Trade in Food
Publisher: Cameron May
Published: February 1, 2007
Language: eng
Format: Hardcover
Number of pages: 540
ISBN-13: 9781905017379
Subjects: Food manufacturing & related industries; Social law; Reference / Law
First sentence: Foreword

This book deals with a crucial matter in the ongoing debate as to the relationship between the regulatory competence of States in the furtherance of domestic policies of general interest and concern, such as food safety, and the preservation of a liberal international trade framework.

The negotiators of the Uruguay Round have addressed these concerns through the WTO Sanitary and Phytosanitary Agreement (SPS) which covers new grounds hitherto not regulated internationally. The SPS Agreement provides for a regime where non-trade concerns and responsibilities of governments as to food products are fully legitimised, even if this results in restrictions to trade, provided that there is no discrimination and that a risk assessment is conducted so that food safety measures be science-based. A distinct feature of the SPS Agreement is that it is not limited to prescribing minimum standards; it sets instead detailed rules as to national SPS measures covered, the goals that may be legitimately pursued through them and requirements of the proceedings (“risk assessment”) that must be carried out as a necessary underpinning of any restriction to trade in a given food product.

This global framework has been adopted at a time when more and more countries have enacted and are progressively enacting domestic risk regulations and are setting up specialized agencies to carry out the necessary investigations and controls. A prominent example of this evolution is offered by the European Union, the main focus of this book.

The starting point of the analysis of Alberto Alemanno is the evolution of food regulation in the EC and the establishment, role and activities of the European Food Safety Agency (EFSA) which is the cornerstone of the new food safety policy of the European Community. EFSA is a relative new institution, still not well known even by experts, and whose organization and efficiency is subject to conflicting evaluations. In this context Alberto Alemanno points to its modest responsibilities compared to the pivotal role attributed to the Food & Drug Administration in the U.S. 

I would like to stress here the original approach followed by Alberto Alemanno in his analysis throughout his book. In comparable investigations authors tend to follow one of two approaches. The first one is to highlight a certain national regulation within the domestic system concerned and thereafter examine its compatibility with relevant international regulation taking into account domestic implementation. The opposite approach is to highlight a given international regulation, including the limitations and requirements it imposes on member countries, in order to test thereafter whether a given national regime is in compliance with the applicable international obligations.

Alberto avoids both approaches. He considers the SPS Agreement not just as a set of prescriptions for WTO Member States, but as a food safety regime of its own, against which a national system such as the European one may not only be tested in order to detect resulting limitations and possible conflicts, but to which it may be compared with a view to analyzing divergence or convergence of the two regimes. This original approach is justified by the comprehensiveness of the SPS Agreement, which relies moreover on various international standards as an indirect tool for harmonizing national regulations in certain respects.

Alberto Alemanno also approaches, in an innovative way, the issue of judicial review of food safety measures in the EC and in the WTO, focusing on the different intensity of the respective reviews and the problems that judges face when reviewing science-based measures. According to the Author, the scientifically intrusive standard of review which tends to be applied within by the WTO judicial bodies is due to the fact that the WTO Agreements do not deal with risk management, and to the different normative and institutional contexts. Of course, while the focus of the WTO is on minimizing the negative impact of legitimate SPS measures on international trade and thus on restraining governmental policies, the EC aims at protecting the health of the consumer from potentially hazardous food product within the unified internal market.

The book offers thus an innovative contribution to the relationship between the WTO and EC regimes both as to substance in the area of ensuring food safety, while taking into account the role of science and precaution, and as to the implications of the respective judicial review mechanisms in a broad comparative perspective.

Thanks to his multifaceted legal background in international, U.S. and European law and his daily experience at the European Court of Justice, the Author has succeeded in mastering the various challenges, so as to offer a comprehensive piece of research which is at the same time informative and provocative. Indeed, by examining WTO law through the lenses of the experience of the major domestic regulatory systems, he injects into his evaluation an element of realism often lacking in those scholars who are more prone to detecting conflicts than engaged in trying to reconcile differences.



Giorgio Sacerdoti

Professor of International Law and Jean Monnet Chair of European Law, Bocconi University

Member of the WTO Appellate Body

Milan/Geneva, October 2006
Description: Trade in Food systematises and illustrates the evolution of the European Community s regulation of food within the broader framework set out by the WTO Agreements. Its main purpose is to provide readers keen to deepen their knowledge of the field with easy access to the EC and WTO food laws accompanied by a critical explanation and commentary. The book is well-suited to legal practitioners, judges, policy-makers, officials of international organisations, national civil servants, academics, research institutions and consumer groups who want to acquire or enhance their knowledge in this growing field of law. This book is also useful to post graduate students of international trade law and policy, international and European economic law, global administrative law and risk regulation. The foreword for this book is written by Professor Giorgio Sacerdoti, Member of the WTO Appellate Body and Jean Monnet Professor at Bocconi University, Milan.
Notes: Contents

INTRODUCTION
A.	Why Food Law?
B.	Why a comparison between the EC and the WTO?
C.	Structure of the research

PART I
 THE EUROPEAN FOOD REGULATION


CHAPTER I: The evolution of European food law: its four major eras of development

1.	The ‘Genesis’: the free movement of foodstuffs and the European “standards of identity” (1962-1985)

1.1. The internal market and free movement of rules
A. Negative integration rules: the scope and application of Article 28 EC
                   1. The exceptions: Art. 30 EC
                   2. The case law development on Article 28 EC
		2.1 Dassonville
		2.2 Cassis de Dijon and the Principle of Mutual Recognition 
		2.3 Keck
               B. Positive integration rules: Articles 94-95 EC
               C. Other positive integration rules
	   D. Conclusions on the ‘Genesis’
               E. The Genesis of food law on the other side of the Atlantic: the first developments in US Food law

      2.   The ‘Traditional’ Approach to Foodstuffs: the “Europroducts” (1969-1985)
      3.   The ‘New approach’: mutual recognition principle and minimum harmonization standards (1985-1997)
      4.  The ‘Emergency’: towards the ‘Europeanisation’ of food risk (1997-2002)
            4.1. The New Approach to food safety after the BSE crisis
   A. Green Paper on the “General principles of Food Law and New Approach to Consumer health and Safety” 

                  B. The White Paper on “Food Safety: towards a comprehensive and integrated approach to EC food policy” 

5.	The ‘Global approach’: the new food safety regime and the establishment of EFSA (2003-present)

CHAPTER II: The European regulatory regime for food safety 

         1. The new regulatory regime for food safety in Europe: a brief analysis
             1.1. Definitions
             1.2. General principles and requirements of food law
                 A. General objectives 
     B. Risk analysis: the EC ‘specificity’ in assessing risk
                      1. The principles of Risk analysis 
                          1.1 Nature of Food Risks 
                          1.2. Risk Assessment (RA)
                          1.3. Risk Management (RM)
                          1.4. Role of non scientific factors 
                          1.5. The relationship between RA and RM
       (a) Science Policies and the structural limitations of scientific knowledge
                               (b) Links between risk assessors and risk managers
1.6. Conclusions: flaws and limits of the first European Risk Analysis model
     C. The precautionary principle (PP): from scientific uncertainty to legal certainty 
                      1. Origin at International and Community level
                         1.1. Origin of the PP in the ECJ's case law
                              (a) The PP as an obiter dictum
                              (b) The early judicial shaping of the PP
                              (c) The 2000 Communication on the PP
                              (d) The EFTA’s Kellog’s case
                     2. Definitions
		2.1 The role of the precautionary principle in risk analysis
		2.2 Precaution: Facultative or obligatory?
                     3. Framing of the Principle and its conditions of application
		3.1 Risk threshold or the "uncertainty paradox"
  		3.2 Scientific uncertainty: What's that?
                     4. Recent case law
		4.1 The Pfizer/Alpharma judgments
		4.2 The Vitamins line of cases
		4.3 The GMO Austrian judgments
5. Conclusions: the Courts & the challenge of reviewing  precautionary measures

                 D. General obligation to ensure that food is safe
                 E. Allocation of responsibilities among food actors 
                      1. Traceability	
                      2. Withdrawal and recall
	     F. External dimension of the EC food legislation

CHAPTER III: The European Food Safety Authority: the cornerstone of the new food safety policy

1. The origins
            2. Mission and tasks of the Authority: the “scientific point of reference" for the  whole Union
                1.1. Mission
                1.2. Tasks
3. Institutional framework 
                3.1. Management Board
                3.2. Executive Director
                3.3. Advisory Forum 
                3.4. Scientific Committee and Scientific Panels: the very heart of EFSA
                3.5. Resources: Personnel and Budget
                3.6. Location
4. Operation
                4.1. Risk Assessment: Scientific Opinions
                      A. Referral to the EFSA
                           1. Refusal of requests for opinions
                           2. Time limits and emergencies
                           3. Transparency requirements for scientific advice
B.	The legal status of the EFSA’s Scientific Opinions 
                           1. Indirect legal effect
C.	Judicial review of EFSA’s scientific opinions
    1. European courts and scientific opinions
  	  2. National courts and scientific opinions     
   4.2. The Rapid Alert System for Food and Feed (RASFF)
4.3	 Risk Communication 

5. Organisational independence and accountability
    5.1. The questionable independency of the management board
    5.2. The scientists' autonomy
    5.3. EFSA and the European Commission

6. The EFSA v. FDA: why the EFSA is not a European-style Food and Drug Administration? Some elements for a comparison

                 6.1. Different missions
                 6.2. Different regulatory universes
                 6.3. Different cultures

Conclusions: Reconciling Science, Traditions, Consumer Concerns and Free Movement
 

PART II
 THE WTO REGULATION OF FOOD

CHAPTER I: Historical background of the GATT/WTO Regulation of Food

             1. SPS Measures under the GATT 

CHAPTER II: The SPS Agreements and its Main Obligations
            1. Non Discrimination
            2. Necessity and Proportionality Test
            3. Scientific Basis 
	   3.1 Article 2.2 SPS: Scientific Principles and Sufficient Scientific Evidence
	   3.2 Article 5.1 SPS: Risk Assessment
               3.3 The relationship between Article 2.2 and 5.1 SPS
            4. Harmonization 
                4.1. The SPS Agreement and the Relevant International Standards Organisations
	        A. Codex Alimentarius Commission (CAC)
		1. Operation
                        2. The EC involvement in Codex: from observer status to full membership
		3. The Role of Codex within the SPS Agreement
	         B. International Office of Epizootics (OIE)
	         C. International Plant Protection Convention (IPPC)
                 4.2. The standard-setting organizations’ role within the SPS Agreement
              5. Mutual Recognition and Equivalence
              6. Internal Consistency
              7. Permission for Precautionary Action
              8. Notification and Transparency requirements 
              9 .The SPS Committee


PART III 
JUDICIAL REVIEW OF FOOD SAFETY MEASURES WITHIN THE EC AND WTO 


Introduction

CHAPTER I: Risk Regulations in EC and WTO law
1. The EC and scientific justification
   1.1. The origins
   1.2. The codification of the scientific justification requirements: from scientific evidence to risk assessment
   1.3. The use of scientific evidence within the EC
   1.4. Conclusions
2. The WTO and scientific justification 
    2.1. The origins
    2.2. The SPS discipline 
    2.3. Conclusions
3. Why do both the EC and the WTO rely on science?


CHAPTER II: Judicial Review of Food Safety (science-based) Measures in the EC and the WTO
	1. An Introduction to Judicial Review
	   1.1. Differing levels of intensity of review
	   1.2. The specificity of reviewing science-based measures

	2. The Standards of Review in the EC
	   2.1. Introduction to the general standard of review
	   2.2. Reviewing EC food safety regulations
	   2.3. Reviewing national food safety regulations
	   2.4. Why diverging standards of control?
               2.5. Towards a more intrusive scrutiny of food safety measures within the EC?
                   A. The Pfizer Judgment
                   B. The Vitamins Line of Cases

           3. The 	Standard of Review in the WTO Dispute Settlement System
	    3.1. An introduction to the general standard of review
	    3.2. The standard of review under the SPS Agreement
	         A. Towards a 'minimum specificity threshold' of science?
	         B. Towards a ‘minimum risk threshold'?
                     C. Conclusions

          4. How to improve the role of the judge in the review of science-based measures?
    4.1 The role of experts in judicial review : the external expert consultation in the WTO
          A. Individual experts vs. expert review group
                      B. The scope of the expert consultation: what a role for scientific experts?
                      C. The legal status and authority of the experts' opinions
                      D. Conclusions on the WTO expert consultation system
            5. Towards an EC expert consultation system?
            6. The role of Peer Review in Judicial Review 
            7. Some proposals to help the Judge when reviewing Science
                7.1. How a judge may assess whether a scientific study is 'scientifically adequate'?
                7.2. What is a ‘minimum scientific threshold’?
            8. Conclusions






PART IV
COMPARING THE EC AND WTO FOOD REGIMES

CHAPTER I: Comparing food safety regulatory frameworks
 
           1. The goals: food safety as an exception (WTO) and as a goal per se (EC)
              1.1. The instruments: negative integration & positive integration tools
                  A. Positive integration in the WTO: internationals standards as WTO “de facto” food legislation

      B. The lack of a risk analysis scheme within the WTO/SPS food regime


CHAPTER II: Comparing food safety risk analysis schemes

           1. Comparing EC and WTO/SPS food safety risk analysis: what risk analysis model for the WTO?

               1.1. Risk analysis in the framework of Codex
           2.  The integration of “other legitimate factors” into the EC and WTO/SPS risk analysis models

                2.1. “Other legitimate factors” in the EC food safety risk analysis: a potential incompatibility issued under the WTO law?

       A. The role of ‘Other Factors’ in Codex’s risk analysis 
                   B. Conclusions on the role of “Other Factors” in Codex
               2.2. Conclusions: “Other Factors” as an open question
           3. What role for the precautionary principle?
               3.1. The role of the precautionary principle within Codex
               3.2. Conclusions on the role of precaution in the EC, WTO/Codex food safety risk analysis regimes

           4. Conclusions on the comparison between the EC and the WTO food safety risk analysis models: towards a common food safety risk analysis regime within Codex?


CHAPTER III: Comparing Standards of Review 

1.	Comparing the EC and WTO courts' standards of judicial review of food safety measures

1.1	Different institutional and normative contexts
1.2	Different risk analysis schemes
1.3	Conclusions
2.	A procedural, intensity variable standard of review for science-based regulatory measures?

2.1	Reviewing Risk Assessment
2.2	Reviewing Risk Choice
2.3	Reviewing Risk Response
2.4	Conclusions on the procedural, intensity-variable standard of review


CONCLUSION