Document: WT/DS320/R Page 141 (b) Summary of the main arguments of the parties315 7.2 With reference to the Panel's question whether panels are permitted to open hearings to public observation under Articles 12 (including Appendix 3), 14.1 and 17.10 of the DSU, the European Communities argues that a panel may adopt working procedures that foresee open hearings, as Article 12.1 of the DSU provides that panels may depart from the working procedures in Appendix 3 after consulting the parties to the dispute. 7.3 The  European Communities also argues that this conclusion is not affected by Article 14.1 of the DSU on confidentiality of panel deliberations .  The term "deliberations" does not cover the meetings with the parties, for which a different terminology is used in Appendix 3 of the DSU. 7.4 The European Communities considers that in the present case where all the parties have
Document codes: WT/DS320/R
Complainant: EU
Respondent: U.S.
Third parties: Australia, Brazil, Canada, China, Taiwan, India, Mexico, New Zealand, Norway
Dispute stage: Appellate Body
Agreements cited: Art. I, II  GATT 1994Art. 3.7, 22, 23.1, 23.2, 21.5  Dispute Settlement Understanding (DSU)

(b) Summary of the main arguments of the parties315
7.2 With reference to the Panel's question whether panels are permitted to open hearings to public
observation under Articles 12 (including Appendix 3), 14.1 and 17.10 of the DSU, the European
Communities argues that a panel may adopt working procedures that foresee open hearings, as
Article 12.1 of the DSU provides that panels may depart from the working procedures in Appendix 3
after consulting the parties to the dispute.
7.3 The European Communities also argues that this conclusion is not affected by Article 14.1 of
the DSU on confidentiality of panel deliberations . The term "deliberations" does not cover the
meetings with the parties, for which a different terminology is used in Appendix 3 of the DSU.
7.4 The European Communities 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 supports the position that parties are entitled to "waive" the confidentiality of their positions.
7.5 Regarding the legal implications of open h earings on covered persons under the Rules of
Conduct, the European Communities considers that no legal issues arise under the Rules of Conduct.
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 ope ned to the public. The Panel's deliberations will in
any event not be affected by the opening and remain confidential, as required by Article 14.1 of the
DSU.
7.6 With respect to the systemic and political impact of opening hearings, the European
Communities is of the view that there are no imp lications for WTO Members who are not parties to
this dispute, or on 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). Also, there are no
implications for third parties because the parties have jointly requested that the public be excluded
from the third parties' session during the presentation by a third party, unless that third party agreed to
make its presentation open for observation by the public.
7.7 Regarding the procedures that may be adopted to protect confidential information in an open
hearing, the European Communities indicates that it does not expect that confidential information will
be submitted in this dispute. The European Commun ities does not consider that there is any issue of
confidentiality in relation to information s ubmitted by other Members or non-Members (under
Article 13 of the DSU), unless the confidentiality requ irement of the last sentence of Article 13.1 of
the DSU applies, in which case the corresponding por tion of any meeting where this information is
discussed could be closed.
7.8 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.
7.9 Regarding the question whether panels are permitted to open hear ings under Articles 12
(including Appendix 3), 14.1 and 17.10 of the DSU, the United States notes that the parties agreed
that the panel meetings in this dispute should be op ened 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.

315 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report.

7.10 The United States agrees that any deliberati ons 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 and does not prohibit opening panel meetings to the public.
7.11 The United States also argues that 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 statements public by allowing the public to observe them as they are delivered. Second,
Article 18.2 of the DSU, which is echoed in Para graph 3 of Appendix 3, explicitly provides that
"[n]othing in this Understanding shall preclude a part y 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 prevents a party from disclosing statements of its own position to the public.
7.12 Concerning the legal implications of open h earings on covered pers ons under the Rules of
Conduct, the United States argues that the provisions in the Rules of Conduct that require panelists to
maintain confidentiality apply only to information that is in fact confidential.
7.13 The United States further argues that since th e procedural rules of the DSU permit public
hearings, the confidentiality provisions of the Rul es of Conduct do not prevent the opening of panel
meetings to the public.
7.14 Regarding the systemic and political impact of opening hearings, the United States argues that
opening the Panel meetings 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.
7.15 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 third-party session with the Panel to the public.
7.16 The United States does not foresee a decision in this dispute to open panel meetings as having
a political or systemic impact. For example, the ope ning of panel meetings in this dispute would not
prejudice the ability of parties to other disputes to choose to open, or keep confidential, their
respective panel meetings.
7.17 Regarding the procedures to be adopted to protect confidential information in an open
hearing, the United States believes that any portions of the Panel meeti ngs 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.
7.18 Finally, the United States argues that the thir d parties would retain their ability to decide
whether their submissions and statements are publ ic. Any confidential statements would not be
broadcast.
(c) Summary of the arguments of the third parties316
7.19 Australia contends that when parties agree 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.317

316 A more detailed account of the third parties' argumen ts can be found in Section V of the descriptive
part of this Report.
317 Replies by Australia to Panel questions concerning open hearings, question 1.

7.20 While not objecting to the opening of the Panel' s hearing for public observation, Australia is
however concerned about the modalities of organizi ng the meetings, equity of access and logistic
issues and believes that the opening of the Panel's meetings to the public should be subject to the
provisions that allow for protection of confidential information.318
7.21 Brazil questions the specific grounds and the DSU provisions on which the Panel based its
decision to accept the parties' request to open the Panel meetings for public observation. According to
Brazil, transparency constitutes an important elem ent in the debate carried out by Members in DSB
meetings, which 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.319
7.22 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 their mandate, playing a role that is exclusive to the
WTO membership.320
7.23 Brazil also contends that opening the meetings to the public would represent a reinterpretation
of Article 14 of the DSU, signalling that there are cases to which confidentiality is not applied, such
as Panel and Appellate Body meetings.321
7.24 China prefers 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 th e right to unilaterally disclose the third-party
submissions and oral presentations.322
7.25 India submits that the issue of external tran sparency is being di scussed in the ongoing
negotiations in the Special Session of the DSB. Un til there is a consensus on the opening of panel
meetings to public observation and the modalities ther efor, India believes that the Panel proceedings
have to be in closed session 323, and its deliberations have to remain confidential 324 as provided in the
DSU.325
7.26 India contends that the possibility of a pa nel to decide to deviate from the Working
Procedures in Appendix 3 has been provided with th e view of having panel procedures with sufficient
flexibility so as to ensure high-quality panel reports. 326 In India's view, although panels are given
some discretion in establishing their own working procedures, they do not have the discretion to
modify the substantive provisions of the DSU, such as confidentiality requirements.327
7.27 India argues that Article VII of the Rules of Conduct 328 requires each "covered person" to
maintain the confidentiality of di spute settlement deliberations and proceedings at all times. India

318 Replies by Australia to Panel questions concerning open hearings, question 2.
320 Replies by Brazil to Panel questions concerning open hearings, question 1.
321 Replies by Brazil to Panel questions concerning open hearings, question 1.
322 Replies by China to Panel questions concerning open hearings, question 1 and 2.
323 Paragraph 2 of the working procedures in Appendix 3 of the DSU.
324 Paragraph 3 of the working procedures in Appendix 3 of the DSU.
325 Replies by India to Panel questions concerning open hearings, question 1.
326 Article 12.2 of the DSU
328 Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of
Disputes, adopted by the DSB on 3 December 1996 (WT/DSB/RC/1).

questions how the Panel is going to ensure th at these requirements are met after opening the
proceedings to the public for observation.329
7.28 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.
330
7.29 According to India, the WTO is a Member-dri ven 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.331
7.30 India posits that the meeting of the Panel with the third parties should be in closed session as
required under paragraph 2 of the Working Procedures contained in Appendix 3 of the DSU.332
7.31 Mexico disagrees with the opening of the Panel mee tings to the public on the grounds that
panel meetings constitute panel "de liberations" and as such should be confidential, as per Article 14.1
of the DSU. Mexico also argues that transparen cy is a sensitive issue that is currently under
discussion in the negotiations to amend the DSU. Me xico argues that the DSU rules require that the
meetings be confidential and, therefore, the deci sion of the two parties should only prevail to the
extent that it does not affect the right of other Members including third parties.333
7.32 Mexico emphasizes that public hearings are a cr oss-cutting issue that should be addressed in
general by the WTO, and should not be imposed by a panel at the request of two Members. Mexico
regrets that the decision will set a precedent that ma y affect the outcome of the negotiations and will
in all likelihood end up complicating the preparation of working procedures of future panels. 334
Mexico suggests that the third-party session follow the established WTO practice of being held in
closed session.335
7.33 According to New Zealand, there are no legal constraints that would prevent the Panel from
opening its hearings to the public. New Zealand quot es Article 12.1 of the DSU which allows panels
to follow the working procedures in the DSU unless the panel decides otherwise after consulting the
parties. New Zealand argues that while Appendix 3 provides for closed session hearings, the working
procedures can be amended with the consent of the Panel and the parties. New Zealand further notes
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

332 Replies by India to Panel questions concerning open hearings, question 2.
333 Oral statement of Mexico, para. 2; Mexico replie s to Panel questions following the first meeting,
paras. 3 and 9.
335 Replies by Mexico to Panel questions concerning open hearings, question 2.

allows parties to waive confidentiality. New Zeala nd did not object to its third party hearings being
public.336
7.34 Norway considers that Article 12.1 of the DSU gives the Panel the discretion to follow other
working procedures than the ones provided in Appendix 3 after consulting the parties. It sees no legal
constraints in granting the parties' request to open the hearings to the public. Norway also agrees to
having the third party session of the hearing open to the public.337
7.35 The Separate Customs Territory of Ta iwan, Penghu, Kinmen and Matsu (Chinese
Taipei) argues that, in accordance with the procedures and customary practices developed over more
than half a century under GATT, which are reflec ted in Articles 14.1, 18.2 and Appendix 3 of the
DSU, panel proceedings are to be kept confidentia l. 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 proceedings to the public.338
7.36 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. Chinese Taipei is therefore of the opinion that this exception does not extend to the
possibility of allowing parties to decide whether to open panel meetings to the public.339
7.37 According Chinese Taipei, "panel deliberations" im plies more than one form of deliberation,
thus including not only internal consideration among panelists, but also the entire process of the
panel's consideration of the dispute.340
7.38 Chinese Taipei argues that the flexibility aris ing from Article 12.1 of the DSU to change
working procedures in Appendix 3 cannot be extended to cover provisions in the working procedures
that directly elaborate on the obligations of the DS U. It further argues that if the drafters had
contemplated that the confidentiality requirement could 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.341
7.39 Chinese Taipei is of the opinion that the th ird-party sessions should be held in closed
session.342
(d) Decision of the Panel
7.40 On 1 August 2005, the Panel decided to accept th e parties' joint request to open the Panel
hearings for public observation. The Panel also deci ded that the meetings at which the parties are
invited to appear, as referred to in paragraph 2 of Appendix 3 to the DSU, would be open for
observation by the public through a closed-circuit br oadcast, keeping in mind the Panel's obligation to
ensure that its Working Procedures are objective, im partial and non-discriminatory, and after careful
consideration of the existing provisions of the DSU a nd its Appendix 3. In addition, since not all third
parties had agreed that their session with the Pa nel be open for observation by the public, the Panel
decided that that session would remain closed. As provided in paragraph 3 of the Panel's Working

336 Replies by New Zealand to Panel questions concerning open hearings, questions 1 and 2.
337 Replies by Norway to Panel questions concerning open hearings, questions 1 and 2.
338 Replies by Chinese Taipei to Panel questions concerning open hearing, question 1, paras. 1 and 2.
339 Replies by Chinese Taipei to Panel questions concerning open hearing, question 1, paras. 4 and 5.
340 Replies by Chinese Taipei to Panel questions concerning open hearing, question 1, para. 3.
341 Replies by Chinese Taipei to Panel questions concerning open hearing, question 1, paras. 6 and 7.
342 Replies by Chinese Taipei to Panel questions concerning open hearing, question 2, para. 12.

Procedures343, the parties retain the right to request at any time, including during panel meetings at
which they are invited to appear, that their specifi c statements not be broadcast so as to remain
confidential. The Panel also reser ved its right to decide on its ow n to suspend broadcasting at any
time, including during such meetings. 344 The Panel sent its revised Working Procedures and timetable
to the parties and third parties on 1 August 2005.
7.41 The Chairman of the Panel also sent letters to the Chairman of the DSB 345 and the Director-
General of the WTO 346, informing them of the Panel decisi on on this matter and requesting the
assistance of the WTO Secretariat in making appropriate logistical arrangements for the open
hearings.
7.42 After the Panel decided to consult scientific experts
347, the opinion of the parties was sought
on whether they wished that any m eeting with the parties and the scientific experts also be open for
public observation. The parties replied affirmatively.
7.43 Since this was the first time in GATT/WTO hist ory that a panel has held hearings open for
public observation, the Panel deems it appropriate to el aborate further on the reasons why it agreed to
open its substantive meetings for public observation.

343 The Panel's working procedures are contained in Annex A-2 to this Report.
344 The letter of the Panel to the Parties of 1 August 2005 is reproduced in Annex A-1 to this Report.
345 See WT/DS320/8, 2 August 2005.
346 Letter of the Chairman of the Panel to the Dir ector-General of the WTO of 2 August 2005. The
letter reads as follows:

"On behalf of the Panels in the two cases referred to above, I would like to request your
assistance concerning the implementation of a procedural decision taken by the Panels.

Following a common request made by the parties on 13 June 2005, we have decided that the
panel meetings to which the parties are invited to appear will be open for observation by the
public through a closed-circuit TV broadcast. We informed the parties of our decision on 1
August 2005. The session with the third parties w ill remain closed as not all the third parties
have agreed to have it open for observation by the public. The third parties were advised of
our decision on 1 August 2005. Finally, the Ch airman of the DSB has also been advised of
our decision, with a request that he informs the entire DSB membership of the possibility to
observe the hearings.

The Panels appreciate the assistance of the Secretariat on these cases to date and would like to
request continued Secretariat assi stance with respect to the logi stical arrangements needed to
implement our decision. In this regard, we would like to ensure transparency and non-
discriminatory access by all, in particular by all WTO Members, to the closed-circuit TV
broadcast. For that purpose, we would requ est the Secretariat to guarantee that each WTO
Member delegation has at least
 two seats available in the ro om where the closed-circuit
broadcast will be shown. We would also ask th e Secretariat through its website to make all
Members and the public aware that they are allo wed to attend the closed-circuit broadcast and
to provide details on pre-registration and seating arrangements.

We have scheduled the first substantive meeting of the Panels with the parties for
12-15 September 2005 and understand that this meeting could take place in Room W with a
closed-circuit TV broadcast of the meeting in the General Council Room.

I would greatly appreciate your assistance in ensuring that the logi stical arrangements to
which I have referred in this letter can be finalized by the Secretariat."

347 See Section VII.A.2 below.

7.44 The Panel first wishes to recall that it acted at the joint request of the parties. Some third
parties, however, objected to the holding of a hear ing that would be observable by the public. As a
result, the hearing with third parties was not opened to public observation.
7.45 The Panel considers that the DSU does not expr essly contemplate the possibility for meetings
of panels to be open for public observation. On the contrary, Paragraph 2 of Appendix 3 to the DSU
provides that "the panel shall meet in closed ses sion" and that "The parties to the dispute, and
interested parties, shall be present at the meeting onl y when invited by the panel to appear before it."
The Panel understands this to mean that it shall always meet in camera, whether or not the parties
and/or interested parties have been invited to appear before it. No reference is made in that provision
to other Members or to the general public.
7.46 However, Article 12.1 of the DSU provides that "[p]anels shall follow the Working
Procedures in Appendix 3 unless the panel decides otherwise after consulting the parties to the
dispute." In other words, the Panel has the possibilit y to depart from any provision of Appendix 3, its
only obligation being to consult the parties to the dispute first.
7.47 This discretion, however, applies only to th e provisions of the Working Procedures in
Appendix 3, not to any other provision of the DSU. The Panel thus is of the view that Article 12.1
entitles it to proceed with any adap tation of the working procedures c ontained in Appendix 3, as long
as such an adaptation is not expressly prohibited by any provision of the DSU. Therefore, we need to
examine whether there is any DSU provision that would explicitly prohibit the opening of panel
meetings to public observation.
7.48 The Panel notes in this respect the confidentia lity requirements contained in Articles 14.1,
18.2 and Appendix 3, paragraph 3 to the DSU. It al so recalls the obligations of its members pursuant
to the Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of
Disputes.348
7.49 Regarding the requirement in Article 14.1 of the DSU that "[p]anel deliberations shall be
confidential", the Panel first notes that one of the ordinary meanings of the word "deliberations" is
"careful consideration, weighing up with a view to decision". The term "deliberations" also applies to
"[c]onsideration and discussion of a question by a legislative assembly, a committee, etc.; debate". 349
However, the Panel is not of the view that a panel h earing is similar to a consideration by a legislative
body or a committee. Even though exchanges of points of view take place in both instances, the
nature of the exchange of arguments by parties to a dispute before an adjudicating body remains
different from that of an assembly or a committee. This suggests that the term "deliberation" was not
intended to cover the exchange of arguments between the parties, but rather the internal discussion of
the Panel with a view to reach its conclusions. We note that our interpretation of the term
"deliberation" conforms to the use of that term in the statutes of other international judicial bodies. 350

348 WT/DSB/RC/1, 11 December 1996.
349 The New Shorter Oxford English Dictionary (4th ed., 1993), p. 624.
350 Article 46 of the Statute of International Court of Justice provides that "[t]he hearing in Court shall
be public, unless the Court decides otherwise, or unless the parties demand that the public be not admitted".
Article 54.3 of the Statute provides that "[t]he deliberatio ns of the Court shall take place in private and remain
secret ...". Article 26 of the Statute of the Internationa l Tribunal for the Law of the Sea provides that" [t]he
hearing shall be public, unless the Tribunal decides otherwise, or unless the parties demand that the public be
not admitted". Article 42 of the Rules of the Tribunal provides that "[t]he delibera tions of the Tribunal shall
take place in private and remain secret ..." Article 20 of the Statute of th e International Criminal Tribunal for
Former Yugoslavia provides that "[t]he hearing in Court shall be public, unless the Trial Chamber decides to
close the proceedings in accordance with its rules of procedure and evidence". Rule 78 of its Rules of Procedure
and Evidence provides: "[a]ll proceedings before a Trial Chamber, other than deliberations of the Chamber,

It is also confirmed by the context of Article 14.1. Article 14 deals with confidentiality in the work of
panels stricto sensu (deliberations, drafting of the panel re port, opinions of panelists), whereas the
provisions dealing with the conduct of the proceedings with the parties are contained in Article 12.
The Panel therefore concludes that Article 14.1 of the DSU does not apply to panel hearings and that
opening the Panel's substantive m eetings with the parties to public observation does not breach that
provision.
7.50 Regarding the requirement contained in Article 18.2 of the DSU that "[w]ritten submissions
to the panel ... shall be treated as confidential", we note that, by opening its hearings to public
observation, the Panel did not disclose to the public the content of the parties' written submissions.
By making statements to which the public could lis ten, the parties themselves exercised their right
under Article 18.2 to "disclos[e] statements of [t heir] own positions to the public". The Panel is
mindful that, by asking questions or seeking clarifi cations during the hearings with respect to written
submissions of the parties, it may have itself "discl osed" the content of such submissions. However,
the Panel notes that at all times the parties retained the right to request that specific statements of
theirs not be broadcasted so as to remain confidentia l and that, in this case, the parties had made their
written submissions public. The Panel notes also th at Article 18.2 provides that "Members shall treat
as confidential information submitted by another Member to the Panel or the Appellate Body which
that Member has designated as confidential ."351 We consider that this sentence clarifies the scope of
the confidentiality requirement which applies to the Panel and to Members, a nd that panels have to
keep confidential only the information that has been designated as confidential or which has otherwise
not been disclosed to the public. Any other inte rpretation would imply a double standard, whereby
panels would have to treat as confidential information which a WTO Member does not have to treat as
confidential. The Panel also notes that, by reques ting that the Panel hold hearings open to public
observation, the parties to this dispute have imp licitly accepted that their arguments be public, with
the exception of those they would identify as confidential.
7.51 Finally, the Panel notes that Article VII of th e Rules of Conduct for the Understanding on the
Rules and Procedures Governing the Settlement of Disputes provides that "[e]ach covered person
shall at all times maintain the confidentiality of dispute settlement deliberations and proceedings
together with any information identified by a pa rty as confidential." The Panel notes that such
confidentiality obligation on the cove red persons during the panel proceedings is applicable to the
extent not inconsistent with the DSU provisions. 352 In this case, the parties waived their right to
confidentiality and requested open hearings. As de monstrated above, the Panel accordingly adapted
its working procedures by departing from Append ix 3 in a manner consistent with the DSU
provisions. Therefore, the Rules of Conduct should not be construed in a manner that would restrict
the rights of Members under the DSU. The Panel concludes that Article VII does not prevent the
Panel from holding hearings open to observation by the public.
7.52 The Panel is mindful that the issue of transp arency of panel and Appellate Body proceedings
is currently under review as part of the negotiati ons on improvements and clarifications of the DSU.
However, the Panel recalls that the dispute settlement system of the WTO serves to preserve the rights
and obligations of Members under the covered agreem ents, which include the DSU, and to clarify the

shall be held in public, unless otherwise provided." Rule 29 provides that "[t]he deliberations of the Chambers
shall take place in private and remain secret."
351 Emphasis added.
352 See Rules of Conduct for the Understanding on Rules and Procedures Governing the Settlement of
Disputes (WT/DSB/RC/1), Article II.1:

"These Rules shall in no way modify the rights and obligations of Members under the DSU
nor the rules and procedures therein."

existing provisions of those agreements in accordance with customary rules of interpretation of public
international law. The Panel considers that its role is not to address transparency in general terms, but
to determine whether the DSU as it currently stands permits that, under the circumstances of this
particular case, the Panel hearing be open to pu blic observation. When called upon to decide on
whether to open hearings to public observation, th e Panel concluded that this was the case. However,
this finding is limited to this particular case and is without prejudice to any approach to the issue of
transparency that the Members may negotiate.
7.53 For the reasons set out in the previous paragra phs, the Panel considers that it is entitled, under
the particular circumstances of this case and pursuant to Article 12.1 of the DSU, to open its hearings
for public observation. This is why the Panel d ecided to accept the parties' request to open its
meetings with the parties for public observation. The third-party session was, however, not open to
public observation, due to the absence of consensus among the third parties on this matter.353
7.54 The first substantive hearing with the parties was held on 12, 13 and 15 September 2005. The
hearing with third parties took place on 14 Septembe r 2005. The hearing with the scientific experts
was held on 27-28 September 2006. The second substantive meeting with the parties was held on
2 and 3 October 2006.
2. Panel's decisions relating to the consultati on of individual scientific experts and
international organizations
(a) Decision to consult scientific experts
7.55 During its first substantive meeting, the Panel requested the parties' views as to whether there
was a need to consult scientific experts should the Panel deem it necessary to examine the consistency
of the EC implementing measure with the SPS Agreement as part of its review of this case.354
7.56 The European Communities replied that it did not believe that it was necessary for this
Panel to look into these scientific issues to make findings and rulings within its terms of reference.
However, the Panel did not have the expertise to de cide on such issues itself, should the Panel decide
to review the scientific issues at st ake. In such a scenario, the consultation of scientific and technical
experts would be absolutely necessary. However, the European Communities considered that this
Panel could not consult the experts that were used in the original EC – Hormones case. New experts
would have to be chosen.355
7.57 The United States considered that, in view of the cl arity of the scientific issues in this
dispute, there was technically no need to consult expe rts in this proceeding. However, the Panel, in a
scientific dispute such as this, had discretion to consult with experts on the scientific evidence in
developing its analysis and making its findings. This said, a panel could not delegate to experts the
panel's central task of interpreting the covered agreements cited in a dispute. Experts may advise only
on factual issues, not on the application of the legal standards in the covered agreements to the facts at
hand.
7.58 On whether the Panel should consult with the scientific experts from the original EC –
Hormones proceedings, the United States noted that the process by which the original experts were
selected differed from that which had evolved over th e course of subsequent disputes and that experts

353 See WT/DS320/8.
354 Question 74 of Panel questions after the first substantive meeting.
355 EC's reply to Panel questions after the first substantive meeting, question 74, Annex B-1.

should be selected pursuant to current practice, whic h would mean that the three experts selected by
the original panel should be consulted.356
7.59 After having considered the parties' replies, the Panel noted that, from the parties' replies to
its questions, it appeared that no party disagreed that, should the Panel proceed with an assessment of
the measure taken by the European Communities to comply with the recommendations and rulings of
the DSB in the EC – Hormones case, advice from technical or scientific experts would be necessary.
7.60 The Panel noted the views expressed by the Eu ropean Communities regarding the nature of
this case and the order in which its claims should be reviewed by the Panel, but it was of the opinion
that, at that stage, it was in its interest, as well as in the interest of the parties, to be fully informed of
all relevant aspects of the dispute. The Panel thus decided to initiate a process for consultation with
experts in relation to the technical or scientific aspects of the compatibility of the EC implementing
measure with the relevant provisions of the SPS Agreement, without prejudice to the positions held by
any party in this respect and without prejudice to the conclusions that the Panel would ultimately
reach on the claims raised by the European Communities. The Panel informed the parties accordingly
in a letter dated 20 October 2005.357
7.61 The Panel does not deem it necessary to add to its reasoning on this issue except to recall that,
as specified by the Appellate Body in US – Shrimp:
"... the DSU accords to a panel established by the DSB, and engaged in a dispute
settlement proceeding, ample and extensive au thority to undertake and to control the
process by which it informs itself ... of the relevant facts of the dispute ... That
authority, and the breadth thereof, is i ndispensably necessary to enable a panel to
discharge its duty imposed by Article 11 of the DSU to 'make an objective assessment
of the matter before it, including an objective assessment of the facts of the case.'"358
7.62 In this particular case, as explained further in the subsequent sections of this report and in
spite of the approach of the European Communities focusing on the breach of certain provisions of the
DSU by the defending party, the Panel deemed it impor tant to consult experts in order to "make an
objective assessment of the matter before it, includ ing an objective assessment of the facts of the
case." In addition, Article 11.2 of the SPS Agreement "explicitly instructs" 359 panels to seek expert
advice in disputes under the SPS Agreement involving scientific and technical issues:
"In a dispute under this Agreement involving scientific or technical issues, a panel
should seek advice from experts chosen by the panel in consultation with the parties
to the dispute."360
7.63 The Panel is mindful that this case is not exactly a dispute "under [the SPS] Agreement" since
its terms of reference do not refer to the SPS Agreement. We nonetheless consider that, since we may
have to determine whether the European Communi ties has complied with its obligations under the
SPS Agreement if we need to determine whether Article 22.8 of the DSU has been breached, this
dispute is, at least indirectly, "under [the SPS] Agreement".
7.64 We therefore conclude that our decision to cons ult scientific experts is consistent with the
requirements of the DSU and the SPS Agreement.

356 US's reply to Panel questions after the first substantive meeting, question 74, Annex B-3.
357 Annex A-3 to this Report.
358 Appellate Body Report on US – Shrimp, para. 106 (emphasis original).
359 See Appellate Body Report on Japan – Agricultural Products II, paras. 127-128.
360 Article 11.2 of the SPS Agreement, emphasis added.

(b) EC request for a single expert review group
7.65 Once it decided to consult scientific experts, the Panel sought comments from the parties on
the proposed Working Procedures for Consultation w ith Scientific and/or Technical Experts, the
technical or scientific aspects on which the Panel should consult experts and on whether the meeting
with the experts and parties should be open for observation by the public.
7.66 In a letter dated 3 November 2005, commenting on the draft working procedures for the
consultation of experts, the European Communities requested that a single expert review group be
called upon to assist the Panel, arguing that it was important that the Panel receive consistent advice
on the issues and that it would reduce the risk of the Panel having to review and decide between
competing scientific views among the experts.
7.67 The United States objected to the request of the Eu ropean Communities in a letter of
8 November 2005, noting that in every sanitary and phytosanitary dispute to date in which experts had
been consulted, including the original EC – Hormones proceeding, they had been consulted on an
individual basis. This method for consultations had proven effective, and there was no reason to
depart from this practice in these proceedings.
7.68 The United States was also concerned by the imp lication of the consultation of the experts as
a group instead of on an individual basis. The requirement that a response be coordinated within the
group of experts could lead to s ubstantial delays and potentially limit the Panel's ability to hear and
weigh the spectrum of opinions as they relate to the ho rmones at issue in this dispute. Also, given the
spectrum of areas of expertise at issue, there would not seem to be much value to a "group" report
since each expert was going to be consulted on different areas.
361
7.69 The European Communities commented that its request was based on a desire to ensure the
legitimacy of the Panel's findings by providing for a systematic, coherent and non-polarizing approach
to complex scientific issues. Conversely, if expe rts acted as individuals, the Panel ran the risk of
having to review and decide between competing scientific views amongst the Panel's experts as well
as the experts advising the parties. This would normally be very difficult, if not impossible, to do in a
way that would ensure transparen cy, excellence and credibility in th is contested area of scientific
research.
7.70 The European Communities also drew the Panel's attention to Article 13.2 and Appendix 4 of
the DSU, Article 11.2 of the SPS Agreement and Article 14.2 and Annex 2 of the TBT Agreement
which, most probably for the reasons just menti oned above, all refer to the possibility to establish
expert review groups. The European Communities did not see any reason to deviate from this normal
procedure which the drafters of the WTO Agreements clearly preferred.362
7.71 The Panel reached its final decision on the working procedures for consultations with
scientific and/or technical experts on 25 November 2005. 363 Regarding the form the consultation of
the experts should take, the Panel was not persuaded that the EC s uggestion to consult an expert
review group was the preferable option. Firstly, the fields of competence proposed by the parties
were quite varied, rendering it difficult to find indi vidual experts with competence in most or all of
these fields to serve in an expert review group. The fact that no expert would have a comprehensive
knowledge of all the relevant subjects made it even more important for the Panel to seek advice from
the experts on an individual basis on their respective fields of expertise. Secondly, the Panel wished

361 US's letter to the Panel of 8 November 2005.
362 EC's letter to the Panel of 11 November 2005.
363 Annex A-5 to this Report. The Panel also decided that the meeting with the experts would be open
for observation by the public in the same manner as the meeting with the parties.

to hear any dissenting or minority views among the e xperts rather than receiving a consensus text
from an expert review group. The Panel did not consider that the risk that experts may have diverging
opinions would generate difficulties as serious as t hose alleged by the European Communities. The
Panel rather saw the risk that an expert revi ew group would only agree on a minimum common
position, thus depriving the Panel of a full picture of the problems. It was also worth noting that so
far, all WTO panels had preferred to consult scientific and/or technical experts on an individual basis.
7.72 The Panel does not deem it necessary to add to the reasons mentioned above, except to clarify
that, in its view, none of the provisions cited by the European Communities sets a preference for
expert review groups. On the contrary, the consulta tion of expert review groups is mentioned only as
one option, both in Article 13.2 of the DSU and in Article 11.2 of the SPS Agreement and the terms of
those provisions suggest that panels enjoy wide di scretion in deciding to seek or not the assistance of
an expert review group rather than that of individual experts. Indeed, Article 13.2 of the DSU
provides that:
"Panels may seek information from any rele vant source and may consult experts to
obtain their opinion on certain aspects of the matter. With respect to a factual issue
concerning a scientific or other technical matter raised by a party to a dispute, a panel
may
 request an advisory report in writing from an expert review group."364
7.73 Article 11.2, second sentence, of the SPS Agreement provides that:
"To this end, the panel may, when it deems it appropriate , establish an advisory
technical experts group, or consult the rele vant international or ganizations, at the
request of either party to the dispute or on its own initiative."365
7.74 We read these provisions as leaving a wide marg in of discretion to the Panel. We find
confirmation of this reading in the Appellate Body Report on EC – Hormones , where the Appellate
Body recalled that:
"Both Article 11.2 of the SPS Agreement and Article 13 of the DSU enable panels to
seek information and advice as they deem appropriate in a particular case ...
We find that in disputes involving scientific or technical issues, neither Article 11.2
of the SPS Agreement, nor Article 13 of the DSU prevents panels from consulting
with individual experts. Rather, both the SPS Agreement and the DSU leave to the
sound discretion of a panel the determina tion of whether the establishment of an
expert review group is necessary or appropriate."366
7.75 We therefore conclude that our decision complies with the DSU, the SPS Agreement and the
practice of the Appellate Body.
(c) Experts selection process
7.76 One single expert selection process was carried out for the two cases WT/DS320 and
WT/DS321.367

364 Emphasis added.
365 Emphasis added. A contrario , Article 14.2 of the TBT Agreement cited by the European
Communities expressly limits the choice of the panel to a technical expert group.
366 Appellate Body Report on EC – Hormones, para. 147.
367 In this section, the term "Panel" refers to the Panel in case WT/DS320 and the Panel in case
WT/DS321. The same individuals served as panelists in the two cases.

7.77 After receiving input from the parties, the Panel, in its letter of 20 January 2006 368, identified
the need for expert advice in seven fields, namely:
(a) risk analysis, in particular, the conduct of a risk assessment as it relates to food safety;
(b) animal science, including good veterinary practices in relation to the administration
of the six hormones369 to cattle through implants or other means;

368 Letter from the Panel to the parties of 20 January 2006.
369 The six hormones can be defined as follows:

Oestradiol-17β

Oestradiol-17β is the most potent mammalian oestrogenic sex hormone, responsible for
female characteristics. It is a member of a cla ss of compounds called steroids. In females, it
functions in the ovarian cycle and maintains uterine health; in males it inhibits the synthesis of
testosterone. It is produced primarily by the ovaries and the pl acenta. In cattle, it is
administered either alone or in combination with testosterone, progesterone and trenbolone by
a subcutaneous implant to the base of the ear to improve body weight and feed conversion in
cattle. The ear is discarded at slaughter. (Replies of Dr. Boisseau, Dr. Boobis and
Dr. Guttenplan to Panel Question 1 to the experts. Annex D, paras. 1; 7-8; 17)

Progesterone

Progesterone is the major mammalian progesta tional hormone, responsible for maintaining
pregnancy. It is a steroid and is secreted primarily by the corpus luteum in the ovary of adult
females and in the placenta. Progesterone is used as a contraceptive and to correct
abnormalities in the menstrual cycle. In cattle, it is administered to steer, usually in
combination with oestradiol-17β or oestradiol benzoate by a subcutaneous implant to the base
of the ear to improve body weight and feed conversion in cattle. The ear is discarded at
slaughter. (Replies of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the
experts. Annex D, paras. 2; 9-10; 18)

Testosterone

Testosterone is a mammalian androgenic hormone, responsible for male characteristics. It is a
steroid and is produced primarily in the testes of adult males. In cattle, testosterone is
administered in combination with oestradiol -17 β or oestradiol benzoate by a subcutaneous
implant to the base of the ear to improve body weight and feed conversion in cattle. The ear is
discarded at slaughter. (Replies of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel
Question 1 to the experts. Annex D, paras. 3; 11; 19)

Trenbolone acetate

Trenbolone acetate is a synthetic steroid with anabolic (growth-stimulating) properties several
fold above that of testosterone. In cattle, it is administered alone or in combination with
oestradiol-17β by a subcutaneous implant to the base of the ear to improve body weight and
feed conversion in cattle. The ear is discar ded at slaughter. (Replies of Dr. Boisseau,
Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the experts. Annex D, paras. 5; 12; 20).

Zeranol

Zeranol is an oestrogenic substance produced by certain fungal, or mold, species. It is a non-
steroidal anabolic (growth-stimulating) agent and has been used for the management of
menopausal and menstrual disorders. Zeranol is administered to cattle either alone, or in
combination with trenbolone acetate by a subcut aneous implant to the base of the ear to

(c) toxicology, including genotoxicity370, and carcinogenicity371 risks arising from the six
hormones in meat;
(d) inspection, sampling and testing methods, par ticularly in relation to residue analysis
and characterization with respect to the six hormones;
(e) human endocrinology 372 , including endogenous 373 production of hormones by
humans, in particular prepubertal children;
(f) dietary intake studies and epidemiology374 linked to meat consumption;
(g) physiology, in particular related to the possible effects of the six hormones when
consumed in meat on the immune and nervous systems, and growth and reproduction.
7.78 As stipulated in the Working Procedures for Consultations with Scientific and/or Technical
Experts adopted by the Panel on 25 Novemb er 2005 after consultation with the parties 375, the Panel
sought information not only from selected experts but also from three relevant international entities,
the Codex Alimentarius Commission (Codex) 376, the Joint FAO/WHO Expert Committee on Food

improve body weight and feed conversion in cattle. The ear is discarded at slaughter (replies
of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the experts. Annex D,
paras. 6; 13-14; 21). Although zeranol occurs naturally, it is sometimes referred to as one of
the synthetic hormones, together with trenbolone and melengestrol acetate.

Melengestrol acetate

Melengestrol acetate (MGA) is an orally active synthetic progestogen about 30 times as active
as progesterone. It is fed to female cattle to improve body weight and feed conversion (replies
of Dr. Boisseau, Dr. Boobis and Dr. Guttenplan to Panel Question 1 to the experts. Annex D,
paras. 4; 15-16; 22).

370 Ability to cause damage to genetic material (DNA). Such damage may be mutagenic and/or
carcinogenic (Replies of Dr. Boobis and Dr. Guttenplan to Panel question 2 to the experts. Annex D, paras. 41
and 58. See also Transcript of the Panel meeting with the experts, Annex G, paras. 85-90).
371 Process of induction of malignant neoplasms (cancer) by chemical, physical or biological agents
(Replies of Dr. Boobis and Dr. Guttenplan to Panel question 2 to the experts. Annex D, paras. 44 and 60).
372 Endocrinology: "A subspecialty of internal medicine concerned with the metabolism, physiology,
and disorders of the endocrine syst em." (Webster Online Dictionary) The endocrine system is defined by the
same dictionary as "The system of glands that release their secretions (hormones) directly into the circulatory
system. In addition to the endocrine glands, include d are the chromaffin system and the neurosecretory
systems."
373 Endogenous: "Produced inside an organism or cell. The opposite is external (exogenous)
production." (Webster's Online Dictionary)
374 "A branch of medical science that deals with the incidence, distribu tion, and control of disease in a
population; the sum of the factors controlling the pres ence or absence of a disease or pathogen" (Merriam-
Webster Online Dictionary (http://www.m-w.com/dictionary/epidemiology)).
375 Annex A-4, letter from the Panel to parties on 25 November 2005, Annex A-5, Working Procedures
for Consultations with Scientific and/or Technical Experts.
376 The Codex Alimentarius Commission was established by FAO and WHO, under the Joint
FAO/WHO Food Standards Programme, to develop international food standards, guidelines and other
recommendations such as codes of practice; its First Session met in 1963. The main purposes of this Programme
are protecting health of the consumers, ensuring fair trade practices in food trade, and promoting coordination of
all food standards work undertaken by international governmental and non-governmental organizations. The
Codex Alimentarius Commission is one of the three international standard-setting organizations referenced in
the SPS Agreement (reference: Codex Alimentarius website – www.codexalimentarius.net). Within the
framework of the Codex Alimentarius Commission and its procedures, the responsibility for providing advice

Additives (JECFA) 377, and the International Agency for Research on Cancer (IARC). 378 While the
questions to experts focused on the seven areas identified, the questions to the above-mentioned
entities focused on institutional and procedural issues as well as definitions relevant to the case.
7.79 Pursuant to the Working Procedures the Panel, on 29 November 2005, requested the
Secretariats of the Codex Alimentarius Commission, JECFA and the IARC to recommend names of
candidate experts in the relevant fields. The Panel contacted the 22 experts suggested by those
international entities and requested that those experts interested and available to provide advice to the
Panel submit their curriculum vitae, including publ ication lists, and disclose potential conflicts of
interests. Eleven experts were interested and available. The Panel provided all the information
received from the experts to the European Comm unities, the United States and Canada, requesting
them to indicate any compelling reasons why partic ular experts should not be chosen to provide
advice to the Panel in this dispute. The par ties provided their comments on the proposed experts on
16 January 2006. The United States provided comments on one issue in the EC comments on 19
January 2006, i.e. the exclusion of experts who ha d participated in JECFA's risk assessment work.
The European Communities responded to the US comments on 30 January 2006.
7.80 Because the parties' positions with respect to the candidate experts differed significantly, on
20 January 2006, the Panel requested the parties to suggest further names of candidate experts, in
application of paragraph 6 of the Working Procedures.
7.81 On 31 January 2006, the Secretary to the Panel sent letters to 49 additional experts suggested
by the parties. The Panel Secretary requested that experts interested and available to provide advice
to the Panel submit their curriculum vitae including a list of publications and a disclosure of any
potential conflicts of interests.
7.82 Of the 71 experts suggested by the internati onal organizations and the parties to the two
disputes, 40 experts indicated that they were ava ilable and 35 responded to the request for curriculum
vitae and information regarding potential conflicts of interests.
7.83 The information provided by the experts was sent to the parties. The parties were once again
given the opportunity to comment on each expe rt and to provide any compelling reasons why
particular experts should not be chosen to provide advice to the Panel in these disputes.
7.84 The parties provided their comments on the second set of experts names on 22 February 2006.
The European Communities replied to comments fr om the United States and Canada on certain
experts proposed by the European Communiti es in an additional letter to the Panel of

on risk management lies with the Commission and its subsidiary bodies while the responsibility for risk
assessment lies primarily with the joint FAO/WHO expert bodies and consultations.
377 The Joint FAO/WHO Expert Committee on Food Additives (JECFA), which has been meeting since
1956, is an international expert scientific committee that is administered jointly by the Food and Agriculture
Organization of the United Nations (FAO) and the World Health Organization (WHO). Its work includes the
evaluation of food additives, contaminants, naturally occurring toxicants and residues of veterinary drugs in
food. JECFA serves as an independ ent scientific committee which perfor ms risk assessments and provides
advice to FAO, WHO and the member co untries of both organizations. The requests for scientific advice are in
general channelled through the Codex Alimentarius Commission (Codex). Some countries use information
from JECFA in the establishment of national food safety control programmes and Codex adopts standards based
on evaluations by JECFA (reference: Fact Sheet – What is JECFA? See Annex 1 attached to Annex E-2).
378 The International Agency for Research on Cancer (I ARC), established in 1965, is part of the World
Heath Organization. IARC's mission is to coordinate and conduct research on the causes of human cancer, the
mechanisms of carcinogenesis, and to develop scientific strategies for cancer control. The Agency is involved in
both epidemiological and laboratory research and disse minates scientific information through publications,
meetings, courses, and fellowships (reference: IARC website – www.iarc.fr).

27 February 2006. The United States and Canada commented on the EC letter of 27 February on
1 and 2 March respectively. One party or another submitted objections with re gard to all but one of
the experts by arguing either that an expert lacked sufficient expertise in the areas of the dispute
identified as needing scientific or technical expertise, or was affiliated with the government of a party
to this dispute; or was affiliated with JECFA; or had received funding from the pharmaceutical
industry; or had been involved in the regulatory approval of any of the six hormones.
7.85 On 24 March 2006, the Panel informed the parties of the names of the experts that it had
selected. The Panel wishes to recall that, in the selection process, it amply consulted the parties and
selected the experts in accordance with procedures previously determined by the Panel in consultation
with the parties.379 The Panel excluded experts with close li nks with governmental authorities directly
involved in policy-making regarding the six hormon es and experts with close links to pharmaceutical
companies or involved in public advocacy ac tivities. The Panel chose not to exclude a priori experts
who had participated in the preparation and drafting of JECFA's risk assessments because this would
deprive the Panel and the parties of the benefit of the contribution of internationally recognized
specialists380 and because the Panel was of the opinion th at experts familiar with the JECFA reports
would be well-placed to assist the Panel in understa nding the work of JECFA extensively referred to
by the parties in their submissions, in partic ular by the European Communities. Moreover, the Panel,
who was fully aware of the fields of compet ence of these experts, considered that they would be
competent to answer questions with respect to risk assessment regarding the hormones at issue. The
Panel also decided not to exclude a priori all experts who were current or past governmental
employees unless a potential conflict of interests could reasonably be assumed from their official
functions. In selecting the experts, the Panel al so had in mind the need to choose experts with
expertise to cover all the fields identified as at issue in the dispute.
7.86 The experts selected by the Panel were:
 Dr. Jacques Boisseau, Former Director, French Agency for Veterinary Medicinal Products;

 Dr. Alan R. Boobis, Director, Experimental Medicine & Toxicology Division of Medicine,
Faculty of Medicine, Imperial College Londo n (also Professor of Biochemical Pharmacology
at Imperial College London);

 Dr. Hubert De Brabander, Professor and Head of Faculty of Veterinary Medicine, Department
of Veterinary Public Health & Food Safety, University of Ghent, Belgium;

 Dr. Ronald L. Melnick, US National Ins titute of Environmental Health Sciences;

 Dr. Wolfgang G. Sippell, Deputy Director, Depa rtment of Pediatrics, University of Kiel;
Head of the Division of Pediatric Endocrinology & Diabetology, Children's Hospital,
Christian-Albrechts-University of Kiel, Germany;

 Dr. Kurt Straif, Scientist, Unit of Carcinoge nic Identification and Evaluation, International
Agency for Research on Cancer, Lyon, France.

7.87 On 28 March 2006, the European Communities requ ested that the Panel reconsider its choice
of two of the experts, reiterating concerns already discussed above by the Panel and arguing that these
experts had real or perceived c onflicts of interests that should disqualify them from assisting the
Panel. The Panel carefully considered the Eur opean Communities' request, including the information

379 Appellate Body Report on EC – Hormones, para. 148.
380 See Annex E-2, JECFA's replies to Panel question 14, regarding the selection process of experts
involved in JECFA's work.

given regarding potential conflicts of interests. Th e Panel found in particular that the statement that
one expert had made before the French Senate in 1996 had not been made in relation to hormones
used for growth promotion purposes. Rather, it ha d been made with respect to hormones used for
medical treatment purposes. The Panel also found that the links of another expert with two companies
involved in research and counselling were not in the area of veterinary drugs or hormonal substances.
The Panel concluded that the EC objections regarding those two experts were not justified. Therefore,
on 31 March 2006, the Panel gave notice to the pa rties that it had found no reason to change its
decision concerning the selection of experts. 381 In addition, having considered the information
available about the various candidates, the Panel found that these two experts were the best choices
among the very few individuals available with exper tise in the area of risk assessment and would be
able to provide the Panel with insight on international standards on the hormones at issue.382
7.88 On 12 April 2006, the Panel gave notice to the pa rties that Dr. Melnick and Dr. Straif were no
longer available to assist the Panel and that the Panel had chosen to replace these experts with:
 Dr. Vincent Cogliano, Head of Programme, IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans, International Agency for Research on Cancer, Lyon, France;
and

 Dr. Joseph Guttenplan, Professor, Department of Basic Science, New York University Dental
Center; Research Associate Professor, Depart ment of Environmental Medicine, New York
University Medical Center.

7.89 In choosing experts to replace Dr. Melnick and Dr. Straif, the Panel was especially mindful of
the need to replace these experts with others who could cover the same fields of expertise. Of the final
six experts selected, three were amongst those originally suggested by the European Communities and
three were suggested by the international organizations consulted by the Panel.
7.90 The United States submitted an objection, on 19 April 2006, to the Panel's selection of an
expert originally recommended by the Europ ean Communities to replace one of the unavailable
experts.
7.91 The United States, in a letter dated 20 April 2006, also requested that the Panel amend its list
of experts to include an expert with relevant e xperience in animal science, including good veterinary
practices as they relate to the administration of the six hormones to cattle. In a letter dated 10 May
2006, the European Communities objected to the requ est for an animal science expert made by
Canada and the United States, stati ng that all relevant questions could already be answered by the six
experts.
7.92 In light of the experts' replies as to which qu estions they would not be in a position to answer,
and in light of the parties' comments, the Panel d ecided that it would first consider the written replies
from the experts to the questions and then would determine if it was necessary to seek advice from
additional experts. The Panel decided not to amend the list of selected expert unless there was a real
need in the future and communicated its decision to the parties in a letter dated 10 May 2006.

381 Letter dated 31 March 2006 from the Panel to parties.
382 The Panel wishes to highlight the challenges it encountered in selecting experts There was a limited
number of specialists suggested and actually available in each of the fields on which the Panel needed assistance
and almost always one or more of the parties objected to that specialist. For example, only six of the identified
available experts were deemed to have extensive expertise in risk analysis. All of these experts were objected to
by at least one party.

7.93 Because the Panel had requested Dr. De Braba nder and Dr. Boisseau to answer the questions
on good veterinary practices to the extent that they could, and because all questions were ultimately
answered by at least one of the selected experts, the Panel did not find a need to consult additional
experts.
7.94 In accordance with the Working Procedures fo r Consultations with Scientific and/or
Technical Experts adopted by the Panel in consultatio n with the parties, the experts were requested to
act in their individual capacities and not as representatives of any entity.
7.95 On 24 February 2006, the Panel sent to the parti es the draft questions to scientific experts and
international organizations for comments. The parties provided the Panel with their comments on
15 March 2006. After considering the parties' comments and after revising the draft questions as
necessary, the Panel sent its 62 written questions to the individual scientific experts and its 26 written
questions to the three international organi zations (namely Codex, JECFA and IARC) on
13 April 2006, together with the parties' submissions and accompanying exhibits.
7.96 The Panel requested that the experts and th e international entitities provide their written
replies to the scientific and technical questions by 12 June 2006.383
7.97 The Panel, after receiving replies from expe rts and Codex, JECFA, and IARC, forwarded
these replies to the parties on 14 June for their comments. The parties provided their comments on
these replies on 30 June 2006. 384 Afterwards, parties were given a further opportunity to comment on
each other's comments on experts' replies and re plies from international organizations. Parties
provided these second rounds of comments on 12 July 2006.385
7.98 The Panel met with the six experts and four representatives from Codex, JECFA and IARC in
the presence of the parties on 27-28 September 2006 in a meeting that was open for public
observation through a closed-circuit television broadcast. In this meeting, Dr. Vincent Cogliano,
Head of the IARC Monographs Programme, served bot h as an individual scientific expert and as the
representative of the IARC. The other representa tives were WHO JECFA Secretary Dr. Angelika
Tritscher, FAO JECFA Secretary Dr. Annika Wennberg, and Codex Secretary Dr. Kazuaki
Miyagishima. The meeting provided an opportunity for the parties and the Panel to ask questions to
the experts and for the experts to cl arify points that they had made in their written responses to the
questions.
386 This meeting was followed by the Panel' s joint second substantive meeting with the
parties on 2-3 October 2006.
7.99 The Panel wishes to record its appreciation to the experts and the representatives of the
international entities for their contributions. They were provided with large volumes of scientific
materials and a limited timeframe to reply to a long set of questions. They were also requested to
reply to extensive questions from the parties and the Panel during the two-day meeting in Geneva.
They provided detailed and comprehensive responses. They provided the necessary scientific input to
assist the Panel in understanding the issues raised by the parties and resolve the trade dispute before it.
The clarity of their explanations and their professionalism were particularly appreciated by the Panel.

383 A compilation of the written replies received from th e scientific experts can be found in Annex D.
The written replies from the Codex Alimentarius Comm ission, JECFA and IARC can be found in Annex E-1,
Annex E-2, and Annex E-3, respectively.
384 See Annexes F-1, F-2, and F-4.
385 See Annexes F-3 and F-5.
386 A copy of the transcript of the meeting (hereafter the "transcript") can be found in Annex G.

3. Other procedural issues
(a) Request by the European Communities that rele vant scientific evidence and data be provided
by the United States
7.100 In a letter dated 21 October 2005, the European Communities requested that the United
States provide the scientific studies on the basis of which it conducted its risk assessments and
approved the six hormones at issue for animal growth promotion so that the Panel, the experts and the
European Communities could be given an opportunity to consider them.
7.101 The United States objected to this request arguing that a panel was not expected to make a
de novo review of the safety of the hormones and draw its own scientific decisions on whether a
Member should apply a measure. Nor was a pane l called upon to conduct its own risk assessment.
The US decision to allow the use of the six grow th promoting hormones was not within the Panel's
terms of reference. Rather, it was the EC impor t ban, and the purported risk assessments and studies
allegedly underpinning that ban, which speak to whether or not the European Communities has
complied with the DSB's recommendations and rulings in the EC – Hormones dispute.387
7.102 In a letter to the Panel dated 8 November 2005, the European Communities argued that the
scientific basis of the EC measure at issue was being challenged with reference to assessments done
by other bodies or institutions, including the de fending party's own regulatory bodies. If the Panel
and the experts were to assess objectively the relevan ce and sufficiency of the scientific information
on which the European Communities relied in order to ban these substances, they would have to
review also the underlying evidence on which JECF A and some WTO Members relied in order to
conclude that the hormones at issue were safe. Due process required that the Panel request the
defending party to submit its underlying scientific studies.
7.103 In addition, the European Communities requested that the Panel ask Codex to submit to the
Panel the underlying scientific evidence and data that served as the basis of the JECFA's assessments,
which were invoked by the defending party in th ese proceedings. In the view of the European
Communities, the Panel was competent to request the information at issue both from the defending
party and from Codex under Article 13 of the DSU.388
7.104 The United States replied to the EC comments in a letter of 9 November 2005, that it did not
refer to its own risk assessment but to determinatio ns of the relevant inte rnational standard setting
bodies (Codex and JECFA) regarding the safety of th e hormones at issue. At the same time, the
United States agreed with the Eu ropean Communities that an examination of JECFA's and Codex's
conclusions regarding the hormones may be useful for an overall review of the EC characterization of
its ban as a "provisional measure" for five of th e hormones and of the EC purported risk assessment
for the sixth hormone.
7.105 The European Communities replied to the comments by the United States and Canada in a
letter to the Panel dated 11 November 2005. The European Communities observed that a substantial
amount of data on which JECFA based its findings came from, and were available only with, the
United States' and Canada's authorities since JECFA ha d to rely exclusively on data provided to it,
inter alia, by its members and the relevant industry. T hus, in the case of the six hormones in question,
JECFA, where it did not base itself on scientific ev idence publicly available, examined and relied on
evidence that was available only w ith the United States' and Canada's regulatory authorities. Most of
these studies were old and had never been published in peer reviewed scientific journals.

387 US's letter to the Panel of 3 November 2005.
388 EC's letter to the Panel of 8 November 2005.

7.106 The European Communities added that, becau se the Panel had decided to examine the
scientific basis of the EC compliance measure, this examination had to be carried out in the light of
the assessments on which the responding party exp licitly based itself in order to question the
European Communities' risk assessme nt and continue its unilateral suspension of concessions, i.e, its
own risk assessments and those of Codex/JECFA.
7.107 On 17 November 2005, the United States commented on the EC arguments by mentioning
that what was at issue in these proceedings w as whether or not the European Communities had,
through the studies it had chosen to rely upon and the Opinions it had put forward in support of its
bans, based its measures on a risk assessment w ithin the meaning of Article 5.1 of the SPS Agreement
or imposed a provisional ban within the meaning of Article 5.7 of the SPS Agreement. In carrying out
its task to examine these issues, the question was whether what the European Communities had
produced and put forward as evidence in support of its ongoing ban met the requirements of the
SPS Agreement.
7.108 Furthermore, according to the United States, de tailed summaries of the studies and materials
relied upon by JECFA were available for each of th e hormones at issue in this proceeding in the
WHO Technical Report Series publications.
389
7.109 The European Communities commented on 21 November 2005 that, because the Panel was
to make an objective assessment of the matter before it, it would also have to evaluate the conclusions
of JECFA. Since the European Communities a nd JECFA had come to differing conclusions, the
question was whether they had done so on the basis of the same data. In particular, it was not enough
to refer to the summaries in the Technical Report Se ries because they were too concise to allow such
an assessment, and they referred to old and unpublished US data from the 1970s.
7.110 The Panel considered the parties' arguments in its letter to the parties on the finalized working
procedures for consultation with scientific and /or technical experts:
"With respect to the EC's request that the Panel ask the US and Canada to provide the
studies underlying the risk assessments of the US, Canada (and JECFA), the Panel is
not in a position to fully assess the necessity fo r this information at this stage. This
said, the Panel notes that its task is not to conduct a comprehensive assessment of the
safety of hormones in meat. Rather, shoul d the Panel consider it necessary for the
resolution of the present dispute, it w ould assess the compatibility of the EC's
measure with the provisions of the SPS Agreement. Nevertheless, to the extent that
this information becomes necess ary for the Panel to make its determination in this
case, the Panel cannot exclude that it may request part or all of the information
referred to by the EC. More generally, the Panel expects the Parties' full
collaboration in gathering the informati on necessary for an objective assessment of
the matter before it. The Panel also recalls that it is for each party to submit sufficient
evidence in support of its assertions."
390
7.111 In addition, the Panel wishes to recall its co mments above on its discretionary power to seek
information or not pursuant to Article 13 of the DS U. The Panel also agrees with the parties that,
while it has to make an objective assessment of the matter before it, including an objective assessment
of the facts, it is not supposed to make a de novo review of factual information, including scientific
evidence, regarding the six hormones at issue. Thus , the Panel considered primarily in this context
the measure taken by the European Communities to comply with the recommendations and rulings of
the DSB in the EC – Hormones dispute. Having regard to the a llocation of the burden of proof, the

389 US's letter to the Panel of 17 November 2005.
390 Panel letter to the parties of 25 November 2005.

Panel deemed it appropriate to rely more partic ularly on the extensive amount of evidence submitted
by the European Communities and the United States in their submissions. The Panel also took into
account the opinions of the experts and the input s from the international entities it consulted under
Article 13 of the DSU. To the extent that the pa rties and the experts discussed the EC implementing
measure in the context of the work of JECFA and Codex, the Panel believes that it was sufficiently
informed to make an objective assessment of the f acts and did not need to ask the United States and
Codex to provide the information requested by the European Communities.
(b) Request by the United States to exclude materials 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
7.112 On 14 March 2006, the United States sent a letter to the Panel requesting it not to provide to
scientific experts materials that had not been cited in the EC risk assessment, nor those published after
the completion of the EC risk assessment and the adop tion of the ban at issue. The United States also
requested the Panel not to consider nor base its findings on these extraneous materials provided by the
European Communities.
7.113 The United States recalled that Directive 2003/74/EC 391 which the European Communities
claimed complies with the recommendations and rulings of the DSB in the underlying EC –
Hormones dispute, was based on the results of its 1999, 2000, and 2002 Op inions which, the
European Communities contended, demonstrated th at the amended ban satisfied the conditions of
Articles 5.1 and 5.7 of the SPS Agreement.
7.114 Accordingly, materials that had no apparent relationship to the European Communities'
alleged risk assessment, including materials publis hed after the completion of the EC risk assessment
and the adoption of its ban, were extraneous for purposes of the Panel's examination in this dispute.
7.115 To the extent that the Europ ean Communities, by submitting th ese materials, was inviting the
Panel (or the experts) to review them as part of a de novo risk assessment, this was not a proper role
for either the Panel or the experts. Rather, the question presented was whether the risk assessment
identified by the European Communities actually had brought the European Communities into
compliance with its WTO obligations.392
7.116 The European Communities stated that it had fundamental objections to the requests of the
defending party. They were contrary to the Appella te Body's interpretation of the requirements of a
"risk assessment", as set out in EC – Hormones . They were in violation of the Panel's Working
Procedures in this case, and they ran diametrica lly counter to the whole purpose of an expert
consultation by the Panel.
7.117 According to the European Communities, the issue of whether a measure could be considered
to be based on scientific evidence that was not cite d or had not been taken into account in a risk
assessment, or both, had already been settled by the Appellate Body in its report on EC – Hormones,
at paragraphs 188 through 191 . There the Appellate Body had dismissed the proposition by the
complaining parties and the finding by the panel that scientific evidence had to be cited in the risk
assessment, as a "minimum procedural requirement". The European Communities failed to understand
why the defending party now re-opened an issue that had already been decided.

391 Directive 2003/74/EC of the European Parliament and of the Council of 22 September 2003
amending Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances
having hormonal or thyrostatic action and beta-agonists, Official Journal No. L 262, 14 October 2003, p. 178
(hereinafter also "the Directive").
392 US's letter to the Panel of 14 March 2006.

7.118 The European Communities had submitted new mate rials as exhibits in its replies to the
Panel's questions and as part of its second written submission. They we re, therefore, lawfully before
the Panel and were directly covered by Paragraph 13 of the Expert Working Procedures.
7.119 In this context, the European Communities also pointed to the fact that the United States itself
had submitted materials that had been published after the EC risk assessment (s ee e.g. US – Exhibits
7, 16, 20; CDA – Exhibits 20, 26, 27, 28, 33). The US request was, therefore, based on a double
standard: In case recent evidence served the objectiv es of the United States it had to be admitted,
whereas evidence that was unfavourable to the United States should not be taken into account.
7.120 According to the European Communities, the Un ited States' request had to be dismissed in
view of the purpose of the experts' consultation. The principal objective of consulting experts was to
provide the Panel with objective information and advice on questions related to the scientific basis of
Directive 2003/74/EC. In order to fulfil this task, the experts could not ignore the most recent and
directly relevant scientific evidence that is publicly available.393
7.121 On 31 March 2006, the Panel addressed this issue in its letter to parties informing the parties
that it would not reject a priori any piece of evidence at that stage. However, the Panel decided to ask
experts to specify whether their reply would have b een different at the time of adoption of Directive
2003/74/EC and why. The Panel also requested the parties to identify, among the exhibits submitted,
those studies to which they had had access before their publication date.
"With respect to the issues raised in the letter of the United States on 14 March 2006,
in Canada's comments of 15 March 2006, and in the European Communities' letter of
23 March 2006, the Panel is reluctant to reject a priori any piece of evidence at this
stage. It will revert to this matter in its findings, as appropriate. In the meantime, and
without prejudice to its final decision, th e Panel has decided to amend some of its
questions to the experts and request them to specify whether their reply would have
been different at the time of adoption of the measure at issue (September 2003) and,
if not, why.
In this respect, the Panel would be gratef ul if the parties could specify by Friday,
7 April 2006, among the exhibits they s ubmitted, those studies to which they had
access before their official publication dates and, if so, specify the date on which they
had access to each of them."394
7.122 Also, in its guideline letter sent on 30 March 2006 to the selected scientific and technical
experts, the Panel specified that "wherever referen ce is made to scientific or technical facts, or
comment is made on scientific evidence or literature , you are requested to provide references to the
relevant studies and publications".395
7.123 The Panel considers that its approach allowed it to have a better understanding of the situation
at the time of the adoption of Directive 2003/74/EC. However, since nothing has been submitted that
became available subsequent to the adoption of th e Directive and that differed in any fundamental
way from the evidence available at that time 396, the Panel does not deem it necessary to address this
issue any further.

393 EC's letter to the Panel of 23 March 2006.
394 Panel letter to the parties of 31 March 2006.
395 Panel guideline letter to selected experts of 30 March 2006.
396 This was confirmed by the experts when they were requested to specify in their replies to questions
of the Panel whether their views would have been different at the time of the adoption of Directive 2003/74/EC.

(c) A new version of Exhibit EC-107, submitted by the European Communities on 29 May 2006.
7.124 On 29 May 2006, the European Communities submitted a new version of its Exhibit
EC-107, entitled "The sensitivity of the child to sex steroids: possible impact of exogenous
estrogens", a study published on 2 May 2006. The European Communities stated that it would leave
it to the Panel to decide whether to forward this version to experts.397
7.125 The Panel decided on 23 June 2006 not to forward this version of Exhibit EC-107 to the
scientific experts for the following reasons:
"With regard to the EC letter of 29 May and its attachment, the Panel takes note of
the fact that the study submitted as Exhibit EC-107 has now been published.
However, the Panel notes that the version of the study submitted as Exhibit EC-107
and the version attached to the EC letter of 29 May are somewhat different and that
the difference are apparently not merely edito rial. In this respect, the Panel recalls
that the parties had been given until 21 December 2005 to submit factual evidence to
the experts. Therefore, the Panel has deci ded not to send the published version of the
study contained in Exhibit EC-107 to the experts."
398
7.126 We confirm the position we took in this letter. We note that previous panels dealing with SPS
measures have, in the context of proceedings under Article 21.5 of the DSU, considered measures
adopted after the establishment of the panel.399 However, as far as evidence is concerned, panels have
generally refused to accept evidence submitted after a cer tain date, generally after the first substantive
meeting, except for rebuttal purposes or upon a showi ng of good cause. In this particular case, the
parties had been given until 21 December 2005, i.e. several weeks after their second written
submissions, to provide factual evidence that they de emed relevant. The Panel considered also that
submitting a modified study to experts at a relatively late stage of the expert consultation proceedings
could generate confusion.
(d) Procedure for allowing the parties to comment on each other's replies to questions after the
second Panel meeting
7.127 On 18 October 2006, the United States requested the Panel to provide the parties with the
opportunity to comment on each other's replies to ques tions posed to the parties by the Panel and the
parties following the second Panel meeting.400
7.128 On 20 October 2006, the Panel confirmed to the parties that the deadline for such counter
comments would be 31 October 2006.401
(e) Request by the European Communities to be a llowed to correct factual errors allegedly
contained in the other party's comments on its replies to questions following the second Panel
meeting
7.129 On 13 November 2006, the European Communities informed the Panel that it had studied
the comments submitted by the United States and Canada on 31 October 2006 and had identified a
number of inaccuracies and factual errors in their comments likely to affect the adjudication of the
cases.

397 EC's letter to the Panel of 29 May 2006.
398 Panel letter to the parties of 23 June 2006.
399 See Australia – Salmon (Article 21.5 – Canada), Japan – Apples (Article 21.5 – US).
400 US's cover letter to its replies to the questions of the Panel after the second substantive meeting,
dated 18 October 2006.
401 Panel letter to the parties of 23 October 2006.

7.130 The European Communities requested that the Panel allow the parties to submit comments on
the factual allegations contained in the comm ents on the responses. These comments would be
restricted to factual matters and would not seek to further discuss any of the legal issues. This would
enable the Panel to make an objective assessment of the facts and ensure a high quality panel
report.402
7.131 According to the United States, the European Communities had already had the opportunity
to present what it considered to be the facts and th ere was no reason to give it another opportunity to
present its view of the facts. Given the brevity of the US comments and the amount of time that the
European Communities had had to study them, the EC request was untimely.
7.132 The United States considered that the Panel w as more than capable of performing the task
assigned to it by the Dispute Settlement Body and sor ting out the various factual elements without the
need for additional filings from the parties. Finall y, the parties would presumably have an opportunity
to point out any factual errors in their comment s on the descriptive part and comments on the interim
report.
403
7.133 The Panel decided, on 20 November 2006, to reject the EC request:
"Having carefully reviewed the arguments of the parties, the Panel does not consider
it appropriate to offer them another opportuni ty to comment on alleged factual errors
made by the other party. Procedurally, the Panel does not see any difference between
comments on factual elements and comments on legal arguments; both can easily
lead to endless discussions. The Panel is c oncerned that giving such an opportunity
to parties could open the door to further de lays in these proceedings since it would be
difficult, once the Panel has allowed comments not foreseen in its timetable, to reject
requests for additional comments on the other party's comments. At this juncture, the
Panel believes that it has been sufficiently in formed by the parties and the experts to
be able to make an objective assessment of the case and deems it preferable to
continue with the preparation of its re port without further exchanges of comments
between the parties. The Panel notes in this respect that the DSU provides
opportunities for the parties to submit written comments, at a later stage, on the
descriptive (factual and arguments) sections of the Panel Report and to request the
Panel to review precise aspects of its Interim Report."404
7.134 The Panel does not deem it necessary to add anything to the reasoning above.
(f) Request by the European Communities for tape recordings of the transcript of the Panel
meeting with scientific experts
7.135 On 31 January 2007, the Panel sent to the parties a draft written transcript of the hearing with
the experts, for their review and comments.
7.136 On 14 February 2007, the European Communities , in the cover letter accompanying its
comments on the transcript, requested the Panel to provi de the parties with the tape recordings of the
meeting with the experts to check the accuracy of the transcription of the experts' replies. The
European Communities argued that the replies of some of the experts were not properly or not fully

402 EC's letter to the Panel of 13 November 2006.
403 US's letter to the Panel of 13 November 2006.
404 Panel letter to the parties of 20 November 2006.

reflected in the transcript, but di d not identify specific parts of the transcript where such errors
allegedly occurred.405
7.137 The Panel, in a letter dated 19 February 2007, requested the European Communities to
identify in the draft transcript the places where the European Commun ities believed the replies of the
experts during the meeting had not been properl y reflected. The Panel added that, once the
information had been provided, the Panel itself woul d further review the draft and make appropriate
corrections if necessary. The Panel added that the parties had until 5 April 2007 to submit such
information.
7.138 The European Communities responded to the Panel on 28 February 2007, confirming that it
was not in a position to identify in advance all the places where the transcript may not be entirely
accurate, unless it was given copies of the tapes. Th e European Communities added that some of its
doubts had already been pointed out by the United States and some more doubts existed as regards the
statements by one expert and by the representa tives of the WHO and JECFA. The European
Communities also stated that the tapes had b een provided to parties in the past in the EC – Hormones,
the EC – Asbestos and the second EC – Bananas cases.406
7.139 The Panel replied that, to its knowledge, in circum stances similar to the present dispute,
panels had never provided the tape recordings used in tran scripts of meetings with scientific or
technical experts to parties for review. As the Pa nel indicated in its message on 19 February to all
parties, parties were welcome to identify any places in the draf t transcript where they believed
inaccuracies could exist and the Panel would fu rther review the draft and make appropriate
corrections if necessary.407
7.140 On 28 March, the European Communities replied that tapes of recordings had been
provided previously upon request. In support of its allegation, it submitted a transmission slip of
21 April 1997 in the EC – Hormones panel procedure. The European Communities added that it was
entitled to expect that tapes be provided in this case as well.
7.141 The European Communities also pointed out that the written transcript of the meeting of the
Panel with the scientific experts had been sent with c onsiderable delay to the parties for verification.
In view of the time which had elapsed, it was very difficult to verify the transcript with the required
degree of certainty, in the absence of the recordings.
7.142 The United States commented on the EC remarks on 5 April 2007, arguing that the experts
had reviewed the draft transcript in order to ensu re that the transcript accurately reflected their
interventions and to make any necessary clarifying changes. Accordingly, in the view of the
United States, the only purpose for which the Eur opean Communities could be seeking access to the
tapes was to verify the transcript with respect to its own interventions. The United States did not see a
reason why the tapes would be needed for this purpose.
7.143 In response to the EC argument that it needed the tapes because time had elapsed between the
preparation of the transcript and the experts meeting, the United States argued that in every panel
proceeding there was significant time between panel meetings and the preparation of the descriptive
part of a panel's report. No party in any dispute to which the United States had been a party had ever
claimed that it needed access to the tapes of a panel meeting in order to be able to verify that the
descriptive part accurately presented the interventions of that party at the panel meeting. Presumably,
if there were a particular portion of the transcr ipt of concern to the European Communities, the

405 EC's letter to the Panel of 14 February 2007.
406 EC's e-mail to the Panel of 28 February 2007.
407 E-mail of the Panel to the parties of 26 March 2007.

European Communities could have identified that in its earlier communications and the Panel could
have consulted the tapes to confirm that the transcript was accurate with respect to that portion.
7.144 The United States indicated that the transmissi on slip attached by the European Communities
to its communication raised a number of questions while failing to demonstrate the EC claim of
"entitlement" to the tape recordi ngs. There was no evidence that copies of the audio tapes from the
meeting with the experts in the original proceedings had been provided to the United States for review
or that similar tapes of expert meetings were pr ovided to the United States in other dispute settlement
proceedings. The European Communities had failed to mention that the transmission slip was not
related to the tapes of the experts meeting in the original EC – Hormones dispute. The United States
noted that the cover slip submitted by the Eu ropean Communities to the Panel cited a date
(7 January 1997) that neither corresponded to the da tes of the meeting with the scientific experts in
the original dispute (17-18 February 1997), nor did it correspond to any of the meeting dates in the
original EC – Hormones dispute between the United States and the EC (WT/DS26). Furthermore,
that transmission slip involved a separate dispute with different panelists and different terms of
reference than the current proceeding. The United States therefore disagreed that the transmission slip
in question was relevant to sharing recordings of m eetings with scientific experts with the parties to a
dispute.408
7.145 The Panel sent to the parties an additional message on 18 April 2007, rejecting the EC
request for tape recordings:
"Since the latest message from the Panel to the parties on 26 March 2007, the Panel
has received from the Eu ropean Communities an additional communication on 28
March, indicating that tape recordings had been provided to the European
Communities in the original EC – Hormones panel proceedings.
The Panel subsequently received a letter from the United States indicating that the EC
failed to mention that the transmission slip it submitted together with its 28 March
letter is not related to the tapes of the expert meeting in the original EC – Hormones
dispute because the date mentioned on that slip (7 January 1997) does not correspond
to the date of the experts meeting (17-18 February 1997) in the original EC –
Hormones dispute between the United States and the European Communities
(WT/DS26).
The Panel found that the meeting date menti oned on the slip provided by the EC was
the date of the first substantive m eeting of the panel in the original EC – Hormones
dispute between the European Communities and Canada. The meeting with experts
in the two disputes was jointly held on 17-18 February 1997, while the meetings with
parties were held separately. After further verification, we can confirm that, to the
best of our knowledge, the tape recordi ngs of the experts meeting on 17 and
18 February in the two original EC – Hormones panels were never provided to the
parties.
The Panel recalls that the European Commun ities' request is based on its desire to
check whether the experts' replies at th e experts meeting have been accurately
reflected in the transcript. Consistent with the practice of other panels, the Panel has
invited the parties and the experts to veri fy the accuracy of their own interventions
during the meetings. In addition, the Pane l invited the parties to identify any places
in the draft transcript where they believe inaccuracies could exist and the Panel was

408 US's letter to the Panel of 5 April 2007.

ready to review those portions of the tran script and make appropriate corrections if
necessary.
By 5 April 2007, a deadline date set by th e Panel in its communication to the parties
on 26 March 2006, none of the parties had identified any such inaccuracies.
Therefore, on the basis of the above, the Panel does not deem it necessary to provide
the tape recordings of the meeting with the experts to the parties."409
7.146 The European Communities sent another message to the Panel on 11 May 2007,
commenting on the Panel's decision:
"The European Communities appreciates the e-mail of the Panel of 18 April replying
to our additional communication on 28 March, indicating that the tape recordings that
had been provided to the Europ ean Communities in the original EC – Hormones
panel proceedings were not from a hearing with scientific experts.
In that case we did indeed receive (and still have in our archives) from the panel five
tapes of 90 minutes each of the meeting held on 7 January 1997, which was indeed a
meeting not with scientific experts. The poi nt we were making is that since panels
have provided the parties in the past tapes of a regular hearing, why is it not possible
to provide the tapes of a hearing with scientific experts (where verification of what
exactly was said is even more important)?
More generally, panels send to parties th e factual part of the draft report for
verification (which is essentially done on th e basis of the written submissions of the
parties). The hearing with scientific experts is also part of the factual part of the
report. So, one can expect that the tapes from such a hearing with scientific experts
can also be sent for verification. This is all the more important in the case of a
hearing with scientific experts, because it is impossible both for the scientific experts
and the parties to take verbatim notes of a hearing that lasted two days and with the
speed at which the oral exchanges take place in such hearing. Indeed, the scientific
experts presumably did not take verbatim notes of what they said during the hearing
and so they are in the same difficult positi on as the parties to remember what exactly
they have said several months ago. Fo r example, the European Communities has
some doubts whether the following paragraphs of the draft report it has received
reflect accurately what exactly has been said by the experts during the hearing on
27-28 September 2006: paragraphs 353, 386, 388, 390, 421-422, 500, 690, 706, 710,
719-720, 734, 779, 785, 891, 994, 1018, 1028. Furthermore, the European
Communities considers that something may be wrong or missing between
paragraphs 972 and 973 of the draft report.
The European Communities resp ectfully requests the Panel to reconsider its position.
If the Panel still feels unable to provide the European Communities with the tapes, it
would ask the Panel to set out its reasons for refusing this request in the Report."
7.147 The United States sent a letter to the Panel on 14 May 2007 in response to the EC message of
11 May 2007 stating that:
"As noted by the Panel in its April 18, 2007, communication to the Parties on this
issue, '[c]onsistent with the practice of ot her panels, the Panel has invited the parties

409 Panel letter to the parties of 18 April 2007.

and the experts to verify the accuracy of their own interventions during the meetings .'
(Emphasis added). The United States was ther efore surprised to note that all but two
of the paragraphs (972-73) cited by the EC in its request relate to interventions of
experts (specifically Drs. Boobis and Boisseau):
Paragraphs 353 (Boobis); 386 (Boobi s); 388 (Boobis); 390 (Boobis); 421-22
(Boobis); 500 (Boobis); 690 (Boobis); 706 (Boobis); 710 (Boobis); 719-20
(Boisseau); 734 (Boisseau); 779 (Boobis); 785 (Boobis); 891 (Boisseau); 994
(Boobis); 1018 (Boobis); 1028 (Boobis).
It is unclear why it took the EC several m onths to identify these paragraphs. Indeed,
the EC has missed the deadline set by th e Panel (April 5, 2007) for identifying
specific issues with the transcript by more th an a month. It is even more perplexing
why the EC, when it finally provided a list of "doubts" regarding the transcript, cited
non-EC interventions, ignoring the Panel's clear instructions in its January 31, 2007
communication to the parties. The United States considers that Drs. Boobis and
Boisseau, both preeminent experts in their resp ective fields, are more than capable of
confirming that what they said or did not say is accurately reflected in the transcript,
without the assistance of the EC or any other party. Were it otherwise, the parties to a
dispute would be afforded the opportunity to rewrite expert opinions after the fact and
based upon their six-month old recollections, thereby calling into question the
purpose of consulting independent experts in the first place.
As for the other two paragraphs cited by the EC (972-73) that actually appear to relate
to EC interventions, the United States consider s that the Panel, should it decide to set
aside its April 5, 2007 deadline for identifyi ng problematic portions of the transcript,
is more than capable of double-checking th e accuracy of this discrete portion of the
transcript without the need to circulate copies of the tapes of the expert meetings to
the Parties (see e-mail from the Panel da ted March 26, 2007, in which the Panel
indicated that, by April 5, 2007, the 'parti es are welcome to identify any places in the
draft transcript where they believe inaccuracies could exist and the Panel will further
review those portions of the transcript and make appropriate corrections if
necessary')."

7.148 On 5 June 2007, the Panel informed the pa rties that the European Communities had not
identified the relevant paragraphs in the draft transcr ipt that it wanted the Panel to review before the
deadline of 5 April 2007, as specified by the Panel in its earlier communication to the parties. At such
a late stage, the Panel had every reason to disregard the request for review of the paragraphs identified
by the European Communities in its letter of 11 May 2007. Nevertheless, as a matter of prudence, the
Panel checked the relevant paragraphs in the draft transcript against the original tape recordings and
did not find any discrepancy beyond minimal editorial adjustments. Theref ore, the Panel saw no
reason to reverse its decision not to provide tape r ecordings of the meeting with scientific experts to
the parties for further review.
7.149 The Panel believes that the reasons for its deci sion not to provide tape recordings of the
meeting with scientific experts were sufficiently d escribed in its communications. It does not deem it
necessary to elaborate on them any further.

4. Scope of the Panel's mandate
(a) The measure at issue and the claims of the European Communities
7.150 The matter before this Panel is the alleged fa ilure of the United States to comply with the
DSU and the GATT 1994 in response to the adoption and notification to the DSB of an alleged
compliance measure by the European Communities in the EC – Hormones case.410
7.151 The measure at issue is the continued application by the United States, after the notification to
the DSB of Directive 2003/74/EC by the European Co mmunities, of its decision to apply, as from 29
July 1999, import duties in excess of bound rates by imposing a 100% ad valorem duty on a number
of products imported from certain member States of the European Communities 411 without recourse to
the procedures under the DSU. This decision had been taken pursuant to an authorization granted by
the DSB to the United States to suspend concessions and other obligations on 26 July 1999.412
7.152 In its request for establishment of a panel, th e European Communities lists Articles I and II of
the GATT 1994 and Articles 23.1, 23.2(a) and (c); 3.7, 22.8 and 21.5 of the DSU as having been
breached by the United States. However, in its first written submission and subsequently, the
European Communities elaborates on the scope of t hose claims. More particularly, it divides its
claims between a set of main claims and one conditional claim.413
7.153 The European Communities also specifies how its main claims of violation of the DSU
should be addressed. The European Communities ma kes a first series of main claims, alleging a
violation of Article 23 of the DSU and, more par ticularly, Article 23.2(a) read in conjunction with
Articles 21.5 and 23.1 of the DSU. The European Communities also makes a second series of main
claims, alleging a violation of Article 23.1, read in conjunction with Articles 22.8 and 3.7 of the DSU.
In support of the second series of claims, the European Communities alleges that it enjoys a
presumption of good faith compliance "which cannot be undermined by a unilateral and
unsubstantiated determination by the United States."
414
7.154 The European Communities also specifies in its first submission that Directive 2003/74/EC,
which it claims implemented the recommendations and rulings of the DSB in the EC – Hormones
case, is compatible with Article 5.1 and 5.7 of the SPS Agreement. However, there is no reference to
provisions of the SPS Agreement in the EC request for establishment of a panel.
7.155 The conditional claim, that of a violation of Article 22.8 of the DSU per se, is "made in the
alternative and only on the condition that the Panel does not establish any violation under
Articles 23.1, 23.2(a), 3.7, 22.8 and 21.5 of the DSU".
415
7.156 This conditional claim is, like the second series of ma in claims raised by the European
Communities, based on the EC view that it has comp lied with the recommendations and rulings of the
DSB in the EC – Hormones case by adopting Directive 2003/74/EC and properly notifying it to the
DSB. The difference is that, under the conditional claim, the European Co mmunities alleges actual
compliance, and not that it should be presumed to have complied in good faith.
7.157 The EC implementing measure imposes a defi nitive import prohibition on meat and meat
products from animals treated for growth promotion purposes with oestradiol-17 β and a provisional

410 WT/DS26.
411 US Federal Register, Vol. 64, No. 143 of 27 July 1999, p. 40638.
412 WT/DSB/M/65, p. 19.
413 EC's first written submission, para. 8.
414 EC's first written submission, para. 72.
415 EC's first written submission, para. 132.

ban on meat and meat products from animals treated for growth promotion purposes with testosterone,
progesterone, trenbolone acetate, zeranol and melengestrol acetate. The EC implementing measure is
allegedly "based on a comprehensive risk assessment and, thus, is fully compliant with the DSB
recommendations and rulings. In particular, [ according to the European Communities and] as
stipulated by the Appellate Body, the results of th e risk assessment 'sufficien tly warrant' the definite
import prohibition regarding one of the hormones (Article 5.1 of the SPS Agreement), [footnote
omitted] and provide the 'available pertinent in formation' on the basis of which the provisional
prohibition regarding the five hormones has been enacted (Article 5.7 of the SPS Agreement)."416
(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?
7.158 As a preliminary remark, the Panel notes that, when dealing with the scope of panel terms of
reference, panels and the Appellate Body so fa r addressed situations where panel requests were
alleged to be insufficiently precise. In the pr esent case, the EC request fo r the establishment of a
panel, while not as explicit as the EC first written s ubmission, explains in its section 2 ("The object of
the dispute") some of the elements of the approach that the European Communities wants the Panel to
follow. Yet, it does not outline its claims as was done in the EC first written submission. For
instance, the request for the establishment of a pane l lists Article 22.8 but it does not differentiate
between the main "systemic" claim relating to Article 22.8 (violation of Article 23.1, read in
conjunction with Articles 22.8 and 3.7 of the DSU) and the conditional "direct" claim of violation of
Article 22.8. Likewise, in the request for establishment of a panel, each provision is identified
separately, without any terms like "read together with" or "read in conjunction with."
7.159 In Korea – Dairy , the Appellate Body defined the meaning of claim and arguments as
follows:
"By claim, we mean a claim that the respondent party has violated, or nullified or
impaired the benefits arising from, an identif ied provision of a particular agreement.
Such a claim of violation must, as we have already noted, be distinguished from the
arguments adduced by a complaining party to demonstrate that the responding party's
measure does indeed infringe upon the identified treaty provision."
417
7.160 In the opinion of the Panel, the approach of the European Communities as developed in its
first written submission does not amount to "argumen ts" insofar as it does not "demonstrate that the
responding party's measure does ind eed infringe upon the identified tr eaty provision". In fact, it does
not purport to explain to what extent the EC claims are justified, but simply circumscribes their scope.
7.161 We further note that, in US – Carbon Steel, the Appellate Body stated that:
"[I]n considering the sufficiency of a pane l request, submissions and statements made
during the course of the panel proceedings, in particular the first written submission
of the complaining party, may be consulte d in order to confirm the meaning of the
words used in the panel request and as part of the assessment of whether the ability of
the respondent to defend itself was prejudiced. Moreover, compliance with the
requirements of Article 6.2 must be dete rmined on the merits of each case, having
considered the panel request as a whole, and in the light of attendant
circumstances."418

416 EC's first written submission, para. 17.
417 Appellate Body Report on Korea – Dairy, para. 139
418 Appellate Body Report on US – Carbon Steel, para. 127.

7.162 The Panel is mindful that this statement was made in relation to a situation where the terms of
reference were alleged not to cover specific claims. On the contrary, in the present case, the European
Communities narrows the terms of reference of the Panel insofar as it requires a specific approach to
the provisions allegedly breached. However, th is statement equally applies in the present
circumstances to the extent that the EC first written submission may be consulted in order to confirm
the meaning of the words used in the request for establishment of a panel.
7.163 In that context, it can be considered that th e approach to this case re quested by the European
Communities and contained in its first written submi ssion is actually a clarification of the claims
listed in its request for establishment of a panel and not arguments, and that it informs those claims.
7.164 We therefore conclude that the EC approach ou tlined in its first written submission is part of
the Panel's terms of reference. One consequence is that since the claim of "direct" violation of
Article 22.8 is made in the alternative , the Panel cannot and will not address it unless the European
Communities fails to establish its main claims. The other consequence is that we should address the
main claims as elaborated by the European Communities in its first written submission and
subsequently.
(c) Meaning of "read together with" and "in conjunction with" in the EC submissions
7.165 The main or principal claims of the European Communities raise an additional question, i.e.
whether the European Communities alleges a violation of Article 23 of the DSU alone or of all the
provisions cited in its submission in support of its claim of violation of Article 23.
7.166 The Panel notes that in questions put to the Eu ropean Communities after the first substantive
meeting, and in its second written submission, the Unit ed States challenges the EC claim of violations
of Article 21.5 "together with" Article 23.2(a) a nd of Article 22.8 "in conj unction with" Article 23.1
on two grounds:
(a) the United States alleges that the Europ ean Communities abandoned its claims of
specific violations of each of these provisions per se;
(b) the United States argues that the EC approach is inconsistent with the customary rules
of interpretation of international law by trying to impose obligations that are not
supported by the text of the provisions concerned.
7.167 The European Communities replies that the United States is acting contrary to Articles 23.1,
23.2(a) and 21.5 read together and that, as a r esult, the European Communities maintains its claim
under Article 21.5. As far as Article 22.8 is con cerned, the European Comm unities states that the
panel request lists all the relevant provisions which the United States is currently violating and, in
particular, Article 22.8 and Article 23.1. The Europ ean Communities also considers that its approach
consisting of citing various provisions to substa ntiate a claim was approved by the Panel in US –
Certain EC Products.
7.168 The Panel recalls that the request for estab lishment of a panel made by the European
Communities refers to "Article 23.1; 23.2(a) and (c); 3.7; 22.8 and 21.5 of the DSU". Thus,
examining the conformity of the US measures with Articles 3.7, 21.5 and 22.8 of the DSU is part of
the Panel mandate.
7.169 The Panel does not believe that the Eur opean Communities abandoned its claims under
Articles 3.7, 21.5 and 22.8 of the DSU because it alleged a violation of those provisions "read
together with" or "in conjunction with" other pr ovisions. This is confirmed by the European
Communities itself in its reply to questions of the United States referred to above.

7.170 The Panel notes the argument of the United States that the European Communities is trying to
impose obligations that are not supported by the text of the provisions concerned. We recall that
paragraph 1 of Article 31 of the Vienna Convention on the Law of Treaties, embodying the customary
rules of interpretation of public international law referred to in Article 3.2 of the DSU, provides that:
"A treaty shall be interpreted in good faith in accordance with the ordinary meaning
to be given to the terms of the treaty in their context and in the light of its object and
purpose."
7.171 The Panel does not exclude that there could be situations where the rights or obligations of
Members could vary depending on which other provision a particular article of the DSU is read
together with. However, either the terms of the provisions concerned interpreted in their ordinary
meaning, in their context and in the light of the object and purpose of the treaty or the provisions
support the claim, or they do not. Likewise, it is often the case that the violation of a particular
provision will have consequences on the legality of the measure at issue under other provisions of the
same or of other covered agreements.
7.172 We note that, in US – Certain EC Products, the panel stated that:
"Since we have already concluded that the 3 March Measure constituted a measure
taken to redress a WTO violation (covered by Article 23.1), we proceed to examine
whether the same 3 March Measure violated the provisions of the sub-paragraph 2(c)
of Article 23 of the DSU, as well as Articles 3.7 and 22.6 of the DSU."
419
7.173 In other words, it would appear that the panel in US – Certain EC Products , even though it
considered the effects of a finding of violation of one provision on the other – this is probably what it
meant by "Article 23.1 together with Articles 23.2( c), 3.7 and 22.6 of the DSU" in the title of the
section where the above quotation is found – neve rtheless made findings of violation of each
provision individually. We note that, likewise, the Appellate Body assessed the panel findings on each
provision separately.420
7.174 The European Communities states that, if it had not specified Articles 21 and 22 in its request
for establishment of a panel, the United States woul d have probably argued that these provisions were
not part of the terms of reference of the Panel. This would suggest that the European Communities is
actually requesting findings only in relation to Artic le 23.1 and 23.2(a), the references to the other
provisions being part of the context in which the obligations under Article 23 have to be assessed.
This seems to be confirmed by the EC conclusion in its first written submission where the European
Communities states that the United States violates Article 23 of the DSU and, more particularly,
Article 23.2(a) read in conjunction with Articles 21. 5 and 23.1 of the DSU and violates Article 23.1,
read in conjunction with Articles 22.8 and 3.7 of the DSU.
7.175 We note, however, that the European Communities listed all these provisions in its request for
establishment of a panel and confirmed in its reply to the US question referred to above that it "is
maintaining its claim under Article 21.5". As far as Article 22.8 is concerned, the European
Communities states that the panel request lists all th e relevant provisions which the United States is
currently violating and, in particular, Article 22.8 and Article 23.1.
7.176 While the European Communities see ms to insist on the violations of Article 23, the Panel
does not believe that the terms "read together with /read in conjunction with" were meant to limit its
findings of violation to Article 23. Rather, the European Communities is seeking findings on all the

419 Panel Report on US – Certain EC Products, para. 6.36.
420 Appellate Body Report on US – Certain EC Products, para.106 et seq.

provisions cited but, because of the broadly cast wo rding of Article 23, the European Communities
seeks to circumscribe the context in which that violati on is to be found. In other words, it wants us to
articulate any findings of violation of Article 23 with the violations of Articles 21.5, 22.8 and 3.7 of
the DSU.
7.177 The Panel concludes that the fact that the European Communities is seeking findings of
violation of Article 23 "read together with" or "r ead in conjunction with" should not be understood as
meaning that the European Communities exclusively claims a violation of Article 23. The Panel
believes that its mandate includes Articles 21.5, 22.8 and 3.7 of the DSU.
(d) Conclusion
7.178 From the above we conclude that:
(a) the indications given by the European Communities on how it wants this case to be
addressed (main claims and alternative claim) are part of the Panel's mandate;
(b) the indication by the European Communities that certain provisions referred to in its
request for establishment of the Panel be "read together" or "in conjunction with"
does not mean that the Panel is not exp ected to make findings on each of these
provisions.
5. Approach of the Panel on the basis of its mandate
7.179 We are mindful of the EC position that this case is primarily about alle ged violations of the
DSU and, in particular, Article 23 thereof. We note in particular the EC argument that it brought this
case because the United States refused to initiate a procedure under Article 21.5 of the DSU and did
not agree to any other procedural arrangement.421 We note that the European Communities also claims
that the United States breaches Article 23 of the DS U read together with Article 22.8 because it failed
to withdraw its suspension of obligations in spite of the EC removal of the measure found to be
inconsistent with a covered agreement.
7.180 We also recall that the United States' defence consists of arguing first that the European
Communities has failed to prove that the United Stat es has breached Article 22.8 of the DSU. The
position of the United States is that it does not br each Article 22.8 of the DSU because the European
Communities has failed to comply with the r ecommendations and ruling of the DSB in the EC –
Hormones case. In support, it argues that Directiv e 2003/74/EC still breaches provisions of the
SPS Agreement, more particularly Articles 3.3, 5.1 and 5.7 thereof. The other violations of the DSU
and GATT 1994 are only addressed by the United States in a second stage.
7.181 In our opinion, the EC claims of violation of Article 23.2(a) read together with Articles 21.5
and 23.1 are not premised on compliance by the European Communities with the DSB
recommendations and ruling in the EC – Hormones case, whereas the claims of violation of
Article 23.1, read together with Articles 22.8 and 3. 7 of the DSU, are. Indeed, the EC claims of
violation of Article 23.2(a), read together with Articles 21.5 and 23.1 of the DSU are premised on the
fact that the respondent would have maintained a measure that could be deemed to be a
"determination to the effect that a violation has occurred" without having recourse to dispute
settlement in accordance with the DS U. Such a determination could take place whether or not the
European Communities has complied with the DSB recommendations and rulings in EC - Hormones.
Comparatively, the second series of EC claims is, to the extent that it includes Article 22.8, premised
on the requirement that the respondent measure can "only be applied until such time as the measure

421 EC's first written submission, para. 5.

found to be inconsistent with a covered agreement has been remo ved", as claimed by the European
Communities. Thus, addressing the second series of main claims of the European Communities
entails that we review the question of the presu med or actual compliance of the EC implementing
measure with the DSB recommendations and rulings in the EC – Hormones case.
7.182 We believe that these two series of claims, as presented by the European Communities, are
independent from each other and can be addressed co mpletely separately. However, while we are free
to structure the order of our analysis as we see fit 422, we see no reasons not to review the EC claims in
the order followed by the European Communities in its submissions. We therefore proceed now with
the first series of claims raised by the European Communities.
B. FIRST SERIES OF EC CLAIMS : VIOLATION OF ARTICLE 23.2(A) READ TOGETHER WITH
ARTICLES 21.5 AND 23.1
1. Summary of the main arguments of the parties423
7.183 The European Communities argues that by maintaining its suspension of obligations, the
United States is seeking redress of a perceived viol ation of the WTO Agreement. Pursuant to
Article 23 of the DSU, any attempt to seek "redr ess" can take place only pursuant to the rules and
procedures of the DSU. The US continued suspen sion of obligations is contrary to the specific
prohibition of unilateral conduct set out in Article 23.2(a) of the DSU. Instead, the United States
should have introduced a compliance procedure under Article 21.5 of the DSU. By not doing so, the
United States has violated the specific prohibition of unilateral conduct set out in Article 23.2(a) of
the DSU. This violation of Articles 23.2(a) and 21 .5 constitutes at the same time a violation of
Article 23.1 of the DSU.
7.184 The European Communities, referring to the panel report in US – Section 301 Trade Act,
notes that the following three conditions need to be fulfilled in order to find a violation of
Article 23.2(a) of the DSU.
(a) First, given the "chapeau" of Article 23.2, it needs to be established that a Member is
seeking to redress a WTO violation. In the opinion of the European Communities,
this is the case here.
(b) 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." 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 m eans (albeit of last resort) of reacting to
a violation and therefore necessarily implies a decision that there is a violation. The
multilateral determination at the origin of the current US suspension of concessions
was, however, made with respect to the me asures previously applied by the European
Communities. Logically, it could not and did not apply to the measures subsequently
adopted and properly notified to the WTO by the European Communities. If the
United States continues to apply the suspension of concessions and related
obligations, it necessarily implies that it has unilaterally determined that there
continues to be a violation. It has, in addition, explicitly said so.

422 Appellate Body Report on Canada – Wheat Export and Grain Imports, paras. 126-129.
423 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective arguments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.

(c) Third, Article 23.2(a) of the DSU is violated if the determination is not made in
accordance with the rules and procedures 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 addr ess the situation that Members disagree over
the existence or consistency of measures taken to comply with the recommendations
and rulings of the DSB.
7.185 In the view of the European Communities, there exists obviously a disagreement as to
whether or not, by adopting Directive 2003/74/EC, the European Communities has implemented the
recommendations and rulings from the DSB in the EC – Hormones case. Article 21.5 of the DSU
requires that that disagreement shall be decided through recourse to dispute settlement. To date, the
United States has refused to initia te a compliance procedure under Article 21.5 (or, for that matter,
any other dispute settlement procedure under the DSU) . Instead, it continues to apply the suspension
of concessions and other obligations as if no "m easure to comply" had been taken or the non-
compliance of the new directive of the Europ ean Communities had already been multilaterally
established.
424
7.186 The United States argues that it does not seek anything within the meaning of Article 23.1
with respect to the EC declaration of complian ce. The United States has already sought and obtained
redress through the multilateral dispute settlement system for a violation found by the DSB. There is
no provision in the WTO Agreement that provides that a single Member can unilaterally invalidate the
multilateral decision of the DSB to authorize susp ension of concessions. The European Communities
has not provided any evidence that it has complied with the conditions of Article 22.8 of the DSU.
7.187 According to the United States, Article 23.2(a), li ke Article 23.1, applies only in situations
where a Member is "seeking redress for a violation" of a WTO obligation. The United States has not,
through the continued application of the DSB au thorization, sought redress for another Member's
violation. Likewise, the United States did not make a "determination" within the meaning of
Article 23.2(a). The United States has simply contin ued to act according to the DSB authorization.
The United States did not need to make further determ inations to continue to apply the suspension of
concessions.
7.188 The United States believes that none of the stat ements made by the United States and referred
to by the European Communities constitute a determ ination within the meaning of Article 23.2(a).
They are simply statements of the status of the US evaluation of the EC measure at that point in time
based on the information available. The statemen ts referred to by the European Communities make
no reference to a WTO violation. The United States remained open to discussing any further
information that the European Communities might have developed in support of its declaration of
compliance and to this end engaged in informal consultation and technical discussions and made a
request under Article 5.8 of the SPS Agreement seeking all of the material underpinning the EC
import ban.
7.189 For the United States, under the European Communities' reading of Article 23.2(a), a
complaining Member need not actually indicate any definitive view on the WTO consistency of an
implementing Members' measure to have made a determination. The implementing Member can
force a complaining Member into breach of Article 23.2(a) by making a unilateral declaration of
compliance that the complaining Member does not immediately agree with or test through the
immediate invocation of Article 21.5 proceedings.
7.190 The United States adds that the US – Section 301 Trade Act panel report concluded that a
"determination" must be sufficiently firm and immutable, in other words "a more or less final

424 EC's first written submission, paras. 35-68.

decision". The definition of the term "determination" emphasizes not only the finality of the decision,
but also its formality. It does not contemplate that a determination can be implicit. The ordinary
meaning of the term makes it clear that the opini ons and views of the United States cited by the
European Communities did not rise to the level of "determinations" within the meaning of
Article 23.2(a).
7.191 The United States argues that the EC Article 21.5 claim fails because the European
Communities has not established that there is a "disag reement as to the existence or consistency with
a covered agreement of measures taken to comply". Article 21.5 sets no deadline by which such a
proceeding must be brought and nothing in the te xt of Article 21.5 places the onus of initiating a
compliance proceeding on the original complaining party (in this case, the United States). Finally, the
phrase "these dispute settlement proceedings" in Arti cle 21.5 is not restricted to proceedings under
Article 21.5, but rather could include proceedings such as arbitration under Article 22.6 of the DSU,
proceedings under Article 25 of the DSU, or the proceedings of a de novo panel, as the European
Communities has sought in this instance.
425
7.192 Regarding the term "seeking redress" in Article 23.1, the European Communities argues that
a DSB authorization which has been granted in view of an original WTO-inconsistent measure cannot
justify the continued application of sanctions against a different m easure which has never been found
multilaterally to constitute a WTO violation. Any presen t application of sanctions must be linked to a
present measure. The US argument leads to the absu rd result that the United States could continue to
apply sanctions irrespective of any event occurring af ter the DSB authorization. The United States
fails to acknowledge that the original situati on has been altered by the adoption of the EC
implementing measure. The United States is under no obl igation to continue to suspend obligations.
The very fact that it does it in this new situation demonstrates that it indeed considers that there is a
causal link between the continuation of the suspensi on and the determination of inconsistency of the
EC compliance measure. If one considers that the United States continues to apply sanctions because
of an import ban as such, it would do so against a new measure, since the current import ban is
different from the one which the DSB found WTO inconsistent.
7.193 With respect to the term "determination" in Article 23.1(a), the European Communities argues
that it is clear from the panel report in US – Section 301 Trade Act , that even an implicit
determination through the continuation of sanctions would be covered by this requirement. Article 23
aims at preventing that a Member seek the redr ess of a violation on the basis of a unilateral
determination. In light of the overall context and fundamental importance of Article 23, it is justified
to look at a Member's behaviour as a whole when con fronted with a particular situation. Not every
policy statement may be equal to a "determination" or made with the purpose of "seeking a redress of
a violation". However, in the present case the United States has clearly stated that it does not consider
the EC compliance measure to be sufficient. For in stance, the US statement at the DSB meeting of
December 2003 is evidence that the United States expressed a definitive judgement about the EC
measure. The United States also continues to apply sanctions. There is no way to consider this as
"inaction" on the part of the United States, just because stopping the sanctio ns would require some
action. The European Communities also recalls th at it notified its implementing measure in 2003,
which begs the question when the United States w ill make a "determination". If the United States
truly wanted to reflect further before making an y "determination" or initiating any procedure under
Article 21.5, it could have suspended the applica tion of sanctions. Article 23 does not prohibit any
determination, it prohibits only unilateral determinations of non-compliance.
7.194 The United States argues that the Panel findings in US – Certain EC Products cited by the
European Communities are based on the lack of any DSB recommendations and rulings. The panel
found that the United States acted without having yet been authorized to do so by the DSB. The

425 US's first written submission, paras. 177-202.

European Communities appears to in sinuate that its declaration of compliance has placed the parties
back in the position they found themselves in the US – Certain EC Products case.
7.195 The United States also argues that, as a proc edural matter, the EC interpretation of
Article 23.2(a) is complicated by the lack of clarit y regarding when a determination on the part of the
suspending Member would be inferred. The Europe an Communities argues that there is a reasonable
period of time during which the suspending Member may review the measure before a determination
is either inferred or due. However, no such reasonable period is set out in the text of Article 23.
7.196 The United States adds that a critical element of the US evaluation is the review of the studies
and Opinions underpinning the EC ban. The United States has not had the opportunity to review all
of these documents. This is why it has not yet been able to reach a determination on the EC ban. The
EC has only recently informed the Un ited States of a number of studies that were not referenced in its
response to the US request for information under Article 5.8 of the SPS Agreement. Given the
difficulty in procuring the material supporting the EC measure, it is perfectly understandable why the
United States has not yet made a "determination" as to the WTO-consistency of the EC import ban.
426
2. Reasoning of the Panel
(a) Introduction
7.197 The European Communities claims a violation of Article 23.2(a), read together with
Articles 21.5 and 23.1. Article 23.2(a) contains sp ecific obligations compared with Article 23.1. We
therefore deem it relevant to address the violation of Article 23.2(a) first.427
7.198 Article 23.2(a) reads as follows:
"2. In such cases, Members shall:
(a) not make a determination to the effect that a violation has occurred, that
benefits have been nullified or impaired or that the attainment of any objective of the
covered agreements has been impeded, ex cept through recourse to dispute settlement
in accordance with the rules and procedur es of this Understanding, and shall make
any such determination consistent with the findings contained in the panel or
Appellate Body report adopted by the DS B or an arbitration award rendered under
this Understanding;"
7.199 In order to decide whether the United States h as or has not breached Article 23.2(a) in this
case, the Panel must first find whether the determin ation was made "in such cases", i.e. when the
conditions of Article 23.1 are met.

426 US's second written submission, paras. 15-22.
427 We note in this respect that, as mentioned by the Appellate Body in Canada – Wheat Export and
Grain Imports, paras. 126-129:

"As a general principle, panels are free to structur e the order of their analysis as they see fit.
In so doing panels may find it useful to take account of the manner in which a claim is
presented to them by a complaining Member. Furthermore, panels may choose to use
assumptions in order to facilitate resolution of a particular issue ..."

7.200 Article 23.1 reads as follows:
"When Members seek the redress of a violation of obligations or other nullification or
impairment of benefits unde r the covered agreements or an impediment to the
attainment of any objective of the covered agreements, they shall have recourse to,
and abide by, the rules and procedures of this Understanding."
7.201 In other words, the Panel must first establish whether the United States, in relation to the facts
of this case, has been seeking redress of a violation of obligations or other nullification or impairment
of benefits under the covered agreements, within the meaning of Article 23.1 of the DSU.
7.202 Thereafter, the Panel will proceed with determ ining whether the United States has breached
Article 23.2(a). Once this is done, it will review the alleged violation of Articles 21.5 and 23.1, as
necessary.
(b) "[S]eeking the redress of a violation of obliga tions or other nullification or impairment of
benefits under the covered agreements" (Article 23.1 of the DSU)
7.203 The United States argues that it does not seek anything within the meaning of Article 23.1
with respect to the EC declaration of compliance with the WTO Agreement. The United States alleges
that it has already sought and obtained redress thr ough the multilateral dispute settlement system for a
violation found by the DSB.
7.204 We agree with the United States that Article 23.1 of the DSU is not breached when a
Member's suspension of concessions or other obliga tions has been multilaterally authorized by the
DSB, because the Member concerned "ha[d] recourse to, and abide[d] by, the rules and procedures of
[the DSU]", within the meaning of Article 23.1. Indeed, the United States already sought redress
against the original EC ban under the DSU.
7.205 In the opinion of the Panel, Article 23.1 a pplies in this case only with respect to a
determination against a measure which has not ye t been subject to a recourse to the rules and
procedures of the DSU. We must therefore dete rmine first whether Directive 2003/74/EC is such a
measure.
7.206 We note the arguments of the European Commun ities that it adopted a new directive which it
considers implements the recommendations and rulings of the DSB in the EC – Hormones case.428
We also note that the United States recognized before the DSB that the EC had adopted a "revised ...
measure" and a "new directive". 429 We first note that Directive 2003/74/EC has never been as such
subject to recourse to the rules and procedures of the DSU by the United States. For instance, no
panel has been established at the request of the Un ited States to review the conformity of Directive
2003/74/EC with the covered agreemen ts. Second, the fact that both parties consider that the EC
implementing measure is not the same measure as that which was found in breach of the WTO
Agreement by the DSB in the EC – Hormones case is confirmed by the allegations they made in
relation to that implementing measure before this Panel. The European Co mmunities considers that
its ban on oestradiol-17 β is compatible with Article 5.1 of the SPS Agreement, whereas its ban on the
other five hormones is justified by Article 5.7. The United States alleges, inter alia , the
incompatibility of the ban on oestradiol-17 β with Article 5.1 and 5.2, and of the provisional ban on
the other five hormones with Article 5.7. These are different provisions than those invoked in the EC

428 EC's first written submission, para. 17.
429 WT/DSB/M/157, paras. 29-30.

– Hormones case with respect to the same hormones. 430 Thus, the United States acknowledges that
the measure is different from the original measure found in breach of the WTO Agreement not only
formally but also in substance and legally, even though an import ban on meat treated with hormones
for growth promotion purposes is still applied.
7.207 We note that the original ban remains in force. We consider, however, that this is insufficient
to conclude that Directive 2003/74/EC is not differe nt from the measure originally found in breach of
the WTO Agreement and should be deemed for that reason to have been subject to the rules and
procedures of the DSU. We recall that it is not the ban on meat treated with growth promotion
hormones as such that was found illegal in the EC – Hormones case, but the justification for this ban
which was found insufficient. The Europ ean Communities is not prevented by the SPS Agreement
from imposing any ban on import of meat treated with growth promotion hormones. The European
Communities can impose such a ban provided it is comp atible with the relevant requirements of the
SPS Agreement. As a result, the Panel does not consider th at the fact that the ban remains in place
means that no new measure has been adopted.
7.208 The United States argues that its suspension of obligations was, and remains, multilaterally
authorized by the DSB. To date, the authori zation to suspend concessions and other obligations
granted on 26 July 1999 to the United States by the DSB has not been revoked by the DSB and the
United States continues to act pursuant to that authority.
431 The United States also argues that there is
no provision in the WTO Agreement that provides that a single Member can unilaterally invalidate the
multilateral decision of the DSB to authorize susp ension of concessions. According to the United
States, the European Communities has not provide d any evidence that it has complied with the
conditions of Article 22.8 of the DSU.
7.209 We agree with the United States that it was authorized to suspend concessions and that this
authorization has not been revoked. We note however, that this is only an authorization, not an
obligation imposed by the DSB. The Panel agrees with the European Commun ities in this respect:
"authorization by the DSB" does not mean "obligati on to suspend concessions". This is confirmed by
the practice under the DSU pursuant to which, in a number of cases where authorizations to suspend
concessions have been requested, no suspensions w as subsequently applied, in spite of the DSB
authorization.432 In other words, the fact that, after the notification of Directive 2003/74/EC, the
United States continues to apply its suspension of concessions even th ough it has no obl igation to do
so is evidence that the United States is actively " seek[ing] the redress of a violation of obligations or
other nullification or impairment of benefits under the covered agreements".
7.210 We note that the DSU does not provide for any procedure regarding the revocation of an
authorization to suspend concessions. The adoption of a decision to revoke such an authorization by
the DSB would require consensus 433, which would in turn require an absence of objection from the
Member suspending concessions or other obligations, which may be di fficult to obtain. We consider
that this is not necessary, essen tially because the DSB grants an authorization, which the Member
concerned is free to apply or not. We also note that Article 22.8 of the DSU does not provide for any
decision of the DSB for a suspension of concessions or other obligations to cease to apply. The first
sentence of Article 22.8 simply provides that:

430 In the original EC – Hormones dispute, the panel noted the EC 's statement that its measures were
not provisional measure in the sense of Article 5.7 of the SPS Agreement. See Panel Report on EC – Hormones
(US), para. 8.249.
431 US's first written submission, para. 26.
432 In the Brazil – Aircraft case and the Canada – Aircraft Credits and Guarantees case, the DSB
authorized Canada and Brazil respectively to suspend obliga tions, but neither of them applied the authorization.
In the EC – Bananas III case, Ecuador was authorized to retaliate but did not exercise its right.
433 See Article 2.4 of the DSU.

"The suspension of concessions or other obligations shall be temporary and shall 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 the nullifi cation or impairment of benefits, or a
mutually satisfactory solution is reached." (Emphasis added)
7.211 In none of the circumstances foreseen by Article 22.8 does this provision require a decision of
the DSB. In other words, it is for the respondent in this case to take appropriate steps to ensure that
the suspension of concessions or other obligations is only applied until such time as foreseen in
Article 22.8.
7.212 We also note that, pursuant to Article XVI:4 of the Agreement Establishing the WTO,
Members must ensure the conformity of their laws, regulations and administrative procedures with
their obligations as provided in the agreements annexed to the Agreement Establishing the WTO,
including the DSU.
7.213 We conclude that the United States does not need a multilateral decision in order to terminate
the suspension of concessions or other obligations for which it got authorization from the DSB.
7.214 For the reasons stated above, we consider that the EC implementing measure is, compared
with the measure for which the United States was granted authorization to suspend concessions and
other obligations by the DSB, a measure which has not been subject to a r ecourse to the rules and
procedures of the DSU.
7.215 The United States, by maintaining its suspension of concessions even after the notification of
the EC implementing measure, is seeking redress of a violation with respect to the EC implementing
measure, within the meaning of Article 23.1 of the DSU. If it were not, as mentioned above, the
United States would not have to maintain that suspension.
7.216 We now proceed to assess whether the United States breached Article 23.2(a).
(c) Violation of Article 23.2(a)
(i) Introduction
7.217 In order to assess whether the United States breaches Article 23.2(a), we must review the
following conditions:
434
(a) whether the United States made a determin ation that the EC implementing measure
violates the WTO Agreement;
(b) whether the United States failed to make such determination through recourse to
dispute settlement in accordance with the rules and procedures of the DSU; and
assuming that it did,
(c) whether the United States failed to make an y such determination consistent with the
findings contained in the panel or Appella te Body report adopted by the DSB or an
arbitration award rendered under this Understanding.
7.218 We will review these requirements successively.

434 We note that a similar approach was applied by the Panel in US – Section 301 Trade Act ,
footnote 657.

(ii) Did the United States make a determination that the EC implementing measure violates the
WTO Agreement?
7.219 We note that, in the present case, the European Communities notified its implementing
measure on 27 October 2003.435 At the DSB meeting of 7 November 2003 the United States made the
following statement which is worth quoting in full in order to better understand its scope:
"The representative of the United States said that her country had reviewed the
communication placed by the EC on the agenda of the present meeting and had
listened to the statement that the EC had ju st made. The United States failed to see
how the revised EC measure could be considered to implement the DSB's
recommendations and rulings in this matter. For nearly 15 years, the EC had banned
the importation of nearly all meat and meat products from the United States. The
purported basis of the EC ban was that the c onsumption of meat from cattle raised in
the United States with growth-promoting horm ones posed a risk to human health. It
was a bedrock principle of the SPS Agreement, however, that banning a product for
purported health reasons had to be based on science. The EC measure was not based
on science. To the contrary, after repeated study, no increased hea lth risk had ever
been associated with the consumption of meat from animals treated with growth-
promoting hormones. The Joint FAO/WHO Expert Committee on Food Additives
had found that there was a wide margin of safety for these products. For example, it
had determined that consumption of beef from treated animals resulted in amounts of
estradiol that were 300 times lower
than the acceptable daily intake level. Moreover,
hormones such as estradiol were already pr oduced in abundance by both the human
body and cattle, and were naturally present in many everyday foods. For example,
each person daily produced amounts of est radiol ranging from 2,000 to 30,000 times
more, or higher, than the amount consumed from eating a 250-gram serving of meat
from treated animals. Due to high levels of naturally-occurring hormones in cattle, it
was not even possible to distinguish any r esidues of such hormones administered for
purposes of growth promotion. A single chicken egg contained many times more
estradiol equivalents than the estradiol contained in a 250 gram serving of meat from
a treated animal. A litre of milk from an untreated cow contained approximately 18
times as much estradiol as a 250 gram serving of meat from a treated animal.
In February 1998, the DSB had adopted findi ngs that the EC ban was not based on an
appropriate risk assessment, as required by Article 5.1 of the SPS Agreement, and had
recommended that the EC bring its me asure into compliance with its WTO
obligations. Near the conclusion of th e 15-month compliance period, on 30 April
1999, the EC had issued a report by an EC veterinary committee claiming increased
health risks from the use of growth-promoting hormones. However, this claim was
not based on science. Just like the reports relied upon by the EC before the panel and
the Appellate Body, the April 1999 report consisted of general discussions of types of
risks, but had never actually assessed or found any increased risk from the
consumption of meat from animals produ ced with growth-promoting hormones.
And, indeed, the EC had never, until now, claimed to the DSB that the April 1999
report was an appropriate basis for adopting a ban on US beef. To the contrary,
during the arbitration under Article 22.6 on the level of nullification and impairment
suffered by the United States, the EC had acknowledged that – even after the issuance
of the April 1999 report – it had not implemented the recommendations and rulings of
the DSB. For example, in its opening submission filed on 11 June 1999, the EC had
written that it "accepts that it has not take n the required measures to comply with the

435 WT/DS26/22.

DSB recommendations". In July 1999, the DSB had authorized the United States and
Canada to suspend concessions. Again, th e EC had never claimed that its April 1999
report served as an appropriate basis for its ban on meat from treated animals. At the
present meeting, the EC had presented Directive 2003/74 to the DSB, and claimed
that this directive implemented the DSB's recommendations and rulings. The
Directive, however, neither removed th e EC's unjustified ban on US beef, nor
presented an appropriate risk assessment as a basis for the ban. Further, aside from
the ban on estradiol, the directive relabe lled its ban on the other five growth-
promoting hormones covered in this matter as "provisional measures". A decision by
the EC to relabel its measures, however, could not bring it into compliance with its
obligations under the SPS Agreement. Nearly six years had passed since the DSB had
recommended that the EC bring its ban on US beef into compliance with its
obligations. The United States, however , could not understand how this new
directive presented now could amount to implementation of the DSB's
recommendation."
436
7.220 The United States made another statement at the DSB meeting of 1 December 2003:
"The representative of the United States said that she would transmit the statement
made by the EC at the present meeting to her authorities for their consideration. As
had been explained at the 7 November DS B meeting, the United States failed to see
how the revised EC measure could be considered to implement the DSB's
recommendations and rulings in this matte r. The United States had always been
ready to discuss with the EC any matters regarding its compliance with the DSB's
recommendations and rulings. The United St ates would be pleased to discuss with
EC officials any outstanding issues regarding the EC's ban on certain beef produced
in the United States, includin g their reactions to the detailed points that the United
States had raised in its statement at the 7 November DSB meeting. With regard to the
suggestion made by the EC at the presen t meeting that multilateral proceedings be
initiated, the United States would be happy to discuss this suggestion with the EC
along with other procedural options."
437
7.221 The European Communities also refers to other statements by the United States.438
7.222 We recall that the Panel in US – Section 301 Trade Act defined a "determination" as follows:
"[W]e consider that – given its ordinary meaning – a "determination" implies a high
degree of firmness or immutability, i.e. a more or less final decision by a Member in
respect of the WTO consistency of a measure taken by another Member."439
7.223 The two statements quoted above were delivered by an official of the US government at a
formal meeting of a WTO body. There is no formal difference between that statement and any other
statement where a formal decision of a Member is conveyed to the DSB.
7.224 We note that the second statement quoted above s uggests that the United States was ready to
consult with the European Communities, including on procedural issues. The Panel notes that, in
response to one of its questions, the parties specified the extent of the cons ultations that took place

436 WT/DSB/M/157, paras. 29-30.
437 WT/DSB/M/159, para. 25.
438 See US press release of 8 November 2003 and 2005 Trade Policy Agenda and 2004 Annual Report
of the President of the United States on the Trade Agreements Program, Exhibit EC-5.
439 Panel Report on US – Section 301 Trade Act, footnote 657.

after the notification of Directive 2003/74/EC. The Pa nel notes that they largely related to procedural
issues.440
7.225 This said, even if the United States showed readiness in its statemen t to discuss with the
European Communities and even if discussions actua lly took place, the United States position at the
time of its statement before the DSB was quite clear , as illustrated by remarks such as: "[t]he United
States failed to see how the revised EC measure could be considered to implement the DSB's
recommendations and rulings in this matter"; "D irective [2003/74/EC], however, neither removed the
EC's unjustified ban on US beef, nor presented an a ppropriate risk assessment as a basis for the ban";
"[a] decision by the EC to relabel its measures, how ever, could not bring it into compliance with its
obligations under the SPS Agreement"; "[t]he United States, however , could not understand how this
new directive presented now could amount to implementation of the DSB's recommendation"; or "[as]
had been explained at the 7 November DSB meetin g, the United States failed to see how the revised
EC measure could be considered to implement the DSB's recommendations and rulings in this
matter."
7.226 The style and content of the statement are such that they can be reasonably deemed to convey,
with a high degree of firmness and immutability, a mo re or less final decision. Nowhere in that
statement is there any indication that the United St ates was still reviewing the new EC Directive, or
that it was expecting more information or planni ng to seek more inform ation from the European
Communities. In this respect, it merely expr essed "readiness to discuss" . The United States
expressed a clear opinion as far as the legality of th e EC notified measure was concerned. The United
States might have still been in the process of revi ewing the EC implementing measure, but this does
not show from this statement or from any other statem ent referred to by the parties. Moreover, the
United States had obviously taken the decision to maintain its suspension of concessions, since the
latter continued to apply. We therefore consider th at the US statement meets all the requirements of
the definition in the Panel Report in US – Section 301 Trade Act and that the United States made a
"determination" within the meaning of Article 23.2(a).
7.227 The United States argues that a critical element of the US evaluation is the review of the
studies and Opinions underpinning the EC ban. The United States claims that it has not had the
opportunity to review all of these documents. This is why it has not yet been able to reach a
determination on the EC ban. The United States notes that the European Communities has only
recently informed the United States of a number of st udies that were not referenced in its response to
the US request for information under Article 5.8 of the SPS Agreement. The United States adds that,
given the difficulty in procuring the material supporting the EC measure, it is perfectly understandable
why the United States has not yet made a "determination" as to the WTO-consistency of the EC
import ban.
441
7.228 We are not convinced by this argument. There is no element in the statements of the United
States before the DSB indicating that it was still reviewing the documents or even that it contemplated
difficulties in obtaining the studies underpinning the EC new Directive.
7.229 As far as the request under Article 5.8 is concer ned, the US letter on this subject was sent on
13 December 2004, more than one year after the notification of the implementing measure by the
European Communities and after consultations on th e present case were requested by the European
Communities. Thus, the Panel finds it difficult to conc lude that this request was linked to any review
of the EC implementing measure that the United States would have been carrying out since the
notification of Directive 2003/74/EC.

440 See Annex B-3, US's replies to Panel questions after the first substantive meeting, question 50.
441 US's second written submission, paras. 19-22.

7.230 Even if one were to consider that the US st atements at the DSB were provisional comments,
the subsequent continuation of the suspension of concessions by the United States without alteration
and without saying that it was still studying th e EC implementing measure is evidence that the
statements before the DSB meant that the United States had no intention to remove its retaliatory
measure, at least until further notice. We note in this respect that the term "determination" does not
necessarily imply a formal decision, all the more so as such a formal d ecision was not necessary in
order to continue the suspension of concessions. The continuation of the suspension of concessions
corroborates the fact that the US statements befo re the DSB constituted "determinations" within the
meaning of Article 23.2(a).
7.231 The United States argues that no period of time is provided for in Article 23 within which a
Member shall make a determination and that, unde r the interpretation advocated by the European
Communities, the European Communities can for ce the United States into a violation of
Article 23.2(a) by making a unilateral declaration of compliance that the complaining Member does
not immediately agree with or test through the immediate invocation of Article 21.5 proceedings.442
7.232 We agree with the United States that there is no deadline in Article 23 by which a Member
shall have recourse to the DSU. This, however, is not the issue before this Panel. The issue is
whether the United States made a determination with in the meaning of Article 23.2(a) or not. We
have found that the United States has made such de termination by making its statements before the
DSB on 7 November and 1 December 2003. Even if the determination was not fully made on that
date, the continued suspension of concessions by the United States over the period between the EC
notification and the date of request of consultatio ns by the European Comm unities in this case is
evidence that the United States made such a determination.
7.233 In this case, the United States could have cl early stated that it was reviewing the EC
implementing measure and expressly stated that it needed more time and more information to do so.
It did not. On the contrary, it stated before the Di spute Settlement Body that it " failed to see how the
revised EC measure could be considered to implement the DSB's recommendations and rulings in this
matter" and went on to explain in details why it thought so.
7.234 We note the argument of the United States that th e situation in this case is different from that
in US – Certain EC Products , where no DSB authorization had b een granted to the United States at
the time of the measure at issue. However, we have concluded above that the authorization to
suspend concession or other obligations on the basis of which the United States imposed its sanctions
had been granted with respect to the original measure. As far as the implementing measure is
concerned, it has not even been subject to a recourse to the rules and procedures of the DSU.
7.235 The United States also argues that the EC inte rpretation would lead to an endless loop of
litigation because any Member could notify a "scam legi slation" and force the original complainant to
request a panel under Article 21.5 of the DSU.
7.236 We are mindful that this argument was raised by the United States in relation to its alleged
violation of Article 21.5 of the DSU. We nonethel ess believe that we should address it to the extent
that the notification of an implementing measure would be the type of measure which could,
according to the United States, start such an "endless loop of litigation".
7.237 First, we believe that not only scam legisla tion, but also any other implementing measures
could lead to recurrent litigations. One could envisage that, in a complex case, a Member could notify
in good faith an implementing measure which would be subsequently found not to fully comply with
the original recommendations and ruling of the DSB. This Member would have to submit a revised

442 US's second written submission, para. 17.

measure which could, once again, be challenged and found to comply only partly with the covered
agreements. Such repeated inconsistencies could ha ve to do with the fact that, pursuant to Article
19.1 of the DSU, panels and the Appellate Body may only recommend that the Member concerned
bring its legislation into conformity with the covered agreement(s) found to be breached, and may
only make non-binding suggestions regarding ways in which the Member concerned could implement
their recommendations. Since Members remain free to implement recommendations and rulings as
they deem appropriate, differences in the interpre tation of the recommendations of the DSB cannot be
excluded, which can result in old inconsistencies remaining in the implementing measure or in new
ones creeping into it.
7.238 Second, we recall that our findings are limited to the facts of this particular case. In this case,
the European Communities has adopted Directiv e 2003/74/EC at the outcome of a lengthy and
complex internal decision-making process. The Pa nel notes in this respect that the Commission
proposal was submitted in 2000 and 2001 and that th e procedure for the adoption of the Directive was
the procedure provided for in Article 251 of the Treaty establishing the European Community. This
procedure involved a number of steps, including an Opinion of the European Parliament (1 February
2001), a Common Position of the Council of the Eur opean Union (20 February 2003) and finally a
Decision of the European Parliament (2 July 2003) , a Decision of the Council of the European Union
(22 July 2003) and an adoption by the European Parliament and the Council of the European Union
on 22 September 2003.443 Without prejudice to the question whether Directive 2003/74/EC is actually
based on the three opinions of the Scientific Co mmittee on Veterinary Measures relating to Public
Health (SCVPH) of 1999, 2000 and 2002 444 within the meaning of the SPS Agreement, the Panel
notes that this Directive expressly refers to those opinions 445 and that, as a result, they were part of the
process that led to the adoption of the Directive. The Panel also notes the efforts of the European
Communities to have the conformity of its measure reviewed under the DSU. 446 Even if the EC
implementing legislation were ultimately found not to comply with the SPS Agreement, the Panel
considers that it shows all the signs of an implem enting measure having gone through all the formal
process required for its adoption and showing, on its face, all the signs of a measure adopted in good
faith.
7.239 We therefore conclude that the United States ma de a "determination" within the meaning of
Article 23.2(a) in relation to Directive 2003/74/EC.
(iii) Did the United States fail to make such determ ination through recourse to dispute settlement
in accordance with the rules and procedures of the DSU?
7.240 We note that the United States argues that it has not made any determination in respect of the
EC implementing measure and therefore did not ha ve to have recourse to the dispute settlement
procedures of the DSU. However, we found above that it made a determination within the meaning of
Article 23.2(a). Therefore, we conclude that th e United States made a determination without having
recourse to the DSU, thus breaching Article 23.2(a) of the DSU.
7.241 The United States also argues that it benefits from a multilateral authorization to suspend
concessions in relation to the breach by the European Communities of the SPS Agreement, as a result
of the recommendations and rulings of the DSB in the EC – Hormones case.

443 See Directive 2003/74/EC, Preamble and footnote 3.
444 Hereafter the "1999 Opinion", the "2000 Opinion" and the "2002 Opinion" or, together, the
"Opinions".
445 See Directive 2003/74/EC, whereas clauses 5 and 8.
446 See EC's replies to Panel questions after the first substantive meeting, question 50, Annex B-1.

7.242 This is not the issue, however. The issue is whether the authorization to suspend concessions
or other obligations granted to the United States under Article 22 of the DSU amounts to a multilateral
determination of inconsistency of the EC implementing measure (i.e., Directive 2003/74/EC) with the
covered agreements through recourse to the DSU. In our opinion, the answer is no.
7.243 We therefore conclude that the United States has not made any determination through
recourse to dispute settlement in accordance with the rules and procedures of the DSU.
(iv) Did the United States fail to make any such determination consistent with the findings
contained in the panel or Appellate Body repor t adopted by the DSB or an arbitration award
rendered under the DSU?
7.244 Since the United States has not made any determination through recourse to dispute
settlement in accordance with the rules and procedures of the DSU, we conclude a fortiori that the
United States has failed 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.
(v) Conclusion
7.245 For the reasons stated above, we find that th e United States has breached Article 23.2(a) of
the DSU.
(d) Violation of Article 21.5 of the DSU
7.246 We note that the European Communities claims that the United States should have had
recourse to Article 21.5 of the DSU. The United St ates argues that it is not obligated to initiate a
compliance procedure under Article 21.5.
7.247 We note that Article 23.2(a) provides that a determination must not be made "except through
recourse to dispute settlement in accordance with [the DSU]". It does not specify which procedure
under the DSU should be followed. While the pro cedure under Article 21.5 of the DSU could be one
of the mechanisms available, in our view, the te rm "recourse to dispute settlement in accordance with
the rules and procedures of this Understanding" en compasses any of the means of dispute settlement
provided in the DSU, including consultation, conciliation, good offices and mediation.
7.248 The last proposition of Article 23.2(a) provides that such determinati on shall be consistent
with the "findings contained in the panel or Appellate Body report adopted by the DSB or an
arbitration award rendered under this understanding." 447 We do not consider, however, that that
proposition requires that Members have recourse to a panel or to arbitration. In the opinion of the
Panel, the last proposition of Article 23.2(a) only requires the Member which decides to have recourse
to a panel or to arbitration to abide by the recommendation of the panel or the Appellate Body or the
award of the arbitrator.448
7.249 As a result, we do not find it necessary to make a finding on whether the United States
breached Article 21.5 by not having recourse to the procedure under that provision. Indeed, the
United States did not have recourse to any procedure under the DSU with respect to the EC
implementing measure (Directive 2003/74/EC). Under those circumstances, we deem it sufficient to

447 Emphasis added.
448 Comparatively, there was no need for the negotiators of the DSU to refer to compliance with the
results of consultations, mediation, conciliation or good offices since the results of such means of dispute
resolution have, by their very nature, to be accepted by the parties in order to produce effects.

limit our findings to Article 23 and exercise judici al economy with regard to the EC claim under
Article 21.5 of the DSU.
(e) Violation of Article 23.1 of the DSU
7.250 Since we found that the United States has sought th e redress of a violation with respect to the
EC implementing measure (Directive 2003/74/EC ) and made a determination without having
"recourse to dispute settlement in accordance with th e rules and procedures of [the DSU]" within the
meaning of Article 23.2(a), we conclude that the United States failed to "have recourse to, and abide
by, the rules and procedures of [the DSU]", in breach of Article 23.1 of the DSU.
3. Conclusion
7.251 On the basis of the above, the Panel concludes that the United States has violated Article 23.1
and 23.2(a) of the DSU by seeking redress of a violation of the WTO Agreement through a
determination that the EC implementing measure did not comply with the DSB recommendations and
rulings in the EC – Hormones case without having recourse to di spute settlement in accordance with
the rules and procedures of the DSU.
C. S
ECOND SERIES OF EC CLAIMS : VIOLATION OF ARTICLE 23.1, READ TOGETHER WITH
ARTICLES 22.8 AND 3.7 OF THE DSU
1. Summary of the main arguments of the parties449
7.252 The European Communities argues that, under Article 23.1 of the DSU, the United States is
obliged to have recourse to, and abide by, the ru les and procedures of the DSU, which encompass,
inter alia, Articles 22.8 and 3.7 of the DSU. 450 The European Communities argues more particularly
that Article 22.8 prohibits the continued unilatera l application of the suspension of concessions or
other obligations when the measure which has been found inconsistent is removed.451
7.253 The European Communities argues that the su spension of obligations should only apply
where and as long as justified and necessary. This is a practical consequence of the fact that
suspension of concessions should only be applied as "a last resort", as specified in Article 3.7 of the
DSU.
7.254 According to the European Communities, one obj ective of the suspension of concessions is to
induce compliance. This entails, however, that once a Member has adopted implementing measures
which are not properly challenged by the compla ining Member, the suspension of concessions or
other obligations can no longer be applied. The objective to induce compliance can only revive after
it has been properly established that the implemen ting measure has been insufficient to remedy a
WTO violation.
7.255 In the opinion of the European Communities, Ar ticle 22.8 of the DSU prohibits the continued
unilateral application of the suspension of concessi ons or other obligations when the measure which
has been found inconsistent is removed. The term "removed" thereby refers to the compliance by a
WTO Member because this provision is based on the respect of the WTO obligations by the Member
concerned.

449 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
450 EC's first written submission, para. 73.
451 EC's first written submission, para. 81.

7.256 The European Communities argues further that 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 countermeasures, it is clear
that a Member cannot unilaterally determine that the WTO inconsistency persists despite the
notification of a compliance measure. Likewise, a Member cannot decide to continue to suspend
concessions or other obligations unilaterally. Unless a procedure under Article 21.5 concludes that the
compliance measure does not fully implement the DSB recommendations and rulings, it cannot be
presumed that this is the case.
7.257 According to the European Communities, this also follows from the general principle of good
faith as it applies in international State relations, unde r which States are normally considered to act in
conformity with their obligations. This principle has been widely confirmed in the international
jurisprudence and in the WTO dispute settlement syst em. Therefore, it is cl ear that the United States
could not unilaterally determine that the European Communities implemented the DSB
recommendations and rulings in a WTO inconsis tent way. To the contrary, the European
Communities must be presumed to have complied with its WTO obligations, if the United States
refuses to establish the contrary.
7.258 The European Communities adds that once th e inconsistency of the measure has been
removed, Article 22.8 of the DSU provides that "the suspension of concessions or other obligations
shall [not be] applied [any longer]." This provisi on does not leave any margin of discretion to the
retaliating Member. 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 the WTO inconsistency of the
measure. It can be inferred from Article 22.8 read together with Article 23.1 of the DSU that the
suspension of obligations should not continue to be applied until the WTO inconsistency of the
properly notified measure has been positively determined by the DSB.
7.259 According to the European Communities, the DSB authorization cannot justify the
maintenance of suspension of concessions or other obligations if a Member properly complies with its
obligations after the imposition of these measures and if its compliance measure is not challenged in
an Article 21.5 proceeding. Again, the mere tem poral 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 suspensi on of concessions or other obligations indefinitely
in the future and on the basis of unilateral determinations.
7.260 Furthermore, the European Communities notes 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.
7.261 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.
7.262 The United States argues that Article 22.8 establishes three conditions under which a
DSB-authorized suspension of concessions may no l onger be applied: (a) the Member imposing the
WTO-inconsistent measure "removes" the measure; (b) that Member "provides a solution to the
nullification or impairment of benefits"; or (c) the parties to the dispute reach a "mutually satisfactory

solution." In order to prevail in its claim th at the United States is breaching Article 22.8, the
European Communities must establish that one of these conditions has been met.
7.263 According to the United States, the asserti on of the European Communities that it has
removed its measure or provided a solution is not supported by any demonstration that it actually has
done either. Instead, the European Communities reli es on an already rejected legal theory that a
Member found to have breached its WTO obligations is to be excused from its burden of proof in
dispute settlement if it invokes "good faith." This argument is no more valid today than when a WTO
panel last rejected it, and the EC failure to meet its burden on the critical element of its case under
Article 22.8 means that the EC claim must likewis e fail. The United States continues to apply the
suspension of concessions to the European Communities in a WTO- consistent manner, fully in
accordance with the authorization of the DSB.
7.264 The United States adds that the European Comm unities failed to demonstrate that it has in
fact removed its WTO-inconsistent measure, the import ban on meat and meat products from cattle
treated with hormones for growth promotion purposes or that it has "provide [d] a solution" to the
nullification or impairment of benefits to the United States caused by the ban.
7.265 According to the United States, Article 22.8 nowhe re 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 h as deemed that it has provided a "solution" to WTO
nullification or impairment, without a DSB determina tion. Indeed the EC proposed interpretation is
directly at odds with the last sentence of Article 22.8 which makes it clear that these are questions for
ongoing DSB surveillance. Article 22.8 stresses that "the DSB shall continue to keep under
surveillance the implementation of adopted reco mmendations or rulings", in situations where
"concessions or other obligations have been susp ended but the [DSB] recommendations ... have not
been implemented." This statement that the DSB' s role is to monitor an implementing Member's
compliance with DSB recommendations as well as the complaining Member's suspension of
concessions further emphasizes that Article 22.8 is concerned with multilateral review of compliance.
The European Communities errs in claiming that unde r Article 22.8, the US authorization to suspend
concessions could be withdrawn in the absence of a DS B determination to that effect. Furthermore,
the EC approach would fundamentally undermine the operation of several critical DSU provisions,
most notably the right of complaining parties to seek authorization to suspend concessions through a
DSB decision taken by negative consensus under Article 22.6 or Article 22.7 of the DSU.
7.266 In the view of the United States, the European Communities argues that the Panel should find
that it has "removed" its WTO-inconsistent measur e within the meaning of Article 22.8 analysis
because 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 III (Article 21.5 – EC) panel highlighted
that there is 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 amended ban in this proceeding. Because compliance of the EC amended ban is a
condition precedent to several of the claims raised by the European Communities as a complaining
party, the European Communiti es bears the burden in this pr oceeding of demonstrating its
compliance.
7.267
The European Communities argues that, contrary to what the United States asserts, the
prohibition to continue the application of sanctions under Article 22.8 does not depend on whether the
DSB authorization has been formally removed. Ar ticle 22.8 is unequivocal in the sense that the
suspension of concessions and related obligations may only be "applied" until the inconsistency of the
measure has been removed. In addition, Article 22.8 subjects the application of sanctions to a measure
which has been found inconsistent. 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.
7.268 Moreover, the European Communities does not agr ee with the United States 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 supported by ge neral public international law, which also applies
to the WTO, as for instance expressed in Article 26 of the Vienna Conventio n on the Law of Treaties
(1969). In this context, the European Communities also considers that due to the specific
circumstances for the adoption of its compliance measure as explained in detail in its various
submissions and in the absence of a concrete challe nge by the United States and in the light of the
time that has passed since the measure was prepar ed and adopted, it is fully entitled to invoke the
principle of good faith and the presumption of compliance.
7.269 The United States argues that the European Communities has failed to make a prima facie
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; mutua lly satisfactory solution), it posits its claim "in
conjunction with" Article 23 and asserts that the "presumption of good faith" or compliance satisfies
its burden of proof. Even were one to presume that the European Communities implemented its
amended bans in good faith, this fact would not in turn demonstrate that the EC bans actually satisfy
the elements of Article 22.8, e.g., the European Communities could be acting in good faith, but still be
wrong about the WTO-consistency or compliance of its amended measure.
2. Approach of the Panel
(a) Duty of the Panel to make an objective assessment of the matter before it
7.270 In light of the EC statement that this case is about procedural violations under the DSU
452, and
in view of our findings above, we could normally exercise judicial economy and complete our review
of this case at this juncture. Indeed, we found th at the United States committed a procedural error
under the DSU, breached Article 23.1 and 23.2(a) an d should have had recourse to dispute settlement
in accordance with the rules and procedures of the DSU if it wanted to seek redress of a violation of
the WTO Agreement through a determination of viol ation of the WTO Agreement with respect to
Directive 2003/74/EC.
7.271 However, the European Communities claims a separate violation of Article 23.1, read
together with Article 22.8 and Article 3.7 of the DSU. Under those claims, the European
Communities alleges inter alia that the United States breached Article 22.8 because it failed to
withdraw its suspension of concessions even though the European Communities removed the measure
found to be inconsistent with a c overed agreement. We also note the US argument that it did not
breach Article 22.8 of the DSU because the EC implementing measure does not comply with the
SPS Agreement.
7.272 We recall that we considered that the two series of main EC claims were such that they could
be addressed independently from each other. 453 Our findings of violation of Article 23.1 and 23.2(a)
under the first series of main EC claims are co mpletely unrelated to whether the European
Communities implemented the DSB re commendations and rulings in the EC – Hormones dispute in
substance. Indeed, our findings are based on the fa ilure of the United States to have recourse to the
procedures under the DSU as a result of the notification of Directive 2003/74/EC – a purely

452 EC's first written submission, para. 24.
453 See para. 7.182 above.

procedural step. In contrast, we note that the sec ond series of main EC claims – and the alternative
claim of "direct" violation of Article 22.8 of the DSU for that matter – are not premised on the mere
existence of an EC implementing measure, but on its conformity (presumed or actual) with the
SPS Agreement.
7.273 Under those circumstances, one cannot exclude that no violation of Article 23.1 of the DSU
may be found under the second series of main EC clai ms even though a violation of Article 23.1 was
found under the first series of main EC claims, if only because they are based on different premises.
7.274 We recall in this regard that Article 11 of the DSU instructs us to assist the DSB in
discharging its responsibilities and provides that, acco rdingly, a panel should make an objective
assessment of the matter before it. In this case, the matter raised by the European Communities
contains two separate elements: a series of claims related to the procedural obligations of the
responding party and a series of claims premised on the violation by the responding party of Article
22.8 of the DSU due to compliance by the European Communities with its obligations under the WTO
Agreement. We should therefore address both series of claims.
7.275 In addition, we also note that, since our repor t may be appealed and the Appellate Body can
only rule on issues of law, we must provide suffici ent factual basis to allow the Appellate Body to
complete the analysis, if necessary. 454 In that context, in order to ensure in all instances a positive
resolution of this dispute, we consider that pr oceeding with a review of the second series of main
claims raised by the European Communities is appropriate.
7.276 Before proceeding with the review of this second series of claims, we want to stress that in
reviewing the EC claims of violation of Article 23.1 read together with Article 22.8 and Article 3.7 of
the DSU, our intention is not to substitute ourselv es for a compliance panel under Article 21.5 of the
DSU. We will make findings with respect to the second series of main claims of the European
Communities with the only purpose to reach a conclusion on the violation of the provisions referred to
in those claims.
(b) Order of review of the second series of main claims by the European Communities
7.277 We recall that the second series of EC claims is that the United States breaches Article 23.1,
read together with Articles 22.8 and 3.7 of the DS U. We also note that the European Communities
argues more particularly that Article 22.8 prohibi ts the continued unilateral application of the
suspension of concessions or other obligations when the measure which has been found inconsistent is
removed. We conclude from this that the EC cl aim under Article 23.1 is conditioned by the EC claim
under Article 22.8 or, more precisely, that the findi ngs that the European Communities wants us to
make in relation to Article 23.1 are dependent on the findings that the European Communities wants
us to make under Article 22.8. In other word s, the second series of claims of the European
Communities is premised on a violation by the United States of its obligations under Article 22.8.
7.278 We therefore conclude that we should begin our analysis of the second series of main claims
of the European Communities with a review of th e compatibility of the US measure at issue with
Article 22.8 of the DSU. We consider that:
(a) if we find a breach of Article 22.8 of th e DSU, we will proceed with reviewing the
EC claims of violation of Articles 23.1 and 3.7 of the DSU, read together with
Article 22.8;

454 See, e.g., Appellate Body Reports on Canada – Periodicals, DSR 1997:I, p. 449 at 469; Australia –

(b) if we find no violation of Article 22.8, th ere will be no need for us to proceed any
further with the review of these second series of claims by the European
Communities.
7.279 We now proceed with our review of the EC claim under Article 22.8 of the DSU.
3. Violation of Article 22.8 of the DSU
(a) Preliminary remarks
7.280 Article 22.8 reads as follows:
"The 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 nullifi cation or impairment of benefits, or a
mutually satisfactory solution is reached. In accordance with paragraph 6 of
Article 21, the DSB shall continue to k eep under surveillance the implementation of
adopted recommendations or rulings, incl uding those cases where compensation has
been provided or concessions or other ob ligations have been suspended but the
recommendations to bring a measure into conformity with the covered agreements
have not been implemented."
7.281 In light of terms of Article 22.8 and the arguments of the parties, we believe that two
preliminary questions have to be addressed with respect to the violation of Article 22.8:
(a) one is when the suspension of concessions should cease to be applied;
(b) another one is what is meant by "the measu re found to be inconsistent with a covered
agreement".
7.282 Regarding the first question, we recall that the terms of Article 22.8 make it clear that
countermeasures may remain in place only until such time as the measure found to be inconsistent by
the DSB is removed. In other words, the removal of the illegal measure by the losing party must lead,
without delay, to the removal of the suspension of obligations by the Member authorized by the DSB
to suspend concessions.
7.283 Regarding what is meant by "the measure found to be inconsistent with a covered agreement",
one interpretation could be to consider that th e measure found to be inconsistent was Directive
96/22/EC.
455 This measure was removed. However, su ch an interpretation is unsatisfactory, as
Directive 96/22/EC was replaced by Directive 2003/74/ EC which also imposes an import ban. The
Panel notes that the European Co mmunities agrees that the phrase " until such time as the measure
found to be inconsistent with a c overed agreement has been removed" means that the illegality itself,
and not only the measure, has been removed.456
7.284 The Panel believes that the term "measure" s hould not be interpreted narrowly as applying
only to the legislation at issue. What the United States challenged as a complainant in the EC –
Hormones case was an import restriction on meat a nd products from cattle treated with growth
promoting hormones. We consider that this in terpretation is confirmed by the second sentence of

455 Official Journal of the European Communities, No. L 125, 23 May 1996, p. 3
456 See EC's first written submission, para. 81, EC's replies to Panel questions after the first substantive
meeting, question 55, Annex B-1.

Article 22.8 which refers to the DSB keeping unde r surveillance situations where obligations have
been suspended "but the recommendations to brin g a measure into conformity with the covered
agreements have not been implemented". We read this phrase as implying that what is to be achieved
is not the removal of the measure but the actual compliance with the recommendations or rulings of
the DSB.
7.285 We therefore conclude that Article 22.8 may be breached only if the European Communities
has complied with the recommendations and rulings of the DSB and the United States has failed to
immediately remove its suspension of concessions or other obligations.
7.286 We recall that the European Comm unities considers that this case is not about its compliance
with the recommendations and rulings of the DSB in the EC – Hormones case. We nonetheless note
that the European Communities requests us to make findings in relation to Article 22.8 under its main
claim and that it did not exclude the possibility fo r the Panel to review the substance of the EC
implementation measure in the context of its conditional allegation of "direct" violation of
Article 22.8. We note, however, that such claim wa s made "in the alternative", i.e. if the Panel found
no violation of the DSU under the other EC claims. In the context of its second series of main claims,
the European Communities alleges th at it does not have to demonstrate that it has complied with the
recommendations and rulings of the DSB since it should benefit from a presumption of good faith
compliance with respect to Directive 2003/74/EC. We note that the United States argues that the
European Communities has not removed the measur e found to be inconsistent with a covered
agreement or provided a solution to the nullification or impairment of benefits. More particularly, the
United States argues that the EC implementing measure breaches the SPS Agreement.
7.287 Having regard to the arguments of the parties regarding the conformity of the EC
implementing measure with the SPS Agreement, the Panel believes that it must determine the scope of
its jurisdiction in this respect.
(b) Jurisdiction of the Panel
(i) Introduction
7.288 This case is not the first one about complian ce of a Member with its obligations under the
DSU and, in particular, under Article 23. 457 However, because of the clai m raised by the European
Communities under Article 22.8 of the DSU, the arguments of the United States and the links between
this case and the EC – Hormones case – in particular through the question of the compliance of the
EC implementing measure with the SPS Agreement – the second series of main claims by the
European Communities raises a number of questions which, to our knowledge, were never directly
addressed before by a panel established under Article 6 of the DSU.
7.289 In support of its claim under Article 23.1 read together with Article 22.8 and Article 3.7 of the
DSU, the European Communities alleges in substan ce that it does not have to demonstrate that its
implementing measure is compatible with the SPS Agreement. Rather, the European Communities
argues that it should be presumed to have removed in good faith the measure found inconsistent with
the SPS Agreement in the EC – Hormones dispute and that this presumption could only be rebutted
through a recourse to Article 21.5 of the DSU by the responding party.

457 In US – Section 301 Trade Act case, Article 23.2(a) and (c) of the DSU was at issue, in US – Certain
EC Products , Article 23.1 and 23.2(c) as well as 23.2(a) of the DSU was addressed by the panel and the
Appellate Body.

7.290 The United States disagrees that the European Communities benefits from any presumption of
compliance and argues, on the contrary, that the European Communities failed to demonstrate that it
has complied with the SPS Agreement.
7.291 Therefore, before we proceed any further, we believe that we should answer the two
following questions:
(a) In light of the EC claim that it benefits from a presumption of good faith compliance,
do we need to determine whethe r 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?
(b) if yes, do we have the jurisdiction to address the conformity of the EC implementing
measure with the SPS Agreement?
(ii) Does the Panel need to determ ine whether the EC implementi ng 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?
Summary of the main arguments of the parties458
7.292 The European Communities considers that, in order to demonstrate that the United States is
in violation of Article 23.1, read in conjunction with Articles 22.8 and 3.7 of the DSU, it is not
required to explain in full the substance of its co mpliance measure and why this measure implements
the DSB recommendations and rulings. Rather, fo r the purposes of establishing a violation of DSU
rules under these claims, the European Communities c onsiders that it is sufficient to refer to the
presumption of good faith which is a cornerstone of the DSU and cannot be undermined by a
unilateral and unsubstantiated determination by the United States.
459
7.293 The European Communities further argues that the WTO inconsistency of the implementing
measure can only be determined in accordance with the appropriate procedure, namely Article 21.5 of
the DSU. Unless such a procedure concludes that the compliance measure does not fully implement
the DSB recommendations and rulings, it cannot be presume d that this is the case . This also follows
from the general principle of good faith as it applies in international state relations (Article 26 of the
Vienna Convention on the Law of Treaties (1969)), under which States are normally considered to act
in conformity with their obligations. This pr inciple has been recurrently recognized in WTO
jurisprudence. The presumption of good faith also applies for implementing measures, as has been
clearly spelt out in Article 21.5 proceedings.
7.294 For the European Communities, the United States could not unilaterally determine that the
European Communities implemented the DSB recomme ndations and rulings in a WTO inconsistent
way. On the contrary, the Europ ean Communities must be presumed to have complied with its WTO
obligations, if the United States refuses to establis h the contrary. This presumption is even more
justified as the EC implementation measure requi red conducting extensive scientific studies and
performing a comprehensive risk assessment over several years in a transparent and objective manner,
to which the United States had access and could provide comments on at any time.
460

458 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective arguments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
459 EC's first written submission, para. 72.
460 EC's first written submission, paras. 86-94.

7.295 The European Communities understands that th e United States is denying the good faith
principle in this case because it considers that the European Communities has not correctly
implemented its obligations. By doing so, however , the defending party c onfuses the notion of good
faith and a possible violation under a covered ag reement. In the present case, the European
Communities bases itself on the same rationale as the Appellate Body in the Byrd Amendment case.
Thus, even though the defending pa rty alleges that the European Communities is still in violation of
the SPS agreement, this does not in any event affect the presumption of good faith.
7.296 The European Communities recalls that in EC – Bananas III (Article 21.5 – EC) the panel
merely said that a Member should not be presumed to agree that another Member is in compliance.
Thus, the decision dealt with what a complaining Me mber is presumed to believe or not to believe.
Yet, the general principle of good faith is an objective criterion that applies to compliance measures
properly adopted and notified to the WTO. This is even more obvious if the other Members do not
challenge the legality of the new implementing measures under Article 21.5 within a reasonable
timeframe.
7.297 The United States considers that the European Comm unities relies on an already rejected
legal theory that a Member found to have breached its WTO obligations is to be excused from its
burden of proof in dispute settlement if it invokes the phrase "good faith." 461 The United States
continues to apply the suspension of concessions to the European Communities in a WTO-consistent
manner, fully in accordance with the authorization of the DSB.462
7.298 The United States first considers that the repor ts cited by the European Communities do not
find a "presumption" but simply highlight the issue of burden of proof for complaining parties in
Article 21.5 proceedings, or WTO proceedings genera lly, rather than setting forth a "presumption of
good faith." The United States does not disagree th at, in WTO dispute settlement, the initial burden
rests with the complaining party alleging a WTO viol ation. In the view of the United States, the
European Communities appears to believe that the concept of good faith would operate only in favour
of the European Communities and either believes no other Member would be able to avail itself of the
concept of good faith, or ignores that it would apply with respect to the United States. In this
proceeding, the European Commun ities, as the complaining party, bears the burden of proving its
prima facie case against the United States. The Eu ropean Communities has failed to satisfy this
burden because it has not demonstrated removal of its measure or that it has provided a solution to US
nullification or impairment within the meaning of Article 22.8.
463
7.299 The United States recalls that, in the EC – Bananas III (Article 21.5 – EC) proceeding
already, the European Communities argued that its measures taken to comply were "presumed to
conform with WTO rules unless their conformity h as been duly challenged under the appropriate
DSU procedures." The panel disagreed, highlight ing that there is simply no basis in the WTO
Agreement for the EC argument that it is presumed co mpliant with its obligations absent a finding
against its measures. Similarly, there is no presumption of compliance for the EC amended ban in this
proceeding.
7.300 According to the United States, there is no presumption of compliance or good faith in WTO
dispute settlement that attaches to measures taken by WTO Members. Such a presumption is not
found in the text of the DSU, nor is it found in the covered agreements, in the light of relevant
provisions of which panels are charged with examin ing a matter under DSU Article 7.1. The findings
of that evaluation then form the basis of the DSB recommendations and rulings, which "cannot add to

461 See Panel Report on EC – Bananas III (Article 21.5 – EC), para. 4.13.
462 US's first written submission, para. 106.
463 US's first written submission, footnote 124.

or diminish the rights and obligations provided in the covered agreements" pursuant to Article 3.2 of
the DSU.
7.301 The United States argues that, while Article 3.10 of the DSU uses the term "good faith", it
does not do so in a manner indicating that a presumption of good faith attaches to measures taken by
Members. Article 3.10 provides, in relevant part, as follows: "It is understood ... that, if a dispute
arises, all Members will engage in these procedures in good faith in an effort to resolve the dispute."
Article 3.10 is not a general incorporation of "good faith" principles of public international law. On
the one hand, Article 3.10 is an understanding, not an obligation. On the other, Article 3.10 simply
notes that, when a dispute has been initiated, Member s will make best efforts to resolve it. It makes
no reference whatsoever to a presumption of good faith which attaches to Member's measures,
making them "presumed compliant" or WTO-consistent.
7.302 The United States adds that presumptions per se are not applicable in WTO dispute
settlement. The only concept that comes close to resembling a presumption in dispute settlement is
that the complaining party bears the burden of proof in making its prima facie case of the WTO
inconsistency of another Member's measure. Rath er than a presumption of good faith in dispute
settlement, this instead is testament to the fact that there is no presumption of bad faith that attaches to
measures taken by a WTO Member.
7.303 The United States considers that the established ru les of burden of proof in dispute settlement
already ensure that a complaining party establish its prima facie case, thereby obviating any need for
such a presumption.
7.304 In the opinion of the United States, the European Communities has failed to demonstrate that
such a presumption exists in WTO dispute settleme nt. When the arbitrator's statement in the EC –
Hormones (Article 22.6) proceeding is viewed in context, it becomes clear that it was simply
discussing relevant burdens of proof in WTO di spute settlement, noting that once a Member has
claimed WTO-inconsistency of a measure in a dispute, it must prove that this is indeed the case.
7.305 The United States further notes that two other disputes cited by the European Communities,
Canada – Aircraft (Article 21.5 – Brazil) and Chile – Alcoholic Beverages, do not mention a
presumption of good faith whatsoever. Rather, they state that there is no presumption of bad faith in
WTO dispute settlement. In these proceedings, the European Communities, as the complaining party,
bears the burden of proving its prima facie case against the United States. The EC has failed to satisfy
this burden because it has not demonstrated removal of its WTO-inconsistent measure or that it has
provided a solution to US nullification or impairment within the meaning of Article 22.8.
7.306 The United States recall that the European Communities cites an opinion of the International
Court of Justice discussing good faith. However, nowhere in the covered agreements is this
presumption or principle discussed. As a panel establis hed under Article 6 of the DSU, this Panel is
charged under its terms of reference (DSU Article 7. 1) with examining this matter "in light of the
relevant provisions in [the c overed agreements]". The relevant provisions of the DSU and the
SPS Agreement do not contain a presumption of good faith in dispute settlement.
464
7.307 Finally, in the opinion of the United States, even were one to presume that the European
Communities 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.

464 US's replies to Panel questions after the first substantive meeting, question 61, Annex B-3.

Reasoning of the Panel
Introductory remarks
7.308 Having regard to the arguments of the parties, the Panel considers that it needs to determine:
(a) whether the European Communities can invoke a presumption of good faith
compliance; and, if yes,
(b) whether, and how, such a presumption could be rebutted.
7.309 The Panel notes that, generally, when good faith is referred to in a dispute, this is in relation
to the measure adopted by the defending party 465, not with respect to a measure adopted by the
complaining party – in this case the European Comm unities. Normally, a complainant does not have
to show that it applies a measure in good faith, sin ce this is normally not the measure at issue in the
dispute. However, the demonstration by the Euro pean Communities of a violation of Article 22.8 by
the United States in this case implies that it pr oves that it has removed the measure found to be
inconsistent with a covered agreement in the EC – Hormones case. The Panel also recalls that it found
above that the United States should have had recourse to the DSU in relation to the EC implementing
measure. If the United States had had recourse to the dispute settlement procedures under the DSU –
including the procedure provided in Article 21.5 – the European Communities would have been the
defending party and its implementing measure would have benefited from a presumption of
compatibility with WTO rules. 466 For these reasons, the Panel deems it appropriate not to take
position on whether good faith can be invoked only by the defendant. Instead, it will address the issue
by disregarding the status of the European Communities as complaining party in this case.
Applicability of the principle of good faith in the WTO and under the DSU
Introduction
7.310 We note that what the European Communities clai ms in this respect is the existence of a
presumption of good faith compliance based on the inte rnational law principle of good faith. We are
mindful of the position expressed by the United States th at the impact of general international law on
the DSU is limited to the application of the custom ary rules of interpretati on of public international
law embodied in the Vienna Convention on the Law of Treaties (cf. Article 3.2 of the DSU).
However, we note that Article 31.3(c) provides that
"[t]here shall be taken into account, together with the context: ... (c) any relevant rule
of international law applicable to the relations between the parties."
7.311 Having regard to the overarching nature of the principle of good faith in international legal
relations, we deem it appropriate to determine first whether there is any basis in public international
law for the principle to which th e European Communities refers. If this is the case, we will then
proceed with determining whether the WTO Agreemen t in general and the DSU in particular exclude
the application of this principle.

465 See, e.g., Appellate Body Report on US – Carbon Steel, para. 157.
466 See, e.g., Appellate Body Report on Canada – Dairy (Article 21.5 – New Zealand and US II) ,
para. 66.

General international law
7.312 We note that what the European Communities refers to in its submissions is a presumption
that it acted in good faith and thus must be presu med to have complied with the recommendations and
rulings of the DSB.
7.313 We are of the view that the principle of good faith could be analysed mainly in respect of the
following categories:
(a) good faith conduct in a dispute settlement procedure;
(b) substantive good faith, i.e. with respect to the substantive obligations of a State;
(c) good faith in the interpretation process (Ar ticle 31 of the Vienna Convention on the
Law of Treaties).
7.314 What the European Communities invokes in this case seems to fall primarily within the
category of substantive good faith.
7.315 This allegation of the European Communities rai ses, in our opinion, two related but distinct
issues under general international law:
(a) the first one is whether a presumption that States act in good faith exists under
general international law;
(b) the second one is whether such presumption of good faith can be assimilated to a
presumption of compliance.
7.316 Good faith is one of the basic principles re garding the creation and execution of legal
obligations in public international law. 467 This principle is expressed inter alia in Article 26 of the
Vienna Convention on the Law of Treaties:
"Every treaty in force is binding upon the parties to it and must be performed by them
in good faith."
7.317 It is implicit from the duty to perform treaty obligations in good faith that a party to an
international agreement should be d eemed to have acted in good faith in the performance of its treaty
obligations. More generally, even though Article 26 provides for an obligation and not a presumption,
pacta sunt servanda is but only one expression of the principl e of good faith. Good faith is a general
principle of international law that governs all reciprocal actions of States.468 We are therefore inclined
to agree with the European Communities that ever y party to an international agreement must be
presumed to be performing its obligation under that agreement in good faith.
7.318 Having concluded that, under general interna tional law, States enjoy a presumption of good
faith, we now proceed to determine whether pr esumption of good faith can be equated with
presumption of compliance with treaty obligations.

467 See, e.g., ICJ, Nuclear Tests Case , Judgement of 20 December 1974, ICJ Reports 1974, p. 473,
para. 49.
468 See also UN Charter, Art.2.2; Malcom N. Shaw: International Law (5 th edition), p. 811-812: "[Pacta
sunt servanda] underlies every international agreement fo r, in the absence of a certain minimum belief that
States will perform their treaties obligations in good faith , there is no reasons for countries to enter into such
obligations with each other."

7.319 The Panel notes in this respect that good faith has been defined as a:
"disposition d'esprit de loyauté et d'honnêteté consistant en ce qu'un sujet de droit ne
7.320 According to this definition, a State acting in good faith should be honestly seeking to comply
with its obligations. A presumption of good fait h could thus extend to compliance. It is the
understanding of the Panel that States benefit in th eir actions from the principle that a breach of the
principle of good faith cannot be presumed and th at any State alleging an abuse of right ( abus de
droit) or, more particularly, a breach of the principle of good faith, must prove it.470
7.321 As a result, we note that, under general intern ational law, the European Communities would
be entitled to claim a presumption of good faith compliance.
7.322 However, that does not mean that the State invoking good faith compliance, while acting in
total good faith, actually complied with its treaty oblig ations. It could make an illegal interpretation
of its obligations without breaching the principl e of good faith. Thus, if good faith compliance is
presumed, it cannot be a non-rebuttable or juris et de jure presumption.
7.323 An additional element to consider is that , under general public international law, every State
benefits from the application of the principle of good faith. We therefore agree with the United States
that if the European Communities can claim good fa ith compliance, the United States too should also
benefit from the same presumption. Unlike in "normal" cases where only the measure adopted by one
Member is at issue, in this case the legality of the US measure challenged by the European
Communities depends on whether the measure taken by the European Communities to comply with
DSB recommendations and rulings is WTO consistent . In other words, both parties can invoke the
presumption of good faith. However, we do not see the f act that both parties can invoke good faith in
relation to diametrically opposed pos itions as affecting the applicability of this principle in this case.
Indeed, we are only dealing with presumptions, not with evidence. As long as these presumptions can
be rebutted before a panel, we see no inherent problem to the fact that both parties claim good faith.
The text of the DSU
7.324 The Panel first notes that, with the exception of Ar ticles 3.10 and 4.3, there is no reference to
good faith in the DSU. Of those two references, that in Article 4.3 relates specifically to
consultations. Only that in Article 3, entitled "Gen eral Provisions", could have a relevance in this
case. However, Article 3.10 reads as follows:
"It is understood that requests for concilia tion and the use of the dispute settlement
procedures should not be intended or consid ered as contentious acts and that, if a
dispute arises, all Members will engage in these procedures in good faith in an effort
to resolve the dispute. It is also understood that complaints and counter-complaints in
regard to distinct matters should not be linked."
7.325 The Panel understands the reference to good faith in Article 3.10 of the DSU to relate to the
manner in which parties to a dispute should particip ate in the dispute (i.e., procedural good faith, as

469 Jean Salmon: Dictionnaire de droit international public , p. 134. Black Law Dictionary, 6 th ed.,
para. 693:
"In common usage the term is ordinarily used to describe that state of mind denoting honesty
of purpose, freedom from intention to defraud and, generally speaking, means being faithful to
one's duty or obligation."

470 PCIJ, Upper Silesia Case, Judgement of 25 May 1926, Series A. No. 7, p. 30.

described above), not specifically to whether Member s should be presumed to be acting in good faith.
Indeed, the reference to good faith is made in re lation to "engage[ing] in [DSU] procedures in good
faith in an effort to resolve the dispute" (emphasis added) and the preceding phrase provides that DSU
procedures "should not be intended or considered as contentious acts".
7.326 The Panel therefore considers that Article 3.10 is of limited direct relevance to determine
whether the European Communities should benef it from a presumption of good faith compliance
under the DSU.
7.327 However, the references to good faith in the DSU are evidence that the DSU does not exclude
the application of the principle of good faith in the resolution of disputes. The Panel is of the view
that, since the application of the principle of good faith is not expressly excluded by the DSU, it is
applicable to WTO Members.
471
The panel and Appellate Body practice
Presumption and burden of proof
7.328 The Panel notes that, in US – Wool Shirts and Blouses, the Appellate Body recalled that:
"[W]e find it difficult, indeed, to see how an y system of judicial settlement could
work if it incorporated the proposition th at the mere assertion of a claim might
amount to proof."472
7.329 However, the Appellate Body also mentioned in Japan – Apples that:
"[T]he Appellate Body statement in EC – Hormones does not imply that the
complaining party is responsible for providing proof of all facts raised in relation to
the issue of determining whether a measure is consistent with a given provision of a
covered agreement. In other words, although the complaining party bears the burden
of proving its case, the responding party must prove the case it seeks to make in
response."
473
7.330 We believe that, in arguing that it enjoys a presumption of good faith compliance, the
European Communities is not merely asserting its claim of violation of Articles 23.1, 22.8 and 3.7.
The EC allegation of existence of a presumption of good faith compliance is only one part – although
an essential one – of the EC argumentation su pporting its claims. Moreover, the European
Communities is not directly asserting that it has complied in relation to the conformity of the US
measure with Article 22.8, but that it enjoys, as a matter of principle, a presumption that it complied
in good faith with its own obligations.
7.331 On its part, the United States argues as a de fence that the Europ ean Communities did not
comply with the recommendations and rulings of the DSB. One may argue that the parties' respective

471 The Panel is not of the view that the fact that some covered agreements, such as the SPS Agreement
(see Article 2.4) expressly provide that measures of a Member which conform to a given agreement shall be
presumed to be in accordance with the obligations of that Member under another covered agreement would
imply that the presumption of good faith does not apply in the WTO Agreements unless expressly referred to.
The Panel considers that the reference to presumption in Article 2.4 of the SPS Agreement is to a legal
presumption and is intended to address potentially c onflicting interpretations between two provisions. The
reference in Article 3.2 of the SPS Agreement can be explained by the fact that the "international standards,
guidelines or recommendations" are not part of the WTO Agreement.
472 Appellate Body Report on US – Wool Shirts and Blouses, DSR 1997:I, p. 323 at 335.
473 Appellate Body Report on Japan – Apples, para. 154.

burdens are unbalanced because th e European Communities, if one agrees with its position, does not
have to demonstrate prima facie that it has comp lied with the recommendations and rulings of the
DSB. However, it should first be recalled that what is at issue in this case is not directly whether the
European Communities has complied with the recomme ndations and rulings of the DSB, but whether
the United States complied with its obligations unde r Articles 23.1, 22.8 and 3.7 of the DSU. By
taking this route, the European Commu nities takes the risk that its clai ms may be rejected if the Panel
disagrees with the existence of a presumption of good faith compliance.
7.332 We therefore conclude that by invoking a presumption of good faith compliance, the
European Communities is not merely asserting its cl aims under Article 22.8, but rather supporting its
claims which are, in essence, claims of violations by the United States, not claims of compliance by
the European Communities.
7.333 We therefore find that the European Communities' reliance on a presumption does not amount
in this case to merely asserting a claim.
Presumption of good faith
7.334 The Panel notes that the Appellate Body has, on several occasions, recalled that the principle
of good faith applies to WTO Members in their relations under the WTO Agreement. The Panel
recalls that, in US – FSC, the Appellate Body stated that:
"This pervasive principle [of good faith] requires both complaining and responding
Members to comply with the requirements of the DSU (and related requirements in
other covered agreements) in good faith." (emphasis added)
474
7.335 Furthermore, it seems that the Appellate Body understands the obligation to comply with the
requirements of the DSU in good faith as implying that Members are to be presumed to act in good
faith. In EC – Tube or Pipe Fittings, the Appellate Body found that:
"This excerpt demonstrates that the Panel took into account the European
Communities' responses to its questions before reaching its finding. It also indicates
that the Panel did not rely exclusively on the presumption of good faith
, as Brazil
suggests, given that some of the Pane l's questions were directed at the validity of
Exhibit EC-12. If the Panel had placed total reliance on the presumption of good
faith, it would have simply accepted the Eu ropean Communities' assertion that
Exhibit EC-12 formed part of the record of the investigation and would not have
posed questions to assess the consistency of Exhibit EC-12 with other evidence
contained in the record. Therefore, we are satisfied that the Panel "took steps to
assure [itself] of the validity of [Exhibit EC-12] and of the fact that it forms part of
the contemporaneous written record of th e EC investigation." (footnotes omitted –
emphasis added)
475
7.336 As mentioned above, there is no express exclusion of the application of the principle of good
faith in the DSU or in the WTO Agreement. As noted by the panel on Korea – Procurement:
"Article 3.2 of the DSU requires that we seek within the context of a particular
dispute to clarify the existing provisions of the WTO agreements in accordance with
customary rules of interpretation of public international law. However, the
relationship of the WTO Agreements to cust omary international law is broader than

474 Appellate Body Report on US – FSC, para. 166.
475 Appellate Body Report on EC – Tube or Pipe Fittings, para. 127.

this. Customary international law app lies generally to the economic relations
between the WTO Members. Such internati onal law applies to the extent that the
WTO agreements do not 'contract out' from it. To put it another way, to the extent
there is no conflict or inconsistency, or an expression in a covered WTO agreement
that implies differently, we are of the view that the customary rules of international
law apply to the WTO treaties and to th e process of treaty formation under the
WTO."
476
7.337 More precisely, in US – Section 211 Appropriations Act, the Appellate Body recalled that:
"... where discretionary authority is v ested in the executive branch of a WTO
Member, it cannot be assumed that the WTO Member will fail to implement its
obligations under the WTO Agreement in good faith. Relying on these rulings, and
interpreting them correctly, the Panel conc luded that it could not assume that OFAC
would exercise its discretionary executiv e authority inconsistently with the
obligations of the United States under the WTO Agreement. Here, too, we agree."
(emphasis added)477
7.338 The parties have argued on the relevance of the report in EC – Bananas III (Article 21.5 –
EC). The European Communities notes that this report was never adopted by the DSB. We
nevertheless recall that the Appellate Body, in Japan – Alcoholic Beverages II, found that panels may
seek guidance from unadopted panel reports. In EC – Bananas III (Article 21.5 – EC), the panel
rejected the EC assertion of a presumption of consiste ncy. In that case, the EC requested the panel to
find that its implementing measures "must be presumed to conform to WTO rules unless their
conformity has been duly challenged under the ap propriate DSU procedures". This position seems
largely similar to the position ad opted by the European Communities in the present case, where it
claims that the United States will breach Article 23 even if it rebuts the presumption of compliance
because it failed to use the right forum to contest it (i.e. Article 21.5 of the DSU).
7.339 The panel in EC – Bananas III (Article 21.5 – EC) , agreed with the European Communities
that there was normally no presumption of inconsis tency attached to a Member's measures in the
WTO dispute settlement system. This was subse quently confirmed by the Appellate Body in Chile –
Alcoholic Beverages478and it is now well established that no pr esumption of bad faith can be applied
to a Member's measure. However, the panel in EC – Bananas III (Article 21.5 – EC) considered that
the failure, as of a given point in time, of one Memb er to challenge another Member's measures could
not be interpreted to create a presumption that th e first Member accepts the measures of the other
Member as consistent with the WTO Agreement.479
7.340 First, we find the above reasoning of the Panel in EC – Bananas III (Article 21.5 – EC)
convincing.
7.341 Second, in the present case, however, the European Communities does not actually allege that
there is a presumption of acceptance by the United States that the measure is consistent with the WTO
Agreement because the United States failed to chal lenge the measure. The European Communities
claims that there is a presumption of compliance based on the presumption of good faith and that this
presumption can only be rebutted in the appropriate forum, i.e. by invoking Article 21.5 of the DSU.

476 Panel Report on Korea – Procurement, para. 7.96.
477 Appellate Body Report on US – Section 211 Appropriations Act , para. 259. (original footnote
omitted)
478 Appellate Body Report on Chile – Alcoholic Beverages, para. 74.
479 Panel Report on EC – Bananas III (Article 21.5 – EC), para. 4.13.

7.342 The United States argues that the presumption of good faith compliance cannot supersede the
multilateral authorization of the DSB to the United States to suspend concessions.
7.343 As already mentioned, we first note that Article 22.2 and 22.7 of the DSU refers to
"authorization" of the DSB. The United States has no obligation under the DSU to apply the
sanctions authorized by the DSB.
480 Second, we note that Article 22.8 provides that the suspension of
obligations "shall 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 for a solution to the nullification or im pairment of benefits". There is no reference to
the DSB in that phrase and nothing in this provision suggests that a Member suspending concessions
can continue to do so as long as the authorization of the DSB has not been repealed by the DSB. On
the contrary, it seems that it is for the Member c oncerned to draw the consequences of a removal of
the violation. In other words, the removal of the measure found to be inc onsistent with a covered
agreement supersedes the DSB authorization to suspend concessions.
7.344 The United States also argues that, if the presumption of good faith compliance were
accepted, nothing would prevent the European Communities from notifying a "scam legislation". The
United States argues that this could open an endless loop of litigation
481, as a mere notification of a
compliance measure would force the United States to initiate a dispute settlement procedure under
Article 21.5 of the DSU.
7.345 We recall that we are called upon to solve this dispute, not to make generally applicable
interpretations of the DSU. We have found above that the EC implementing legislation was not a
"scam legislation". Therefore, we do not find it necessary to address the situation that would result
from our finding if a Member notified a "scam legislation".
Is the presumption of good faith compliance rebuttable only in a
specific forum?
7.346 We note that the European Communities cl aims that the presumption of good faith
compliance is rebuttable, but only in the appropria te forum, i.e. by the complaining party in the
original case taking the initiative of having r ecourse to a dispute settlement procedure under
Article 21.5 of the DSU. 482 The European Communities alleges a "jurisprudential" need for an
irrebuttable presumption to fill up a gap in the DSU and allow respondents to exit from post-
retaliation situations.
7.347 The United States argues, on the contrary, that an Article 21.5 proceeding is not the only
avenue available if there is a disagreement as to the adoption of a compliance measure and that, in any
event, it is not open exclusively to the United States, but also to the European Communities.
7.348 It is therefore important for the Panel to dete rmine the extent to which the unavailability of
any legal recourse for the European Communities in a post retaliation situation may justify that the
presumption of good faith compliance be irrebuttabl e, except through recourse to the procedure
provided in Article 21.5 of the DSU.
7.349 We first note that nowhere does the DSU provide that a presumption of good faith compliance
should be rebuttable only through recourse to Article 21.5 of the DSU.

480 See, e.g., Canada – Aircraft Credits and Guarantees and Brazil – Aircraft . In both cases
authorization of retaliation has been granted by the DSB but the complaining party has not applied the
authorized sanctions.
481 See, e.g., US's reply to Panel question 40 after the first substantive meeting, Annex B-3, para. 6.
482 EC's reply to Panel question 4(b) after the first substantive meeting.

7.350 Second, it appears that, even under th e current DSU, several means seem a priori to be
available to the European Commun ities to obtain termination of the suspension of concessions or
other obligations:
(a) Good offices and consultations;483
(b) Article 21.5 of the DSU;
(c) Arbitration under Article 25 of the DSU; and
(d) recourse to a normal panel against the continuation of the retaliations (as in this case).
7.351 The Panel is mindful that the option naturally coming to mind when it comes to reviewing
compliance is the procedure provided under Article 21. 5 of the DSU. The Panel is aware of the broad
language ("such dispute shall be decided through recourse to these dispute settlement procedures")
used in Article 21.5 and that such language could be deemed to encompass any procedure available
under the DSU for the resolution of disputes. The Pa nel is, however, of the opinion that other terms
in Article 21.5 support the view that the Article 21. 5 procedure is actually a panel procedure with a
shorter deadline. In this regard, the Panel reads the phrase "including whenever possible resort to the
original panel" not as meaning that resort to a pane l is generally preferred, but as requesting resort to
the panelists that reviewed the original case, rather than to other individuals.
7.352 The Panel also notes that this dispute is eviden ce that a practicable alternative exists to a
recourse to Article 21.5. We recall in this respect that even though the European Communities claims
a violation of the DSU by the United States, its cl aim under Article 22.8 of the DSU is based on the
compliance of its implementing measure with the WTO Agreement, whether presumed (as part of the
second series of main EC claims under Article 23.1 read together with Article 22.8 and Article 3.7) or
demonstrated (as in its alternative "direct" claim of violation of Article 22.8). While Members enjoy
complete discretion in the way they bring the measu re at issue into conformity with the covered
agreements, the findings already made by the Panel with respect to Article 23.2(a) and 23.1 of the
DSU and the findings the Panel will make under Ar ticle 22.8 will have an impact on whether the
United States may maintain, suspend or withdraw the suspension of obligations it currently applies.
7.353 We recall that the European Communities consid ered that Article 21.5 was not an avenue
open to the party claiming compliance, but only to the complainant in the original case.
484 Both
parties have discussed the relevance of the only case where a party found in br each of its obligations
requested an Article 21.5 panel, i.e. the EC – Bananas III (Article 21.5 – EC) panel.
7.354 We note that, in the EC – Bananas III (Article 21.5 – EC) case, the panel did not conclude
that it could not perform its duties under Article 21.5. The panel, referring to the comments made by
Japan as a third party, noted that allowing the de fendant before the original panel to initiate a
procedure under Article 21.5 presented certain "practical problems or anomalies". The panel was also
sympathetic to the concerns of India as a third party that, in an appropriate case, a respondent-
initiated Article 21.5 proceeding should be allowed.485 The Panel concluded:

483 Such a solution seems to be implicitly suggested by the United States when it refers to Article 22.8
which mentioned that "a mutually satisfactory solution is reached".
484 EC's reply to Panel question 1 after the first su bstantive meeting, Annex B-1; EC's second written
submission, para. 61.
485 Panel Report on EC – Bananas III (Article 21.5 – EC), para. 4.18.

"In our view, we would not rule out the possibility of using Article 21.5 in such a
manner, particularly when the purpose of such initiation was clearly the examination
of the WTO-consistency of implementing measures."486
7.355 We are therefore not convinced that Article 21.5 is the only avenue available to address a
claim of compliance by a Member alleging to have complied with recommendations and rulings of the
DSB. Neither do we believe that proceedings un der Article 21.5 are open only to the original
complainant.
7.356 For these reasons, the Panel does not agree th at the presumption of good faith compliance
which the European Communities enjoys should be rebuttable only through a recourse by the
complainants in the original case to Article 21.5 of the DSU.
(iii) Conclusion
7.357 On the basis of the above:
(a) We note that, under general international law, the corollary to the obligation to
perform treaty obligations in good faith is the presumption that Members act in good
faith when performing such obligations.
(b) We find that the general principle of good faith and the presumption of good faith
performance of a Member's obligations appl y in relation to Members' obligations
under the WTO Agreements, including the DS U, as interpreted in accordance with
customary rules of interpretation of public international law.
(c) We also note that there is no presumption of bad faith under general international law
and find that no presumption of bad faith applies under the DSU as interpreted in
accordance with customary rules of interpretation of public international law.
(d) We find that the presumption of good fa ith compliance alleged by the European
Communities is at best legally identical to the principle of good faith performance of
treaty obligations. We do not find in th e DSU as interpreted in accordance with
customary rules of interpretation of public international law any ground supporting a
specific presumption of compliance for Members having to implement DSB
recommendations and rulings.
(e) Moreover, we find no support in the DSU to suggest that this presumption may only
apply to the measure taken by the Europ ean Communities and not to the measures
adopted by the United States.
(f) As a consequence, while we agree with the existence of a presumption of good faith
compliance, we do not agree with the Eur opean Communities that the presumption of
good faith that it enjoys may only be rebutted in an Article 21.5 procedure. We find,
on the contrary, that this presumption, b ecause it applies to measures taken by all
parties, must be rebuttable before this Pane l. Just as the EC allegations are intended
to rebut the presumption of good faith conformity of the US retaliatory measures with
Article 22.8 of the DSU, the United States should be allowed to rebut the
presumption of EC compliance by proving actual non-compliance.

486 Ibid.

7.358 In reaching these conclusions, we do not consider that we add to or diminish the rights and
obligations of WTO Members. We do not apply the presumption of good faith compliance
independently from the obligations of the Eu ropean Communities under the WTO Agreement. The
European Communities has an obligation to co mply with the WTO Agreement in general 487 and with
the recommendations and rulings of the DSB and the general principle of good faith implies that the
European Communities do so in good faith. In doing so we apply the principle of good faith
consistently with WTO law and general public international law.488
7.359 We have also found above that we could not agree with th e European Communities and base
our findings of violation of Article 23.1 read in conjunction with Article 22.8 and 3.7 of the DSU on
an irrebuttable presumption of good faith complia nce by the European Co mmunities. Whereas the
European Communities enjoys a presumption of good faith compliance, this presumption is
rebuttable. We agree that, for all practical purpo ses, this amounts to addressing the EC "alternative"
claim of violation of Article 22.8 per se. However, this is not the result of us merely disregarding the
order in which the European Communities wanted us to review this case. We are still reviewing the
EC claim of violation of Article 23.1, read together with Articles 22.8 and 3.7. We are not reviewing a
claim of violation of Article 22.8 in isolation.
(iv) Does the Panel have jurisdiction to address the compliance of the EC implementing measure
with the SPS Agreement?
7.360 We are mindful that our terms of reference do not include any provision of the
SPS Agreement referred to by the parties during these pro ceedings and that "[A] panel cannot assume
jurisdiction that it does not have."
489 Stricto sensu , the conformity of the EC measure with the
provisions of the SPS Agreement referred to in this case is not part of our mandate. This means that
reviewing alleged violations of the SPS Agreement is not part of our mandate either and that we are
not expected to make findings on those provisions.
7.361 However, this absence of reference to the SPS Agreement is understandable since the
European Communities is not seeking a finding of violation of the SPS Agreement by the responding
party.
7.362 Moreover, we note that the European Communities claims in its request for establishment of a
panel that the United States breached Article 22.8
"[b]y failing to apply the suspension of concessions or other obligations only until
such time as the measure found to be incons istent 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."490
7.363 This statement, which essentially repeats the terms of Article 22.8, must be read in
conjunction with other relevant remarks of the Eu ropean Communities in its request for establishment
of a panel. For instance, in the introduction, the European Communities stated that:
"[t]his request concerns the United States ' continued suspension of concessions and
other obligations under the covered agreem ents, without recourse to the procedures
established by the DSU, after the Europ ean Communities has removed the measures

487 See Article XVI:4 of the WTO Agreement.
488 As explicitly expressed in Article 2.2 of the Charte r of the United Nations, as well as in Article 26
of Vienna Convention on the Law of Treaties.
489 Appellate Body Report on India – Patents (US), para. 92.
490 WT/DS320/6.

found to be inconsistent with WTO law in case DS26 , European Communities –
Measures concerning meat and meat products (Hormones) ('EC – Hormones')."491
and subsequently:
"[t]he European Communities subsequently removed the measure found to be
inconsistent with a covered agreement. It adopted Directive 2003/74/EC of the
European Parliament and of the Counc il of 22 September 2003 amending Council
Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain
substances having a hormonal or thyrosta tic action and of beta-agonists. The
Directive was published and entered into force on 14 October 2003.
In conformity with the recommendations and rulings of the DSB and the covered
agreements, the new EC legislation is b ased on comprehensive risk assessments, in
particular on the opinions of the independe nt Scientific Committee on Veterinary
Measures relating to Public Health. The ri sk assessments focussed on potential risks
to human health from hormone residues in bovine meat and meat products, in
particular such risks arising from residues of six hormonal substances: oestradiol-17 β,
testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate. In
carrying out the risk assessment s, the European Communitie s initiated and funded a
number of specific scientific studies and research projects. It addressed specific
requests to the United States, Canada a nd third countries to provide any recent
scientific data and information in their possession. It took account of the findings of
various independent expert bodies.
In light of the risk analyses carried out, the European Communities concluded that the
avoidance of intake of oestradiol-17 β is of absolute importance to human health and
that, consequently, the placing on the market of meat containing this substance should
be prohibited. With respect to testoste rone, progesterone, trenbolone acetate, zeranol
and melengestrol acetate, and on the basis of the available pertinent scientific
information reflected in the above-me ntioned risk analyses, the European
Communities provisionally prohibited the placing on the market of meat containing
these substances because the relevant scientific evidence was insufficient.
On 27 October 2003, the European Commun ities notified to the DSB the adoption,
publication and entry into force of this Directive as well as the preceding scientific
risk assessments. In the same communicati on, the European Communities explained
that it considers itself to have fully impl emented the recommendations and rulings of
the DSB in the EC – Hormones dispute and that, as a consequence, it considers the
United States' suspension of concessions vi s-à-vis the European Communities to be
no longer justified."
492
7.364 In the Panel's view, one instance of violation of Article 22.8 occurs when the suspension is
maintained even though the "measure found to be inconsistent ... has been removed". The lengthy
explanation above demonstrates that the claims of the European Communities under Article 22.8 are
related to its alleged removal of the "measure found to be inconsistent" with the SPS Agreement.
7.365 The Panel notes the arguments of the parties in reply to a question on its jurisdiction to review
the compatibility of the EC implementing measure with the SPS Agreement. The United States
replied that, pursuant to Article 7 of the DSU, a panel's standard terms of reference include the

491 WT/DS320/6 (emphasis added).
492 WT/DS320/6 (original footnotes omitted).

provisions referred to by the responding party. 493 The European Communities re plied that, in light of
the Appellate Body practice, the Panel has, in th e present case, no jurisdiction to address Articles 3.3,
5.1 and 5.7 of the SPS Agreement. The European Communities adds that, at best, one could venture
to draw an analogy to affirmative defences.494
7.366 The Panel is not convinced by any of the views of the parties. Regarding the argument of the
United States, the Panel recalls that the matter before the Panel is defined by the request for
establishment of the Panel. 495 The matter before this Panel is whether the measure maintained by the
United States suspending concessions or other obligations vis-à-vis the European Communities has
breached, inter alia, Article 22.8 of the DSU, not whether the European Communities has complied
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, to the extent necessary to make an objective
assessment of the matter, including an objective assessment of the EC claims, as part of its findings on
Article 22.8 of the DSU.
7.367 Neither does the Panel consider that an analog y could be drawn between the reference by the
parties to provisions of the SPS Agreement in this case and the notion of "affirmative defence". In the
opinion of the Panel, an affirmative defence would imply that the responding party invoke a provision
of a covered agreement as a justification for a breac h of another provision. This is not the case here.
The United States does not argue the incompa tibility of the EC implementing measure as a
justification for a breach of Article 22.8. Nor does it seem to invoke the incompatibility of the EC
implementing measure as a justification for a breac h of Article 23. The Panel concludes that any
jurisdiction it may have to review the compa tibility of the EC implementing measure with the
SPS Agreement cannot result from the fact that the United States would have invoked the
SPS Agreement, including as an affirmative defence.
7.368 We also note the argument of the European Communities that:
"[this] issue is a perfect illustration of the problems arising if an implementing
member is forced to bring a case allegi ng compliance, instead of the original
complaining party bringing a case alleging n on compliance ... The terms of reference
become wholly devoid of their meaning and the panel's jurisdiction turns into a
moving target depending on whatever allega tions of inconsistency the 'defending'
parties will come up with. It is clear that the dispute settlement system is not
designed to accommodate such a procedural constellation."
496
7.369 We do not agree that the terms of reference of the Panel become wholly devoid of meaning
because of the references made by the parties to provisions of the SPS Agreement. Neither do we
consider that this modifies our terms of reference. We recall that the European Communities claims a
violation by the United States of Article 22.8 of the DSU which is premised on the compliance of the
EC implementing measure (D irective 2003/74/EC) with the SPS Agreement. A discussion of the

493 US's reply to Panel question 65 after the first substantive meeting, Annex B-3, para. 64.
494 EC's reply to Panel question 65 after the first substantive meeting, Annex B-1, paras. 239-241.
495 See Appellate Body Report in Brazil – Desiccated Coconut, DSR 1997:I, p. 186:

"… the 'matter' referred to a panel for considera tion consists of the specific claims stated by
the parties to the dispute in the relevant documents specified in the terms of reference. We
agree with the approach taken in previous adopted panel reports that a matter, which includes
the claims composing that matter, does not fall within a panel's terms of reference unless the
claims are identified in the documents referred to or contained in the terms of reference."

496 EC's reply to Panel question 65 after the first substantive meeting, Annex B-1, para. 240. See also
EC's reply to Panel question 62 after the first substantive meeting, Annex B-1.

compatibility of the measure with provisions of the SPS Agreement is, thus, the immediate
consequence of the inclusion of Article 22.8 of the DSU in the EC request for establishment of a
panel. As such, our mandate remains defined by the EC request for establishment of a panel.
7.370 We are mindful that the responding party could bring several allegations of violations with
respect to the EC implementing measure. We not e however that the European Communities did not
exclude the possibility for the Panel to consider th e actual compatibility of Directive 2003/74/EC with
the SPS Agreement as part of its alternative "direct" clai m under Article 22.8 of the DSU. Such a
review would imply that the Panel address the compatibility of the EC implementing measure with the
SPS Agreement. While the Panel must comply with its terms of reference, nothing in the DSU
prevents the Panel from considering the compatib ility of the EC implementing measure with the
SPS Agreement if this is necessary in order to make the findings required by those terms of reference.
7.371 Moreover, we note that, whereas the European Communities "[did] not believe that it [was]
necessary for the Panel to look into any scientific issue to make its necessary findings and rulings
within its terms of reference in this particular case", the European Commun ities did not exclude that
the Panel could address the scientific issues at stak e since it suggested that, in such a case, the
consultation of scientific experts would be absolutely necessary. 497 The parties have extensively
discussed the question of the compa tibility of the EC implementing measure with certain provisions
of the SPS Agreement, have agreed to the consultation of experts on the scientific issues relating to the
compatibility of the measure with the SPS Agreement and have extensively commented on these
scientific issues.
7.372 We conclude from this that the Panel should be entitled to determine whether the European
Communities has removed the measure found to be inc onsistent with a covered agreement in order to
establish whether Article 22.8 has been breached by the United States. Indeed, the Panel considers
that, since the European Communities made a claim of violation of Article 22.8, the compatibility of
its implementing measure becomes ipso facto an issue that the Panel will have to address if it reviews
any of the EC claim relating to Article 22.8. The fact that the European Communities alleges that it
benefits from a presumption of good faith compliance does not affect this conclusion. Under both of
its Article 22.8 claims, the European Communities needs to demonstrate that it has removed the
measure found to be inconsistent. The presumpti on of good faith compliance does not affect what
needs to be demonstrated. It simply shifts the burden of proof since, in application of the presumption
of good faith compliance, the European Communities h as, in this dispute, made a prima facie case of
violation of Article 22.8 which the United States has to rebut.
7.373 The Panel notes that, pursuant to its mandate, it is only expected to make findings of violation
in relation to Article 22.8 of the DSU, the breach of which is alleged by the complaining party. The
Panel nonetheless recalls that, for the reasons menti oned above and irrespective of which one of the
two Article 22.8 claims is addressed, it will have to determine whether the European Communities has
removed the measure found to be inconsistent. Since what has to be demonstrated is a consistency or
inconsistency with provisions of the SPS Agreement, this is not really an issue of fact but a legal
question, which adds to the complexity of the situation before the Panel.
7.374 The Panel is fully conscious of the cha llenges attached to assessing whether the EC
implementing measure is not inconsistent with the provisions of the SPS Agreement referred to by the
parties in this case. The Panel also notes that, in a case like this one, it is largely dependent on the
responding party, not on the complainant, as fa r as allegations of incompatibility of the EC

497 EC's reply to Panel question 74 after the first substantive meeting, Annex B, para. 275. The Panel
notes that the European Communities raised an alternativ e claim of violation of Article 22.8 of the DSU and
Articles I and II of the GATT 1994, based on its a lleged actual compliance with the recommendations and
rulings of the DSB in the EC – Hormones case.

implementing measure are concerned. However, we be lieve that it is in the interest of the responding
party to demonstrate the incompatibility of the im plementing measure. We can count on its full
cooperation in this respect, and we have experienced it in this case. The Panel also agrees that, since
the allegations of violation of the SPS Agreement were not exhaustively listed in its terms of reference
and depended on the parties raising them in the cour se of the procedure, this could have made it
difficult to circumscribe the scope of its review under the SPS Agreement. We note, however, that in
this particular case the legal arguments regardi ng the conformity of the EC implementing measure
with the SPS Agreement were all raised early in the proceedings and that no party complained that it
had not been given sufficient opportunity to comment on the other party's allegations.
7.375 We therefore conclude that we should addr ess the compatibility of the EC implementing
measure with the provisions of the SPS Agreement referred to by the parties to the extent necessary to
determine, with respect to the EC claim relating to Article 22.8, whether the EC "measure found to be
inconsistent" in the EC – Hormones case has been removed. We are mindful of the procedural
problems raised by this approach, but we do not cons ider that, by proceeding in this manner, we are
exceeding our jurisdiction to the exte nt that such a review is necessary in order to address the EC
claims under Article 22.8.
7.376 The Panel notes in this respect that it is not the first time that a dispute settlement entity, when
confronted with a procedurally a-typical issue, decided to adopt a pragmatic solution and perform
functions similar to those of an Article 21.5 panel. In the Article 22.6 arbitration in the EC –
Bananas III case the arbitrator decided to adopt the most "logical way forward":
"4.10 ... the European Communities argues that we should not consider the
consistency of its new banana regime. First, it argues that to do so would go beyond
our terms of reference, which it suggests are limited to determining the level of
suspension and its equivalence to the level of nullification or impairment. As noted
above, however, setting the level of nullif ication or impairment may require
consideration of whether there is nullification or impairment flowing from a WTO-
inconsistency of the new banana regime."
7.377 We too believe that our approach to consider, to the extent necessary, the compatibility of the
EC implementing measure with the SPS Agreement is the most logical way forward under the
circumstances, having regard to our duty to assist th e parties and the DSB in solving this dispute and,
in particular, to determine whether, as claimed by the European Communities, there is a violation of
Article 23.1 in conjunction with Article 22.8 and Articl e 3.7 of the DSU. This is consistent with our
duty to make an objective assessment of the matter before us pursuant to Article 11 of the DSU.
498
7.378 We also note that panels have not hesitated in the past to consider other provisions than those
on which findings had been requested as part of the context of those provisions.499
7.379 Therefore, the Panel believes that these are suffi cient reasons for it to conclude that it has
jurisdiction to consider the compatibility of the EC implementing measure with the SPS Agreement as
part of its review of the claim raised by the Eur opean Communities with respect to Article 22.8 of the
DSU.
(c) Burden of proof
7.380 We note that the European Communities consid ers that it has made a prima facie case of
violation of the DSU provisions, and that, since it ca nnot be requested to prove a negative, it is for the

498 See Section VII.C.2.(a) above.
499 Panel Report on India – Quantitative Restrictions, para. 5.26.

United States to prove a violation of the SPS Agreement by the EC implementing measure. The
European Communities also argues that it enjoys a presumption of good faith compliance with the
recommendations and rulings of the DSB in the EC – Hormones dispute. 500 The United States
considers that it is for the European Communities to show that it has complied with Article 22.8 of the
DSU and, thus, to demonstrate that its implementing measure actually complies with the provisions of
the SPS Agreement.501
7.381 The principles regarding allocation of burden of proof have been well established since the
early days of the WTO dispute settlement system and the Panel did not deem it necessary to repeat
them in relation to the other claims of the Eur opean Communities. However, having regard to the
importance given by the parties to the question of bu rden of proof in relation to the compatibility of
the EC measure with the SPS Agreement, the Panel considers that it needs to clarify how it addressed
burden of proof in relation to the EC claim under Article 22.8.
7.382 First, we deem it necessary to recall that, in US – Wool Shirts and Blouses , the Appellate
Body stated that:
"... various international tri bunals, including the International Court of Justice, have
generally and consistently accepted and app lied the rule that the party who asserts a
fact, whether the claimant or the resp ondent, is responsible for providing proof
thereof. Also, it is a generally-accepted ca non of evidence in civil law, common law
and, in fact, most jurisdictions, that the burden of proof rests upon the party, whether
complaining or defending, who asserts the affirmative of a particular claim or
defence."502
7.383 With respect to the violation of Article 22.8 as such, the Panel considered that it had, in
principle, no reason to address burden of proof any differently than any other panel established under
Article 6 of the DSU. Indeed, as stated by the Co mplainant itself, this case is about a measure taken
by the United States. The fact that this dis pute takes place in the context of the EC alleged
compliance with the recommendations and rulings of the DSB in the EC – Hormones dispute should
have no impact on the question of the burden of proof regarding the actual claim before us. This
means that the principles identified by the Appe llate Body above apply, and that the European
Communities must prove its claim that the United States breaches Article 22.8 of the DSU.
7.384 Yet, one of the particularities of this case is th at the EC claim of violation of Article 22.8 of
the DSU by the United States is premised on the rem oval of the EC measure fo und to be inconsistent
with the SPS Agreement. In other words, in order to demonstrate that the United States has breached
Article 22.8, the European Communities also alle ges that its implementing measure is itself in
conformity with the SPS Agreement.
7.385 In theory, this should not raise any difficulty in terms of burden of proof since it is well
established that each party has to prove its own alle gations. We agree, however, with the European
Communities that in a case like this one, this coul d generate for the complainant at the beginning of
the proceedings a situation equiva lent to having to "prove a negative", since the spectrum of
provisions against which the legality of the EC meas ure may have to be reviewed remains very broad
as long as the respondent has not made its own alle gations of inconsistenc y of the implementing
measure. However, we recall that we found above that the European Communities enjoyed a
presumption of good faith compliance, even though that presumption was rebuttable before this Panel.

500 EC's first written submission, paras. 92-94.
501 US's first written submission, paras. 102, 103 and 106.
502 Appellate Body Report on US – Wool Shirts and Blouses, p. 14. See also Appellate Body Report on
Canada – Dairy (Article 21.5 – New Zealand and US II), para. 66.

As soon as the European Communiti es established a prima facie case 503 thanks to the presumption of
good faith compliance, the burden shifted on the United States to rebut that presumption. We recall
that "... a prima facie case is one which, in the ab sence of effective refutation by the defending party,
requires a panel, as a matter of law, to rule in favour of the complainin g party presenting the prima
facie case."504 We believe that the United States sufficien tly refuted the EC allegation of compliance
in its first written submission throug h positive evidence of breach of the SPS Agreement by the
European Communities. In its subsequent submi ssions before the Panel, the European Communities
responded to the allegations of violation made by the United States. Thus, the European Communities
never actually had to "prove a negative" in this case.
7.386 While the presumptions based on good faith enjoye d by each party may have played a role in
the burden of proof in the early st age of the Panel proceedings, it is the opinion of the Panel that they
eventually "neutralized" each ot her since each party also subm itted evidence in support of its
allegations. Ultimately, each party had to prove its specific allegations in response to the evidence
submitted by the other party. 505 Thereafter, when considering wh ether an allegation had been proven
or not, the Panel followed the practice of other panels to weigh all the evidence before it.
(d) Compatibility of the EC implementing measure with the provisions of the SPS Agreement
(i) The EC implementing measure
7.387 As already noted, the Europ ean Communities has had a ban on the placing on the market,
including a ban on the importation, of beef treat ed with certain hormones for growth promotion
purposes since 1988. The hormones concerned are oestradiol-17 β, testosterone, progesterone,
trenbolone acetate, zeranol and melengestrol acetate. We note that the European Communities stated
in its first submission that the DSB recommendations in the EC – Hormones cases had been
implemented through the adoption, on 22 September 2003, of Directive 2003/74/EC the transposition
deadline of which was 14 October 2004.
7.388 The European Communities claims that the Directive is based on a risk assessment the results
of which "sufficiently warrant" the definitive im port prohibition on meat and meat products treated
with oestradiol-17 β and "provide the available pertinent information" on the basis of which the
provisional prohibition regarding the other five hormones has been enacted.
7.389 The Panel understands that, according to the European Communities, its risk assessment:
(a) is composed of three opinions issued by the EC Scientific Committee on Veterinary
measures relating to Public Health (SCV PH) in 1999, 2000 and 2002, the 2000 and
2002 Opinions constituting reviews of the 1999 Opinion;
(b) is supported by the 17 studies initiated and funded by the European Communities
between 1998 and 2001 in order to obtain as much as possible of the missing
scientific information that was identified by the panel and the Appellate Body in the
EC – Hormones case.
7.390 Specifically, the European Communities argues that the 17 scientific studies it commissioned
resulted in numerous publications which, along with the pre-existing scientific data, were examined
by the SCVPH. The SCVPH issued its first op inion entitled "Assessment of Potential Risks To

503 See Appellate Body Report on EC – Hormones, para. 98.
504 Appellate Body Report on EC – Hormones, para. 104.
505 See Appellate Body Report on Japan – Apples, para. 154.

Human Health From Hormone Residues in Bovine Meat And Meat Products" on 30 April 1999
(hereafter the "1999 Opinion").
7.391 The 1999 Opinion contained the following major conclusions:
(a) As concerns excess intake of hormone residu es and their metabolites, and in view of
the intrinsic properties of hormones and ep idemiological findings, a risk to the
consumer had been identified with differen t levels of conclusive evidence for the six
hormones in question.
(b) In the case of oestradiol-17 β, there was a substantial body of recent evidence
suggesting that it had to be considered as a complete carcinogen, as it exerted both
tumour initiating and tumour promoting effect s. The data available did not, however,
allow a quantitative estimate of the risk.
(c) For the other five hormones at issue, in spite of the individual toxicological and
epidemiological data described in the report, the current state of knowledge did not
allow a quantitative estimate of the risk.
(d) For all six hormones endocrine, developm ental, immunological, neurobiological,
immunotoxic, genotoxic and carcinogenic effects could be envisaged. Of the various
susceptible risk groups, prepubertal childre n was the group of greatest concern.
Again the available data did not enable a quantitative estimate of the risk.
(e) In view of the intrinsic properties of the hormones and in consideration of
epidemiological findings, no threshold leve ls could be defined for any of the six
substances.
506
7.392 In 2000, the SCVPH reviewed two reports, one from the Committee on Veterinary Medicinal
Products and one from the UK Veterinary Products Committee, to determine whether the science
contained within warranted altering the findings an d conclusions of the 1999 Opinion. In May 2000,
the SCVPH concluded the following:
"The reports of the UK's Veterinary Products Committee subgroup and of the
Committee on Veterinary Medicinal Products presented for review to the Scientific
Committee, as well as recent scientific info rmation, did not prov ide convincing data
and arguments demanding revision of the conclusions drawn in the opinion of the
SCVPH of April 30th, 1999, on the potential risks to human health from hormone
residues in bovine meat and meat products.
The SCVPH discussed again the obvious gaps in the present knowledge on target
animal metabolism and residue dispositi on of the hormones under consideration,
including the synthetic hormones. The SC VPH expects that the ongoing EU research
programs will provide additional data on both topics."
507
7.393 Finally, in 2002, the SCVPH reviewed both the 2000 Opinion and the 1999 Opinion and
found that review of the 17 studies launched by the European Commission and recent scientific
literature allowed the following conclusions:

506 1999 Opinion, p. 73 (Exhibit US-4).
507 2000 Opinion, p. 4 (Exhibit US-17).

(a) Ultra-sensitive methods to detect residues of hormones in animal tissues had become
available, but needed further validation.
(b) Studies on the metabolism of oestradiol-17β in bovine species indicated the formation
of lipoidal esters, disposed particularly in body fat. These lipoidal esters showed a
high oral bioavailability 508 in rodent experiments. Thus, the consequence of their
consumption needed to be considered in a risk assessment.
(c) Experiments with heifers, one of the majo r target animal groups for the use of
hormones, indicated a dose-dependent incr ease in residue levels of all hormones,
particularly at the implantation sites. Misplaced implants and repeated implanting,
which seemed to occur frequently, represen ted a considerable risk that highly
contaminated meats could enter the food chain. There was also a dose-dependent
increase in residue levels following the oral administration of melengestrol acetate at
doses exceeding approved levels, with a corresponding increased risk that
contaminated meats could enter the food chain.
(d) Convincing data had been published c onfirming the mutagenic and genotoxic
potential of oestradiol-17 β as a consequence of metabolic activation to reactive
quinones. In vitro
509 experiments indicated that oestrogenic compounds might alter
the expression of an array of genes. Cons idering that endogenous oestrogens also
exerted these effects, the data highlighted the diverse biological effects of this class of
hormones.
(e) No new data regarding testosterone and progesterone relevant to bovine meat or meat
products were available. However, it w as emphasized that these natural hormones
were used only in combination with oestradiol-17 β or other oestrogenic compounds
in commercial preparations.
(f) Experiments with zeranol and trenbolone acetate suggested a more complex oxidative
metabolism than previously assumed. These da ta needed further clarification as they
might influence a risk assessment related to tissue residues of these compounds.
(g) Zeranol and trenbolone acetate had been tested for their mutagenic and genotoxic
potential in various systems with differe nt endpoints. Both compounds exhibited
only very weak effects.
(h) Data on the genotoxicity of melengestrol acetate indicated only weak effects.
However, pro-apoptotic effects were note d in some cell-based assays, which were
attributed to the impurities in commercial formulation. Further experiments should
clarify the toxicological significance of these impurities.
(i) Model experiments with rabbits treated with zeranol, trenbolone actetate or
melengestrol acetate, mirroring their use in bovines, were designed to study the
consequences of pre- and perinatal exposure to exogenous hormones. All compounds

508 Bioavailability is the capacity of a substance to enter the general blood circulation and to diffuse
into the whole body of the animal or the human being admi nistered this substance, or the fraction of a dose of a
substance that is available for system ic circulation (replies of Dr. Boisse au, Dr. Boobis and Dr. Guttenplan to
Panel question 43 to the experts, Annex D, paras. 344-357).
509 In vitro means outside of the body, usually in a cell-ba sed system in a test tube or culture dish.
(Transcript of the Panel meeting with the experts, Annex G, para. 96 (Dr. Boobis)).

crossed the placental barrier easily and influenced to varying degrees the
development of the foetus, at the doses used in the experiments.
(j) Epidemiological studies with opposite-sexed twins suggested that the exposure of the
female co-twin in utero to hormones resulted in an increased birth weight and
consequently an increased adult breast cancer risk.
(k) Several studies were devoted to the potential impact of the extensive use of hormones
on the environment. Convincing data were presented indicating the high stability of
trenbolone acetate and melengestrol acetate in the environment, whereas preliminary
data were provided on the potential detr imental effects of hormonal compounds in
surface water.
7.394 After re-appraisal of the data from the 17 st udies and recent scientific literature, the SCVPH
confirmed the validity of its previous Opinions (in 1999 and 2000) on the Assessment of Potential
Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products, and that no
amendments to those opinions were justified.
510
7.395 A year and a half later, the European Par liament and the Council of the European Union
amended Directive 96/22/EC, which was the subject of the original EC – Hormones dispute, by
adopting Directive 2003/74/EC. In Directive 2003/ 74/EC, the European Co mmunities restated the
SCVPH assessment that "recent evid ence suggests that [oestradiol-17 β] has to be considered as a
complete carcinogen, as it exerts both tumour-initiating and tumour-promoting effects and that the
data currently available do not make it possible to give a quantitative estimate of the risk."
511
7.396 The European Communities went on to conclude in its amended Directive that oestradiol-17 β
"can potentially be used in all farm animals a nd residue intake for all segments of the human
population and in particular the susceptible groups at high risk can therefore be especially relevant.
The avoidance of such intake is of absolute importance to safeguard human health."512
7.397 Finally, the European Communities concluded that in order to achieve its chosen level of
protection from the risks posed, in particular to human health, by the routine use of these hormones
for growth promotion and the consumption of resi dues found in meat derived from animals to which
these hormones have been administered for growth promotion purposes, it was necessary to maintain
the permanent prohibition laid down in Directive 96/22/EC on oestradiol-17 β, and provisionally ban
the other five hormones at issue.
(ii) Scope of the Panel review
7.398 Given the particular circumstances under which we engage in a review of the compatibility of
the EC implementing measure with the SPS Agreement, we deem it necessary to clearly circumscribe
the scope of our review under that Agreement.
7.399 Indeed, the EC claim of violation of Article 22.8 of the DSU by the United States is premised
on the alleged compatibility of the EC implementing measure with the SPS Agreement. We note in
this respect that the European Communities itself stated in its first written submission that:
"The new Directive provides that the use fo r animal growth promotion of one of the
six hormones in dispute is permanently prohi bited while the use of the other five is

510 2002 Opinion, pp. 21-22 (Exhibit US-1).
511 EC Directive 2003/74/EC.
512 Directive 2003/74/EC, whereas clause 9.

provisionally forbidden. It is based on a comprehensive risk assessment and, thus, is
fully compliant with the DSB recommenda tions and rulings. In particular, as
stipulated by the Appellate Body, the r esults of the risk assessment 'sufficiently
warrant' the definite import prohibition regard ing one of the hormones (Article 5.1 of
the SPS Agreement),513 and provide the 'available pertinent information' on the basis
of which the provisional prohibition regarding the other five hormones has been
enacted (Article 5.7 of the SPS Agreement). Consequently, through Directive
2003/74/EC the European Communities has implemented the rulings and
recommendations in the Hormones case."514
7.400 In its subsequent submissions, the European Communities has argued the compatibility of its
implementing measure with the provisions referred to in the quotation above (i .e. Article 5.1 and 5.7
of the SPS Agreement). This is, in our view, indicative of the provisions within the scope of which
the European Communities considers its implementing me asure to fall. Yet, we do not consider that
the scope of our review of the SPS Agreement can be determined exclusively on the basis of the EC
allegations of compatibility.
7.401 Indeed, we note the argument of the United States in reply to a question from the Panel that:
"[T]he EC must demonstrate that it has broug ht its measure into conformity with the
DSB recommendations and rulings in the Hormones dispute. Those recommendations
and rulings include findings of EC breaches of SPS Articles 5.1 and 3.3. The EC
argues that it has satisfied the DSB r ecommendations and rulings by basing its
permanent ban for estradiol on a risk assessme nt and satisfying the four conditions of
SPS Article 5.7 for the other five hormones in lieu of a risk assessment. These
arguments call for findings as to whether or not the EC has in fact demonstrated that
it has brought itself into conformity with the DSB's recommendations and rulings, as
these findings are integral part of the EC's Article 22.8 claim."515
7.402 As already mentioned above, we consider that we must determine whether the European
Communities has removed the measure found to be in consistent with the covered agreement or has
provided a solution to the nullification or impairment of benefits. Therefore, we agree with the
United States that we need to review the EC measu re against (a) the recommendations and rulings of
the DSB in the EC – Hormones case and (b) the provisions which the European Communities claims
to comply with as part of its claim of violation of Article 22.8 of the DSU by the United States.
7.403 This said, we also agree with the Europ ean Communities that it is difficult for the
complainant in a case like this one to identify all potential problems of incompatibility. We see other
difficulties if, in cases like this one where a finding of violation by a Member is conditioned by the
compliance of a measure of the complainant with th e WTO Agreement, the scope of review of that
measure is defined only by the complainant. Ind eed, the complainant could limit the scope of the
panel review to provisions with which it believes that its measure is most likely to be found
compatible.
7.404 Under those circumstances, we find it preferable, both from a legal and a practical point of
view, to consider all the allegations and arguments raised by each party, as long as the other party had

513 The European Communities refers to the Appellate Body Report on EC – Hormones , para. 253
lit. (l).
514 EC's first written submission, para. 17.
515 US's replies to Panel questions after the second substantive meeting, Annex C-3, para. 24.

the opportunity to comment on those allegations and arguments. 516 We consider that this was the case
in these proceedings, since both parties were gran ted ample opportunities and time to reply to each
other's submissions.
7.405 We note that the United States argues an inco mpatibility of the EC implementing measure
with Article 5.1 with respect to the import ban relating to meat and meat products treated with
oestradiol-17β. The United States alleges an incompatib ility of the EC implementing measure with
Article 5.7 with respect to the provisional impor t ban on meat and meat products treated with
testosterone, progesterone, trenbolone acetate, zeranol and melengestrol acetate. The United States
alleges an incompatibility of the EC implementing measure with Article 3.3 of the SPS Agreement
regarding each of the bans applied under that measu re with respect to meat from cattle treated with
growth promotion hormones for which interna tional standards exist, i.e. oestradiol-17 β, testosterone,
progesterone, trenbolone acetate and zeranol.
517
7.406 We nonetheless note that the United States referred to other provisions of the SPS Agreement
in its submissions. These are Articles 5.2 and 5.6. The United States also makes a reference to
Article 2.2 in its rebuttal.518
7.407 At our request, the United States clarified that the reference to Article 2.2 of the
SPS Agreement "was not intended to elicit a finding of a breach of Article 2.2".
7.408 However, "[t]he United States believes that a finding of compliance or non-compliance with
the requirements of Article 5.2 would be appropriate as part of the Pa nel's analysis of whether the EC
has based its measure on a risk assessment within the meaning of Article 5.1". We note that the
United States argued a violation of Article 5.2 of the SPS Agreement in its second written
submission.519
7.409 With respect to the allegation of the United States regarding a violation of Article 5.2 of the
SPS Agreement, we note that the European Communities, in its comments of 31 October 2006 on the
US replies to the questions of the Panel after the first meeting, states that:
"The European Communities takes note of the United States reply that the Panel
would be required to look only at Articl es 3.3, 5.1 (including an examination of
Article 5.2) and 5.7 [of the SPS Agreement]."
7.410 We consider that the European Communities do es not exclude that the Panel may review the
compatibility of its implementing measure with Article 5.2 of the SPS Agreement as part of its review
of the compatibility of the EC implementing measure with Article 5.1. Therefore, we will also review
the compatibility of the EC implementing measure with Article 5.2.
7.411 We conclude that we shall review, to the extent necessary, the compatibility of the EC
implementing measure with Articles 5.1, 5.2, 5.7 and 3.3 of the SPS Agreement. We therefore proceed
with a review of the compatibility of the EC im plementing measure with those provisions in the
following sections, once we have addressed other procedural issues.

516 We are aware of the risk that the responding party may make a new allegation of violation at a late
stage of the proceedings, thus making it difficult for the complainant to reply to this allegation. We nonetheless
consider that such a circumstance will not have any impact on due process as long as the complaining party is
given sufficient opportunities to comment.
517 US's reply to Panel question 20 after the second substantive meeting, Annex C-3. The Panel notes
that, as far as melengestrol acetate is concerned, JECF A has conducted a risk assessment, set an ADI, and
proposed an MRL. However, Codex has not yet adopted an MRL.
518 US's second written submission, para. 27.
519 US's second written submission, paras. 50-65.

(iii) Standard applicable to the review of the compa tibility of the EC implementing measure with
the SPS Agreement
7.412 We believe that, in light of the importance and complexity of the scientific information
provided by the parties and the experts, it is necessary to lay down the way we plan to review all this
information.
7.413 As recalled by the Appellate Body in EC – Hormones , the standard of review applicable to
legal and factual issues regarding measures reviewed against the SPS Agreement is found in Article 11
of the DSU which reads in relevant part that " ...a panel should make an objective assessment of the
matter before it, including an objective assessment of the facts of the case".
7.414 In EC – Hormones, the Appellate Body recalled that:
"So far as fact-finding by panels is concer ned, their activities are always constrained
by the mandate of Article 11 of the DSU; the applicable standard is neither de novo
review as such, nor 'total deference', but rather 'the objective assessment of the
facts'."
520
7.415 The Appellate Body further noted that "under current practice and systems, [panels] are in
any case poorly suited to engage in such a [de novo] review."521
7.416 We note that we have a duty to consider the evidence presented to us and to make factual
findings on the basis of that evidence. It is also generally within our discretion to decide which
evidence we choose to utilise in making findings. 522 Likewise, a panel is not expected to refer to all
statements made by the experts advising it and should be allowed a substantial margin of discretion as
to which statements are useful to refer to explicitly 523 as long as we do not deliberately disregard or
distort evidence.524
7.417 We also recall that we consulted six scientif ic experts individually, and not as an expert
review group. This may have some consequences in terms of the sometimes diverging views which
they expressed. We note that, in EC – Hormones , the Appellate Body considered with respect to
divergent views taken into account in risk assessment that:
"We do not believe that a risk assessment has to come to a monolithic conclusion that
coincides with the scientific conclusion or view implicit in the SPS measure. The risk
assessment could set out both the prevaili ng view representing the "mainstream" of
scientific opinion, as well as the opinions of scientists taking a divergent view.
Article 5.1 does not require that the risk assessment must necessarily embody only
the view of a majority of the relevant scientific community … In most cases,
responsible and representative governments tend to base their legislative and
administrative measures on "mainstream" scientific opinion. In other cases, equally
responsible and representative governments ma y act in good faith on the basis of
what, at a given time, may be a divergent opinion coming from qualified and
respected sources. By itself, this does not necessarily signal the absence of a
reasonable relationship between the SPS measure and the risk assessment, especially
where the risk involved is life-threatening in character and is perceived to constitute a

520 Appellate Body Report on EC – Hormones, para. 117.
521 Appellate Body Report on EC – Hormones, para. 117.
522 Appellate Body Report on EC – Hormones, para. 135.
523 Appellate Body Report on EC – Hormones, para. 138.
524 Appellate Body Report on EC – Hormones, para. 139.

clear and imminent threat to public health and safety. Determination of the presence
or absence of that relationship can only be done on a case-to-case basis, after account
is taken of all considerati ons rationally bearing upon the issue of potential adverse
health effects."525
7.418 Although the Panel is not carrying out its own risk assessment, its situation is similar in that it
may benefit from hearing the full spectrum of expert s' views and thus obtain a more complete picture
both of the mainstream scientific opinion and of any divergent views.
7.419 Likewise, in EC – Asbestos, the Appellate Body stated that:
"In justifying a measure under Article XX(b) of the GATT 1994, a Member may also
rely, in good faith, on scientific sources which, at that time, may represent a
divergent, but qualified and respected, opinion. A Member is not obliged, in setting
health policy, automatically to follow what, at a given time, may constitute a majority
scientific opinion. Therefore, a panel need not, necessarily, reach a decision under
Article XX(b) of the GATT 1994 on the basis of the 'preponderant' weight of the
evidence."
526
7.420 We note that, in some circumstances, only one or two experts have expressed their views on
an issue. Sometimes these views were similar or co mplemented each other. In other circumstances, a
larger number of experts expressed opinions and, sometimes, they expressed diverging opinions.
While, on some occasions, we followed the majority of experts expressing concurrent views, in some
others the divergence of views were such that we could not follow that approach and decided to
accept the position(s) which appeared, in our view, to be the most specific in relation to the question
at issue and to be best supported by arguments a nd evidence. As we have told the parties and the
experts during these proceedings, this Pa nel is not composed of scientists. 527 The experts were also
made fully aware of their role – which was inter alia to present scientific issues to the Panel members
in a way that could be understood by them – and of the role of the Panel in the WTO dispute
settlement system – which is inter alia one of trier of fact. In assessing the scientific advice received
from the experts, we also fully took into account the comments of the parties, when appropriate.

525 Appellate Body Report on EC – Hormones, para. 194.
526 Appellate Body Report on EC – Asbestos, para. 178.
527 In the letter sent to the experts in relation to the preparation of their written replies, the Panel made
the following remark:

"In drafting your replies, please remember that the three panelists serving on the case have no
scientific background and are trying to digest the extensive scientific material submitted by
the parties with your help. Therefore, please provide concise answers which clarify the issues
at hand and which will eventually assist the Panel in reaching its legal findings." (Emphasis in
the original)

Likewise, at the outset of the meeting with the experts, the Chairman mentioned the
following:

"Last but not least, I would lik e to recall that the Panel members do NOT have scientific
expertise. Therefore, I would like to ask the experts to bear this in mind in replying to
questions and explain issues in layman's terms, providing information on underlying concepts
as necessary. In order to get a clearer pictur e with respect to each of the six hormones at
issue, I would also like to invite all those taking the floor to clarify which of the six hormones
their question or reply applies to."

However, as already mentioned, we disregarded t hose comments that attempted to put into question
the objectivity of specific experts. We believe that such questions had to be dealt with separately.528
7.421 We also recall that we are expected to make findings with respect to each of the hormones
concerned. Indeed, in Japan – Apples , the Appellate Body recalled th at findings should be made for
each precise agent that may possibly cause the harm (in this case each of the hormones concerned):
"Under the SPS Agreement, the obligation to conduct an assessment of 'risk' is not
satisfied merely by a general discussion of the disease sought to be avoided by the
imposition of a phytosanitary measure. The Appellate Body found the risk assessment
at issue in EC — Hormones not to be 'sufficiently speci fic' even though the scientific
Articles cited by the importing Member had evaluated the 'carcinogenic potential of
entire categories of hormones, or of the hormones at issue in general .' In order to
constitute a 'risk assessment' as defined in the SPS Agreement, the Appellate Body
concluded, the risk assessment should have reviewed the carcinogenic potential, not
of the relevant hormones in general, but of 'residues of those hormones found in meat
derived from cattle to which the hormones had been administered for growth
promotion purposes'. Therefore, when discussi ng the risk to be specified in the risk
assessment in EC – Hormones , the Appellate Body referre d in general to the harm
concerned (cancer or genetic damage) as well as to the precise agent that may
possibly cause the harm (that is, the speci fic hormones when used in a specific
manner and for specific purposes)."529
7.422 We will therefore address the compatibility of the EC implementing measure with respect to
each hormone concerned, as appropriate. However, in situations where, for instance, information and
evidence are similar for all hormones, or where in formation was not provided for each hormone in
spite of our insistence, specific issues are addr essed with respect to th e hormones concerned as a
whole.
7.423 There is another question raised in these proceedings which the Panel believes it must address
at this stage. It is the issue of "old" versus "n ew" evidence, data or studies. Indeed, the European
Communities relied extensively on the date of the evidence relied upon by JECFA to support its view
that the risk assessments performed by JECFA ar e outdated and the ensuing recommendations of
Codex unreliable.
7.424 In its submissions before the Panel and during the hearing with the scientific experts, the
European Communities contested the validity of JECFA's findings 530 on the basis that it had relied in
its assessments on studies that dated back to th e 1960s, 1970s and 1980s. The Panel sought the views
of the experts on this point.531 Dr. Boisseau pointed out that "It is just a banality to say that JECFA is
provided with new data when it is requested to assess veterinary drugs recently placed on the market
and older data in the case of veterinary drugs alr eady marketed since a long time ago. Anyway, the
quality and the number of the available data are more important than the dates at which these data
have been produced."
532
7.425 During the hearing with the experts, the Eur opean Communities sought the view of Dr. De
Brabander as to whether the validity of "old" data from the 1970s and 1980s should be put in doubt

528 See Section VII.A.2(c) above.
529 Appellate Body Report on Japan – Apples, para. 202. (original footnotes omitted)
530 For a comprehensive list and explanation of JECFA's risk assessment on the six hormones
concerned, see Annex E-2, JECFA's reply to Panel question 17.
531 See questions 34 and 35 of the Panel to the scientific experts, Annex D.
532 Reply of Dr. Boisseau to question 35 of the Panel, Annex D.

because they are old and they have been measured with measurement methods which, it argues, are by
today's standards not credible, or are not accurate, because there are new, more powerful and more
accurate analytical methods. 533 Dr. De Babander replied: "[t]hat is my conclusion. I cannot say that
the data are bad, I don't say that, I just say you don't know that they are good."534
7.426 During the same hearing, Dr. Wennberg specified that: "... even if [the studies used by
JECFA] were older [than the 1970s], if the methodology that was used, and if the methods had been
validated properly, there is no reason to discred it any studies because they were done a long time
ago."535 Dr. Boisseau added that:
"What the Commission said is true as regards the results that are at the level of the
limits of detection of the methods previous ly used. But once the results obtained are
clearly over the limits of detection, what counts is the precision of the method and its
reproducibility. The fact that the method used to provide these results is old is
irrelevant to the extent that they have b een validated. Indeed, we need only concern
ourselves with the uncertainty that we may ha ve regarding the very low values at the
level of the limits of detection."
536
7.427 The Panel first notes that the experts agree that data do not become invalid only because they
are old, but that more recent measurement or an alytical methods may be more accurate. The Panel
notes, however, that a problem related to accuracy is lik ely to occur with respect to results at the level
of the detection limits of the older methods. Outside th is particular situation, what matters is whether
the method has been validated. The Panel thus concludes that whether a study is old or not is not per
se a criterion to put in doubt the validity of this study.
(iv) Whether the EC implementing measure is an SPS measure
7.428 Before the Panel can determine whether the EC ban is consistent with the SPS Agreement, we
must first determine whether the measure is subject to the disciplines of the SPS Agreement, i.e.,
whether the measure is an SPS measure. In order to determine whether the ban is an SPS measure,
the Panel will determine whether the measure fits with in the definition of an SPS measure set forth in
Annex A(1) of the SPS Agreement.537

533 Transcript of the Panel meeting with the experts, Annex G, para. 674.
534 Transcript of the Panel meeting with the experts, Annex G, para. 675.
535 Transcript of the Panel meeting with the experts, Annex G, para. 651.
536 Transcript of the Panel meeting with the experts, Annex G, para. 679.
537 Article 1 of the SPS Agreement reads as follows:

"General Provisions

1. This Agreement applies to all sanitary and phytosanitary measures which may,
directly or indirectly, affect international trade. Such measures shall be developed and applied
in accordance with the provisions of this Agreement.

2. For the purposes of this Agreement, the definitions provided in Annex A shall apply.

3. The annexes are an integral part of this Agreement.

4. Nothing in this Agreement shall affect the rights of Member s under the Agreement
on Technical Barriers to Trade with respect to measures not within the scope of this
Agreement."

Annex A, paragraph 1, to the SPS Agreement reads as follows:

7.429 As the panel in EC – Approval and Marketing of Biotech Products explained, in determining
whether a measure is an SPS measure, regard must be had to such elements as the purpose of the
measure, its legal form and its nature. The purpose element is addressed in Annex A(1)(a) through (d)
("any measure applied to"). The form element is referred to in the second paragraph of Annex A(1)
("laws, decrees, regulations"). Finally, the natu re of measures qualifying as SPS measures is also
addressed in the second paragraph of Annex A(1) ("requirements and procedures, including, inter alia,
end product criteria; processes and production methods; testing, inspection, certification and approval
procedures; [etc.]").
7.430 The European Communities explained in Directive 2003/74/EC that the purpose of the ban on
the six hormones at issue is to prevent meat and meat products from cattle treated with such hormones
for growth promotion purposes from being placed on the EC market. 538 The Panel notes that
Annex A(1)(b) defines an SPS measure as any measur e applied "to protect human or animal life or
health within the territory of the Member from ri sks arising from additives, contaminants, toxins or
disease-causing organisms in foods, beverages or feedstuffs."
7.431 Consistent with the Panel in EC – Approval and Marketing of Biotech Products we consider
that a substance which a human being or an animal consumes for nutritional reasons may be classified
as a "food". 539 The Panel also takes notice of the foot note to Annex A, which specifically defines

DEFINITIONS [footnote 4]

"1. Sanitary or phytosanitary measure – Any measure applied:

(a) to protect animal or plant life or health within the territory of the Member from risks
arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms
or disease-causing organisms;

(b) to protect human or animal life or hea lth within the territory of the Member from
risks arising from additives, contaminants, toxi ns or disease-causing organisms in foods,
beverages or feedstuffs;

(c) to protect human life or health within the territory of the Member from risks arising
from diseases carried by animals, plants or products thereof, or from the entry, establishment
or spread of pests; or

(d) to prevent or limit other damage within th e territory of the Me mber from the entry,
establishment or spread of pests.

Sanitary or phytosanitary measures include all relevant laws, decrees, regulations,
requirements and procedures including, inte r alia, end product criteria; processes and
production methods; testing, inspection, cer tification and approval procedures; quarantine
treatments including relevant requirements associ ated with the transport of animals or plants,
or with the materials necessary for their survival during tran sport; provisions on relevant
statistical methods, sampling procedures and methods of risk assessment; and packaging and
labelling requirements directly related to food safety."

Footnote 4 to Annex A reads as follows:

"For the purpose of these definitions, "animal" includes fish and wild fauna; "plant" includes forests
and wild flora; "pests" include weed s; and "contaminants" include pesticide and veterinary drug residues and
extraneous matter."

538 Directive 2003/74/EC, Article 1.
539 Panel Report on EC – Approval and Marketing of Biotech Products, paras. 7.291-7.292.

"contaminants" as including veterinary drug residues, such as the residues of the hormones which are
the subject of the EC measure.
7.432 Comparing the definition of an SPS measure in Annex A(1)(b) to the stated purpose of the EC
ban on the hormones at issue, the Panel concludes th at the purpose of the EC measure is that of an
SPS measure within the meaning of Annex A(1)(b) of the SPS Agreement.
7.433 The second paragraph of Annex A states that san itary or phytosanitary measures include all
relevant laws, decrees and regulations as well as requirements and procedures. 540 In this instance, the
EC measure is a directive adopted by the Council of the European Union and the European Parliament
which was published in the Official Journal of th e European Communities. Therefore, this Panel
finds that the measure in question is included within the phrase "all relevant laws, decrees,
regulations ..." as used in Annex A of the SPS Agreement. This Panel also agrees with the panel in
EC– Approval and Marketing of Biotech Products that a ban may be considered a "requirement"
within the meaning of the second paragraph of Annex A of the SPS Agreement.541 Therefore, this
Panel finds that the EC measure constitutes such a "requirement".
7.434 In conclusion, because the EC Directive 2003/74/EC was adopted for the purpose of
protecting human life from contaminants in food and takes the form and nature contemplated in the
second paragraph of Annex A, this Panel finds that the EC Directive 2003/74/EC is an SPS measure
within the meaning of Annex A(1)(b) and the second paragraph of Annex A.
(e) Compatibility of the EC implementing measure with Article 5.1 and Article 5.2 of the
SPS Agreement with respect to oestradiol-17β
(i) Introduction
7.435 The Panel notes that the European Communiti es has asserted that it adopted the Directive
banning the placing on the market of meat and meat products from cattle trea ted with oestradiol-17 β
for growth promotion purposes based on a risk assessm ent conducted by the SCVPH consistent with
Article 5.1 of the SPS Agreement.
7.436 Specifically, the European Communities states that in order to comply with the rulings and
recommendations of the DSB in the EC – Hormones dispute, it conducted a comprehensive risk
assessment, which focused on potential risks to human health from hormone residues in bovine meat
and meat products. 542 The European Communities also ass erts that Directive 2003/74/EC, which
provides for a permanent ban on meat and meat pro ducts from animals treated for growth promotion
purposes with oestradiol-17β, is based on the above referenced risk assessment.543
7.437 The DSB found in the EC – Hormones dispute that the ban on meat and meat products from
cattle treated with the six hormones for growth promotion purposes, according to good veterinary
practice ("GVP"), was inconsistent with Article 5.1 of the SPS Agreement because it was not based on
a risk assessment within the meaning of that Article. In this case, the European Communities has
asserted that it has removed that inconsistency with respect to oestradiol-17 β by conducting a
comprehensive risk assessment and basing its implem enting measure on that risk assessment so that

540 "Including inter alia end product criteria; processes and production methods; testing, inspection,
certification and approval procedures; quarantine treatments including releva nt requirements associated with
the transport of animals or plants, or with the materials necessary for their survival during transport; provisions
on relevant statistical methods, sampling procedures an d methods of risk assessment; and packaging and
labelling requirements directly related to food safety."
541 Panel Report on EC – Approval and Marketing of Biotech Products, para. 7.1334.
542 EC's first written submission, para. 142.
543 EC's first written submission, para. 145.

the measure is now consistent with Article 5.1 of the SPS Agreement. We also recall that the United
States has claimed that the EC definitive ban on oestradiol-17 β breaches Article 5.1 and 5.2 of the
SPS Agreement. Therefore, as mentioned above, the Pane l considers that it should address the
conformity of the EC implementing measure with Article 5.1 and 5.2 of the SPS Agreement.
7.438 Article 5.1 of the SPS Agreement reads as follows:
"Members shall ensure that their sanitary or phytosanitary measures are based on an
assessment, as appropriate to the circumstances, of the risks to human, animal or
plant life or health, taking into account risk assessment techniques developed by the
relevant international organizations."
7.439 An analysis under Article 5.1 consists of tw o fundamental questions. First, was a risk
assessment, appropriate to the circumstances a nd taking into account risk assessment techniques
developed by the relevant intern ational organizations conducted? Second, is the sanitary measure
based on that risk assessment? The Panel will address each question successively.
7.440 This said, Article 5.2 of the SPS Agreement further instructs Members on how to conduct a
risk assessment. Specifically, Article 5.2 states that:
"In the assessment of risks, Members sha ll take into account available scientific
evidence; relevant processes and production methods; relevant inspection, sampling
and testing methods; prevalence of specific di seases or pests; existence of pest- or
disease-free areas; relevant ecological and environmental conditions; and quarantine
and other treatment."
7.441 The Panel agrees with the panel in Japan – Apples that Articles 5.1 and 5.2 "directly inform
each other, in that paragraph 2 sheds light on the el ements that are of relevance in the assessment of
risks foreseen in paragraph 1".544 This is because, in the opinion of the Panel, if it were possible for a
risk assessment that did not take into account the f actors listed in Article 5.2 to be consistent with
Article 5.1, Article 5.2 would have no purpose and we must construe the covered agreements in a way
that gives meaning to each provision. 545 Essentially, "Article 5.2 imparts meaning to the general
obligation contained in paragraph 1 to base measures on an 'assessment ...of risks'." 546 Therefore, we
must also consider whether the European Commun ities took into account the elements contained in
Article 5.2 in the course of our analysis under Article 5.1.
(ii) Is there a risk assessment within the meaning of Article 5.1 of the SPS Agreement?
7.442 In assessing whether a measure is based on a risk assessment within the meaning of
Article 5.1 of the SPS Agreement, the Panel must first determine whether a risk assessment was
conducted at all. The Panel is aware that the Appellate Body in EC – Hormones determined that
"Article 5.1 does not insist that a Member that adopts a sanitary measure sh all have carried out its
own risk assessment … The SPS measure might we ll find its objective justification in a risk

544 Panel Report on Japan – Apples, para. 8.230.
545 Article 31.1 of the Vienna Convention on Law of Treaties requires that "[a] treaty shall be
interpreted in good faith ..." Article 26 requires that "[ e]ach treaty is binding upon the parties to it and must be
performed by them in good faith". Given these fundamental principles in the Vienna Convention, it is
unreasonable to assume that a provision of a treaty is written without any meaning at all. The Appellate Body
also stated in Japan – Alcoholic Beverages II, that "a fundamental tenet of treaty interpretation flowing from the
general rule of interpretation set out in Article 31 [of the Vienna Convention] is the principle of effectiveness (ut
res magis valeat quam pereat)", p. 12.
546 Panel Report on Japan – Apples, para. 8.232.

assessment carried out by another Member, or an international organization". 547 In the present case,
the European Communities has asserte d that the three Opinions produced by the SCVPH, an organ of
the European Communities, constitute the required ri sk assessment. Therefore, the task before the
Panel is to determine whether the European Communities conducted a risk assessment within the
meaning of Article 5.1 of the SPS Agreement.
7.443 To determine whether the Opinions constitute a risk assessment, the Panel must measure the
European Communities' actions ag ainst the requirements of the SPS Agreement. The Panel recalls
that it is not the appropriate role of the Panel to conduct its own risk assessment based on scientific
evidence gathered by the Panel or submitted by the parties during the Panel proceedings.548 Similarly,
the Panel believes that it is not its role to impose any scientific opinion on the European Communities.
The Panel must objectively measure the Opinions agai nst 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. Therefore, we examined
and evaluated the evidence – including the informa tion received from the experts advising the Panel –
and the arguments put before us in light of the relevant WTO provisions and based our conclusions on
this evidence and these arguments.549
7.444 The text of Article 5.1 requires that in the assessment of risks the Members take into account
risk assessment techniques developed by the releva nt international organi zations. Article 5.2,
likewise, prescribes several factors that a Member must take into account when making its assessment
of the risks. Additionally, Annex A(4) provides a definition of what constitutes a risk assessment.
Finally, as the Panel and Appellate Body explained in Japan – Apples, for a risk assessment to be
valid the science evaluated must support the conclusions reached in the risk assessment.550
7.445 The European Communities asserts that the 1999, 2000, and 2002 Opinions constitute its risk
assessment for oestradiol-17 β. Therefore, in determining whethe r these Opinions are indeed a risk
assessment as appropriate to the circumstances, within the meaning of Article 5.1 of the
SPS Agreement, the Panel will examine whether the Opin ions (1) took into account risk assessment
techniques of the relevant international organiza tions; (2) took into account the factors listed in
Article 5.2; (3) satisfied the definition in Annex A(4) and: (4) whether the conclusions in the Opinions
are supported by the scientific evidence evaluated.
Do the Opinions take into account risk assessm ent techniques of the relevant international
organizations?
Introduction
7.446 Article 5.1 includes the proviso that Members, when developing sanitary and phytosanitary
measures based on risk assessments, take into acco unt risk assessment techniques developed by the
relevant international organizations. The SPS Agreement does not specifically identify the relevant
international organizations for purposes of Artic le 5.1. However, the Preamble of the SPS Agreement
speaks of harmonizing SPS measures between Member s on the basis of international standards,

547 Appellate Body Report on EC – Hormones , para. 190, followed in the Panel Report on EC –
Approval and Marketing of Biotech Products, para. 7.3024.
548 Panel Report on EC – Hormones (Canada) , para. 8.104; Panel Report on EC – Hormones (US),
para. 8.101.
549 Panel Report on Australia – Salmon , para. 8.41. A similar statement was made by the Panel on
Japan – Agricultural Products II, in para. 8.42.
550 This is not to say, as already recalled above, th at a risk assessment cannot be based on a minority
opinion of the scientists. A risk assessment can be based on a minority opinion which is supported by sufficient
scientific evidence. See Appellate Body Report on EC– Hormones , para. 194; and Panel Report on EC–
Approval and Marketing of Biotech Products, para. 7.3240.

guidelines and recommendations developed by the rele vant international organizations, including the
Codex Alimentarius Commission (Codex). Additiona lly, Annex A(3) states that for food safety the
standards, guidelines and recommendations estab lished by the Codex Alimentarius Commission
(Codex) relating to food additives, veterinary drug and pesticide residues, contaminants, methods of
analysis and sampling, and codes and guidelines of hygienic practice will constitute international
standards, guidelines, and recommendations within the meaning of the SPS Agreement. Article 3.2
states that SPS measures which conform to the above referenced standards are deemed to be necessary
to protect human, animal, or plant life or hea lth and are presumed to be consistent with the
SPS Agreement and GATT 1994. Moreover, Article 3.4 of the SPS Agreement requires Members to
participate fully in Codex work, within the limits of their resources. After an examination of these
provisions of the SPS Agreement and the context of Article 5.1 as part of the process for adopting SPS
measures which are consistent with the SPS Agreement, the Panel concludes that the Codex
Alimentarius Commission constitutes a "relevant inte rnational organization" within the meaning of
Article 5.1.
7.447 The parties in this dispute as well as the experts have made significant references to JECFA's
work. JECFA, while officially not part of the C odex structure, provides independent scientific expert
advice to the Codex Alimentarius Commission and its specialist Committees. JECFA conducts risk
assessments on various substances, establishes ADIs 551 where appropriate, and in the case of residues
of veterinary drugs in foods, recommends MRLs 552 for consideration by the Codex Committee on
Residues of Veterinary Drugs in Foods (CCRVDF). The MRLs adopted by Codex with respect to
oestradiol-17β and four of the other five hormones 553 are based on the recommendations of JECFA.
Therefore, this Panel believes that the risk assessme nt techniques of JECFA are also relevant to an
analysis of compliance with Article 5.1.

551 The Codex Committee on Residues of Veterinary Drugs in Foods defines an Acceptable Daily
Intake (ADI) as "[a]n estimate by JECFA of the amount of a veterinary drug, expressed on a body weight basis,
that can be ingested daily over a lifetime without appreciab le health risk (standard man = 60 kg)." Glossary of
Terms and Definition (CAC/MISC 5-1993). The "Glossary of Terms and Definition" has been elaborated by the
Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) with a view to providing information
and guidance to the committee and is intended for internal Codex use only. (The definition was previously
established and adopted by JECFA and modified by the Codex Committee on Veterinary Drugs in Foods).
More information on how ADIs are set is contained in Annex E-2, responses by JECFA to questions 9 and 10.
552 Codex defines the maximum limit for residues of veterinary drugs (MRLVD) as the maximum
concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or μg/kg on a fresh
weight basis) that is recommended by the Codex Alimentarius Commission to be legally permitted or
recognized as acceptable in or on a food.

It is based on the type and amount of residue considered to be without any toxicological hazard for
human health as expressed by the Acce ptable Daily Intake (ADI), or on the basis of a temporary ADI that
utilizes an additional safety factor. It also takes into acco unt other relevant public health risks as well as food
technological aspects.

When establishing an MRL, consideration is also given to residues that occur in food of plant origin
and/or the environment. Furthermore, the MRL may be reduced to be consistent with good practices in the use
of veterinary drugs and to the extent that practical analytical methods are available. From: Definitions for the
Purposes of the Codex Alimentarius, Codex Alimentarius Commission Procedural Manual (15
th Edition), FAO
and WHO, 2006, page 43. More information on how MRLs are set is contained in Annexes E-1 and E-2,
responses by Codex and JECFA to questions 9 and 10.
553 Progesterone, testosterone, zeranol and trenbolone acetate
(http://www.codexalimentarius.net/mrls/vetdrugs/jsp/vetd_q-e.jsp).

7.448 Codex and JECFA have develope d definitions of the relevant phases of a risk assessment as
well as guidelines and practices fo r conducting a risk assessment. 554 The European Communities
indicated in the 1999 Opinion, that the accepted de finition of a risk assessment, as used by both
Codex and JECFA, is an assessment which is "str uctured to address independently the intrinsic
properties of the compound under consideration (hazard identification), the evaluation of the nature of
effects in terms of a dose-response relationship (hazard characterization), the estimate of the
dose/concentration of a compound in a daily diet (exposure assessment) resulting in the assessment of
the incidence and severity of potential adverse effects". 555 In its Procedural Manual, Codex defines
the four phases of risk assessment as follows:
(a) hazard identification: The identification of biological , chemical, and physical agents
capable of causing adverse health effects and which may be present in a particular
food or group of foods.
(b) hazard characterization: The qualitative and/or quantitative evaluation of the nature
of the adverse health effects associated with biological, chemical, and physical agents
which may be present in food. For ch emical agents, a do se-response assessment556
should be performed. For biological or physical agents, a do se-response assessment
should be performed if the data are obtainable.
(c) exposure assessment : The qualitative and/or quantitative evaluation of the likely
intake of biological, chemical, or physical agents via food as well as exposures from
other sources if relevant.
(d) risk characterization : The qualitative and/or quantitative estimation, including
attendant uncertainties, of the probabilit y of occurrence and severity of known
potential adverse health effects in a give n population based on hazard identification,
hazard characterization, and exposure assessment.
557
7.449 Although Codex and JECFA base their relevant work on some general principles and the
definition of risk assessment stated above and JE CFA relies on a variety of guidance documents on
how to conduct a risk assessment with respect to veterinary drug residues in food, the experts
confirmed that no specific "techniques" or guidelines had thus far been formally adopted by Codex for
use by national governments in conducting risk assessments of veterinary drug residues.558

554 In response to the Panel's questions regarding international guidance documents for conducting a
risk assessment, in particular with respect to veterinary drug residues, the representative of Codex and JECFA as
well as the experts referred to a variety of documents from the Codex Alimentarius Commission, JECFA, the
World Health Organization, the Food and Agriculture Orga nization, and other scientific bodies, see replies of
the Codex Alimentarius Commission and JECFA to Panel questions 3 and 4, Annexes E-1 and E-2 respectively,
and replies by the scientific experts to Panel questions, Annex D, paras. 62-71.
555 1999 Opinion, page 70.
556 Codex defines a dose-response assessment as the determination of the relationship between the
magnitude of exposure (dose) to a chemical, biological, or physical agent and the severity and/or frequency of
associated adverse health effects (response). Codex Alimentarius Commission , Procedural Manual, Fifteenth
Edition (2005), p. 45.
557 Ibid.
558 At its 30th session in July 2007, the Codex Alimentarius Commission adopted "Working Principles
for Risk Analysis for Food Safety for Application by Governments".

Summary of the main arguments of the parties559
7.450 The United States recalls that the EC – Hormones panel noted that, "even though no formal
decision has as yet been taken by Codex with respec t to [sanitary] risk assessment techniques, Codex,
and more particularly JECFA, has a long-standing practice with respect to the assessment of risks
related to veterinary drug residues (including hormone residues)."
560
7.451 The United States believes that the Opinions pr edominantly focus on the first step of risk
assessment (hazard identification). The United States argues that the potential biological effects of
hormones, some of which are adverse, are generally not in dispute in the scientific community. The
United States argues that the European Co mmunities failed to engage in adequate hazard
characterization. Specifically, the United States alleges that the European Communities did not
conduct a dose-response assessment.
7.452 The United States argues that the Opinions also fail to complete an exposure assessment in
terms useful for estimating risks to consumers. The United States alleges that a risk assessment
evaluating the potential risk from hormone residues in meat and meat products to consumers, in the
absence of a discussion of actual residues, should include a thorough analysis of the relevant pathway,
starting with cattle treated with hormones fo r growth promotion purposes according to good
veterinary practices, processing an d shipping meat and meat prod ucts from those cattle and ending
with the consumption of any residues from that meat by humans ( e.g., taking into account how
humans process ingested hormones). The United States argues that the European Communities'
purported risk assessment fails to evaluate either the available residue data or these steps in the
exposure pathway.
561
7.453 The United States considers that the Opinions evaluate identified sources of high exposure
inconsistently by dismissing the introduction of pr egnant heifers with high levels of endogenous
oestradiol-17β into the food chain in Europe while assu ming that misplaced and repeated implanting,
as well as the entry of the implants into the food chain, are frequent and represent a considerable
risk.562
7.454 The United States also argues that the European Communities fails to take into account the
relative impact on exposure assessment of the lo w bioavailability of the six hormones for growth
promotion purposes, in light of JECFA's conclusion that oestradiol is generally inactive when given
orally because it is transported to the liver where it is rapidly inactivated.563
7.455 The European Communities agrees that the risk assessment techniques developed by Codex
are relevant and contemplated in Article 5.1's re quirement to take into account the risk assessment
techniques developed 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.564
7.456 The European Communities also points out that there is no Codex standard specifically on the
risk assessment of the effect of residues of veteri nary drugs and that Code x techniques or standards

559 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective arguments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
560 US's first written submission, para. 139, citing Panel Report on EC – Hormones, para. 8.103.
561 US's first written submission, para. 144.
562 US's first written submission, para. 145.
563 US's first written submission, para. 146, citing 52nd JECFA Report (2000), p. 58 (Exhibit US-5).
564 EC's second written submission, para. 192; EC's rep lies to Panel questions after the first substantive
meeting, question 24, Annex B-1.

exclusively apply to risk assessments on food safety and not to other risk assessments such as those
for animal health and environmental risks.565
7.457 The European Communities mainta ins that its Opinions take into account the conventional
risk assessment techniques in addition to other factors that are expressly permissible under the
definition of a risk assessment in Article 5.1. 566 The European Communiti es argues that it went
beyond the international standards for a risk assess ment to consider "real life" situations as
contemplated by the Appellate Body's ruling in EC – Hormones.
7.458 The European Communities argues that the ri sk assessment at the basis of Directive
2003/74/EC precisely follows the four steps of risk assessment as defined by Codex, enabling it to
identify different levels of risks presented by differe nt uses, and that this Directive then adapts the
management of these risks accordingly. 567 However, the European Communities also notes that the
Codex approach has serious limitations in non-lin ear situations, such as with regard to these
hormones. The European Communities argues that the currently available Codex guidance poorly
addresses cases such as this wher e the risks are embedded in cha nges in exposure to biologically
active molecules which may, with minute differences in their bioavailability, ha ve dramatic effects,
such as turning on or off complete developmen tal programmes of the human genome, or inducing
pathological conditions.568
7.459 Specifically, the European Communities argued th at with hormones that are also produced
endogenously when you add more of the same ki nd of hormone, such as oestrogen, you are just
increasing the response that is already taking place, a nd in that case there cannot be a threshold. The
threshold has already been exceeded by the concentrati on of hormones in circulation. So this specific
set of conditions results in dose-response curves th at will have no threshold, and if there is no
threshold, there is no safe dose, unlike the suggestion that there is an acceptable daily intake.569
7.460 The European Communities asserts that it is ge nerally recognized that for substances which
have genotoxic potential (as is the case with oestradiol-17 β) a threshold cannot be identified. This
would mean that there is no level below which inta kes from residues should be considered to be safe.
The fact that the doses used in growth promotion are low is not of relevance. 570 Therefore, the
European Communities argues that it was not requi red to do a quantitative evaluation of the dose-
response.571
7.461 As regards the level of the risk, the Eur opean Communities argues that it has undertaken
specific studies to evaluate the ex posure resulting from real as well as experimental situations of
abuse and/or misuse in the market of the United States. The European Communities notes that it

565 EC's second written submission, para. 192.
566 1999 Opinion, p. 2 (citing Appellate Body Report on EC – Hormones for the premise that the risk to
be evaluated is "not only risk ascertainable in a labo ratory operating under strictly controlled conditions, but
also risk in human societies as they actually exist, in other words the actual potential for adverse effects in
human health in the real world where people live and work and die.")
567 EC's replies to Panel questions after the firs t substantive meeting, question 24, Annex B-1,
para. 142.
568 EC's replies to Panel questions after the firs t substantive meeting, question 24, Annex B-1,
para. 140.
569 Transcript of the Panel meeting with the experts, Annex G, para. 252.
570 EC's second written submission, paras. 201-202.
571 EC's second written submission, para. 200.

carried out specific veterinary inspections in the United States and argues that it has made a specific
calculation of the level of the risk for imports coming from the United States.572
Reasoning of the Panel
7.462 In determining whether the European Comm unities took into account the risk assessment
techniques of the relevant international organizati ons in the Opinions, the Panel requested that the
experts evaluate the Opinions in light of the Codex definitions, guidelines, and practices.
7.463 The experts who answered the Panel's question on this issue concluded that the Opinions were
not entirely consistent with the Codex guidelines and definitions.
7.464 Dr. Guttenplan pointed out that the Eur opean Communities had done a thorough hazard
identification, but that its hazard characterization was limited and that the extrapolation of the one
animal model study from hamster kidney to humans was uncertain. He noted that the European
Communities also relied on older studies with no re ports of replication and had no epidemiological
studies comparing cancer incidence or prevalence in populations consuming hormone-treated or
untreated meat.573 Dr. Boobis stated that the European Communities had not identified the potential
for adverse effects on human health of residues of oestradiol in meat as a result of the cattle being
treated with the hormone for growth promotion pur poses. This was because th e analysis undertaken
was focused primarily on hazard identification. There was little in the way of hazard characterization,
and no independent exposure assessment was undertak en. Dr. Boobis stated that because no adequate
exposure assessment was undertaken it was not possible to complete the risk characterization phase of
the assessment.574 In sum, Dr. Boobis concluded that the European Communities' risk assessment of
oestradiol did not follow the four steps of the Codex risk assessment paradigm.575
7.465 Dr. Boobis indicates in his written replies that a "hazard-based" approach, which is making
recommendations as to potential safety based on intr insic capacity to cause harm rather than on the
probability of harm occurring is most commonly used for substances that are genotoxic or have
genotoxic potential, although not all such substances would be treated this way. 576 Dr. Boobis further
explained the "hazard-based" approach at the meeti ng with the Panel where he stated that if, for
example, a compound is shown to be a direct-acting genotoxicant, this is considered unacceptable at
any level of exposure. As pe rmitting exposure would not be appropriate, one stops the risk
assessment at that point. It does not need to ta ke account of exposure, because any level of exposure
is deemed to be of concern. 577 Dr. Cogliano agrees that there have been cases where calling
something a carcinogenic hazard has led an agency to make a decision just on the qualitative element
alone. 578 However, Dr. Tritscher, the representative of JECFA maintains that a hazard identification
is not a risk assessment; a risk assessment comprises the four steps.579
7.466 Both Drs. Cogliano and Boobis explain that the issue of thresholds and whether an acceptable
daily intake can be established a nd all four steps of a risk assessment as defined by Codex can be

572 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 15, citing
Exhibit EC-67 and Exhibit EC-73.
573 Replies by the scientific experts to Panel question 14, Annex D, para. 149.
574 Replies by the scientific experts to Panel question 13, Annex D, para. 144.
575 Replies by the scientific experts to Panel question 14, Annex D, para. 148.
576 Replies by the scientific experts to Panel question 36, Annex D, paras. 310-311.
577 Transcript of the Panel meeting with the experts, Annex G, para. 385.
578 Transcript of the Panel meeting with the experts, Annex G, para. 438.
579 Transcript of the Panel meeting with the experts, Annex G, para. 453.

conducted has to do with the assumptions and interp retations that the scientists conducting the risk
assessment are willing to make.580
7.467 Although there was considerable debate among th e parties and the experts advising the Panel
about whether the European Communities followed a ll four steps of a risk assessment as defined by
Codex or indeed whether it was even necessary to do so in the case of a substance such as oestradiol-
17β, the 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 techni ques. This suggests that such techniques
should be considered relevant, but that a fa ilure to respect each and every aspect of
them would not necessarily, per se , signal that the risk assessment on which the
measure is based is not in conformity with the requirements of Article 5.1."581
7.468 This means that although the risk assessment techniques of Codex and JECFA are relevant
and must be considered by the risk assessor, compliance with Codex or JECFA risk assessment
techniques is not required by the SPS Agreement. What is required is that the risk assessor take those
techniques into account and that it comply with th e other requirements of Article 5 and Annex A of
the SPS Agreement with respect to conducting a risk assessment.
7.469 It is undisputed that the European Communities was aware of the Codex and JECFA
guidelines and considered them in the preparation of the Opinions. Therefore, the Panel concludes
that although it may not have strictly followed th em, the European Communities did take into account
the risk assessment techniques of the relevant in ternational organizations in the conduct of the
Opinions.
Do the Opinions take into account the factors listed in Article 5.2?
Summary of the main arguments of the parties582
7.470 The United States argues that whether the European Communities engaged in a proper
evaluation of the Article 5.2 factors, in particular relevant inspection, sampling, and testing methods,
would inform a decision on whether or not it has ind eed 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. The
United States asserts that the European Communitie s has not engaged in the necessary evaluation of
the factors under Article 5.2.583
7.471 The United States reasons that Article 5.2 is no t mutually exclusive of Article 5.1 of the
SPS Agreement; rather, it sets out the specific components of the risk assessment on which Members
are required to base their measures for purposes of Ar ticle 5.1. The United States argues that if the
European Communities has not satisfied the requirement s of Article 5.2, it has not conducted a risk
assessment, as appropriate to the circumstances a nd, as such, the permanent ban on oestradiol-17 β
cannot be based on a risk assessment within the meaning of Article 5.1.584

580 Transcript of the Panel meeting with the experts, Annex G, paras. 1021-1027.
581 Panel Report on Japan – Apples, para. 8.241.
582 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
583 US's second written submission, para. 52.
584 US's replies to Panel questions after the second substantive meeting, Annex C-4, para. 26.

7.472 The United States argues that the Opinions igno re or fail to take into account available
scientific evidence with respect to the bioavailability of oestradiol-17 β, evidence relating to
susceptible populations, and evidence relating to in vivo585 repair mechanisms.586
7.473 The United States argues that the Opinions fail to adduce scientific evidence of a risk to
consumers posed by meat from cattle treated with oestradiol-17 β for growth promotion purposes
according to good veterinary practices. Assessments which conclude otherwise ( i.e., that such a risk
exists), such as the 1999, 2000 and 2002 Opinions, do not "take into account available scientific
evidence" as required by Article 5.2 of the SPS Agreement and are not risk assessments as appropriate
to the circumstances within the meaning of Article 5.1 of the SPS Agreement.587
7.474 The United States argues that the European Co mmunities fails to assess the specific risks at
issue in this dispute because it does not consider the available evidence directly related to the
expected doses from dietary exposures to hormones. In particular, the United States contends that the
European Communities did not make use of rele vant bioavailability data, and used unrealistic
scenarios to calculate possible exposure estimates.588
7.475 Additionally, the United States argues that the Opinions' study of the potential adverse effects
from use of hormones without regard to good vete rinary practices does not take into account the
actual inspection, sampling, and testing methods of the US regulatory agencies, but is rather based on
hypothetical violations of GVP induced in a laboratory.
7.476 The European Communities argues that the 1999 Opinion took account of all pertinent
scientific information available at the time, includi ng JECFA's revised assessment of the three natural
hormones oestradiol-17 β, testosterone, and progesterone that had been issued in February 1999. 589
The European Communities also points out that th e Opinions have found that the data on which
JECFA based its finding on bioavailability are incorrect or insufficient.590
7.477 The European Communities contends that it ex amined relevant inspection, sampling, and
testing methods when it specifically examined the is sue of the risks to human health if GVP was not
observed in the United States. 591 In the Working Document on Assessment of Risks of hormonal
growth promoters in cattle with respect to risks ar ising from abusive use and difficulties of control ,
the European Communities points to the Appellate Body finding in the EC – Hormones case that
Article 5.2 in conjunction with Ar ticle 8 and Annex C authorizes "the taking into account of risks
arising from failure to comply with the requirements of good veterinary practice in the administration
of hormones for growth promotion purposes, as well as risks arising from difficulties of control,
inspection and enforcement of the requirements of good veterinary practice."
592
7.478 The European Communities argues that its findings regarding misplaced implants, off-label
use, black-market drugs, and secondary risks, ar e based on realistic conditions of use and the

585 In vivo means in the whole organism, the intact organism (transcript of the Panel meeting with the
experts, Annex G, para. 96 (Dr. Boobis)).
586 US's second written submission, paras. 41-46.
587 US's second written submission, para. 47, footnote 89.
588 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 72.
589 EC's second written submission, para. 103.
590 EC's second written submission, para. 123.
591 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 83.
592 Assessment of risks of hormonal growth promoter s in cattle with respect to risks arising from
abusive use and difficulties of control, Exhibit EC-73, p. 5, citing Appellate Body Report on EC – Hormones ,
para. 205.

possibilities of abuse or misuse which these hormones offer to farmers and are documented as regards
the United States in the Working Document.593
Reasoning of the Panel
7.479 The United States has specifically alleged that the European Communities, in formulating the
Opinions, failed to take into account two of the elements listed in Article 5.2, specifically the
available scientific information and the relevant inspection, sampling, and testing methods.
Therefore, the Panel must determine first whethe r the Opinions take into account the available
scientific information and, second, whether the Op inions take into account relevant inspection,
sampling, and testing methods.
7.480 As noted above in the context of risk assessment techniques, taking available scientific
evidence into account does not require that a Member conform its actions to a particular conclusion in
a particular scientific study. The available scientif ic information may contain a multiplicity of views
and data on a particular topic. It is the view of the Panel that the requirement in Article 5.2 is to
ensure that a Member, when assessi ng risk with the aim of formulating an appropriate SPS measure,
has as wide a range as possible of scientific informati on before it to ensure that its measure will be
based on sufficient scientific data and supported by scientific principles.
7.481 The United States' argument can be reduced to the contention that because the conclusions in
the Opinions are not supported by the scientific ev idence, the European Communities must not have
considered the available scientific evidence when it formulated the Opinions. However, whether the
conclusions in the Opinions are supported by th e scientific evidence considered by the European
Communities is a question that is not relevant to the issue of whether the European Communities took
the available scientific evidence into account in fo rmulating the Opinions, within the meaning of
Article 5.2.
7.482 The Opinions specifically addr essed the evidence available with respect to bioavailability,
susceptibility of sensitive populations, and DNA adduc ts and DNA damages. The Opinions even
included reference to the very scientific studies the United States is alleging they did not take into
account. Therefore, the Panel concludes that th e European Communities did take the available
scientific information into account as required by Article 5.2.
7.483 The second question before the Panel with r espect to whether the European Communities
took into account the factors listed in Article 5.2 is whether the Opinions take into account relevant
inspection, sampling, and testing methods. Th e Panel notes that the European Communities has
compiled a Working Document on the abusive use and difficulties of control in the administration of
hormones for growth promotion purposes. The Europ ean Communities details visits to US regulatory
agencies and on-site inspections as well as a review of data related to failures in the US inspection
regime. The SCVPH also dedicated a significant por tion of the 1999 Opinion to discussing the issue.
Whether the conclusions the European Communities reached regarding the likelihood of abuse or
misuse of hormone implants given relevant inspec tion, sampling, and testing methods in the United
States are scientifically supported is of no releva nce in an analysis of whether the European
Communities fulfilled its obligations pursuant to Article 5.2 to take such methods into account.
7.484 Because the European Communities considered th e available scientific information as well as
relevant inspection, sampling, and testing methods in the preparation of its Opinions, the Panel
concludes that the European Communities took these factors into account as required by Article 5.2 of
the SPS Agreement.

593 EC's second written submission, para. 126, citing Exhibit EC-73.

Do the Opinions satisfy the definition in Annex A(4) of the SPS Agreement?
Introduction
7.485 Annex A(4) defines a risk assessment as:
"[t]he evaluation of the likelihood of entry, establishment or spread of a pest or
disease within the territory of an importi ng Member according to the sanitary or
phytosanitary measures which might be applied, and of the associated potential
biological and economic consequences; or the evaluation of th e potential for adverse
effects on human or animal health aris ing from the presence of additives,
contaminants, toxins or disease-causing or ganisms in food, bever ages or feedstuffs. "
(Emphasis added)
7.486 In this dispute, the measure at issue is intende d to protect human health as a sanitary measure
defined in Annex A(1)(b) and, thus, is to be based on a risk assessment in the sense of the second
definition in Annex A(4).
594
Summary of the main arguments of the parties595
7.487 The United States argues that the Opinions do not app ear to be risk assessments within the
meaning of Article 5.1.596
7.488 The United States refers to the definition fo r a risk assessment established by the panel in
EC – Hormones that a risk assessment must "(i) identify th e adverse effects on human health (if any)
arising from the presence of the hormones at issue wh en used as growth promoters in meat or meat
products, and (ii) if any such adverse effects ex ist, evaluate the potential ... occurrence of these
effects." In the case of an import ban on meat an d meat products such as that maintained by the
European Communities, the relevant "evaluation" is that of "the potential for adverse effects arising
from the presence in food of the hormones in dispute."597
7.489 The United States notes that the European Communities relies on studies that demonstrate
adverse effects of hormones at concentrations expo nentially greater than would be present in residues
of meat from cattle treated with hormones for growth promotion purposes, and discusses the effects of
substances, such as diethylstilbestrol ("DES"), that have been banned in the United States for decades
in support of the notion that hormones can be harmful. 598 The United States argues that the European
Communities fails to hone the general risk, or identified hazards, down through hazard
characterization and an exposure assessment in order to demonstrate ( i.e., identify and evaluate) a
specific risk to consumers.599
7.490 The United States argues that the Opinions are not a risk assessment within the meaning of
Article 5.1 and Annex A of the SPS Agreement because they fail to examine relevant pathways,
explore the fate of the relevant risk (that posed by meat products to consum ers) or to support their

594 Panel Report on Australia – Salmon , paras. 8.72 and 8.116 (finding that because the measure at
issue was meant to protect animal health as a sanitary measure as defined in Annex A(1)(a), the first definition
in Annex A(4) applied).
595 A more detailed account of the parties' arguments can be found in Section IV the descriptive part of
this Report. The order in which the respective argumen ts of the parties are pres ented does not reflect any
allocation of the burden of proof by the Panel.
596 US's first written submission, para. 137.
597 US's first written submission, para. 138 citing Panel Report on EC – Hormones, paras. 8.98, 8.127.
598 US's first written submission, para. 141.
599 US's first written submission, para. 142.

conclusions with scientific evidence. The United St ates contends that the Opinions neither "identify
the adverse effects on human health" arising from th e 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 he alth" arising from consumption of meat products
from cattle treated with hormones for growth promotion purposes.600
7.491 The United States faults the European Commun ities for relying upon statements from the US
Department of Health and Human Services that estrogens generally are known to be human
carcinogens. The United States argues that the conc lusions in the report cited by the European
Communities are based upon epidemiological t ests focused on women and the use of hormone
replacement therapies and oral contraception whic h contain estrogens and are based upon levels of
oestradiol-17β or other estrogens high enough to have a hormonal effect on the consumer, not the
levels of oestradiol-17 β found in meat from cattle treated with the hormone for growth promotion
purposes according to good veterinary practices. Such levels of oestradiol-17 β that are found in meat,
the United States asserts, are exponentially lower than those causing hormonal effects.601
7.492 The United States argues that scientific evidence concerning the need to regulate the use of
hormones generally is different from specific evid ence concerning the health risk associated with
consumption of meat and meat products from cattle treated with hormones for growth promotion
purposes.602 The United States asserts that the Euro pean Communities did not consider whether
consumer dietary exposure to hormone residues in meat and meat products from cattle is specifically a
source of risk.603
7.493 The United States argues that the European Communities continues to rely on studies such as
the 1999 IARC Monograph, which have already been found by the Appellate Body to "constitute
general studies which do indeed show the existence of a general risk of cancer; but they do not focus
on and do not address the particular kind of risk here at stake – the carcinogenic or genotoxic potential
of the residues of those hormones found in meat de rived from cattle to which the hormones had been
administered for growth promotion purposes." 604 The United States maintains that although the
potential for adverse effects from hormones at these high levels is not in dispute, the materials and
findings cited by the European Communities (1999 IARC Monograph; 11
th Report on Carcinogens)
are not, however, evidence of a risk from meat from cattle treated with oestradiol for growth
promotion purposes.605
7.494 The European Communities argues that the Opinions do cons titute a risk assessment within
the meaning of Article 5.1 of the SPS Agreement. Specifically, the European Communities argues that
there is a difference between a scientific risk asse ssment in the narrow sense re ferred to by the United
States and the risk assessment within the me aning of Article 5.1 and Annex A(4) of the
SPS Agreement.606

600 US's first written submission, para. 147.
601 US's second written submission, para. 38.
602 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 70.
603 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 72.
604 US's replies to Panel questions after the second substantive meeting, para. 23 citing Appellate Body
Report on EC – Hormones, Annex C-4, para. 200.
605 US's replies to Panel questions after the second substantive meeting, Annex C-4, para. 24.
606 EC's second written submission, para. 191; EC's rep lies to Panel questions after the first substantive
meeting, Annex B-1, para. 135 et seq.

7.495 The European Communities argues that the Ap pellate Body has confirmed that a risk
assessment within in 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.607
7.496 Although the European Communities agrees that in principle the risk resulting from human
consumption of meat from cattle treated with oestradiol-17 β for growth promotion purposes,
according to good veterinary practice is the relevant risk, it argues that the assessment of such a risk is
qualified by the difficulty in estimating the intake of such hormones. Specifically, the European
Communities argues that human beings, including th e populations at risk, are exposed to cumulative
and synergistic effects, as they may be expo sed to multiple sources of hormones and hormone
residues, via several intake routes, as well as from endogenous production of some of these hormones.
The European Communities contends that it is extr emely difficult or impossible to assess accurately
consumer exposure patterns, or other exposures fro m other environmental or endogenous sources, but
it is also virtually impossible to assess all cumulativ e and synergistic effects that may arise from all
potential exposure patterns, including for simultaneous exposure to several of these hormones.608
7.497 The European Communities argues that the onl y rationale that can be inferred from the
available scientific data is that the higher the exposure to residues from these hormones, the greater
the risk is likely to be. 609 The European Communities points out that the Opinions noted that the
DNA-damaging effects of oestrogen indicate that no threshold exists for the risk from oestrogen
metabolites. The Opinions concl uded that, in light of the recent data on the formation of genotoxic
metabolites of oestradiol, suggesting that 17 β-oestradiol acts as complete carcinogen by exerting
tumour initiating and promoting effects, it has to be concluded that no quantitative estimate of risk
related to residues in meat could be presented.610
7.498 The European Communities goes on to say that the risk resulting from human consumption of
meat from cattle treated with oestradiol-17 β for growth promotion purposes, according to good
veterinary practice, is "assessed in the real worl d" where "people live, work and die", or may be
suffering from clinical disorders, or may be particularly vulnerable segments of the population ( e.g.,
like prepubertal children), etc. 611 The European Communities asserts that it considered in its
assessment the potential risks resu lting from the actual residues from non-treated as well as treated
animals for growth promotion, and came to the conc lusion that under realistic conditions of use such
residues from treated animals for growth promotion do pose a higher risk and that it could not achieve
the level of protection it has considered appropriate in its territory.612
7.499 The European Communities argues that it is not necessary to compare the two situations and
then try to quantify how much one is more risky th an the other and to what measurable level the risk
is likely to occur, but rather to assess a situa tion of additive risks arising from the cumulative
exposures of humans to multiple hazards, in additio n to the endogenous production of some of these
hormones by animals and human beings.613
7.500 The European Communities contends that eviden ce from both the health risk associated with
the use of hormones generally and the administration of hormones in animals for growth promotion

607 EC's second written submission, para. 191.
608 EC's replies to Panel questions after the first substantive meeting, Annex B-1, paras. 92-96.
609 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 94.
610 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 38.
611 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 96.
612 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para.151.
613 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 151.

purposes, is relevant for the performance of a risk assessment in the sense of the SPS Agreement,
because both sources of evidence impact upon and inform each other.614
7.501 The European Communities notes that it is scientifically undisputed that life-time exposure of
humans to the levels of endogenous production of oestrogen (and in particular to oestradiol-17 β and
its metabolites) is sufficient to cause and/or promot e cancer in some individuals. This is frequently
called risk of cancer from background (endogenous) exposure. This kind of exposure (and the
attentive risk of cancer) cannot be avoided. Th e European Communities also notes that humans are
exposed daily to variable levels of residues of oestradiol-17 β from many exogenous sources where
these hormones naturally occur, which likewise cannot be avoided.615
7.502 The European Communities argues that "additive risk" refers to exposure which is "further
added on humans from the levels of residues in meat from animals treated with these hormones for
growth promotion." Such exposure leads to a risk of cancer which is "added" to the cancer risk from
the existing endogenous exposure through the b ackground levels of hormones and through the
exposure to exogenous sources, such as non-treated natural food. The European Communities cites to
the 2002 US Report on Carcinogenesis and argues that it agrees with the conclusions in the SCVPH
Opinions that "veterinary use of steroidal estroge ns to promote growth and treat illness can increase
estrogens in tissues of food-producing animals to ab ove their normal levels", in general substantially
higher than the normal (endogenously produced) le vels. The European Communities argues that
exposure to residues from hormone-treated meat is avoidable because these hormones are chemical
substances that are deliberately added to meat.616
7.503 The European Communities states in response to the Panel's questions on additive risk:
"The risk of cancer from the consumption of residues in hormone-treated meat are
'additive' (to risk of cancer from the two other sources of exposure), irrespective of
whether these hormones are genotoxic carcinogens or only promote cancer through
receptor-mediated mechanisms. Indeed, if they cause cancer by direct genotoxic
action, the addition of such exposure increases the likelihood of the adverse effect to
occur. If they act only through receptor-med iated mechanism, the risk from such
exposure will be again 'additive', when th ey cause the presumed threshold to be
exceeded. The risk assessment of the European Communities has established that
oestradiol-17β is a proven genotoxic carcinogen and that the other two natural
hormones (testosterone and progesterone) are also suspected to be genotoxic.
Moreover, the risk assessment of the Eur opean Communities has also demonstrated
that the ADIs recommended by JECFA for all these hormones will be exceeded under
realistic conditions of use of these hormones in the US and Canada. They will also be
exceeded in any case if the more recent data on the endogenous production of the
natural hormones by pre-pubertal children is taken into account."
617
Reasoning of the Panel
7.504 In EC – Hormones , with respect to the methodology for a risk assessment under the second
definition of paragraph 4 of Annex A of the SPS Agreement, the panel stated that "in this dispute, a
risk assessment carried out in accordance with the SPS Agreement should (i) identify the adverse
effects on human health (if any) arising from the pr esence of the hormones at issue when used as

614 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 254.
615 EC's replies to Panel questions after the second substantive meeting, Annex C-1, paras. 48-49.
616 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 50.
617 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 51.

growth promoters in meat or meat products , and (ii) if any such adverse effects exist, evaluate the
potential or probability of occurrence of these effects".618
7.505 Although the Appellate Body did not disagree with the panel, in its report in EC – Hormones
it noted "that the Panel's use of 'probability' as an alternative term for 'potential' creates a significant
concern. The ordinary meaning of 'potential' relate s to 'possibility' and is different from the ordinary
meaning of 'probability'. 'Probability' implies a higher degree or a threshold of potentiality or
possibility. It thus appears that here the Pane l introduces a quantitative dimension to the notion of
risk."619
7.506 In Australia – Salmon, the Appellate Body further elaborated on the distinction between the
two standards for risk assessment contained in Anne x A(4) and the need for a substantive distinction
between the evaluation of "likelihood" in the firs t sentence and the evaluation of "potential" in the
second sentence. Specifically, the Appellate Body stated:
"[w]e note that the first type of risk assessment in paragraph 4 of Annex A is
substantially different from the second type of risk assessment contained in the same
paragraph. While the second requires only th e evaluation of the potential for adverse
effects on human or animal health, the first type of risk assessment demands an
evaluation of the likelihood of entry, estab lishment or spread of a disease, and of the
associated potential biological and economic consequences. In view of the very
different language used in paragraph 4 of Annex A for the two types of risk
assessment, we do not believe that it is correct to diminish the substantial differences
between these two types of risk assessments ..."620
7.507 Therefore, the Panel considers that it is necessar y to clarify what constitutes a risk assessment
as defined by Annex A(4), second sentence. The Pane l considers that Annex A(4) requires a Member
to (a) identify the additives, cont aminants, toxins or disease-causing organisms in food, beverages or
feedstuffs at issue (if any); (b) identify any possibl e adverse effect on human or animal health; and (c)
evaluate the potential for that adverse effect to arise from the presence of the identified additives,
contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs.
7.508 The Panel concludes that the European Commun ities has satisfied the first requirement of
Annex A(4) second sentence, in that it has identifie d the contaminant and food at issue; namely meat
and meat products from cattle treated with oestradiol-17 β for growth promotion purposes. The
European Communities has also id entified the possible adverse effects on human or animal health,
namely neurobiological, developmental, reproduc tive and immunological effects, as well as
immunotoxicity, genotoxicity, and carcinogenicity.621
7.509 The Panel must now evaluate whether it has satisfied the third requirement of the definition of
a risk assessment. To do so, the Panel needs to define the terms "potential" and "arise from." The
Oxford English Dictionary defines potential as "[p]ossible as opposed to actual; having or showing
the capacity to develop into something in the future; latent; prospective." 622 Additionally, in EC –
Hormones the Appellate Body observed that the ordi nary meaning of 'potential' relates to

618 Panel Report on EC – Hormones (Canada), para. 8.101; Panel Report on EC – Hormones (US),
para. 8.98.
619 Appellate Body Report on EC – Hormones, para. 184.
620 Appellate Body Report on Australia – Salmon, footnote 69.
621 1999 Opinion, page 72, Exhibit US-4.
622 The New Shorter Oxford English Dictionary (Thumb Index Edition, 1993), p. 2310.

'possibility'.623 The American Heritage Dictionary defines "a rise" as to come into being, originate, to
result, issue or proceed.624
7.510 The Appellate Body's findings in both EC – Hormones and Japan – Apples inform the
definition of risk assessment in Annex A(4) second sentence. The Appellate Body has found that the
requirement to conduct a risk assessment is not satis fied merely by a general discussion of the disease
sought to be avoided by the imposition of a sanitary of phytosanitary measure.625
7.511 Specifically, in EC – Hormones the Appellate Body concluded th at a risk assessment in this
instance required not a general evaluation of th e carcinogenic potential of entire categories of
hormones, but rather should include an examina tion of residues of those hormones found in meat
derived from cattle to which the hormones had been administered for growth promotion purposes.626
7.512 In Japan – Apples the Appellate Body clarified that a ri sk assessment should refer in general
to the harm concerned as well as to the precise agent that may possibly cause the harm. 627 In a
footnote, the Appellate Body explained
"Indeed, we are of the view that, as a general matter, 'risk' cannot usually be
understood only in terms of the disease or ad verse effects that may result. Rather, an
evaluation of risk must connect the possibilit y of adverse effects with an antecedent
or cause. For example, the abstract re ference to the 'risk of cancer' has no
significance, in and of itself, under the SPS Agreement, but when one refers to the
'risk of cancer from smoking cigarettes', the particular risk is given content."628
7.513 Given the Appellate Body's guidance and the or dinary meaning of the terms "potential" and
"arising from", the Panel concludes that the Eur opean Communities was required to evaluate the
possibility that the identified adver se effect came into being, orig inated, or resulted from the presence
of residues of oestradiol-17 β in meat or meat products as a result of the cattle being treated with the
hormone for growth promoting purposes.
7.514 The Panel, as noted above, will not conduct its own risk assessment or impose its own
scientific opinions on the European Communities. 629 However, the Panel must make an objective
assessment of whether the Opinions issued by the SCVPH satisfy the definition contained in
Annex A(4) to the SPS Agreement.
7.515 As a preliminary matter, the Panel notes that there has been significant debate between the
parties about the relevance of the Codex and JE CFA definitions of the various phases of a risk
assessment as well as about a risk assessment's role in the larger process of risk analysis, which
consists of three components: risk assessment, risk management, and risk communication.630

623 (footnote original) The dictionary meaning of "potential" is "that which is possible as opposed to
actual; a possibility"; L. Brown (ed.), The New Shorter Oxford English Dictionary on Historical Principles ,
Vol. 2, p. 2310 (Clarendon Press, 1993). In contrast , "probability" refers to "degrees of likelihood; the
appearance of truth, or likelihood of being realized", and "a thing judged likely to be true, to exist, or to
happen"; Ibid., p. 2362.
624 The American Heritage Dictionary of the English Language (4th ed., 2000).
625 Appellate Body Report on Japan – Apples, para. 202.
626 Appellate Body Report on EC – Hormones, para. 200.
627 Appellate Body Report on Japan – Apples, para. 202.
628 Appellate Body Report on Japan – Apples, at footnote 372.
629 See para. 7.443 above.
630 Codex Procedural Manual, 15th ed., p. 44.

7.516 The Panel also recalls that the European Comm unities argues that the broader concept of risk
analysis, as defined by Codex, including the risk management phase, must be considered in evaluating
whether the European Communities conducted a risk assessment within the meaning of Article 5.1
and Annex A(4).
7.517 Specifically, the European Communities points out that, as defined by Codex, risk assessment
is normally considered to be only the first component of a three part process. 631 The European
Communities argues that the United States ignores the second component of risk analysis, which has
to be completed after the completion of the four steps of risk assessment, namely risk management.
The European Communities defines risk management as the process of "weighing policy alternatives
in the light of the results of risk assessment and, if required, selecting a nd implementing appropriate
control options, including regulatory measures." 632 The European Communities also asserts that the
Appellate Body has confirmed that a risk assessment within 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.633
7.518 The Panel agrees with the European Communities that the relevant definition against which to
measure the EC Opinions in order to determine wh ether they constitute a ri sk assessment is the one
contained in the SPS Agreement, namely that set forth in Annex A(4). As noted above, the Panel has
found that the text of Annex A(4) second senten ce defines a risk assessment as evaluating the
possibility that an identified adverse effect came in to being, originated, or resulted from the presence
of the identified additives, contam inants, toxins or disease-causing organisms in food, beverages or
feedstuffs.
7.519 The European Communities argues that th e Appellate Body in the original EC – Hormones
case confirmed that a risk assessment within the meaning of Article 5.1 includes a "risk management"
stage which entails weighing policy alternatives in li ght of the results of risk assessment and, if
required, selecting and implementin g appropriate control options, in cluding regulatory measures.
Although the Appellate Body disapproved of the original panel's distinction between "risk
assessment" and "risk management" because it had no textual basis in the Agreement, this Panel can
find no statement by the Appellate Body confirmi ng that what the European Communities describes
as risk management is included within the definition of a risk assessment as set forth in Annex A(4) of
the SPS Agreement. In fact, the Appellate Body stressed that Article 5 and Annex A 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.
634
7.520 The Panel agrees with the Appellate Body that its role as a treaty interpreter is to "read and
interpret the words actually used by the agreem ent under examination, and not words which the
interpreter may feel sh ould have been used." 635 The Panel takes note of the Appellate Body's finding
that a risk assessment can take into account "matte rs not susceptible of quantitative analysis by the
empirical or experimental laboratory methods commonly associated with the physical sciences." 636
However, the Panel finds that neither that finding nor the text of the Agreement includes within the
definition of a risk assessment the concepts put forward by the European Communities as "risk
management." Therefore, the Panel maintains that it must determine whether the European
Communities evaluated the possibility that the identifi ed adverse effects came into being, originated,
or resulted from the presence of residues of oestradiol-17 β in meat or meat products as a result of the

631 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 135.
632 EC's replies to Panel questions after the first substantive meeting, Annex B-1, paras. 136-137.
633 EC's second written submission, para. 191.
634 Appellate Body Report on EC – Hormones, para. 181.
635 Appellate Body Report on EC – Hormones, para. 181.
636 Appellate Body Report on EC – Hormones, para. 187.

cattle being treated with the hormone for growth promotion purposes. To that end, the Panel
requested the opinions of the scientific experts on what, exactly, the European Communities evaluated
in its Opinions.
7.521 The Panel specifically asked the experts whether the EC Opinions identified the potential for
adverse effects on human health, including the carcinogenic or genotoxic potential, of the residues of
oestradiol-17β found in meat derived from cattle to whic h this hormone had been administered for
growth promotion purposes in accordance with good ve terinary practice and to what extent the
Opinions evaluated the potential occurrence of these adverse effects.
637
7.522 Dr. Boobis concluded that "the EC has not identified the potential for adverse effects on
human health of residues of oestradiol found in m eat from treated cattle. This is because the analysis
undertaken was focused primarily on hazard identifi cation. There was little in the way of hazard
characterization, and no independent exposure assessment was undertaken.638
7.523 Dr. Guttenplan concluded that the European Communities had done a thorough job in
identifying the potential for adverse effe cts on human health of oestradiol-17 β found in meat derived
from cattle to which this hormone had been administ ered. Specifically, Dr. Guttenplan found that the
European Communities had identified a number of po tential adverse effects, established metabolic
pathways relevant to these effects, and examined mechanisms of these effects. In addition it had
performed thorough studies of residue levels in ca ttle, and the environment. Dr. Guttenplan also
concluded that the evidence evaluating the occurrence of adverse effects is weak. He found that the
animal models were very limited a nd the target organs do not coincide well with the target organs in
humans. He also pointed out that there are "b asically no epidemiological studies comparing matched
populations consuming meat from untreated and horm one-treated cattle. Thus, little can be inferred
about the potential occurrence of the adverse ef fects, the potential for adverse effects seems
reasonable."639
7.524 Dr. Boisseau noted that "in the 1999 report, SC VPH concluded also that '... it is clear that
exogenous oestrogens, present in oral contraceptives or used in hormonal replacement therapy in
women, are responsible for an increase of endometri al cancer and, to lesser extent, some increased
risk of breast cancer, [but] there is no direct ev idence on the consequences of the contribution of
exogenous oestradiol-17β originating from the consumption of treated meat'."640
7.525 Dr. Cogliano observed that even though th e European Communities does demonstrate
through scientific evidence that oestradiol-17 β is genotoxic, the issue is whether this genotoxicity
would occur at levels found in meat. In that respect, Dr. Cogliano concluded that the European
Communities has not established that genotoxicity and cell proliferation would be induced by levels
found in treated meat added to the pre-existing levels occurring in exposed humans.641
7.526 The Panel specifically asked the expert s whether the European Communities had
demonstrated that a potential for adverse effects on human health arises from the consumption of meat
from cattle treated with any of the six hormones in dispute for growth promotion purposes.
Dr. Boisseau concluded that the European Comm unities did not demonstrate that a potential for
adverse effects on human health arises from the cons umption of meat from cattle treated with any of
the six hormones in dispute for growth promotion purposes. Additionally, Dr. Boisseau stated that the
kind of evidence required to demonstrate such poten tial adverse effects should be (a) toxicological

637 Panel question 13 to the scientific experts, Annex D, p. 22.
638 Replies by the scientific experts to Panel questions, Annex D, para. 144.
639 Replies by the scientific experts to Panel question 13, Annex D, para. 145.
640 Replies by the scientific experts to Panel questions, Annex D, para. 132.
641 Replies by the scientific experts to Panel questions, Annex D, para. 180.

data indicating that the values of the ADIs established by JECFA are not conservative enough, and (b)
data on residues in treated/non-treated cattle and on daily production of hormones in sensitive
individuals642 indicating that the hormonal residue intake associated with the consumption of meat
from treated cattle is such that the established ADI s would be exceeded in the case of use of growth
promoters.643
7.527 Dr. Boobis stated that, in his view, none of the information provided by the European
Communities demonstrates the potential for adverse e ffects in humans of any of the six hormones in
meat from cattle in which they are used for growth promotion purposes at the levels to which those
consuming such meat would be exposed. The studies on genotoxicity provide no convincing evidence
of potential for harm in consumers. The carcinogeni c effects observed are entirely consistent with a
hormonal mode of action that exhibits a threshold that would be well above the intake arising from
consumption of meat from treated cattle.644
7.528 Dr. Guttenplan found that the levels in meat could result in bioavailable oestrogen exceeding
the daily production rate of oestradiol in pre-pubertal children. "For pre-pubertal children, even with
the low bioavailabilty of estrogen ... and its low levels in meats, it appears possible that intake levels
would be within an order of magnitude of those of the daily production rate. This is greater than
FDA's ADI and suggests some risk to this population. If there [are] genotoxic effects of estradiol in
children, they may be reflected over a lifetime, as mutations arising from DNA damage are
permanent. It seems the more accurate methods of analysis could now be used to measure the effect
of eating hormone-treated beef on blood levels of estrogen in children and post-menopausal women.
If practical, this experiment would be important in establishing or refuting the arguments of the
EC."645
7.529 To the extent that the Europ ean Communities argues that the re levant risk from hormones is
an "additive risk" the experts concluded that th e European Communities di d not assess the extent to
which residues of hormones in meat and meat products as a result of the cattle being treated with the
hormones for growth promoting purposes contribute to additive risks arising from the cumulative
exposures of humans to multiple hazards, in additio n to the endogenous production of some of these
hormones by animals and human beings.646
7.530 Dr. Cogliano explains that even if the fact that a substance is a carcinogenic hazard led an
agency to make a decision on the qualitative element alone, many agencies still prefer to examine the
exposure in their country to determine what to do. 647 Indeed Dr. Boobis indicates that stopping the
risk assessment once it was identified that the hazar d was such that the dose response was going to be
linear, i.e. there is no threshold, would be an unusual circumstance. He states that in most
circumstances one would want to understand the re lationship between the hazard and the level of
exposure that was occurring. For that reason one would progress at least to a semi-quantitative
evaluation of the exposure and risk, rather than just stopping at a simple identification of hazard.648
7.531 Finally, the Panel has looked at the Opinions and found statements that indicate that specific
studies on the potential for the adverse health effect s identified by the European Communities to arise
from consumption of meat and meat products from cattle treated with oestradiol-17 β for growth
promotion purposes were not conducted.

642 Such as prepubertal children.
643 Replies by the scientific experts to Panel questions, Annex D, para. 406.
644 Replies by the scientific experts to Panel questions, Annex D, para. 408.
645 Replies by the scientific experts to Panel question 52, Annex D, para. 413.
646 Replies by the scientific experts to Panel question 56, Annex D, paras. 422-431.
647 Transcript of the Panel meeting with the experts, Annex G, para. 438.
648 Transcript of the Panel meeting with the experts, Annex G, para. 442.

7.532 The 1999 Opinion looked at three main areas of potential adverse effects: developmental
effects on different stages of life; the relationship between oestrogens and cancer; and the effect of sex
hormones on the immune system. In each of these areas, little or no data was presented directly that
any of the potential adverse health effects identifie d come into being, originate, or result from the
consumption of meat and meat products which contain veterinary residues of oestradiol-17 β as a
result of the cattle being treated with the hormone for growth promoting purposes.
7.533 With respect to the developm ental effects of exogenous sex hormones, the 1999 Opinion
recites generally the biological functions of sex hormones in the biological development of a human
being and cites to studies that involve the appli cation of diethylstilbestrol (DES) in experimental
settings, even though, as the United States notes, DES is not one of the possible sources of oestradiol-
17β residues in meat from treated cattle.
649 With respect to prepubertal children, the 1999 Opinion
again cites studies having to do with DES as well as t estosterone and allylestrenol (a steroid used in
prevention of spontaneous abortion). 650 Although the developmental effects of oestrogens are
discussed generally, including some potential adverse health effects, there is no examination of
whether these effects arise from the pr esence of residues of oestradiol-17 β in meat and meat products
as a result of the cattle being treated with the hormone for growth promotion purposes. In fact, the
1999 Opinion states that "the information available so far falls short of the ideal, or even the sufficient
standard to allow observers a well informed j udgment when assessing exposure regarding what is
acceptable from what is not."
651
7.534 Regarding cancer, the 1999 Opinion states that "no study has assessed the effects of hormones
as growth promoters in farm animals on cancer occu rrence in humans. Arguments to be considered
when evaluating the hypothesis of a potential link betw een the use of food promoters in farm animals
and cancer in humans come both from descriptive ep idemiology, including studies in migrants, and
etiologic epidemiology on diet an d cancer as well as on hormones and cancer." 652 "Currently one
cannot confirm nor refute the association between high rates of breast cancer and high hormone-
treated meat consumption in North-Ameri ca. This should be urgently studied."
653 Additionally, the
1999 Opinion noted that:
"The difficulty of evaluating health effects at low dose is here compounded by the
fact that the data on exposures of human populations are exceedingly limited. No
large data are available on representative samples of foods collected in countries
allowing or banning growth promoters in farm animals. Most often, published levels
concern measurements realized by the pr oducers of the substances themselves under
experimental conditions. However, data on the concentration of hormones and their
metabolites present in edible tissues of treated animals are lacking. In addition, the
methods used for measurements require a criti cal reappraisal. Data on the nature and
amount of metabolites produced by the target animal are missing."654
7.535 Finally, in examining the effect of sex hormones on the immune system, the 1999 Opinion
states that "no sound epidemiological data are currently available to establish a link between nutrition,
especially meat consumption, and the occurrence of (and apparent current increase in) autoimmune
diseases."655 Additionally, the 1999 Opinion found that relevant data:

649 1999 Opinion, pp. 5-16.
650 1999 Opinion, p. 13.
651 1999 Opinion, p. 6.
652 1999 Opinion, p. 16.
653 Ibid.
654 Ibid., p. 20.
655 1999 Opinion, pp. 22-23.

"[I]ndicate that oestrogens modulate the immune system in many species. Direct
human data at near physiological levels of oestradiol are lacking. Vingerhoets et. al.,
(1998) have conducted a self-reporting ques tionnaire study of DES daughters. A
statistically significant difference in the incidence of infections was identified
compared with control. This may be consid ered to be linked to imprinting by DES in
utero.
In conclusion, at relatively high doses o estradiol does produce a number of adverse
effects on the immune system in humans, e. g. allergy to topical oestradiol (Boehnke
and Gall, 1996). The above findings while indicating a possible concern are
insufficient to identify whether immune e ffects could occur in consumers from the
ingestion of meat or meat products containing oestradiol residues."656
7.536 The 1999 Opinion cited a new method for determ ining blood levels of oestradiol which
suggested that the levels were 100 fold lower than previously determined and the metabolic clearance
rate too high by a factor of 10. The 1999 Opinio n concluded that if these methods were correct the
acceptable daily intake established by the US Food and Drug Administration for meat and meat
products derived from treated cattle would be at least 85 fold and possibly as much as 1,700 fold too
high. However, the 1999 Opinion went on to note that "[g]iven all of the uncertainties in these
estimates, it appears that the data are insufficient to form the basis of a sound risk assessment."657
7.537 All of the statements of the experts, and ind eed statements from the Opinions, indicate that
the European Communities has evaluated the poten tial for the identified adverse effects to be
associated with oestrogens in general, but has not provided analysis of the potential for these effects to
arise from consumption of meat and meat produc ts which contain residues of oestradiol-17 β as a
result of the cattle they are derived from being treated with the hormone for growth promotion
purposes. The Panel, therefore, concludes that although the European Communities has evaluated the
association between excess hormones and neurobi ological, developmental, reproductive and
immunological effects, as well as immunotoxicity , genotoxicity, and carcinogenicity, it has not
satisfied the requirements of the definition of a risk assessment contained in Annex A(4) because it
has not evaluated specifically the po ssibility that these adverse effects co me into being, originate, or
result from the consumption of meat or meat products which contain veterinary residues of
oestradiol-17β as a result of the cattle being treated with the hormone for growth promotion purposes.
Does the science support the conclusions of the Opinions?

Introduction
7.538 The Panel agrees with the reasoning of the Panel in Japan – Apples (Article 21.5 – US) that
"the scientific evidence which is being evalua ted must support the conclusions of the [risk
assessment]. Therefore, if the conclusions of the ri sk assessment are not sufficiently supported by the
scientific evidence referred to in the [risk asse ssment], then there cannot be a risk assessment
appropriate to the circumstances, w ithin the meaning of Article 5.1". 658 Although the Panel has
already found, above, that the Opinions do not satisfy the definition of a risk assessment in
Annex A(4) of the SPS Agreement, the Panel wishes to ensure that it has conducted a complete and
objective assessment of the facts. Therefore, in determining whether the European Communities
complied with Article 5.1, the Pane l will determine whether the scientif ic evidence referred to in the
Opinions supports the conclusions contained therein.

656 1999 Opinion, p. 45.
657 1999 Opinion, pp. 38-39.
658 Panel Report on Japan – Apples (Article 21.5 – US), para. 8.136 (original footnote omitted).

Summary of the main arguments of the parties659
7.539 The United States points out that the United Kingdom's Sub-Group of the Veterinary
Products Committee, a service of the UK's Depart ment for Environment, Food and Rural Affairs,
concluded that "none of the publications reviewed in the 1999 Opinion provide any substantive
evidence that oestradiol is mutagenic/genotoxic at relevant levels of exposure from residues in
meat."660
7.540 The United States also refers to the report of the Committee for Veterinary Medicinal
Products ("CVMP") (a subcommittee of the European Medicines Agency) on the Safety Evaluation of
Steroidal Sex Hormones, also from 1999. The Un ited States notes that the CVMP reaffirmed its
conclusions that oestradiol-17 β is mainly devoid of genotoxic activity and exerts its carcinogenic
action after prolonged exposure a nd/or at levels considerably higher than those required for a
physiological response. 661 Additionally, the CVMP concluded that the previous data as well as the
recent EC studies described in the 1999 Opinion, support the notion that oestradiol belongs to the
group of non-genotoxic carcinogens. According to the CVMP, the new studies "indicate that the
presumed genotoxicity alone would not be sufficient to elicit the carcinogenic effects observed in the
target tissues."
662
7.541 The United States argues that the European Communities relies on studies that demonstrate
adverse effects of hormones at concentrations expo nentially greater than would be present in residues
of meat from cattle treated with hormones for growth promotion purposes, and discusses the effects of
substances, such as DES, that have been banned in the United States for deca des in support of the
notion that hormones can be harmful.663
7.542 The United States argues that the European Co mmunities draws conclusions on the effects of
oestradiol-17β in concentrations in the normal physiological range ( i.e., concentrations equivalent to
those found in both treated and untreated meat) based solely on observations of DNA damage from
doses greatly exceeding that range. This extrapolation fails to take into account the available data on,
e.g., differences between oestradiol metabolism at high compared to low concentrations in tissues, the
potential for threshold doses for adverse biological effects and the possibility of different dose-
response relationships for high and low doses of the compound.664
7.543 The United States notes that a central unde rpinning of the European Communities'
determination to ban the importation of meat or m eat products from cattle treated with hormones for
growth promotion purposes according to good ve terinary practices is that oestradiol-17 β is
genotoxic. 665 However, the United States argues, th e European Communities has not in fact
demonstrated through scientific ev idence that oestradiol has carcinogenic effects other than through
the receptor mediated, cell division stimulating activit y 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.666

659 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
660 US's first written submission, para. 83, citing the "UK Report" in Exhibit US-12.
661 US's first written submission, para. 90, citing the "CVMP Report" in Exhibit US-13.
662 US's first written submission, para. 91.
663 US's first written submission, para. 141.
664 US's first written submission, para. 154.
665 US's second written submission, para. 35.
666 US's second written submission, para. 36.

7.544 The United States argues that the Eur opean Communities reliance upon the JECFA
conclusion that oestradiol has "genotoxic potential" for its conclusion that oestradiol is genotoxic is
misplaced, because it fails to take into account JECFA's findings that oestradiol-17 β did not cause
gene mutations in vitro, although in some other assays, sporadic but unconfirmed positive results were
obtained.667
7.545 The United States also argues that although the European Communities relies on the JECFA
report to support its argument that oestradiol-17β is genotoxic, the European Communities ignores the
ultimate conclusion of the JECFA report, i.e., that a maximum residue level for oestradiol-17β in meat
need not be specified because ther e is a "wide margin of safety for consumption of residues in food
when the drug is administered according to good practice in the use of veterinary drugs."668
7.546 The United States argues that the Opinions focus on several hypothetical "failure of control"
scenarios that ignore actual regulatory processes in the United States, and fo r which the European
Communities presents no support. The European Co mmunities asserts that these scenarios "clearly
identify a risk for excessive exposure of consumer to residues from misplaced or off-label used
implants and incorrect dose regimes." Yet, th e European Communities, according to the United
States, fails to produce any evidence identifying a real risk of failure of controls or failure to satisfy
good veterinary practices in the United States.669
7.547 The United States relies upon the conclusions of the panel in Japan – Apples (Article 21.5 –
US) for the premise that evidence relied upon by a Member must actually support the conclusions
reached in that Member's risk assessment. The Un ited States argues, theref ore, that the European
Communities may not simply set out conclusions in its Opinions that are not actually grounded in the
studies or evidence it cites as support.670
7.548 The United States argues that the European Communities continues to rely on studies such as
the 1999 IARC Monograph, which have already been found by the Appellate Body to "constitute
general studies which do indeed show the existence of a general risk of cancer; but they do not focus
on and do not address the particular kind of risk here at stake – the carcinogenic or genotoxic potential
of the residues of those hormones found in meat de rived from cattle to which the hormones had been
administered for growth promotion purposes." 671 The United States maintains that although the
potential for adverse effects from hormones at these high levels is not in dispute, the materials and
findings cited by the European Communities (1999 IARC Monograph; 11 th Report on Carcinogens)
are not, however, evidence of a risk from meat from cattle treated with oestradiol for growth
promotion purposes.672
7.549 The European Communities argues that it is important to understand that the issue of the
dose administered is not relevant for the in vivo genotoxicity in the case of oestradiol-17 β. The
European Communities goes on to note that it appears that the doses used to elicit in vivo

667 US's second written submission, para. 37, citing the 52 nd JECFA Report (2000), p. 58
(Exhibit US-5).
668 US's second written submission, para. 37, citing the 52nd JECFA Report (2000), p. 74, footnote 1
(Exhibit US-5).
669 US's second written submission, para. 56.
670 US's second written submission, para. 56, citing the Panel Report on Japan – Apples (Article 21.5 –
US), para. 8.145.
671 US's reply to questions from EC after the second substantive meeting, para. 23, citing Appellate
Body Report on EC – Hormones, para. 200, Annex C-4.
672 Ibid., para. 24.

mutagenicity673 are not massively high, but rather that they seem to fall within the safety margin
established by JECFA, which means that the residu es in meat from hormone-treated cattle are also
capable of producing this adverse effect.674
7.550 The European Communities argues that the onl y rationale that can be inferred from the
available scientific data is that the higher the exposure to residues from these hormones, the greater
the risk is likely to be. 675 The European Communities goes on to say that the risk resulting from
human consumption of meat from cattle treated with oestradiol-17 β for growth promotion purposes,
according to good veterinary practice, is "assessed in the real world" where "people live, work and
die", or may be suffering from clinical disorders, or may be particularly vulnerable segments of the
population (e.g., like prepubertal children), etc.
676
7.551 The European Communities notes that it is scientifically undisputed that life-time exposure of
humans to the levels of endogenous production of oestrogen (and in particular to oestradiol-17 β and
its metabolites) is sufficient to cause and/or promot e cancer in some individuals. This is frequently
called risk of cancer from background (endogenous) exposure. This kind of exposure (and the
attentive risk of cancer) cannot be avoided. Th e European Communities also notes that humans are
exposed daily to variable levels of residues of oestradiol-17 β from many exogenous sources where
these hormones naturally occur, which likewise cannot be avoided.677
Reasoning of the Panel
7.552 The Panel's task is to determine whether the scientific evidence supports the conclusions in
the Opinions. The Panel notes in this respect that the 1999 Opinion concluded that "for oestradiol
genotoxicity has already been demonstrated explicitly." 678 The 1999 Opinion also concluded that
oestradiol-17β is a complete carcinogen that exhibits tumour initiating and tumour promoting
effects.679 Finally, the 1999 Opinion found that "any excess exposure towards 17 β-oestradiol and its
metabolites resulting from the consumption of meat and meat products presents a potential risk to
public health in particular to those groups of the population which have been identified as particularly
sensitive, such as prepubertal children. 680 In the 2000 and 2002 Opinions, the SCVPH concluded that
none of the additional science developed in the intervening years justified changing those conclusions.
7.553 The Panel is not in a position to evaluate the scientific data the SCVPH reviewed in drawing
its conclusions. For this reason, the Panel consulted a group of scientific experts and asked them to
evaluate the EC Opinions as well as the underlying science.
7.554 The European Communities urged the Panel to disregard the responses of two particular
experts because their positions are "purely theoreti cal" and for the additional reason that they have
"never done any specific research on these hormones nor have they published something on these
substances."681 In that vein, the European Communities cit es to the Appellate Body's rejection of an
opinion given by a scientist in the original EC – Hormones dispute in 1998 because it did not "purport
to be the result of scientific studies carried out by him or under his supervision focusing specifically

673 Ability of a physical, chemical, or biological agent to induce heritable changes (mutations) in the
genetic material in a cell as a consequence of alteratio ns or loss of genes or chromosomes (or parts thereof)
(replies of Dr. Boobis and Dr. Guttenplan to Panel question 2 to the experts. Annex D, paras. 34 and 55).
674 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 23.
675 EC's replies to Panel questions after the first substantive meeting, Annex B-1, paras. 94 and 96.
676 Ibid.
677 EC's replies to Panel questions after the second substantive meeting, Annex C-1, paras. 48-49.
678 1999 Opinion, p. 75, Exhibit US-4.
679 1999 Opinion, p. 73.
680 1999 Opinion, p. 71.
681 EC's comments on experts replies to Panel questions, Annex F-1, pp. 35-36.

on residues of hormones in meat from cattle fattened with such hormones ..." 682 However, the Panel
finds that Appellate Body in its report on EC – Hormones spoke to a different issue. In that instance
the scientist was making specific estimates about the likelihood of breast cancer being caused by
eating meat containing oestrogens, even though the scientist had not studied the matter.
7.555 In this case, the Panel has asked the experts not to make their own scientific conclusions but
to evaluate the Opinions as experts in the conducting of risk assessments on food additives and
contaminants and to assist the Panel in determin ing whether the evidence relied upon by the SCVPH
supports the conclusions in its Opinions. To that end the Panel found the comments by all the experts
helpful in its analysis and none shall be disregarded.
7.556 In response to specific questions from the Panel, the experts provided the following
information.
7.557 With respect to the genotoxicity of oestradiol-17 β, Dr. Boisseau explained that JECFA's
conclusion that oestradiol-17 β had genotoxic potential was based on the general agreement that
oestradiol-17β is associated with a genotoxic effect, thus
"... although it recognized that oestradiol-17 β does not lead to positive results in all
the classical tests which have been used to demonstrate its genotoxicity and its
mutagenicity (oestradiol-17β did not cause gene mutations in vitro and gives, in some
assays, sporadic but unconfirmed positive results), JECFA, in its fifty second session
held in 1999 concluded 'that oestradiol-17β has genotoxic potential.' "
683
7.558 In evaluating the EC assertion that th e fact that doses of oestradiol-17 β used in growth
promotion are low is irrelevant because there is no threshold for substances which have genotoxic
potential, Dr. Boisseau stated that the general principle did not apply to naturally occurring hormones,
which are produced by both humans and food producing an imals. Dr. Boisseau noted that even in the
absence of any consumption of food coming from animals treated by growth promoting hormones,
humans are naturally and continuously exposed to these natural hormones through, among others, (a)
their own production of these hormone s which may be very high, for example in the case of pregnant
women, (b) the consumption of meat from non treated cattle, (c) the consumpti on of meat from other
food producing animals, (d) the consumption of milk and eggs. There is no epidemiological survey
indicating that this continuous exposure of humans to these natural hormones results in any identified
risk for health.684
7.559 Dr. Cogliano explained that "the EC's statemen t that a threshold cannot be identified reflects
their view of genotoxic mechanisms, just as the contra ry statement that there is a threshold and that
this threshold is above the levels found in meat residues reflects how Canada and the US view
genotoxic mechanisms. Neither statement has been demonstrated by the scientific evidence, rather,
they are different assumptions that each party uses in their interpretation of the available evidence."685
7.560 Dr. Guttenplan replied that:
"[T]he data referred to by the EC s upports a genotoxic mechanism as well as a
hormonal mechanism. It is true that there is no reason to expect a threshold to exist
for a genotoxic chemical. Although DNA repair can occur, it presumably is

682 EC's comments on experts replies to Panel que stions, Annex F-1, p. 14, citing Appellate Body
683 Replies by the scientific experts to Panel questions, Annex D, paras. 134-135.
684 Replies by the scientific experts to Panel questions, Annex D, para. 182.
685 Replies by the scientific experts to Panel questions, Annex D, para. 186.

occurring at all doses and the fraction of DNA damage repaired probably does not
change at physiological levels, because th e repair enzymes are unlikely to be
saturated. The statement that, 'the fact that doses used in growth promotion are low is
not of relevance' is not necessarily true. (para. 118-119 of EC Rebuttal Submission
(US case)). For any toxin the dose determin es the risk. When exposure is very low
risk will be very low. However, one can ar gue about the definition of 'low'. It should
also be noted that at very low levels of genotoxic carcinogens the decrease in risk is
more than proportional than the decrease in applied dose."686
7.561 Dr. Cogliano stated in his written responses that the identification of oestradiol-17 β as a
human carcinogen indicates that there are poten tial adverse effects on human health when
oestrodiol-17β is consumed in meat from cattle treated with hormones for growth promotion
purposes.687 At the meeting with the Panel, Dr. Cogliano clarified that the IARC has classified
oestradiol-17β as possibly carcinogenic based on sufficient ev idence in experimental animals. The
agents that are known to be carcinogenic in hum ans are the steroidal oestrogens, non-steroidal
oestrogens, and various oestrogen- progestin combinations as used e ither as birth-control pills or
menopausal therapy.688
7.562 Dr. Boobis concluded that there is no good evidence that oestradiol is genotoxic in vivo or
that it causes cancer by a genotoxic mechanism. I ndeed the evidence is agai nst this. Hence, the
scientific evidence does not support the European Communities' position that the levels of the
hormones in meat from treated cattle are not of relevance.689
7.563 In a review of the scientific literature and the 1999 report of the Committee for Veterinary
Medicinal Products of the European Medicine Agency, Dr. Boisseau concluded that the
demonstration remains to be made that the observed indicator effects are representative of
mutagenesis at the gene or chromosome level and also occur in somatic cells in vivo . This is not
likely in the view of the following: earlier studi es had mostly indicated that hormones do not induce
micronuclei or other chromosomes aberration types in vivo. With the exception of the study reported
by Dhillon and Dhillon, the recent data confirm the earlier findings and clearly indicate that hormones
and/or their synthetic analogues are not associated with genotoxicity properties in the bone marrow
micronucleas assay in vivo.
690
7.564 With respect to the carcinogenic and tumour promoting qualities of oestradiol-17 β,
Dr. Boisseau noted that if the SCVPH, in the 1999 Opinion, expresses its concern in concluding that
"[f]inally, in consideration of the recent data on the formation of genotoxic metabolites of oestradiol
suggesting oestradiol-17 β acts as complete carcinogen by exerting tumour initiating and promoting
effects ... no quantitative estimate of the risk related to residues in meat could be presented," it
provides no data indicating that oestradiol-17 β is associated with the increase of tumours in tissues or
organs which are not hormone dependent.
691 Dr. Boisseau concludes that "the EC risk assessment did
not support that residues of oestradiol-17 β, despite the genotoxic potential of this hormone, can
initiate and promote tumours in humans."692

686 Replies by the scientific experts to Panel questions, Annex D, para. 187.
687 Replies by the scientific experts to Panel questions, Annex D, para. 154.
688 Transcript of the experts meeting with the Panel, Annex G, para. 327.
689 Replies by the scientific experts to Panel questions, Annex D, para. 184.
690 Replies by the scientific experts to Panel questions, Annex D, para. 136.
691 Replies by the scientific experts to Panel questions, Annex D, para. 141.
692 Replies by the scientific experts to Panel questions, Annex D, para. 142.

7.565 In addition, Dr. Boisseau concluded that the scientific evidence relied upon in the Opinions
does not support the conclusion that carcinogenic effects of oestradiol-17 β are related to a mechanism
other than hormonal activity.693
7.566 Dr. Boobis also pointed out that the evidence is against direct modification of DNA in vivo by
hormones in meat from treated animals, or by their metabolites produced in vivo . Indirect
modification could conceivably come about by product of reactive oxygen species. The DNA
repair694 processes for this are amongst the most efficient ( Arai et al, 2006; Russo et al, 2004) and
even if such modification did occur, it is anticipat ed that no heritable change would result, because of
DNA repair ( Arai et al, 2006) . This would be true even at the levels of exposure that could arise
should GVP not be followed.695
7.567 Dr. Boisseau also expressed his opinion that epidemiological studies carried out in humans
during long enough to take into account this "long late ncy period" will not be able to discriminate, in
the case of a possible but limited increase of tumours, between the responsibilities of (a) hormone
residues resulting from the treatment of food produc ing animals by growth promoting hormones, (b)
hormone residues resulting from the endogenous production of these animals, and (c) other
components of the diet including other food additives and contaminants. That is the reason for which,
to his knowledge, even though the hormones in disput e have already been used as growth promoters
over a significant number of years, the epidemiologi cal studies in humans already carried out in this
domain have failed to identify any relation between the occurrence of hormonally dependent tumours
and the consumption of meat containing hormonally active residues resulting from the treatment of
cattle with growth promoters.696
7.568 In response to the citation by the European Communities of da ta indicating different cancer
rates between the United States and Europe, Dr. Boobi s stated that there is no scientific evidence
demonstrating any association between consumpti on of meat from animals treated with growth
promoting hormones and the risk of cancer in humans. Dr. Boobis acknowledged that an appreciable
number of studies show an association between a risk of certain cancer types and the consumption of
meat, however he pointed out that the studies show little relationship with whether the meat is from
animals treated with growth promoting hormones or not. Dr. Cogliano noted that although it is
possible that differences in exposure to exogenous hormones could be one cause of the different
breast cancer rates in the United States and the Eur opean Communities, the data are not sufficiently
specific to establish a link. Dr. Guttenplan also c oncluded that the epidemiological studies do not
identify a relationship between cancer and residues of hormonal growth promoters.
697
7.569 Additionally, in response to direct questioni ng during the Panel meeting with the experts,
Drs. Boobis, Boisseau, and Guttenplan all agreed th at there is no appreciable risk of cancer from
residues of oestradiol-17β in meat and meat products from cattle treated with the hormone for growth
promotion purposes. While all the experts who r esponded to the question agreed that a zero risk
could not be guaranteed, the actual level of risk was in their view so small as to not be calculable.698
7.570 Finally, the Opinions themselves contain stat ements that indicate th at the science does not
support the conclusions in the Opinions. The 1999 Opin ion considered that the link, if any, between

693 Replies by the scientific experts to Panel questions, Annex D, para. 156.
694 DNA repair mechanisms refer to the ability of an organism to recognize different types of damage
to DNA and repair it (replies of Dr. Boobis and Dr. Gutte nplan to Panel question 22 to the experts. Annex D,
paras. 201 and 204).
695 Replies by the scientific experts to Panel questions, Annex D, para. 202.
696 Replies by the scientific experts to Panel questions, Annex D, para. 209.
697 Replies by the scientific experts to Panel questions, Annex D, paras. 224, 230, 231, 238, 239, 241
and 242.
698 Transcript of the Panel meeting with the experts, Annex G, paras. 707-742.

cancer and consumption of hormone-treated meat cannot, at present, be confirmed nor refuted. 699 It is
also important to note that the only study cited with respect to cancer in susceptible populations, such
as foetuses and prepubertal children, has to do with in utero exposure to DES, which is banned in the
United States and is not the source of the oestradiol-17 β residues in the meat and meat products that
are the subject of the European Communities' ban.700
7.571 With respect to the other potential adverse e ffects identified by the European Communities,
the 1999 Opinion also concludes that no sound ep idemiological data are currently available to
establish a link between nutrition, especially meat c onsumption, and the occurrence of (and apparent
current increase in) autoimmune diseases. 701 As to the developmental effects of exogenous sex
hormones on puberty in humans, the 1999 Opinion, noted that although precocious puberty is
somewhat common in the United States, "the im portance of environmental oestrogenic compounds
present in plastics, insecticides, and meat from animals treated with sex hormones , while suggestive,
remains as only a possibility in affecting an early onset of puberty."
702
7.572 The Panel has evaluated the evidence. The Panel considered the SCVPH's own
characterization of the science in the Opinions as we ll as the replies of the experts to the Panel's
questions, the transcript of the experts meeting with the Panel, and the submissions of the parties. The
Panel found that the views expressed by the experts who answered the questions, provided clear and
consistent answers, and who had particular expertise in the re levant areas being discussed, were
consistent with the statements in the Opinions cited above. The Panel's evaluation of the expert views
and the plain language of the Opinions themselves leads the Panel to conclude that the scientific
evidence referred to in the Opinions does not suppor t the European Communities' conclusion that for
oestradiol-17β genotoxicity had already been demonstrated explicitly 703 , nor does it support the
conclusion that the presence of residues of oestradiol-17 β in meat and meat products as a result of the
cattle being treated with the hormone for growth promotion purposes leads to increased cancer risk.
Additionally, the scientific evidence does not suppor t the European Communities' conclusions about
the adverse immunological and developmental effe cts of consuming meat and meat products from
cattle treated with oestradiol-17 β for growth promotion purposes. Therefore, the Panel is of the view
that the scientific evidence referred to in the Opinions does not support the conclusions reached by the
European Communities.
Conclusion
7.573 On the basis of the above, the Panel concl udes that, in its Opin ions, the European
Communities took into account risk assessment techniqu es of the relevant international organizations
and took into account the factors listed in Article 5.2 of the SPS Agreement. The Panel nonetheless
concludes that the European Communities has not satisfied the requirements of the definition of a risk
assessment contained in Annex A(4) of the SPS Agreement and the scientific evidence evaluated does
not support the conclusions in the risk assessmen t. The Panel concludes that the European
Communities has not conducted a risk assessment as appropriate to the circumstances within the
meaning of Article 5.1 of the SPS Agreement.

699 1999 Opinion., pp. 17-18.
700 1999 Opinion, p. 21.
701 1999 Opinion, pp. 22-23.
702 1999 Opinion, p. 14. (emphasis added).
703 1999 Opinion, p. 75.

(iii) Is the measure "based on" a risk assessment?
Introduction
7.574 The second question to address when determining wh ether an SPS measure is consistent with
Article 5.1 is whether that measure is "based on" a risk assessment. For an SPS measure to be based
on a risk assessment, there must be a rational relationship between the measure and the risk
assessment.
704
7.575 Specifically, the Appellate Body in EC – Hormones explained that "Article 5.1, when
contextually read as it should be, in conjunction with and as informed by Article 2.2 of the
SPS Agreement, requires that the results of the risk assessme nt must sufficiently warrant – that is to
say, reasonably support – the SPS measure at stake." 705 The Appellate Body went on to explain that
this requirement is a substantive one.706
Summary of the main arguments of the parties707
7.576 The United States argues that the EC failed to demons trate that its amended ban is "based
on" a risk assessment within the meaning of Article 5.1, i.e. that the results of the risk assessment
sufficiently warrant – that is to say, reasonably support – the SPS measure at stake.
7.577 The European Communities concludes that the United Stat es has failed to demonstrate that
the scientific risk assessment carried out by th e SCVPH does not reasonably support the measures
adopted.708 The European Communities argues that not only does the SCVPH's assessment support
the ban on oestradiol-17β, but more recent research equally confirms and further reinforces its opinion
that the measure is warranted.709
Reasoning of the Panel
7.578 The Panel has concluded that the Opinions do not constitute a risk assessment because the
Opinions do not satisfy the definition of a risk assessment contained in A nnex A(4) second sentence
and because the scientific evidence referred to in the Opinions does not support the conclusions
therein. Because the Opinions are not a risk assessment as appropriate to the circumstances, the
measure cannot be based on a risk assessment within the meaning of Article 5.1.710
(iv) Conclusion
7.579 In light of the above, the Panel conclud es that the EC implementing measure on
oestradiol-17β is not compatible with Article 5.1 of the SPS Agreement.

704 Appellate Body Report on EC – Hormones, para. 193.
705 Appellate Body Report on EC – Hormones, paras. 193-194.
706 Ibid.
707 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
708 EC's second written submission, para. 210.
709 EC's second written submission, para. 211.
710 Panel Report on Japan – Apples (Article 21.5 – US) , para. 8.156 (concluding that because the 2004
pest risk assessment did not amount to a risk assessment as appropriate to the circumstances, Japan's measure
was not based on a risk assessment).

(f) Compatibility of the EC implementing measure with Article 5.7 of the SPS Agreement
(i) Introduction
7.580 We have already concluded that the EC implementing measure does not comply with the
provisions of Article 5.1 of the SPS Agreement. To the extent that we are not seeking to determine
any level of nullification or impairment, but rath er whether the European Communities has removed
the measure found to be inconsistent with a covered agreement in the EC – Hormones dispute, we
could conclude at this stage that, by adopting Directive 2003/74/EC, the European Communities has
not – fully – removed the measure found to be inconsistent with the SPS Agreement. We recall,
however, the purpose of our considering the EC claims of violation of Article 23.1 of the DSU, read
together with Article 22.8 and Article 3.7 of the DSU. It is to assist the DSB in achieving a
satisfactory settlement of the matter in accordance w ith the rights and obligations under the DSU and
under the covered agreements, and to allow the Appe llate Body to make findings as may be necessary
should it disagree with our findings in relation to Ar ticle 23.1 and 23.2(a) of the DSU. We therefore
proceed with a review of the conformity of the EC measure with Article 5.7 of the SPS Agreement.
(ii) Summary of the main arguments of the parties
711
7.581 The European Communities argues that Directive 2003/74/EC provides that the use of five
of the six hormones at issue is provisionally forbid den. This ban is based on a comprehensive risk
assessment and, thus, is fully compliant with the DSB recommendations and rulings. In particular, as
stipulated by the Appellate Body, the results of the risk assessment provide the "available pertinent
information" on the basis of which the provisional prohibition regarding these five hormones has been
enacted. Consequently, the European Communities cl aims that, through Directive 2003/74/EC, it has
implemented the rulings and recommendations in the EC – Hormones case.712
7.582 The United States considers that, because the EC ban fails to meet the requirements of
Article 5.7, the European Communities is not provi sionally exempted from satisfying the obligations
set out, inter alia, in Articles 2.2 and 5.1 of the SPS Agreement.
7.583 The United States recalls that the Appellate Body in Japan – Agricultural Products II ,
clarified that Article 5.7 sets out four requirements that must be cumulatively satisfied in order to
adopt and maintain a provisional measure.
7.584 First the United States argues that the Europ ean Communities fails to demonstrate how its
provisional ban is imposed in a situation where "r elevant scientific evidence is insufficient". The
United States adds that Codex has adopted standa rds based on several JECFA risk assessments of the
hormones which determined that they are safe at the levels implicated by residues in meat from cattle
treated with the hormones according to good veterinary practice. In light of the quality and quantity
of scientific evidence relating to the five hormones, there is simply no need to obtain the additional
information necessary for a more objective assessment of risk. According to the United States, studies
completed since the EC – Hormones case reaffirm earlier conclusions. New safety assessments have
been conducted for progesterone and testosterone, reaffirming their safety when used according to
good veterinary practices.
7.585 In the opinion of the United States, the Europ ean Communities also fails to demonstrate how
its provisional ban has been adopted on the basis of available pertinent inform ation. For the United

711 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
712 EC's first written submission, para. 17.

States, the studies relied upon by the European Communities as a basis for its provisional ban do not
in fact demonstrate a risk associated with residu es in meat and meat products from cattle that have
been treated with hormones for growth promotion purposes according to good veterinary practices.
7.586 The United States further argues that the Europ ean Communities has not sought to obtain the
additional information necessary for a more objective assessment of risk.
7.587 The United States finally argues that the Eu ropean Communities has not reviewed the
measure accordingly within a reasonable period of time. The United States considers that the only
apparent change over 15 years of ban is the re labeling of its application from "definitive" to
"provisional". The United States is of the view that 15 years is not a reasonable period of time
especially given the fact that the ban addresses subs tances as intensively reviewed and studied as the
five hormones at issue.
7.588 The European Communities argues that, since the EC – Hormones case, the body of
evidence has developed and, while still not providi ng enough knowledge to carry out a complete and
definitive risk assessment, supports the conclusion that precautionary measures are required in order
to achieve its chosen level of protection.
7.589 According to the European Communities, the evidence, while pointing to a number of risks, is
full of gaps in pertinent information and important contradictions have de veloped that render no
longer valid the conclusions reached by JECFA in 1988, 1999 and 2000, thus not allowing a
quantitative or qualitative risk assessment. Accord ing to the European Communities, a number of
significant scientific developments, taken together with all other available evidence, indicates that it is
not possible to undertake a definitive risk assessment for the five hormones concerned.
(iii) Approach of the Panel
7.590 As a first remark, the Panel recalls its conclusion that the measure at issue, to the extent that it
provisionally bans the import of meat from ca ttle treated with the hormones progesterone,
testosterone, trenbolone acetate, melengestrol acet ate and zeranol, is an SPS measure within the
meaning of Article 1 of, and paragraph 1 of Annex A to, the SPS Agreement.713
7.591 Second, both parties address the issue of the compatibility of the provisional ban on the
above-mentioned five hormones with the provisions of Article 5.7 of the SPS Agreement. None of the
parties discussed the compatibility of the ban impo sed with respect to these five hormones with
Article 5.1.714 The Panel will therefore limit its review to the conformity of the EC ban on the five
hormones with the requirements of Article 5.7.
7.592 Article 5.7 of the SPS Agreement provides as follows:
"In cases where relevant scientific evid ence is insufficient, a Member may
provisionally adopt sanitary ... measures on the basis of available pertinent

713 See para. 7.434 above.
714 The Panel asked a question to the parties on a possible "automatic" violation of Articles 2.2 and 5.1
as a result of a violation of Article 5.7 (second series of questions from the Panel to the parties, question 2).
The Panel notes, however, that neither the European Communities nor the United States requested the Panel to
review the compatibility of the EC implementing measure regarding the five hormones subject to a provisional
ban with Article 5.1 or Article 2.2. The Panel also no tes that the EC implementing measure is supposed to have
removed the violation of Article 5.1 through the adoption of a provisional ban compatible with Article 5.7. In
light of our approach to the aspect of this case rela ting to the compatibility of the EC implementing measure
with the SPS Agreement, we decided to limit our review to the compatibility of the "provisional ban" with
Article 5.7.

information, including that from the releva nt international organizations as well as
from sanitary ... measures applied by other Members. In such circumstances,
Members shall seek to obtain the add itional information necessary for a more
objective assessment of risks and review the sanitary ... measure accordingly within a
reasonable period of time."
7.593 In Japan – Agricultural Products II , the Appellate Body recalled that Article 5.7 "set[s] out
four requirements that must be satisfied in order to adopt and maintain a provisional measure." These
requirements are:
(a) the measure is imposed in respect to a situ ation where "relevant scientific evidence is
insufficient";
(b) the measure is adopted "on the basis of available pertinent information";
(c) the Member which adopted the measure must "seek to obtain the additional
information necessary for a more objective assessment of risk"; and
(d) the Member which adopted the measure mu st "review the ... measure accordingly
within a reasonable period of time".715
7.594 The Appellate Body noted that the four require ments are "clearly cumulative in nature", and
that "[w]henever one of these four requirements is not met, the measure at issue is inconsistent with
Article 5.7."716
7.595 The Panel recalls that previous panels have addressed each of these requirements
successively. Having regard to our duty to revi ew the situation for each of the five hormones
concerned by the provisional ban, we will proceed first with the examination of the requirement under
(a) above, i.e. whether the measure is imposed with respect to a situation where "relevant scientific
evidence is insufficient".
7.596 Moreover, having regard to the arguments of the parties and in line with our duty not to
perform a de novo risk assessment, we will limit ourselves to re view the issues with respect to which
the parties exchanged arguments and provided sufficient evidence.
7.597 We also note that the United States' main line of argumentatio n is based on the fact that
"international standards and a significant body of scientific studies exist on the risks posed by each
hormone. [JECFA] and several national regulator y bodies have determined that the scientific
evidence regarding these hormones is adequate or sufficient to conduct a risk assessment." 717 In that
context, we deem it appropriate to determine to what extent relevant scientific evidence can become
insufficient within the meaning of Article 5.7 in the presence of international standards.
7.598 The Panel does not believe that the issue of the possibility or not to make a quantitative
estimate of the risk to consumers constitutes a subject on which a discussion of whether "relevant
scientific evidence is insufficient" is needed. The Panel recalls in this respect that the standard applied
by the Appellate Body to determine whether relevant scientific evidence is insufficient is that:

715 See Appellate Body Report on Japan – Apples , para. 176, citing the Appellate Body Report on
716 Appellate Body Report on Japan – Agricultural Products II, para. 89.
717 US's second written submission, para. 29.

"relevant scientific evidence" will be "insuffi cient" within the meaning of Article 5.7
if the body of available scientific 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."718
7.599 Moreover, we note that the Appellate Body considered that Article 5.1 does not require that
risk assessments be quantitative, but that qualitati ve risk assessments are also compatible with
Article 5.1.719 We recall in this regard that Codex itself does not necessarily require the performance
of quantitative risk assessments.720
7.600 We also deem it important to recall that, in Japan – Agricultural Products II , the Appellate
Body stated that:
"Article 5.7 allows members to adopt provisional SPS measures '[i]n case where
relevant scientific evidence is insufficient' and certain other requirements are fulfilled.
Article 5.7 operates as a qualified exemption from the obligation under Article 2.2 not
to maintain SPS measures without sufficient scientific evidence. An overly broad and
flexible interpretation of that obligation would render Article 5.7 meaningless."
721
7.601 The European Communities also refers to paragraphs 194 (on minority scientific views) and
205 (on Article 5.2 and good vete rinary practices) of the report of the Appellate Body in EC –
Hormones.
7.602 We have already addressed above 722 the question of the treatment of minority views among
experts and do not find it necessary to come back on this matter. As far as the second issue is
concerned, we note that, as reca lled by the Appellate Body in EC – Hormones , it is also appropriate
for the European Communities to consider situations of misuse:
"… The SPS Agreement requires assessment of the potential for adverse effects on
human health arising from the presence of contaminants and toxins in food. We
consider that the object and purpose of the SPS Agreement justify the examination
and evaluation of all such risks for hum an health whatever their precise and
immediate origin may be. We do not mean to suggest that risks arising from potential
abuse in the administration of controlled substances and from control problems need
to be, or should be, evaluated by risk asses sors in each and every case. When and if
risks of these types do in fact arise, risk assessors may examine and evaluate them.
Clearly, the necessity or propriety of examination and evaluation of such risks would
have to be addressed on a case-by-case basis. What, in our view, is a fundamental
legal error is to exclude, on an a priori basis, any such risks from the scope of
application of Articles 5.1 and 5.2 …"
723
7.603 The above statement was made in relation to the performance of a risk assessment under
Article 5.1 and 5.2 of the SPS Agreement . We recall that Article 5.7 is applicable when relevant
scientific evidence is not sufficient to undertake a ri sk assessment in conformity with Article 5.1.
Whether instances of misuse or abuse in the administ ration of hormones exist or not is not as such a

718 Appellate Body Report on Japan – Apples, para. 179 (emphasis added).
719 Appellate Body Report on EC – Hormones, para.187.
720 Working Principles for Risk Analysis for Application within the Framework of the Codex
Alimentarius, para. 20.
721 Appellate Body Report on Japan – Agricultural Products II, para. 80.
722 See para. 7.420 above.
723 Appellate Body Report on EC – Hormones, para. 206. See also Appellate Body Report on Japan –
Apples, para. 179.

scientific issue likely to make a risk assessment w ithin the meaning of Article 5.1 and Annex A(4) of
the SPS Agreement impossible. In our opinion, the scientific issue is related to the effect of the
ingestion of high doses of hormones residues, not to potential or actual misuse or abuse in the
administration of hormones. Therefore, we will not address the issue of non compliance with good
veterinary practices in our analysis under Article 5.7 of the SPS Agreement.
(iv) When will "relevant scientific evidence" be deemed "insufficient"?
Effect of the level of protection on the considera tion of the insufficiency of relevant scientific
evidence under Article 5.7
7.604 According to the European Communities, whether a risk assessment can reach a definitive
conclusion depends not only on the da ta available but also on how a risk assessment has been framed
by the risk manager.724 The European Communities argues that a Member may disagree with the risk
assessment underlying an international standard for sci entific reasons and, in particular, on the issue
of whether the scientific evidence relied upon is su fficient. Such a disagreement may result from the
fact that in order to meet a higher level of prot ection, a Member may require more information than
that provided.725 The European Communities argues that th e evidence which serv ed as the basis for
the 1988 and 1999-2000 JECFA evaluations is not su fficient "to perform a definitive risk assessment
within the meaning of Article 5.7, in particular by the WTO Members applying a high level of health
protection of no risk from exposure to unnecessary a dditional residues in meat of animals treated with
hormones for growth promotion".
726
7.605 The Panel first notes that the European Communities refers to the fact that the evidence is not
sufficient to perform a "definitiv e risk assessment". However, the European Communities nowhere
defines what it means by a "definiti ve risk assessment". The Panel r ecalls the definition of adequate
risk assessment proposed by the European Communities in EC – Approval and Marketing of Biotech
Products: "one which has been 'delivered by a reput able source, [which] unequivocally informs the
legislator about what the risk is with a sufficient degree of precision, and [which] has withstood the
passage of time and is unlikely to be revised'."
727 It is unclear to the Panel whether this is what the
European Communities refers to in this case as a "definitive risk assessment". The Panel would like
to specify that there is no obligation under the SPS Agreement to perform a definitive risk assessment
for that risk assessment to be valid under Article 5.1. Moreover, the Panel doubts that a definitive risk
assessment can in practice ever be performed, since new evidence becomes available and risk
assessments may need to be reviewed and update d accordingly, or else the measure based on these
risk assessments will have to be adjusted to the evoluti on of the scientific evidence. 728 The Panel
understands the terms "based on an assessment, as appropriate to the circumstances" to suggest that
the link between the SPS measure adopted by a Memb er and the risk assessment on which it is based
may evolve depending on the circumstances, thus implying that Article 5.1 does not require a
definitive risk assessment. This is also confirmed by the fact that risk assessments do not have to be
"monolithic" as recalled by the Appellate Body in EC – Hormones .
729 In any event, the criterion
allowing the adoption of sanitary measures on the b asis of available pertinent information under
Article 5.7 is that "relevant scientific evidence is insufficient" to permit the performance of a risk
assessment as required under Article 5.1 and Annex A(4), not that the risk assessment to be performed

724 EC's oral statement at the second substantive meeting, para. 22.
725 EC's replies to Panel questions after the firs t substantive meeting, question 72, Annex B-1,
para. 266.
726 EC's second written submission, para. 149; EC's rep lies to Panel questions after the first substantive
meeting, question 31, Annex B-1, paras. 167-172.
727 Panel Report in EC – Approval and Marketing of Biotech Products, para. 7.3238.
728 See Panel Report in EC – Approval and Marketing of Biotech Products, paras. 7.3239-7.3240.
729 Appellate Body Report on EC – Hormones, para. 194.

pursuant to Article 5.1 be a definitive one. 730 The Panel is of the view that, by suggesting that a risk
assessment be definitive, the European Communities actually di sregards the Appellate Body
interpretation mentioned above and seeks to im pose a higher threshold for compliance with
Article 5.1, or a lower one to meet the conditions of Article 5.7. However, the Panel does not believe
that this approach is supported by Article 5.1, Annex A(4) or Article 5.7.
7.606 The Panel also notes the EC view that, in determining whether the relevant scientific evidence
is insufficient, within the meaning of Article 5.7, the Panel should take into account the level of health
protection applied by the Member concerned. Mo re particularly, the European Communities argue
that, when the level of health protection of a Member is particularly high and the body of evidence is
in the process of moving from a state of sufficiency to a state of insufficiency, that Member should
not be required to demonstrate positively the existence of a clear harm.
7.607 Regarding the issue of whether the level of h ealth protection of a particular Member should
play a role in its assessment of whether the relevant scientific evidence is insufficient, the Panel notes
that the EC level of health protection is that of " no (avoidable) risk, that is a level of protection that
does not allow any unnecessary additi on from exposure to genotoxic chemical substances that are
intended to be added deliberately to food."731
7.608 We recall that the Appellate Body in Japan – Apples stated that relevant scientific evidence
will be insufficient within the meaning of Article 5. 7 if the body of availabl e scientific evidence does
not allow, in quantitative or qualitative terms, the pe rformance of an adequate assessment of risks as
required under Article 5.1 and as defined in Annex A to the SPS Agreement.732
7.609 The terms of Article 5.1 and Annex A to the SPS Agreement and, in particular, the definition
of "risk assessment" do not indicate that a Member's level of protection is pertinent to determine
whether a risk assessment can be performed or not. We agree with the Panel in EC – Approval and
Marketing of Biotech Products when it states that:
"[W]e are not convinced that the protection goa ls pursued by a legislator are relevant
to such a determination. The protection goals of a legislator may have a bearing on
the question of which risks a Member d ecides to assess with a view to taking
regulatory action, if necessary. And a le gislator protection goals are certainly
relevant to the determination of the measure ... to be taken for achieving a Member's
level of protection against risk. Yet there is no apparent link between a legislator's
protection goals and the task of assessing th e existence and magnitude of potential
risks."733
7.610 We note that sufficient scientific evidence is what is needed to make a risk assessment. The
assessment whether there is sufficient scientific ev idence or not to perform a risk assessment should
be an objective process. The level of protecti on defined by each Member may be relevant to

730 The Panel notes in this respect that in Australia – Salmon, the Appellate Body stated that:

"We might add that the existence of unknown and uncertain elements does not justify a
departure from the requirements of Articles 5.1, 5.2 and 5.3, read together with paragraph 4 of
Annex A, for a risk assessment."(Appellate Body Report on Australia – Salmon, para. 130).

The Panel also notes Dr. Boisseau's remark, that "it is always possible to ask for more data in order to
clarify more issues so that the will to eliminate any sc ientific uncertainty could result in an endless assessment
process." Replies by the scientific experts to Panel questions, Annex D, para. 452.
731 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 69.
732 Appellate Body Report on Japan – Apples, para. 179.
733 Panel Report on EC – Approval and Marketing of Biotech Products, para. 7.3238.

determine the measure to be selected to address the assessed risk, but it should not influence the
performance of the risk assessment as such.
7.611 Indeed, whether a Member considers that its population should be exposed or not to a
particular risk, or at what level, is not relevant to determining whether a risk exists and what its
magnitude is. A fortiori , it should have no effect on whether there is sufficient evidence of the
existence and magnitude of this risk.
7.612 A risk-averse Member may be inclined to ta ke a protective position when considering the
measure to be adopted. However, the determinatio n of whether scientific evidence is sufficient to
assess the existence and magnitude of a risk mu st be disconnected from the intended level of
protection.
7.613 This is not to say, however, that we disagree with the European Communities that when the
body of evidence is in the process of moving from a st ate of sufficiency to a state of insufficiency a
Member should not be required "to demonstr ate positively the existence of clear harm." 734 In fact,
even when the scientific evidence is sufficient, a Member is not required, under the provisions of the
SPS Agreement, to "demonstrate positively the existence of a clear harm". Rather, the objective of a
risk assessment is to evaluate the potential for harm to occur unde r certain circumstances (e.g., from
the consumption of a foodstuff containing certain contaminants).
Can relevant scientific evidence become "insufficient"?
7.614 The United States notes, and the European Communities agrees, that the Appellate Body
clarified in Japan – Apples that relevant scientific evidence will be insufficient within the meaning of
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative
terms, the performance of an adequate assessment of risks as required under Article 5.1. According to
the United States, there is more than sufficient ev idence to allow performance of an adequate risk
assessment for the five provisionally banned hormones. 735 The United States ar gues that the relevant
question is not the specificity of the evidence relatin g to the five hormones, but whether the evidence
in toto permits the European Communities to c onduct a risk assessment for those hormones. 736 The
United States recalls that JECFA has performed risk assessments for the hormones at issue and
concludes that, in the case at hand, while any new studies could hypothetically affect the conclusion
of the risk assessment, their existence would not make the scientific evidence "insufficient" for
conducting such an assessment.737
7.615 The European Communities considers that Article 5.7 of the SPS Agreement is applicable
not only when no risk assessment can be made at all, but also when the latest scientific evidence from
any credible and objective source raises doubts or puts into question the previously held scientific
opinion about the safety or dangerous nature of the substance in question. 738 The European
Communities adds that the evid ence assessed by the SCVPH, while inconclusive in terms of
demonstrating a risk, does nonetheless point to the possible occurrence of certain adverse effects,
which invalidate or put into serious doubt prev iously held assumptions about the safety of these
hormones by the defending parties and Codex/JECFA. 739 The European Communities concludes that
serious doubt may exist when the pertinent availabl e evidence is contradictory, inconclusive or

734 EC's second written submission, para. 149.
735 US's first written submission, para. 124; US's second written submission , para. 28; EC's second
written submission, para. 134.
736 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 67.
737 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 68.
738 EC's replies to Panel questions after the first substantive meeting, question 67, Annex B-1.
739 EC's second written submission, para. 181.

incomplete.740 To guard against potential abuses, th e new evidence should not be arbitrary but
credible and should show that there is a genui ne scientific disagreement identified in a risk
assessment.
7.616 The European Communities further argues that, due to the dynamic nature of scientific
knowledge, a risk assessment that may at one point in tim e have been based on sufficient scientific
evidence may need to be reviewed when new scientific evidence becomes available. In addition, new
international risk assessment standards may become av ailable that have to be taken into account in
new risk assessments.741
7.617 The United States acknowledges that scientific evidence that at one point in time might be
sufficient to conduct a risk assessment could be insufficient at a later point, for example if a new
pathway for a risk came to light on which information was insufficient.
742 The United States recalls
that in the EC – Hormones case, the European Communities argued that its ban on all six hormones
was definitive, and that it was based on sufficien t scientific evidence. The United States considers
that nothing has occurred in the interim to render insufficient the scientific evidence on the safety of
residues of the five provisionally banned hormones in meat products as a result of the cattle being
treated with these hormones for growth promotion. According to the United States, studies completed
since the EC – Hormones case, including by JECFA, reaffirm earlier conclusions. 743 The United
States indicates that it did not uncover any new ev idence of risk when reviewing the European
Communities' 17 studies and other materials put forward by the European Communities.744
7.618 In response to this argument, the European Communities recalls that the Appellate Body
had found that what the European Communities ha d considered sufficient evidence was in fact
insufficient, and that this had been confirmed by risk assessment standards developed in the years
after the EC – Hormones ruling. The European Communities al so argues that the body of evidence
has developed in the meantime. While the evidence is still insufficient to carry out a "complete and
definitive risk assessment", it "supports the conclu sion that precautionary measures are required in
order to achieve its chosen level of protection".745
7.619 First, the Panel notes that parties agree to the fact that scientific evidence which was
previously deemed sufficient could subsequently beco me insufficient. Both parties agree that there
could be situations where new studies can affect the conclusion of existing risk assessments. The
United States considers, however, that in the case at hand the existence of such new studies would not
make the scientific evidence "insufficient" for conducting such an assessment.
7.620 The Panel agrees with the parties that there could be situations where existing scientific
evidence can be put in question by new studies and information. There could even be situations
where evidence which supported a risk assessment is unsettled by new studies which do not constitute
sufficient relevant scientific eviden ce as such to support a risk assess ment but are sufficient to make
the existing, previously relevant scientific evidence insufficient.746

740 EC's replies to Panel questions after the second substantive meeting, Annex C-1, para. 43.
741 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 268-273.
742 US's replies to Panel questions after the first substantive meeting, question 73, Annex B-3, para. 82.
743 US's first written submission, paras. 125-128.
744 US's second written submission para. 29; US oral statement at the second substantive meeting, 3
October 2006, para. 20.
745 EC's second written submission para. 137; EC's rep lies to Panel questions after the first substantive
meeting, question 19, Annex B-1, paras. 108-109.
746 See also Article 2.2 which provides that a sanitary measure must not be maintained without
sufficient scientific evidence except as provided for in paragraph 7 of Article 5. This seems to imply that the

7.621 Indeed, nothing in Article 5.7 prevents such an interpretation. We also note in this respect
that Article 2.2 foresees such a possibility when it mentions that sanitary measures must not be
"maintained without sufficient scientific evidence ex cept as provided for in paragraph 7 of
Article 5."747 The use of the word "maintained" read together with the reference to Article 5.7
suggests the possibility of an evolution from a situ ation of sufficient evidence to perform a risk
assessment to one where, in substance, a risk assessment can no longer be performed.
7.622 The Panel notes in this respect that a procedure is available for Codex members and observers
to request the inclusion of a particular compound fo r evaluation or re-evaluation on a "priority list"
that the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) communicates to
JECFA.
748 The European Communities refers to an exchange of letters between the European
Commission and Codex and JECFA regarding a postpone ment of the re-evaluation due to be carried
out by JECFA in 1999. 749 The European Communities seems to allege that there was a commitment
from Codex and JECFA to re-evaluate the hormones at issue once the studies commissioned by the
European Communities would be available. 750 However, this explanation was not confirmed by
Codex or JECFA. From the information communi cated by the representatives of Codex and JECFA
at the meeting of the Panel with scientific expert s, it appears on the cont rary that the European
Communities never actually requested Codex or JECF A to re-evaluate any of the hormones for which
risk assessments had been carried out by JECFA and standards adopted by Codex. The representative
of Codex stated that there was no record in the re ports of the CCRVDF of proposals, either from the
European Communities or from Member States of the European Communities to include the five
substances at issue in the priority list for re-evaluation by JECFA. 751 The representative of Codex
added that, even at the latest session of the CCRVDF in 2006, no such request had been made.752
7.623 Second, since the present situation is one where it is alleged that existing relevant scientific
evidence has become insufficient, it seems important to determine which circumstances could make
such existing evidence insufficient.
7.624 The Panel recalls that, in Japan – Apples, the Appellate Body found that:
" '[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. Thus, the
question is not whether there is sufficient evidence of a general nature or whether
there is sufficient evidence related to a speci fic aspect of a phytosanitary problem, or
a specific risk. The question is whether th e relevant evidence, be it 'general' or
'specific', in the Panel's parlance, is sufficient to permit the evaluation of the
likelihood of entry, establishment or spread of, in this case, fire blight in Japan."753

information relied upon under Article 5.7 may include evidence, including relevant scientific evidence and not
merely information, as long as that evidence remains insufficient.
747 Emphasis added.
748 Statement by Dr. Miyagishima, Codex representa tive, transcript of the Panel meeting with the
experts, Annex G, paras. 523-524.
749 Exhibit EC-63.
750 EC statement, Transcript of the Panel meeting with the experts, Annex G, para. 527.
751 Statement by Dr. Miyagishima, Codex representa tive, transcript of the Panel meeting with the
experts, Annex G, para. 524.
752 Statement by Dr. Miyagishima, Codex representa tive, transcript of the Panel meeting with the
experts, Annex G, para. 529.
753 Appellate Body Report on Japan – Apples, para. 179.

7.625 We also note that in EC – Approval and Marketing of Biotech Products, the panel stated that:
"[I]t must be determined on a case-by-case basis whether the body of available
scientific evidence is insufficient to permit the performance of a risk assessment."
7.626 We agree with the EC – Approval and Marketing of Biotech Products panel and we will base
our assessment on the evidence submitted by the parties in this case, having regard to the views of the
experts on each issue.
7.627 This said, the Panel believes that it needs to determine under which circumstances relevant
scientific evidence may more particularly be deemed "insufficient" in this case.
7.628 The Panel first reads the first sentence from the extract of the Appellate Body report in Japan
– Apples quoted above as meaning that relevant scientific evidence will be deemed insufficient within
the meaning of Article 5.7 if the relevant scientif ic evidence does not make it possible to complete a
risk assessment on which a san itary measure can be based in substance . It is always possible to
perform the four successive steps of a risk assessment as defined by Codex and ultimately reach the
conclusion that relevant scientific evidence is in sufficient (as the European Communities did in the
case of the five hormones in respect of which it appli es a provisional ban). However, the fact that the
Codex four steps can be formally completed does not mean that such a process is equated with a risk
assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement. There will be a
risk assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement when the
assessor has analysed fully the potential for the identified adverse effects to arise from the presence of
the substance at issue in food, beverages, or foodstu ffs. We believe that this was the intention of the
Appellate Body when it used the term adequate754 in "adequate assessment of risks as required under
Article 5.1 and as defined in Annex A to the SPS Agreement." This is confirmed by the second
sentence of Article 5.7 which provides that "Member s shall seek to obtain the additional information
necessary for a more objective assessment of risk." 755 In other words, Article 5.7 will apply in
situations where, in substance, the relevant sci entific evidence does not allow the completion of an
objective evaluation of the potential for adverse effe cts on human or animal health arising from the
presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or
feedstuffs.
7.629 While this gives a general idea of the circum stances under which Article 5.7 may be invoked,
we should strive to ascertain more precisely the scope of "insufficient", if possible. In doing that, we
should keep in mind that Article 5.7 operates as a qualified exemption from the obligation under
Article 2.2 not to maintain SPS measures without sufficient scientific evidence and that an overly
broad and flexible interpretation of that obligation would render Article 5.7 meaningless.756
7.630 As a first step, we note that, in Japan – Apples , the Appellate Body seemed to consider that
relevant scientific evidence is insufficient if, irrespec tive of the quantity of evidence available, it has
not led to reliable or conclusive results. 757 It also seems that evidence providing unreliable or
inconclusive results should not be confused with "scientific uncertainty", as it appears from the
following Appellate Body statement in Japan – Apples:

754 "commensurate in fitness, sufficient, satisfactory" (The Shorter Oxford English Dictionary, fifth ed.,
2002, p. 26).
755 Emphasis added.
756 Appellate Body Report on Japan – Agricultural Products II, para. 80.
757 Appellate Body Report on Japan – Apples, para. 185:

"We do not read the Panel's interpretation as ex cluding cases where the available evidence is
more than minimal in quantity, but has not led to reliable or conclusive results."

"The application of Article 5.7 is trigge red not by the existence of scientific
uncertainty, but rather by the insufficiency of scientific evidence. The text of
Article 5.7 is clear: it refers to 'cases where relevant scientific evidence is
insufficient', not to 'scientific uncer tainty'. The two concepts are not
interchangeable."
758
7.631 We understand this statement to mean that th e existence of scientific uncertainty does not
automatically amount to a situation of insufficiency of relevant scientific evidence. In other words,
the fact that a number of aspects of a given scien tific issue remain uncerta in may not prevent the
performance of a risk assessment. First, we shoul d exclude theoretical uncertainty, which is the
uncertainty that always remains because science can never provide absolute certainty about the safety
of a given substance. In EC – Hormones, the panel and the Appellate Body concurred in agreeing that
theoretical uncertainty was not the kind of risk to be assessed under Article 5.1. 759 In the Panel's
view, theoretical uncertainly therefore should also not determine the applicability of Article 5.7.
7.632 Second, we note that in EC – Hormones , the Appellate Body stated that the presence of
divergent views on an issue could be a form of scientific uncertainty. 760 We nevertheless note that
scientific uncertainty may be factored into the conclusions of the risk assessment. We find support for
this conclusion in the following comment of the Appellate Body in Australia – Salmon:
"We might add that the existence of unknown and uncertain elements does not justify
a departure from the requirements of Article s 5.1, 5.2 and 5.3, read together with
paragraph 4 of Annex A, for a risk assessment."761
7.633 This issue was further addressed by the panel in EC – Approval and Marketing of Biotech
Products, which acknowledged that the conclusions of a risk assessment may not be free from
uncertainties or other constraints even though ther e was sufficient relevant scientific evidence to
perform the risk assessment.762 The panel, in agreement with the Appellate Body in EC – Hormones,
found "that such uncertainties may be legitimately ta ken into account by a Member when determining
the SPS measure, if any, to be ta ken" and that the scientific uncer tainties present in a risk assessment
may support a range of possible measures and within the range of measures reasonably supported by
the risk assessment and consistent with other applicable SPS Agreement provisions, the Member was
entitled to choose one that best protects human health and/or the environment. 763 As recalled by the
panel in EC – Approval and Marketing of Biotech Products , Members were also justified in taking
into account factors like a limited body of releva nt scientific evidence, assumptions and other
constraints that would affect the level of confidence in the risk assessment:
"We consider that if there are factors which affect scientists' level of confidence in a
risk assessment they have carried out 764, a Member may in principle take this into
account in determining the measure to be applied for achieving it s appropriate level
of protection from risks. 765 Thus, there may conceivably be cases where a Member

758 Appellate Body Report on Japan – Apples, para. 184.
759 Appellate Body Report on EC – Hormones, para. 186.
760 Appellate Body Report on EC – Hormones, para. 194.
761 Appellate Body Report on Australia – Salmon, para. 130.
762 Panel Report on EC – Approval and Marketing of Biotech Products, para. 7.1525.
763 Panel Report on EC – Approval and Marketing of Biotech Products, para. 7.1525.
764 (footnote original) E.g., a limited body of relevant scientific evidence may be such a factor.
765 (footnote original) This view is consistent with risk asse ssment techniques established by relevant
international organizations. For instance, the Working Principles for Risk Analysis for Application in the
Framework of the Codex Alimentarius state that "[t]he report of the ri sk assessment should indicate any
constraints, uncertainties, assumptions and their impact on the risk assessment. Minority opinions should also
be recorded. The responsibility for resolving the impact of uncertainty on the risk management decision lies

which follows a precautionary approach, an d which confronts a risk assessment that
identifies uncertainties 766 or constraints, would be justified in applying (i) an SPS
measure even though another Member might not decide to apply any SPS measure on
the basis of the same risk assessment, or (ii) an SPS measure which is stricter than the
SPS measure applied by another Member to address the same risk".
767
7.634 The panel explicitly recognized that, even thoug h scientific uncertainty existed, there could
still be sufficient scientific evidence to perform a risk assessment.768
7.635 We note in this respect the comments of Dr. Boisseau and Dr. Boobis before the Panel on
how scientific uncertainty is addressed in risk assessment.769

with the risk manager, not the risk assessors". Codex Alimentarius Commission, Working Principles for Risk
Analysis for Application in the Framework of the Codex Alimentarius (adopted in June/July 2003), Section III,
Codex Procedural Manual, 14 th edition, 2004, para. 25. Along similar lines, the Codex Principles for the Risk
Analysis of Foods Derived from Modern Biotechnology state that "[r]isk managers should take into account the
uncertainties identified in the risk assessment and implement appropriate measures to manage these
uncertainties". Codex Alimentarius Commission, Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology (adopted in June/July 2003), CAC/GL 44-2003, para. 18. Similarly, the IPPC's ISPM
#11 (2001) states in relevant part that "[t]he uncertainty noted in the assessments of economic consequences and
probability of introduction should also be considered and included in the selection of a pest management
option". IPPC, ISPM #11: Pest Risk Analysis for Quarantine Pests , April 2001, para. 3. The quoted passage
stayed the same in the 2004 version of ISPM #11, which applies specifically to living modified organisms.
766 (footnote original) We are not referring here to the theoretical uncertainty which inevitably remains
because science can never provide absolute certainty th at a product will never have adverse effects on human
health or the environment. The Appellate Body has made it clear that this theoretical uncertainty is not the kind
of risk which is to be assessed under Article 5.1. Appellate Body Report on EC – Hormones, para. 186.
767 Panel Report on EC – Approval and Marketing of Biotech Products Products, para. 7.3065.
768 Panel Report on EC – Approval and Marketing of Biotech Products Products, para. 7.1525.
769 See replies of Dr. Boisseau and Dr. Boobis to question 12 of the Panel, Annex D, paras. 123-128.

Dr. Boisseau expressed the following views:

"In assessing the risk for human health associ ated with the exposure to veterinary drug
residues, JECFA adresses the scientific uncertainty by using the safety factors listed above in
my reply to the question n°8 describing, among others, how JECFA builds a margin of safety
into its final recommendations.

For the hormonal growth promoters, JECFA has considered that, given the quality and the
quantity of the available data, it was possible to carry out a complete quantitative risk
assessment. For establishing ADIs and MRLs fo r the three synthetic hormones, melengestrol,
trenbolone and zeranol, JECFA has implemented the usual procedure regarding the safety
factors. For the three natural hormones, oestradiol-17 β, progesterone and testosterone,
JECFA has decided that the margin of safety deriving from the values of the established ADIs
and from a maximum estimated intake of residue was such that it was not necessary to set up
MRLs.

For oestradiol-17β, the European Communities did not consider any scientific uncertainty as it
decided that it was not possible, for reason of principle, to establish an ADI for a genotoxic
compound. For the five other hormones at issue, the European Communities did not really
consider any scientific uncertainty as it decided that the available data were too limited to
allow a complete quantitative risk assessment to be carried out."

Dr. Boobis mentioned the following:
"Scientific uncertainty is dealt with in a variety of ways in risk assessment. ...

7.636 We find further support for this position in the view of the Appellate Body as expressed in
Japan – Apples that whether relevant scientific evidence is insufficient must be assessed "not in the
abstract, but in the light of a particular inquiry".770
7.637 While we agree that under certain circumstan ces what was previous ly sufficient evidence
could become insufficient, we do not believe that the existence of scientific uncertainty means that
previously sufficient evidence has in fact become insufficient nor should it ipso facto justify the
applicability of Article 5.7 of the SPS Agreement.
Relationship between insufficiency of the evid ence and the existence of an international
standard
7.638 The United States considers that international standards serve as an indicator that evidence is
sufficient to conduct a risk assessment, but since Memb ers may be able to react more quickly to new
information than international standard setting bodies , the existence of international standards is not

One way of dealing with uncertainty is to defa ult to the worst case in the absence of evidence
to the contrary. Hence, the most sensitive relevant endpoint in the most sensitive species is
used as the basis of the risk assessment. In extrapolating to humans a default factor of 10 is
used to allow for species differences, which a ssumes that humans are more sensitive than the
experimental species. A further factor of 10 is included for interindividual differences. These
differences may be due to gender, genetics, life stage or other factors. However, to some
extent such differences have already been taken into account in the choice of endpoint, as this
will usually represent the most sensitive lifestage, gender and to some extent genetics by using
data from the most sensitive species. Where th ere are additional uncertainties, such as no
NOEAL or the absence of a non-critical study, an additional safety factor will be included,
and this is almost always conservative, as when the data gaps have been completed, the
appropriate safety factor is almost always less th an that used to account for these data gaps.
The residue may be assumed to be all as active as the most active moiety, which is almost
always a conservative assumption. Dietary intake is based on conservative data for food
consumption. It is also assume d that all meat that could contai n veterinary drug residue will
contain the residue and that this will be present at the high end of the range (MRL or other
appropriate level). In respect of the ADI, the assumption is that intake will be at this high
level for a lifetime, when in reality there will be occasions when little or no meat is consumed
or that which is consumed contains less or ev en no residue. In their risk assessment of the
hormones, JECFA applied all of these approaches to dealing with the uncertainty.

In dealing with scientific uncertainty much depends on the expert judgment of the risk
assessor. Issues such as biological cohere nce, whether effects ar e considered compound
related, relevance to humans, the reliability of model systems at predicting effects in vivo all
impact on the interpretation of the data. Within the EU, it is clear that there are also
differences in the interpretation of data, as illustrated by the differing conclusions of the
CVMP (1999) and the SCVPH (1999). In part, the EC assessment of the hormones did not go
as far as including some of the considerations for uncertainty used by JECFA because of the
conclusion that there was insufficient informati on to determine whether there was a threshold
for the carcinogenic effects. However, for some of the compounds this was based on the
results of a small number of non-standard tests of genotoxicity, with equivocal of very weak
responses. It is not clear whether the EC app lied a weight of evidence approach to evaluating
the genotoxicity of all of the compounds, taking account the totality of the available data, as
was the case by JECFA."
770 Appellate Body Report on Japan – Apples, para. 179. See also Panel Report on EC – Approval and
Marketing of Biotech Products , where the Panel "agree[ed] that it must be determined on a case-by-case basis
whether the body of available scientific evidence is insufficient to permit the performance of a risk assessment."
(para. 7.3238).

dispositive under Article 5.7.771 Although there can be situations wh ere there is insufficient scientific
information for a Member to perform a risk assessment even when an international standard exists, in
this case international standards and a significant body of scientific studies exist on the risks posed by
each of the five hormones, including the JECFA reports and the studies cited therein. According to
the United States, it would therefore in this case be very difficult to demonstrate that scientific
evidence concerning the hormones at issue is insufficient in the context of Article 5.7.
772
7.639 The United States argues that JECFA and several national regulatory bodies have determined
that the scientific evidence regarding the five pr ovisionally banned hormones is sufficient, and have
completed risk assessments on this basis. Accordi ng to the United States, the European Communities
fails to support its argument that the evidence is insufficient to complete a risk assessment with
scientific evidence demonstrating risks to consumer s from the five hormones when used for growth
promotion purposes according to good veterinary practices.
7.640 The European Communities notes that the United States ac knowledges that there can be
situations where there is insuffi cient scientific information even though a relevant international
standard exists. Contrary to the United States, th e European Communities believes this to be the case
for the five provisionally banned hormones. 773 In addition, the Europ ean Communities argues that a
Member may disagree with the risk assessment underl ying an international standard for scientific
reasons and, in particular, on the issue of whethe r the scientific evidence relied upon is sufficient.
Such a disagreement may result from the fact that in order to meet a higher level of protection, a
Member may require more information than that provided for the development of the international
standard.774
7.641 The European Communities further argues that th e relevant Codex standards on four of the
five provisionally banned hormones are not capable of achieving the chosen high level of protection
of the European Communities. According to th e European Communities, the overall evidence and
recent scientific developments have now "tipped th e balance against the previously held assumption
(by the defending parties and Codex/JECFA) that residues of these hormones in meat from animals
treated for growth promotion pose no risk to human health". The European Communities argues that
the evidence which served as the b asis for the 1999-2000 JECFA eval uations is not sufficient "to
perform a definitive risk assessment within the meaning of Article 5.7, 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".
775
7.642 Referring to the way in which JECFA addresses sci entific uncertainty through safety factors,
the European Communities states that there is "almos t universal agreement that this approach is not
scientifically correct". According to the European Communities, a state of uncertainty may result
from a number of factors including lacking, incomplete or contradictory data; the quality of the data is
more important than the quantity. An issue thought to be clear can become uncertain as more data
become available. The European Communities argues that if uncertainty is understood in this sense, it
cannot be addressed through safety factors, especially for countries applying a high level of health
protection.776

771 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 82.
772 US's replies to Panel questions after the first substantive meeting, Annex B-3, para. 81.
773 EC's second written submission, paras. 133-136.
774 EC's replies to Panel questions after the first substantive meeting, Annex B-1, para. 266.
775 EC's second written submission, para. 149; EC's rep lies to Panel questions after the first substantive
meeting, question 31, Annex B-1, paras. 167-172.
776 EC's comments on experts replies to Panel question 12, Annex F-1.

7.643 Having regard to the arguments of the parties, the Panel deems it important to recall that
international standards, guidelines or recommendations exist with respect to four out of the five
hormones at issue in this section. 777 The Panel notes in this respect the important role given to
international standards, guidelines or recommendations by the SPS Agreement.778 We also note that
Article 3.2 of the SPS Agreement reads as follows:
"Sanitary or phytosanitary measures whic h conform to international standards,
guidelines or recommendations shall be deem ed to be necessary to protect human,
animal or plant life or health, and presume d to be consistent with the relevant
provisions of this Agreement and of GATT 1994."
7.644 The presumption of consistency of measures conforming to international standards, guidelines
and recommendations with the relevant provisions of the SPS Agreement implies that these standards,
guidelines or recommendations, particularly those referred to in this case, are based on risk
assessments that meet the requirements of the SPS Agreement. This means, therefore, that there was
sufficient evidence for JECFA to undertake the appropriate risk assessments.
7.645 As mentioned above, the Panel is also mindful that science continuously evolves. It cannot be
excluded that new scientific evidence or information call into question existing evidence. Likewise, it
cannot be excluded that different risk assessments reach different interpretations of the same scientific
evidence.
7.646 Yet, some meaning has to be given to the role assigned by the SPS Agreement to international
standards, guidelines and recommendations, even though the rights of Members under Article 3.3
should be acknowledged 779, and this should not lead to the im position of a special or generalized
burden of proof upon the European Communities.780

777 For melengestrol acetate, the situation is as follows: JECFA concluded its evaluation of MGA at its
sixty-sixth meeting in Rome on 22-28 February 2006 and proposed MRLs. These MRLs were considered by
CCRVDF in 2006, but because there was no consensus for their adoption, the CCRVDF agreed to consider
them again at its session in 2007. (For more detail, incl uding references to relevant Codex and JECFA reports,
see Annex E-1, p. 103 and Annex E-2, p. 116). Annex A, paragraph 3 of the SPS Agreement defines
international standards, guidelines and recommendations for food safety as follows:

"International standards, guidelines and recommendations

(a) for food safety, the standards, guidelines and recommendations established by the Codex
Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants,
methods of analysis and sampling, and codes and guidelines of hygienic practice".
778 See Article 3.1 of the SPS Agreement, which reads as follows:

"To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base
their sanitary or phytosanitary measures on internati onal standards, guidelines or recommendations, where they
exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3." (Emphasis added)
779 See Appellate Body Report on EC – Hormones, para. 172. Article 3.3 of the SPS Agreement reads
as follows:

"Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level
of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international
standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of
sanitary or phytosanitary protection a Member determines to be appropriate in accordan ce with the relevant
provisions of paragraphs 1 through 8 of Article 5. Notwithstanding the above, all measures which result in a
level of sanitary or phytosanitary protection different from that which would be achieved by measures based on

7.647 As a result, we consider that, in order to properly take into account the existence of
international standards, guidelines and recommendations in this case, our approach should be to assess
whether scientific evidence has become insuffi cient by determining whether the European
Communities has produced any evidence of some sufficient change in the scientific knowledge so that
what was once sufficient to perform an adequate ri sk assessment has now become insufficient (i.e.,
"deficient in force, quality or amount"). 781 In this respect, suggesting hypothetical correlations or
merely arguing that there could be more evidence on one concern or another should not be deemed
sufficient to successfully claim that relevant scientific evidence has become insufficient. Indeed, more
studies can always be performed and there can always be more evidence. We note in this regard that
the European Communities shares our position in its second written submission, where it makes a
"brief description of insufficiency of pertinent scientific information for all five hormones (except
oestradiol-17β)". We interpret the use of the word "pertin ent" and not "relevant" as in Article 5.7 as
meaning that the European Comm unities agrees that not any insufficiency of relevant scientific
evidence would make the performance of a risk assessment impossible. Indeed, "insufficiencies in the
evidence" does not necessarily equal "insufficient evidence" to do a risk assessment, as recalled
above. Moreover, as mentioned by the Appellate Body in EC – Hormones , risk assessments do not
need to be based on "monolithic" evidence.
Conclusion
7.648 We therefore conclude that if relevant evidence already exists, not any degree of insufficiency
will satisfy the criterion under Article 5.7 that "rel evant scientific evidence is insufficient". Having
regard to our reasoning above, particularly with resp ect to scientific uncertain ty and the existence of
international standards, we consider that, depending on the existing relevant evidence, there must be a
critical mass of new evidence and/or information that calls into question the fundamental precepts of
previous knowledge and evidence so as to make relevant, previously sufficient, evidence now
insufficient.782 In the present case where risk assessments have been performed and a large body of
quality evidence has been accumulated, this would be possible only if it pu t into question existing
relevant evidence to the point that this evidence is no longer suffici ent to support the conclusions of
existing risks assessments. We therefore need to determine whether this is the case here.
(v) Alleged insufficiencies which should be addressed by the Panel
7.649 The European Communities argues that the most important gaps in the evidence are related
to carcinogenicity, genotoxicity, dose-response and l ack of safe thresholds, endogenous production of
hormones by pre-pubertal children, lack of reliable bioavailability data, possibilities of abuse and lack

international standards, guidelines or recommendations shall not be inconsistent with any other provision of this
Agreement." (original footnote omitted)
780 Appellate Body Report on EC – Hormones, para. 102. Regarding the allocation of burden of proof
in relation to the SPS Agreement in this case, see paras. 7.380-7.386 above.
781 The New Shorter Oxford English Dictionary (1993), p. 1384.
782 In its second written submission, at para. 149, the European Communities refers to the long latency
period of cancer and the numerous confounding factors to claim that it may not be in a position to demonstrate
the existence of a clear harm in case of cancer because of the long latency period and the numerous confounding
factors that play a role in the development of cancer. We understand this argument to mean that we should
accept the "new scientific reality" referred to by the European Communities as c onstituting a situ ation where
relevant scientific evidence has become insuffic ient within the meaning of Article 5.7 of the SPS Agreement.
We do not consider that our test amounts to reque sting that the European Communities demonstrate the
existence of a clear harm in order for Article 5.7 to apply to its measure. Under the "critical mass" test, the new
scientific information and evidence must be such that they are at the origin of a change in the understanding of a
scientific issue.

of control. In addition, the European Communities maintains that since the latest SCVPH assessment,
new scientific developments further support SCVPH conclusions.783
7.650 According to the United States, the experts' responses confirm the following points regarding
the scientific evidence relating to the six hormone s: (a) each hormone has been used for growth
promotion purposes in cattle and evaluated for a su fficient period of time with no evidence of adverse
effects to address concerns related to long latency periods of cancer; (b) epidemiological studies cited
by the European Communities do not identify a lin k between cancer and hormone residues in meat;
(c) the European Communities has failed to demonstr ate a risk to sensitive populations; and (d) the
European Communities has failed to demonstrate "oth er risks" to human health from consumption of
hormone residues in meat from cattle treated for growth promotion purposes, such as effects on the
immune system.784
7.651 At this juncture, the Panel deems it appropriate to recall th at parties have submitted a large
amount of materials which was often very intricate and complex. The Panel believes that, as part of
its obligations to make an objective assessment of the matter before it, including an objective
assessment of the facts pursuant to Article 11 of th e DSU, it had to devise an approach which would
allow it to address the issues on which insufficiencies were alleged in a clear and transparent manner.
7.652 Whereas, in application of the burden of proof in relation to Article 5.7 of the SPS Agreement,
it should be for the party challenging the applicability of Article 5.7 to make a prima facie case that
the relevant scientific evidence regarding the five hormones is sufficient 785, it is also for the European
Communities, in application of the principle that it is for each party to prove its allegations, to support
its own allegations with a ppropriate evidence. This also has to be considered in the light of the fact
that, even though in this case the European Communiti es is the complainant, it also argues as part of
its allegations under Article 22.8 of the DSU that its implementing measure complies with Article 5.7
of the SPS Agreement. Moreover, we recall the consequence of the presumption of consistency with
the SPS Agreement and GATT 1994 of measures which conform to international standards, guidelines
and recommendations on the risk assessmen ts on which such measures are based. 786 Since, in that
context, the European Communities argues that the relevant scientific evidence is insufficient, we
consider that it is for the European Communities to identify the issues for which such evidence is
insufficient.
7.653 Therefore, we do not consider that, as Pane l, we have any obligation to go beyond the
insufficiencies identified by the European Communiti es. We recall that we are neither equipped, nor
supposed to make a de novo review of the scientific evidence rega rding the hormones at issue. Under
the circumstances, we deem it appropriate to limit our review exclusively to the "insufficiencies"
expressly identified by the European Communities in its submissions to the Panel.
7.654 We note that, in its second written submission, the European Communities considers that the
scientific evidence on which JECFA and Codex relied is insufficient with respect to the following
issues: (a) carcinogenicity; (b) hormones daily produc tion rate, in particular in pre-pubertal children;

783 EC's second written submission, paras. 143-144.
784 US's comments on experts' replies to Panel questions, Annex F-4, para. 56 (more detail on each
point may be found in paras. 57-87).
785 See Appellate Body Report in Japan – Agricultural Products II , para. 80; Panel Report in Japan –
Agricultural Products II, para. 8.13 ; Panel Report in EC – Approval and Marketing of Biotech Products ,
paras. 7.2969-7.2979.
786 See paras. 7.643-7.647.

(c) dose response and lack of a safe threshold; (d) bioavailability; and (e) misuse or abuse (misplaced
implants, off-label use, black market drugs, etc.)787
7.655 The European Communities also inserted in its re plies to the first series of questions of the
Panel and in its second written submission extensive portions of the 1999 and 2002 Opinions.788
7.656 In other words, the European Communities made its own description of the issues with
respect to which it believes that evidence is insu fficient and added quotations in support of its
allegations. These passages also identify insufficiencies.
7.657 A number of issues discussed by the Europ ean Communities as part of the arguments
contained in its submissions seem to overlap with the issues identified in the portions of the Opinions
quoted by the European Communities. However, a number of specific issues identified in the
quotations are simply not directly discussed by the European Communities in its submissions.
7.658 We believe that it is incumbent upon a party ma king a particular allegation to identify in its
submissions the relevance of the evidence on which it relies to support its arguments. 789 We consider
that, for some of the issues identified in the Opin ions, this was not the case. The Opinions were
obviously quoted by the European Communities as ev idence of the insufficiencies it has identified in
its Opinions. However, the European Communiti es, while stating that the Opinions identified
relevant issues, basically left it to the Panel to find out on its own the relevance of certain issues
identified in the quotations for the question whethe r relevant scientific evidence was insufficient or
not.790
7.659 The Panel is therefore of the view that, in light of its functions under the DSU, it should limit
its review of alleged insufficiencies in the relevant scientific evidence to those specifically discussed
by the European Communities in its submissions. It will only address the issues identified in the
Opinions to the extent they are sufficiently related to an issue discussed by the European
Communities.
7.660 A second question relates to the fact that, even when a particular insufficiency was
specifically discussed by the European Communities, elements were not always available to address
this insufficiency on a hormone-specific basis. The arguments and generally the information
presented to the Panel were not always specific en ough to permit this. In spite of our repeated
requests, several questions were addressed by the par ties or the experts in general terms, rather than
specifically for each of the five hormones, thus making an assessment of particular issues hormone-
by-hormone sometimes impossible.
7.661 Under the circumstances, the Panel decided:
(a) first, to address the insufficiencies as identified and discussed by the European
Communities in its arguments and only to the extent evidence had been submitted by
the parties in relation to them. This appro ach is, in our opinion, consistent with the
requirement identified by the Appellate Body in its report on Japan – Agricultural

787 We have already explained in para. 7.603 why we do not believe that abuse or misuse is an issue of
insufficency of relevant evidence. To the extent necessary for our finding, this issue has been addressed in
para. 7.483.
788 See EC's reply to questions 22 and 30 of the questions of the Panel after its first substantive
meeting, Annex B-1, and paras. 153-172 of the EC's second written submission.
789 See Appellate Body Report in Canada – Wheat Exports and Grain Imports, para. 191.
790 See Appellate Body Report on US – Gambling, para. 140.

Products II that panels refrain from "making a case" for one party in the absence of a
prima facie case by that party;791
(b) second, to address some concerns aggregately fo r all of the five hormones at issue, to
the extent that information was not submitted on an hormone-specific basis, or to the
extent an issue was raised with respect to all hormones, but evidence submitted only
for one or two of them; and
(c) third, to address individually for each hormone the issues for which specific
information on that hormone was provided to the Panel.
7.662 For these reasons, we have decided to address first, in a "common issues" section, the
insufficiencies which were not addressed by the pa rties and the experts in a hormone-specific manner
(i.e. those for which arguments or evidence were not hormone-specific), or which were not addressed
specifically enough to justify a separate analysis for each of the hormones concerned. At a second
stage, we address for each hormone the alleged insu fficiencies which have been discussed in relation
to that hormone and for which arguments and evidence were specifically provided.
(vi) Issues common to all five hormones for which evidence was not provided on a hormone-
specific basis
Introduction

7.663 We note that, despite our insistence that in formation be provided for each of the five
hormones at issue, arguments, information and opini ons have sometimes addressed all or part of the
scientific evidence on these hormones together. As a r esult, in this section, we will address the issues
that were specifically discussed by the European Communities in these proceedings in relation to all
five hormones in general regarding their use as growth promoters in cattle. More particularly, we will
address:
(a) the effects of hormones on certain categories of population, such as pre-pubertal
children;
(b) dose response;
(c) bioavailability;
(d) the EC claim that the long latency period of cancer makes it more difficult to
demonstrate insufficiency of the relevant evidence regarding the carcinogenicity of
the hormones at issue;
(e) the impact of the five hormones at issue on the immune system, and
(f) the impact of the five hormones at issue on development and reproduction.
Effects of hormones on certain categories of population
7.664 Regarding the effect of the hormones at issu e on certain categories of populations, we note
that the European Communities refers to the conclu sions contained in the Opinions. We recall that
the 1999 Opinion mentions that prepubertal and postmenopausal women and prepubertal and adult
men have the lowest levels of endogenous oestrogens and progest erone and thus would represent the

791 See Appellate Body Report on Japan – Agricultural Products II, para. 129.

individuals most likely to be at increased risk for the adverse health effects that might be associated
with exposure to exogenous sour ces of oestrogens. Likewise, the 1999 Opinion provides that all
women and prepubertal men represent the individuals at greatest risk for adve rse health effects that
might be associated with exposure to exogenous sources of testosterone.
7.665 The 1999 Opinion specifies that the hormone le vels on which it relies were determined by
radio-immunoassays (RIA) and that the use of th ese assays has frequently been associated with
production of variable results, particularly when used to detect low levels of endogenous hormones.
The 1999 Opinion notes that Klein et al. (1994) developed an ultrasensitive assay (100-fold more
sensitive than RIAs) which identifie d values of oestradiol considerably lower than the range of
oestradiol levels found through RIAs for prepubertal children. The 1999 Opinion concludes that "[a]
corollary is that perhaps the hormone residues in beef, which are also low and which have been
determined by RIA are equally variable a nd over representative of the actual hormones
concentration." The 1999 Opinion concludes that this is a critical area requiring additional study.792
7.666 We recall our test regarding insufficiency of relevant evidence in this case, i.e. that there must
be a critical mass of new eviden ce and/or information that calls into question the fundamental
precepts of knowledge and evidence so as to make relevant, previously sufficient, evidence now
insufficient. In that context, we believe that the question before us is whether the more sensitive
detection methods which identified lower hormonal levels in pre-pubertal children than thought until
now are such as to call into question the range of physiological levels of the sex hormones in humans
currently believed to exist.
7.667 Dr. Sippell specified that:
"There is no doubt that the development of an ultrasensitive recombinant cell
bioassay (RCBA) of E 2 by Karen Klein, Gordon Cutler and co-workers at the N.I.H.
in Bethesda, USA (Klein et al 1994) represented a quantum leap in E 2 assay
methodology. It opened a new door on our understanding of basic physiological
phenomena, e.g. why normal puberty starts so much earlier in girls than in boys or
why bone maturation in children differs so much between the sexes. The validity of
the N.I.H.-RCBA has now been confirmed by another RCBA of E 2 which was
developed by Charles Sultan's group at the University of Montpellier, France (Paris et
al 2002). Unfortunately, the complexity of the RCBA so far prevents its wider use
for routine measurements in small serum samples from infants and prepubertal
children."793
7.668 We also note Dr. Sippell's statement that "[t]he risk to children arising from hormones which
are naturally present in meat as compared to that from residues of hormonal growth promoters has, to
my knowledge, been estimated for E 2 [i.e., oestradiol-17β] only and only in beef (Daxenberger et al.
2001)."794

792 The 2002 Opinion refers to a new method to detect trace amounts of hormones in meats and to three
complementary bioassays involving different recombinant-DNA technology for screening and determination of
oestrogenic potency of substances used as growth promoters (2002 Opinion, p. 9). The Panel nonetheless
understands that these method and bioassays address a different issue than the identification of endogenous
levels of hormones in humans.
793 Reply of Dr. Sippell to question 40 of the Panel, Annex D, para. 328.
794 Reply of Dr. Sippell to question 41 of the Panel, Annex D, para. 335.

7.669 We recall the statement of the 2000 Opinion referring to novel techniques in chemical
analysis 795 but mentioning that "additional time will be required to validate and apply this
methodology in a reliable, accepted fashion before a re-evaluation of this issue can be conducted." 796
This opinion is confirmed by Dr. Boobis. 797 Dr. Boobis expressed additional concerns about the
validity of the Klein et al. (1994) study:
"There is certainly some evidence that e ndogenous levels of hormones in children are
lower than previously thought. However, th e suggestion that this is by orders of
magnitude is not substantiated by the data. One group has reported very low levels of
oestradiol in male children, 0.08 pg/ml (Klein et al, 1994), but in a later study (Klein
et al, 1998), the same group reported mean levels somewhat higher, at 0.27 pg/ml.
The reliability of the Klein et al assay h as yet to be determined. The assay is
particularly sensitive to oestradiol, but th ere is no obvious explanation for this, as it
relies upon affinity for the oestrogen receptor. Diethylstilbestrol is a potent oestrogen
yet is much less sensitive than oestradiol in the assay. Klein et al (1994) have
reported that there are unidentified factors in plasma and in blood collection tubes
that can interfere in the assay. In c ontrast, using a similar yeast-based assay,
Coldham et al (1997) found that oestradiol and DES had similar potency, and others
have found that, if anything, DES is more potent than oestradiol in such assays
(Folmer et al, 2002). At the very least, this shows that results with the yeast reporter
assay are not consistent, and use of such data in risk assessment requires that the
assay be adequately validated.798
However, there are studies from two other gr oups using more specific methods than
the original radioimmunoassay, reporting that le vels were somewhat higher than this.
Ikegami et al (2001) used a very sensitive, 2-stage immunoassay technique. This was
shown to be specific and sensitive. In th is assay, mean levels of oestradiol in
prepubertal males were 1.85 pg/ml (6.8 pmol/ml). Paris et al (2002) used a
recombinant oestrogen receptor assay in a ma mmalian cell line, a similar principle to
the assay of Klein et al. In this study, estogenic levels in prepubertal males were
found to be 1.44 pg/ml. There are many issues affecting such measurements. These
include the presence of binding proteins, rela tive specificity and sensitivity. None of
the assays is entirely specific for oestradi ol. Both the oestrogen receptor and the

795 Results of "hormone" residue analyses of bov ine meat and liver imported into the EU and
originating from the USA "Hormone Free Cattle Program" analysis – First Interim Report, May 1999 –
R.W. Stephany and F. André (rapporteurs).
796 2000 Opinion, p. 3.
797 Transcript of the Panel meeting with the experts, Annex G, para. 572.
798 Dr. Boobis' reply to question 40 of the Panel, Annex D, para. 324. Dr. Boobis cites to:

Coldham NG, Dave M, Sivapathasundaram S, McDonnell DP, Connor C and Sauer MJ
(1997). Evaluation of a recombinant yeast ce ll estrogen screening assay. Environ Health
Perspect, 105:734-742
Folmar LC, Hemmer MJ, Denslow ND, Kroll K, Chen J, Cheek A, Richman H, Meredith H
and Grau EG (2002). A comparison of the estrog enic potencies of estradiol, ethynylestradiol,
diethylstilbestrol, nonylphenol and methoxychlor in vivo and in vitro. Aquat Toxicol,
60:101-110
Klein KO, Baron J, Colli MJ, McDonnell DP and Cutler GB Jr (1994). Estrogen levels in
childhood determined by an ultrasensitive recombinant cell bioassay. J Clin Invest,
94:2475-2480
Klein KO, Baron J, Barnes KM, Pescovitz OH and Cutler GB Jr (1998). Use of an
ultrasensitive recombinant cell bioassay to determ ine estrogen levels in girls with precocious
puberty treated with a luteinizing hormone-re leasing hormone agonist. J Clin Endocrinol
Metab, 83:2387-2389

antibodies used could cross-react with st ructurally relayed compounds. Depending
on how the assay is performed, protein bind ing could reduce the concentration of
hormone detectable in the assay by sequestering hormone from the assay target.
However, it should be noted that whilst binding to protein in plasma my reduce
clearance it will also reduce the biologically active dose. In general, it is the free
concentration that determines biological activity (Teeguarden and Barton, 2004) .
Hence, if SHBG is elevated in children th is would tend to reduce the effect of an
equivalent total plasma concentration by reducing the free concentration.
The advantage of the recombinant assays is that they measure biologically active
material, whereas the immunoassays may include cross-reacting less or inactive
metabolites. Whilst the recombinant assays may include hormonally active material
other than the specific analyte, this does pr ovide an indication of to what the body is
exposed in vivo. Hence, on balance, the data of Paris et al (2002) may be the most
meaningful to date. This presumably reflects circulating total active oestrogenic
material, but not that bound to proteins."
799
7.670 We note that the evidence presented relates only to oestradiol, but that the claim we are
examining with regard to the insufficiencies of the evidence are with resp ect to the five other
hormones at issue, not oestradiol. We note furt hermore that the 2002 Opinion concludes that these
more sensitive detection methods have not yet been validated.800
7.671 On the basis of the above, we are not convinced that the studies discussed by the experts call
into question the fundamental precepts of previous knowledge and evidence so as to make relevant,
previously sufficient evidence now insufficient in relation to the effect of the five hormones on pre-
pubertal children. Particularly, it has not been est ablished that the data regarding the effects of
hormones on which the JECFA assessments are based are insufficient in light of new evidence
relating to the other five hormones at issue.
Dose response
7.672 The European Communities, in its reply to a question of the Panel 801, quotes an extract of the
1999 Opinion.802 Whereas this quotation relates to trenbolone acetate, we decided to address it in this
general section to the extent that the impossibility to perform a dose-response assessment is referred
to by the European Communities with respect to the five hormones at issue.803

799 Reply of Dr. Boobis to question 40 of the Panel, Annex D, paras.325-326. Dr. Boobis cites to:

Ikegami S, Moriwake T, Tanaka H, Inoue M, Kubo T, Suzuki S, Kanzakili S and Seino Y
(2001). An ultrasensitive assay revealed age- related changes in serum oestradiol at low
concentrations in both sexes from infancy to puberty. Clin Endocrinol (Oxf), 55:789-795
Paris F, Servant N, Terouanne B, Balaguer P, Nicolas JC and Sultan C (2002). A new
recombinant cell bioassay for ultrasensitive dete rmination of serum estrogenic bioactivity in
children. J Clin Endocrinol Metab, 87:791-797
Teeguarden JG and Barton HA (2004). Computational modeling of serum-binding proteins
and clearance in extrapolations across life stages and species for endocrine active compounds.
Risk Anal, 24:751-770

800 2002 Opinion, Section 4.1.1, p. 9.
801 EC's replies to Panel questions after the first substantive meeting, question 22, Annex B-1.
802 1999 Opinion, para. 4.4.8.
803 See the following paragraphs of the EC's second written submission:

7.673 The European Communities also questions JECFA's findings on dose response as follows:
"The above findings establish that the le vels of endogenous production of these
hormones by pre-pubertal children is much lower than previously thought and this
finding, which is subsequent to the 1999 JECFA report, casts serious doubts about the
validity of JECFA’s findings on the dose-response relationship, because the data on
endogenous production on which JECFA based its findings are also very old (since
1974)."804
7.674 The Panel can only conclude from the comme nts of the European Communities that it
considers that a dose response would be required to complete a risk assessment for the five hormones
other than oestradiol-17 β, but that it disagrees with JECFA's findings on dose response. The Panel
notes that JECFA could identify a dose response for th e five hormones at issue. Comparatively, the
European Communities has not provided convincing elements to support its view that there is
insufficient relevant evidence on dose response. Th e EC position on dose response, at least for the
natural hormones other than oestradiol, seems to be based on the belief th at levels of endogenous
production of hormones are much lower than previously thought. The Panel notes in this regard that
it has been demonstrated that the ultrasensitive assay relied upon by the European Communities to
conclude that endogenous production is lower than assumed by JECFA has not yet been validated and
applies only to oestradiol.
7.675 For these reasons, the Panel believes that it h as not been established that new evidence was
such as to put into question existing data on dose response and prevent the performance of a risk
assessment.
Bioavailability
7.676 The European Communities argues that another area where recent developments put in doubt
the findings of the 1999 JECFA report concerns the bioavailability of residues of the hormones
concerned. According to the European Communities, the 1999 and 2002 Opinions have found that
data on which JECFA based its findings are incorrect or insufficient.
805
7.677 The Panel notes that the studies referred to in th e 1999 and 2002 Opinions (one of them being
study 3 of the 17 studies commissioned by the European Communities) 806 relate to oestradiol-17β, not
to any of the specific hormones with respect to which the European Communities applies a

– para. 155, regarding the effect of progesterone on growth and reproduction: "No assessment of
the dose response relationship has been presented yet." Also: " In conclusion, these data
indicate that progesterone can cause immuno de pression; however, they are insufficient to
make any realistic assessment of the dose response relationship." (Both from the 1999
Opinion, pp. 51-55);
– para. 160, regarding the effect of testosterone on growth and reproduction: "No assessment of
the dose response relationship has been presented yet." Also: "There are limited experimental
data on the effects of testosterone on immuno response but none on the dose response
aspects." (Both from the 1999 Opinion, p. 50);
– para. 165, regarding the effects of trenbolone on growth and reproduction: "These data do not
allow a realistic assessment of a dose response relationship."(1999 Opinion, p. 60);
– para. 172, regarding melengestrol acetate: "These data do not allow an estimate of the dose
response relationship." (1999 Opinion, p. 68);
– para. 168, on the effects of zeranol on growth and reproduction: "No estimate of the dose-
response relationship for these effects can be made."(
 1999 Opinion, p. 65).
804 EC's second written submission, para. 122.
805 EC's second written submission, para. 123.
806 2002 Opinion, p.12, point 4.1.5, Exhibit US-1.

provisional ban under Article 5.7 of the SPS Agreement. Moreover, there is no indication that the
conclusions can be applied to other hormones than oestrogens.
7.678 The Panel recalls that the European Commun ities argued that "similar findings [had been]
made for all of the other five hormones." 807 However, the European Communities did not specify
where such findings had been made. The European Communities also refers to study 10 of the
17 studies, by Dr. Florence Le Gac, but does not clearly explain to what extent the results of this study
establish or discuss the bioavailability of the five ot her hormones. This allegation of the European
Communities has to be considered in light of the statements of Dr. Boisseau and Dr. Boobis according
to which the bioavailability of melengestrol, trenbolone and zeranol residues has not been
determined.808
7.679 The Panel considers that bioavailabity would be an issue if the new ev idence suggested that
bioavailability in the case of ingestion of meat tr eated for growth promotion purposes is higher than
previously thought. However, it appears that , in the absence of data, JECFA assumed 100%
bioavailability.
7.680 In this respect, Dr. Boisseau said:
"The bioavailability of melengestrol, tre nbolone and zeranol residues have not been
determined. Therefore all their residues have been considered as being totally
bioavailable."809
7.681 Dr. Boobis stated, with respect to natural hormones, that "change in bioavailability is likely to
be a consequence of changes in the enzymes of metabolism in the liver and/or small intestine."810
7.682 Dr. Boobis also confirms for the non-natural hormones:
"However, it should be noted that in the risk assessment of these hormones by
JECFA, the risk characterization involved comparison of the theoretical maximum
daily intake with the ADI. No correction was made for bioavailability. Hence, the
situation is likely to be similar to that for the natural hormones, in that changes in
bioavailability from the normal value would change the margin of safety."811
7.683 These statements were not contradicted by Dr . Guttenplan, the third and last expert who
replied to question 43 of the Panel, and who limited his remarks to oestrogens. 812
7.684 We therefore conclude that it has not been established that any new evidence on
bioavailability has been developed regarding specifi cally the five hormones at issue, which would
affect the current knowledge on the subject. More pa rticularly, no new evidence has been submitted
regarding the three non-natural hormones which would make it impossible to perform a risk
assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement.

807 EC reply to question 28 of the questions of the Pa nel after the first substantive meeting, Annex B-1,
para. 158.
809 Annex D, para. 347.
810 Annex D, para. 350.
811 Annex D, para. 351.
812 Annex D, para. 357.

Long latency period of cancer and confounding factors
7.685 Regarding the long latency of can cer, in its second written submission 813 , the European
Communities claims that it may not be in a position to demonstrate the existence of a clear harm in
case of cancer because of the long latency period a nd the numerous confounding factors that play a
role in the development of cancer.
7.686 We first note the importance of latency period in the assessment of cancer, as confirmed by
Dr. Cogliano, Dr. Guttenplan and Dr. Boobis:
7.687 Dr. Cogliano stated that:
"It is definitely necessary to take into acc ount the latency period of cancer in the
conduct of a risk assessment. In this regard, the guidelines for developing IARC
Monographs state, 'Experience with human cance r indicates that the period from first
exposure to the development of clinical cancer is sometimes longer than 20 years;
latent periods substantially shorter than 30 years cannot provide evidence for lack of
carcinogenicity.' [International Agency for Research on Cancer, Preamble to the
IARC Monographs, http://monographs.iarc.fr]"814
7.688 Dr. Guttenplan confirmed that:
"When epidemiological data is used in performing a risk assessment, the latency
period is extremely important. Usually a latent period of 20 years is taken for cancer,
but this varies with the carcinogen. It is indeed necessary to determine incidence or
prevalence at different times after the onset of exposure. Attempting to perform a risk
assessment based on epidemiological data obtained too soon after the onset of
exposure can seriously underestimate risk.
815
7.689 Dr. Boobis stated that:
"The latency period is an important cons ideration in risk assessment, both in the
design and in the interpretation of studies. Thus, the duration of exposure, either of
experimental animals or in epidemiology studies, should be sufficiently long to
permit assessment of effects with a long latency period. Most forms of cancer come
into this category."
816
7.690 Dr. Boobis added that:
"The observational studies of humans (e.g. on HRT or oral contraceptives) and the
experimental studies in animals covered a su fficiently long period to encompass the
latency period for any carcinogenic effects of the hormones (see IARC, 1999).
7.691 Dr. Boisseau highlighted the practical difficulti es resulting from confounding factors, arguing
that:

813 EC's second written submission, para. 149.
814 Reply of Dr. Cogliano to question 23 of the Panel, Annex D, para. 213.
815 Reply of Dr. Guttenplan to question 23 of the Panel, Annex D, para. 214. Dr. Guttenplan cited to
Lagiou P. Trichopoulou A. Tric hopoulos D. Nutritional epidemiology of can cer: accomplishments and
prospects. [Lectures] Proceedings of the Nutrition Society. 61(2):217-22, 2002.
816 Reply of Dr. Boobis to question 23 of the Panel, Annex D, para. 210.

"[He did] not think possible/useful to take into account the "long latency period" of
cancer in order to assess properly and specifi cally the carcinogenic effects of residues
of natural hormones only resulting from the treatment of food producing animals by
growth promoting hormones. ... epidemiological studies carried out in humans during
[periods] long enough in order to take into account this "long latency period" will not
be able to discriminate, in the case of a possible but limited increase of tumours,
between the responsibilities of (1) hormone residues resulting from the treatment of
food producing animals by growth promoting hormones, (2) hormone residues
resulting from the endogenous production of these animals, (3) other components of
the diet including other food additives and contaminants. That is the reason for which,
... the epidemiological studies in humans al ready carried out in this domain have
failed to identify any relation between the occurrence of hormonally dependent
tumours and the consumption of meat containing hormonally active residues resulting
from the treatment of cattle with growth promoters."
817
7.692 Dr. Boobis added that:
"The long term studies of the hormones undertaken in experimental animals and in
humans, involved much higher doses than w ould be encountered on consumption of
meat from animals treated with growth promoting hormones. The maximum risk
from such low levels of exposure, even assuming a linear dose-response relationship
for cancer, would be such that it woul d be necessary to study extremely large
populations to detect any increase in cancer incidence, particularly as the most likely
cancers are quite common. This is because the lower the risk the greater the number
of subjects that are required to detect it, a function of the power of the study which
takes account the magnitude of the risk and the difference from the background rate
(Hunter, 1997) . Hence, in the risk assessment of the hormones used as growth
promoters, it is questionable whether an incr ease in risk, even if it existed, could be
detected in exposed populations. However, it is still necessary to protect against such
a risk. The risk assessment of the horm ones conducted by JECFA suggested that
there would be no risk at exposure levels up to the respective ADI. Even if duration
of exposure were for a sufficiently long period (usually 20-25 years for solid tissue
tumours), any increase in risk would probabl y not be detectable. Hence, a negative
result from such an observational study would not resolve the issue.
A second issue with respect to the latency is the significance it has for interpretation
of the exposure pattern. Where there is a long latency, and regular exposure is
necessary before a carcinogenic response is manifest, as appears to be the case for the
hormones in question (Coombs et al, 2005), occasional exposures above the ADI will
not pose any additional risk (Larsen and Richold, 1999) . Hence, latency is of value
in assessing the risks from different exposure scenarios."
818

817 Reply of Dr. Boisseau to question 23 of the Panel, Annex D, para. 209.
818 Dr. Boobis cites to the following studies:

Coombs NJ, Taylor R, Wilcken N, Fiorica J and Boyages J (2005). Hormone replacement therapy and
breast cancer risk in California. Breast J, 11:410-415
Hunter DJ (1997). Methodological issues in the us e of biological markers in cancer epidemiology:
cohort studies. IARC Sci Publ, 142:39-46
IARC (1999). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol 72.
Hormonal Contraception and Post-menopausal Hormonal Therapy, IARC, Lyon, France
Larsen JC and Richold M (199). Report of workshop on the significance of excursions of intake above
the ADI. Regul Toxicol Pharmacol, 30:S2-12.

7.693 The European Communities acknow ledges that epidemiological studies will not be able to
discriminate (or separate out) the true origin of cancer because of so many confounding factors. In this
respect, we note that Dr. Cogliano specified that it was generally possible to identify confounding
factors in epidemiological studies. It was often di fficult, however, to determine whether the observed
tumours can be attributed to the agent under study or to a confounding factor. Dr. Cogliano adds that
"[w]hen a causal interpretation is credible but confounding factors cannot be ruled out, IARC
considers this to provide limited evidence of carcinogenicity."
819
7.694 The European Communities insists, however, that this undermines the opinion of the
respondent that the hormones at issue have been in use for a sufficiently long time to rule out their
carcinogenic effect on humans. The European Co mmunities points at IARC studies showing that the
frequency of breast cancer in countries where use of hormones for growth promotion is allowed is
higher compared with countries where the hormones have not been used.820
7.695 Three experts addressed this issue. Dr. Cogliano mentioned that:
"The difference between the US and the EC in rates of breast cancer and prostate
cancer almost certainly has multiple causes. It is possible that differences in exposure
to exogenous hormones can be one cause, but the data are not sufficiently specific to
establish a link between these observations."821
7.696 Dr. Guttenplan confirmed that:
"The epidemiological studies do not identify a relationship between cancer and
residues of hormonal growth promoters. The references to the higher rates of breast
and prostate cancer observed in the Unite d States as compared to the European
Communities are not very convincing as there is considerable variation in rates in
different geographical locations. Also, the differences in rates of breast and prostate
cancer observed in the United States as co mpared to the European Communities are
relatively small. There is no way to defin itely establish a link between these statistics
and the consumption of meat from animals treated with the hormones at issue as there
are many possible confounders, and the differences in cancer rates are small.
However, the results are at least consistent with a possible effect of hormones on
breast and prostate cancer."
822
7.697 In this regard, Dr. Boobis added the following:
"There are an appreciable number of studies showing an association between the risk
of certain cancer types, including breast and prostate and the consumption of meat
(Colli and Colli, 2006; Norat et al, 2005; see also SCVPH Opinion, 1999) . For
breast, the incidence is similar in develope d countries such as Western Europe, North
America and Australasia. The correlation is strongest with meat consumption and
shows little relationship with whether the meat is from animals treated with growth
promoting hormones or not. For example rates in Iceland (87.2 per 100,000), where
such hormones are not used, are not dissimilar to those in the USA (101.1 per
100,000), where they are used. Prostate cancer rates are 124.8/100,000 in the USA

See Reply of Dr. Boobis to question 23 of the Panel, Annex D, para. 212.
819 Reply of Dr. Cogliano to question 24 of the Panel, Annex D, para. 220. See also Dr. Guttenplan,
Annex D, para. 221.
820 EC's comments on experts replies to questions 23 and 24 of the Panel, Annex F-1, pp. 19-20.
821 Reply of Dr. Cogliano to question 26 of the Panel, Annex D, para. 241.
822 Reply of Dr. Guttenplan to question 26 of the Panel, Annex D, para. 242.

and 90.9 per 100,000 in Sweden (IARC, 2002) . For comparison, average daily
consumption of meat (as protein) in 2000 was as follows: USA 40.2 g/day; Iceland
29.5 g/day; Sweden 24.8 g/day (FAO, 2003) . Hence, there is a much better
association with meat consumption and risk of breast or prostate cancer than there is
with the use of growth promoting hormones to treat cattle. It is also important not to
infer too much from geographical differences in cancer incidence rates with respect to
causation. This is because of what is know n as the ecological fallacy. This has been
defined as the inference that a correla tion between variables derived from data
grouped in social or other aggregates ( ecological units) will hold between persons
(individual units) (Society for Risk Assessment, 2004). The difficulty is that many
factors will vary between populations, including ethnicity, genetics, health and
socioeconomic status, diet, lifestyle and environment. Without considering the
possibility of confounding, such ecological da ta is really only of value in generating
hypotheses (Morgenstern, 1995) . These would need to be evaluated in more
structured investigations, with better control of confounding variables."
823
7.698 We also note Dr. Boobis statement at the meeting of the Panel with the experts:
"The paradigm we have, and there is some ev idence to justify the case that this is a
reasonable assumption, is that the eff ects observed scale to the lifetime of the
organism, and so that is one of the reasons we use shorter-lived organisms in our
toxicological testing. We use rats and mice which live for a couple of years;
otherwise we would have to test for a li fetime in a longer-lived species which might
be 40 or 50 years. So we are working on th e principle that effects that are not evident
within the lifetime of a rodent would not be evident, all other things being equal,
within the lifetime of a human being. And there is actually very good evidence that
that is the case. For a number of carci nogens that IARC have evaluated it takes
approximately a quarter of a lifetime after an initial exposure for those tumours to
become apparent, and that is true in rodents, it's true in dogs and it's true in humans.
So I think that the paradigm is reasonable that if there is going to be an effect
manifest over a lifetime, it will be revealed in those experimental systems and
therefore be predictive of lifetime effects in humans by and large."
824
7.699 On the one hand, the comments of the experts suggest that epidemiological studies have not
been able to single out residues of hormones in meat treated for growth promotion purposes as a cause
of cancer, and that this would be quite difficult. On the other hand, the Panel notes that it is possible to
assess long term effects through long term studies of e xperimental animals, even if they involve much
higher doses than would be encountered in consump tion of meat from animals treated with growth
promoting hormones. It has also been possible to take into account the risk attached to latency
through the setting of ADI. The European Communities has not identified any evidence
quantitatively and qualitatively sufficient to call into question the fundamental precepts of existing
knowledge and evidence and the approach followed so far in order to integrate the long latency of
cancer in risk assessment.

823 Reply of Dr. Boobis to question 26 of the Panel, Annex D, para. 239. Dr. Boobis cited to the
following:

Morgenstern H (1995). Ecologic studies in epid emiology: concepts, principles, and methods.
Annu Rev Public Health, 16:61-81
Society for Risk Assessment (2004). Glossary of Risk Analysis Terms.
(http://www.sra.org/resources_glossary.php)
824 Annex G, para. 1031.

7.700 Having regard to the opinions of the experts, the Panel concludes that it has not been
established that the difficulties attached to the lo ng latency of cancer make it impossible to perform a
risk assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement . More
particularly, the European Communities did not point at a "critical mass" of new evidence and/or
information that would call into question the fu ndamental precepts of previous knowledge and
evidence in relation to the long latency period of cancer and the existence of confounding factors.
Effect of hormones on the immune system
7.701 The 1999 Opinion considers, for each of the fi ve hormones for which a provisional ban is
applied, that there is insufficient eviden ce as to their effect on the immune system. 825 The Panel notes
that no arguments have been raised specifically in relation to the effects of hormones on the immune
system with respect to each of the five hormones at issue. The Panel noted, however, the contention of
the European Communities that new important gaps , insufficiencies and contradictions had been
identified in the scientific information and knowle dge now available as a result of the 17 studies
commissioned by the European Co mmunities. The Panel considered that an appropriate way to
address this question with respect, inter alia, to the effect of hormones on the immune system was to
seek the views of the scientific experts on the f actual question whether the new scientific studies
initiated since 1997 and relied upon by the European Communities identify any adverse effects on the
immune system from the consumption of meat fr om cattle treated with the growth promoting
hormones at issue.
826
7.702 Three experts expressed their views on the matter. Dr. Boobis argued that:
"The evidence on immune effects of hormon es such as oestradiol referred to by the
EC does not identify any adverse effects on the immune system from consumption of
meat from treated cattle. In general, clear evidence for immune effects were observed
only at high doses. There is no evidence that doses such as those resulting from
consumption of meat from treated animals has any effect on the immune system
(JECFA, 2000b; CVMP, 1999). It should also be noted, that in the case of immune
effects, exposure relative to endogenous leve ls is a critical issue. Given the large
margin of exposure on anticipated intake fro m residues in meat fro m treated animals,
no effect on the immune system is anticip ated, as immune modulation is dependent
on dose and there are thresholds for such effects."
827
7.703 Dr. Guttenplan noted that:
"The relationship between estrogen and autoimmune diseases has received
considerable attention (Opinion SCVPH, April 30, 1999, section 2.4). There is
evidence that estrogens can be involved in L upus, rheumatoid arthritis, thyroiditis. In

825 There does not seem to be any additional development on this matter in the 2000 and 2002
Opinions.
826 Question 59 of the panel to the experts.
827 Reply of Dr. Boobis to question 59 of the Panel, Annex D, para. 445. Dr. Boobis cited to:

Barton HA and Clewell HJ 3rd (2000). Evaluating noncancer effects of trichloroethylene:
dosimetry, mode of action, and risk assessment. Environ Health Perspect, 108
(Suppl 2):323-334
Kroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, Schilter B,
Schlatter J, van Schothorst F, Vos JG and Wurtzen G; European branch of the International
Life Sciences Institute (2004). Structure-base d thresholds of toxicological concern (TTC):
guidance for application to substances present at low levels in the diet.Food Chem Toxicol,
42:65-83

addition the development of allergies is t hought to be at least partially related to
estrogens. The studies in experimental an imals also did not identify any immune-
related effects, although it is not certain the types of possible effects in humans would
be detected in experimental animals. No definitive studies have related intake of
meat from hormone-treated animals to the above disorders."828
7.704 We note that the Panel question related to a ll hormones and the experts gave details in
relation to oestrogens in general. We also note that the European Communitie s, in its comments on
the experts' replies, referred to effects identifie d by Dr. Guttenplan in relation to oestrogens. The
European Communities concludes that it has offered serious evidence and pointed to a number of gaps
and uncertainties in the knowledge. The European Communities considers that it is for the United
States, Canada and JECFA to "ensure the Panel that adverse immune effects are not possible to occur
from residues in meat treated with these hormones for animal growth promotion".829
7.705 First, the Panel doubts that, in this particular case, the standard of proof is that the United
States should prove to the satisfaction of the Panel that "adverse immune effects are not possible to
occur from residues in meat treated with these hormo nes for animal growth promotion" purposes. As
already specified, in this case the United States has to prove its allegation that relevant scientific
evidence is not insufficient to perform an adequate risk assessment under Article 5.1 and Annex A(4)
of the SPS Agreement.
7.706 Second, with regard to the evidence and ga ps allegedly identified by the European
Communities, the Panel notes that the statemen t of Dr. Guttenplan on which the European
Communities relies relates exclusively to oestrogens. The Panel notes in this respect that the other
experts' replies to question 59 of th e Panel relate to oestradiol or o estrogens. None of those replies
related to any of the five hormones at issue. The Panel notes that the 1999 Opinion itself does not
provide evidence of impact on the immune system for testosterone.
830 For progesterone, the data were
deemed to indicate that progesterone can cause imm uno depression. However they were described as
insufficient to make a realistic assessment of the dose response relationship. 831 On trenbolone, the
information was deemed insufficient to assess the possible impact of low levels of trenbolone in meat
and meat products on consumers. 832 For zeranol, the 1999 Opinion states that no relevant data on the
effect of zeranol on the immune system were found.833 Finally, for MGA, the 1999 Opinion concluded
that the information was insufficient to make a scientific judgement on whether MGA may cause
effects on the immune system at a level which co uld occur in meat treated with MGA as a growth
promoters. The 2000 and 2002 Opinions do not seem to contradict these findings.
7.707 The Panel also notes that the three experts w ho replied to question 59 addressed the potential
effects of hormones on the immune system through a dose-response approach. 834 The Panel has
received no evidence suggesting that a dose response would not apply to the effect of the five
hormones on the immune system as a result of the co nsumption of meat treated for growth promotion
purposes.
7.708 We therefore conclude that it is not established that there exists a critical mass of new
evidence and/or information that calls into questi on the fundamental precepts of previous knowledge

828 Reply of Dr. Guttenplan to question 59 of the Panel, Annex D, para. 447.
829 EC's comments to experts replies to Panel questions, Annex F-1, pp. 37-38.
830 1999 Opinion, p. 51.
831 1999 Opinion, p. 55.
832 1999 Opinion, p. 60.
833 1999 Opinion, p. 66.
834 See also reply of Dr. Boissau to question 59 of the Panel, Annex D, para. 443.

and evidence so as to make relevant, previously sufficient, evidence on hormones effects on the
immune system now insufficient.
Effect of hormones on growth and reproduction
7.709 The Panel notes that no arguments have been ra ised specifically in relation to growth and
reproduction with respect to each of the five hormon es at issue, except for the EC reference to the
1999 Opinion. The Panel notes, however, the cont ention of the European Communities that new
important gaps, insufficiencies and contradictions had been identified in the scientific information and
knowledge now available as a result of the 17 studi es commissioned by the Eu ropean Communities.
The Panel considers that an appropriate way to address this question with respect, inter alia, to the
effect of hormones on growth and reproduction was to seek the views of the scientific experts on the
factual question whether the new scientific st udies initiated since 1997 and relied upon by the
European Communities actually support its contention.835
7.710 Three experts commented on our question, Dr. Boisseau, Dr. Boobis and Dr. Guttenplan.
Only Dr. Boobis and Dr. Guttenplan discussed matte rs related to growth and reproduction.
Dr. Guttenplan originally identified a number of gaps that could relate to growth and reproduction.836
However, Dr. Guttenplan subsequently stated that "on subsequent reading, [he] could not find
anything to indicate adverse effect", and he considered that it was possible to undertake a risk
assessment.837 He added that "the ability [to make a ri sk assessment] varies between compounds, but
that does not mean you can't make a risk assessment , it just means the accuracy of the risk assessment
is different."838
7.711 Dr. Boobis considered in general that:
"[T]here is little information in the scien tific studies initiated by the EC since 1997
that support the contention that they have identified important new gaps,
insufficiencies and contradictions in the scientific information and knowledge on the
hormones, and that additional studies are necessary before the risks to health of
consumption of meat from treated animals can be assessed. Whilst additional
information has been obtained on a number of aspects of the hormones in question,
this was often not definitive, sometimes it was not relevant, in some instances it
confirmed or expanded on previous k nowledge. The evidence obtained did not
indicate any additional concern regarding the risk from exposure to residues of the
hormones in meat from cattle treated for growth promotion."
839
7.712 Dr. Boobis also discussed the recent data on en docrine and developmental effects of the
hormones at issue. Regarding the experimental studies on the effect of in utero exposure of rabbits to
the three exogenous hormones: melengestrol acetate, trenbolone acetate and zeranol, also referred to
in the 2002 Opinion (study 11), Dr. Boobis noted that, to date, only information on metabolism and
disposition had been published (Lange et al, 2002).840 According to Dr. Boobis:

835 See question 62 of the Panel to the scientific experts, Annex D.
836 Reply of Dr. Guttenplan to question 62 of the Panel, Annex D, paras. 497-499.
837 Transcript of the Panel meeting with the experts, Annex G, para. 981.
838 Transcript of the Panel meeting with the experts, Annex G, para. 983.
839 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 495.
840 Dr. Boobis noted that, given the time that had elapsed since this paper was published (submitted
September 2001), it was somewhat surprising the data from the remainder of the study had not been published
yet.

"[the Lange et al. paper (2002)] 841 demonstrates transplacental transfer of the three
hormones. This is not surprising given the physicochemical properties of the
compounds (lipid solubility, non-polar, molecular size) (Syme et al, 2004) .842 In
addition, endogenous hormones ar e known to cross the placenta. It is notable that in
the study of Lange et al, fetal concentra tions of the hormones and their metabolites
were similar to or less than, sometim es much less than, t hose in corresponding
maternal tissues, suggesting that there w as no net accumulation of the compounds in
fetal tissues. It is also noted that the nu mber of animals studied was very small, a
point commented on by the authors themselves.
The unpublished component of this study was an investigation of the potential health
consequences of in utero exposure of ra bbits to the three hormones. From the
information provided, low dose exposure in utero caused modest changes in some
parameters, but was not associated with wither cancer or adverse effects on
reproductive capacity. There were no changes in sperm number. It is not clear
whether the changes observed were consis tent and hence compound-related as a only
a single dose was used for each compound. No r is it apparent whether the magnitude
of all of changes discussed reached statis tical significance (often the changes were
described as slight and no measure of vari ance is provided). The doses used in this
study would have provided much higher leve ls of exposure than those predicted to
arise from residues in meat. In the case of trenbolone acetate and zeranol exposure
was via the subcutaneous route, thus bypassing presystemic metabolism in the
intestine and/or the liver. In the case of MGA the oral dose was over 16,500 times
the ADI. Hence, even if the effects obser ved were of toxicological significance the
ADI would provide a more than adequate margin of protection.
Overall, this study cannot be said to confirm a risk to human health from
consumption of meat from animals treated with these hormones."
843
7.713 While the European Communiti es commented negatively on other considerations by
Dr. Boobis, it does not seem to make any specific comment on the remarks of Dr. Boobis on study 11.
7.714 Dr. Sippell mentioned that "the synthetic androgen Trenbolone and the gestagen Melengestrol
bind with high affinity to the human androgen and progesterone receptors, respectively (Bauer et al.,
2000). Exposure during pregnancy might result in severe transplacental virilisation of a female
fetus."
844
7.715 We note that Dr. Sippell does not indicate at what doses such an effect might occur. It is also
not clear whether the last sentence (about exposure during pregnancy) refers to one of the studies
identified by the European Commun ities, or whether it is expressing Dr. Sippell's own opinion. We
note, however, that Dr. Boobis said: "There is no ba sis to think that the effect of hormone growth

841 Dr. Boobis cited to Lange IG, Daxenberger A, Meyer HH, Rajpert-De Meyts E, Skakkebaek NE and
Veeramachaneni DN (2002). Quantitative assessment of fo etal exposure to trenbolone acetate, zeranol and
melengestrol acetate, following matern al dosing in rabbits. Xenobiotica, 32:641-65; see reply of Dr. Boobis to
question 63 of the Panel, Annex D, para. 488.
842 Dr. Boobis cites to Syme MR, Paxton JW and K eelan JA (2004). Drug transfer and metabolism by
the human placenta. Clin Pharmacokinet, 43:487-514.
843 Dr. Boobis also discussed the study called "Retrospective study on long-term effects in children of
following suspected exposure to oestrogen-contaminated meat" (study 12) and the study "In utero exposure and
breast cancer: a study in opposite sexed twins" (Study 13). However these studies seemed to relates primarily to
oestradiol. See reply of Dr. Boobis to questions from the Panel, Annex D, paras. 493 and 491.
844 Reply of Dr. Sippell to question 41 of the Panel, Annex D, para. 336.

promoters would be different in any way whatso ever from hormones naturally present in meat, at
equivalent internal exposure levels."845
7.716 In paragraph 804 of Annex G, Dr. Sippell also st ates that: "It is, of course, difficult to answer
such a question as a clinician, but from the experien ce we have with the low levels, I mentioned this
several times before, with the extremely low levels that have been measured by these new
recombinant assays, it is conceivable really that this extra burden of oestradiol poses a risk to very
small children and particularly prepubertal boys, and th is is in line with the very very high sensitivity
of prepubertal children to oestrogens induced for other purposes."846
7.717 We consider that, in that paragraph, Dr. Sippell merely argues that it is conceivable that there
is a risk, but he is not saying that there is evidence of such a risk. Dr. Sippell also stated: "I think that
as much as children are concerned, we know really by no means enough and the data are really
insufficient to tell or to be confident that this additional exposure from hormone-treated meat poses no
risk."847 Dr. Sippell's statements focused on oestradiol.
7.718 At the hearing, Dr. Guttenplan also mentioned: "So the potential genotoxic damage that is
done in an adult would overwhelm that that could be done in a child. However, in boys the levels are
even lower, and there I think we have to worry a bout developmental effects, and there has been less
said on that – Dr. Sippell has been the major proponent of that – and I still think that these could be
investigated epidemiologically or in some type of study. We might, as Dr. Boobis suggested, need a
surrogate, perhaps saliva or urine, but I think it is perhaps the most important issue to address is the
sensitivity of children. I should also mention hor mone-sensitive cancers in post-menopausal women,
it could be another concern."848
7.719 These two statement express doubts but do not cons titute evidence of risks. The Panel notes
that science does not stop studying a substance ju st because there is sufficient evidence to conduct a
risk assessment, but continuously re-evaluates subs tances. Nothing in th e above cited passages
suggests that the existing evidence w as insufficient to complete a risk assessment. In fact, the Panel
notes that the European Communiti es has once again pointed the Pane l to evidence that deals only
with oestradiol, a hormone for which it claims to have completed a risk assessment. The European
Communities has not explained how the interventions from the experts support a conclusion that the
scientific evidence was insufficient to conduct a ri sk assessment with respect to the other five
hormones.
7.720 The European Communities does not provide a dditional evidence in its comments regarding
other hormones than oestradiol.849
7.721 Having regard to the opinions of the experts, the Panel is of the view that it has not been
established that there is a critical mass of new eviden ce and/or information that calls into question the
fundamental precepts of previous knowledge and evidence so as to make relevant, previously
sufficient evidence now insufficient in relation to the growth and reproduction effects of the hormones
at issue.

845 Reply of Dr. Boobis to question 41 of the Panel, Annex D, para. 333.
846 Annex G, para. 804.
847 Annex G, para. 1063.
848 Annex G, para. 1061.
849 EC's comments on replies from experts, question 41, Annex F-1, p. 29.

(vii) Is relevant scientific evidence insufficient in the case of progesterone?
Summary of the main arguments of the parties850
7.722 The United States argues in general that the hormones at the centre of these proceedings have
been intensively studied over the last twen ty-five years and nothing has occurred since the EC –
Hormones case, except that the five hormones have been studied in greater details, including by
JECFA. New safety assessments were conducted for progesterone in 1999, reaffirming its safety
when used according to good veterinary practices. Included in these safety assessments were new,
detailed epidemiological studies on the effect of the hormones on post-menopausal women, marking
some of the most relevant studies of the effect of hormones on human beings to date.
851 852
7.723 The United States adds that the European Co mmunities' CVMP recently re-evaluated the
scientific evidence relating to the hormones and r eaffirmed its earlier conclusions on the safety of
progesterone.
7.724 The United States concludes that there is more than sufficient scientific evidence to permit an
adequate assessment of any potential risk.
7.725 The European Communities argues that the body of ev idence has developed since the EC –
Hormones case 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 chosen level of protection.
7.726 The European Communities, quoting the 1999 Opinion, identifies the following
insufficiencies in the evidence:853
(a) little knowledge about the specific enzymes in cattle that metabolize progesterone;
(b) considerable uncertainty associated with the validity of daily production rate data
used by the US Food and Drug Administration;
(c) no information available on mutagenicity and genotoxicity;
(d) no information available on DNA adducts and DNA damage;
(e) inadequate evidence for carcinogenicity in humans;
(f) regarding effects of progesterone on gr owth and reproduction, alterations of
spermatogenesis can be induced by progest erone treatments, but no assessment of the
dose-response relationship is available;
(g) regarding effects on the immune system, there are data indicating that progesterone
can cause immuno depression, but they are in sufficient to make a realistic assessment
of the dose-response relationship.

850 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
851 The United States refers to the 52nd JECFA report (2000), pp. 59-60.
852 US's first written submission, paras. 125-128.
853 EC's second written submission, para. 155.

7.727 In response to the US reference to the 1999 JECFA assessment, the European Communities
notes that the 1999 Opinion took JECFA's assessm ent into account, expressing concern regarding the
determination of the ADI since neither the actual data nor a reference to a peer-reviewed publication
were provided, and since the dose-response was li mited to two doses and the ADI was estimated from
just a single dose rather than a curve derived from all the data available.
854
7.728 In addition, the European Communities indicates that the Opinions, in particular the 2002
Opinion, have taken the 1999 CVMP assessment into account. The European Communities argues
that the CVMP opinion was not used as the only basis of the EC measure for progesterone as a growth
promoter because new scientific evidence had appeared since and the SCVPH assessment had
identified risks that were incompatible with the le vel of health protection applied by the European
Communities to these hormones when used for animal growth promotion purposes. Secondly, the
European Communities argues that the CVMP conclu sion applies only when progesterone is used in
veterinary medicinal products authorized in accordance with relevant EC legislation, which would
exclude over the counter products freely available to laypeople.
855
Reasoning of the Panel
7.729 In light of the arguments of the parties, a nd having regard to the 1999 and 2002 Opinions 856
and to the fact that some of the insufficiencies identified by th e European Communities have been
addressed in the common section above or were si mply not discussed by the European Communities
in its submissions, the Panel will limit its analysis to determining whether relevant scientific evidence
is insufficient concerning progesterone with regard to evidence of carcinogenicity in humans.
7.730 We note that the European Communities, referri ng to the 1999 Opinion, argues that there is
no information available on the mutagenicity and genotoxicity of progesterone.857
7.731 We recall, however, that with respect to ge notoxicity, the 2002 Opinion concludes that
"[t]here is no evidence that progesterone or testosterone have genotoxic potential."858
7.732 Regarding this aspect, we note that Dr. Boi sseau quoted the report of JECFA in its thirty-
second session (1999), where it concludes that "[a]lt hough equivocal results have been reported for
the induction of single-strand DNA breaks and DNA adduc ts have been seen in vivo and in vitro in
some studies, progesterone was not mutagenic … progesterone has no genotoxic potential ".
Dr. Boisseau also quotes JECFA's conclusion that "t hese effects on tumour production occurred only
with doses of progesterone causing obvious hormonal e ffects … the effect of progesterone on tumour
production was directly related to its hormonal activity".859
7.733 Dr. Boobis concurred with the above by saying that:
"there is no evidence that the hormones test osterone or progester one have genotoxic
potential. ... Micronuclei can arise via a non-genotoxic mechanism, particularly at
concentrations that may have caused some toxicity. In addition, the 32P-post-

854 EC's second written submission, para. 157-158; EC 's replies to Panel questions after the first
substantive meeting, question 22, Annex B-1, para. 126.
855 EC's second written submission, para. 159; EC's rep lies to Panel questions after the first substantive
meeting, Annex B-1, paras. 130-133, Exhibit US-13, p. 12.
856 The 2000 Opinion did not identify essentially new toxicological information concerning
progesterone and testosterone in the data presented in the toxicological evaluation of the natural hormones
oestradiol-17β, progesterone and testosterone in animal production by JECFA (2000 Opinion, section 2.2, p. 4).
857 EC's second written submission, quoting 1999 Opinion, paras. 155-156.
858 2000 Opinion, section 4.3, p. 15.
859 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 157.

labelling assay is not specific, and data cited above suggest that DNA adduction can
arise by mechanisms other than direct interaction with DNA. In no case did any of
the compounds produce a mutagenic response. These data are insufficient to support
the conclusion that these hormones have genot oxic potential in vivo. Thus, there is
no evidence that any of the hormones are genotoxic in vivo at the levels found in
meat from treated animals. Even if GVP we re not followed, the levels of exposure to
the hormones would be such that no genotoxicity would be anticipated in vivo."860
7.734 Dr. Guttenplan added that "there is no c onclusive evidence presen ted by the European
Communities that the five hormones other than oestradiol-17 β, when consumed as residues in meat
have genotoxic potential. There is some eviden ce that certain of the hormones have genotoxic
potential, but generally the potential is weak. ... progesterone [is] negative in genotoxic assays. ... Any
genotoxic effects of the five hormones are likely to be minimized by good veterinary practice."861
7.735 The European Communities considers that JECF A was more prudent than the experts when
rejecting the genotoxicity of progesterone in 1999. The European Communities argues that the 1999,
2000 and 2002 risk assessments by the SCVPH pr ovide enough evidence to demonstrate that
genotoxicity from these hormones is possible.
862
7.736 We note that, on the one hand, the SCVPH in its 2002 Opinion concluded "[t]here is no
evidence that progesterone or testosterone have genotoxic potential". We note, on the other hand, that
the European Communities did not point to any st udy subsequent to the 2002 Opinion which would
contradict this conclusion.
7.737 Regarding evidence of carcinogenicity in humans, we note that IARC has evaluated
progestins as possibly carcinogenic to humans (Group 2B) 863 based on sufficient evidence of
carcinogenicity in experimental animals. 864 We note, however, that IARC's evaluation relates to the

860 Reply of Dr. Boobis to question 21 of the Panel, Annex D, para. 198.
861 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200.
862 EC's comments on experts replies to question 21 of the Panel, Annex F-1, pp. 17-18.
863 In its reply to question 24 of the Panel, Annex E-3, p. 128, IARC mentioned that it uses the
following groupings to characterize potential carcinogenic agents:

"Carcinogenic to humans (Group 1). This category is used when there is sufficient evidence of
carcinogenicity in humans.

Probably carcinogenic to humans (Group 2A). This category is generally used when there is limited
evidence in humans and sufficient evidence in experimental animals.

Possibly carcinogenic to humans (Group 2B). This category is generally used when there is limited
evidence in humans or sufficient evidence in experimental animals, but not both.

Not classifiable as to its carcinogenicity to humans (Group 3). This category is generally used when
there is inadequate evidence in humans and inadequate or limited evidence in experimental animals.
Agents that do not fall into any other group are also placed in this category.

Probably not carcinogenic to humans (Group 4). This category is generally used when there is
evidence suggesting lack of carcinogenicity in humans and in experimental animals.

Mechanistic and other relevant data also contribute to the grouping. Further details can be found in the
Preamble to the IARC Monographs (http://monographs.iarc.fr)."

864 IARC written replies to question 25 of the Panel, Annex E-3, p. 129.

carcinogenicity of hormones in general, not to the carcinogenicity due to exposure to hormone
residues in meat as a result of the cattle being treated with growth promoting hormones.
7.738 Dr. Boisseau mentioned that "[i]n its 1999 report, SCVPH concluded, about the
carcinogenicity of progesterone, that 'At present, th e data are insufficient to make any quantitative
estimate of the risk arising from th e exposure to residues in meat.' Therefore, the scientific evidence
relied upon in the SCVPH Opinions does not support the conclusion that the carcinogenic effects of
progesterone are related to a mechanism other than hormonal activity."865
7.739 On the basis of the arguments of the parties a nd of the experts' opinions, we conclude that
there is no new evidence and/or information that calls into question the fundamental precepts of
previous knowledge and evidence so as to make relevant, previously sufficient evidence, now
insufficient. We therefore conclude that the elements before us do not support the conclusion that the
relevant scientific evidence has become insufficien t, within the meaning of Article 5.7 of the
SPS Agreement, regarding the genotoxicity, mutagenicity and carcinogenicity of progesterone.
Conclusion
7.740 Having regard to our specific conc lusions above, we recall that the Appellate Body clarified
in Japan – Apples that relevant scientific evidence will be insufficient within the meaning of
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative
terms, the performance of an adequate assessment of risks as required under Article 5.1. In this
respect, we note that, at our request, the experts also expressed their views on the more general
question whether the scientific evidence available at the time of the adoption of Directive 2003/74/EC
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated,
inter alia, with progesterone. Dr. Boobis replied that:
"[T]here was sufficient information availabl e to the EC to have enabled it to have
conducted an assessment of the risks to human health arising from consumption of
meat from cattle treated with any of the six hormones at issue."
7.741 We also note Dr. Guttenplan's comment that:
"Progesterone, testosterone have been ex tensively investigated and the assessment
seems sound and is based on the no effect level and a safety factor. (JECFA
meeting 52, report-WHA TRS 893)."
7.742 These general remarks support our conclusions on the specific elements discussed above. We
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with
respect to progesterone, within the meaning of Article 5.7 of the SPS Agreement.
(viii) Is relevant scientific evidence insufficient in the case of testosterone?
Summary of the main arguments of the parties
866
7.743 As described above, the United States argues that JECFA assessments have shown that
hormone residues in meat from animals treated for growth promotion are safe and that evidence is
sufficient for a risk assessment. The United States also states that new safety assessments have been

865 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 158.
866 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.

conducted for progesterone and test osterone, reaffirming their safety when used according to good
veterinary practices.
7.744 The European Communities , quoting the 1999 Opinion, identifies the following
insufficiencies in the evidence regarding testosterone:867
(a) the mechanism of androgen activity is only partially understood, including the role of
androgen receptors in ovarian tumorigenesis;
(b) little information is available about the specific metabolic routes and elimination rates
for testosterone in cattle;
(c) there is uncertainty regarding daily production rate data;
(d) genotoxicity of testosterone has not been demonstrated with the limited testing done
to date;
(e) no information is available on DNA damage induced by testosterone or its
metabolites;
(f) data on carcinogenicity in humans are limited;868
(g) no dose-response estimate can be given for effects on growth and reproduction;
(h) there is limited experimental data on the effects of testosterone on the immune system
and none on dose-response aspects.
7.745 In response to the US reference to the 1999 JECFA assessment, the European Communities
notes that the 1999 Opinion questions the quality of the study that provided the data for JECFA's
determination of the ADI. According to the Eu ropean Communities, neither the actual data nor
reference to a peer-reviewed publication were provi ded, the dose-response was limited to two doses
and the ADI was estimated from just a single dose wh ere no effect was observed rather than a curve
derived from all the data available.
869
Reasoning of the Panel
7.746 In light of the arguments of the parties, a nd having regard to the 1999 and 2002 Opinions 870
and to the fact that some of the insufficiencies identified by th e European Communities have been
addressed in the common section above, or were si mply not discussed by the European Communities
in its submissions, the Panel does not deem it necessary to address the mechanism of androgen
activity, the metabolic routes and elimination rates for testosterone in cattle or the daily production

867 EC's second written submission, paras. 160-161.
868 In its conclusion on carcinogenicity, the SCVPH notes that evidence about the role of endogenous
testosterone in the occurrence of prostate cancer is weak, that there is limited data on genotoxicity but that
testosterone might be aromatized to oestradiol, which had been found to be genotoxic, and that no conclusive
quantitative estimate of the risk arising from the excess intake with meat and meat products from treated animals
can be made.
869 EC's second written submission, para. 162; EC's rep lies to Panel questions after the first substantive
870 The 2000 Opinion did not identify essentially new toxicological information concerning
progesterone and testosterone in the data presented in the toxicological evaluation of the natural hormones
oestradiol-17β, progesterone and testosterone in animal prod uction by the JECFA (2000 Opinion, section 2.2,
p. 4).

rate data since these issues have either not been discussed specifically by the parties, or were
addressed above.
7.747 We also note that the 1999 Opinion found that genotoxicity of testosterone has not been
demonstrated with the limited testing done to date. 871 The 2002 Opinion adds that "[t]here is no
evidence that progesterone or testosterone have genotoxic potential."872
7.748 Likewise, the 1999 Opinion states that no info rmation is available on DNA damage induced
by testosterone or its metabolites. 873 This said, it states that "testosterone is ... aromatized to
oestradiol, which is metabolized to reactive fo rms that damage DNA and induce mutation." The
1999 Opinion then refers to its section on oestradiol-17β.
7.749 The 1999 Opinion also reports that "[w]hereas the evidence in favour of carcinogenicity was
considered sufficient for testosterone in experi mental animals, data in humans are limited." 874 This
reference has to be read in conjunction with the following paragraph of the 1999 Opinion, which
states that the evidence regarding the role of testos terone in prostate cancer is currently weak. In
addition, it seems to relate to endogenous testosterone. The 1999 Opinion adds that no conclusive
quantitative estimate of the risk arising from the excess intake with meat and meat products from
treated animals can be made.
7.750 These comments do not, in our opinion, meet our test that there be a critical mass of new
evidence and/or information that calls into questi on the fundamental precepts of previous knowledge
and evidence to make relevant, previously sufficien t, evidence now insufficient and would lead us to
consider that no risk assessment could be performed. We note in this respect that the 1999 Opinion
notes that testosterone is "considered as pr obable carcinogenic to humans (IARC group 2A)". 875
IARC specified that "this category is generally used when there is limited evidence in humans and
sufficient evidence in experimental animals." 876 We also note that IARC assessments are made in
general terms, not specifically in relation to cons umption of meat treated with hormones for growth
promotion purposes.
7.751 Regarding carcinogenicity of testosterone, Dr . Boisseau mentioned that IARC confirms the
1999 Opinion to the extent that it has determined that there is sufficient evidence of carcinogenicity in
experimental animals and advised, "In the absence of adequate data in humans, it is reasonable, for
practical purposes, to regard testosterone as if it presented a carcinogenic risk to humans".877
7.752 Dr. Boisseau also stated that "the scientific evidence relied upon in the SCVPH Opinions does
not support the conclusion that the carcinogenic effects of testosterone are related to a mechanism
other than hormonal activity."
878
7.753 Having regard to the positions taken by the SCVPH in its 1999 and 2002 Opinions and the
views expressed by the experts, we do not find it ne cessary to address any further the questions of the
genotoxicity and carcinogencity of testosterone in our attempt at determ ining whether relevant

871 1999 Opinion, section 4.2.5.
872 2000 Opinion, section 4.3, p. 15. This was confirmed by the experts who expressed views on this
question. For instance, Dr. Guttenplan mentioned that: "there is no conclusive evidence presented by the EC that
the five hormones other than oestradiol-17 β, when consumed as residues in meat have genotoxic potential."
Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200.
873 EC's second written submission, para. 160, quoting 1999 Opinion, p. 49.
874 Ibid.
875 1999 Opinion, section 4.2.7.
876 See IARC reply to question 24 of the Panel, Annex E-3, p. 128.
877 IARC reply to question 25 of the Panel, Annex E-3, p. 129.
878 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 160.

scientific evidence is insufficient w ith respect to this hormone, within the meaning of Article 5.7 of
the SPS Agreement.
Conclusion
7.754 Having regard to our specific conc lusions above, we recall that the Appellate Body clarified
in Japan – Apples that relevant scientific evidence will be insufficient within the meaning of
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative
terms, the performance of an adequate assessment of risks as required under Article 5.1. In this
respect, we note that, at our request, the experts also expressed their views on the more general
question whether the scientific evidence available at the time of the adoption of Directive 2003/74/EC
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated,
inter alia, with testosterone. Dr. Boobis replied that:
"[T]here was sufficient information availabl e to the EC to have enabled it to have
conducted an assessment of the risks to human health arising from consumption of
meat from cattle treated with any of the six hormones at issue."
7.755 We also note Dr. Guttenplan's comment that:
"Progesterone, testosterone have been ex tensively investigated and the assessment
seems sound and is based on the no effect level and a safety factor. (JECFA
meeting 52, report-WHA TRS 893)."
7.756 These general remarks support our conclusions on the specific elements discussed above. We
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with
respect to testosterone, within the meaning of Article 5.7 of the SPS Agreement.
(ix) Is relevant scientific evidence insufficient in the case of trenbolone acetate?
Summary of the main arguments of the parties
879
7.757 As described above, the United States argues that JECFA assessments have shown that
hormone residues in meat from animals treated for growth promotion are safe and that evidence is
sufficient for a risk assessment. The United States also notes that the authors of one of the 17 studies
relied upon by the European Communities later concl uded that none of the three synthetic growth
promoters tested demonstrated evidence of genotoxicity.880
7.758 The European Communities , quoting the 1999 Opinion, identifies the following
insufficiencies in the scientific evidence:881
(a) the need to further investigat e the metabolic fate and chemical nature of covalently
bound residues of trenbolone acetate;
(b) in humans, no data are currently availabl e to assess the carcinogenicity of trenbolone
acetate;882

879 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
880 US's second written submission, footnote 41.
881 EC's second written submission, para. 165.

(c) regarding effects on reproduction, the av ailable data do not allow a realistic
assessment of a dose-response relationship;
(d) investigations of the effects of trenbolone acetate on the immune system are very
limited.
7.759 The European Communities adds that the SC VPH concluded that the information is
insufficient to assess the possible impacts of low levels of trenbolone acetate in meat on consumers.
7.760 The European Communities indicates that, in its 2002 Opinion, th e SCVPH found these
conclusions to be compounded by da ta obtained in certain of the 17 studies and more recent research,
none of which was considered by the 1988 JECFA report. The European Communities argues that the
only assessment on trenbolone acetate publicly available is that of JECFA, and that the SCVPH took
this assessment into account, but di sagreed with a number of its basic findings on the basis of more
recent scientific research.883
Reasoning of the Panel
7.761 In light of the arguments of the parties and of the fact that some of the insufficiencies
identified by the European Comm unities have been addressed in th e common section above, or were
simply not discussed by the European Communities in its submissions, the Panel will limit its analysis
to determining whether relevant scientific eviden ce is insufficient concerning trenbolone acetate with
regard to the following aspects:
(a) metabolism of trenbolone acetate;884
(b) inadequate evidence of carcinogenicity in humans.
Metabolism of trenbolone acetate
7.762 The European Communities refers to the 2002 Op inion which states that "experiments with
zeranol and trenbolone acetate suggested a more complex oxidative metabolism than previously
assumed. These data need further clarification as they might influence a risk assessment related to
tissue residues of these compounds."
885
7.763 We note that Dr. Boobis discussed study 4 of the 17 studies:
"The metabolism of zeranol and trenbolone ha d been further investigated (study 4).
These data do not appear to have been pub lished in the peer reviewed literature to
date.
The data on trenbolone show that the alpha enantiomer in liver slices from bovine is
extensively conjugated and hence inactivated. There is some conversion of the alpha
to the active β isomer by human liver microsomes, but the kinetics of the reaction and
the extent of conjugation have not been determined. No data were presented on

882 In its conclusion on carcinogenicity, the SCVPH notes that in consideration of the lack of in vitro
short-term assays on mutagenicity and genotoxicity of certain TBOH metabolites and in consideration of the
equivocal results of cell transformation assays and the in vivo studies, the available information is insufficient to
complete a quantitative risk assessment. 1999 Opinion, section 4.4.7, p 59.
883 EC's second written submission, paras 166-167; EC's replies to Panel questions after the first
substantive meeting, question 22, Annex B-1, para. 126.
884 EC's second written submission, para. 165, quoting 1999 Opinion at pp. 55-60.
885 2002 Opinion, section 7, p. 21.

levels of the alpha enantiomer in meat fro m treated cattle. However, these data do
not affect the risk assessment of trenbol one acetate. This is because a) the
toxicological studies were conducted in animal s that would have been exposed to the
metabolites of concern, b) JECFA consider ed residues of both the alpha and the β
enantiomers in recommending MRLs for trenbolone acetate."886
7.764 No other expert expressed views on the subject.
7.765 The Panel is cognizant that the European Communities argues that Dr. Boobis' comments on
a number of the studies generated by the European Communities are flawed and has given examples
of those alleged flaws. 887 However, it does not expressly address Dr. Boobis' comments on the study
discussed above. As a result, the Panel sees no reas on not to take the comments of Dr. Boobis fully
into account in its assessment of the sufficiency of existing relevant scientific evidence.
Inadequate evidence of carcinogenicity in humans
7.766 The European Communities refers to the 1999 Opinion which recalls that trenbolone acetate
is a synthetic androgen and that both the parent compound and its metabolite have been extensively
tested for their mutagenic/genotoxic potential. The 1999 Opinion notes that it might be concluded
that the genotoxic effects of trenbolone acetate are not related to their hormonal activity. It notes that
"[f]ormation of DNA adducts has been observed in rat hepatocytes ... (Metzler, 1999)." On
carcinogenicity, the 1999 Opinion mentions inter alia that a two-year carcinogenesis 888 bioassay in
rats and mice did not provide definitive results. In humans, no data are currently available to assess
the carcinogenicity of trenbolone acetate. The 1999 Opinion concludes that the available information
is insufficient to complete a quantitative risk assessment.889
7.767 Regarding this aspect, Dr. Boisseau mentioned the following:
"In its thirty second session held in 1987 , JECFA concluded from carcinogenic
studies in animals that "the liver hyperplasia and tumours in mice … and the slight
increase in the incidence of islet-cell of the pancreas of rats arose as a consequence of
the hormonal activity of trenbolone". In its thirty fourth session held in 1989, JECFA,
having reviewed a comprehensive battery of short term tests, concluded that 'it was
unlikely that trenbolone acetate was genotoxic' and decided to confirm its previous
conclusion to base the evaluation of trenbolone acetate and its metabolites on their
no-hormonal-effect."890

886 Reply of Dr. Boobis to question 62 of the Panel, Annex D, paras. 479-480.
887 EC's comments on the replies of the experts, Annex F-1, p. 40.
888 Mechanism (or mode of action) of carcinogenesis:a mode of action is series of key events which are
necessary to lead to the formation of a tumour. Thes e key events comprise the biological changes induced by
the chemical and subsequent events which then lead to the development of cancer. A mechanism refers to the
molecular events that are responsibl e for those changes. A hormonal mech anism means that it is the endocrine
or hormonal effect of a compound that leads to growth or proliferation of certain cells that are responsive to the
hormone, resulting in the development of a tumour. A genotoxic mechanism means th at there is a mechanism
independent of the hormonal action resulting in direct damage to the DNA that leads to a tumour. There are
situations where elements of more than one mechanism could apply (Transcript of the Panel meeting with the
experts, Annex G, paras. 103-109 (Dr. Boobis, Dr. Cogliano and Dr. Guttenplan)).
889 1999 Opinion, pp. 57-59.
890 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 163.

7.768 The 2002 Opinion refers to the results of study 2 of the 17 studies with respect to
mutagenicity and genotoxicity (Metzler and Pfeiffer, 2001).891
7.769 Three experts expressed their views in relation to the subject of this study. Dr. Boobis
mentions the following:
"There is no convincing evidence that trenbolone acetate, MGA and zeranol are
genotoxic. They were negative in a range of tests for genotoxicity. They were very
weakly positive in a micronucleus test, at high (potentially cytotoxic) concentrations.
Trenbolone also produced a low level of DNA adducts measured by 32P-post-
labelling (Metzler and Pfeiffer, 2001) .892 As indicated above, micronuclei can arise
via a non-genotoxic mechanism, particularly at concentrations that may have caused
some toxicity. In addition, the 32P-post-la belling assay is not specific, and data cited
above suggest that DNA adduction can arise by mechanisms other than direct
interaction with DNA. In no case did a ny of the compounds produce a mutagenic
response. These data are insufficient to support the conclusion that these hormones
have genotoxic potential in vivo. Thus, there is no evidence that any of the hormones
are genotoxic in vivo at the levels found in meat from treated animals. Even if GVP
were not followed, the levels of exposur e to the hormones would be such that no
genotoxicity would be anticipated in vivo."893
7.770 Dr. Boobis added that:
"Study 4 reports recent observations on the genotoxicity and mutagenicity of zeranol
and trenbolone. Both compounds were ne gative for tests of mutagenicity, i.e.
induction of lacI mutations in E coli and induction of hprt mutations inV79 cells.
Zeranol did not produce DNA adducts in ra t hepatocytes whilst a low level of DNA
adducts was observed with trenbolone. Both were very weakly positive in a
micronucleus test, at high (potentially cytotoxic) concentrations. As indicated above
..., micronuclei can arise via a non-genotoxic mechanism, particularly at
concentrations that may have caused some toxicity. In addition, the 32P-post-
labelling assay is not specific, and data cited above suggest that DNA adduction can
arise by mechanisms other than direct interaction with DNA. These data are
insufficient, given the number of well conducted studies in which the compounds
were negative, to alter the conclusion that neither zeranol nor trenbolone acetate has
genotoxic potential in vivo. Indeed, the SVCPH (2002) concluded that "both
compounds exhibited only very weak effects" in those in vitro tests in which positive
effects were observed."
894
7.771 Dr. Guttenplan confirmed the conclusions of the two other experts:
"[t]here is no conclusive evidence presented by the EC that the five hormones other
than oestradiol-17 β, when consumed as residues in meat have genotoxic potential.
There is some evidence that certain of the hormones have genotoxic potential, but
generally the potential is weak. ... Trenbolone is either negative or marginally active
in in vitro genotoxic assays. ... Any genotoxic effects of the five hormones are likely

891 2002 Opinion, section 4.4.3.
892 Dr. Boobis cited to Metzler M and Pfeiffer E (2001). Genotoxic potential of xenobiotic growth
promoters and their metabolites. APMIS, 109:89-95
893 Reply of Dr. Boobis to question 21of the Panel, Annex D, para. 198.
894 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 483.

to be minimized by good veterinary practice. My reply for the hormones would not
have been different in September 2003 (SCVPH 2002 Opinion)."895
7.772 The European Communities argues essentially that the 1999, 2000 and 2002 Opinions provide
enough evidence to demonstrate that genotoxicity an d other adverse effects from these hormones are
possible and that there are a number of uncertainties surrounding their mechanism of action to warrant
further investigations. The European Communities refers to Dr. Guttenplan's statement.896
7.773 We do not read the statement above as the European Communities does. Rather we
understand Dr. Guttenplan to say that the genotoxic potential of trenbolone acetate is weak.
7.774 Regarding carcinogenicity, we first note that trenbolone acetate has not been evaluated by
IARC, nor have the specific risks from the consumpti on of meat from cattle treated with this growth
promotion hormone.897
7.775 Dr. Boisseau made the following comments:
"In its 1999 report, SCVPH concluded, about the carcinogenicity of trenbolone, that
'in consideration of the lack of in vitr o short term assays on mutagenicity and
genotoxicity of other trenbolone metabolites other than α-trenbolone and in
consideration of the equivocal results of the transformation assays and the in vivo
studies, the available information is insu fficient to complete a quantitative risk
assessment'. Therefore, the scientific evidence relied upon in the SCVPH Opinions
does not support the conclusion that the car cinogenic effects of trenbolone are related
to a mechanism other than hormonal activity."898
7.776 The European Communities seeks to refute Dr. Boisseau's co mments on the basis that he
refers only to the JECFA's reports, which are outdate d and based on old data, and that he interprets
lack of data as lack of adverse effects.
7.777 We recall our test in order to assess whether releva nt scientific evidence is insufficient is that
there should be new evidence and/or information that calls into question the fundamental precepts of
previous knowledge and evidence so as to make relevant, previously sufficient evidence, now
insufficient. We note that the European Commun ities points at possibilities which are not confirmed
by the experts who expressed their views. We theref ore conclude that the elements before us do not
support the conclusion that the relevant scientific evidence has become in sufficient, within the
meaning of Article 5.7 of the SPS Agreement, regarding the carcinogenicity of trenbolone acetate.
Conclusion
7.778 Having regard to our specific conclusions above, we recall that the Appellate Body clarified
in Japan – Apples that relevant scientific evidence will be insufficient within the meaning of
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative
terms, the performance of an ade quate assessment of risks as required under Article 5.1. In this
respect, we note that, at our request, the experts also expressed their views on the more general
question whether the scientific evidence available at the time of the adoption of Directive 2003/74/EC
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated,
inter alia, with trenbolone acetate. Dr. Boobis replied that:

895 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200.
896 EC's comments on expert replies to question 21 of the Panel, Annex F-1, pp. 17-18.
897 IARC reply to question 25 of the Panel, Annex E-3, p. 129.
898 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 164.

"[T]here was sufficient information availabl e to the EC to have enabled it to have
conducted an assessment of the risks to human health arising from consumption of
meat from cattle treated with any of the six hormones at issue."
7.779 We also note Dr. Guttenplan's comment that:
"There is more limited evidence available for Trenbolone and Zera nol and most of it
is in vitro (SCVPH 2002 Opinion) or not recent (e.g., JECFA meeting 34 th report,
1989 and 32 nd report, 1988). However, both appear to be potentially significantly
estrogenic. Experimental and analytic al methods have improved but it does not
appear that accurate ADI's can be established at this point. Studies in experimental
animals and studies on levels in beef ar e still needed. However, from the data
available at the time of the Directive, th e potential for adverse effects could not be
ruled out."899
7.780 We note, however, that during our meeting with the experts, Dr. Guttenplan clarified, at the
EC request, that "the ability [to make a risk assess ment] varies between compounds, but that does not
mean that you can't make a risk assessment, it just means that the accuracy of the risk assessment is
different."900 Regarding the establishment of accurate ADI s, Dr. Guttenplan clarified that "accurate
means – if it's not accurate, there is just a larger range, but you can still do a risk assessment."901
7.781 These general remarks support our conclusions on the specific elements discussed above. We
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with
respect to trenbolone acetate, within the meaning of Article 5.7 of the SPS Agreement.
(x) Is relevant scientific evidence insufficient in the case of zeranol?
Summary of the main arguments of the parties902
7.782 As described above, the United States argues that JECFA assessments have shown that
hormone residues in meat from animals treated for growth promotion are safe and that evidence is
sufficient for a risk assessment. The United States also notes that the authors of one of the 17 studies
relied upon by the European Communities later concl uded that none of the three synthetic growth
promoters tested demonstrated evidence of genotoxicity.903
7.783 The European Communities , quoting the 1999 Opinion, identifies the following
insufficiencies in the evidence:904
(a) there are only few tests with equivocal results on the genotoxic properties of zeranol,
which are insufficient for an evaluation of its mutagenic/genotoxic properties;

899 Reply of Dr. Guttenplan to question 61 of the Panel, Annex D, para. 457.
900 Transcript of the Panel meeting with the experts, Annex G, para. 983.
901 Transcript of the Panel meeting with the experts, Annex G, para. 985.
902 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
903 US's second written submission, footnote 41.
904 EC's second written submission, para. 168.

(b) no data are available on cancer risk fo r humans linked to meat with zeranol
residues;905
(c) no dose-response relationship for effects of zeranol on growth and reproduction can
be made;
(d) no relevant data on effects on the immune system were found.
7.784 The European Communities notes that, in conclusion, the 1999 Opinion finds that the
available data do not allow a quantitative estimate of the risk arising from exposure to zeranol
residues, and that further data are needed on the nature of the metabolites formed in bovines. The
European Communities indicates that in its 2002 Op inion, the SCVPH found these conclusions to be
compounded by data obtained in certain of the 17 studies and more recent research.906
7.785 The European Communities cites a study by US scientists according to which meat and serum
from zeranol-implanted cattle possess "heat-stable mit ogenicity for cultured breast cells, and that both
normal and cancerous human breast cells exhibit estrogenic responses to zeranol". 907 These scientists
then point to potential tumorigenic effects for oestrogen, including direct genotoxic effects of
oestrogen metabolites. They point out that the mechanisms responsible for oestrogen stimulated
carcinogenesis remain undefined. The European Communities argues that these studies clearly
invalidate the findings of the 1988 JECFA opinion.
908
7.786 The European Communities also argues th at the only assessment on zeranol publicly
available is that performed by JECFA in 1988. The European Communities indicates that the SCVPH
took this assessment into account, but disagreed with a number of its basic findings on the basis of
more recent scientific research, some of which was generated by the 17 studies 909 (studies Nos. 2, 4
and 10) and more recent research.
Reasoning of the Panel
7.787 In light of the arguments of the parties and of the fact that some of the insufficiencies
identified by the European Comm unities have been addressed in th e common section above, or were
simply not discussed by the European Communities in its submissions, the Panel will limit its analysis
to determining whether relevant scientific evidence is insufficient concerning zeranol with regard to
the alleged inadequate evidence of carcinogenicity in humans, such as lack of information available
on mutagenicity and genotoxicity and lack of information on DNA adducts and DNA damages.
7.788 The 1999 Opinion referred to by the European Communities states that the mutagenicity and
genotoxicity of zeranol was investigated only in a few tests which gave equivocal results insufficient
for an evaluation of the mutagenic/genotoxic prope rties of zeranol. As far as carcinogenicity is
concerned, the 1999 Opinion concludes that ther e is clear evidence for the induction of liver

905 In its conclusion on carcinogenicity, the SCVP H states that considering the limited data on
mutagenicity/genotoxicity and the clear evidence for an induction of liver ad enomas and carcinomas in
hamsters, no assessment of the possible carcinogenicity of zeranol can be made. See 1999 Opinion,
section 4.5.7, p. 65.
906 EC's second written submission, paras. 168-169.
907 EC's second written submission, paras. 145-146, citing a study by Suling Liu and Young C. Lin,
Exhibit EC-8.
908 EC's second written submission, para. 170.
909 EC's second written submission, para. 168; EC's rep lies to Panel questions after the first substantive

adenomas and carcinomas in one animal species, but no assessment of the possible carcinogenicity of
zeranol can be made.910
7.789 Five experts provided views on this matter. Dr. Cogliano limited his comments to the study
by Norat et al. (2005) 911, one of the three recently publishe d studies on which the Panel sought the
views of the experts, which addresses the association between consumption of red meat and colorectal
cancer. The comments by Dr. Cogliano are not specifi c with respect to the question of the potential
carcinogenicity of zeranol.
7.790 Dr. Boisseau expressed the following opinion:
"In its thirty second session held in 1987, JECFA concluded that zeranol and its
metabolites, zearalanone and taleranol, were not mutagenic in a number of tests in
bacterial and mammalian systems even if it has noted that zeranol gives a positive
result in the Rec-assay and taleranol giv es a positive result in the test with Chinese
hamster ovary cells in the absence of activa tion but a negative result with activation.
After having reviewed the carcinogenicity st udies in animals, JECFA concluded that
'the tumorigenic effect of zeranol was associated with its oestrogenic properties'."912
7.791 The 2002 Opinion refers to a comparative study (study 4 of the 17 studies) designed to
determine the potential of zeranol, trenbolone and melengestrol acetate to ca use genetic damages in
various in vitro systems. The 2002 Opinion states that "[i]n this study zeranol did not induce
genotoxicity or mutagenicity."913
7.792 Dr. Sippell mentioned that "[S]ynthetic hormone growth promoters such as Zeranol and its
metabolites have been shown to be as potent as [est radiol] and diethylstilbestrol (DES) in increasing
the expression of estrogen-related genes in human breast cancer cells ( Leffers et al 2001 –
study 17)."914 However, Dr. Boobis specified that:
"The study referred to (study 17), reported in Leffers et al (2001) , showed that a
number of oestogenic compounds affected th e expression of several genes in the ER
positive breast cancer cell line, MCF7. The responsiveness of this cell line to
oestrogens is well established. It was of interest that all of the changes reported by
Leffers et al (2001) were blocked by the selective ERantagonist ICI82.780. The
relevance of effects observed in a cultured cell line to the situation in vivo , where
kinetic and metabolic factors will influen ce the magnitude of the response is not
known, nor is the significance of changes in gene expression to the toxicity of the
hormones known. Many of the changes will reflect the proliferative response to an
oestrogenic stimulus. However, in general toxicogenomic data, in the absence on any
information on the functional consequences, is not considered a sound basis for use in
risk assessment (IPCS, 2003)."
915

910 1999 Opinion, sections 4.5.5 to 4.5.7.
911 Exhibit EC-71.
912 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 165.
913 2002 Opinion, section 4.4.3, p. 16.
914 Reply of Dr. Sippell to question 41 of the Panel, Annex D, para. 336.
915 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 475. Dr. Boobis cites to:

IPCS (2003). Toxicogenomics and the Risk Assessment of Chemicals for the Protection of
Human Health
(http://www.who.int/entity/ipcs/methods/en/toxicogenomicssummaryreport.pdf)

7.793 Dr. Boobis added that:
"There is no evidence that the hormones t estosterone or progesterone have genotoxic
potential. There is no convincing evidence that trenbolone acetate, MGA and zeranol
are genotoxic. They were negative in a range of tests for genotoxicity. They were
very weakly positive in a micronucleus test, at high (potentially cytotoxic)
concentrations. Trenbolone also produced a low level of DNA adducts measured by
32P-post-labelling (Metzler and Pfeiffer, 2001) .916 As indicated above, micronuclei
can arise via a non-genotoxic mechanism, particularly at concentrations that may
have caused some toxicity. In addition, the 32P-post-labelling assay is not specific,
and data cited above suggest that DNA adduc tion can arise by mechanisms other than
direct interaction with DNA. In no case did any of the compounds produce a
mutagenic response. These data are insuffi cient to support the conclusion that these
hormones have genotoxic potential in vivo. Thus, there is no evidence that any of the
hormones are genotoxic in vivo at the levels found in meat from treated animals.
Even if GVP were not followed, the levels of exposure to the hormones would be
such that no genotoxicity would be anticipated in vivo."
7.794 Dr. Boobis, commenting on study 4, added the following:
"Study 4 reports recent observations on the genotoxicity and mutagenicity of zeranol
and trenbolone. Both compounds were ne gative for tests of mutagenicity, i.e.
induction of lacI mutations in E coli and induction of hprt mutations inV79 cells.
Zeranol did not produce DNA adducts in ra t hepatocytes whilst a low level of DNA
adducts was observed with trenbolone. Both were very weakly positive in a
micronucleus test, at high (potentially cytotoxic) concentrations. As indicated above
..., micronuclei can arise via a non-genotoxic mechanism, particularly at
concentrations that may have caused some toxicity. In addition, the 32P-post-
labelling assay is not specific, and data cited above suggest that DNA adduction can
arise by mechanisms other than direct interaction with DNA. These data are
insufficient, given the number of well conducted studies in which the compounds
were negative, to alter the conclusion that neither zeranol nor trenbolone acetate has
genotoxic potential in vivo. Indeed, the SVCPH (2002) concluded that 'both
compounds exhibited only very weak effects' in those in vitro tests in which positive
effects were observed."
917
7.795 Dr. Guttenplan commented in more general terms that:
"There is no conclusive evidence presented by the EC that the five hormones other
than oestradiol-17 β, when consumed as residues in meat have genotoxic potential.
There is some evidence that certain of the hormones have genotoxic potential, but
generally the potential is weak. .... Zeranol can induce transformation of breast
epithelial cells in culture with efficiency similar to that of estradiol, but the
mechanism is not known, and it is negative or marginally active in other assays. ...
Any genotoxic effects of the five hormone s are likely to be minimized by good

Leffers H, Naesby M, Vendelbo B, Skakkebaek NE and Jorgensen M (2001). Oestrogenic
potencies of Zeranol, oestradiol, diethylstilboestrol, Bisphenol-A and genistein: implications
for exposure assessment of potential endocrine disrupters. Hum Reprod, 16:1037-1045.

916 Dr. Boobis cited to Metzler M and Pfeiffer E (2001). Genotoxic potential of xenobiotic growth
promoters and their metabolites. APMIS, 109:89-95; see Reply of Dr. Boobis to question 21 of the Panel,
Annex D, para. 198.
917 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 483.

veterinary practice. My reply for the hormones would not have been different in
September 2003 (SCVPH 2002 Opinion)."918
7.796 Regarding carcinogenicity of zeranol, Dr. Boisseau mentioned that:
"In its 1999 report, SCVPH concluded, about the carcinogenicity of zeranol, that "in
consideration of the lack of data on muta genicity/genotoxicity and the clear evidence
for an induction of liver adenomas a nd carcinomas in one animal species, no
assessment of the possible carcinogenicity of zeranol can be made". Therefore, the
scientific evidence relied upon in the SCVPH Opinions does not support the
conclusion that the carcinogenic effects of zeranol are related to a mechanism other
than hormonal activity."919
7.797 Referring to the study by Liu S and Lin YC (2002)920, Dr. Guttenplan stated that:
"The first of the studies suggests a risk from zeranol. That observation was not
previously reported. However, the results were obtained in cultured cells and the
relevance to human exposure to hormone-tr eated cannot be extrapolated from this
study because of a myriad of uncertainti es in such extrapolation. The study does
suggest that additional tests of zeranol should be carried out. There is also some
evidence that a metabolite of zeranol ( zearalenone) induces oxidative damage in
cultured cells. This is a possible genotoxic effect, but again it cannot be extrapolated
to meat consumption."
921
7.798 Zeranol has not been evaluated by IARC, nor ha ve the specific risks from the consumption of
meat from cattle treated with this growth promotion hormone.922
7.799 The European Communities argues that Dr. Gutte nplan made a "careful and scientifically
sound statement".923 We note, however, that Dr. Guttenplan c oncluded that a genotoxic effect cannot
be extrapolated to meat consumption, because of th e "myriad of uncertainties" that such extrapolation
would entail.
7.800 On the basis of the arguments of the parties and of the experts' opinions, we conclude that it is
not established that relevant scientific evidence is insufficient in relation to the carcinogenicity of
zeranol, within the meaning of Article 5.7 of the SPS Agreement.
Conclusion
7.801 Having regard to our specific conc lusions above, we recall that the Appellate Body clarified
in Japan – Apples that relevant scientific evidence will be insufficient within the meaning of
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative
terms, the performance of an ade quate assessment of risks as required under Article 5.1. In this
respect, we note that, at our request, the expert s also expressed their views on the more general
question whether the scientific evidence available at the time of the adoption of Directive 2003/74/EC
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated,
inter alia, with zeranol. Dr. Boobis replied that:

918 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200.
919 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 166.
920 Liu S and Lin YC (2004). Transformation of MCF-10A human breast epithelial cells by zeranol
and oestradiol-17.β Breast J, 10:514-521, Exhibit EC-62.
921 Reply of Dr. Guttenplan to question 25 of the Panel, Annex D, para. 234.
922 IARC reply to question 25 of the Panel, Annex E-3, p. 129.
923 EC's comments on experts replies to question 25 of the Panel, Annex F-1, p. 21.

"[T]here was sufficient information availabl e to the EC to have enabled it to have
conducted an assessment of the risks to human health arising from consumption of
meat from cattle treated with any of the six hormones at issue."
7.802 We also note Dr. Guttenplan's comment that:
"There is more limited evidence available for Trenbolone and Zera nol and most of it
is in vitro ( SCVPH 2002 Opinion ) or not recent (e.g., JECFA meeting 34 th report,
1989 and 32 nd report, 1988). However, both appear to be potentially significantly
estrogenic. Experimental and analytic al methods have improved but it does not
appear that accurate ADI's can be established at this point. Studies in experimental
animals and studies on levels in beef ar e still needed. However, from the data
available at the time of the Directive, th e potential for adverse effects could not be
ruled out."924
7.803 We note, however, that during our meeting with the experts, Dr. Guttenplan clarified, at the
EC request, that "the ability [to make a risk assess ment] varies between compounds, but that does not
mean that you can't make a risk assessment, it just means that the accuracy of the risk assessment is
different."925 Regarding the establishment of accurate ADI s, Dr. Guttenplan clarified that "accurate
means – if it's not accurate, there is just a larger range, but you can still do a risk assessment."926
7.804 These general remarks support our conclusions on the specific elements discussed above. We
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with
respect to zeranol, within the meaning of Article 5.7 of the SPS Agreement.
(xi) Is relevant scientific evidence insufficient in the case of melengestrol acetate (MGA)?
Summary of the main arguments of the parties927
7.805 The United States considers that there is suffici ent evidence for a risk assessment on
melengestrol acetate and argues that JECFA has carried out a risk assessment. The United States also
notes that the authors of one of the 17 studi es relied upon by the European Communities later
concluded that none of the three synthetic grow th promoters tested demonstrated evidence of
genotoxicity.928
7.806 The European Communities , quoting passages the 1999 Opinio n, identified the following
insufficiencies in the evidence:929
(a) only limited data are available concerning residues of melengestrol acetate in treated
cattle;
(b) no information is available on mutagenicity and genotoxicity;
(c) no information is available on DNA adducts and DNA damage.;

924 Reply of Dr. Guttenplan to question 61 of the Panel, Annex D, para. 457.
925 Transcript of the Panel meeting with the experts, Annex G, para. 983.
926 Transcript of the Panel meeting with the experts, Annex G, para. 985.
927 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
928 US's second written submission, footnote 41.
929 EC's second written submission, paras. 172-173.

(d) carcinogenicity studies have been conducte d in only one animal species, which is
inadequate to assess the carcinogenic potential of melengestrol acetate;930
(e) available data on effects of melengestrol acetate on growth and reproduction do not
allow an estimate of the dose-response relationship;
(f) data on the effect of melengestrol acetate on the immune system are also very limited.
7.807 The European Communities adds that the SCVPH concluded that the available information is
insufficient for a quantitative estimate of the risk to the consumer of meat from treated animals. The
European Communities indicates that in its 200 2 Opinion, the SCVPH found these conclusions
compounded by data obtained in certain of the 17 studies.
7.808 The European Communities recalls the finding of the Appellate Body in EC – Hormones that
no risk assessment had been performed and notes that Codex has not adopted an international standard
on melengestrol acetate, although JECFA assessed melengestrol acetate in 2000 (and in 2004 as
regards calculation of the MRL). The European Communities argues that in the absence of a Codex
standard, the opinion of JECFA becomes irrelevant. In addition, the European Communities indicates
that JECFA failed to take into account the more recent data generated by its 17 studies and the 2002
Opinion.931
7.809 The European Communities argues that the SC VPH took into account the JECFA assessment
and noted that no original data had been presente d in the JECFA report and that the majority of
references were to reports that had not been published in the peer-reviewed scientific literature.932
7.810 The European Communities notes that the United States refers to a draft 2005 report from the
UK Committee on Veterinary Practices. According to the European Communities, this report notes
that there are important gaps in the evidence base for oestradiol-17 β and the other five hormonally-
active substances, as acknowledged in the Opinions. The cited passage then states a need for certain
information, including a number of issues where more information is needed to improve future risk
assessments.933
7.811 The European Communities concludes that ther e is no doubt that the 1999-2002 Opinions
constitute the only currently available risk assessme nt on melengestrol acetate, based on the most
recent, peer-reviewed, pertinent information ava ilable publicly from the European Communities. The
European Communities notes that these Opinions reached the conclu sion that the current state of
scientific knowledge does not permit a more definitive risk assessment to be carried out.934
Reasoning of the Panel
7.812 In light of the arguments of the parties and of the fact that some of the insufficiencies
identified by the European Comm unities have been addressed in th e common section above, or were
simply not discussed by the European Communities in its submissions, the Panel will limit its analysis
to determining whether relevant scientific evid ence is insufficient concerning melengestrol acetate
with regard to the following aspects:

930 In its conclusion on carcinogenicity, the SCVPH notes that in view of the lack of data on
mutagenicity/carcinogenicity and on DNA interaction, and in consideration of carcinogenicity studies conducted
only in one animal species, the data are inadequate to assess the carcinogenetic potential of melengestrol acetate.
931 EC's second written submission, para. 171.
932 EC's second written submission, para. 174; EC's rep lies to Panel questions after the first substantive
meeting, question 22, Annex B-1, paras. 126-127.
933 EC's second written submission, para. 175.
934 EC's second written submission, para. 176.

(a) only limited data are available concerning residues of melengestrol acetate in treated
cattle;
(b) 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. 935
7.813 As a preliminary remark, the Panel notes that C odex did not adopt any standard with respect
to melengestrol acetate. The Panel recalls, however, that while there is no international standard as
such, intensive work has been perfo rmed at the international level. JECFA made two assessments of
melengestrol acetate in 2000 and 2004 (the second time in order to propose a MRL). It was included
in the priority list for recalculation of MRLs and TMDI by the fifteenth session of CCRVDF that met
in 2005.936 The Panel notes in this respect that for mele ngestrol acetate, the draft MRL is currently at
Step 7 of the Codex elaboration procedure. 937 Moreover, the role of JECFA in the international risk
assessment process is such that some degree of rele vance should be given to that work. The Panel
also notes that at no time did the European Co mmunities request that melengestrol acetate be
considered by Codex.938
Data on residues of melengestrol acetate
7.814 The two main criticisms of the European Co mmunities regarding JECFA' s assessments are
that the residue data used by JECFA on melengestrol acetate are outdated and that JECFA did not take
into account the more recent studies commissioned by the European Communities. In the 2002
Opinion, the SCVPH noted that in the JECFA report no original data had been presented and that the
majority of references were to reports that had not been published in the peer-reviewed scientific
literature.939
7.815 We sought the views of the experts on this matter and two of them gave an opinion
(Dr. Boisseau, Dr. De Brabander). Both concurre d in saying that nearly all the studies used by
JECFA dated back to the 1960s and 1970s. However, neither of the two experts stated that these
studies were no longer valid.940
7.816 The Panel first recalls its position on so-called "old" data in paragraph 7.423 et seq. above.
7.817 Second, the Panel notes the opinion of Dr. Boisseau: "It is correct to say that nearly all the
studies referred to in the 2000 JECFA report on melengestrol acetate date from the 1960s and 1970s.
The comment to be made on this issue is [that] JECFA considered a wide series of toxicological
studies in its assessment, used as an end point a n on hormonal effect dose by far more conservative
than a NOAEL based on tumorigenic effect and adopt ed a 200 safety factor to derive an ADI from
this NOAEL."
941
7.818 Dr. Boobis also expressed his views on the more recent studies commissioned by the
European Communities. With r espect to the findings of study 4 referred to by the European
Communities regarding residues of melengestrol acetate, Dr. Boobis mentioned the following:

935 EC's second written submission, para. 172, quoting 1999 Opinion, p. 77.
936 Dr. Miyagishima, Codex representative, transcript of the Panel meeting with the experts, Annex G,
para. 524.
937 As explained by Dr. Miyagishima, transcript of the Panel meeting with the experts, Annex G,
para. 896.
938 Dr. Miyagishima, transcript of the Panel meeting with the experts, Annex G, para. 524.
939 2002 Opinion, p. 16.
940 Reply of Dr. De Brabander to question 35 of the Panel, Annex D, paras. 304-305.
941 Reply of Dr. Boisseau to question 35, Annex D, para. 303.

"In study 4, unpublished preliminary findi ngs on the in vitro metabolism of MGA
were reported. This study provided some evidence for the formation of multiple
metabolites of MGA by liver from human, rat and bovine. However, these findings
do not affect the risk assessment of MGA because a) the toxicological studies were
conducted in animals that would have been exposed to all of the metabolites of
concern, b) JECFA assumed that all of the residues in meat from animals treated with
MGA were as hormonally active as MGA when it proposed MRLs in 2002 (JECFA,
2002b). It was subsequently shown that this was a conservative decision, as not all of
the residues were as active as MGA itself (JECFA, 2006c)."
942
7.819 Although the European Communities criticized Dr. Boobis' analysis of some of the 17 studies
in its comments on the replies of the experts 943, it did not specifically address Dr. Boobis's comments
on study 4.
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
7.820 We note that the 2002 Opinion mentions that the genotoxicity of melengestrol acetate was
investigated (study 4) and that "[t]he resu lts were negative in several experiments using
concentrations in either 15-125 uM for HPRT muta tions, 20-100 uM for micronuclei induction, and
400uM for LacI mutations."944
7.821 This statement seems to confirm JECFA's conclusions, as recalled by Dr. Boisseau:
"[I]n its fifty fourth session, JECFA concluded from the review of a range of assays
in vitro and in vivo that melengestrol acetat e is not genotoxic. It also agreed upon the
fact that 'no firm conclusion could be drawn about the carcinogenic potential of
melengestrol acetate in ICR mice … the increased incidence of malignant tumors in
the highest-dose group of prepubertal C3Han/f mice was assumed to be due not to a
direct carcinogenic effect of melengestrol acetate but to the promoting effect of
increased prolactin concentrations'."
945
7.822 Dr. Boisseau's comment is confirmed by Dr. Boobis, referring inter alia to study 4 of the
17 studies commissioned by the European Communities:
"There is no convincing evidence that trenbolone acetate, MGA and zeranol are
genotoxic. They were negative in a range of tests for genotoxicity. They were very
weakly positive in a micronucleus test, at high (potentially cytotoxic) concentrations.
Trenbolone also produced a low level of DNA adducts measured by 32P-post-

942 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 484. Dr. Boobis cites to:

– JECFA (2002b). Residues of some veterinary drugs in animals and foods. FAO Food
and Nutrition Paper 41/14, Rome, Italy; and

– JECFA (2006c). Residues of some veterinary drugs in animals and foods. FAO,
Rome, Italy (in press).

943 EC's comments on the replies of the experts, Annex F-1, p. 40.
944 2002 Opinion, section 4.5.3, p. 18,"The general conclusions", states that "[d]ata on the genotoxicity
of melengestrol acetate indicate only weak effects", p. 22.
945 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 161.

labelling (Metzler and Pfeiffer, 2001) .946 As indicated above, micronuclei can arise
via a non-genotoxic mechanism, particularly at concentrations that may have caused
some toxicity. In addition, the 32P-post-la belling assay is not specific, and data cited
above suggest that DNA adduction can arise by mechanisms other than direct
interaction with DNA. In no case did a ny of the compounds produce a mutagenic
response. These data are insufficient to support the conclusion that these hormones
have genotoxic potential in vivo. Thus, there is no evidence that any of the hormones
are genotoxic in vivo at the levels found in meat from treated animals. Even if GVP
were not followed, the levels of exposur e to the hormones would be such that no
genotoxicity would be anticipated in vivo."
7.823 Dr. Guttenplan also agreed that:
"[T]here is no conclusive evidence presente d by the EC that the five hormones other
than oestradiol-17 β, when consumed as residues in meat have genotoxic potential.
There is some evidence that certain of the hormones have genotoxic potential, but
generally the potential is weak. ... MGA is negative in genotoxicity assays. Any
genotoxic effects of the five hormones are lik ely to be minimized by good veterinary
practice."947
7.824 We note that the European Communities argues that new studies have brought fresh evidence
which depart from the majority view. At our request, the experts commented on the 17 studies
commissioned by the European Communities. Rega rding study 4, which is referred to in the 2002
Opinion, Dr. Boobis confirmed the negative results concerning mutagenicity and genotoxicity of
melengestrol acetate:
"[i]n study 4 (mutagenicity and genotoxic ity of MGA), MGA was negative in studies
of the induction of hprt mutations in V79 cells, the induction of micronuclei in V79
cells and the induction of lacI mutations in E coli . Pure MGA had no effect on
apoptosis, which could potentially conf ound interpretation of studies using V79
cells."948
7.825 Dr. Boobis adds, with respect to DNA adducts, that:
"[P]reliminary studies with rat liver slices, reported in an abstract but not yet
published in the peer reviewed literatu re, suggested that MGA could produce
unidentified adducts with DNA. As indicat ed above, there are mechanisms of adduct
formation that do not involve direct inte raction of the inducing compound with DNA.
Overall, a report of putative covalent binding to DNA observed using 32P-post-
labelling is not sufficient to over-ride the consistently negative results of MGA in a
range of tests for mutagenicity. Hence, on the basis of the findings in study 5, there is
no reasons to change the risk assessment or MGA."949
7.826 Regarding carcinogenicity of melengestrol acetat e, we note that melengestrol acetate has not
been evaluated by IARC, nor have the specific risks from the consumption of meat from cattle treated

946 Dr. Boobis cited to Metzler M and Pfeiffer E (2001). Genotoxic potential of xenobiotic growth
promoters and their metabolites. APMIS, 109:89-95, see Annex D, para. 198.
947 Reply of Dr. Guttenplan to question 21 of the Panel, Annex D, para. 200. Dr. Guttenplan, referring
to the 2002 Opinion, mentioned that his reply for the hormones at issue would not have been different in
September 2003.
948 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 486.
949 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 486.

with this growth promotion hormone. 950 In reply to a question from the Panel on whether the
carcinogenic effects of the hormones at issue were related to a mechanism other than hormonal
activity, Dr. Boisseau replied that:
"[i]n its 1999 report, SCVPH concluded, a bout the carcinogenicity of melengestrol,
that: 'in view of the lack of data on mutagenicity/carcinogenicity and on DNA
interactions and in consideration of ca rcinogenicity studies conducted only in one
animal species, these data are inadequate to assess the carcinogenic potential of
melengestrol.' Therefore, the scientific evidence relied upon in the SCVPH Opinions
does not support the conclusion that the carcinogenic effects of melengestrol are
related to a mechanism other than hormonal activity."951
7.827 The European Communities cont ests these comments, arguing th at Dr. Boisseau interprets
lack of data as lack of adverse effect. 952 We do not agree with the European Communities. The test
to be met under Article 5.7 is that relevant scientific evidence be insufficient, and we have considered
that, in this case, this implied that there be a cr itical mass of new evidence and/or information that
calls into question the fundamental precepts of previous knowledge and evidence so as to make
relevant, previously sufficient, evidence now insufficient. This is also the case for melengestrol
acetate. We recall that JECFA evaluated this horm one on two occasions. This suggests that evidence
has been at one point sufficient. Having regard to this context, we do not read the EC comment, nor
any evidence presented in the course of these proceedings, as meeting the above-mentioned test.
Conclusion
7.828 Having regard to our specific conclusions above, we recall that the Appellate Body clarified
in Japan – Apples that relevant scientific evidence will be insufficient within the meaning of
Article 5.7 if the body of available scientific ev idence does not allow, in quantitative or qualitative
terms, the performance of an adequate assessment of risks as required under Article 5.1. In this
respect, we note that, at our request, the experts also expressed their views on the more general
question whether the scientific evidence available at the time of the adoption of Directive 2003/74/EC
and subsequently allowed the conduct of a risk assessment, in relation to meat from cattle treated,
inter alia, with melengestrol acetate. Dr. Boobis replied that:
"[T]here was sufficient information availabl e to the EC to have enabled it to have
conducted an assessment of the risks to human health arising from consumption of
meat from cattle treated with any of the six hormones at issue."
7.829 We also note Dr. Guttenplan's comment with respect to JECFA's risk assessment that:
"The assessment for melengestrol acetate seems sound. Thorough metabolic and
estrogenic studies have been carried out."
953
7.830 These general remarks support our conclusions on the specific elements discussed above. We
therefore conclude that it is not established that th e relevant scientific evidence is insufficient with
respect to melengestrol acetate, within the meaning of Article 5.7 of the SPS Agreement.

950 IARC reply to question 25 of the Panel, Annex E-3, p. 129.
951 Reply of Dr. Boisseau to question 16 of the Panel, Annex D, para. 162.
952 EC's comments on the experts replies, question 16, Annex F-1, p. 13.
953 Reply of Dr. Guttenplan to question 61 of the Panel, Annex D, para. 458.

(xii) Conclusion
7.831 We recall that we asked the scientific expert s whether the scientific evidence relied upon by
the European Communities supports th e EC contention that the new scientific studies that have been
initiated since 1997 have identified new important gaps, insufficiencies and contradictions in the
scientific information and knowledge now availabl e on these hormones such that more scientific
studies are necessary before the risk to human he alth from the consumption of meat from cattle
treated with these hormones for growth promotion purposes can be assessed.954
7.832 Three experts replied. In his written reply, Dr. Guttenplan saw several important gaps and
gave examples. However, at the meeting with the Panel, he specified that, "on subsequent reading,
[he] could not find anything to indicate adverse e ffect, and [he] now think[s] that risk assessment is
alright."955 He added that "the ability [to make a risk assessment] varies between compounds, but that
does not mean you can't make a risk assessment, it just means the accuracy of the risk assessment is
different."956 The other two experts considered that "these new data [provided by the European
Communities] [did] not demonstrate any important ga ps, insufficiencies or contradictions in the
scientific information used by JECFA for c onducting its risk assessments" (Dr. Boisseau) 957, or that
"[t]here was little information in the scientific studies initiated by the EC since 1997 that support the
contention that they have identified important ne w gaps, insufficiencies and contradictions in the
scientific information and knowledge on the horm ones, and that additional studies are necessary
before the risks to health of consumption of meat from treated animals can be assessed"
(Dr. Boobis).958 Dr. Boobis elaborated as follows:
"Whilst additional information has been obtained on a number of aspects of the
hormones in question, this was often not de finitive, sometimes it was not relevant, in
some instances it confirmed or expanded on previous knowledge. The evidence
obtained did not indicate any additional concern regarding the risk from exposure to
residues of the hormones in meat from cattle treated for growth promotion."
7.833 We also note that, at our meeting with expert s, Dr. Cogliano and Dr. Boobis confirmed, in
response to a question from the Panel, that the data were sufficient to perform a risk assessment based
on ADI, as done by JECFA.959
7.834 We recall that the test we applied in this case was that there must be a critical mass of new
evidence and/or information that calls into questi on the fundamental precepts of previous knowledge
and evidence so as to make relevant, previously su fficient evidence now insufficient. We note that the
experts who expressed themselves in detail on this ma tter have confirmed, both in general and for
each of the five hormones subject to a provisional ban, that such critical mass had not been reached.
7.835 For all these reasons, we conclude that it has not been demonstrated that relevant scientific
evidence was insufficient, within the meaning of Article 5.7 of the SPS Agreement, in relation to any
of the five hormones with respect to which the European Communities applies a provisional ban.
7.836 We recall that all four of the requireme nts identified by the Appellate Body in Japan –
Agricultural Products II with regard to the application of Article 5.7 of the SPS Agreement must be
satisfied in order to adopt and maintain a provisional measure. The Appellate Body noted that the four

954 Panel question 62.
955 Transcript of the Panel meeting with the experts, Annex G, para. 981.
956 Transcript of the Panel meeting with the experts, Annex G, para. 983.
957 Reply of Dr. Boisseau to question 62 of the Panel, Annex D, para. 460.
958 Reply of Dr. Boobis to question 62 of the Panel, Annex D, para. 495.
959 Transcript of the Panel meeting with the experts, Annex G, Dr. Cogliano, para. 871; Dr. Boobis,
para. 873.

requirements are "clearly cumulative in nature". Since we found that the first requirement (the
measure is imposed in respect to a situation wher e "relevant scientific evid ence is insufficient") has
not been satisfied, we do not find it necessary to address any of the three other requirements. We
therefore conclude that the EC compliance measure does not meet the requirements of Article 5.7 of
the SPS Agreement as far as the provisional ban on progesterone, testosterone, zeranol, trenbolone
acetate and melengestrol acetate is concerned.
7.837 Having reached that conclusion, we want to make clear that we only determined that it had
not been established that the existing relevant sci entific evidence was insuffi cient. This does not
mean that no measure can be imposed by the European Communities under the SPS Agreement in
relation to the five hormones at issue. Indeed, our determinations are without prejudice to the legality
of any EC measure regarding these hormones, shoul d the European Communities decide to complete
its risk assessments pursuant to Article 5.1 of the SPS Agreement.
(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 melengestrol acetate
Summary of the main arguments of the parties
960
7.838 The United States argues that the European Communities' import ban is not "based on"
international standards within the meaning of Artic le 3.3 as the relevant standards adopted by Codex
permit trade in meat and meat products from cattle treated with hormones for growth promotion
purposes by setting MRLs, as necessary, for residues of the hormones.961
7.839 The United States argues that, although Memb ers may introduce or maintain sanitary
measures which result in a higher level of sanitary protection than would be achieved by measures
based on the relevant international standard s, guidelines or recommendations, the European
Communities is not permitted to do so because it does not satisfy the requirement in Article 3.3 that
such stricter measures be in accordance with paragr aphs 1 through 8 of Article 5. Specifically, the
United States argues that because the European Communities measure is not based on a risk
assessment within the meaning of Article 5.1, or otherwise satisfies the conditions for maintaining a
provisional measure within the meaning of Article 5.7, the European Communities is acting contrary
to Article 3.3.962
7.840 The United States contends that Article 3.3 of the SPS Agreement requires that Members base
their measures on international standards where they exist and only permits Members to diverge from
such standards if there is a scientific justificati on for doing so. For purposes of this dispute, the
United States contends that such scientific justif ication could have taken the form of a properly
conducted risk assessment for oestradiol. However, the United States believes it has demonstrated
that the European Communities has failed to provide such a justification.963
7.841 The European Communities does not dispute that its ban on oestradiol-17 β is not based on
international standards, namely the Codex stan dard which requires no average daily intake or
maximum residue levels for oestradiol-17 β. Instead, the European Co mmunities argues that it is
permitted instead to prohibit the placing on the market , including a ban on imports, of meat and meat

960 A more detailed account of the parties' arguments can be found in Section IV of the descriptive part
of this Report. The order in which the respective argu ments of the parties are presented does not reflect any
allocation of the burden of proof by the Panel.
961 US's first written submission, para. 163.
962 US's first written submission, para. 164.
963 US's replies to Panel questions after the second substantive meeting, Annex C-3, para. 27.

products treated with oestradiol-17β for growth promotion purposes because its decision is based on a
comprehensive risk assessment, which is not in violation of Article 5.1 of the SPS Agreement.964
7.842 Additionally, the European Communities argues th at it decided not to use the Codex standard
on oestradiol-17 β, because the Codex recommendations are not only old but also do not allow the
European Communities to achieve the level of protection it considers appropriate in its territory.965
7.843 With respect to the other five hormones, th e European Communities considers that it is
possible, in the presence of an international sta ndard, guideline or recommenda tion that is based on a
risk assessment, to adopt a provisional sanitary measu re on the grounds that the relevant scientific
evidence is insufficient. A Member may disagree w ith the risk assessment for scientific reasons and,
in particular, on the issue of whether the scien tific evidence relied upon is sufficient. Such
disagreement may stem from differences of views on scientific questions such as methodology, data
interpretation etc. It may also result from the fact that in order to meet a higher level of protection,
the Member concerned may require more information than what is provided in the risk assessment in
question. As a concrete example, the JECFA study referred to by the defending parties did not take
into account the data obtained in the seventeen studies which had been performed upon the initiative
and with the funding of the European Communities.966
Reasoning of the Panel
7.844 Article 3.3 reads as follows:
"Members may introduce or maintain sanitary ... measures which result in a higher
level of sanitary ... protection than wo uld be achieved by measures based on the
relevant international standards, guid elines or recommendations, if there is a
scientific justification, or as a consequen ce of the level of sanitary ... protection a
Member determines to be appropriate in acco rdance with the relevant provisions of
paragraphs 1 through 8 of Article 5. 967 Notwithstanding the above, all measures
which result in a level of sanitary ... protection different from that which would be
achieved by measures based on international standards, guidelines or
recommendations shall not be inconsiste nt with any other provision of this
agreement."
7.845 We concluded above that the European Comm unities did not comply with Article 5.1 and
with Article 5.7 of the SPS Agreement. In light of our mandate and of our objectives in engaging in a
review of the conformity of the EC implementing measure with the SPS Agreement, we see no reason
to reach a conclusion on Article 3.3 of the SPS Agreement, to the extent that this conclusion depends
on a violation of Article 5.
7.846 We therefore refrain from drawing any conclu sion with respect to Article 3.3 of the
SPS Agreement.

964 EC's second written submission, paras. 213-214.
965 EC's second written submission, para. 119; EC's rep lies to Panel questions after the first substantive
meeting, Annex B-1, para. 129.
966 EC's replies to Panel questions after the first substantive meeting, question 72, Annex B-1.
967 (footnote original) For the purpose of paragraph 3 of Article 3, there is a scientific justification if, on
the basis of an examination and evaluation of available sc ientific information in conformity with the relevant
provisions of this agreement, a Member determines that the relevant international standards, guidelines or
recommendations are not sufficient to achieve its appropriate level of sanitary ... protection.

(h) Conclusion on Article 22.8 of the DSU
7.847 For the reasons stated above, we conclude that it has not been established that the European
Communities has removed the measure found to be inconsistent with a covered agreement.
7.848 We also note that the European Communities does not claim that it has provided a solution to
the nullification or impairment of benefits suffe red by the United States within the meaning of
Article 22.8 of the DSU.
7.849 None of the parties has claimed that a mutua lly satisfactory solution had been found in the
context of the EC – Hormones case.
7.850 For these reasons and those developed above, we find that the European Communities did not
demonstrate a breach of Article 22.8 of the DSU by the United States.
4. Violation of Articles 23.1 and 3.7 of the DSU
7.851 The Panel recalls its understanding that violations of Articles 23.1 and 3.7 were only claimed
in relation to the violation of Article 22.8 of the DS U. To the extent that Article 22.8 has not been
breached, the European Communities has not establishe d a violation of Articles 23.1 and 3.7 of the
DSU. The Panel concludes that there is no viol ation of Articles 23.1 and 3.7 of the DSU by the
United States as a result of a breach of Article 22.8.
D. VIOLATION OF ARTICLE I.1 AND ARTICLE II OF THE GATT 1994
7.852 The European Communities has clai med that there is a violation of Articles I:1 and II of the
GATT 1994 because the US continued suspension of obligations could not be justified anymore under
Article 22 of the DSU.
7.853 In light of our conclusions above, we see no basis to make findings in relation to these claims.
E. CONDITIONAL CLAIM OF VIOLATION OF ARTICLE 22.8 OF THE DSU MADE IN THE
ALTERNATIVE
7.854 We recall that the European Communities also raised a conditional claim of violation of
Article 22.8 of the DSU per se. The European Communities specified in its first written submission
that this claim was "made in the alternative and only on the condition that the Panel does not establish
any violation under Articles 23.1, 23.2(a), 3.7, 22.8 and 21.5 of the DSU".968
7.855 We note that we have established a violation of Article 23.1 and 23.2(a). We also recall that
we have already addressed the alleged violation of Ar ticle 22.8 of the DSU as part of our review of
the EC claim of violation of Article 23.1 read togeth er with Article 22.8 and Article 3.7 of the DSU.
Under those circumstances, it is not necessary fo r the Panel to address the conditional claim of
violation 22.8 of the DSU per se in the alternative.
F. CONCLUSION
7.856 For the reasons set forth in this report, the Pane l concludes that, with respect to the claims of
the European Communities concerning the violati on of Article 23.2(a) read together with
Articles 21.5 and 23.1 of the DSU, the United States made the following procedural violations:

968 EC's first written submission, para. 132.

(a) by seeking, through the measure at issue – that is the suspension of concessions or
other obligations subsequent to the notif ication of the EC implementing measure
(Directive 2003/74/EC) – the redress of a violation of obligations under a covered
agreement without having recourse to, and abiding by, the rules and procedures of the
DSU, the United States has breached Article 23.1 of the DSU;
(b) by making a determination within the meani ng of Article 23.2(a) of the DSU to the
effect that a violation had occurred without having recourse to dispute settlement in
accordance with the rules and procedures of the DSU, the United States has breached
Article 23.2(a) of the DSU.
7.857 In addition, having addressed the claims ra ised by the European Communities concerning
Article 23.1 read together with Articles 22.8 a nd 3.7 of the DSU based on the considerations
mentioned above
969, the Panel concludes that:
(a) to the extent that the measure found to be inconsistent with the SPS Agreement in the
EC – Hormones dispute (WT/DS26) has not been removed by the European
Communities, the United States has not breached Article 22.8 of the DSU;
(b) to the extent that Article 22.8 has not been breached, the Eur opean Communities has
not established a violation of Articles 23.1 and 3.7 of the DSU as a result of a breach
of Article 22.8.
VIII. RECOMMENDATIONS
8.1 Article 3.8 of the DSU provides that "[i]n cases where there is an infringement of the
obligations assumed under a covered agreement, the ac tion is considered prima facie to constitute a
case of nullification or impairment". The United States failed to rebut this presumption. Therefore, to
the extent the United States has acted inconsistently with its obligations under the DSU, it must be
presumed to have nullified or impaired benefits accruing to the European Communities under that
Agreement.
8.2 In the light of these conclusions, the Panel recommends that the Dispute Settlement Body
request the United States to bring its measure into conformity with its obligations under the DSU.
8.3 Whereas it is for the Members to decide on the appropriate steps needed to bring measures
found in breach of their WTO obligations into conf ormity, the Panel deems it important to recall its
conclusion in paragraph 7.251 as the parties have a pparently diverging opinions as to how this report
should be implemented by the respondent. As already mentioned, while the Panel performed
functions similar to that of an Article 21.5 panel, this was done only in order to determine whether
Article 22.8 of the DSU had been breach ed. This Panel was not called upon, nor does it have
jurisdiction, to determine the compatibility of Di rective 2003/74/EC with th e covered agreements. In
that context, the Panel suggests that, in order to implement its findings under Article 23 and in order
to ensure the prompt settlement of this dispute, the United States should have recourse to the rules and
procedures of the DSU without delay.