WT/DS291/R/Add.7
WT/DS292/R/Add.7
WT/DS293/R/Add.7
Page I-199
ANNEX I-4
COMMENTS BY THE EUROPEAN COMMUNITIES ON THE REPLIES BY THE SCIENTIFIC EXPERTS TO THE QUESTIONS POSED BY THE PANEL
28 JANUARY 2005
TABLE OF CONTENTS
TABLE OF ABBREVIATIONS i-199
I. Introduction I-201
II. The Advice Available and the varying approaches of the experts to their task I-202
A. The incompleteness of the responses I-202
B. The different approaches of the experts I-203
C. The independence of the experts I-204
D. The assessment of the reasonableness of time taken I-204
III. General and Methodological Issues I-204
A. Complexity I-204
B. Case by case assessment I-204
C. Systemic issues (interactions and cumulative effects) I-205
D. Familiarity I-205
E. Evolving science I-205
F. Scientific evidence of risks or absence of risks I-206
G. Controversy I-206
H. Absence of agreed scientific criteria I-206
I. Judging when the scientific information is sufficient I-206
J. Interpretation of scientific information I-207
K. Availability of risk mitigation and risk management tools I-207
L. Post market monitoring and general surveillance I-208
M. Surveillance and food safety I-208
N. Removing uncertainties with large scale cultivation I-208
O. Detection methods I-209
P. New developments of risk assessment concepts for genetically modified products I-209
1. The "substantial equivalence concept" I-210
2. Codex principles for the risk assessment of GM foods I-210
3. The environmental safety assessment of GMOs I-211
4. The plant health assessment of GMOs I-213
5. Starting points for assessing effects of GMOs on food safety, mediated through the environment I-213
6. The animal health assessment of GMOs I-214
Q. Other general issues – dealt with in the comments on the questions I-214
IV. The Panel's General Questions (N°s 1 to 9 and 110 to 114) I-214
V. The Panel's Questions on Issue 1 ("delay") (NOS 10 to 58) I-266
VI. The Panel's Questions on Issue 2 ("safeguard measures") (NOS59to 95) I-340
A. Introductory remarks I-340
B. Questions 59 through 65 I-341
C. Topas 19/2 (notification C/UK/95/M5/1) (France and Greece) (Questions 66, 67 and68) I-346
D. Maize Bt-176 (notification C/F/11-03) (Austria, Germany, Luxembourg) (Questions69 to 77) I-348
1. Introductory remarks I-348
2. Anti-biotic resistance I-348
3. Non-target organisms I-349
4. Resistance management I-351
E. Maize Mon 810 (notification C/F/95/12-02) (Austria, Italy) (Questions 78 to 80) I-352
F. Maize T25 (notification C/F/95/12-07) (Austria, Italy) (Questions 84 to 89) I-358
G. Maize Mon 809 (notification C/F/95/12-01/B) (Italy) (Questions 90 to 92) I-360
H. Maize Bt-11 (reference C/GB/96/M4/1) (Italy) (Questions 93 to 95) I-362
VII. The Panel's Questions on Issue 3 ("likeness") (NOS 96 to 109) I-363
VIII. The Panel's Additional Questions I-381
WT/DS291/R/Add.7
WT/DS292/R/Add.7
WT/DS293/R/Add.7
Page I-199
TABLE OF ABBREVIATIONS
ACRE / UK Government's Advisory Committee on Releases to the EnvironmentACT / Australian Capital Territory
AIA procedure / Advance Informed Agreement procedure
ASEAN / Association of South East Asian Nations
BINAS / Biosafety Information Network and Advisory Service
Bt / Bacillus thuringiensis
CA / Competent authority
CTFBT / Codex Alimentarius Commission established an Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology
Directive 2001/18 / Directive 2001/18/EC of the European Parliament and of the Council of 12March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
Directive 90/220 / Council Directive 90/220/EEC of 23 April 1990 on the deliberate release of genetically modified organisms
DNA / Deoxyribonucleic Acid
ECJ / European Court of Justice
EFSA / European Food Safety Authority
EPA / United States Environmental Protection Agency
FAO / Food and Agriculture Organization of the United Nations
FDA / Food and Drug Administration
FSE / Crops and Farm Scale Evaluations
GATT 1994 / General Agreement on Tariffs and Trade 1994
GEF / Global Environment Facility
GILSP / Good industrial large-scale practice
GM foods / Food products containing, consisting or produced from GMOs
GM products / Genetically modified products
GMHT / Genetically Modified Herbicide Tolerant
GMOs / Genetically modified organisms
HT / Herbicide Tolerant
IANB / UN Inter-Agency Network for Safety in Biotechnology
ICPM / Interim Commission on Phytosanitary Measures
IOE / The International Office of Epizootics
IPPC / International Plant Protection Convention
LMO-FFPs / Living modified organism intended for direct use as food or feed, or for processing
LMOs / Living modified organisms
NAS / United States National Academy of Science
OECD / Organisation for Economic Cooperation and Development
OSR / Oilseed rape
Regulation 258/97 / Regulation (EC) N° 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
SCP / Scientific Committee on Plants
SPS Agreement / Agreement on the Application of Sanitary and Phytosanitary Measures
TBT Agreement / Agreement on Technical Barriers to Trade
UNEP / United Nations Environmental Programme
UNIDO / The United Nations Industrial Development Organisation
WHO / World Health Organisation
ORF / Open Reading Frame (Protein Coding Sequence of the DNA)
I. Introduction
1. In this submission the European Communities responds to the invitation by the Panel to comment on the advice provided by the Panel's experts, in the form of comments on their replies, and, where appropriate, in the form of further scientific and technical evidence in relation to the Panel's questions.
2. The European Communities has taken very seriously its task of providing science based comments, to contribute to the Panel's understanding of the expert replies. In this regard the European Communities has sought to rely on the most up-to-date science available. For the purpose of ensuring scientific and technical accuracy of its comments, the European Communities has also relied upon independent scientific advice from internationally renowned scientists, as appropriate.
3. By way of introduction, the European Communities is pleased to note that the replies provided by the Panel's experts very largely confirm the Communities' view that the scientific and technical issues involved in considering whether to authorise the release into the environment and the marketing of GM products are very complex and often controversial. The independent experts have confirmed that the science has developed considerably over the last ten years and is still evolving at a fast pace. And most significantly they have confirmed that each case is to be taken on its own merits, and indeed that each case was taken on its own merits. This in turn confirms the approach taken by the European Communities and the Member States and is inconsistent with any claim as to a 'moratorium'.
4. The European Communities does not however agree with all the advice and every answer (or specific parts thereof) provided by the experts, and will comment in detail below. These comments follow the order of the Panel's questions and are divided into sections corresponding to the main issues as identified by the Panel (Sections IV to VIII below).
5. At this stage, the European Communities will provide comments only in relation to a number of replies, as, on these, it considers appropriate to submit them in advance of the meeting with experts. This approach is intended to contribute to the Panel's understanding of the experts' replies, having regard also to the time resources available to comment within the rather tight deadlines.
6. One of the consequences of the lack of time is that this submission is not as concise and well prepared as the European Communities would have wished. Some repetition has been unavoidable and although this submission is long, it is not complete. The European Communities reserves its right to revisit its replies in due course, as well as other replies and questions, and provide further comments and scientific or technical evidence, as provided for in paragraphs 13 and 14 of the Panel's additional working procedures for consultations with scientific and/or technical experts. The absence of any response or comment in respect of an answer to any question should not necessarily be taken as acceptance on the part of the Communities of the adequacy or accuracy of the response to the question.
7. Before commenting on the replies to the questions, however, the European Communities comments on the varying approaches taken by the various experts in undertaking their task and on some general and methodological issues (Sections II and III). As will be explained below, this has a bearing on the interpretation of the advice, on the weight to be given to the various expert opinions, and consequently on the Panel's ability to make findings of fact on that basis.
8. In this submission, the European Communities does not discuss the questions of definitions on which international organisations have recently provided advice. As requested by the Panel in its letter of 22 December 2004, these issues will be the subject of comment in a separate submission that the European Communities will present to the Panel on 4 February.
9. The European Communities welcomes the opportunity to discuss these scientific and technical issues further with the Panel and the experts on 17 and 18 February. On this occasion it reserves its right to provide the Panel with further scientific and technical evidence in response to the many aspects of the questions that remain unanswered. The European Communities may bring some additional scientific and technical experts to that meeting as part of its delegation.
10. The European Communities is providing only one exhibit to this submission, Exhibit EC-156, containing the unpublished scientific literature referred to herein. Other documents that are publicly available are not exhibited.
II. The Advice Available and the varying approaches of the experts to their task
11. The European Communities wishes, through the Panel, to thank the Panel's experts for their valuable contributions, which was extremely difficult in the light of the amount of information to process, the number of issues to address, as well as the number of scientific and technical disciplines to cover. The Communities is especially conscious of the fact that responses were provided within the very short timeframe provided for in DSU proceedings.
A. The incompleteness of the responses
12. It is therefore not surprising that the Panel's experts could not cover all necessary disciplines and aspects of the Panel's questions, and provided in several instances answers only on certain aspects (or occasionally no answer at all), in accordance with what they had already made clear in their correspondences from last November. They provided replies, sometimes with detailed and extensive elements on some specific aspects, which, all together, left a large number of elements of the Panel's questions unanswered.
13. There are at least 18 questions which are either not answered at all (e.g. 2, 26, 114), or for which necessary elements of the replies are explicitly omitted by the experts. There are many more, as identified below in the detailed comments of the European Communities, where necessary elements of the replies are implicitly omitted by the experts, in accordance with their own scientific or technical expertise, and/or their initial commitment identified in their correspondence of last November.
14. The European Communities has endeavoured to collect the necessary scientific and technical evidence to provide the Panel with complementary elements of replies to the many aspects that remain unanswered. It has not, however, had the necessary time to submit all this information at this stage, and will seek to provide further evidence at the meeting with the Panel and the experts, if appropriate.
15. The European Communities also regrets, in light of the complexity of the advice sought by the Panel, and more generally of this case, that often only one opinion (and sometimes a partial one) has been made available to the Panel on many questions, or parts thereof. For many questions a number of scientific disciplines and issues are involved, and these do not allow for much overlap between the limited number of selected experts. It is doubtful whether the Panel can make definitive findings of fact on the basis of advice which is, on its own terms, so limited and incomplete.
B. The different approaches of the experts
16. The Communities notes that the Panel's experts have taken very different approaches, and frequently disagree among themselves, as indicated below. This confirms that there is legitimate room for disagreement on many of the issues. Such disagreement contributes to uncertainty and is bound to be taken into account by the Panel as it carries out its tasks.
17. After consultation and peer review with several independent scientists which all concur with the same opinion, the European Communities has come to the firm view that, among the four experts which were allocated the whole set of questions, only three (Dr. Andow, Snow and Squire) have adopted a balanced and fully reasoned approach, including an indication of their processes of thinking. These experts have provided for transparency on their conclusions and well-structured replies. They have critically evaluated the available information, questioned claims, and presented their own rigorous and logic scientific thinking, based on their own expertise, and each within the limited framework of their respective scientific disciplines.
18. Dr. Andow has been very thorough and plainly has carried out extensive work in preparing his detailed replies, which are often accurate and relevant. He may however on some aspects, as explained below, have overstepped his scientific expert mandate. Dr. Snow and Squire have covered fewer issues, and often in less depth than Dr. Andow, but they have nevertheless also given quite a number of accurate, sensible and fair replies.
19. In contrast, the responses of Dr. Nutti are much less scientific, and largely superficial in character. For the most part, no detailed explanation has been given into the basis for her thinking. Often Dr. Nutti has taken the information provided at face value without personal critical scientific assessment regarding its data basis and validity. As a consequence, her replies, which miss references of the most appropriate work, including as regards Codex references, seem unbalanced and incomplete as they often reach an identical conclusion (usually a systematic pattern of disagreement with any request for more information from Member States). The European Communities is bound to conclude that her replies are frequently inconsistent and often lack proper scientific argumentation.