantees, such as transparency and participation, and a scientific basis. For the former we noticed that not all the guarantees provide enough insurance of impartiality, openness, equality and proper accountability; for what concerns science, it is uncertainty and science policy, and the socio-political discretion of risk managers discussing the draft standard in the Committees, that might undermine neutrality and soundness. It is useful to stress that while discretion is granted to standard-setters inside the Codex, it is instead refused, by the SPS Agreement, to those Member States wanting to justify their measures based on risk management. As we saw in the cases analyzed supra (Chapter 2), only a scientific risk assessment can justify a national SPS measure, while standards are only based on risk assessment and rely also on political considerations. This, as evident, is a clear discrepancy between principles and rules applied to global food safety regulators (as CAC) and principles and rules applied to domestic food safety regulators: the former subjects are granted a certain amount of discretion, even if they have a reduced legitimacy, as they are not directly representative and enjoy limited transparency; the second ones have reduced discretional powers and can justify their measures only upon scientific demonstrations, while they are normally structured in democratic systems, although with no international guarantees of nonprotectionist orientations. Finally, it is peculiar that global law is stringent and demanding on national governments for their domestic acts with a global effect, while being loosen and permissive with the same subjects, but as actors of the decision-making in the global arena, i.e., in this case, at the CAC. A justification and an explanation of the presented model are to be find in the international character of the CAC: the standard setting procedure involves 57

D. Bevilacqua, The Codex Alimentarius Commission: increasing accountability through transparency, p. 11, available on line at http://iilj.org/GAL/documents/BevilacquaCodex.doc.

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national States and produces common decisions translated into global standards; therefore it does not need further legitimacy than the one it already has through scientific risk assessment, procedural guarantees and indirect representation. Nonetheless, the previous analysis showed that both the indirect legal force of the standard and the limited effectiveness of the legitimacy tools demonstrate the need for a better justification of CAC’s activity, which could be made more transparent, more accountable, more impartial.



2.2.1 A global administrative procedure: features, positive issues and pitfalls

As previously noted, the standard-setting procedure finds its legitimacy in the scientific basis of the risk assessment’s phase, in the procedural mechanisms, structured in order to involve a multiplicity of actors and to guarantee participation and a transparent and impartial process, and in the indirect representativeness of national delegates, nominated by democratically elected bodies. However, we had the chance to remark that, considering the factual legal force of the standards, the relevance of their scope, which implies the myriads of interests surrounding food, and the political implications of the decisionmaking over the standard, all three kinds of guarantees for legitimacy appear to be insufficient, weak or only partial. We noted the need for science to be more sound, transparent and independent. We focused on the lack of transparency and on the impairment of public participation in the standard-setting procedure. Moreover, to date, a significant prevalence of industry- and trade-related interests is registered, while health and consumers protection are still underrepresented.58 In addition, standards are not properly motivated, as it is difficult to trace all the steps of every single procedure leading to a determinate standard and to understand its scientific and political rationale. The two cases mentioned at para. 2, for instance, confirm this trend: they set limits and specify codes of practices but they do not indicate the reasons and the rationale, which led to those conclusions. Finally, it is to stress that the mechanism of indirect representation: “shows an evident weakness as the combination of international power-sharing and the introduction of new “rings” in the long chain of government make it increasingly difficult to ensure the accountability of the delegates’ activities inside the CAC. State delegations, comprised of bureaucrats and sector representatives, 58

We already had the chance to underline the reduced representation of weak interests (such as health, the environment, small producers, indigenous traditional foods, and so on) in some parts of this book. Moreover, a detailed analysis of the list of the observers is confirming an unbalanced representation of the different stakes involved. The list is available on the Codex’s website: http://www.codexalimentarius. org/members-observers/observers/en/?filterby=NGO.

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are not required to give account directly to their parliaments. This shifts the power from the representative to the executive, leading to a democratic deficit”.59

By comparing the system of governance instituted with the Codex with national administrative models, we can notice the pitfalls and flaws of the former, above all in terms of democratic consensus, impartiality and interest-representation, and transparency, still at a rudimentary stage of development. On the other side, we also noted that if global regulatory regimes are not accountable and representative enough, national governments are not globally oriented, so that despite being formally democratic, they only respond to national constituencies and do not offer guarantees of impartial and non-protectionist policies. This is a typical dilemma of harmonization: increasing powers at the national levels may impair foreign interests, increase forms of nationalism and reduce the impartiality of the decisions; while, on the opposite, the centralization of the decision upon global bodies may reduce the accountability of the policy-makers and encourage forms of pressure and lobbies against the latter and by corporate interests. Nonetheless, assessing the Codex for itself and considering the need for harmonized rules, and the fact that standards have become quasi binding only since 1995, the positive terms entailed by the CAC should be stressed. For instance, without a world Parliament and a world Constitution, it is not an easy task to accomplish proper democratic decision-making and it is impossible to require the division of those institutional powers drawn by Montesquieu that occur inside national States. In addition, it is notable that the CAC does not only rely on its intergovernmental nature and on indirect representation, but it also relies on formal and procedural mechanisms to guarantee a better legitimacy and more effective and impartial decision-making. Moreover, with its horizontal structure, it creates a global network involving all the competent actors in the field and positing decision-makers in the same arena with decision-recipients. Finally, the scientific reference, if properly combined with socio-political discussion, can be a matter of force and legitimacy for the Organization. As it is impossible to neutralize completely the decision-making as well as to always obtain sound scientific results, standard negotiation must also have a political implication. This is coherent with the rationale of the risk analysis, but also requires the application of effective mechanisms of accountability and impartiality. Which, as noted, still need to be enhanced and developed.

59

D. Bevilacqua – J. Duncan, Towards a New Cosmopolitanism: Global Reflexive Interactive Democracy as a New Mechanism for Civil Society Participation in Agri-food Governance, Global Jurist 2010, Vol. 10, Iss. 1 (Advances), Article 2. Available at: http://www.degruyter.com/view/j/gj.2010.10.1/gj.2010.10.1.1348/ gj.2010.10.1.1348.xml.

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3 The legitimacy of the Codex Alimentarius Commission: values and drawbacks

The discussion about the CAC raises several problematic insights concerning the content of the standardization, the procedures leading to the standards and the legitimacy of the Organization as a global regulator. We can develop some questions and try to provide answers. According to the dual purpose of the CAC, can we say that the two interests of health and fair trade are equally balanced? Are the structure and the legal sources of the Organization functional to obtain a balanced decision? Or, is it exposed to the prevalence of some corporate interests’ pressures? What about the organization of the CAC? Should it be more centralized or more dislocated? How much power should be granted to the national authorities and how much should be given to the international regulators or to IGOs and NGOs? Is the procedural mechanism to approve the standards fair and effective? Should it be reduced in length? How? Does it coincide with the risk analysis procedure? Should the scientific phase be prevailing or succumbing, on behalf of the political decision? Does the CAC need a stronger legitimization of its activity? Can we consider it, at present, sufficiently democratic and impartial? If the CAC is to be improved, how can this be done? By increasing indirect representation or by enhancing procedural guarantees? For what concerns the first series of questions, the previous analysis suggests that, considering the dual purpose of the CAC, the balance between the two interests of health and fair trade depends much on the equilibrium between the forces operating in the Codex. As seen, there is not a clear line or directive, but decisions are made case by case, relying on scientific opinions but also involving political and economic bargaining. For what concerns this issue, it is to insist on the fact that the structure and the legal sources of the Organization should be functional to obtain a balanced decision. This shows the need to have more transparency, more accountability and effective procedural norms in order to have an open negotiation, which could show when science is sound, when it is ignored by political institutions, how the latter balance conflicting interests, and so on. As for the organization of the CAC, we noted how complex and articulated the system is. A useful reform may imply a clearer separation of functions and powers between the Commission – with the subordinated bodies – and the States. The presence of States’ delegates, protected by the accountability towards local constituencies, has the effect of impairing democracy and impartiality. However, at the same time, a centralization of the decision-making power in only one international body may also reduce it. The logical approach, to develop a new path towards a better organization of the CAC, would lead to more accountable, transparent and purely global decision-making – attributed to the

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CAC’s institutions, which should be made politically responsible for its activity. At the same time, this should be added to safeguard clauses and rights of opt out for the Member States – for instance implying the application of a precautionary approach – in order to avoid a too strong centralization of decisional power on behalf of the CAC. Finally, considering the aims of making the standard-setting procedure and the CAC in general more efficient, impartial and democratic, it is to say that one interesting way to increase legitimacy and accountability inside the CAC relies on a proper and wider application of the general principles of law to the decision making. This would mean increasing transparency and impartiality, enhancing efficiency and timeliness, foreseeing a duty to give reason to the mechanism of judicial review, increasing participation and making it more balanced in the representation of interests. Such approach might be a way to strengthen the legitimacy and accountability of the CAC. For instance, more transparency would also improve the quality of participation, as the decision-recipients would easily see how certain interests influenced CAC’s decision: “The more governments are required to make their decision processes public, the more difficult it is for concentrated interest groups to obtain the results they prefer and the more likely it is that the interest of the general public will be served”.60 Would relying on legal principles be a good solution? Would this be effective or would it only slow down the procedures? What alternative might be found to increase the legitimacy of global regulators? These questions are still open to several answers and to future discussions.

60

A.T. Guzman, Food Fears: Health and Safety at the WTO, in Virginia Journal of International Law, 2004, p. 15.

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Extra reading: On the Codex Alimentarius Commission: N. Rees – D. Watson (ed.), International Standards for Food Safety, Aspen Publications, Gaithersburg, Maryland, 2000. S. Poli, The EC and the Adoption of International Food Standards within the Codex Alimentarius Commission, in European Law Journal, 2004. F. Veggeland and S.O. Borgen, Negotiating Food Standards. The WTO’s Impact on the Codex Alimentarius Commission, in Governance: An international Journal of Policy, Administration, and Institutions, Vol. 18, No. 4, 2005. D. Bevilacqua, The Codex Alimentarius Commission and its Influence on European and National Food Policy, in European Food and Feed Law Review, 1/2006. D.E. Winickoff & D.M. Bushey, Science and Power in Global Food Regulation: The Rise of the Codex Alimentarius, in Science, Technology & Human Values, 35 (3), 2010.

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Concluding Remarks

chapter 5

concluding remarks

From the previous analysis, we can try to draw some general conclusions: 1) We noticed that global food safety law and regulation present several problematic issues related to the complexity of the matter – interdisciplinary and multidimensional – and to the extra-nationality of the competences of public intervention into such a sector. We had the chance to see how food safety regulation involves procedural and formal issues related to administrative law and to the democratic guarantees of decision-making. This is also crucial for the substance of such regulation: negotiating, approving and implementing food safety norms have an omni-comprehensive approach and involve a highly discretionary power for the policy-makers. Making decisions on the quantity and the quality of veterinary drugs used in breeding, on the admissibility of a genetically modified good, on the use of contaminants, pesticides and other agricultural methods has a significant impact on the environment, the economy and the health of the citizens. It is much more than assessing the hygienic conditions of a food and the way it is conserved or than inspecting a farm and enacting a sanction against a company for some illegal process in the conservation of a food. Above all, such regulatory policy has a strong and significant impact on society and on its development. This is why it needs to be reasonable, scientifically backed up, democratic, impartial and formally justifiable. And this is why general legal principles and administrative procedures are fundamental to ensure all the necessary guarantees of impartial, fair, general interestsoriented and effective regulation. Notably, in the global legal space where, as noted, certain typical democratic guarantees are lacking due to the structure of the extra-national system. 2) Global food safety law and regulation in action, i.e. as actually applied and implemented by adjudicatory bodies and executive authorities, presents the following problematic insights: a) national administrative regulations of food safety are no longer independent and exclusive, as their internal policies and rules may have a transboundary effect, of a factual and legal nature. Therefore, the domestic rule-makers need to abide by common principles and common regulations and to ensure a minimum set of democratic and impartial guarantees. Nevertheless, in this way they lose the discretion and capacity to give reasons to their local constituencies; b) The centre of the global food safety legal framework is food trade. Trade is still the main issue around which food safety legislation is conceived at the global level. Because of this prevalence of trade and of the fragmentation and the sectorality of the global legal framework on food safety, there is a spill-over of trade interests over health’s and consumers’ ones, which are then underrepresented; c) Global food safety law is strongly based on science. This responds to the need of neutralizing the decision-making, but both for factual reasons (science is not always able to be sound and objective) and for legal-administrative reasons (not all the organizational mechanisms are put in place in a way to avoid pres-

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sures, influences and bias on experts’ will), science is not always able to neutralize the decision-making. Therefore, it causes an increased development of (unaccountable) science policy; d) Global food safety law is not legitimized enough, as national democracies and local policies are diminished by decisions coming from extra-national organizations, which – being very far away in a long chain of government – are unable to guarantee the same level of transparency, accountability and people empowerment. At the same time, for the interconnectedness of economies and societies, national authorities cannot be left free to make decisions affecting also the citizens of other Countries. 3) The global legal framework regulating food safety also presents features of complexity, pluralism and proceduralism. This is evident both in the sources of law and in the organizational structure. The former are derived: by general principles applied and interpreted in a heterogeneous way in accordance to the different regulatory regimes; by several sectoral international agreements interacting, overlapping or conflicting among one other; by the regulatory acts of international organizations and by the factual influence of the States’ policies, also developing through a reciprocal dialectic. Thus, there is an articulated and heterogeneous legal framework, which increases pluralism and opens up the rule of law, while, at the same time, can reduce transparency and accountability over the actual rule-makers. For what concerns the organizational structure, this is composed of several bodies entailing different functions and with different powers, interacting together through procedural patterns of decision-making, operating in the same decisional arena, sharing information and approaches, performing decisions through contractualistic models. In this way, the organizational model is decentralized and plural, including a significant numbers of subjects in the decisionmaking. At the same time, it becomes complicated, blurred for what concerns competences and jurisdiction, not enough open to participation and not transparent. In a few words, the present system still lacks in terms of accountability. 4) The Codex Alimentarius Commission embodies a central role. This, as noted, is fundamental to produce harmonization in the field of food safety and as a way through which States can agree on common principles, common detailed rules and common policies in the field of food. In addition, it is a significant body in global law, as it is able to issue detailed, specific worldwide acts with a quasi-binding force inside the national States. Nonetheless, the CAC still presents problematic insights for accountability, legitimacy, transparency and impartiality in the standard-setting procedure and in the way in which it is organized. 5) As indicated in the first introductory chapter, the threefold premise to our analysis is that global food safety law and regulation is multidimensional, extranational and interdisciplinary. All the three features have been confirmed by the empirical and theoretical study we went through: we noted the multidimensionality of food safety in the adjudicatory cases commented upon in Chapter 2 and

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in the purposes of the most important legal texts on the matter (Chapter 3). We faced the extra-national character of food safety during all the analysis, either in practical examples or in the study of the abstract norms. Finally, the interdisciplinarity was confirmed by the relevant use of natural sciences in the decisionmaking and in the interaction of different legal and socio-economic approaches, related to agriculture, food security, trade and economic development, health, the environment, and so on. Finally, we can try to answer to the questions we asked in the introduction to the book. Which are the actual dominant objectives inspiring global food safety regulation? They are both free trade and consumers’ health. The two objectives, however, are often in a dialectic relationship, in which trade interests tend to spill over on to health protection ones. At the global level, without a constitution, there is no hierarchy among principles and values and therefore the protection of the latter is often the result of a dialectical relationship between interests, which has reflections both in the factual and in the legal field. Moreover, as evident, interests that are more developed, meaning that reached a more developed status of legal protection – such as trade – tend to prevail over the weaker ones, such as health or the environment. Assessing the present food safety regulation and its development, what kind of substantial consequences does it have on health protection, trade, agriculture and the other issues forming it? As noted, the present development of global regulation of food safety tends to follow a market-oriented rationale, with a reduction in public intervention and a preference for market solutions. This responds to the logic of economic freedom enhancement and wants to foster the efficiency of the market and all its benefits in terms of food access, price decreases and quality improvement. However, the system has not produced the expected results as the phenomenon of agflation (the increment of prices of agricultural products) occurring in these years has demonstrated. In addition, the difficulty to prevent and to foresee possible risks coming from modern biotechnology and from an industrial-oriented approach to agriculture may also have an effect on the safety of the public. As noted for the exclusion of the precautionary principle from global food safety law, the substantial rationale of such a legal order is risk-taking. And this, as evident, has a considerable impact on the substance of national policies on this matter, above all on the health oriented ones. Who and what kinds of authorities do make decisions over food safety? Several. They are national authorities, for instance related to the Minister of Agriculture or of Health, but also international authorities, for instance international organizations or international courts, and there are technical bodies,

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for instance scientific committees, which, through their scientific reports, can influence formal regulatory decisions. At which level of governance does the decision-making happen? It is difficult to say, as decision-making occurs at all levels of governance. As said, it involves national, regional and international regulators; it comprises several phases, some performed inside international organizations, some in the territories of the States and some others in neutral arenas mixing the intervention of more kinds of policy-makers. Thus, there are phases, which are not simply multi-level – that is involving two or more levels of government – but even common, in which the two or more levels of governance are so involved and combined together to result in one single model. In many respects, the Codex Alimentarius Commission is one of the latter. What kind of principles, criteria and rules apply to establish when food can be considered safe? How does the policy-making procedure work? Several. As said, there is a plurality of the sources of law and of the decisional criteria: some regulate the substance of the decision-making, indicating purposes and priorities and some others concern the procedure, disciplining the way these develop in order to produce policies, rules and detailed standards. In the CAC, the procedure of standard setting is directed to define substantial standards and the final decision relies on scientific criteria and on the bargain between decision-makers. According to the SPS Agreement, instead, the level of safety is left to national Member States, but they are required to respect procedural and formal limits set by the Agreement and to justify any market restriction through scientific demonstration. Which guarantees of democracy, fairness and impartiality are ensured in the enactment, interpretation and implementation of food safety law and regulation? Some. Problems of legitimacy, impartiality and accountability can be found either at the global level, or at the national one. Either for the legislative moment, or for the implementation. Either for the policy-making, or for the material administrative activities. Nonetheless, several principles and mechanisms of decision and control apply to these regulatory activities. They are still insufficient to ensure democracy in such a complex and fragmented system, but they also have a significant effect in enhancing the rule of law, fostering its function of instruments to enhance a fairer regulation. What are the advantages, drawbacks and perspectives of the present global food safety framework? As noted, the trend of food production, trade and consumption is following the dominant path of globalization, with all its industrial-, trade- and development-oriented features. Theoretically and at the beginning of the process, this tendency promises positive effects: increment in yields and in food security;

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facilities in food access; development of mechanisms for food exchange; decrement of prices in favour of more quality. However, if we focus on the empirical results of such ongoing process, food insecurity has been increasing and still is;1 agflation is developing fast and affecting the main food productions, such as cereals and grain;2 food salubriousness, as well, is continuously endangered by novel foods and by hazardous methods of production (confirmed by the frequent outbreaks of worldwide foodborne diseases). The most appropriate answer to the mentioned problems may exist in a counter-revolution of the agricultural sector, featured by localization of the food chain, by the use of traditional agricultural knowledge and skill in food production and by stronger public incentives for organic methods of agriculture. At the same time, the governance of this sector is in need of a higher democratization of the processes of decision-making on food issues, of being tackled in the short period by proper, fair and effective global regulations based on shared legal principles and rules, and on common policy views. The developing and evolving global legal order reduces national sovereignty and discretion, sometimes decreasing the democratic guarantees of the decision-making, sometimes fostering the procedural guarantees in favour of the individuals. However, it is still following an unbalanced approach, too tradeoriented and too insensitive to the petitions of the weak interests, as the ones of consumers or small producers. Notwithstanding, the examined legal framework has shown also positive aspects and its main drawbacks could be reduced or eradicated during its development. The present food safety legal system can also be seen as a great opportunity to work for a common goal, made out of a balance between all the general interests involved in the subject, reached through new models of democratic representation. It is an occasion to ensure better health, without reducing development, to improve food quality, without denying food security, to enhance democracy and improve the architecture of global governance and, finally, to extend the benefits of a common regulation to the entire world population. The road to walk, however, is still long.

1

FAO, Declaration of the World Summit on Food Security, Rome, 16-18 November 2009, consultabile al sito http://www.fao.org/fileadmin/templates/wsfs/Summit/Docs/Final_Declaration/WSFS09_Declaration.pdf.

2

On this see E. Holt-Giménez, R. Patel, and A. Shattuck, Food Rebellions (Oakland: Food First/Fahamu, 2009, passim.

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