WORLD TRADE  
ORGANIZATION  WT/DS320/R 
31 March 2008 
 (08-0898) 
 Original:   English 
 
 
 
 
  
 
UNITED STATES – CONTINUED SUSPENSION OF 
OBLIGATIONS IN THE EC  – HORMONES DISPUTE 
 
 
Report of the Panel 
 
 
 
   WT/DS320/R 
 Page i 
 
 
  TABLE OF CONTENTS 
Page  
I. INTRODUCTION ................................................................................................................... .1 
A. REQUEST FOR CONSULTATIONS  AND REQUEST FOR THE ESTABLISHMENT OF A PANEL .............1  
B. ESTABLISHMENT AND COMPOSITION OF THE PANEL ...................................................................1  
C. PANEL PROCEEDINGS ..................................................................................................................1  
II. FACTUAL ASPECTS ..............................................................................................................2  
A. HISTORY OF THE DISPUTE ...........................................................................................................2  
B. MEASURE AT ISSUE .....................................................................................................................4  
III. PARTIES' REQUESTS FOR FIND INGS AND RECOMMENDATIONS.........................4  
IV. ARGUMENTS OF THE PARTIES ........................................................................................5  
A. INTRODUCTION ...........................................................................................................................5  
B. PARTIES ' REQUESTS AND ARGUMENTS ON OPENING THE PANEL MEETING FOR PUBLIC 
OBSERVATION .............................................................................................................................5  
1. Arguments of the Euro pean Communities .............................................................................5  
(a) Whether panels are permitted to ope n hearings under Article 12 (including 
Appendix 3), Articles 14.1 and 17.10 of the DSU......................................................................5  
(b) Legal implications of open hearings on c overed persons under the Rules of Conduct ..............6  
(c) Systemic and political impact of opening hearings ....................................................................6  
(d) What  procedures can be adopted to protect confidential information in an open 
hearing ........................................................................................................................ ................6  
2. Arguments of the United States ...............................................................................................7  
(a) Whether panels are permitted to open hearings under Article 12 (including the 
Appendix 3), Articles 14.1 and 17.10 of the DSU......................................................................7  
(b) Legal implications of open hearings on c overed persons under the Rules of Conduct ..............7  
(c) Systemic and political impact of opening  hearings ...................................................................8  
(d) What procedures can be adopted to protect  confidential information in an open 
hearing ........................................................................................................................ ................8  
C. FIRST WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES .................................................9  
1. Introduction................................................................................................................... ............9  
2. Factual aspects ................................................................................................................ ..........9  
3. Legal arguments:  Part I – Violation of Articles 23, 21.5, 22.8 and 3.7 of the DSU 
and Articles I and II of the GATT...........................................................................................9  
(a) The structure of Article 23 of the DSU.......................................................................................9  
(b) Applicability of Article 23 – Article 23.1 of the DSU: Seeking the redress of a WTO 
violation ...................................................................................................................... ..............10  
(c) Violation of Articles 23.2(a) and 21.5 and of Article 23.1 of the DSU ....................................10  
(d) The United States' continued suspension of concessions and related obligations is in 
violation of Article 23.1, read together with Articles 22.8 and 3.7 of the DSU .......................11  WT/DS320/R 
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  (e) The United States is in violation of Article I:1 of the GATT 1994 because of the 
continued suspension of concessi ons and related obligations...................................................15  
(f) The United States is acting inconsistently with Article II of the GATT by the 
continued application of countermeasures on products originating in the European 
Communities.................................................................................................................... .........15  
4. Legal Arguments: Part II – Conditional claim in the event that the Panel does 
not find any violation of Article 23 of the DSU as set out in Part I ....................................16  
(a) The United States is violating Article 22.8 of the DSU because the measure found to 
be inconsistent has been remove d by the European Communities ...........................................16  
(b) The United States is in violation of Articles I and II of the GATT 1994 following the 
continued application of suspension of concessions.................................................................17  
D. FIRST WRITTEN SUBMISSI ON OF THE UNITED STATES ...............................................................17  
1. Introduction................................................................................................................... ..........17  
2. Factual background............................................................................................................. ...18 
(a) The six hormones used for growth promotion purposes...........................................................18  
3. Legal arguments................................................................................................................ ......19  
(a) The EC has failed to demonstrate that  the United States has breached DSU 
Article 22.8 because the EC has neither demonstrated that it has "removed" the WTO-
inconsistencies of the original hormones ba n, nor demonstrated how the amended ban 
has provided a solution to the nullification or  impairment of benefits to the United 
States......................................................................................................................... ................20  
(b) The EC has failed to demonstrate that its amended import ban on meat and meat 
products treated with hormones for growth  promotion purposes is WTO-consistent ..............21  
(c) The United States has not breached any othe r WTO obligations by continuing to 
suspend concessions to the EC .................................................................................................2 2 
(i) The United States continues to satisfy its ob ligations under Article 23 of the DSU.................22  
(ii) The US suspension of concessions does not b reach Articles 23.2(a), 21.5 and 23.1 of 
the DSU........................................................................................................................ .............23  
(iii) The United States has not violated Article 23.1 of the DSU, read together with 
Articles 22.8 and 3.7 of the DSU ..............................................................................................2 4 
(iv) The United States has not breached its obligations under Article I or II of the 
GATT 1994...................................................................................................................... ..........25  
4. Conclusion ..................................................................................................................... ..........25  
E. ORAL STATEMENT OF THE EUROPEAN COMMUNI TIES DURING THE FIRST SUBSTANTIVE 
MEETING ............................................................................................................................... .....25  
1. Introduction................................................................................................................... ..........25  
2. Seeking redress – Article 23.1................................................................................................2 5 
3. Article 23.2(a)  of the DSU in conjunction with Article 21.5 of the DSU ...........................26  
4. Article 23.1 in conjunction with Articles 22.8 and 3.7 .........................................................26  
5. Concluding statement of the European Communities.........................................................29  
F. ORAL STATEMENT OF THE UNITED STATES DURING THE FIRST SUBSTANTIVE MEETING ..........31   WT/DS320/R 
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  1. Introduction................................................................................................................... ..........31  
2. The European Communities' amended ban .........................................................................31  
3. The six hormones used for growth promotion purposes according to good 
veterinary practices ........................................................................................................... .....32  
4. The EC's assertion of its own compliance.............................................................................33  
5. Burden of proof................................................................................................................ .......33  
6. "Presumption of good faith"..................................................................................................33  
7. The EC's interpretation of the DSU ......................................................................................33  
(a) Article 21.5 ................................................................................................................... ............34  
(b) Article 23 ..................................................................................................................... .............34  
8. Conclusion ..................................................................................................................... ..........35  
9. Concluding statement of  the United States...........................................................................35  
G. SECOND WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES ...........................................38  
1. Introduction................................................................................................................... ..........38  
2. PART 1: Violation of Articles 23.1, 23.2(a), 21.5 and 22.8 of the DSU (systemic 
issues) ........................................................................................................................ ...............39  
(a) The United States is in violation of Article 23.1 and 23.2(a) read together with 
Article 21.5 ................................................................................................................... ............39  
(b) The United States' continued suspension of concessions and related obligations is in 
violation of Article 23.1, read toge ther with Articles 22.8 and 3.7...........................................41  
3. PART 2: The WTO-consistency of the EC compliance measure .......................................42  
(a) Article 5.7 of the SPS Agreement .............................................................................................43  
(b) Article 5.1 of the SPS Agreement .............................................................................................45  
(c) Article 3.3 of the SPS Agreement .............................................................................................46  
H. SECOND WRITTEN SUBMISSION OF THE UNITED STATES ...........................................................46  
1. Introduction................................................................................................................... ..........46  
2. Legal arguments................................................................................................................ ......47  
(a) The EC has failed to demonstrate a US breach of DSU Articles 21.5, 22.8 or 23....................47  
(b) The EC has neither removed its WTO-inconsis tent bans nor provided a solution to US 
nullification or impairment within the meaning of Article 22.8 of the DSU............................49  
(i) The EC has failed to demonstrate that its import ban is a provisional measure within 
the meaning of SPS Article 5.7 ................................................................................................. 49 
(ii) The EC has failed to base its import ba n on meat from cattle treated with 
oestradiol-17 β for growth promotion purposes according to good veterinary 
practices on a risk assessment within the meaning of SPS Article 5.1 .....................................50  
(iii) The EC fails to demonstrate that there is a risk of failure of controls or failure to 
satisfy good veterinary practices .............................................................................................. 52 
3. Conclusion ..................................................................................................................... ..........54  WT/DS320/R 
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  I. ORAL STATEMENT OF THE EUROPEAN COMMU NITIES ON EXPERTS OPINIONS DURING 
THE SECOND SUBSTANTIVE MEETING ........................................................................................54  
J. ORAL STATEMENT OF THE UNITED STATES  ON EXPERTS OPINIONS DURING THE 
SECOND SUBSTANTIVE MEETING ...............................................................................................59  
K. ORAL STATEMENT OF THE EUROPEAN COMMUNITIES ON LEGAL ISSUES DURING THE 
SECOND SUBSTANTIVE MEETING ...............................................................................................63  
1. Introduction................................................................................................................... ..........63  
2. Article 5.1 of the SPS Agreement ...........................................................................................63  
3. Article 3.3 of the SPS Agreement ...........................................................................................65  
4. Article 5.7 of the SPS Agreement ...........................................................................................66  
5. Article 5.5 of the SPS Agreement ...........................................................................................66  
6. Conclusion on the SPS Agreement .........................................................................................66  
7. Concluding statement of the European Communities.........................................................66  
(a) Introduction................................................................................................................... ............66  
(b) The scientific debate .......................................................................................................... .......68  
(c) The context of the scientific debate ..........................................................................................6 9 
(d) Conclusion ..................................................................................................................... ...........71  
L. ORAL STATEMENT OF THE UNITED STATES  ON LEGAL ISSUES DURING THE SECOND 
SUBSTANTIVE MEETING .............................................................................................................71  
1. Oral statement................................................................................................................. ........71  
2. Concluding statement by  the United States..........................................................................75  
V. ARGUMENTS OF THE THIRD PARTIES ........................................................................76  
A. AUSTRALIA ............................................................................................................................... 76 
1. Introduction................................................................................................................... ..........76  
2. Opening Panel meetings for public observation...................................................................76  
3. Whether the DSB authorizat ion remains in effect...............................................................76  
4. Article 21.5 of the DSU ........................................................................................................ ...76 
B. BRAZIL ............................................................................................................................... .......78  
1. Introduction................................................................................................................... ..........78  
2. Opening Panel meetings for public observation...................................................................78  
3. Whether the DSB authorizat ion remains in effect...............................................................78  
4. Article 21.5 of the DSU ........................................................................................................ ...79 
5. Burden of proof................................................................................................................ .......80  
C. CANADA ............................................................................................................................... .....80  
1. Introduction................................................................................................................... ..........80  
2. Opening Panel meetings for public observation...................................................................80  
D. CHINA ............................................................................................................................... .........81   WT/DS320/R 
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  1. Introduction................................................................................................................... ..........81  
2. Opening Panel meetings for public observation...................................................................81  
3. The current status of the DSB authorized suspension of concessions................................81  
4. Article 21.5 of the DSU and burden of proof........................................................................82  
5. Article 23.2 of the DSU ........................................................................................................ ...84 
E. INDIA ............................................................................................................................... ..........85  
1. Introduction................................................................................................................... ..........85  
2. Opening Panel meetings for public observation...................................................................85  
F. MEXICO ............................................................................................................................... ......86  
1. Introduction................................................................................................................... ..........86  
2. Opening Panel meetings for public observation...................................................................87  
3. Whether the DSB authorizat ion remains in effect...............................................................87  
4. Article 21.5 of the DSU ........................................................................................................ ...88 
G. NEW ZEALAND ..........................................................................................................................88  
1. Introduction................................................................................................................... ..........88  
2. Opening Panel meetings for public observation...................................................................88  
3. Whether the DSB authorizat ion remains in effect...............................................................88  
4. Articles 21.5, 22.8 and 23 of the DSU ....................................................................................89  
5. Burden of proof................................................................................................................ .......90  
6. Article 5.7 of the SPS Agreement ...........................................................................................91  
7. Article 5.1 of the SPS Agreement ...........................................................................................93  
H. NORWAY ............................................................................................................................... ....95  
1. Opening Panel meetings for observation by the public .......................................................95  
2. Whether the DSB authorizat ion remains in effect...............................................................95  
3. Article 21.5 of the DSU ........................................................................................................ ...96 
I. SEPARATE CUSTOMS TERRITORY OF TAIWAN , PENGHU , KINMEN AND MATSU .........................97  
1. Introduction................................................................................................................... ..........97  
2. Opening Panel meetings for public observation...................................................................98  
3. Whether the DSB authorizat ion remains in effect...............................................................98  
4. Article 21.5 of the DSU ........................................................................................................ ...99 
5. The relationship between DSU Ar ticle 22.8 and Article 23...............................................100  
VI. INTERIM REVIEW.............................................................................................................101  
A. INTRODUCTION .......................................................................................................................101  
B. PARTIES ' COMMENTS ON THE DESCRIPTIVE PART ...................................................................102  
C. PARTIES ' COMMENTS REGARDING THE FINDINGS OF THE PANEL ............................................104  
1. Preliminar y remarks ............................................................................................................ 104 WT/DS320/R 
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  2. Parties' requests for review related to aspects of the report on procedural issues .........105  
(a) Comments by the European Communities..............................................................................105  
(b) Comments by the United States..............................................................................................108  
3. Comments of the parties regarding the Panel's findings of violation of 
Article 23.2(a) read together with Articles 21.5 and 23.1 of the DSU and on the 
EC claims on Article 23.1, read together with Articles 22.8 and 3.7 of the DSU ............109  
(a) Comments by the European Communities..............................................................................109  
(b) Comments by the United States..............................................................................................111  
4. Comments of the parties on the complia nce of the EC ban on meat and meat 
products treated with the six hormones at issue for growth promotion purposes 
with the SPS Agreement  in relation to the Panel's findings on the EC claims on 
Article 23.1, read together with Articles 22.8 and 3.7 of the DSU ....................................113  
(a) Comments by the European Communities..............................................................................113  
(i) Introductory comments .......................................................................................................... .113 
(ii) General comments on the Panel's analysis regarding oestradiol-17 β...................................119  
(iii) Comments on "risk assessment techniques"............................................................................120  
(iv) Assessment of the scientific arguments ...................................................................................122  
(v) Comments on the Panel analysis regarding the other five hormonal substances...................129  
(b) Comments by the United States..............................................................................................139  
VII. FINDINGS....................................................................................................................... ......140  
A. PROCEDURAL ISSUES ...............................................................................................................140  
1. Opening of the Panel meetings with the parties and experts for public 
observation .................................................................................................................... ........140  
(a) Introduction................................................................................................................... ..........140  
(b) Summary of the main argum ents of the parties ......................................................................141  
(c) Summary of the arguments of the third parties.......................................................................142  
(d) Decision of the Panel .......................................................................................................... ....145  
2. Panel's decisions relating to the consulta tion of individual scientific experts and 
international organizations ..................................................................................................14 9 
(a) Decision to consult scientific experts .....................................................................................149  
(b) EC request for a single expert review group...........................................................................151  
(c) Experts select ion process ...................................................................................................... ..152  
3. Other procedur al issues........................................................................................................ 159 
(a) Request by the European Communities that relevant scientific evidence and data be 
provided by the United States.................................................................................................1 59 
(b) Request by the United States to exclude mate rials not cited in the EC risk assessment 
as well as those published after the completion of its risk assessment by the European 
Communities and the adoption of the ban ..............................................................................161   WT/DS320/R 
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  (c) A new version of Exhibit EC-107, su bmitted by the European Communities on 
29 May 2006. ................................................................................................................... .......163  
(d) Procedure for allowing the parties to comme nt on each other's replies to questions 
after the second Panel meeting ...............................................................................................16 3 
(e) Request by the European Communities to be allowed to correct factual errors 
allegedly contained in the other party's co mments on its replies to questions following 
the second Pane l meeting....................................................................................................... .163 
(f) Request by the European Communities for ta pe recordings of the transcript of the 
Panel meeting with scientific experts .....................................................................................164  
4. Scope of the Panel's mandate...............................................................................................169  
(a) The measure at issue and the claims of the European Communities ......................................169  
(b) Are the indications provided by the European Communities on how it wants its 
claims to be addressed part of the mandate of the Panel?.......................................................170  
(c) Meaning of "read together with" and "in conjunction with" in the EC submissions ..............171  
(d) Conclusion ..................................................................................................................... .........173  
5. Approach of the Panel on the basis of its mandate ............................................................173  
B. FIRST SERIES OF EC CLAIMS : VIOLATION OF ARTICLE  23.2( A) READ TOGETHER WITH 
ARTICLES  21.5  AND 23.1.........................................................................................................174  
1. Summary of the main argu ments of the parties.................................................................174  
2. Reasoning of the Panel......................................................................................................... .177 
(a) Introduction................................................................................................................... ..........177  
(b) "[S]eeking the redress of a violation of obligations or other nullification or 
impairment of benefits under  the covered agreements" (Article 23.1 of the DSU)................178  
(c) Violation of Article 23.2(a)................................................................................................... ..180  
(i) Introduction ................................................................................................................... .........180  
(ii) Did the United States make a determination that the EC implementing measure 
violates the WTO Agreement? ................................................................................................181  
(iii) Did the United States fail to make such de termination through recourse to dispute 
settlement in accordance with the rules and procedures of the DSU? ...................................185  
(iv) Did the United States fail to make any such determination consistent with the findings contained in the panel or Appellate Body report adopted by the DSB or an arbitration 
award rendered under the DSU?............................................................................................186
 
(v) Conclusion ..................................................................................................................... .........186  
(d) Violation of Article 21.5 of the DSU......................................................................................186  
(e) Violation of Article 23.1 of the DSU......................................................................................187  
3. Conclusion ..................................................................................................................... ........187  
C. SECOND SERIES OF EC CLAIMS : VIOLATION OF ARTICLE  23.1,  READ TOGETHER WITH 
ARTICLES 22.8  AND 3.7 OF THE DSU......................................................................................187  
1. Summary of the main argu ments of the parties.................................................................187  
2. Approach of the Panel .......................................................................................................... 190 WT/DS320/R 
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  (a) Duty of the Panel to make an objectiv e assessment of the matter before it............................190  
(b) Order of review of the second series of main claims by the European Communities ............191  
3. Violation of Article 22.8 of the DSU ....................................................................................192  
(a) Preliminary remarks............................................................................................................ ....192  
(b) Jurisdiction of the Panel...................................................................................................... ....193  
(i) Introduction ................................................................................................................... .........193  
(ii) Does the Panel need to determine wheth er the EC implementing measure actually 
complies with the SPS Agreement in order to address the EC claim of violation of 
Article 23.1 read together with Article 22.8 and Article 3.7 of the DSU?..............................194  
Summary of the main argum ents of the parties................................................................................... .. 194 
Reasoning of the Panel......................................................................................................... ................. 197  
Introductory remarks........................................................................................................... ........... 197  
Applicability of the principl e of good faith in the WT O and under the DSU................................ 197  
Introduc tion................................................................................................................... ............ 197  
General intern ational law ...................................................................................................... ... 198  
The text of  the DSU ............................................................................................................ ....... 199  
The panel and Appellate  Body practice..................................................................................... 200  
(iii) Conclusion ..................................................................................................................... .........205  
(iv) Does the Panel have jurisdiction to address the compliance of the EC implementing 
measure with the SPS Agreement? .........................................................................................206  
(c) Burden of proof................................................................................................................ .......210  
(d) Compatibility of the EC implementing measure with the provisions of the 
SPS Agreement ........................................................................................................................212  
(i) The EC implementing measure ...............................................................................................212  
(ii) Scope of the Panel review...................................................................................................... .215 
(iii) Standard applicable to the review of the compatibility of the EC implementing 
measure with the SPS Agreement ...........................................................................................218  
(iv) Whether the EC implementing me asure is an SPS measure ...................................................221  
(e) Compatibility of the EC implementing measure with Article 5.1 and Article 5.2 of the 
SPS Agreement  with respect to oestradiol-17 β.......................................................................223  
(i) Introduction ................................................................................................................... .........223  
(ii) Is there a risk assessment within the meaning  of Article 5.1 of the SPS Agreement?.............224  
Do the Opinions take into acco unt risk assessment techniques of the relevant international 
organizations?................................................................................................................. ....................... 225  
Introduc tion ................................................................................................................... ................ 225  
Summary of the main argumen ts of the parties ............................................................................. 228  
Reasoning of the Panel ......................................................................................................... ......... 230  
Do the Opinions take into account th e factors listed in Article 5.2? ..................................................... 231  
Summary of the main argumen ts of the parties ............................................................................. 231   WT/DS320/R 
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  Reasoning of the Panel ......................................................................................................... ......... 233  
Do the Opinions satisfy the definition in Annex A(4) of the SPS Agreement ? ..................................... 234  
Introduc tion ................................................................................................................... ................ 234  
Summary of the main argumen ts of the parties ............................................................................. 234  
Reasoning of the Panel ......................................................................................................... ......... 237  
Does the science support the conc lusions of the Opinions? .................................................................. 244  
Introduc tion ................................................................................................................... ................ 244  
Summary of the main argumen ts of the parties ............................................................................. 245  
Reasoning of the Panel ......................................................................................................... ......... 247  
Conclusion..................................................................................................................... ........................ 251  
(iii) Is the measure "based on" a risk assessment?........................................................................252  
Introduc tion ................................................................................................................... ........................ 252  
Summary of the main argum ents of the parties................................................................................... .. 252 
Reasoning of the Panel......................................................................................................... ................. 252  
(iv) Conclusion ..................................................................................................................... .........252  
(f) Compatibility of the EC implementing measure with Article 5.7 of the 
SPS Agreement ........................................................................................................................253  
(i) Introduction ................................................................................................................... .........253  
(ii) Summary of the main argume nts of the parties.......................................................................253  
(iii) Approach of the Panel .......................................................................................................... ..254  
(iv) When will "relevant scientific evidence" be deemed "insufficient"?.......................................257  
Effect of the level of protection on the considera tion of the insufficiency of relevant scientific 
evidence under Article 5.7..................................................................................................... ................ 257  
Can relevant scientific evidence become  "insuffici ent"?....................................................................... 259  
Relationship between insufficiency of the evid ence and the existence of an international 
standard ....................................................................................................................... .......................... 265  
Conclusion..................................................................................................................... ........................ 268  
(v) Alleged insufficiencies which s hould be addressed by the Panel ...........................................268  
(vi) Issues common to all five hormones for which evidence was not provided on a 
hormone-specific basis......................................................................................................... ...271  
Introduc tion ................................................................................................................... ........................ 271  
Effects of hormones on certain  categories of population ...................................................................... 27 1 
Dose response.................................................................................................................. ...................... 274  
Bioavaila bility ................................................................................................................ ....................... 275  
Long latency period of cancer  and confoundin g factors ....................................................................... 277  
Effect of hormones on  the immune system ........................................................................................ ... 281  
Effect of hormones on gr owth and reproduction.................................................................................. .2 8 3 
(vii) Is relevant scientific evidence insufficient in the case of progesterone? ................................286  
Summary of the main argum ents of the parties................................................................................... .. 286 WT/DS320/R 
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  Reasoning of the Panel......................................................................................................... ................. 287  
Conclusion..................................................................................................................... ........................ 289  
(viii) Is relevant scientific evidence insufficient in the case of testosterone? ..................................289  
Summary of the main argum ents of the parties................................................................................... .. 289 
Reasoning of the Panel......................................................................................................... ................. 290  
Conclusion..................................................................................................................... ........................ 292  
(ix) Is relevant scientific evidence insufficient in the case of trenbolone acetate?........................292  
Summary of the main argum ents of the parties................................................................................... .. 292 
Reasoning of the Panel......................................................................................................... ................. 293  
Metabolism of tr enbolone acetate............................................................................................... ... 293  
Inadequate evidence of carc inogenicity in  humans ....................................................................... 294  
Conclusion..................................................................................................................... ........................ 296  
(x) Is relevant scientific evidence insufficient in the case of zeranol? .........................................297  
Summary of the main argum ents of the parties................................................................................... .. 297 
Reasoning of the Panel......................................................................................................... ................. 298  
Conclusion..................................................................................................................... ........................ 301  
(xi) Is relevant scientific evidence insufficient in the case of melengestrol acetate (MGA)?........302  
Summary of the main argum ents of the parties................................................................................... .. 302 
Reasoning of the Panel......................................................................................................... ................. 303  
Data on residues of melengestro l acetat e....................................................................................... 304 
Inadequate evidence for carcinogenicity in humans, such as no information available on 
mutagenicity and genotoxicity and no information available on DNA adducts and DNA 
damage......................................................................................................................... .................. 305  
Conclusion..................................................................................................................... ........................ 307  
(xii) Conclusion ..................................................................................................................... .........308  
(g) Compatibility of the EC implementing measure with Article 3.3 of the 
SPS Agreement  with respect to all hormones at issue with the exception of 
melengestro l acetate........................................................................................................... .....309  
Summary of the main argum ents of the parties................................................................................... .. 309 
Reasoning of the Panel......................................................................................................... ................. 310  
(h) Conclusion on Article 22.8 of the DSU ..................................................................................311  
4. Violation of Articles 23.1 and 3.7 of the DSU .....................................................................311  
D. VIOLATION OF ARTICLE  I.1 AND ARTICLE  II OF THE GATT  1994..........................................311  
E. CONDITIONAL CLAIM OF VIOLATION OF ARTICLE 22.8  OF THE DSU  MADE IN THE 
ALTERNATIVE ..........................................................................................................................311  
F. CONCLUSION ...........................................................................................................................311  
VIII.  RECOMMENDATIONS......................................................................................................312  
  WT/DS320/R 
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  LIST OF ANNEXES 
 
ANNEX A 
 
CORRESPONDENCE FROM THE PANEL TO THE PARTIES 
AND WORKING PROCEDURES 
 
Contents Page 
Annex A-1 Letter to the Parties dated 1 August 2005 on the Panel Decision on 
Open Hearings for Public Observation A-2 
Annex A-2 Working Procedures for the Panel A-3 
Annex A-3 Letter to the Parties date d 20 October 2005 on the Panel Decision 
on Consulting Scientific and Technical Experts A-6 
Annex A-4 Letter to the Parties dated 25 November 2005 on the Panel 
Decision on Certain Issues concerning the Experts' Working 
Procedures A-8 
Annex A-5 Working Procedures for Cons ultations with Scientific and/or 
Technical Experts A-10 
 
 
 
ANNEX B 
 
REPLIES OF THE PARTIES TO QU ESTIONS POSED BY THE PANEL 
AND OTHER PARTIES AFTER THE FIRST SUBSTANTIVE MEETING 
 
Contents Page 
Annex B-1 Replies of the European Communities to questions posed by the 
Panel after the first substan tive meeting (3 October 2005) B-2 
Annex B-2 Replies of the European Communities to questions posed by the 
United States after the first subs tantive meeting (3 October 2005) B-73 
Annex B-3 Replies of the United States to  questions posed by the Panel after 
the first substantive meeting (3 October 2005) B-76 
Annex B-4 Replies of the United States to questions posed by the European 
Communities after the first substa ntive meeting (3 October 2005) B-98 
 
  WT/DS320/R 
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  ANNEX C 
 
REPLIES OF THE PARTIES TO QU ESTIONS POSED BY THE PANEL 
AND OTHER PARTIES AFTER THE SECOND SUBSTANTIVE MEETING 
AND COMMENTS BY THE PARTIES ON THE OTHER PARTIES' REPLIES 
 
Contents Page 
Annex C-1 Replies of the European Communities to questions posed by the 
Panel after the second substantive meeting (18 October 2006) C-2 
Annex C-2 Comments by the European Communities on the replies of the 
United States and Canada to questions posed by the Panel and 
other parties after the second substantive meeting 
(31 October 2006) C-24 
Annex C-3 Replies of the United States to  questions posed by the Panel after 
the second substantive meeting (18 October 2006) C-40 
Annex C-4 Replies of the United States to questions posed by the European 
Communities after the second substantive meeting 
(18 October 2006) C-47 
Annex C-5 Comments by the United States on the replies of the European 
Communities to questions posed by the Panel after the second 
substantive meeting (31 October 2006) C-55 
 
 
 
ANNEX D 
 
REPLIES OF THE SCIENTIFIC EXPERTS 
TO QUESTIONS POSED BY THE PANEL 
  
 
ANNEX E 
 
REPLIES OF THE CODEX ALIMENTARIUS COMMISSION,  
THE JOINT FAO/WHO JECFA SECRETARIAT AND  
THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER 
TO CERTAIN QUESTIONS POSED BY THE PANEL 
TO INTERNATIONAL ORGANIZATIONS 
 
Contents Page 
Annex E-1 Replies of the Codex Alimentarius Commission to certain 
questions posed by the Panel to  international organizations E-2 
Annex E-2 Replies of the joint FAO/ WHO JECFA Secretariat to certain 
questions posed by the Panel to  international organizations E-104 
Annex E-3 Replies of the Internationa l Agency for Research on Cancer to 
certain questions posed by the Pane l to international organizations E-127 
 
 
  WT/DS320/R 
 Page xiii 
 
 
  ANNEX F 
 
COMMENTS BY THE PARTIES ON THE REPLIES  
OF THE SCIENTIFIC EXPERTS, CODEX, JECFA AND IARC 
TO QUESTIONS POSED BY THE PANEL AND  
COMMENTS BY THE PARTIES ON THE OTHER PARTIES' COMMENTS 
 
Contents Page 
Annex F-1 Comments by the European Communities on the replies of the 
scientific experts to the qu estions posed by the Panel 
(30 June 2006) F-2 
Annex F-2 Comments by the European Communities on the replies of Codex, 
JECFA and IARC to questions posed by the Panel (30 June  2006) F-41 
Annex F-3 Comments by the European Communities to the comments by the 
United States and Canada on the replies of the scientific experts to 
questions posed by the Panel (12 July 2006) F-54 
Annex F-4 Comments by the United States on the replies of the scientific 
experts, Codex, JECFA and IARC to questions posed by the Panel 
(30 June 2006)  F-101 
Annex F-5 Comments by the United States to the comments by the European 
Communities on the replies of the scientific experts, Codex, 
JECFA and IARC to questions posed by the Panel (12 July 2006) F-141 
 
 
 
ANNEX G 
 
TRANSCRIPT OF THE PANEL'S JOINT MEETING 
WITH SCIENTIFIC EXPERT S ON 27-28 SEPTEMBER 2006 
 WT/DS320/R 
Page xiv 
 
 
  TABLE OF WTO CASES CITED IN THIS REPORT  
 
Short Title Full Case Title and Citation 
Argentina – Footwear (EC)  Appellate Body Report, Argentina – Safeguard Measures on Imports of 
Footwear , WT/DS121/AB/R, adopted 12 January 2000, DSR 2000:I, 515 
Argentina – Footwear (EC)  Panel Report, Argentina – Safeguard Measur es on Imports of Footwear , 
WT/DS121/R, adopted 12 January 2000, as modified by Appellate Body 
Report, WT/DS121/AB/R, DSR 2000:II, 575 
Australia – Salmon  Appellate Body Report, Australia – Measures Affecting Importation of Salmon , 
WT/DS18/AB/R, adopted 6 November 1998, DSR 1998:VIII, 3327 
Australia – Salmon  Panel Report, Australia – Measures Affecting Importation of Salmon , 
WT/DS18/R and Corr.1, adopted 6 November 1998, as modified by Appellate Body Report, WT/DS18/AB/R, DSR 1998:VIII, 3407 
Australia – Salmon  (Article 21.5 – Canada)
  Panel Report, Australia – Measures Affecting Importation of Salmon – 
Recourse to Article 21.5 of the DSU by Canada , WT/DS18/RW, adopted 
20 March 2000, DSR 2000:IV, 2031 
Brazil – Desiccated Coconut  Appellate Body Report, Brazil – Measures Affe cting Desiccated Coconut , 
WT/DS22/AB/R, adopted 20 March 1997, DSR 1997:I, 167 
Brazil – Desiccated Coconut  Panel Report, Brazil – Measures Affecting Desiccated Coconut , WT/DS22/R, 
adopted 20 March 1997, upheld by Appellate Body Report, WT/DS22/AB/R, 
DSR 1997:I, 189 
Canada – Aircraft  (Article 21.5 – Brazil)
  Appellate Body Report, Canada – Measures Affecting the Export of Civilian 
Aircraft – Recourse by Brazil to Article 21.5 of the DSU , WT/DS70/AB/RW, 
adopted 4 August 2000, DSR 2000:IX, 4299 
Canada – Aircraft  
(Article 21.5 – Brazil)  Panel Report, Canada – Measures Affecting the Export of Civilian Aircraft  
– Recourse by Brazil to Article 21.5 of the DSU , WT/DS70/RW, adopted 
4 August 2000, as modified by Appellate Body Report, WT/DS70/AB/RW, 
DSR 2000:IX, 4315 
Canada – Aircraft Credits and 
Guarantees  Panel Report, Canada – Export Credits and Loan Guarantees for Regional 
Aircraft , WT/DS222/R and Corr.1, adopted 19 February 2002, DSR 2002:III, 
849 
Canada – Dairy  (Article 21.5 – New Zealand 
and US II)
  Appellate Body Report, Canada – Measures Affecting the Importation of Milk 
and the Exportation of Dairy Products – Second Recourse to Article 21.5 of the 
DSU by New Zealand and the United States , WT/DS103/AB/RW2, 
WT/DS113/AB/RW2, adopted 17 January 2003, DSR 2003:I, 213 
Canada – Dairy  
(Article 21.5 – New Zealand 
and US II)  Panel Report, Canada – Measures Affecting the Importation of Milk and the 
Exportation of Dairy Products – Second Recourse to Article 21.5 of the DSU by 
New Zealand and the United States , WT/DS103/RW2, WT/DS113/RW2, 
adopted 17 January 2003, as modified by Appellate Body Report, 
WT/DS103/AB/RW2, WT/DS113/AB/RW2, DSR 2003:I, 255 
Canada – Periodicals  Appellate Body Report, Canada – Certain Measures Concerning Periodicals , 
WT/DS31/AB/R, adopted 30 July 1997, DSR 1997:I, 449 
Canada – Periodicals  Panel Report, Canada – Certain Measures Concerning Periodicals , 
WT/DS31/R and Corr.1, adopted 30 July 1997, as modified by Appellate Body 
Report, WT/DS31/AB/R, DSR 1997:I, 481 
Canada – Wheat Exports and 
Grain Imports Appellate Body Report, Canada – Measures Relating to Exports of Wheat and 
Treatment of Imported Grain , WT/DS276/AB/R, adopted 27 September 2004, 
DSR 2004:VI, 2739 
Canada – Wheat Exports and 
Grain Imports Panel Report, Canada – Measures Relating to Exports of Wheat and Treatment 
of Imported Grain , WT/DS276/R, adopted 27 September 2004, upheld by 
Appellate Body Report, WT/DS276/AB/R, DSR 2004:VI, 2817  WT/DS320/R 
 Page xv 
 
 
  Short Title Full Case Title and Citation 
Chile – Alcoholic Beverages  Appellate Body Report, Chile – Taxes on Alcoholic Beverages , 
WT/DS87/AB/R, WT/DS110/AB/R, adopted 12 January 2000, DSR 2000:I, 
281 
Chile – Alcoholic Beverages  Panel Report, Chile – Taxes on Alcoholic Beverages , WT/DS87/R, 
WT/DS110/R, adopted 12 January 2000, as modified by Appellate Body 
Report, WT/DS87/AB/R, WT/DS110/AB/R, DSR 2000:I, 303 
EC – Approval and Marketing 
of Biotech Products Panel Report, European Communities – Measures  Affecting the Approval and 
Marketing of Biotech Products , WT/DS291/R, WT/DS292/R, WT/DS293/R, 
Corr.1 and Add.1, 2, 3, 4, 5, 6, 7, 8 and 9, adopted 21 November 2006 
EC – Asbestos  Appellate Body Report, European Communities – Measures Affecting Asbestos 
and Asbestos-Containing Products , WT/DS135/AB/R, adopted 5 April 2001, 
DSR 2001:VII, 3243 
EC – Asbestos  Panel Report, European Communities – Measur es Affecting Asbestos and 
Asbestos-Containing Products , WT/DS135/R and Add.1, adopted 5 April 2001, 
as modified by Appellate Body Report, WT/DS135/AB/R, DSR 2001:VIII, 
3305 
EC – Bananas III  Appellate Body Report, European Communities – Regime for the Importation, 
Sale and Distribution of Bananas , WT/DS27/AB/R, adopted 25 September 
1997, DSR 1997:II, 591 
EC – Bananas III  (Article 21.5 – EC)  Panel Report, European Communities – Regime for the Importation, Sale and 
Distribution of Bananas – Recourse to Article 21.5 of the DSU by the European 
Communities , WT/DS27/RW/EEC and Corr.1, 12 April 1999, unadopted, 
DSR 1999:II, 783 
EC – Bananas III (US)  (Article 22.6 – EC)
  Decision by the Arbitrators, European Communities – Regime for the 
Importation, Sale and Distribution of Bananas – Recourse to Arbitration by the 
European Communities under Article 22.6 of the DSU , WT/DS27/ARB, 9 April 
1999, DSR 1999:II, 725 
EC – Bed Linen  (Article 21.5 – India)
  Appellate Body Report, European Communities – Anti-Dumping Duties on 
Imports of Cotton-Type Bed Linen from I ndia – Recourse to Article 21.5 of the 
DSU  by India , WT/DS141/AB/RW, adopted 24 April 2003, DSR 2003:III, 965  
EC – Bed Linen  
(Article 21.5 – India)  Panel Report, European Communities – Anti-Dumping Duties on Imports of 
Cotton-Type Bed Linen from India – Recourse to Article 21.5 of the DSU  by 
India , WT/DS141/RW, adopted 24 April 2003, as modified by Appellate Body 
Report, WT/DS141/AB/RW, DSR 2003:IV, 1269  
EC – Commercial Vessels Panel Report, European Communities – Measures Affecting Trade in 
Commercial Vessels , WT/DS301/R, adopted 20 June 2005 
EC – Hormones  Appellate Body Report, EC Measures Concerning Meat and Meat Products 
(Hormones) , WT/DS26/AB/R, WT/DS48/AB/R, adopted 13 February 1998, 
DSR 1998:I, 135 
EC – Hormones (Canada)  Panel Report, EC Measures Concerning Meat and Meat Products (Hormones), 
Complaint by Canada , WT/DS48/R/CAN, adopted 13 February 1998, as 
modified by Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R, 
DSR 1998:II, 235 
EC – Hormones (US)  Panel Report, EC Measures Concerning Meat and Meat Products (Hormones), 
Complaint by the United States , WT/DS26/R/USA, adopted 13 February 1998, 
as modified by Appellate Body Report, WT/DS26/AB/R, WT/DS48/AB/R, 
DSR 1998:III, 699 
EC – Hormones  Award of the Arbitrator, EC Measures Concerning Meat and Meat Products 
(Hormones) – Arbitration under Article 21.3(c) of the DSU , WT/DS26/15, 
WT/DS48/13, 29 May 1998, DSR 1998:V, 1833 WT/DS320/R 
Page xvi 
 
 
  Short Title Full Case Title and Citation 
EC – Hormones (Canada) 
(Article 22.6 – EC)  Decision by the Arbitrators, European Communities – Measures Concerning 
Meat and Meat Products (Hormones), Original Complaint by Canada – 
Recourse to Arbitration by the Eur opean Communities under Article 22.6 of the 
DSU , WT/DS48/ARB, 12 July 1999, DSR 1999:III, 1135 
EC – Hormones (US)  
(Article 22.6 – EC)  Decision by the Arbitrators, European Communities – Measures Concerning 
Meat and Meat Products (Hormones), Original Complaint by the United States
 – Recourse to Arbitration by the Eu ropean Communities under Article 22.6 of 
the DSU , WT/DS26/ARB, 12 July 1999, DSR 1999:III, 1105 
EC – Tube or Pipe Fittings Appellate Body Report, European Communities – Anti-Dumping Duties on 
Malleable Cast Iron Tube or Pipe Fittings from Brazil , WT/DS219/AB/R, 
adopted 18 August 2003, DSR 2003:VI, 2613 
EC – Tube or Pipe Fittings Panel Report, European Communities – Anti-Dumping Duties on Malleable 
Cast Iron Tube or Pipe Fittings from Brazil , WT/DS219/R, adopted 18 August 
2003, as modified by Appellate Body Report, WT/DS219/AB/R, 
DSR 2003:VII, 2701 
India – Patents (US)  Appellate Body Report, India – Patent Protection for Pharmaceutical and 
Agricultural Chemical Products , WT/DS50/AB/R, adopted 16 January 1998, 
DSR 1998:I, 9 
India – Patents (US)  Panel Report, India – Patent Protection for Pharmaceutical and Agricultural 
Chemical Products, Complaint by the United States , WT/DS50/R, adopted 
16 January 1998, as modified by Appellate Body Report, WT/DS50/AB/R, 
DSR 1998:I, 41 
Japan – Agricultural Products II  Appellate Body Report, Japan – Measures Affecting Agricultural Products , 
WT/DS76/AB/R, adopted 19 March 1999, DSR 1999:I, 277 
Japan – Agricultural 
Products II  Panel Report, Japan – Measures Affecting Agricultural Products , WT/DS76/R, 
adopted 19 March 1999, as modified by Appellate Body Report, 
WT/DS76/AB/R, DSR 1999:I, 315 
Japan – Alcoholic Beverages II  Appellate Body Report, Japan – Taxes on Alcoholic Beverages , 
WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R, adopted 1 November 1996, DSR 1996:I, 97  
Japan – Apples  Appellate Body Report, Japan - Measures Affecting the Importation of Apples , 
WT/DS245/AB/R, adopted 10 December 2003, DSR 2003:IX, 4391 
Japan – Apples  Panel Report, Japan – Measures Affecting the Importation of Apples , 
WT/DS245/R, adopted 10 December 2003, upheld by Appellate Body Report, 
WT/DS245/AB/R, DSR 2003:IX, 4481  
Japan – Apples  
(Article 21.5 – US)  Panel Report, Japan – Measures Affecting the Importation of Apples – Recourse 
to Article 21.5 of the DSU by the United States , WT/DS245/RW, adopted 
20 July 2005 
Korea – Dairy  Appellate Body Report, Korea – Definitive Safeguard Measure on Imports of 
Certain Dairy Products , WT/DS98/AB/R, adopted 12 January 2000, 
DSR 2000:I, 3 
Korea – Dairy  Panel Report, Korea – Definitive Safeguard Measure on Imports of Certain 
Dairy Products , WT/DS98/R and Corr.1, adopted 12 January 2000, as modified 
by Appellate Body Report, WT/DS98/AB/R, DSR 2000:I, 49 
Korea – Procurement  Panel Report, Korea – Measures Affecting Government Procurement , 
WT/DS163/R, adopted 19 June 2000, DSR 2000:VIII, 3541 
US – Carbon Steel  Appellate Body Report, United States – Countervailing Duties on Certain 
Corrosion-Resistant Carbon Steel Flat Products from Germany , 
WT/DS213/AB/R and Corr.1, adopted 19 December 2002, DSR 2002:IX, 3779  WT/DS320/R 
 Page xvii 
 
 
  Short Title Full Case Title and Citation 
US – Carbon Steel  Panel Report, United States – Countervailing Duties on Certain Corrosion-
Resistant Carbon Steel Flat Products from Germany , WT/DS213/R and Corr.1, 
adopted 19 December 2002, as modified by Appellate Body Report, 
WT/DS213/AB/R and Corr.1, DSR 2002:IX, 3833 
US – Certain EC Products  Appellate Body Report, United States – Import Measures on Certain Products 
from the European Communities , WT/DS165/AB/R, adopted 10 January 2001, 
DSR 2001:I, 373 
US – Certain EC Products  Panel Report, United States – Import Measures on Certain Products from the 
European Communities , WT/DS165/R and Add.1, adopted 10 January 2001, as 
modified by Appellate Body Report, WT/DS165/AB/R, DSR 2001:II, 413 
US – FSC  Appellate Body Report, United States – Tax Treatment for "Foreign Sales 
Corporations" , WT/DS108/AB/R, adopted 20 March 2000, DSR 2000:III, 1619 
US – FSC  Panel Report, United States – Tax Treatment for "Foreign Sales Corporations" , 
WT/DS108/R, adopted 20 March 2000, as modified by Appellate Body Report, 
WT/DS108/AB/R, DSR 2000:IV, 1675 
US – Gambling Appellate Body Report, United States – Measures Affecting the Cross-Border 
Supply of Gambling and Betting Services , WT/DS285/AB/R and Corr.1, 
adopted 20 April 2005, DSR 2005:XII, 5663 
US – Gambling Panel Report, United States – Measures Affecting the Cross-Border Supply of 
Gambling and Betting Services , WT/DS285/R, adopted 20 April 2005, as 
modified by Appellate Body Report, WT/DS285/AB/R, DSR 2005:XII, 5797 
US – Hot-Rolled Steel  Appellate Body Report, United States – Anti-Dumping Measures on Certain 
Hot-Rolled Steel Products from Japan , WT/DS184/AB/R, adopted 23 August 
2001, DSR 2001:X, 4697 
US – Hot-Rolled Steel  Panel Report, United States – Anti-Dumping Measures on Certain Hot-Rolled 
Steel Products from Japan , WT/DS184/R, adopted 23 August 2001 modified 
by Appellate Body Report, WT/DS184/AB/R, DSR 2001:X, 4769 
US – Line Pipe  Appellate Body Report, United States – Definitive Safeguard Measures on 
Imports of Circular Welded Car bon Quality Line Pipe from Korea , 
WT/DS202/AB/R, adopted 8 March 2002, DSR 2002:IV, 1403 
US – Line Pipe  Panel Report, United States – Definitive Safeguard Measures on Imports of 
Circular Welded Carbon Quality Line Pipe from Korea , WT/DS202/R, adopted 
8 March 2002, as modified by Appellate Body Report, WT/DS202/AB/R, 
DSR 2002:IV, 1473 
US – Offset Act  (Byrd Amendment
 ) Appellate Body Report, United States – Continued Dumping and Subsidy Offset 
Act of 2000 , WT/DS217/AB/R, WT/DS234/AB/R, adopted 27 January 2003, 
DSR 2003:I, 375 
US – Offset Act  
(Byrd Amendment ) Panel Report, United States – Continued Dumping and Subsidy Offset Act of 
2000 , WT/DS217/R, WT/DS234/R, adopted 27 January 2003, as modified by 
Appellate Body Report, WT/DS217/AB/R, WT/DS234/AB/R, DSR 2003:II, 
489 
US – Section 211 
Appropriations Act  Appellate Body Report, United States – Section 211 Omnibus Appropriations 
Act of 1998 , WT/DS176/AB/R, adopted 1 February 2002, DSR 2002:II, 589 
US – Section 211 
Appropriations Act  Panel Report, United States – Section 211 Omnibus Appropriations Act of 
1998 , WT/DS176/R, adopted 1 February 2002, as modified by Appellate 
Body Report, WT/DS176/AB/R, DSR 2002:II, 683 
US – Section 301 Trade Act  Panel Report, United States – Sections 301-310 of the Trade Act of 1974 , 
WT/DS152/R, adopted 27 January 2000, DSR 2000:II, 815 WT/DS320/R 
Page xviii 
 
 
  Short Title Full Case Title and Citation 
US – Shrimp  Appellate Body Report, United States – Import Prohibition of Certain Shrimp 
and Shrimp Products , WT/DS58/AB/R, adopted 6 November 1998, 
DSR 1998:VII, 2755 
US – Shrimp  Panel Report, United States – Import Prohibition of Certain Shrimp and Shrimp 
Products , WT/DS58/R and Corr.1, adopted 6 November 1998, as modified by 
Appellate Body Report, WT/DS58/AB/R, DSR 1998:VII, 2821 
US – Softwood Lumber VI  Panel Report, United States – Investigation of the International Trade 
Commission in Softwood Lumber from Canada , WT/DS277/R, adopted 
26 April 2004, DSR 2004:VI, 2485 
US – Upland Cotton Appellate Body Report, United States – Subsidies on Upland Cotton , 
WT/DS267/AB/R, adopted 21 March 2005 
US – Upland Cotton Panel Report, United States – Subsidies on Upland Cotton , WT/DS267/R, and 
Corr.1, adopted 21 March 2005, as modified by Appellate Body Report, 
WT/DS267/AB/R 
US – Wool Shirts and Blouses  Appellate Body Report, United States – Measure Affecting Imports of Woven 
Wool Shirts and Blouses from India , WT/DS33/AB/R and Corr.1, adopted 
23 May 1997, DSR 1997:I, 323 
US – Wool Shirts and Blouses  Panel Report, United States – Measure Affecting Imports of Woven Wool Shirts 
and Blouses from India , WT/DS33/R, adopted 23 May 1997, upheld by 
Appellate Body Report, WT/DS33/AB/R, DSR 1997:I, 343 
 
  WT/DS320/R 
 Page 1 
 
 
  I. INTRODUCTION 
A. REQUEST FOR CONSULTATIONS AND REQUEST FOR THE ESTABLISHMENT OF A PANEL  
1.1 On 8 November 2004, the European Communiti es requested consultations with the United 
States pursuant to Article XXII:1 of the Ge neral Agreement on Tariffs and Trade 1994 
("GATT 1994") and Article 4 of the Understa nding on Rules and Procedures Governing the 
Settlement of Disputes ("DSU") regarding the Unite d States' continued suspension of concessions and 
other obligations under the cove red agreements, after the European Communities' adoption of 
Directive 2003/74/EC on 22 September 2003 and its notification to the Dispute Settlement Body 
(DSB) that it has fully implemented the recommend ations and rulings of the DSB in the dispute 
European Communities – Measures Concerni ng Meat and Meat Products (Hormones) (EC – 
Hormones).   The consultation request was circulated in document WT/DS320/1 dated 10 November 
2004.  The consultations were held  on 16 December 2004 but the par ties failed to reach a mutually 
satisfactory resolution of the dispute.  
1.2 On 14 January 2005, the European Communiti es requested the establishment of a Panel 
pursuant to Articles 4.7 and 6 of the DSU, as well as Article XXIII of the GATT 1994.1 
B. ESTABLISHMENT AND COMPOSITION OF THE PANEL  
1.3 At its meeting on 17 February 2005, the DSB established a Panel pursu ant to the request of 
the European Communities in document WT/DS320 /6, in accordance with Article 6 of the DSU 
(WT/DSB/M/183), with standard terms of reference as below: 
"To examine, in the light of the relevant provisions of the covered agreements cited 
by the European Communities in document WT/DS320/6, the matter referred to the 
DSB by the European Communiti es in that document, and to  make such findings as 
will assist the DSB in making the recommendations or in giving the rulings provided for in those agreements."
2 
1.4 On 27 May 2005, the European Communities request ed the Director-General to determine the 
composition of the Panel, pursuant to paragraph 7 of Article 8 of the DSU.  On 6 June 2005, the 
Director-General accordingly composed the Panel as follows: 
Chairman: Mr. Tae-yul Cho 
 
 Members: Mr. William Ehlers    Ms. Claudia Orozco 
 
1.5 Australia, Brazil, Canada, China, India, Mexi co, New Zealand, Norway and Chinese Taipei, 
have reserved their rights to participate in  the Panel proceedings as a third party. 
C. P
ANEL PROCEEDINGS  
1.6 At the joint request of the parties, on 1 August 2005, the Panel decided that its meetings at 
which the parties were invited to appear, would be  open for public observation through closed-circuit 
broadcast, provided the Secretariat could maintain sa tisfactory logistical arrangements.  The Panel, 
however, after consulting the third parties, also de cided that the session with the third parties would 
                                                      
1 WT/DS320/6. 
2 WT/DS320/7. WT/DS320/R 
Page 2 
 
 
  remain closed.3  The Panel notified the DSB Chairman of this decision on the same day.4  The Panel 
held its first joint substantive meeting with the parti es to this dispute and the parties to the dispue on 
Canada – Continued Suspension of Obligat ions to the EC – Hormones Dispute  (WT/DS321) on 
12-15 September 2005.  The meeting with the pa rties was opened for public observation through 
closed-circuit broadcast.  The Panel also met with  the third parties in a closed special session on 
14 September 2005.  
1.7 The Panel in this dispute also decided to seek  advice from scientific and technical experts 
after consultation with the parties on 20 October 2005.5  After consulting the parties, it finalized its 
Working Procedures for Consultations with Scien tific and/or Technical Experts on 25 November 
2005.6  It selected six scientific and technical experts in consultation with parties, sought their advice 
as well as advice from Codex Alimentarius Co mmission (Codex), the Joint FAO/WHO Expert 
Committee on Food Additives (JECFA), and the Inte rnational Agency for Research on Cancer 
(IARC) on scientific and technical questions in writi ng.  The Panel also met with the six experts and 
four representatives from Codex, JECFA and IARC in the presence of the parties to this dispute and 
the parties to the dispute on Canada – Continued Suspension of Obligations to the EC – Hormones 
Dispute  (WT/DS321) on 27-28 September 2006.  The e xpert from IARC served both as an individual 
scientific expert and as the representative of the IARC.  The Panel held its joint second substantive 
meeting with the parties on 2-3 October 2006. These  meetings were also open for public observation 
through a closed-circuit broadcast. 
1.8 On 31 July 2007, the Panel issued its interim report to the parties.  On 28 September and 
19 October 2007, the Panel received comments from the pa rties on the interim report.  Neither of the 
parties requested an interim review meeting.  On  21 December 2007, the Pane l issued its final report 
to the parties. 
II. FACTUAL ASPECTS 
A. HISTORY OF THE DISPUTE  
2.1 On 13 February 1998, the Dispute Settlement B ody ("DSB") adopted th e Panel and Appellate 
Body reports in EC – Hormones .  In doing so, the DSB recommended that the European Communities 
bring the measures at issue into conformity with WTO rules.  The Arbitrator appointed pursuant to 
Article 21.3(c) of the DSU determined that the European Communities should  have a "reasonable 
period of time" up to 13 May 1999 to comply with the recommendations.  On 26 July 1999, the United States obtained from the DSB the authorization to suspend obligations up to the level of 116.8 
million US Dollars per year.  The arbitrators ac ting pursuant to Article 22.6 of the DSU had 
previously determined this leve l to be equivalent to the leve l of nullification or impairment 
(Article 22.4 of the DSU) suffered by the United St ates at the time of its recourse to arbitration in 
May 1999.  On 29 July 1999 and pursuant to the DSB's authorization, the United States introduced 
import duties in excess of bound rates on imports from the European Communities by imposing a 
100 % ad valorem rate of duty on a list of articles that are the products of certain EC Member States.
7 
                                                      
3 See Annex A-1, Letter to the Parties dated 1 Augu st 2005 on the Panel Decision on Open Hearings 
for Public Observation.  Annex A-2, Working Procedures for the Panel. 
4 WT/DS320/8. 
5 Annex A-3, Letter to the Parties dated 20 October  2005 on the Panel Decision on Consulting 
Scientific and Technical Experts. 
6 Annex A-4, Letter to the Parties dated 25 November 2005 on the Panel Decision on Certain Issues 
concerning the Experts' Working Procedures;  Annex A-5, Working Procedures for Consultations with Scientific and/or Technical Experts. 
7 These measures were published in the Federal Register Notice in Vol. 64, No. 143 of 27 July 1999.  WT/DS320/R 
 Page 3 
 
 
  2.2 The original measures in the EC – Hormones (US)  dispute were provided in 
Directive 96/22/EC, which prohibited the administer ing to farm animals of substances having a 
thyrostatic  action or substances having an oestrogenic, androgenic,  or gestagenic  action as well as the 
placing on market of meat from such animals.8  On 22 September 2003, the European Communities 
adopted Directive 2003/74/EC of the European Pa rliament and of the Council amending Council 
Directive 96/22/EC concerning the prohibition on th e use in stockfarming of certain substances 
having a hormonal or thyrostatic action and of beta-agonists.  The Directive was published and 
entered into force on 14 October 2003.  It provid es for a permanent prohibition on oestradiol-17 β and 
a provisional prohibition on testosterone, progester one, trenbolone acetate, zeranol and melengestrol 
acetate.  
2.3 Prior to the adoption of the Directive 2003/74/EC, and in order to comply with the 
recommendations and rulings of the DSB and the covered agreements, the European Communities 
initiated and funded a number of specific scientific  studies and research projects for the purpose of  
conducting risk assessment (17 in total).  The Scie ntific Committee on Veterinary Measures relating 
to Public Health (SCVPH), an independent e xperts committee established under EC legislation, 
reviewed the results of these studies and other publ icly available information as well as the data it 
collected from various sources including CODEX/JECFA, and published its opinion entitled 
"Assessment of Potential Risks to Human Health from Hormones Residues in Bovine meat and Meat 
Products" ("the 1999 SCVPH Opinion") on 30 April 1999.   The SCVPH subsequently reviewed this 
Opinion on two occasions and adopted review re ports on 3 May 2000 (" the 2000 SCVPH Opinion") 
and on 10 April 2002 (the 2002 SCVPH Opinion").   The SCVPH Opinions address six hormonal 
substances: oestradiol-17 β, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol 
acetate . 9   
2.4 In light of these Opinions, which the European  Communities contends are risk assessments, 
the European Communities prohibited the placing on  the market of meat and meat products from 
animals that have been treated with oestradiol-17 β  for growth promotion purposes on the grounds 
that there was a substantial body of evidence s howing that its residues are both carcinogenic and 
genotoxic.  With respect to testosterone, progest erone, trenbolone acetate, zeranol and melengestrol 
acetate, the European Communiti es introduced the same measure on a provisional basis on the 
grounds that the available pertinent scientific info rmation reflected in the above-mentioned Opinions, 
showed the existence of risks but all the inform ation and data necessary to conduct a more objective 
and complete risk assessment were insufficient or missing.10 
2.5 On 27 October 2003, the European Communities notified to the DSB the adoption, 
publication and entry into force of the Directive as  well as the preceding scientific Opinions.  In the 
same communication, the European Communities expl ained that it considered itself to have fully 
implemented the recommendations and rulings of the DSB in the EC – Hormones dispute, and as a 
consequence, it considers the United States' su spension of concessions vis-à-vis the European 
Communities to be no longer justified.11 
2.6 The United States raised doubt in the DSB meeting held on 7 November 2003 on whether the 
new Directive was based on science and on whet her the European Communities implemented the 
DSB's recommendations and rulings as well as the European Communities' obligations under the 
                                                      
8 WT/DS26/R/USA, paras. 2.1-2.5. 
9 See Request for the Establishment of a Panel by the European Communities, WT/DS320/6. 
10 Ibid.  See also , EC's second written submission, para. 139. 
11 European Communities – Measures Concerning Meat and Meat Products (Hormones) , 
Communication from the European Communities, WT/DS26/22, WT/DS48/20, 28 October 2003. WT/DS320/R 
Page 4 
 
 
  SPS Agreement.12  The United States continued to impose retaliatory duties on certain products from 
the European Communities. 
B. MEASURE AT ISSUE  
2.7 The measure challenged by the European Comm unities is the suspension of concessions and 
other obligations under the covered agreements, c ontinued without recourse to the procedures under 
the DSU, after the European Communities' adoption of Directive 2003/74/EC on 22 September 2003 
amending Council Directive 96/22/EC concerning th e prohibition on the use in stock-farming of 
certain substances having a hormonal or thyrostatic  action and of beta-agonists.  The measure is 
provided in the Federal Register Notice in Vol. 64, No. 143 of 27 July 1999 and is enforced as of 29 July 1999.  The EC's Directive 2003/74/EC was published and entered into force on 14 October 2003.  The EC stated in its notificati on to the Dispute Settlement Body (DSB) that it had 
fully implemented the recommendations and rulings of the DSB in the dispute European 
Communities – Measures concerning Me at and Meat Products (Hormones) (WT/DS26/AB/R, 
WT/DS26/R/USA) .
13 
III. PARTIES' REQUESTS FOR FINDINGS AND RECOMMENDATIONS  
3.1 The European Communities requests that the Panel find that the United States continued 
suspension of concessions and related oblig ations under the covered agreements: 
(a) violates Article 23.2(a), read together with Article 21.5 and Article 23.1 of the DSU; 
(b) violates Article 23.1 of the DSU read in conjunction with Articles 22.8 and 3.7 of the 
DSU; and 
(c) violates Articles I and II of the GATT 1994.14 
3.2 In the alternative, should the Panel find no viol ation of Article 23 of the DSU, the European 
Communities requests the Panel to find that the United States measure violates Article 22.8 of the 
DSU and Articles I and II of the GATT 1994.15 
3.3 The United States requests the Panel to find that: 
(a) the European Communities h as failed to demonstrate that the United States has 
breached Article 22.8 of the DSU, and that the United States continued suspension of concessions to the European Communities is c onsistent with the requirements of that 
provision; 
(b) the United States has not breached Articles 3.7, 21.5, 23.1 or 23.2(a) of the DSU; and 
(c) the United States has not breached Articles I or II of the GATT 1994.
16 
                                                      
12 DSB, Minutes of Meeting held on 7 November 2003 , WT/DSB/M/157, 18 December 2003, 
paras. 29-30. 
13 WT/DS320/6. WT/DS26/22. 
14 EC's first written submission, para. 149. 
15 EC's first written submission, para. 150. 
16 US's first written submission, para. 210.  WT/DS320/R 
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  IV. ARGUMENTS OF THE PARTIES 
A. INTRODUCTION  
4.1 The arguments of the parties are set out in their written submissions to the Panel and in their 
oral statements made during Panel meetings, as well  as in their written replies to questions from the 
Panel.  This Section presents  a  summary of the arguments of the parties based on the executive 
summaries prepared by the parties where such su mmaries were made available to the Panel. 
B. PARTIES ' REQUESTS AND ARGUMENTS ON OPENING THE PANEL MEETING FOR PUBLIC 
OBSERVATION  
4.2 At the Panel's organizational meeting with par ties on 13 June 2005, the parties requested that 
the Panel hold open meetings with the parties in this  dispute.  The Panel posed written questions to the 
parties and the third parties regarding this joint re quest after its organizational meeting.  The parties 
answered these questions in writing on  20 June 2005 and 7 July 2005. 
1. Arguments of the European Communities 
(a) Whether panels are permitted to open hearings  under Article 12 (inc luding Appendix 3), 
Articles 14.1 and 17.10 of the DSU   
4.3 The European Communities argues th at open hearings are permissible at the panel level.  The 
European Communities submits that Appendix 3,  second paragraph, first sentence of the DSU 
excludes public access to the panel hearings, but this rule is not obligatory, as Article 12.1 of the DSU 
states: "Panels shall follow the Working Procedures in Appendix 3 unless the panel decides otherwise 
after consulting the parties to the dispute."  In  the European Communities' view, it is therefore 
permissible for a panel to adopt, under the procedur e of Article 12.1 of the DSU, working procedures 
that foresee open hearings.   
4.4 The European Communities also argues that this conclusion is not affected by Article 14.1 of 
the DSU. The term "deliberations" under Article 14. 1 of the DSU designates the part of the panel's 
work where it internally discusses the case, including the decision it intends to pronounce in its report 
and the supporting reasoning.  This is the ordinary m eaning of this term, in which it is also used in 
other systems of adjudication, and the Fren ch ("délibérations") and Spanish versions 
("deliberaciones") fully coincide w ith this meaning.  These deliberations take place in the presence of 
the Secretariat team working on the dispute, but w ithout the parties.  The term "deliberations" does 
not cover the meetings with the parties, for which di fferent terminology is used in Appendix 3 of the 
DSU.  The context supports this reading because ever ything that is addressed in the three paragraphs 
of Article 14 of the DSU relates to the independe nt work which the panel conducts alone, in the 
absence of the parties.  Had the drafters of the DSU wanted to exclude open panel hearings, they 
would have used  different language  in Article 14.1 of the DSU.  They would not have addressed this 
question solely in the Appendix 3 working procedur es from which a panel may depart, as Article 12.1 
expressly stipulates. 
4.5 In the European Communities' view, this interpre tation is also corroborated by the use of the 
term "proceedings" in Article 17.10 of the DSU which appears to be broader.  Meaning must therefore 
be given to the DSU negotiators' deliberate choice of  the term "deliberations" in Article 14.1 of the 
DSU. 
4.6 The European Communities argues that such interpretation is the long-standing position of 
several Members and has never been rejected by any WTO Member in any dispute.  WTO Members 
have repeatedly stated that the DSU rules on pane l procedures are flexible and allow the provision of WT/DS320/R 
Page 6 
 
 
  open hearings (Articles 14.1, 12.1, Appendix 3).  Obviously, since a panel is obliged to consult the 
parties before departing from the working proce dures suggested in Appendix 3, the parties' position 
carries significant weight for the panel's decision.  The EC considers that in the present case where all 
the parties have agreed to open hearings, the Panel should accommodate the parties' request.  
Article 18.2 of the DSU also provides context and s upports this position as it implies that parties are 
entitled to "waive" the confidentiality of their positions. 
(b) Legal implications of open hearings on covered persons under the Rules of Conduct 
4.7 The European Communities considers that no lega l issues arise under the Rules of Conduct.  
These Rules state in Section II, paragraph 1 that each covered person "shall r espect the confidentiality 
of proceedings" (see also Section VII, paragraph 1) , and also that "[t]hese Rules shall in no way 
modify the rights and obligations of Members under the DSU nor the rules and procedures therein."    In the European Communities view, the Rules of Conduct are and remain fully binding on all covered 
persons in this dispute, even if the hearings are opened to the public. Simultaneously, the Rules of 
Conduct do not prevent the panel from fulfilling its task under the DSU and in accordance with the 
procedural rules contained therein, which permit public hearings.  The Rules of Conduct expressly 
state that they do not modify these DSU rules. 
4.8 The European Communities also considers th at Article 18.2 of the DSU again provides 
context in that it shows that the parties are entitled to "waive" the confidentiality of their positions.  
The Panel's deliberations will in any event not be a ffected by the opening and remain confidential, as 
required by Article 14.1 of the DSU. 
(c) Systemic and political impact of opening hearings 
4.9 The European Communities is of the view that  there are no implications for WTO Members 
who are not parties to this dispute, notably the parti es to another dispute remain able to adhere to their 
preference, if any, not to open the hearings in th eir dispute. Opening a hearing for observers who will 
remain completely passive during the session would not  change anything about the intergovernmental 
character of the WTO, nor would it impair the chances to reach a mutually  agreed solution, as 
preferred by the DSU (Article 3.7), if the parties jo intly request the hearings to be open, in line with 
their general policy to apply transparency where the DSU rules allow (for in stance by making public 
their submissions).  Also, there are no implications for third parties and accordingly there is no need 
to consult them before the Panel adopts its wo rking procedures because the parties have jointly 
requested that the public be excluded from the thir d parties' session during the presentation by a third 
party who prefers this.  Thus, opening hearings to  public observation will not affect third parties 
beyond the extent to which they themselves agree.  The DSU is clear in that the panel must consult the parties, not the third parties,  before adop ting Working Procedures in departing from Appendix 3. 
4.10 The European Communities also states that consulting the DSB and General Council Chairs 
or the Director-General before opening the h earing for public observation does not seem necessary 
because under the DSU the Panel has the power to ta ke decisions regarding its Working Procedures 
and is required to fulfil its task in full independence.   If all parties are in agreement on this question of 
working procedures, the Panel should accommodate thei r request if the parties consider that this is 
part of the best way to "secure a positive solution to the dispute", which is the aim of the dispute 
settlement mechanism (Article 3.7 of the DSU ).   
(d) What  procedures can be adopted to protect confidential information in an open hearing 
4.11 The 
European Communities indicates that it does not expect that confidential information will 
be submitted in this dispute.  Should this neve rtheless happen, one could easily apply appropriate 
means to close the portion of any meeting where confidential information is discussed.   WT/DS320/R 
 Page 7 
 
 
  4.12 The European Communities does not consider that  there is any issue of confidentiality in 
relation to information submitted by other Member s or non-Members (under Article 13 of the DSU), 
unless the confidentiality requirement of the last sente nce of Article 13.1 of the DSU applies, in which 
case the corresponding portion of any meeting where this information is discussed could be closed. 
4.13 With respect to the third party session, the Eu ropean Communities considers that each third 
party should decide whether to open the part of th e third party session dealing with that third party's 
statement. 
2. Arguments of the United States 
(a) Whether panels are permitted to open hearings under Article  12 (including the Appendix 3), 
Articles 14.1 and 17.10 of the DSU 
4.14 The United States notes that in the Panel's organizational meeting held on June 13, 2005, the 
United States, Canada and the European Communities ag reed that the panel meetings in these disputes 
should be opened to interested Members and the public .  In the  view of the United States, open panel 
meetings are permissible under the DSU, including under Appendix 3 thereto.   
4.15 The United States argues that whether substan tive meetings of the Panel are open is not 
affected by Article 14.1 of the DSU, which provi des that the deliberations of a panel shall be 
confidential.  The United States agrees that any delib erations among the three panel members must be 
confidential.  However, Article 14.1 of the DSU does not apply to the meetings of the panel with the 
parties.  Therefore, DSU Article 14.1 does not prohibit opening panel meetings to the public. 
4.16 The United States also argues that although Paragraph 2 of Appendix 3 states that a panel 
"shall meet in closed session", Article 12.1 of the DSU states that a panel may depart from the working procedures in Appendix 3 after consulting with the parties.  In other words, the Panel has the 
ability to remove any provision of Appendix 3 that might be perceived as an impediment to 
accommodating the parties' decision to make their stat ements public by allowing the public to observe 
them as they are delivered.  Second, Article 18.2 of the DSU, which is echoed in Paragraph 3 of 
Appendix 3, explicitly provides that "[n]othing in this Understanding shall preclude a party to a 
dispute from disclosing statements of its own positions  to the public."  Appendix 3 is part of the DSU 
and so, per Article 18.2, nothing in Appendix 3 preven ts a party from disclosing statements of its own 
position to the public.  Since each of the parties to this dispute agrees to the opening of panel meetings 
to the public, the United States cons iders that the parties should not be prevented from allowing the 
public to view the meetings at which the parti es present their positions.  The United States believes 
that the best way for the United States to disclose it s statements to the public is to allow the public to 
observe those statements as they are being made. 
4.17 The United States also argues that Article 17 of  the DSU pertains to the Appellate Review 
process.  As such, its provisions, in cluding Article 17.10, do  not apply to a determ ination of whether a 
panel can or will open its meetings to the public.  A decision to open a panel meeting to the public 
would not have any bearing on any subsequent deci sion to open the Appellate Body proceedings to 
the public.  Therefore, Article 17.10 of the DSU should not act as a bar to open panel meetings.   The United States also believes that this dispute will ha ve a substantial public in terest, and permitting the 
public to observe the proceedings and be able to see first-hand the professional, impartial and 
objective manner in which they are conducted can only  further enhance the credibility of the result. 
(b) Legal implications of open hearings on covered persons under the Rules of Conduct 
4.18 The United States argues that the provisions in th e Rules of Conduct that require panelists to 
maintain confidentiality apply only to information that is in fact confid ential.  For information that is WT/DS320/R 
Page 8 
 
 
  not confidential in the first place, there is no confid entiality to be "maintained."  However, the parties 
to this dispute are affirmatively exercising their rights under Article 18.2 of the DSU to make their 
written and oral statements public.  The parties ha ve also agreed to open to the public the panel 
meetings in which these oral statements will be read and written submissions discussed.  The parties 
believe that they have the ability under the DSU to  have open proceedings a nd that nothing prevents 
the Panel from adapting its working procedures to re flect that ability.  The United States considers 
that the opening of Panel meetings would not incl ude the deliberations of the Panel, which would 
remain confidential under Article 14.1 of the DSU. 
4.19 The United States further argues that while the Rules of Conduct state that covered persons 
"shall respect the confidentiality of proceedings,"17 they also clarify that "[t]hese Rules shall in no 
way modify the rights and obligations of Memb ers under the DSU nor the rules and procedures 
therein."18  As already noted by the United States in  its response to the Panel's question, the 
procedural rules of the DSU permit public hearings.  Therefore, the confidentiality provisions of the 
Rules of Conduct do not prevent the openi ng of panel meetings to the public. 
(c) Systemic and political impact of opening  hearings 
4.20 The United States argues that opening the panel mee tings to the public is a natural extension 
of the discretion provided to the parties in Article 18.2 of the DSU for a party to disclose its 
statements to the public.  In this dispute, the par ties have agreed to waive their rights to keep written 
and oral statements confidential, and to open the meetings in which these submissions will be 
discussed to the public.  It is not necessary or appr opriate to consult the chairpersons of the Dispute 
Settlement Body ("DSB"), the General Council or the DSB Special Session, or the WTO Director-
General, on whether or not panel meetings in this di spute will or can be opened to the public.   In the 
view of the United States, Article 12.1 of the DSU provides for panels to adapt their working 
procedures after consulting the parties.  Article 12.1 nowhere refers to c onsulting other WTO bodies 
and such consultation could be viewed as setting an unfortunate precedent since panels routinely 
adopt working procedures beyond or different from those in Appendix 3. 
4.21 The United States believes that the third parties should be consulted, but only to determine if 
they would also choose to open portions of the thir d party session with the Panel to the public.  The 
third parties need not be consulted regarding th e opening of panel meetings with the parties. 
4.22 The United States considers that opening panel meetings to the public will have a positive 
impact on the perception of the WTO dispute settlement system, but does not foresee a decision in this dispute to open panel meetings as having a political or systemic impact.  For example, the 
opening of panel meetings in this  dispute would not prejudice the ability of parties to other disputes to 
choose to open, or keep confidentia l, their respective panel meetings. 
(d) What procedures can be adopted to protect confidential information in an open hearing 
4.23 The United States believes that  any portions of the Panel meetings dealing with confidential 
information would not be open to the public.  Addi tional safeguards to provide against the disclosure 
of confidential information could be included in the working procedures.  The United States notes that 
the issue of access to confidential information is not limited to the question of open panel meetings, 
but is one that panels have had to deal with in a number of disputes.  For example, if meetings are 
                                                     
 
17 Rules of Conduct for the Understanding on the Rules and Procedures Governing the Settlement of 
Disputes ("Rules of Conduct"), II.1; see Rules of Conduct, VII.1 ("Each covered person shall at all times 
maintain the confidentiality of dispute se ttlement deliberations and proceedings."). 
18 Rules of Conduct, II.1.  WT/DS320/R 
 Page 9 
 
 
  broadcast electronically, it may be possible to includ e a delay in the broadcast to ensure that there 
would be no inadvertent disclosur e of confidential information. 
4.24 The United States argues that the third parties would retain their ability to decide whether 
their submissions and statements are public.  Any co nfidential statements would not be broadcast.  It 
also considers that it is uncertain what information would come from a Member that is not a party or a 
third party to the dispute, but any such information that is confidential would be respected in the same 
manner as any other confidential information. 
C. FIRST WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES  
1. Introduction 
4.25 This case is about procedural obligations under the DSU of Members that continue to apply 
the suspension of concessions or other obligatio ns after almost two years despite the proper 
notification by the responding party that it has a dopted the necessary measures to implement the DSB 
recommendations and rulings.  In the alternativ e, the European Comm unities makes conditional 
substantive claims under Article 22.8 of the DSU and Articles I:1 and II of the GATT 1994. 
2. Factual aspects 
4.26 Following an authorization by the DSB, th e United States suspended tariff concessions and 
other related obligations up to the level of US$ 116.8 million. Subsequently, the European 
Communities implemented the original DSB r ecommendations and rulings by adopting Council 
Directive 2003/74/EC.  However, the United States continues to suspend concessions and related 
obligations against certain products originating in the European Communities based on a unilateral 
determination that the EC's implementation meas ure is insufficient to comply with the DSB 
recommendations and rulings. 
3. Legal arguments:  Part I – Violation of Ar ticles 23, 21.5, 22.8 and 3.7 of the DSU and 
Articles I and II of the GATT  
(a) The structure of Article 23 of the DSU 
4.27 Article 23 of the DSU lays down the fundamental principle that the dispute settlement system 
of the WTO is the exclusive means to redress any vi olation of any provision of the WTO Agreement. 
Any attempt to seek "redress" can take place only in the institutional framework of the WTO and 
pursuant to the rules and procedures of th e DSU.  This has been confirmed in US – Section 301 Trade 
Act and US – Certain EC Products.  
4.28 Article 23.1 of the DSU contains a general obligation to follow the rules and procedures of 
the DSU whereas Article 23.2 of the DSU lists a number of "specific and clearly-defined forms of prohibited unilateral action".  The relationship be tween the two paragraphs has two distinguishing 
features: One, Article 23.2 of the DSU has to be read  in the context of the first paragraph ("in such 
cases"), that is, it has to be established that the Member's action is performed with a view to 
redressing a WTO violation.  Two, the specific forms described in paragraph 2 do not exhaust the list 
of prohibited unilateral action.  There is a relationship of lex specialis  and lex generalis which 
implies, on the one hand, that whenever there is a violation of a specific case in Paragraph 2 of 
Article 23, there always is also a violation of Para graph 1 of that provision; and on the other hand, that 
a particular conduct that may not come under the sp ecific cases listed in Paragraph 2 of Article 23, 
may still constitute a violat ion under Paragraph 1. WT/DS320/R 
Page 10 
 
 
  (b) Applicability of Article 23 – Article 23.1 of the DSU: Seeking the redress of a WTO violation 
4.29 The meaning of "seeking the redress of a violation" under Article 23.1 of the DSU has been 
extensively discussed by previous panels, i.e. US – Section 301 Trade Act and US – Certain EC 
Products .  The "violation" with regard to which redr ess is sought need not be one that has been 
identified as such by the relevant WTO bodies.  It suffices if it is perceived as being one by the Member in question.  The suspension of concessions  or other obligations is a means of "redress." 
Indeed it is the very means the WTO system envisa ges as a last resort remedy to WTO violations 
according to Articles 3.7 and 22.1 of the DSU. 
4.30 It is obvious that when it suspended concessions in July 1999, the United States was seeking 
to redress a (WTO-determined) violation. Back then, the United States reacted to the European 
Communities' failure to implement, within the reasonable period of time, the DSB recommendations 
in the EC –  Hormones  case.  It requested and obtained a DSB authorisation under Article 22.2 
(respectively 22.7) of the DSU, following which the United States decided on the imposition of  
additional duties at a rate of 100% ad valorem  for the listed imports.  The United States' way of 
proceeding back then is the very example of a "see king to redress a WTO violation" in line with the 
rules and procedures of the DSU. 
4.31 There can equally be no doubt that, if the United States is continuing the suspension of 
concessions to this day despite th e European Communities' adoption of an implementation measure, it 
does so because it is still seeking to redress a WTO viol ation.  This can be deduced from the fact that 
the July 1999 measure of applying duties in excess  of bound rates is being continued without any 
modification.  Because that measure was imposed as  "a result of the EC's failure to implement the 
recommendations and rulings of the WTO," and sin ce the United States has neither abolished nor 
changed the measure, nor modified  its reasons for the imposition, the United States is obviously of the 
view that the EC's failure to implement the reco mmendations and rulings of the WTO still persists.  
Indeed, the continuation of the suspension of concess ions is an unequivocal indication that the United 
States believes that there continues to be a violatio n.  Otherwise it would have ended the suspension 
of concessions in accordance with its obligations under Article 22.8 of the DSU.  Moreover, this is the 
explicit view the United States has formally taken in the DSB and in various official statements. 
(c) Violation of Articles 23.2(a) and 21.5 and of Article 23.1 of the DSU 
4.32 This conduct of the United States is contrary to the specific prohibition of unilateral conduct 
set out in Article 23.2(a) of the DSU.  Instead of seeking redress of the perceived continued failure of the European Communities to implement the DS B's recommendations and rulings through the 
continued suspension of concessions, the United States should have introduced a compliance 
procedure under Article 21.5 of the DSU.  Because  it has not done so, it has violated the specific 
prohibition of unilateral conduct set out in Artic le 23.2(a) of the DSU.  This violation of 
Article 23.2(a) and 21.5 constitutes at the same time a violation of Article 23.1 of the DSU. 
4.33 As the Panel in US – Section 301 Trade Act  has noted, the following conditions need to be 
fulfilled in order to find a violation of Article 23.2( a) of the DSU.  First, given the "chapeau" of 
Article 23.2, it needs to be established that there is  "such a case", namely that a Member is seeking to 
redress a WTO violation. This is the case here. 
4.34 Second, Article 23.2(a) of the DSU requires that a Member has made a "determination to the 
effect that a WTO violation has occurred."  The or dinary meaning of the term "determination," has 
been noted by the Panels in US – Section 301 Trade Act  and US – Certain EC Products.  Such a 
decision need not have a specific form, and can  be inferred from action.  The suspension of 
concessions or other obligations is the very means (a lbeit of last resort) to react to a violation and 
therefore necessarily implies a decision that ther e is a violation.  That such a decision bears  WT/DS320/R 
 Page 11 
 
 
  consequences in WTO trade relations hardly requir es any explanation.  The present case is similar to 
the situation in US – Certain EC Products .  Again, the action in question is the suspension of 
concessions and related obligations.  In contrast to the above case, nevertheless, the suspension here 
had initially been authorised by  the DSB based on a multilateral determination that there was a 
violation.  This multilateral dete rmination, however, was made with  respect to the measures applied 
by the European Communiti es at the time.  Logically, it could not and did not apply to the measures 
subsequently adopted and properly notified to the WTO by the European Comm unities.  With regard 
to the current legislative situation in the Eur opean Communities, no multila teral determination has 
been made by the time at which this Panel wa s established.  If the United States nevertheless 
continues to apply the suspension of concessions a nd related obligations, it necessarily implies that it 
has unilaterally determined that there continues to be a violation.  It has, in addition, explicitly said so. 
4.35 Third, Article 23.2(a) of the DSU is violated if the determination to suspend concessions is 
not made in accordance with the rules and procedur es of the DSU, or is not consistent with the 
findings of a dispute settlement organ.  The DSU provides for a specific procedure, namely Article 21.5 of the DSU, to address the situati on that Members disagree over the existence or 
consistency of measures taken to comply with  the recommendations and rulings of the DSB. 
4.36 There exists obviously a disagreement as to wh ether, by adopting Directive 2003/74/EC, the 
European Communities has implemented the reco mmendations and rulings from the DSB in the 
Hormones case.  Article 21.5 of the DSU requires that such a disagreement shall  be decided through 
recourse to dispute settlement.  The European Communities has invited the United States several 
times to initiate a compliance procedure under Article 21.5 (or, for that matter, any other dispute settlement procedure under the DSU), but to this date  the United States refuses to do so.  Instead, it 
simply continues to apply the suspension of concessi ons and related obligations as if no "measure to 
comply" had been taken or the non-compliance of the new directive of the European Communities 
had already been established. 
4.37 As the determination in th e present case has been made before the commencement, let alone 
the exhaustion of the Article 21.5 pr ocedure, it is necessarily not one that has been made consistent 
with the findings contained in an adop ted panel or Appellate Body report. 
(d) The United States' continued suspension of concessi ons and related obligations is in violation 
of Article 23.1, read together with Articles 22.8 and 3.7 of the DSU 
4.38 Under Article 23.1 of the DSU, the United States is obliged to have recourse to, and abide by, 
the rules and procedures of this Understanding.  This encompasses, inter alia , Articles 22.8 and 3.7 of 
the DSU.  In this respect, the following should be noted: 
4.39 The suspension of concessions or other obliga tions is limited in time.  This temporal 
limitation is the very foundation of the retaliation system under the DSU.  The importance of this 
principle is already demonstrated by the fact that  the "temporary nature" of countermeasures appears 
contextually at two places in Article 22 of the DSU, in Paragraph 8 and in Para graph 1.  The temporal 
limitation is a practical consequence of the fact that suspension of concessions should only be applied 
as "a last resort", Article 3.7 of the DSU.  This  means that the suspension of concessions should only 
apply where justified and necessary. 
4.40 The temporary nature of the suspension of concessions or other obligations has been 
recurrently interpreted by arbitrators to indicate th at one of the main objects and purposes of sanctions 
is to induce the violating WTO member to comply with its obligations.  Indeed, in reaching this 
conclusion the arbitrators followed a suggestion by the United States (see  EC - Bananas III (US) 
(Article 22.6 – EC) ).  The objective of inducing compliance en tails, however, that once a Member has 
adopted compliance measures which are not properly challenged by the complaining Member, the WT/DS320/R 
Page 12 
 
 
  suspension of concessions or other obligations can no longer be applied.  Indeed, in such a scenario 
the suspension of concessions or other obligations w ould be deprived of one of its main objectives, 
i.e. to achieve implementation of a DSB decision, for the simple reason that the WTO Member has already taken measures to implement the DSB reco mmendation.  In this case, the objective to induce 
compliance can only revive after it has been prope rly established that the implementing measure has 
been insufficient to remedy a WTO violation. 
4.41 Article 22.8 of the DSU prohibits the continue d unilateral application of the suspension of 
concessions or other obligations when the measure which has been found inc onsistent is removed. 
The term "removed" thereby refers to the complia nce by a WTO Member because this provision is 
based on the respect of the WTO obligations by the Member concerned (see Article XVI:4 of the 
WTO Agreement and Article 19.1 of the DSU).  The scope of the compliance obligation is 
determined by the DSB recommendations and ruling s following the adoption of the Panel and/or 
Appellate Body report (Articles 21.5, 22.2 of the DSU). 
4.42 Article 22.8 of the DSU does not specify how the removal of the WTO inconsistency is 
determined.  However, in the light of its context, i.e. Articles 21.5 and 23.2(a) of the DSU, and given 
the exceptional nature of countermeasu res, i.e. their temporal limitation, it is clear that a Member can 
not unilaterally determine that the WTO inconsis tency persists despite the notification of a 
compliance measure.  In very much the same vein, a Member can not decide to continue to suspend 
concessions or other obligations unilaterally.  Th e WTO inconsistency of the implementing measure 
can only be determined in accordance with the appr opriate procedure, namely Article 21.5 of the 
DSU. Unless such a procedure concludes that th e compliance measure does not fully implement the 
DSB recommendations and rulings, it cannot be presumed that this is the case. 
4.43 This also follows from the general principle of  good faith as it applies in international State 
relations, under which States are normally considered to  act in conformity with their obligations. This 
principle has been widely confirmed in the international (trade) jurisprudence (see ICJ Corfu Channel , 
EC – Hormones (Article 22.6) , Chile – Alcoholic Beverages , Canada – Aircraft  (Article 21.5 – Brazil) 
and it also applies for implementing measures ( Canada – Dairy (Article 21.5 – New Zeal and and 
US II), EC – Bed Linen (Article 21.5 –India)).  
4.44 Therefore, it is clear that the United States coul d not unilaterally determine that the European 
Communities implemented the DSB recommendations a nd rulings in a WTO inconsistent way.  To 
the contrary, the European Communities must be presumed to have complied with its WTO obligations, if the United States re fuses to establish the contrary. 
4.45 Once the inconsistency of the measure has been  removed, Article 22.8 of the DSU provides 
that "the suspension of concessions or other obligations shall be tem porary, and shall only be applied 
until such time as the measure found to be inconsiste nt with a covered agreement has been removed." 
This provision is mandatory.  It does not leave an y margin of discretion to the retaliating Member, 
thereby corroborating the exceptional nature of th e imposition of countermeasures.  As explained 
above, a Member which contests the removal of the in consistency of the measure has to abide by the 
rules and procedures under the DSU, i.e. Article 21.5 of the DSU.  Only if it is established in such a 
procedure that the WTO inconsistency persists is th e application of the suspension of concessions or 
other obligations permissible under Article 22.8 of the DSU. 
4.46 Under the same logic, Article 22.8 of the DSU does not allow for the application of 
countermeasures on the basis of a 
unilateral  determination regarding th e WTO inconsistency of a 
measure. Rather, Article 22.8 of the DSU, read in  its context with Articles 21.5 and 23.2(a) of the 
DSU, requires that in the absence of an adver se finding, the suspension of concessions or other 
obligations shall not "be applied" any longer.  This langua ge is open in, at least, three directions:  WT/DS320/R 
 Page 13 
 
 
  4.47 Firstly, it indicates that the suspension of concessi ons or other obligations must be terminated 
in case a compliance measure is not challenged, th e measure thus being accepted as being in full 
accordance with the WTO agreements.  
4.48 Secondly, Article 22.8 of the DSU shows th at the suspension of concessions or other 
obligations must not be applied any longer if th e complaining Member delays, postpones or refuses 
the initiation of an Article 21.5 proceeding.  As a WTO Member is presumed to act in conformity 
with its obligations, it follows necessarily that thro ugh the compliance measure it is presumed to have 
removed the WTO inconsistency of the measure at  least when the followi ng three conditions are 
fulfilled: (1) the Member has followed its intern al decision-making procedures that are normally 
applied for the purpose of adopting compliance measures of that kind; (2) the elaboration, deliberation 
and adoption of the compliance measure is done in an open and transparent manner, and (3) the compliance measure is notified properly to the WTO.   Therefore, the suspension of concessions or 
other obligations should not apply an y longer.  This case is particularly relevant in the present dispute 
where the United States has been re fusing for almost two years to initiate the compliance procedure 
under Article 21.5 and to cease the suspension of concessions and related obligations against the 
European Communities.  Thus, the United States continues the susp ension of concessions and related 
obligations on the basis of a unilateral determinati on regarding the WTO-inconsistency of the notified 
compliance measure. 
4.49 In the light of the two first conclusions, it woul d also be appropriate to infer from Article 22.8 
read together with Article 23.1 of the DSU that the suspension of concessions or other obligations 
should not continue to be applied until the WTO inconsistency of the prope rly notified measure has 
been positively determined by the DSB. 
4.50 This result is also corroborated by the system  and overall thrust of Article 23 of the DSU, 
which is to strengthen the multilateral system.  If a WTO Member were allowed to continue the 
application of suspension of concessions without  challenging the implementing measure, it would 
necessarily have to base its assessment on a unilatera l determination of the WT O inconsistency of the 
new measure.  This would be in plain contra diction of Article 23.2(a), in conjunction with 
Article 21.5 of the DSU, as explained above. 
4.51 The scenario described above follows the same ratio legis  that applies for the initial 
imposition of suspension of concessions or other ob ligations.  Thus, whether a Member suspends 
concessions for the first time or other obligations or wishes to ma intain the suspension despite an 
implementation act does not make a difference.  In both cases, a Member must not substitute 
unilaterally its assessment of a WTO inconsistency of an implementation measure to the procedures 
under the DSU. 
4.52 In the case of the initial imposition of suspensi on of concessions or other obligations, the 
DSU implies first a determination that the Me mber concerned has not implemented the DSB 
recommendations and rulings. The DSB would not au thorize the suspension of concessions or other 
obligations, if a WTO Member has taken implem enting measures.  If a WTO Member has taken 
implementing measures, it is established practice that the Member which intends to suspend 
concessions or other obligations first obtains a DSB decision regarding the insufficiency of the 
implementing measure following an Article 21.5 of the DSU proceeding.  This normal course of events and legal steps in the case of the imposition of  suspension of concessions or other obligations 
is in full accordance with the ov erarching principle set out in Article 23 of th e DSU prohibiting 
Members from making unilateral determinations that  another Member has violated its obligations. 
4.53 Regarding the question of the conditions under wh ich the suspension of concessions or other 
obligations could be maintained,  there is no reason to assume that this fundamental logic should 
change in any way whatsoever.  In fact, the le gal situation is identical where the implementing WT/DS320/R 
Page 14 
 
 
  Member has taken the necessary measures to comply with its WTO obligations in accordance with its 
internal rules and procedures and notifie d the measures in question to the WTO. 
4.54 This comparability is even more striking if one focuses on the timing of an implementation 
measure.  In the case of the initial imposition  of the suspension of concessions or other obligations, a 
WTO Member has not implemented its obligations before  the DSB's authorization to suspend 
concessions or other obligations.  In the case of the maintenance  of suspension of concessions or other 
obligations, a WTO Member implements its obligations after the DSB's authorization to suspend 
concessions or other obligations.  This difference in timing, however, does not alter the normal legal 
sequencing between the multilateral review of th e compliance measure and the application of 
suspension of concessions or other obl igations.  Indeed, the sole diff erence in timing does not give the 
retaliating Member all of a sudden the substantive right to make unilateral  decisions as to whether or 
not the implementing measure is appropriate and suffici ent and, if it is not considered sufficient, to 
continue applying the countermeasu res as if nothing had happened. 
4.55 In light of the above, there is an absolute need to refrain from continuing to apply the 
suspension of concessions or othe r obligations in cases where the retaliating Member has not properly 
challenged the compliance measure in an Article 21.5 proceeding.  In fact, if a Member were allowed 
to maintain the suspension of concessions or other ob ligations even in such a new legal situation, it 
could make the kind of unilateral determinations which Article 23 sp ecifically outlaws.  Also, it could 
continue to apply the suspension of concessions or other obligations even if the WTO violation has 
been objectively removed.  The implementing Member  would then have to suffer from the suspension 
of concessions or other obligations even though it has fully abided by its obligations.  It goes without 
saying that such a result would be in plain contradiction to the DSU provisions governing the suspension of concessions or other obligati ons, in particular Articles 3.7 and 22. 
4.56 These fundamental principles are not altered by th e fact that there exists a DSB authorization 
under Article 22.7 of the DSU to suspend concessions  or other obligations.  The DSB authorization 
cannot change the fundamental rul es under the DSU. Rather, the DSB implements these rules.  Thus, 
as the DSU provides that the susp ension of concessions or other ob ligations should not be applied 
unless it has been properly established that a Memb er's measure violates its WTO obligations, the 
DSB authorization cannot be interpreted to jus tify such a suspension if a WTO violation of a 
Member's (new) measures has not been properly determined. 
4.57 The basis for a DSB authorization to suspend concessions or other obligations is a prior 
multilateral  determination that the implementing WTO Member has failed to comply with its 
obligations.  This is the case if an Article 21.5 proceeding concludes that the implementing measure 
was insufficient.  This is also implicitly the case if a Member has not adopted any implementing 
measure at all at the time of the DSB decision under Article 22.7 of the DSU.  On the contrary, if a 
WTO Member implements properly its obligations after the DSB has authorized the suspension of 
concessions or other obligations, the basis for this decision changes fundamentally.  As the original 
DSB authorization was taken in view of the origin al measure, it cannot logically encompass the new 
implementing measure.  Hence, the DSB authorizati on cannot cover the continued application of the 
suspension of concessions or other obligations, if  a WTO Member subsequently implements its 
obligations in the absence of a multilateral review regarding the compliance (or not) of this new 
measure. 
4.58 Regarding this DSB authorization it is once again useful to compare the two situations of the 
imposition  and the maintenance  of the suspension of concessions or other obligations.  The DSB 
could not authorize the imposition of retaliatory measures under Article 22.7 of the DSU, if the 
implementing Member had undertaken measures to comp ly with its obligations and if those had not 
been found WTO inconsistent following an Article 21. 5 proceeding.  In the very same vein, the DSB 
authorization cannot justify the maintenance of su spension of concessions or other obligations if a  WT/DS320/R 
 Page 15 
 
 
  Member properly complies with its obligations af ter the imposition of these measures and if its 
compliance measure is not challenged in an Article  21.5 proceeding.  Again, the mere temporal 
difference of the new implementing measure does not mean that the DSB authorization, once 
received, serves as a blank authorization for a Member  to continue the application of the suspension 
of concessions or other obligations indefinitely in the future and on the basis of unilateral 
determinations. 
4.59 Furthermore, the European Communities would note, that from a systemic point of view, 
Article 22.8 of the DSU is subsequent to Article 22.7 of the DSU. This indicates that once the situation under Paragraph 8 occurs it overtak es the authorization granted under Paragraph 7. 
Paragraph 8 conditions Pa ragraph 7.  As it must be assumed that the DSU negotiators followed a 
logical sequencing in the way they drafted Article 22, it is clear that Article 22.8 of the DSU was 
supposed to impact on the authorization under Article  22.7 of the DSU.  Indeed, to assume that the 
removal of the inconsistency of the measure under Paragraph 8 has no impact on the DSB 
authorization under Paragraph 7 is not  legally coherent or reasonable. 
4.60 Moreover, this reading of the DSB authorization is corroborated if one takes a closer look at 
the substance of this authorization. The level of nu llification or impairment has to be determined in 
relation to the violation determined for the existing measure (Article 3.8 of the DSU).  Thus, assuming 
that a WTO Member has not undertaken any implemen tation steps, the level of nullification should be 
determined in relation to the original violation.   But assuming, in a second scenario, that a Member 
has implemented partly or fully its WTO obligations , the level of nullification or impairment would 
have to be determined accordingl y.  Obviously, in the area where the Member implemented properly 
its obligations there would be no nullification or im pairment.  This logic had also been recognized by 
the arbitrators in EC – Bananas III (US) (Article 22.6 – EC).  
4.61 Applying the same reasoning in the present case, it is clear that the level of suspension of 
concessions or other obligations as authorized by the DSB was based on a non-implementation by the European Communities.  However, this level and, th erefore, the scope of the authorization may not be 
justified any longer once the European Commun ities has properly implemented its obligations. 
4.62 Finally, following the jurisprudence by the Appellate Body, once a Member violates 
Article 23.1 read in conjunction with Article 22.8 of the DSU it necessarily also acts contrary to 
Article 3.7 of the DSU. 
(e) The United States is in violation of Article I:1 of the GATT 1994 because of the continued 
suspension of concessions and related obligations 
4.63 The United States is acting inconsistently w ith Article I:1 of the GATT 1994 by imposing 
import duties in excess of bound rates on products originating in certain EC Member States. 
(f) The United States is acting inconsistently w ith Article II of the GATT by the continued 
application of countermeasures on products originating in the European Communities. 
4.64 The United States is violating its obligations u nder Article II:1(a) and Article II:1(b) of the 
GATT by suspending concessions and related obligations against the European Communities. WT/DS320/R 
Page 16 
 
 
  4. Legal Arguments: Part II – Conditional claim in the event that the Panel does not find 
any violation of Article 23 of the DSU as set out in Part I  
(a) The United States is violating Article 22.8 of the DSU because the measure found to be 
inconsistent has been remove d by the European Communities 
4.65 The United States is violating Article 22.8 of the DSU by continuing to suspend concessions 
and related obligations even though the measure found to be inconsistent has been removed. 
Consequently, the United States is under an obligation  not to apply the suspension of concessions any 
longer. In the following, the European Communities will set out in more detail why the new measure 
is not only in presumed compliance as argued above but in actual compliance with the 
recommendations and rulings of the DSB. 
4.66 The rulings of both the Panel and the Appella te Body essentially turned on the reading of 
Article 5.1 of the SPS Agreement , and in particular, the requirement that a measure be based on a risk 
assessment.  The Appellate Body upheld the Panel's finding that the EC measures at issue were 
inconsistent with the requirements of Article 5.1 of the SPS Agreement .  At the same time, the report 
contains an important clarification as to how th e European Communities could bring its regime for 
hormones-treated meat into accordance with its ob ligations under the covere d agreements.  As seen 
above in relation to Part I, the Appellate Body held "that Article 5.1, read in conjunction with 
Article 2.2, requires that the results of the risk  assessment must sufficiently warrant the SPS measure 
at stake." 
4.67 On the basis of the scientific data presented by the European Communities, the Appellate 
Body found that that data did not sufficiently wa rrant or reasonably suppor t the import prohibition. 
The Appellate Body found, in pa rticular, that the scientific reports and studies submitted by the 
European Communities did not rationally support the EC 's import prohibition or were too general, i.e. 
relevant but not sufficiently specific to the case.  It  is important to understand, therefore, that the 
Appellate Body did not find that an import pr ohibition for beef from hormone treated cattle was per se  
in violation of the SPS Agreement .  Rather it found that the EC's import prohibition was not 
sufficiently warranted, that is to say reasonably supported, by the specific risk assessment relied upon 
at that time by the European Communities. 
4.68 In order to comply with the above findings the European Communities conducted a 
comprehensive risk assessment.  The risk assessment focussed on potential risks to human health from 
hormone residues in bovine meat and meat products, in particular such risks arising from residues of 
the six hormonal substances (oestradiol-17 β, testosterone, progesterone, trenbolone acetate, zeranol 
and melengestrol acetate).  In carrying out the ri sk assessment, the European Communities initiated 
and during 1998-1999 funded altogether 17 specific scientific studies and research projects in order to 
obtain as much as possible of the missing scientific information as identified in the above rulings.  
Moreover, the European Communities addressed in  1998 specific requests for the submission of 
scientific data  to the United States, Canada, Aust ralia and New Zealand which all authorise the use of 
these six hormones for animal growth promotion.  It also published an open call for documentation 
requesting any interested party, including the indu stry, to provide any relevant and recent scientific 
data and information in their possession to be taken into account in the complementary risk 
assessment. 
4.69 The data collected was submitted to the Scientific Committee on Veterinary Measures relating 
to Public Health (SCVPH), an independent expert Committe e established under EC legislation to 
evaluate these kind of substances in the EC legal system.  This scientific body was the one responsible 
for scientific and technical questions concerning  consumer health and food safety related to 
production, processing and supply of food of animal origin.  The SCVPH reviewed all the old and  WT/DS320/R 
 Page 17 
 
 
  new data and issued its opinion on 30 April 1999, wh ich it reviewed and confirmed again in 2000 and 
once more in 2002 on the basis of additional and new information submitted subsequently. 
4.70 Based on this comprehensive risk assess ment, the European Communities adopted 
Directive 2003/74/EC.  In accordance with the above scientific conclusions the Directive provides for 
a definite import prohibition on meat and meat pr oducts from animals treated for growth promotion 
purposes with oestradiol-17 β.  Furthermore, on the basis of the available but still incomplete data, the 
Directive provides for a provisional ban on meat an d meat products from animals treated for growth 
promotion purposes with testosterone, progesterone , trenbolone acetate, zeranol and melengestrol 
acetate.  The Directive places an obligation on th e Commission to seek more complete scientific 
information from any source which c ould shed light and clar ify gaps in the present state of knowledge 
on these substances. 
4.71 Article 22.8 of the DSU  obliges the United States to ce ase applying the suspension of 
concessions, once an inconsistent measure has been removed. However, even though the inconsistent 
measure has been removed, the United States contin ues to apply the suspen sion of concessions. The 
United States, therefore, is in violation of Article 22.8 of the DSU. 
(b) The United States is in violation of Articles I and II of the GATT 1994 following the 
continued application of suspension of concessions 
4.72 As explained above, the illegal continued susp ension of concessions and related obligations 
automatically entails a violation of Articles I and II of the GATT.  
D. FIRST WRITTEN SUBMISSI ON OF THE UNITED STATES  
1. Introduction 
4.73 On 26 July 1999, the Dispute Settlement Body ("DSB") authorized the United States to 
suspend concessions to the European Communities ("EC") in the amount of $116.8 million because 
the EC failed to implement the DSB's recommendations and rulings in European Communities – 
Measures Concerning Meat and Meat Products (Hormones)  (WT/DS26). 
4.74 That authorization has never been revoked.  In this proceeding, the EC claims that multilateral 
decisions of the DSB can be overridden by implicat ion when the Member who has been determined 
not to have complied merely asserts that it has complied .  However, there is no basis in the text of the 
DSU for the EC's claim.  Instead , the EC approach would unsustainably create an endless loop of 
litigation and nullify the right of complaining pa rties to suspend concessions for non-compliance 
following DSB-authorization by negative consensus. 
4.75 The EC has strenuously tried to avoid any multilateral examination of its claim of 
compliance, claiming that this proceeding "is about procedural violations" and "is not about the 
European Communities' compliance in the previous case EC – Hormones ".  The EC consequently 
strongly urges this Panel not to examine whether the EC has complied, but rather to take at face value 
the EC's assertion and to find that this asse rtion not only overrides the DSB's multilateral 
authorization, but also would revoke US  rights under the covered agreements. 
4.76 However, the EC, having made an Article 22. 8 claim, bears the burden of establishing its 
claim of an inconsistency with Article 22.8 of the DSU.  Accordingly, the issue presented to the Panel 
in this proceeding can be reduced to the simple qu estion of whether the EC has established that it has 
come into compliance. WT/DS320/R 
Page 18 
 
 
  4.77 The EC has failed to even attempt to establish th at it has come into compliance, and the EC's 
DSU Article 22.8 claim should be rejected on this basis alone.  The EC's Article 21.5 of the DSU 
claim should likewise be rejected. 
4.78 The EC's claims under Articles 23.1 and 23.2(a) of the DSU also fail.  In compliance with 
Article 23.1 of the DSU, the United States has alrea dy sought and received multilateral authorization  
in relation to the EC's failure to comply with  DSB recommendations and rulings.  The United States 
has made no determination concerning whether the EC  has come into compliance.  Accordingly there 
is no basis for the EC's claims under these provisions.  
2. Factual background 
4.79 At the core of the matter described in the EC's  panel request, and squarely within the Panel's 
terms of reference, lies the EC's assertion that it has removed the measure found to be inconsistent 
with its WTO obligations in the original Hormones  dispute.  In its panel re quest, the EC states:  "The 
European Communities subsequently removed the m easure found to be inconsistent with a covered 
agreement," and that "it considers itself to have  fully implemented the recommendations and rulings 
of the DSB in the EC – Hormones  dispute."  The latter statement was confirming the EC's statement 
at the DSB meeting held on November 7, 2003, that the EC "consider[s] that with the entry into force 
of [Directive 2003/74, amending Directive 96/22], it [is] in conformity with the recommendations and 
rulings made by the DSB." 
4.80 The EC alleges that its amended import ban, which continues to prohibit the importation of 
animals and meat from animals to which any of six growth promoting hormones have been administered, according to good veterinary practices,  is "fully compliant" with its WTO obligations 
and the DSB's recommendations and rulings.  Accord ing to the EC, the amended import ban is "based 
on comprehensive risk assessments, in particular on  the opinions of the EC independent Scientific 
Committee on Veterinary Measures relating to Public Health" (the "Opinions"). 
4.81 The EC complains of the "continued" US susp ension of concessions to the EC "after the 
European Communities has removed the measure found to be inconsistent with WTO law in [the EC 
– Hormones dispute]."  It suggests, in the wake of a declaration of its own compliance with DSB 
recommendations and rulings, that the United States' authorization to suspend concessions to the EC 
is no longer in effect or valid. 
4.82 However, US suspension of concessions to the EC  was, and remains, multilaterally authorized 
by the DSB.  On 26 July1999, the DSB authorized  the United States to suspend concessions or other 
obligations to the EC in the amount  of $116.8 million as a consequence of the EC's failure to comply 
with its recommendations and rulings in the EC – Hormones  dispute.  To date, this authorization has 
not been revoked by the DSB, and the United States  continues to act pursuant to that authority. 
(a) The six hormones used for growth promotion purposes 
4.83 The EC's hormone ban prohibits the importati on and marketing of meat and meat products 
from cattle to which the hormones have been admi nistered for growth promotion purposes, according 
to good veterinary practices.  The United States perm its the administering of these hormones to cattle 
for that very purpose, i.e., in order to increase the growth, feed  conversion efficiency and leanness of 
carcass. 
4.84 For purposes of growth promotion, five of the six hormones (oestradiol-17 β, progesterone, 
testosterone, zeranol, and trenbolone acetate) are admi nistered to cattle as subcutaneous implants in 
the animals' ears.  The ears are then discarded at slaughter.  The sixth hormone, melengestrol acetate, a synthetic progestogen, is administered as a feed additive.  WT/DS320/R 
 Page 19 
 
 
  4.85 International standards exist regarding the u se of five of the six hormones for growth 
promotion purposes.  Upon review of safety assessments conducted by JECFA and recommendations 
by CCRVDF, the Codex Alimentarius Commission ("Code x"), specified as the relevant international 
standards-setting body in the SPS Agreement , adopted recommended maximum residue limits 
("MRLs"), where appropriate, for oestradiol-17 β, progesterone, testosterone, trenbolone acetate and 
zeranol.  Codex adopted these recommended MRLs to  ensure that consumption of animal tissue 
containing residues of these substances does not pose a risk to consumers and to facilitate fair trading 
practices in international commerce. 
4.86 Scientific reviews of the six hormones, interna tional standards pertaining to their use, and a 
longstanding history of administering the six hormo nes to cattle for growth promotion purposes point 
to a single conclusion – that the use of the si x hormones as growth promoters, according to good 
veterinary practices, is safe.  Th is conclusion remains valid, and is supported by all relevant risk 
assessments. 
4.87 The EC's 1999 and 2002 Opinions purport to offer a contrary view.  However, as will be 
discussed below, the EC has not demonstrated how its Opinions indeed constitute risk assessments 
and the conclusions reached in the Opinions have been summarily dismissed by numerous regulatory 
bodies (including review bodies within the EC). 
4.88 As in the original EC –  Hormones panel proceeding, the EC has neglected to present any new 
scientific evidence of a risk, or a risk assessment drawn from that evidence, which would contradict 
the reams of scientific evidence demonstrating that residues in meat from cattle treated with the six 
hormones for growth promotion acco rding to good veterinary practi ce, are safe for consumers. 
3. Legal arguments 
4.89 The core of the EC case in this proceeding is  that the United States is not authorized to 
suspend concessions and related oblig ations as a result of the EC's failure to comply with the DSB's 
recommendations and rulings.  However, the simple  response to the EC is that the DSB granted 
multilateral authorization to the United States to su spend concessions and related obligations.  The EC 
cannot deny that the DSB's authorization has never been revoked.  Because the EC cannot claim that 
the DSB has ever decided to revoke the authoriza tion, the EC instead attempts to construct a new 
legal theory under which the EC's unsupported assertion of its own compliance has somehow 
invalidated the DSB's authorization. 
4.90 The EC's theory is not contemplated by the text  of the DSU and should be rejected.  The EC's 
argument that an implementing Member may, th rough a unilateral declaration of compliance, 
invalidate the DSB's multilateral authorization woul d undermine the right of Members to obtain that 
authorization through operation of the negative con sensus rule.  According to the EC's logic, a 
Member could effectively invalidate another Memb er's authority to suspend concessions and force 
further litigation through a unilateral declaration of co mpliance the very day after the DSB grants that 
authority.  According to the EC's approach, that implementing Member could then continuously force 
successive new rounds of litigation at will simply  by asserting that it has complied.  The EC's 
approach would create the very endless loop of litigation the DSU operates to prevent. 
4.91 The EC's argument simply assumes a key elemen t it must establish to prevail in this 
proceeding – that it has, in fact, "removed" its WTO- inconsistent measure.  The EC's various claims 
based on this assumption must therefore fail. 
4.92 Before addressing the EC's claims, it is worthwh ile to review the applicable burden of proof 
in this proceeding.  It is well-established that the complaining Member in WTO dispute settlement 
bears the burden of proof.  This means, as an in itial matter, that the EC, as the complaining party, WT/DS320/R 
Page 20 
 
 
  bears the burden of coming forward with evid ence and argument that establish a prima facie  case of a 
violation.  In establishing its prima facie case, the complaining party must set forth sufficient facts and 
arguments to establish each element of its case.  Me re assertions are not sufficient.  The EC has failed 
to meet this burden in these proceedings. 
(a) The EC has failed to demonstrate that the United States has breached DSU Article 22.8 
because the EC has neither demonstrated that it has "removed" the WTO-inconsistencies of 
the original hormones ban, nor demonstrated how the amended ban has provided a solution to 
the nullification or impairment of benefits to the United States 
4.93 Article 22.8 states, in relevant part, that: 
[t]he suspension of concessions or other obligations shall be temporary and shall only 
be applied until such time as the measure f ound to be inconsiste nt with a covered 
agreement has been removed , or the Member that must implement recommendations 
or rulings provides a solution  to the nullification or impairment of benefits, or a 
mutually satisfactory solution is reached .  (Emphasis added) 
Article 22.8 thus establishes three conditions under which a DSB-authorized suspension of 
concessions may no longer be applied:  (1) the Member imposing the WTO-inconsistent measure 
"removes" the measure; (2) that Member "provides a solution to the nullification or impairment of 
benefits"; or (3) the parties to the dispute reach a "m utually satisfactory solution."  In order to prevail 
in its claim that the United States is breaching Artic le 22.8, the EC must establish that one of these 
conditions has been met.  
 4.94 The EC's assertion that it has removed its meas ure or provided a solution is not supported by 
any demonstration that it actually has done either.  Instead, it relies on an already rejected legal theory 
that a Member found to have breached its WTO oblig ations is to be excused from its burden of proof 
in dispute settlement if it invokes the phrase "good faith ."  This argument is no more valid today than 
when a WTO panel last rejected it, and the EC's failu re to meet its burden on the critical element of its 
case under Article 22.8 means that the EC's claim must  likewise fail.  The United States continues to 
apply the suspension of concessions to the EC in a WTO-consistent manner, fully in accordance with 
the authorization of the DSB. 
4.95 The EC fails to demonstrate that it has in f act removed its WTO-inconsistent measure, the 
import ban on meat and meat pr oducts from cattle treated with hormones for growth promotion 
purposes or that it has "provide[d] a solution" to th e nullification or impairment of benefits to the 
United States caused by the ban. 
4.96 Article 22.8 nowhere provides that the issue of removal of a measure or providing a solution 
can be decided by a Member's simple assertion that  it has developed a new, WTO-consistent measure, 
or that it alone has deemed that it has provided a "solution" to WTO nullification or impairment, 
without a DSB determination.  Indeed the EC's proposed  interpretation is directly at odds with the last 
sentence of Article 22.8 which makes it clear  that these are questi ons for ongoing DSB
 surveillance.  
Article 22.8 stresses that "the DSB shall continue  to keep under surveillance the implementation of 
adopted recommendations or rulings", in situations where "concessions or other obligations have been 
suspended but the [DSB] recommendations ... have no t been implemented."  This statement that the 
DSB's role is to monitor an implementing Memb er's compliance with DSB recommendations as well 
as the complaining Member's suspension of con cessions further emphasizes that Article 22.8 is 
concerned with multilateral review of compliance.   The EC simply errs in claiming that under 
Article 22.8 the US authorization to suspend concessi ons could be withdrawn in the absence of a DSB 
determination to that effect.  Furthermore, th e EC's approach would fundamentally undermine the 
operation of several critical DSU provisions, most notably the right of complaining parties to seek  WT/DS320/R 
 Page 21 
 
 
  authorization to suspend concessions through a DSB decision taken by negative consensus under 
Article 22.6 or Article 22.7 of the DSU. 
4.97 The EC argues that the Panel should find that it has "removed" its WTO-inconsistent measure 
within the meaning of Article 22.8 analysis becau se it "must be presumed to have complied with its 
WTO obligations, if the United States refuses to establish to the contrary."  However, the EC – 
Bananas compliance panel highlighted that there is si mply no basis in the WTO Agreement for the 
EC's argument that it is presumed compliant with its  obligations absent a finding against its measures.  
Similarly, there is no presumption of compliance for the EC's amended ban in this proceeding.  Because compliance of the EC's amended ban is a co ndition precedent to several of the claims raised 
by the EC as a complaining party, the EC bears th e burden in this proceeding of demonstrating its 
compliance. 
(b) The EC has failed to demonstrate that its am ended import ban on me at and meat products 
treated with hormones for growth promotion purposes is WTO-consistent 
4.98 Whereas the EC claims in its Opinions and Di rective 2003/74 to ha ve developed a risk 
assessment and scientific evidence suppor ting its import ban on oestradiol-17 β, it qualifies the ban on 
the other five hormones as "provisional."  Consis tent with this character ization, the EC invokes 
Article 5.7 of the SPS Agreement  in its first written submission, alleging that the results of its 
Opinions provide "‘the available pertinent info rmation' on the basis of which the provisional 
prohibition regarding the other five hormones ha s been enacted."  Howe ver, the EC fails to 
demonstrate how its ban satisfies Article 5.7's four  cumulative elements, and it thereby fails to 
demonstrate how its ban is a legitimate provisiona l measure within the meaning of that Article. 
4.99 Specifically, the EC: (1) fails to demonstrate that its "provisional" ban on meat and meat 
products from cattle treated with five of the hormon es for growth promotion purposes is maintained in 
a situation where "relevant scientific evidence is insufficient"; (2) fails to demonstrate how its 
"provisional" ban has been adopted on the "basis of  available pertinent information"; (3) has not 
sought "to obtain the additional information necessar y for a more objective assessment of risk"; and 
(4) has not "reviewed [its] ... measu re accordingly within a reasonabl e period of time" within the 
meaning of Article 5.7. 
4.100  In addition, the EC fails to demonstrate that  its amended ban is "based on" a risk assessment 
within the meaning of Article 5.1 since: (1) the EC 's Opinions do not appear to be risk assessments 
within the meaning of Article 5.1, and (2) the result s of the EC's Opinions do not rationally relate to 
or reasonably support its import ban. 
4.101  The EC fails to demonstrate how its Opinions  are indeed "risk assessments" within the 
meaning of Article 5.1 and Annex A of the SPS Agreement .  By failing to examine relevant pathways, 
explore the fate of the relevant risk (that posed by meat products to consum ers) or to support their 
conclusions with scientific evidence, the Opinions  neither "identify the adverse effects on human 
health" arising from the consumption of meat from cattle treated with hormones for growth promotion 
purposes according to good veterinary practice nor "evaluat[e] the potential for adverse effects on human or animal health" arising from consumpt ion of meat products from cattle treated with 
hormones for growth promotion purposes. 
4.102
 Furthermore, the EC's Opinions and their unde rlying studies identify theoretical risks from 
oestradiol-17 β generally, but fail to address the relevant risk – that arising from the presence in meat 
of residues resulting from the administration to animal s, according to good veterinary practice, of any 
of the six hormones for growth promotion purposes.  Therefore, the EC's Opinions fail to sufficiently 
warrant or reasonably support the EC's ban on m eat from cattle treated with hormones for growth WT/DS320/R 
Page 22 
 
 
  promotion purposes according to good veterinary practi ce.  As a result, the EC's ban is not based on a 
risk assessment within the meaning of Article 5.1 of the SPS Agreement . 
4.103  Finally, the EC fails to demonstrate that its am ended ban, which is not based on international 
standards, satisfies the conditions of Article 3.3 of the SPS Agreement .  Specifically, the EC maintains 
its amended ban in breach of Article 3.3 because it fails to base its amended ban on a risk assessment 
within the meaning of Article 5.1 of the SPS Agreement . 
(c) The United States has not breached any other WTO obligations by continuing to suspend 
concessions to the EC 
4.104  The EC argues that the United States has breached  Articles 3.7, 21.5, 22.8, 23.1 and 23.2(a) 
of the DSU.  There are two cornerstones to this  argument, through which the EC seeks to avoid 
having to demonstrate how its amende d ban in fact cures the WTO-incons istencies of the original ban.  
First, the EC argues that the original complaining pa rty, in this case the United States, is obligated to 
seek recourse to dispute settlement in order to c ontinue to suspend properl y-authorized concessions.  
In particular the EC cites to the United States' failure "to initiate dispute settlement proceedings 
pursuant to Article 21.5 of the DSU."  The EC links this failure to initiate a compliance proceeding to 
breaches of Articles 23.2(a) and 23.1 of the DSU, and asserts that a US failure to initiate an 
Article 21.5 proceeding equates to a presumption of EC compliance.  As discussed below, 
Article 21.5 does not, among other things, obligate th e original complaining party to seek immediate 
recourse to dispute settlement to evaluate a Member's  unilateral declaration that it has taken a measure 
to comply. 
4.105  Second, the EC asserts that it has "removed" its measure within the meaning of Article 22.8 of 
the DSU, and that as a result the United States now  violates the provisions of that Article by 
suspending concessions to the EC.  The EC links its  "removal" of the offending measure and alleged 
US breach of Article 22.8 to breaches of Articles 23.1 and 3.7 of the DSU. 
(i) The United States continues to satisfy its obligations under Article 23 of the DSU 
4.106  Prior to addressing the EC's intertwined claims alleging breaches of several DSU provisions, 
it is first necessary to examine an alleged DSU bre ach common to each of those claims  – that the 
United States has breached its obligations under DSU Ar ticle 23.  Notwithstanding the EC's claim that 
by continuing to suspend concessi ons the United States seeks redress of a perceived violation on the 
part of the EC, the United States does not now, and did not at the time of the EC's unilateral 
declaration of compliance, "seek" anything within the meaning of Article 23.1 with respect to the EC's 
declaration.  The United States did not make a determ ination that the EC's am ended hormone ban is in 
violation of a covered agreement (the current proceeding provides an opportunity for the WTO to 
resolve that question), nor did the United States try to obtain or bring about compensation or remedy 
for some new wrong or alleged WTO violation. 
4.107  In fact, the United States, at the appropriate time, adhered to the letter of Article 23.1 by 
seeking redress of the nullification or impairment cau sed by the EC's import ban on hormone-treated 
meat and meat products through recourse to the pr ovisions of the DSU.  The multilaterally-authorized 
suspension of concessions stemming from the US recour se to dispute settlement remains valid to this 
day, and is unaffected by the EC's unilateral decl aration of compliance.  In other words, the United 
States has already sought and obtained redress thr ough the multilateral dispute settlement system for a 
violation found by the DSB.  There is no provision  in the WTO Agreement th at provides that a single 
Member can unilaterally invalidate the multilateral decision of the DSB to authorize suspension of 
concessions.  WT/DS320/R 
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  4.108  While Article 22.8 does set forth conditions under which that authorization may no longer be 
applied, as discussed above, the EC has offere d no meaningful argumentation as to how those 
conditions have been fulfilled.  Absent such a demons tration, the EC has quite simply failed to meet 
its burden in this proceeding that the US suspension of concessions is in any wa y inconsistent with the 
DSB's authorization and US WTO obligations.  Th e United States is not seeking redress for anything 
but the import ban which the DSB ruled inconsistent with EC obligations, rega rding which the EC has 
presented no evidence of having removed or provided a solution to the resu lting nullification or 
impairment. 
(ii) The US suspension of concessions does not breach  Articles 23.2(a), 21.5 and 23.1 of the DSU 
4.109  The EC argues that the United States "should have introduced a compliance procedure under 
Article 21.5 of the DSU," and in failing to do so  "violated the specific prohibition of unilateral 
conduct set out in Article 23.2(a) of the DSU."  The EC argues that the alleged breach of 
Articles 23.2(a) and 21.5 further constitutes a breach of  Article 23.1 of the DSU.  To the contrary, the 
United States continues to satisfy its obligations unde r each of these Articles, and the EC has failed to 
demonstrate the contrary. 
4.110  As discussed above, the United States has not, th rough its continued application of the DSB's 
authorization to suspend concessions, sought redress for another Member's violation, in breach of 
Article 23.1.  This also means the United States is not breaching Article 23.2(a).  Likewise, the United 
States is not breaching Article 23.2(a) because it did not make a "determination" within the meaning 
of Article 23.2(a). 
4.111  Since it received authorization to suspend con cessions to the EC, the United States has simply 
continued to act according to its DSB authorization to  suspend concessions to th e EC.  Contrary to the 
EC's claims in this panel proceeding, the United States made no determinations concerning the EC's 
import ban, amended or not.  The United States did not  need to make any further determinations to 
continue to apply that suspension of concessions , and it did not.  Further, as noted above, the 
conditions under which a Member may no longer apply a DSB-authorized suspension of concessions 
are set forth in Article 22.8, and the EC has made no effort to demonstrate that those conditions have 
been met. 
4.112  Further, the EC alleges that, contrary to the requirements of Article 23.2(a) of the DSU, the 
United States made a determination not "in accord ance with the rules and procedures of the DSU," 
and in a manner "not consistent with the findings of  a dispute settlement organ."  Specifically, the EC 
alleges that the United States made a determin ation that the EC had not implemented the 
recommendations and rulings of the DSB in breach of  Article 21.5 of the DSU.  As demonstrated 
below, the United States has not breached its obligations under Article 21.5 of the DSU. 
4.113  The EC's Article 21.5 claim fails for four reasons : (1) the EC has not established that there is 
a "disagreement as to the existence or consistency with a covered agreement of measures taken to 
comply;"  (2) Article 21.5 sets no deadline by whic h such a proceeding must be brought; (3) nothing 
in the text of Article 21.5 places the onus of in itiating a compliance proceeding on the original 
complaining party (in this case, the United States); and (4) the phrase "these dispute settlement 
proceedings" in Article 21.5 is not restricted to proceedings under Article 21.5, but rather could 
include proceedings under the DSU such as Ar ticle 22.6 arbitration proceedings, Article 25 
proceedings, or the proceedings of a de novo  panel, as the EC has sought in this instance. 
4.114  First, the United States has continued to evalua te the EC's claim, and at the time of panel 
establishment had been awaiting the EC's response to the US request under Article 5.8 of the 
SPS Agreement .  The United States has continued to eval uate the EC's claim, including its 19 May 
2005 response to the US request.  The US evaluation de pends to a large extent on the EC's response to WT/DS320/R 
Page 24 
 
 
  questions such as those posed in this submissi on, including why the EC believes that scientific 
evidence has now become insufficient to perform a risk assessment for five of the six hormones.  To 
date the EC has been less than t horough in its responses.  Article 21.5 only applies "[w]here there is 
disagreement." 
4.115  Next, the EC interpretation of Article 21.5 as requiring immediate resort to litigation by a 
complaining party would definitively prevent that complaining party from exercising any judgment as 
to the fruitfulness of dispute settlement, and would preclude Members from seeking mutually 
agreeable solutions through negotia tions.  The aim of the dispute settlement system is to secure a 
positive solution by whatever means possible, and not simply through litigation.  In the absence of 
any obligation in Article 21.5 to immediately resort to litigation, the fact that the United States had not done so by the time the EC initiated this pro ceeding cannot constitute a breach of Article 21.5. 
4.116  Thirdly, contrary to the EC's argument, the text of Article 21.5 assi gns no obligation to the 
complaining  party to seek recourse to "these dispute settleme nt procedures" in the event that there is a 
disagreement "as to the existence or consistency with a covered agreement of measures taken to 
comply."  The text does not require that the or iginal complaining Member, in this case the United 
States, initiate dispute settlement proceedings in the event of a disagreement.   Thus, the mere fact that 
the United States had not yet decided to invoke Artic le 21.5 proceedings before the EC undertook the 
present challenge is not in itself grounds for concluding that the United States breached Article 21.5, 
any more than the EC's failure to do so was.  
4.117  Finally, it is important to recognize that the te xt of Article 21.5 refers to "these dispute 
settlement procedures," without specifying any pa rticular subset of WTO dispute settlement 
procedures.  The panel in the US – Certain EC Products dispute recognized that the ordinary meaning 
of this phrase covers any dispute settlement proced ure provided in the DSU "that could be used to 
assess the compatibility of the new implementing measu re, including Article 25 or Article 22 of the 
DSU".  In other words, there is no basis in Ar ticle 21.5 for excluding any WTO dispute settlement 
procedure that could be used to assess the WTO-co mpatibility of a new implementing measure.  In 
bringing these proceedings, the EC availed itself of  one such means, though, as discussed above, it 
has failed to meet its required burden to prevail.   Also, in bringing these proceedings, the EC has 
conceded that an Article 21.5 compliance panel is not  the exclusive means to resolve a "disagreement" 
even if one existed.  If it were the exclusiv e means, then the EC itself would have invoked 
Article 21.5, as it has done in the past.  However, it did not, nor did it seek to  have the matter that is 
the subject of this proceeding referred to the "origina l panel" as provided in Article 21.5.  None of the 
original panelists are serving on this Panel.  Thus  the EC's approach in this proceeding itself refutes 
the EC's Article 21.5 claim. 
(iii) The United States has not violated Article 23.1 of the DSU, read together with Articles 22.8 
and 3.7 of the DSU 
4.118  The EC claims that the United States violates Article 23.1 of the DSU, when read together 
with Articles 22.8 and 3.7 of the DSU.  The EC asserts that these three Articles, together, demonstrate "that a WTO Member shall not apply the suspensi on of concessions or other obligations in the 
presence of an implementation act, which has not been found to be inconsistent following an 
Article 21.5 proceeding."  Contrary to this claim, the United States continues to satisfy its obligations 
under each of these Articles. 
4.119  As discussed above, the United States does not seek to redress a WTO violation within the 
meaning of Article 23.1 of the DSU, and it continues to act pursuant to its multilateral authorization to 
suspend concessions to the EC.  Therefore, the EC 's claim that the United States has violated DSU 
Article 23.1, read together with Articles 22.8 and 3.7 of the DSU fails.  WT/DS320/R 
 Page 25 
 
 
  (iv) The United States has not breached its obligat ions under Article I or II of the GATT 1994 
4.120  Finally, the EC claims that the United Stat es acts in breach of Articles I and II of the 
GATT 1994.  However, the DSB has specifically aut horized the United States to suspend concessions 
under Articles I and  II of the GATT 1994.  Unt il the DSB withdraws its authorization or the 
conditions of Article 22.8 have b een found to have been met, the United States cannot be found in 
breach of GATT 1994 Articles I or II. 
4. Conclusion 
4.121  In light of the foregoing, the United States asks th e Panel to find that: (1) the EC has failed to 
demonstrate that the United States has breached Article 22.8 of the DSU, and that the United States continues to suspend concessions to the EC consiste nt with the requirements of that provision; (2) The 
United States has not breached Articles 3.7, 21.5, 23.1 or 23.2(a) of the DSU; and (3) The United 
States has not breached Articles I or II of  the GATT 1994. 
E. O
RAL STATEMENT OF THE EUROPEAN COMMUNITIES DURING THE FIRST SUBSTANTIVE 
MEETING  
1. Introduction 
4.122  The central provision on which the European Communities bases its claims is Article 23 of 
the DSU.  Article 23 requires WTO Members to have recourse to the procedures set out in the DSU  
instead of resorting to any kind of "self-help."  Article 23, in other words, prohibits a WTO Member 
from making itself the judge over other WTO Members.  What is and what is not a violation of the 
covered agreements and what one can do to re medy it, are to be determined multilaterally, not 
unilaterally. 
2. Seeking redress – Article 23.1 
4.123  As to Article 23.1 all parties seem to agree th at when, in 1999, the US and Canada requested, 
obtained and started using a DSB authorization to suspend concessions, they were seeking to redress a 
violation established at that time.  The parties di ffer on what the US and Canada are doing right now. 
One should think that they are still seeking redress.  After all, they are still applying their suspension 
of concessions stating explicitly that they fail to  see how the European Communities' implementation 
measure achieves compliance.  This can only mean that they still see a violation, especially given that 
Article 22.8 of the DSU would prohibit the con tinuation of sanctions in the opposite case. 
4.124  The defending parties, however, flatly deny that what they are doing right now is seeking 
redress of a violation against an alleged WTO-in consistency of the implementing measure.  The 
United States states that it "has already sought and obtained redress through the multilateral dispute settlement system for a violation found by the DSB" .  Canada not only uses th e same terms – "sought 
and obtained" – but also takes the trouble of under lining those words in its submission in order for 
everyone to understand the difference between the present tense ("seeking"), in Article 23.1 of the 
DSU, and the past tense of "sought and obtained". That difference seems obvious enough.  What is much less obvious, however, is how, by referring to th e past, the defending parties want to explain 
what they are doing right now.  Applying sanctions  is a form of seeking redress as the defending 
parties have admitted themselves.  They are curren tly applying sanctions – present tense, not past 
tense – so how could they not be seeking redress? 
4.125  They are not seeking redress, so the defending parties say, because they are acting under an 
authorization.  An authorization, however, can neither deny facts nor derogate from a Member's 
obligations outside its scope.  Thus, as regards specifi cally Article 23 of the DSU, it is clear that the WT/DS320/R 
Page 26 
 
 
  mere existence of an authorization cannot simply do  away with the obligation to abide by the rules 
and procedures of the DSU, when a Member is seeking redress of a violation. 
3. Article 23.2(a)  of the DSU in conjunction with Article 21.5 of the DSU 
4.126  As regards specifically the EC's claim under Ar ticle 23.2(a) in conjunction with Article 21.5 
the defending parties put forward a number of reas ons as to why there is no determination by them. 
Interestingly enough, they hardly deal with one of the main points the European Communities has 
raised, namely that their "unilateral determination" can be inferred from the fact that they continue to 
apply sanctions unilaterally.  And how could it not be inferred from it?   It is inconceivable – and 
indeed would be even worse than what we are discussing now – if they did so without any good reason.  On the other hand, both spend considerable  time in their first written submissions explaining - 
in a rather defensive manner - that their public stat ements do not constitute de terminations, that they 
never alluded to a violation, that they have not  yet concluded on non-compliance, etc.  And finally, 
elsewhere in their submissions, they spend ev en more time explaining why the European 
Communities' implementing measure actu ally falls short of compliance. 
4.127  Whether or not a specific statement reaches – as Canada puts it – the "threshold" of a 
determination is one thing.  Yet,  another thing is if that statement is accompanied by conduct that 
severely affects the EC's trade.  We are not looking at statements made in abstracto  here.  A 
"determination" need not be pinned down to a speci fic statement in a specific form, it is the whole 
conduct a WTO Member is displaying that needs to be looked at. 
4.128  The defending parties further claim that they do not have an obligation under Article 21.5 of 
the DSU to launch compliance proceedings.  This Panel, however, is asked to find whether, under 
Article 23 of the DSU, in conjunction with Artic le 21.5, a Member has an obligation to launch a 
compliance procedure if and because it continues to  apply sanctions against another Member, even 
though there is a new implementing measure.  It is no t relevant for this dispute what obligations can 
be found directly in 21.5 in the absence of such unilateral conduct. 
4.129  Finally, the United States claims that there is  no obligation for the retaliating complainants to 
immediately  launch a compliance review.  In the present context and circumstances, with almost one 
and a half years that have passed after the a doption of the European Communities' implementing 
measure at the moment when this Panel was estab lished and with all the discussions that took place 
between the parties to this dispute regarding this  implementing measure, both before and after it was 
adopted, the question of how quickly a retaliating complainant must react to an implementing measure does not pose itself.  If anything, one could discuss the defendants' bad faith and their contradictory behaviour ( venire contra factum proprium).  
4. Article 23.1 in conjunction with Articles 22.8 and 3.7 
4.130  As regards the EC' claim under Article 23.1 in  conjunction with Article 22.8, 3.7, the 
defending parties submit that th e conditions of Article 22.8 are not fulfilled because the European 
Communities did not prove that it has "removed"  the inconsistency of the measure.  This 
argumentation overlooks the fact that dispute settlement proceedings are about a non-compliance 
review not a compliance review.  Indeed, in all di spute settlement proceedings that have ever been 
adopted by the DSB it was for a complaining Member to prove the WTO inconsistency of a measure 
by another Member.  This is explicitly confirmed by  Article 6 of the DSU, the provision under which 
panels are established. 
4.131  
The defending parties ignore that the Europ ean Communities makes its systemic claim under 
Article 22.8, in conjunction with Article 23.1.   Thus, the Panel is called upon to decide whether or not 
the conditions under Article 22.8 are fulfilled in view of the prohibition under Article 23 to make  WT/DS320/R 
 Page 27 
 
 
  unilateral determinations of non co mpliance.  It is not possible for the defending parties to contest the 
removal by the EC of the inconsistency of our ol d measure (Article 22.8), without making a unilateral 
determination under Article 23. 
4.132  Further, both defending parties submit that the European Communities cannot base itself on a 
presumption of good faith compliance.  The European Communities bases itself on the same rationale  
as the Appellate Body in the Byrd Amendment  case.  Thus, even though the defending parties allege 
that the European Communities is still in violation of the SPS Agreement , this does not in any event 
affect the presumption of good faith.  As the Appella te Body has made clear, these are two completely 
different questions. 
4.133  The defending parties claim that there is a reversed burden of proof in a compliance case. 
Contrary to what Canada believes, a reversal of  presumption can also not be deduced from the DSB 
authorization granted in 1999.  The DSB authorizati on is limited to giving a Member the right to 
apply sanctions.  However, it does not go further than that.  The DSB authorization cannot reverse the 
normal rules which apply for subsequent implementing measures. 
4.134  If Canada's criterion of a "day-to-day busin ess" conduct for the presumption of good faith 
should bear any relevance at all, the European Co mmunities considers that in  the present case it even 
supports the EC' reliance on goo d faith.  Indeed, the European Communities prepared the 
implementation of the DSB recommendations and ruli ngs with extraordinary carefulness.  During the 
compliance process, the European Communities has made every effort to analyse the relevant 
scientific evidence in full transparen cy and with an open mind.  All st akeholders – whether inside or 
outside the European Communities - had at every mome nt in time the opportunity to submit relevant 
information and to intervene in the whole process. 
4.135  It is therefore also absurd, and indeed turns rea lity on its head, to main tain that the European 
Communities in this case seeks to  end the sanctions on the basi s of a "mere declaration of 
compliance", and that this could be done also just "a  week after" the DSB authorization.  It insinuates 
that the European Communities abu sed its rights and it just waives its hand to claim compliance.  In 
the light of the whole process, as just described, it is instead fully leg itimate for the European 
Communities to rely on the presumption of good faith for its compliance. 
4.136  As to the relevance of the DSB authorization fo r the continued application of sanctions in the 
context of Article 22.8, obviously, the defending parties and the European Communities have different views about the scope of the DSB authori zation.  For the United States and Canada, the DSB 
authorization operates like a sort of "absolut e justification" which makes every behaviour per se  WTO 
consistent, irrespective of any subsequent events  and compliance acts.  On the other hand, the 
European Communities considers that it is necess ary to put the DSB authorization in its proper 
context under the DSU. 
4.137  In this case, the DSB authorization has been granted under Article 22.7 following an 
arbitration procedure under Article 22.6 of the DSU.  The subject-matter of this Article 22.6 
arbitration was the level of nullification or impa irment caused by the original EC's Hormones 
legislation.  Thus, it is crucial to note that the ve ry basis of the DSB authorization has been the WTO-
inconsistency of the Member before  the authorization was granted.  On the other hand, the DSB 
authorization is not based on any (alleged) WTO in consistency of a compliance measure that has been 
adopted afterwards . 
4.138  What follows from this important and undisputab le fact is that, first of all, in case of a 
subsequent compliance that is properly adopted an d duly notified to the WTO, the basis on which the 
DSB has granted its authorization has fundamentally changed.  The DSB only granted the 
authorization to suspend concessions precisely b ecause a WTO Member had been found to be WTO WT/DS320/R 
Page 28 
 
 
  inconsistent in the past and no implementation me asure was taken within the reasonable period of 
time.  The DSB's authorization was to induce co mpliance by the other Member and to rebalance 
temporarily the rights and obligations until the other Member has complied. 
4.139  Second, the DSB authorization is even mo re fundamentally changed in the case of a 
subsequent compliance measure which has neve r been found WTO-inconsistent, because the 
defending parties do not dare to ch allenge it under Article 21.5.  In  its first written submission, the 
European Communities has referred to the "seque ncing" discussion and practice of WTO Members in 
case of a compliance act before the DSB authorizatio n is granted. Quite remarkably, in the "Bananas" 
dispute the DSB Chairman explicitly stated that the sequencing of a determination of 
(non-)compliance and the suspension of concessions should be treated in a "logical way forward". 
4.140  As it happened, the logical way forward at th e time was to assess first whether the compliance 
measure was sufficient before determining the nullification or impairment caused by the WTO-
inconsistent measure.  In stark contrast to this se quencing, the defending parties consider now that the 
logical way forward is to continue to apply san ctions even though the EC' compliance measure has 
not been challenged by them and not been found WT O-inconsistent.  And what is more, they even 
refuse to challenge the EC's compliance measure, pr etending that this is not necessary becuase they 
have a DSB  authorization. 
4.141  But how can Canada and the United States know th at the European Communities is still not in 
compliance with its obligations?  They do so solely  on the basis of a unilateral determination of the 
EC's compliance measure which is in obvious contra diction to Article 23 and Article 21.5 of the DSU. 
4.142  One might argue that the DSU is not explicit on this question.  However, the DSU contains 
several elements which indicate that the DSB aut horization can not serve as a blank cheque for the 
continuous application of the sanctions even afte r a subsequent compliance measure has been adopted 
and notified properly to the DSB. 
4.143  First, let us consider the wording of Article 22.8 of the DSU and what it does not say.  Even 
in case of a removal of the inconsistency of the measure, Article 22.8 does not say that the "DSB 
authorization ceases to apply".  Instead, it states  that the suspension of concessions or other 
obligations shall not "be applied" any longer.  Thus , Article 22.8 does not formally address the fate of 
the DSB authorization.  In an Article 22.8 situation it is, therefore, perfectly conceivable that although 
the DSB authorization is not formally  terminated or withdrawn, a WTO Member is not entitled to 
continue the application of suspension of concessions.  Furthermore, Article 22.8 does not say that the 
removal of the inconsistency or the termination of  the application of suspension requires whatever 
kind of DSB decision.  Rather, Article 22.8 is self-e xecuting.  The use of the word "shall" supports 
this interpretation, which does not give any marg in of manoeuvre and requires no additional acts. 
4.144  Second, contextually, Article 22.8 describes the next  procedural step in the course of a dispute 
after an authorization has been granted.  Article 22.8, therefore, provides for the next logical step. 
Consequently, once the inconsistency of the measure has been removed, the application of suspension 
of concessions or other obliga tions is no longer permitted. 
4.145  In addition, Article 22.8 should be interpreted in  the context of Article 23 of the DSU, which 
prohibits WTO Members from judging unilaterally the properly adopted and notified compliance 
measures of other WTO members.  According to the text, object, purpose and context of Articles 22.8 
and 23, the defending parties must seek a determ ination of non-compliance under the normal DSU 
procedures.  This general principle is not altered in whatever way under Article 22.8. 
4.146  Another contextual element which should be ta ken into account is Articles 3.7 and 22.1 of the 
DSU, which underline the exceptional and temporal nature of the application of suspension of  WT/DS320/R 
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  concessions or other obligations.  Their exceptional and temporal nature effectively complements the 
principle of good faith.  In case of a properly adopted and notified compliance measure, the 
exceptional and temporal justifica tion of countermeasures is put into question. In the presence of a 
subsequent compliance measure, the "normal" s ituation revives and sanctions can no longer be 
applied as if nothing has changed. 
4.147  Canada tries to draw contextual support fo r its position from Article 3.2, emphasizing the 
security and predictability given by the DSB authori zation.  The "security and predictability" under 
Article 3.2, also applies to the WTO Member w ho properly implements its obligations.  Once this 
Member has removed the inconsistency of the meas ure it should have the reassurance that sanctions 
are no longer applied.  At a minimum, the implemen ting Member must have the reassurance that its 
measure is properly challenged under the DSU by th e retaliating Member, which does not agree with 
the compliance measure.  But even this, Canada  and the United States refuse to do despite the 
repeated requests by the Eur opean Communities to do so.  
4.148  The European Communities would also recall th e object and purpose of the trade sanctions, 
which is to induce compliance and to rebalance th e rights and obligations under the WTO agreements. 
However, both objectives require that a Member 's measure has been found first to be WTO-
inconsistent in accordance with the DSU rules.  And such a determina tion concerns logically not just 
any measure, but the measure that is currently in fo rce in the Member concerned.  Transposed in the 
present context, it means that Canada and the Un ited States cannot simply argue that the "old" 
measure has been found to be WTO- inconsistent in 1998.  This meas ure is not any longer in force, 
since the European Communities adopted and notified its compliance measure in 2003.  It is simply 
not rational and credible to argue that the obj ect and purpose of the suspension of concessions 
continues to exist, if its basic reason, i.e.  the old WTO-inconsistency, has disappeared. 
5. Concluding statement of the European Communities 
4.149  The EC believes that allowing public observation of the debate during this hearing has been 
very beneficial for the public's understanding of  the dispute settlement process as well as this 
particular dispute.  The public observation has in no way hindered an efficient conduct of this hearing.  
On the contrary, the third parties have clearly be nefited from their observation of this hearing during 
the first two days for the purpose of their participation in this dispute.  
4.150  What we have heard from the defendants in the last few days is essentially that a retaliating 
Member has no obligation whatsoever under the DSU.   Instead, the retaliating Member may continue 
to apply sanctions until the authorization is "re voked" by the DSB.  The United States and Canada 
argue that by virtue of this authorization they  can simply lean back and see what the complying 
Member comes up with.  If eventually the complying Member adopts an implementation measure 
they do not even see a need to review it in due tim e.  Let me remind that in this case the United States 
and Canada claim that they have even after two y ears (and I should add after an additional three years 
of preparation) not made up their mind whether the EC's measure is WTO consistent.  Indeed there 
seems to be no prospect that the United States and Canada will ever make up their minds.  Canada has 
stated that it would never make a determination about the EC's new measures and the United States 
gave even less cause for reassurance stubbornly refusing ev en to agree that there is a disagreement.   
4.151  Whatever the defendants may mean by these statem ents, it is clear that the United States and 
Canada do not accept a responsibility to submit the EC 's legislation to a multilateral review as has 
been done in any other case by WTO Members wh ich ended in an adopted WTO decision.  And 
although they do not contest that the EC has acted in good faith, they do not even concede that the 
EC's measure can benefit from a presumption of good faith compliance.  WT/DS320/R 
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  4.152  This is a very easy going way for the United Stat es and Canada.  But it cannot be the correct 
one under the DSU. 
4.153  The EC would recall some essential points which have been discussed by the parties: 
4.154  First, the EC has advanced what would be the logi cal solution to this dispute, i.e. to follow its 
example in the US – FSC  case (launching Article 21.5 compliance procedure by original complaining 
party, suspension of sanctions in the meantime).  Quite remarkably, the Un ited States fully agreed 
with the EC's approach and considered it as "the appropriate solution" in the US – FSC  dispute.  Yet, 
the EC struggles to understand why in a reverse situ ation where the United States is retaliating, the 
United States does not follow this exam ple if it considers it as "appropriate". 
4.155  Second, there has been a lot of discussion about the presumption of good faith and the 
presumption of compliance, which is important for the EC's claim under Article 22.8 and Article 23.1 
of the DSU.  Neither the United States nor Canada nor  any of the Third Parties have contested that the 
EC has adopted its compliance measure in good faith .  Yet, the United States and Canada refuse to 
accept that the EC may rely on this principle in a "post-implementation" scenario.  The United States 
even wants to go so far as to say that the principle of good faith is not part of the DSU.  Obviously, 
this view is contrary to what the Appellate Body has consistently ruled but also irreconcilable with 
general principles of public international law.  Mo reover, when we asked Canada about the basis in 
the DSU of its assumption that an implementing Memb er faced with retaliation is not entitled to this 
presumption, it could not provide any answer.  Indeed, this is so because there is no basis for Canada's 
theory.  
4.156  Third, during the proceeding we have heard a lot about the risks of an "endless loop of 
litigation" by a "mere declaration of compliance".  Ye t, as everybody agrees that the EC has adopted 
its compliance measure in good faith, it is clear that this "endless loop of litigation" does not arise in 
this dispute.  Indeed, such an endless loop scenar io presupposes a sort of scam measure notified by a 
WTO Member in bad faith.  This is not the case befo re us.  Indeed, even the EC would not consider 
that a "mere declaration of compliance" is sufficien t but what matters is that a Member complies with 
its obligations.  This is what the EC has actually d one in this case after a most thorough review of its 
measure involving a comprehensive review and assess ment of the available scientific evidence.  
4.157  There is a paradox about the approach of the defendants to the principle of good faith. They 
do not contest that the EC has acted in good faith but they argue that WTO Members in general cannot be expected to act in good faith.  They argue, Members with a duty to implement will adopt 
sham or scam measures to escape retaliation, it is argued that implementing Members must have the burden of proving their compliance.  The EC does not  believe that WTO Members act in bad faith.  
No Member wants to lose WTO disputes – and to do  so repeatedly and igno miniously.  There would 
be a high political cost.  Also, WTO Members are not  excessively litigious and do not gaily engage in 
endless loops of litigation.  This fear is unfounded.  But if this argument about bad faith is allowed, it 
can also be used the other way around – to argue th at the United States' and Canada's approach will 
lead to Members seeking and expl oiting retaliation rights for imprope r purposes.  Seeking redress of 
WTO violations must not be too difficult; and impl ementation and removal of retaliation must not be 
made subject to the often impossible task of provi ng a negative.  Retaliation rights should not become 
a new means of advancing unilateralist agendas. 
4.158  Fourth, when it comes to the DSB authorization, the United States and Canada argue that this 
may be revoked if the EC would launch a proceed ing under the DSU, be it Article 21.5, 22.8 or 
Article 25 etc. However, both defending parties cannot explain how this would even result in 
revocation of the DSB authorization. Well, Canada  argues that the DSB coul d probably eventually 
make a recommendation to itself to revoke the DSB authorization but there is absolutely no basis for this in the DSU.  And I am not talking about the pr ocedural implications which this could entail.  For  WT/DS320/R 
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  instance – according to Canada – in an Article 21.5 proceeding brought by the EC against itself the 
burden of proof would be partly on the EC for the implementation of the original DSB 
recommendations and ruling.  On the other hand, Cana da could bring in its "defence" (in which they 
would complain about the WTO consistency of the measure) new claims for which it would bear the 
burden of proof.  And of course, Canada's theo ry cannot even address the question on how these new 
claims could be reconciled with the more limited Panel request.  
4.159  Finally, let me once stress again that the EC is  not seeking to avoid a proper examination of 
its compliance measures in the Hormones dispute.  We would be delighted if the United States and Canada would initiate an Article 21.5 dispute to morrow and would do all we can to facilitate and 
accelerate its conclusion.  However the United Stat es and Canada stubbornly refuse to take this 
logical – indeed appropriate – step.  It is they who have sought to avoid ha ving to confront the new 
EC measures and set out their objections to it in a manner in which the EC can properly respond.  
They have, it is true, started to set out – for the first time – their objections in their first written 
submissions.  The EC does not understand why they did not want to do this in a proper Article 21.5 
proceeding. 
4.160  We hope that we have assisted you in your importa nt task and look forward to helping you in 
any further way that we can in coming weeks. 
F. O
RAL STATEMENT OF THE UNITED STATES DURING THE FIRST SUBSTANTIVE MEETING  
1. Introduction 
4.161  There are two central facts in this dispute.  The first is that the WTO's Dispute Settlement 
Body authorized the United States to suspend con cessions against the Eur opean Communities in the 
EC –  Hormones  dispute over five years ago because the DSB found that the EC lacked a scientific 
risk assessment to justify its ban on imports of m eat in connection with hormones and that the EC 
then failed to implement the DSB's recommendations  and rulings.  The second is that the EC has 
made no effort to demonstrate that the conditions in the WTO's  DSU for ending that DSB-authorized 
suspension have been met.  Those conditions are se t forth in DSU Article 22.8.  While the EC has 
alleged that the United States is breaching this pr ovision, the EC apparently considers that it can 
simply assert that those conditions have been met, that it can unilaterally declare itself to be in 
compliance and that it can thereby invalidate  the multilateral authorization of the DSB. 
4.162  This position is not sustainable.  The EC is alleging that the United States is breaching its 
WTO obligations, and there can be no dispute that the EC bears the burden of demonstrating this – including demonstrating that it has removed the meas ure or provided a solution to the nullification or 
impairment suffered by the Member suspending concessions. 
4.163  Despite this burden, the EC has insisted that this proceeding should not reach the question of 
whether it has actually complied with its WTO obligations in the EC –  Hormones dispute.  We can 
understand the EC's reluctance to deal with this i ssue, since we do not see how the EC can credibly 
claim it is in compliance with those obligations.  Neve rtheless, the EC's failure to make any effort at 
all to demonstrate its compliance is by itself grounds for rejecting the EC's claims, since this question 
goes to the heart of those claims. 
2. The European Communities' amended ban 
4.164  It is notable what the EC has not argued in these proceedings – how and why it has come into 
compliance with the DSB's recommendations and ru lings.  The absence of this argument is odd since 
the majority of its claims are premised on the asser tion that its ban is now WTO-consistent.  Let us 
look for a moment at what, exactly, the EC has done.  As far as the United States can tell in the WT/DS320/R 
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  absence of any explanation by the EC, the EC's "amended" ban simply preserves the status quo  of its 
original ban found by a WTO panel and the WTO Appellate Body to violate the SPS Agreement  in 
1997 and 1998, respectively.  Under the ban, fo und in Directives 96/22/EC and 2003/74/EC, the same 
products that were prohibited entry into the EC al most ten years ago when we first challenged the 
measure still may not enter the EC today. 
3. The six hormones used for growth promotio n purposes according to good veterinary 
practices 
4.165  The six hormones at issue are oestradiol-17 β, testosterone, progesterone, zeranol, trenbolone 
acetate and melengestrol acetate (or "MGA").  These hormones have been used for growth promotion 
purposes in cattle for decades in several countries, and meat from treated animals has been consumed 
by millions of people, without any eviden ce of risk or harm to human health. 
4.166   In terms of human food safety, the six hormones have been studied extensively, by national 
authorities and by Codex, the relevant internationa l standard-setting body with scientific expertise in 
this area.  In fact, the study of these hormones dates back over twenty years.  The consensus 
throughout the course of this study is that meat from cattle treated with these six hormones for growth 
promotion purposes according to good veterinary practices is safe. 
4.167  In stark contrast to the several reviews finding  the use of these hormones to be safe, there is 
one view that the EC portrays as dissenting – that of its Scientific Committee on Veterinary Measures 
Relating to Public Health ("SCVPH"), containe d in the SCVPH's 1999 and 2002 Opinions and 2000 
Review, ostensibly supported by several (17) studies commissioned by the EC.  It is this view which 
the EC now asks the Panel to accept wholesale without any explanation or analysis. 
4.168  It is therefore not surprising that the EC h as been unable to convince several of its own 
agencies of the conclusions set out in its Opinions and studies.  For example, in 1999, a sub-group of 
the United Kingdom's Veterinary Products Committe e dismissed the methodology and conclusions of 
the EC's 1999 Opinion.  Recently, in a May 2005 draft report reviewing the EC's 2002 Opinion and 
the 17 studies, the Veterinary Products Committee (" UK Group") again concluded that it was "unable 
to support the conclusion reached by the SCVPH that  risks associated with the consumption of meat 
from hormone-treated cattle may be greater than prev iously thought."  The UK Group also stated that, 
regarding estradiol 17 β, "there is ample information to show th at zoo-technical and therapeutic uses of 
oestradiol-17 β do not pose any risk to humans unless an active implant site is ingested." 
4.169  Regarding the other five hormones, the majority of the U.K. Group determined that the 
"available evidence on genotoxicity, tumorigenici ty, hormonal activity and endocrine disrupting 
effects was supportive of the view that eating meat  from animals treated with these five hormones was 
unlikely to be harmful to human health."  
4.170  In addition, the EC's own Committee for Veteri nary Medicinal Products ("CVMP"), which in 
1999 evaluated the conclusions of the 1999 Opinion and the new EC studies on oestradiol and progesterone, determined that the EC had not pr esented sufficient new evidence to cause the CVMP 
to conduct a new risk assessment on either hormone or  alter its previous conclusions on their safety.   
4.171  Let me reiterate: these are internal criticisms of the work produced by the EC and of the very 
documents it now asserts bring its measure into co mpliance with DSB recommendations and rulings.  
Despite these criticisms, and despite  the extensive history of study of these hormones finding their use 
to be safe, the EC would have this Panel endorse its  assertion that its new measure is WTO-consistent 
without a demonstration of why this is so.  A determination of an Article 22.8 breach absent a 
thorough evaluation of these documents would not on ly ignore the rules of burden of proof in WTO 
dispute settlement, it would cast aside the substantial history of review of these hormones – a history  WT/DS320/R 
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  that has, time and again, demonstrated that their use for growth promotion purposes according to good 
veterinary practices, is safe for consumers. 
4. The EC's assertion of its own compliance 
4.172  Contrary to the EC's argument, a WTO Member may not, in effect, revoke DSB authorization 
to suspend concessions, and consequently establish a breach of Article 22.8 of the DSU, by simply 
asserting that it has brought its measure into complia nce.  This interpretation ignores the rules of 
burden of proof in WTO dispute settlement as well as the Article's text and context. 
5. Burden of proof 
4.173  As a threshold matter, the EC fails to meet its burden of proving that the United States has 
breached Article 22.8 of the DSU.  As the complaining party, it shoulders the burden of proving each element of its claims against the United States.  Ar ticle 22.8 requires that a Member either remove its 
WTO-inconsistent measure or provide a solution to  the nullification or impairment suffered by the 
Member suspending concessions in order to demonstrate a breach.  In other words, for purposes of its 
Article 22.8 claim, the EC must demonstrate how it has in fact accomplished either of these two conditions. 
4.174  The EC's bald assertion of compliance in the c ontext of this scientific and factual landscape 
highlights the fact that it has made no effort to demonstrate how its new import ban satisfies the 
conditions of a "provisional" ban under Article 5.7 of the SPS Agreement  or "rationally relates" to or 
is "reasonably supported" by a risk assessme nt for purposes of Article 5.1 of the SPS Agreement .  Its 
mere assertion that it can invoke Article 5.7 for the five hormones, and that it has developed a proper 
risk assessment for the sixth and that its ban is now  based on such an assessment is not sufficient to 
demonstrate that it has removed its WTO-inconsiste nt measure or provided a solution to the EC's 
nullification or impairment of benefits, and thereb y does not satisfy its burden of proof and make its 
prima facie case. 
6. "Presumption of good faith" 
4.175  In lieu of an attempt to satisfy its burden of proof, the EC argues the existence of a 
presumption or principle of good faith.  Or, at least  such a presumption applied selectively on the EC's 
terms.  For the EC, the presumption applies to its uni lateral declaration of compliance, but apparently 
does not apply to a Member's suspension of con cessions in accordance with a DSB authorization. 
4.176  In support of its argument, the EC cites dicta from WTO disputes in which panels, arbitrators, 
and the Appellate Body are simply elaborating on the appropriate burdens of proof in WTO dispute 
settlement.  It is unexceptional an d uncontested that, in a dispute, the complaining party bears the 
initial burden of proof to establish its claims of a WTO violation, and that there is no presumption of 
bad faith with respect to the responding party.  Were it otherwise, complaining Members would not 
have to mount any case whatsoever to demonstrate a WT O violation.  They could simply allege that it 
was so and prevail. 
7. The EC's interpretation of the DSU 
4.177  The EC claims that the United States has br eached Articles 21.5 and 23 of the DSU by 
continuing to suspend concessions to the EC despit e its claim of compliance.  However, the EC's 
analysis of these provisions is not consistent with their terms, nor does it reflect the fact that the 
United States' DSB authorization remains valid. WT/DS320/R 
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  (a) Article 21.5 
4.178  For instance, the EC reads into Article 21.5 of the DSU an obligation that a Member duly 
authorized to suspend concessions must request an Article 21.5 panel the moment that another 
Member declares its own compliance with DSB reco mmendations and rulings.  However, nothing in 
Article 21.5's text hints at such an obligation.   Indeed, the DSU simply does not prescribe the 
particular procedures to follow in a situation wh ere the DSB has granted authorization to suspend 
concessions to a Member, and the implementing Member  later claims to have complied.  Rather, it 
leaves open to the parties to choose one of various means to proceed, including bilateral consultations, 
use of good offices, conciliation and mediation under Article 5 of the DSU, recourse to DSU 
Article 21.5, arbitration under Article 25 of the DS U, and recourse to normal panel proceedings such 
as we are party to here.  
4.179  Despite this fact, the EC would instead re move all alternatives except an Article 21.5 
compliance proceeding and would read into that Arti cle a deadline that is not there.  The EC would 
also read into Article 21.5 an obligation for th e complaining Member, and only that Member, to 
invoke Article 21.5.  The EC does not base its proposed  approach on the actual text of the Article, but 
rather constructs a series of policy arguments as to  why the DSU should be re-written in the manner it 
desires. 
4.180  There are three basic shortcomings in the EC's Article 21.5 analysis.  First, Article 21.5 only 
applies in situations where there is a disagreement  regarding the WTO-consis tency of a measure taken 
to comply.  Prior to the EC's request for the establis hment of this Panel (and so by definition prior to 
the EC's request for consultations), the United Stat es had not formulated an opinion as to the WTO-
consistency of the EC's ban. 
4.181  Second, Article 21.5 does not contain any time limitation or deadline by which a Member 
must initiate dispute settlement proceedings – a poi nt emphasized by the fact that there is often 
substantial delay between claims of compliance and the initiation of Ar ticle 21.5 proceedings 
(presumably responding Members normally welcome such delays since they would not be in a hurry to have their claims of compliance questioned before  a panel).  The EC's interpretation of Article 21.5 
would prevent Members such as the United States from exercising any judgmen t as to the fruitfulness 
of dispute settlement prior to finding themselves obligated to do so and would similarly preclude 
Members from seeking mutually agreeab le solutions through negotiations. 
4.182  Third, and finally, the EC argues that the Unite d States was obligated to seek recourse to an 
Article 21.5 compliance panel, and only such a pane l, upon hearing the EC's declaration.  However, 
the text of Article 21.5 simply refers to "these dispute settlement procedures," without specifying any 
particular subset of procedures.  Therefore, the EC's argument that the United States was specifically 
obligated to initiate a compliance pro ceeding under Article 21.5 is groundless. 
(b) Article 23 
4.183  In addition to its claim of a US breach of Artic le 21.5, the EC also contends that the United 
States has breached Article 23.1 by seeking redress of a perceived WTO violation without recourse to dispute settlement and made a "determination" of th e WTO-consistency of the EC's ban in breach of 
Article 23.2(a).  We have done neither. 
4.184  The United States was not obligated to seek r ecourse to dispute settlement pursuant to the 
general rule set out in Article 23.1 once the EC d eclared its own compliance at the DSB.  The United 
States adhered to the letter of Article 23.1 by seeki ng redress of the nullification or impairment caused 
by the EC's import ban through recourse to the provisions of the DSU.  The multilaterally-authorized 
suspension of concessions stemming from US recourse to  dispute settlement remains valid to this day.   WT/DS320/R 
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  It is unaffected by the EC's unilateral declaration of compliance, and the EC has failed to demonstrate 
to the contrary. 
4.185  Similarly, the United States has made no Article 23.2(a) determination as to the WTO-
consistency of the EC's amended ban.  Since r eceiving authorization to su spend concessions to the 
EC, we have simply continued to act according to that  authorization.  Contrary to the EC's claims in 
this panel proceeding, we have made no determinat ions regarding the WTO-consistency of its import 
ban, amended or not.  We did not have to make an y further determinations in  order to continue to 
suspend concessions.  Article 22.8, discussed earlier , sets the parameters for when we would no 
longer have been authorized to do so.  The EC h as made no effort to demonstrate that any of the 
conditions of that Article have been met. 
8. Conclusion 
4.186  For all the reasons discussed above and in its  first written submission, the United States 
respectfully requests the Panel to reject  the EC's claims in their entirety. 
9. Concluding statement of the United States 
4.187  The United States has actively engaged in this w eek's debate, examined in detail provisions of 
the DSU and the facts of this dispute.  Taking into account all of these discussions and facts, it becomes clear that we find ourselves here today for a simple reason: the EC, a WTO Member who 
claimed to have come into conformity with DSB recommendations in the EC – Hormones dispute, did 
not want to undertake the effort of explaining why th is was indeed the case.  It chose not to attempt to 
satisfy its burden despite its eagerness to have the suspension of concessions lifted, and despite its 
possession of new Opinions and studies it so confid ently alleged to support its ongoing ban.  It has 
chosen not to make this attempt despite several ave nues available to it in the current text of the DSU, 
including Article 22.8 (as well as Articles 5 and 25).   
4.188  Instead, it chose to seek a suspension of sancti ons in the most roundabout way possible – by 
alleging that the United States, by not lifting its suspension of concessions, breached its obligations 
under elaborate, intertwining interpretations of the DS U.  This choice is remarkable given the fanfare 
that the EC attached to its ban and Opinions.  On e would have thought that an Article 22.8 finding 
that it had removed the ban or provided a solution to  nullification or impairment would have been a 
logical and simple approach. 
4.189  Yet, the EC did not pursue this straightforwar d course.  Instead, it alleged that the United 
States had made a unilateral determination that the EC's new ban was not WTO-consistent.  In this, it 
ignored the fact that the United States has been suspending concessions to the EC pursuant to DSB 
authorization.  Moreover, having eschewed Article  22.8, the EC could not identify a standalone 
provision in the DSU regarding which it could alle ge a US breach.  So, rather than looking to 
Members' obligations as they currently exist in th e text of the DSU, the EC concocted two claims, 
melding and rewriting provisions of the DSU, and c ontending that it has demonstrated that the US 
suspension of concessions can no longer be applied. 
4.190  The EC asserts that these claims are a "refinemen t" of the individual claims described in its 
panel request.  However, rather than becoming more  clear or "refined", the EC's claims blending 
multiple DSU provisions have become more and more  muddled.  I would like to take a moment to 
discuss a few of these "in conjunction with" claims. 
4.191  I would first reiterate a question raised in Tuesday's session, and add one additional question 
for future consideration.  In that meeting, the United States asked the EC whether it still alleged a US 
breach of Article 21.5 of the DSU per se.  I would now ask a further question: does the EC still allege WT/DS320/R 
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  that the United States has breached Article 22.8 of the DSU?  Why do I ask if there is a violation of 
these provisions per se ?  Because the EC has failed to identify, an ywhere in the text of either Article, 
an obligation breached by the United States, and those are the only breaches possible under the DSU 
as currently written.  Instead, the EC cloaks its alle ged claims of breach "in conjunction" with claims 
of breach of other DSU provisions, ranging from Article 3.7 to Article 23. 
4.192  The EC's repeated invocation of the phrase "in conjunction with" does not make the EC's 
interpretive approach any more credible.  To the c ontrary, the phrase should be viewed as a signal that 
the argument which follows is based not on the text of the DSU, but on how the EC would like to see 
the DSU rewritten.  Or, at least, how it would like to see the DSU rewritten for purposes of this 
dispute. 
4.193  From our standpoint, it is impossible to tell if , through these "in conjunction with" claims, the 
EC still alleges an actual US breach of these provi sions (Articles 21.5 and 22.8).  Ironically, the EC 
refers to our attempts to respond to their jumbled claims on an individual, article-by-article basis as 
"obfuscat[ion]", yet it has told us all that, if the Panel makes a finding in its favour on one of these "in 
conjunction" claims, it expects very real, individu al, un-conjoined breaches of  Articles 21.5 and 22.8 
to be an integral part of those findings.   
4.194  According to the EC, an analysis of the black-and-white text of Articles 22.8 and 21.5 is 
"obfuscation," since these can only be analysed "in c onjunction with" other provisions.  In particular, I 
would highlight the following quotes from the EC's oral statement: 
"This Panel is asked to find whether,  under Article 23, in conjunction with 
Article 21.5, a Member has an obligation ..." but that "[i]t is not relevant for this 
dispute what obligations can be found directly in 21.5 in the absence of such 
unilateral conduct." 
"The defending parties ... ignore that the European Communities makes its systemic 
claim under Article 22.8, in conjunc tion with Article 23.1 .  Thus, the Panel is called 
upon to decide whether or not the cond itions under Article 22.8 are fulfilled in view 
of the prohibition under Article 23 ..." 
4.195  The EC's non-textual approach appears to be an  attempt to distract from the fact that it does 
not wish to attempt to make its prima facie case of an Article 22.8 breach by demonstrating, pursuant to the actual, current, text of that provision that it has either removed its WTO-inconsistent measure or 
provided a solution to the nullification or impairme nt.  Likewise, it seeks to avoid any analysis of 
what obligations are actually found in the text of Article 21.5, since that provision does not in fact 
obligate the United States to bring an Article 21.5 pr oceeding, nor does it contain a time limitation for 
doing so. 
4.196  Rather than a "refinement" of the EC's case,  these "in conjunction" arguments only make the 
EC's case all the more obtuse – creating in essence a moving target for responding parties.  We are forced to defend ourselves against accusations that we ar e in breach of provisions that do not, in fact, 
exist.  We have exposed in the question and an swer session the potentially confusing outcome of 
recommendations and rulings on some of the EC's claims – an outcome that would result from the 
EC's inability to demonstrate a US breach of a ny of these provisions standing alone.  Fortunately, 
there is a simple way to avoid this confusing outcome  – to look instead to the text of the DSU as it is 
currently written, not as a single Member's policy would have it rewritten. 
4.197  We have demonstrated in our submissions that  Article 21.5 does not contain any obligations 
that the United States could theoretically have breached .  For example, there is no obligation that the 
United States bring a compliance proceeding upon lear ning of the EC's declaration of compliance.   WT/DS320/R 
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  Further, there is no time period, whether that peri od is immediate or is unspecified, indefinable and 
unwritten "reasonable delay" championed by the EC.  Pursuant to this fictional new Article 21.5 
requirement developed by the EC, if a Member re quests an Article 21.5 panel "a month or two – 
rather than two years – into implementation" it has satisfied its imaginary dead line to do so.  Maybe I 
have not been looking hard enough at the text of Ar ticle 21.5, but I have not been able to locate the 
"reasonable delay" deadline yet.  This is not surp rising, because the EC makes every effort to avoid 
the actual text of Article 21.5.  According to the EC, the fact that we can demonstrate that we have not 
breached the provisions of Article 21.5 is not the poin t – because "[i]t is not relevant for this dispute 
what obligations can be found directly in 21.5." 
4.198  We have demonstrated in our submissions th at we have not breached Article 22.8, which 
requires that the suspension of concessions "only be applied until such time as the measure found to be inconsistent with a covered agreement has been  removed, or the Member that must implement 
recommendations or rulings provides a solution to th e nullification or impairment of benefits, or a 
mutually satisfactory solution is reached."  We have shown that the EC has failed to demonstrate that 
any of these three conditions have been met.  Th ere is no satisfactory solution, no removal of the 
measure, and no provision of a solution to US nu llification or impairment.  Indeed, the EC does not 
engage in a discussion of whether or not it has sa tisfied these conditions whatsoever.  In the eyes of 
the EC any substantive analysis of Article 22.8 would involve analysis of a "(direct) violation" of 
Article 22.8.  Evidently, a direct analysis of a direct violation of the actual text of Article 22.8 is not relevant to this proceeding.  This is the case because,  for the EC, its reference to Article 22.8 in Part I 
of its submission is only to be read "in conjunction with" Article 23.  As a result, the United States is 
evidently left to rebut an "indirect" claim.  Indi rect, that is, in that it evidently does not involve 
analysis of the obligations specifically set out in Ar ticle 22.8.  Not so indirect in that, through this 
Article 22.8 "in conjunction with" Artic le 23 claim, the EC seeks a finding of a very full-fledged, very 
direct US violation of Article 22.8. 
4.199  So, finally, we come to the "central provision"  of the EC's claims against the United States – 
Article 23.  Like it did for Articles 21.5 and 22.8, the United States set out clear arguments, based on the text of this provision as it is currently set out in the DSU.  We demonstrated that, at the 
appropriate time, we sought recourse to dispute settlement and obtained the proper DSB authorization.  
We continued to suspend those concessi ons pursuant to this authorization. 
4.200  It is critical to note that, just because the DS U does not set out an explicit path for Members 
to pursue in this "post-suspension" scenario, it provid es several options by which, pursuant to its text 
as currently written, the EC may have sought review  of its measure.  The EC, contrary to what it 
would apparently have this Pa nel believe, was not without ave nues for obtaining a multilateral 
determination that its measure was or was not WTO- consistent.  For example,  I should reiterate that, 
as we have indicated on several occasions, we find ourselves in a perfectly suitable panel proceeding 
to examine the EC's compliance pur suant to DSU Article 22.8.  While the EC would argue that an 
Article 22.8 claim against the United States, and a n eed to make a prima facie case that it has either 
removed its offending measure or pr ovided a solution to nullification or impairment is only raised in 
its Part II claim, we would note that it is also squarely  before this Panel in the Part I claims set out in 
the EC's first written submission, only in the form of  the opaque "23 in conjun ction with 22.8" claim, 
which evidently sets out an "indirect" Article 22.8 claim. 
4.201  We have also commented that an Article 21.5 compliance panel could be a possible avenue 
for determining whether or not the EC has brought its measure into compliance with DSB 
recommendations and rulings.  The EC has raised various issues concerning a Member bringing a 
compliance proceeding against itself.  Among these, it has argued that the EC –  Bananas 
(Article 21.5)
 proceeding does not demonstrate that a Member  may do so.  In the third party session, it 
responded to another party's comment that, by the ve ry fact that the EC composed an Article 21.5 
panel, it demonstrated that this is a possible ave nue.  However, the EC's dismissal of this comment WT/DS320/R 
Page 38 
 
 
  because the report was not adopted ignored the point being made.  Apart from the fact that the report 
was not adopted for the simple reason that the EC never requested its adoption, it is unclear why 
adoption or lack of adoption of the report has any bearing on the simple fact that the EC was indeed 
able to request the Article 21.5 panel. 
4.202  I would now like to turn to Part II of the EC's argument. 
4.203  Part II of the EC's argument, its "direct" Article 22.8 claim against the United States, is the 
embodiment of what this case would look like if th e EC chose to put its amended measure forward for 
multilateral review.  That the EC has brought this claim is testament to the fact that it is possible to do 
so, that it is possible for an implementing Member to put its measure squarely before an Article 6 
panel and to seek multilateral review and finding s of the WTO-consistency of that measure. 
4.204  The issue of burden of proof came up in yesterday's meetings, and I think that we should 
touch upon it at this point.  Yesterday, the EC  expressed its concern regarding what would be 
involved in setting out a prima facie case of rem oval of its measure or providing a solution to 
nullification or impairment for purposes of an Artic le 22.8 claim against the United States.  I think 
that everyone here would agree that this is not exactly an insurmountable task, in particular, for a 
Member like the EC who has just spent the last  six years producing studies on these hormones and 
developing Opinions evaluating those risks.  The EC believes its ongoing ban is tied neatly to these 
studies and Opinions, and one would think it of little  consequence for the EC to explain why it felt 
justified in declaring itself to be in complian ce with the DSB's recommendations and rulings, why it 
believes that its ban on oestradiol-17 β is based on a risk assessment within the meaning of Article 5.1 
of the SPS Agreement , and whether its provisional ban on th e five other hormones satisfied the 
conditions of Article 5.7.  The EC could, for ex ample, have addressed its alleged compliance with 
specific panel and Appellate Body findings.  But the EC did not do so, and instead relies on 
unsupported assertions.  
4.205  It is worth noting that the question of th e precise level of evidence and argumentation 
necessary to establish a prima facie case is rarely at  issue in WTO dispute settlement, for the simple 
reason that both sides typically engage on the merits, allowing the panel to evaluate the totality of the 
evidence presented to determine whether the r esponding party has adequately rebutted the 
complaining party's arguments.  Indeed, the Un ited States in this proceeding has engaged on the 
substance of the EC's new studies as if the EC had attempted to make its prima facie  case.  The EC's 
failure to actually do so, and its reliance in this di spute on creative redrafting of the DSU, says more 
about the EC's lack of confidence in its own scientific evidence than it does about the supposed 
difficulty of understanding how to establish a prima facie  case. 
G. SECOND WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES  
1. Introduction  
4.206  The European Communities' case is straightfo rward.  WTO Members that apply sanctions 
against another WTO Member cannot adopt a lean-b ack-and-wait-attitude over years and continue to 
suspend concessions in the presence of a subseque nt compliance measure.  Just as WTO Members 
who have been found to be in violation of the covered agreemen ts have a positive obligation to 
implement, so have retaliating Members a positiv e obligation under Article 22.8 not to apply 
sanctions any more and/or, if they disagree with the compliance measure, to initiate WTO proceedings under Article 21.5.  This has always  been the practice in WTO proceedings.  If a 
retaliating WTO Member fails to respect these ru les and procedures under the DSU, it will be in 
violation of Articles 23.1 and 23.2(a).  WT/DS320/R 
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  2. PART 1: Violation of Articles 23.1, 23.2(a), 21.5 and 22.8 of the DSU (systemic issues) 
(a) The United States is in violation of Article 23. 1 and 23.2(a) read together with Article 21.5 
4.207  The existence of a DSB authorization does not exclude that a WTO Member is still seeking 
the redress of a violation within the meaning of Ar ticle 23.1. The very fact of applying sanctions 
implies that a Member is seeking to redress a viola tion.  Such an application of sanctions may be 
justified if a measure by a WTO-Member has been properly found to be WTO-inconsistent and, if on 
that basis, the DSB authorizes th e suspension of concessions. However, the situation is different 
regarding the continuation  of sanctions in the presence of a compliance measure which the DSB has 
never found to be WTO-inconsiste nt or which has not even been challenged.  In such case, a DSB 
authorization which has been granted in view of an  original WTO-inconsistent  measure can not justify 
the continued application of sanctions against a diffe rent measure.  Rather, since the application of 
sanctions requires a causal relationship to a WTO-inconsistent measure, any present  application of 
sanctions must be linked to a present  measure, i.e. violation.  Conversely, the present  application of 
sanctions to a past, no longer existing measure is not justifie d just as it would be unjustified to link the 
present  application of sanctions to a future , not yet existing measure.  
4.208  The US counter-argument would lead to the absurd result that the United States could 
continue to apply sanctions irresp ective of any events occurring afte r the DSB authorization and thus 
ignoring the object and purpose of sanctions, i.e. to induce compliance and to rebalance rights and 
obligations in case of a WTO violation.  If the Un ited States applies sanctions merely because of the 
existence of a DSB authorization and irrespectiv e of a subsequent compliance measure, they are 
neither inducing nor rebalancing anything.  The Unit ed States fails to acknowledge that the situation 
has changed by the adoption of the EC implemen ting measure.  Yet, since the United States has 
adopted a negative position on the EC compliance me asure and since the United States has been under 
no obligation to continue the suspension of concessi ons, the very fact that it nevertheless continues 
the application of sanctions proves that despite its claim to the contrary the United States is indeed 
drawing a causal link between the continuation of the suspension and the determination of 
inconsistency of the EC compliance measure.  
4.209  The opposite US view would lead to the c onclusion that the United States is currently 
applying sanctions against a no longer existing measure, because it is uncontested that the original 
measure which the DSB found inconsistent has been  removed by the EC.  However, the true reason 
for the US application of sanctions is that it cons iders the existence of an "import ban" as such as a 
violation.  The United States does so on the basis of a unilateral determination since the current 
import ban is a totally new measure which has neve r been found WTO-inconsistent.  Thus, in the 
presence of a compliance measure the United States assumes a right to determine unilaterally whether 
this measure is sufficient or not.  Furthermore, th e fact that the United States seeks redress is also 
evidenced for instance by its st atement in the 2005 Trade Policy Agenda whereby the United States 
openly links the continued application of sanctions  to the EC compliance measure.  Conversely, the 
United States did not state that it continues to apply sancti ons because of the DSB authorization.  
4.210  The United States has also made a unilateral "d etermination" that a violation has occurred. 
The term "determination" is defined, inter alia , as an "authoritative opinion"; "a conclusion reached"; 
"the action of coming to a decision"; "the result of this"; "a fixed intention".  This term has been 
further elaborated by the Panel in US – Section 301 .  Thus, even an implicit determination by the 
appropriate behaviour, such as the continuation of sa nctions, would be covered by a "broad reading" 
of this requirement, in particular if the con tinuation occurs deliberately and is accompanied by 
respective statements. 
4.211  Moreover, the interpretation of the word "deter mination" should be guided by the context of 
Article 23.2(a), which is Article 23.1, and the object  and purpose of this provision.  This provision as WT/DS320/R 
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  a whole aims at preventing that a Member takes "the law in its hands" and seeks the redress of a 
violation on the basis of a unilateral determination.  The importance of this general principle is also 
confirmed by the title of this provision. The cr ucial importance of Article 23 has also been 
acknowledged by the Panel in US – Section 301 .  It is therefore necessary to look at a Member's 
behaviour as a whole when confronted with a respec tive situation.  If a WTO Member repeatedly and 
consistently states that a violation by another Member exists and, in this context, this Member applies 
concrete measures against the other Member, it can be concluded that this Member is seeking a 
redress against a violation on the basis of a unilatera l determination.  Applying these principles to the 
present case, there can be no doubt that the United States has made a unilateral "determination" of 
non-compliance of the EC measure.  This is demons trated by the 2005 Trade Policy Agenda and, for 
instance, the US statement in the DSB meeting of  December 2003.  In addition, it deliberately 
continues to apply sanctions against the European Comm unities.  Contrary to what the US purports, 
this continuation is also a positive ac tion and not just some "inaction".  
4.212  The European Communities adopted and notified its compliance measure over two years ago. 
To these two years one could add another three ye ars since the European Communities notified its 
legislative proposal to the SPS Comm ittee in November 2000.  Against this time lag it is not credible 
for the United States to argue that it has still not made a determination.  Rather the US attitude is 
explained by the attempt to declare its rights sacros anct and to refuse any responsibility for a prompt 
resolution (see Article 3.3) of the dispute. 
4.213  Finally, Article 23 in conjunction with Article  22.8 obliges a retaliating Member to take note 
of a compliance measure and to decide if the con tinued application of sanc tions is still justified. 
Furthermore, Article 23 prohibits ma king a unilateral determination of non-compliance .  Conversely, 
nothing prevents the United States under Article  23 to make a unilate ral determination of compliance . 
Thus, unlike what the United States pretends Article 23 does not prohibit any "determination". 
4.214  The European Communities considers that, by re fusing to initiate a compliance proceeding in 
this situation, the United States is in breach of Ar ticle 21.5.  Contrary to what the United States 
purports, there exists a "disagreement" between the European Communities and the United States.  
The term "disagreement" is defined as "a refusal to  accord or agree, difference of opinion, quarrel".  
The US attitude towards the EC compliance measure cannot escape this basic definition in the light of 
its statements and the continuation of sanctions.  There is no contradiction between Articles 21.5 
and 23.  Article 23 does not apply to any sort of "disagreement' but only in case of a "determination" of a violation which a Member is "seeking to redr ess".  This is exactly what the United States is 
currently doing.  In any event Article 23 contai ns an explicit reference to dispute settlement 
proceedings, which includes Article 21.5 of the DSU.  Thus, had the United States invoked a 
procedure under Article 21.5 of the DSU, it would ha ve fully satisfied Article 23.2(a) of the DSU.  
4.215  Finally, it is appropriate to read into Ar ticle 21.5 a reasonable timeframe until which a 
retaliating Member can be expected to decide wh ether an implementing member is WTO consistent 
and whether to launch a compliance proceeding.  This  is not to be confused with a "deadline" as the 
United States asserts.  According to Article 3.3, disputes should be settled "promptly".  Also, every 
treaty must be performed in good faith, according to  Article 26 of the Vienna  Convention.  Moreover, 
Article 21.5 provides that a Panel has 90 days to  determine whether an implementing measure is 
WTO-consistent.  If a Panel can be asked to decide in 90 days whether there is compliance, it is not 
acceptable that a retaliating Member argues eight times as long that it cannot determine the consistency of the measure. This is even more re levant in a case like this one which involves the 
continued application of sanctions.  
4.216
 Regarding the US argument about alternative procedures other than Article 21.5 the US 
conceptual approach is not clear.  In any case, Article 21.5 literally provides for a specific panel 
proceeding in case there is a disagreement about the WTO consistency of a compliance measure.  This  WT/DS320/R 
 Page 41 
 
 
  is consistent with Article 3.3. Contrary to what the United States asserts, Article 21.5 is therefore not 
purely a matter of political opportunity in particul ar if at the same time it assumes the right to 
continue to sanction the implementing WTO Member .  As explained in detail in its second written 
submission, the European Communities considers that the US examples in this respect demonstrate an 
extraordinary denial of any responsibility for the well-functioning of the di spute settlement system 
and the prompt settlement of disputes.  This is al so corroborated by the US reply to Questions 46 and 
42 of the Panel where the United States first misch aracterizes the correct implementation in this case 
and, second, where the United States contradicts it self regarding its alleged interest for a quick 
resolution of the dispute.  Finally, the special procedure under Article 21.5 is also not overridden by 
any alternative means such as good offices, conciliati on, mediation or arbitration under Articles 5 and 
25 which are neither enforceable nor legally binding.  
4.217  Regarding the self-initiation of an Article  21.5 proceeding the European Communities 
demonstrated that also in the light of the Bananas  case, the whole approach does not work and it 
would be inconsistent to the logic of the DSU as well as specific provisions such as Article 6 or 1.1.  
(b) The United States' continued suspension of concessi ons and related obligations is in violation 
of Article 23.1, read together with Articles 22.8 and 3.7 
4.218  The European Communities disagre es with the US assertion that the continued application of 
the sanctions is unrelated to the EC compliance me asure.  Since the original EC measure has been 
removed, the US argument would mean that the US is currently applying sanctions against a non-existing measure.  Such a conclusion would no t only be illogical it would also be in plain 
contradiction with the purpose of sanctions, namely to rebalance rights and obligations and to induce 
compliance in the light of a current WTO violation.  As explained several times, it is obvious that the 
United States continues to apply the sanctions b ecause it considers the EC compliance measure as 
WTO inconsistent.  However, the continued appli cation of an "old" DSB authorization cannot be 
justified against a "new" measure on which the DS B authorization is not based and if this new 
measure has never properly been found to be WTO-inconsistent. 
4.219  Contrary to what the United States asserts th e prohibition to continue the application of 
sanctions under Article 22.8 does not depend on wh ether the DSB authorization has been formally 
removed.  Article 22.8 is unequivocal in the sen se that the suspension of concessions and related 
obligations may only be "a pplied" until the inconsistency of th e measure has been removed.  In 
addition, Article 22.8 subjects the application of  sanctions to a measure which has been found 
inconsistent.  Yet, this can only occur throug h a proper proceeding under WTO but not through a 
unilateral determination. Article 22.8 is also of  self-executing nature and the termination of the 
application of sanctions under this provision does not depend on a specific finding of the DSB or a 
withdrawal of the DSB authorization.  Rather, once the conditions under Article 22.8 of the DSU are 
met – including in the presence of an unchallenge d compliance measure – the application of 
suspension "shall" automatically stop.  
4.220  Finally, the European Communities does not agr ee with the US that the principle of good 
faith is not relevant for WTO proceedings in general or only relevant for the issue of burden of proof. 
This radical position is not supporte d by the general public internationa l law, which also applies to the 
WTO, as for instance expressed in Article 26 of the Vi enna Convention.  In this context, the European 
Communities also considers that due to the specifi c circumstances for the adoption of its compliance 
measure as explained in detail in its  various submissions and in the absence of a concrete challenge by 
the United States and in the light of the time that  has passed since the measure was prepared and 
adopted, it is fully entitled to invoke the principle of good faith and the presumption of compliance.  WT/DS320/R 
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  3. PART 2: The WTO-consistency of the EC compliance measure  
4.221  The European Communities, in its Oral Statemen t at the first substantive hearing as well as in 
a number of replies to the Panel's questions, has e xplained the various steps undertaken to carry out 
the comprehensive risk assessment which led to the adoption of its implementation measure, i.e. the 
revised Hormones Directive 2003/74/EC.  As the Appellate Body found that the studies and other evidence presented by the European  Communities was relevant but not  sufficiently specific, the 
objective of the compliance effort undertaken was to  re-assess all existing and most recent data from 
any relevant source for the six hormones and to comple ment these data in particular in three respects, 
namely: (a) on certain issues regarding specific he alth risks from residues in meat treated with 
hormones for growth promotion purposes, (b) on  risks arising from possible abusive use and 
difficulties of control, and (c) on an appropria te risk assessment for melengestrol acetate (MGA), 
which had not been carried out so far.  To this effect the European Communities launched 17 specific 
studies and tried to collect information from all relevant sources, including from third countries, 
international scientific bodies (such as JECFA) and i ndustry.  All these steps were undertaken in full 
transparency and after consulting the relevant sci entific committees and bodies that are responsible 
under Community law to conduct this kind of assessment. 
4.222  In November 1998, the European Communiti es mandated its Scientific Committee on 
Veterinary measures relating to Public Health (SCV PH), to address the potential risks to human health 
from hormone residues in bovine meat and meat products treated with the six hormones for growth promotion.  The SCVPH adopted its opinion unanim ously taking into account all pertinent scientific 
information available at the time, including JECFA' s revised assessment of the three natural hormones 
oestradiol-17 β, testosterone and progesterone that had b een issued in February 1999.  The 1999 
Opinion concluded that a risk to the consumer had b een identified with different levels of conclusive 
evidence for the six hormones evaluated.  Subsequent ly, the SCVPH was twice requested to review its 
opinion in light of new assessments carried out by other bodies or institutions and new evidence.  The 
SCVPH did so in 2000 and 2002.  The SCVPH concluded both times that the new evidence did not provide convincing data and arguments demanding revi sion of its previous conclusions.  On the basis 
of the above scientific risk assessments provided by  the SCVPH, the competent European regulatory 
authorities carried out an analysis of risk manageme nt options in light of the appropriate level of 
protection it had chosen.  This lead to the adoption of the EC compliance measure 2003/74/EC.  
4.223  As explained in detail in the second writte n submission, JECFA's assessment proved 
insufficient in various respects and where the SCVPH conducted a more thorough analysis.  These areas concern carcinogenicity  of the three natural hormones and the outdated residues data  as well as 
for data concerning the dose-response relationship.  In  respect of the latter, JECFA also neglected the 
endogenous production in the case of pre-pubertal children.   Furthermore, the 1999 JECFA report has 
been seriously undermined by recent developments concerning the bioavailability of residues of these 
hormones.  JECFA also failed to address the possibilities for misuse or abuse  when the administration 
of these hormones is freely authorised "over the c ounter", as is the situation in the United States. 
4.224  Turning to the legal arguments, the European  Communities disagrees with the US arguments 
regarding the burden of proof.  The European Commun ities, at the oral hearing and in reply to the 
Panel's questions, has demonstrated a violation of Articles I:1 and II of the GATT 1994 by the US and 
that the measure found to be inconsistent has been  "removed" in the context of a direct claim under 
Article 22.8.  In particular, the European Commun ities has pointed out that it cannot be required to 
prove a negative, namely that there is no violatio n of WTO obligations.  In line with the established 
case law of the Appellate Body, it is for the United Stat es, in this case, to set out a prima facie case of 
violation, and not for the European Comm unities to set out a case of non-violation.  WT/DS320/R 
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  (a) Article 5.7 of the SPS Agreement  
4.225  In respect of the provisional prohibition of the relevant hormones under Article 5.7 SPS the 
European Communities considers that the complianc e measure fully respects the respective standard. 
As regards the "insufficiency" of the scientif ic evidence for conducting a risk assessment the 
European Communities recalls that: (1) what th e European Communities had considered to be 
sufficient evidence had been found to be insufficien t by the Appellate Body and proved indeed to be 
insufficient also in the light of risk assessment standards that were developed in the years after the 
Hormones decision; and (2) the body of evidence, in th e meantime, has developed and, while still not 
providing enough knowledge to carry out a complete  and definitive risk assessment, supports the 
conclusion that precautionary measures are required in order to achieve its chos en level of protection. 
4.226  As further detailed in its Written and Oral Submissions the European Communities considers, 
on the basis of the 1999 – 2002 SCVPH opinions, that the current evidence is full of gaps in pertinent 
information and important contradi ctions that render the conclusions reached by JECFA in 1988, 
1999 and 2000 no longer valid.  Thus, it does not allo w, in qualitative or quantitative terms, the 
performance of an adequate assessme nt of risks as required under Article 5.1 and as defined in Annex 
A to the SPS Agreement .  Furthermore, since the latest risk assessment by the SCVPH in 2002, there 
appeared internationally a number of further scien tific developments all of  which converge toward, 
and provide further support to, the conclusions r eached by the relevant scientific committee of the 
European Communities, such as a study supported by the Ohio State University, the US National 
Cancer Institute and the US Department of Defe nce Breast Cancer Research program concerning 
zeranol (and oestradiol-17 β) or a large scale epidemiological study in Europe suggesting that high red 
meat intake is associated with (statistically signif icant) increased colorectal cancer risk, confirming 
results from previous smaller studies.  Additionally,  in 2002 results were published from the women's 
health Initiative Randomised Controlled Trial findings  indicating that the risks outweigh the benefits 
from the use of oestrogen plus progestin in hea lthy postmenopausal women, thus reinforcing the 
previous findings made by the IARC in this resp ect.  All this evidence and most recent scientific 
developments have now clearly tipped the balance against the previously held assumption (by the US 
and Codex/JECFA) that residues of these hormones in meat from animals treated for growth 
promotion pose no risk to human health.  
4.227  Consequently, the evidence which served as the basis in the 1988 and 1999-2000 JECFA 
evaluations of these hormones is not sufficient to pe rform a definitive risk assessment, in particular by 
the WTO Members applying a high level of health pr otection of no risk from exposure to unnecessary 
additional residues in meat of animals treated with hormones for growth promotion.  To deny the existence of this new scientific reality would deprive the European Communities and other WTO 
Members of their autonomous right to choose their a ppropriate level of protection, because it would in 
effect impose on them a requirement to demonstrat e positively the existence of clear harm, which they 
may not always be able to fulfil in case of cancer because of the long latency period and the numerous 
confounding factors that play a role.  This will re nder the application of Article 5.7 impossible in a 
situation where the body of the pertinent scientific  evidence is in the process of moving from a state 
of presumed "sufficiency" into a state of pertinent "i nsufficiency".  The text and preparatory history of 
the SPS Agreement  do not support such a (restrictive) construction of Article 5.7, which would 
moreover be against the principle of  effective treaty interpretation. 
4.228
 In its second written submission the European Co mmunities has set out in detail the state of 
insufficient evidence as determin ed by the SCVPH for each of the hormones which have been 
provisionally (progesterone, testosterone, tr enbolone, zeranol, MGA) prohibited by the 
Directive 2003/74/EC.  
4.229  As regards progesterone, the US has not pointed  to relevant evidence to rebut the SCVPH 
conclusions.  The US instead merely relies on old JECFA conclusions which have been overtaken by WT/DS320/R 
Page 44 
 
 
  more recent studies in 2002.  Equally erroneous is the US' reference to the CVMP's opinion which is 
irrelevant for the purposes of this dispute as it concerns an assessment of progesterone for 
zootechnical and therapeutic purposes.  In any case,  even the CVMP's assessment pointed out that 
only few recent data were available for re-evalua tion of the carcinogenic and/or genotoxic properties 
of progesterone and had concluded that the compound (1) is not genotoxic in most of the tests performed and (2) increases tumor incidences in animals at exposure levels clearly above the 
physiological levels. 
4.230  As regards testosterone, the US other than referring to the 1999 JECFA assessment, does not 
put forward any specific argument.  However, the JECFA assessment had been addressed by the 
SCVPH in 1999.  As pointed out above with re gard to progesterone, the US' reference to the 
epidemiological studies on the effects of the horm ones on post-menopausal women, in the context of 
an assessment of testosterone, is equally errone ous.  Furthermore, as regards the US' comparison 
between bulls and steers and which have different en dogenous testosterone leve ls very much depends 
on the age at slaughter, the breed used, and the type of husbandry employed in rearing these animals. The US argument is therefore at best irrelevant in  deciding the central issues of the present dispute. 
4.231  As regards trenbolone, the US does not put fo rward any specific argument as to why the 
evidence assessed by the SCVPH would not be insuffic ient.  As a matter of fact, the only assessment 
on trenbolone publicly available is that of JECFA 1988.  The SCVPH took into account this 
assessment but disagreed with a number of its b asic findings on the bases of more recent scientific 
evidence, some of which was generated by the 17 EC studies.  
4.232  As regards zeranol, the US does not put forward any specific argument as to why the evidence 
assessed by the SCVPH would not be insufficient.  The only assessment on zeranol publicly available 
is that of JECFA which dates back to 1988.  The SCVPH took into account this assessment but 
disagreed with a number of its basic findings on th e bases of more recent scientific evidence, some of 
which was generated by the 17 EC studies.  Moreover, the most recent study on zeranol and the risks 
associated with its administration to meat producin g animals is done by independent US scientists 
mentioned above and it clearly invalidates the findings of the 1988 JECFA opinion.  
4.233  As regards MGA, there is currently no intern ational standard or recommendation on MGA, as 
Codex has not adopted one.  JECFA assessed MGA fo r the first time in 2000 (and in 2004 as regards 
the calculation of the MRL only), but this has not yet led to the adoption of a standard. If one examines the evidence that served as the basis of the 2000 JECFA report it can be seen that nearly all 
the studies referred to therein date from the 1960s an d 1970s.  These very old studies constitute in fact 
the evidence which the defending parties have refu sed to provide to the European Communities, 
despite its repeated requests on the grounds that th ey are confidential.  In the absence of a Codex 
standard, the opinion of JECFA becomes irrelevant, fo r the additional reason that it failed to take into 
account the more recent data generated by the 17  EC studies and the 2002 SCVPH assessment.  The 
US does not put forward any specific argument as to  why the evidence assessed by the SCVPH would 
not be insufficient.  It does not even refer, in this  context, to the fact that MGA, in the meantime 
(2000), has been assessed (for the first time) by th e JECFA and which subsequently has been taken 
into account by the SCVPH in its 2002 Opinion.  Moreover, the US referred to a draft 2005 report 
from the UK CVP in support of its arguments.  Ho wever, even this draft report confirms the 
insufficiency of the current ly available evidence.  
4.234  Contrary to what the US asserts, the EC's co mpliance measure has been adopted on the basis 
of available pertinent information.  In this cont ext, the European Communities would reject the US 
assumption that a risk has to be demonstrated in or der to justify a measure adopted on the basis of 
Article 5.7 of the SPS Agreement .  The whole point of evidence being "insufficient" is that it does not 
allow the clear demonstration of a risk.  If a risk can  be demonstrated, it means that there is sufficient 
evidence to carry out a proper risk assessment.  In  its reply to the Panel Question 68 the European  WT/DS320/R 
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  Communities explained the difference between th e objective or rational relationship between 
sufficient scientific evidence and a measure within the meaning of Article 5.1, on the one hand, and 
insufficient evidence and a measure  within the meaning of Article 5.7, on the other.  Under 
Article 5.1, an objective or rational relationship is required between the evidence and the measure.  
Under Article 5.7 a scientifically established doubt mu st be sufficient.  As explained for each of the 
five hormones, the available pertinent information wh ile being inconclusive in  terms of demonstrating 
a risk, nevertheless points to the possible occurrence of  certain adverse effects, which invalidate or put 
into serious doubts previously held assumptions a bout the safety of these hormones by the defending 
parties and Codex/JECFA. 
4.235  Furthermore, in contrast to the US, the European Communities do es see itself under an 
obligation, under Article 5.7 of the SPS Agreement , to seek additional information.  It has specifically 
laid down that obligation in Directive 2003/74/ EC and the European Communities has already 
undertaken initiatives to seek additional information.   In particular, it has issued a new call for 
scientific data and research from 2002 onwards, on s ubstances with hormonal activity which may be 
used for growth promotion purposes in bovine meat. 
4.236  Finally, the European Communities has not violated its obligation to review the provisional 
measure within a reasonable period of time as argued by the US.  First, it is erroneous for the US to 
apply a review requirement to a measure before that  measure has even come into existence.  That 
shortcoming becomes even more apparent as it raises  the question how the US explains what it is the 
European Communities has actually done between 1998 and 2003 if not to review the measure in 
question.  In the view of the European Commun ities a requirement to review a measure "within a 
reasonable period of time" can only apply after the provisional measure has come into effect.  In the light of the time it took to review the original measure (1998-2002) it can hardly be argued that a 
reasonable period of time has actually already elapsed.   Furthermore, the only new information that 
has come to the knowledge of the European Commun ities until now is the recent draft assessment of 
the UK Group.  That draft report has already been  forwarded to European Food Safety Authority 
(EFSA) for review.  Equally, should the recent cal l for new scientific information yield any new 
evidence, such evidence would also be a ssessed by EFSA without any undue delay. 
(b) Article 5.1 of the SPS Agreement   
4.237  The European Communities has based the permanent prohibition of oestradiol-17 β on an 
appropriate risk assessment.  The European Comm unities has already pointed out in its reply to 
Question 24 of the Panel, the difference between a scientific risk assessment in the narrow sense 
clearly referred to here by the United States and th e risk assessment within the meaning of Article 5.1 
and Annex A Point 4 of the SPS Agreement.  The latter, as has been stated by the Appellate Body, 
also comprises a risk management stage which is the responsibility of the regulator to carry out and 
not of the scientific bodies.  Furthermore, the SC VPH has explicitly based its assessment on the three 
elements of hazard identification, hazard charact erization and exposure assessment recommended and 
applied by the Codex.  A few qualifications, however, apply.  First, risk assessment criteria as they 
have been developed by the dispute settlement bodies are clearly more relevant to the application of 
the SPS Agreement than those developed by international sci entific bodies.  This follows naturally 
from the fact that it is the former's duty and privilege to interpret the provisions of the 
SPS Agreement . 
Second, there is no Codex standard specifically on the risk assessment of effects of residues of veterinary drugs.  There only exists a general st andard on microbiological assessment.  Third, Codex 
techniques or standards exclusively apply to risk assessments on food safety and not to other risk 
assessments such as those for animal health and environm ental risks.  This is of relevance here insofar 
as the SCVPH Opinions also discuss environmental ri sks of the hormonal substances in question and 
some of the 17 EC studies have generated for the first time pioneering results in these areas.  WT/DS320/R 
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  4.238  Regarding the various steps of the risk assessment, the US does not criticize the hazard 
identification by the SCVPH but its hazard charact erization because no or no adequate dose response 
assessment would have been carried out.  However,  the US' equation of hazard characterization and 
dose-response assessment is clearly erroneous.  As de fined by Codex, hazard characterization refers to 
the possibility of either a quantitative  or a qualitative  evaluation.  While a dose-response assessment 
is a quantitative evaluation, a qualitative evaluation may equally be done, in particular in the absence 
of available data on dose-response.  That is conf irmed by the last sentence of the definition which 
recognises that data may not be available on biolog ical or physical agents.  More generally, it is 
confirmed by the Appellate Body which stressed  that a risk assessment within the meaning of 
Article 5.1 does not necessarily require a quantitative  evaluation.  Moreover, it should be further 
clarified that it is generally recognised that for substances which have genot oxic potential (as is the 
case with oestradiol-17 β) a threshold cannot be identified.  Ther efore it cannot be said that there exists 
a level below which intakes from residue should be c onsidered to be safe.  Therefore the fact the 
doses used in growth promotion are low is not of re levance.  Thus, the argument of the United States 
that there is no hazard characterization is incorrect. 
4.239  Regarding the exposure assessment, the US argum ent concerning pathway/residue analysis, 
no risks of abuse and low bioavailability do not dem onstrate that the Opinions of the SCVPH fail to 
complete an exposure assessment as defined by Codex.   Moreover, what the US does also not explain 
is that its own responsible health authorities ha ve, for the first time since 2002, declared that 
oestradiol-17 β is proven to be a human carcinogen and it is now listed as such, since 2002, in the 
USA Annual Report on Carcinogens.  
4.240  The European Communities' ban on oestradiol-17 β is also based on a risk assessment.  
Contrary to what the United States asserts, the SCVPH's assessment supports the ban on 
oestradiol-17 β, but more recent research as referred to in detail in the EC second written submission 
equally confirms that that measure is warranted. 
(c) Article 3.3 of the SPS Agreement  
4.241  The US argues that a violation of Article 3.3 exists because the ban would not be in 
conformity with Article 5.1 of the SPS Agreement .  The European Communities does not contest that 
the ban on oestradiol-17 β is not based on international standards.   The only relevant standard is the 
Codex recommendation on MRLs for oestradiol-17 β.  The European Communities, however, has 
decided not to set MRLs as recommended by Codex, but instead to prohibit the use of oestradiol-17 β 
for growth promotion purposes altogether.  That d ecision is based on a comprehensive risk assessment 
which, as has been demonstrated above is in  full conformity with Article 5.1 of the SPS Agreement . 
H. SECOND WRITTEN SUBMISSION OF THE UNITED STATES  
1. Introduction 
4.242  The United States maintains the measures at issue in this dispute in accordance with express 
authority from the Dispute Settlement Body.  At this poi nt in this dispute, it is clear that the European 
Communities has not, and cannot, demonstrate that  these measures breach US obligations under the 
DSU or the  GATT 1994, nor has nor can the EC demonstrate that other so-called "measures" that it 
challenges in fact existed as of th e time this Panel was established.   
4.243  As the United States has already pointed out, th e EC's arguments relating to its DSU claims 
underscore its inability to meet its burden in this disput e, that is, to demonstrate that it has satisfied the 
Article 22.8 condition of removing the WTO-inconsiste ncies of its measures or providing a solution to 
US nullification or impairment.  Moreover, for the reasons already set forth in previous submissions 
and discussed further below, the EC's arguments th at various DSU provisions can create obligations  WT/DS320/R 
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  "in conjunction with" each other cannot change the fact  that whether a provision is read on its own or 
"in conjunction with" another provision does not a lter the substance of the provision.  Nor can 
unilateral declarations by a Member concerned create a "presumption of good faith." 
4.244  The United States has not breached Article 23 of the DSU.  The United States was authorized 
to suspend concessions by the DSB, and the EC's  declaration of compliance did not cause this 
authorization to lapse, to be revoked or to be susp ended.  The EC's declaration did not mean that the 
United States could no longer apply the suspensi on of concessions without breaching its obligations 
under the DSU.  Nor did the EC's declaration and development of a "new" measure create a scenario whereby US application of the suspension of concessi ons could be considered a "determination" as to 
the WTO-consistency or inconsis tency of the amended ban.   
4.245  Regarding the EC's purported demonstration of  how it has come into compliance, the EC 
merely asserted in its first submission that it had come into compliance.  Notwithstanding the EC's 
failure to even undertake the required demonstrati on, the United States responded in its first written 
submission by explaining in detail that the EC's  import bans, despite DSB recommendations and 
rulings, continue not to be based on a risk assess ment within the meaning of Article 5.1 of the 
SPS Agreement .  Neither are they legitimate "provisional" bans within the meaning of Article 5.7 of 
the SPS Agreement .  The materials put forward by the EC in its replies to questions from the Panel do 
little to change these conclusions.  In fact, in several of its replies, the EC appears to have completely 
shifted its focus from theoretical ri sks posed by the six hormones themselves to a perceived "risk" of 
failure to satisfy good veterinary practices in ad ministering the hormones to cattle in the United 
States. 
2. Legal arguments 
(a) The EC has failed to demonstrate a US breach of DSU Articles 21.5, 22.8 or 23 
4.246  The EC has failed to demonstrate that the Un ited States has breached its obligations under 
Article 21.5 of the DSU.  In fact, the EC has fa iled to link US action or inaction to any obligation 
contained in Article 21.5's text whatsoever.  In stead, it claims that the United States has breached 
Article 21.5 by acting in contravention of Article 23 of the DSU.  The United States has not acted in 
breach of Article 23, and therefore, even under the EC's theory, the United States can not have 
breached any obligations under Article 21.5 of the DSU.  
4.247  Rather than pointing the Panel to a particular  obligation in Article 21.5 of the DSU that it 
alleges the United States breached, the EC instead persists in its argument that a violation of 
Article 21.5 can only be found "in conjunction with" or  when that Article is "read together" with DSU 
Article 23.  In support of this claim, the EC not es that "there is nothing unusual to cite various 
provisions to substantiate a claim.  This follows  actually the same approach the Panel took in the 
dispute US - Certain Measures ."   
4.248  The EC is simply wrong about the approach  that the Panel took, however.  When the 
Appellate Body examined the findi ngs to which the EC is referring, the Appellate Body pointed out 
that "[o]ur reading of the Panel Report does not lead us to conclude that the Panel based its finding of 
the inconsistency of the 3 March Measure with Ar ticle 21.5 on its conclusion that the measure was 
inconsistent with Article  23.2(a) ... The Panel's  references to Article 23.2(a) cannot be construed as 
the basis upon which the Panel reached  its conclusions under Article 21.5
." 
4.249  As the United States has demonstrated, nowher e in Article 21.5 of the DSU is there an 
obligation for the United States to have sought recour se to an Article 21.5 compliance panel, and only 
such a panel, upon hearing the EC's declaration of  compliance.  Nor does Article 21.5 contain any 
time limitation or deadline by which a Member must  initiate dispute settlement proceedings.  Indeed, WT/DS320/R 
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  the EC does not claim that such obligations can be found in the text of Article 21.5.  Yet, it seeks a 
specific finding of a US breach of Article 21.5 just the same.  Taking into account the Appellate 
Body's guidance in India – Patent and  US –  Shrimp , the EC's theory in this dispute ( i.e., a violation of 
Article 21.5 read "in conjunction with" Article 23) h as no textual basis and must therefore be rejected.  
Any analysis of whether US actions have breached Ar ticle 21.5 of the DSU must be based on the text 
of that provision. 
4.250  In addition to its attempt to impute obligations into the text of Article 21.5, the EC provides 
other non-textual arguments in support of its claim of a US Article 21.5 breach.  Primary among these is the EC's reference to a presumption or principle of good faith.  The EC considers that referring to 
such a presumption justifies imputing into Article 21.5 an unspecified and unwritten obligation that 
"[a] retaliating Member has at a minimum a good faith obligation  to assess within a reasonable delay 
the compliance measure".  As noted above, the ke y to interpretation of the DSU, and Members' 
obligations under its provisions, lies in the actual te xt of the provisions.  The text of Article 21.5 does 
not contain a time limitation, let alone what w ould amount to a case-by-case-determined "reasonable 
time period".  Neither does it contain an obligation that, in the post-suspension setting, the suspending 
Member initiate dispute settlement proceedings upo n a declaration of compliance by the Member 
concerned.  "Good faith" applies to implementing th e obligations that are agreed upon by Members, 
evidenced in the text; "good faith" cannot serve to create new obligations that were never agreed by 
Members. 
4.251  Similarly, the EC has failed to make a prima faci e case of a US violation of Article 22.8 of the 
DSU.  Rather than presenting any evidence of how  it has satisfied the conditions of Article 22.8 
(removal of WTO-inconsistent measure; provision of solution to nullification or impairment of 
benefits; mutually satisfactory so lution), it posits its claim "in conj unction with" Article 23 and asserts 
that the "presumption of good faith" or compliance sa tisfies its burden of proof.  Even were one to 
presume that the EC implemented its amended bans  in good faith, this fact would not in turn 
demonstrate that the EC's bans actually satisfy the elements of Article 22.8,  e.g., the EC could be 
acting in good faith, but still be wrong about the WTO-consistency or compliance of its amended 
measure. 
4.252  The United States notes that the EC's interpretation of Article 23, and specifically 
Article 23.2(a), is complicated by a lack of clar ity regarding when, exactly, a determination on the 
part of the suspending Member would be inferred.  Regardless of whether this fictional deadline is a 
"reasonable period" or immediate, the EC's in terpretation establishing such a deadline is not 
sustainable.  Not only would it beg litigation to determine on a case-by-case basis whether a Member 
has unreasonably delayed in making a determinati on, it would convert Article 23.2(a) from a 
prohibition on making determinations into an oblig ation to make them – ironically, a Member would 
in effect be required to make a determination upon learning of a nother Member's declaration of 
compliance, and to do so within some unspecified time frame.   
4.253  Furthermore, as the United States has noted on several occasions, the United States was in the 
course of reviewing the EC's materials at the outset of this dispute.  In light of this fact, it is difficult 
to comprehend how the United States could have ma de a "determination" as to the WTO-consistency 
of the EC's amended bans.  A critical element of th is US evaluation is the review of the studies and 
Opinions ostensibly underpinning the EC's bans.  Specifically, the EC refers to a number of studies 
which it commissioned after the Appellate Body proceedings in the EC –
 Hormones  dispute, referring 
to them as the "17 Studies".  The EC invokes these studies throughout its 2000 Review and 2002 
Opinion, and a review of their methodology and results are therefore critical to an analysis of the EC's 
measure.  However, as noted at the first substantiv e meeting with the Panel, the United States has not 
had the opportunity to review all of these documents, a nd referred to this fact in explaining why it had 
not yet been able to reach a determination of the EC 's Opinions or its bans.  Indeed, the EC has only 
recently informed us of a number of studies – which it contends comprise the basis for its claim of  WT/DS320/R 
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  compliance with the DSB's recommendations and rulings  –  that were not referenced in the EC's 
response to the US request for information under Article 5.8 of the SPS Agreement , through which the 
United States sought all relevant scientific in formation on which the EC premised its bans. 
4.254  Because the EC has failed to demonstrate a US  breach of its obligations under the DSU, there 
can be no "in conjunction with" breach of the objectiv es set out in Article 3.7 of the DSU, even were 
such a claim possible.  
4.255  Because the United States has not breached its obligations under the DSU and continues to 
suspend concessions pursuant to DSB authorization, there can be no US breach of Articles I or II of the GATT 1994.  Any finding of a breach of these prov isions would be premised on a finding that the 
United States did not have authorization to suspend concessions to the EC. 
(b) The EC has neither removed its WTO-inconsis tent bans nor provided a solution to US 
nullification or impairment within the meaning of Article 22.8 of the DSU 
4.256  A determination of whether or not the EC has complied with the DSB's recommendations and 
rulings in the EC –  Hormones  dispute is central to an analysis of  whether or not it has satisfied the 
conditions of Article 22.8 by either  removing its WTO-inconsistent measure or providing a solution to 
US nullification or impairment.  The EC has failed to make its prima facie case of a US breach of 
Article 22.8 of the DSU because it has not demonstrated , other than by simple assertions that it deems 
its own measure to satisfy DSB recommendations  and rulings, how its import bans are now WTO-
consistent. 
(i) The EC has failed to demonstrate that its im port ban is a provisional measure within the 
meaning of SPS Article 5.7 
4.257  Despite several opportunities to present evidence as to why its ban on five of the hormones 
(testosterone, progesterone, trenbolone acetate, zeranol and MGA) is a legitimate provisional 
measure, the EC fails to demonstrate how its ban on meat and meat products from cattle treated with 
these five hormones in fact satisfies the criteria of Article 5.7 of the SPS Agreement .  Because the 
EC's ban fails to meet the requirements of Article 5.7, the EC is therefore not exempt from satisfying 
its obligations under Article 2.2 (measures not to be  maintained without suffi cient scientific evidence) 
and Article 5.1 (measures to be based on a risk assessment) of the SPS Agreement . 
4.258  The simple fact regarding the five hormones at  issue is that international standards and a 
significant body of scientific studies exist on the risks posed by each hormone.  The Joint FAO/WHO 
Expert Committee on Food Additives ("JECFA") and several national regulatory bodies have determined that the scientific ev idence regarding these hormones is adequate or sufficient to conduct a 
risk assessment.  The EC alone alleges that this bo dy of information is not "sufficient" to conduct a 
risk assessment, as required by Article 5.1 of the SPS Agreement , and the EC has only taken this 
position after firmly stating to the WTO several tim es that the information is sufficient and only after 
the WTO finding that the EC had breached its SPS ob ligations.  In so doing, however, the EC does 
little more than assert that this is the case, failing to  cite to any scientific evidence demonstrating risks 
to consumers from the five hormones when used fo r growth promotion purposes in meat according to 
good veterinary practices.  Indeed, our review of the available materials comprising the 17 Studies has 
failed to uncover any new evidence of risk from th e five provisionally banned hormones, further 
casting doubt on the EC's conclusion that evidence relating to these hormones is now somehow 
insufficient. 
4.259  In the case of the five hormones "provisionally" banned by the EC, there is no "pertinent 
information" upon which the EC's import ban can be  based because none of the information presented 
by the EC in its Opinions suggests that meat and meat products from cattle treated with the five WT/DS320/R 
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  hormones for growth promotion purposes according to good veterinary practice pose a risk to 
consumers.  The EC does not consider informati on pertaining to the specific risk in question ( i.e., that 
to consumers ingesting hormones in meat from cattle treated according to good veterinary practices), 
including relevant international standards for the fi ve hormones and their underpinning studies, which 
indicates that hormone residues in such meat are safe.   Instead, the EC restricts its consideration to 
general information or evidence on the hormones – evidence that was considered by Codex and 
JECFA in determining that the hormones do not pose a risk to consumers. 
4.260  Finally, the EC has failed to demonstrate that  it has reviewed its ban within a reasonable 
period of time.  As noted by the Appellate Body, th e "reasonable period of time" is not a fixed period, 
but rather reflects circumstances on a case-by-case basi s.  Furthermore, in determining whether a 
reasonable time has elapsed, one of the factors that  should be taken into account is the "difficulty of 
obtaining the additional information necessary for the review and the characteristics of the provisional 
SPS measure."  In the case of the five hormones bann ed by the EC, as noted above, there is already a 
substantial body of evidence available for completi ng a risk assessment, contradicting the suggestion 
that any "additional information" whatsoever migh t be required to review the amended ban.  In 
addition, the "provisional" ban simply prolongs the original ban, marking over fifteen years that the import ban, the most trade-restrictive measure possible, has been in place.  Taking into account the 
severity of the measure, and the ready availability of information on the five hormones, the EC has 
not reviewed its measure within a reasonable peri od of time within the meaning of Article 5.7. 
(ii) The EC has failed to base its import ban on me at from cattle treated with oestradiol-17 β for 
growth promotion purposes according to good veterinary practices on a risk assessment 
within the meaning of SPS Article 5.1 
4.261  The EC has failed to base its import ban on me at from cattle treated with oestradiol-17 β on a 
risk assessment within the meaning of SPS Article 5. 1.  Indeed, the EC's Opinions and underpinning 
studies fail to demonstrate a risk from residues in  meat from cattle treated with oestradiol-17 β for 
growth promotion purposes according to good veterinary practices.  Instead, the studies on which the 
Opinions rely only succeed in demonstrating theoretic al risks when the hormones are administered at 
doses or levels well-above those present in residues from hormone-treated meat; when good 
veterinary practices are not met; or in ways not germane to the relevant risk pathway. 
4.262  The EC's assumption that oestradiol is ge notoxic is essential to its overall conclusions 
regarding this hormone.  Nevertheless, despite  reaching the conclusion that oestradiol-17 β is 
genotoxic in its Opinions, the EC does not in fact demonstrate through scientific  evidence that this is 
the case.  It fails to provide evidence demonstrating that oestradiol has carcinogenic effects other than 
through the receptor mediated, cell division stimulati ng activity of the hormone – in other words, at 
levels exerting a hormonal effect on consumers, and not at the exponentially smaller levels that would 
be found in meat residues.  The fact that eff ects may be observed at exposure levels above the 
hormonal effect level or threshold is well established,  and is one of the reasons that groups such as 
Codex set acceptable daily intakes ("ADIs") and ma ximum residue levels ("MRLs") at levels 
exponentially lower than this threshold. 
4.263  The EC seeks support for its argument that oestradiol-17 β is genotoxic in a JECFA 
conclusion that "oestradiol-17 β has genotoxic potential", yet fails to cite to the rest of the relevant 
paragraph, in which JECFA notes, "[t]he Committe e reviewed studies of the genotoxic potential of 
oestradiol-17 β.  Estradiol-17 β did not cause gene mutations in vitro .  In some other assays, sporadic 
but unconfirmed positive results were obtained."  Fu rthermore, the EC's citation to the JECFA safety 
assessment ignores its ultimate conclusion, i.e., that a maximum residue level for oestradiol-17 β in 
meat need not be specified because there is a "wid e margin of safety for consumption of residues in 
food when the drug is administered according to good practice in the use of veterinary drugs."   WT/DS320/R 
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  JECFA's conclusion corresponds to that of the EC's  own Center for Veterinary Medicinal Products 
("CVMP").  
4.264  The EC's CVMP, upon review of the 1999 IARC monograph cited in the US Report on 
Carcinogens, as well as the scientific materials comp rising the EC's 1999 Opinion, concluded that 
oestradiol-17 β "belong[s] to the group of non-genotoxic carcinogens" and "exogenous exposure to 
hormones would need to be substantial ( i.e., in the order of post-menopausal therapy levels) before 
carcinogenic effects would be detectable in humans."  These conclusions do not ignore the fact that, at 
physiological, hormonal-effect concentrations, there are carcinogenic risks from oestrogens.  
However, they do not support a theory that oestradiol-17 β is either genotoxic, or will have 
carcinogenic effects, at concentrations present in  meat from cattle treated with the hormone for 
growth promotion purposes according to good veterinary practices. 
4.265  The severe limitations of the alleged "evi dence" for genotoxicity of oestradiol-17 β was also 
noted in the recent 2005 U.K. Report.  In that Report, the Veterinary Products Committee ("VPC") 
concluded that only limited evidence was av ailable to indicate that oestradiol-17 β is capable of 
inducing gene mutations, and cautioned that even this "evidence" has been obtained using non-
standard assays, some of which suffer from flawed experimental design. 
4.266  The EC also asserts that the US argument that oestradiol-17 β is generally inactive when given 
orally, while "well known", is "still controversia l and not consensually accepted by the scientific 
community."  To the contrary, oestradiol's low or al bioavailability has found international support in 
Codex and JECFA ("[i]n general, oestradiol-17 β is inactive when given orally because it is inactivated 
in the gastrointestinal tract and liver"), as well as support within the EC from the CVMP, which noted 
that "the bioavailability of 17 β-oestradiol esters after oral administration is low (3% as unchanged 
oestradiol) , but might be higher if estron, an oestrogenic metabolite, is included."  The EC's assertion 
is also surprising in light of unpublished, EC-gen erated data which the EC only recently provided to 
the US which confirmed the internationally-accepted principle that bioavailability of oestradiol-17 β is 
low in humans.  
4.267  In an attempt to bolster its argument on the bioavailability of estradiol 17 β, the EC cites to 
data it has developed on estrogen le vels in young children.  While it is unclear how this comparison 
relates in any way to a discussion on bioavailability,  we can only assume that the EC makes this 
argument in an attempt to cast doubt on prev iously established standards for estradiol 17 β and the 
other hormones at issue, i.e., that the relevant standard setting groups were not taking into account 
populations identified as more sensitive than previo usly thought.  The EC's argument fails for two 
fundamental reasons: (1) populations such as youn g children were indeed taken into account in 
establishing international standards and domestic requirements for the six hormones; and (2) the 
studies cited by the EC by which it attempts to cast such groups as even more susceptible than 
previously thought are flawed.   
4.268  As to the first point, JECFA, in its saf ety assessment for the hormones, including 
oestradiol-17 β, took into account data on most sensitive populations.  The CVMP, in determining that 
oestradiol-17 β is safe within certain concentrations also took into account data on prepubertal boys.  
As to the second point, the EC's own CVMP and th e U.K. Group raised serious doubts relating to the 
methodology of the Klein assay, and determined that  these concerns were sufficient to cast doubt on 
the conclusions drawn in the EC's Opinions. 
4.269  The EC's Opinions also conclude that meat from cattle treated with oestrogens may accelerate 
the onset of puberty in children.  The EC attemp ts to support this conclusion with a publication 
describing an outbreak of breast enlargement (gyneco mastia) in school childre n in Milan in 1977.  
The study's authors state that oestrogenic contamin ation of meat served in the school canteen was the 
"suspected" cause of breast enlargement.  However,  the presence of oestrogen in meat consumed by WT/DS320/R 
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  the students was never confirmed and a causal link be tween oestrogen in meat and gynecomastia was 
never demonstrated.  Indeed, in a retrospective study conducted some twenty years later, the original 
study's author questions his own earlier conclusi ons and recognizes the likelihood that some other 
factor caused the early onset of puberty.  The results  of this unpublished, and previously unavailable 
study clearly demonstrate that the conclusion that  hormones in meat are causative factors for early 
onset of puberty is unfounded. 
4.270  In addition, the EC's Opinions ignore the scientific evidence relating to human in vivo  DNA 
repair mechanisms, specifically that genotoxic effect s of relevant residue leve ls of growth promoting 
hormones would not be expressed  in vivo  based in part on the existen ce of the efficient DNA repair 
mechanisms that exist in all mammalian cells.  The efficacy of these repair mechanisms is 
exemplified in one of the unpublishe d reports recently provided by the EC.  In this study, it was 
suggested that the lack of genotoxic effects of oestradiol-17 β on human intestinal cells was due to a 
very efficient and rapid repair system.  Despite these relevant findings, however, the EC's Opinions 
completely ignore the influence of endogenous DNA repair mechanisms, and instead attempt to 
implicate genotoxicity as a basis for the purported human health risk associated with oestradiol-17 β 
residues in meat and meat products at any concentration.   
(iii) The EC fails to demonstrate that there is a risk of  failure of controls or failure to satisfy good 
veterinary practices 
4.271  The EC's replies to the Panel's questions were  enlightening regarding what, exactly, is the 
perceived "risk" against which the EC has imposed  its import bans on US me at and meat products.  
From the outset, the United States has argued that th e scientific evidence, and the EC's Opinions and 
17 Studies, do not demonstrate a risk from the six growth promoting hormones when used for growth 
promotion purposes according to good veterinary pr actices.  Our focus on this specific risk and 
exposure pathway seemed obvious because this is the legally permitted use of growth promoting 
hormones in the United States.  This focus also  seemed obvious since, if a WTO Member were 
concerned about a failure of controls, or a failure  to satisfy good veterinary practices, there are 
countless less trade restrictive methods for mitigating against this perceived risk than an absolute ban 
on another Member's goods, and Article 5.6 of the SPS Agreement  requires Members to ensure that 
their SPS measures are not more trade-restrictive than  required.  Furthermore, a logical extension of 
the EC's argument is that since the EC cannot be confident its own controls will never fail (indeed, as 
discussed below, there is evidence th at these controls have failed), the EC should ban all EC meat and 
meat products.  Nevertheless, the EC's replies consis tently invoke the "risk" of a failure to satisfy 
good veterinary practices.  Indeed, it is as a result of this additional perceived "risk" that the EC 
appears to discount the conclusions reached in prev ious JECFA risk assessments and set out in Codex 
standards as MRLs and ADIs. 
4.272  In its replies to the Panel's questions, the EC frequently cites to the processes of "risk 
analysis" and "risk management", neither of whic h are explicitly referred to in the text of the 
SPS Agreement .  This is not to say that concepts such as "risk management" and "risk analysis" find 
no expression in the SPS Agreement  whatsoever.  Rather, they may be found in, e.g., Article 5.2 of the 
SPS Agreement .  Whether or not the EC engaged in a proper evaluation of the factors set out in SPS 
Article 5.2 would inform a decision on whether or not they have indeed properly assessed the risk of failure to satisfy good veterinary practices within  the meaning of Article 5.1 and Annex A of the 
SPS Agreement .  As discussed below, the EC has not e ngaged in the necessary evaluation of these 
factors as required by Articles 5.1, 5.2 and Annex A of the SPS Agreement . 
4.273  The United States has rigorous controls in place, which include the establishment of 
tolerances (maximum allowable levels) for horm one residues in food by the Food and Drug 
Administration, and USDA/Food Safety and Insp ection Service ("FSIS") enforcement of these 
tolerances through (1) residue control programs; a nd (2) ante mortem, post mortem, and processing  WT/DS320/R 
 Page 53 
 
 
  inspection, to which all cattle entering the human food supply are subjected.  This system provides 
extremely efficient safeguards against a hypothetical fa ilure of controls in the United States, while at 
the same time being significantly less trade restrict ive than an outright ban on US meat and meat 
products.  A review of these relevant factors in its Opinions would have assisted the EC in making its 
ultimate determination of whether a ban on US meat  and meat products is "not maintained without 
sufficient scientific evidence" and is not "significantly  more trade restrictive than required to achieve 
the appropriate level of sanitary or phyt osanitary protection" as required by the SPS Agreement . 
4.274  Instead, the EC's Opinions focu s on several hypothetical "failure of control" scenarios that 
ignore actual regulatory processes in the United States , and for which it presents no support.  It asserts 
that these scenarios "clearly iden tify a risk for excessive exposure of consumers to residues from 
misplaced or off-label used implants and incorrect dose regimes."  Yet, the EC fails to produce any  
evidence identifying a real risk of fa ilure of controls or failure to sa tisfy good veterinary practices in 
the United States. 
4.275  The EC's 1999 Opinion alleges that "from 6% to 30% of the original dose [of a hormone 
implant] remained in the ears from 65 to 150 days  after implantation ...  These data indicate that 
consumption of tissue from implantation sites w ould result in substantial exposure."  This 
hypothetical assumes that ears containing implants will enter the human food chain, but provides no 
evidence in support of this scenario.  Contrary to the EC's assumption, very clear instructions are 
provided on manufacturers' labels on all FDA-appr oved growth promoting implants, indicating that 
implants must be placed beneath the skin of the mi ddle third of ears of cattle.  Because ears are then 
discarded at slaughter, excess dietary exposure to hormone residues via consumption of implant sites does not occur.  USDA inspectors confirm through ante- and post-mortem inspections that ears are 
discarded and that no hypothetical misplaced implants enter the human food chain.  Therefore, the 
EC's conclusion that cattle ears containing hormone  implants will enter the human food chain is 
unsupported by relevant scientific evidence and real world conditions. 
4.276  The EC's Opinions also contemplate a scenario whereby growth promoting hormone implants 
are placed in parts of cattle other than the ear.  In su pport of its claim that this is a realistic scenario, 
the EC asserts that "correct implantation can neither  be guaranteed nor expected."  However, the EC 
provides no evidence in support of this claim.  In  the real world, the likelihood that a US beef 
producer would intentionally misplace hormone implan ts in muscle is neglig ible given the economic 
and enforcement considerations at stake.  First,  the implants are specifically designed to achieve 
maximum effect when inserted into  the animal's ear.  There is therefore no economic benefit for 
injecting cattle in other parts of the body.  Second,  misplaced implants would ruin surrounding muscle 
tissue, thereby decreasing the value of the carcass.  Third, discovery of any intramuscular (non-ear) 
implants at slaughter by a federal inspector w ould cause the entire carcass to be condemned, resulting 
in not only zero profit, but significant economic loss to the producer. 
4.277  In another portion of the failure of controls  discussion, the EC's Opinions allege that 
overdosing cattle with hormone implants is comm onplace in the United States.  The EC fails to 
provide evidence to support its conclusion that off-lab el use actually occurs in the United States.  The 
EC Opinion cites to one publication from which it ex trapolates its conclusion that off-label use of 
hormones occurs, but it appears to misinterpret the data and information provi ded in that document.  
Furthermore, there is no economic incentive for the off-label implant use alleged by the EC; to the 
contrary, such use would have negative economi c effects on cattle producer s.  Therefore, the 
Opinions' conclusion that off-label use of hormone im plants occurs in cattle for export to the EC in 
the United States is unsupported by available scientif ic evidence and real world conditions.  Indeed, 
the conclusion that multiple impl anting poses a hypotheti cal health risk to consumers appears to 
ignore the findings of some of the very laboratory studies commissioned by the EC ostensibly in support of its claim that multiple implanting actually occurs and poses a risk to consumers in the real WT/DS320/R 
Page 54 
 
 
  world.  Accordingly, the EC fails to take into account available scientific evidence related to this 
"risk" within the meaning of SPS Article 5.2. 
4.278  The EC's Opinions also cite to the existence of "black market" drugs, other non-authorized 
pharmaceutical formulations, or hormone "cocktails " as contributing to the risk of a failure of 
controls.  However, the EC again provides no evidence of such a black market actually existing in the 
United States.  Indeed, the analysis  set out in the EC's Opinions ig nores available evidence relating to 
black markets, as well as relevant processes a nd production methods and relevant inspection, 
sampling and testing methods as they exist in the United States.  Available materials focusing on the black market use of growth promoting hormones onl y discuss evidence of such a market for their use 
within the EC (and thus would indicate that the EC, under its own approach in this dispute, should ban 
the sale of EC meat and meat products).  EC inspection missions appear to confirm this fact.  The presence of this market emphasizes that a total ban is not necessarily the most effective (and certainly 
not the least trade restrictive) means of preventing a theoretical failure of good veterinary practices.  
The Hormones panel reiterated this concern, noting th at "the banning of a substance does not 
necessarily offer better protection of human hea lth than other means of regulating its use." 
3. Conclusion 
4.279  In light of the foregoing, the United States asks th e Panel to find that: (1) the EC has failed to 
demonstrate that the United States has breached Article 22.8 of the DSU, and that the United States 
continues to suspend concessions to the EC consistent  with the requirements of that provision; (2) the 
United States has not breached Articles 3.7, 21.5, 23.1 or 23.2(a) of the DSU; and (3) the United 
States has not breached Articles I or II of the GATT 1994. 
I. O
RAL STATEMENT OF THE EUROPEAN COMMUNI TIES ON EXPERTS OPINIONS DURING THE 
SECOND SUBSTANTIVE MEETING  
4.280  There are certain "procedural" aspects to th is expert meeting which the European 
Communities would like to comment on before turning to  the substantive results of this meeting.  As 
you are well aware, the European Communities, during the selection process last year, had objected to 
the selection of Drs. Boobis and Boisseau as experts to  this Panel.  This mainly, because both have 
been involved in drafting and adopting the very  same risk assessment s which the European 
Communities has not accepted as valid basis for its me asures regarding hormone treated beef, that is 
JECFA's risk assessments.  The European Commun ities' concern was that Drs. Boobis and Boisseau 
would lack the objectivity required to give the Panel the advice needed to make an objective 
assessment of the facts in this dispute.  Last week 's meeting has confirmed that this concern was more 
than justified.  It is unavoidable what Drs. Boobis and Boisseau have done, namely to defend the 
conclusions of the risk assessment they were invol ved in against any alternative conclusions which 
the EC's risk assessment has come to.  We do not  blame them for doing so. However, we do believe 
that their obvious partiality was not only unacceptable for the purpose of the role of experts in this 
dispute, it also made it necessary, at times, to enter into technical scientific discussions that we would 
probably all have rather avoided.  
4.281  The European Communities does not wish to discr edit in general the work which is done by 
JECFA and Codex, nor does it believe that these latter would wish to put into question in any way the 
EC's sovereign choices on the desired level of hea lth protection.  This is not a case "EC against 
JECFA".  This is a case between Members of the WTO and it currently turns on the question whether 
a WTO Member has legitimately relied on its right under the SPS Agreement  to base its measures on 
its own assessment of scientific evidence and ava ilable pertinent information, assessment which may 
deviate from that performed (but not necessarily adop ted) by an international standard setting body.  
Objective expert advice of the kind that came from Drs. Guttenplan, Cogliano, Sippell and De 
Brabander, can explain what the scientific positions on eith er side are.  It is not helpful, therefore, to  WT/DS320/R 
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  have had (not only one but even tw o) scientific experts at this m eeting who considered themselves to 
be representatives of JECFA.  
4.282  It is not helpful either to have had JECFA representatives at this meeting who considered 
themselves to be scientific experts.  Both Dr. Tritsch er's and Dr. Wennberg 's role would have been to 
provide, in their capacity as secretaries to JECFA, factual information on how JECFA works, the way 
Dr. Miyagishima did for Codex.  Instead, both have  repeatedly overstepped their role and ventured 
into statements on the substance of the scientific i ssues.  Although we are, for example, quite grateful 
for Dr. Tritscher's indiscretion on the origin of JECFA's reference to "potential genotoxicity" (she 
stated that it was because JECFA felt there was scie ntific uncertainty), we do not think that it was 
appropriate for her to provide information on the su bstance of the science or to assume the role of 
defending the substance of JECFA's work.  And we certainly feel that Dr. Wennberg would have done 
better not to intervene on the issue of residue da ta used in the 1999 evaluation (on which she was 
obviously not informed) or to keep  her opinion, for example on Radio Immuno Assays, to herself.   
4.283  Let me end my comments on the procedural aspect s of this expert meeting here by inviting 
the Panel to take them into account when it assesses all the different advice it has been given at this 
meeting. 
4.284  I will now turn to the substantive results of this  meeting and place them in the legal context.  
For the sake of this discussion, the European Communities accepts for a mo ment the assumption that 
your task in this dispute is indeed to assess whethe r measures taken to comply with DSB rulings and 
recommendations are consistent or not with Articles 5.1 and 5.7 of the SPS Agreement .  However, we 
will come back to this at a later stage. 
4.285  The United States and Canada claim that the Eu ropean Communities has violated Article 5.1 
of the SPS Agreement  in re-adopting its ban on oestradiol-17 β for growth promotion purposes. (I'll 
open a parenthesis here: this is not quite the way th ey put it as they believe the burden of proof is on 
the EC to demonstrate compliance.  However, the EC  strongly rejects this point, and I will also come 
back to that later. Fact is that they have raised  a number of arguments as to why the EC allegedly 
violated Articles 5.1 and also 5.7 and therefore is not in compliance).  
4.286  They argue essentially on two levels.  First, that there is no risk assessment, supposedly 
because the EC Opinions of 1999, 2000 and 2002 fa iled to perform the second and third of the four 
steps usually done in a risk assessment on substances of this kind by the members of Codex.  Second, 
that the evidence put forward by the EC allegedly does not support the ban.  
4.287  Last week's expert meeting has yielded a wealth  of information which is crucial to dealing 
with these two levels of argument.  Rather than repeating all the legal arguments as set out in our 
submissions, I will concentrate on where the scientif ic advice you got helps to clarify the issues. 
4.288  On the first level of argument, we learned from the rather unisono statements of the experts.  
We have learned that while everyo ne (including the European Comm unities) accepts that in a risk 
assessment you may proceed in the four steps of hazard identification, hazard characterization, 
exposure assessment and risk characterization, you onl y do that to the extent possible and necessary. 
In other words, how you proceed exactly is a functi on of the data you have av ailable and of how your 
risk assessment is framed, namely by the mandate you have received from the risk manager.  Thus, 
we learned from Drs. Boobis and Cogliano that data  are never complete, but are or are not sufficient 
for the purpose of completing a risk assessment.  We learned that this is a matter of judgment 
involving considerations on what sort of possible ga p/uncertainty/insufficiency we are dealing with 
and whether that can be dealt with through interp retation or bridging tools such as safety factors and 
assumptions, or not.  Most importantly, however, we learned that this judgment is informed – indeed, 
is framed – by the risk manager .  It is the risk manager, as Dr. Miyagishima pointed out, who decides WT/DS320/R 
Page 56 
 
 
  whether or not to carry out an evaluation and who factors into that decisi on the question of whether 
there are sufficient data.  I draw your attention in th is context to paragraph 19 of the Codex draft Risk 
Analysis Principles for the CCRVDF, which are about to  be adopted.  Paragraph 19 specifies that it is 
for the CCRVDF to provide "a qualitative prelimin ary risk profile as well as specific guidance [to 
JECFA] on the CCRVDF risk assessment request."  
4.289  Finally, it is the risk manager, as several e xperts repeatedly confirmed, who decides on the 
acceptable level of risk, in other words on the level of  protection.  This informs for example concepts 
such as that of "appreciable risk", as Dr. Guttenplan e xplained in reply to your question.  Let us not go 
into the whole concept of risk communication, but it is important for you to understand that risk assessors and risk managers – as two different instances of a risk analysis process – do not make decisions in isolation from each other.  This has al ready been confirmed by the Appellate Body in the 
1998 Hormones  report. 
4.290  This brings us back to the famous four step s of the risk assessment. If there is a  risk 
management decision that the intended acceptable level of  risk is "additional risk to the extent such a 
risk is judged ‘insignificant' or ‘non appreciable,'" here is what you do as a risk assessor: once you have identified that there is the possibility of an adverse effect, you go on and calculate whether and at 
what threshold the risk becomes "non appreciable" using safety factors and whatever other tools you 
have available to bridge possible gaps of  knowledge.  This is what JECFA has done.  
4.291  If, on the other hand, there is a risk manageme nt decision that the intended acceptable level of 
risk is "no additional risk," the situation is diffe rent: as a risk assessor, once you have identified the 
possibility of an adverse effect and the possibility of  its occurrence in real life, there is no point in 
going on and calculating a threshold, as no additiona l risk, however minimal, would be accepted.  As 
a risk assessor you have done enough for the purposes of the risk assessment that  the risk manager has 
asked from you.  Essentially (I am saying essentia lly because the European  Communities, as even 
Dr. Boobis had to confirm, has actually quantified exposure to the extent possible) this is what the EC risk assessors have done. Your e xperts have confirmed this, not least Dr. Boobis, who first advised 
you that the European Communities had not carried out a proper risk assessment and then qualified 
his reply by stating that it was based on the assumpti on that a threshold would apply.  Where this is 
not the case, so he explained last week and in hi s written replies to Questions 11, 19 and 37, the 
remaining steps after hazard identification look quite different.  In particular, a dose response 
assessment is unnecessary (see in particular reply to Question 37).  However, as to what exactly the 
remaining steps are supposed to look like in a non- threshold scenario, neither Dr. Boobis nor the other 
experts gave you clear advice on that question.  Y ou heard statements that the European Communities 
failed to present new residue data or failed to refer to the problem of endocrine effects in its risk 
assessment or failed to present evidence on in vivo genotoxicity, all of which the European 
Communities proved to be wrong by pointing the Pa nel to the exact page where this issue was 
discussed or a study was referred to in the EC Op inions.  Frankly, Chairman, one might choose to 
disagree with the conclusions the EC has come to, but to claim that the EC has not carried out a 
proper risk assessment is a bit of a joke, obvious to anyone who has actually taken pains to read the 
EC risk assessments (and, if I may add, to comp are them to other relevant risk assessments).  
4.292  So let me turn to the second level of argumen t, which turns on whether the evidence presented 
by the European Communities supports  - or, as the Appellate Body would put it – sufficiently warrants a prohibition on oestradiol-17 β.  Chairman, I could go back to the details of all the adverse 
effects that the EC risk assessment h as identified and that were at least in part discussed at last week's 
meeting.  I could now launch into discussing everyt hing that was said about old and new residue data, 
old and new detection methods, good veterinary  practice and abuse, hormonal development of 
children and the value of epidemiological studies.  But I think there is probably no better way of 
putting in a nutshell the controversy at the heart of this debate than the way Dr. Cogliano has done it. 
He said essentially "at the heart of the scientific disagreement here is the interpretation of data.  WT/DS320/R 
 Page 57 
 
 
  JECFA's assessment felt that a threshold could be assumed even if there was some evidence on 
genotoxicity.  Therefore they assumed there was a thres hold.  It seems to me that the EC is unwilling 
to assume a threshold, because of genotoxicity and b ecause of low dose response and the fact that the 
shape of the curve cannot be defined with certainty .  Those are the scientific arguments on both sides 
– depending on how you phrase the question, you will get a response of yes or no."  Dr. Cogliano 
answered your question of whether this disagreement is arbitrary or unreasonable by stating "this is a 
longstanding area of disagreement for scientists since many years, the r eason for the controversy 
being the assumptions that scientists bring to the risk assessment.  It is an area of legitimate 
disagreement." 
4.293  Even Dr. Boobis, who may have wanted to make  you believe that JECFA's - that is: his - 
interpretation of the data is the only reasonable inte rpretation, had to concede that both genotoxicity 
and low dose response are issues that are a long way from being resolved.  What better way to 
demonstrate this than the vivid debate betw een Dr. Guttenplan and Dr. Boobis on proof of in vivo  
genotoxicity?  What better way to say it than Dr. Bo obis' reply to the EC expert's intervention on low 
dose response, when he stated "this is a major issue of scientific controversy.  Dr. Vom Saal can point 
to so many papers which support his argument, but currently this is not resolved in the scientific 
community." 
4.294  I could add to this now an account of the many things that were said last week about pre-
pubertal children, where the advice you received from the Panel's experts ranges all the way from warning you not to feed your children broccoli (Dr. De  Brabander) to stating that there is no problem 
whatsoever for hormonal substances despite eviden ce demonstrating that JECFA's calculations on 
endogenous production of hormones are actually wrong (Dr. Boobis).   
4.295  But the point can already be made: what you shou ld take away from last week's meeting is the 
following: First, the European Communities bases itself on evidence wh ich well respected scientists, 
including some of your own experts (Drs. Guttenpl an and Cogliano) understand to demonstrate direct 
genotoxicity of Oestradiol 17 β.  Direct genotoxicity, not only for the EC risk manager but actually for 
most risk managers in this world (see Dr. Boobis' reply to Question 11) is a reason not to accept any 
added risk and therefore to decline setting a thr eshold.  Second, the European Communities bases 
itself on evidence which is read by respected scien tists – and, apart from Drs. Cogliano and Sippell 
this may well include most endocrinologists in the world – to mean that one actually knows precious little about what hormonal substances do at low doses, and in particular, what they do to especially 
sensitive populations such as pre-pubertal children.  For the EC risk manager, and this may well be a 
position not shared by the risk mana gers in the US and Canada, this is a reason to decline setting any 
threshold.   
4.296  The European Communities considers that it is not for this Panel to enter into the deep 
scientific theories and try to resolve the scientific controversies, to which you became witnesses last 
week. The scientists have not managed to resolve it and you will not be able to do it with the legal 
provisions and tools you are supposed to apply here.  Indeed, you are not asked to now come down on either side of the debate, apply your own – as Dr. Boobis would put it – "weight of evidence" 
approach, provide your own interpretation of how the data should be read.  It is sufficient for you to 
ascertain that there is a genuine divergence of sci entific opinions here, which may indeed – as the 
Appellate Body has put it – "indicat e a state of scientific uncertainty"
19 and that the European 
Communities has relied on – and I quote the Appe llate Body again – "divergent opinion[s] coming 
from qualified and respected sources"20 as your own experts have conf irmed.  The US  and Canada 
may think that this source may not (yet) represent "mainstream" scientific opinion (although one may 
well argue that there is at least equal balance betw een the different opinions) but this, as the Appellate 
                                                      
19 Appellate Body Report, EC – Hormones , at para. 194. 
20 Ibid. WT/DS320/R 
Page 58 
 
 
  Body teaches us, "does not necessarily indicate th e absence of a reasonable relationship between the 
SPS measure and the risk assessment, especially wh ere the risk involved is life-threatening in 
character and is perceived to constitute a clear a nd imminent threat to public health and safety."21 
There is no other indication that the European Communities may not have acted in good faith (may those who cherish protectionist theories go back to reading what the Appellate Body had to say about 
that).
22  Therefore, Chairman and Members of the Panel,  your conclusion must be that the EC's risk 
assessment sufficiently warrants – that is to say reasonably supports – its  ban on oestradiol-17 β.    
4.297  This concludes my comments on the United States' and Canada's claim that there is a 
violation of Article 5.1 of the SPS Agreement  as regards the EC's implementation measure on 
Oestradiol 17 β.  I should add that this also deals with the rather vague claim made by the United 
States and Canada that there would also be a violation of Article 3.3 of the SPS Agreement .  "Vague" 
because it is not clear what they would be relying on with regard to oestradiol-17 β.  The standard 
adopted by Codex on this substance dates back to 1988 and is outdated, not only in the EC's view but 
also in the view of Codex' own scientific comm ittee JECFA, which has re-evaluated the substance 
since.  However, JECFA's updated assessment of 19 99 has never been adopted as a standard.  In any 
event, as is clear from the above, the European Co mmunities who has a scientific justification not to 
base itself on the Codex standard, and also (not "or")23 has a higher level of protection than that 
implied in the Codex standard, acted c onsistently with Article 5.1. of the SPS Agreement .  Therefore, 
there is no violation of Article 3.3. 
4.298  Let me turn to the European Communities pr ovisional ban on the other five substances, 
progesterone, testosterone, zeranol, trenbolone acetate and melengestrol acetate (MGA).  With regard to that measure the United States and Canada claim that there is a violation of Article 5.7 of the 
SPS Agreement .  I will not go back to all legal arguments  that have been exchanged between the 
parties on the four conditions that Article 5.7 of the SPS Agreement requires, but will instead 
concentrate on what the expert meeting has yielded in  this regard, which mainly relates to the issue of 
sufficiency.  
4.299  Obviously, you as the Panel wonder what to make of the fact that an international body such 
as Codex and its scientific committee JECFA, with regard at least to four of these substances, has 
considered that there is sufficient  evidence to come to a conclusion on them, while the EC claims that 
this is not the case. 
4.300  This brings us back to the debate touc hed upon earlier about completeness of data, 
sufficiency, gaps and scientific uncertainty.  For all of those among us lawyers who love to think in 
clear cut-categories, this is a bit of a disappointme nt.  The world of science clearly does not think in 
terms of definitive and provisional measures, of suffi ciency and insufficiency of evidence.  Data are 
never complete, as we learned; whether you can come to definitive conclusions on a risk assessment is 
a function of what data you have and how your risk  assessment has been frame d by the risk manager. 
Dr. Boobis, who emphasised several times how care ful he was about choosing his words, certainly 
was careful when replying to the question of whethe r it was possible to complete a risk assessment on 
the five substances.  He agreed  with the European Communities th at this was a question of risk 
management and then stated: "I can  only speak for JECFA, not for th e EC, we considered the data to 
be sufficient."  Indeed, he speaks for a different set  of data and against the background of a different 
decision on acceptable level of risk/intended level of protection!  The EC's scientific committee 
worked on the basis of the most up to date resear ch on these substances and against the background of 
the risk manager's decision not to accept any add itional risk from residues in hormone treated-meat. 
                                                     
 
21 Ibid. 
22 Appellate Body Report, EC – Hormones at para. 245. 
23 As the Appellate Body has put it so delicately, "Ar ticle 3.3. is evidently not a model of clarity in 
drafting and communication", see Appellate Body Report, EC – Hormones , para. 175.  WT/DS320/R 
 Page 59 
 
 
  Under these circumstances, the EC scientific committ ee, in the face of evidence indicating that there 
may be risks with regard to genotoxicity and in li ght of the scientific uncer tainty regarding the low-
dose response problem, was careful to conclude only provisionally on the existence of a risk, and to 
recommend further research.  Chairman, members of the Panel, would you have preferred a bold 
conclusion based on all sorts of gap-bridging assump tions, that these substances present a risk, and on 
the basis of that a definitive ban adopted by the EC regulator?  
4.301  This concludes my remarks on the Article 5.7 cl aim, which has been shown to be unfounded.  
Let me add a brief remark, once again on the Article 3.3 claim made by the United States and Canada.  
The United States and Canada are relying on standa rds for zeranol and trenbolone acetate adopted in 
1988, which are as outdated as the standards for prog esterone and testosterone also dating back to 
1988.  Again, as is clear from the above, the Europ ean Communities, who has a scientific justification 
not to base itself on the Codex standard, and also a hi gher level of protection than that implied in the 
Codex standard, acted consistently with Article 5.7 of the SPS Agreement . Therefore, there is no 
violation of Article 3.3. 
4.302  These remarks of the European Communities attempted to help you place the results of last 
week's experts' meeting in the context of your  analysis on the relevant provisions of the 
SPS Agreement .  Before turning to my reservation on that ex ercise, which I stated in the beginning, let 
me make one final remark.  It seems  fashionable, in the debate on the SPS Agreement , to raise the 
spectre of regulators who close off their markets by  putting never ending demands for more evidence 
on scientists on the basis of a declared need to pr ove safety.  There is a danger for abuse of the 
SPS Agreement in this respect, no doubt.  But there is a nother spectre out there, which is equally 
haunting: that the SPS Agreement would be abused by those who value market profit over safety.  
That those who do not bother to look into possible hea lth concerns, referring, at best, to industry data 
that no member of the public has ever seen, woul d benefit from some sort of presumption of being 
right under the SPS Agreement .      
4.303  With this, I have ended my opening remarks on the outcome of the expert hearing.  Now, with 
regard to my earlier reservation: Chairman, we want  to raise the question with you, why it is we are 
going through this exercise of looking into a violation of the SPS Agreement .  As suggested in your e-
mail we will come back to this issue in the sec ond part of our opening statement when we discuss 
legal issues.   
J. ORAL STATEMENT OF THE UNI TED STATES ON EXPERTS OPINIONS DURING THE SECOND 
SUBSTANTIVE MEETING  
4.304  The United States has repeatedly argued thro ughout these proceedings that the European 
Communities' ("EC") permanent ban on oestradiol-17 β ("estradiol") is not based on a risk assessment 
within the meaning of Article 5.1 of the Agreement on the Application of Sanitary and Phytosanitary 
Measures  ("SPS Agreement ").  We have also argued that the EC's provisional bans on progesterone, 
testosterone, zeranol, trenbolone acetate ("TBA"), and melengestrol acetate ("MGA") do not satisfy the necessary conditions for a provisional measure  within the meaning of Article 5.7 of the 
SPS Agreement .  Indeed, the very conclusions underpinning the EC's decision-making are 
unsupported by the scientific evidence relating to th ese hormones.  The experts' written responses and 
oral testimony support these US arguments. 
4.305  At the outset of this meeting, it is essential to  recall the purpose of last week's meetings and 
today's discussions.  The World Trade Organization (" WTO") and this Panel are not being called upon 
to conduct a risk assessment for the EC.  You have  not been requested to provide or complete a 
de novo  review of the numerous scientific materials relating to the six hormones at issue.  The 
pertinent analysis, as discussed a moment ago, is what  the EC has done.  Not what the EC could have 
done, or may still do.  Not what this Panel can do for the EC.  To conduct an analysis of what the EC WT/DS320/R 
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  has actually done, we may ask much less complex qu estions such as:  has the EC presented scientific 
evidence of a risk from these hormon es when consumed as residues in meat and assessed this risk in 
the proper fashion?  
4.306  As I will highlight this morning, the experts' responses confirm that the EC has not based its 
ban on meat from cattle treated with oestradiol fo r growth promotion purposes on a risk assessment.  
It has not satisfied the four necess ary steps for a risk assessment, and several of the conclusions set 
out in the EC's Opinions are not  supported by scientif ic evidence.  A measure banning meat from 
cattle treated with oestradiol cannot be "sufficien tly warranted" or "reasonabl y supported" by this 
absence of a risk or assessment of the risk. 
4.307  Likewise, the experts' responses confirm that  there is sufficient scientific evidence to 
complete a risk assessment for each of the five "p rovisionally banned" hormones and that the EC has 
not based its provisional bans on available pertinent in formation.  In other words, the EC's measures 
and "risk assessment" do not satis fy its obligations under the SPS Agreement . 
4.308  I think that a brief discussion of the term zero risk provides a good starting point for today's 
discussions.  It is an important principle and one to  which the EC referred several times in the meeting 
with the experts.  Indeed, the EC at several point s asked the experts whether they could ensure that 
there was "zero risk" of a certain event occurring .  The EC used this same tactic in its written 
comments on the experts' answers.  Fo r example, it demanded that Dr. Boobis  "provide the necessary 
assurance" to the EC that residues in meat will ne ver be shown to pose a risk to consumers.  ( See, e.g., 
EC Comments on Question 20). 
4.309  The analysis must refocus on the question of whether the EC has provided any evidence of a 
risk.  The relevant discussion is one of whether the EC, in support of its ban, has adduced sufficient evidence to demonstrate a risk fro m meat from cattle treated with oestradiol for growth promotion 
purposes.  Included in this discussion is an anal ysis of whether the EC has provided scientific 
evidence that oestradiol is genotoxic, mutagenic or  carcinogenic (at levels found in residues in meat 
from treated cattle).  Whether a scientist refuses to co mmit to a stance that there will never be a risk 
from meat treated with oestradiol at some point in th e future is not pertinent to  this analysis because it 
is not scientific evidence of a risk.  It is simply theoretical uncertainty and cannot be the basis for a 
risk assessment or an SPS measure. 
4.310  Regarding what, exactly, makes up a risk assessment, the experts and international 
organizations reiterated the four steps of risk assessment.  In addition, the Codex representative 
stressed that a risk assessment must be based on all available data. 
4.311  As to whether and when a risk assessment must sa tisfy each of the four steps, there was clear 
agreement among Drs. Boobis and Boisseau
 and JECFA that an evaluation of the human food safety 
of a drug should include all four steps of risk  assessment.  JECFA noted that a hazard identification 
does not qualify as a risk assessment and that the a ssessment should continue through each of the four 
steps unless there is "cl ear cut" evidence, both in vitro  and in vivo , of genotoxicity.  Dr. Boobis  
commented that the only instance in  which such an assessment would stop at the hazard identification 
stage would be if the compound were iden tified as a DNA-reactive mutagen.  Dr. Boisseau  confirmed 
Dr. Boobis'  opinion.   
4.312  Recalling that, as we learned last week, genotoxi city and mutagenicity are not synonymous.  
Genotoxic substances damage DNA but the damage ma y be repaired.  If the damage results in a 
mutation and the cell divides, then the substance is  a "mutagen."  As will be discussed in a moment, 
the experts did not identify any scientific evid ence in the EC's Opinions that confirms, in vivo , the 
effects of oestradiol at levels below those causi ng a hormonal response, let alone any evidence that 
effects at that level are those of a DNA-reactive mutagen.    WT/DS320/R 
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  4.313  There are four steps for a risk assessment that have been clearly defined by the experts and 
the original Hormones  panel.  And the EC accepts that these four steps are required.  As just 
mentioned, a risk assessment for oestradiol may no t stop at the first step of hazard identification 
unless there is in vivo -confirmed evidence that oestradiol is  either a genotoxin or a DNA-reactive 
mutagen.  The EC has failed to present any evidence that oestradiol is genotoxic at levels below those 
eliciting a hormonal response, nor has it provided evid ence that oestradiol is mutagenic at relevant 
levels in vivo .  The EC was therefore not justified in failing to complete the three remaining steps.   
4.314  The experts confirmed that the EC did not  complete the remaining steps.  Dr. Boobis  noted, 
and Dr. Boisseau  agreed, that the EC's Opinions are focu sed on the first step of risk assessment, 
hazard identification.  As noted by JECFA, a hazar d identification does not equal a risk assessment.  
An assessor must finish all four steps.  Although he did not speak on this subject in last week's 
meetings, Dr. Guttenplan  has described the EC materials as dese rving at best a "mixed rating" in 
terms of the four steps of risk assessment(Question 14) .  He noted particular deficiencies in the hazard 
characterization and risk characterization sections (Questions 13 and 14). 
4.315  Another avenue for finding that the EC has not completed a risk assessment for oestradiol is 
by determining that the conclusions set out in its assessment are not supported by scientific evidence.  
For example, the experts agree that the EC has not presented any scientific evidence that oestradiol is 
genotoxic in vitro  or in vivo  at physiological levels.  The norma l action of oestradiol on a cell is 
mediated through the oestrogen receptor.  The genotoxic effects, which are abnormal, are not mediated through the estrogen receptor but instead  involve direct damage to DNA.  To date, 
concentrations of oestradiol required to cause ge notoxic effects have been well above those required 
to elicit normal physiological effects. 
4.316  As noted by Dr. Boobis
, positive in vitro  tests require positive in vivo  confirmation, as 
toxicity is not always expressed in vivo .  For Dr. Boobis , in vivo  confirmation is critical because, 
among other things, it takes into account DNA repair mechanisms.  He commented that he was "not 
persuaded" that oestradiol is genotoxic at leve ls below the normal hormonal concentrations present in 
vivo.  In other words, that the genotoxicity has a threshold that requires overwhelming the DNA repair 
mechanisms – an event that will only occur at concentrations well beyond physiological levels. 
4.317  The experts could not identify any studies providing evidence of the in vivo  confirmation of 
genotoxicity of oestradiol at levels below those required to elicit a hormonal response.  When put on 
the spot at last week's meetings with a new stud y produced by the EC in a last minute attempt to 
provide evidence of in vivo  effects, Dr. Boobis  quickly dismissed the study as irrelevant.  The study's 
authors had treated the subject rats with so much o estradiol that the sheer level of the dose itself killed 
fifty percent of them, precluding any interpretation of oestradiol-specific effects. 
4.318  Another example of an unsupported conclusion in  the EC's Opinions is that oestradiol 
residues in meat from treated cattle are carcinogeni c.  The EC has failed to present any scientific 
evidence that oestradiol will have carcinogenic effect s at levels found in residues in meat from treated 
cattle.  Their failure to provide any evidence make s abundant sense.  We consume oestradiol residues 
from numerous sources every day at levels much gr eater than those found in meat residues, whether 
from cattle treated for growth promotion or not.  Milk, butter, eggs and, as noted by Dr. Boobis , a 
great number of phytoestrogens in plant products  are all sources of oestrogen in our diets.  
4.319  The EC has failed to support either of th ese major conclusions on genotoxicity or 
carcinogenicity with scientific evidence.  The SPS Agreement  does not permit the EC to do so.  An 
assessment that fails to adduce scien tific evidence in support of its underlying conclusions is not a risk 
assessment, as appropriate to the circumstances, under SPS Article 5.1. WT/DS320/R 
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  4.320  There is a similarly uncomplicated analysis by  which it can be determined that the EC's 
"provisional bans" do not satisfy the requirements of SPS Article 5.7.  The first of Article 5.7's 
requirements for a provisional ban is that the eviden ce be insufficient to conduct a risk assessment.  
None of the experts believes that this is the case for testosterone, progesterone, zeranol, TBA or 
MGA. 
4.321  Because the experts have confirmed that th e evidence for each of the five hormones is 
sufficient to complete a risk assessment, discussion of the "provisional" bans ma y stop here in light of 
the cumulative nature of Article 5.7's requirements.   The EC's ban is not a provisional measure for 
purposes of the SPS Agreement . 
4.322  The second of Article 5.7's requirements is that  a provisional measure be maintained on the 
basis of available pertinent information.  The EC's  "provisional" bans do not satisfy this requirement 
because there is no available pertinent information indicating that any of the five hormones poses a 
risk to consumers when used as a growth promoter in cattle. 
4.323  The views of the experts are evidence of a lack  of available pertinent information indicating 
that the five hormones pose a risk when consumed as residues in meat.  Indeed, all available pertinent 
information indicates that consumption of these residu es is safe.  The EC has therefore not based its 
"provisional" bans on available pertinent inform ation within the meaning of SPS Article 5.7. 
4.324  In light of the experts' responses,  it is clear that the EC has ne ither based its permanent ban on 
oestradiol on a risk assessment nor developed legiti mate provisional bans.  An analysis of these points 
would not entail the type of de novo  review to which I alluded earlier.  As noted, none of us are 
equipped for such a review and the SPS Agreement  does not require or condone such a review. 
4.325  While the Panel's analysis need not extend to th is issue, I will now take a moment to discuss 
the EC's arguments relating to pre-pubertal children.  The EC claims that oestradiol residues in meat 
from treated cattle pose a risk to this sub-population.   However, the EC fails to provide scientific 
evidence of this risk. 
4.326  In particular, the EC relies on an assay that, to  date, remains unvalidated; the EC has failed to 
produce any scientific evidence demonstrating that JE CFA's ADIs do not sufficiently protect children; 
and the EC has failed to complete the necessary steps of a risk assessment for this population. 
4.327  This does not mean that the doubts and theoretical uncertainty on circulating oestradiol levels 
in pre-pubertal children identified in last week's meetings are unimportant.  They are important.  
Indeed, JECFA reaffirmed that ensuring the safety of children is a "basic principle" of risk assessment 
and a fundamental focus of its work.  As such, it is a safe guess that JECFA would be interested in 
any new evidence relating to this sub-population.  As we have learned from the JECFA and Codex 
representatives, however, the EC has not shared any in formation with them.  If the EC believes that 
the information it possesses has been properly validated and that the evidence is sound, then every 
Codex member around the world would benefit from its c onclusions.  The EC is not alone in its desire 
to protect the health of pre-pubertal children and other sensitive sub-populations. 
4.328  Finally, we come to the issue of misuse of gr owth promoting hormones in the United States.  I 
have left this subject for last because, quite frankly,  it is unclear what role misuse plays in the EC's 
Opinions and arguments.  The EC apparently consid ers potential misuse to be a risk, but has failed to 
provide any evidence or argument as to how it h as actually assessed this risk.  It provides no 
evaluation of the actual system of controls in pl ace in the United States.  We have described these 
controls at length in our previous submi ssions to the Panel.  Dr. De Brabander  claimed to have 
examined the US system of controls when he opine d that the US system is nothing but "audits and 
paper work."  However, he provided no analysis of the actual US system.  Neither did the EC.  In fact,  WT/DS320/R 
 Page 63 
 
 
  when asked in last week's meetings whether he was familiar with the US and Canadian meat safety 
systems, Dr. De Brabander  noted that he was not a meat inspector and was not qualified to make 
judgments on these systems. 
4.329  Even if one were to assume the unrealistic and hypothetical misuse scenarios developed by 
the EC, the EC has failed to presen t convincing evidence that misuse l eads to violative residue levels. 
4.330  Finally, the EC fails to assess the risk of misuse .  While the experts did not have a chance to 
turn to this point last week, th e necessary evidence of the EC's failure may be found in their written 
responses.  ( See, e.g.,  the responses of Drs. Boobis and Boisseau  to Question 48). 
4.331  When you take a step back from the EC's Opini ons, it becomes more and more clear that they 
are flawed in larger ways than the EC would like us to see or focus on.  In light of its line of 
questioning to the experts last week, the EC appare ntly hopes to make this dispute one about getting 
lost in the weeds of several scientific dead-ends.  The spectr es of misuse, risks to sensitive 
populations and the unwillingness of the experts to  commit to a position that there will never be 
evidence of a risk from any of these hormones in the future are examples of these scientifically 
unfounded pitfalls.  We could go on ad nauseam  in a debate as to whether science in these areas is 
evolving.  As we know from our discussions with  the experts last week, science is continually 
evolving.  This evolution cannot be equated with ev idence of a risk, however.  We are not scientists, 
and an attempt to thrust ourselves into the de bates on these issues would be nothing more than a 
misguided de novo  review of the science by us, laypersons.   
4.332  If we follow the paths laid out by the EC, we will lose sight of the larger problems of the EC's 
Opinions and the fundamental obligations and requir ements against which they are to be measured – 
those set out in the SPS Agreement .  When we view the EC's measures in this context – in which we 
have the necessary knowledge and can perform the n ecessary analysis – it is clear that there are 
several avenues by which we can conclude that th e EC has not based its permanent ban on oestradiol 
on a risk assessment within the meaning of SPS Ar ticle 5.1, nor has it impl emented a provisional ban 
on the other five hormones within the meaning of  SPS Article 5.7.  I have discussed these avenues 
and the appropriate conclusions that  can be reached for each based on the scientific record in this 
dispute this morning. 
K. ORAL STATEMENT OF THE EUROPEAN COMMUNITI ES ON LEGAL ISSUES DURING THE SECOND 
SUBSTANTIVE MEETING  
1. Introduction 
4.333  The European Communities made a reservation in  its statement yesterday when it questioned 
the point of going through this exercise of looking at the possible violation of provisions under the SPS Agreement.  I am afraid that we have to postpone our discussion of that issue once again, to the 
end of this meeting, as it seems more  important at this stage to respond to the Panel's request to clarify 
a few issues about the SPS Agreement and its application to the facts of this case.  This is without 
prejudice to our position on the provisions of the SPS Agreement  which, if any, might be invoked 
against our measures . 
2. Article 5.1 of the SPS Agreement  
4.334  Let us start with the main violation found by the Appellate Body in the original EC –
Hormones case, Article 5.1.  The first point to make is that the situation today is very different from 
that which confronted the Appellate Body in 1998.  WT/DS320/R 
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  4.335  The Appellate Body had found that the old risk assessment performed by the European 
Communities was not specific enough to address r esidues in meat treated with hormonal growth 
promoters.  
4.336  The optimal way to remedy that would be  to establish a quantitative dose response 
relationship.  However, the scientists last week have  agreed (even though we did not need them to tell 
us) that this is not possible to perform because the necessary studies would entail, as the 2002 US 
Carcinogenesis Report says, conductin g studies of long term human exposure and cancer incidence in 
very restricted environments which will be able to  eliminate with confidence confounding factors in 
the initiation and promotion of cancer over a long latent period.  
4.337  Visualize the study: a perfect place would seem a prison where you have a sufficient number 
of very long term prisoners living in identical  conditions, half of whom would eat non-hormone 
treated beef and the other would eat hormone treated beef.  Chairman, even under these 
circumstances, which can not possibly be more restri cted, the results of the study would be rebuttable 
due to differences in the past exposure history of  those in custody. You may visualize another 
situation where you have a sufficient number of  newly born children with whom you perform a 
similar experiment for about 30 years.  Do I need to go on?   
4.338  In the absence of such studies we had to follo w an alternative approach which is also 
acceptable under the SPS Agreement .  Let's review what we ha ve done and some important 
knowledge that we have acquired:  
4.339  First, we now have sufficient scien tific evidence that oestradiol-17 β is genotoxic.  This is not 
a theoretical risk, it is not negligible and definite ly not "zero", it is a real risk however minimal. 
4.340  Second, we have sufficient evidence that e ndogenous production of natural hormones by pre-
pubertal children is many times less than wh at was originally thought to be the case. 
4.341  Third, most of the scientists have agreed that  the dose-response curve cannot be defined with 
certainty for low exposure to these substances. 
4.342  Fourth, there is sufficient evidence, which is consistent with the observation that already 
exposure from background endogenous production can lead to cancer; 
4.343  Fifth, we know today that the old data used by the defending parties and JECFA and the 
method by which they have been collected, are questionable or no longer valid ( e.g. depletion data 
produced with method of analysis not apt to detect metabolites); 
4.344  Sixth, there is a sufficient body of evidence i ndicating increased rates of cancer in the US and 
Canada which is consistent with the argument th at residues of meat treated with these hormones can 
contribute to these higher rates. 
4.345  Seventh, we know that under r ealistic conditions of use, good veterinary practice cannot be 
respected in the administration of hormones in th e US and Canada and this invalidates the ADIs and 
MRLs (as Dr. Boisseau confirmed last week). 
4.346  These things we did not know back then in the 1990s, but do know them now.  Last week we 
have heard that there is a difference of scientific views and of interpretation of data about some of 
these issues, but that this difference is not arbitrar y and indeed reflects genuine scientific uncertainty.  
In light of this, it is not indispensable that the third step of the risk assessment, the exposure 
assessment, is performed in a quantitative manner.   WT/DS320/R 
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  4.347  With these data the European Communiti es has conducted a qualitative dose-response 
assessment and has come to the conclusion that r esidues of hormone-treated meat will constitute an 
added risk to human health.  As the Appellate Body has explained in 1998, risk is not measured in the 
laboratories but in the real world where people live, work and die. 
4.348  In conclusion on this point, we believe that the European Communities performed a risk 
assessment as appropriate to the circumstances and th e very nature of these substances, and therefore 
the ban on oestradiol-17 β is based thereon – that is: sufficien tly warranted by that risk assessment. 
4.349  Before turning to some comments on other SPS provisions, I would like to stress the 
important point that we have made.  A proper risk  assessment can come to th e legitimate conclusion 
that there are gaps in knowledge.  This is expr essly recognized in point 11 of the General Working 
Principles for Risk Analysis of Codex Alimentari us Commission.  JECFA's risk assessment bridges 
all knowledge gaps and scientific uncertainty by  assumptions in favor of allowing the use of 
hormones in growth promoters. 
4.350  It seems that the US and Canada do not accept th at a proper risk assessment can conclude that 
there are gaps and scientific uncertainty.  For example, the US relies on a contention, at para 56 of its statement of yesterday, that a risk assessment must fully address the four "mandatory" steps (and it 
claims that the European Communities has not done so). 
4.351  There is no basis for this.  Article 5.1 of the SPS Agreement  states that a risk assessment must 
be "appropriate to the circumstances" and take into account techniques developed by international 
organizations.  As the European Communities has so often explained, and the experts have confirmed, 
the four steps of the Codex guidelines only need to be taken where possible and necessary.  A 
qualitative assessment of the exposure of the kind pe rformed by the EC must be acceptable.  Our 
exposure assessment is not worse than that perform ed by the defending parties and JECFA, because 
both are based on assumptions and extrapolations from data on animal experiments to human beings.   
4.352  It seems that the US and Canada would like to  make it almost impossible for the European 
Communities to conduct a risk assessment they would ever accept.  If they were  to succeed with this 
tactic, however, the result would not be more au thorizations but more provisional measures under 
Article 5.7 SPS. 
3. Article 3.3 of the SPS Agreement  
4.353  There has also been mention of Article 3.3 of the SPS Agreement .  The argument is not clear 
but the European Communities would like to make a couple of important points.  First, WTO Members have a sovereign right to set a higher leve l of protection than reflected in international 
standards.  Article 3.3 only requires Members to ha ve a scientific justification for their measures 
reflecting this higher level of protection, not  for the higher level of protection itself.  
4.354  Another point that needs to be made is that Article 3 of the SPS Agreement  applies to 
standards and measures, and does not require Members to accept risk assessments by organizations such as JECFA. Accordingl y, the fact that JECFA may have made a different risk assessment, which 
is outdated by today's standards and reflects a lowe r level of protection is not a basis for holding the 
EC risk assessment to be inadequate.  In any ev ent, the European Commun ities has shown that its 
measure has the necessary scientific justification and ai ms to achieve a higher level of protection.  For 
this reason we fail to see the relevance of Article 3 of the SPS Agreement  as a basis for the claims of 
US and Canada in this case. WT/DS320/R 
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  4. Article 5.7 of the SPS Agreement  
4.355  Similarly, the fact that JECFA could carry out risk assessments on the 5 other hormones, is 
not a reason for holding that the European Communities cannot adopt provisional measures based on Article 5.7 of the SPS Agreement .  For JECFA, the information is appa rently sufficient to conduct risk 
assessments; for the European Communities it is not.  Even Dr. Boobis agreed (and the US 
misrepresents his position at paragraph 35 of its statement yesterday morning). 
4.356  The United States is also wrong to say (in para  6 of its statement) that the European 
Communities has failed to review the provisional bans within a reasonable time.  The European 
Communities is in fact now conducting such a review once again. 
5. Article 5.5 of the SPS Agreement  
4.357  There have also been suggestions that the EC ban on oestradiol-17 β (and the provisional 
prohibition of the other five hormones) are unreasonable or arbitrary in view of the large amounts of 
hormones that human beings are already exposed to fro m many different sources.  Here again, we are 
not sure what the argument is.  We cannot see how compatibility with Article 5.5 of the SPS Agreement  is relevant to this case because no viola tion of this provision has been invoked by the 
Defendants.  But even if it were, we would remind you of the interpretation of the Appellate Body of 
this provision.  You cannot compare natural presen ce of these substances in a great many products 
with added risk from hormone-treated meat.
24 
6. Conclusion on the SPS Agreement  
4.358  Chairman, Members of the Panel, our re view of the possible relevance of the SPS Agreement  
has been somewhat cursory.  Our problem is that  we do not know what we are accused of.  The US 
and Canada have not set out their claims in a Panel Request and their arguments criticizing our 
measures are varied and wide-ranging.  We would be  happy to discuss these issues in more detail if 
only we would be told exactly what it is we ar e doing wrong, because it is scientifically unsound and 
arbitrary. 
7. Concluding statement of the European Communities 
(a) Introduction 
4.359  The European Communities would first of all thank you again for the professionalism and 
objectivity with which you have conducted these proceedi ngs.  Let me just recall that it was more than 
a year ago that we met for the first time to di scuss the main claims of the European Communities 
against the US and Canada's illegal unilateral determination of the a lleged inconsistency of the EC's 
implementing measure and, based thereupon, their il legal continuation of the sanctions against the 
European Communities.   
4.360  The European Communities has explained in deta il why in order to resolve these disputes it is 
not necessary for you to address the scientific issues re lated to the use of hormones as animal growth 
promoters.  The Panel has nevertheless decided to lo ok at these scientific issues.  And we are the first 
to acknowledge that the scientific debate has not f acilitated your life.  As we have learned, the 
questions related to the use of these hormones are subject to a longstanding legitimate scientific 
debate amongst scientists with respected and reasonable arguments on both side.  
                                                      
24 See para.221 of the Appellate Body Report in EC – Hormones .  WT/DS320/R 
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  4.361  However, one bottom line with which probabl y everybody will agree is that these hormones 
do not improve your health.  These hormones are animal growth promoters but not health promoters. 
Instead we discuss scientif ic issues such as genotoxocity, muta genicity, carcinogenesis, DNA repair 
mechanism, the risks of early puberty to our child ren, obesity, cancer as well as abuse and misuse of 
these hormones.  Whatever one may think about th is, it does certainly not increase our appetite for 
meat. 
4.362  Another bottom line, which can be safely draw n, is that these hormones present a hazard and 
potentially a risk.  Now, I agree that this is where the controversy starts.  But whatever one may think 
about it as lawyers or consumers, neither of the scientists nor of the respondents can reasonably argue that there is no potential risk related to the u se of these hormones as growth promoters in cattle. 
Instead, we have heard a lot of talk about "threshol ds", "appreciable risk" or "acceptable risk".  But 
whether a risk is appreciable or not, whether a ri sk is acceptable or not, it still remains a risk. And 
contrary to what the responding parties have argued yesterday this is not a theoretical risk.  No, the 
risk is real, however minimal it may be. 
4.363  Why should we accept such a risk?  Why should we  expose our public to an additional risk to 
human health?  Indeed, Chairman, Members of the Pa nel, we have heard repeatedly that we should 
not care about the addition of the natural hormones sin ce they are also present in  natural food, such as 
broccoli, milk, eggs or butter or produced endogen ously.  But the question persists why we should add 
on top of this an additional burden on the consumer wit hout any health benefit in return.  It is true that 
we all take risks in life whether we drive with a car, or when we take a plane or if we drink a glass of 
milk.  However, we take these risks because we also  see the benefit.  Driving a car is comfortable, 
taking the plane is fast and milk contains a lot of vitamins.  Yet, the story is different with hormones 
used as growth promoters in cattle.  Here the risk is on the consumer.  He has to face an additional 
health risk by being exposed to higher hormone levels , but he has no additional health benefit.  Thus, 
from the perspective of a public health regulator, the risk/benefit calculation does not speak in favour 
of the use of these hormones either.  
4.364  If at all, one may argue that the issue of not allowing hormones as growth promoters in cattle 
while we allow our children to drink milk is a matte r of consistency.  Howeve r, that would also be a 
very superficial view of the issues at stake.  As  we have explained yesterday and as the Appellate 
Body has already decided, one cannot compare thes e two things.  On the one hand, we talk about 
natural food products that are part of our daily life over centuries and where there is a concrete 
risk/benefit for the consumer.  On the other hand, th e use of hormones in beef is an unavoidable risk 
which does not bring any advantages to public health. 
4.365  How can this be better exemplified than by lo oking at our children.  Children are the most 
sensitive part of the population and we must protec t them wherever we can.  There is a lot of 
uncertainty about how the mechanism of hormones in  these children work but one can be sure that 
doubling the oestradiol doses - as would be the case by allowing hormones in beef - will have an 
effect.  One of your experts, Dr. Sippell, has confirmed this pointing to the examples of early puberty or obesity.  We should take his judgment very serious ly when he drew the conclusion of the scientific 
hearing that he is "very concerned".  Whatever t oxicologists or veterinarian may have to say we 
should take this testimony of a p aediatrician very, very seriously. 
4.366  This brings me to one last point in this introduction which is about misuse and abuse of 
hormones as growth promoters.  It is already striking that we always refer to "Good Veterinary Practices" even though no veterinarian or other traine d health professionals is involved in the use of 
these hormones in the United States and Canada.  As they are sold freely over the counter to farmers 
you will admit that controlling the correct use of these substances is difficult under these circumstances.  It should strike us all that one implant contains the amount of hormones contained to 
up to 10,000 carcasses of animals.  The Europ ean Communities has assessed what happens if these WT/DS320/R 
Page 68 
 
 
  implants are misused and, indeed, there exists c oncrete evidence on this in the United States and 
Canada.  
(b) The scientific debate 
4.367  Let me now turn briefly to the outcome of th e scientific debate regarding the use of these 
hormones as growth promoters in cattle.  The Eur opean Communities is still puzzled by the United 
States' and Canada's attempts to present this de bate as if there were only one single monolithic 
opinion in the scientific world on the safety of th ese hormones.  This serves the US' and Canada's 
purpose but it is not objective. 
4.368  It is true that we are all sometimes tempte d to provide easy answers to difficult questions. 
And, certainly, this natural reflex is made even easier  in the face of scientists who are able to "quickly 
dismiss"  scientific evidence that they have not taken into account in the first place.  
4.369  What is important for your decision, however, is to look at the differences and to see whether 
these differences are scientifically legitimate.  The European Communities has never claimed that its 
scientific findings are the only valid ones, unlik e what the United States and Canada have done. 
However, what the European Communi ties has repeatedly insisted upon is that its scientific views and 
its risk assessment are appropriate to the circum stances and that they come from respected and 
legitimate sources.  One may not like the EC' conclusions but one cannot ignore or discredit them 
either. 
4.370  It also appears sometimes ironic to present the EC' risk assessment in opposition to the 
JECFA's assessment.  There is no doubt that the JE CFA 's assessments have been based on outdated 
data since despite its assessment in 1999 this does not mean that the data also come from the 90's. 
Rather the JECFA representative  admitted that they only review data as they receive them and in this 
particular case they had only received data from the FDA some of which date back to the 1960s. 
Despite the general acknowledgement  that science is constantly moving forward and reveals new 
evidence this is an astonishing pro cedure itself which, again, we leave to your discretion on how you 
take this into account.  A second undisputable issu e is that JECFA's (and indeed the United States and 
Canada's) approach to risk is different to the one by the European Communities.  JECFA has set 
thresholds in order to minimize the risk, the Eu ropean Communities has prohibited the use of these 
hormones in order to exclude avoidable risks.   
4.371  These are two completely different risk manage ment decisions.  Both are legitimate and we 
are, therefore, not criticizing JECFA for what it has done.  However, we also cannot be blamed for deviating from JECFA's approach.  It is ultimately the responsibility of the regulator or risk manager 
to decide what level of risk he wants to accept, and as I have indicated earlier, this is a very complex 
decision to which no easy answer can be given.  
4.372  Let me then turn to our puzzl ement by the United States and Canada's characterization of the 
scientific debate.  We mentioned already yesterday that they very selectively refer to the scientific 
evidence in order to make their case.  Chairman, Members of the Panel, we trust that you have a better recollection of what was actually said.  
4.373  Let me just give a few examples. The United Stat es has stated that "the experts agree that the 
EC has not presented any scientific evidence that oestradiol is genotoxic in vitro  or in vivo  at 
physiological levels".  However, may I remind yo u about the lively debate between Dr. Boobis and 
Dr. Guttenplan on this particular issue where Dr . Boobis "quickly dismissed" a study that was co-
authored by one of his expert colleagues.  Isn't it simply disingenuous to present this debate as if "all 
experts agree" that there is no evidence?  And I'm not even talking about the experts that have not 
expressed an opinion on this issue.  WT/DS320/R 
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  4.374  Another example is the US' statement that "the  experts have confirmed that the evidence for 
each of the five hormones is sufficient to complete a risk assessment".  This is again incorrect.  First, 
some of the experts have not even expressed a vi ew on this.  And even Dr. Boobis, who the United 
States often likes to rely on has merely stated that JECFA had enough information for completing a 
risk assessment whereas he could not say this for the European Communities.  Again, as we have just 
explained, we all know the difference in these pe rceptions which is based on the fundamentally 
different approach by JECFA and the European Co mmunities on how to deal with risks and whether 
or not it is appropriate to set a threshold in light of the possible direct and indirect genotoxcity of these 
substances. 
4.375  A third and last example is Canada's statement today that "nothing in what the Experts have 
written, nothing in what we have heard from the E xperts (…) or the Experts have said demonstrates 
that there is any risk to human health, adult or chil d, old or young, man or woman, boy or girl, arising 
out of the correct use of these growth-promoting agen ts in cattle".  It suffices to contrast this 
simplistic summary by Canada with Dr. Sippell's conclu sion of last week that he is "very concerned" 
about the health of children if they were exposed to  these hormones in beef.  Again, we trust the Panel 
Members that they take into account what has actually  been said by the scientists in their variety and 
not what the United States or Canada make out of it. 
4.376  In this context, let me also refer to the closi ng statements by some of the experts during last 
week's hearing and which summarizes adequately th e level of differences in the scientific world.  
Dr. Guttenplan stated that as regards young girls and boys we have to worry about the developmental 
effects of oestradiol on them and that hormon es sensitive cancer might be  increased by raising the 
level of oestradiol.  Dr. Sippell stated that we do not know enough about children and that the data are 
insufficient to be confident that the additional exposure from hormones treated beef poses no risk.  
Dr. Cogliano himself referred to the messiness of science and to the split within the scientific 
community.  He also stated that these issues are not  likely to be resolved any time soon.  Finally, 
Dr. De Brabander even referred to other aspects re lated to the use of hormones as growth promoters 
such as animal welfare or environmental concern. 
4.377  There is a bottom line which one cannot ignore.  The scientific issues on which the European 
Communities and the United States and Canada disagree are not arbitrary but they are the result of a 
legitimate and genuine disagreement amongst scientists .  This was the main result of the Panel' 
experts hearing.  We do not believe that this Panel is in a position, or required, to resolve these long-
standing scientific issues.  Instead we would ur ge you to acknowledge the legitimate scientific 
controversy and to draw the respective conclu sions from it in resolving these two disputes. 
(c) The context of the scientific debate 
4.378  With these remarks, let me come back to where we ended last year after our discussion on the 
systemic issues under the DSU.  
4.379  The European Communities would recall that these two disputes are still not about the 
SPS Agreement , despite the extensive scientific debate th at has taken place on the public health risk 
related to hormones in animal treated beef.  Chai rman, Members of the Panel, the panel requests by 
the European Communities which pr ovide the legal basis for these two disputes do not refer to any 
single provision under the SPS Agreement .  Rather, as we discussed extensively last year, the 
European Communities has based its  case against the illegal continua tion of sanctions by the United 
States and Canada on systemic violations of the DSU,  in particular Article 23, paragraphs1 and 2(a), 
Article 21.5 and Article 22.8.  
4.380  As repeatedly stated, in order to resolve th ese disputes it is not necessary for you to make a 
substantive finding on the scientific issues.  We have  already set out that in our view the proper forum WT/DS320/R 
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  and the right procedural way to deal with these w ould be a compliance Panel under Article 21.5 of the 
DSU initiated by the United States or Canada.   
4.381  This said, it is true that the European Comm unities has also made an alternative claim which 
requires you to address the substantive scientific as pects in order to determine that the original 
inconsistent measure has been removed and that  the European Communities has addressed all the 
rulings and recommendations of the DSB.  
4.382  However, this alternative claim has been only made "if, and only if"  the Panel were to 
disagree with the European Communities on its sy stemic arguments under the DSU.  Up until now, 
the Panel has not decided that this is the case.  Ther efore, the main claims and arguments as set out by 
the European Communities in its submissions ar e still valid and you are still called upon to take a 
decision.  
4.383  Our discussion of the scientific issues may nevertheless be useful in respect of the main 
systemic claims made by the European Communities.  I would just like to recall that one of the claims 
is that the US and Canada's continued suspension of  obligations is in violation of Article 23.1 and 
Article 22.8 of the DSU.  This is so because by continuing to apply sanctio ns against the European 
Communities, the United States and Canada are unilaterally seeking to redress an alleged WTO 
inconsistency of the EC compliance measure with th e WTO obligations.  Furthermore, as you recall, 
in view of the requirements of Article 22.8 of th e DSU, the European Communities has explained in 
great detail that its implementing measure must be presumed to be WTO-consistent since there is no 
multilateral finding to the contrary.  This presump tion is derived from the general principle of good 
faith whereby WTO Members are presumed to act in conformity with their obligations.   
4.384  In this particular context, the European Comm unities considers that the scientific debate fully 
supports its proposition of a presumed compliance of its implementing measure.  Indeed, since the 
scientific evidence demonstrates that the EC complia nce measure is in actual compliance, it follows 
a fortiori  that the lower standard of presume d compliance is also fulfilled.   
4.385  Let me explain this aspect in more detail. 
4.386  From the beginning of these two proceedings, th e United States and Canada have tried to 
discredit the European Communities' compliance m easure and its scientific foundations.  Arguably, 
by this criticism the defendants have tried to undermine the European Communities' reliance on the 
principle of good faith (or in this case the presump tion of compliance) under Article 22.8 of the DSU. 
And one has to admit that this litigation tactic by  the United States and Canada was not completely 
unsuccessful because you felt the need to address the scientific issues related to the use of these six 
hormones as growth promoters in cattle notwithstanding the applicability of the general principle of good faith.  
4.387  However, following the extensive discussion of th e scientific issues, it is clear that this 
approach by the United States and Canada is no longer  sustainable.  As we have seen last week, there 
can be no doubt that there exists a real and actual risk to public h ealth related to the use of the six 
hormones as growth promoters.  The European Co mmunities was therefore fully entitled to ban the 
use of these hormones in beef.  And in legal term s, the European Commun ities was therefore also 
right in invoking the principle of presumed compliance within the context of its systemic claim under 
Article 23.1, 22.8 of the DSU. 
4.388  The logic of this argument may also be further elucidated when the invocation of good faith is 
linked to the issue of burden of proof.  The Un ited States and Canada have attempted to make a
 prima 
facie case against the EC compliance measure.  Ye t, following the scientific  debate the European 
Communities has refuted this prima facie case. The burden of proof is therefore still on the United  WT/DS320/R 
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  States and Canada for questioning the European Co mmunities' conclusion that the use of these six 
hormones for animal growth promotion is a risk to public health.  The United States and Canada have 
failed to meet this burden of proof  and they could not support their conclusions that the EC's ban on 
hormones treated beef was scientifically unsound.  
4.389  We would like to recall that the European Communities also made violation claims under 
Articles 23 and 21.5 of the DSU that do not depend on the WTO-consistency of the EC's compliance 
measure.  Rather these claims are directly linked to  the US' and Canada's unilateral determination of 
the alleged inconsistency of the EC' compliance measure.  
4.390  Finally, we have heard again this morning th at the United States maintains that it could not 
have possibly made a "determination" that the EC's ne w ban is in fact WTO-cons istent by the time the 
EC initiated these proceedings  because the Europ ean Communities failed to provide all the necessary 
materials relevant to its measure. 
4.391  This is a rather disingenuous characterization of  the real facts and I will, at this stage not 
recall all our arguments that we have submitted to you.  Let me just first point out that the United 
States erroneously keeps referring to a determinati on of WTO-consistency whic h it claims it could not 
make. The DSU neither requires nor forbids such  "consistency determination".  What the DSU 
prohibits, however, is the unila teral determination of a WTO violation by another Member. 
4.392  Let me also recall, that while the United Stat es in its view struggled to come up with a 
"determination" as early as November 2003 they di smissed the EC compliance measure and explicitly 
stated in its Trade Policy Review of 2005 that "the y failed to see how the revised measure could be 
considered to implement the recommendations and ruli ngs of the DSB".  And in addition to that, since 
then the United States simply continued to apply its sanctions against the European Communities.  
There is no other way than to qualify this behavi our as an illegal determination of non-compliance.  
And, finally, it is also simply not true that the United States had been confronted with the evidence for 
the first time in 2003.  All the underlying studies have been peer-reviewed and been published in 
journals and the European Communities undertook even  an effort to discuss with the United States in 
Washington the scientific evidence. All this is on th e record.  The European Communities, therefore, 
cannot express again its puzzlement by the way the Un ited States represents the facts in this dispute. 
(d) Conclusion 
4.393  For all these reasons, the European Comm unities would ask the Panel to find: 
(a) First, that the United States' and Canada 's continued suspension of concessions 
against the European Communities was inconsis tent with the provisions referred to 
under Part I of the EC's first written submission. 
(b) In the alternative, the United States' and Canada's continued suspension of 
concessions against the European Communities is inconsistent with the provisions set 
out under Part II of the EC's first written submission. 
L. ORAL STATEMENT OF THE UNITED STATES  ON LEGAL ISSUES DURING THE SECOND 
SUBSTANTIVE MEETING  
1. Oral statement 
4.394  The United States considers that last week's m eeting with the scientific experts reinforced a 
fundamental point – that the European Communiti es ("EC") has failed to demonstrate that the 
conditions of Article 22.8 of the WTO's  Understanding on Rules and  Procedures Governing the WT/DS320/R 
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  Settlement of Disputes  (the "DSU") for ending the Dispute Settlement Body ("DSB") - authorized 
suspension of concessions in the Hormones  dispute have been met.  To prevail on its claim that the 
United States has breached Article 22.8, the EC must demonstrate that it has either removed its WTO-inconsistent measures or provided a solution to the nullification or impairment suffered by the United 
States as a result of its ongoing bans on US meat  and meat products.  The EC has done neither. 
4.395  The EC could have satisfied its burden by de monstrating that its "amended" ban brought it 
into conformity with its obligations under the WTO  Agreement on the Application of Sanitary and 
Phytosanitary Measures ("SPS Agreement ").  But it did not.  The experts have provided valuable 
scientific and technical advice that confirms this fact.  Their written and verbal responses demonstrate 
that the EC has failed to complete a risk assessment  for oestradiol or base its ban on a risk assessment 
within the meaning of SPS Article 5.1.   
4.396  Similarly, the experts' responses confirm that the EC has not imposed provisional bans within 
the meaning of SPS Article 5.7.  Before discussing the EC's failure to bring its measures into 
conformity with the SPS Agreement  and DSB recommendations and rulings, and thereby satisfy the 
conditions of DSU Article 22.8, however, I would lik e to briefly touch on the other DSU claims raised 
by the EC in the course of these proceedings. 
4.397  The Panel will recall that the EC initially a lleged that the United States was breaching its 
WTO obligations by failing to meet the requirements of several provisions of the DSU – namely 
Articles 21.5, 22.8, 3.7 and several provisions of Article 23 read "in conjunction" with each other.  
The United States has demonstrated that the EC's DS U claims are merely a reflection of how the EC 
would like to see the DSU rewritten rather than b ased in the actual text of the DSU as written and 
agreed to by WTO Members.  As noted by the Appellate Body, "[d]etermining what the rules and 
procedures of the DSU ought to be is not our r esponsibility nor the responsibility of panels; it is 
clearly the responsibility solely of the Members of the WTO." 
4.398  The EC alleges that its "provisional bans" on me at and meat products from cattle treated with 
the five other hormones (testosterone; progester one; zeranol; trenbolone acetate; and melengestrol 
acetate) satisfy its obligations under SPS Article 5. 7 and thereby bring it into conformity with the 
DSB recommendations and rulings that it must base its measures for these hormones on a risk 
assessment, as appropriate to the circumstances, within the meaning of Article 5.1 of the 
SPS Agreement .   
4.399  Article 5.7 is a qualified exem ption from Article 2.2 of the SPS Agreement  which stipulates, 
among other things, that Members shall not mainta in sanitary measures without sufficient scientific 
evidence "except as provided for in paragraph 7 of Artic le 5".  In light of the fact that "Article 5.1 
may be viewed as a specific application of the basi c obligations contained in Article 2.2" and that 
"Articles 2.2 and 5.1 should constantly  be read together," it is clear that Article 5.7 is also a temporary 
exception from a Member's obligation to base its measu re on a risk assessment within the meaning of 
Article 5.1.  In order to qualify for this excep tion, however, the EC must demonstrate that it has 
satisfied the four cumulative conditions of Article 5.7.   
4.400  The experts' written and oral comments confirm that the EC has failed to do so and thereby 
failed to demonstrate that it has brought its meas ures into conformity with DSB recommendations and 
rulings.  As a result, the EC has not removed the WTO-inconsistencies of its measures or provided a 
solution of the nullification or impairment suffere d by the United States within the meaning of DSU 
Article 22.8. 
4.401  For example, the EC's bans on the other five hormones are not imposed in a situation where 
relevant scientific information relating to the hor mones is insufficient within the meaning of SPS 
Article 5.7.  As demonstrated by the United States and confirmed by the written and oral responses of  WT/DS320/R 
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  the experts, there is more than sufficient scientific  evidence to permit "performance of an adequate 
assessment of risks as required under Article 5.1" for the five hormones. 
4.402  In addition, the EC's bans on the other five  hormones are not based on available pertinent 
information within the meaning of SPS Article 5.7.  Its bans cannot be based on available pertinent 
information, because none of that information s uggests that meat and meat products from cattle 
treated with the five hormones for growth promo tion purposes according to good veterinary practices 
pose a risk to consumers.   
4.403  The EC alleges that its permanent ban on meat  and meat products from cattle treated with 
oestradiol for growth promotion purposes is based  on a risk assessment within the meaning of 
Article 5.1 of the SPS Agreement .  In these proceedings we have examined what, exactly, constitutes a 
risk assessment for Article 5.1 purposes from several  angles and have confirmed a few basic concepts 
regarding the necessary components of a risk assessme nt for oestradiol.  A risk assessment must 
identify adverse effects from the consumption of meat  from cattle treated with oestradiol and evaluate 
the potential occurrence of such effects, and it mu st engage in four fundamental steps:  hazard 
identification; hazard characterization; expos ure assessment; and risk characterization. 
4.404  Rather than concluding that the EC's Opini ons constitute a complete risk assessment, the 
experts' responses indicate that the EC has failed to  progress beyond the first step of risk assessment, 
hazard identification.  As noted by the United St ates, this stage of risk assessment addresses the 
simple question of what can possibly go wrong, not the likelihood of something going wrong. 
4.405  The EC has also failed to base its permanent ban on meat and meat products from cattle 
treated with oestradiol for growth promotion purposes on a risk assessment, as appropriate to the 
circumstances, within the meaning of SPS Article 5.1.   In order for the EC's measure to be "based" on 
a risk assessment, its assessment (the Opinions) mu st sufficiently warrant or reasonably support its 
measure, a ban on meat and meat products from cattle  treated with oestradiol for growth promotion 
purposes.  Yet, the EC's Opinions and their underl ying studies simply identify theoretical risks from 
oestradiol generally rather than the specific ri sk ostensibly addressed by the EC's measure.   
4.406  The materials relied on by the EC focus on potential adverse effects from exposure to 
oestradiol or estrogens generally rather than provi ding evidence of the speci fic risk from residues in 
meat from cattle treated with oestradiol for growth  promotion purposes.  In its most recent set of 
exhibits, the EC has failed yet again to provide evidence of the specific risk allegedly posed by 
residues in meat from treated cattle.  
4.407  While the sort of scientific evidence of a gene ral risk presented by the EC, of which the US 
Report on Carcinogens  it has referred to is a good example,  may be handy for completing the hazard 
identification (first) component of a risk assessment , it is not evidence of the specific risk against 
which the EC purports to mitigate with its bans. 
4.408  A measure banning the import of meat treated with oestradiol for growth promotion purposes 
cannot be premised on the EC's failure to produce ev idence of a risk from this product.  This failure 
represents the very type of theoretical uncertainty that  is "not the kind of risk which, under Article 5.1, 
is to be assessed."  As a result, th e EC's Opinions fail to sufficiently warrant or reasonably support its 
measure. 
4.409  This point is highlighted by the fact that so many of the studies relied on by the EC in its 
Opinions do not actually support the conclusions it has drawn from them.  For instance, as discussed 
yesterday morning, the EC's Opinions reach conclusions on the genotoxicity, carcinogenicity and mutagenicity of oestradiol that simply are unsup ported by scientific evidence.  The experts have 
confirmed this point.  The experts looked at the materials put forward by the EC in its attempt to WT/DS320/R 
Page 74 
 
 
  produce evidence of the specific risk, yet have disag reed with the fundamental conclusions the EC 
draws from those materials.  For example, the e xperts agreed that the sci entific evidence did not 
support the conclusion that residue levels  found in meat would be carcinogenic. 
4.410  This is why, in yesterday's meeting, the Un ited States made the point in the discussion of 
Appellate Body guidance from the original Hormones  dispute that the Appellate Body's language on 
appropriate levels of pr otection was not necessarily relevant to the debate at hand.  The point the 
United States made is that if there is no evidence of a risk from meat treated with oestradiol for 
growth promotion purposes, it does not matter what level of protection the EC has set for itself.  Its level of protection could be zero risk, no additional ri sk, negligible risk, or some risk – if the product 
in question is safe, all of these levels of protec tion are satisfied and there is no need to parse 
distinctions between them.  Despite this fact, if th e Panel wishes to delve deeper into this Appellate 
Body discussion, the United States would note that the Appellate Body provided additional guidance 
on the matter of appropriate levels of protection and existence of distinctions in those levels in its 
Report in the Australia – Salmon  dispute beginning at page 42. 
4.411  For these reasons, those set out in the US submissions, and in light of the responses of the 
Panel's scientific experts, the EC has failed to c onduct a risk assessment for oestradiol and has failed 
to base its permanent import ban on meat and meat products from cattle treated with oestradiol for 
growth promotion purposes on a risk assessment, as appropriate to the circumstances, within the 
meaning of Article 5.1 of the SPS Agreement . 
4.412  Finally, by failing to base its permanent ban on  meat from cattle treated with oestradiol on a 
risk assessment within the meaning of  SPS Article 5.1 or to satisfy the conditions of SPS Article 5.7 
for its provisional bans on meat from cattle treated with the other five hormones, the EC has not brought its measures into conformity with its obligat ions under SPS Article 3. 3.  As a consequence, 
the EC has again failed to satisfy the conditions of DSU Article 22.8 because it has not removed the 
WTO-inconsistencies of its measure.  
4.413  The EC's measures are not based on international standards, and must therefore be premised 
on a "scientific justification" or maintained "as a consequence of the level of ... protection [the EC] 
determined to be appropriate in accordance with  the relevant provisions of [Article 5 of the 
SPS Agreement ]."
25  Because the EC's measures are neither based on a risk assessment nor satisfy the 
necessary conditions for a provisional ban as required by Article 5 of the SPS Agreement , they fail to 
satisfy its obligations under SPS Article 3.3. 
4.414  In conclusion, the EC has failed to base its permanent ban on oestradiol on a risk assessment 
within the meaning of Article 5.1 of the SPS Agreement  or to satisfy the conditions of SPS Article 5.7 
with its provisional ban on the other five hormones.  As  a consequence, the EC also fails to satisfy its 
obligations under Article 3.3 of the SPS Agreement .  The experts' responses and comments provide 
the necessary scientific underpinning for these c onclusions, as well as the corresponding conclusion 
that the EC has not satisfied the conditions of DS U Article 22.8, the conditions by which the United 
States would have been obligated to cease to  apply the suspension of concessions in the Hormones 
dispute to the EC. 
4.415  For all the reasons discussed above and in its va rious submissions to the Panel, as well as the 
arguments raised by Canada in these proceedings, the United States respectfully  requests the Panel to 
reject the EC's claims in their entirety. 
                                                      
25 SPS Article 3.3.  WT/DS320/R 
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  2. Concluding statement by the United States 
4.416  The United Stated considers that we have ha d a very productive debate over the last week-
and-a-half.  In the course of our discussions, whic h included meetings with the panel of scientific 
experts, a few central issues have come to light. 
4.417  First, as I noted yesterday, the task at hand is  not one of conducting a risk assessment for the 
European Communities.  It is not one of conducting a review for the EC of the numerous materials it 
has put forward since completion of its Opinions.  Rath er, the relevant analysis is one of what the EC 
has actually accomplished in its Opinions. 
4.418  Second, the Panel has consulted scientific expe rts to sift  through the EC's Opinions and 
related materials in an attempt to determine whet her any of these materials actually addressed the 
specific risk at issue in these pr oceedings – that from oestradiol re sidues in meat from animals treated 
with growth promoting hormones.  The experts also  looked at information put forward by the EC in 
support of its provisional bans on the other five horm ones.  The experts noted, as discussed in the US 
statement yesterday, that the EC had not complete d the necessary steps of a risk assessment for 
oestradiol.  Nor had the EC presented evidence that oestradiol residues in meat from treated cattle are 
carcinogenic.  The United States described how these majo r conclusions factor into an analysis of the 
EC's permanent ban on oestradiol.  They demonstrate that it is not based on risk assessment for 
purposes of SPS Article 5.1. 
4.419  As to the other five hormones, the experts indicated that there was sufficient scientific 
evidence to conduct a risk assess ment for each one and that the scientific evidence did not 
demonstrate a risk at levels found in residues in meat from treated cattle.  This means that the EC 
failed to demonstrate that scientific evidence was insufficient to conduct a risk assessment for these 
hormones or that it had based its ban on available pe rtinent information.  Therefore, the EC's bans do 
not satisfy the conditions of Article 5.7 of the SPS Agreement . 
4.420  Third, the EC has claimed a US breach of Ar ticle 22.8 of the DSU.  To demonstrate this 
breach, it must show that it has removed the WTO-inconsistencies of its measures or provided a solution to the nullification or impairment of bene fits suffered by the United States.  These conditions 
could theoretically be met if the EC's measures satisfy its obligations under the SPS Agreement .  
However, they do not.  The experts' comments inform this analysis. 
4.421  Fourth, and finally, the EC's various other DSU claims reflect the EC's hopes for how the 
DSU should be rewritten rather than finding a basis in the text of the DSU as it currently reads.  
Through a string of provisions read "in conjunction" with each other, it seeks very specific findings of 
specific provisions of the DSU.  As the Appellate Body cautioned, "[d]etermining what the rules and 
procedures of the DSU ought to be is not our r esponsibility nor the responsibility of panels; it is 
clearly the responsibility solely of the Member of the WTO. Disregarding this guidance, the EC seeks 
to insert new obligations into the text of the DSU through the vehicle of dispute settlement.  It may 
not do this.  The EC, like the rest of the Membership of  the WTO, is left with the text of the DSU as it 
reads today, and the EC has failed to demonstrate any US violation of the specific provisions of that text. 
4.422  In closing, I would like to thank you fo r the professional manner in which you have 
conducted these proceedings.  Thank you very much. WT/DS320/R 
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  V. ARGUMENTS OF THE THIRD PARTIES 
A. AUSTRALIA  
1. Introduction 
5.1 According to Australia, this dispute is about  one fundamental question; whether the DSU 
provides that a Member's announcement of its co mpliance with DSB recommendations and rulings 
triggers an obligation on a retaliating Member to  either (i) cease retaliation or (ii) initiate a new 
process for a multilateral determination of compliance.26 
2. Opening Panel meetings for public observation 
5.2 Australia contends that when parties agr ee not to follow the Working Procedures in 
Appendix 3, or parts thereof, it would be difficult fo r the Panel to justify a decision that goes against 
the wishes of the parties.  In Australia's view, to do so would undermine a basic principle of dispute 
settlement whereby parties consult with each other and with the Panel and seek mutual agreement on 
the conduct of disputes, according to Article 12.1 of the DSU.27 
5.3 Australia submits that the decision to open the meetings with the parties to the public would 
not pose a problem, in principle, to Australia.  Australia was however concerned about the modalities 
of organising the meetings, equity of access and logistic issues.  Australia was of the view that the opening of the Panel's meetings to the public shoul d be subject to the provisions that allow for 
protection of confidential information.
28 
3. Whether the DSB authorization remains in effect 
5.4 Australia argues that a Member's annou ncement of its compliance with DSB 
recommendations and rulings triggers an obligation on a retaliating Member to  either cease retaliation 
or initiate a new process for a multilateral determinati on of compliance.  Australia claims that as seen 
in Articles 22.1 and 22.8 of the DSU, the right to  suspend concessions authorised by the DSB is 
temporary and conditional upon the respondent continuing to be in non compliance or upon a solution 
not being reached.  According to Australia, by c ontinuing retaliation in the face of a respondent's 
notification of compliance, a complainant is effectively challenging the measure(s) taken to comply.  According to Australia therefore, in such a case it is for the complainant to invoke a compliance panel 
pursuant to Article 21.5 of the DSU.
29 
5.5 Australia contends that the suspension of concessi ons or other obligations is the "last resort" 
for Members invoking the dispute settlement proce dures, as stated in Article 3.7 of the DSU.30 
4. Article 21.5 of the DSU 
5.6 Australia acknowledges that Article 21.5 of th e DSU does not explicitly place the obligation 
to invoke a compliance panel on a complaining part y.  The text simply provides that in cases of 
disagreement over compliance such dispute shall be decided through recourse to the dispute 
settlement procedure.  Australia however argues that requiring a respondent to invoke a compliance 
panel against its own measure(s) constitutes an impl icit unilateral determinati on of inconsistency by 
                                                      
26 Third party submission of Australia, para. 4. 
27 Replies to Panel questions concerning an open hearing by Australia, question 1. 
28 Replies to Panel questions concerning an open hearing by Australia, question 2. 
29 Third party submission of Australia, para. 5. 
30 Replies to Panel questions by Australia, question 5.  WT/DS320/R 
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  the complainant and undermines the presumption that  Members act in good faith in taking action to 
comply with DSB recommendations and rulings.31 
5.7 Australia further submits that this position is consistent with Appella te Body findings on the 
presumption of good faith in Chile – Alcoholic Beverages ,32 where the Appellate Body stated that  
Members of the WTO should not be assumed, in any way, to have continued  previous protection or 
discrimination through the adoption of a new measure , as this would come close to a presumption of 
bad faith.33  Australia also noted observations on good faith made by the Appellate Body in US – 
Hot- Rolled Steel34and US – Line Pipe .35 
5.8 Australia thus points out that the fact that a complainant may have been granted temporary 
authorisation to retaliate against a Member f ound to be in non-compliance does not change the 
fundamental application of the presumption of good faith.  Australia stresses that disregarding the 
presumption in the specific circumstances of a Member announcing that it has taken action which it 
considers brings it into compliance would go against the design and underlying logic of the DSU.36  
5.9 Australia posits that the DSU is explicit on th e following points, which provide context for 
the interpretation of Article 21.5:37 
• Members must not take unilateral action to  seek redress for alleged violations of 
obligations or other nullification or im pairment of benefits (Article 23). 
• Instead, Members must have recourse to the DSU and abide with its rules and 
procedures (Article 23). 
• DSU procedures, including those provided for in Article 21, must be used to resolve 
disagreements over compliance (Article 23.1). 
• The suspension of concessions or other oblig ations is a "last resort" by Members and 
is temporary. That is, it is only authorised  until compliance is achieved (Articles 3.7 
and 22). 
5.10 Australia contends that by refusing to in voke a "compliance panel", a complainant who 
disagrees with the respondent's announcement of its  compliance allows the dispute to continue 
unresolved.38  Australia argues that the longer the time period in which the United States did not take 
action under Article 21.5, the greater the firmness or immutability the United States made of its determination. Australia emphasizes that this is  because a determination within the meaning of 
Article 23.2(a) of the DSU may be inferred on ce a certain amount of time has passed after 
communication by a responding party that it has complied and in which a complaining party continues to retaliate.  According to Australia therefore, th e longer the period of time that a complaining party 
continues its retaliation in the face of this communica tion, the greater degree of certainty there is for 
the inference that the retaliating party has determined  that a violation has occurred, that benefits have 
                                                     
 
31 Third party submission of Australia, para. 6. 
32 Chile – Taxes on Alcoholic Beverages , (WT/DS87/AB/R and WT/DS110/AB/R), para. 74, (emphasis 
in original, footnote omitted). 
33 Third party submission of Australia, para. 7. 
34 US – Anti-Dumping Measures on Certain Hot-Rolled Steel Products from Japan  (WT/DS184/AB/R), 
para. 101. 
35 US – Definitive Safeguard Measures on Imports of Circular Welded Carbon Quality Line Pipe from 
Korea (WT/DS202/AB/R), para. 110. 
36 Third party submission of Australia, para. 8. 
37 Third party submission of Australia, para. 9. 
38 Third party submission of Australia, para. 10. WT/DS320/R 
Page 78 
 
 
  been nullified or impaired or that the attainment of  any objective of the covered agreements has been 
impeded.39  
5.11 Australia argues that there is no procedure that  a Member claiming compliance can invoke in 
order to obtain a multilateral determination of act ual compliance.  According to Australia, the 
possibility of a new dispute whereby the origin al respondent complains against the continued 
retaliating measures on the basis of actual  compliance assumes that there is no obligation upon the 
retaliating Member to either initiate an Article 21.5 panel or cease retaliation after communication of 
compliance by a respondent, which is an incorrect interpretation of the DSU.40 
B. BRAZIL  
1. Introduction 
5.12 Brazil claims that it files the present submission in light of its interests in  the interpretation to 
be developed by the parties and the Panel in these proceedings.  Brazil states that it will address what 
it considers to be the fundamental objective of th e European Communities in the current dispute, 
namely to obtain multilateral recognition that it has fully implemented the recommendations of the 
DSB without having to bear the burden of proving how it would have effectively implemented those 
rulings.41 
2. Opening Panel meetings for public observation  
5.13 Brazil questioned the specific grounds and the DSU provisions on which the Panel based its 
decision to accept the parties' request to open the pa nel meetings for public observation.  According to 
Brazil, transparency is one of the key issues in the DSU review process and constitutes an important 
element in the debate carried out by Members in the DSB meetings.  As such, Brazil notes that the 
debate on transparency will largely benefit from any further clarification by the Panel as to the legal 
reasons which motivated its decision to open the meetings to the public.42  
5.14 Brazil argues that a decision on whether or not to open panels' proceedings to the public relies 
solely on the WTO membership, in particular th e DSU review process which is the appropriate locus  
to deal with issues regarding the Dispute Settlement Mechanism.  According to Brazil, if panels were 
to decide on this issue, they would go beyond thei r mandate,  playing a role that is exclusive to the 
WTO membership.43 
5.15 Brazil further submits that the right to be presen t at or to watch a panel meeting should be 
granted first to WTO Members subject to the rules fo r third party participation set forth in Article 10 
of the DSU.  Brazil also contends that opening  the meetings to the public would represent a 
reinterpretation of Article 14 of the DSU, signaling that there are cases to wh ich confidentiality is not 
applied, such as Panel  a nd Appellate Body meetings.44 
3. Whether the DSB authorization remains in effect 
5.16 In Brazil's point of view, the European Commun ities must prove that the new measure is in 
full compliance with the DSB recommendations.  Brazil stresses that the European Communities' 
claim is based only on a unilateral sole assertion of compliance. However, a mere assertion is 
                                                      
39 Third party submission of Australia, para. 10. 
40 Replies by Australia to Panel questions, question 4. 
41 Third party submission of Brazil, paras. 1 and 2. 
42 Oral statement of Brazil, para. 2. 
43 Replies by Brazil to Panel questions concerning open hearings, question 1. 
44 Replies by Brazil to Panel questions concerning open hearings, question 1.  WT/DS320/R 
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  insufficient to prove compliance.  Brazil submits  that the European Co mmunities may modify its 
legislation over and over and notify changes to th e WTO without actually bringing the measures into 
conformity with WTO rules.45 
5.17 Brazil considers that if the European Commun ities argument were accepted, it would give the 
implementing Member the power to unilaterally dispel a previous multilateral determination 
authorizing suspension of concessions.  Brazil contends  that such Member would therefore be allowed 
to act as arbitrator, making use of a procedural artifice that could go on ad infinitum .  Brazil notes that 
it would be absurd to have that practice accepted as the common practice in the implementation of 
WTO disputes.  It would mean that  a mere asse rtion that a Member has changed a measure found to 
be inconsistent automatically revokes a DSB aut horization to suspend concessions, while exempting 
the Member from proving why and how the new measure complies with the DSB recommendations and rulings.
46  
5.18 Brazil submits that only in the case of a multilate ral determination  confirming that the EC 
has fully complied could there be grounds for consid eration of whether the United States is in breach 
of  Articles 23, 21.5, 3.7 and 22.8 of the DSU and Articles I:1 and II of the GATT 1994, as claimed.47  
5.19 Brazil argues that just as the initial imposition of  suspension of concessions must be preceded 
by a DSB determination of non-compliance, the au thorization for a Member to discontinue the 
suspension of those concessions can only be made by a DSB determination of compliance, be it for 
the initial suspension of concessions, or at a later st age for the lifting of the authorized suspension of 
concessions.48 
5.20 Brazil posits that the right to suspend concessi ons is temporary and conditional because it can 
only be applied based on a multilateral authorization (A rticle 23.2 (c) of the DS U) and until the party 
in violation complies with the recommendations of th e DSB or a mutually satisfied solution is agreed 
between the parties in the dispute (Article 22.1 and 22.8 of the DSU).49 
4. Article 21.5 of the DSU 
5.21 Brazil contends that the present situation is different from the one resulting from the 
relationship between Articles 21.5 and 22.6 of the DSU and it does not consider examples referred to 
by the European Communities regarding the US – Upland Cotton  dispute50, and Softwood 
Lumber51disputes, to be applicable to the present pr oceedings.  Brazil argues that the proceedings 
under Article 21.5 in those disputes had been already established at the time the implementing party requested the arbitration to determine the level of  the suspension of concessions.  Brazil stresses that 
in the current dispute, Article 21.5 proceedings an d Article 22.6 arbitration are not "simultaneously 
ongoing", since no request for a comp liance panel has been presented.
52  
5.22 Brazil submits that in the post-retaliation phase,  one should bear in mind that there is a 
multilateral authorization in effect.  According to Brazil, a presumption of good faith in carrying out 
the implementing measure cannot by itself override a DSB authorization.  That authorization should 
                                                      
45 Third party submission of Brazil, paras. 5 and 6. 
46 Third party submission of Brazil, para. 8. 
47 Third party submission of Brazil, para. 9. 
48 Third party submission of Brazil, para. 20. 
49 Replies by Brazil to questions from the European Communities, question 3. 
50 US –Upland Cotton , WT/DS267/22. 
51 US – Softwood Lumber VI , WT/DS277/11. 
52 Third party submission of Brazil, paras. 22-24. WT/DS320/R 
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  be revoked by a multilateral determination of co mpliance not by a unilateral declaration of 
implementation or a presumption of compliance.53 
5. Burden of proof 
5.23 Brazil posits that the party who makes a partic ular claim bears the burden of proof. Brazil 
further contends that by merely asserting that it h as removed the inconsistency found by the DSB, the 
European Communities is not supporting its claim.54  
5.24 Brazil also argues that the European Communiti es professes that no Member shall be 'judged' 
except through multilateral judicial proceedings.55  However, Brazil notes that this notwithstanding, 
the European Communities serves it self with a "blank authorization" to determine unilaterally its 
compliance with WTO obligations and the inconsis tency of the continued suspension of concessions 
granted by the DSB to the United States.  Brazil st ates that had the European Communities wanted to 
follow multilateral rules, it should have requested  an Article 21.5 compliance panel, as it did in EC – 
Bananas III (Article 21.5 – EC) .56   
5.25 Brazil argues that Article 21.5 of the DSU does not specify which Member is to initiate an 
Article 21.5 proceeding.  Therefore, in Brazil's poi nt of view, when disagreement exists as to the 
consistency of the measures taken to comply with  the DSB recommendations, any party to a dispute 
may have recourse to the Article 21.5 proceedings.  Brazil asserts that nothing in the DSU precludes 
an implementing Member from resorting to an Artic le 21.5 panel review. Brazil further argues that 
Article 6 of the DSU provides a rule for the develo pment of special terms of reference, which could 
be applied in those cases where the implementi ng Member requests a panel to analyse its own 
measure.57 
C. CANADA  
1. Introduction 
5.26 Canada submits that for the reasons set  out in its first written submission in Canada – 
Continued Suspension of Obligations in the EC – Hormones Dispute (WT/DS321)58, the continued 
suspension by the United States of concessions to th e European Communities is fully consistent with 
the obligations of the United States under the Ma rrakesh Agreement Establishing the World Trade 
Organization.  Consequently, Cana da agrees with the United States th at the claims of the European 
Communities have no basis in the DSU or GATT 1994.59  
2. Opening Panel meetings for public observation  
5.27 Canada submits that its views on this matter ha ve been expressed in the relevant portion of 
the Panel's Report (Section IV.B.2) in Canada – Continued Suspension of Obligations in the EC – 
Hormones Dispute  (WT/DS321).  The arguments that Canada expressed in that dispute as the 
defendant equally apply to the present case as Canada's third party arguments.60 
                                                      
53 Replies by Brazil to Panel questions, question 3. 
54 Third party submission of Brazil, paras. 10 and 11. 
55 See EC's first written submission, para. 1. 
56 Third party submission of Brazil, paras. 13 and 14. 
57 Replies by Brazil to Panel questions, questions 2 and 5. 
58 WT/DS321/06. 
59 Letter of 19 August 2005 to the Panel explaining Canada's third party submission. 
60 Letter of 30 June 2005 from Canada to the Panel.  WT/DS320/R 
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  D. CHINA  
1. Introduction 
5.28 China submits that the disputes raised in th is case are derived from loopholes embedded in the 
DSU.  China states that this brings to attenti on the importance of amending those loopholes in the new 
round of negotiation.  According to China, in absence of any revision of the DSU, it is a challenge for 
this Panel to find suitable dispute settleme nt solution according to the current DSU.61 
2. Opening Panel meetings for public observation 
5.29 China did not provide a reply on the potential le gal constraint that would exclude the Panel 
from opening the Panel meeting for public observation.   China however preferred the Panel to meet 
the third parties in closed session.  It argues that based on Article 18.2 of the DSU, panels do not have 
the right to unilaterally disclose the thir d party submissions a nd oral presentations.62 
3. The current status of the DSB authorized suspension of concessions 
5.30 China submits that under Article 22.8, a DSB au thorized suspension of concessions shall not 
be applied, if one of three of the following conditions has been met:63 
(a) The measure found to be inconsistent with  a covered agreement has been removed; 
(b) The Member that must implement the recommendations or rulings provides a solution 
to the nullification or impairment of benefits; 
(c) A mutually satisfactory solution is reached. 
5.31 China contends that if a mutually satisfactory so lution is reached by the parties on (a) or (b) 
above, it will fall into condition (c) and then a DSB authorized suspension of concessions shall not be 
applied.  China posits that if there is no mutua lly satisfactory solution reached by the parties on 
whether condition (a) and/or (b) above has been met, the parties have to invoke the dispute settlement 
procedures to let the Panel make such determinati on. China posits that in case the responding party 
declares any of the above conditions has been satisfi ed, there are only two options for the complaining 
party: (a) to admit the compliance of  new measures; or (b) to deny it.64  
5.32 In China's view, in case the original complaining party denies the compliance of new 
measures, that is, if no agreement is reached be tween the parties as to whether the conditions under 
Article 22.8 of the DSU have been met, under Article  23 of the DSU, the parties shall have recourse 
to the DSB's determination to avoid unilateral determination.65 
5.33 China thus considers that there are only two wa ys to terminate a DSB authorized suspension 
of concessions:  (i) to reach a mutually satisfactory solution; (ii) to get a final determination from the 
DSB.  According to China, this  is the case, even when the orig inal complaining party needs a 
reasonable period of time to evaluate the WT O consistency of the implementation measure.66 
                                                      
61 Third party submission of China, paras. 1 and 2. 
62 Replies by China to Panel questions concerning open hearings, questions 1 and 2. 
63 Third party submission of China, para. 6. 
64 Third party submission of China, paras. 7 and 8. 
65 Replies by China to Panel questions, question 7. 
66 Third party submission of China, para. 9. WT/DS320/R 
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  5.34 China argues that the European  Communities' allegation that it has removed the measure at 
issue in itself could not give the European Comm unities ground to terminate the authorization of 
suspension of concessions.  China asserts that Artic le 23 of the DSU lays down the fundamental 
principle that the dispute settlement system of  the WTO is the exclusive means to redress any 
violation of any provision of the WTO Agreement.  It argues that since there is no mutually satisfactory solution between the European Commun ities and the United States, the DSB authorized 
suspension of concessions shall be applied un til the DSB makes a new determination on the 
authorization of suspension of concessions.  Chin a notes that the suspensi on of concessions pursuant 
to a DSB authorization is temporary and conditiona l, with the condition being that the original 
responding party fully implements the rulings and recommendations of the DS B.  China emphasizes 
that no party can make a unilateral determination on whether condition (i) and/or (ii) has been met.
67 
5.35 China emphasizes that if this Panel allows th e original responding party to terminate a DSB 
authorized suspension of concessions by introducing an  implementing measure, there is a risk that it 
could be abused by an original responding party who, instead of bringing its measures into full 
conformity with the recommendations and rulings of  the DSB, may implement legislation which does 
not cure all the defects in its earlier inconsistent le gislation.  China argues that if this Panel finds a 
DSB authorized suspension of con cessions to remain in effect after the original responding party 
introduced an implementing measure, it can he lp enforcing WTO rules by inducing actual 
compliance.68 
5.36 China is of the view that the suspension of concessions has at least two functions: (i) to 
rebalance the interests among parties; (ii) to fo rce the responding party to bring its measure into 
compliance with the covered agreement.  China posits that if this Panel allows the original responding 
party to introduce an implementing measure to  override the DSB-authorized suspension of 
concessions, it invalidates the second function of suspension of concessions.69 
4. Article 21.5 of the DSU and burden of proof 
5.37 China states that Article 21.5 of the DSU does not preclude the original responding party 
from having recourse to the dispute settlement procedur es in the event that there is disagreement as to 
the existence or consistency w ith a covered agreement of measures taken to comply with the 
recommendations and rulings.  China advan ces the following reasons for this argument.70 
5.38 First, according to China, it would be natural and logical only for the original complaining 
party to initiate an Article 21.5 proceeding. China quotes Chile – Alcoholic Beverages71 and Canada – 
Aircraft (Article 21.5 – Brazil)72 and argues that the original responding party when adopting 
measures to implement recommendations and rulings of the DSB shall be presumed to have fulfilled 
its WTO obligations, and therefore, shall not bear the burden to demonstrate compliance.  China notes 
that this is further justified because the Eur opean Communities' implementation measure requires 
conducting extensive scientific studies and perfo rming a comprehensive risk assessment in a 
transparent and objective manner.  According to China therefore, after the European Communities 
notifies the DSB of its measure to implement the recommendation and rulings of the DSB, it has 
                                                      
67 Third party submission of China, para. 10. 
68 Third party submission of China, paras. 11 and 12. 
69 Replies by China to Panel questions, question 3. 
70 Third party submission of China, para. 15. 
71 Third party submission of China, para. 17. 
72 Third party submission of China, para. 18.  WT/DS320/R 
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  fulfilled the procedure obligation under the DSU, a nd should not be required to bear the burden of 
proof.73 
5.39 Secondly, China refers to the practice of treaty interpretation as elucidated in Article 31.3 of 
the Vienna Convention on the Law of Treaties and Japan – Alcoholic Beverages II 74, and points out 
that the statistics of panel proceedings on compliance under Article 21.5 of the DSU show that in most cases, it is the original complaining party that initiates the dispute settlement procedure under 
Article 21.5 of the DSU.  China stresses that the only precedent for an original responding party to 
initiate the dispute settlement procedure under Article 21.5 of the DSU is in the EC – Bananas
75 
dispute where the European Commun ities as an original responding party sought the establishment of 
a compliance panel under Article 21.5 of the DSU wi th the hope of preventing the United States from 
having recourse to Article 22.6 of the DSU directly.  China asserts that this subsequent practice in the 
application of Article 21.5 of the DSU establishe s the agreement of the parties regarding their 
interpretation that the original complaining pa rty should initiate the Article 21.5 proceeding.76 
5.40 Thirdly, China argues, the balance of hardship  to initiate an Article 21.5 proceeding does not 
favour the original complaining party.  China belie ves that the original complaining party will suffer 
no cognizable harm if it initiates an Article 21.5 proceeding, because the DSB authorized suspension 
of concessions is still in effect.  China asserts that  it is not proper to let the European Communities 
initiate an Article 21.5 proceeding simply because the original complaining party is reluctant or has 
no incentive to do so.77 
5.41 China stresses that it should be presumed that wh en the original responding party introduces 
an implementation measure, it has fulfilled its WT O obligation, and it should be the duty of the 
original complaining party to demonstrate that th e implementation measure is still inconsistent with 
the covered agreement.  China believes if this Panel rules that the European Communities, as an 
original responding party, should initiate an Artic le 21.5 proceeding, it will unduly shift the heavy 
burden onto the shoulders of the European Communiti es to establish compliance, which is against the 
nature and logic of th e Article 21.5 proceeding.78 
5.42 China contends that it is usually the case that  the responding party has more information on 
its implementation measure, therefore it is better positioned to demonstrate the WTO consistency of 
the measure.  However, according to China, the nature and logic of Article 21.5 proceedings stands 
against this approach. China stresses that subse quent practice in the application of Article 21.5 
confirms this conclusion.  China is therefore of  the opinion that the United States as an original 
complaining party should bear the burden to institute the Article 21.5 proceeding.79 
5.43 China continues that the unique part of this case is that the original complaining party has a 
DSB authorized suspension of concessions.  Accord ing to China, in addition to the function of 
inducing compliance, this authorized suspension of  concessions can rebalance the trading relationship 
between the complaining and the original responding party in order to restore the economic equilibrium embodied in the original WTO deal.  China submits that if after the original panel 
proceeding, an original complaining party finds that the original responding party does not implement 
                                                     
 
73 Third party submission of China, paras. 19 and 20. 
74 See Appellate Body Report, Japan – Alcoholic Beverages II (WT/DS8/AB/R, WT/DS10/AB/R, 
WT/DS11/AB/R) p. 13 
75 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse 
to Article 21.5 by the European Communities , Report by the Panel (WT/DS27/RW/EEC), 12 April 1999 – 
report never adopted. 
76 Third party submission of China, paras. 21-24. 
77 Third party submission of China, para. 25. 
78 Third party submission of China, para. 26. 
79 Third party submission of China, paras. 27 and 28. WT/DS320/R 
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  the recommendations and rulings of the DSB, it has incentive to initiate an Article 21.5 proceeding, 
because it still suffers from a WTO inconsistent measur e.  However, in this case, China submits that 
due to the rebalance by the authorized suspension of concessions, the original complaining party may 
not have the same incentive, therefore it may be necessary to set up a time limit for it to initiate an 
Article 21.5 proceeding.80 
5.44 China argues that the proceedings under Artic le 21.5 of the DSU shall be initiated in a 
reasonable period of time.  China points out that it is in line with the good faith requirement 
established by Article 26 of the Vienna Convention on the Law of Treaties and it is also consistent 
with the requirement of "prompt settlement of situa tions" in Article 3.3 and the "temporary nature" of 
the retaliation system of the DSU.81 
5.45 China stresses that it wants to bring to th e Panel's attention that both Article 22.8 and 
Article 21.5 of the DSU do not preclude this Panel from setting a time limit to initiate the dispute 
settlement proceedings.  If this Panel holds that it sh ould be the original complaining party to invoke 
Article 21.5 of the DSU, to facilitate the implemen tation of this recommendation and ruling, it may be 
necessary to set up a time limit for the original complaining party to in itiate an Article 21.5 
proceeding.82 
5. Article 23.2 of the DSU 
5.46 China argues that to establish a violation of Article 23.2 (a), the Panel shall firstly assess 
whether the act of "determination" is made "in such cases", where a Member seeks the redress of a 
WTO violation.83 
5.47 China analyses the different interpretations of the term "seek the redress of violation" in  US – 
Section 301 Trade Act,84 in US – Certain EC Products "85 and in European Communities – Measures 
Affecting Trade in Commercial Vessels,86 and states that the term "seek  the redress of a violation" 
should be read broadly to cover any act as long as it seeks to obtain unilateral results that can be 
achieved through means other than recourse to the DSU.   China states that in this case, the original 
complaining party's continued suspension of con cessions could be considered as a measure seeking 
the redress of a WTO violation, if it had a chan ce to challenge the European Communities' WTO 
violation but held back, allowing the DSB au thorized suspension of concessions to apply 
continuously.87 
5.48 China argues that after the European Communitie s provided notice of the Directive to the 
DSB in October 2003, the original complaining part y raised doubt on the WTO consistency of this 
European Communities' implementation measure.  Sin ce then it has had a reasonable period of time to 
review the European Communities measure and to initiate Article 21.5 proceedings.  China argues 
that it is the lack of action under Article 21.5 of the DSU by the original co mplaining party, rather 
than the DSB authorized suspension of concessions  itself, that may be considered as seeking the 
redress of a violation.88 
                                                      
80 Third party submission of China, para. 29. 
81 Third party submission of China, para. 31. 
82 Third party submission of China, para. 32. 
83 Third party submission of China, para. 35. 
84 See Panel Report, US – Section 301 Trade Act , para. 7.50, footnote 657. 
85 See Panel Report, US – Certain EC Products, paras. 6.22 and 6.23. 
86 See Panel Report, EC – Commercial Vessels, WT/DS301/R, para. 7.196 
87 Third party submission of China, paras. 36-39. 
88 Third party submission of China, para. 41.  WT/DS320/R 
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  5.49 With respect to the meaning of the term "d etermination", China refers to the panel in US – 
Section 301 Trade Act89 and argues that the term "determination" in Article 23.2(a) of the DSU needs 
to be read broadly and it does not require that a measure clearly sets out in its text that a WTO 
violation has occurred.  China argues that such a determination may be inferred from actions.  
According to China, the longer the time period in which the original complaining party took no action under Article 21.5 of the DSU, the greater the firmness or immutability that it made such a 
determination.
90 
5.50 China argues that where there is  no official determination, the Panel has to find a way to 
evaluate the firmness and immutability of the alle ged determination.  China notes that before the 
decision becomes final, there could be a gradual change process in which a time lapse can be a 
parameter.  According to China, in the post-retaliati on phase, the clock starts ticking when the original 
responding party introduces a new measure.  Chin a argues that the amount of time needed to 
constitute a final determination by the original  complaining party under Article 23 of the DSU 
depends on several factors, including  but not limited to (1) the complexity of the compliance measure; 
(2) sufficiency of information related to the comp liance measure; and (3) the ability of the original 
complaining party to evaluate such new measure.91   
E. INDIA  
1. Introduction 
5.51 India submits that it takes no position on the r espective assertions of the parties in this 
dispute.  India notes however that the treaty text is  not clear on the respective rights and obligations of 
the party taking a compliance measure and the party a pplying sanctions.  India contends that this is 
evidenced by the fact that this is one of the major issues on which the WTO Membership is currently 
engaged in negotiation with a view to improve or cl arify the legal text.  India states that it has views 
on how the lacunae in the DSU on this issue can be improved or clarified, but that is a matter for the 
Membership to decide through future negotiations.92 
2. Opening Panel meetings for public observation  
5.52 India submits that the issue of external tr ansparency is being di scussed in the ongoing 
negotiations in the Special Session of the Dispute Settlement Body. India states that the negotiations 
have not yet been completed, and there is no c onsensus on whether and wh ich form of external 
transparency is acceptable to the WTO Members.  Until that happens, India believes that the Panel 
proceedings have to be in closed session,93 and its deliberations have  to remain confidential94 as 
provided in the DSU.95 
5.53 India posits that it is not a function of a panel to respond to any requests from the parties that 
do not assist in resolution of the matter before it, an d which are not in  the terms of reference of the 
panel.96 
5.54 India contends that the possibility of a pa nel to decide to deviate from the Working 
Procedures in Appendix 3 has been provided with a view to have panel procedures with sufficient 
                                                      
89 See Panel Report, US – Section 301 Trade Act , para. 7.50, footnote 657. 
90 Third party submission of China, paras. 41 and 42. 
91 Replies by China to Panel questions, question 1. 
92 Oral statement by India, para. 3. 
93 Paragraph 2 of the Working Procedures in Appendix 3 of the DSU 
94 Paragraph 3 of the Working Procedures in Appendix 3 of the DSU 
95 Replies by India to Panel questions concerning open hearings, question 1. 
96 Oral statement of India, para. 5. WT/DS320/R 
Page 86 
 
 
  flexibilities so as to ensure high-quality panel reports.97  In India's view, deviation from the Working 
Procedures, therefore, should meet this qualitative objective.  India quotes Article 12.1 of the DSU 
and the Panel in India – Patents (US)98 and argues that although p anels are given  some discretion in 
establishing their own working procedures, they do no t have the discretion to modify the substantive 
provisions of the DSU.  India argues that the conf identiality requirements for panel proceedings are a 
substantive provision of the DSU, and the Panel cannot  use its discretion to modify them in order to 
cater to a request by the parties on a matter that does not serve to improve the quality of the Panel's 
Report.99 
5.55 India argues that Article VII of the Rules of Conduct100 requires each 'covered person' to 
maintain the confidentiality of di spute settlement deliberations and proceedings at all times.  India 
questions how the Panel is going to ensure th at these requirements are met after opening the 
proceedings to the public for observation.101 
5.56 India submits that the decision of the Panel to  open its proceedings to the public necessarily 
involves some issues on which consultation and decisions with WTO Members, and not just the parties and third parties, would have been necessary.   For example, India questions how the Panel, at 
its own level, addressed issues relating to the implicat ions on the functioning of the WTO Secretariat, 
budgetary implications and implications relating to the use of the official languages of the WTO, for 
which rules and practices have been established by other bodies of the WTO.  India also questions 
how the Panel could take a view on the additiona l costs arising out of the opening up of the 
proceedings to public without the Budget  Committee having considered the matter.
102 
5.57 According to India, the WTO is a Member driven organization and it is solely for the WTO 
Members to decide whether or not to change th e WTO rules and open up panel proceedings to the 
public; a Panel cannot take upon itself that function, even at the request of parties to the dispute.103  
5.58 India posits that the meeting of the Panel's ses sion with the third parties should be in closed 
session as required under paragraph 2 of the Work ing Procedures contained in Appendix 3 of the 
DSU.104 
F. MEXICO  
1. Introduction 
5.59 Mexico submits that the systemic implications of  this dispute are of great importance in terms 
of the functioning of the DSU and in particular of defining a way of proceeding when there is an 
authorization to suspend benefits and then furt her disagreement as to whether or not the DSB's 
recommendations and rulings have been implemented.  In Mexico's view, the most important issue in 
this case is whether the adoption of implementati on measures "require" immediate termination of 
retaliatory measures and if not, who should require termination and how.  According to Mexico, the 
role of the Panel in this case is to give precise answ ers to these questions and to ensure that they fulfil 
                                                      
97 Article 12.2, DSU 
98 India – Patent Protection for Pharmaceutical and Agricultural Chemical Products – Complaint by 
the United States,  Panel Report, WT/DS50/R. 
99 Oral statement of India, para. 6. 
100 Rules of conduct for the understanding on rules an d procedures governing the settlement of disputes 
adopted by the DSB on 3 December 1996 (WT/DSB/RC/1). 
101 Oral statement of India, para. 7. 
102 Oral statement of India, para. 8. 
103 Oral statement of India, para. 9. 
104 Replies by India to Panel questions concerning open hearings, question 2.  WT/DS320/R 
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  not only the letter of the DSU, but also the objectiv es of security, predictability and prompt settlement 
of the dispute.105 
2. Opening Panel meetings for public observation  
5.60 Mexico disagreed with the opening of the panel meetings to the public on the grounds that 
panel meetings constitute panel "de liberations" and as such should be confidential, as per Article 14.1 
DSU.  Mexico also argues that tr ansparency is a sensitive issue that  is currently under discussion in 
the negotiations to amend the DSU thus to force one  or another negotiating position by taking such a 
decision is inappropriate.  Mexico argues that the DS U rules require that the meetings be confidential 
and therefore, bilateral agreement among parties is not suffice to bend the rules.  In its view, the 
decision of the two parties should only prevail to the extent that it does not affect the right of other DSB Members including third parties.  Mexico contends that if the Panel is to depart from the Working Procedures of Appendix 3, the Panel must do so with caution as such deviation is meant to 
grant flexibility so as to ensure high qualit y panel reports, as seen in Article 12.2 DSU.
106 
5.61 Mexico emphasizes that public hearings are a cr oss-cutting issue that should be addressed in 
all the discussions conducted in the WTO, and shou ld not be imposed by a panel at the request of 
three Members.  Mexico regrets that the decision w ill set a precedent that may affect the outcome of 
the negotiations and will in all lik elihood end up complicating the pr eparation of working procedures 
of future panels.107 
5.62 Mexico notes that if the Panel is to open the meetings to the public observation, as a policy 
perspective, it poses systemic questions as to the n ecessity to open negotiation meetings and ordinary 
sessions of the WTO  to the public.108  Mexico suggests that third party sessions follow the established 
WTO practice of being in closed session.109 
3. Whether the DSB authorization remains in effect 
5.63 According to Mexico, the Panel should reject the argument that a simple unilateral 
notification is enough to reduce multila teral effort to nothing.  Mexico contends that the Panel should 
bear in mind the lengthy procedure and high po litical costs to Members of obtaining a multilateral 
authorization to suspend concessions.110 
5.64 Mexico stresses that it can not allow a dispute se ttlement system to deprive all effect of the 
authority to suspend benefits when a Member has failed to implement the DSB's recommendations 
and rulings within the reasonable peri od.  In its view, in such a case, if the parties fail to agree, the 
matter must be resolved by a multilateral decision.111 
5.65 Mexico argues in its reply to the questions posed by the European Communities that a DSB 
decision may be affected only by another DSB deci sion taking away the effect of the first decision.112  
                                                      
105 Replies by Mexico to Panel questions concerning open hearings, question 1, paras. 2, 3 and 9. 
106 Oral statement of Mexico, para. 2;  Replies by Mexico to Panel questions, paras. 9 and 3. 
107 Oral statement of Mexico, para. 3. 
108 Replies by Mexico to Panel questions concerning open hearings, question 1, para. 7. 
109 Replies by Mexico to Panel questions concerning open hearings, question 2. 
110 Oral statement of Mexico, para. 5. 
111 Oral statement of Mexico, para. 4. 
112 Replies by Mexico to questions from the European Communities, question 4. WT/DS320/R 
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  4. Article 21.5 of the DSU 
5.66 Mexico claims that Article 21.5 DSU affords th e most suitable procedure for resolving this 
dispute and it could be initiated by any party.  Me xico however submits that the dispute could be dealt 
with either by an ordinary panel, or through arbitr ation under Article 25 DSU or indeed by any of the 
proceedings provided for in Article 5 DSU.  Mexi co however points out that it takes a constructive 
approach and good will by the parties to make Artic le 21.5 DSU function and be able to resolve any 
disagreements.113   
G. NEW ZEALAND  
1. Introduction 
5.67 New Zealand submits that this case raises  important issues about the integrity and 
effectiveness of the WTO dispute settlement system , as it is principally about issues of compliance 
and the proper interpretation and application of the rules of the DSU as they relate to the post-
retaliation phase.  In New Zealand's view, the cas e taken by the European Communities is for all 
intents and purposes a compliance case and is thus akin to an Article 21.5 case.  According to New 
Zealand, the same determinations are required to r esolve the case at hand, as would be required had it 
been commenced under Article 21.5. In New Zeal and's view, the Panel's terms of reference114 are 
sufficiently broad to encompass this question a nd in doing so, the Panel should focus on actual 
compliance and not presumed compliance.115 
2. Opening Panel meetings for public observation  
5.68 According to New Zealand, there are no legal constraints that would prevent the Panel from 
opening the Panel hearings to the public.  New Z ealand quotes Article 12.1 which allows panels to 
follow Working Procedures unless the panel decid es otherwise after consulting the parties.  
New Zealand argues that while Appendix 3 provi des for closed session hearings, the Working 
Procedure can be amended on the cons ent of the panel and the parties.  New Zealand further stipulates 
that the reference in Article 14.1 of the DSU to pa nel deliberations being confidential refers to the 
internal deliberations of the panel, not the hearings with the parties.  New Zealand submits that this is 
in line with the practice of other internationa l tribunals which have open hearings but whose 
deliberations are nonetheless confidential.  According to New Zealand, Article 18.2 of the DSU 
allows parties to waive confidentiality.  New Zeala nd did not object to its third party hearings being 
public.116  
3. Whether the DSB authorization remains in effect 
5.69 New Zealand submits that there is no obligati on on the United States to take an Article 21.5 
case, and that in the absence of a determination of  compliance from the DSB, the DSB's authorisation 
of suspension of concessions remains valid.117 
                                                      
113 Oral statement of Mexico, para. 6. 
114 WT/DS320/6 of 14 January 2005 and WT/DS/320/7.  The  Request for the Establishment of a Panel 
by the European Communities states, inter alia , that: 
The United States has acted inconsistently with Article 22.8 of the DSU by failing to apply the 
suspension of concessions or other obligations only until such time as the measure found to be inconsistent with 
a covered agreement has been removed,  or the implementing Member has provided a solution to the 
nullification or impairment of benefits previously  caused to the United States. (emphasis added). 
115 Third party submission of New Zealand, paras. 1.06 and 2.19. 
116 Replies by New Zealand to Panel questions concerning open hearings, questions 1 and 2. 
117 Third party submission of New Zealand, para. 2.09.  WT/DS320/R 
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  5.70 New Zealand argues that underlying the Eur opean Communities' arguments is the assumption 
that it should benefit in these circumstances from a presumption of compliance on the basis of the 
principle of good faith.118  New Zealand however does not agree that the said principle applies in the 
current circumstances, to require the United St ates to cease the suspension of concessions and 
commence Article 21.5 proceedings simply because the European Communities has notified that it 
now considers itself to be in compliance.  Accord ing to New Zealand, a presumption of good faith 
cannot override an explicit multilateral authorisati on from the DSB to impose a retaliatory suspension 
of concessions.119 
5.71 In New Zealand's view, the cases cited by the European Communities in support of the 
application of a presumption of compliance involve  measures that were implemented within the 
reasonable period of time and where there was no authorisation to suspend concessions, which is not the situation at present.  New Zealand opines that  even if it can be said that a presumption of 
compliance operates in the pre-retaliation period wh ile the reasonable period of time is still pending, 
in the current circumstances any presumed complia nce on the part of the European Communities has 
given way to the actual compliance of the suspensi on of concessions which has been duly authorised 
by the DSB.
120 
4. Articles 21.5, 22.8 and 23 of the DSU 
5.72 New Zealand argues that while it would be ope n to the respondent to initiate compliance 
review under Article 21.5, the argument that Article  23 read with Articles 21.5, 22.8 and 3.7 imposes 
a requirement to do so cannot be sustained.  New Zealand insists that Article 21.5 merely states that the disagreement shall be dealt with through recour se to the dispute settlement procedures, but does 
not place any particular onus on any one to commence proceedings.
121 
5.73 New Zealand contends that Article 23 is the framework provision setting up the requirement 
to have recourse to dispute settlement when seek ing redress of a violation of obligations.  New 
Zealand however argues that Article 23 does not addr ess the specific situation in this case, where the 
United States has had recourse to dispute settlement in accordance with this Article and has taken all 
the steps there identified.  New Zealand submits th at Article 23 does not impose an obligation on the 
United States to cease the applicati on of the suspension of concessions or to take a compliance review 
case where it does not accept that the measure ha s been removed.  Nor does it do so when "read 
together" with Articles 3.7 and 22.8.  New Zeala nd argues that it cannot see how these provisions can 
be read to displace the specific authorisation under Article 22.6, which has never been revoked.122 
5.74 New Zealand posits that if the Panel were to adopt the European Communities' approach, it 
would give rise to a situation where an implementing Member could continually impose successive rounds of litigation at will, by a mere assertion of compliance.  In New Zealand's view this could 
render useless the mechanism of suspension of concessions.  According to New Zealand, this 
approach is inconsistent with the aims and obj ectives of the dispute settlement system given the 
fundamental importance of suspension of concessions  as the 'last resort' of the dispute settlement 
system, as per Article 3.7 of the DSU.
123 
                                                      
118 The European Communities sets out its arguments on the 'presumption of compliance' in 
paras. 81-94 of its first written submission in addressing its argument that the United States is in violation of 
Article 23.1 read together with Articles 22.8 and 3.7 of the DSU. 
119 Third party submission of New Zealand, paras. 2.10 and 2.11. 
120 Third party submission of New Zealand, para. 2.12. 
121 Third party submission of New Zealand, para 2.14. 
122 Third party submission of New Zealand, paras. 2.14-2.16. 
123 Third party submission of New Zealand, para. 2.17. WT/DS320/R 
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  5.75 New Zealand points out that the suspensi on of concessions may not be maintained 
indefinitely in circumstances where the violation h as been addressed as stipulated in Article 22.8 of 
the DSU. According to New Zealand, if the r espondent maintains the suspension notwithstanding, 
then there is a "disagreement as to  the existence or consistency ... of measures taken to comply" with 
the recommendations within the terms of Article 21.5. As a consequence it is open to the party 
concerned about this to have recourse to th e dispute settlement procedures to resolve the 
disagreement.124   
5.76 New Zealand notes that this does not mean howev er, that sanctions may go on forever even in 
cases where there is full compliance but the new me asure has not been challenged.  New Zealand 
considers that if a measure taken to comply do es indeed remove the inconsistency with  the 
recommendations and rulings of the DSB, the su spension of concessions should be ceased.  In its 
view, the justification for continuing to suspend concessions would be the combination of the 
continuing DSB authorisation and the absence of any agreement that the original respondent has 
brought its measures into compliance.125 
5.77 In New Zealand's view, it is possible for an im plementing Member to initiate an Article 21.5 
proceeding in any case "where there is disagreement as to the existence or consistency with a covered 
agreement of measures taken to comply with  the recommendations and rulings" of the DSB.126 
5.78 New Zealand states that Article 21.5 does not sp ecify the procedures to be applied, beyond 
stipulating that the matter be referred to the origin al panel and that there be an accelerated timeframe 
for circulation of the report.  It further contends th at the consequence is that it is up to the Panel to 
establish the Panel procedures in accordance with Article 12 of the DSU.127 
5.79 New Zealand submits that there is no textual basi s in the DSU for concluding that an original 
complainant that maintains a multilaterally authori zed suspension of concessions after notification of 
a compliance measure by the original respondent and does not initiate Article 21.5 proceedings, is in 
violation of its obligations under the DSU.128 
5. Burden of proof 
5.80 New Zealand submits that the European Co mmunities bears the burden of proving a prima 
facie inconsistency with Article 22.8 of the DSU.  New Zealand refers to the Appellate Body decision 
in US – Wool Shirts and Blouses129, and contends that the European Communities must adduce 
evidence sufficient to raise a presumption that th e suspension of concessions continues to apply and 
that: (a) it has removed the measure found to be inconsistent with the SPS Agreement ; or (b) it has 
provided a solution to the nullification or impairme nt of benefits; or (c) a mutually satisfactory 
solution has been reached.  The EC does not argue (b ), and (c) is clearly not the case, but it instead 
relies on (a).130 
5.81 New Zealand submits that the European Commun ities has not demonstrated in its first written 
submission that it has removed the inconsistent measur e.  According to New Zealand, 'removal' of an 
inconsistent measure for the purposes of Article 22.8 of the DSU may be interpreted as compliance 
with the recommendations and rulings of the DSB.   'Removal' of the measure in this case could 
                                                      
124 Third party submission of New Zealand, para. 2.18. 
125 Replies by New Zealand to questions from the European Communities, questions 4 and 5. 
126 Replies by New Zealand to questions from the European Communities, question 6. 
127 Replies by New Zealand to Panel questions, question 2. 
128 Replies by New Zealand to Panel questions, question 5. 
129 United States – Measure Affecting Imports of Woven Wool Shirts and Blouses from India (US – 
Wool Shirts and Blouses) , WT/DS33/AB/R, 25 April 1997, p. 14. 
130 Third party submission of New Zealand, paras. 2.21-2.22.  WT/DS320/R 
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  involve the removal of the import prohibition and/or  establishing a justification for the prohibition 
through a risk assessment consistent with the SPS Agreement , taking into account the particular 
requirements which the Panel and Appellate Body reports identified.131 
6. Article 5.7 of the SPS Agreement  
5.82 New Zealand posits that as the Member seeking to have recourse to Article  5.7, the burden of 
proof rests on the European Communities to demonstrat e that the four requirements of that provision 
have been met.132  New Zealand is of the view that while not explicitly stated by the European 
Communities, the provisional import ban on the five hormones other than oestradiol-17 β appears to 
be an attempt to bring those measures within the qualified exemption provide d of Article 5.7 of the 
SPS Agreement .  According to New Zealand, as seen in Japan – Agricultural Products II133, the 
European Communities must demonstrate that: (a) its measure was imposed in a situation where 
'relevant scientific evidence is insufficient'; and th at (b) its measure was adopted "on the basis of 
available pertinent information, including that from relevant international organisations as well as 
from sanitary or phytosanitary measures applied by other Members."134 
5.83 New Zealand claims that pursuant to the sec ond sentence of Article 5.7, the European 
Communities may not maintain its measure unless it also: (a) 'seek[s] to obtain the additional 
information necessary for a more objective assessmen t of risk'; and (b) 'review[s] the measure 
accordingly within a reasonable period of time'.  Ne w Zealand posits further that the Appellate Body 
added that "[w]herever one of these four requirements is not met, the measure at issue is inconsistent 
with Article 5.7."135  New Zealand argues that the European Communities states that its provisional 
ban on five of the six hormones was adopted "on the basis of the available but still incomplete 
data".136  However, according to New Zealand, the European Communities is not required under 
Article 5.7 to show that the relevant scientific  evidence was 'incomplete', but rather that it was 
'insufficient'.  New Zealand quotes the Appellate Body in the Japan – Apples  case, which analysed the 
meaning of this expression that:137 
" '[R]elevant scientific evidence' will be  'insufficient' within the meaning of 
Article 5.7 if the body of available scien tific evidence does not allow, in quantitative 
or qualitative terms, the performance of an adequate assessment of risks as required 
under Article 5.1 and as defined in Annex A to the SPS Agreement ."138 
5.84 New Zealand is of the opinion that the Eur opean Communities in its first written submission 
does not establish a prima facie case that relevant sc ientific evidence does not allow an adequate risk 
assessment to be carried out.  New Zealand argues that the European Commun ities fails in its first 
written submission to explain how the current st ate of scientific knowledge has prevented it from 
conducting an adequate risk assessment with respect  to the five hormones.  According to New 
Zealand, this is even more difficult to understand when the same measure, an import ban, which the 
                                                      
131 Third party submission of New Zealand, para. 2.26. 
132 The Panel in Japan – Measures Affecting the Importation of Apples  (Japan – Apples ), 
WT/DS245/R, 15 July 2003, discussed at para. 8.212 the burden of proof under Article 5.7. 
133 Appellate Body Report on Japan – Measures Affecting Agricultu ral Products (Japan  – Agricultural 
Products II) , WT/DS76/AB/R, 22 February 1999, para. 89. 
134 Third party submission of New Zealand, paras. 2.28 and 2.29. 
135 Appellate Body Report on Japan – Agricultural Products II , para. 89.  Emphasis original. 
136 First written submission of the European Communities, para. 145. 
137 Third party submission of New Zealand, paras. 2.30-2.32. 
138 Appellate Body Report on Japan – Apples , para. 179. WT/DS320/R 
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  European Communities previously maintained was based on sufficient scientific evidence to be 
definitive, is now held out as a merely 'provisional' measure.139  
5.85 New Zealand submits that  on the other hand, the respondent in its first written submissions 
shows that a considerable body of relevant scientif ic evidence exists as to the use of hormones for 
growth promotion purposes.140  New Zealand argues that the United States points out that the 
hormones at issue have been "intensively studied over the last twenty-five years"141 and that the five 
particular hormones subject to the provisional ban have been "studied in greater detail in the 
intervening period (since the original Hormones  case)".142  According to New Zealand, the inference 
to be taken is that the relevant scientific evidence is both quantitatively and qualitatively sufficient to 
have enabled the European Communities to conduct an  adequate risk assessment, and avoid the need 
for recourse to provisional measures.143 
5.86 New Zealand further opines that even if the Pa nel were to accept that there was insufficient 
scientific evidence for the European Communities to conduct an adequate risk assessment, the 
European Communities must also show that its ne w measure was adopted 'on the basis of available 
pertinent information'.  New Zealand stresses that in order to satisfy the burden of proof, the European 
Communities must present the 'available pertinent info rmation' it evaluated and the factors that led it 
to conclude that a provisional import ban on the five hormones could reasona bly be based on this 
information.  New Zealand states that the Europ ean Communities failed in its first written submission 
to establish any connection between its provisional  import ban and: (a) the available pertinent 
information; (b) information from relevant inte rnational organisations; and (c) information from 
sanitary or phytosanitary measures applied by other Members.144 
5.87 According to New Zealand, by contrast, the United States claims that a large body of 
'available pertinent information'145 indicates that proper use of the hormones in question poses no risk 
to consumers.146   
5.88 New Zealand submits that under the third prong of Article 5.7, in a situation where the 
relevant scientific evidence is in sufficient to conduct an adequate  risk assessment, the European 
Communities is required to 'seek to obtain the a dditional information necessary for a more objective 
assessment of risk'.  New Zealand contends th at the European Communities implies that this 
requirement is reflected in Directive 2003/74/E C, which obliges the Commission "to seek more 
complete scientific information from any source whic h could shed light and cl arify gaps in the present 
state of knowledge on [the hormones]."147  New Zealand however submits that the European 
Communities offers no evidence in its first writte n submission to explain how the Commission is 
fulfilling this obligation.148 
5.89 New Zealand further opines that the final element of Article 5.7 requires the European 
Communities to 'review' its provisional measures 'w ithin a reasonable period of time'.  New Zealand 
notes that while a competent WTO body has yet to analyse what constitutes a 'reasonable period of 
time,' Directive 2003/74/EC has been in force for nearly two years, but the European Communities 
makes no suggestion in its first written submission th at a review of the provisional import ban is 
                                                      
139 Third party submission of New Zealand, para. 2.34. 
140 See US's first written submission, paras. 55-91. 
141 US's first written submission, para. 122. 
142 US's first written submission, para. 123. 
143 Third party submission of New Zealand, para. 2.35. 
144 Third party submission of New Zealand, para. 2.36. 
145 See US's first written submission at paras. 127-128. 
146 Third party submission of New Zealand, para. 2.37. 
147 EC's first written submission, para. 145. 
148 Third party submission of New Zealand, para. 2.38.  WT/DS320/R 
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  contemplated at all, let alone within a 'reasona ble period of time'.  New Zealand submits that the 
European Communities has failed to discharge its burden of proof with respect to the four elements of 
Article 5.7 in its first written submission.149 
7. Article 5.1 of the SPS Agreement  
5.90 New Zealand alleges that the European Commun ities has not demonstrated in its first written 
submission that its new measures meet the requirements of Article 5.1 SPS Agreement .  New Zealand 
contends that the Appellate Body in EC – Hormones  established that the obligation in Article 5.1 
contains two elements: (a) an assessment of risk s; and (b) that Members ensure that their SPS 
measures are "based on" such an assessment.  New Z ealand argues that concerning the first element of 
Article 5.1, paragraph 4 of Annex A of the SPS Agreement  sets out the definition of a "risk 
assessment".  New Zealand quotes the Appellate Body150  that recalled Article 5.2 of the 
SPS Agreement , which provides an indicative list of factors that must be taken into account in a risk 
assessment.151 
5.91 New Zealand further argues that the panel in the Japan – Apples  case summarized its 
consideration of the elements of Article 5.1 by r ecalling that a risk assessment would also involve an 
evaluation of whether the risk assessment was 'as ap propriate to the circumstances', and whether it 
took into account 'risk assessment techniques develope d by the relevant international organizations'.152  
New Zealand posits that the panel in that case adde d that these two factors would "pervade the entire 
assessment of the risk".153 
5.92 New Zealand stresses that while the European Communiti es claims to have conducted "a 
comprehensive risk assessment" since the Appellate Body decision in 1998154, it devotes only three 
paragraphs of its first written s ubmission to attempting to establish what constitutes a valid risk 
assessment for the purposes of Article 5.1.  New Zealand submits that the European Communities 
notes that it has initiated 17 scientific studies and resear ch projects, but enters into no discussion of 
the substance, conduct or conclusions of these studies.155  According to New Zealand, the European 
Communities observes that it addressed specific request s for scientific data to several countries and 
published an open call for relevant and recent scien tific data and information from any interested 
party, but makes no comment on the information received.156   
5.93 New Zealand further opines that in its firs t written submission, the European Communities 
simply refers to the SCVPH Opinions and presents a three-paragraph excerpt from Directive 2003/74/EC
157 which provide, on the face of it, a rath er limited and constrained justification 
for the European Communities' import ban.  Further, New Zealand posits that the European Communities articulates no clear link between "excess intake of hormone residues" (which is not 
defined in relation to use as a growth-promoting hormone) and "a risk" that has been identified.
158 
5.94 In New Zealand's view, the European Communitie s' recital and its bare conclusion fall well 
short of demonstrating that the European Comm unities has met the threshold required under the 
SPS Agreement  for the existence of a valid risk assessment.   New Zealand notes that in particular, the 
                                                      
149 Third party submission of New Zealand, paras. 2.38 and 2.39. 
150 Appellate Body Report on EC – Hormones , para. 187. 
151 Third party submission of New Zealand, paras. 2.42-2.44. 
152 Panel Report on Japan – Apples , para. 8.236. 
153 Panel Report on Japan – Apples , para. 8.237. 
154 EC's first written submission, para. 142. 
155 EC's first written submission, para. 142. 
156 Third party submission of New Zealand, para. 2.48. 
157 EC's first written submission, para. 144. 
158 Third party submission of New Zealand, para. 2.49. WT/DS320/R 
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  European Communities fails in its first written subm ission to adduce sufficient evidence that its risk 
assessment: (a) adequately identifies any adverse ef fects on human health arising from the presence of 
the hormones in question when used as growth promoters in meat;159 (b) evaluates the potential or 
possibility of occurrence of  such adverse effects;160 (c) is 'as appropriate to the circumstances';161 
(d) takes into account risk assessment techniqu es developed by the relevant international 
organisations;162 and (e) takes into account the available scientific evidence as ma tters specified in 
Article 5.2 of the SPS Agreement .163 
5.95 New Zealand argues that none of these criteria is optional in the performance of a risk 
assessment, and therefore the Europ ean Communities is required to demonstrate that all of them have 
been satisfied in the development of its opini ons.  New Zealand submits that the European 
Communities has failed to adduce sufficien t evidence to discharge this burden.164 
5.96 New Zealand contends that in contrast, the United States outlines some of the scientific 
evidence that exists on the u se of growth-promoting hormones,165 and evokes long-standing practice 
on the proper assessment of risks related to veterinary drug residues.166  According to New Zealand, 
this casts doubt on both the process and the s ubstance of the European Communities' risk 
assessment.167 
5.97 New Zealand states that in the event that the Panel decides that the European Communities' 
opinions constitute a valid risk ass essment for the purposes of Article 5.1, the European Communities 
is also required to demonstrate that the measure s in question are 'based  on' a risk assessment.  
According to New Zealand, the Appellat e Body analysed this relationship in EC – Hormones ,168 and 
states that the term 'based on' required a certain objective relationship between the risk assessment and 
the measure in question.169   
5.98 New Zealand argues that the European Communitie s does not attempt to explain in what way 
or to what extent its new measures are considered to be 'in accordance' with the scientific conclusions 
of the SCVPH.  New Zealand further stipulates that  the European Communities offers no basis at all 
for concluding that its risk assessment 'reasonabl y supports' its new measures.  New Zealand argues 
that in this case, the European Communities bears the burden of establishing that its risk assessment 
'sufficiently warrants' the new measures it adopted.  In New Zealand's view it was not open to the 
European Communities to leave the existence of a 'rational relations hip' to be inferred from a brief 
summary of the conclusions of the European Communities' opinions.170 
                                                      
159 SPS Agreement , Annex A, paragraph 4.  Extrapolated from the Panel Report in EC – Hormones , 
para. 8.101, as considered in the Appellate Body Report at paras. 183-184. 
160 SPS Agreement , Annex A, paragraph 4.  Extrapolated from the Panel Report in EC – Hormones , 
para. 8.101, as considered and modified in the Appellate Body Report at paras. 183-184. 
161 SPS Agreement , Article 5.1. 
162 SPS Agreement , Article 5.1. 
163 Third party submission of New Zealand, para. 2.51. 
164 Third party submission of New Zealand, para. 2.52. 
165 See, for example, US's first written submission, paras. 55–91. 
166 US's first written submission, para. 136. 
167 Third party submission of New Zealand, para. 2.53. 
168 Appellate Body Report on EC – Hormones , para. 193. 
169 Third party submission of New Zealand, para. 2.55. 
170 Third party submission of New Zealand, para. 2.58.  WT/DS320/R 
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  H. NORWAY  
1. Opening Panel meetings for observation by the public 
5.99 Norway considers that Article 12.1 of the DSU gives the Panel the discretion to follow other 
working procedures than the ones provi ded in Appendix 3 after consulting the parties.  It sees no legal 
constraints in granting the request to the parties to  open the hearings to the public.  Norway also 
agrees to have the third party session of  the hearing open to the public.171 
2. Whether the DSB authorization remains in effect 
5.100  Norway considers that the right to apply th e suspension of concessions pursuant to a DBS 
authorization is temporary and conditional.  Accordi ng to Norway, the application of the right rests on 
two basic conditions.  First; that there be an aut horization pursuant to Article 22.6 DSU and that the 
conditions set out in Article 22.6 DSU and 22.7 DSU, are respected  and secondly, that the temporal 
condition of Article 22.8 is met.172 
5.101  Norway opines that the temporal condition in Article 22.8 has three alternative elements: 
(a) the measure found to be inconsistent with a covered agreement has been removed; or (b) the 
Member that must implement recommendations or rulings provides a solution to the nullification or impairment of benefits; or (c) a mutually satisfactory solution is reached.
173  
5.102  Norway contends that the common concept in all three elements is that continued suspension 
is related to continued non-complia nce or lack of any other mutually satisfactory solution to the 
inconsistency.  According to Norway therefore, th e temporal condition is intrinsically linked to the 
substance of compliance.  Norway posits that out of the three elements, the third one, "a mutually 
satisfactory solution", can in principle be achieve d at any point in time and once achieved, would 
resolve the matter and no suspension may continue.  Norw ay adds that this is even so if the original 
measure found to be inconsistent with  a covered agreement is still in place.174 
5.103  Norway considers that the first two elements are in reference to compliance, which can be 
achieved through the removal of the original measur e or through another solution to the nullification 
or impairment of benefits, and the second elemen t is the normal situation where one measure is 
replaced by another measure.175 
5.104  Norway submits that once compliance is achieve d, be it through a simple revocation of the 
inconsistent measure or its repla cement with another measure that ensures compliance, the right to 
suspend obligations automatically lapses.  Norway is  of the view that similarly, once compliance has 
been established by a panel pursuant to Article 21. 5 of the DSU, the previous authorization lapses 
ipso facto  once the report is adopted, without there being a need for the DSB to revoke it formally as 
the temporal condition no longer exists.176 
5.105  Norway contends that once a measure taken to comply is notified by the original respondent, 
the question arises whether this amounts to full co mpliance or not.  Norway submits that if the 
original complainant considers that the measure taken to comply falls short of what is required by the 
                                                      
171 Replies by Norway to Panel questions concerning open hearings, questions 1 and 2. 
172 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 2. 
173 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 3. 
174 Replies by Norway to questions from the Europ ean Communities, questions 3, 4 and 5, paras. 4 
and 5. 
175 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 6. 
176 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 7. WT/DS320/R 
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  adopted rulings and recommendations, then the obliga tion to refer a "compliance dispute" to a panel 
according to Article 21.5 is incumbent upon them.177 
3. Article 21.5 of the DSU 
5.106  Norway argues that the situation addressed by Article 21.5 DSU occurs when the original 
respondent claims to have complied with the recomm endation and ruling of the DSB, but the original 
complainant disagrees.  According to Norway, Ar ticle 21.5 is competent both where the parties 
disagree as to the very existence of measures take n to comply, and where they disagree as to whether 
the measures taken to comply actually achieve complia nce.  Norway is of the view that the case at 
hand is typical in this respect, and falls squarely w ithin the ambit of Article 21.5. Norway notes that 
neither Article 22.8 nor Article 21.5 sets forth time lines in this respect.178 
5.107  According to Norway, the origin al complainant must be accorded a certain amount of time to 
assess the measure before going to a compliance panel.  Norway posits that the length of time needed 
will vary from case to case, and it is hard to set a fixed dead-line. In Norway's view, the DSU does not 
include such a fixed dead-line, however, this does not  mean that the original complainant can refuse 
to take action according to Article 21.5 within a reas onable time. Norway thus contends that in order 
to avoid such unreasonable delay, Article 21.5 allows  the original respondent to have recourse to a 
compliance panel.179  
5.108  Norway contends that the obligation to refer a "compliance dispute" to a panel according to 
Article 21.5 rests on both parties in the dispute.  According to Norway, Article 21.5 does not specify that it must be the original complainant to refer the matter to a "compliance panel".  Norway submits 
that Article 21.5 is written in the passive form, conc entrating on the result, specifically to place this 
obligation on all parties to the original dispute.
180 
5.109  Norway submits that the standard practice has b een that the original complainant refers the 
matter to the panel.  It argues th at the one exception so far has been  the referral to a compliance panel 
by the European Communities in EC – Bananas III (Article 21.5 – EC).181  According to Norway, the 
fact that the report remains unadopted and that the panel in that case refused to make any recommendations or rulings in the case, does not in itself prove that an original respondent may not 
invoke Article 21.5.
182  Rather, the position of the Panel in that  case must be seen in the light of the 
fact that Ecuador also requested a separate compliance panel183, and that the United States had 
submitted a request for retaliation that led to arbitration.184  Norway submits that the panel in that 
                                                      
177 Replies by Norway to Panel questions, question 5 para. 10. 
178 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 8. 
179 Replies by Norway to Panel questions, question 5, paras. 11 and 12. 
180 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities, 
para. 13. 
181 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse 
to Article 21.5 by the European Communities , Report by the Panel (WT/DS27/RW/EEC), 12 April 1999 – 
report never adopted. 
182 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities, 
para. 14. 
183 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse 
to Article 21.5 by the Ecuador , Report by the Panel (WT/DS27/RW/ECU), 12 April 1999. 
184 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse 
to Arbitration by the European Communities under Article 22.6 of the DSU , (WT/DS27/ARB), Report of the 
arbitrators dated 9 April 1999.  WT/DS320/R 
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  particular case could thus justify not making any recommendations or rulings by pointing to these 
other proceedings.185 
5.110  In Norway's view, a panel launched by the respondent cannot just make a declaratory 
judgment based on the presentation of the original respondent, but must make an objective assessment 
of the matter before it.  The scope of the "terms  of reference" would be to examine whether the 
measures taken to comply imply that there is now compliance with the rulings and recommendations 
of the original panel, i.e., that the original violation has been removed.  Only the violations 
specifically addressed in the original report will be  addressed by the compliance panel, not any other 
violations that the new measure may cause.186 
5.111  Norway argues that where the orig inal complainants refuse to par ticipate, then any claim that 
the new measure is inconsistent with other provis ions of the covered agreements will not be heard 
(will be outside of the "terms of the referen ce" for the compliance panel), and the original 
complainants risk a finding of co mpliance that does not take into acc ount all the arguments that they 
would otherwise have presented.  By not launchin g the Article 21.5 panel in a timely manner, the 
original complainants thus lose certain rights to pr esent new claims that they would have had, had 
they themselves launched the panel request first.  Such  claims will thus have to await another panel.  
As such, the incentive structure th at is created by allowing the original respondent to launch an 
Article 21.5 panel proceeding works to provide the original complainants w ith the incentive to go 
ahead themselves and launch the Article 21.5 panel first.187 
5.112  In case a compliance panel is requested by the orig inal respondent, the reference in Article 6.2 
to "provide a brief summary of the legal basis of the complaint sufficient to present the problem 
clearly" can be fulfilled by referring to the original pa nel report, together with the identification of the 
specific measure taken to comply and how it ensures compliance.188  Where the original respondent 
has to request an Article 21.5 panel because the origin al complainants refused to do so, the original 
respondent may be considered as "complainant" for the purpose of Article 6.1 and "applicant" for the 
purpose of Article 6.2.  The question who is "com plainant" and who is "respondent" does not matter 
for the rest of the proceedings.189 
I. SEPARATE CUSTOMS TERRITORY OF TAIWAN , PENGHU , KINMEN AND MATSU  
1. Introduction 
5.113  The Separate Customs Territory of Taiwan , Penghu, Kinmen and Matsu (Chinese Taipei) 
submits that it presents its views in this dispute b ecause of the important systemic issues involved, in 
particular, the DSU provisions that are under negotiations in the Special Session of the Dispute Settlement Body.  In its view, the resolution of cer tain issues in this case could significantly impact 
these negotiations.
190 
                                                      
185 See paras. 4.15 and 4.16 of the Panel Report in WT/DS27/RW/EEC. 
186 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities, 
paras. 16 and 18. 
187 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities, 
para. 16. 
188 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities, 
para. 18. 
189 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities, 
paras. 17 and 19. 
190 Third party submission of Chinese Taipei, para. 1. WT/DS320/R 
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  2. Opening Panel meetings for public observation  
5.114  Chinese Taipei argues that in  accordance with the procedures and customary practices 
developed over more than half a century under GA TT, which are reflected in Articles 14.1, 18.2 and 
Appendix 3 of the DSU, panel proceedings are to be kept confidential.  It argues that only Members 
by consensus can change the rules of confidentiality.   According to Chinese Taipei, a panel, even with 
the consent of the parties does not have the legal authority to open the pro ceedings to the public.191 
5.115  Chinese Taipei refers to Article VII of the Ru les of Conduct which requires that each covered 
person shall at all times maintain the confidentia lity of the dispute settlement deliberations and 
proceedings.  According to it, the only exception to this confidentiality obliga tion is Article 18.2 of 
the DSU which states that nothing in the DSU sh all preclude a party to a dispute from disclosing 
statements of its own positions to the public.  Chin ese Taipei is therefore of the opinion that this 
exception does not extend to the possibility of allo wing parties to decide whether to open panel 
meetings to the public.192 
5.116  According to Chinese Taipei, "panel deliber ations" implies more than one form of 
deliberation, thus includes not only internal consid eration among panelists, but also the entire process 
of the panel's consideration of the dispute.193 
5.117  Chinese Taipei argues that the flexibility from Article 12.1 of the DSU to change Working 
Procedures in Appendix 3 cannot be extended to c over provisions in the Working Procedures that 
directly elaborate on the obligations of the DSU.   It further argues that if the drafters had 
contemplated that the confidentiality requirement can be changed, they would have said so, just like in 
Article 18.2 of the DSU.  In the absence of such  language, only an amendment to the DSU by the 
Members through negotiations can change the requirement of confidential deliberations.194 
5.118  Chinese Taipei is of the opinion that th e third party sessions be in closed session.195 
3. Whether the DSB authorization remains in effect 
5.119  Chinese Taipei contends that the new implementi ng measure is required to be confirmed by a 
multilateral determination that the measure is compli ant with the DSB's recommendations and rulings.  
According to it, a unilateral claim of compliance t ogether with the principle of good faith does not 
overturn the DSB authorization of suspension of co ncessions, and that suspension of concessions can 
continue until the conditions in Article 22.8 have been met.196 
5.120  According to Chinese Taipei, the suspension of concessions can only be lifted after a 
multilateral determination of compliance, which involves an examination of the implementing 
measure against the recommendations and rulings of th e DSB, or by mutual agreement of the parties. 
In its view, until then, the DSB authorization re mains valid and the suspension of concessions may 
continue.  Chinese Taipei further states that if none of the parties brings the implementing measure to 
the panel, whether through Article 21.5 or Article 22.8, the suspension of concessions may continue.  
It contends that without the initiation of a dispute that results in the examination of the implementing 
                                                      
191 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 1 and 2. 
192 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 4 and 5. 
193 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, para. 3. 
194 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 6 and 7. 
195 Replies by Chinese Taipei to Panel questions concerning open hearings, question 2, para. 12. 
196 Replies by Chinese Taipei to questions from the European Communities, question 1.  WT/DS320/R 
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  measure, the status quo  would be considered as maintaining the existing balance of rights and 
obligations among WTO Members.197  
5.121  Chinese Taipei does not consider that there is a need to justify the continuing suspension of 
concessions after the implementing Member's cl aim that it has complied with the DSB's 
recommendations and rulings.198  
5.122  Chinese Taipei rejects the view that  the lack of action for any period of time on the part of the 
United States and Canada constitutes an expression of the US and Canada's determination.  According 
to Chinese Taipei, the existence of  the determination by the Unite d States and Canada cannot depend 
on such an indeterminate criteria as the length of tim e it takes for the United States and Canada to take 
action under Article 21.5 of the DSU.  Therefore, in its view, Article 22.8 of the DSU allows the 
United States and Canada to continue its suspen sion of concessions until one of the three conditions 
therein have been met.199 
4. Article 21.5 of the DSU 
5.123  Chinese Taipei considers that one of the ways to  arrive at a multilateral determination in the 
current situation is through Article 21.5 of the DS U.  With respect to the European Communities' 
argument that in the absence of the initiation by the United States of an Article 21.5 compliance panel, 
the European Communities' implementing measure mu st be presumed to be consistent with WTO 
rules and the continuation of the suspension of concessions by the United States would amount to a 
unilateral determination of a violation of WTO rules200, it argues that Article 23.2(a) is valid only if 
two requirements are present in the text of Article  21.5, namely, (a) a deadline by which a 21.5 panel 
must be initiated, and (b) an obligation only on the original complaining party to initiate the proceeding.
201   
5.124  Chinese Taipei considers that neither one of th ese requirements currently exists in the text, 
nor is it reasonable to interpret their existence.  It submits that it is up to the Member involved to 
choose whether and when to initiate the Article 21. 5 proceeding.  It opines that while it recognizes 
that the party suffering the suspension of concessions h as an interest to lift such suspension as early as 
possible, that interest has to be balanced with the fact that the same party had originally been 
determined, through a lengthy WTO pr ocess, to be in violation of it s obligations, and had a chance to 
implement, but failed to do so, within a reasonable period of time.  Further, it argues that consistent 
with the text of Article 21.5, if the original r espondent considers the conditions for the suspension of 
concessions to be no longer valid, the respondent  may initiate the Article 21.5 proceeding at any 
time.202  
5.125  Chinese Taipei stresses that as the DSU currently stands, th ere is no deadline and no 
designated party to initiate the Ar ticle 21.5 proceeding.  Chinese Taip ei agrees with the United States 
that just because the United States has not initiated the Article 21.5 proceeding does not mean that the 
European Communities automatically enjoys the presumption of compliance.  According to Chinese 
Taipei, at this stage, only a multilateral procedure can  reach that conclusion, and one of the ways the 
European Communities can obtain su ch a multilateral determination is  through its initiation of an 
Article 21.5 panel.   
                                                      
197 Replies by Chinese Taipei to questions from the European Communities, question 4. 
198 Replies by Chinese Taipei to questions from the European Communities, question 5. 
199 Replies by Chinese Taipei to Panel questions, question 1. 
200 EC's first written submission para. 61. 
201 Oral statement of Chinese Taipei, para. 2. 
202 Oral statement of Chinese Taipei, para. 3. WT/DS320/R 
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  5.126  Chinese Taipei to remind the Panel that the procedural issues involved in this case are 
currently under discussion in the negotiations on the improvement and clarification of the DSU.  It 
argues that several competing proposals are on  the table, including one from the European 
Communities.  Chinese Taipei notes that it is a vi ew widely shared by Members that the DSU 
procedures in this so-called "post-retaliation stage" are imperfect.  In its view, it is not the task of the 
Panel, or indeed any Member, through litigation, to make up for such imperfection.  Therefore, 
Chinese Taipei urges the Panel to avoid interpre ting the current provisions in a way that would 
impose rules or requirements that are not written in the text.203 
5. The relationship between DSU Article 22.8 and Article 23  
5.127  Chinese Taipei argues that Articles 23 and 22.8 apply to different situations and therefore 
should not be read together, as this would lead to a weakening of the WTO dispute settlement system.  It contends that Article 22.8 differs from Article 23 in that it deals with the specific post-retaliation 
situation, outlining the conditi ons under which the suspension of the concessions pursuant to 
authorization from the DSB can be lifted.  Chinese Taip ei states that the general principle of resolving 
disputes under the multilateral system in Article 23 has been specifically modified by Article 22.8.  
Article 22.8 thus has its own independent set of requirements applicable specifically to the post-
retaliation situation, apart from th e general principles in Article 23.
204 
5.128  Chinese Taipei opines that the basis upon which European Co mmunities builds its arguments 
for its interpretation of DSU Articles 23 and 22.8 is  the general principle of good faith under which 
States are normally considered to act in conformity with their obligations.205  Chinese Taipei agrees 
that Article 23.2(a) embodies that principle in  prohibiting Members from making any unilateral 
determination to the effect that a violation has occurred.206   
5.129  Chinese Taipei argues that by its title, Article 23 applies to the normal situations when the 
Member is responding to a perceive d violation, nullification, impairme nt, or impediment, to which the 
Member is seeking remedy.  It argues that this is  the normal situation under which most cases begin 
and are first brought to the attention of the Dispute Settlement Body.207 
5.130  According to Chinese Taipei, Article 23.2 prescr ibes the actions Members may take in the 
normal situation described in Article 23.1.  Accord ing to it, specifically, 23.2(a) prevents a Member 
from acting upon the unilateral perception of viol ation until it is validat ed under multilateral 
procedures. Chinese Taipei considers that this amount s to the presumption that a Member is normally 
considered to be acting in conformity with its obligations until a multilateral determination under the 
WTO says otherwise.208 
5.131  Chinese Taipei posits that Article 22.8 on the ot her hand describes situations that depart from 
the norm.  It submits that the general principle in Article 23 relating to normal situations therefore has 
limited application and must be modified by the speci fic requirements spelt out in Article 22.8.  In its 
view, the situation at hand is one where the redress of violation has already been determined at least 
once through multilateral procedures and where susp ension of concessions has been authorized.  
Chinese Taipei argues that the requirement is not that  the suspension of concessions must be lifted in 
                                                      
203 Oral statement of Chinese Taipei, para. 4. 
204 Third party submission of Chinese Taipei, paras. 2 and 7. 
205 EC's first written submission para. 87. 
206 Third party submission of Chinese Taipei, paras. 2-4. 
207 Third party submission of Chinese Taipei, para. 5. 
208 Third party submission of Chinese Taipei, para. 6.  WT/DS320/R 
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  the absence of an adverse finding, but rather that the suspension shall be applied until the violation 
has been removed or any of the other two conditions in the provision have been met.209 
5.132  According to Chinese Taipei, it therefore follo ws from this difference in situation and 
requirement that the normal presumption that a Member  is considered to be in conformity with its 
obligations until proven otherwise in a multilateral de termination does not apply.  It contends that 
since Article 22.8  provides that the suspension of concessions can continue until the removal of the 
violation, the presumption here is that there is  no removal of the violation until a multilateral 
determination says otherwise.210 
5.133  Chinese Taipei contends that if the normal presu mption were to apply to Article 22.8, despite 
the existence of a multilateral determination and au thorization for retaliation, any offending Member 
can simply declare itself to have removed the violatio n.  It submits that this would create the incentive 
for Members to implement partially or not at all, and drag the Member suspending concessions into an 
endless loop of Article 21.5 litigations.211 
5.134  Chinese Taipei is of the view that under both normal and Article 22.8 s ituations, a multilateral 
determination is the prerequisite  to any action that changes the existing balance of rights and 
obligations.  It further notes that normally, a Me mber cannot seek redress of a violation without a 
multilateral determination because a balance is presume d to exist.  Similarly, Chinese Taipei argues 
that under the Article 22.8 situation where suspension of concessions is in place, that situation is the 
presumed balance, and that existing balance cannot be changed without another multilateral 
determination.212 
5.135  Chinese Taipei thus argues that the suspensi on of concessions by the United States does not 
fall into the normal situation described in Artic le 23 and until a multilateral determination deems the 
European Communities' implementing measure to  have removed the previously multilaterally 
determined inconsistency, the c ontinuation of suspension of concessions by the United States does not 
violate the existing provisions of the DSU.213 
VI. INTERIM REVIEW 
A. INTRODUCTION  
6.1 Pursuant to Article 15.3 of the DSU, the findi ngs of the final panel report shall include a 
discussion of the arguments made by the parties at th e interim review stage.  This section of the Panel 
report provides such a discussion.  As is clear from Article 15.3, this Section is part of the Panel's 
findings. 
6.2 The European Communities and the United States separately requested an interim review by 
the Panel of certain aspects of the interim report issued to the Parties on 31 July 2007.214  The 
European Communities stated that it stood ready to attend an interim review hearing to discuss the 
issues raised in its letter, "should the Panel consider it useful".  The Panel notes that it is not for it to 
decide whether holding an interim review hearing w ould be useful.  Article 15.2 of the DSU provides 
that it is "[a]t the request of a party [that] the panel shall hold a further meeting with the parties on the issues identified in the written comments."  The Pane l does not understand the EC statement above as 
                                                     
 
209 Third party submission of Chinese Taipei, para. 7. 
210 Third party submission of Chinese Taipei, para. 8. 
211 Third party submission of  Chinese Taipei, para. 9. 
212 Third party submission of Chinese Taipei, para. 10. 
213 Third party submission of Chinese Taipei, para. 11. 
214 Letters of the parties dated 28 September 2007. WT/DS320/R 
Page 102 
 
 
  a request by the European Communities for the Panel to hold an additional mee ting with the parties.  
Furthermore, the Panel notes that the United States di d not request such a meeting.  As a result, the 
Panel did not hold an interim review meeting. 
6.3 In accordance with the Panel working procedures and timetable, the parties had, and used, the 
opportunity to submit further written comments on each other's requests for review of specific aspects 
of the interim report.215  These comments are discussed, where rele vant, together with the requests to 
which they relate.  
6.4 The Panel issued its final report to the parties on a confidential basis on 21 December 2007. 
6.5 The Panel has structured its treatment of the Parties' requests below in the following manner: 
(a) first, it addresses a number of the comments made in relation to the descriptive part of 
the report (Section IV) that the Panel could not address at an earlier stage of the proceedings; 
(b) second, it discusses the comments of the parti es relating to the findings of the Panel 
and, more particularly: 
(i) the aspects of the report regarding procedural issues (Section VII.A); 
(ii) the comments of the parties regarding the Panels findings of violation of 
Article 23.2(a) read together with Articles 21.5 and 23.1 of the DSU 
(Section VII.B); and 
(iii) the comments of the parties regarding the compliance of the EC ban on meat 
and meat products treated with the six hormones at issue for growth promotion purposes with the SPS Agreement  in relation to the Panel's 
findings on the EC claims on Article 23.1, read together with Articles 22.8 and 3.7 of the DSU (Section VII.C). 
6.6 In addition, minor editing changes where made , which the Panel did not deem necessary to 
list in this section. 
B. P
ARTIES ' COMMENTS ON THE DESCRIPTIVE PART  
6.7 The Panel considered and incorporated in its revised descriptive part the majority of the 
parties' comments.  In two instances, however, the Panel partly rejected the modifications requested 
by the European Communities and deems it appropria te to provide its reasons in this section. 
6.8 The first instance relates to the EC request that  the Panel incorporate in the descriptive part 
the parties' arguments on logistical issues relating to the opening to public observation of the Panel's 
substantive meetings with the parties and with the experts. 
6.9 In its comments on paragraph 4.2 and following of the descriptive part of this report, the 
European Communities notes that, while the parties'  answers of 20 June 2005 to a number of 
questions of the Panel have been reported in full, ther e is no reference to the parties' replies of 7 July 
2005 to the additional questions of the Panel.  Th is, in the opinion of the European Communities, 
raises a question of the completeness of the record of the parties' arguments.  Inserting the replies of 
the parties of 7 July 2005 is also important according to the European  Communities since the 
                                                      
215 Letters of the parties dated 19 October 2007.  WT/DS320/R 
 Page 103 
 
 
  comments of the third parties on logistical matters ha ve been reported in the descriptive part.  Thus, 
the European Communities requested  the Panel to reflect the parties' responses to these additional 
questions in its report.  
6.10 The Panel notes that the parties' replies of  7 July 2005 essentially addressed technical 
questions of a logistical nature.  The Panel did no t deem it necessary to insert in its report any account 
of the logistical aspects of the opening of the hear ings to public observation.  The Panel notes in this 
respect that it did not include in the descriptive pa rt of the report extracts from the replies of the 
parties of 20 June 2005 that related to logistical issues. Given that among the third parties, only India 
and Mexico mentioned, in a general manner, the logi stical implications of opening hearings to public 
observation, the discussion on logistical issues essenti ally took place between the parties themselves, 
or between the parties and the Secretariat.  The Pane l did not address the details of the logistical issues 
in its decision on opening meetings for public observati on.  This matter is, in the opinion of the Panel, 
purely administrative. It is neither procedurally nor factually relevant for the resolution of the dispute 
before us. The Panel is mindful that such an account might be useful from a practical point of view for 
future panels. However, it considers that the techni cal solutions found in this case may not necessarily 
be extended to other panel procedures,  if only because the parties' expect ations and constraints, e.g. in 
terms of confidentiality, may be different in future cases.216  Whereas the Panel provided a detailed 
account of the legal issues related to the opening of the Panel's heari ngs for public observation, for the 
reasons mentioned above, it decided not to follo w the suggestion of the European Communities. 
6.11 The Panel nonetheless wishes to confirm that the technical options available were extensively 
discussed with the parties and that the solutions fina lly selected, more particularly the broadcast of the 
hearings into a separate room through closed-circuit television, were adopted in accordance with the 
positions expressed by the parties. 
6.12 The second instance where a request for modificat ion of the descriptive part was at least 
partly rejected by the Panel relates to paragraph 4.234.  In its second written submission to the Panel, 
the European Communities stated that, "[u]nder Article 5.1 of the SPS Agreement , a convincing  link is 
required between the evidence and the measure.  Under Article 5.7 a mere  doubt must be 
sufficient."217  In its comments on the descriptive part of  the report and in its comments of 19 October 
2007218 in response to a request by the United States for review of a precise aspect of the interim 
report219, the European Communities requested us to re place the term "convincing link" with "rational 
relationship", and to replace "mere doubt" with "reas onable doubt".  We recall that in its reply to 
question 9 of the Panel, after th e second substantive meeting, the European Communities had clarified 
that what it meant by "mere doubt" was "doubt that h as been scientifically established".  In light of 
that request, we replaced "mere" with "scientifica lly established". The Panel also notes that the EC 
reply to question 68 of the questions of the Pane l after the first substantive meeting qualified the 
relationship addressed by Article 5.1 of the SPS Agreement  as an "objective or rational relationship". 
As a result, the Panel replaced the term "convincin g link" with "objective or rational relationship." 
                                                      
216 In the present dispute, after comparing different alternatives, the Secretariat was able to arrange 
open hearings through closed-circuit broadcast from one room to another utilizing the existing facilities of the 
Secretariat.  The cost of open hearings was covered by the regular budget under the Secretariat arrangement.  
There may be different cost implications for future disputes in different circumstances but that consideration would fall outside of the remit of this Panel. 
217 See EC's second written submission, para. 181, and second executive summary, para. 29 (emphasis 
added). 
218 EC's comments of 19 October 2007, para. 24. 
219 US's written request of 28 September 2007, p. 9. WT/DS320/R 
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  C. PARTIES ' COMMENTS REGARDING THE FINDINGS OF THE PANEL  
1. Preliminary remarks 
6.13 As a preliminary remark, the Panel notes that  the European Communities mentions in the 
introduction to its written request for the Panel to re view precise aspects of the interim report that it: 
"[W]ill try to provide some examples  of the numerous and serious errors in the 
reasoning of the Panel on the scientific issues underpinning this dispute.  However, it 
is not possible in the time available to provide a detailed and complete list of all 
omissions and errors of the two interim reports  as it would in reality require re-
writing substantial parts of the Panel's repor t in order to rectify its analysis and 
reasoning ...  Therefore, the European Comm unities reserves the right to make all its 
comments at the appeal stage , if the Panel's findings on the issue were to be 
maintained."220 (emphasis added) 
6.14 This statement suggests that the European Communities did not identify all the precise 
aspects of the interim report with which it disag rees due to lack of time and because this would 
require rewriting substantial parts of the Panel report.  It would, however, be able to make all its 
comments at the appeal stage.  The Panel wishes first to make it clear that parties were free to request 
an extension if they needed more time to revi ew the interim report and identify precise aspects that 
should be addressed by the Panel.  The Panel notes in this respect that it is at the request of the 
European Communities that parties were granted several additional weeks to review the interim 
report.  The Panel also notes that the European Co mmunities gave as a justification for its request the 
expected length and complexity of the report.  The Panel therefore regrets that the European 
Communities is now alleging lack of time as a justification for providing only "some examples" of 
errors in the reasoning of the Panel on the scientific issues underpinning this dispute.   
6.15 In contrast, the European Communities mentions that it may make "all its comments" at the 
appeal stage.  The Panel is surprised by the appa rent choice of the European Communities to "make 
all its comments" before the Appellate Body rather than before the Panel, at the procedural stage 
expressly designed for the purpose of considering any and all comments on the interim report.  This is 
because the decision of the European  Communities to provide only "som e examples" of errors of the 
Panel suggests that it has already decided to app eal the Panel report unless the Panel makes changes 
which the European Communities will not specify.  It  is also not clear whether the "examples" given 
by the European Communities exhaust all its factua l comments or whether it intends to make further 
comments on factual issues before the Appellate Body .  Having regard to Article 17.6 of the DSU, we 
consider this to be equivalent to deprivi ng the interim review stage of its purpose.  
6.16 The Panel therefore regrets that the European Communities did not request an extension so as 
to ensure that all the comments it deemed necessar y on precise aspects of the interim report be made 
at the procedural stage of the dispute settleme nt process intended for that very purpose. 
6.17 The Panel also notes that some of the EC comments are general statements on whole sections 
of the report, not a written request for the Panel to review precise aspects  of the interim report.  We 
recall that the panel in Australia – Salmon221 stated as follows: 
"According to Canada, it is not open to the Panel to consider anything other than 
comments dealing with 'precise aspects' of th e interim report.  We agree with Canada 
                                                      
220 EC's written request of 28 September 2007, para. 5. 
221 Panel Report on Australia – Salmon , para. 7.3.  WT/DS320/R 
 Page 105 
 
 
  and have therefore only reviewed our interi m report in light of the comments made by 
the parties which relate to 'precise aspects' of the interim report." 
6.18 We agree with the reasoning of the above-menti oned panel and therefore consider that the 
general comments by the European Communities did not  require a specific reply from the Panel.  We 
limited our replies to the portions of the report on which specific comments, in the form of precise 
requests for reconsideration on specific paragraphs , had been made by the European Communities.  
We addressed the EC general comments as part of our review of specific paragraphs. 
2. Parties' requests for review related to aspects of the report on procedural issues 
(a) Comments by the European Communities 
6.19 The European Communities considers the Panel' s reference to Article 17.10 of the DSU in 
paragraph 7.50 of the interim report unnecessary a nd potentially detrimental as implicitly suggesting 
that the Appellate Body could be legally barred by Article 17.10 of the DSU from opening its own 
hearings to public observation.  The European Co mmunities requests that we remove that paragraph 
from our findings.  We note that a similar request wa s made by the United States.  Since this reference 
was only an additional argument, we accepted the pa rties' requests and removed our discussion of the 
term "proceedings" in Article 17.10 of the DSU. 
6.20 The European Communities considers that  the description of IARC contained in 
paragraph 7.78 footnote 378  is incomplete.  It refers to Dr. Cogliano's statement in Annex G, 
paragraph 541.  In paragraph 541, Dr. Cogliano essentially say s that IARC monographs simply 
indicate which substances are carcinogenic or are probably not carcinogenic to humans.  Monographs 
identify occurrence (i.e. exposure to a chemical through some particular pathway), but not the specific 
level of exposure for a particular population. Dr. Cogliano also says in paragraph 541 that different 
decision-making authorities will decide whethe r the evidence contained in IARC monographs 
sufficiently supports an SPS decision or whether they  need to conduct further analysis. Thus it seems 
that IARC monographs provide inform ation and serve in risk assessment.  This said, as also pointed 
out by the United States in its comments on comments of 19 October 2007222, the text in the footnote 
is a verbatim quote from the IARC website, describing what IARC does.  Thus the Panel did not deem 
it necessary to augment the footnote.   
6.21 The European Communities argu es that the second sentence of paragraph 7.85 does not 
reflect reality, since the European Communities di d not agree with the final decision on Working 
Procedures for Consultation with Scientific and/or T echnical Experts adopted by the Panel.  The Panel 
notes that, in a letter of 3 November  2005, th e European Communities  commented on the draft 
expert working procedures.  One of the comments w as that the experts should act as a single expert 
review group in order to provide a c onsistent advice on the issues concerned.   The European 
Communities also suggested that the experts should be independent from the industry or regulatory bodies which had a vested interest in the issue on wh ich they would be consulted.  The Panel rejected 
the EC request that experts should act as a single review group in its letter sent to the parties on 
25 November 2005, together with its finalized Wo rking Procedures for Consultation with Scientific 
and/or Technical Experts.  We therefore modified paragraph 7.85 to reflect the absence of full agreement of the European Communities on the Pa nel's Working Procedures for Consultation with 
Scientific and/or Technical Experts. 
6.22 The European Communities further requests us to redraft the fourth sentence of 
paragraph 7.85 to reflect better its concerns that tw o of the experts selected by the Panel participated 
in the preparation and drafting of the JECFA risk assessment of the hormonal substances at issue in 
                                                     
 
222 Para. 3. WT/DS320/R 
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  this case, with which the EC risk assessment disagrees.  The Panel sees no problem in clarifying the 
nature of the work of these two experts with JECFA  It remains however puzzled by the EC 
suggestions that a scientist who worked with JECF A could be deemed to be biased in assessing the 
scientific evidence on which EC Directive 2003/ 74/EC relies and could be assumed to defend 
JECFA's work.  First, scientists would readily admit that science is constantly evolving and the fact 
that new studies are peer revi ewed is evidence that assessing new ideas and findings is part of 
scientific work. Assuming that scientists may lack  objectivity because they participated in the 
preparation and drafting of JECFA's risk assessments on the hormones at issue would call into question the whole principle of peer review.  Th e Panel also notes that JECFA is the body that 
provides the independent scientific advice on whic h the work of Codex is based and Codex is 
expressly recognized by the SPS Agreement  as having responsibilities for the establishment of 
"international standards, guidelines and recommendations ".  The Panel also recalls the role given to 
international standards, guidelines and reco mmendations by Article 3.1 and 3.2 of the SPS Agreement . 
It is therefore consistent with this role for th e Panel to rely on experts who contributed in the 
preparation and drafting of JECFA's risk assessments of the substances at issue.  
6.23 The Panel does not agree either with the EC ar guments according to which the two experts at 
issue should not be described as "internationally rec ognized specialists".  The Panel recalls that they 
have been selected by the FAO and WHO as part  of the JECFA selection process.  The selection 
procedure has been described in JECFA's reply to question 14 to JECFA.
223  The Panel fails to 
understand why the JECFA selection would not be evidence of the international reputation of the scientists at issue.
224  The EC concerns about JECFA's work and the selection of experts to participate 
in that work are in contradiction with the role attributed by the SPS Agreement  to Codex and to 
international standards, guidelines and recommendati ons.  The Panel was fully aware of the area of 
expertise of the two scientists at issue, and believed that they would be more at liberty to comment on 
the content of JECFA's work than officials of the JECFA Secretariat.   It also specified the reasons 
why those experts were selected in spite of not ha ving carried out experiments with the substances at 
issue and does not see any need for further substant ial elaboration. The Panel notes that the United 
States, in its comments of 19 October 2007, considered that any new objection on the experts by the 
European Communities would be untimely.  The Pa nel has nevertheless deemed it necessary to make 
some clarifications, in response to the EC request, to paragraph 7.85. 
6.24 The European Communities requests that we modi fy the first sentence of paragraph 7.87 to 
better reflect the content of its letter of 28 March 20 06.  We consider that the letter largely reiterated 
points which the Panel already addressed in paragra ph 7.85 i.e. the involvement of experts in the 
preparation and drafting of JECFA's risk assessments and their alleged lack of scientific expertise.  
Besides this, the EC letter of 28 March deals exclusiv ely with conflict of interest, which is the subject 
addressed by the Panel in paragraph 7.87.  While th e Panel has modified the paragraph to reflect the 
fact that the EC letter addressed other issues alre ady discussed in this report, it did not deem it 
necessary to modify the rest of the paragraph, excep t to clarify the elements on the basis of which the 
Panel considered that the experts concerned shoul d be deemed to be the best among the very few 
individuals available. 
6.25 Having reviewed the EC comments on paragraph 7.89  of the interim report , the Panel agrees 
that this paragraph did not directly relate to the i ssue of the alleged conflict of interest of two of the 
experts consulted by the Panel and has deleted it.   
6.26 The European Communities argues that th e statements in paragraph 7.123 and  footnote  396 
are not accurate as some of the subsequent evidence  did expand and confirm the scientific basis of 
                                                      
223 Annex E-2, pp. 115-116. 
224 See also Dr. Boobis, Annex G, para. 511;  Dr. Tritscher, Annex G, para. 515;  Dr. Wennberg, 
Annex G, para. 517.  WT/DS320/R 
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  Directive 2003/74/EC.  The European Communities refers to the replies of Dr. Guttenplan and 
Dr. Sippell.  The Panel also notes the US comments of 19 October 2007 on this request for review 
from the European Communities.  In paragraph 7.123  and footnote  396, the Panel states that nothing 
new was submitted after the adoption of Directive 2003/74/EC that differed in any fundamental way  
from previous evidence.  This is not contradicted  by the EC comment that subsequent evidence 
expanded and confirmed the scientific basis of its Di rective, including the EC reply to question 5 of 
the Panel after the second substantive meeting.225  The statements of Dr. Guttenplan referred to by the 
European Communities226 do not support the EC argument.  Dr . Sippell mentions in paragraph 611 of 
Annex G that he changed his opinion on exposure  to exogenous oestrogens and precocious puberty 
because the acceptance of the signifi cance of the ultrasens itive assays within paediatric endocrinology 
increased tremendously after he published his review  article in 1999.  However, the ultrasensitive 
assays he is referring to were not carried out or p ublished after the adoption of Directive 2003/74/EC.  
In his written replies227, where he discusses the u ltrasensitive assay techniques, Dr. Sippell refers to 
Klein et al (1994)  and Larmore et al (2002)  and other studies dated 1999 or 2001.  As a result, in the 
opinion of the Panel, the statement of Dr. Sippell cited by the European Communities is not about evidence that became available after the adoption of  the Directive. Consequently the Panel did not 
modify paragraph 7.123 and footnote 396. 
6.27 The European Communities also ar gues with respect to paragraph  7.124  that it had reserved 
its right to submit the finally published version of the study contained in Exhibit EC-107.  According 
to the European Communities, this study was submitt ed in time and should have been accepted.  The 
Panel notes that, when it submitted Exhibit EC-107 on 21 December 2005, the European 
Communities specified that it "reserve[d] its right to s ubmit further evidence, if and to the extent this 
appears necessary for the purpose of commenting on any further submissions by the other parties as 
well as on replies of the panel's experts".  The Pane l does not read this reservation as reserving the EC 
right to submit the finally published version of th e study.  Moreover, the Panel recalls that the 
European Communities stated that it left it to the discretion of the Panel whether to forward the 
published version to the experts.
228  The Panel, having regard to the comments of the United States of 
19 October 2007, considers that it sufficiently explai ned in its report the reasons why the published 
version of this study had not been sent to the expe rts.  In particular, it considered that submitting a 
modified study to experts at a relatively late st age of the expert consultation proceedings could 
generate confusion. 
6.28 The European Communities also considers with respect to paragraph 7.133 that the Panel 
should accept that the European Communities submit the comments it wished to make in relation to 
some factual errors made by the United States in its replies to the Panel questions posed after the 
second substantive meeting.  The Panel considers th at its decision was clear.   If inaccuracies resulting 
from US factual arguments had been reflected in the interim report, the European Communities could 
have identified them in its comments or in its co mments on comments.  There does not seem to be any 
need for the Panel to reverse its decision of 20 November 2006. 
6.29 The European Communities also alleges,  with respect to paragraphs 7.135 et seq.,  that one 
paragraph was added to the transcript of the experts'  hearing annexed to this report compared with the 
version sent to the parties in January 2007.  Ther e are, indeed, more paragraph numbers. However, 
there is no additional text in Annex G as compared to the version sent to the parties in January 2007. 
In fact, the difference results from a correction to the paragraph numbers of the transcript.  In the 
version sent to the parties for comments, there was a paragraph between paragr aphs 29 and 30 that did 
not have a number.  This paragraph became the new paragraph 30 in the final version of the transcript, 
                                                      
225 Annex C, pp. 5-7. 
226 Annex G, paras. 709 and 713. 
227 Annex D, para. 319. 
228 See EC's letter to the Panel dated 29 May 2006. WT/DS320/R 
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  and as a consequence, all the other paragraph number s shifted by one.  On the same subject, two more 
changes were made in paragraph numbers: paragra ph 827 of the draft transcript was divided into two 
paragraphs, following a comment by the United States229, and became paragraphs 828 and 829 in the 
final version of the transcript.  Finally, another paragraph lacked a number,  between paragraphs 926 
and 927.  This paragraph corres ponded to a short statement by Dr. Boisseau clarifying that he had 
asked a question to Dr. Boobis, not to the Eur opean Communities.  This  unnumbered paragraph 
became paragraph 929.  In conclusion, three add itional paragraph numbers we re added in the final 
version of the transcript compared to the draft ve rsion sent for comments to the parties.  The draft 
version had 1069 numbered para graphs; the final version h as 1072 numbered paragraphs. 
6.30 The European Communities also seems to request , with respect to paragraph 7.148 that the 
Panel specify the nature of the "e ditorial adjustments" made in th e transcript.  The Panel deems it 
appropriate to recall that the tapes of the meeting of  the Panel with the experts were given to a typist 
who transcribed them.  Two types of editorial adjust ments were made to the transcript.  First, the 
Secretariat proofread the transcript, identifying any words or passages the typist had misunderstood 
and checking these passages against th e tapes.  The type of errors identified were limited to 
confusions regarding technical terms (e.g. "N-point" instead of "endpoint"; "safe defactual" instead of 
"safety factor"230 or "defactual threshold" instead of "de facto threshold"231).  Other corrections 
involved minimal adjustments to sentences, for ex ample to remove repeated words and occasionally 
adding punctuation marks.  Once these corrections we re made, the transcript was sent to the experts 
and subsequently to the parties in order to give each  speaker the chance to verify that his or her own 
interventions had been accurately reflected.  The expe rts' comments consisted of  further corrections of 
technical words which had been improperly transcribed, or corrections of word order or colloquial expressions to make the transcript more legible.  This is the reason why the Panel considered that 
these corrections did not go beyond "minimal editorial adjustments". 
(b) Comments by the United States 
6.31 With respect to the discussion of the procedural question of the opening of the Panel meetings 
with parties and experts for public observation,  the United States requests that we remove our 
discussion of the term "proceedings" as it appears in Article 17.10 of the DSU.  We note that the same 
request was made by the European Communities.  Since this reference was only an additional 
argument, we accepted the parties' requests and re moved our discussion of the term "proceedings" in 
Article 17.10 of the DSU. 
6.32 The United States also requests that we modify paragraphs  7.151  and 2.7.  We see no reason 
not to adjust the description of the measure since it is actually the absence of recourse to the DSU by 
the United States which seems to be at the orig in of the EC complaint. However, under the 
circumstances, we also deem in n ecessary to specify that the issue stems from the fact that the United 
States maintained the measure after the notifica tion of Directive 2003/74/EC to the DSB and we 
modified paragraphs 2.7 and 7.151 accordingly.  
6.33 The United States contests the conclusion of th e Panel in paragraphs 7.162-7.164 that the 
European Communities narrowed the terms of referen ce of the Panel through the approach it followed 
in its first written submission.  For the United States , the EC approach is a "choice of legal strategy" 
which is not binding on the Panel.  The Europ ean Communities cannot constrain the terms of 
reference of the Panel by adopting a specific approa ch to its claims in its first written submission. 
                                                     
 
229 See US letter dated 14 February 2007. 
230 Annex G, para. 422. 
231 Annex G, para. 707.  WT/DS320/R 
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  6.34 The Panel agrees that it is well established that  a complainant cannot change the terms of 
reference of a panel in its first submission or sub sequently.  As stated by the Appellate Body in EC – 
Bananas III :  
"If a claim  is not specified in the request for the establishment of a panel, then a 
faulty request cannot be subsequently 'cur ed'  by a complaining party's argumentation 
in its first written submission to the panel or in any other submission or statement 
made later in the panel proceeding."232 
6.35 However, the Panel does not believe that this is  the issue in the pre sent case.  The European 
Communities did not try to cure a faulty request. It ma de its claims more specific.  As the Panel itself 
noted233, there could be several ways to find a violation of Article 23 of the DSU. The European 
Communities has clarified how it considered that this  violation should be approached by the Panel.  
As stated by the Panel on EC – Tube or Pipe Fittings234: 
"In our view, it is in the nature of the Pane l process that the claims made by a party 
may be progressively clarified and re fined throughout the proceedings."  
6.36 The Panel also quotes the Appellate Body in US – Carbon Steel .235  It seems to be accepted 
that complainants can clarify their claims througho ut the proceedings.  In this instance however, it 
appears that the United States is concerned by the conclusion of the Panel that it is bound  by these 
clarifications or that they are part of the Panel's terms of reference. 
6.37 Panels are free to address claims in the order that they deem appropriate.236  However, if a 
party specifies in its first written submission that a claim is raised in the alternative, can a panel 
disregard this clarification?  To a lesser extent, can a panel disregard the fact that the complainant 
addressed the violation of a given pr ovision in a particular way? Regarding the first question, it seems 
that panels should be bound by a claim made "in the alternative" as acknowledged by the Appellate 
Body.237  Regarding the second question, the reply mi ght be less clear and depend on the type of 
"clarification" made by the complainant.  In this  case, the clarification had serious consequences on 
how the Panel could address the claims  listed in the terms of reference.  It was not a violation of 
Article 23 in general, but a viola tion of Article 23 as a consequence of a breach of Article 22.8 of the 
DSU.  The Panel also notes the arguments of  the European Communities in its comments of 
19 October 2007.  The Panel recalls, in particular, that the rights of the respondent or its ability to 
defend itself were in no way affected by the "narro wing" of its claims by the European Communities. 
The Panel remains of the view that it is bound by th e EC approach to its claims and, accordingly, has 
not modified paragraphs 7.162-7.164. 
3. Comments of the parties regarding the Panel's  findings of violation of Article 23.2(a) 
read together with Articles 21.5 and 23.1 of the DSU and on the EC claims on 
Article 23.1, read together with Articles 22.8 and 3.7 of the DSU 
(a) Comments by the European Communities 
6.38 The European Communities disagrees with th e interpretation the Panel makes, in 
paragraphs 7.174  et seq ., as well as in paragraph 7.272  of the EC claims as set out in its first written 
                                                      
232 Appellate Body Report on EC – Bananas III , paras. 141-143; Appellate Body Report on US – Lead 
and Bismuth II , paras. 72 and 73. 
233 See para. 7.176. 
234 Panel Report on EC – Tubes and Pipes Fittings , para. 7.10. 
235 See para. 7.161. 
236 Appellate Body Report in Canada – Wheat Exports and Grain Imports , para. 126. 
237 See, e.g., Appellate Body Report on EC – Selected Customs Matters , para. 308. WT/DS320/R 
Page 110 
 
 
  submission. The European Communities insists in its  comments that "it did not argue [in its main 
claims] that there was a violation of Article 22.8 itself,  but rather one of Article 23.1".  In other words, 
the European Communities seems to suggest that th e Panel should not have addressed the conformity 
of the US measure under Article 22.8 of the DSU – even though this article was listed in the EC 
request for establishment of a panel – but only unde r Article 23.1.  Yet, the European Communities 
alleges a violation of Article 22.8 in various parts of its first submission and subsequently.238 
6.39 In the opinion of the Panel, the use of the term "in conjunction with" or "read together with" 
is not indicative that the European Communities only claims a violation of Article 23.  In Section III.E.3 of its first written submission, th e European Communities alleges a violation of 
Article 3.7 even though in its conclusions it states  that the United States' and Canada's unilateral 
conduct "violates Article 23.1 of the DSU read in conjunction with Articles 22.8 and 3.7 of the DSU".  
One cannot conclude either that the European Communities draws a conclusion of violation of 
Article 22.8 from the violation of Article 23.1 since its allegation of violati on of Article 23.1 stems 
from the obligation to withdraw the measure if the violation has been removed.  Rather, one must 
conclude the opposite, i.e. that the European Communities draws a conclusion of violation of 
Article 23.1 from a violation of Article 22.8.  Fo r those reasons, the Panel does not agree with the 
argument made by the European Co mmunities at the interim review stage that it never made a claim 
of violation of Article 22.8 of the DSU, and that its  claims related only to vi olations of Article 23. 
6.40 The European Communities also contests the qua lifications made by the Panel of its second 
series of main claims (i.e. its claims of viola tion of Article 23.1 of the DSU in conjunction with 
Article 22.8 and Article 3.7 of the DSU) as cl aims "premised on compliance by the European 
Communities with the DSB recommendations and rulings in the EC – Hormones  case" in 
paragraph 7.181.  The Panel notes that it has clearly explained in paragraphs 7.277-7.278  why it 
believes that this claim was premised on complianc e with the DSB recommendations and rulings in 
the EC – Hormones  case. 
6.41 Consequently, the Panel will not delete the sec tion of its report cons idering the allegedly 
non-existent EC claim under Article 22.8 of the DSU. 
6.42 The Panel, however, deems it appropriate to clarify paragraph 7.181, and to make the 
modification suggested by the United States in its comments of 19 October 2007 with respect to 
paragraph 7.359 in order to make clear that it is  not reviewing the EC claim of violation of 
Article 22.8 in isolation. 
                                                     
 
238  See, for instance: 
– EC's first written submission, para. 73: "Under Article 23.1 of the DSU, the United States is 
obliged to have recourse to, and abide by, the rules and procedures of this Understanding.  
This encompasses, inter alia , Articles 22.8 and 3.7 of the DSU"; 
– EC's first written submission, section III.E.2, title: "The obligation not to apply suspension of 
concessions or other obligations under Article 22.8 of the DSU"; 
– EC's first written submission, Section III:E.3, title "Violation of Article 23.1 and Article 22.8 
of the DSU necessary entails a violation of Article 3.7"; 
– EC's first written submission, para. 122: "For these reasons, the United States, by violating 
Articles 23.1, 22.8 of the DSU, also acted  contrary to Article 3.7 of the DSU"; 
– EC's oral statement at first meeting, pa ra. 56: a "systemic claim under Article 22.8, in 
conjunction with Article 23.1 "; 
– EC's reply to questions of the United States af ter the first substantive meeting, para. 8: "More 
specifically, the European Communities considers that the continued application of sanctions 
despite the unchallenged EC compliance measure is in violation of Articles 23.1 and 22.8 read 
together." 
– EC's second written submission, para. 217.  WT/DS320/R 
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  6.43 The European Communities also argues that, even though the obligation of the respondent 
clearly emerges from the Panel's reasoning, the Pane l should clarify its recommendations.  This could 
be done either by removing from the findings any consideration of the second series of main EC 
claims (i.e. its claim of violation of Article 23.1 of the DSU in conjunction with Articles 22.8 and 3.7 
of the DSU) or, if necessary, through suggesti ons under Article 19.1 of the DSU, or through 
clarifications in the Panel's reasoning.  A somewhat  similar request has been made by the respondent 
in its request for review of precise aspects of the interim report. However, the European Communities 
suggests that the Panel should clarify that the United States must remove its suspension of 
concessions, whereas the United Stat es requests that we note that, once our findings are adopted by 
the DSB, recourse to dispute settlement in accordan ce with the rules and procedures of the DSU for 
the purpose of Article 23.2(a) read together with  Articles 21.5 and 23.1 of the DSU will have been 
achieved in respect of this matter. 
6.44 The Panel is mindful of its duty to assist the DSB in making recommendations or rulings 
aimed at achieving a satisfactory settlement of the ma tter.  The Panel notes that the parties have both 
requested that the Panel make suggestions or conclu ding remarks aimed at clarifying what is expected 
from the United States.  The Panel notes, however, that their proposed suggestions or concluding 
remarks are divergent.  The Panel wishes to  recall its conclusion in paragr aph 7.251.  This conclusion 
is based on the terms of Article 23.1 and 23.2(a).  Those provisions require that recourse should be 
had to "the rules and procedures of the [DSU]" (Article 23.1) or, in the case of Article 23.2(a), that recourse be had to "dispute settlement in acco rdance with the rules an d procedures of this 
Understanding".  Moreover, for reas ons explained in this report, the Panel does not believe that 
recourse by the European Communities to disput e settlement exempts the United States from its 
obligations under Article 23.1 and 23.2(a) of the DSU.  The Panel has clarified this point in 
paragraph 8.3. 
(b) Comments by the United States 
6.45 The United States requests the Panel to harmonize the lists of means of dispute settlement 
which appear in paragraphs  7.247  and 7.350.  While the Panel sees no reason not to expressly refer to 
panel proceedings in paragraph 7.247 , it notes that paragraph 7.247 u ses the word "including" before 
listing means of dispute settlement.  Its list is, thus, not exhaustive.  The Panel also believes that this 
would be more necessary for the sake of completeness than for the sake of cons istency.  Indeed, the 
two lists relate to different ma tters.  In paragraph 7.247, the Panel listed the means of dispute 
settlement available to the United States  to comply with the requirements of Article 23.2(a) of the 
DSU to have "recourse to dispute settlement in acc ordance with the rules and procedures of [the 
DSU".  Comparatively, paragraph 7.350, addresses the means available to the European Communities  
to obtain the termination of the suspension of c oncessions or other obliga tions.  The addition of 
recourse to a "normal" panel in paragraph 7.247 s hould not be taken to imply that the United States 
would satisfy its obligation under Ar ticle 23.2(a) if any party to the dispute such as, for instance, the 
European Communities had recourse to dispute settle ment.  The Panel reads Article 23.2(a) and 23.1 
as requiring that the dispute settlement procedure be initiated by the United States.  Having also 
regard to the EC comments of 19 October 2007239, the Panel does not deem it necessary to modify 
paragraph 7.247.   
6.46 The Panel also accepted the US request to harm onize certain terms of paragraph 7. 270 with 
the terms of paragraph 7.251. 
6.47 In its comments on paragraphs  7.308  through 7.359, the United States argues that, whereas it 
is the case that a complaining party in WTO disput e settlement bears the burden of proof to make out 
a prima facie case of the WTO-inconsistency of the defending Member's measure, that concept does 
                                                      
239 Paras. 14-16. WT/DS320/R 
Page 112 
 
 
  not equate to, nor does it imply that, there exists a presumption that the responding Member is in good 
faith compliance with its WTO obligations.  The Un ited States argues that questions of good faith or 
bad faith do not form a basis for a presu mption of consistency or inconsistency. 
6.48 The Panel agrees with the United States that good faith in the performance of treaties and the 
question of consistency are ultimat ely to be distinguished in the panel proceedings.  A finding of 
violation of a Member's obligations will ultimat ely be based on an obj ective assessment of the 
conformity of the measure at issue.  However, th e Panel considers that, whereas a party to a dispute 
may ultimately be found in breach of  its obligation irrespective of whet her it is acting in good faith or 
not, good faith remains the premise on which the presumption of compliance is based.  In other 
words, it is because a Member is s upposed to comply with its obligati ons in good faith that it can be 
presumed to be in conformity with its obligations  and that it is for the complaining Member in a 
dispute to make a prima facie case of violation. 
6.49 The United States argues, on the cont rary, that the burden of proof is testament solely to the 
fact that there is no presumption of bad faith that  attaches to measures taken by a WTO Member.  The 
Panel disagrees.  The Panel note that the United Stat es does not cite to any re port in support of its 
position.  Comparatively, the Panel notes that the Appellate Body, in EC – Sardines , stated that: 
"We must assume that Members of the WTO will abide by their treaty obligations in 
good faith, as required by the principle of pacta sunt servanda  articulated in 
Article 26 of the Vienna Convention . And, always in dispute settlement, every 
Member of the WTO must assume the good faith of every other Member."240 
6.50 In that context, the Panel fails to see why bur den of proof should be based on an absence of 
presumption of bad faith. 
6.51 Likewise, the Panel does not understand why good faith should not form the basis for a 
presumption of consistency because it is ultimately irrelevant for purposes of finding whether a 
measure is consistent or not with the WTO.  Sin ce WTO Members are to be assumed to abide by their 
treaty obligations in good faith, it is normal that , until a prima facie case has been made by the 
complaining Member, the responding Member enjoy this presumption of compliance in good faith. Whereas this presumption goes to the substance or th e "merits" of the measures at issue, it does not 
affect the ultimate finding of the Panel, which w ill be ultimately based on an objective assessment of 
the matter, including all the relevant evidence submit ted by the parties.  For these reasons, the Panel 
sees no reason to modify its findings in paragraphs 7.308  through  7.359. 
6.52 The United States also requests that we modify paragraph 7.360.   According to the United 
States , the fact that the Panel's terms of reference do not include provisions of the SPS Agreement  
does not necessarily mean that the conformity of the EC Directive 2003/74/EC with the SPS Agreement  lies outside the Panel's mandate.  The Un ited States refers to the Appellate Body 
report in Argentina – Footwear (EC)
241 to conclude that the Panel would not exceed its terms of 
reference by examining provisions not cited in the Panel request and would comply with its 
obligations under Artic le 11 of the DSU. 
6.53 The European Communities, in its comments of 19 October 2007242, disagrees with the 
comments of the United States to the extent that, un like in the case referred to by the United States 
where there was an express reference to another prov ision in the article allegedly breached, there is no 
reference in the term "removed" in Article 22.8 to any other provision.  The European Communities 
                                                      
240 Appellate Body Report in EC – Sardines , para. 278. 
241 Appellate Body Report on Argentina – Footwear (EC),  paras. 74-75. 
242 Para. 21.  WT/DS320/R 
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  considers that if the US interpretation prevailed,  the responding party would effectively be free to 
refer to any provision of the covered agreemen ts and the terms of reference would become 
meaningless. 
6.54 The Panel considers that it has extensively explained why it believes that, while making 
actual findings regarding the compatibility of the EC Directive 2003/74/EC with the SPS Agreement  
is not part of its mandate, it h as jurisdiction to address the compa tibility of the Directive with the 
SPS Agreement  to the extent necessary to make findings in relation to Article 22.8 of the DSU, which 
is part of its mandate.  The Panel agrees with the Un ited States that this is part of its duty to make an 
objective assessment of the matter pursuant to Article 11 of the DSU and a sentence has been added to that effect in paragraph 7.377. The Panel also believ es that its approach is consistent with the scope of 
a panel mandate as confirmed by the Appellate Body.  
6.55 The United States also requests that we modi fy the second sentence of paragraph 7.366 to 
take into account the terms of Article 7.2 of th e DSU which provides that "Panels shall address the 
relevant provisions of a ny covered agreement cited by the parties to the dispute " (emphasis added). 
The Panel agrees with the United States that provision s invoked by the responding party, for instance, 
as affirmative defence must be addressed by a pane l.  The Panel notes, however, that the "matter" 
before it is defined by the request for establishment of the Panel.  The matter before this Panel is 
whether the United States' measure has breached, inter alia , Article 22.8 of the DSU, not whether EC 
Directive 2003/74/EC complies with the SPS Agreement .  As a result, the US references to provisions 
of the SPS Agreement  are not claims. The Panel may address them, however, as part of its findings on 
Article 22.8 of the DSU.  The Panel has neve rtheless clarified paragr aphs 7.366 and 7.367.   
6.56 Finally, the United States requests a modifica tion to paragraph 8.2 and the addition of 
concluding observations.  Regardi ng paragraph 8.2, having duly considered the EC comments on 
comments, we nonetheless decided to replace the te rm "legislation" with the term "measure", 
consistent with Article 19.1 of the DSU. 
6.57 Regarding the addition of concluding observati ons, we do not agree with the United States 
that, "once [our findings are] adopted by the Dis pute Settlement Body, recourse to dispute settlement 
in accordance with the rules and procedures of th e DSU for the purpose of Article 23.2(a) read 
together with Articles 21.5 and 23.1 of the DSU will have been achieved in respect of this matter."  
For reasons explained in this report, the Pane l does not believe that recourse by the European 
Communities to dispute settlement exempts the Unit ed States from its obligations under Article 23.1 
and 23.2(a) of the DSU.  The Panel has clarified this point in paragraph 8.3. 
4. Comments of the parties on the compliance of  the EC ban on meat and meat products 
treated with the six hormones at issue for growth promotion purposes with the 
SPS Agreement  in relation to the Panel's findings on the EC claims on Article 23.1, read 
together with Articles 22.8 and 3.7 of the DSU 
(a) Comments by the European Communities 
(i) Introductory comments 
6.58
 In an introduction to its specific comme nts, the European Communities alleges: 
(a) that the Panel has dismissed the 1999, 2000 and 2002 Opinions as not constituting a 
proper risk assessment based on an alleged absence of specific evidence which, the 
European Communities claims, is impossible to provide; WT/DS320/R 
Page 114 
 
 
  (b) that the Panel dismissed the Opinions as not having presented sufficient evidence to 
call into question the conclusions of JECFA; 
(c) that the Panel should have scrutinized JECFA's evaluations, which are based on old 
studies which were not publicly available a nd were not communicated to the Panel or 
the Panel's experts for review; 
(d) that the Panel has reached its conclu sions on the EC implementing measure 
(Directive 2003/74/EC) by relying selectively, for a number of important issues, on 
the statements of two experts in a group of six.  The European Communities recalls 
that those two experts had participated in  the drafting of the JECFA's assessments 
contradicted by the EC Opinions and we re obviously defending their own work and 
the methodology applied by JECFA and Codex.  Comparatively, the other four experts had overall validated and supported th e conclusions of the EC Opinions; and, 
finally, 
(e) that the Panel's methodology and reasoning are contrary to established principles on 
burden of proof and standards of review of genuine scientific questions by WTO 
panels and ordinary courts of law. 
6.59 Regarding the argument under (a) above, the Panel will address this question when it 
addresses the EC comments on the Panel' s findings under Article 5.1 of the SPS Agreement . As a 
preliminary remark, however, the Panel wishes to clarify that it did not "dismiss the opinion of a relevant committee constituted of highly regarded , independent scientific experts".  The Panel 
concluded that the European Communities had not evaluated specifically the possibility that the 
adverse effects related to the association between excess hormones and neurobiological, developmental, reproductive and im munological effects, as well as immunotoxicity, genotoxicity and 
carcinogenicity coming into being, originating or resulting from the consumption of meat or meat 
products which contain veterinary residues of oestradiol-17 β as a result of the cattle being treated with 
oestradiol-17 β for growth promotion purposes.  The Pane l also found that the scientific evidence 
referred to in the Opinions does not support the EC conclusions on genotoxicity, or the conclusion that the presence of residues of oestradiol-17 β in meat and meat products as a result of a cattle being 
treated with this hormone for growth promotion purposes leads to increase cancer risk.  Nor does the 
scientific evidence support the EC conclusions a bout the adverse immunologi cal and developmental 
effects of consuming meat and meat produc ts from cattle treated with oestradiol-17 β for growth 
promotion purposes.  This does not put into ques tion the results of the studies and research relied 
upon by the SCVPH, nor the conclusions reached by  the scientists, but simply the conclusions drawn 
by the European Communities on the basis of the science.  
6.60 Regarding the argument under (b) above, it is co rrect that the Panel considered that, in order 
to determine whether relevant scientific evidence was insufficient within the meaning of Article 5.7 of 
the SPS Agreement , it had to take the results of the risk assessments made by JECFA as a 
"benchmark" of the existence of suffi cient scientific evidence.  This is  in line with the findings of the 
Appellate Body in Japan – Apples  that the relevant scientific evid ence will be insufficient within the 
meaning of Article 5.7 if the body of available scien tific evidence does not allow, in quantitative or 
qualitative terms, the performance of an adequate assessment of risks as re quired under Article 5.1 
and as defined in Annex A to the SPS Agreement
243, as well as with the presumption of compliance 
under Article 3.2 of the SPS Agreement .  
                                                      
243 Appellate Body Report on Japan - Apples , para. 179.  WT/DS320/R 
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  6.61 As far as the argument under (c) is concerned, th e Panel explained in its findings why it relied 
on JECFA's work without questioning it.244  First, using JECFA's risk assessments as "benchmarks" 
did not mean that the Panel had to examine the scientific evidence supporting JECFA's conclusions.  
Second, none of the parties contested that JECFA and Codex work on the hormones at issue (with the exception of MGA) constitute international standa rds, guidelines and recommendations within the 
meaning of Article 3.2.  Because sanitary meas ures which conform to international standards, 
guidelines or recommendations are deemed to be  consistent with the provisions of the SPS Agreement , 
the Panel had no reason to scrutinize the evaluation made by JECFA. The only benefit of such an evaluation would have been to determine whethe r JECFA's risk assessment met the conditions of 
Article 5.1.  However, the question before the Pane l is not to review the validity of international 
standards:  the Panel has no mandate to do that.  It is not to review whether JECFA's risk assessments 
are compatible with Article 5.1, but whether the EC implementing measure is compatible with 
Article 5.1 as far as oestradiol-17 β is concerned or justified unde r Article 5.7 for the other five 
hormones at issue.  The Panel also notes in this  respect that, whereas Members have, pursuant to 
Article 3.3, a right to introduce or maintain sanita ry measures which result in a higher level of sanitary 
protection than would be achieved by measures b ased on the relevant international standards, 
guidelines and recommendations, the way to do this is not by seeking to demonstrate that those 
standards, guidelines and recommendations are flawed  or outdated, which would simply show that 
they have become insufficient and would not ju stify the EC measure, but by providing positive 
evidence or information supporting the conformity of  the measure at issue with Article 5.1 and/or 
Article 5.7.  It was, thus, for the European Communities to provide convincing evidence, in line with the requirements of Article 3.3 of the SPS Agreement , to justify its definitive ban on oestradiol and 
that relevant scientific evidence was in sufficient for the other five hormones. 
6.62 Regarding the argument according to which th e two experts involved in the drafting of 
JECFA's risk assessments were defending their ow n work and the methodology applied by JECFA 
and Codex, the Panel wishes to add to what it has already said above that, since JECFA's risk 
assessments were used as the reference risk assessments for purposes of the analysis under Article 5.7 of the SPS Agreement , it was necessary for the Panel to be able to rely on the advice of experts 
intimately knowledgeable about the su bstance of JECFA's risk assessments.
245  The purpose was not 
to check whether JECFA's risk assessments were supp orted by sufficient scientific evidence or carried 
out in accordance with Article 5 of the SPS Agreement , but to identify to what extent the concerns 
raised by the European Communities in its submissions  had been considered in the development of its 
risk assessments by JECFA (e.g. how the risk to pr epubertal children had been taken into account by 
JECFA).  Second, the Panel recalls that JECFA is an international, indepe ndent entity composed of 
highly qualified experts selected by the WHO or FAO according to strict procedures.246 JECFA also 
regularly reassesses its risk assessments, normally at th e request of Members of Codex, and evidence 
before the Panel suggest that the European Co mmunities did not request JECFA to reassess the 
hormones at issue on the basis of the new evid ence it had gathered.  Instead, the European 
Communities relied on its own risk assessment.  Moreover, JECFA reaches its conclusions by 
consensus.  So the opinions expr essed by the two experts were given with regard to the consensual 
view of JECFA on this matter, not just their own personal positions in the past.  This does not mean, 
however, that JECFA's work is these particular expe rts' own work:  it is a joint work by several 
experts.  The experts that the European Communitie s claims were defending their work acknowledge 
that the state of knowledge can evolve. For instance, Dr. Boobis stated that: 
                                                      
244 Paras. 7.643-7.647. 
245 In order to assess the appropriat eness for the Panel to seek advi ce from experts involved in the 
preparation of JECFA's risk assessment, it is also importa nt to recall that the experts are being consulted in the 
context of an assessment of the EC implementing measure under Articles 5.1, 5.2, 5.7 and 3.3 of the 
SPS Agreement , and of the presumption of conformity with the SPS Agreement . 
246 JECFA's reply to question 14 of the Panel.  See also Dr. Boobis, Annex G, para. 511;  Dr. Tritscher, 
Annex G, para. 515;  Dr. Wennberg, Annex G, para. 517. WT/DS320/R 
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  "[S]cience moves on, and it would be co mplacent for a risk assessment body to 
assume that it knew everything about a substance at a particular point in time.  We 
have to work within the available informa tion, and the question we  ask is: do we have 
sufficient information at this point to conduct a risk assessment? – not: is the data 
complete and are there no scientific questions remaining to be answered."247 
6.63 The experts consulted by the Panel are used to  considering and peer reviewing studies that go 
beyond what they have published themselves or perhap s even contradict them.  In other words, they 
are not likely to feel any need to defend their ow n previous work results in the light of new, 
convincing evidence or techniques that put such prev ious work into doubt.  The Panel also notes that 
other experts referred to JECFA's work in their replies, just as they also referred to studies 
commissioned by the European Communities.248  
6.64 The European Communities also argues that the remaining four experts "overall validated and 
supported the conclusions of the [SCVPH] Opinion[s]".   The Panel does not share this point of view.  
First, not all experts expressed their views on all the issues. The experts who expressed their views 
often agreed with each other.  Second, the impressi on that a majority of experts overall validated and 
supported the conclusions of the SCVPH Opinions is incorrect.  With respect to the five provisionally 
banned hormones, to different degrees, the experts agreed that new studies would be useful.  This 
does not mean, however, that they considered them useful for the reasons a dvocated by the European 
Communities. The four experts agreed regarding the hazard related to hormones, or the risk attached 
to high doses.  But so did the two experts with JECFA experience.   
6.65 As to the argument that the Panel's methodol ogy and reasoning are contrary to established 
principles on burden of proof and standards of review  of genuine scientific questions by WTO panels 
and ordinary courts of law, the Panel wishes to  recall its findings at pa ragraphs 7.380-7.386 and 
7.412-7.427  on the standard of review and burden of proof .  The Panel has also explained why it gave 
particular relevance to JECFA's risk assessments  and why, to the extent that the European 
Communities disagreed with JECFA, it had to prove that its measure was based on a risk assessment 
consistent with Article 5. 1 and Annex A(4) of the SPS Agreement,  or that the relevant scientific 
evidence was insufficient.  
6.66 The European Communities argues that the statement originally found in paragraph 7.371 was 
not accurate as the European Communities was alle gedly replying to a hypothetical question and 
stated that it was not necessary to lo ok into the scientific issues.  Th e Panel notes that the European 
Communities stated in its reply to question 74 of the Panel249 that "it did not believe that it [was] 
necessary to look into the scientific issues".  The European Communities did not formally object  to 
the Panel seeking scientific opinion even if  the Panel proceeded with reviewing the SPS Agreement .  
Indeed, the European Communities added in its reply to the same question 74:250 
"However, the European Communities does not believe that the Panel would have the 
expertise to decide on such issues itself, should the Panel decide to go down [the road] of deciding the scientific issues at st ake.  In such a scenario, the European 
Communities believes that the consultation of scientific and technical advice would 
be absolutely necessary." 
6.67 The European Communities argues th at it was replying to an hypothetical question. Yet, the 
European Communities uses the affirmative and not th e conditional in its reply when it states that  
                                                     
 
247 See Annex G, para. 346. 
248 See, e.g., Dr. Guttenplan, Annex D, para. 145. 
249 EC's replies to Panel questions after the first substantive meeting, Annex B, para. 274. 
250 EC's replies to Panel questions after the first substantive meeting, Annex B, para. 275.  WT/DS320/R 
 Page 117 
 
 
  "New experts will have to be consulted".251  The Panel concludes that, whereas the European 
Communities was not of the view that it was n ecessary to look into the sci entific issues, it was 
nevertheless in favour of the consultation of scien tific experts if the Panel decided to address the 
scientific issues at stake.  Paragraph 7.371 was modified accordingly. 
6.68 The European Communities suggests that the Pane l contradicted itself in paragraph 7.377 of 
the interim report when it stated, on the one hand, that parties had had sufficient opportunity to 
comment on the other party's allegations and, on the other hand, in paragraph 7.133, refused to allow 
the European Communities clarify the nature of a number of factual errors allegedly made by the 
United States and Canada.  In paragraph 7.133, the Panel took the view that the European 
Communities should not be allowed to make furthe r comments, lest the other parties would also 
comment and this would launch an endless exchange of arguments.  The Panel notes that parties were 
allowed to comment on the experts' responses and to  comment on the comments of the other party. In 
addition, the parties were allowed to comment on each  other's replies to the questions of the Panel 
after the second substantive meeting. This is fully co nsistent with usual pane l procedures.  Moreover, 
the European Communities could correct any fact ual error appearing in the interim report by 
requesting the Panel to review precise aspects of the interim report, if the allegedly erroneous 
information provided by the United States and Canada  had been used in the findings.  The Panel notes 
that the EC request to correct some factual statemen ts made by the other parties was limited to factual 
aspects, not to legal issues such as a llegations of inconsistency with the SPS Agreement , which was 
the subject of this paragraph.  The Panel nonetheless decided to clarify paragraph 7.374. 
6.69 The European Communities argues that, in para graphs 7.376-7.377, the Panel states that its 
approach was a "pragmatic solution" and the "most l ogical way forward" without further explanation.  
The European Communities considers that the appr oach of the Panel is arbitrary and negatively 
affects the interests of the parties and reverses  existing case law and established practice. The Panel 
first notes that the European Communities doe s not specify which "existing case law" and 
"established practice" it refers to, and that it does no t make any reference to its previous submissions.  
Second, the Panel notes that these paragraphs c ontain only additional arguments.  The Panel has 
amply justified its decision to address the compa tibility of the EC implementing measure with the 
SPS Agreement  throughout the preceding paragraphs.  Th e Panel also explains the reason why it 
follows this approach in paragraph 7.377, emphasi zing the need to assist the parties and the DSB in 
solving this dispute and the need to determine whether there is a violation of Article 23.1 in 
conjunction with Article 22.8 and Article 3.7 of th e DSU.  The Panel's choice was directed by the 
requirement to make an objective assessment of th e matter before it, in accordance with Article 11 of 
the DSU, having regard to the particular circumstan ces of this case, as recalled in section VII.C.2.(a) 
of this report.   
6.70 The European Communities stat es that paragraph 7.404 and footnote 516 are factually 
inaccurate.  This comment can only relate to and be  limited to the refusal of the Panel to let the 
European Communities correct alleged factual  errors in the comments of Canada and the United 
States on the EC replies to the questions of the Pane l after the second substantive meeting.  First, the 
European Communities never identifie d the factual errors at issue.  Second, the Panel explained its 
position in its letter of 20 November 2006.  The Panel recalls that it followed the standard practice of 
panels in terms of procedure, allowing comments on replies to the questions of the Panel.  The Panel 
felt justified in not allowing further comments.  Th e Panel stressed that the European Communities 
could address these factual errors at the interim review  stage, if they were reflected in the findings of 
the Panel.  It appears that the European Communities did not take advantage of this opportunity as no 
                                                      
251 The Panel also notes that the European Communities made an alternative claim of violation of 
Article 22.8 of the DSU and Articles I and II of the GA TT 1994, in isolation from its claim under Articles 23.1 
and 3.7 of the DSU which was based on an allegatio n of actual compliance with the recommendations and 
rulings of the DSB in the EC – Hormones  case.   WT/DS320/R 
Page 118 
 
 
  such factual corrections were made.  Thus, the Panel sees no reason to correct paragraph  7.404 and 
footnote 516. 
6.71 With respect to paragraph 7.410 , the European Communities argues that the statement of the 
Panel is unsupported and is an error of law.  We  do not share the European Communities' opinion. 
First, the Panel did not base its decision to include Article 5.2 of the SPS Agreement  in its review of 
the conformity of Directive 2003/74/EC exclusiv ely on the comment of the European Communities 
quoted in paragraph 7.409.   In paragraph  7.404, the Panel mentioned that it would "consider all 
allegations and arguments raised by each party".  Since the United States had alleged a violation of 
Article 5.2, the Panel could look at it irresp ective of the EC position on this matter.  In 
paragraph 7.410, the Panel simply notes the absen ce of objection of the European Communities. It 
was, therefore, not deemed necessary to modify paragraph 7.410.  
6.72 The European Communities argues, with resp ect to paragraph 7.420, that the Panel 
misconstrued its role by engaging in settling a scien tific debate and arbitrating the opinions expressed 
by the scientific community by "picking and choosin g" from individual replies of experts without any 
valid explanation.  The Panel explained in its find ings in paragraph 7.71 why it deemed it preferable 
to consult experts individually.  The Panel had al so explained in its letter to the parties of 25 
November 2005 how it understood its ro le in terms of assessment of scientific opinions.  The Panel 
believes that weighing the scientific evidence before it was necessary to reply to the two main legal 
questions in relation to the SPS Agreement , i.e. whether the European Communities had performed a 
risk assessment within the meaning of Article 5.1 for oestradiol-17 β and if the relevant scientific 
evidence was sufficient within th e meaning of Article 5.7 as far as the other hormones were 
concerned.  In fact, the Appellate Body confirme d the discretion of Panels in weighing evidence in 
EC – Asbestos .252  This is also part of the role of panels under Articles 11 and 13 of the DSU.  The 
Panel also considers that the role of the experts was to act as an "interface" between the scientific 
evidence and the Panel, so as to allow it to perform its  task as the trier of fact.  If panels were not to 
weigh the scientific evidence before them, then th e DSU would have mandated the recourse to experts 
review groups.  The Panel also notes that  the Appellate Body took the view in EC – Hormones , that 
both the SPS Agreement  and the DSU leave to the discretion of a panel the determination of whether 
the establishment of an expert review group is necessary or appropriate.253  The Panel explained its 
approach in detail in paragraph 7.420 and thus does not believe that it engaged into "picking and 
choosing" without any valid explanation.  The Pane l notes that some replies to its questions were 
more detailed than others and supported by bibliogr aphical references.  The Panel believes that, in 
case of divergence of opinions between the experts, and having due regard to the comments of the 
parties and the clarifications provided by the expe rts at the meeting with the Panel, it was a sound 
approach to take into account, in forming its own op inion,  the opinions that were the most precise 
and elaborate.  Therefore, having also consider ed the comments of the respondent of 19 October 
2007, the Panel did not deem it necessary to revise paragraph 7.420. 
6.73 The European Communities considers that, in pa ragraphs 7.423-7.427, the Panel missed the 
point made by the European Communities, namely that neither the United States, Canada nor JECFA 
have provided conclusive proof that the methods used to generate the outdated evidence on which 
they based and continue to base th eir risk assessment were validated.  The Panel first notes that the 
paragraphs at issue are part of an introductory section, not one where the validity of the evidence 
actually relied upon by JECFA is being discussed.  S econd, the purpose of the discussion contained in 
the paragraphs at issue is clearly stated in para graph 7.427.  The point made by the Panel is that a 
study is not ipso facto  irrelevant because it is old.  The Pa nel makes two points in paragraph 7.427:  
(i) that accuracy is a problem when one is at the limits of detection of the older methods and (ii) that in any event an essential question is whet her a given method has been validated. 
                                                     
 
252 Appellate Body Report on EC – Asbestos , para. 161. 
253 See para. 7.74.  WT/DS320/R 
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  6.74 Second, the European Communities' comment rais es the question whether there is a need for 
the United States and Canada to prove that JECFA' s risk assessments were based on validated studies. 
In the opinion of the Panel, this is not a question that needs to be addressed in order to resolve this 
dispute.  JECFA's risk assessments were used as the bases for Codex recommendations which are, 
pursuant to Article 3.1 and Annex A(3) of the SPS Agreement , "international standards, guidelines or 
recommendations".  Pursuant to Article 3.3, it is for the WTO Member wishing to introduce or 
maintain sanitary measures which result in a higher  level of sanitary protection than would be 
achieved by measures based on the re levant international standard s, guidelines and recommendations 
to provide scientific justification in support of such measures.  In that context, the question before the 
Panel is not whether JECFA's risk assessments were based on validated studies254, but whether the 
European Communities' permanent ban on meat and meat products containing veterinary residues of 
oestradiol-17 β derived from cattle treated with this hormone  for growth promotion purposes is based 
on a risk assessment within the meaning of Artic le 5.1 and, for the five provisionally banned 
hormones, whether there exists validated  studies that sufficiently put into question the evidence on 
which JECFA's risk assessments are based, so as to s upport a conclusion that the relevant scientific 
evidence is insufficient to pe rmit the assessment of risk. 
(ii) General comments on the Panel's analysis regarding oestradiol-17 β 
6.75 The European Communities argues that the use of  the term "measure" in paragraphs 7.443 
and 7.518 to describe the Panel's function is unfor tunate because "it is clear that a panel does not 
measure anything (which implies that there is something quantitative to measure), but simply 
examines the conformity of the measure with the relevant provisions."255  The Panel notes that it used 
the term "measure" in the sense, as defined by the Oxford English Dictionary, to "judge or estimate 
the greatness or value of (a person, a quality, et c.) by a certain standard or rule; appraise by 
comparison with something else."256  The Panel believes that judging or appraising something, in this 
case the SCVPH Opinions, against a certain standard or rule, in this case Articles 5.1 (including an 
examination of Article 5.2) and Annex A(4) of the SPS Agreement , is precisely examining the 
conformity of the measure with the relevant provi sions.  Therefore, the Panel will not change the 
                                                      
254 The Panel did not use the quotation from Dr. Wennberg in paragraph 7.426 to argue that JECFA's 
studies were actually validated, but to stress that if a study used a validated method, there is no reason to reject it simply because it is old. The problem with some of the more recent stud ies on which the Eu ropean Communities 
relies is that they have not been validated.  The Europe an Communities also refers to statements of Dr. De 
Brabander (Annex G, paras. 670, 675, 681 and 687) and Dr. Sippell (Annex G, para. 689).  The Panel understands from Dr. De Brabander's comments that there would be reasons to re-do certain assessments, inter 
alia because the separation power of components has incr eased considerably since th e 1980s (see para. 681).  
However, the Panel notes that Dr. De Brabander insists on the fact that one cannot say that the "old" data are not 
correct on not valid un til they are checked with modern analytical methods, which, according to him, has not 
been done.  Dr. Sippell states that, for infant a nd young children, a standard commercially available 
radioimmunoassay is not able to pick up the real concentrations, because there are numerous other cross-
reacting steroids.  Dr. Sippell concludes that "one should really look at the new data".  Whereas this statement 
suggests that old data are not valid, Dr. Sippel stops short of formally concluding that they are not valid. We also note Dr. Boobis' comment following Dr. Sippell's intervention (Annex G, para. 691): 
 
"I would make the point that a method that is used to measure low levels of oestrogens in infants is a different question from a method that is being used to measure residues in food.  
The analytical challenges are quite different and the methods that were developed in the 1980s 
for the residues were fit for that purpose, and that is what they were used for.  If you ask the 
question about the circulating concentrations, that is a different issue.  So in terms of residues 
the methods were suitable." 
 
255 EC's comments on inte rim report, para. 50. 
256 Shorter Oxford English Dictionary , 5th edition (1993), p.1730. WT/DS320/R 
Page 120 
 
 
  term.  However, the Panel wishes to clarify here th at it did not intend to use the term "measure" to 
imply any sort of quantitative analysis.   
6.76 The European Communities also st ates that it did not understand the Panel's use of the term 
"objective measures" in the paragraph of the inte rim report corresponding to  paragraph 7.443.  The 
European Communities correctly points out an error in the paragraph.  The fourth sentence should 
read "The Panel must objectively measure the Opini ons against the relevant standard for whether a 
risk assessment has been conducted,  which can be found in the texts of Articles 5.1 (including an 
examination of Article 5.2) as well as Annex A(4) of the SPS Agreement ."  Again, the Panel notes that 
it is using the term "measure" in the sense of a qualitative appraisal of the SCVPH Opinions against a 
standard or rule, namely the SPS Agreement . 
(iii) Comments on "risk assessment techniques" 
6.77 The European Communities argues that the discussion by the Panel of risk assessment 
techniques in paragraphs 7.446  to 7.469  is irrelevant and unnecessar y given that no relevant 
international risk assessment techniques for ve terinary drug residues have been agreed upon.257   
6.78 The Panel notes that Article 5.1 requires that Members take into account the risk assessment 
techniques of the relevant international organi zations when ensuring that their sanitary and 
phytosanitary measures are based on a risk assessment.  Therefore, the Panel believes that an analysis 
of whether such techniques exist and whether th e European Communities took them into account is 
necessary and appropriate to an analysis of wh ether the European Comm unities has removed the 
previously found inconsistency of its ban on the importation of meat and meat products treated with 
oestradiol-17 β for growth promotion purposes with Article 5.1 of the SPS Agreement .   
6.79 The Panel notes in paragraph 7.449 that no specifi c techniques or guidelines had thus far been 
formally adopted by Codex for use by nationa l governments in conducting risk assessments of 
veterinary drug residues.  However, there are relevant  definitions of the phases of a risk assessment as 
well as guidelines and practices for conducting a risk assessment in the general sense and the Panel, 
therefore, analyses whether th e European Communities took these into account when it adopted 
Directive 2003/74/EC.   
6.80 The European Communities also  argues that these passages convey the erroneous message 
that the concept of risk assessment as defined in the SPS Agreement  is the same as in Codex 
Alimentarius.258   
6.81 The Panel is surprised by this comment, because it states in paragraph 7.467: 
"[T]he Panel must concur with  the reasoning of the panel in Japan – Apples , that the 
requirement to 'take into account' the risk  assessment techniques of international 
organizations: 
'[D]oes not impose that a risk assessment under Article 5.1 be 'based 
on' or 'in conformity with' such risk assessment techniques.  This 
suggests that such techniques should be considered relevant, but that a failure to respect each and every aspect of them would not 
necessarily, per se , signal that the risk assessment on which the 
                                                     
 
257 EC's comments on inte rim report, para. 51. 
258 EC's comments on inte rim report, para. 51.  WT/DS320/R 
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  measure is based is not in conformity with the requirements of 
Article 5.1.'"259 
6.82 The Panel finds that this quotation adequately  conveys the Panel's opinion that although the 
risk assessment techniques of the relevant interna tional organizations must be considered by the 
Members, they are not binding on Members and that  not following them would not necessarily lead to 
the conclusion that the risk assessment did not co nform with Article 5.1 and Annex A(4) of the 
SPS Agreement .  However, to avoid confusion, the Pa nel clarified paragraph 7.467 and added 
paragraph 7.468. 
6.83 The European Communities also ta kes issue with paragraph 7.455.  In that paragraph the 
Panel summarizes the arguments of th e European Communities as follows: 
"The European Communities  agrees that the risk assessment techniques developed 
by Codex are relevant and contemplated in  Article 5.1's requirement to take into 
account the risk assessment techniques de veloped by relevant international 
organizations.  However, the European  Communities maintains that the risk 
assessment criteria as developed by the WTO dispute settlement bodies are clearly more relevant to the application of the SPS Agreement. " 
6.84 The European Communities argues that this pa ragraph is misleading because the European 
Communities has followed the four steps of risk assessment described by Codex.  The European 
Communities asserts that it has followed the four step s because its legislation so provides, not because 
it is required to do so under the SPS Agreement , since such techniques do not exist. 
6.85 The arguments summarized in this paragraph are contained in paragraph 192 of the European 
Communities' second written submission.  
6.86 Paragraph 192 of the European Commun ities' second written submission states: 
"[A]ll parties to this dispute agree on the relevance of the risk assessment techniques 
developed by Codex recently.  Indeed, Article 5.1 itself points to the relevance of risk 
assessment techniques developed by rele vant international organisations.  
Furthermore, the SCVHP has explicitly based its assessment on the three elements of 
risk identification, risk characterizatio n and exposure assessment recommended and 
applied by the Codex.
260  A few qualifications, however, apply.  First, risk assessment 
criteria as they have been developed by the dispute settlement bodies are clearly more relevant to the application of the SPS Agreement than those developed by 
                                                     
 
259 Panel Report on  Japan – Apples , para. 8.241. 
260 In response to a question from the Panel, th e European Communities clarified the following: "As 
regards the statement in para. 192 of its Rebuttal Submission, the European Communities is grateful to the Panel 
for pointing out the error and oversigh t. The error is double because: first,  the steps of a risk assessment as 
defined by Codex are four (not three) and, second, the terminology used in para. 192 to describe the first three of them is not correct either (see following para. 193 where the proper terminology is used for the first three steps). 
The words used in para. 192 is an isolated oversight and does not re flect the position which the European 
Communities has expressed in so many other places in its written submissions and the or al hearing. Indeed, with 
its reply of 3 October 2005 to Written Question No. 24 fr om the Panel, in particular paragraphs 140-143, the 
European Communities has properly described the four st eps of a risk assessment and the reasons for which it 
thinks it has complied with them in this case. See also  paragraphs 145-152 of its reply of 3 October to Written 
Question No. 25 from the Panel.  Moreover, a careful examination of the 1999 Opinion shows beyond doubt that 
the European Communities has completed the four steps, albeit it made a qualitative exposure assessment for the reasons explained therein." (EC's rep lies to Panel questions after the second substantive meeting, question 8, 
para. 34, Annex C-1) WT/DS320/R 
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  international scientific bodies.  This follows  naturally from the fact that it is the 
former's duty and privilege to interpret the provisions of the SPS Agreement ." 
6.87 The Panel believes that the sentiment of the Eu ropean Communities' argument is adequately 
summarized in paragraph 7.455  and will not alter the paragraph. 
6.88 As to the European Communities' argument th at paragraph 7.455 is misleading because the 
European Communities has followed th e four steps of risk assessment as defined by Codex, the Panel 
notes that it does not discuss in any way in paragr aph 7.455 whether the European Communities' has 
complied with the four steps.  In addition, the Panel notes in paragraph 7.458 that "the European Communities argues that the risk assessment at the basis of Direct ive 2003/74/EC precisely follows 
the four steps of risk assessment as defined by Codex ..."  
6.89 It is irrelevant for the Panel whether the EC in ternal legislation mandates that the European  
Communities follow the four steps or whether th e European Communities complied with its own 
legislation.  The Panel's analysis focuses on whether the European Communities "took into account" 
the relevant risk assessment techniques of the re levant international organizations as required by 
Article 5.1 of the SPS Agreement  and, in paragraph 7.469, the Panel finds that it has. 
6.90 The European Communities asks the Panel to  more fully summarize its arguments in 
paragraphs 7.502 and 7.503.
261  The Panel has, therefore, modified those paragraphs.  
(iv) Assessment of the scientific arguments 
6.91 The European Communities, ar gues that paragraphs 7.504  through 7.573 are incoherent and 
confused.  Specifically, the European Communities be lieves that they do not adequately present the 
debate on the "threshold approach" which it  believes is the central scientific debate.262  The Panel 
notes that the content of paragraphs 7.504  through 7.573 contains the reasoning of the Panel on 
whether the Opinions satisfy the definition of a risk assessment set forth in Annex A(4) of the 
SPS Agreement .  This section of the Panel's reasoning is not the appropriate place to present a debate 
between the parties about a particular scientific issue.   
6.92 The Panel, however, is mindful that the par ties did expend a significant amount of argument 
on the relevance of "thresholds" to the risk assessment process and that perhaps it would provide 
further clarity to include more explanation of th e various arguments.  Therefore, the Panel made 
modifications to the summaries of the parties' argume nts.  The Panel believes that the debate over the 
"threshold" issue can be divided into two main co mponents.  First, whether all four of the risk 
assessment steps as defined by Codex should be foll owed when the substance under review exhibits 
no threshold.  Second, whether oestradiol-17 β is such a substance that exhibits no threshold because it 
is genotoxic in vivo and therefore would lead to adverse effects even at the doses found in meat as a 
result of treatment of cattle with oestradiol-17 β for growth promotion purposes. 
6.93 The Panel also feels that it would be helpful to  include some additional information provided 
by the experts with respect to this matter.  Th erefore, the Panel inserte d a new paragraph after 
paragraph 7.464.   The Panel also changed the first sentence of paragraph 7.467. 
6.94 With respect to whether oestradiol-17 β, in particular, is genotoxic in vivo  and has no 
threshold, the Panel finds that the issue arises in two different contexts:  first, in the context of what 
such a conclusion means for evaluating whether th e SCVPH Opinions constitute a risk assessment 
within the meaning of the SPS Agreement;   second, in the context of the analysis of whether the 
                                                      
261 EC's comments on inte rim report, para. 52. 
262 EC's comments on inte rim report, para. 53.  WT/DS320/R 
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  science supports the conclusions reached by the Eu ropean Communities with respect to the genotoxic 
properties of oestradiol-17 β.  To address both of these issues the Panel edited paragraph 7.497. 
6.95 The Panel also feels that it would be helpful to  include some additional information provided 
by the experts with respect to this matter.  Th erefore, the Panel inserte d a new paragraph after 
paragraph 7.529. 
6.96 With respect to whether the science s upports the conclusion that oestradiol-17 β is a substance 
that exhibits no threshold, the Panel has adde d Dr. Cogliano's response to question 19 from the 
Panel263 as paragraph 7.559. 
6.97 The European Communities argues that paragraphs 7.518 and 7.519 of the interim report are a 
misinterpretation of what the Appellate Body found in the original EC – Hormones  case about the 
concept of risk assessment and its significance in the SPS Agreement .264  The European Communities 
does not provide any specific parts of the analysis th at it feels are a misinterpretation, neither does it 
provide what it believes is the correct interpretati on.  The Panel can only assume that the European 
Communities maintains its position as summarized in paragraph 7.517. 
6.98 The Panel based its reasoning in paragraphs 7. 518 and 7.519 of the interim report on several 
passages in the Appellate Body Report on EC – Hormones .  Paragraph 181 of the Appellate Body 
Report reads as follows: 
"The second preliminary consideration relat es to the Panel's effort to distinguish 
between 'risk assessment' and 'risk manage ment'.  The Panel observed that an 
assessment of risk is, at least with resp ect to risks to human life and health, a 
'scientific' examination of data and factual studi es;  it is not, in the view of the Panel, 
a 'policy' exercise involving social value judgments made by political bodies.265  The 
Panel describes the latter as 'non-scientific' and as pertaining to 'risk management' 
rather than to 'risk assessment'.266  We must stress, in this connection, that Article 5 
and Annex A of the SPS Agreement  speak of 'risk assessment' only and that the term 
'risk management' is not to be found either  in Article 5 or in any other provision of 
the SPS Agreement .  Thus, the Panel's distinction, which it apparently employs to 
achieve or support what appears to be a r estrictive notion of risk assessment, has no 
textual basis.  The fundamental rule of treaty interpretation requires a treaty 
interpreter to read and interpret the wo rds actually used by the agreement under 
examination, and not words which the interp reter may feel should have been used." 
6.99 The Appellate Body disapproved of the panel's use in the original EC – Hormones dispute of 
the distinction between "risk assessment" and "risk management" because it had no textual basis.  
However, this did not mean that the Appellate Bo dy endorsed an interpretation of Article 5.1 or 
Annex A(4) of the SPS Agreement  that included a risk management stage.  In fact, it emphatically 
                                                      
263 Panel question 19, Annex D, p. 34 ("The Europe an Communities states that '... it is generally 
recognized that for substances which have genotoxic potential (as is the case with oestradiol-17 β) a threshold 
can not be identified.  Therefore it cannot be said that  there exist a safe level below which intakes from residue 
should be considered to be safe.  Therefore the fact that doses used in growth promotion are low is not of 
relevance'.  Does the scientific evidence referred to by the European Communities support these conclusions?  
Would your reply have been different at the time of adoption of the EC Directive in September 2003? If so, 
why? [see para. 201 of EC Rebuttal Submission (US case), paras. 120-122 of EC Rebuttal Submission (Canada case), paras. 73 and 86-98 of Canada Rebuttal Submission, paras. 87-91 and 153-156 of US First Submission 
and paras. 35-40 and 46 of US Rebuttal Submission]"). 
264 EC's comments on inte rim report, para. 55. 
265 (footnote original ) US Panel Report, para. 8.94;  Canada Panel Report, para. 8.97. 
266 (footnote original ) US Panel Report, para. 8.95;  Ca nada Panel Report, para. 8.98.  WT/DS320/R 
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  stated that the term "risk management" is not to be  found in Article 5 or any other provision of the 
SPS Agreement.  The Panel, therefore, finds no basis for the European Communities' assertion that the 
Appellate Body "confirmed that a risk assessment w ithin the meaning of Article 5.1 includes a risk 
management stage which is the responsibility of the regulator to carry out and not of the scientific 
bodies."267   
6.100  This Panel, following the advice of the Appellate  Body, has adhered strictly to the text of 
Article 5.1 and Annex A(4) of the SPS Agreement  in its interpretation. In analysing the European 
Communities' compliance with Article 5.1 and Annex A(4) of the SPS Agreement , the Panel is also 
cognisant of the Appellate Body's finding that: 
"The listing in Article 5.2 begi ns with 'available scientific evidence';  this, however, is 
only the beginning.  We note in this connection that the Panel states that, for purposes 
of the EC measures in dispute, a risk assessment required by Article 5.1 is 'a scientific  
process aimed at establishing the scientific  basis for the sanitary measure a Member 
intends to take'.268  To the extent that the Panel intended to refer to a process 
characterized by systematic, disciplined a nd objective enquiry and analysis, that is, a 
mode of studying and sorting out facts and opinions, the Panel's statement is 
unexceptionable.269  However, to the extent that the Panel purports to exclude from 
the scope of a risk assessment in the sense of Article 5.1, all matters not susceptible 
of quantitative analysis by the empirical  or experimental laboratory methods 
commonly associated with the physical sciences, we believe that the Panel is in error.  
Some of the kinds of factors listed in Article 5.2 such as 'relevant processes and production methods' and 'relevant inspection, sampling and testing methods' are not 
necessarily or wholly susceptible of investigation according to laboratory methods of, 
for example, biochemistry or pharmacolog y.  Furthermore, there is nothing to 
indicate that the listing of factors that may be taken into account in a risk assessment 
of Article 5.2 was intended to be a closed list.  It is essential to bear in mind that the 
risk that is to be evaluated in a risk assessment under Article 5.1 is not only risk ascertainable in a science laboratory opera ting 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."
270 
6.101  Therefore, the Panel finds that a risk assessmen t consistent with Article 5.1 need not be 
limited to empirical or experimental laborator y methods commonly associated with the physical 
sciences.  However, the Panel also agrees with the Appellate Body's statement that a requirement that 
a risk assessment be "a process characterized by systematic, disciplined and objective enquiry and 
analysis, that is, a mode of studying and so rting out facts and opinions" is unexceptionable. 
6.102  Nowhere in the texts of Article 5.1 and Annex A(4) does the Panel find support for the 
European Communities' contention that a ri sk assessment within the meaning of the SPS Agreement  
                                                      
267 EC's second written submission, para. 191. 
268 (footnote original ) US Panel Report, para. 8.107;  Ca nada Panel Report, para. 8.110.  
269 (footnote original ) "The ordinary meaning of 'scientific' , as provided by dictionary definitions, 
includes of, relating to, or used in science', broadly, ha ving or appearing to have an  exact, objective, factual, 
systematic or methodological basis', of, relating to, or e xhibiting the methods or principles of science' and of, 
pertaining to, using, or based on the methodology of scienc e'.  Dictionary definitions of science' include the 
observation, identification, descripti on, experimental investigation, and theoretical explanation of natural 
phenomena', any methodological activity, discipline, or study', and knowledge attained through study or practice'".  
(footnotes omitted)  United States' Statement of Administrative Action, Uruguay Round Agreements Act , 203d 
Congress, 2d Session, House Document 103-316, Vol. 1, 27 September 1994, p. 90.  
270 Appellate Body Report on EC – Hormones , para. 187.  WT/DS320/R 
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  includes "weighing policy alternativ es in light of the results of ri sk assessment and, if required, 
selecting and implementing appropriate cont rol options, including regulatory measures."271  What the 
European Communities seems to be describing is  how a government choos es an appropriate SPS 
measure based on a risk assessment.  The Panel does not  find that this is contemplated by the texts of 
Article 5.1 and Annex A(4) of the SPS Agreement . 
6.103  To avoid any confusion or misunderstandi ng the Panel modified paragraphs 7.518  through  
7.521. 
6.104  The Panel is aware that the experts responded to the Panel's questions with respect to what the 
European Communities had evaluated in its Opinions by  using a terminology that is standard for risk 
assessments conducted according to th e process outlined in the Codex Procedural Manual.  Although 
the scientific experts' responses may include term s such as "hazard characterization" or "exposure 
assessment", the Panel is at all times aware that the relevant standard against which it is assessing the 
European Communities' measure is that of the SPS Agreement .  In order to emphasize this point, the 
Panel added a new paragraph be fore paragraph 7.522.   
6.105  The European Communities takes i ssue with the reliance of the Panel on certain statements by 
the experts in paragraphs 7.522  to 7.528 and cites to various other statements by the same experts 
which it claims stand for the opposite proposition.272  The Panel takes note that Annex D, which 
contains the replies of the experts to the Pane l's questions is 116 pages long and Annex G which 
contains the transcript of the Panel's meeting with  the experts is 170 pages long.  This does not 
include the various comments and comments on comme nts of the parties on the experts' responses and 
on the transcripts.  With this volume of informa tion, every comment by the experts could not be 
included in the Panel findings and, fo r that matter, did not have to be.273  Therefore, the Panel made a 
decision to select quotations that are representative of a particular expert's opinion on a given topic.  
The Panel has reviewed the specific paragraphs referred to by the European Communities in an 
attempt to determine if it misunderstood or misrep resented a particular expert's opinion.  It also 
considered the comments of the United States of 19 October 2007.   
6.106  With respect to Dr. Guttenplan, the European Communities objects to the Panel's reliance on 
paragraph 145 of the experts replies to the Panel's questions and refers the Pa nel to paragraphs 366, 
393, 713 and 716-718 of Annex G as well as his written reply to Panel qu estion 17 which is at 
paragraph 176 of Annex D.274 
6.107  With respect to the Panel's reliance on paragra ph 145 of Annex D, which is Dr. Guttenplan's 
response to Panel question 13, cite d in paragraph 7.523, the Panel amended the para graph to better 
reflect Dr. Guttenplan's complete response to the question.  
6.108  Additionally, to more fully reflect Dr. Gutte nplan's written answer to question 52 of the 
Panel, the Panel modified paragraph 7.528.  
6.109  With respect to Dr. Guttenplan's other interven tions cited by the European Communities, the 
Panel did not deem it necessary to make an y additional changes in this section.   
6.110  Paragraph 366 of Annex G refers to Dr. Guttenplan's opinion that oestrogen is genotoxic, but 
that it may not be possible to "really estimate the ri sk at this point from such low levels of genotoxic 
                                                      
271 EC's reply to question 24 of the Panel after the first substantive meeting, Annex B-1, para. 137. 
272 EC's comments on inte rim report, para. 56. 
273 Appellate Body Report on EC – Hormones , para. 138; see also section VI I.C.3.(d)(iii) of this report. 
274 EC's comments on inte rim report, para. 56. WT/DS320/R 
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  effects."275  Paragraph 393 of Annex G re fers generally to the issue of  conducting risk assessments of 
genotoxic substances with no threshold.276  The Panel believes it has dealt with these issues in the 
amendments mentioned above.   
6.111  Paragraphs 713 and 716-718 of Annex G reflect  Dr. Guttenplan's opinion that although, 
because anything is possible, there may be a risk  from consumption of meat derived from cattle 
treated with oestradiol-17 β for growth promotion purposes, it is so low that it is not susceptible to 
calculation.  It also reflects an interjection by  the European Communities asking Dr. Guttenplan to 
confirm his statement that, although the risk is smal l and cannot be evaluated or calculated, it is not 
zero. 
6.112  The Panel does not believe that these statements ar e directly relevant to the Panel's reasoning 
on whether the European Communities conducted a risk  assessment consistent with the definition set 
forth in Annex A(4) of the SPS Agreement .  As the Panel has noted, the purpose of the risk assessment 
is to evaluate the possibility that an identified adve rse effect comes into bei ng, originates, or results 
from the presence of the identifie d additives, contaminants, toxins or disease-causing organisms in 
food, beverages or feedstuffs.  It is not to guara ntee that said possibility w ill be below the Member's 
appropriate level of protection or indeed will be zero.   
6.113  Finally, the European Communities cites Dr. Guttenplan's written response to question 17 of 
the Panel.  In that paragraph, Dr. Guttenplan st ates that the absence of catechol metabolites in meat 
from treated animals does not imply that the meat is  without risk for genotoxicity.  Dr. Guttenplan 
was being asked to evaluate a particular argument by Canada.  The Panel does not read this statement 
as implying that the residues of oestradiol-17 β in meat from treated cattle are definitely genotoxic.  
However, even if this were the case, the  issue of ge notoxicity is only relevant  to the issue of whether 
a threshold could be determined for this substance.   Again, the Panel believes it has addressed this 
point with the additions and edits suggested above. 
6.114  The European Communities also refers the Panel to various interventions by Dr. Cogliano at 
the Panel meeting with the experts, namely, pa ragraphs 400, 404, 406, 409, 870, and 1021-1025 of 
Annex G.277 In paragraphs 400, 404, and 406 of Anne x G, Dr. Cogliano provides the Panel with 
general background information on the issue of th resholds and linear dose response curves.  The 
comments are not specific to the Opinions of the European Communities and therefore are not 
relevant to the analysis the Panel is undertaking in  this particular section.  Paragraph 409 of Annex G 
contains a question from the Chairman.  The Pane l is unsure whether the European Communities 
meant to refer to paragr aph 408 or paragraph 410.278  In any event, in both those paragraphs 
Dr. Cogliano provides general background informa tion on what is meant by a linear dose response 
curve.   
6.115  Dr. Cogliano, in paragraph 871 of Annex G279, states that the data are not sufficient to conduct 
a "JECFA-style" risk assessment if oestradiol-17 β has no threshold.  The Panel finds this statement 
unremarkable for two reasons.  First, the Panel is  not evaluating whether the European Communities 
has done a "JECFA-style" risk assessment, but whet her it has done a risk assessment consistent with 
                                                      
275 Transcript of the Panel meeting with the experts, Annex G, para. 366. 
276 Transcript of the Panel meeting with the experts, Annex G, para. 393. 
277 EC's comments on interim report, paras. 56-58. 
278 Because the specific paragraph references by th e European Communities in its comments on the 
interim report frequently tend to differ from the versio n in Annex G, the Panel believes that the European 
Communities must have prepared its interim comments with  a different version of the transcript than the one 
contained in Annex G.  In each instance of mistaken citation, the Panel has read the paragraphs in the transcript 
surrounding those cited by the European Communities to en sure that it has correctly identified and is responding 
to the concerns expressed by the European Communities.   
279 Paragraph 870 is the Chairman giving the floor to Dr. Cogliano.  WT/DS320/R 
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  the definition set forth in Annex A(4) of the SPS Agreement .  Second, the European Communities has 
not argued that there is insufficient data to conduct a risk assessment of oestradiol-17 β, it has argued 
that it has conducted a risk assessment of oestradiol-17 β that is consistent with the SPS Agreement , 
that its measure is based on that risk assessment and that, consequently, it has acted consistently with 
Article 5.1 of the SPS Agreement .  Dr. Cogliano's statement, in the paragraph cited by the European 
Communities, is not directly relevant in this context.  
6.116  Paragraphs 1021 through 1025 of the transcript of  the panel meeting with the experts report a 
discussion where both Drs. Boobis and Cogliano confir m that the fundamental difference between the 
JECFA study and the SCVPH Opinions is the willingn ess to assume a threshold and interpret the data 
from that standpoint.  The Panel has now cited these interventions in the new paragraphs 7.465, 7.466 
and 7.530.   
6.117  In its comments on the interim report, the Eur opean Communities argues that if the Panel had 
properly looked at Dr. Cogliano's interventions in th ese paragraphs of the transcript the Panel would 
have had to conclude that the European Communities' risk assessm ent has followed one side of a 
legitimate debate while JECFA has followed another.280  The European Communities seems to imply 
that if the Panel recognizes this it would also c onclude that the European Communities' ban on the 
importation of meat and meat products from cattle treated with oestradiol-17 β for growth promotion 
purposes was based on a risk assessment within the meaning of Article 5.1 and Annex A(4) of the 
SPS Agreement .  The Panel does not see the issue in quite the same manner as the European 
Communities.  The issue is not whether a risk assessment following the four steps as defined by 
Codex could or should have been completed.  Th e issue is whether the European Communities has 
conducted a risk assessment within the meani ng of Article 5.1 and Annex A(4) of the SPS Agreement .   
6.118  The Panel does not take a position on the science or  on how to evaluate da ta when a particular 
substance exhibits no threshold.281  However, whatever approach  the European Communities adopts 
in its assessment of the risks, it is obligated to co nduct a risk assessment that is consistent with the 
definition set forth in Annex A(4) of the SPS Agreement .  The Panel finds that the SPS Agreement  
requires an analysis that goes beyo nd the identification of a potential adverse effect.  The analysis 
must include an examination of the potential for that adverse affect to come into being, originate, or 
result from the presence of the specific substance under review in food, beverages, or feedstuffs, in 
this case oestradiol-17 β in meat and meat products derived fro m cattle treated with the hormone for 
growth promotion purposes.  The Pa nel will not prescribe a particular manner or approach for how the 
analysis should be conducted, but  the analysis must be conducted. 
6.119  The intervention by Dr. Sippell in paragra ph 576 of Annex G cited by the European 
Communities mentions a scientific study cited in the 1999 Opinion wh ich posits that the radioimmuno 
assays originally used to calculate daily endoge nous production levels of the hormones may have 
overestimated these levels.  The Panel addressed this i ssue, by inserting in pa ragraph 7.535 quotations 
from the 1999 SCVPH Opinion on this issue directly, and a new paragraph 7.536. 
6.120  Additionally, the Panel felt that more direct quotation from the Opinions with respect to the 
other identified potential adverse effects would provide greater clarity.  Therefore, the Panel modified 
paragraphs 7.534  and 7.535. 
                                                      
280 EC's comments on interim report, paras. 57-64. 
281 EC's comments on interim report, para. 78. Contra ry to the assertion of the European Communities, 
the Panel does not endorse any one particular way to approach risk assessment. WT/DS320/R 
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  6.121  The European Communities also refers to a statement by Dr. Boobis at paragraph 725 of 
Annex G.282  The Panel has reviewed the surrounding pa ragraphs and found that, like Dr. Guttenplan, 
Dr. Boobis had engaged in an exchange with th e European Communities about the concept of zero 
risk.  Again, Dr. Boobis confirms that science cannot provide absolute assu rance of the absence of 
risk or an absolute guarantee of safety.  Dr. Boobis  also states "it is not clear to me how you would 
ever conduct a risk assessment and guarantee that, w ithout ensuring zero exposure, and of course that 
would cease all use of all compounds where there is any risk whatsoever, and they all have some 
risk."283 
6.122  As with the citations to Dr. Guttenplan's statemen ts at the meeting with the Panel, the Panel is 
unclear what the European Commun ities believes this reference to certain statements by Dr. Boobis 
will add to the Panel's reasoning on whether it c onducted a risk assessment consistent with the 
definition set forth in Annex A(4) of the SPS Agreement .  The Panel notes again that the purpose of a 
risk assessment is to evaluate th e possibility that an identified a dverse effect comes into being, 
originates, or results from the pr esence of the identified additives,  contaminants, toxins or disease-
causing organisms in food, beverages or feedstuffs, not to guarantee that said possibility will be below 
a Member's appropriate level of protection or indeed will be zero.284   
6.123  The European Communities argues that in paragraphs 7.557 to  7.566 the Panel relies solely 
on the responses of Drs. Boobis and Boisseau and do es not reflect the opinions of the other experts.285 
6.124  The Panel notes that the relevant sec tion is from paragraphs 7.552 to 7.572  and that the Panel 
cites Dr. Cogliano and Dr. Guttenplan in paragraph 7.568, and Dr. Guttenplan again in paragraph 7.569.  Nevertheless, the Panel has examin ed the written answers of the other experts to the 
same questions of the Panel as well as the transcript of the Panel meeting with the experts and made 
additional references to  experts' statements. 
6.125  The European Communities argues that the Panel is  in error in paragraph 7.570 when it states 
that the only study cited with respect to su sceptible populations was one having to do with in utero  
exposure to DES, which is banned in the United States.
286  The Panel has reviewed the paragraphs in 
the 1999 Opinion referenced by the European Co mmunities.  Although the European Communities is 
correct that other studies regarding susceptible popul ations are referenced in section 2.2.2.4 entitled 
"Potential adverse effects of exogenous sex hor mones on growth and puberty upon exposure of 
prepubertal children," the Panel, in paragraph 7.57 0, was specifically referring to the link between 
cancer and consumption of hormone treated meat.  With  respect to that specific identified potential 
adverse effect, the only study mentioned in section 2.3.2.4 under susceptible populations with respect 
to oestrogen is one involving in utero  exposure to DES.  The Panel modified the third sentence of 
paragraph 7.570. 
6.126  Additionally, based on the European Communitie s' comment, the Panel also reviewed the 
paragraphs in the interim report wh ich dealt with Section 2.2.2.4 of the 1999 Opinion.  In order to 
ensure that the Panel fully reflect s the science the European Communiti es relied upon in this section, 
the Panel amended paragraph 7.533. 
                                                      
282 Paragraph 725 is an interjection by Canada.  See transcript of the Panel meeting with the experts, 
Annex G, para. 725.   
283 Transcript of the Panel meeting with the experts, Annex G, paras. 723 and 729. 
284 The Panel notes that the Appellate Body in para 186 of its report on EC – Hormones , asked "if a risk 
is not ascertainable, how does a Member ever know or demonstrate that it exists?" 
285 EC's comments on interim report, footnote 11. 
286 EC's comments on interim report, footnote 11.  WT/DS320/R 
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  6.127  The European Communities argues with respect to paragraph 7.572  that because the Panel 
based its findings on the views expressed by the "most convincing" experts,  the Panel has failed to 
make an objective assessment of the matter, failed to  take properly into account the totality of the 
available evidence and failed to give proper weight  to different scientific views which are based on 
genuine and legitimate scientific grounds.  The Eu ropean Communities also argues that the Panel's 
"most convincing" experts are the ones it ha d alleged had a conflict of interest.   
6.128  The Panel bases its analysis in this section on its  own reading of the plain language in the 
Opinions which was corroborated by the views expr essed by the experts and this combination leads 
the Panel to its conclusions.  Additionally, the Pa nel disagrees with the European Communities that it 
fails to examine the totality of the evidence or to give proper weight to  particular scientific views.  As 
the Panel notes, it does not disregard any of the statem ents by the experts.  However, the Panel could 
not possibly provide full quotations of every answer or  statement of every expert.  The fact that the 
Panel may have cited specific passages from speci fic experts does not mean that the Panel did not 
consider and weigh all of the responses.   
6.129  The Panel, after reading the Opinions, the expert s' answers to questions, the transcript of the 
meeting with the experts, and the parties submis sions and comments, made a determination about 
which experts had provided the Pane l with answers that responded to the questions asked in a clear 
and consistent manner supported by  expertise and evidence.  This determination is the essence of 
weighing the evidence.  As the Panel noted in paragraphs 7.552 -7.572, the section to which paragraph 
7.572 belongs, the Panel cited Dr. Boisseau, Dr. B oobis, Dr. Cogliano and Dr. Guttenplan.  These are 
the experts who answered the relevant questions and who had identified expertise in risk assessment, 
toxicology, studies of carcinogens, and biochemistry.287  The Panel regrets if it caused any confusion 
by using the phrase "most convincing" and accordingly clarified paragraph 7.572. 
6.130  The European Communities fails to  see why the Panel, after having concluded that there is no 
risk assessment, goes on to examine whether the scien ce supports the conclusions in the Opinions and 
asks for more explanation than pr eviously provided for.  The Panel modified paragraph 7.538  in order 
to provide additional explanation. 
(v) Comments on the Panel analysis regarding the other five hormonal substances 
6.131  The European Communities argues that paragra ph 7.605 is unclear and seems irrelevant for 
the further analysis of the Panel.  The European Co mmunities first argues that, in its oral statement, it 
spoke about whether a risk assessment can reach a definitive conclusion, not whether or not it is 
possible to perform a definitive risk assessment.  Firs t, the Panel recalls that the EC reference to a 
"definitive risk assessment" is found in the EC second written submission.288  Second, the Panel does 
not see any real difference between "reach[ing] a de finitive conclusion" and making a "definitive risk 
assessment".  Its reasoning in paragraph 7.605 thus applies equally to both statements.   
6.132  Second, the European Communities considers that the Panel should have referred to what the 
experts said at the hearing about the issue of whet her scientific data can ever allow for a definitive 
conclusion to be reached.  This seems to suggest that the European Communities no longer argues that 
what matters in order to justify the application of Ar ticle 5.7 is whether a definitive conclusion can be 
reached or whether a definitive ri sk assessment can be made. If this is correct, the Panel does not 
believe that it is entitled to address new argument s at the interim review stage.  The Panel 
nevertheless reviewed the comments of Dr. Cogliano  referred to by the Eu ropean Communities. In 
paragraph 776 of Annex G, Dr. Cogliano suggests that there can be different types of risk assessments, depending on the specificity of the risk one wishes to identify.  The Panel fails to see in 
                                                     
 
287 Transcript of the Panel meeting with the experts, Annex G, paras. 54-72.   
288 Inter alia  in paras. 137, 143, 149, 153, 176 and 183. WT/DS320/R 
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  what respect this statement affects its finding in paragraph 7.605.  As recalled by the Panel in its 
findings289, the type of risk assessment requested under  Article 5.1 is a risk assessment within the 
meaning of Annex A(4) of the SPS Agreement , which is not one of the types of risk assessment 
identified by Dr. Cogliano.  It is in the context of the completion of a risk assessment within the 
meaning of Article 5.1 and Annex A(4) of the SPS Agreement  that the Panel discussed the EC 
argument regarding a "definitive risk assessment" or a "risk asse ssment reach[ing] a definitive 
conclusion".  The other comment of Dr. Cogliano referred to by the European Communities290 
suggests that data may be sufficient to do one type  of risk assessment (e.g. "the JECFA-style ADI") 
but not one based on a theory according to which it is not possible to identify a dose below which 
there is no risk, because there is a risk at an y dose level, even the low doses one might find in 
hormone-treated meat.  The Panel notes in this rega rd that this is different from arguing that one 
should be able to invoke Article 5.7 because one cannot make a "definitive risk assessment".  As 
mentioned by the Panel, the Appellate Body in Japan – Apples  did not say that relevant scientific 
evidence would become insufficien t if a Member could not perform a particular type of risk 
assessment, but only if it would be unable to perform a risk assessment within the meaning of 
Article 5.1 and Annex A(4) of the SPS Agreement . 
6.133  Having also regard to the comments of the United States of 19 October 2007, the Panel did 
not deem it necessary to delete or modify paragraph 7.605. 
6.134  The European Communities make s a general reference to its second written submission and 
takes issue with the assessment of the Panel in paragraphs  7.649 to 7.721  by stating that the Panel did 
not properly and fully examine the reasons contained in the Opinions and relied exclusively on certain 
statements of a minority of the experts it had chosen  to advise it, while ignoring pertinent statements 
of the other experts.  The Panel notes that it addressed the EC comments on its findings where they 
were directed at precise aspects of the interim report.  This was the case regarding comments on the 
Panel's reliance on the views expressed by some  of the experts it consulted and for comments 
regarding the existence of sufficient relevant scientific evidence. The Panel does not deem it 
necessary to address those issues in general terms here. 
6.135  The European Communities finds the Panel refere nce to a risk assessment "in substance" in 
paragraph 7.628 to be "entirely unclear".  In the opinion of the Panel, one can always follow each of 
the Codex steps provided for the gathering and analysis  of scientific evidence. However, in order to 
be a risk assessment within the meaning of Article 5.1, that exercise must reach scientific conclusions 
that are supported by the scientific evidence therein.291  Thus, the possibility to complete a risk 
assessment depends on whether the relevant scientific  evidence is sufficient to support a conclusion 
on whether the identified adverse effect arises from, comes into being, or occurs as a result of the 
presence of the substance at issue in  food, beverages, or feedstuffs. 
6.136  The European Communities seems to suggest, in  substance, that whether a risk assessment 
can be completed depends on the level of protec tion chosen by a given Member.  The European 
Communities seems to link the conduct of the risk assessment with the desired outcome of a given 
SPS measure; i.e., to ensure zero risk.  The Panel believes that this is not what the SPS Agreement  
requires.  The Panel considers that the European Communities' interpretation is not supported by the 
text of Article 5.7, which only refers to the insuffi ciency of relevant scientific evidence.  There is no 
indication that this insufficiency is to be assessed in relation to the Member's level of protection.  
Otherwise the negotiators would have stated "in cases where relevant scientific evidence is 
insufficient in the light of the level of protecti on chosen by the Member adopting of maintaining a 
sanitary measure".  Nothing in the context of Ar ticle 5.7 suggests this interpretation either.  
                                                      
289 See paras. 7.443-7.444. 
290 Annex G, para. 871. 
291 Panel Report on Japan – Apples (Article 21.5 – US) , para. 8.136.  WT/DS320/R 
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  Articles 2.2, 3.3 and 5.1 provide relevant contextual support for th e proposition that the purpose of the 
SPS Agreement was to ensure that Member's SPS measures are "objectively justified"292 by science.  
This purpose would be defeated if a Member could invoke Article 5.7 whenever relevant scientific 
evidence is insufficient to objectiv ely justify the type of measure that would achieve a particular 
desired level of protection.  The Panel modified pa ragraph 7.628 in order to clarify what it meant. 
6.137  Regarding paragraphs 7.630 to  7.637, the European Communities argues that the Panel's 
discussion does not do justice to the role genuine sci entific uncertainty plays in risk assessment.  It 
contests the Panel's exclusive reliance on the opinion s of Dr. Boisseau and Dr. Boobis and refers to 
statements by experts other than those quoted by the Panel.  As far as the Panel's reliance on 
Dr. Boisseau and Dr. Boobis is concerned, it should be recalled that this is a risk assessment issue and 
these two scientists were selected by the Panel inter alia  because of their expertise on risk assessment.  
Yet, Dr. Boisseau and Dr. Boobis were not the only ones with the same view.  Dr. Tritscher's remarks 
on the subject also support the Panel's conclusion.293 
6.138  None of the interventions of experts cited by the European Communities in its comments 
contradicts the conclusions reached by the Panel in its interim report, which are clearly spelled out in 
paragraph 7.637. More particular ly, none of Dr. Cogliano's statements cited by the European 
Communities contradicts the Panel.  In the pa ragraphs cited by the European Communities, 
Dr. Cogliano mainly explains the role of IARC and whether there is uncertainly about genotoxicity.  
Similarly, in the paragraphs cited by the Europ ean Communities, Dr. Guttenplan says that there is 
uncertainty about certain scientific issues, but he does not address the role of uncertainty in risk 
assessment.  Dr. Sippell addresses an issue unrelated to risk assessment.  Dr. De Brabander addresses the quality of data and improved methods.  Regardi ng the alleged misinterpretation of some of the 
statements of Dr. Boobis on the existence or not of  genuine scientific uncertainty, it seems that the 
paragraph referred to by the European Communities (Annex G, paragraph 1049) deals with a different 
issue:  that of scientific uncertainty in relation to U-shaped dose-response curves, not how scientific 
uncertainty is treated in risk assessment. 
6.139  The European Communities argues, with respect to paragraph 7.644 , that the risk assessments 
performed by JECFA do not contain the specific evidence that the Panel allegedly found to be missing 
in the EC Opinions and, therefore, cannot constitu te proper risk assessments.  The Panel notes that 
there is no reference to the JECFA risk assessment of oestradiol-17 β in the Panel's analysis of the 
consistency of the European Communities' perman ent ban on meat and meat products derived from 
cattle treated with oestradiol-17 β for growth promotion purposes, because the European Communities 
claimed that it completed its own risk assessment for oestradiol-17 β.  The Panel thus conducted an 
analysis of the SCVPH Opinions and sought to de termine whether they complied with the definition 
of a risk assessment in Annex A(4) and whether the science contained therein supported the European 
Communities' decision to institute a total ban.  Unlik e the analysis under Article 5.7, with respect to 
oestradiol-17 β the Panel was not trying to determine whether there was sufficient scientific 
information to conduct a risk assessment.  The Panel r ecalls that the fault it found with the Opinions 
was not that any particular piece of evidence was missing, but rather that the Opinions did not 
specifically analyse the risk of  the identified adverse effects arising from  the presence of 
oestradiol-17 β in food, beverages, or feedstuffs.  Th erefore, whether JECFA relied on the same 
evidence as the European Communities in  its analysis of oestradiol-17 β is irrelevant.  The Panel notes 
that JECFA did take into account the dose levels in  meat and meat products an d attempted to calculate 
the risk to humans from consuming typical amounts of meat.  JECFA used a series of assumptions 
regarding meat consumption, circula ting levels of oestrogen in the bl ood for various sub-groups of the 
population, etc.  The European Communities may very  well be right that there are other ways to 
analyse the risk than those JECFA utilized.  The Pa nel does not take a position on that issue.  What 
                                                     
 
292 Appellate Body Report on EC – Hormones , para. 190. 
293 Annex G, para. 348. WT/DS320/R 
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  the Panel has said, is that such an analysis is  required by Article 5.1 and Annex A(4) of the 
SPS Agreement .  
6.140  With respect to the Panel's reference to the con cept of "critical mass" in paragraph 7.648, the 
European Communities request that we provide an explanation of where this criterion comes from and 
whether it is in conformity with th e findings of the Appellate Body in EC – Hormones . 
6.141  The Panel used the term "critical mass" in full knowledge of its meaning.294  It used it in the 
sense of a situation where evidence becomes quan titatively and qualitatively sufficient to call into 
question the fundamental precepts of previous know ledge and evidence.  The Panel does not mean 
that there must be sufficient evid ence to perform a new risk assessment.   Otherwise, Article 5.7 of the 
SPS Agreement  would become meaningless.  It used the term "critical mass" very much in its 
common scientific usage, i.e. the new scientific info rmation and evidence must be such that they are 
at the origin  of a change in the understanding of a scientific  issue.  We do not see in what respect this 
approach by the Panel, which applies to the speci fic situation in this case (i.e. one where a party 
alleges that previously sufficient scientific evidence has become insuffi cient) would be contrary to the 
findings of the Appellate Body in EC – Hormones.    
6.142  The United States suggests in its counter-comments295 that the Panel consider using the term 
"weight of evidence" to explain its use of the "cr itical mass" criterion in conducting its analysis and 
reaching its conclusions.  The United States adds that the weight of evidence approach is standard in 
science.  Weight of evidence is explained by the e xperts primarily in paragra phs 487, 489, 493, 501 of 
Annex G.  At the experts' hearing, Dr. Boobis defined weight of evidence as: 
"[T]he evaluation of the available information about a particular toxicological 
endpoint taking into account factors such as the adequacy and number of available 
studies and the consistency of results across studies.  It is not an issue of seeking to 
weigh one person's opinion against another." (para. 487) 
and: 
"This is not a question of what people think and minority opinions, it is a question of looking at the data ... There is an element of  interpretation of the quality of the study, 
I accept, but that is why you have experts on the evaluation committee." (para. 501) 
6.143  From the above it may be conclude d that weight of evidence is in the first instance concerned 
with the quality of studies.  "Badly done" studies ar e excluded so that the evaluation is based only on 
studies that are "well done" i.e. studies carefully carried out using validated methods.  In a second 
stage, an assessor taking a weight of the eviden ce approach looks at the number of studies and the 
consistency of results across studies.  If one follows Dr. Boobis, in particular his comment in 
paragraph 501 of the transcript (Annex G), the weig ht of the evidence approach may contradict the 
views of the Appellate Body in paragraph 194 of its report in EC – Hormones  because it would favour 
the "mainstream" scientific opinion, whereas the A ppellate Body accepted that an SPS measure may 
be based on a "divergent opinion coming from qualified and respected sources" and still be in 
compliance with the substantive obligations of the SPS Agreement .  This is why we do not wish to 
replace the terms "critical mass" used in our report w ith "weight of evidence".  In our view, a "critical 
                                                     
 
294 In mathematics and physics "critical" is defined as  "constituting or relating to a point of transition 
from one state, etc. to another".  "C ritical size" or "critical mass" are defined as the minimum size or mass of a 
body of a given fissile material which is capable of sustaining a nuclear chain reaction (Shorter Oxford English 
Dictionary, 5th edition (1993), p. 558). In other words, the Pane l assessed whether it had been provided with the 
minimum evidence necessary to conclude that knowledge has become quantitatively and qualitatively sufficient to call into question the fundamental precepts of previous knowledge and evidence. 
295 At para. 28.  WT/DS320/R 
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  mass" of scientific evidence and information could be small and may include situations where the 
weight of the evidence has not shifted away fro m the existing prevailing knowledge, but where the 
new knowledge is qualitatively and quantitatively suffic ient to create a situation where a Member can 
legitimately decide that the pre-ex isting scientific evidence is no longe r sufficient to complete a risk 
assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement . 
6.144  The European Communities takes issue with paragraph 7.662.  The European Communities 
contests the Panel's approach in defining a list of general issues common to all five hormones.  The 
European Communities argues that it  has identified exactly, for each hormonal substance, the sections 
in the 1999 Opinion that deals i ndividually with that substance a nd suggests that the Panel's list of 
"general issues" common to all five hormones is arbitrary. 
6.145  The Panel first recalls that, as a general principle, panels are free to structure the order of their 
analysis as they see fit.296  The Panel does not deny that the EC Opinions addressed each hormone 
individually.  However, as explained in paragra phs 7.660 to 7.662, some issues were common to all 
five hormones and the evidence provided was not alwa ys sufficiently specific to address a particular 
issue in relation to each hormone individually. The Panel modified paragraph 7.652 to 7.663 and the 
title to Section VII.C.3.(f)(vi) to reflect the fact  that what is discussed are issues common to all 
hormones for which hormone-specific evidence was not provided. 
6.146  The Panel also clarified that certain insuffici encies identified in the EC Opinions had not as 
such been discussed by the Europ ean Communities in its submissions.  The Panel concluded that the 
European Communities was not arguing that these pa rticular insufficiencies were what made it 
impossible to complete a risk assessment.  Ther efore, the Panel decided not to address these 
insufficiencies.  This may have prompted the EC comment that the Panel analysis on the individual 
hormonal substances in paragraphs 7.722 to 7.830 was incomplete.  The clarification brought by the 
Panel demonstrates that it did not draw a random lis t of issues common to all hormones and explains 
the reasons why a more limited number of issues was discussed compared with what had been 
identified in the Opinions. The Panel has also clar ified this point in the sections relating to each 
hormone individually and did not fo llow the request of the European  Communities that it address each 
and every issue of insufficien cy raised in the Opinions.297  
6.147  The European Communities contests the c onclusions of the Panel in paragraph  7.665, 
footnote 792  as inaccurate, but without specifying why.  In that footnote, the Panel refers to a new 
method and new assays to detect small amounts of ho rmones in meat, mentioned in the 2002 Opinion. 
From what is mentioned in the 2002 Opinion, the studies were on the subject of hormone levels in 
meat, not in people.  Whereas it might be possible to apply these method and assays to detect endogenous levels of hormones in humans, the Eu ropean Communities does not argue this in its 
comments, and this is not what the method and assays  are about.  It also app ears that, according to the 
2002 Opinion, the method and assays mentioned were not exactly successful or trustworthy.  The 
conclusion in section 4.1.1 of the 2002 Opinion, where the new met hod is discussed, reads: "[D]espite 
a number of positive analytical results in this study, the low number of samples does not allow a 
qualified validation of typical characteristics such as sensitivity, specificity, accuracy and 
reproductibility." (2002 Opinion, page 9).  The c onclusion of section 4.1.2, where the bioassays are 
discussed, is that:  "[T]he obtained results suggest that the use of recombinant yeast and rainbow trout hepatocytes to detect oestrogenic compounds is not justified in view of their lack of sensitivity". 
(2002 Opinion, page 9).  It seems that, even if they  were relevant in the context of paragraph 7.665, 
this new method and assays do not contribute to a critical mass of evidence that would put into 
question existing knowledge.  The Panel,  therefore, did not modify footnote  792. 
                                                     
 
296 Appellate Body Report on Canada – Wheat Exports and Grain Imports , para. 126. 
297 EC's comments on Sections VII.C.3(f)(vii), (viii), (ix), (x), (xi). WT/DS320/R 
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  6.148  With respect to paragraphs 7.667 to 7.670, the European Communities argues that the Panel 
reduces the discussion to only two quot ations and draws a conclusion th at is not based on the debate 
with the experts at the hearing.  The European Communities argues that "much more was said about 
this issue" at that hearing.298  The Panel notes, however, that the discussion related to the sensitivity of 
children to hormones in general, without drawing an y direct link with any of the five hormones at 
issue in this section, and to the validation of met hods, particularly of the new ultrasensitive assay (the 
"Klein" methodology).  The only hormone expressly di scussed in relation to this assay was oestradiol-
17β.  The Panel notes that it concludes in this secti on that (a) the studies using the new ultrasensitive 
assay were limited to oestradiol-17 β; and (b) that the ultrasensitive assay had not been validated.  
Thus, the  Panel does not agree with the European Communities that its conclusions are not based on 
the debate referred to above.   
6.149  The European Communities requests that we cl arify the first sentence in paragraph 7.670. 
More particularly, the European Communities requ ests that we specify whether this is a legal 
argument or a scientific argument.  The Panel consid ers that the finding that the evidence relates only 
to oestradiol is not an argument but a factual cons ideration.  The Panel considers that, since the new 
detection method measured oestradiol only299 and since no evidence was pr ovided that suggested that 
extrapolation had been made or could be made to  other hormones, the evidence is insufficient to 
conclude, with respect to the five hormones subj ect to a provisional ban under Article 5.7 of the 
SPS Agreement , that existing knowledge has been put into question. 
6.150  With respect to the EC comment on the second sentence of paragraph 7.670, the Panel 
confirms that, indeed, its understanding is that th e ultrasensitive detection method used by Klein and 
subsequently relates only to oestradiol and has not  been validated.  This has been confirmed by 
Dr. Boobis at the hearing.300  As a result, the Panel cannot c onclude that existing knowledge and 
evidence have been put into questio n by the results of the ultrasen sitive assay with regard to the 
impact of the five hormones on prepubertal chil dren if the available evidence relates only to 
oestradiol. 
6.151  Even if the ultrasensitive assay had been validated  and had demonstrated lower levels of the 
five hormones at issue in this section – and not only oestradiol – in sensitive populations, the Panel 
notes that the 1999 Opinion itself states that "[A] corollary is that perhap s the hormones residues in 
beef, which are also low and which have also been  determined by RIA are equally variable and over 
representative of the actual hormone concentrations."301 
6.152  In its comments regarding paragraphs 7.672-7.675  the European Communities considers that 
the Panel's approach to the issue of dose response is flawed and circular. 
6.153  The European Communities bases its contention th at the Panel's reasoning is circular on the 
assumption that the Panel rejected the EC approach  based on an absence of a dose response analysis.  
Even though it rejected that approach in  this particular case for oestradiol-17 β, the Panel did not 
exclude that there could be situations where dose response would not apply.  The Panel believes, on 
the contrary, that it is the European Communities that is making contradictory arguments. The European Communities cannot argue that "the Appella te Body clearly judged that a risk assessment 
[could] be either qualitative or quantitative"
302 and that a dose response is not required  in order to 
complete a risk assessment and, at the same time, ar gue for the five hormones at issue that relevant 
                                                      
298 Annex G, para. 561 et seq . 
299 See para. 7.668 quoting Dr. Sippell.  See, also, Dr. Sippell's statement in Annex G, para. 588. 
300 Annex G, para. 572. 
301 1999 Opinion, section 3.2, p. 30. 
302 See EC reply to question 26 of the first series of questions of the Panel, para. 153, Annex B; see also 
EC's second written submission, paras. 196-200.  WT/DS320/R 
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  scientific evidence is insufficient to perform a risk assessment because the data available do not allow 
a dose response assessment.  Yet, this is what app ears to be concluded in the 1999 Opinion as far as 
the five hormones are concerned.  The Panel nonetheless clarified the paragraphs at issue. 
6.154  The European Communities argues that, in pa ragraph 7.677, the Panel declines to discuss 
bioavailability on the basis that the studies relied upon by the European Communities do not relate to the five hormones in question, but only to oestradiol and that there is no indication that the 
conclusions can be applied to hormones other than  oestrogens.  The European Communities considers 
that this assertion by the Panel is without foundation. 
6.155  In order to reach its conclusion, the Panel examin ed most particularly the portions of the 1999 
and 2002 Opinions quoted by the European Communities in its reply to question 28 of the questions of the Panel after the first substantive meeting
303 and in its second written submission.304  The two 
extracts quoted by the European Communities addr ess only oestradiol, while making references to 
oestrogens.  Furthermore, the extract of the 199 9 Opinion quoted by the European Communities is 
part of the section of the Opinion regarding oestradiol.  The Panel notes that the European Communities argued that "similar findings [had been] made for all the other five hormones".
305 
However, the European Communities did not specify  where such findings had been made.  This 
allegation has to be considered in relation to th e comments of the experts.  The Panel nonetheless 
deemed it necessary to clarify the section on bioavailability. 
6.156  In its comments on the interim report, the Europ ean Communities also refers to the experts' 
replies to question 43.  The Panel first notes that th is question concerns bioavailability in general, not 
the sufficiency of evidence regarding bioavailabili ty.  The Panel has included quotations of the 
relevant passages of the experts' replies in its findings.  The Eur opean Communities also refers to 
paragraphs 132 et seq.  of the transcript of the hearing (Anne x G). The Panel reviewed the comments 
of the experts on bioavailability and found that t hose comments address neither the bioavailability of 
the five hormones at issue, nor the sufficien cy or insufficiency of evidence on it.   
6.157  With respect to paragraphs 7.685 to 7.700, the European Communities argues first that the 
discussion on long latency of cancer and confounding f actors should have been in the Panel's analysis 
under Article 5.1 of the SPS Agreement .  We note that the Panel addressed this question to the extent 
this was necessary for its analysis under Article 5. 1. The question of the latency period of cancer and 
of the epidemiological survey of  the occurrence of cancer in various populations was addressed in 
paragraphs 7.567  et seq.   The Panel also deemed it necessary to address the latency of cancer in its 
section under Article 5.7 because the European Co mmunities argued that the long latency period of 
cancer made it impossible to demonstrate positively th e existence of clear harm in relation to the 
hormones at issue.  The Panel first determined wh ether long latency of cancer was relevant for the 
performance of a risk assessment for the hormones at issue.  It then proceeded to determine whether 
relevant scientific evidence in relation to the latenc y of cancer was insufficient to the point of making 
it impossible to perform a risk assessment within th e meaning of Article 5.1 and Annex A(4) of the 
SPS Agreement .  In order to do this, it assessed whether it c ould be considered that a "critical mass" of 
new information or evidence was now available wh ich could unsettle the way long latency of cancer 
has been taken into account in risk assessment so far.  The Panel clarified the part of 
Section VII.C.3.(f)(vi) dealing with long latency of cancer and confounding factors in order to better 
present its analysis.  
                                                      
303 Annex B-1, paras. 155-159. 
304 Paras. 133-176. 
305 EC reply to question 28 of the questions of the Pa nel after the first substantive meeting, Annex B-1, 
para. 158. WT/DS320/R 
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  6.158  The European Communities also  argues that the section on long latency of cancer and 
confounding factors is evidence that we applied a "double standard" of evid ence for the removal as 
compared to the approval of the hormones at issue.  We did not argue that JECFA or the respondent performed the epidemiological studi es necessary to demonstrate an absen ce of long term effect of the 
hormones at issue in terms of cancer.  We not e that the long latency of cancer has been 
acknowledged.  We also note that confounding factors make it difficult to assign a particular cancer to 
specific circumstances of ingestion of hormone resi dues.  We recall that JECFA's risk assessments 
take into account the long latency of cancer thr ough the ADI.  To the extent that the European 
Communities disagrees with the approach followed by  JECFA, it is for the European Communities to 
provide a "critical mass" of evidence – not a "posi tive evidence" – that this approach is no longer 
valid.
306  We conclude that, in these proceedings, the European Communities has not pointed at 
evidence suggesting that long latency of cancer h as not been appropriately taken into account in 
existing risk assessments. 
6.159  The European Communities also takes issue with the Panel's discussion on the immunological 
effect of the five hormones in paragraphs  7.701 to 7.708.  The European Communities seems to raise 
two issues in its comments.  The first one is relate d to the question of whether a threshold approach 
must be followed.  The second one is whether the Pa nel dismissed the EC arguments on the basis that 
the scientific evidence relates to oestrogens only. 
6.160  Regarding the first issue, the Panel notes that  all three experts who answered question 59307 
stated that there is no evidence of effects on th e immune system from doses such as those resulting 
from consumption of meat from treated animals.  If the point the Europ ean Communities wishes to 
make in its comments is that the approach based on a "threshold" is not required to assess the effect of 
the five hormones at issue on the immune system, th en the Panel fails to unde rstand why, under those 
circumstances, the relevant scientific evidence on the effect of the five hormones on the immune 
system is insufficient for the European Communities to perform a risk assessme nt for those hormones. 
6.161  With respect to the second issue, the Panel notes that Dr. Boobis and Dr. Guttenplan address 
the effect of oestrogen/oestradiol on the immune system (Dr. Boobis refers to "hormones such as 
oestradiol").  As the Panel mentions in paragraph 7.704, the main reason for dismissing the EC 
arguments on insufficiency of evid ence regarding the effect of hormones on the immune system is the 
fact that the evidence made available to the Panel re lates exclusively to the effect of oestrogens.  The 
European Communities has not identified any eviden ce that specifically addresses any of the five 
hormones at issue in this section.  The European Communities has not explained either to the Panel 
why it thinks the evidence on oestrogens would be relevant for the other hormones.  The Panel notes in this respect that the Opinions do not identify an y evidence with respect to the five hormones that 
residue levels in meat might have an effect on the immune system.  The Panel nonetheless clarified 
paragraphs 7.706-7.707. 
6.162  Regarding paragraphs 7.709 to 7.721, the European Communities argues that the Panel quotes 
Dr. Sippell as identifying adverse effects, but does not discuss his statement.  The European 
Communities adds that there is also no discussion of  the other experts' views put forward at the 
hearing. 
6.163  Regarding Dr. Sippell's statement in paragra ph 7.714, the Panel has further discussed the 
points raised by the experts on this matt er in paragraphs 7.715 through 7.721. 
                                                     
 
306 In this respect, the Panel inserted a footnote in para. 7.648  to address the EC argument on standard 
of proof. 
307 Annex D, paras. 443-448.  WT/DS320/R 
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  6.164  With respect to paragraphs 7.700 to 7.713 of  the interim report, the European Communities 
argues that the Panel's discussion of the potential misuse and abuse in the administration of hormones 
is in the wrong place, to the extent that this is an  aspect of risk assessment, in the sense of Article 5.1 
to 5.3 of the SPS Agreement , that is applicable across all iden tified potential risks and for all six 
hormones.  The Panel agrees with the European Communities that the question of misuse and abuse in 
the administration of hormones may apply to all six hormones at issue and is an element that can be 
taken into account in risk assessment, as set forth in Article 5.2 of the SPS Agreement  and confirmed 
by the Appellate Body in EC – Hormones .  However, the Panel did not deem it necessary to address 
this question in the section regarding the conform ity with Article 5.1 of the definitive ban on 
oestradiol-17 β, to the extent that the question whether misu se or abuse exists in the administration of 
hormones did not have an impact on the issues addressed by the Panel under Article 5.1.308  Indeed, 
the question of misuse or abuse in the administration of hormones is relevant to the extent that it can 
lead to higher concentrations of hormone residues in meat and meat products than would occur if 
good veterinary practices were applied.  As stated by the 1999 Opinion, it is an aspect of exposure 
assessment.  In this case, the Panel found that  the European Communities had not evaluated 
specifically the possibility that the a dverse effect that it had identified in its risk assessment come into 
being, originate, or result from the consumption of meat or meat products which contain veterinary 
residues of oestradiol-17 β as a result of the cattle being treated with this hormone for growth 
promotion purposes.  Therefore, whether the concentrations of hormone residues in meat and meat products could be higher as a result of misuse or ab use did not have to be addressed.  The Panel does 
not deem it necessary to move this secti on to another part of its findings. 
6.165  Having regard to the point made by the Europ ean Communities that misuse and abuse in the 
administration of hormones is an aspect of risk asse ssment within the meaning of Article 5.1 to 5.3, 
the Panel reflected further on whether this issue re lated at all to the question of insufficiency of 
relevant scientific evidence under Article 5.7.  In the view of the Panel, the question of whether 
JECFA properly took into account misuse and abuse in  its risk assessments is irrelevant to the 
question whether the European Communities can ta ke this matter into account in its own risk 
assessment, since it has full discretion to do so pursuan t Article 5.2 and to the Appellate Body finding 
in EC – Hormones .  In that context, whether evidence exists  of misuse or abuse in the administration 
of hormones is not as such a scientific issue likely to make a risk assessment within the meaning of 
Article 5.1 and Annex A(4) of the SPS Agreement  impossible.   
6.166  For these reasons, the Panel decided to delete th e section regarding misuse or abuse in the 
administration of hormones from its fina l report and modified paragraph 7.603. 
6.167  The European Communities argues that the Panel' s analysis on the issue of carcinogenicity of 
progesterone in Section VII.C.3(f)(vii) is flawed .  However, the European Communities does not 
explain specifically in what respect it is flawed.  The Panel therefore did not modify its reasoning. 
6.168  The European Communities argues that the Panel' s analysis on the issue of carcinogenicity 
and genotoxicity of testosterone in Section VII. C.3(f)(viii) is clearly incorrect and flawed. The 
European Communities refers to a statement by Dr . Tritscher allegedly admitting that JECFA found 
that there was scientific uncertainty about genotoxicity of testosterone.
309  The Panel consulted the 
transcript and noted that Dr. Tritcher discussed the genot oxicity of oestradiol, not that of testosterone.  
She did say that "all information is being looked  at, in particular with compounds that have a 
genotoxic potential", but she did not mention that progesterone had a genotoxic potential. 
6.169  The European Communities argues that the approach  and analysis of the Panel on the issue of 
metabolism and carcinogenicity of trenbolone acet ate in Section VII.C.3(f)(ix) is flawed, inter alia , 
                                                      
308 It is nonetheless discussed in para. 7.483, in relation to Article 5.2 of the SPS Agreement . 
309 Statement of Dr. Tritcher, Annex G, para. 463. WT/DS320/R 
Page 138 
 
 
  because JECFA's assessment defended by Dr. Boobi s and Dr. Boisseau dates back to 1988 and is 
clearly outdated.  The Panel has already discussed th is argument and considers that a risk assessment 
does not become invalid merely because it is "old".  The Panel believes that, in order to demonstrate 
that a risk assessment is "outdated", a party must pr ovide studies showing that the data on which the 
risk assessment is based are no longer valid. 
6.170  The European Communities argues that the reasoning of the Panel regarding carcinogenicity 
of zeranol is flawed, inter alia , because if the extrapolation to meat consumption mentioned by 
Dr. Guttenplan was necessary, as the Panel seems to  require in paragraph 7.799, this would have 
amounted to a complete risk assessment in the sense of Article 5.1 of the SPS Agreement .  The 
European Communities argues that this is not the releva nt standard in the context of Article 5.7.  We 
agree with the European Communities that being able  to perform a risk assessment compatible with 
Article 5.1 is not the standard applicable in the cont ext of Article 5.7 and we do not consider that we 
applied any such standard in this case.  Indeed, the reason why the Panel paraphrased Dr. Guttenplan's 
statement was not to say that th e European Communities could demonstrate that relevant scientific 
evidence was insufficient only if it we re able to extrapolate some genotoxic effect of zeranol to meat 
consumption.  The point that the Panel wanted to  make was that the extrapolation of the study 
commented by Dr. Guttenplan would have entail ed, according to Dr. Guttenplan, a "myriad of 
uncertainties".  As a result, this study could ha rdly serve as a basis to put in question existing 
knowledge.  We clarified th is in paragraph 7.799. 
6.171  As regards the alleged application of a similar standard in paragraphs 7.803-7.804, the Panel 
recalls that what has to be demonstrated for Article  5.7 to apply is that no risk assessment within the 
meaning of Article 5.1 and Annex A(4) of the SPS Agreement  can be performed.  Our reference to 
Dr. Guttenplan means that we consider, as mentioned in paragraph 7.637, that not just any form of 
scientific uncertainty can justify a recourse to Article 5.7.  As previously noted, we consider that when 
scientific evidence has been  sufficient, it may only be considered as insufficient if a critical mass of 
scientific information and evidence exists, in terms of quantity and quality, to put into question 
existing knowledge and evidence.  We therefor e did not consider it necessary to modify our 
reasoning. 
6.172  In paragraph 7.812, the European Communities expresses its disagreement with the Panel's 
approach consisting of applying a presumption of conformity with the SPS Agreement  to JECFA's risk 
assessment on melengestrol acetate (MGA), even t hough that risk assessment has not yet been 
endorsed by Codex.  The Panel has explained in  paragraph 7.813 why some degree of relevance 
should be given to JECFA's work, even though it is not formally a "standard, guideline or 
recommendation" within the meaning of Article 3.2 of the SPS Agreement .  The Panel also notes that 
the European Communities does not sp ecify in which respect the Panel's analysis of the issue of the 
residue data used by JECFA on carcinogenicity is fl awed, except for suggesting that the residue data 
is "outdated", a question already addressed by the Panel in paragraphs 7.814 to 7.817.   
6.173  Finally, the European Communities requests the Pa nel to clarify the meaning and extent of its 
conclusion in paragraph 7.837.  Th is paragraph simply states that, because relevant scientific evidence 
is not insufficient, the European Communities cannot invoke Article 5.7.  The corollary is that the 
European Communities should be able to complete a risk assessment under Article 5.1.  The European 
Communities argues that the Panel should clarify fu rther how the risk assessment could be completed 
in the presence of the gaps identified in the EC Opinions with respect to oestradiol-17 β.  The gaps 
identified in the EC Opinions for oestradiol-17 β are: 
(a) that the European Communities has not eval uated specifically the possibility of the 
adverse effects related to the association between excess hormones and neurobiological, developmen tal, reproductive and immunological effects, as well as 
immunotoxicity, genotoxicity and carcinogenici ty coming into being, originating or  WT/DS320/R 
 Page 139 
 
 
  resulting from the consumption of meat or meat products which contain veterinary 
residues of oestradiol-17 β as a result of the cattle being treated with this hormone for 
growth promotion purposes; 
(b) The scientific evidence referred to in th e Opinions does not support the European 
Communities' conclusions on  genotoxicity, or the conclusion that the presence of 
residues of oestradiol-17 β in meat and meat products as a result of cattle being treated 
with the hormone for growth promotion pur poses leads to increased cancer risk.  The 
scientific evidence does not support the EC conclusions on the adverse immunological and developmental effects of consuming meat and meat products 
from cattle treated with oestradiol-17 β for growth promotion purposes. 
6.174  Thus, the problems identified by the Panel are not related to the the fact that a risk assessment 
cannot be performed, but rather that the Europ ean Communities did not conduct a risk assessment 
pursuant to Article 5.1 and Annex A(4) and that the scientific evidence did not support the 
conclusions which the European Communities re ached.  The European Communities' comment 
apparently underlines an approach to risk assessment that seems to consist of identifying a risk from a 
particular substance and if there is any possib ility, no matter how remote, of that risk occurring 
because of that substance, deciding that there is no need to further study whether the risk could arise 
from the levels of that substance found in food , beverages, or feedstuffs.  As discussed in 
paragraph 6.112 above, the purpose of a risk assessm ent under Article 5.1 and Annex A(4) is not to 
provide guarantees that risks will be below a particul ar appropriate level of protection or even zero, 
but to objectively determine the possibility for the risk to arise from the presence of the substance 
under review in food, beverages, or feedstuffs.  The Panel therefore, does not believe that the 
European Communities' approach to  risk assessment, whereby the desired level of protection informs 
the risk assessment rather than the risk assessment providing objec tive data to be utilized by a 
government in determining how to achieve its appropri ate level of protection, is consistent with the 
object and purpose of Article 5 of the SPS Agreement.  
(b) Comments by the United States 
6.175  The United States observes that the EC Opinions  to which the Panel refers in the first 
sentence of paragraph 7.482 address bioavailability  and susceptibility of sensitive populations, but not 
in vivo  repair mechanisms.  The United States refers the Panel to paragraph 46 of its second written 
submission, where it noted that the Opinions ig nore the scientific evidence relating to human in vivo  
DNA repair mechanisms.  Therefore, the United Stat es requests that the Panel strike the phrase "and 
in vivo  repair mechanisms" from the fi rst sentence of paragraph 7.482.
310 
6.176  The Panel has reviewed paragraph 46 of the US second written submission as well as the 
Opinions themselves and has found that the United St ates is correct that the SCVPH Opinions do not 
mention the phrase " in vivo  repair mechanisms".  However,  as also noted by the European 
Communities in its comments of 19 October 2007, th ey do contain reviews of data on DNA adducts 
and DNA damage and the Panel ma intains its conclusion that the European Communities did not 
ignore the scientific evidence with resp ect to the effects of oestradiol-17 β on DNA.  Therefore, the 
Panel clarified paragraph 7.482 accordingly. 
6.177  The United States also suggests that the Pa nel change the phrase "general risk" in 
paragraph 7.537 as it may be confusing to the read er, because the Panel has carefully defined "risk", 
but has not defined "general risk".311  The European Communities, in its comments of 19 October 
                                                      
310 US's comments on interim report, p. 7. 
311 US's comments on interim report, p. 8. WT/DS320/R 
Page 140 
 
 
  2007312, argues that the Appellate Body has already found, in EC – Hormones , that the EC risk 
assessment at that time had indeed shown the "existence of a general risk of cancer".313 
6.178  The United States' point about avoiding confus ion in terminology is well taken.  The Panel 
accordingly modified paragraph 7.537.  However, the Panel will not use the term "identified the 
hazard" as this too has very specific meanings as set  forth in the Codex Pro cedural Manual and cited 
in paragraph 7.448.  Instead, it w ill modify paragraph 7.537 to read: 
"All of the statements of the experts, a nd indeed statements from the Opinions, 
indicate that the European Communities has evaluated the potential for the identified 
adverse effects to be associated with oest rogens in general, but has not provided 
analysis of the potential for these effects to arise from consumption of meat and meat 
products which contain residues of oestradiol-17 β as a result of the cattle they are 
derived from being treated with the hor mone for growth promotion purposes." 
6.179  The Panel also considers this correction to be in  line with the finding of the Appellate Body in 
paragraph 200 of its report on EC – Hormones  referred to above by the European Communities. 
6.180  When necessary, the Panel also made a number of minor editorial or typographical 
corrections suggested by the United States.  Howe ver, the Panel refrained from making the changes 
suggested in two instances.  With respect to the correction suggested in paragraph 4.234, the Panel 
refers to paragraph 6.12 above.  With respect to another correction suggested by the United States but 
opposed by the European Communities (in paragraph 7.566), the Panel decided not to modify the existing sentence to the extent that it paraphrase d a statement of Dr. Boobis.  The European 
Communities objected to any change by arguing th at it did not know what Dr. Boobis had actually 
said since it did not have access to the tape recordi ng of the hearing with the experts.  The Panel 
notes, however, that the statement at issue comes from the written reply of Dr. Boobis to question 22 
of the Panel, Annex D, paragraph 202.  
VII. FINDINGS 
A. P
ROCEDURAL ISSUES  
1. Opening of the Panel meetings with the parties and experts for public observation  
(a) Introduction 
7.1 On 13 June 2005, at the first organizational mee ting of the Panel, the parties jointly requested 
that the Panel's substantive meetings with parti es be open for public observation.  Through written 
questions, the Panel requested the parties to specif y the legal basis in the DSU for such a request.  
Parties replied on 20 June 2005.  On  30 June 2005, the Panel posed add itional questions to the parties 
on the logistical implications of a hearing that was open to the public. The parties replied on 7 July 2005.  The Panel held a second organizational meeting with the parties to discuss this issue on 
8 July 2005.
314 
                                                      
312 Para. 23. 
313 Appellate Body Report on EC – Hormones , para. 200. 
314 The parties agreed to hold joint panel meetings in this case and that against Canada (WT/DS321) 
and to harmonize the Panels' timetables.