UNITED STATES – CONTINUED SUSPENSION OF OBLIGATIONS IN THE EC – HORMONES DISPUTE
Document: Report of the Panel
Date: 31 March 2008
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)

UNITED STATES – CONTINUED SUSPENSION OF
OBLIGATIONS IN THE EC – HORMONES DISPUTE

Report of the Panel

I. INTRODUCTION
A. REQUEST FOR CONSULTATIONS AND REQUEST FOR THE ESTABLISHMENT OF A PANEL
1.1 On 8 November 2004, the European Communiti es requested consultations with the United
States pursuant to Article XXII:1 of the Ge neral Agreement on Tariffs and Trade 1994
("GATT 1994") and Article 4 of the Understa nding on Rules and Procedures Governing the
Settlement of Disputes ("DSU") regarding the Unite d States' continued suspension of concessions and
other obligations under the cove red agreements, after the European Communities' adoption of
Directive 2003/74/EC on 22 September 2003 and its notification to the Dispute Settlement Body
(DSB) that it has fully implemented the recommend ations and rulings of the DSB in the dispute
European Communities – Measures Concerni ng Meat and Meat Products (Hormones) (EC –
Hormones). The consultation request was circulated in document dated 10 November
2004. The consultations were held on 16 December 2004 but the par ties failed to reach a mutually
satisfactory resolution of the dispute.
1.2 On 14 January 2005, the European Communiti es requested the establishment of a Panel
pursuant to Articles 4.7 and 6 of the DSU, as well as Article XXIII of the GATT 1994.1
B. ESTABLISHMENT AND COMPOSITION OF THE PANEL
1.3 At its meeting on 17 February 2005, the DSB established a Panel pursu ant to the request of
the European Communities in document WT/DS320 /6, in accordance with Article 6 of the DSU
(WT/DSB/M/183), with standard terms of reference as below:
"To examine, in the light of the relevant provisions of the covered agreements cited
by the European Communities in document , the matter referred to the
DSB by the European Communiti es in that document, and to make such findings as
will assist the DSB in making the recommendations or in giving the rulings provided
for in those agreements."
2
1.4 On 27 May 2005, the European Communities requested the Director-General to determine the
composition of the Panel, pursuant to paragraph 7 of Article 8 of the DSU. On 6 June 2005, the
Director-General accordingly composed the Panel as follows:
Chairman: Mr. Tae-yul Cho

 Members: Mr. William Ehlers
 Ms. Claudia Orozco

1.5 Australia, Brazil, Canada, China, India, Mexi co, New Zealand, Norway and Chinese Taipei,
have reserved their rights to participate in the Panel proceedings as a third party.
C. P
ANEL PROCEEDINGS
1.6 At the joint request of the parties, on 1 August 2005, the Panel decided that its meetings at
which the parties were invited to appear, would be open for public observation through closed-circuit
broadcast, provided the Secretariat could maintain sa tisfactory logistical arrangements. The Panel,
however, after consulting the third parties, also de cided that the session with the third parties would

1 WT/DS320/6.
2 WT/DS320/7.

remain closed.3 The Panel notified the DSB Chairman of this decision on the same day. 4 The Panel
held its first joint substantive meeting with the parti es to this dispute and the parties to the dispue on
Canada – Continued Suspension of Obligat ions to the EC – Hormones Dispute (WT/DS321) on
12-15 September 2005. The meeting with the pa rties was opened for public observation through
closed-circuit broadcast. The Panel also met with the third parties in a closed special session on
14 September 2005.
1.7 The Panel in this dispute also decided to seek advice from scientific and technical experts
after consultation with the parties on 20 October 2005. 5 After consulting the parties, it finalized its
Working Procedures for Consultations with Scien tific and/or Technical Experts on 25 November
2005.6 It selected six scientific and technical experts in consultation with parties, sought their advice
as well as advice from Codex Alimentarius Co mmission (Codex), the Joint FAO/WHO Expert
Committee on Food Additives (JECFA), and the Inte rnational Agency for Research on Cancer
(IARC) on scientific and technical questions in writi ng. The Panel also met with the six experts and
four representatives from Codex, JECFA and IARC in the presence of the parties to this dispute and
the parties to the dispute on Canada – Continued Suspension of Obligations to the EC – Hormones
Dispute (WT/DS321) on 27-28 September 2006. The e xpert from IARC served both as an individual
scientific expert and as the representative of the IARC. The Panel held its joint second substantive
meeting with the parties on 2-3 October 2006. These meetings were also open for public observation
through a closed-circuit broadcast.
1.8 On 31 July 2007, the Panel issued its interim report to the parties. On 28 September and
19 October 2007, the Panel received comments from the pa rties on the interim report. Neither of the
parties requested an interim review meeting. On 21 December 2007, the Pane l issued its final report
to the parties.
II. FACTUAL ASPECTS
A. HISTORY OF THE DISPUTE
2.1 On 13 February 1998, the Dispute Settlement B ody ("DSB") adopted the Panel and Appellate
Body reports in EC – Hormones. In doing so, the DSB recommended that the European Communities
bring the measures at issue into conformity with WTO rules. The Arbitrator appointed pursuant to
Article 21.3(c) of the DSU determined that the European Communities should have a "reasonable
period of time" up to 13 May 1999 to comply with the recommendations. On 26 July 1999, the
United States obtained from the DSB the authorization to suspend obligations up to the level of 116.8
million US Dollars per year. The arbitrators ac ting pursuant to Article 22.6 of the DSU had
previously determined this leve l to be equivalent to the leve l of nullification or impairment
(Article 22.4 of the DSU) suffered by the United St ates at the time of its recourse to arbitration in
May 1999. On 29 July 1999 and pursuant to the DSB's authorization, the United States introduced
import duties in excess of bound rates on imports from the European Communities by imposing a
100 % ad valorem rate of duty on a list of articles that are the products of certain EC Member States.
7

3 See Annex A-1, Letter to the Parties dated 1 Augu st 2005 on the Panel Decision on Open Hearings
for Public Observation. Annex A-2, Working Procedures for the Panel.
4 WT/DS320/8.
5 Annex A-3, Letter to the Parties dated 20 October 2005 on the Panel Decision on Consulting
Scientific and Technical Experts.
6 Annex A-4, Letter to the Parties dated 25 November 2005 on the Panel Decision on Certain Issues
concerning the Experts' Working Procedures; Annex A-5, Working Procedures for Consultations with
Scientific and/or Technical Experts.
7 These measures were published in the Federal Register Notice in Vol. 64, No. 143 of 27 July 1999.

2.2 The original measures in the EC – Hormones (US) dispute were provided in
Directive 96/22/EC, which prohibited the administer ing to farm animals of substances having a
thyrostatic action or substances having an oestrogenic, androgenic, or gestagenic action as well as the
placing on market of meat from such animals. 8 On 22 September 2003, the European Communities
adopted Directive 2003/74/EC of the European Pa rliament and of the Council amending Council
Directive 96/22/EC concerning the prohibition on th e use in stockfarming of certain substances
having a hormonal or thyrostatic action and of beta-agonists. The Directive was published and
entered into force on 14 October 2003. It provid es for a permanent prohibition on oestradiol-17 β and
a provisional prohibition on testosterone, progester one, trenbolone acetate, zeranol and melengestrol
acetate.
2.3 Prior to the adoption of the Directive 2003/74/EC, and in order to comply with the
recommendations and rulings of the DSB and the covered agreements, the European Communities
initiated and funded a number of specific scientific studies and research projects for the purpose of
conducting risk assessment (17 in total). The Scie ntific Committee on Veterinary Measures relating
to Public Health (SCVPH), an independent e xperts committee established under EC legislation,
reviewed the results of these studies and other publ icly available information as well as the data it
collected from various sources including CODEX/JECFA, and published its opinion entitled
"Assessment of Potential Risks to Human Health from Hormones Residues in Bovine meat and Meat
Products" ("the 1999 SCVPH Opinion") on 30 April 1999. The SCVPH subsequently reviewed this
Opinion on two occasions and adopted review re ports on 3 May 2000 (" the 2000 SCVPH Opinion")
and on 10 April 2002 (the 2002 SCVPH Opinion"). The SCVPH Opinions address six hormonal
substances: oestradiol-17β, testosterone, progesterone, trenbolone acetate, zeranol and melengestrol
acetate. 9
2.4 In light of these Opinions, which the European Communities contends are risk assessments,
the European Communities prohibited the placing on the market of meat and meat products from
animals that have been treated with oestradiol-17 β for growth promotion purposes on the grounds
that there was a substantial body of evidence s howing that its residues are both carcinogenic and
genotoxic. With respect to testosterone, progest erone, trenbolone acetate, zeranol and melengestrol
acetate, the European Communiti es introduced the same measure on a provisional basis on the
grounds that the available pertinent scientific info rmation reflected in the above-mentioned Opinions,
showed the existence of risks but all the inform ation and data necessary to conduct a more objective
and complete risk assessment were insufficient or missing.10
2.5 On 27 October 2003, the European Communities notified to the DSB the adoption,
publication and entry into force of the Directive as well as the preceding scientific Opinions. In the
same communication, the European Communities expl ained that it considered itself to have fully
implemented the recommendations and rulings of the DSB in the EC – Hormones dispute, and as a
consequence, it considers the United States' su spension of concessions vis-à-vis the European
Communities to be no longer justified.11
2.6 The United States raised doubt in the DSB meeting held on 7 November 2003 on whether the
new Directive was based on science and on whet her the European Communities implemented the
DSB's recommendations and rulings as well as the European Communities' obligations under the

8 WT/DS26/R/USA, paras. 2.1-2.5.
9 See Request for the Establishment of a Panel by the European Communities, WT/DS320/6.
10 Ibid. See also, EC's second written submission, para. 139.
11 European Communities – Measures Concerning Meat and Meat Products (Hormones) ,
Communication from the European Communities, WT/DS26/22, WT/DS48/20, 28 October 2003.

SPS Agreement.12 The United States continued to impose retaliatory duties on certain products from
the European Communities.
B. MEASURE AT ISSUE
2.7 The measure challenged by the European Comm unities is the suspension of concessions and
other obligations under the covered agreements, c ontinued without recourse to the procedures under
the DSU, after the European Communities' adoption of Directive 2003/74/EC on 22 September 2003
amending Council Directive 96/22/EC concerning th e prohibition on the use in stock-farming of
certain substances having a hormonal or thyrostatic action and of beta-agonists. The measure is
provided in the Federal Register Notice in Vol. 64, No. 143 of 27 July 1999 and is enforced as of
29 July 1999. The EC's Directive 2003/74/EC was published and entered into force on
14 October 2003. The EC stated in its notificati on to the Dispute Settlement Body (DSB) that it had
fully implemented the recommendations and rulings of the DSB in the dispute European
Communities – Measures concerning Me at and Meat Products (Hormones) (WT/DS26/AB/R,
WT/DS26/R/USA).
13
III. PARTIES' REQUESTS FOR FINDINGS AND RECOMMENDATIONS
3.1 The European Communities requests that the Panel find that the United States continued
suspension of concessions and related obligations under the covered agreements:
(a) violates Article 23.2(a), read together with Article 21.5 and Article 23.1 of the DSU;
(b) violates Article 23.1 of the DSU read in conjunction with Articles 22.8 and 3.7 of the
DSU; and
(c) violates Articles I and II of the GATT 1994.14
3.2 In the alternative, should the Panel find no viol ation of Article 23 of the DSU, the European
Communities requests the Panel to find that the United States measure violates Article 22.8 of the
DSU and Articles I and II of the GATT 1994.15
3.3 The United States requests the Panel to find that:
(a) the European Communities h as failed to demonstrate that the United States has
breached Article 22.8 of the DSU, and that the United States continued suspension of
concessions to the European Communities is c onsistent with the requirements of that
provision;
(b) the United States has not breached Articles 3.7, 21.5, 23.1 or 23.2(a) of the DSU; and
(c) the United States has not breached Articles I or II of the GATT 1994.
16

12 DSB, Minutes of Meeting held on 7 November 2003 , WT/DSB/M/157, 18 December 2003,
paras. 29-30.
13 WT/DS320/6. WT/DS26/22.
14 EC's first written submission, para. 149.
15 EC's first written submission, para. 150.
16 US's first written submission, para. 210.

IV. ARGUMENTS OF THE PARTIES
A. INTRODUCTION
4.1 The arguments of the parties are set out in their written submissions to the Panel and in their
oral statements made during Panel meetings, as well as in their written replies to questions from the
Panel. This Section presents a summary of the arguments of the parties based on the executive
summaries prepared by the parties where such summaries were made available to the Panel.
B. PARTIES' REQUESTS AND ARGUMENTS ON OPENING THE PANEL MEETING FOR PUBLIC
OBSERVATION
4.2 At the Panel's organizational meeting with par ties on 13 June 2005, the parties requested that
the Panel hold open meetings with the parties in this dispute. The Panel posed written questions to the
parties and the third parties regarding this joint re quest after its organizational meeting. The parties
answered these questions in writing on 20 June 2005 and 7 July 2005.
1. Arguments of the European Communities
(a) Whether panels are permitted to open hearings under Article 12 (inc luding Appendix 3),
Articles 14.1 and 17.10 of the DSU
4.3 The European Communities argues that open hearings are permissible at the panel level. The
European Communities submits that Appendix 3, second paragraph, first sentence of the DSU
excludes public access to the panel hearings, but this rule is not obligatory, as Article 12.1 of the DSU
states: "Panels shall follow the Working Procedures in Appendix 3 unless the panel decides otherwise
after consulting the parties to the dispute." In the European Communities' view, it is therefore
permissible for a panel to adopt, under the procedur e of Article 12.1 of the DSU, working procedures
that foresee open hearings.
4.4 The European Communities also argues that this conclusion is not affected by Article 14.1 of
the DSU. The term "deliberations" under Article 14. 1 of the DSU designates the part of the panel's
work where it internally discusses the case, including the decision it intends to pronounce in its report
and the supporting reasoning. This is the ordinary m eaning of this term, in which it is also used in
other systems of adjudication, and the Fren ch ("délibérations") and Spanish versions
("deliberaciones") fully coincide with this meaning. These deliberations take place in the presence of
the Secretariat team working on the dispute, but w ithout the parties. The term "deliberations" does
not cover the meetings with the parties, for which di fferent terminology is used in Appendix 3 of the
DSU. The context supports this reading because ever ything that is addressed in the three paragraphs
of Article 14 of the DSU relates to the independe nt work which the panel conducts alone, in the
absence of the parties. Had the drafters of the DSU wanted to exclude open panel hearings, they
would have used different language in Article 14.1 of the DSU. They would not have addressed this
question solely in the Appendix 3 working procedur es from which a panel may depart, as Article 12.1
expressly stipulates.
4.5 In the European Communities' view, this interpre tation is also corroborated by the use of the
term "proceedings" in Article 17.10 of the DSU which appears to be broader. Meaning must therefore
be given to the DSU negotiators' deliberate choice of the term "deliberations" in Article 14.1 of the
DSU.
4.6 The European Communities argues that such interpretation is the long-standing position of
several Members and has never been rejected by any WTO Member in any dispute. WTO Members
have repeatedly stated that the DSU rules on pane l procedures are flexible and allow the provision of

open hearings (Articles 14.1, 12.1, Appendix 3). Obviously, since a panel is obliged to consult the
parties before departing from the working proce dures suggested in Appendix 3, the parties' position
carries significant weight for the panel's decision. The EC considers that in the present case where all
the parties have agreed to open hearings, the Panel should accommodate the parties' request.
Article 18.2 of the DSU also provides context and s upports this position as it implies that parties are
entitled to "waive" the confidentiality of their positions.
(b) Legal implications of open hearings on covered persons under the Rules of Conduct
4.7 The European Communities considers that no lega l issues arise under the Rules of Conduct.
These Rules state in Section II, paragraph 1 that each covered person "shall respect the confidentiality
of proceedings" (see also Section VII, paragraph 1) , and also that "[t]hese Rules shall in no way
modify the rights and obligations of Members under the DSU nor the rules and procedures therein."
In the European Communities view, the Rules of Conduct are and remain fully binding on all covered
persons in this dispute, even if the hearings are opened to the public. Simultaneously, the Rules of
Conduct do not prevent the panel from fulfilling its task under the DSU and in accordance with the
procedural rules contained therein, which permit public hearings. The Rules of Conduct expressly
state that they do not modify these DSU rules.
4.8 The European Communities also considers th at Article 18.2 of the DSU again provides
context in that it shows that the parties are entitled to "waive" the confidentiality of their positions.
The Panel's deliberations will in any event not be a ffected by the opening and remain confidential, as
required by Article 14.1 of the DSU.
(c) Systemic and political impact of opening hearings
4.9 The European Communities is of the view that there are no implications for WTO Members
who are not parties to this dispute, notably the parti es to another dispute remain able to adhere to their
preference, if any, not to open the hearings in th eir dispute. Opening a hearing for observers who will
remain completely passive during the session would not change anything about the intergovernmental
character of the WTO, nor would it impair the chances to reach a mutually agreed solution, as
preferred by the DSU (Article 3.7), if the parties jo intly request the hearings to be open, in line with
their general policy to apply transparency where the DSU rules allow (for in stance by making public
their submissions). Also, there are no implications for third parties and accordingly there is no need
to consult them before the Panel adopts its wo rking procedures because the parties have jointly
requested that the public be excluded from the thir d parties' session during the presentation by a third
party who prefers this. Thus, opening hearings to public observation will not affect third parties
beyond the extent to which they themselves agree. The DSU is clear in that the panel must consult
the parties, not the third parties, before adopting Working Procedures in departing from Appendix 3.
4.10 The European Communities also states that consulting the DSB and General Council Chairs
or the Director-General before opening the h earing for public observation does not seem necessary
because under the DSU the Panel has the power to ta ke decisions regarding its Working Procedures
and is required to fulfil its task in full independence. If all parties are in agreement on this question of
working procedures, the Panel should accommodate thei r request if the parties consider that this is
part of the best way to "secure a positive solution to the dispute", which is the aim of the dispute
settlement mechanism (Article 3.7 of the DSU ).
(d) What procedures can be adopted to protect confidential information in an open hearing
4.11 The
European Communities indicates that it does not expect that confidential information will
be submitted in this dispute. Should this neve rtheless happen, one could easily apply appropriate
means to close the portion of any meeting where confidential information is discussed.

4.12 The European Communities does not consider that there is any issue of confidentiality in
relation to information submitted by other Member s or non-Members (under Article 13 of the DSU),
unless the confidentiality requirement of the last sentence of Article 13.1 of the DSU applies, in which
case the corresponding portion of any meeting where this information is discussed could be closed.
4.13 With respect to the third party session, the Eu ropean Communities considers that each third
party should decide whether to open the part of th e third party session dealing with that third party's
statement.
2. Arguments of the United States
(a) Whether panels are permitted to open hearings under Article 12 (including the Appendix 3),
Articles 14.1 and 17.10 of the DSU
4.14 The United States notes that in the Panel's organizational meeting held on June 13, 2005, the
United States, Canada and the European Communities agreed that the panel meetings in these disputes
should be opened to interested Members and the public . In the view of the United States, open panel
meetings are permissible under the DSU, including under Appendix 3 thereto.
4.15 The United States argues that whether substan tive meetings of the Panel are open is not
affected by Article 14.1 of the DSU, which provi des that the deliberations of a panel shall be
confidential. The United States agrees that any delib erations among the three panel members must be
confidential. However, Article 14.1 of the DSU does not apply to the meetings of the panel with the
parties. Therefore, DSU Article 14.1 does not prohibit opening panel meetings to the public.
4.16 The United States also argues that although Paragraph 2 of Appendix 3 states that a panel
"shall meet in closed session", Article 12.1 of the DSU states that a panel may depart from the
working procedures in Appendix 3 after consulting with the parties. In other words, the Panel has the
ability to remove any provision of Appendix 3 that might be perceived as an impediment to
accommodating the parties' decision to make their statements public by allowing the public to observe
them as they are delivered. Second, Article 18.2 of the DSU, which is echoed in Paragraph 3 of
Appendix 3, explicitly provides that "[n]othing in this Understanding shall preclude a party to a
dispute from disclosing statements of its own positions to the public." Appendix 3 is part of the DSU
and so, per Article 18.2, nothing in Appendix 3 preven ts a party from disclosing statements of its own
position to the public. Since each of the parties to this dispute agrees to the opening of panel meetings
to the public, the United States cons iders that the parties should not be prevented from allowing the
public to view the meetings at which the parti es present their positions. The United States believes
that the best way for the United States to disclose it s statements to the public is to allow the public to
observe those statements as they are being made.
4.17 The United States also argues that Article 17 of the DSU pertains to the Appellate Review
process. As such, its provisions, including Article 17.10, do not apply to a determination of whether a
panel can or will open its meetings to the public. A decision to open a panel meeting to the public
would not have any bearing on any subsequent deci sion to open the Appellate Body proceedings to
the public. Therefore, Article 17.10 of the DSU should not act as a bar to open panel meetings. The
United States also believes that this dispute will ha ve a substantial public in terest, and permitting the
public to observe the proceedings and be able to see first-hand the professional, impartial and
objective manner in which they are conducted can only further enhance the credibility of the result.
(b) Legal implications of open hearings on covered persons under the Rules of Conduct
4.18 The United States argues that the provisions in th e Rules of Conduct that require panelists to
maintain confidentiality apply only to information that is in fact confid ential. For information that is

not confidential in the first place, there is no confid entiality to be "maintained." However, the parties
to this dispute are affirmatively exercising their rights under Article 18.2 of the DSU to make their
written and oral statements public. The parties ha ve also agreed to open to the public the panel
meetings in which these oral statements will be read and written submissions discussed. The parties
believe that they have the ability under the DSU to have open proceedings a nd that nothing prevents
the Panel from adapting its working procedures to re flect that ability. The United States considers
that the opening of Panel meetings would not incl ude the deliberations of the Panel, which would
remain confidential under Article 14.1 of the DSU.
4.19 The United States further argues that while the Rules of Conduct state that covered persons
"shall respect the confidentiality of proceedings," 17 they also clarify that "[t]hese Rules shall in no
way modify the rights and obligations of Memb ers under the DSU nor the rules and procedures
therein." 18 As already noted by the United States in its response to the Panel's question, the
procedural rules of the DSU permit public hearings. Therefore, the confidentiality provisions of the
Rules of Conduct do not prevent the opening of panel meetings to the public.
(c) Systemic and political impact of opening hearings
4.20 The United States argues that opening the panel mee tings to the public is a natural extension
of the discretion provided to the parties in Article 18.2 of the DSU for a party to disclose its
statements to the public. In this dispute, the par ties have agreed to waive their rights to keep written
and oral statements confidential, and to open the meetings in which these submissions will be
discussed to the public. It is not necessary or appr opriate to consult the chairpersons of the Dispute
Settlement Body ("DSB"), the General Council or the DSB Special Session, or the WTO Director-
General, on whether or not panel meetings in this di spute will or can be opened to the public. In the
view of the United States, Article 12.1 of the DSU provides for panels to adapt their working
procedures after consulting the parties. Article 12.1 nowhere refers to c onsulting other WTO bodies
and such consultation could be viewed as setting an unfortunate precedent since panels routinely
adopt working procedures beyond or different from those in Appendix 3.
4.21 The United States believes that the third parties should be consulted, but only to determine if
they would also choose to open portions of the thir d party session with the Panel to the public. The
third parties need not be consulted regarding the opening of panel meetings with the parties.
4.22 The United States considers that opening panel meetings to the public will have a positive
impact on the perception of the WTO dispute settlement system, but does not foresee a decision in
this dispute to open panel meetings as having a political or systemic impact. For example, the
opening of panel meetings in this dispute would not prejudice the ability of parties to other disputes to
choose to open, or keep confidential, their respective panel meetings.
(d) What procedures can be adopted to protect confidential information in an open hearing
4.23 The United States believes that any portions of the Panel meetings dealing with confidential
information would not be open to the public. Addi tional safeguards to provide against the disclosure
of confidential information could be included in the working procedures. The United States notes that
the issue of access to confidential information is not limited to the question of open panel meetings,
but is one that panels have had to deal with in a number of disputes. For example, if meetings are

17 Rules of Conduct for the Understanding on the Rules and Procedures Governing the Settlement of
Disputes ("Rules of Conduct"), II.1; see Rules of Conduct, VII.1 ("Each covered person shall at all times
maintain the confidentiality of dispute settlement deliberations and proceedings.").
18 Rules of Conduct, II.1.

broadcast electronically, it may be possible to includ e a delay in the broadcast to ensure that there
would be no inadvertent disclosure of confidential information.
4.24 The United States argues that the third parties would retain their ability to decide whether
their submissions and statements are public. Any co nfidential statements would not be broadcast. It
also considers that it is uncertain what information would come from a Member that is not a party or a
third party to the dispute, but any such information that is confidential would be respected in the same
manner as any other confidential information.
C. FIRST WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES
1. Introduction
4.25 This case is about procedural obligations under the DSU of Members that continue to apply
the suspension of concessions or other obligatio ns after almost two years despite the proper
notification by the responding party that it has a dopted the necessary measures to implement the DSB
recommendations and rulings. In the alternativ e, the European Comm unities makes conditional
substantive claims under Article 22.8 of the DSU and Articles I:1 and II of the GATT 1994.
2. Factual aspects
4.26 Following an authorization by the DSB, th e United States suspended tariff concessions and
other related obligations up to the level of US$ 116.8 million. Subsequently, the European
Communities implemented the original DSB r ecommendations and rulings by adopting Council
Directive 2003/74/EC. However, the United States continues to suspend concessions and related
obligations against certain products originating in the European Communities based on a unilateral
determination that the EC's implementation meas ure is insufficient to comply with the DSB
recommendations and rulings.
3. Legal arguments: Part I – Violation of Ar ticles 23, 21.5, 22.8 and 3.7 of the DSU and
Articles I and II of the GATT
(a) The structure of Article 23 of the DSU
4.27 Article 23 of the DSU lays down the fundamental principle that the dispute settlement system
of the WTO is the exclusive means to redress any vi olation of any provision of the WTO Agreement.
Any attempt to seek "redress" can take place only in the institutional framework of the WTO and
pursuant to the rules and procedures of th e DSU. This has been confirmed in US – Section 301 Trade
Act and US – Certain EC Products.
4.28 Article 23.1 of the DSU contains a general obligation to follow the rules and procedures of
the DSU whereas Article 23.2 of the DSU lists a number of "specific and clearly-defined forms of
prohibited unilateral action". The relationship be tween the two paragraphs has two distinguishing
features: One, Article 23.2 of the DSU has to be read in the context of the first paragraph ("in such
cases"), that is, it has to be established that the Member's action is performed with a view to
redressing a WTO violation. Two, the specific forms described in paragraph 2 do not exhaust the list
of prohibited unilateral action. There is a relationship of lex specialis and lex generalis which
implies, on the one hand, that whenever there is a violation of a specific case in Paragraph 2 of
Article 23, there always is also a violation of Paragraph 1 of that provision; and on the other hand, that
a particular conduct that may not come under the sp ecific cases listed in Paragraph 2 of Article 23,
may still constitute a violation under Paragraph 1.

(b) Applicability of Article 23 – Article 23.1 of the DSU: Seeking the redress of a WTO violation
4.29 The meaning of "seeking the redress of a violation" under Article 23.1 of the DSU has been
extensively discussed by previous panels, i.e. US – Section 301 Trade Act and US – Certain EC
Products. The "violation" with regard to which redr ess is sought need not be one that has been
identified as such by the relevant WTO bodies. It suffices if it is perceived as being one by the
Member in question. The suspension of concessions or other obligations is a means of "redress."
Indeed it is the very means the WTO system envisa ges as a last resort remedy to WTO violations
according to Articles 3.7 and 22.1 of the DSU.
4.30 It is obvious that when it suspended concessions in July 1999, the United States was seeking
to redress a (WTO-determined) violation. Back then, the United States reacted to the European
Communities' failure to implement, within the reasonable period of time, the DSB recommendations
in the EC – Hormones case. It requested and obtained a DSB authorisation under Article 22.2
(respectively 22.7) of the DSU, following which the United States decided on the imposition of
additional duties at a rate of 100% ad valorem for the listed imports. The United States' way of
proceeding back then is the very example of a "see king to redress a WTO violation" in line with the
rules and procedures of the DSU.
4.31 There can equally be no doubt that, if the United States is continuing the suspension of
concessions to this day despite the European Communities' adoption of an implementation measure, it
does so because it is still seeking to redress a WTO viol ation. This can be deduced from the fact that
the July 1999 measure of applying duties in excess of bound rates is being continued without any
modification. Because that measure was imposed as "a result of the EC's failure to implement the
recommendations and rulings of the WTO," and sin ce the United States has neither abolished nor
changed the measure, nor modified its reasons for the imposition, the United States is obviously of the
view that the EC's failure to implement the reco mmendations and rulings of the WTO still persists.
Indeed, the continuation of the suspension of concess ions is an unequivocal indication that the United
States believes that there continues to be a violatio n. Otherwise it would have ended the suspension
of concessions in accordance with its obligations under Article 22.8 of the DSU. Moreover, this is the
explicit view the United States has formally taken in the DSB and in various official statements.
(c) Violation of Articles 23.2(a) and 21.5 and of Article 23.1 of the DSU
4.32 This conduct of the United States is contrary to the specific prohibition of unilateral conduct
set out in Article 23.2(a) of the DSU. Instead of seeking redress of the perceived continued failure of
the European Communities to implement the DS B's recommendations and rulings through the
continued suspension of concessions, the United States should have introduced a compliance
procedure under Article 21.5 of the DSU. Because it has not done so, it has violated the specific
prohibition of unilateral conduct set out in Artic le 23.2(a) of the DSU. This violation of
Article 23.2(a) and 21.5 constitutes at the same time a violation of Article 23.1 of the DSU.
4.33 As the Panel in US – Section 301 Trade Act has noted, the following conditions need to be
fulfilled in order to find a violation of Article 23.2( a) of the DSU. First, given the "chapeau" of
Article 23.2, it needs to be established that there is "such a case", namely that a Member is seeking to
redress a WTO violation. This is the case here.
4.34 Second, Article 23.2(a) of the DSU requires that a Member has made a "determination to the
effect that a WTO violation has occurred." The or dinary meaning of the term "determination," has
been noted by the Panels in US – Section 301 Trade Act and US – Certain EC Products. Such a
decision need not have a specific form, and can be inferred from action. The suspension of
concessions or other obligations is the very means (a lbeit of last resort) to react to a violation and
therefore necessarily implies a decision that ther e is a violation. That such a decision bears

consequences in WTO trade relations hardly requir es any explanation. The present case is similar to
the situation in US – Certain EC Products . Again, the action in question is the suspension of
concessions and related obligations. In contrast to the above case, nevertheless, the suspension here
had initially been authorised by the DSB based on a multilateral determination that there was a
violation. This multilateral dete rmination, however, was made with respect to the measures applied
by the European Communiti es at the time. Logically, it could not and did not apply to the measures
subsequently adopted and properly notified to the WTO by the European Comm unities. With regard
to the current legislative situation in the Eur opean Communities, no multila teral determination has
been made by the time at which this Panel wa s established. If the United States nevertheless
continues to apply the suspension of concessions a nd related obligations, it necessarily implies that it
has unilaterally determined that there continues to be a violation. It has, in addition, explicitly said so.
4.35 Third, Article 23.2(a) of the DSU is violated if the determination to suspend concessions is
not made in accordance with the rules and procedur es of the DSU, or is not consistent with the
findings of a dispute settlement organ. The DSU provides for a specific procedure, namely
Article 21.5 of the DSU, to address the situati on that Members disagree over the existence or
consistency of measures taken to comply with the recommendations and rulings of the DSB.
4.36 There exists obviously a disagreement as to wh ether, by adopting Directive 2003/74/EC, the
European Communities has implemented the reco mmendations and rulings from the DSB in the
Hormones case. Article 21.5 of the DSU requires that such a disagreement shall be decided through
recourse to dispute settlement. The European Communities has invited the United States several
times to initiate a compliance procedure under Article 21.5 (or, for that matter, any other dispute
settlement procedure under the DSU), but to this date the United States refuses to do so. Instead, it
simply continues to apply the suspension of concessi ons and related obligations as if no "measure to
comply" had been taken or the non-compliance of the new directive of the European Communities
had already been established.
4.37 As the determination in th e present case has been made before the commencement, let alone
the exhaustion of the Article 21.5 pr ocedure, it is necessarily not one that has been made consistent
with the findings contained in an adopted panel or Appellate Body report.
(d) The United States' continued suspension of concessi ons and related obligations is in violation
of Article 23.1, read together with Articles 22.8 and 3.7 of the DSU
4.38 Under Article 23.1 of the DSU, the United States is obliged to have recourse to, and abide by,
the rules and procedures of this Understanding. This encompasses, inter alia, Articles 22.8 and 3.7 of
the DSU. In this respect, the following should be noted:
4.39 The suspension of concessions or other obliga tions is limited in time. This temporal
limitation is the very foundation of the retaliation system under the DSU. The importance of this
principle is already demonstrated by the fact that the "temporary nature" of countermeasures appears
contextually at two places in Article 22 of the DSU, in Paragraph 8 and in Paragraph 1. The temporal
limitation is a practical consequence of the fact that suspension of concessions should only be applied
as "a last resort", Article 3.7 of the DSU. This means that the suspension of concessions should only
apply where justified and necessary.
4.40 The temporary nature of the suspension of concessions or other obligations has been
recurrently interpreted by arbitrators to indicate that one of the main objects and purposes of sanctions
is to induce the violating WTO member to comply with its obligations. Indeed, in reaching this
conclusion the arbitrators followed a suggestion by the United States (see EC - Bananas III (US)
(Article 22.6 – EC)). The objective of inducing compliance en tails, however, that once a Member has
adopted compliance measures which are not properly challenged by the complaining Member, the

suspension of concessions or other obligations can no longer be applied. Indeed, in such a scenario
the suspension of concessions or other obligations w ould be deprived of one of its main objectives,
i.e. to achieve implementation of a DSB decision, for the simple reason that the WTO Member has
already taken measures to implement the DSB reco mmendation. In this case, the objective to induce
compliance can only revive after it has been prope rly established that the implementing measure has
been insufficient to remedy a WTO violation.
4.41 Article 22.8 of the DSU prohibits the continue d unilateral application of the suspension of
concessions or other obligations when the measure which has been found inc onsistent is removed.
The term "removed" thereby refers to the complia nce by a WTO Member because this provision is
based on the respect of the WTO obligations by the Member concerned (see Article XVI:4 of the
WTO Agreement and Article 19.1 of the DSU). The scope of the compliance obligation is
determined by the DSB recommendations and ruling s following the adoption of the Panel and/or
Appellate Body report (Articles 21.5, 22.2 of the DSU).
4.42 Article 22.8 of the DSU does not specify how the removal of the WTO inconsistency is
determined. However, in the light of its context, i.e. Articles 21.5 and 23.2(a) of the DSU, and given
the exceptional nature of countermeasu res, i.e. their temporal limitation, it is clear that a Member can
not unilaterally determine that the WTO inconsis tency persists despite the notification of a
compliance measure. In very much the same vein, a Member can not decide to continue to suspend
concessions or other obligations unilaterally. Th e WTO inconsistency of the implementing measure
can only be determined in accordance with the appr opriate procedure, namely Article 21.5 of the
DSU. Unless such a procedure concludes that th e compliance measure does not fully implement the
DSB recommendations and rulings, it cannot be presumed that this is the case.
4.43 This also follows from the general principle of good faith as it applies in international State
relations, under which States are normally considered to act in conformity with their obligations. This
principle has been widely confirmed in the international (trade) jurisprudence (see ICJ Corfu Channel,
EC – Hormones (Article 22.6), Chile – Alcoholic Beverages, Canada – Aircraft (Article 21.5 – Brazil)
and it also applies for implementing measures ( Canada – Dairy (Article 21.5 – New Zeal and and
US II), EC – Bed Linen (Article 21.5 –India)).
4.44 Therefore, it is clear that the United States coul d not unilaterally determine that the European
Communities implemented the DSB recommendations a nd rulings in a WTO inconsistent way. To
the contrary, the European Communities must be presumed to have complied with its WTO
obligations, if the United States refuses to establish the contrary.
4.45 Once the inconsistency of the measure has been removed, Article 22.8 of the DSU provides
that "the suspension of concessions or other obligations shall be tem porary, and shall only be applied
until such time as the measure found to be inconsiste nt with a covered agreement has been removed."
This provision is mandatory. It does not leave an y margin of discretion to the retaliating Member,
thereby corroborating the exceptional nature of th e imposition of countermeasures. As explained
above, a Member which contests the removal of the in consistency of the measure has to abide by the
rules and procedures under the DSU, i.e. Article 21.5 of the DSU. Only if it is established in such a
procedure that the WTO inconsistency persists is th e application of the suspension of concessions or
other obligations permissible under Article 22.8 of the DSU.
4.46 Under the same logic, Article 22.8 of the DSU does not allow for the application of
countermeasures on the basis of a
unilateral determination regarding th e WTO inconsistency of a
measure. Rather, Article 22.8 of the DSU, read in its context with Articles 21.5 and 23.2(a) of the
DSU, requires that in the absence of an adver se finding, the suspension of concessions or other
obligations shall not "be applied" any longer. This language is open in, at least, three directions:

4.47 Firstly, it indicates that the suspension of concessi ons or other obligations must be terminated
in case a compliance measure is not challenged, th e measure thus being accepted as being in full
accordance with the WTO agreements.
4.48 Secondly, Article 22.8 of the DSU shows th at the suspension of concessions or other
obligations must not be applied any longer if th e complaining Member delays, postpones or refuses
the initiation of an Article 21.5 proceeding. As a WTO Member is presumed to act in conformity
with its obligations, it follows necessarily that thro ugh the compliance measure it is presumed to have
removed the WTO inconsistency of the measure at least when the followi ng three conditions are
fulfilled: (1) the Member has followed its intern al decision-making procedures that are normally
applied for the purpose of adopting compliance measures of that kind; (2) the elaboration, deliberation
and adoption of the compliance measure is done in an open and transparent manner, and (3) the
compliance measure is notified properly to the WTO. Therefore, the suspension of concessions or
other obligations should not apply an y longer. This case is particularly relevant in the present dispute
where the United States has been re fusing for almost two years to initiate the compliance procedure
under Article 21.5 and to cease the suspension of concessions and related obligations against the
European Communities. Thus, the United States continues the susp ension of concessions and related
obligations on the basis of a unilateral determinati on regarding the WTO-inconsistency of the notified
compliance measure.
4.49 In the light of the two first conclusions, it woul d also be appropriate to infer from Article 22.8
read together with Article 23.1 of the DSU that the suspension of concessions or other obligations
should not continue to be applied until the WTO inconsistency of the prope rly notified measure has
been positively determined by the DSB.
4.50 This result is also corroborated by the system and overall thrust of Article 23 of the DSU,
which is to strengthen the multilateral system. If a WTO Member were allowed to continue the
application of suspension of concessions without challenging the implementing measure, it would
necessarily have to base its assessment on a unilatera l determination of the WTO inconsistency of the
new measure. This would be in plain contra diction of Article 23.2(a), in conjunction with
Article 21.5 of the DSU, as explained above.
4.51 The scenario described above follows the same ratio legis that applies for the initial
imposition of suspension of concessions or other ob ligations. Thus, whether a Member suspends
concessions for the first time or other obligations or wishes to ma intain the suspension despite an
implementation act does not make a difference. In both cases, a Member must not substitute
unilaterally its assessment of a WTO inconsistency of an implementation measure to the procedures
under the DSU.
4.52 In the case of the initial imposition of suspensi on of concessions or other obligations, the
DSU implies first a determination that the Me mber concerned has not implemented the DSB
recommendations and rulings. The DSB would not au thorize the suspension of concessions or other
obligations, if a WTO Member has taken implem enting measures. If a WTO Member has taken
implementing measures, it is established practice that the Member which intends to suspend
concessions or other obligations first obtains a DSB decision regarding the insufficiency of the
implementing measure following an Article 21.5 of the DSU proceeding. This normal course of
events and legal steps in the case of the imposition of suspension of concessions or other obligations
is in full accordance with the ov erarching principle set out in Article 23 of th e DSU prohibiting
Members from making unilateral determinations that another Member has violated its obligations.
4.53 Regarding the question of the conditions under wh ich the suspension of concessions or other
obligations could be maintained, there is no reason to assume that this fundamental logic should
change in any way whatsoever. In fact, the le gal situation is identical where the implementing

Member has taken the necessary measures to comply with its WTO obligations in accordance with its
internal rules and procedures and notified the measures in question to the WTO.
4.54 This comparability is even more striking if one focuses on the timing of an implementation
measure. In the case of the initial imposition of the suspension of concessions or other obligations, a
WTO Member has not implemented its obligations before the DSB's authorization to suspend
concessions or other obligations. In the case of the maintenance of suspension of concessions or other
obligations, a WTO Member implements its obligations after the DSB's authorization to suspend
concessions or other obligations. This difference in timing, however, does not alter the normal legal
sequencing between the multilateral review of th e compliance measure and the application of
suspension of concessions or other obligations. Indeed, the sole difference in timing does not give the
retaliating Member all of a sudden the substantive right to make unilateral decisions as to whether or
not the implementing measure is appropriate and suffici ent and, if it is not considered sufficient, to
continue applying the countermeasures as if nothing had happened.
4.55 In light of the above, there is an absolute need to refrain from continuing to apply the
suspension of concessions or other obligations in cases where the retaliating Member has not properly
challenged the compliance measure in an Article 21.5 proceeding. In fact, if a Member were allowed
to maintain the suspension of concessions or other ob ligations even in such a new legal situation, it
could make the kind of unilateral determinations which Article 23 specifically outlaws. Also, it could
continue to apply the suspension of concessions or other obligations even if the WTO violation has
been objectively removed. The implementing Member would then have to suffer from the suspension
of concessions or other obligations even though it has fully abided by its obligations. It goes without
saying that such a result would be in plain contradiction to the DSU provisions governing the
suspension of concessions or other obligations, in particular Articles 3.7 and 22.
4.56 These fundamental principles are not altered by th e fact that there exists a DSB authorization
under Article 22.7 of the DSU to suspend concessions or other obligations. The DSB authorization
cannot change the fundamental rul es under the DSU. Rather, the DSB implements these rules. Thus,
as the DSU provides that the susp ension of concessions or other ob ligations should not be applied
unless it has been properly established that a Memb er's measure violates its WTO obligations, the
DSB authorization cannot be interpreted to jus tify such a suspension if a WTO violation of a
Member's (new) measures has not been properly determined.
4.57 The basis for a DSB authorization to suspend concessions or other obligations is a prior
multilateral determination that the implementing WTO Member has failed to comply with its
obligations. This is the case if an Article 21.5 proceeding concludes that the implementing measure
was insufficient. This is also implicitly the case if a Member has not adopted any implementing
measure at all at the time of the DSB decision under Article 22.7 of the DSU. On the contrary, if a
WTO Member implements properly its obligations after the DSB has authorized the suspension of
concessions or other obligations, the basis for this decision changes fundamentally. As the original
DSB authorization was taken in view of the origin al measure, it cannot logically encompass the new
implementing measure. Hence, the DSB authorizati on cannot cover the continued application of the
suspension of concessions or other obligations, if a WTO Member subsequently implements its
obligations in the absence of a multilateral review regarding the compliance (or not) of this new
measure.
4.58 Regarding this DSB authorization it is once again useful to compare the two situations of the
imposition and the maintenance of the suspension of concessions or other obligations. The DSB
could not authorize the imposition of retaliatory measures under Article 22.7 of the DSU, if the
implementing Member had undertaken measures to comp ly with its obligations and if those had not
been found WTO inconsistent following an Article 21. 5 proceeding. In the very same vein, the DSB
authorization cannot justify the maintenance of su spension of concessions or other obligations if a

Member properly complies with its obligations af ter the imposition of these measures and if its
compliance measure is not challenged in an Article 21.5 proceeding. Again, the mere temporal
difference of the new implementing measure does not mean that the DSB authorization, once
received, serves as a blank authorization for a Member to continue the application of the suspension
of concessions or other obligations indefinitely in the future and on the basis of unilateral
determinations.
4.59 Furthermore, the European Communities would note, that from a systemic point of view,
Article 22.8 of the DSU is subsequent to Article 22.7 of the DSU. This indicates that once the
situation under Paragraph 8 occurs it overtak es the authorization granted under Paragraph 7.
Paragraph 8 conditions Pa ragraph 7. As it must be assumed that the DSU negotiators followed a
logical sequencing in the way they drafted Article 22, it is clear that Article 22.8 of the DSU was
supposed to impact on the authorization under Article 22.7 of the DSU. Indeed, to assume that the
removal of the inconsistency of the measure under Paragraph 8 has no impact on the DSB
authorization under Paragraph 7 is not legally coherent or reasonable.
4.60 Moreover, this reading of the DSB authorization is corroborated if one takes a closer look at
the substance of this authorization. The level of nu llification or impairment has to be determined in
relation to the violation determined for the existing measure (Article 3.8 of the DSU). Thus, assuming
that a WTO Member has not undertaken any implementation steps, the level of nullification should be
determined in relation to the original violation. But assuming, in a second scenario, that a Member
has implemented partly or fully its WTO obligations , the level of nullification or impairment would
have to be determined accordingl y. Obviously, in the area where the Member implemented properly
its obligations there would be no nullification or im pairment. This logic had also been recognized by
the arbitrators in EC – Bananas III (US) (Article 22.6 – EC).
4.61 Applying the same reasoning in the present case, it is clear that the level of suspension of
concessions or other obligations as authorized by the DSB was based on a non-implementation by the
European Communities. However, this level and, therefore, the scope of the authorization may not be
justified any longer once the European Communities has properly implemented its obligations.
4.62 Finally, following the jurisprudence by the Appellate Body, once a Member violates
Article 23.1 read in conjunction with Article 22.8 of the DSU it necessarily also acts contrary to
Article 3.7 of the DSU.
(e) The United States is in violation of Article I:1 of the GATT 1994 because of the continued
suspension of concessions and related obligations
4.63 The United States is acting inconsistently w ith Article I:1 of the GATT 1994 by imposing
import duties in excess of bound rates on products originating in certain EC Member States.
(f) The United States is acting inconsistently w ith Article II of the GATT by the continued
application of countermeasures on products originating in the European Communities.
4.64 The United States is violating its obligations u nder Article II:1(a) and Article II:1(b) of the
GATT by suspending concessions and related obligations against the European Communities.

4. Legal Arguments: Part II – Conditional claim in the event that the Panel does not find
any violation of Article 23 of the DSU as set out in Part I
(a) The United States is violating Article 22.8 of the DSU because the measure found to be
inconsistent has been removed by the European Communities
4.65 The United States is violating Article 22.8 of the DSU by continuing to suspend concessions
and related obligations even though the measure found to be inconsistent has been removed.
Consequently, the United States is under an obligation not to apply the suspension of concessions any
longer. In the following, the European Communities will set out in more detail why the new measure
is not only in presumed compliance as argued above but in actual compliance with the
recommendations and rulings of the DSB.
4.66 The rulings of both the Panel and the Appella te Body essentially turned on the reading of
Article 5.1 of the SPS Agreement, and in particular, the requirement that a measure be based on a risk
assessment. The Appellate Body upheld the Panel's finding that the EC measures at issue were
inconsistent with the requirements of Article 5.1 of the SPS Agreement. At the same time, the report
contains an important clarification as to how th e European Communities could bring its regime for
hormones-treated meat into accordance with its ob ligations under the covere d agreements. As seen
above in relation to Part I, the Appellate Body held "that Article 5.1, read in conjunction with
Article 2.2, requires that the results of the risk assessment must sufficiently warrant the SPS measure
at stake."
4.67 On the basis of the scientific data presented by the European Communities, the Appellate
Body found that that data did not sufficiently wa rrant or reasonably suppor t the import prohibition.
The Appellate Body found, in pa rticular, that the scientific reports and studies submitted by the
European Communities did not rationally support the EC 's import prohibition or were too general, i.e.
relevant but not sufficiently specific to the case. It is important to understand, therefore, that the
Appellate Body did not find that an import prohibition for beef from hormone treated cattle was per se
in violation of the SPS Agreement. Rather it found that the EC's import prohibition was not
sufficiently warranted, that is to say reasonably supported, by the specific risk assessment relied upon
at that time by the European Communities.
4.68 In order to comply with the above findings the European Communities conducted a
comprehensive risk assessment. The risk assessment focussed on potential risks to human health from
hormone residues in bovine meat and meat products, in particular such risks arising from residues of
the six hormonal substances (oestradiol-17 β, testosterone, progesterone, trenbolone acetate, zeranol
and melengestrol acetate). In carrying out the ri sk assessment, the European Communities initiated
and during 1998-1999 funded altogether 17 specific scientific studies and research projects in order to
obtain as much as possible of the missing scientific information as identified in the above rulings.
Moreover, the European Communities addressed in 1998 specific requests for the submission of
scientific data to the United States, Canada, Australia and New Zealand which all authorise the use of
these six hormones for animal growth promotion. It also published an open call for documentation
requesting any interested party, including the indu stry, to provide any relevant and recent scientific
data and information in their possession to be taken into account in the complementary risk
assessment.
4.69 The data collected was submitted to the Scientific Committee on Veterinary Measures relating
to Public Health (SCVPH), an independent expert Committe e established under EC legislation to
evaluate these kind of substances in the EC legal system. This scientific body was the one responsible
for scientific and technical questions concerning consumer health and food safety related to
production, processing and supply of food of animal origin. The SCVPH reviewed all the old and

new data and issued its opinion on 30 April 1999, wh ich it reviewed and confirmed again in 2000 and
once more in 2002 on the basis of additional and new information submitted subsequently.
4.70 Based on this comprehensive risk assess ment, the European Communities adopted
Directive 2003/74/EC. In accordance with the above scientific conclusions the Directive provides for
a definite import prohibition on meat and meat pr oducts from animals treated for growth promotion
purposes with oestradiol-17β. Furthermore, on the basis of the available but still incomplete data, the
Directive provides for a provisional ban on meat an d meat products from animals treated for growth
promotion purposes with testosterone, progesterone , trenbolone acetate, zeranol and melengestrol
acetate. The Directive places an obligation on th e Commission to seek more complete scientific
information from any source which could shed light and clarify gaps in the present state of knowledge
on these substances.
4.71 Article 22.8 of the DSU obliges the United States to ce ase applying the suspension of
concessions, once an inconsistent measure has been removed. However, even though the inconsistent
measure has been removed, the United States contin ues to apply the suspen sion of concessions. The
United States, therefore, is in violation of Article 22.8 of the DSU.
(b) The United States is in violation of Articles I and II of the GATT 1994 following the
continued application of suspension of concessions
4.72 As explained above, the illegal continued susp ension of concessions and related obligations
automatically entails a violation of Articles I and II of the GATT.
D. FIRST WRITTEN SUBMISSION OF THE UNITED STATES
1. Introduction
4.73 On 26 July 1999, the Dispute Settlement Body ("DSB") authorized the United States to
suspend concessions to the European Communities ("EC") in the amount of $116.8 million because
the EC failed to implement the DSB's recommendations and rulings in European Communities –
Measures Concerning Meat and Meat Products (Hormones) (WT/DS26).
4.74 That authorization has never been revoked. In this proceeding, the EC claims that multilateral
decisions of the DSB can be overridden by implicat ion when the Member who has been determined
not to have complied merely asserts that it has complied . However, there is no basis in the text of the
DSU for the EC's claim. Instead , the EC approach would unsustainably create an endless loop of
litigation and nullify the right of complaining pa rties to suspend concessions for non-compliance
following DSB-authorization by negative consensus.
4.75 The EC has strenuously tried to avoid any multilateral examination of its claim of
compliance, claiming that this proceeding "is about procedural violations" and "is not about the
European Communities' compliance in the previous case EC – Hormones ". The EC consequently
strongly urges this Panel not to examine whether the EC has complied, but rather to take at face value
the EC's assertion and to find that this asse rtion not only overrides the DSB's multilateral
authorization, but also would revoke US rights under the covered agreements.
4.76 However, the EC, having made an Article 22. 8 claim, bears the burden of establishing its
claim of an inconsistency with Article 22.8 of the DSU. Accordingly, the issue presented to the Panel
in this proceeding can be reduced to the simple qu estion of whether the EC has established that it has
come into compliance.

4.77 The EC has failed to even attempt to establish th at it has come into compliance, and the EC's
DSU Article 22.8 claim should be rejected on this basis alone. The EC's Article 21.5 of the DSU
claim should likewise be rejected.
4.78 The EC's claims under Articles 23.1 and 23.2(a) of the DSU also fail. In compliance with
Article 23.1 of the DSU, the United States has alrea dy sought and received multilateral authorization
in relation to the EC's failure to comply with DSB recommendations and rulings. The United States
has made no determination concerning whether the EC has come into compliance. Accordingly there
is no basis for the EC's claims under these provisions.
2. Factual background
4.79 At the core of the matter described in the EC's panel request, and squarely within the Panel's
terms of reference, lies the EC's assertion that it has removed the measure found to be inconsistent
with its WTO obligations in the original Hormones dispute. In its panel re quest, the EC states: "The
European Communities subsequently removed the m easure found to be inconsistent with a covered
agreement," and that "it considers itself to have fully implemented the recommendations and rulings
of the DSB in the EC – Hormones dispute." The latter statement was confirming the EC's statement
at the DSB meeting held on November 7, 2003, that the EC "consider[s] that with the entry into force
of [Directive 2003/74, amending Directive 96/22], it [is] in conformity with the recommendations and
rulings made by the DSB."
4.80 The EC alleges that its amended import ban, which continues to prohibit the importation of
animals and meat from animals to which any of six growth promoting hormones have been
administered, according to good veterinary practices, is "fully compliant" with its WTO obligations
and the DSB's recommendations and rulings. Accord ing to the EC, the amended import ban is "based
on comprehensive risk assessments, in particular on the opinions of the EC independent Scientific
Committee on Veterinary Measures relating to Public Health" (the "Opinions").
4.81 The EC complains of the "continued" US susp ension of concessions to the EC "after the
European Communities has removed the measure found to be inconsistent with WTO law in [the EC
– Hormones dispute]." It suggests, in the wake of a declaration of its own compliance with DSB
recommendations and rulings, that the United States' authorization to suspend concessions to the EC
is no longer in effect or valid.
4.82 However, US suspension of concessions to the EC was, and remains, multilaterally authorized
by the DSB. On 26 July1999, the DSB authorized the United States to suspend concessions or other
obligations to the EC in the amount of $116.8 million as a consequence of the EC's failure to comply
with its recommendations and rulings in the EC – Hormones dispute. To date, this authorization has
not been revoked by the DSB, and the United States continues to act pursuant to that authority.
(a) The six hormones used for growth promotion purposes
4.83 The EC's hormone ban prohibits the importati on and marketing of meat and meat products
from cattle to which the hormones have been admi nistered for growth promotion purposes, according
to good veterinary practices. The United States perm its the administering of these hormones to cattle
for that very purpose, i.e., in order to increase the growth, feed conversion efficiency and leanness of
carcass.
4.84 For purposes of growth promotion, five of the six hormones (oestradiol-17 β, progesterone,
testosterone, zeranol, and trenbolone acetate) are admi nistered to cattle as subcutaneous implants in
the animals' ears. The ears are then discarded at slaughter. The sixth hormone, melengestrol acetate,
a synthetic progestogen, is administered as a feed additive.

4.85 International standards exist regarding the u se of five of the six hormones for growth
promotion purposes. Upon review of safety assessments conducted by JECFA and recommendations
by CCRVDF, the Codex Alimentarius Commission ("Code x"), specified as the relevant international
standards-setting body in the SPS Agreement, adopted recommended maximum residue limits
("MRLs"), where appropriate, for oestradiol-17 β, progesterone, testosterone, trenbolone acetate and
zeranol. Codex adopted these recommended MRLs to ensure that consumption of animal tissue
containing residues of these substances does not pose a risk to consumers and to facilitate fair trading
practices in international commerce.
4.86 Scientific reviews of the six hormones, interna tional standards pertaining to their use, and a
longstanding history of administering the six hormo nes to cattle for growth promotion purposes point
to a single conclusion – that the use of the si x hormones as growth promoters, according to good
veterinary practices, is safe. Th is conclusion remains valid, and is supported by all relevant risk
assessments.
4.87 The EC's 1999 and 2002 Opinions purport to offer a contrary view. However, as will be
discussed below, the EC has not demonstrated how its Opinions indeed constitute risk assessments
and the conclusions reached in the Opinions have been summarily dismissed by numerous regulatory
bodies (including review bodies within the EC).
4.88 As in the original EC – Hormones panel proceeding, the EC has neglected to present any new
scientific evidence of a risk, or a risk assessment drawn from that evidence, which would contradict
the reams of scientific evidence demonstrating that residues in meat from cattle treated with the six
hormones for growth promotion according to good veterinary practice, are safe for consumers.
3. Legal arguments
4.89 The core of the EC case in this proceeding is that the United States is not authorized to
suspend concessions and related oblig ations as a result of the EC's failure to comply with the DSB's
recommendations and rulings. However, the simple response to the EC is that the DSB granted
multilateral authorization to the United States to suspend concessions and related obligations. The EC
cannot deny that the DSB's authorization has never been revoked. Because the EC cannot claim that
the DSB has ever decided to revoke the authoriza tion, the EC instead attempts to construct a new
legal theory under which the EC's unsupported assertion of its own compliance has somehow
invalidated the DSB's authorization.
4.90 The EC's theory is not contemplated by the text of the DSU and should be rejected. The EC's
argument that an implementing Member may, th rough a unilateral declaration of compliance,
invalidate the DSB's multilateral authorization woul d undermine the right of Members to obtain that
authorization through operation of the negative con sensus rule. According to the EC's logic, a
Member could effectively invalidate another Memb er's authority to suspend concessions and force
further litigation through a unilateral declaration of co mpliance the very day after the DSB grants that
authority. According to the EC's approach, that implementing Member could then continuously force
successive new rounds of litigation at will simply by asserting that it has complied. The EC's
approach would create the very endless loop of litigation the DSU operates to prevent.
4.91 The EC's argument simply assumes a key elemen t it must establish to prevail in this
proceeding – that it has, in fact, "removed" its WTO- inconsistent measure. The EC's various claims
based on this assumption must therefore fail.
4.92 Before addressing the EC's claims, it is worthwh ile to review the applicable burden of proof
in this proceeding. It is well-established that the complaining Member in WTO dispute settlement
bears the burden of proof. This means, as an in itial matter, that the EC, as the complaining party,

bears the burden of coming forward with evid ence and argument that establish a prima facie case of a
violation. In establishing its prima facie case, the complaining party must set forth sufficient facts and
arguments to establish each element of its case. Me re assertions are not sufficient. The EC has failed
to meet this burden in these proceedings.
(a) The EC has failed to demonstrate that the United States has breached DSU Article 22.8
because the EC has neither demonstrated that it has "removed" the WTO-inconsistencies of
the original hormones ban, nor demonstrated how the amended ban has provided a solution to
the nullification or impairment of benefits to the United States
4.93 Article 22.8 states, in relevant part, that:
[t]he suspension of concessions or other obligations shall be temporary and shall only
be applied until such time as the measure f ound to be inconsiste nt with a covered
agreement has been removed, or the Member that must implement recommendations
or rulings provides a solution to the nullification or impairment of benefits, or a
mutually satisfactory solution is reached. (Emphasis added)
Article 22.8 thus establishes three conditions under which a DSB-authorized suspension of
concessions may no longer be applied: (1) the Member imposing the WTO-inconsistent measure
"removes" the measure; (2) that Member "provides a solution to the nullification or impairment of
benefits"; or (3) the parties to the dispute reach a "m utually satisfactory solution." In order to prevail
in its claim that the United States is breaching Artic le 22.8, the EC must establish that one of these
conditions has been met.

4.94 The EC's assertion that it has removed its meas ure or provided a solution is not supported by
any demonstration that it actually has done either. Instead, it relies on an already rejected legal theory
that a Member found to have breached its WTO oblig ations is to be excused from its burden of proof
in dispute settlement if it invokes the phrase "good faith ." This argument is no more valid today than
when a WTO panel last rejected it, and the EC's failure to meet its burden on the critical element of its
case under Article 22.8 means that the EC's claim must likewise fail. The United States continues to
apply the suspension of concessions to the EC in a WTO-consistent manner, fully in accordance with
the authorization of the DSB.
4.95 The EC fails to demonstrate that it has in f act removed its WTO-inconsistent measure, the
import ban on meat and meat pr oducts from cattle treated with hormones for growth promotion
purposes or that it has "provide[d] a solution" to th e nullification or impairment of benefits to the
United States caused by the ban.
4.96 Article 22.8 nowhere provides that the issue of removal of a measure or providing a solution
can be decided by a Member's simple assertion that it has developed a new, WTO-consistent measure,
or that it alone has deemed that it has provided a "solution" to WTO nullification or impairment,
without a DSB determination. Indeed the EC's proposed interpretation is directly at odds with the last
sentence of Article 22.8 which makes it clear that these are questi ons for ongoing DSB
 surveillance.
Article 22.8 stresses that "the DSB shall continue to keep under surveillance the implementation of
adopted recommendations or rulings", in situations where "concessions or other obligations have been
suspended but the [DSB] recommendations ... have no t been implemented." This statement that the
DSB's role is to monitor an implementing Memb er's compliance with DSB recommendations as well
as the complaining Member's suspension of con cessions further emphasizes that Article 22.8 is
concerned with multilateral review of compliance. The EC simply errs in claiming that under
Article 22.8 the US authorization to suspend concessions could be withdrawn in the absence of a DSB
determination to that effect. Furthermore, th e EC's approach would fundamentally undermine the
operation of several critical DSU provisions, most notably the right of complaining parties to seek

authorization to suspend concessions through a DSB decision taken by negative consensus under
Article 22.6 or Article 22.7 of the DSU.
4.97 The EC argues that the Panel should find that it has "removed" its WTO-inconsistent measure
within the meaning of Article 22.8 analysis becau se it "must be presumed to have complied with its
WTO obligations, if the United States refuses to establish to the contrary." However, the EC –
Bananas compliance panel highlighted that there is si mply no basis in the WTO Agreement for the
EC's argument that it is presumed compliant with its obligations absent a finding against its measures.
Similarly, there is no presumption of compliance for the EC's amended ban in this proceeding.
Because compliance of the EC's amended ban is a co ndition precedent to several of the claims raised
by the EC as a complaining party, the EC bears th e burden in this proceeding of demonstrating its
compliance.
(b) The EC has failed to demonstrate that its am ended import ban on me at and meat products
treated with hormones for growth promotion purposes is WTO-consistent
4.98 Whereas the EC claims in its Opinions and Di rective 2003/74 to ha ve developed a risk
assessment and scientific evidence suppor ting its import ban on oestradiol-17 β, it qualifies the ban on
the other five hormones as "provisional." Consis tent with this character ization, the EC invokes
Article 5.7 of the SPS Agreement in its first written submission, alleging that the results of its
Opinions provide "‘the available pertinent info rmation' on the basis of which the provisional
prohibition regarding the other five hormones ha s been enacted." Howe ver, the EC fails to
demonstrate how its ban satisfies Article 5.7's four cumulative elements, and it thereby fails to
demonstrate how its ban is a legitimate provisional measure within the meaning of that Article.
4.99 Specifically, the EC: (1) fails to demonstrate that its "provisional" ban on meat and meat
products from cattle treated with five of the hormones for growth promotion purposes is maintained in
a situation where "relevant scientific evidence is insufficient"; (2) fails to demonstrate how its
"provisional" ban has been adopted on the "basis of available pertinent information"; (3) has not
sought "to obtain the additional information necessar y for a more objective assessment of risk"; and
(4) has not "reviewed [its] ... measu re accordingly within a reasonabl e period of time" within the
meaning of Article 5.7.
4.100 In addition, the EC fails to demonstrate that its amended ban is "based on" a risk assessment
within the meaning of Article 5.1 since: (1) the EC 's Opinions do not appear to be risk assessments
within the meaning of Article 5.1, and (2) the result s of the EC's Opinions do not rationally relate to
or reasonably support its import ban.
4.101 The EC fails to demonstrate how its Opinions are indeed "risk assessments" within the
meaning of Article 5.1 and Annex A of the SPS Agreement. By failing to examine relevant pathways,
explore the fate of the relevant risk (that posed by meat products to consum ers) or to support their
conclusions with scientific evidence, the Opinions neither "identify the adverse effects on human
health" arising from the consumption of meat from cattle treated with hormones for growth promotion
purposes according to good veterinary practice nor "evaluat[e] the potential for adverse effects on
human or animal health" arising from consumpt ion of meat products from cattle treated with
hormones for growth promotion purposes.
4.102
 Furthermore, the EC's Opinions and their unde rlying studies identify theoretical risks from
oestradiol-17β generally, but fail to address the relevant risk – that arising from the presence in meat
of residues resulting from the administration to animal s, according to good veterinary practice, of any
of the six hormones for growth promotion purposes. Therefore, the EC's Opinions fail to sufficiently
warrant or reasonably support the EC's ban on m eat from cattle treated with hormones for growth

promotion purposes according to good veterinary practi ce. As a result, the EC's ban is not based on a
risk assessment within the meaning of Article 5.1 of the SPS Agreement.
4.103 Finally, the EC fails to demonstrate that its am ended ban, which is not based on international
standards, satisfies the conditions of Article 3.3 of the SPS Agreement. Specifically, the EC maintains
its amended ban in breach of Article 3.3 because it fails to base its amended ban on a risk assessment
within the meaning of Article 5.1 of the SPS Agreement.
(c) The United States has not breached any other WTO obligations by continuing to suspend
concessions to the EC
4.104 The EC argues that the United States has breached Articles 3.7, 21.5, 22.8, 23.1 and 23.2(a)
of the DSU. There are two cornerstones to this argument, through which the EC seeks to avoid
having to demonstrate how its amended ban in fact cures the WTO-inconsistencies of the original ban.
First, the EC argues that the original complaining pa rty, in this case the United States, is obligated to
seek recourse to dispute settlement in order to c ontinue to suspend properl y-authorized concessions.
In particular the EC cites to the United States' failure "to initiate dispute settlement proceedings
pursuant to Article 21.5 of the DSU." The EC links this failure to initiate a compliance proceeding to
breaches of Articles 23.2(a) and 23.1 of the DSU, and asserts that a US failure to initiate an
Article 21.5 proceeding equates to a presumption of EC compliance. As discussed below,
Article 21.5 does not, among other things, obligate th e original complaining party to seek immediate
recourse to dispute settlement to evaluate a Member's unilateral declaration that it has taken a measure
to comply.
4.105 Second, the EC asserts that it has "removed" its measure within the meaning of Article 22.8 of
the DSU, and that as a result the United States now violates the provisions of that Article by
suspending concessions to the EC. The EC links its "removal" of the offending measure and alleged
US breach of Article 22.8 to breaches of Articles 23.1 and 3.7 of the DSU.
(i) The United States continues to satisfy its obligations under Article 23 of the DSU
4.106 Prior to addressing the EC's intertwined claims alleging breaches of several DSU provisions,
it is first necessary to examine an alleged DSU bre ach common to each of those claims – that the
United States has breached its obligations under DSU Article 23. Notwithstanding the EC's claim that
by continuing to suspend concessi ons the United States seeks redress of a perceived violation on the
part of the EC, the United States does not now, and did not at the time of the EC's unilateral
declaration of compliance, "seek" anything within the meaning of Article 23.1 with respect to the EC's
declaration. The United States did not make a determination that the EC's amended hormone ban is in
violation of a covered agreement (the current proceeding provides an opportunity for the WTO to
resolve that question), nor did the United States try to obtain or bring about compensation or remedy
for some new wrong or alleged WTO violation.
4.107 In fact, the United States, at the appropriate time, adhered to the letter of Article 23.1 by
seeking redress of the nullification or impairment cau sed by the EC's import ban on hormone-treated
meat and meat products through recourse to the pr ovisions of the DSU. The multilaterally-authorized
suspension of concessions stemming from the US recour se to dispute settlement remains valid to this
day, and is unaffected by the EC's unilateral decl aration of compliance. In other words, the United
States has already sought and obtained redress through the multilateral dispute settlement system for a
violation found by the DSB. There is no provision in the WTO Agreement th at provides that a single
Member can unilaterally invalidate the multilateral decision of the DSB to authorize suspension of
concessions.

4.108 While Article 22.8 does set forth conditions under which that authorization may no longer be
applied, as discussed above, the EC has offere d no meaningful argumentation as to how those
conditions have been fulfilled. Absent such a demons tration, the EC has quite simply failed to meet
its burden in this proceeding that the US suspension of concessions is in any way inconsistent with the
DSB's authorization and US WTO obligations. Th e United States is not seeking redress for anything
but the import ban which the DSB ruled inconsistent with EC obligations, regarding which the EC has
presented no evidence of having removed or provided a solution to the resu lting nullification or
impairment.
(ii) The US suspension of concessions does not breach Articles 23.2(a), 21.5 and 23.1 of the DSU
4.109 The EC argues that the United States "should have introduced a compliance procedure under
Article 21.5 of the DSU," and in failing to do so "violated the specific prohibition of unilateral
conduct set out in Article 23.2(a) of the DSU." The EC argues that the alleged breach of
Articles 23.2(a) and 21.5 further constitutes a breach of Article 23.1 of the DSU. To the contrary, the
United States continues to satisfy its obligations unde r each of these Articles, and the EC has failed to
demonstrate the contrary.
4.110 As discussed above, the United States has not, th rough its continued application of the DSB's
authorization to suspend concessions, sought redress for another Member's violation, in breach of
Article 23.1. This also means the United States is not breaching Article 23.2(a). Likewise, the United
States is not breaching Article 23.2(a) because it did not make a "determination" within the meaning
of Article 23.2(a).
4.111 Since it received authorization to suspend concessions to the EC, the United States has simply
continued to act according to its DSB authorization to suspend concessions to the EC. Contrary to the
EC's claims in this panel proceeding, the United States made no determinations concerning the EC's
import ban, amended or not. The United States did not need to make any further determinations to
continue to apply that suspension of concessions , and it did not. Further, as noted above, the
conditions under which a Member may no longer apply a DSB-authorized suspension of concessions
are set forth in Article 22.8, and the EC has made no effort to demonstrate that those conditions have
been met.
4.112 Further, the EC alleges that, contrary to the requirements of Article 23.2(a) of the DSU, the
United States made a determination not "in accord ance with the rules and procedures of the DSU,"
and in a manner "not consistent with the findings of a dispute settlement organ." Specifically, the EC
alleges that the United States made a determin ation that the EC had not implemented the
recommendations and rulings of the DSB in breach of Article 21.5 of the DSU. As demonstrated
below, the United States has not breached its obligations under Article 21.5 of the DSU.
4.113 The EC's Article 21.5 claim fails for four reasons : (1) the EC has not established that there is
a "disagreement as to the existence or consistency with a covered agreement of measures taken to
comply;" (2) Article 21.5 sets no deadline by whic h such a proceeding must be brought; (3) nothing
in the text of Article 21.5 places the onus of in itiating a compliance proceeding on the original
complaining party (in this case, the United States); and (4) the phrase "these dispute settlement
proceedings" in Article 21.5 is not restricted to proceedings under Article 21.5, but rather could
include proceedings under the DSU such as Ar ticle 22.6 arbitration proceedings, Article 25
proceedings, or the proceedings of a de novo panel, as the EC has sought in this instance.
4.114 First, the United States has continued to evalua te the EC's claim, and at the time of panel
establishment had been awaiting the EC's response to the US request under Article 5.8 of the
SPS Agreement. The United States has continued to eval uate the EC's claim, including its 19 May
2005 response to the US request. The US evaluation depends to a large extent on the EC's response to

questions such as those posed in this submissi on, including why the EC believes that scientific
evidence has now become insufficient to perform a risk assessment for five of the six hormones. To
date the EC has been less than t horough in its responses. Article 21.5 only applies "[w]here there is
disagreement."
4.115 Next, the EC interpretation of Article 21.5 as requiring immediate resort to litigation by a
complaining party would definitively prevent that complaining party from exercising any judgment as
to the fruitfulness of dispute settlement, and would preclude Members from seeking mutually
agreeable solutions through negotia tions. The aim of the dispute settlement system is to secure a
positive solution by whatever means possible, and not simply through litigation. In the absence of
any obligation in Article 21.5 to immediately resort to litigation, the fact that the United States had not
done so by the time the EC initiated this proceeding cannot constitute a breach of Article 21.5.
4.116 Thirdly, contrary to the EC's argument, the text of Article 21.5 assi gns no obligation to the
complaining party to seek recourse to "these dispute settleme nt procedures" in the event that there is a
disagreement "as to the existence or consistency with a covered agreement of measures taken to
comply." The text does not require that the or iginal complaining Member, in this case the United
States, initiate dispute settlement proceedings in the event of a disagreement. Thus, the mere fact that
the United States had not yet decided to invoke Artic le 21.5 proceedings before the EC undertook the
present challenge is not in itself grounds for concluding that the United States breached Article 21.5,
any more than the EC's failure to do so was.
4.117 Finally, it is important to recognize that the te xt of Article 21.5 refers to "these dispute
settlement procedures," without specifying any pa rticular subset of WTO dispute settlement
procedures. The panel in the US – Certain EC Products dispute recognized that the ordinary meaning
of this phrase covers any dispute settlement proced ure provided in the DSU "that could be used to
assess the compatibility of the new implementing measu re, including Article 25 or Article 22 of the
DSU". In other words, there is no basis in Ar ticle 21.5 for excluding any WTO dispute settlement
procedure that could be used to assess the WTO-co mpatibility of a new implementing measure. In
bringing these proceedings, the EC availed itself of one such means, though, as discussed above, it
has failed to meet its required burden to prevail. Also, in bringing these proceedings, the EC has
conceded that an Article 21.5 compliance panel is not the exclusive means to resolve a "disagreement"
even if one existed. If it were the exclusiv e means, then the EC itself would have invoked
Article 21.5, as it has done in the past. However, it did not, nor did it seek to have the matter that is
the subject of this proceeding referred to the "origina l panel" as provided in Article 21.5. None of the
original panelists are serving on this Panel. Thus the EC's approach in this proceeding itself refutes
the EC's Article 21.5 claim.
(iii) The United States has not violated Article 23.1 of the DSU, read together with Articles 22.8
and 3.7 of the DSU
4.118 The EC claims that the United States violates Article 23.1 of the DSU, when read together
with Articles 22.8 and 3.7 of the DSU. The EC asserts that these three Articles, together, demonstrate
"that a WTO Member shall not apply the suspensi on of concessions or other obligations in the
presence of an implementation act, which has not been found to be inconsistent following an
Article 21.5 proceeding." Contrary to this claim, the United States continues to satisfy its obligations
under each of these Articles.
4.119 As discussed above, the United States does not seek to redress a WTO violation within the
meaning of Article 23.1 of the DSU, and it continues to act pursuant to its multilateral authorization to
suspend concessions to the EC. Therefore, the EC 's claim that the United States has violated DSU
Article 23.1, read together with Articles 22.8 and 3.7 of the DSU fails.

(iv) The United States has not breached its obligations under Article I or II of the GATT 1994
4.120 Finally, the EC claims that the United Stat es acts in breach of Articles I and II of the
GATT 1994. However, the DSB has specifically aut horized the United States to suspend concessions
under Articles I and II of the GATT 1994. Unt il the DSB withdraws its authorization or the
conditions of Article 22.8 have b een found to have been met, the United States cannot be found in
breach of GATT 1994 Articles I or II.
4. Conclusion
4.121 In light of the foregoing, the United States asks th e Panel to find that: (1) the EC has failed to
demonstrate that the United States has breached Article 22.8 of the DSU, and that the United States
continues to suspend concessions to the EC consistent with the requirements of that provision; (2) The
United States has not breached Articles 3.7, 21.5, 23.1 or 23.2(a) of the DSU; and (3) The United
States has not breached Articles I or II of the GATT 1994.
E. O
RAL STATEMENT OF THE EUROPEAN COMMUNITIES DURING THE FIRST SUBSTANTIVE
MEETING
1. Introduction
4.122 The central provision on which the European Communities bases its claims is Article 23 of
the DSU. Article 23 requires WTO Members to have recourse to the procedures set out in the DSU
instead of resorting to any kind of "self-help." Article 23, in other words, prohibits a WTO Member
from making itself the judge over other WTO Members. What is and what is not a violation of the
covered agreements and what one can do to re medy it, are to be determined multilaterally, not
unilaterally.
2. Seeking redress – Article 23.1
4.123 As to Article 23.1 all parties seem to agree th at when, in 1999, the US and Canada requested,
obtained and started using a DSB authorization to suspend concessions, they were seeking to redress a
violation established at that time. The parties di ffer on what the US and Canada are doing right now.
One should think that they are still seeking redress. After all, they are still applying their suspension
of concessions stating explicitly that they fail to see how the European Communities' implementation
measure achieves compliance. This can only mean that they still see a violation, especially given that
Article 22.8 of the DSU would prohibit the continuation of sanctions in the opposite case.
4.124 The defending parties, however, flatly deny that what they are doing right now is seeking
redress of a violation against an alleged WTO-in consistency of the implementing measure. The
United States states that it "has already sought and obtained redress through the multilateral dispute
settlement system for a violation found by the DSB" . Canada not only uses th e same terms – "sought
and obtained" – but also takes the trouble of under lining those words in its submission in order for
everyone to understand the difference between the present tense ("seeking"), in Article 23.1 of the
DSU, and the past tense of "sought and obtained". That difference seems obvious enough. What is
much less obvious, however, is how, by referring to th e past, the defending parties want to explain
what they are doing right now. Applying sanctions is a form of seeking redress as the defending
parties have admitted themselves. They are curren tly applying sanctions – present tense, not past
tense – so how could they not be seeking redress?
4.125 They are not seeking redress, so the defending parties say, because they are acting under an
authorization. An authorization, however, can neither deny facts nor derogate from a Member's
obligations outside its scope. Thus, as regards specifi cally Article 23 of the DSU, it is clear that the

mere existence of an authorization cannot simply do away with the obligation to abide by the rules
and procedures of the DSU, when a Member is seeking redress of a violation.
3. Article 23.2(a) of the DSU in conjunction with Article 21.5 of the DSU
4.126 As regards specifically the EC's claim under Ar ticle 23.2(a) in conjunction with Article 21.5
the defending parties put forward a number of reas ons as to why there is no determination by them.
Interestingly enough, they hardly deal with one of the main points the European Communities has
raised, namely that their "unilateral determination" can be inferred from the fact that they continue to
apply sanctions unilaterally. And how could it not be inferred from it? It is inconceivable – and
indeed would be even worse than what we are discussing now – if they did so without any good
reason. On the other hand, both spend considerable time in their first written submissions explaining -
in a rather defensive manner - that their public stat ements do not constitute de terminations, that they
never alluded to a violation, that they have not yet concluded on non-compliance, etc. And finally,
elsewhere in their submissions, they spend ev en more time explaining why the European
Communities' implementing measure actually falls short of compliance.
4.127 Whether or not a specific statement reaches – as Canada puts it – the "threshold" of a
determination is one thing. Yet, another thing is if that statement is accompanied by conduct that
severely affects the EC's trade. We are not looking at statements made in abstracto here. A
"determination" need not be pinned down to a speci fic statement in a specific form, it is the whole
conduct a WTO Member is displaying that needs to be looked at.
4.128 The defending parties further claim that they do not have an obligation under Article 21.5 of
the DSU to launch compliance proceedings. This Panel, however, is asked to find whether, under
Article 23 of the DSU, in conjunction with Artic le 21.5, a Member has an obligation to launch a
compliance procedure if and because it continues to apply sanctions against another Member, even
though there is a new implementing measure. It is no t relevant for this dispute what obligations can
be found directly in 21.5 in the absence of such unilateral conduct.
4.129 Finally, the United States claims that there is no obligation for the retaliating complainants to
immediately launch a compliance review. In the present context and circumstances, with almost one
and a half years that have passed after the a doption of the European Communities' implementing
measure at the moment when this Panel was estab lished and with all the discussions that took place
between the parties to this dispute regarding this implementing measure, both before and after it was
adopted, the question of how quickly a retaliating complainant must react to an implementing measure
does not pose itself. If anything, one could discuss the defendants' bad faith and their contradictory
behaviour (venire contra factum proprium).
4. Article 23.1 in conjunction with Articles 22.8 and 3.7
4.130 As regards the EC' claim under Article 23.1 in conjunction with Article 22.8, 3.7, the
defending parties submit that th e conditions of Article 22.8 are not fulfilled because the European
Communities did not prove that it has "removed" the inconsistency of the measure. This
argumentation overlooks the fact that dispute settlement proceedings are about a non-compliance
review not a compliance review. Indeed, in all di spute settlement proceedings that have ever been
adopted by the DSB it was for a complaining Member to prove the WTO inconsistency of a measure
by another Member. This is explicitly confirmed by Article 6 of the DSU, the provision under which
panels are established.
4.131
The defending parties ignore that the Europ ean Communities makes its systemic claim under
Article 22.8, in conjunction with Article 23.1. Thus, the Panel is called upon to decide whether or not
the conditions under Article 22.8 are fulfilled in view of the prohibition under Article 23 to make

unilateral determinations of non co mpliance. It is not possible for the defending parties to contest the
removal by the EC of the inconsistency of our ol d measure (Article 22.8), without making a unilateral
determination under Article 23.
4.132 Further, both defending parties submit that the European Communities cannot base itself on a
presumption of good faith compliance. The European Communities bases itself on the same rationale
as the Appellate Body in the Byrd Amendment case. Thus, even though the defending parties allege
that the European Communities is still in violation of the SPS Agreement, this does not in any event
affect the presumption of good faith. As the Appellate Body has made clear, these are two completely
different questions.
4.133 The defending parties claim that there is a reversed burden of proof in a compliance case.
Contrary to what Canada believes, a reversal of presumption can also not be deduced from the DSB
authorization granted in 1999. The DSB authorizati on is limited to giving a Member the right to
apply sanctions. However, it does not go further than that. The DSB authorization cannot reverse the
normal rules which apply for subsequent implementing measures.
4.134 If Canada's criterion of a "day-to-day busin ess" conduct for the presumption of good faith
should bear any relevance at all, the European Co mmunities considers that in the present case it even
supports the EC' reliance on goo d faith. Indeed, the European Communities prepared the
implementation of the DSB recommendations and ruli ngs with extraordinary carefulness. During the
compliance process, the European Communities has made every effort to analyse the relevant
scientific evidence in full transparen cy and with an open mind. All st akeholders – whether inside or
outside the European Communities - had at every mome nt in time the opportunity to submit relevant
information and to intervene in the whole process.
4.135 It is therefore also absurd, and indeed turns rea lity on its head, to main tain that the European
Communities in this case seeks to end the sanctions on the basi s of a "mere declaration of
compliance", and that this could be done also just "a week after" the DSB authorization. It insinuates
that the European Communities abu sed its rights and it just waives its hand to claim compliance. In
the light of the whole process, as just described, it is instead fully leg itimate for the European
Communities to rely on the presumption of good faith for its compliance.
4.136 As to the relevance of the DSB authorization fo r the continued application of sanctions in the
context of Article 22.8, obviously, the defending parties and the European Communities have
different views about the scope of the DSB authorization. For the United States and Canada, the DSB
authorization operates like a sort of "absolute justification" which makes every behaviour per se WTO
consistent, irrespective of any subsequent events and compliance acts. On the other hand, the
European Communities considers that it is necess ary to put the DSB authorization in its proper
context under the DSU.
4.137 In this case, the DSB authorization has been granted under Article 22.7 following an
arbitration procedure under Article 22.6 of the DSU. The subject-matter of this Article 22.6
arbitration was the level of nullification or impa irment caused by the original EC's Hormones
legislation. Thus, it is crucial to note that the ve ry basis of the DSB authorization has been the WTO-
inconsistency of the Member before the authorization was granted. On the other hand, the DSB
authorization is not based on any (alleged) WTO inconsistency of a compliance measure that has been
adopted afterwards.
4.138 What follows from this important and undisputab le fact is that, first of all, in case of a
subsequent compliance that is properly adopted an d duly notified to the WTO, the basis on which the
DSB has granted its authorization has fundamentally changed. The DSB only granted the
authorization to suspend concessions precisely b ecause a WTO Member had been found to be WTO

inconsistent in the past and no implementation me asure was taken within the reasonable period of
time. The DSB's authorization was to induce co mpliance by the other Member and to rebalance
temporarily the rights and obligations until the other Member has complied.
4.139 Second, the DSB authorization is even mo re fundamentally changed in the case of a
subsequent compliance measure which has neve r been found WTO-inconsistent, because the
defending parties do not dare to ch allenge it under Article 21.5. In its first written submission, the
European Communities has referred to the "seque ncing" discussion and practice of WTO Members in
case of a compliance act before the DSB authorizatio n is granted. Quite remarkably, in the "Bananas"
dispute the DSB Chairman explicitly stated that the sequencing of a determination of
(non-)compliance and the suspension of concessions should be treated in a "logical way forward".
4.140 As it happened, the logical way forward at the time was to assess first whether the compliance
measure was sufficient before determining the nullification or impairment caused by the WTO-
inconsistent measure. In stark contrast to this se quencing, the defending parties consider now that the
logical way forward is to continue to apply san ctions even though the EC' compliance measure has
not been challenged by them and not been found WT O-inconsistent. And what is more, they even
refuse to challenge the EC's compliance measure, pr etending that this is not necessary becuase they
have a DSB authorization.
4.141 But how can Canada and the United States know that the European Communities is still not in
compliance with its obligations? They do so solely on the basis of a unilateral determination of the
EC's compliance measure which is in obvious contradiction to Article 23 and Article 21.5 of the DSU.
4.142 One might argue that the DSU is not explicit on this question. However, the DSU contains
several elements which indicate that the DSB aut horization can not serve as a blank cheque for the
continuous application of the sanctions even afte r a subsequent compliance measure has been adopted
and notified properly to the DSB.
4.143 First, let us consider the wording of Article 22.8 of the DSU and what it does not say. Even
in case of a removal of the inconsistency of the measure, Article 22.8 does not say that the "DSB
authorization ceases to apply". Instead, it states that the suspension of concessions or other
obligations shall not "be applied" any longer. Thus , Article 22.8 does not formally address the fate of
the DSB authorization. In an Article 22.8 situation it is, therefore, perfectly conceivable that although
the DSB authorization is not formally terminated or withdrawn, a WTO Member is not entitled to
continue the application of suspension of concessions. Furthermore, Article 22.8 does not say that the
removal of the inconsistency or the termination of the application of suspension requires whatever
kind of DSB decision. Rather, Article 22.8 is self-e xecuting. The use of the word "shall" supports
this interpretation, which does not give any margin of manoeuvre and requires no additional acts.
4.144 Second, contextually, Article 22.8 describes the next procedural step in the course of a dispute
after an authorization has been granted. Article 22.8, therefore, provides for the next logical step.
Consequently, once the inconsistency of the measure has been removed, the application of suspension
of concessions or other obligations is no longer permitted.
4.145 In addition, Article 22.8 should be interpreted in the context of Article 23 of the DSU, which
prohibits WTO Members from judging unilaterally the properly adopted and notified compliance
measures of other WTO members. According to the text, object, purpose and context of Articles 22.8
and 23, the defending parties must seek a determ ination of non-compliance under the normal DSU
procedures. This general principle is not altered in whatever way under Article 22.8.
4.146 Another contextual element which should be taken into account is Articles 3.7 and 22.1 of the
DSU, which underline the exceptional and temporal nature of the application of suspension of

concessions or other obligations. Their exceptional and temporal nature effectively complements the
principle of good faith. In case of a properly adopted and notified compliance measure, the
exceptional and temporal justifica tion of countermeasures is put into question. In the presence of a
subsequent compliance measure, the "normal" s ituation revives and sanctions can no longer be
applied as if nothing has changed.
4.147 Canada tries to draw contextual support fo r its position from Article 3.2, emphasizing the
security and predictability given by the DSB authori zation. The "security and predictability" under
Article 3.2, also applies to the WTO Member w ho properly implements its obligations. Once this
Member has removed the inconsistency of the meas ure it should have the reassurance that sanctions
are no longer applied. At a minimum, the implemen ting Member must have the reassurance that its
measure is properly challenged under the DSU by th e retaliating Member, which does not agree with
the compliance measure. But even this, Canada and the United States refuse to do despite the
repeated requests by the European Communities to do so.
4.148 The European Communities would also recall th e object and purpose of the trade sanctions,
which is to induce compliance and to rebalance the rights and obligations under the WTO agreements.
However, both objectives require that a Member 's measure has been found first to be WTO-
inconsistent in accordance with the DSU rules. And such a determina tion concerns logically not just
any measure, but the measure that is currently in fo rce in the Member concerned. Transposed in the
present context, it means that Canada and the Un ited States cannot simply argue that the "old"
measure has been found to be WTO- inconsistent in 1998. This meas ure is not any longer in force,
since the European Communities adopted and notified its compliance measure in 2003. It is simply
not rational and credible to argue that the obj ect and purpose of the suspension of concessions
continues to exist, if its basic reason, i.e. the old WTO-inconsistency, has disappeared.
5. Concluding statement of the European Communities
4.149 The EC believes that allowing public observation of the debate during this hearing has been
very beneficial for the public's understanding of the dispute settlement process as well as this
particular dispute. The public observation has in no way hindered an efficient conduct of this hearing.
On the contrary, the third parties have clearly be nefited from their observation of this hearing during
the first two days for the purpose of their participation in this dispute.
4.150 What we have heard from the defendants in the last few days is essentially that a retaliating
Member has no obligation whatsoever under the DSU. Instead, the retaliating Member may continue
to apply sanctions until the authorization is "re voked" by the DSB. The United States and Canada
argue that by virtue of this authorization they can simply lean back and see what the complying
Member comes up with. If eventually the complying Member adopts an implementation measure
they do not even see a need to review it in due tim e. Let me remind that in this case the United States
and Canada claim that they have even after two y ears (and I should add after an additional three years
of preparation) not made up their mind whether the EC's measure is WTO consistent. Indeed there
seems to be no prospect that the United States and Canada will ever make up their minds. Canada has
stated that it would never make a determination about the EC's new measures and the United States
gave even less cause for reassurance stubbornly refusing even to agree that there is a disagreement.
4.151 Whatever the defendants may mean by these statem ents, it is clear that the United States and
Canada do not accept a responsibility to submit the EC 's legislation to a multilateral review as has
been done in any other case by WTO Members wh ich ended in an adopted WTO decision. And
although they do not contest that the EC has acted in good faith, they do not even concede that the
EC's measure can benefit from a presumption of good faith compliance.

4.152 This is a very easy going way for the United Stat es and Canada. But it cannot be the correct
one under the DSU.
4.153 The EC would recall some essential points which have been discussed by the parties:
4.154 First, the EC has advanced what would be the logi cal solution to this dispute, i.e. to follow its
example in the US – FSC case (launching Article 21.5 compliance procedure by original complaining
party, suspension of sanctions in the meantime). Quite remarkably, the Un ited States fully agreed
with the EC's approach and considered it as "the appropriate solution" in the US – FSC dispute. Yet,
the EC struggles to understand why in a reverse situ ation where the United States is retaliating, the
United States does not follow this example if it considers it as "appropriate".
4.155 Second, there has been a lot of discussion about the presumption of good faith and the
presumption of compliance, which is important for the EC's claim under Article 22.8 and Article 23.1
of the DSU. Neither the United States nor Canada nor any of the Third Parties have contested that the
EC has adopted its compliance measure in good faith . Yet, the United States and Canada refuse to
accept that the EC may rely on this principle in a "post-implementation" scenario. The United States
even wants to go so far as to say that the principle of good faith is not part of the DSU. Obviously,
this view is contrary to what the Appellate Body has consistently ruled but also irreconcilable with
general principles of public international law. Mo reover, when we asked Canada about the basis in
the DSU of its assumption that an implementing Memb er faced with retaliation is not entitled to this
presumption, it could not provide any answer. Indeed, this is so because there is no basis for Canada's
theory.
4.156 Third, during the proceeding we have heard a lot about the risks of an "endless loop of
litigation" by a "mere declaration of compliance". Ye t, as everybody agrees that the EC has adopted
its compliance measure in good faith, it is clear that this "endless loop of litigation" does not arise in
this dispute. Indeed, such an endless loop scenar io presupposes a sort of scam measure notified by a
WTO Member in bad faith. This is not the case befo re us. Indeed, even the EC would not consider
that a "mere declaration of compliance" is sufficien t but what matters is that a Member complies with
its obligations. This is what the EC has actually d one in this case after a most thorough review of its
measure involving a comprehensive review and assessment of the available scientific evidence.
4.157 There is a paradox about the approach of the defendants to the principle of good faith. They
do not contest that the EC has acted in good faith but they argue that WTO Members in general
cannot be expected to act in good faith. They argue, Members with a duty to implement will adopt
sham or scam measures to escape retaliation, it is argued that implementing Members must have the
burden of proving their compliance. The EC does not believe that WTO Members act in bad faith.
No Member wants to lose WTO disputes – and to do so repeatedly and igno miniously. There would
be a high political cost. Also, WTO Members are not excessively litigious and do not gaily engage in
endless loops of litigation. This fear is unfounded. But if this argument about bad faith is allowed, it
can also be used the other way around – to argue th at the United States' and Canada's approach will
lead to Members seeking and expl oiting retaliation rights for imprope r purposes. Seeking redress of
WTO violations must not be too difficult; and impl ementation and removal of retaliation must not be
made subject to the often impossible task of provi ng a negative. Retaliation rights should not become
a new means of advancing unilateralist agendas.
4.158 Fourth, when it comes to the DSB authorization, the United States and Canada argue that this
may be revoked if the EC would launch a proceed ing under the DSU, be it Article 21.5, 22.8 or
Article 25 etc. However, both defending parties cannot explain how this would even result in
revocation of the DSB authorization. Well, Canada argues that the DSB coul d probably eventually
make a recommendation to itself to revoke the DSB authorization but there is absolutely no basis for
this in the DSU. And I am not talking about the pr ocedural implications which this could entail. For

instance – according to Canada – in an Article 21.5 proceeding brought by the EC against itself the
burden of proof would be partly on the EC for the implementation of the original DSB
recommendations and ruling. On the other hand, Cana da could bring in its "defence" (in which they
would complain about the WTO consistency of the measure) new claims for which it would bear the
burden of proof. And of course, Canada's theo ry cannot even address the question on how these new
claims could be reconciled with the more limited Panel request.
4.159 Finally, let me once stress again that the EC is not seeking to avoid a proper examination of
its compliance measures in the Hormones dispute. We would be delighted if the United States and
Canada would initiate an Article 21.5 dispute to morrow and would do all we can to facilitate and
accelerate its conclusion. However the United Stat es and Canada stubbornly refuse to take this
logical – indeed appropriate – step. It is they who have sought to avoid ha ving to confront the new
EC measures and set out their objections to it in a manner in which the EC can properly respond.
They have, it is true, started to set out – for the first time – their objections in their first written
submissions. The EC does not understand why they did not want to do this in a proper Article 21.5
proceeding.
4.160 We hope that we have assisted you in your importa nt task and look forward to helping you in
any further way that we can in coming weeks.
F. O
RAL STATEMENT OF THE UNITED STATES DURING THE FIRST SUBSTANTIVE MEETING
1. Introduction
4.161 There are two central facts in this dispute. The first is that the WTO's Dispute Settlement
Body authorized the United States to suspend con cessions against the Eur opean Communities in the
EC – Hormones dispute over five years ago because the DSB found that the EC lacked a scientific
risk assessment to justify its ban on imports of m eat in connection with hormones and that the EC
then failed to implement the DSB's recommendations and rulings. The second is that the EC has
made no effort to demonstrate that the conditions in the WTO's DSU for ending that DSB-authorized
suspension have been met. Those conditions are se t forth in DSU Article 22.8. While the EC has
alleged that the United States is breaching this pr ovision, the EC apparently considers that it can
simply assert that those conditions have been met, that it can unilaterally declare itself to be in
compliance and that it can thereby invalidate the multilateral authorization of the DSB.
4.162 This position is not sustainable. The EC is alleging that the United States is breaching its
WTO obligations, and there can be no dispute that the EC bears the burden of demonstrating this –
including demonstrating that it has removed the meas ure or provided a solution to the nullification or
impairment suffered by the Member suspending concessions.
4.163 Despite this burden, the EC has insisted that this proceeding should not reach the question of
whether it has actually complied with its WTO obligations in the EC – Hormones dispute. We can
understand the EC's reluctance to deal with this i ssue, since we do not see how the EC can credibly
claim it is in compliance with those obligations. Neve rtheless, the EC's failure to make any effort at
all to demonstrate its compliance is by itself grounds for rejecting the EC's claims, since this question
goes to the heart of those claims.
2. The European Communities' amended ban
4.164 It is notable what the EC has not argued in these proceedings – how and why it has come into
compliance with the DSB's recommendations and ru lings. The absence of this argument is odd since
the majority of its claims are premised on the asser tion that its ban is now WTO-consistent. Let us
look for a moment at what, exactly, the EC has done. As far as the United States can tell in the

absence of any explanation by the EC, the EC's "amended" ban simply preserves the status quo of its
original ban found by a WTO panel and the WTO Appellate Body to violate the SPS Agreement in
1997 and 1998, respectively. Under the ban, fo und in Directives 96/22/EC and 2003/74/EC, the same
products that were prohibited entry into the EC al most ten years ago when we first challenged the
measure still may not enter the EC today.
3. The six hormones used for growth promotio n purposes according to good veterinary
practices
4.165 The six hormones at issue are oestradiol-17 β, testosterone, progesterone, zeranol, trenbolone
acetate and melengestrol acetate (or "MGA"). These hormones have been used for growth promotion
purposes in cattle for decades in several countries, and meat from treated animals has been consumed
by millions of people, without any evidence of risk or harm to human health.
4.166 In terms of human food safety, the six hormones have been studied extensively, by national
authorities and by Codex, the relevant internationa l standard-setting body with scientific expertise in
this area. In fact, the study of these hormones dates back over twenty years. The consensus
throughout the course of this study is that meat from cattle treated with these six hormones for growth
promotion purposes according to good veterinary practices is safe.
4.167 In stark contrast to the several reviews finding the use of these hormones to be safe, there is
one view that the EC portrays as dissenting – that of its Scientific Committee on Veterinary Measures
Relating to Public Health ("SCVPH"), containe d in the SCVPH's 1999 and 2002 Opinions and 2000
Review, ostensibly supported by several (17) studies commissioned by the EC. It is this view which
the EC now asks the Panel to accept wholesale without any explanation or analysis.
4.168 It is therefore not surprising that the EC h as been unable to convince several of its own
agencies of the conclusions set out in its Opinions and studies. For example, in 1999, a sub-group of
the United Kingdom's Veterinary Products Committe e dismissed the methodology and conclusions of
the EC's 1999 Opinion. Recently, in a May 2005 draft report reviewing the EC's 2002 Opinion and
the 17 studies, the Veterinary Products Committee (" UK Group") again concluded that it was "unable
to support the conclusion reached by the SCVPH that risks associated with the consumption of meat
from hormone-treated cattle may be greater than prev iously thought." The UK Group also stated that,
regarding estradiol 17β, "there is ample information to show that zoo-technical and therapeutic uses of
oestradiol-17β do not pose any risk to humans unless an active implant site is ingested."
4.169 Regarding the other five hormones, the majority of the U.K. Group determined that the
"available evidence on genotoxicity, tumorigenici ty, hormonal activity and endocrine disrupting
effects was supportive of the view that eating meat from animals treated with these five hormones was
unlikely to be harmful to human health."
4.170 In addition, the EC's own Committee for Veteri nary Medicinal Products ("CVMP"), which in
1999 evaluated the conclusions of the 1999 Opinion and the new EC studies on oestradiol and
progesterone, determined that the EC had not pr esented sufficient new evidence to cause the CVMP
to conduct a new risk assessment on either hormone or alter its previous conclusions on their safety.
4.171 Let me reiterate: these are internal criticisms of the work produced by the EC and of the very
documents it now asserts bring its measure into co mpliance with DSB recommendations and rulings.
Despite these criticisms, and despite the extensive history of study of these hormones finding their use
to be safe, the EC would have this Panel endorse its assertion that its new measure is WTO-consistent
without a demonstration of why this is so. A determination of an Article 22.8 breach absent a
thorough evaluation of these documents would not on ly ignore the rules of burden of proof in WTO
dispute settlement, it would cast aside the substantial history of review of these hormones – a history

that has, time and again, demonstrated that their use for growth promotion purposes according to good
veterinary practices, is safe for consumers.
4. The EC's assertion of its own compliance
4.172 Contrary to the EC's argument, a WTO Member may not, in effect, revoke DSB authorization
to suspend concessions, and consequently establish a breach of Article 22.8 of the DSU, by simply
asserting that it has brought its measure into complia nce. This interpretation ignores the rules of
burden of proof in WTO dispute settlement as well as the Article's text and context.
5. Burden of proof
4.173 As a threshold matter, the EC fails to meet its burden of proving that the United States has
breached Article 22.8 of the DSU. As the complaining party, it shoulders the burden of proving each
element of its claims against the United States. Ar ticle 22.8 requires that a Member either remove its
WTO-inconsistent measure or provide a solution to the nullification or impairment suffered by the
Member suspending concessions in order to demonstrate a breach. In other words, for purposes of its
Article 22.8 claim, the EC must demonstrate how it has in fact accomplished either of these two
conditions.
4.174 The EC's bald assertion of compliance in the c ontext of this scientific and factual landscape
highlights the fact that it has made no effort to demonstrate how its new import ban satisfies the
conditions of a "provisional" ban under Article 5.7 of the SPS Agreement or "rationally relates" to or
is "reasonably supported" by a risk assessme nt for purposes of Article 5.1 of the SPS Agreement. Its
mere assertion that it can invoke Article 5.7 for the five hormones, and that it has developed a proper
risk assessment for the sixth and that its ban is now based on such an assessment is not sufficient to
demonstrate that it has removed its WTO-inconsiste nt measure or provided a solution to the EC's
nullification or impairment of benefits, and thereb y does not satisfy its burden of proof and make its
prima facie case.
6. "Presumption of good faith"
4.175 In lieu of an attempt to satisfy its burden of proof, the EC argues the existence of a
presumption or principle of good faith. Or, at least such a presumption applied selectively on the EC's
terms. For the EC, the presumption applies to its uni lateral declaration of compliance, but apparently
does not apply to a Member's suspension of concessions in accordance with a DSB authorization.
4.176 In support of its argument, the EC cites dicta from WTO disputes in which panels, arbitrators,
and the Appellate Body are simply elaborating on the appropriate burdens of proof in WTO dispute
settlement. It is unexceptional an d uncontested that, in a dispute, the complaining party bears the
initial burden of proof to establish its claims of a WTO violation, and that there is no presumption of
bad faith with respect to the responding party. Were it otherwise, complaining Members would not
have to mount any case whatsoever to demonstrate a WT O violation. They could simply allege that it
was so and prevail.
7. The EC's interpretation of the DSU
4.177 The EC claims that the United States has br eached Articles 21.5 and 23 of the DSU by
continuing to suspend concessions to the EC despit e its claim of compliance. However, the EC's
analysis of these provisions is not consistent with their terms, nor does it reflect the fact that the
United States' DSB authorization remains valid.

(a) Article 21.5
4.178 For instance, the EC reads into Article 21.5 of the DSU an obligation that a Member duly
authorized to suspend concessions must request an Article 21.5 panel the moment that another
Member declares its own compliance with DSB reco mmendations and rulings. However, nothing in
Article 21.5's text hints at such an obligation. Indeed, the DSU simply does not prescribe the
particular procedures to follow in a situation wh ere the DSB has granted authorization to suspend
concessions to a Member, and the implementing Member later claims to have complied. Rather, it
leaves open to the parties to choose one of various means to proceed, including bilateral consultations,
use of good offices, conciliation and mediation under Article 5 of the DSU, recourse to DSU
Article 21.5, arbitration under Article 25 of the DS U, and recourse to normal panel proceedings such
as we are party to here.
4.179 Despite this fact, the EC would instead re move all alternatives except an Article 21.5
compliance proceeding and would read into that Arti cle a deadline that is not there. The EC would
also read into Article 21.5 an obligation for th e complaining Member, and only that Member, to
invoke Article 21.5. The EC does not base its proposed approach on the actual text of the Article, but
rather constructs a series of policy arguments as to why the DSU should be re-written in the manner it
desires.
4.180 There are three basic shortcomings in the EC's Article 21.5 analysis. First, Article 21.5 only
applies in situations where there is a disagreement regarding the WTO-consistency of a measure taken
to comply. Prior to the EC's request for the establis hment of this Panel (and so by definition prior to
the EC's request for consultations), the United Stat es had not formulated an opinion as to the WTO-
consistency of the EC's ban.
4.181 Second, Article 21.5 does not contain any time limitation or deadline by which a Member
must initiate dispute settlement proceedings – a poi nt emphasized by the fact that there is often
substantial delay between claims of compliance and the initiation of Ar ticle 21.5 proceedings
(presumably responding Members normally welcome such delays since they would not be in a hurry
to have their claims of compliance questioned before a panel). The EC's interpretation of Article 21.5
would prevent Members such as the United States from exercising any judgment as to the fruitfulness
of dispute settlement prior to finding themselves obligated to do so and would similarly preclude
Members from seeking mutually agreeable solutions through negotiations.
4.182 Third, and finally, the EC argues that the Unite d States was obligated to seek recourse to an
Article 21.5 compliance panel, and only such a pane l, upon hearing the EC's declaration. However,
the text of Article 21.5 simply refers to "these dispute settlement procedures," without specifying any
particular subset of procedures. Therefore, the EC's argument that the United States was specifically
obligated to initiate a compliance proceeding under Article 21.5 is groundless.
(b) Article 23
4.183 In addition to its claim of a US breach of Artic le 21.5, the EC also contends that the United
States has breached Article 23.1 by seeking redress of a perceived WTO violation without recourse to
dispute settlement and made a "determination" of th e WTO-consistency of the EC's ban in breach of
Article 23.2(a). We have done neither.
4.184 The United States was not obligated to seek r ecourse to dispute settlement pursuant to the
general rule set out in Article 23.1 once the EC d eclared its own compliance at the DSB. The United
States adhered to the letter of Article 23.1 by seeking redress of the nullification or impairment caused
by the EC's import ban through recourse to the provisions of the DSU. The multilaterally-authorized
suspension of concessions stemming from US recourse to dispute settlement remains valid to this day.

It is unaffected by the EC's unilateral declaration of compliance, and the EC has failed to demonstrate
to the contrary.
4.185 Similarly, the United States has made no Article 23.2(a) determination as to the WTO-
consistency of the EC's amended ban. Since r eceiving authorization to su spend concessions to the
EC, we have simply continued to act according to that authorization. Contrary to the EC's claims in
this panel proceeding, we have made no determinat ions regarding the WTO-consistency of its import
ban, amended or not. We did not have to make an y further determinations in order to continue to
suspend concessions. Article 22.8, discussed earlier , sets the parameters for when we would no
longer have been authorized to do so. The EC h as made no effort to demonstrate that any of the
conditions of that Article have been met.
8. Conclusion
4.186 For all the reasons discussed above and in its first written submission, the United States
respectfully requests the Panel to reject the EC's claims in their entirety.
9. Concluding statement of the United States
4.187 The United States has actively engaged in this week's debate, examined in detail provisions of
the DSU and the facts of this dispute. Taking into account all of these discussions and facts, it
becomes clear that we find ourselves here today for a simple reason: the EC, a WTO Member who
claimed to have come into conformity with DSB recommendations in the EC – Hormones dispute, did
not want to undertake the effort of explaining why th is was indeed the case. It chose not to attempt to
satisfy its burden despite its eagerness to have the suspension of concessions lifted, and despite its
possession of new Opinions and studies it so confid ently alleged to support its ongoing ban. It has
chosen not to make this attempt despite several ave nues available to it in the current text of the DSU,
including Article 22.8 (as well as Articles 5 and 25).
4.188 Instead, it chose to seek a suspension of sancti ons in the most roundabout way possible – by
alleging that the United States, by not lifting its suspension of concessions, breached its obligations
under elaborate, intertwining interpretations of the DS U. This choice is remarkable given the fanfare
that the EC attached to its ban and Opinions. On e would have thought that an Article 22.8 finding
that it had removed the ban or provided a solution to nullification or impairment would have been a
logical and simple approach.
4.189 Yet, the EC did not pursue this straightforwar d course. Instead, it alleged that the United
States had made a unilateral determination that the EC's new ban was not WTO-consistent. In this, it
ignored the fact that the United States has been suspending concessions to the EC pursuant to DSB
authorization. Moreover, having eschewed Article 22.8, the EC could not identify a standalone
provision in the DSU regarding which it could alle ge a US breach. So, rather than looking to
Members' obligations as they currently exist in th e text of the DSU, the EC concocted two claims,
melding and rewriting provisions of the DSU, and c ontending that it has demonstrated that the US
suspension of concessions can no longer be applied.
4.190 The EC asserts that these claims are a "refinemen t" of the individual claims described in its
panel request. However, rather than becoming more clear or "refined", the EC's claims blending
multiple DSU provisions have become more and more muddled. I would like to take a moment to
discuss a few of these "in conjunction with" claims.
4.191 I would first reiterate a question raised in Tuesday's session, and add one additional question
for future consideration. In that meeting, the United States asked the EC whether it still alleged a US
breach of Article 21.5 of the DSU per se. I would now ask a further question: does the EC still allege

that the United States has breached Article 22.8 of the DSU? Why do I ask if there is a violation of
these provisions per se? Because the EC has failed to identify, an ywhere in the text of either Article,
an obligation breached by the United States, and those are the only breaches possible under the DSU
as currently written. Instead, the EC cloaks its alle ged claims of breach "in conjunction" with claims
of breach of other DSU provisions, ranging from Article 3.7 to Article 23.
4.192 The EC's repeated invocation of the phrase "in conjunction with" does not make the EC's
interpretive approach any more credible. To the contrary, the phrase should be viewed as a signal that
the argument which follows is based not on the text of the DSU, but on how the EC would like to see
the DSU rewritten. Or, at least, how it would like to see the DSU rewritten for purposes of this
dispute.
4.193 From our standpoint, it is impossible to tell if , through these "in conjunction with" claims, the
EC still alleges an actual US breach of these provi sions (Articles 21.5 and 22.8). Ironically, the EC
refers to our attempts to respond to their jumbled claims on an individual, article-by-article basis as
"obfuscat[ion]", yet it has told us all that, if the Panel makes a finding in its favour on one of these "in
conjunction" claims, it expects very real, individu al, un-conjoined breaches of Articles 21.5 and 22.8
to be an integral part of those findings.
4.194 According to the EC, an analysis of the black-and-white text of Articles 22.8 and 21.5 is
"obfuscation," since these can only be analysed "in conjunction with" other provisions. In particular, I
would highlight the following quotes from the EC's oral statement:
"This Panel is asked to find whether, under Article 23, in conjunction with
Article 21.5, a Member has an obligation ..." but that "[i]t is not relevant for this
dispute what obligations can be found directly in 21.5 in the absence of such
unilateral conduct."
"The defending parties ... ignore that the European Communities makes its systemic
claim under Article 22.8, in conjunc tion with Article 23.1 . Thus, the Panel is called
upon to decide whether or not the cond itions under Article 22.8 are fulfilled in view
of the prohibition under Article 23 ..."
4.195 The EC's non-textual approach appears to be an attempt to distract from the fact that it does
not wish to attempt to make its prima facie case of an Article 22.8 breach by demonstrating, pursuant
to the actual, current, text of that provision that it has either removed its WTO-inconsistent measure or
provided a solution to the nullification or impairme nt. Likewise, it seeks to avoid any analysis of
what obligations are actually found in the text of Article 21.5, since that provision does not in fact
obligate the United States to bring an Article 21.5 pr oceeding, nor does it contain a time limitation for
doing so.
4.196 Rather than a "refinement" of the EC's case, these "in conjunction" arguments only make the
EC's case all the more obtuse – creating in essence a moving target for responding parties. We are
forced to defend ourselves against accusations that we ar e in breach of provisions that do not, in fact,
exist. We have exposed in the question and an swer session the potentially confusing outcome of
recommendations and rulings on some of the EC's claims – an outcome that would result from the
EC's inability to demonstrate a US breach of a ny of these provisions standing alone. Fortunately,
there is a simple way to avoid this confusing outcome – to look instead to the text of the DSU as it is
currently written, not as a single Member's policy would have it rewritten.
4.197 We have demonstrated in our submissions that Article 21.5 does not contain any obligations
that the United States could theoretically have breached . For example, there is no obligation that the
United States bring a compliance proceeding upon lear ning of the EC's declaration of compliance.

Further, there is no time period, whether that peri od is immediate or is unspecified, indefinable and
unwritten "reasonable delay" championed by the EC. Pursuant to this fictional new Article 21.5
requirement developed by the EC, if a Member re quests an Article 21.5 panel "a month or two –
rather than two years – into implementation" it has satisfied its imaginary deadline to do so. Maybe I
have not been looking hard enough at the text of Ar ticle 21.5, but I have not been able to locate the
"reasonable delay" deadline yet. This is not surp rising, because the EC makes every effort to avoid
the actual text of Article 21.5. According to the EC, the fact that we can demonstrate that we have not
breached the provisions of Article 21.5 is not the poin t – because "[i]t is not relevant for this dispute
what obligations can be found directly in 21.5."
4.198 We have demonstrated in our submissions th at we have not breached Article 22.8, which
requires that the suspension of concessions "only be applied until such time as the measure found to
be inconsistent with a covered agreement has been removed, or the Member that must implement
recommendations or rulings provides a solution to th e nullification or impairment of benefits, or a
mutually satisfactory solution is reached." We have shown that the EC has failed to demonstrate that
any of these three conditions have been met. Th ere is no satisfactory solution, no removal of the
measure, and no provision of a solution to US nu llification or impairment. Indeed, the EC does not
engage in a discussion of whether or not it has sa tisfied these conditions whatsoever. In the eyes of
the EC any substantive analysis of Article 22.8 would involve analysis of a "(direct) violation" of
Article 22.8. Evidently, a direct analysis of a direct violation of the actual text of Article 22.8 is not
relevant to this proceeding. This is the case because, for the EC, its reference to Article 22.8 in Part I
of its submission is only to be read "in conjunction with" Article 23. As a result, the United States is
evidently left to rebut an "indirect" claim. Indi rect, that is, in that it evidently does not involve
analysis of the obligations specifically set out in Ar ticle 22.8. Not so indirect in that, through this
Article 22.8 "in conjunction with" Article 23 claim, the EC seeks a finding of a very full-fledged, very
direct US violation of Article 22.8.
4.199 So, finally, we come to the "central provision" of the EC's claims against the United States –
Article 23. Like it did for Articles 21.5 and 22.8, the United States set out clear arguments, based on
the text of this provision as it is currently set out in the DSU. We demonstrated that, at the
appropriate time, we sought recourse to dispute settlement and obtained the proper DSB authorization.
We continued to suspend those concessions pursuant to this authorization.
4.200 It is critical to note that, just because the DS U does not set out an explicit path for Members
to pursue in this "post-suspension" scenario, it provid es several options by which, pursuant to its text
as currently written, the EC may have sought review of its measure. The EC, contrary to what it
would apparently have this Pa nel believe, was not without ave nues for obtaining a multilateral
determination that its measure was or was not WTO- consistent. For example, I should reiterate that,
as we have indicated on several occasions, we find ourselves in a perfectly suitable panel proceeding
to examine the EC's compliance pur suant to DSU Article 22.8. While the EC would argue that an
Article 22.8 claim against the United States, and a n eed to make a prima facie case that it has either
removed its offending measure or pr ovided a solution to nullification or impairment is only raised in
its Part II claim, we would note that it is also squarely before this Panel in the Part I claims set out in
the EC's first written submission, only in the form of the opaque "23 in conjun ction with 22.8" claim,
which evidently sets out an "indirect" Article 22.8 claim.
4.201 We have also commented that an Article 21.5 compliance panel could be a possible avenue
for determining whether or not the EC has brought its measure into compliance with DSB
recommendations and rulings. The EC has raised various issues concerning a Member bringing a
compliance proceeding against itself. Among these, it has argued that the EC – Bananas
(Article 21.5)
 proceeding does not demonstrate that a Member may do so. In the third party session, it
responded to another party's comment that, by the ve ry fact that the EC composed an Article 21.5
panel, it demonstrated that this is a possible ave nue. However, the EC's dismissal of this comment

because the report was not adopted ignored the point being made. Apart from the fact that the report
was not adopted for the simple reason that the EC never requested its adoption, it is unclear why
adoption or lack of adoption of the report has any bearing on the simple fact that the EC was indeed
able to request the Article 21.5 panel.
4.202 I would now like to turn to Part II of the EC's argument.
4.203 Part II of the EC's argument, its "direct" Article 22.8 claim against the United States, is the
embodiment of what this case would look like if the EC chose to put its amended measure forward for
multilateral review. That the EC has brought this claim is testament to the fact that it is possible to do
so, that it is possible for an implementing Member to put its measure squarely before an Article 6
panel and to seek multilateral review and findings of the WTO-consistency of that measure.
4.204 The issue of burden of proof came up in yesterday's meetings, and I think that we should
touch upon it at this point. Yesterday, the EC expressed its concern regarding what would be
involved in setting out a prima facie case of rem oval of its measure or providing a solution to
nullification or impairment for purposes of an Artic le 22.8 claim against the United States. I think
that everyone here would agree that this is not exactly an insurmountable task, in particular, for a
Member like the EC who has just spent the last six years producing studies on these hormones and
developing Opinions evaluating those risks. The EC believes its ongoing ban is tied neatly to these
studies and Opinions, and one would think it of little consequence for the EC to explain why it felt
justified in declaring itself to be in complian ce with the DSB's recommendations and rulings, why it
believes that its ban on oestradiol-17 β is based on a risk assessment within the meaning of Article 5.1
of the SPS Agreement, and whether its provisional ban on th e five other hormones satisfied the
conditions of Article 5.7. The EC could, for ex ample, have addressed its alleged compliance with
specific panel and Appellate Body findings. But the EC did not do so, and instead relies on
unsupported assertions.
4.205 It is worth noting that the question of th e precise level of evidence and argumentation
necessary to establish a prima facie case is rarely at issue in WTO dispute settlement, for the simple
reason that both sides typically engage on the merits, allowing the panel to evaluate the totality of the
evidence presented to determine whether the r esponding party has adequately rebutted the
complaining party's arguments. Indeed, the Un ited States in this proceeding has engaged on the
substance of the EC's new studies as if the EC had attempted to make its prima facie case. The EC's
failure to actually do so, and its reliance in this di spute on creative redrafting of the DSU, says more
about the EC's lack of confidence in its own scientific evidence than it does about the supposed
difficulty of understanding how to establish a prima facie case.
G. SECOND WRITTEN SUBMISSION OF THE EUROPEAN COMMUNITIES
1. Introduction
4.206 The European Communities' case is straightfo rward. WTO Members that apply sanctions
against another WTO Member cannot adopt a lean-b ack-and-wait-attitude over years and continue to
suspend concessions in the presence of a subseque nt compliance measure. Just as WTO Members
who have been found to be in violation of the covered agreemen ts have a positive obligation to
implement, so have retaliating Members a positiv e obligation under Article 22.8 not to apply
sanctions any more and/or, if they disagree with the compliance measure, to initiate WTO
proceedings under Article 21.5. This has always been the practice in WTO proceedings. If a
retaliating WTO Member fails to respect these ru les and procedures under the DSU, it will be in
violation of Articles 23.1 and 23.2(a).

2. PART 1: Violation of Articles 23.1, 23.2(a), 21.5 and 22.8 of the DSU (systemic issues)
(a) The United States is in violation of Article 23.1 and 23.2(a) read together with Article 21.5
4.207 The existence of a DSB authorization does not exclude that a WTO Member is still seeking
the redress of a violation within the meaning of Ar ticle 23.1. The very fact of applying sanctions
implies that a Member is seeking to redress a viola tion. Such an application of sanctions may be
justified if a measure by a WTO-Member has been properly found to be WTO-inconsistent and, if on
that basis, the DSB authorizes th e suspension of concessions. However, the situation is different
regarding the continuation of sanctions in the presence of a compliance measure which the DSB has
never found to be WTO-inconsiste nt or which has not even been challenged. In such case, a DSB
authorization which has been granted in view of an original WTO-inconsistent measure can not justify
the continued application of sanctions against a diffe rent measure. Rather, since the application of
sanctions requires a causal relationship to a WTO-inconsistent measure, any present application of
sanctions must be linked to a present measure, i.e. violation. Conversely, the present application of
sanctions to a past, no longer existing measure is not justified just as it would be unjustified to link the
present application of sanctions to a future, not yet existing measure.
4.208 The US counter-argument would lead to the absurd result that the United States could
continue to apply sanctions irresp ective of any events occurring afte r the DSB authorization and thus
ignoring the object and purpose of sanctions, i.e. to induce compliance and to rebalance rights and
obligations in case of a WTO violation. If the Un ited States applies sanctions merely because of the
existence of a DSB authorization and irrespectiv e of a subsequent compliance measure, they are
neither inducing nor rebalancing anything. The Unit ed States fails to acknowledge that the situation
has changed by the adoption of the EC implemen ting measure. Yet, since the United States has
adopted a negative position on the EC compliance measure and since the United States has been under
no obligation to continue the suspension of concessi ons, the very fact that it nevertheless continues
the application of sanctions proves that despite its claim to the contrary the United States is indeed
drawing a causal link between the continuation of the suspension and the determination of
inconsistency of the EC compliance measure.
4.209 The opposite US view would lead to the c onclusion that the United States is currently
applying sanctions against a no longer existing measure, because it is uncontested that the original
measure which the DSB found inconsistent has been removed by the EC. However, the true reason
for the US application of sanctions is that it cons iders the existence of an "import ban" as such as a
violation. The United States does so on the basis of a unilateral determination since the current
import ban is a totally new measure which has neve r been found WTO-inconsistent. Thus, in the
presence of a compliance measure the United States assumes a right to determine unilaterally whether
this measure is sufficient or not. Furthermore, th e fact that the United States seeks redress is also
evidenced for instance by its st atement in the 2005 Trade Policy Agenda whereby the United States
openly links the continued application of sanctions to the EC compliance measure. Conversely, the
United States did not state that it continues to apply sanctions because of the DSB authorization.
4.210 The United States has also made a unilateral "d etermination" that a violation has occurred.
The term "determination" is defined, inter alia, as an "authoritative opinion"; "a conclusion reached";
"the action of coming to a decision"; "the result of this"; "a fixed intention". This term has been
further elaborated by the Panel in US – Section 301 . Thus, even an implicit determination by the
appropriate behaviour, such as the continuation of sa nctions, would be covered by a "broad reading"
of this requirement, in particular if the con tinuation occurs deliberately and is accompanied by
respective statements.
4.211 Moreover, the interpretation of the word "deter mination" should be guided by the context of
Article 23.2(a), which is Article 23.1, and the object and purpose of this provision. This provision as

a whole aims at preventing that a Member takes "the law in its hands" and seeks the redress of a
violation on the basis of a unilateral determination. The importance of this general principle is also
confirmed by the title of this provision. The cr ucial importance of Article 23 has also been
acknowledged by the Panel in US – Section 301 . It is therefore necessary to look at a Member's
behaviour as a whole when confronted with a respec tive situation. If a WTO Member repeatedly and
consistently states that a violation by another Member exists and, in this context, this Member applies
concrete measures against the other Member, it can be concluded that this Member is seeking a
redress against a violation on the basis of a unilatera l determination. Applying these principles to the
present case, there can be no doubt that the United States has made a unilateral "determination" of
non-compliance of the EC measure. This is demons trated by the 2005 Trade Policy Agenda and, for
instance, the US statement in the DSB meeting of December 2003. In addition, it deliberately
continues to apply sanctions against the European Comm unities. Contrary to what the US purports,
this continuation is also a positive action and not just some "inaction".
4.212 The European Communities adopted and notified its compliance measure over two years ago.
To these two years one could add another three ye ars since the European Communities notified its
legislative proposal to the SPS Comm ittee in November 2000. Against this time lag it is not credible
for the United States to argue that it has still not made a determination. Rather the US attitude is
explained by the attempt to declare its rights sacros anct and to refuse any responsibility for a prompt
resolution (see Article 3.3) of the dispute.
4.213 Finally, Article 23 in conjunction with Article 22.8 obliges a retaliating Member to take note
of a compliance measure and to decide if the con tinued application of sanc tions is still justified.
Furthermore, Article 23 prohibits ma king a unilateral determination of non-compliance. Conversely,
nothing prevents the United States under Article 23 to make a unilateral determination of compliance.
Thus, unlike what the United States pretends Article 23 does not prohibit any "determination".
4.214 The European Communities considers that, by re fusing to initiate a compliance proceeding in
this situation, the United States is in breach of Ar ticle 21.5. Contrary to what the United States
purports, there exists a "disagreement" between the European Communities and the United States.
The term "disagreement" is defined as "a refusal to accord or agree, difference of opinion, quarrel".
The US attitude towards the EC compliance measure cannot escape this basic definition in the light of
its statements and the continuation of sanctions. There is no contradiction between Articles 21.5
and 23. Article 23 does not apply to any sort of "disagreement' but only in case of a "determination"
of a violation which a Member is "seeking to redr ess". This is exactly what the United States is
currently doing. In any event Article 23 contai ns an explicit reference to dispute settlement
proceedings, which includes Article 21.5 of the DSU. Thus, had the United States invoked a
procedure under Article 21.5 of the DSU, it would have fully satisfied Article 23.2(a) of the DSU.
4.215 Finally, it is appropriate to read into Ar ticle 21.5 a reasonable timeframe until which a
retaliating Member can be expected to decide wh ether an implementing member is WTO consistent
and whether to launch a compliance proceeding. This is not to be confused with a "deadline" as the
United States asserts. According to Article 3.3, disputes should be settled "promptly". Also, every
treaty must be performed in good faith, according to Article 26 of the Vienna Convention. Moreover,
Article 21.5 provides that a Panel has 90 days to determine whether an implementing measure is
WTO-consistent. If a Panel can be asked to decide in 90 days whether there is compliance, it is not
acceptable that a retaliating Member argues eight times as long that it cannot determine the
consistency of the measure. This is even more re levant in a case like this one which involves the
continued application of sanctions.
4.216
 Regarding the US argument about alternative procedures other than Article 21.5 the US
conceptual approach is not clear. In any case, Article 21.5 literally provides for a specific panel
proceeding in case there is a disagreement about the WTO consistency of a compliance measure. This

is consistent with Article 3.3. Contrary to what the United States asserts, Article 21.5 is therefore not
purely a matter of political opportunity in particul ar if at the same time it assumes the right to
continue to sanction the implementing WTO Member . As explained in detail in its second written
submission, the European Communities considers that the US examples in this respect demonstrate an
extraordinary denial of any responsibility for the well-functioning of the di spute settlement system
and the prompt settlement of disputes. This is al so corroborated by the US reply to Questions 46 and
42 of the Panel where the United States first misch aracterizes the correct implementation in this case
and, second, where the United States contradicts it self regarding its alleged interest for a quick
resolution of the dispute. Finally, the special procedure under Article 21.5 is also not overridden by
any alternative means such as good offices, conciliati on, mediation or arbitration under Articles 5 and
25 which are neither enforceable nor legally binding.
4.217 Regarding the self-initiation of an Article 21.5 proceeding the European Communities
demonstrated that also in the light of the Bananas case, the whole approach does not work and it
would be inconsistent to the logic of the DSU as well as specific provisions such as Article 6 or 1.1.
(b) The United States' continued suspension of concessi ons and related obligations is in violation
of Article 23.1, read together with Articles 22.8 and 3.7
4.218 The European Communities disagre es with the US assertion that the continued application of
the sanctions is unrelated to the EC compliance me asure. Since the original EC measure has been
removed, the US argument would mean that the US is currently applying sanctions against a non-
existing measure. Such a conclusion would no t only be illogical it would also be in plain
contradiction with the purpose of sanctions, namely to rebalance rights and obligations and to induce
compliance in the light of a current WTO violation. As explained several times, it is obvious that the
United States continues to apply the sanctions b ecause it considers the EC compliance measure as
WTO inconsistent. However, the continued appli cation of an "old" DSB authorization cannot be
justified against a "new" measure on which the DS B authorization is not based and if this new
measure has never properly been found to be WTO-inconsistent.
4.219 Contrary to what the United States asserts th e prohibition to continue the application of
sanctions under Article 22.8 does not depend on wh ether the DSB authorization has been formally
removed. Article 22.8 is unequivocal in the sen se that the suspension of concessions and related
obligations may only be "a pplied" until the inconsistency of th e measure has been removed. In
addition, Article 22.8 subjects the application of sanctions to a measure which has been found
inconsistent. Yet, this can only occur throug h a proper proceeding under WTO but not through a
unilateral determination. Article 22.8 is also of self-executing nature and the termination of the
application of sanctions under this provision does not depend on a specific finding of the DSB or a
withdrawal of the DSB authorization. Rather, once the conditions under Article 22.8 of the DSU are
met – including in the presence of an unchallenge d compliance measure – the application of
suspension "shall" automatically stop.
4.220 Finally, the European Communities does not agr ee with the US that the principle of good
faith is not relevant for WTO proceedings in general or only relevant for the issue of burden of proof.
This radical position is not supported by the general public international law, which also applies to the
WTO, as for instance expressed in Article 26 of the Vienna Convention. In this context, the European
Communities also considers that due to the specifi c circumstances for the adoption of its compliance
measure as explained in detail in its various submissions and in the absence of a concrete challenge by
the United States and in the light of the time that has passed since the measure was prepared and
adopted, it is fully entitled to invoke the principle of good faith and the presumption of compliance.

3. PART 2: The WTO-consistency of the EC compliance measure
4.221 The European Communities, in its Oral Statemen t at the first substantive hearing as well as in
a number of replies to the Panel's questions, has e xplained the various steps undertaken to carry out
the comprehensive risk assessment which led to the adoption of its implementation measure, i.e. the
revised Hormones Directive 2003/74/EC. As the Appellate Body found that the studies and other
evidence presented by the European Communities was relevant but not sufficiently specific, the
objective of the compliance effort undertaken was to re-assess all existing and most recent data from
any relevant source for the six hormones and to comple ment these data in particular in three respects,
namely: (a) on certain issues regarding specific he alth risks from residues in meat treated with
hormones for growth promotion purposes, (b) on risks arising from possible abusive use and
difficulties of control, and (c) on an appropria te risk assessment for melengestrol acetate (MGA),
which had not been carried out so far. To this effect the European Communities launched 17 specific
studies and tried to collect information from all relevant sources, including from third countries,
international scientific bodies (such as JECFA) and i ndustry. All these steps were undertaken in full
transparency and after consulting the relevant sci entific committees and bodies that are responsible
under Community law to conduct this kind of assessment.
4.222 In November 1998, the European Communiti es mandated its Scientific Committee on
Veterinary measures relating to Public Health (SCVPH), to address the potential risks to human health
from hormone residues in bovine meat and meat products treated with the six hormones for growth
promotion. The SCVPH adopted its opinion unanim ously taking into account all pertinent scientific
information available at the time, including JECFA's revised assessment of the three natural hormones
oestradiol-17β, testosterone and progesterone that had b een issued in February 1999. The 1999
Opinion concluded that a risk to the consumer had b een identified with different levels of conclusive
evidence for the six hormones evaluated. Subsequently, the SCVPH was twice requested to review its
opinion in light of new assessments carried out by other bodies or institutions and new evidence. The
SCVPH did so in 2000 and 2002. The SCVPH concluded both times that the new evidence did not
provide convincing data and arguments demanding revi sion of its previous conclusions. On the basis
of the above scientific risk assessments provided by the SCVPH, the competent European regulatory
authorities carried out an analysis of risk manageme nt options in light of the appropriate level of
protection it had chosen. This lead to the adoption of the EC compliance measure 2003/74/EC.
4.223 As explained in detail in the second writte n submission, JECFA's assessment proved
insufficient in various respects and where the SCVPH conducted a more thorough analysis. These
areas concern carcinogenicity of the three natural hormones and the outdated residues data as well as
for data concerning the dose-response relationship. In respect of the latter, JECFA also neglected the
endogenous production in the case of pre-pubertal children. Furthermore, the 1999 JECFA report has
been seriously undermined by recent developments concerning the bioavailability of residues of these
hormones. JECFA also failed to address the possibilities for misuse or abuse when the administration
of these hormones is freely authorised "over the counter", as is the situation in the United States.
4.224 Turning to the legal arguments, the European Communities disagrees with the US arguments
regarding the burden of proof. The European Commun ities, at the oral hearing and in reply to the
Panel's questions, has demonstrated a violation of Articles I:1 and II of the GATT 1994 by the US and
that the measure found to be inconsistent has been "removed" in the context of a direct claim under
Article 22.8. In particular, the European Commun ities has pointed out that it cannot be required to
prove a negative, namely that there is no violatio n of WTO obligations. In line with the established
case law of the Appellate Body, it is for the United Stat es, in this case, to set out a prima facie case of
violation, and not for the European Communities to set out a case of non-violation.

(a) Article 5.7 of the SPS Agreement
4.225 In respect of the provisional prohibition of the relevant hormones under Article 5.7 SPS the
European Communities considers that the complianc e measure fully respects the respective standard.
As regards the "insufficiency" of the scientif ic evidence for conducting a risk assessment the
European Communities recalls that: (1) what th e European Communities had considered to be
sufficient evidence had been found to be insufficien t by the Appellate Body and proved indeed to be
insufficient also in the light of risk assessment standards that were developed in the years after the
Hormones decision; and (2) the body of evidence, in th e meantime, has developed and, while still not
providing enough knowledge to carry out a complete and definitive risk assessment, supports the
conclusion that precautionary measures are required in order to achieve its chosen level of protection.
4.226 As further detailed in its Written and Oral Submissions the European Communities considers,
on the basis of the 1999 – 2002 SCVPH opinions, that the current evidence is full of gaps in pertinent
information and important contradi ctions that render the conclusions reached by JECFA in 1988,
1999 and 2000 no longer valid. Thus, it does not allo w, in qualitative or quantitative terms, the
performance of an adequate assessment of risks as required under Article 5.1 and as defined in Annex
A to the SPS Agreement. Furthermore, since the latest risk assessment by the SCVPH in 2002, there
appeared internationally a number of further scien tific developments all of which converge toward,
and provide further support to, the conclusions r eached by the relevant scientific committee of the
European Communities, such as a study supported by the Ohio State University, the US National
Cancer Institute and the US Department of Defe nce Breast Cancer Research program concerning
zeranol (and oestradiol-17β) or a large scale epidemiological study in Europe suggesting that high red
meat intake is associated with (statistically signif icant) increased colorectal cancer risk, confirming
results from previous smaller studies. Additionally, in 2002 results were published from the women's
health Initiative Randomised Controlled Trial findings indicating that the risks outweigh the benefits
from the use of oestrogen plus progestin in hea lthy postmenopausal women, thus reinforcing the
previous findings made by the IARC in this resp ect. All this evidence and most recent scientific
developments have now clearly tipped the balance against the previously held assumption (by the US
and Codex/JECFA) that residues of these hormones in meat from animals treated for growth
promotion pose no risk to human health.
4.227 Consequently, the evidence which served as the basis in the 1988 and 1999-2000 JECFA
evaluations of these hormones is not sufficient to perform a definitive risk assessment, in particular by
the WTO Members applying a high level of health pr otection of no risk from exposure to unnecessary
additional residues in meat of animals treated with hormones for growth promotion. To deny the
existence of this new scientific reality would deprive the European Communities and other WTO
Members of their autonomous right to choose their appropriate level of protection, because it would in
effect impose on them a requirement to demonstrate positively the existence of clear harm, which they
may not always be able to fulfil in case of cancer because of the long latency period and the numerous
confounding factors that play a role. This will re nder the application of Article 5.7 impossible in a
situation where the body of the pertinent scientific evidence is in the process of moving from a state
of presumed "sufficiency" into a state of pertinent "insufficiency". The text and preparatory history of
the SPS Agreement do not support such a (restrictive) construction of Article 5.7, which would
moreover be against the principle of effective treaty interpretation.
4.228
 In its second written submission the European Co mmunities has set out in detail the state of
insufficient evidence as determin ed by the SCVPH for each of the hormones which have been
provisionally (progesterone, testosterone, tr enbolone, zeranol, MGA) prohibited by the
Directive 2003/74/EC.
4.229 As regards progesterone, the US has not pointed to relevant evidence to rebut the SCVPH
conclusions. The US instead merely relies on old JECFA conclusions which have been overtaken by

more recent studies in 2002. Equally erroneous is the US' reference to the CVMP's opinion which is
irrelevant for the purposes of this dispute as it concerns an assessment of progesterone for
zootechnical and therapeutic purposes. In any case, even the CVMP's assessment pointed out that
only few recent data were available for re-evalua tion of the carcinogenic and/or genotoxic properties
of progesterone and had concluded that the compound (1) is not genotoxic in most of the tests
performed and (2) increases tumor incidences in animals at exposure levels clearly above the
physiological levels.
4.230 As regards testosterone, the US other than referring to the 1999 JECFA assessment, does not
put forward any specific argument. However, the JECFA assessment had been addressed by the
SCVPH in 1999. As pointed out above with re gard to progesterone, the US' reference to the
epidemiological studies on the effects of the horm ones on post-menopausal women, in the context of
an assessment of testosterone, is equally errone ous. Furthermore, as regards the US' comparison
between bulls and steers and which have different en dogenous testosterone levels very much depends
on the age at slaughter, the breed used, and the type of husbandry employed in rearing these animals.
The US argument is therefore at best irrelevant in deciding the central issues of the present dispute.
4.231 As regards trenbolone, the US does not put fo rward any specific argument as to why the
evidence assessed by the SCVPH would not be insuffic ient. As a matter of fact, the only assessment
on trenbolone publicly available is that of JECFA 1988. The SCVPH took into account this
assessment but disagreed with a number of its b asic findings on the bases of more recent scientific
evidence, some of which was generated by the 17 EC studies.
4.232 As regards zeranol, the US does not put forward any specific argument as to why the evidence
assessed by the SCVPH would not be insufficient. The only assessment on zeranol publicly available
is that of JECFA which dates back to 1988. The SCVPH took into account this assessment but
disagreed with a number of its basic findings on th e bases of more recent scientific evidence, some of
which was generated by the 17 EC studies. Moreover, the most recent study on zeranol and the risks
associated with its administration to meat producin g animals is done by independent US scientists
mentioned above and it clearly invalidates the findings of the 1988 JECFA opinion.
4.233 As regards MGA, there is currently no intern ational standard or recommendation on MGA, as
Codex has not adopted one. JECFA assessed MGA fo r the first time in 2000 (and in 2004 as regards
the calculation of the MRL only), but this has not yet led to the adoption of a standard. If one
examines the evidence that served as the basis of the 2000 JECFA report it can be seen that nearly all
the studies referred to therein date from the 1960s and 1970s. These very old studies constitute in fact
the evidence which the defending parties have refu sed to provide to the European Communities,
despite its repeated requests on the grounds that th ey are confidential. In the absence of a Codex
standard, the opinion of JECFA becomes irrelevant, fo r the additional reason that it failed to take into
account the more recent data generated by the 17 EC studies and the 2002 SCVPH assessment. The
US does not put forward any specific argument as to why the evidence assessed by the SCVPH would
not be insufficient. It does not even refer, in this context, to the fact that MGA, in the meantime
(2000), has been assessed (for the first time) by th e JECFA and which subsequently has been taken
into account by the SCVPH in its 2002 Opinion. Moreover, the US referred to a draft 2005 report
from the UK CVP in support of its arguments. Ho wever, even this draft report confirms the
insufficiency of the currently available evidence.
4.234 Contrary to what the US asserts, the EC's co mpliance measure has been adopted on the basis
of available pertinent information. In this cont ext, the European Communities would reject the US
assumption that a risk has to be demonstrated in or der to justify a measure adopted on the basis of
Article 5.7 of the SPS Agreement. The whole point of evidence being "insufficient" is that it does not
allow the clear demonstration of a risk. If a risk can be demonstrated, it means that there is sufficient
evidence to carry out a proper risk assessment. In its reply to the Panel Question 68 the European

Communities explained the difference between th e objective or rational relationship between
sufficient scientific evidence and a measure within the meaning of Article 5.1, on the one hand, and
insufficient evidence and a measure within the meaning of Article 5.7, on the other. Under
Article 5.1, an objective or rational relationship is required between the evidence and the measure.
Under Article 5.7 a scientifically established doubt mu st be sufficient. As explained for each of the
five hormones, the available pertinent information while being inconclusive in terms of demonstrating
a risk, nevertheless points to the possible occurrence of certain adverse effects, which invalidate or put
into serious doubts previously held assumptions a bout the safety of these hormones by the defending
parties and Codex/JECFA.
4.235 Furthermore, in contrast to the US, the European Communities do es see itself under an
obligation, under Article 5.7 of the SPS Agreement, to seek additional information. It has specifically
laid down that obligation in Directive 2003/74/ EC and the European Communities has already
undertaken initiatives to seek additional information. In particular, it has issued a new call for
scientific data and research from 2002 onwards, on s ubstances with hormonal activity which may be
used for growth promotion purposes in bovine meat.
4.236 Finally, the European Communities has not violated its obligation to review the provisional
measure within a reasonable period of time as argued by the US. First, it is erroneous for the US to
apply a review requirement to a measure before that measure has even come into existence. That
shortcoming becomes even more apparent as it raises the question how the US explains what it is the
European Communities has actually done between 1998 and 2003 if not to review the measure in
question. In the view of the European Commun ities a requirement to review a measure "within a
reasonable period of time" can only apply after the provisional measure has come into effect. In the
light of the time it took to review the original measure (1998-2002) it can hardly be argued that a
reasonable period of time has actually already elapsed. Furthermore, the only new information that
has come to the knowledge of the European Commun ities until now is the recent draft assessment of
the UK Group. That draft report has already been forwarded to European Food Safety Authority
(EFSA) for review. Equally, should the recent cal l for new scientific information yield any new
evidence, such evidence would also be assessed by EFSA without any undue delay.
(b) Article 5.1 of the SPS Agreement
4.237 The European Communities has based the permanent prohibition of oestradiol-17 β on an
appropriate risk assessment. The European Comm unities has already pointed out in its reply to
Question 24 of the Panel, the difference between a scientific risk assessment in the narrow sense
clearly referred to here by the United States and th e risk assessment within the meaning of Article 5.1
and Annex A Point 4 of the SPS Agreement. The latter, as has been stated by the Appellate Body,
also comprises a risk management stage which is the responsibility of the regulator to carry out and
not of the scientific bodies. Furthermore, the SC VPH has explicitly based its assessment on the three
elements of hazard identification, hazard charact erization and exposure assessment recommended and
applied by the Codex. A few qualifications, however, apply. First, risk assessment criteria as they
have been developed by the dispute settlement bodies are clearly more relevant to the application of
the SPS Agreement than those developed by international sci entific bodies. This follows naturally
from the fact that it is the former's duty and privilege to interpret the provisions of the
SPS Agreement.
Second, there is no Codex standard specifically on the risk assessment of effects of residues of
veterinary drugs. There only exists a general st andard on microbiological assessment. Third, Codex
techniques or standards exclusively apply to risk assessments on food safety and not to other risk
assessments such as those for animal health and environmental risks. This is of relevance here insofar
as the SCVPH Opinions also discuss environmental ri sks of the hormonal substances in question and
some of the 17 EC studies have generated for the first time pioneering results in these areas.

4.238 Regarding the various steps of the risk assessment, the US does not criticize the hazard
identification by the SCVPH but its hazard charact erization because no or no adequate dose response
assessment would have been carried out. However, the US' equation of hazard characterization and
dose-response assessment is clearly erroneous. As defined by Codex, hazard characterization refers to
the possibility of either a quantitative or a qualitative evaluation. While a dose-response assessment
is a quantitative evaluation, a qualitative evaluation may equally be done, in particular in the absence
of available data on dose-response. That is conf irmed by the last sentence of the definition which
recognises that data may not be available on biolog ical or physical agents. More generally, it is
confirmed by the Appellate Body which stressed that a risk assessment within the meaning of
Article 5.1 does not necessarily require a quantitative evaluation. Moreover, it should be further
clarified that it is generally recognised that for substances which have genot oxic potential (as is the
case with oestradiol-17β) a threshold cannot be identified. Therefore it cannot be said that there exists
a level below which intakes from residue should be c onsidered to be safe. Therefore the fact the
doses used in growth promotion are low is not of re levance. Thus, the argument of the United States
that there is no hazard characterization is incorrect.
4.239 Regarding the exposure assessment, the US argum ent concerning pathway/residue analysis,
no risks of abuse and low bioavailability do not dem onstrate that the Opinions of the SCVPH fail to
complete an exposure assessment as defined by Codex. Moreover, what the US does also not explain
is that its own responsible health authorities ha ve, for the first time since 2002, declared that
oestradiol-17β is proven to be a human carcinogen and it is now listed as such, since 2002, in the
USA Annual Report on Carcinogens.
4.240 The European Communities' ban on oestradiol-17 β is also based on a risk assessment.
Contrary to what the United States asserts, the SCVPH's assessment supports the ban on
oestradiol-17β, but more recent research as referred to in detail in the EC second written submission
equally confirms that that measure is warranted.
(c) Article 3.3 of the SPS Agreement
4.241 The US argues that a violation of Article 3.3 exists because the ban would not be in
conformity with Article 5.1 of the SPS Agreement. The European Communities does not contest that
the ban on oestradiol-17 β is not based on international standards. The only relevant standard is the
Codex recommendation on MRLs for oestradiol-17 β. The European Communities, however, has
decided not to set MRLs as recommended by Codex, but instead to prohibit the use of oestradiol-17 β
for growth promotion purposes altogether. That decision is based on a comprehensive risk assessment
which, as has been demonstrated above is in full conformity with Article 5.1 of the SPS Agreement.
H. SECOND WRITTEN SUBMISSION OF THE UNITED STATES
1. Introduction
4.242 The United States maintains the measures at issue in this dispute in accordance with express
authority from the Dispute Settlement Body. At this poi nt in this dispute, it is clear that the European
Communities has not, and cannot, demonstrate that these measures breach US obligations under the
DSU or the GATT 1994, nor has nor can the EC demonstrate that other so-called "measures" that it
challenges in fact existed as of the time this Panel was established.
4.243 As the United States has already pointed out, th e EC's arguments relating to its DSU claims
underscore its inability to meet its burden in this dispute, that is, to demonstrate that it has satisfied the
Article 22.8 condition of removing the WTO-inconsistencies of its measures or providing a solution to
US nullification or impairment. Moreover, for the reasons already set forth in previous submissions
and discussed further below, the EC's arguments th at various DSU provisions can create obligations

"in conjunction with" each other cannot change the fact that whether a provision is read on its own or
"in conjunction with" another provision does not a lter the substance of the provision. Nor can
unilateral declarations by a Member concerned create a "presumption of good faith."
4.244 The United States has not breached Article 23 of the DSU. The United States was authorized
to suspend concessions by the DSB, and the EC's declaration of compliance did not cause this
authorization to lapse, to be revoked or to be susp ended. The EC's declaration did not mean that the
United States could no longer apply the suspensi on of concessions without breaching its obligations
under the DSU. Nor did the EC's declaration and development of a "new" measure create a scenario
whereby US application of the suspension of concessi ons could be considered a "determination" as to
the WTO-consistency or inconsistency of the amended ban.
4.245 Regarding the EC's purported demonstration of how it has come into compliance, the EC
merely asserted in its first submission that it had come into compliance. Notwithstanding the EC's
failure to even undertake the required demonstrati on, the United States responded in its first written
submission by explaining in detail that the EC's import bans, despite DSB recommendations and
rulings, continue not to be based on a risk assess ment within the meaning of Article 5.1 of the
SPS Agreement. Neither are they legitimate "provisional" bans within the meaning of Article 5.7 of
the SPS Agreement. The materials put forward by the EC in its replies to questions from the Panel do
little to change these conclusions. In fact, in several of its replies, the EC appears to have completely
shifted its focus from theoretical ri sks posed by the six hormones themselves to a perceived "risk" of
failure to satisfy good veterinary practices in ad ministering the hormones to cattle in the United
States.
2. Legal arguments
(a) The EC has failed to demonstrate a US breach of DSU Articles 21.5, 22.8 or 23
4.246 The EC has failed to demonstrate that the Un ited States has breached its obligations under
Article 21.5 of the DSU. In fact, the EC has fa iled to link US action or inaction to any obligation
contained in Article 21.5's text whatsoever. In stead, it claims that the United States has breached
Article 21.5 by acting in contravention of Article 23 of the DSU. The United States has not acted in
breach of Article 23, and therefore, even under the EC's theory, the United States can not have
breached any obligations under Article 21.5 of the DSU.
4.247 Rather than pointing the Panel to a particular obligation in Article 21.5 of the DSU that it
alleges the United States breached, the EC instead persists in its argument that a violation of
Article 21.5 can only be found "in conjunction with" or when that Article is "read together" with DSU
Article 23. In support of this claim, the EC not es that "there is nothing unusual to cite various
provisions to substantiate a claim. This follows actually the same approach the Panel took in the
dispute US - Certain Measures."
4.248 The EC is simply wrong about the approach that the Panel took, however. When the
Appellate Body examined the findi ngs to which the EC is referring, the Appellate Body pointed out
that "[o]ur reading of the Panel Report does not lead us to conclude that the Panel based its finding of
the inconsistency of the 3 March Measure with Ar ticle 21.5 on its conclusion that the measure was
inconsistent with Article 23.2(a) ... The Panel's references to Article 23.2(a) cannot be construed as
the basis upon which the Panel reached its conclusions under Article 21.5
."
4.249 As the United States has demonstrated, nowher e in Article 21.5 of the DSU is there an
obligation for the United States to have sought recour se to an Article 21.5 compliance panel, and only
such a panel, upon hearing the EC's declaration of compliance. Nor does Article 21.5 contain any
time limitation or deadline by which a Member must initiate dispute settlement proceedings. Indeed,

the EC does not claim that such obligations can be found in the text of Article 21.5. Yet, it seeks a
specific finding of a US breach of Article 21.5 just the same. Taking into account the Appellate
Body's guidance in India – Patent and US – Shrimp, the EC's theory in this dispute (i.e., a violation of
Article 21.5 read "in conjunction with" Article 23) has no textual basis and must therefore be rejected.
Any analysis of whether US actions have breached Ar ticle 21.5 of the DSU must be based on the text
of that provision.
4.250 In addition to its attempt to impute obligations into the text of Article 21.5, the EC provides
other non-textual arguments in support of its claim of a US Article 21.5 breach. Primary among these
is the EC's reference to a presumption or principle of good faith. The EC considers that referring to
such a presumption justifies imputing into Article 21.5 an unspecified and unwritten obligation that
"[a] retaliating Member has at a minimum a good faith obligation to assess within a reasonable delay
the compliance measure". As noted above, the ke y to interpretation of the DSU, and Members'
obligations under its provisions, lies in the actual te xt of the provisions. The text of Article 21.5 does
not contain a time limitation, let alone what w ould amount to a case-by-case-determined "reasonable
time period". Neither does it contain an obligation that, in the post-suspension setting, the suspending
Member initiate dispute settlement proceedings upo n a declaration of compliance by the Member
concerned. "Good faith" applies to implementing th e obligations that are agreed upon by Members,
evidenced in the text; "good faith" cannot serve to create new obligations that were never agreed by
Members.
4.251 Similarly, the EC has failed to make a prima 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; mutually satisfactory solution), it posits its claim "in conjunction with" Article 23 and asserts
that the "presumption of good faith" or compliance sa tisfies its burden of proof. Even were one to
presume that the EC implemented its amended bans in good faith, this fact would not in turn
demonstrate that the EC's bans actually satisfy the elements of Article 22.8, e.g. , the EC could be
acting in good faith, but still be wrong about the WTO-consistency or compliance of its amended
measure.
4.252 The United States notes that the EC's interpretation of Article 23, and specifically
Article 23.2(a), is complicated by a lack of clar ity regarding when, exactly, a determination on the
part of the suspending Member would be inferred. Regardless of whether this fictional deadline is a
"reasonable period" or immediate, the EC's in terpretation establishing such a deadline is not
sustainable. Not only would it beg litigation to determine on a case-by-case basis whether a Member
has unreasonably delayed in making a determinati on, it would convert Article 23.2(a) from a
prohibition on making determinations into an oblig ation to make them – ironically, a Member would
in effect be required to make a determination upon learning of a nother Member's declaration of
compliance, and to do so within some unspecified time frame.
4.253 Furthermore, as the United States has noted on several occasions, the United States was in the
course of reviewing the EC's materials at the outset of this dispute. In light of this fact, it is difficult
to comprehend how the United States could have ma de a "determination" as to the WTO-consistency
of the EC's amended bans. A critical element of th is US evaluation is the review of the studies and
Opinions ostensibly underpinning the EC's bans. Specifically, the EC refers to a number of studies
which it commissioned after the Appellate Body proceedings in the EC –
 Hormones dispute, referring
to them as the "17 Studies". The EC invokes these studies throughout its 2000 Review and 2002
Opinion, and a review of their methodology and results are therefore critical to an analysis of the EC's
measure. However, as noted at the first substantiv e meeting with the Panel, the United States has not
had the opportunity to review all of these documents, a nd referred to this fact in explaining why it had
not yet been able to reach a determination of the EC 's Opinions or its bans. Indeed, the EC has only
recently informed us of a number of studies – which it contends comprise the basis for its claim of

compliance with the DSB's recommendations and rulings – that were not referenced in the EC's
response to the US request for information under Article 5.8 of the SPS Agreement, through which the
United States sought all relevant scientific information on which the EC premised its bans.
4.254 Because the EC has failed to demonstrate a US breach of its obligations under the DSU, there
can be no "in conjunction with" breach of the objectiv es set out in Article 3.7 of the DSU, even were
such a claim possible.
4.255 Because the United States has not breached its obligations under the DSU and continues to
suspend concessions pursuant to DSB authorization, there can be no US breach of Articles I or II of
the GATT 1994. Any finding of a breach of these prov isions would be premised on a finding that the
United States did not have authorization to suspend concessions to the EC.
(b) The EC has neither removed its WTO-inconsis tent bans nor provided a solution to US
nullification or impairment within the meaning of Article 22.8 of the DSU
4.256 A determination of whether or not the EC has complied with the DSB's recommendations and
rulings in the EC – Hormones dispute is central to an analysis of whether or not it has satisfied the
conditions of Article 22.8 by either removing its WTO-inconsistent measure or providing a solution to
US nullification or impairment. The EC has failed to make its prima facie case of a US breach of
Article 22.8 of the DSU because it has not demonstrated , other than by simple assertions that it deems
its own measure to satisfy DSB recommendations and rulings, how its import bans are now WTO-
consistent.
(i) The EC has failed to demonstrate that its im port ban is a provisional measure within the
meaning of SPS Article 5.7
4.257 Despite several opportunities to present evidence as to why its ban on five of the hormones
(testosterone, progesterone, trenbolone acetate, zeranol and MGA) is a legitimate provisional
measure, the EC fails to demonstrate how its ban on meat and meat products from cattle treated with
these five hormones in fact satisfies the criteria of Article 5.7 of the SPS Agreement. Because the
EC's ban fails to meet the requirements of Article 5.7, the EC is therefore not exempt from satisfying
its obligations under Article 2.2 (measures not to be maintained without sufficient scientific evidence)
and Article 5.1 (measures to be based on a risk assessment) of the SPS Agreement.
4.258 The simple fact regarding the five hormones at issue is that international standards and a
significant body of scientific studies exist on the risks posed by each hormone. The Joint FAO/WHO
Expert Committee on Food Additives ("JECFA") and several national regulatory bodies have
determined that the scientific evidence regarding these hormones is adequate or sufficient to conduct a
risk assessment. The EC alone alleges that this bo dy of information is not "sufficient" to conduct a
risk assessment, as required by Article 5.1 of the SPS Agreement, and the EC has only taken this
position after firmly stating to the WTO several tim es that the information is sufficient and only after
the WTO finding that the EC had breached its SPS ob ligations. In so doing, however, the EC does
little more than assert that this is the case, failing to cite to any scientific evidence demonstrating risks
to consumers from the five hormones when used fo r growth promotion purposes in meat according to
good veterinary practices. Indeed, our review of the available materials comprising the 17 Studies has
failed to uncover any new evidence of risk from th e five provisionally banned hormones, further
casting doubt on the EC's conclusion that evidence relating to these hormones is now somehow
insufficient.
4.259 In the case of the five hormones "provisionally" banned by the EC, there is no "pertinent
information" upon which the EC's import ban can be based because none of the information presented
by the EC in its Opinions suggests that meat and meat products from cattle treated with the five

hormones for growth promotion purposes according to good veterinary practice pose a risk to
consumers. The EC does not consider informati on pertaining to the specific risk in question ( i.e., that
to consumers ingesting hormones in meat from cattle treated according to good veterinary practices),
including relevant international standards for the fi ve hormones and their underpinning studies, which
indicates that hormone residues in such meat are safe. Instead, the EC restricts its consideration to
general information or evidence on the hormones – evidence that was considered by Codex and
JECFA in determining that the hormones do not pose a risk to consumers.
4.260 Finally, the EC has failed to demonstrate that it has reviewed its ban within a reasonable
period of time. As noted by the Appellate Body, th e "reasonable period of time" is not a fixed period,
but rather reflects circumstances on a case-by-case basi s. Furthermore, in determining whether a
reasonable time has elapsed, one of the factors that should be taken into account is the "difficulty of
obtaining the additional information necessary for the review and the characteristics of the provisional
SPS measure." In the case of the five hormones bann ed by the EC, as noted above, there is already a
substantial body of evidence available for completi ng a risk assessment, contradicting the suggestion
that any "additional information" whatsoever migh t be required to review the amended ban. In
addition, the "provisional" ban simply prolongs the original ban, marking over fifteen years that the
import ban, the most trade-restrictive measure possible, has been in place. Taking into account the
severity of the measure, and the ready availability of information on the five hormones, the EC has
not reviewed its measure within a reasonable period of time within the meaning of Article 5.7.
(ii) The EC has failed to base its import ban on me at from cattle treated with oestradiol-17 β for
growth promotion purposes according to good veterinary practices on a risk assessment
within the meaning of SPS Article 5.1
4.261 The EC has failed to base its import ban on me at from cattle treated with oestradiol-17 β on a
risk assessment within the meaning of SPS Article 5. 1. Indeed, the EC's Opinions and underpinning
studies fail to demonstrate a risk from residues in meat from cattle treated with oestradiol-17 β for
growth promotion purposes according to good veterinary practices. Instead, the studies on which the
Opinions rely only succeed in demonstrating theoretic al risks when the hormones are administered at
doses or levels well-above those present in residues from hormone-treated meat; when good
veterinary practices are not met; or in ways not germane to the relevant risk pathway.
4.262 The EC's assumption that oestradiol is ge notoxic is essential to its overall conclusions
regarding this hormone. Nevertheless, despite reaching the conclusion that oestradiol-17 β is
genotoxic in its Opinions, the EC does not in fact demonstrate through scientific evidence that this is
the case. It fails to provide evidence demonstrating that oestradiol has carcinogenic effects other than
through the receptor mediated, cell division stimulati ng activity of the hormone – in other words, at
levels exerting a hormonal effect on consumers, and not at the exponentially smaller levels that would
be found in meat residues. The fact that eff ects may be observed at exposure levels above the
hormonal effect level or threshold is well established, and is one of the reasons that groups such as
Codex set acceptable daily intakes ("ADIs") and ma ximum residue levels ("MRLs") at levels
exponentially lower than this threshold.
4.263 The EC seeks support for its argument that oestradiol-17 β is genotoxic in a JECFA
conclusion that "oestradiol-17 β has genotoxic potential", yet fails to cite to the rest of the relevant
paragraph, in which JECFA notes, "[t]he Committe e reviewed studies of the genotoxic potential of
oestradiol-17β. Estradiol-17 β did not cause gene mutations in vitro . In some other assays, sporadic
but unconfirmed positive results were obtained." Fu rthermore, the EC's citation to the JECFA safety
assessment ignores its ultimate conclusion, i.e., that a maximum residue level for oestradiol-17 β in
meat need not be specified because there is a "wid e margin of safety for consumption of residues in
food when the drug is administered according to good practice in the use of veterinary drugs."

JECFA's conclusion corresponds to that of the EC's own Center for Veterinary Medicinal Products
("CVMP").
4.264 The EC's CVMP, upon review of the 1999 IARC monograph cited in the US Report on
Carcinogens, as well as the scientific materials comp rising the EC's 1999 Opinion, concluded that
oestradiol-17β "belong[s] to the group of non-genotoxic carcinogens" and "exogenous exposure to
hormones would need to be substantial ( i.e., in the order of post-menopausal therapy levels) before
carcinogenic effects would be detectable in humans." These conclusions do not ignore the fact that, at
physiological, hormonal-effect concentrations, there are carcinogenic risks from oestrogens.
However, they do not support a theory that oestradiol-17 β is either genotoxic, or will have
carcinogenic effects, at concentrations present in meat from cattle treated with the hormone for
growth promotion purposes according to good veterinary practices.
4.265 The severe limitations of the alleged "evi dence" for genotoxicity of oestradiol-17 β was also
noted in the recent 2005 U.K. Report. In that Report, the Veterinary Products Committee ("VPC")
concluded that only limited evidence was av ailable to indicate that oestradiol-17 β is capable of
inducing gene mutations, and cautioned that even this "evidence" has been obtained using non-
standard assays, some of which suffer from flawed experimental design.
4.266 The EC also asserts that the US argument that oestradiol-17 β is generally inactive when given
orally, while "well known", is "still controversia l and not consensually accepted by the scientific
community." To the contrary, oestradiol's low or al bioavailability has found international support in
Codex and JECFA ("[i]n general, oestradiol-17β is inactive when given orally because it is inactivated
in the gastrointestinal tract and liver"), as well as support within the EC from the CVMP, which noted
that "the bioavailability of 17 β-oestradiol esters after oral administration is low (3% as unchanged
oestradiol), but might be higher if estron, an oestrogenic metabolite, is included." The EC's assertion
is also surprising in light of unpublished, EC-gen erated data which the EC only recently provided to
the US which confirmed the internationally-accepted principle that bioavailability of oestradiol-17β is
low in humans.
4.267 In an attempt to bolster its argument on the bioavailability of estradiol 17 β, the EC cites to
data it has developed on estrogen le vels in young children. While it is unclear how this comparison
relates in any way to a discussion on bioavailability, we can only assume that the EC makes this
argument in an attempt to cast doubt on prev iously established standards for estradiol 17 β and the
other hormones at issue, i.e., that the relevant standard setting groups were not taking into account
populations identified as more sensitive than previo usly thought. The EC's argument fails for two
fundamental reasons: (1) populations such as youn g children were indeed taken into account in
establishing international standards and domestic requirements for the six hormones; and (2) the
studies cited by the EC by which it attempts to cast such groups as even more susceptible than
previously thought are flawed.
4.268 As to the first point, JECFA, in its saf ety assessment for the hormones, including
oestradiol-17β, took into account data on most sensitive populations. The CVMP, in determining that
oestradiol-17β is safe within certain concentrations also took into account data on prepubertal boys.
As to the second point, the EC's own CVMP and th e U.K. Group raised serious doubts relating to the
methodology of the Klein assay, and determined that these concerns were sufficient to cast doubt on
the conclusions drawn in the EC's Opinions.
4.269 The EC's Opinions also conclude that meat from cattle treated with oestrogens may accelerate
the onset of puberty in children. The EC attemp ts to support this conclusion with a publication
describing an outbreak of breast enlargement (gyneco mastia) in school childre n in Milan in 1977.
The study's authors state that oestrogenic contamin ation of meat served in the school canteen was the
"suspected" cause of breast enlargement. However, the presence of oestrogen in meat consumed by

the students was never confirmed and a causal link be tween oestrogen in meat and gynecomastia was
never demonstrated. Indeed, in a retrospective study conducted some twenty years later, the original
study's author questions his own earlier conclusi ons and recognizes the likelihood that some other
factor caused the early onset of puberty. The results of this unpublished, and previously unavailable
study clearly demonstrate that the conclusion that hormones in meat are causative factors for early
onset of puberty is unfounded.
4.270 In addition, the EC's Opinions ignore the scientific evidence relating to human in vivo DNA
repair mechanisms, specifically that genotoxic effect s of relevant residue leve ls of growth promoting
hormones would not be expressed in vivo based in part on the existen ce of the efficient DNA repair
mechanisms that exist in all mammalian cells. The efficacy of these repair mechanisms is
exemplified in one of the unpublishe d reports recently provided by the EC. In this study, it was
suggested that the lack of genotoxic effects of oestradiol-17 β on human intestinal cells was due to a
very efficient and rapid repair system. Despite these relevant findings, however, the EC's Opinions
completely ignore the influence of endogenous DNA repair mechanisms, and instead attempt to
implicate genotoxicity as a basis for the purported human health risk associated with oestradiol-17 β
residues in meat and meat products at any concentration.
(iii) The EC fails to demonstrate that there is a risk of failure of controls or failure to satisfy good
veterinary practices
4.271 The EC's replies to the Panel's questions were enlightening regarding what, exactly, is the
perceived "risk" against which the EC has imposed its import bans on US me at and meat products.
From the outset, the United States has argued that th e scientific evidence, and the EC's Opinions and
17 Studies, do not demonstrate a risk from the six growth promoting hormones when used for growth
promotion purposes according to good veterinary pr actices. Our focus on this specific risk and
exposure pathway seemed obvious because this is the legally permitted use of growth promoting
hormones in the United States. This focus also seemed obvious since, if a WTO Member were
concerned about a failure of controls, or a failure to satisfy good veterinary practices, there are
countless less trade restrictive methods for mitigating against this perceived risk than an absolute ban
on another Member's goods, and Article 5.6 of the SPS Agreement requires Members to ensure that
their SPS measures are not more trade-restrictive than required. Furthermore, a logical extension of
the EC's argument is that since the EC cannot be confident its own controls will never fail (indeed, as
discussed below, there is evidence that these controls have failed), the EC should ban all EC meat and
meat products. Nevertheless, the EC's replies consis tently invoke the "risk" of a failure to satisfy
good veterinary practices. Indeed, it is as a result of this additional perceived "risk" that the EC
appears to discount the conclusions reached in prev ious JECFA risk assessments and set out in Codex
standards as MRLs and ADIs.
4.272 In its replies to the Panel's questions, the EC frequently cites to the processes of "risk
analysis" and "risk management", neither of whic h are explicitly referred to in the text of the
SPS Agreement. This is not to say that concepts such as "risk management" and "risk analysis" find
no expression in the SPS Agreement whatsoever. Rather, they may be found in, e.g., Article 5.2 of the
SPS Agreement. Whether or not the EC engaged in a proper evaluation of the factors set out in SPS
Article 5.2 would inform a decision on whether or not they have indeed properly assessed the risk of
failure to satisfy good veterinary practices within the meaning of Article 5.1 and Annex A of the
SPS Agreement. As discussed below, the EC has not e ngaged in the necessary evaluation of these
factors as required by Articles 5.1, 5.2 and Annex A of the SPS Agreement.
4.273 The United States has rigorous controls in place, which include the establishment of
tolerances (maximum allowable levels) for horm one residues in food by the Food and Drug
Administration, and USDA/Food Safety and Insp ection Service ("FSIS") enforcement of these
tolerances through (1) residue control programs; a nd (2) ante mortem, post mortem, and processing

inspection, to which all cattle entering the human food supply are subjected. This system provides
extremely efficient safeguards against a hypothetical fa ilure of controls in the United States, while at
the same time being significantly less trade restrict ive than an outright ban on US meat and meat
products. A review of these relevant factors in its Opinions would have assisted the EC in making its
ultimate determination of whether a ban on US meat and meat products is "not maintained without
sufficient scientific evidence" and is not "significantly more trade restrictive than required to achieve
the appropriate level of sanitary or phytosanitary protection" as required by the SPS Agreement.
4.274 Instead, the EC's Opinions focu s on several hypothetical "failure of control" scenarios that
ignore actual regulatory processes in the United States, and for which it presents no support. It asserts
that these scenarios "clearly iden tify a risk for excessive exposure of consumers to residues from
misplaced or off-label used implants and incorrect dose regimes." Yet, the EC fails to produce any
evidence identifying a real risk of fa ilure of controls or failure to sa tisfy good veterinary practices in
the United States.
4.275 The EC's 1999 Opinion alleges that "from 6% to 30% of the original dose [of a hormone
implant] remained in the ears from 65 to 150 days after implantation ... These data indicate that
consumption of tissue from implantation sites w ould result in substantial exposure." This
hypothetical assumes that ears containing implants will enter the human food chain, but provides no
evidence in support of this scenario. Contrary to the EC's assumption, very clear instructions are
provided on manufacturers' labels on all FDA-appr oved growth promoting implants, indicating that
implants must be placed beneath the skin of the mi ddle third of ears of cattle. Because ears are then
discarded at slaughter, excess dietary exposure to hormone residues via consumption of implant sites
does not occur. USDA inspectors confirm through ante- and post-mortem inspections that ears are
discarded and that no hypothetical misplaced implants enter the human food chain. Therefore, the
EC's conclusion that cattle ears containing hormone implants will enter the human food chain is
unsupported by relevant scientific evidence and real world conditions.
4.276 The EC's Opinions also contemplate a scenario whereby growth promoting hormone implants
are placed in parts of cattle other than the ear. In su pport of its claim that this is a realistic scenario,
the EC asserts that "correct implantation can neither be guaranteed nor expected." However, the EC
provides no evidence in support of this claim. In the real world, the likelihood that a US beef
producer would intentionally misplace hormone implan ts in muscle is neglig ible given the economic
and enforcement considerations at stake. First, the implants are specifically designed to achieve
maximum effect when inserted into the animal's ear. There is therefore no economic benefit for
injecting cattle in other parts of the body. Second, misplaced implants would ruin surrounding muscle
tissue, thereby decreasing the value of the carcass. Third, discovery of any intramuscular (non-ear)
implants at slaughter by a federal inspector w ould cause the entire carcass to be condemned, resulting
in not only zero profit, but significant economic loss to the producer.
4.277 In another portion of the failure of controls discussion, the EC's Opinions allege that
overdosing cattle with hormone implants is comm onplace in the United States. The EC fails to
provide evidence to support its conclusion that off-lab el use actually occurs in the United States. The
EC Opinion cites to one publication from which it ex trapolates its conclusion that off-label use of
hormones occurs, but it appears to misinterpret the data and information provi ded in that document.
Furthermore, there is no economic incentive for the off-label implant use alleged by the EC; to the
contrary, such use would have negative economi c effects on cattle producer s. Therefore, the
Opinions' conclusion that off-label use of hormone im plants occurs in cattle for export to the EC in
the United States is unsupported by available scientif ic evidence and real world conditions. Indeed,
the conclusion that multiple impl anting poses a hypotheti cal health risk to consumers appears to
ignore the findings of some of the very laboratory studies commissioned by the EC ostensibly in
support of its claim that multiple implanting actually occurs and poses a risk to consumers in the real

world. Accordingly, the EC fails to take into account available scientific evidence related to this
"risk" within the meaning of SPS Article 5.2.
4.278 The EC's Opinions also cite to the existence of "black market" drugs, other non-authorized
pharmaceutical formulations, or hormone "cocktails " as contributing to the risk of a failure of
controls. However, the EC again provides no evidence of such a black market actually existing in the
United States. Indeed, the analysis set out in the EC's Opinions ig nores available evidence relating to
black markets, as well as relevant processes a nd production methods and relevant inspection,
sampling and testing methods as they exist in the United States. Available materials focusing on the
black market use of growth promoting hormones onl y discuss evidence of such a market for their use
within the EC (and thus would indicate that the EC, under its own approach in this dispute, should ban
the sale of EC meat and meat products). EC inspection missions appear to confirm this fact. The
presence of this market emphasizes that a total ban is not necessarily the most effective (and certainly
not the least trade restrictive) means of preventing a theoretical failure of good veterinary practices.
The Hormones panel reiterated this concern, noting th at "the banning of a substance does not
necessarily offer better protection of human health than other means of regulating its use."
3. Conclusion
4.279 In light of the foregoing, the United States asks th e Panel to find that: (1) the EC has failed to
demonstrate that the United States has breached Article 22.8 of the DSU, and that the United States
continues to suspend concessions to the EC consistent with the requirements of that provision; (2) the
United States has not breached Articles 3.7, 21.5, 23.1 or 23.2(a) of the DSU; and (3) the United
States has not breached Articles I or II of the GATT 1994.
I. O
RAL STATEMENT OF THE EUROPEAN COMMUNI TIES ON EXPERTS OPINIONS DURING THE
SECOND SUBSTANTIVE MEETING
4.280 There are certain "procedural" aspects to th is expert meeting which the European
Communities would like to comment on before turning to the substantive results of this meeting. As
you are well aware, the European Communities, during the selection process last year, had objected to
the selection of Drs. Boobis and Boisseau as experts to this Panel. This mainly, because both have
been involved in drafting and adopting the very same risk assessment s which the European
Communities has not accepted as valid basis for its me asures regarding hormone treated beef, that is
JECFA's risk assessments. The European Commun ities' concern was that Drs. Boobis and Boisseau
would lack the objectivity required to give the Panel the advice needed to make an objective
assessment of the facts in this dispute. Last week 's meeting has confirmed that this concern was more
than justified. It is unavoidable what Drs. Boobis and Boisseau have done, namely to defend the
conclusions of the risk assessment they were invol ved in against any alternative conclusions which
the EC's risk assessment has come to. We do not blame them for doing so. However, we do believe
that their obvious partiality was not only unacceptable for the purpose of the role of experts in this
dispute, it also made it necessary, at times, to enter into technical scientific discussions that we would
probably all have rather avoided.
4.281 The European Communities does not wish to discr edit in general the work which is done by
JECFA and Codex, nor does it believe that these latter would wish to put into question in any way the
EC's sovereign choices on the desired level of hea lth protection. This is not a case "EC against
JECFA". This is a case between Members of the WTO and it currently turns on the question whether
a WTO Member has legitimately relied on its right under the SPS Agreement to base its measures on
its own assessment of scientific evidence and ava ilable pertinent information, assessment which may
deviate from that performed (but not necessarily adop ted) by an international standard setting body.
Objective expert advice of the kind that came from Drs. Guttenplan, Cogliano, Sippell and De
Brabander, can explain what the scientific positions on eith er side are. It is not helpful, therefore, to

have had (not only one but even tw o) scientific experts at this m eeting who considered themselves to
be representatives of JECFA.
4.282 It is not helpful either to have had JECFA representatives at this meeting who considered
themselves to be scientific experts. Both Dr. Tritsch er's and Dr. Wennberg 's role would have been to
provide, in their capacity as secretaries to JECFA, factual information on how JECFA works, the way
Dr. Miyagishima did for Codex. Instead, both have repeatedly overstepped their role and ventured
into statements on the substance of the scientific i ssues. Although we are, for example, quite grateful
for Dr. Tritscher's indiscretion on the origin of JECFA's reference to "potential genotoxicity" (she
stated that it was because JECFA felt there was scie ntific uncertainty), we do not think that it was
appropriate for her to provide information on the su bstance of the science or to assume the role of
defending the substance of JECFA's work. And we certainly feel that Dr. Wennberg would have done
better not to intervene on the issue of residue da ta used in the 1999 evaluation (on which she was
obviously not informed) or to keep her opinion, for example on Radio Immuno Assays, to herself.
4.283 Let me end my comments on the procedural aspect s of this expert meeting here by inviting
the Panel to take them into account when it assesses all the different advice it has been given at this
meeting.
4.284 I will now turn to the substantive results of this meeting and place them in the legal context.
For the sake of this discussion, the European Communities accepts for a mo ment the assumption that
your task in this dispute is indeed to assess whethe r measures taken to comply with DSB rulings and
recommendations are consistent or not with Articles 5.1 and 5.7 of the SPS Agreement. However, we
will come back to this at a later stage.
4.285 The United States and Canada claim that the Eu ropean Communities has violated Article 5.1
of the SPS Agreement in re-adopting its ban on oestradiol-17 β for growth promotion purposes. (I'll
open a parenthesis here: this is not quite the way th ey put it as they believe the burden of proof is on
the EC to demonstrate compliance. However, the EC strongly rejects this point, and I will also come
back to that later. Fact is that they have raised a number of arguments as to why the EC allegedly
violated Articles 5.1 and also 5.7 and therefore is not in compliance).
4.286 They argue essentially on two levels. First, that there is no risk assessment, supposedly
because the EC Opinions of 1999, 2000 and 2002 fa iled to perform the second and third of the four
steps usually done in a risk assessment on substances of this kind by the members of Codex. Second,
that the evidence put forward by the EC allegedly does not support the ban.
4.287 Last week's expert meeting has yielded a wealth of information which is crucial to dealing
with these two levels of argument. Rather than repeating all the legal arguments as set out in our
submissions, I will concentrate on where the scientific advice you got helps to clarify the issues.
4.288 On the first level of argument, we learned from the rather unisono statements of the experts.
We have learned that while everyo ne (including the European Comm unities) accepts that in a risk
assessment you may proceed in the four steps of hazard identification, hazard characterization,
exposure assessment and risk characterization, you onl y do that to the extent possible and necessary.
In other words, how you proceed exactly is a functi on of the data you have av ailable and of how your
risk assessment is framed, namely by the mandate you have received from the risk manager. Thus,
we learned from Drs. Boobis and Cogliano that data are never complete, but are or are not sufficient
for the purpose of completing a risk assessment. We learned that this is a matter of judgment
involving considerations on what sort of possible ga p/uncertainty/insufficiency we are dealing with
and whether that can be dealt with through interp retation or bridging tools such as safety factors and
assumptions, or not. Most importantly, however, we learned that this judgment is informed – indeed,
is framed – by the risk manager. It is the risk manager, as Dr. Miyagishima pointed out, who decides

whether or not to carry out an evaluation and who factors into that decisi on the question of whether
there are sufficient data. I draw your attention in th is context to paragraph 19 of the Codex draft Risk
Analysis Principles for the CCRVDF, which are about to be adopted. Paragraph 19 specifies that it is
for the CCRVDF to provide "a qualitative prelimin ary risk profile as well as specific guidance [to
JECFA] on the CCRVDF risk assessment request."
4.289 Finally, it is the risk manager, as several e xperts repeatedly confirmed, who decides on the
acceptable level of risk, in other words on the level of protection. This informs for example concepts
such as that of "appreciable risk", as Dr. Guttenplan explained in reply to your question. Let us not go
into the whole concept of risk communication, but it is important for you to understand that risk
assessors and risk managers – as two different instances of a risk analysis process – do not make
decisions in isolation from each other. This has al ready been confirmed by the Appellate Body in the
1998 Hormones report.
4.290 This brings us back to the famous four step s of the risk assessment. If there is a risk
management decision that the intended acceptable level of risk is "additional risk to the extent such a
risk is judged ‘insignificant' or ‘non appreciable,'" here is what you do as a risk assessor: once you
have identified that there is the possibility of an adverse effect, you go on and calculate whether and at
what threshold the risk becomes "non appreciable" using safety factors and whatever other tools you
have available to bridge possible gaps of knowledge. This is what JECFA has done.
4.291 If, on the other hand, there is a risk management decision that the intended acceptable level of
risk is "no additional risk," the situation is diffe rent: as a risk assessor, once you have identified the
possibility of an adverse effect and the possibility of its occurrence in real life, there is no point in
going on and calculating a threshold, as no additiona l risk, however minimal, would be accepted. As
a risk assessor you have done enough for the purposes of the risk assessment that the risk manager has
asked from you. Essentially (I am saying essentia lly because the European Communities, as even
Dr. Boobis had to confirm, has actually quantified exposure to the extent possible) this is what the EC
risk assessors have done. Your e xperts have confirmed this, not least Dr. Boobis, who first advised
you that the European Communities had not carried out a proper risk assessment and then qualified
his reply by stating that it was based on the assumpti on that a threshold would apply. Where this is
not the case, so he explained last week and in hi s written replies to Questions 11, 19 and 37, the
remaining steps after hazard identification look quite different. In particular, a dose response
assessment is unnecessary (see in particular reply to Question 37). However, as to what exactly the
remaining steps are supposed to look like in a non-threshold scenario, neither Dr. Boobis nor the other
experts gave you clear advice on that question. Y ou heard statements that the European Communities
failed to present new residue data or failed to refer to the problem of endocrine effects in its risk
assessment or failed to present evidence on in vivo genotoxicity, all of which the European
Communities proved to be wrong by pointing the Pa nel to the exact page where this issue was
discussed or a study was referred to in the EC Op inions. Frankly, Chairman, one might choose to
disagree with the conclusions the EC has come to, but to claim that the EC has not carried out a
proper risk assessment is a bit of a joke, obvious to anyone who has actually taken pains to read the
EC risk assessments (and, if I may add, to compare them to other relevant risk assessments).
4.292 So let me turn to the second level of argument, which turns on whether the evidence presented
by the European Communities supports - or, as the Appellate Body would put it – sufficiently
warrants a prohibition on oestradiol-17 β. Chairman, I could go back to the details of all the adverse
effects that the EC risk assessment h as identified and that were at least in part discussed at last week's
meeting. I could now launch into discussing everyt hing that was said about old and new residue data,
old and new detection methods, good veterinary practice and abuse, hormonal development of
children and the value of epidemiological studies. But I think there is probably no better way of
putting in a nutshell the controversy at the heart of this debate than the way Dr. Cogliano has done it.
He said essentially "at the heart of the scientific disagreement here is the interpretation of data.

JECFA's assessment felt that a threshold could be assumed even if there was some evidence on
genotoxicity. Therefore they assumed there was a thres hold. It seems to me that the EC is unwilling
to assume a threshold, because of genotoxicity and b ecause of low dose response and the fact that the
shape of the curve cannot be defined with certainty . Those are the scientific arguments on both sides
– depending on how you phrase the question, you will get a response of yes or no." Dr. Cogliano
answered your question of whether this disagreement is arbitrary or unreasonable by stating "this is a
longstanding area of disagreement for scientists since many years, the r eason for the controversy
being the assumptions that scientists bring to the risk assessment. It is an area of legitimate
disagreement."
4.293 Even Dr. Boobis, who may have wanted to make you believe that JECFA's - that is: his -
interpretation of the data is the only reasonable inte rpretation, had to concede that both genotoxicity
and low dose response are issues that are a long way from being resolved. What better way to
demonstrate this than the vivid debate betw een Dr. Guttenplan and Dr. Boobis on proof of in vivo
genotoxicity? What better way to say it than Dr. Bo obis' reply to the EC expert's intervention on low
dose response, when he stated "this is a major issue of scientific controversy. Dr. Vom Saal can point
to so many papers which support his argument, but currently this is not resolved in the scientific
community."
4.294 I could add to this now an account of the many things that were said last week about pre-
pubertal children, where the advice you received from the Panel's experts ranges all the way from
warning you not to feed your children broccoli (Dr. De Brabander) to stating that there is no problem
whatsoever for hormonal substances despite eviden ce demonstrating that JECFA's calculations on
endogenous production of hormones are actually wrong (Dr. Boobis).
4.295 But the point can already be made: what you should take away from last week's meeting is the
following: First, the European Communities bases itself on evidence wh ich well respected scientists,
including some of your own experts (Drs. Guttenpl an and Cogliano) understand to demonstrate direct
genotoxicity of Oestradiol 17 β. Direct genotoxicity, not only for the EC risk manager but actually for
most risk managers in this world (see Dr. Boobis' reply to Question 11) is a reason not to accept any
added risk and therefore to decline setting a thr eshold. Second, the European Communities bases
itself on evidence which is read by respected scien tists – and, apart from Drs. Cogliano and Sippell
this may well include most endocrinologists in the world – to mean that one actually knows precious
little about what hormonal substances do at low doses, and in particular, what they do to especially
sensitive populations such as pre-pubertal children. For the EC risk manager, and this may well be a
position not shared by the risk mana gers in the US and Canada, this is a reason to decline setting any
threshold.
4.296 The European Communities considers that it is not for this Panel to enter into the deep
scientific theories and try to resolve the scientific controversies, to which you became witnesses last
week. The scientists have not managed to resolve it and you will not be able to do it with the legal
provisions and tools you are supposed to apply here. Indeed, you are not asked to now come down on
either side of the debate, apply your own – as Dr. Boobis would put it – "weight of evidence"
approach, provide your own interpretation of how the data should be read. It is sufficient for you to
ascertain that there is a genuine divergence of sci entific opinions here, which may indeed – as the
Appellate Body has put it – "indicat e a state of scientific uncertainty"
19 and that the European
Communities has relied on – and I quote the Appe llate Body again – "divergent opinion[s] coming
from qualified and respected sources" 20 as your own experts have conf irmed. The US and Canada
may think that this source may not (yet) represent "mainstream" scientific opinion (although one may
well argue that there is at least equal balance betw een the different opinions) but this, as the Appellate

19 Appellate Body Report, EC – Hormones, at para. 194.
20 Ibid.

Body teaches us, "does not necessarily indicate th e absence of a reasonable relationship between the
SPS measure and the risk assessment, especially wh ere the risk involved is life-threatening in
character and is perceived to constitute a clear a nd imminent threat to public health and safety." 21
There is no other indication that the European Communities may not have acted in good faith (may
those who cherish protectionist theories go back to reading what the Appellate Body had to say about
that).
22 Therefore, Chairman and Members of the Panel, your conclusion must be that the EC's risk
assessment sufficiently warrants – that is to say reasonably supports – its ban on oestradiol-17β.
4.297 This concludes my comments on the United States' and Canada's claim that there is a
violation of Article 5.1 of the SPS Agreement as regards the EC's implementation measure on
Oestradiol 17 β. I should add that this also deals with the rather vague claim made by the United
States and Canada that there would also be a violation of Article 3.3 of the SPS Agreement. "Vague"
because it is not clear what they would be relying on with regard to oestradiol-17 β. The standard
adopted by Codex on this substance dates back to 1988 and is outdated, not only in the EC's view but
also in the view of Codex' own scientific comm ittee JECFA, which has re-evaluated the substance
since. However, JECFA's updated assessment of 19 99 has never been adopted as a standard. In any
event, as is clear from the above, the European Co mmunities who has a scientific justification not to
base itself on the Codex standard, and also (not "or") 23 has a higher level of protection than that
implied in the Codex standard, acted c onsistently with Article 5.1. of the SPS Agreement. Therefore,
there is no violation of Article 3.3.
4.298 Let me turn to the European Communities pr ovisional ban on the other five substances,
progesterone, testosterone, zeranol, trenbolone acetate and melengestrol acetate (MGA). With regard
to that measure the United States and Canada claim that there is a violation of Article 5.7 of the
SPS Agreement. I will not go back to all legal arguments that have been exchanged between the
parties on the four conditions that Article 5.7 of the SPS Agreement requires, but will instead
concentrate on what the expert meeting has yielded in this regard, which mainly relates to the issue of
sufficiency.
4.299 Obviously, you as the Panel wonder what to make of the fact that an international body such
as Codex and its scientific committee JECFA, with regard at least to four of these substances, has
considered that there is sufficient evidence to come to a conclusion on them, while the EC claims that
this is not the case.
4.300 This brings us back to the debate touc hed upon earlier about completeness of data,
sufficiency, gaps and scientific uncertainty. For all of those among us lawyers who love to think in
clear cut-categories, this is a bit of a disappointme nt. The world of science clearly does not think in
terms of definitive and provisional measures, of suffi ciency and insufficiency of evidence. Data are
never complete, as we learned; whether you can come to definitive conclusions on a risk assessment is
a function of what data you have and how your risk assessment has been framed by the risk manager.
Dr. Boobis, who emphasised several times how care ful he was about choosing his words, certainly
was careful when replying to the question of whethe r it was possible to complete a risk assessment on
the five substances. He agreed with the European Communities th at this was a question of risk
management and then stated: "I can only speak for JECFA, not for th e EC, we considered the data to
be sufficient." Indeed, he speaks for a different set of data and against the background of a different
decision on acceptable level of risk/intended level of protection! The EC's scientific committee
worked on the basis of the most up to date research on these substances and against the background of
the risk manager's decision not to accept any add itional risk from residues in hormone treated-meat.

21 Ibid.
22 Appellate Body Report,EC – Hormones at para. 245.
23 As the Appellate Body has put it so delicately, "Ar ticle 3.3. is evidently not a model of clarity in
drafting and communication", see Appellate Body Report, EC – Hormones, para. 175.

Under these circumstances, the EC scientific committ ee, in the face of evidence indicating that there
may be risks with regard to genotoxicity and in li ght of the scientific uncer tainty regarding the low-
dose response problem, was careful to conclude only provisionally on the existence of a risk, and to
recommend further research. Chairman, members of the Panel, would you have preferred a bold
conclusion based on all sorts of gap-bridging assump tions, that these substances present a risk, and on
the basis of that a definitive ban adopted by the EC regulator?
4.301 This concludes my remarks on the Article 5.7 cl aim, which has been shown to be unfounded.
Let me add a brief remark, once again on the Article 3.3 claim made by the United States and Canada.
The United States and Canada are relying on standa rds for zeranol and trenbolone acetate adopted in
1988, which are as outdated as the standards for prog esterone and testosterone also dating back to
1988. Again, as is clear from the above, the Europ ean Communities, who has a scientific justification
not to base itself on the Codex standard, and also a hi gher level of protection than that implied in the
Codex standard, acted consistently with Article 5.7 of the SPS Agreement. Therefore, there is no
violation of Article 3.3.
4.302 These remarks of the European Communities attempted to help you place the results of last
week's experts' meeting in the context of your analysis on the relevant provisions of the
SPS Agreement. Before turning to my reservation on that exercise, which I stated in the beginning, let
me make one final remark. It seems fashionable, in the debate on the SPS Agreement, to raise the
spectre of regulators who close off their markets by putting never ending demands for more evidence
on scientists on the basis of a declared need to pr ove safety. There is a danger for abuse of the
SPS Agreement in this respect, no doubt. But there is a nother spectre out there, which is equally
haunting: that the SPS Agreement would be abused by those who value market profit over safety.
That those who do not bother to look into possible hea lth concerns, referring, at best, to industry data
that no member of the public has ever seen, woul d benefit from some sort of presumption of being
right under the SPS Agreement.
4.303 With this, I have ended my opening remarks on the outcome of the expert hearing. Now, with
regard to my earlier reservation: Chairman, we want to raise the question with you, why it is we are
going through this exercise of looking into a violation of the SPS Agreement. As suggested in your e-
mail we will come back to this issue in the sec ond part of our opening statement when we discuss
legal issues.
J. ORAL STATEMENT OF THE UNI TED STATES ON EXPERTS OPINIONS DURING THE SECOND
SUBSTANTIVE MEETING
4.304 The United States has repeatedly argued thro ughout these proceedings that the European
Communities' ("EC") permanent ban on oestradiol-17 β ("estradiol") is not based on a risk assessment
within the meaning of Article 5.1 of the Agreement on the Application of Sanitary and Phytosanitary
Measures ("SPS Agreement"). We have also argued that the EC's provisional bans on progesterone,
testosterone, zeranol, trenbolone acetate ("TBA"), and melengestrol acetate ("MGA") do not satisfy
the necessary conditions for a provisional measure within the meaning of Article 5.7 of the
SPS Agreement. Indeed, the very conclusions underpinning the EC's decision-making are
unsupported by the scientific evidence relating to th ese hormones. The experts' written responses and
oral testimony support these US arguments.
4.305 At the outset of this meeting, it is essential to recall the purpose of last week's meetings and
today's discussions. The World Trade Organization ("WTO") and this Panel are not being called upon
to conduct a risk assessment for the EC. You have not been requested to provide or complete a
de novo review of the numerous scientific materials relating to the six hormones at issue. The
pertinent analysis, as discussed a moment ago, is what the EC has done. Not what the EC could have
done, or may still do. Not what this Panel can do for the EC. To conduct an analysis of what the EC

has actually done, we may ask much less complex qu estions such as: has the EC presented scientific
evidence of a risk from these hormon es when consumed as residues in meat and assessed this risk in
the proper fashion?
4.306 As I will highlight this morning, the experts' responses confirm that the EC has not based its
ban on meat from cattle treated with oestradiol fo r growth promotion purposes on a risk assessment.
It has not satisfied the four necess ary steps for a risk assessment, and several of the conclusions set
out in the EC's Opinions are not supported by scientif ic evidence. A measure banning meat from
cattle treated with oestradiol cannot be "sufficien tly warranted" or "reasonabl y supported" by this
absence of a risk or assessment of the risk.
4.307 Likewise, the experts' responses confirm that there is sufficient scientific evidence to
complete a risk assessment for each of the five "p rovisionally banned" hormones and that the EC has
not based its provisional bans on available pertinent in formation. In other words, the EC's measures
and "risk assessment" do not satisfy its obligations under the SPS Agreement.
4.308 I think that a brief discussion of the term zero risk provides a good starting point for today's
discussions. It is an important principle and one to which the EC referred several times in the meeting
with the experts. Indeed, the EC at several point s asked the experts whether they could ensure that
there was "zero risk" of a certain event occurring . The EC used this same tactic in its written
comments on the experts' answers. Fo r example, it demanded that Dr. Boobis "provide the necessary
assurance" to the EC that residues in meat will never be shown to pose a risk to consumers. (See, e.g.,
EC Comments on Question 20).
4.309 The analysis must refocus on the question of whether the EC has provided any evidence of a
risk. The relevant discussion is one of whether the EC, in support of its ban, has adduced sufficient
evidence to demonstrate a risk fro m meat from cattle treated with oestradiol for growth promotion
purposes. Included in this discussion is an anal ysis of whether the EC has provided scientific
evidence that oestradiol is genotoxic, mutagenic or carcinogenic (at levels found in residues in meat
from treated cattle). Whether a scientist refuses to co mmit to a stance that there will never be a risk
from meat treated with oestradiol at some point in th e future is not pertinent to this analysis because it
is not scientific evidence of a risk. It is simply theoretical uncertainty and cannot be the basis for a
risk assessment or an SPS measure.
4.310 Regarding what, exactly, makes up a risk assessment, the experts and international
organizations reiterated the four steps of risk assessment. In addition, the Codex representative
stressed that a risk assessment must be based on all available data.
4.311 As to whether and when a risk assessment must sa tisfy each of the four steps, there was clear
agreement among Drs. Boobis and Boisseau
 and JECFA that an evaluation of the human food safety
of a drug should include all four steps of risk assessment. JECFA noted that a hazard identification
does not qualify as a risk assessment and that the a ssessment should continue through each of the four
steps unless there is "cl ear cut" evidence, both in vitro and in vivo , of genotoxicity. Dr. Boobis
commented that the only instance in which such an assessment would stop at the hazard identification
stage would be if the compound were iden tified as a DNA-reactive mutagen. Dr. Boisseau confirmed
Dr. Boobis' opinion.
4.312 Recalling that, as we learned last week, genotoxi city and mutagenicity are not synonymous.
Genotoxic substances damage DNA but the damage ma y be repaired. If the damage results in a
mutation and the cell divides, then the substance is a "mutagen." As will be discussed in a moment,
the experts did not identify any scientific evid ence in the EC's Opinions that confirms, in vivo, the
effects of oestradiol at levels below those causi ng a hormonal response, let alone any evidence that
effects at that level are those of a DNA-reactive mutagen.

4.313 There are four steps for a risk assessment that have been clearly defined by the experts and
the original Hormones panel. And the EC accepts that these four steps are required. As just
mentioned, a risk assessment for oestradiol may no t stop at the first step of hazard identification
unless there is in vivo -confirmed evidence that oestradiol is either a genotoxin or a DNA-reactive
mutagen. The EC has failed to present any evidence that oestradiol is genotoxic at levels below those
eliciting a hormonal response, nor has it provided evid ence that oestradiol is mutagenic at relevant
levels in vivo. The EC was therefore not justified in failing to complete the three remaining steps.
4.314 The experts confirmed that the EC did not complete the remaining steps. Dr. Boobis noted,
and Dr. Boisseau agreed, that the EC's Opinions are focu sed on the first step of risk assessment,
hazard identification. As noted by JECFA, a hazar d identification does not equal a risk assessment.
An assessor must finish all four steps. Although he did not speak on this subject in last week's
meetings, Dr. Guttenplan has described the EC materials as dese rving at best a "mixed rating" in
terms of the four steps of risk assessment(Question 14). He noted particular deficiencies in the hazard
characterization and risk characterization sections (Questions 13 and 14).
4.315 Another avenue for finding that the EC has not completed a risk assessment for oestradiol is
by determining that the conclusions set out in its assessment are not supported by scientific evidence.
For example, the experts agree that the EC has not presented any scientific evidence that oestradiol is
genotoxic in vitro or in vivo at physiological levels. The norma l action of oestradiol on a cell is
mediated through the oestrogen receptor. The genotoxic effects, which are abnormal, are not
mediated through the estrogen receptor but instead involve direct damage to DNA. To date,
concentrations of oestradiol required to cause ge notoxic effects have been well above those required
to elicit normal physiological effects.
4.316 As noted by Dr. Boobis
, positive in vitro tests require positive in vivo confirmation, as
toxicity is not always expressed in vivo . For Dr. Boobis , in vivo confirmation is critical because,
among other things, it takes into account DNA repair mechanisms. He commented that he was "not
persuaded" that oestradiol is genotoxic at leve ls below the normal hormonal concentrations present in
vivo. In other words, that the genotoxicity has a threshold that requires overwhelming the DNA repair
mechanisms – an event that will only occur at concentrations well beyond physiological levels.
4.317 The experts could not identify any studies providing evidence of the in vivo confirmation of
genotoxicity of oestradiol at levels below those required to elicit a hormonal response. When put on
the spot at last week's meetings with a new stud y produced by the EC in a last minute attempt to
provide evidence of in vivo effects, Dr. Boobis quickly dismissed the study as irrelevant. The study's
authors had treated the subject rats with so much oestradiol that the sheer level of the dose itself killed
fifty percent of them, precluding any interpretation of oestradiol-specific effects.
4.318 Another example of an unsupported conclusion in the EC's Opinions is that oestradiol
residues in meat from treated cattle are carcinogeni c. The EC has failed to present any scientific
evidence that oestradiol will have carcinogenic effect s at levels found in residues in meat from treated
cattle. Their failure to provide any evidence make s abundant sense. We consume oestradiol residues
from numerous sources every day at levels much gr eater than those found in meat residues, whether
from cattle treated for growth promotion or not. Milk, butter, eggs and, as noted by Dr. Boobis , a
great number of phytoestrogens in plant products are all sources of oestrogen in our diets.
4.319 The EC has failed to support either of th ese major conclusions on genotoxicity or
carcinogenicity with scientific evidence. The SPS Agreement does not permit the EC to do so. An
assessment that fails to adduce scientific evidence in support of its underlying conclusions is not a risk
assessment, as appropriate to the circumstances, under SPS Article 5.1.

4.320 There is a similarly uncomplicated analysis by which it can be determined that the EC's
"provisional bans" do not satisfy the requirements of SPS Article 5.7. The first of Article 5.7's
requirements for a provisional ban is that the eviden ce be insufficient to conduct a risk assessment.
None of the experts believes that this is the case for testosterone, progesterone, zeranol, TBA or
MGA.
4.321 Because the experts have confirmed that th e evidence for each of the five hormones is
sufficient to complete a risk assessment, discussion of the "provisional" bans may stop here in light of
the cumulative nature of Article 5.7's requirements. The EC's ban is not a provisional measure for
purposes of the SPS Agreement.
4.322 The second of Article 5.7's requirements is that a provisional measure be maintained on the
basis of available pertinent information. The EC's "provisional" bans do not satisfy this requirement
because there is no available pertinent information indicating that any of the five hormones poses a
risk to consumers when used as a growth promoter in cattle.
4.323 The views of the experts are evidence of a lack of available pertinent information indicating
that the five hormones pose a risk when consumed as residues in meat. Indeed, all available pertinent
information indicates that consumption of these residu es is safe. The EC has therefore not based its
"provisional" bans on available pertinent information within the meaning of SPS Article 5.7.
4.324 In light of the experts' responses, it is clear that the EC has neither based its permanent ban on
oestradiol on a risk assessment nor developed legitimate provisional bans. An analysis of these points
would not entail the type of de novo review to which I alluded earlier. As noted, none of us are
equipped for such a review and the SPS Agreement does not require or condone such a review.
4.325 While the Panel's analysis need not extend to th is issue, I will now take a moment to discuss
the EC's arguments relating to pre-pubertal children. The EC claims that oestradiol residues in meat
from treated cattle pose a risk to this sub-population. However, the EC fails to provide scientific
evidence of this risk.
4.326 In particular, the EC relies on an assay that, to date, remains unvalidated; the EC has failed to
produce any scientific evidence demonstrating that JECFA's ADIs do not sufficiently protect children;
and the EC has failed to complete the necessary steps of a risk assessment for this population.
4.327 This does not mean that the doubts and theoretical uncertainty on circulating oestradiol levels
in pre-pubertal children identified in last week's meetings are unimportant. They are important.
Indeed, JECFA reaffirmed that ensuring the safety of children is a "basic principle" of risk assessment
and a fundamental focus of its work. As such, it is a safe guess that JECFA would be interested in
any new evidence relating to this sub-population. As we have learned from the JECFA and Codex
representatives, however, the EC has not shared any in formation with them. If the EC believes that
the information it possesses has been properly validated and that the evidence is sound, then every
Codex member around the world would benefit from its conclusions. The EC is not alone in its desire
to protect the health of pre-pubertal children and other sensitive sub-populations.
4.328 Finally, we come to the issue of misuse of growth promoting hormones in the United States. I
have left this subject for last because, quite frankly, it is unclear what role misuse plays in the EC's
Opinions and arguments. The EC apparently consid ers potential misuse to be a risk, but has failed to
provide any evidence or argument as to how it h as actually assessed this risk. It provides no
evaluation of the actual system of controls in pl ace in the United States. We have described these
controls at length in our previous submi ssions to the Panel. Dr. De Brabander claimed to have
examined the US system of controls when he opine d that the US system is nothing but "audits and
paper work." However, he provided no analysis of the actual US system. Neither did the EC. In fact,

when asked in last week's meetings whether he was familiar with the US and Canadian meat safety
systems, Dr. De Brabander noted that he was not a meat inspector and was not qualified to make
judgments on these systems.
4.329 Even if one were to assume the unrealistic and hypothetical misuse scenarios developed by
the EC, the EC has failed to present convincing evidence that misuse leads to violative residue levels.
4.330 Finally, the EC fails to assess the risk of misuse . While the experts did not have a chance to
turn to this point last week, th e necessary evidence of the EC's failure may be found in their written
responses. (See, e.g., the responses of Drs. Boobis and Boisseau to Question 48).
4.331 When you take a step back from the EC's Opini ons, it becomes more and more clear that they
are flawed in larger ways than the EC would like us to see or focus on. In light of its line of
questioning to the experts last week, the EC appare ntly hopes to make this dispute one about getting
lost in the weeds of several scientific dead-ends. The spectr es of misuse, risks to sensitive
populations and the unwillingness of the experts to commit to a position that there will never be
evidence of a risk from any of these hormones in the future are examples of these scientifically
unfounded pitfalls. We could go on ad nauseam in a debate as to whether science in these areas is
evolving. As we know from our discussions with the experts last week, science is continually
evolving. This evolution cannot be equated with ev idence of a risk, however. We are not scientists,
and an attempt to thrust ourselves into the de bates on these issues would be nothing more than a
misguided de novo review of the science by us, laypersons.
4.332 If we follow the paths laid out by the EC, we will lose sight of the larger problems of the EC's
Opinions and the fundamental obligations and requir ements against which they are to be measured –
those set out in the SPS Agreement. When we view the EC's measures in this context – in which we
have the necessary knowledge and can perform the n ecessary analysis – it is clear that there are
several avenues by which we can conclude that th e EC has not based its permanent ban on oestradiol
on a risk assessment within the meaning of SPS Ar ticle 5.1, nor has it impl emented a provisional ban
on the other five hormones within the meaning of SPS Article 5.7. I have discussed these avenues
and the appropriate conclusions that can be reached for each based on the scientific record in this
dispute this morning.
K. ORAL STATEMENT OF THE EUROPEAN COMMUNITI ES ON LEGAL ISSUES DURING THE SECOND
SUBSTANTIVE MEETING
1. Introduction
4.333 The European Communities made a reservation in its statement yesterday when it questioned
the point of going through this exercise of looking at the possible violation of provisions under the
SPS Agreement. I am afraid that we have to postpone our discussion of that issue once again, to the
end of this meeting, as it seems more important at this stage to respond to the Panel's request to clarify
a few issues about the SPS Agreement and its application to the facts of this case. This is without
prejudice to our position on the provisions of the SPS Agreement which, if any, might be invoked
against our measures.
2. Article 5.1 of the SPS Agreement
4.334 Let us start with the main violation found by the Appellate Body in the original EC –
Hormones case, Article 5.1. The first point to make is that the situation today is very different from
that which confronted the Appellate Body in 1998.

4.335 The Appellate Body had found that the old risk assessment performed by the European
Communities was not specific enough to address r esidues in meat treated with hormonal growth
promoters.
4.336 The optimal way to remedy that would be to establish a quantitative dose response
relationship. However, the scientists last week have agreed (even though we did not need them to tell
us) that this is not possible to perform because the necessary studies would entail, as the 2002 US
Carcinogenesis Report says, conducting studies of long term human exposure and cancer incidence in
very restricted environments which will be able to eliminate with confidence confounding factors in
the initiation and promotion of cancer over a long latent period.
4.337 Visualize the study: a perfect place would seem a prison where you have a sufficient number
of very long term prisoners living in identical conditions, half of whom would eat non-hormone
treated beef and the other would eat hormone treated beef. Chairman, even under these
circumstances, which can not possibly be more restri cted, the results of the study would be rebuttable
due to differences in the past exposure history of those in custody. You may visualize another
situation where you have a sufficient number of newly born children with whom you perform a
similar experiment for about 30 years. Do I need to go on?
4.338 In the absence of such studies we had to follo w an alternative approach which is also
acceptable under the SPS Agreement. Let's review what we ha ve done and some important
knowledge that we have acquired:
4.339 First, we now have sufficient scien tific evidence that oestradiol-17 β is genotoxic. This is not
a theoretical risk, it is not negligible and definitely not "zero", it is a real risk however minimal.
4.340 Second, we have sufficient evidence that e ndogenous production of natural hormones by pre-
pubertal children is many times less than what was originally thought to be the case.
4.341 Third, most of the scientists have agreed that the dose-response curve cannot be defined with
certainty for low exposure to these substances.
4.342 Fourth, there is sufficient evidence, which is consistent with the observation that already
exposure from background endogenous production can lead to cancer;
4.343 Fifth, we know today that the old data used by the defending parties and JECFA and the
method by which they have been collected, are questionable or no longer valid ( e.g. depletion data
produced with method of analysis not apt to detect metabolites);
4.344 Sixth, there is a sufficient body of evidence i ndicating increased rates of cancer in the US and
Canada which is consistent with the argument th at residues of meat treated with these hormones can
contribute to these higher rates.
4.345 Seventh, we know that under r ealistic conditions of use, good veterinary practice cannot be
respected in the administration of hormones in th e US and Canada and this invalidates the ADIs and
MRLs (as Dr. Boisseau confirmed last week).
4.346 These things we did not know back then in the 1990s, but do know them now. Last week we
have heard that there is a difference of scientific views and of interpretation of data about some of
these issues, but that this difference is not arbitrar y and indeed reflects genuine scientific uncertainty.
In light of this, it is not indispensable that the third step of the risk assessment, the exposure
assessment, is performed in a quantitative manner.

4.347 With these data the European Communiti es has conducted a qualitative dose-response
assessment and has come to the conclusion that r esidues of hormone-treated meat will constitute an
added risk to human health. As the Appellate Body has explained in 1998, risk is not measured in the
laboratories but in the real world where people live, work and die.
4.348 In conclusion on this point, we believe that the European Communities performed a risk
assessment as appropriate to the circumstances and th e very nature of these substances, and therefore
the ban on oestradiol-17β is based thereon – that is: sufficiently warranted by that risk assessment.
4.349 Before turning to some comments on other SPS provisions, I would like to stress the
important point that we have made. A proper risk assessment can come to th e legitimate conclusion
that there are gaps in knowledge. This is expr essly recognized in point 11 of the General Working
Principles for Risk Analysis of Codex Alimentari us Commission. JECFA's risk assessment bridges
all knowledge gaps and scientific uncertainty by assumptions in favor of allowing the use of
hormones in growth promoters.
4.350 It seems that the US and Canada do not accept th at a proper risk assessment can conclude that
there are gaps and scientific uncertainty. For example, the US relies on a contention, at para 56 of its
statement of yesterday, that a risk assessment must fully address the four "mandatory" steps (and it
claims that the European Communities has not done so).
4.351 There is no basis for this. Article 5.1 of the SPS Agreement states that a risk assessment must
be "appropriate to the circumstances" and take into account techniques developed by international
organizations. As the European Communities has so often explained, and the experts have confirmed,
the four steps of the Codex guidelines only need to be taken where possible and necessary. A
qualitative assessment of the exposure of the kind pe rformed by the EC must be acceptable. Our
exposure assessment is not worse than that perform ed by the defending parties and JECFA, because
both are based on assumptions and extrapolations from data on animal experiments to human beings.
4.352 It seems that the US and Canada would like to make it almost impossible for the European
Communities to conduct a risk assessment they would ever accept. If they were to succeed with this
tactic, however, the result would not be more au thorizations but more provisional measures under
Article 5.7 SPS.
3. Article 3.3 of the SPS Agreement
4.353 There has also been mention of Article 3.3 of the SPS Agreement. The argument is not clear
but the European Communities would like to make a couple of important points. First, WTO
Members have a sovereign right to set a higher leve l of protection than reflected in international
standards. Article 3.3 only requires Members to ha ve a scientific justification for their measures
reflecting this higher level of protection, not for the higher level of protection itself.
4.354 Another point that needs to be made is that Article 3 of the SPS Agreement applies to
standards and measures, and does not require Members to accept risk assessments by organizations
such as JECFA. Accordingl y, the fact that JECFA may have made a different risk assessment, which
is outdated by today's standards and reflects a lowe r level of protection is not a basis for holding the
EC risk assessment to be inadequate. In any ev ent, the European Commun ities has shown that its
measure has the necessary scientific justification and aims to achieve a higher level of protection. For
this reason we fail to see the relevance of Article 3 of the SPS Agreement as a basis for the claims of
US and Canada in this case.

4. Article 5.7 of the SPS Agreement
4.355 Similarly, the fact that JECFA could carry out risk assessments on the 5 other hormones, is
not a reason for holding that the European Communities cannot adopt provisional measures based on
Article 5.7 of the SPS Agreement. For JECFA, the information is apparently sufficient to conduct risk
assessments; for the European Communities it is not. Even Dr. Boobis agreed (and the US
misrepresents his position at paragraph 35 of its statement yesterday morning).
4.356 The United States is also wrong to say (in para 6 of its statement) that the European
Communities has failed to review the provisional bans within a reasonable time. The European
Communities is in fact now conducting such a review once again.
5. Article 5.5 of the SPS Agreement
4.357 There have also been suggestions that the EC ban on oestradiol-17 β (and the provisional
prohibition of the other five hormones) are unreasonable or arbitrary in view of the large amounts of
hormones that human beings are already exposed to fro m many different sources. Here again, we are
not sure what the argument is. We cannot see how compatibility with Article 5.5 of the
SPS Agreement is relevant to this case because no viola tion of this provision has been invoked by the
Defendants. But even if it were, we would remind you of the interpretation of the Appellate Body of
this provision. You cannot compare natural presen ce of these substances in a great many products
with added risk from hormone-treated meat.
24
6. Conclusion on the SPS Agreement
4.358 Chairman, Members of the Panel, our re view of the possible relevance of the SPS Agreement
has been somewhat cursory. Our problem is that we do not know what we are accused of. The US
and Canada have not set out their claims in a Panel Request and their arguments criticizing our
measures are varied and wide-ranging. We would be happy to discuss these issues in more detail if
only we would be told exactly what it is we ar e doing wrong, because it is scientifically unsound and
arbitrary.
7. Concluding statement of the European Communities
(a) Introduction
4.359 The European Communities would first of all thank you again for the professionalism and
objectivity with which you have conducted these proceedings. Let me just recall that it was more than
a year ago that we met for the first time to di scuss the main claims of the European Communities
against the US and Canada's illegal unilateral determination of the a lleged inconsistency of the EC's
implementing measure and, based thereupon, their il legal continuation of the sanctions against the
European Communities.
4.360 The European Communities has explained in detail why in order to resolve these disputes it is
not necessary for you to address the scientific issues re lated to the use of hormones as animal growth
promoters. The Panel has nevertheless decided to lo ok at these scientific issues. And we are the first
to acknowledge that the scientific debate has not f acilitated your life. As we have learned, the
questions related to the use of these hormones are subject to a longstanding legitimate scientific
debate amongst scientists with respected and reasonable arguments on both side.

24 See para.221 of the Appellate Body Report in EC – Hormones.

4.361 However, one bottom line with which probabl y everybody will agree is that these hormones
do not improve your health. These hormones are animal growth promoters but not health promoters.
Instead we discuss scientif ic issues such as genotoxocity, muta genicity, carcinogenesis, DNA repair
mechanism, the risks of early puberty to our child ren, obesity, cancer as well as abuse and misuse of
these hormones. Whatever one may think about th is, it does certainly not increase our appetite for
meat.
4.362 Another bottom line, which can be safely draw n, is that these hormones present a hazard and
potentially a risk. Now, I agree that this is where the controversy starts. But whatever one may think
about it as lawyers or consumers, neither of the scientists nor of the respondents can reasonably argue
that there is no potential risk related to the u se of these hormones as growth promoters in cattle.
Instead, we have heard a lot of talk about "threshol ds", "appreciable risk" or "acceptable risk". But
whether a risk is appreciable or not, whether a ri sk is acceptable or not, it still remains a risk. And
contrary to what the responding parties have argued yesterday this is not a theoretical risk. No, the
risk is real, however minimal it may be.
4.363 Why should we accept such a risk? Why should we expose our public to an additional risk to
human health? Indeed, Chairman, Members of the Pa nel, we have heard repeatedly that we should
not care about the addition of the natural hormones sin ce they are also present in natural food, such as
broccoli, milk, eggs or butter or produced endogenously. But the question persists why we should add
on top of this an additional burden on the consumer without any health benefit in return. It is true that
we all take risks in life whether we drive with a car, or when we take a plane or if we drink a glass of
milk. However, we take these risks because we also see the benefit. Driving a car is comfortable,
taking the plane is fast and milk contains a lot of vitamins. Yet, the story is different with hormones
used as growth promoters in cattle. Here the risk is on the consumer. He has to face an additional
health risk by being exposed to higher hormone levels , but he has no additional health benefit. Thus,
from the perspective of a public health regulator, the risk/benefit calculation does not speak in favour
of the use of these hormones either.
4.364 If at all, one may argue that the issue of not allowing hormones as growth promoters in cattle
while we allow our children to drink milk is a matte r of consistency. Howeve r, that would also be a
very superficial view of the issues at stake. As we have explained yesterday and as the Appellate
Body has already decided, one cannot compare thes e two things. On the one hand, we talk about
natural food products that are part of our daily life over centuries and where there is a concrete
risk/benefit for the consumer. On the other hand, th e use of hormones in beef is an unavoidable risk
which does not bring any advantages to public health.
4.365 How can this be better exemplified than by lo oking at our children. Children are the most
sensitive part of the population and we must protec t them wherever we can. There is a lot of
uncertainty about how the mechanism of hormones in these children work but one can be sure that
doubling the oestradiol doses - as would be the case by allowing hormones in beef - will have an
effect. One of your experts, Dr. Sippell, has confirmed this pointing to the examples of early puberty
or obesity. We should take his judgment very serious ly when he drew the conclusion of the scientific
hearing that he is "very concerned". Whatever t oxicologists or veterinarian may have to say we
should take this testimony of a paediatrician very, very seriously.
4.366 This brings me to one last point in this introduction which is about misuse and abuse of
hormones as growth promoters. It is already striking that we always refer to "Good Veterinary
Practices" even though no veterinarian or other traine d health professionals is involved in the use of
these hormones in the United States and Canada. As they are sold freely over the counter to farmers
you will admit that controlling the correct use of these substances is difficult under these
circumstances. It should strike us all that one implant contains the amount of hormones contained to
up to 10,000 carcasses of animals. The Europ ean Communities has assessed what happens if these

implants are misused and, indeed, there exists c oncrete evidence on this in the United States and
Canada.
(b) The scientific debate
4.367 Let me now turn briefly to the outcome of th e scientific debate regarding the use of these
hormones as growth promoters in cattle. The Eur opean Communities is still puzzled by the United
States' and Canada's attempts to present this de bate as if there were only one single monolithic
opinion in the scientific world on the safety of th ese hormones. This serves the US' and Canada's
purpose but it is not objective.
4.368 It is true that we are all sometimes tempte d to provide easy answers to difficult questions.
And, certainly, this natural reflex is made even easier in the face of scientists who are able to "quickly
dismiss" scientific evidence that they have not taken into account in the first place.
4.369 What is important for your decision, however, is to look at the differences and to see whether
these differences are scientifically legitimate. The European Communities has never claimed that its
scientific findings are the only valid ones, unlik e what the United States and Canada have done.
However, what the European Communities has repeatedly insisted upon is that its scientific views and
its risk assessment are appropriate to the circum stances and that they come from respected and
legitimate sources. One may not like the EC' conclusions but one cannot ignore or discredit them
either.
4.370 It also appears sometimes ironic to present the EC' risk assessment in opposition to the
JECFA's assessment. There is no doubt that the JE CFA 's assessments have been based on outdated
data since despite its assessment in 1999 this does not mean that the data also come from the 90's.
Rather the JECFA representative admitted that they only review data as they receive them and in this
particular case they had only received data from the FDA some of which date back to the 1960s.
Despite the general acknowledgement that science is constantly moving forward and reveals new
evidence this is an astonishing pro cedure itself which, again, we leave to your discretion on how you
take this into account. A second undisputable issu e is that JECFA's (and indeed the United States and
Canada's) approach to risk is different to the one by the European Communities. JECFA has set
thresholds in order to minimize the risk, the Eu ropean Communities has prohibited the use of these
hormones in order to exclude avoidable risks.
4.371 These are two completely different risk manage ment decisions. Both are legitimate and we
are, therefore, not criticizing JECFA for what it has done. However, we also cannot be blamed for
deviating from JECFA's approach. It is ultimately the responsibility of the regulator or risk manager
to decide what level of risk he wants to accept, and as I have indicated earlier, this is a very complex
decision to which no easy answer can be given.
4.372 Let me then turn to our puzzl ement by the United States and Canada's characterization of the
scientific debate. We mentioned already yesterday that they very selectively refer to the scientific
evidence in order to make their case. Chairman, Members of the Panel, we trust that you have a better
recollection of what was actually said.
4.373 Let me just give a few examples. The United Stat es has stated that "the experts agree that the
EC has not presented any scientific evidence that oestradiol is genotoxic in vitro or in vivo at
physiological levels". However, may I remind yo u about the lively debate between Dr. Boobis and
Dr. Guttenplan on this particular issue where Dr . Boobis "quickly dismissed" a study that was co-
authored by one of his expert colleagues. Isn't it simply disingenuous to present this debate as if "all
experts agree" that there is no evidence? And I'm not even talking about the experts that have not
expressed an opinion on this issue.

4.374 Another example is the US' statement that "the experts have confirmed that the evidence for
each of the five hormones is sufficient to complete a risk assessment". This is again incorrect. First,
some of the experts have not even expressed a vi ew on this. And even Dr. Boobis, who the United
States often likes to rely on has merely stated that JECFA had enough information for completing a
risk assessment whereas he could not say this for the European Communities. Again, as we have just
explained, we all know the difference in these pe rceptions which is based on the fundamentally
different approach by JECFA and the European Co mmunities on how to deal with risks and whether
or not it is appropriate to set a threshold in light of the possible direct and indirect genotoxcity of these
substances.
4.375 A third and last example is Canada's statement today that "nothing in what the Experts have
written, nothing in what we have heard from the E xperts (…) or the Experts have said demonstrates
that there is any risk to human health, adult or chil d, old or young, man or woman, boy or girl, arising
out of the correct use of these growth-promoting agen ts in cattle". It suffices to contrast this
simplistic summary by Canada with Dr. Sippell's conclu sion of last week that he is "very concerned"
about the health of children if they were exposed to these hormones in beef. Again, we trust the Panel
Members that they take into account what has actually been said by the scientists in their variety and
not what the United States or Canada make out of it.
4.376 In this context, let me also refer to the closi ng statements by some of the experts during last
week's hearing and which summarizes adequately th e level of differences in the scientific world.
Dr. Guttenplan stated that as regards young girls and boys we have to worry about the developmental
effects of oestradiol on them and that hormon es sensitive cancer might be increased by raising the
level of oestradiol. Dr. Sippell stated that we do not know enough about children and that the data are
insufficient to be confident that the additional exposure from hormones treated beef poses no risk.
Dr. Cogliano himself referred to the messiness of science and to the split within the scientific
community. He also stated that these issues are not likely to be resolved any time soon. Finally,
Dr. De Brabander even referred to other aspects re lated to the use of hormones as growth promoters
such as animal welfare or environmental concern.
4.377 There is a bottom line which one cannot ignore. The scientific issues on which the European
Communities and the United States and Canada disagree are not arbitrary but they are the result of a
legitimate and genuine disagreement amongst scientists . This was the main result of the Panel'
experts hearing. We do not believe that this Panel is in a position, or required, to resolve these long-
standing scientific issues. Instead we would ur ge you to acknowledge the legitimate scientific
controversy and to draw the respective conclusions from it in resolving these two disputes.
(c) The context of the scientific debate
4.378 With these remarks, let me come back to where we ended last year after our discussion on the
systemic issues under the DSU.
4.379 The European Communities would recall that these two disputes are still not about the
SPS Agreement, despite the extensive scientific debate th at has taken place on the public health risk
related to hormones in animal treated beef. Chai rman, Members of the Panel, the panel requests by
the European Communities which pr ovide the legal basis for these two disputes do not refer to any
single provision under the SPS Agreement. Rather, as we discussed extensively last year, the
European Communities has based its case against the illegal continua tion of sanctions by the United
States and Canada on systemic violations of the DSU, in particular Article 23, paragraphs1 and 2(a),
Article 21.5 and Article 22.8.
4.380 As repeatedly stated, in order to resolve th ese disputes it is not necessary for you to make a
substantive finding on the scientific issues. We have already set out that in our view the proper forum

and the right procedural way to deal with these w ould be a compliance Panel under Article 21.5 of the
DSU initiated by the United States or Canada.
4.381 This said, it is true that the European Comm unities has also made an alternative claim which
requires you to address the substantive scientific as pects in order to determine that the original
inconsistent measure has been removed and that the European Communities has addressed all the
rulings and recommendations of the DSB.
4.382 However, this alternative claim has been only made "if, and only if" the Panel were to
disagree with the European Communities on its sy stemic arguments under the DSU. Up until now,
the Panel has not decided that this is the case. Ther efore, the main claims and arguments as set out by
the European Communities in its submissions ar e still valid and you are still called upon to take a
decision.
4.383 Our discussion of the scientific issues may nevertheless be useful in respect of the main
systemic claims made by the European Communities. I would just like to recall that one of the claims
is that the US and Canada's continued suspension of obligations is in violation of Article 23.1 and
Article 22.8 of the DSU. This is so because by continuing to apply sanctio ns against the European
Communities, the United States and Canada are unilaterally seeking to redress an alleged WTO
inconsistency of the EC compliance measure with th e WTO obligations. Furthermore, as you recall,
in view of the requirements of Article 22.8 of th e DSU, the European Communities has explained in
great detail that its implementing measure must be presumed to be WTO-consistent since there is no
multilateral finding to the contrary. This presump tion is derived from the general principle of good
faith whereby WTO Members are presumed to act in conformity with their obligations.
4.384 In this particular context, the European Comm unities considers that the scientific debate fully
supports its proposition of a presumed compliance of its implementing measure. Indeed, since the
scientific evidence demonstrates that the EC complia nce measure is in actual compliance, it follows
a fortiori that the lower standard of presumed compliance is also fulfilled.
4.385 Let me explain this aspect in more detail.
4.386 From the beginning of these two proceedings, th e United States and Canada have tried to
discredit the European Communities' compliance m easure and its scientific foundations. Arguably,
by this criticism the defendants have tried to undermine the European Communities' reliance on the
principle of good faith (or in this case the presump tion of compliance) under Article 22.8 of the DSU.
And one has to admit that this litigation tactic by the United States and Canada was not completely
unsuccessful because you felt the need to address the scientific issues related to the use of these six
hormones as growth promoters in cattle notwithstanding the applicability of the general principle of
good faith.
4.387 However, following the extensive discussion of th e scientific issues, it is clear that this
approach by the United States and Canada is no longer sustainable. As we have seen last week, there
can be no doubt that there exists a real and actual risk to public h ealth related to the use of the six
hormones as growth promoters. The European Co mmunities was therefore fully entitled to ban the
use of these hormones in beef. And in legal term s, the European Commun ities was therefore also
right in invoking the principle of presumed compliance within the context of its systemic claim under
Article 23.1, 22.8 of the DSU.
4.388 The logic of this argument may also be further elucidated when the invocation of good faith is
linked to the issue of burden of proof. The Un ited States and Canada have attempted to make a
 prima
facie case against the EC compliance measure. Ye t, following the scientific debate the European
Communities has refuted this prima facie case. The burden of proof is therefore still on the United

States and Canada for questioning the European Co mmunities' conclusion that the use of these six
hormones for animal growth promotion is a risk to public health. The United States and Canada have
failed to meet this burden of proof and they could not support their conclusions that the EC's ban on
hormones treated beef was scientifically unsound.
4.389 We would like to recall that the European Communities also made violation claims under
Articles 23 and 21.5 of the DSU that do not depend on the WTO-consistency of the EC's compliance
measure. Rather these claims are directly linked to the US' and Canada's unilateral determination of
the alleged inconsistency of the EC' compliance measure.
4.390 Finally, we have heard again this morning th at the United States maintains that it could not
have possibly made a "determination" that the EC's new ban is in fact WTO-consistent by the time the
EC initiated these proceedings because the Europ ean Communities failed to provide all the necessary
materials relevant to its measure.
4.391 This is a rather disingenuous characterization of the real facts and I will, at this stage not
recall all our arguments that we have submitted to you. Let me just first point out that the United
States erroneously keeps referring to a determination of WTO-consistency which it claims it could not
make. The DSU neither requires nor forbids such "consistency determination". What the DSU
prohibits, however, is the unilateral determination of a WTO violation by another Member.
4.392 Let me also recall, that while the United Stat es in its view struggled to come up with a
"determination" as early as November 2003 they di smissed the EC compliance measure and explicitly
stated in its Trade Policy Review of 2005 that "the y failed to see how the revised measure could be
considered to implement the recommendations and rulings of the DSB". And in addition to that, since
then the United States simply continued to apply its sanctions against the European Communities.
There is no other way than to qualify this behavi our as an illegal determination of non-compliance.
And, finally, it is also simply not true that the United States had been confronted with the evidence for
the first time in 2003. All the underlying studies have been peer-reviewed and been published in
journals and the European Communities undertook even an effort to discuss with the United States in
Washington the scientific evidence. All this is on th e record. The European Communities, therefore,
cannot express again its puzzlement by the way the United States represents the facts in this dispute.
(d) Conclusion
4.393 For all these reasons, the European Communities would ask the Panel to find:
(a) First, that the United States' and Canada 's continued suspension of concessions
against the European Communities was inconsis tent with the provisions referred to
under Part I of the EC's first written submission.
(b) In the alternative, the United States' and Canada's continued suspension of
concessions against the European Communities is inconsistent with the provisions set
out under Part II of the EC's first written submission.
L. ORAL STATEMENT OF THE UNITED STATES ON LEGAL ISSUES DURING THE SECOND
SUBSTANTIVE MEETING
1. Oral statement
4.394 The United States considers that last week's m eeting with the scientific experts reinforced a
fundamental point – that the European Communiti es ("EC") has failed to demonstrate that the
conditions of Article 22.8 of the WTO's Understanding on Rules and Procedures Governing the

Settlement of Disputes (the "DSU") for ending the Dispute Settlement Body ("DSB") - authorized
suspension of concessions in the Hormones dispute have been met. To prevail on its claim that the
United States has breached Article 22.8, the EC must demonstrate that it has either removed its WTO-
inconsistent measures or provided a solution to the nullification or impairment suffered by the United
States as a result of its ongoing bans on US meat and meat products. The EC has done neither.
4.395 The EC could have satisfied its burden by de monstrating that its "amended" ban brought it
into conformity with its obligations under the WTO Agreement on the Application of Sanitary and
Phytosanitary Measures ("SPS Agreement"). But it did not. The experts have provided valuable
scientific and technical advice that confirms this fact. Their written and verbal responses demonstrate
that the EC has failed to complete a risk assessment for oestradiol or base its ban on a risk assessment
within the meaning of SPS Article 5.1.
4.396 Similarly, the experts' responses confirm that the EC has not imposed provisional bans within
the meaning of SPS Article 5.7. Before discussing the EC's failure to bring its measures into
conformity with the SPS Agreement and DSB recommendations and rulings, and thereby satisfy the
conditions of DSU Article 22.8, however, I would like to briefly touch on the other DSU claims raised
by the EC in the course of these proceedings.
4.397 The Panel will recall that the EC initially a lleged that the United States was breaching its
WTO obligations by failing to meet the requirements of several provisions of the DSU – namely
Articles 21.5, 22.8, 3.7 and several provisions of Article 23 read "in conjunction" with each other.
The United States has demonstrated that the EC's DS U claims are merely a reflection of how the EC
would like to see the DSU rewritten rather than b ased in the actual text of the DSU as written and
agreed to by WTO Members. As noted by the Appellate Body, "[d]etermining what the rules and
procedures of the DSU ought to be is not our r esponsibility nor the responsibility of panels; it is
clearly the responsibility solely of the Members of the WTO."
4.398 The EC alleges that its "provisional bans" on me at and meat products from cattle treated with
the five other hormones (testosterone; progester one; zeranol; trenbolone acetate; and melengestrol
acetate) satisfy its obligations under SPS Article 5. 7 and thereby bring it into conformity with the
DSB recommendations and rulings that it must base its measures for these hormones on a risk
assessment, as appropriate to the circumstances, within the meaning of Article 5.1 of the
SPS Agreement.
4.399 Article 5.7 is a qualified exem ption from Article 2.2 of the SPS Agreement which stipulates,
among other things, that Members shall not mainta in sanitary measures without sufficient scientific
evidence "except as provided for in paragraph 7 of Artic le 5". In light of the fact that "Article 5.1
may be viewed as a specific application of the basi c obligations contained in Article 2.2" and that
"Articles 2.2 and 5.1 should constantly be read together," it is clear that Article 5.7 is also a temporary
exception from a Member's obligation to base its measu re on a risk assessment within the meaning of
Article 5.1. In order to qualify for this excep tion, however, the EC must demonstrate that it has
satisfied the four cumulative conditions of Article 5.7.
4.400 The experts' written and oral comments confirm that the EC has failed to do so and thereby
failed to demonstrate that it has brought its measures into conformity with DSB recommendations and
rulings. As a result, the EC has not removed the WTO-inconsistencies of its measures or provided a
solution of the nullification or impairment suffere d by the United States within the meaning of DSU
Article 22.8.
4.401 For example, the EC's bans on the other five hormones are not imposed in a situation where
relevant scientific information relating to the hor mones is insufficient within the meaning of SPS
Article 5.7. As demonstrated by the United States and confirmed by the written and oral responses of

the experts, there is more than sufficient scientific evidence to permit "performance of an adequate
assessment of risks as required under Article 5.1" for the five hormones.
4.402 In addition, the EC's bans on the other five hormones are not based on available pertinent
information within the meaning of SPS Article 5.7. Its bans cannot be based on available pertinent
information, because none of that information s uggests that meat and meat products from cattle
treated with the five hormones for growth promo tion purposes according to good veterinary practices
pose a risk to consumers.
4.403 The EC alleges that its permanent ban on meat and meat products from cattle treated with
oestradiol for growth promotion purposes is based on a risk assessment within the meaning of
Article 5.1 of the SPS Agreement. In these proceedings we have examined what, exactly, constitutes a
risk assessment for Article 5.1 purposes from several angles and have confirmed a few basic concepts
regarding the necessary components of a risk assessme nt for oestradiol. A risk assessment must
identify adverse effects from the consumption of meat from cattle treated with oestradiol and evaluate
the potential occurrence of such effects, and it mu st engage in four fundamental steps: hazard
identification; hazard characterization; exposure assessment; and risk characterization.
4.404 Rather than concluding that the EC's Opini ons constitute a complete risk assessment, the
experts' responses indicate that the EC has failed to progress beyond the first step of risk assessment,
hazard identification. As noted by the United St ates, this stage of risk assessment addresses the
simple question of what can possibly go wrong, not the likelihood of something going wrong.
4.405 The EC has also failed to base its permanent ban on meat and meat products from cattle
treated with oestradiol for growth promotion purposes on a risk assessment, as appropriate to the
circumstances, within the meaning of SPS Article 5.1. In order for the EC's measure to be "based" on
a risk assessment, its assessment (the Opinions) mu st sufficiently warrant or reasonably support its
measure, a ban on meat and meat products from cattle treated with oestradiol for growth promotion
purposes. Yet, the EC's Opinions and their underl ying studies simply identify theoretical risks from
oestradiol generally rather than the specific risk ostensibly addressed by the EC's measure.
4.406 The materials relied on by the EC focus on potential adverse effects from exposure to
oestradiol or estrogens generally rather than provi ding evidence of the speci fic risk from residues in
meat from cattle treated with oestradiol for growth promotion purposes. In its most recent set of
exhibits, the EC has failed yet again to provide evidence of the specific risk allegedly posed by
residues in meat from treated cattle.
4.407 While the sort of scientific evidence of a gene ral risk presented by the EC, of which the US
Report on Carcinogens it has referred to is a good example, may be handy for completing the hazard
identification (first) component of a risk assessment , it is not evidence of the specific risk against
which the EC purports to mitigate with its bans.
4.408 A measure banning the import of meat treated with oestradiol for growth promotion purposes
cannot be premised on the EC's failure to produce ev idence of a risk from this product. This failure
represents the very type of theoretical uncertainty that is "not the kind of risk which, under Article 5.1,
is to be assessed." As a result, th e EC's Opinions fail to sufficiently warrant or reasonably support its
measure.
4.409 This point is highlighted by the fact that so many of the studies relied on by the EC in its
Opinions do not actually support the conclusions it has drawn from them. For instance, as discussed
yesterday morning, the EC's Opinions reach conclusions on the genotoxicity, carcinogenicity and
mutagenicity of oestradiol that simply are unsup ported by scientific evidence. The experts have
confirmed this point. The experts looked at the materials put forward by the EC in its attempt to

produce evidence of the specific risk, yet have disag reed with the fundamental conclusions the EC
draws from those materials. For example, the e xperts agreed that the sci entific evidence did not
support the conclusion that residue levels found in meat would be carcinogenic.
4.410 This is why, in yesterday's meeting, the Un ited States made the point in the discussion of
Appellate Body guidance from the original Hormones dispute that the Appellate Body's language on
appropriate levels of pr otection was not necessarily relevant to the debate at hand. The point the
United States made is that if there is no evidence of a risk from meat treated with oestradiol for
growth promotion purposes, it does not matter what level of protection the EC has set for itself. Its
level of protection could be zero risk, no additional ri sk, negligible risk, or some risk – if the product
in question is safe, all of these levels of protec tion are satisfied and there is no need to parse
distinctions between them. Despite this fact, if th e Panel wishes to delve deeper into this Appellate
Body discussion, the United States would note that the Appellate Body provided additional guidance
on the matter of appropriate levels of protection and existence of distinctions in those levels in its
Report in the Australia – Salmon dispute beginning at page 42.
4.411 For these reasons, those set out in the US submissions, and in light of the responses of the
Panel's scientific experts, the EC has failed to c onduct a risk assessment for oestradiol and has failed
to base its permanent import ban on meat and meat products from cattle treated with oestradiol for
growth promotion purposes on a risk assessment, as appropriate to the circumstances, within the
meaning of Article 5.1 of the SPS Agreement.
4.412 Finally, by failing to base its permanent ban on meat from cattle treated with oestradiol on a
risk assessment within the meaning of SPS Article 5.1 or to satisfy the conditions of SPS Article 5.7
for its provisional bans on meat from cattle treated with the other five hormones, the EC has not
brought its measures into conformity with its obligat ions under SPS Article 3. 3. As a consequence,
the EC has again failed to satisfy the conditions of DSU Article 22.8 because it has not removed the
WTO-inconsistencies of its measure.
4.413 The EC's measures are not based on international standards, and must therefore be premised
on a "scientific justification" or maintained "as a consequence of the level of ... protection [the EC]
determined to be appropriate in accordance with the relevant provisions of [Article 5 of the
SPS Agreement]."
25 Because the EC's measures are neither based on a risk assessment nor satisfy the
necessary conditions for a provisional ban as required by Article 5 of the SPS Agreement, they fail to
satisfy its obligations under SPS Article 3.3.
4.414 In conclusion, the EC has failed to base its permanent ban on oestradiol on a risk assessment
within the meaning of Article 5.1 of the SPS Agreement or to satisfy the conditions of SPS Article 5.7
with its provisional ban on the other five hormones. As a consequence, the EC also fails to satisfy its
obligations under Article 3.3 of the SPS Agreement. The experts' responses and comments provide
the necessary scientific underpinning for these c onclusions, as well as the corresponding conclusion
that the EC has not satisfied the conditions of DS U Article 22.8, the conditions by which the United
States would have been obligated to cease to apply the suspension of concessions in the Hormones
dispute to the EC.
4.415 For all the reasons discussed above and in its va rious submissions to the Panel, as well as the
arguments raised by Canada in these proceedings, the United States respectfully requests the Panel to
reject the EC's claims in their entirety.

25 SPS Article 3.3.

2. Concluding statement by the United States
4.416 The United Stated considers that we have ha d a very productive debate over the last week-
and-a-half. In the course of our discussions, whic h included meetings with the panel of scientific
experts, a few central issues have come to light.
4.417 First, as I noted yesterday, the task at hand is not one of conducting a risk assessment for the
European Communities. It is not one of conducting a review for the EC of the numerous materials it
has put forward since completion of its Opinions. Rath er, the relevant analysis is one of what the EC
has actually accomplished in its Opinions.
4.418 Second, the Panel has consulted scientific expe rts to sift through the EC's Opinions and
related materials in an attempt to determine whet her any of these materials actually addressed the
specific risk at issue in these pr oceedings – that from oestradiol re sidues in meat from animals treated
with growth promoting hormones. The experts also looked at information put forward by the EC in
support of its provisional bans on the other five horm ones. The experts noted, as discussed in the US
statement yesterday, that the EC had not complete d the necessary steps of a risk assessment for
oestradiol. Nor had the EC presented evidence that oestradiol residues in meat from treated cattle are
carcinogenic. The United States described how these majo r conclusions factor into an analysis of the
EC's permanent ban on oestradiol. They demonstrate that it is not based on risk assessment for
purposes of SPS Article 5.1.
4.419 As to the other five hormones, the experts indicated that there was sufficient scientific
evidence to conduct a risk assess ment for each one and that the scientific evidence did not
demonstrate a risk at levels found in residues in meat from treated cattle. This means that the EC
failed to demonstrate that scientific evidence was insufficient to conduct a risk assessment for these
hormones or that it had based its ban on available pe rtinent information. Therefore, the EC's bans do
not satisfy the conditions of Article 5.7 of the SPS Agreement.
4.420 Third, the EC has claimed a US breach of Ar ticle 22.8 of the DSU. To demonstrate this
breach, it must show that it has removed the WTO-inconsistencies of its measures or provided a
solution to the nullification or impairment of bene fits suffered by the United States. These conditions
could theoretically be met if the EC's measures satisfy its obligations under the SPS Agreement.
However, they do not. The experts' comments inform this analysis.
4.421 Fourth, and finally, the EC's various other DSU claims reflect the EC's hopes for how the
DSU should be rewritten rather than finding a basis in the text of the DSU as it currently reads.
Through a string of provisions read "in conjunction" with each other, it seeks very specific findings of
specific provisions of the DSU. As the Appellate Body cautioned, "[d]etermining what the rules and
procedures of the DSU ought to be is not our r esponsibility nor the responsibility of panels; it is
clearly the responsibility solely of the Member of the WTO. Disregarding this guidance, the EC seeks
to insert new obligations into the text of the DSU through the vehicle of dispute settlement. It may
not do this. The EC, like the rest of the Membership of the WTO, is left with the text of the DSU as it
reads today, and the EC has failed to demonstrate any US violation of the specific provisions of that
text.
4.422 In closing, I would like to thank you fo r the professional manner in which you have
conducted these proceedings. Thank you very much.

V. ARGUMENTS OF THE THIRD PARTIES
A. AUSTRALIA
1. Introduction
5.1 According to Australia, this dispute is about one fundamental question; whether the DSU
provides that a Member's announcement of its co mpliance with DSB recommendations and rulings
triggers an obligation on a retaliating Member to either (i) cease retaliation or (ii) initiate a new
process for a multilateral determination of compliance.26
2. Opening Panel meetings for public observation
5.2 Australia contends that when parties agr ee not to follow the Working Procedures in
Appendix 3, or parts thereof, it would be difficult fo r the Panel to justify a decision that goes against
the wishes of the parties. In Australia's view, to do so would undermine a basic principle of dispute
settlement whereby parties consult with each other and with the Panel and seek mutual agreement on
the conduct of disputes, according to Article 12.1 of the DSU.27
5.3 Australia submits that the decision to open the meetings with the parties to the public would
not pose a problem, in principle, to Australia. Australia was however concerned about the modalities
of organising the meetings, equity of access and logistic issues. Australia was of the view that the
opening of the Panel's meetings to the public shoul d be subject to the provisions that allow for
protection of confidential information.
28
3. Whether the DSB authorization remains in effect
5.4 Australia argues that a Member's annou ncement of its compliance with DSB
recommendations and rulings triggers an obligation on a retaliating Member to either cease retaliation
or initiate a new process for a multilateral determinati on of compliance. Australia claims that as seen
in Articles 22.1 and 22.8 of the DSU, the right to suspend concessions authorised by the DSB is
temporary and conditional upon the respondent continuing to be in non compliance or upon a solution
not being reached. According to Australia, by c ontinuing retaliation in the face of a respondent's
notification of compliance, a complainant is effectively challenging the measure(s) taken to comply.
According to Australia therefore, in such a case it is for the complainant to invoke a compliance panel
pursuant to Article 21.5 of the DSU.
29
5.5 Australia contends that the suspension of concessi ons or other obligations is the "last resort"
for Members invoking the dispute settlement procedures, as stated in Article 3.7 of the DSU.30
4. Article 21.5 of the DSU
5.6 Australia acknowledges that Article 21.5 of th e DSU does not explicitly place the obligation
to invoke a compliance panel on a complaining part y. The text simply provides that in cases of
disagreement over compliance such dispute shall be decided through recourse to the dispute
settlement procedure. Australia however argues that requiring a respondent to invoke a compliance
panel against its own measure(s) constitutes an impl icit unilateral determinati on of inconsistency by

26 Third party submission of Australia, para. 4.
27 Replies to Panel questions concerning an open hearing by Australia, question 1.
28 Replies to Panel questions concerning an open hearing by Australia, question 2.
29 Third party submission of Australia, para. 5.
30 Replies to Panel questions by Australia, question 5.

the complainant and undermines the presumption that Members act in good faith in taking action to
comply with DSB recommendations and rulings.31
5.7 Australia further submits that this position is consistent with Appella te Body findings on the
presumption of good faith in Chile – Alcoholic Beverages ,32 where the Appellate Body stated that
Members of the WTO should not be assumed, in any way, to have continued previous protection or
discrimination through the adoption of a new measure , as this would come close to a presumption of
bad faith. 33 Australia also noted observations on good faith made by the Appellate Body in US –
Hot- Rolled Steel34and US – Line Pipe.35
5.8 Australia thus points out that the fact that a complainant may have been granted temporary
authorisation to retaliate against a Member f ound to be in non-compliance does not change the
fundamental application of the presumption of good faith. Australia stresses that disregarding the
presumption in the specific circumstances of a Member announcing that it has taken action which it
considers brings it into compliance would go against the design and underlying logic of the DSU.36
5.9 Australia posits that the DSU is explicit on th e following points, which provide context for
the interpretation of Article 21.5:37
• Members must not take unilateral action to seek redress for alleged violations of
obligations or other nullification or impairment of benefits (Article 23).
• Instead, Members must have recourse to the DSU and abide with its rules and
procedures (Article 23).
• DSU procedures, including those provided for in Article 21, must be used to resolve
disagreements over compliance (Article 23.1).
• The suspension of concessions or other oblig ations is a "last resort" by Members and
is temporary. That is, it is only authorised until compliance is achieved (Articles 3.7
and 22).
5.10 Australia contends that by refusing to in voke a "compliance panel", a complainant who
disagrees with the respondent's announcement of its compliance allows the dispute to continue
unresolved.38 Australia argues that the longer the time period in which the United States did not take
action under Article 21.5, the greater the firmness or immutability the United States made of its
determination. Australia emphasizes that this is because a determination within the meaning of
Article 23.2(a) of the DSU may be inferred on ce a certain amount of time has passed after
communication by a responding party that it has complied and in which a complaining party continues
to retaliate. According to Australia therefore, th e longer the period of time that a complaining party
continues its retaliation in the face of this communica tion, the greater degree of certainty there is for
the inference that the retaliating party has determined that a violation has occurred, that benefits have

31 Third party submission of Australia, para. 6.
32 Chile – Taxes on Alcoholic Beverages, (WT/DS87/AB/R and WT/DS110/AB/R), para. 74, (emphasis
in original, footnote omitted).
33 Third party submission of Australia, para. 7.
34 US – Anti-Dumping Measures on Certain Hot-Rolled Steel Products from Japan (WT/DS184/AB/R),
para. 101.
35 US – Definitive Safeguard Measures on Imports of Circular Welded Carbon Quality Line Pipe from
36 Third party submission of Australia, para. 8.
37 Third party submission of Australia, para. 9.
38 Third party submission of Australia, para. 10.

been nullified or impaired or that the attainment of any objective of the covered agreements has been
impeded.39
5.11 Australia argues that there is no procedure that a Member claiming compliance can invoke in
order to obtain a multilateral determination of act ual compliance. According to Australia, the
possibility of a new dispute whereby the origin al respondent complains against the continued
retaliating measures on the basis of actual compliance assumes that there is no obligation upon the
retaliating Member to either initiate an Article 21.5 panel or cease retaliation after communication of
compliance by a respondent, which is an incorrect interpretation of the DSU.40
B. BRAZIL
1. Introduction
5.12 Brazil claims that it files the present submission in light of its interests in the interpretation to
be developed by the parties and the Panel in these proceedings. Brazil states that it will address what
it considers to be the fundamental objective of th e European Communities in the current dispute,
namely to obtain multilateral recognition that it has fully implemented the recommendations of the
DSB without having to bear the burden of proving how it would have effectively implemented those
rulings.41
2. Opening Panel meetings for public observation
5.13 Brazil questioned the specific grounds and the DSU provisions on which the Panel based its
decision to accept the parties' request to open the panel meetings for public observation. According to
Brazil, transparency is one of the key issues in the DSU review process and constitutes an important
element in the debate carried out by Members in the DSB meetings. As such, Brazil notes that the
debate on transparency will largely benefit from any further clarification by the Panel as to the legal
reasons which motivated its decision to open the meetings to the public.42
5.14 Brazil argues that a decision on whether or not to open panels' proceedings to the public relies
solely on the WTO membership, in particular th e DSU review process which is the appropriate locus
to deal with issues regarding the Dispute Settlement Mechanism. According to Brazil, if panels were
to decide on this issue, they would go beyond thei r mandate, playing a role that is exclusive to the
WTO membership.43
5.15 Brazil further submits that the right to be presen t at or to watch a panel meeting should be
granted first to WTO Members subject to the rules fo r third party participation set forth in Article 10
of the DSU. Brazil also contends that opening the meetings to the public would represent a
reinterpretation of Article 14 of the DSU, signaling that there are cases to wh ich confidentiality is not
applied, such as Panel and Appellate Body meetings.44
3. Whether the DSB authorization remains in effect
5.16 In Brazil's point of view, the European Commun ities must prove that the new measure is in
full compliance with the DSB recommendations. Brazil stresses that the European Communities'
claim is based only on a unilateral sole assertion of compliance. However, a mere assertion is

39 Third party submission of Australia, para. 10.
40 Replies by Australia to Panel questions, question 4.
41 Third party submission of Brazil, paras. 1 and 2.
43 Replies by Brazil to Panel questions concerning open hearings, question 1.
44 Replies by Brazil to Panel questions concerning open hearings, question 1.

insufficient to prove compliance. Brazil submits that the European Co mmunities may modify its
legislation over and over and notify changes to th e WTO without actually bringing the measures into
conformity with WTO rules.45
5.17 Brazil considers that if the European Commun ities argument were accepted, it would give the
implementing Member the power to unilaterally dispel a previous multilateral determination
authorizing suspension of concessions. Brazil contends that such Member would therefore be allowed
to act as arbitrator, making use of a procedural artifice that could go on ad infinitum. Brazil notes that
it would be absurd to have that practice accepted as the common practice in the implementation of
WTO disputes. It would mean that a mere asse rtion that a Member has changed a measure found to
be inconsistent automatically revokes a DSB aut horization to suspend concessions, while exempting
the Member from proving why and how the new measure complies with the DSB recommendations
and rulings.
46
5.18 Brazil submits that only in the case of a multilate ral determination confirming that the EC
has fully complied could there be grounds for consid eration of whether the United States is in breach
of Articles 23, 21.5, 3.7 and 22.8 of the DSU and Articles I:1 and II of the GATT 1994, as claimed.47
5.19 Brazil argues that just as the initial imposition of suspension of concessions must be preceded
by a DSB determination of non-compliance, the au thorization for a Member to discontinue the
suspension of those concessions can only be made by a DSB determination of compliance, be it for
the initial suspension of concessions, or at a later st age for the lifting of the authorized suspension of
concessions.48
5.20 Brazil posits that the right to suspend concessi ons is temporary and conditional because it can
only be applied based on a multilateral authorization (A rticle 23.2 (c) of the DS U) and until the party
in violation complies with the recommendations of th e DSB or a mutually satisfied solution is agreed
between the parties in the dispute (Article 22.1 and 22.8 of the DSU).49
4. Article 21.5 of the DSU
5.21 Brazil contends that the present situation is different from the one resulting from the
relationship between Articles 21.5 and 22.6 of the DSU and it does not consider examples referred to
by the European Communities regarding the US – Upland Cotton dispute 50 , and Softwood
Lumber51disputes, to be applicable to the present pr oceedings. Brazil argues that the proceedings
under Article 21.5 in those disputes had been already established at the time the implementing party
requested the arbitration to determine the level of the suspension of concessions. Brazil stresses that
in the current dispute, Article 21.5 proceedings an d Article 22.6 arbitration are not "simultaneously
ongoing", since no request for a compliance panel has been presented.
52
5.22 Brazil submits that in the post-retaliation phase, one should bear in mind that there is a
multilateral authorization in effect. According to Brazil, a presumption of good faith in carrying out
the implementing measure cannot by itself override a DSB authorization. That authorization should

45 Third party submission of Brazil, paras. 5 and 6.
46 Third party submission of Brazil, para. 8.
47 Third party submission of Brazil, para. 9.
48 Third party submission of Brazil, para. 20.
49 Replies by Brazil to questions from the European Communities, question 3.
50 US –Upland Cotton, WT/DS267/22.
51 US – Softwood Lumber VI, WT/DS277/11.
52 Third party submission of Brazil, paras. 22-24.

be revoked by a multilateral determination of co mpliance not by a unilateral declaration of
implementation or a presumption of compliance.53
5. Burden of proof
5.23 Brazil posits that the party who makes a partic ular claim bears the burden of proof. Brazil
further contends that by merely asserting that it h as removed the inconsistency found by the DSB, the
European Communities is not supporting its claim.54
5.24 Brazil also argues that the European Communiti es professes that no Member shall be 'judged'
except through multilateral judicial proceedings. 55 However, Brazil notes that this notwithstanding,
the European Communities serves it self with a "blank authorization" to determine unilaterally its
compliance with WTO obligations and the inconsis tency of the continued suspension of concessions
granted by the DSB to the United States. Brazil st ates that had the European Communities wanted to
follow multilateral rules, it should have requested an Article 21.5 compliance panel, as it did in EC –
Bananas III (Article 21.5 – EC).56
5.25 Brazil argues that Article 21.5 of the DSU does not specify which Member is to initiate an
Article 21.5 proceeding. Therefore, in Brazil's poi nt of view, when disagreement exists as to the
consistency of the measures taken to comply with the DSB recommendations, any party to a dispute
may have recourse to the Article 21.5 proceedings. Brazil asserts that nothing in the DSU precludes
an implementing Member from resorting to an Artic le 21.5 panel review. Brazil further argues that
Article 6 of the DSU provides a rule for the develo pment of special terms of reference, which could
be applied in those cases where the implementi ng Member requests a panel to analyse its own
measure.57
C. CANADA
1. Introduction
5.26 Canada submits that for the reasons set out in its first written submission in Canada –
Continued Suspension of Obligations in the EC – Hormones Dispute (WT/DS321)58, the continued
suspension by the United States of concessions to th e European Communities is fully consistent with
the obligations of the United States under the Ma rrakesh Agreement Establishing the World Trade
Organization. Consequently, Cana da agrees with the United States th at the claims of the European
Communities have no basis in the DSU or GATT 1994.59
2. Opening Panel meetings for public observation
5.27 Canada submits that its views on this matter ha ve been expressed in the relevant portion of
the Panel's Report (Section IV.B.2) in Canada – Continued Suspension of Obligations in the EC –
Hormones Dispute (WT/DS321). The arguments that Canada expressed in that dispute as the
defendant equally apply to the present case as Canada's third party arguments.60

53 Replies by Brazil to Panel questions, question 3.
54 Third party submission of Brazil, paras. 10 and 11.
55 See EC's first written submission, para. 1.
56 Third party submission of Brazil, paras. 13 and 14.
57 Replies by Brazil to Panel questions, questions 2 and 5.
58 WT/DS321/06.
59 Letter of 19 August 2005 to the Panel explaining Canada's third party submission.
60 Letter of 30 June 2005 from Canada to the Panel.

D. CHINA
1. Introduction
5.28 China submits that the disputes raised in this case are derived from loopholes embedded in the
DSU. China states that this brings to attention the importance of amending those loopholes in the new
round of negotiation. According to China, in absence of any revision of the DSU, it is a challenge for
this Panel to find suitable dispute settlement solution according to the current DSU.61
2. Opening Panel meetings for public observation
5.29 China did not provide a reply on the potential le gal constraint that would exclude the Panel
from opening the Panel meeting for public observation. China however preferred the Panel to meet
the third parties in closed session. It argues that based on Article 18.2 of the DSU, panels do not have
the right to unilaterally disclose the third party submissions and oral presentations.62
3. The current status of the DSB authorized suspension of concessions
5.30 China submits that under Article 22.8, a DSB au thorized suspension of concessions shall not
be applied, if one of three of the following conditions has been met:63
(a) The measure found to be inconsistent with a covered agreement has been removed;
(b) The Member that must implement the recommendations or rulings provides a solution
to the nullification or impairment of benefits;
(c) A mutually satisfactory solution is reached.
5.31 China contends that if a mutually satisfactory so lution is reached by the parties on (a) or (b)
above, it will fall into condition (c) and then a DSB authorized suspension of concessions shall not be
applied. China posits that if there is no mutua lly satisfactory solution reached by the parties on
whether condition (a) and/or (b) above has been met, the parties have to invoke the dispute settlement
procedures to let the Panel make such determinati on. China posits that in case the responding party
declares any of the above conditions has been satisfied, there are only two options for the complaining
party: (a) to admit the compliance of new measures; or (b) to deny it.64
5.32 In China's view, in case the original complaining party denies the compliance of new
measures, that is, if no agreement is reached be tween the parties as to whether the conditions under
Article 22.8 of the DSU have been met, under Article 23 of the DSU, the parties shall have recourse
to the DSB's determination to avoid unilateral determination.65
5.33 China thus considers that there are only two wa ys to terminate a DSB authorized suspension
of concessions: (i) to reach a mutually satisfactory solution; (ii) to get a final determination from the
DSB. According to China, this is the case, even when the orig inal complaining party needs a
reasonable period of time to evaluate the WTO consistency of the implementation measure.66

61 Third party submission of China, paras. 1 and 2.
62 Replies by China to Panel questions concerning open hearings, questions 1 and 2.
63 Third party submission of China, para. 6.
64 Third party submission of China, paras. 7 and 8.
65 Replies by China to Panel questions, question 7.
66 Third party submission of China, para. 9.

5.34 China argues that the European Communities' allegation that it has removed the measure at
issue in itself could not give the European Comm unities ground to terminate the authorization of
suspension of concessions. China asserts that Artic le 23 of the DSU lays down the fundamental
principle that the dispute settlement system of the WTO is the exclusive means to redress any
violation of any provision of the WTO Agreement. It argues that since there is no mutually
satisfactory solution between the European Commun ities and the United States, the DSB authorized
suspension of concessions shall be applied un til the DSB makes a new determination on the
authorization of suspension of concessions. Chin a notes that the suspensi on of concessions pursuant
to a DSB authorization is temporary and conditiona l, with the condition being that the original
responding party fully implements the rulings and recommendations of the DS B. China emphasizes
that no party can make a unilateral determination on whether condition (i) and/or (ii) has been met.
67
5.35 China emphasizes that if this Panel allows th e original responding party to terminate a DSB
authorized suspension of concessions by introducing an implementing measure, there is a risk that it
could be abused by an original responding party who, instead of bringing its measures into full
conformity with the recommendations and rulings of the DSB, may implement legislation which does
not cure all the defects in its earlier inconsistent le gislation. China argues that if this Panel finds a
DSB authorized suspension of con cessions to remain in effect after the original responding party
introduced an implementing measure, it can he lp enforcing WTO rules by inducing actual
compliance.68
5.36 China is of the view that the suspension of concessions has at least two functions: (i) to
rebalance the interests among parties; (ii) to fo rce the responding party to bring its measure into
compliance with the covered agreement. China posits that if this Panel allows the original responding
party to introduce an implementing measure to override the DSB-authorized suspension of
concessions, it invalidates the second function of suspension of concessions.69
4. Article 21.5 of the DSU and burden of proof
5.37 China states that Article 21.5 of the DSU does not preclude the original responding party
from having recourse to the dispute settlement procedur es in the event that there is disagreement as to
the existence or consistency w ith a covered agreement of measures taken to comply with the
recommendations and rulings. China advances the following reasons for this argument.70
5.38 First, according to China, it would be natural and logical only for the original complaining
party to initiate an Article 21.5 proceeding. China quotes Chile – Alcoholic Beverages71 and Canada –
Aircraft (Article 21.5 – Brazil) 72 and argues that the original responding party when adopting
measures to implement recommendations and rulings of the DSB shall be presumed to have fulfilled
its WTO obligations, and therefore, shall not bear the burden to demonstrate compliance. China notes
that this is further justified because the Eur opean Communities' implementation measure requires
conducting extensive scientific studies and perfo rming a comprehensive risk assessment in a
transparent and objective manner. According to China therefore, after the European Communities
notifies the DSB of its measure to implement the recommendation and rulings of the DSB, it has

67 Third party submission of China, para. 10.
68 Third party submission of China, paras. 11 and 12.
69 Replies by China to Panel questions, question 3.
70 Third party submission of China, para. 15.
71 Third party submission of China, para. 17.
72 Third party submission of China, para. 18.

fulfilled the procedure obligation under the DSU, a nd should not be required to bear the burden of
proof.73
5.39 Secondly, China refers to the practice of treaty interpretation as elucidated in Article 31.3 of
the Vienna Convention on the Law of Treaties and Japan – Alcoholic Beverages II 74, and points out
that the statistics of panel proceedings on compliance under Article 21.5 of the DSU show that in
most cases, it is the original complaining party that initiates the dispute settlement procedure under
Article 21.5 of the DSU. China stresses that the only precedent for an original responding party to
initiate the dispute settlement procedure under Article 21.5 of the DSU is in the EC – Bananas
75
dispute where the European Commun ities as an original responding party sought the establishment of
a compliance panel under Article 21.5 of the DSU wi th the hope of preventing the United States from
having recourse to Article 22.6 of the DSU directly. China asserts that this subsequent practice in the
application of Article 21.5 of the DSU establishe s the agreement of the parties regarding their
interpretation that the original complaining party should initiate the Article 21.5 proceeding.76
5.40 Thirdly, China argues, the balance of hardship to initiate an Article 21.5 proceeding does not
favour the original complaining party. China belie ves that the original complaining party will suffer
no cognizable harm if it initiates an Article 21.5 proceeding, because the DSB authorized suspension
of concessions is still in effect. China asserts that it is not proper to let the European Communities
initiate an Article 21.5 proceeding simply because the original complaining party is reluctant or has
no incentive to do so.77
5.41 China stresses that it should be presumed that wh en the original responding party introduces
an implementation measure, it has fulfilled its WT O obligation, and it should be the duty of the
original complaining party to demonstrate that th e implementation measure is still inconsistent with
the covered agreement. China believes if this Panel rules that the European Communities, as an
original responding party, should initiate an Artic le 21.5 proceeding, it will unduly shift the heavy
burden onto the shoulders of the European Communiti es to establish compliance, which is against the
nature and logic of the Article 21.5 proceeding.78
5.42 China contends that it is usually the case that the responding party has more information on
its implementation measure, therefore it is better positioned to demonstrate the WTO consistency of
the measure. However, according to China, the nature and logic of Article 21.5 proceedings stands
against this approach. China stresses that subse quent practice in the application of Article 21.5
confirms this conclusion. China is therefore of the opinion that the United States as an original
complaining party should bear the burden to institute the Article 21.5 proceeding.79
5.43 China continues that the unique part of this case is that the original complaining party has a
DSB authorized suspension of concessions. Accord ing to China, in addition to the function of
inducing compliance, this authorized suspension of concessions can rebalance the trading relationship
between the complaining and the original responding party in order to restore the economic
equilibrium embodied in the original WTO deal. China submits that if after the original panel
proceeding, an original complaining party finds that the original responding party does not implement

73 Third party submission of China, paras. 19 and 20.
74 See Appellate Body Report, Japan – Alcoholic Beverages II (WT/DS8/AB/R, WT/DS10/AB/R,
WT/DS11/AB/R) p. 13
75 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse
to Article 21.5 by the European Communities , Report by the Panel (WT/DS27/RW/EEC), 12 April 1999 –
report never adopted.
76 Third party submission of China, paras. 21-24.
77 Third party submission of China, para. 25.
78 Third party submission of China, para. 26.
79 Third party submission of China, paras. 27 and 28.

the recommendations and rulings of the DSB, it has incentive to initiate an Article 21.5 proceeding,
because it still suffers from a WTO inconsistent measur e. However, in this case, China submits that
due to the rebalance by the authorized suspension of concessions, the original complaining party may
not have the same incentive, therefore it may be necessary to set up a time limit for it to initiate an
Article 21.5 proceeding.80
5.44 China argues that the proceedings under Artic le 21.5 of the DSU shall be initiated in a
reasonable period of time. China points out that it is in line with the good faith requirement
established by Article 26 of the Vienna Convention on the Law of Treaties and it is also consistent
with the requirement of "prompt settlement of situa tions" in Article 3.3 and the "temporary nature" of
the retaliation system of the DSU.81
5.45 China stresses that it wants to bring to th e Panel's attention that both Article 22.8 and
Article 21.5 of the DSU do not preclude this Panel from setting a time limit to initiate the dispute
settlement proceedings. If this Panel holds that it sh ould be the original complaining party to invoke
Article 21.5 of the DSU, to facilitate the implementation of this recommendation and ruling, it may be
necessary to set up a time limit for the original complaining party to in itiate an Article 21.5
proceeding.82
5. Article 23.2 of the DSU
5.46 China argues that to establish a violation of Article 23.2 (a), the Panel shall firstly assess
whether the act of "determination" is made "in such cases", where a Member seeks the redress of a
WTO violation.83
5.47 China analyses the different interpretations of the term "seek the redress of violation" in US –
Section 301 Trade Act, 84 in US – Certain EC Products "85 and in European Communities – Measures
Affecting Trade in Commercial Vessels, 86 and states that the term "seek the redress of a violation"
should be read broadly to cover any act as long as it seeks to obtain unilateral results that can be
achieved through means other than recourse to the DSU. China states that in this case, the original
complaining party's continued suspension of con cessions could be considered as a measure seeking
the redress of a WTO violation, if it had a chan ce to challenge the European Communities' WTO
violation but held back, allowing the DSB au thorized suspension of concessions to apply
continuously.87
5.48 China argues that after the European Communitie s provided notice of the Directive to the
DSB in October 2003, the original complaining part y raised doubt on the WTO consistency of this
European Communities' implementation measure. Since then it has had a reasonable period of time to
review the European Communities measure and to initiate Article 21.5 proceedings. China argues
that it is the lack of action under Article 21.5 of the DSU by the original co mplaining party, rather
than the DSB authorized suspension of concessions itself, that may be considered as seeking the
redress of a violation.88

80 Third party submission of China, para. 29.
81 Third party submission of China, para. 31.
82 Third party submission of China, para. 32.
83 Third party submission of China, para. 35.
84 See Panel Report, US – Section 301 Trade Act, para. 7.50, footnote 657.
85 See Panel Report, US – Certain EC Products, paras. 6.22 and 6.23.
86 See Panel Report, EC – Commercial Vessels, WT/DS301/R, para. 7.196
87 Third party submission of China, paras. 36-39.
88 Third party submission of China, para. 41.

5.49 With respect to the meaning of the term "d etermination", China refers to the panel in US –
Section 301 Trade Act 89 and argues that the term "determination" in Article 23.2(a) of the DSU needs
to be read broadly and it does not require that a measure clearly sets out in its text that a WTO
violation has occurred. China argues that such a determination may be inferred from actions.
According to China, the longer the time period in which the original complaining party took no action
under Article 21.5 of the DSU, the greater the firmness or immutability that it made such a
determination.
90
5.50 China argues that where there is no official determination, the Panel has to find a way to
evaluate the firmness and immutability of the alle ged determination. China notes that before the
decision becomes final, there could be a gradual change process in which a time lapse can be a
parameter. According to China, in the post-retaliation phase, the clock starts ticking when the original
responding party introduces a new measure. Chin a argues that the amount of time needed to
constitute a final determination by the original complaining party under Article 23 of the DSU
depends on several factors, including but not limited to (1) the complexity of the compliance measure;
(2) sufficiency of information related to the comp liance measure; and (3) the ability of the original
complaining party to evaluate such new measure.91
E. INDIA
1. Introduction
5.51 India submits that it takes no position on the r espective assertions of the parties in this
dispute. India notes however that the treaty text is not clear on the respective rights and obligations of
the party taking a compliance measure and the party a pplying sanctions. India contends that this is
evidenced by the fact that this is one of the major issues on which the WTO Membership is currently
engaged in negotiation with a view to improve or cl arify the legal text. India states that it has views
on how the lacunae in the DSU on this issue can be improved or clarified, but that is a matter for the
Membership to decide through future negotiations.92
2. Opening Panel meetings for public observation
5.52 India submits that the issue of external tr ansparency is being di scussed in the ongoing
negotiations in the Special Session of the Dispute Settlement Body. India states that the negotiations
have not yet been completed, and there is no c onsensus on whether and wh ich form of external
transparency is acceptable to the WTO Members. Until that happens, India believes that the Panel
proceedings have to be in closed session, 93 and its deliberations have to remain confidential 94 as
provided in the DSU.95
5.53 India posits that it is not a function of a panel to respond to any requests from the parties that
do not assist in resolution of the matter before it, an d which are not in the terms of reference of the
panel.96
5.54 India contends that the possibility of a pa nel to decide to deviate from the Working
Procedures in Appendix 3 has been provided with a view to have panel procedures with sufficient

89 See Panel Report, US – Section 301 Trade Act, para. 7.50, footnote 657.
90 Third party submission of China, paras. 41 and 42.
91 Replies by China to Panel questions, question 1.
93 Paragraph 2 of the Working Procedures in Appendix 3 of the DSU
94 Paragraph 3 of the Working Procedures in Appendix 3 of the DSU
95 Replies by India to Panel questions concerning open hearings, question 1.

flexibilities so as to ensure high-quality panel reports. 97 In India's view, deviation from the Working
Procedures, therefore, should meet this qualitative objective. India quotes Article 12.1 of the DSU
and the Panel in India – Patents (US) 98 and argues that although p anels are given some discretion in
establishing their own working procedures, they do no t have the discretion to modify the substantive
provisions of the DSU. India argues that the conf identiality requirements for panel proceedings are a
substantive provision of the DSU, and the Panel cannot use its discretion to modify them in order to
cater to a request by the parties on a matter that does not serve to improve the quality of the Panel's
Report.99
5.55 India argues that Article VII of the Rules of Conduct 100 requires each 'covered person' to
maintain the confidentiality of di spute settlement deliberations and proceedings at all times. India
questions how the Panel is going to ensure th at these requirements are met after opening the
proceedings to the public for observation.101
5.56 India submits that the decision of the Panel to open its proceedings to the public necessarily
involves some issues on which consultation and decisions with WTO Members, and not just the
parties and third parties, would have been necessary. For example, India questions how the Panel, at
its own level, addressed issues relating to the implicat ions on the functioning of the WTO Secretariat,
budgetary implications and implications relating to the use of the official languages of the WTO, for
which rules and practices have been established by other bodies of the WTO. India also questions
how the Panel could take a view on the additiona l costs arising out of the opening up of the
proceedings to public without the Budget Committee having considered the matter.
102
5.57 According to India, the WTO is a Member driven organization and it is solely for the WTO
Members to decide whether or not to change th e WTO rules and open up panel proceedings to the
public; a Panel cannot take upon itself that function, even at the request of parties to the dispute.103
5.58 India posits that the meeting of the Panel's ses sion with the third parties should be in closed
session as required under paragraph 2 of the Work ing Procedures contained in Appendix 3 of the
DSU.104
F. MEXICO
1. Introduction
5.59 Mexico submits that the systemic implications of this dispute are of great importance in terms
of the functioning of the DSU and in particular of defining a way of proceeding when there is an
authorization to suspend benefits and then furt her disagreement as to whether or not the DSB's
recommendations and rulings have been implemented. In Mexico's view, the most important issue in
this case is whether the adoption of implementati on measures "require" immediate termination of
retaliatory measures and if not, who should require termination and how. According to Mexico, the
role of the Panel in this case is to give precise answ ers to these questions and to ensure that they fulfil

97 Article 12.2, DSU
98 India – Patent Protection for Pharmaceutical and Agricultural Chemical Products – Complaint by
the United States, Panel Report, WT/DS50/R.
100 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).
104 Replies by India to Panel questions concerning open hearings, question 2.

not only the letter of the DSU, but also the objectiv es of security, predictability and prompt settlement
of the dispute.105
2. Opening Panel meetings for public observation
5.60 Mexico disagreed with the opening of the panel meetings to the public on the grounds that
panel meetings constitute panel "de liberations" and as such should be confidential, as per Article 14.1
DSU. Mexico also argues that tr ansparency is a sensitive issue that is currently under discussion in
the negotiations to amend the DSU thus to force one or another negotiating position by taking such a
decision is inappropriate. Mexico argues that the DS U rules require that the meetings be confidential
and therefore, bilateral agreement among parties is not suffice to bend the rules. In its view, the
decision of the two parties should only prevail to the extent that it does not affect the right of other
DSB Members including third parties. Mexico contends that if the Panel is to depart from the
Working Procedures of Appendix 3, the Panel must do so with caution as such deviation is meant to
grant flexibility so as to ensure high quality panel reports, as seen in Article 12.2 DSU.
106
5.61 Mexico emphasizes that public hearings are a cr oss-cutting issue that should be addressed in
all the discussions conducted in the WTO, and shou ld not be imposed by a panel at the request of
three Members. Mexico regrets that the decision w ill set a precedent that may affect the outcome of
the negotiations and will in all lik elihood end up complicating the pr eparation of working procedures
of future panels.107
5.62 Mexico notes that if the Panel is to open the meetings to the public observation, as a policy
perspective, it poses systemic questions as to the n ecessity to open negotiation meetings and ordinary
sessions of the WTO to the public.108 Mexico suggests that third party sessions follow the established
WTO practice of being in closed session.109
3. Whether the DSB authorization remains in effect
5.63 According to Mexico, the Panel should reject the argument that a simple unilateral
notification is enough to reduce multila teral effort to nothing. Mexico contends that the Panel should
bear in mind the lengthy procedure and high po litical costs to Members of obtaining a multilateral
authorization to suspend concessions.110
5.64 Mexico stresses that it can not allow a dispute se ttlement system to deprive all effect of the
authority to suspend benefits when a Member has failed to implement the DSB's recommendations
and rulings within the reasonable peri od. In its view, in such a case, if the parties fail to agree, the
matter must be resolved by a multilateral decision.111
5.65 Mexico argues in its reply to the questions posed by the European Communities that a DSB
decision may be affected only by another DSB decision taking away the effect of the first decision.112

105 Replies by Mexico to Panel questions concerning open hearings, question 1, paras. 2, 3 and 9.
106 Oral statement of Mexico, para. 2; Replies by Mexico to Panel questions, paras. 9 and 3.
108 Replies by Mexico to Panel questions concerning open hearings, question 1, para. 7.
109 Replies by Mexico to Panel questions concerning open hearings, question 2.
112 Replies by Mexico to questions from the European Communities, question 4.

4. Article 21.5 of the DSU
5.66 Mexico claims that Article 21.5 DSU affords th e most suitable procedure for resolving this
dispute and it could be initiated by any party. Mexico however submits that the dispute could be dealt
with either by an ordinary panel, or through arbitr ation under Article 25 DSU or indeed by any of the
proceedings provided for in Article 5 DSU. Mexi co however points out that it takes a constructive
approach and good will by the parties to make Artic le 21.5 DSU function and be able to resolve any
disagreements.113
G. NEW ZEALAND
1. Introduction
5.67 New Zealand submits that this case raises important issues about the integrity and
effectiveness of the WTO dispute settlement system , as it is principally about issues of compliance
and the proper interpretation and application of the rules of the DSU as they relate to the post-
retaliation phase. In New Zealand's view, the cas e taken by the European Communities is for all
intents and purposes a compliance case and is thus akin to an Article 21.5 case. According to New
Zealand, the same determinations are required to r esolve the case at hand, as would be required had it
been commenced under Article 21.5. In New Zeal and's view, the Panel's terms of reference 114 are
sufficiently broad to encompass this question a nd in doing so, the Panel should focus on actual
compliance and not presumed compliance.115
2. Opening Panel meetings for public observation
5.68 According to New Zealand, there are no legal constraints that would prevent the Panel from
opening the Panel hearings to the public. New Z ealand quotes Article 12.1 which allows panels to
follow Working Procedures unless the panel decid es otherwise after consulting the parties.
New Zealand argues that while Appendix 3 provi des for closed session hearings, the Working
Procedure can be amended on the consent of the panel and the parties. New Zealand further stipulates
that the reference in Article 14.1 of the DSU to pa nel deliberations being confidential refers to the
internal deliberations of the panel, not the hearings with the parties. New Zealand submits that this is
in line with the practice of other internationa l tribunals which have open hearings but whose
deliberations are nonetheless confidential. According to New Zealand, Article 18.2 of the DSU
allows parties to waive confidentiality. New Zeala nd did not object to its third party hearings being
public.116
3. Whether the DSB authorization remains in effect
5.69 New Zealand submits that there is no obligati on on the United States to take an Article 21.5
case, and that in the absence of a determination of compliance from the DSB, the DSB's authorisation
of suspension of concessions remains valid.117

114 WT/DS320/6 of 14 January 2005 and WT/DS/320/7. The Request for the Establishment of a Panel
by the European Communities states, inter alia, that:
The United States has acted inconsistently with Article 22.8 of the DSU by failing to apply the
suspension of concessions or other obligations only until such time as the measure found to be inconsistent with
a covered agreement has been removed, or the implementing Member has provided a solution to the
nullification or impairment of benefits previously caused to the United States. (emphasis added).
115 Third party submission of New Zealand, paras. 1.06 and 2.19.
116 Replies by New Zealand to Panel questions concerning open hearings, questions 1 and 2.
117 Third party submission of New Zealand, para. 2.09.

5.70 New Zealand argues that underlying the Eur opean Communities' arguments is the assumption
that it should benefit in these circumstances from a presumption of compliance on the basis of the
principle of good faith. 118 New Zealand however does not agree that the said principle applies in the
current circumstances, to require the United St ates to cease the suspension of concessions and
commence Article 21.5 proceedings simply because the European Communities has notified that it
now considers itself to be in compliance. Accord ing to New Zealand, a presumption of good faith
cannot override an explicit multilateral authorisati on from the DSB to impose a retaliatory suspension
of concessions.119
5.71 In New Zealand's view, the cases cited by the European Communities in support of the
application of a presumption of compliance involve measures that were implemented within the
reasonable period of time and where there was no authorisation to suspend concessions, which is not
the situation at present. New Zealand opines that even if it can be said that a presumption of
compliance operates in the pre-retaliation period wh ile the reasonable period of time is still pending,
in the current circumstances any presumed complia nce on the part of the European Communities has
given way to the actual compliance of the suspensi on of concessions which has been duly authorised
by the DSB.
120
4. Articles 21.5, 22.8 and 23 of the DSU
5.72 New Zealand argues that while it would be ope n to the respondent to initiate compliance
review under Article 21.5, the argument that Article 23 read with Articles 21.5, 22.8 and 3.7 imposes
a requirement to do so cannot be sustained. New Zealand insists that Article 21.5 merely states that
the disagreement shall be dealt with through recour se to the dispute settlement procedures, but does
not place any particular onus on any one to commence proceedings.
121
5.73 New Zealand contends that Article 23 is the framework provision setting up the requirement
to have recourse to dispute settlement when seek ing redress of a violation of obligations. New
Zealand however argues that Article 23 does not addr ess the specific situation in this case, where the
United States has had recourse to dispute settlement in accordance with this Article and has taken all
the steps there identified. New Zealand submits th at Article 23 does not impose an obligation on the
United States to cease the application of the suspension of concessions or to take a compliance review
case where it does not accept that the measure ha s been removed. Nor does it do so when "read
together" with Articles 3.7 and 22.8. New Zeala nd argues that it cannot see how these provisions can
be read to displace the specific authorisation under Article 22.6, which has never been revoked.122
5.74 New Zealand posits that if the Panel were to adopt the European Communities' approach, it
would give rise to a situation where an implementing Member could continually impose successive
rounds of litigation at will, by a mere assertion of compliance. In New Zealand's view this could
render useless the mechanism of suspension of concessions. According to New Zealand, this
approach is inconsistent with the aims and obj ectives of the dispute settlement system given the
fundamental importance of suspension of concessions as the 'last resort' of the dispute settlement
system, as per Article 3.7 of the DSU.
123

118 The European Communities sets out its arguments on the 'presumption of compliance' in
paras. 81-94 of its first written submission in addressing its argument that the United States is in violation of
Article 23.1 read together with Articles 22.8 and 3.7 of the DSU.
119 Third party submission of New Zealand, paras. 2.10 and 2.11.
120 Third party submission of New Zealand, para. 2.12.
121 Third party submission of New Zealand, para 2.14.
122 Third party submission of New Zealand, paras. 2.14-2.16.
123 Third party submission of New Zealand, para. 2.17.

5.75 New Zealand points out that the suspensi on of concessions may not be maintained
indefinitely in circumstances where the violation h as been addressed as stipulated in Article 22.8 of
the DSU. According to New Zealand, if the r espondent maintains the suspension notwithstanding,
then there is a "disagreement as to the existence or consistency ... of measures taken to comply" with
the recommendations within the terms of Article 21.5. As a consequence it is open to the party
concerned about this to have recourse to th e dispute settlement procedures to resolve the
disagreement.124
5.76 New Zealand notes that this does not mean however, that sanctions may go on forever even in
cases where there is full compliance but the new me asure has not been challenged. New Zealand
considers that if a measure taken to comply do es indeed remove the inconsistency with the
recommendations and rulings of the DSB, the su spension of concessions should be ceased. In its
view, the justification for continuing to suspend concessions would be the combination of the
continuing DSB authorisation and the absence of any agreement that the original respondent has
brought its measures into compliance.125
5.77 In New Zealand's view, it is possible for an im plementing Member to initiate an Article 21.5
proceeding in any case "where there is disagreement as to the existence or consistency with a covered
agreement of measures taken to comply with the recommendations and rulings" of the DSB.126
5.78 New Zealand states that Article 21.5 does not sp ecify the procedures to be applied, beyond
stipulating that the matter be referred to the origin al panel and that there be an accelerated timeframe
for circulation of the report. It further contends th at the consequence is that it is up to the Panel to
establish the Panel procedures in accordance with Article 12 of the DSU.127
5.79 New Zealand submits that there is no textual basi s in the DSU for concluding that an original
complainant that maintains a multilaterally authori zed suspension of concessions after notification of
a compliance measure by the original respondent and does not initiate Article 21.5 proceedings, is in
violation of its obligations under the DSU.128
5. Burden of proof
5.80 New Zealand submits that the European Co mmunities bears the burden of proving a prima
facie inconsistency with Article 22.8 of the DSU. New Zealand refers to the Appellate Body decision
in US – Wool Shirts and Blouses 129, and contends that the European Communities must adduce
evidence sufficient to raise a presumption that th e suspension of concessions continues to apply and
that: (a) it has removed the measure found to be inconsistent with the SPS Agreement; or (b) it has
provided a solution to the nullification or impairme nt of benefits; or (c) a mutually satisfactory
solution has been reached. The EC does not argue (b ), and (c) is clearly not the case, but it instead
relies on (a).130
5.81 New Zealand submits that the European Communities has not demonstrated in its first written
submission that it has removed the inconsistent measur e. According to New Zealand, 'removal' of an
inconsistent measure for the purposes of Article 22.8 of the DSU may be interpreted as compliance
with the recommendations and rulings of the DSB. 'Removal' of the measure in this case could

124 Third party submission of New Zealand, para. 2.18.
125 Replies by New Zealand to questions from the European Communities, questions 4 and 5.
126 Replies by New Zealand to questions from the European Communities, question 6.
127 Replies by New Zealand to Panel questions, question 2.
128 Replies by New Zealand to Panel questions, question 5.
129 United States – Measure Affecting Imports of Woven Wool Shirts and Blouses from India (US –
Wool Shirts and Blouses), WT/DS33/AB/R, 25 April 1997, p. 14.
130 Third party submission of New Zealand, paras. 2.21-2.22.

involve the removal of the import prohibition and/or establishing a justification for the prohibition
through a risk assessment consistent with the SPS Agreement, taking into account the particular
requirements which the Panel and Appellate Body reports identified.131
6. Article 5.7 of the SPS Agreement
5.82 New Zealand posits that as the Member seeking to have recourse to Article 5.7, the burden of
proof rests on the European Communities to demonstrat e that the four requirements of that provision
have been met. 132 New Zealand is of the view that while not explicitly stated by the European
Communities, the provisional import ban on the five hormones other than oestradiol-17 β appears to
be an attempt to bring those measures within the qualified exemption provide d of Article 5.7 of the
SPS Agreement. According to New Zealand, as seen in Japan – Agricultural Products II 133, the
European Communities must demonstrate that: (a) its measure was imposed in a situation where
'relevant scientific evidence is insufficient'; and th at (b) its measure was adopted "on the basis of
available pertinent information, including that from relevant international organisations as well as
from sanitary or phytosanitary measures applied by other Members."134
5.83 New Zealand claims that pursuant to the sec ond sentence of Article 5.7, the European
Communities may not maintain its measure unless it also: (a) 'seek[s] to obtain the additional
information necessary for a more objective assessmen t of risk'; and (b) 'review[s] the measure
accordingly within a reasonable period of time'. Ne w Zealand posits further that the Appellate Body
added that "[w]herever one of these four requirements is not met, the measure at issue is inconsistent
with Article 5.7."135 New Zealand argues that the European Communities states that its provisional
ban on five of the six hormones was adopted "on the basis of the available but still incomplete
data".136 However, according to New Zealand, the European Communities is not required under
Article 5.7 to show that the relevant scientific evidence was 'incomplete', but rather that it was
'insufficient'. New Zealand quotes the Appellate Body in the Japan – Apples case, which analysed the
meaning of this expression that:137
" '[R]elevant scientific evidence' will be 'insufficient' within the meaning of
Article 5.7 if the body of available scien tific evidence does not allow, in quantitative
or qualitative terms, the performance of an adequate assessment of risks as required
under Article 5.1 and as defined in Annex A to the SPS Agreement."138
5.84 New Zealand is of the opinion that the Eur opean Communities in its first written submission
does not establish a prima facie case that relevant sc ientific evidence does not allow an adequate risk
assessment to be carried out. New Zealand argues that the European Commun ities fails in its first
written submission to explain how the current st ate of scientific knowledge has prevented it from
conducting an adequate risk assessment with respect to the five hormones. According to New
Zealand, this is even more difficult to understand when the same measure, an import ban, which the

131 Third party submission of New Zealand, para. 2.26.
132 The Panel in Japan – Measures Affecting the Importation of Apples ( Japan – Apples ),
WT/DS245/R, 15 July 2003, discussed at para. 8.212 the burden of proof under Article 5.7.
133 Appellate Body Report on Japan – Measures Affecting Agricultural Products (Japan – Agricultural
Products II), WT/DS76/AB/R, 22 February 1999, para. 89.
134 Third party submission of New Zealand, paras. 2.28 and 2.29.
135 Appellate Body Report on Japan – Agricultural Products II, para. 89. Emphasis original.
136 First written submission of the European Communities, para. 145.
137 Third party submission of New Zealand, paras. 2.30-2.32.
138 Appellate Body Report on Japan – Apples, para. 179.

European Communities previously maintained was based on sufficient scientific evidence to be
definitive, is now held out as a merely 'provisional' measure.139
5.85 New Zealand submits that on the other hand, the respondent in its first written submissions
shows that a considerable body of relevant scientif ic evidence exists as to the use of hormones for
growth promotion purposes. 140 New Zealand argues that the United States points out that the
hormones at issue have been "intensively studied over the last twenty-five years" 141 and that the five
particular hormones subject to the provisional ban have been "studied in greater detail in the
intervening period (since the original Hormones case)".142 According to New Zealand, the inference
to be taken is that the relevant scientific evidence is both quantitatively and qualitatively sufficient to
have enabled the European Communities to conduct an adequate risk assessment, and avoid the need
for recourse to provisional measures.143
5.86 New Zealand further opines that even if the Pa nel were to accept that there was insufficient
scientific evidence for the European Communities to conduct an adequate risk assessment, the
European Communities must also show that its ne w measure was adopted 'on the basis of available
pertinent information'. New Zealand stresses that in order to satisfy the burden of proof, the European
Communities must present the 'available pertinent info rmation' it evaluated and the factors that led it
to conclude that a provisional import ban on the five hormones could reasona bly be based on this
information. New Zealand states that the Europ ean Communities failed in its first written submission
to establish any connection between its provisional import ban and: (a) the available pertinent
information; (b) information from relevant inte rnational organisations; and (c) information from
sanitary or phytosanitary measures applied by other Members.144
5.87 According to New Zealand, by contrast, the United States claims that a large body of
'available pertinent information'145 indicates that proper use of the hormones in question poses no risk
to consumers.146
5.88 New Zealand submits that under the third prong of Article 5.7, in a situation where the
relevant scientific evidence is in sufficient to conduct an adequate risk assessment, the European
Communities is required to 'seek to obtain the a dditional information necessary for a more objective
assessment of risk'. New Zealand contends th at the European Communities implies that this
requirement is reflected in Directive 2003/74/E C, which obliges the Commission "to seek more
complete scientific information from any source which could shed light and clarify gaps in the present
state of knowledge on [the hormones]." 147 New Zealand however submits that the European
Communities offers no evidence in its first writte n submission to explain how the Commission is
fulfilling this obligation.148
5.89 New Zealand further opines that the final element of Article 5.7 requires the European
Communities to 'review' its provisional measures 'w ithin a reasonable period of time'. New Zealand
notes that while a competent WTO body has yet to analyse what constitutes a 'reasonable period of
time,' Directive 2003/74/EC has been in force for nearly two years, but the European Communities
makes no suggestion in its first written submission th at a review of the provisional import ban is

139 Third party submission of New Zealand, para. 2.34.
140 See US's first written submission, paras. 55-91.
141 US's first written submission, para. 122.
142 US's first written submission, para. 123.
143 Third party submission of New Zealand, para. 2.35.
144 Third party submission of New Zealand, para. 2.36.
145 See US's first written submission at paras. 127-128.
146 Third party submission of New Zealand, para. 2.37.
147 EC's first written submission, para. 145.
148 Third party submission of New Zealand, para. 2.38.

contemplated at all, let alone within a 'reasona ble period of time'. New Zealand submits that the
European Communities has failed to discharge its burden of proof with respect to the four elements of
Article 5.7 in its first written submission.149
7. Article 5.1 of the SPS Agreement
5.90 New Zealand alleges that the European Commun ities has not demonstrated in its first written
submission that its new measures meet the requirements of Article 5.1 SPS Agreement. New Zealand
contends that the Appellate Body in EC – Hormones established that the obligation in Article 5.1
contains two elements: (a) an assessment of risk s; and (b) that Members ensure that their SPS
measures are "based on" such an assessment. New Zealand argues that concerning the first element of
Article 5.1, paragraph 4 of Annex A of the SPS Agreement sets out the definition of a "risk
assessment". New Zealand quotes the Appellate Body 150 that recalled Article 5.2 of the
SPS Agreement, which provides an indicative list of factors that must be taken into account in a risk
assessment.151
5.91 New Zealand further argues that the panel in the Japan – Apples case summarized its
consideration of the elements of Article 5.1 by r ecalling that a risk assessment would also involve an
evaluation of whether the risk assessment was 'as ap propriate to the circumstances', and whether it
took into account 'risk assessment techniques developed by the relevant international organizations'.152
New Zealand posits that the panel in that case adde d that these two factors would "pervade the entire
assessment of the risk".153
5.92 New Zealand stresses that while the European Communiti es claims to have conducted "a
comprehensive risk assessment" since the Appellate Body decision in 1998 154, it devotes only three
paragraphs of its first written s ubmission to attempting to establish what constitutes a valid risk
assessment for the purposes of Article 5.1. New Zealand submits that the European Communities
notes that it has initiated 17 scientific studies and resear ch projects, but enters into no discussion of
the substance, conduct or conclusions of these studies. 155 According to New Zealand, the European
Communities observes that it addressed specific request s for scientific data to several countries and
published an open call for relevant and recent scien tific data and information from any interested
party, but makes no comment on the information received.156
5.93 New Zealand further opines that in its firs t written submission, the European Communities
simply refers to the SCVPH Opinions and presents a three-paragraph excerpt from
Directive 2003/74/EC
157 which provide, on the face of it, a rath er limited and constrained justification
for the European Communities' import ban. Further, New Zealand posits that the European
Communities articulates no clear link between "excess intake of hormone residues" (which is not
defined in relation to use as a growth-promoting hormone) and "a risk" that has been identified.
158
5.94 In New Zealand's view, the European Communitie s' recital and its bare conclusion fall well
short of demonstrating that the European Comm unities has met the threshold required under the
SPS Agreement for the existence of a valid risk assessment. New Zealand notes that in particular, the

149 Third party submission of New Zealand, paras. 2.38 and 2.39.
150 Appellate Body Report on EC – Hormones, para. 187.
151 Third party submission of New Zealand, paras. 2.42-2.44.
152 Panel Report on Japan – Apples, para. 8.236.
153 Panel Report on Japan – Apples, para. 8.237.
154 EC's first written submission, para. 142.
155 EC's first written submission, para. 142.
156 Third party submission of New Zealand, para. 2.48.
157 EC's first written submission, para. 144.
158 Third party submission of New Zealand, para. 2.49.

European Communities fails in its first written subm ission to adduce sufficient evidence that its risk
assessment: (a) adequately identifies any adverse effects on human health arising from the presence of
the hormones in question when used as growth promoters in meat; 159 (b) evaluates the potential or
possibility of occurrence of such adverse effects; 160 (c) is 'as appropriate to the circumstances'; 161
(d) takes into account risk assessment techniqu es developed by the relevant international
organisations;162 and (e) takes into account the available scientific evidence as ma tters specified in
Article 5.2 of the SPS Agreement.163
5.95 New Zealand argues that none of these criteria is optional in the performance of a risk
assessment, and therefore the Europ ean Communities is required to demonstrate that all of them have
been satisfied in the development of its opini ons. New Zealand submits that the European
Communities has failed to adduce sufficient evidence to discharge this burden.164
5.96 New Zealand contends that in contrast, the United States outlines some of the scientific
evidence that exists on the u se of growth-promoting hormones, 165 and evokes long-standing practice
on the proper assessment of risks related to veterinary drug residues. 166 According to New Zealand,
this casts doubt on both the process and the s ubstance of the European Communities' risk
assessment.167
5.97 New Zealand states that in the event that the Panel decides that the European Communities'
opinions constitute a valid risk ass essment for the purposes of Article 5.1, the European Communities
is also required to demonstrate that the measure s in question are 'based on' a risk assessment.
According to New Zealand, the Appellat e Body analysed this relationship in EC – Hormones ,168 and
states that the term 'based on' required a certain objective relationship between the risk assessment and
the measure in question.169
5.98 New Zealand argues that the European Communitie s does not attempt to explain in what way
or to what extent its new measures are considered to be 'in accordance' with the scientific conclusions
of the SCVPH. New Zealand further stipulates that the European Communities offers no basis at all
for concluding that its risk assessment 'reasonabl y supports' its new measures. New Zealand argues
that in this case, the European Communities bears the burden of establishing that its risk assessment
'sufficiently warrants' the new measures it adopted. In New Zealand's view it was not open to the
European Communities to leave the existence of a 'rational relations hip' to be inferred from a brief
summary of the conclusions of the European Communities' opinions.170

159 SPS Agreement, Annex A, paragraph 4. Extrapolated from the Panel Report in EC – Hormones ,
para. 8.101, as considered in the Appellate Body Report at paras. 183-184.
160 SPS Agreement, Annex A, paragraph 4. Extrapolated from the Panel Report in EC – Hormones ,
para. 8.101, as considered and modified in the Appellate Body Report at paras. 183-184.
161 SPS Agreement, Article 5.1.
162 SPS Agreement, Article 5.1.
163 Third party submission of New Zealand, para. 2.51.
164 Third party submission of New Zealand, para. 2.52.
165 See, for example, US's first written submission, paras. 55–91.
166 US's first written submission, para. 136.
167 Third party submission of New Zealand, para. 2.53.
168 Appellate Body Report on EC – Hormones, para. 193.
169 Third party submission of New Zealand, para. 2.55.
170 Third party submission of New Zealand, para. 2.58.

H. NORWAY
1. Opening Panel meetings for observation by the public
5.99 Norway considers that Article 12.1 of the DSU gives the Panel the discretion to follow other
working procedures than the ones provided in Appendix 3 after consulting the parties. It sees no legal
constraints in granting the request to the parties to open the hearings to the public. Norway also
agrees to have the third party session of the hearing open to the public.171
2. Whether the DSB authorization remains in effect
5.100 Norway considers that the right to apply th e suspension of concessions pursuant to a DBS
authorization is temporary and conditional. According to Norway, the application of the right rests on
two basic conditions. First; that there be an aut horization pursuant to Article 22.6 DSU and that the
conditions set out in Article 22.6 DSU and 22.7 DSU, are respected and secondly, that the temporal
condition of Article 22.8 is met.172
5.101 Norway opines that the temporal condition in Article 22.8 has three alternative elements:
(a) the measure found to be inconsistent with a covered agreement has been removed; or (b) the
Member that must implement recommendations or rulings provides a solution to the nullification or
impairment of benefits; or (c) a mutually satisfactory solution is reached.
173
5.102 Norway contends that the common concept in all three elements is that continued suspension
is related to continued non-complia nce or lack of any other mutually satisfactory solution to the
inconsistency. According to Norway therefore, th e temporal condition is intrinsically linked to the
substance of compliance. Norway posits that out of the three elements, the third one, "a mutually
satisfactory solution", can in principle be achieve d at any point in time and once achieved, would
resolve the matter and no suspension may continue. Norw ay adds that this is even so if the original
measure found to be inconsistent with a covered agreement is still in place.174
5.103 Norway considers that the first two elements are in reference to compliance, which can be
achieved through the removal of the original measur e or through another solution to the nullification
or impairment of benefits, and the second elemen t is the normal situation where one measure is
replaced by another measure.175
5.104 Norway submits that once compliance is achieve d, be it through a simple revocation of the
inconsistent measure or its repla cement with another measure that ensures compliance, the right to
suspend obligations automatically lapses. Norway is of the view that similarly, once compliance has
been established by a panel pursuant to Article 21. 5 of the DSU, the previous authorization lapses
ipso facto once the report is adopted, without there being a need for the DSB to revoke it formally as
the temporal condition no longer exists.176
5.105 Norway contends that once a measure taken to comply is notified by the original respondent,
the question arises whether this amounts to full co mpliance or not. Norway submits that if the
original complainant considers that the measure taken to comply falls short of what is required by the

171 Replies by Norway to Panel questions concerning open hearings, questions 1 and 2.
172 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 2.
173 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 3.
174 Replies by Norway to questions from the Europ ean Communities, questions 3, 4 and 5, paras. 4
and 5.
175 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 6.
176 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 7.

adopted rulings and recommendations, then the obliga tion to refer a "compliance dispute" to a panel
according to Article 21.5 is incumbent upon them.177
3. Article 21.5 of the DSU
5.106 Norway argues that the situation addressed by Article 21.5 DSU occurs when the original
respondent claims to have complied with the recomm endation and ruling of the DSB, but the original
complainant disagrees. According to Norway, Ar ticle 21.5 is competent both where the parties
disagree as to the very existence of measures take n to comply, and where they disagree as to whether
the measures taken to comply actually achieve complia nce. Norway is of the view that the case at
hand is typical in this respect, and falls squarely w ithin the ambit of Article 21.5. Norway notes that
neither Article 22.8 nor Article 21.5 sets forth time lines in this respect.178
5.107 According to Norway, the origin al complainant must be accorded a certain amount of time to
assess the measure before going to a compliance panel. Norway posits that the length of time needed
will vary from case to case, and it is hard to set a fixed dead-line. In Norway's view, the DSU does not
include such a fixed dead-line, however, this does not mean that the original complainant can refuse
to take action according to Article 21.5 within a reas onable time. Norway thus contends that in order
to avoid such unreasonable delay, Article 21.5 allows the original respondent to have recourse to a
compliance panel.179
5.108 Norway contends that the obligation to refer a "compliance dispute" to a panel according to
Article 21.5 rests on both parties in the dispute. According to Norway, Article 21.5 does not specify
that it must be the original complainant to refer the matter to a "compliance panel". Norway submits
that Article 21.5 is written in the passive form, conc entrating on the result, specifically to place this
obligation on all parties to the original dispute.
180
5.109 Norway submits that the standard practice has b een that the original complainant refers the
matter to the panel. It argues th at the one exception so far has been the referral to a compliance panel
by the European Communities in EC – Bananas III (Article 21.5 – EC). 181 According to Norway, the
fact that the report remains unadopted and that the panel in that case refused to make any
recommendations or rulings in the case, does not in itself prove that an original respondent may not
invoke Article 21.5.
182 Rather, the position of the Panel in that case must be seen in the light of the
fact that Ecuador also requested a separate compliance panel 183 , and that the United States had
submitted a request for retaliation that led to arbitration. 184 Norway submits that the panel in that

177 Replies by Norway to Panel questions, question 5 para. 10.
178 Replies by Norway to questions from the European Communities, questions 3, 4 and 5, para. 8.
179 Replies by Norway to Panel questions, question 5, paras. 11 and 12.
180 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities,
para. 13.
181 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse
to Article 21.5 by the European Communities , Report by the Panel (WT/DS27/RW/EEC), 12 April 1999 –
report never adopted.
182 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities,
para. 14.
183 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse
to Article 21.5 by the Ecuador, Report by the Panel (WT/DS27/RW/ECU), 12 April 1999.
184 European Communities – Regime for the Importation, Sale and Distribution of Bananas – Recourse
to Arbitration by the European Communities under Article 22.6 of the DSU , (WT/DS27/ARB), Report of the
arbitrators dated 9 April 1999.

particular case could thus justify not making any recommendations or rulings by pointing to these
other proceedings.185
5.110 In Norway's view, a panel launched by the respondent cannot just make a declaratory
judgment based on the presentation of the original respondent, but must make an objective assessment
of the matter before it. The scope of the "terms of reference" would be to examine whether the
measures taken to comply imply that there is now compliance with the rulings and recommendations
of the original panel, i.e., that the original violation has been removed. Only the violations
specifically addressed in the original report will be addressed by the compliance panel, not any other
violations that the new measure may cause.186
5.111 Norway argues that where the orig inal complainants refuse to par ticipate, then any claim that
the new measure is inconsistent with other provis ions of the covered agreements will not be heard
(will be outside of the "terms of the referen ce" for the compliance panel), and the original
complainants risk a finding of co mpliance that does not take into acc ount all the arguments that they
would otherwise have presented. By not launchin g the Article 21.5 panel in a timely manner, the
original complainants thus lose certain rights to pr esent new claims that they would have had, had
they themselves launched the panel request first. Such claims will thus have to await another panel.
As such, the incentive structure th at is created by allowing the original respondent to launch an
Article 21.5 panel proceeding works to provide the original complainants w ith the incentive to go
ahead themselves and launch the Article 21.5 panel first.187
5.112 In case a compliance panel is requested by the original respondent, the reference in Article 6.2
to "provide a brief summary of the legal basis of the complaint sufficient to present the problem
clearly" can be fulfilled by referring to the original pa nel report, together with the identification of the
specific measure taken to comply and how it ensures compliance. 188 Where the original respondent
has to request an Article 21.5 panel because the origin al complainants refused to do so, the original
respondent may be considered as "complainant" for the purpose of Article 6.1 and "applicant" for the
purpose of Article 6.2. The question who is "com plainant" and who is "respondent" does not matter
for the rest of the proceedings.189
I. SEPARATE CUSTOMS TERRITORY OF TAIWAN, PENGHU, KINMEN AND MATSU
1. Introduction
5.113 The Separate Customs Territory of Taiwan , Penghu, Kinmen and Matsu (Chinese Taipei)
submits that it presents its views in this dispute b ecause of the important systemic issues involved, in
particular, the DSU provisions that are under negotiations in the Special Session of the Dispute
Settlement Body. In its view, the resolution of cer tain issues in this case could significantly impact
these negotiations.
190

185 See paras. 4.15 and 4.16 of the Panel Report in WT/DS27/RW/EEC.
186 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities,
paras. 16 and 18.
187 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities,
para. 16.
188 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities,
para. 18.
189 Joint reply by Norway to question 2 from the Panel and question 6 from the European Communities,
paras. 17 and 19.
190 Third party submission of Chinese Taipei, para. 1.

2. Opening Panel meetings for public observation
5.114 Chinese Taipei argues that in accordance with the procedures and customary practices
developed over more than half a century under GA TT, which are reflected in Articles 14.1, 18.2 and
Appendix 3 of the DSU, panel proceedings are to be kept confidential. It argues that only Members
by consensus can change the rules of confidentiality. According to Chinese Taipei, a panel, even with
the consent of the parties does not have the legal authority to open the proceedings to the public.191
5.115 Chinese Taipei refers to Article VII of the Ru les of Conduct which requires that each covered
person shall at all times maintain the confidentia lity of the dispute settlement deliberations and
proceedings. According to it, the only exception to this confidentiality obliga tion is Article 18.2 of
the DSU which states that nothing in the DSU sh all preclude a party to a dispute from disclosing
statements of its own positions to the public. Chin ese Taipei is therefore of the opinion that this
exception does not extend to the possibility of allo wing parties to decide whether to open panel
meetings to the public.192
5.116 According to Chinese Taipei, "panel deliber ations" implies more than one form of
deliberation, thus includes not only internal consid eration among panelists, but also the entire process
of the panel's consideration of the dispute.193
5.117 Chinese Taipei argues that the flexibility from Article 12.1 of the DSU to change Working
Procedures in Appendix 3 cannot be extended to c over provisions in the Working Procedures that
directly elaborate on the obligations of the DSU. It further argues that if the drafters had
contemplated that the confidentiality requirement can be changed, they would have said so, just like in
Article 18.2 of the DSU. In the absence of such language, only an amendment to the DSU by the
Members through negotiations can change the requirement of confidential deliberations.194
5.118 Chinese Taipei is of the opinion that the third party sessions be in closed session.195
3. Whether the DSB authorization remains in effect
5.119 Chinese Taipei contends that the new implementi ng measure is required to be confirmed by a
multilateral determination that the measure is compliant with the DSB's recommendations and rulings.
According to it, a unilateral claim of compliance t ogether with the principle of good faith does not
overturn the DSB authorization of suspension of co ncessions, and that suspension of concessions can
continue until the conditions in Article 22.8 have been met.196
5.120 According to Chinese Taipei, the suspension of concessions can only be lifted after a
multilateral determination of compliance, which involves an examination of the implementing
measure against the recommendations and rulings of th e DSB, or by mutual agreement of the parties.
In its view, until then, the DSB authorization re mains valid and the suspension of concessions may
continue. Chinese Taipei further states that if none of the parties brings the implementing measure to
the panel, whether through Article 21.5 or Article 22.8, the suspension of concessions may continue.
It contends that without the initiation of a dispute that results in the examination of the implementing

191 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 1 and 2.
192 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 4 and 5.
193 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, para. 3.
194 Replies by Chinese Taipei to Panel questions concerning open hearings, question 1, paras. 6 and 7.
195 Replies by Chinese Taipei to Panel questions concerning open hearings, question 2, para. 12.
196 Replies by Chinese Taipei to questions from the European Communities, question 1.

measure, the status quo would be considered as maintaining the existing balance of rights and
obligations among WTO Members.197
5.121 Chinese Taipei does not consider that there is a need to justify the continuing suspension of
concessions after the implementing Member's cl aim that it has complied with the DSB's
recommendations and rulings.198
5.122 Chinese Taipei rejects the view that the lack of action for any period of time on the part of the
United States and Canada constitutes an expression of the US and Canada's determination. According
to Chinese Taipei, the existence of the determination by the Unite d States and Canada cannot depend
on such an indeterminate criteria as the length of time it takes for the United States and Canada to take
action under Article 21.5 of the DSU. Therefore, in its view, Article 22.8 of the DSU allows the
United States and Canada to continue its suspen sion of concessions until one of the three conditions
therein have been met.199
4. Article 21.5 of the DSU
5.123 Chinese Taipei considers that one of the ways to arrive at a multilateral determination in the
current situation is through Article 21.5 of the DS U. With respect to the European Communities'
argument that in the absence of the initiation by the United States of an Article 21.5 compliance panel,
the European Communities' implementing measure mu st be presumed to be consistent with WTO
rules and the continuation of the suspension of concessions by the United States would amount to a
unilateral determination of a violation of WTO rules 200, it argues that Article 23.2(a) is valid only if
two requirements are present in the text of Article 21.5, namely, (a) a deadline by which a 21.5 panel
must be initiated, and (b) an obligation only on the original complaining party to initiate the
proceeding.
201
5.124 Chinese Taipei considers that neither one of th ese requirements currently exists in the text,
nor is it reasonable to interpret their existence. It submits that it is up to the Member involved to
choose whether and when to initiate the Article 21. 5 proceeding. It opines that while it recognizes
that the party suffering the suspension of concessions has an interest to lift such suspension as early as
possible, that interest has to be balanced with the fact that the same party had originally been
determined, through a lengthy WTO pr ocess, to be in violation of it s obligations, and had a chance to
implement, but failed to do so, within a reasonable period of time. Further, it argues that consistent
with the text of Article 21.5, if the original r espondent considers the conditions for the suspension of
concessions to be no longer valid, the respondent may initiate the Article 21.5 proceeding at any
time.202
5.125 Chinese Taipei stresses that as the DSU currently stands, th ere is no deadline and no
designated party to initiate the Ar ticle 21.5 proceeding. Chinese Taip ei agrees with the United States
that just because the United States has not initiated the Article 21.5 proceeding does not mean that the
European Communities automatically enjoys the presumption of compliance. According to Chinese
Taipei, at this stage, only a multilateral procedure can reach that conclusion, and one of the ways the
European Communities can obtain su ch a multilateral determination is through its initiation of an
Article 21.5 panel.

197 Replies by Chinese Taipei to questions from the European Communities, question 4.
198 Replies by Chinese Taipei to questions from the European Communities, question 5.
199 Replies by Chinese Taipei to Panel questions, question 1.
200 EC's first written submission para. 61.
201 Oral statement of Chinese Taipei, para. 2.
202 Oral statement of Chinese Taipei, para. 3.

5.126 Chinese Taipei to remind the Panel that the procedural issues involved in this case are
currently under discussion in the negotiations on the improvement and clarification of the DSU. It
argues that several competing proposals are on the table, including one from the European
Communities. Chinese Taipei notes that it is a vi ew widely shared by Members that the DSU
procedures in this so-called "post-retaliation stage" are imperfect. In its view, it is not the task of the
Panel, or indeed any Member, through litigation, to make up for such imperfection. Therefore,
Chinese Taipei urges the Panel to avoid interpre ting the current provisions in a way that would
impose rules or requirements that are not written in the text.203
5. The relationship between DSU Article 22.8 and Article 23
5.127 Chinese Taipei argues that Articles 23 and 22.8 apply to different situations and therefore
should not be read together, as this would lead to a weakening of the WTO dispute settlement system.
It contends that Article 22.8 differs from Article 23 in that it deals with the specific post-retaliation
situation, outlining the conditi ons under which the suspension of the concessions pursuant to
authorization from the DSB can be lifted. Chinese Taip ei states that the general principle of resolving
disputes under the multilateral system in Article 23 has been specifically modified by Article 22.8.
Article 22.8 thus has its own independent set of requirements applicable specifically to the post-
retaliation situation, apart from the general principles in Article 23.
204
5.128 Chinese Taipei opines that the basis upon which European Co mmunities builds its arguments
for its interpretation of DSU Articles 23 and 22.8 is the general principle of good faith under which
States are normally considered to act in conformity with their obligations. 205 Chinese Taipei agrees
that Article 23.2(a) embodies that principle in prohibiting Members from making any unilateral
determination to the effect that a violation has occurred.206
5.129 Chinese Taipei argues that by its title, Article 23 applies to the normal situations when the
Member is responding to a perceived violation, nullification, impairment, or impediment, to which the
Member is seeking remedy. It argues that this is the normal situation under which most cases begin
and are first brought to the attention of the Dispute Settlement Body.207
5.130 According to Chinese Taipei, Article 23.2 prescr ibes the actions Members may take in the
normal situation described in Article 23.1. Accord ing to it, specifically, 23.2(a) prevents a Member
from acting upon the unilateral perception of viol ation until it is validat ed under multilateral
procedures. Chinese Taipei considers that this amount s to the presumption that a Member is normally
considered to be acting in conformity with its obligations until a multilateral determination under the
WTO says otherwise.208
5.131 Chinese Taipei posits that Article 22.8 on the ot her hand describes situations that depart from
the norm. It submits that the general principle in Article 23 relating to normal situations therefore has
limited application and must be modified by the speci fic requirements spelt out in Article 22.8. In its
view, the situation at hand is one where the redress of violation has already been determined at least
once through multilateral procedures and where susp ension of concessions has been authorized.
Chinese Taipei argues that the requirement is not that the suspension of concessions must be lifted in

203 Oral statement of Chinese Taipei, para. 4.
204 Third party submission of Chinese Taipei, paras. 2 and 7.
205 EC's first written submission para. 87.
206 Third party submission of Chinese Taipei, paras. 2-4.
207 Third party submission of Chinese Taipei, para. 5.
208 Third party submission of Chinese Taipei, para. 6.

the absence of an adverse finding, but rather that the suspension shall be applied until the violation
has been removed or any of the other two conditions in the provision have been met.209
5.132 According to Chinese Taipei, it therefore follo ws from this difference in situation and
requirement that the normal presumption that a Member is considered to be in conformity with its
obligations until proven otherwise in a multilateral de termination does not apply. It contends that
since Article 22.8 provides that the suspension of concessions can continue until the removal of the
violation, the presumption here is that there is no removal of the violation until a multilateral
determination says otherwise.210
5.133 Chinese Taipei contends that if the normal presu mption were to apply to Article 22.8, despite
the existence of a multilateral determination and au thorization for retaliation, any offending Member
can simply declare itself to have removed the violation. It submits that this would create the incentive
for Members to implement partially or not at all, and drag the Member suspending concessions into an
endless loop of Article 21.5 litigations.211
5.134 Chinese Taipei is of the view that under both normal and Article 22.8 situations, a multilateral
determination is the prerequisite to any action that changes the existing balance of rights and
obligations. It further notes that normally, a Me mber cannot seek redress of a violation without a
multilateral determination because a balance is presume d to exist. Similarly, Chinese Taipei argues
that under the Article 22.8 situation where suspension of concessions is in place, that situation is the
presumed balance, and that existing balance cannot be changed without another multilateral
determination.212
5.135 Chinese Taipei thus argues that the suspensi on of concessions by the United States does not
fall into the normal situation described in Artic le 23 and until a multilateral determination deems the
European Communities' implementing measure to have removed the previously multilaterally
determined inconsistency, the continuation of suspension of concessions by the United States does not
violate the existing provisions of the DSU.213
VI. INTERIM REVIEW
A. INTRODUCTION
6.1 Pursuant to Article 15.3 of the DSU, the findi ngs of the final panel report shall include a
discussion of the arguments made by the parties at th e interim review stage. This section of the Panel
report provides such a discussion. As is clear from Article 15.3, this Section is part of the Panel's
findings.
6.2 The European Communities and the United States separately requested an interim review by
the Panel of certain aspects of the interim report issued to the Parties on 31 July 2007. 214 The
European Communities stated that it stood ready to attend an interim review hearing to discuss the
issues raised in its letter, "should the Panel consider it useful". The Panel notes that it is not for it to
decide whether holding an interim review hearing w ould be useful. Article 15.2 of the DSU provides
that it is "[a]t the request of a party [that] the panel shall hold a further meeting with the parties on the
issues identified in the written comments." The Pane l does not understand the EC statement above as

209 Third party submission of Chinese Taipei, para. 7.
210 Third party submission of Chinese Taipei, para. 8.
211 Third party submission of Chinese Taipei, para. 9.
212 Third party submission of Chinese Taipei, para. 10.
213 Third party submission of Chinese Taipei, para. 11.
214 Letters of the parties dated 28 September 2007.

a request by the European Communities for the Panel to hold an additional mee ting with the parties.
Furthermore, the Panel notes that the United States di d not request such a meeting. As a result, the
Panel did not hold an interim review meeting.
6.3 In accordance with the Panel working procedures and timetable, the parties had, and used, the
opportunity to submit further written comments on each other's requests for review of specific aspects
of the interim report. 215 These comments are discussed, where rele vant, together with the requests to
which they relate.
6.4 The Panel issued its final report to the parties on a confidential basis on 21 December 2007.
6.5 The Panel has structured its treatment of the Parties' requests below in the following manner:
(a) first, it addresses a number of the comments made in relation to the descriptive part of
the report (Section IV) that the Panel could not address at an earlier stage of the
proceedings;
(b) second, it discusses the comments of the parti es relating to the findings of the Panel
and, more particularly:
(i) the aspects of the report regarding procedural issues (Section VII.A);
(ii) the comments of the parties regarding the Panels findings of violation of
Article 23.2(a) read together with Articles 21.5 and 23.1 of the DSU
(Section VII.B); and
(iii) the comments of the parties regarding the compliance of the EC ban on meat
and meat products treated with the six hormones at issue for growth
promotion purposes with the SPS Agreement in relation to the Panel's
findings on the EC claims on Article 23.1, read together with Articles 22.8
and 3.7 of the DSU (Section VII.C).
6.6 In addition, minor editing changes where made , which the Panel did not deem necessary to
list in this section.
B. P
ARTIES' COMMENTS ON THE DESCRIPTIVE PART
6.7 The Panel considered and incorporated in its revised descriptive part the majority of the
parties' comments. In two instances, however, the Panel partly rejected the modifications requested
by the European Communities and deems it appropriate to provide its reasons in this section.
6.8 The first instance relates to the EC request that the Panel incorporate in the descriptive part
the parties' arguments on logistical issues relating to the opening to public observation of the Panel's
substantive meetings with the parties and with the experts.
6.9 In its comments on paragraph 4.2 and following of the descriptive part of this report, the
European Communities notes that, while the parties' answers of 20 June 2005 to a number of
questions of the Panel have been reported in full, ther e is no reference to the parties' replies of 7 July
2005 to the additional questions of the Panel. Th is, in the opinion of the European Communities,
raises a question of the completeness of the record of the parties' arguments. Inserting the replies of
the parties of 7 July 2005 is also important according to the European Communities since the

215 Letters of the parties dated 19 October 2007.

comments of the third parties on logistical matters ha ve been reported in the descriptive part. Thus,
the European Communities requested the Panel to reflect the parties' responses to these additional
questions in its report.
6.10 The Panel notes that the parties' replies of 7 July 2005 essentially addressed technical
questions of a logistical nature. The Panel did no t deem it necessary to insert in its report any account
of the logistical aspects of the opening of the hear ings to public observation. The Panel notes in this
respect that it did not include in the descriptive pa rt of the report extracts from the replies of the
parties of 20 June 2005 that related to logistical issues. Given that among the third parties, only India
and Mexico mentioned, in a general manner, the logi stical implications of opening hearings to public
observation, the discussion on logistical issues essenti ally took place between the parties themselves,
or between the parties and the Secretariat. The Panel did not address the details of the logistical issues
in its decision on opening meetings for public observati on. This matter is, in the opinion of the Panel,
purely administrative. It is neither procedurally nor factually relevant for the resolution of the dispute
before us. The Panel is mindful that such an account might be useful from a practical point of view for
future panels. However, it considers that the technical solutions found in this case may not necessarily
be extended to other panel procedures, if only because the parties' expectations and constraints, e.g. in
terms of confidentiality, may be different in future cases. 216 Whereas the Panel provided a detailed
account of the legal issues related to the opening of the Panel's hearings for public observation, for the
reasons mentioned above, it decided not to follow the suggestion of the European Communities.
6.11 The Panel nonetheless wishes to confirm that the technical options available were extensively
discussed with the parties and that the solutions finally selected, more particularly the broadcast of the
hearings into a separate room through closed-circuit television, were adopted in accordance with the
positions expressed by the parties.
6.12 The second instance where a request for modificat ion of the descriptive part was at least
partly rejected by the Panel relates to paragraph 4.234. In its second written submission to the Panel,
the European Communities stated that, "[u]nder Article 5.1 of the SPS Agreement, a convincing link is
required between the evidence and the measure. Under Article 5.7 a mere doubt must be
sufficient."217 In its comments on the descriptive part of the report and in its comments of 19 October
2007218 in response to a request by the United States for review of a precise aspect of the interim
report219, the European Communities requested us to re place the term "convincing link" with "rational
relationship", and to replace "mere doubt" with "reas onable doubt". We recall that in its reply to
question 9 of the Panel, after the second substantive meeting, the European Communities had clarified
that what it meant by "mere doubt" was "doubt that h as been scientifically established". In light of
that request, we replaced "mere" with "scientifica lly established". The Panel also notes that the EC
reply to question 68 of the questions of the Pane l after the first substantive meeting qualified the
relationship addressed by Article 5.1 of the SPS Agreement as an "objective or rational relationship".
As a result, the Panel replaced the term "convincing link" with "objective or rational relationship."

216 In the present dispute, after comparing different alternatives, the Secretariat was able to arrange
open hearings through closed-circuit broadcast from one room to another utilizing the existing facilities of the
Secretariat. The cost of open hearings was covered by the regular budget under the Secretariat arrangement.
There may be different cost implications for future disputes in different circumstances but that consideration
would fall outside of the remit of this Panel.
217 See EC's second written submission, para. 181, and second executive summary, para. 29 (emphasis
added).
218 EC's comments of 19 October 2007, para. 24.
219 US's written request of 28 September 2007, p. 9.

C. PARTIES' COMMENTS REGARDING THE FINDINGS OF THE PANEL
1. Preliminary remarks
6.13 As a preliminary remark, the Panel notes that the European Communities mentions in the
introduction to its written request for the Panel to review precise aspects of the interim report that it:
"[W]ill try to provide some examples of the numerous and serious errors in the
reasoning of the Panel on the scientific issues underpinning this dispute. However, it
is not possible in the time available to provide a detailed and complete list of all
omissions and errors of the two interim reports as it would in reality require re-
writing substantial parts of the Panel's repor t in order to rectify its analysis and
reasoning ... Therefore, the European Comm unities reserves the right to make all its
comments at the appeal stage , if the Panel's findings on the issue were to be
maintained."220 (emphasis added)
6.14 This statement suggests that the European Communities did not identify all the precise
aspects of the interim report with which it disag rees due to lack of time and because this would
require rewriting substantial parts of the Panel report. It would, however, be able to make all its
comments at the appeal stage. The Panel wishes first to make it clear that parties were free to request
an extension if they needed more time to revi ew the interim report and identify precise aspects that
should be addressed by the Panel. The Panel notes in this respect that it is at the request of the
European Communities that parties were granted several additional weeks to review the interim
report. The Panel also notes that the European Co mmunities gave as a justification for its request the
expected length and complexity of the report. The Panel therefore regrets that the European
Communities is now alleging lack of time as a justification for providing only "some examples" of
errors in the reasoning of the Panel on the scientific issues underpinning this dispute.
6.15 In contrast, the European Communities mentions that it may make "all its comments" at the
appeal stage. The Panel is surprised by the appa rent choice of the European Communities to "make
all its comments" before the Appellate Body rather than before the Panel, at the procedural stage
expressly designed for the purpose of considering any and all comments on the interim report. This is
because the decision of the European Communities to provide only "som e examples" of errors of the
Panel suggests that it has already decided to app eal the Panel report unless the Panel makes changes
which the European Communities will not specify. It is also not clear whether the "examples" given
by the European Communities exhaust all its factua l comments or whether it intends to make further
comments on factual issues before the Appellate Body . Having regard to Article 17.6 of the DSU, we
consider this to be equivalent to depriving the interim review stage of its purpose.
6.16 The Panel therefore regrets that the European Communities did not request an extension so as
to ensure that all the comments it deemed necessar y on precise aspects of the interim report be made
at the procedural stage of the dispute settlement process intended for that very purpose.
6.17 The Panel also notes that some of the EC comments are general statements on whole sections
of the report, not a written request for the Panel to review precise aspects of the interim report. We
recall that the panel in Australia – Salmon221 stated as follows:
"According to Canada, it is not open to the Panel to consider anything other than
comments dealing with 'precise aspects' of th e interim report. We agree with Canada

220 EC's written request of 28 September 2007, para. 5.
221 Panel Report on Australia – Salmon, para. 7.3.

and have therefore only reviewed our interim report in light of the comments made by
the parties which relate to 'precise aspects' of the interim report."
6.18 We agree with the reasoning of the above-menti oned panel and therefore consider that the
general comments by the European Communities did not require a specific reply from the Panel. We
limited our replies to the portions of the report on which specific comments, in the form of precise
requests for reconsideration on specific paragraphs , had been made by the European Communities.
We addressed the EC general comments as part of our review of specific paragraphs.
2. Parties' requests for review related to aspects of the report on procedural issues
(a) Comments by the European Communities
6.19 The European Communities considers the Panel' s reference to Article 17.10 of the DSU in
paragraph 7.50 of the interim report unnecessary a nd potentially detrimental as implicitly suggesting
that the Appellate Body could be legally barred by Article 17.10 of the DSU from opening its own
hearings to public observation. The European Co mmunities requests that we remove that paragraph
from our findings. We note that a similar request was made by the United States. Since this reference
was only an additional argument, we accepted the pa rties' requests and removed our discussion of the
term "proceedings" in Article 17.10 of the DSU.
6.20 The European Communities considers that the description of IARC contained in
paragraph 7.78 footnote 378 is incomplete. It refers to Dr. Cogliano's statement in Annex G,
paragraph 541. In paragraph 541, Dr. Cogliano essentially say s that IARC monographs simply
indicate which substances are carcinogenic or are probably not carcinogenic to humans. Monographs
identify occurrence (i.e. exposure to a chemical through some particular pathway), but not the specific
level of exposure for a particular population. Dr. Cogliano also says in paragraph 541 that different
decision-making authorities will decide whethe r the evidence contained in IARC monographs
sufficiently supports an SPS decision or whether they need to conduct further analysis. Thus it seems
that IARC monographs provide inform ation and serve in risk assessment. This said, as also pointed
out by the United States in its comments on comments of 19 October 2007 222, the text in the footnote
is a verbatim quote from the IARC website, describing what IARC does. Thus the Panel did not deem
it necessary to augment the footnote.
6.21 The European Communities argu es that the second sentence of paragraph 7.85 does not
reflect reality, since the European Communities di d not agree with the final decision on Working
Procedures for Consultation with Scientific and/or Technical Experts adopted by the Panel. The Panel
notes that, in a letter of 3 November 2005, th e European Communities commented on the draft
expert working procedures. One of the comments w as that the experts should act as a single expert
review group in order to provide a c onsistent advice on the issues concerned. The European
Communities also suggested that the experts should be independent from the industry or regulatory
bodies which had a vested interest in the issue on wh ich they would be consulted. The Panel rejected
the EC request that experts should act as a single review group in its letter sent to the parties on
25 November 2005, together with its finalized Wo rking Procedures for Consultation with Scientific
and/or Technical Experts. We therefore modified paragraph 7.85 to reflect the absence of full
agreement of the European Communities on the Pa nel's Working Procedures for Consultation with
Scientific and/or Technical Experts.
6.22 The European Communities further requests us to redraft the fourth sentence of
paragraph 7.85 to reflect better its concerns that tw o of the experts selected by the Panel participated
in the preparation and drafting of the JECFA risk assessment of the hormonal substances at issue in

222 Para. 3.

this case, with which the EC risk assessment disagrees. The Panel sees no problem in clarifying the
nature of the work of these two experts with JECFA It remains however puzzled by the EC
suggestions that a scientist who worked with JECF A could be deemed to be biased in assessing the
scientific evidence on which EC Directive 2003/ 74/EC relies and could be assumed to defend
JECFA's work. First, scientists would readily admit that science is constantly evolving and the fact
that new studies are peer revi ewed is evidence that assessing new ideas and findings is part of
scientific work. Assuming that scientists may lack objectivity because they participated in the
preparation and drafting of JECFA's risk assessments on the hormones at issue would call into
question the whole principle of peer review. Th e Panel also notes that JECFA is the body that
provides the independent scientific advice on whic h the work of Codex is based and Codex is
expressly recognized by the SPS Agreement as having responsibilities for the establishment of
"international standards, guidelines and recommendations ". The Panel also recalls the role given to
international standards, guidelines and recommendations by Article 3.1 and 3.2 of the SPS Agreement.
It is therefore consistent with this role for th e Panel to rely on experts who contributed in the
preparation and drafting of JECFA's risk assessments of the substances at issue.
6.23 The Panel does not agree either with the EC ar guments according to which the two experts at
issue should not be described as "internationally rec ognized specialists". The Panel recalls that they
have been selected by the FAO and WHO as part of the JECFA selection process. The selection
procedure has been described in JECFA's reply to question 14 to JECFA.
223 The Panel fails to
understand why the JECFA selection would not be evidence of the international reputation of the
scientists at issue.
224 The EC concerns about JECFA's work and the selection of experts to participate
in that work are in contradiction with the role attributed by the SPS Agreement to Codex and to
international standards, guidelines and recommendati ons. The Panel was fully aware of the area of
expertise of the two scientists at issue, and believed that they would be more at liberty to comment on
the content of JECFA's work than officials of the JECFA Secretariat. It also specified the reasons
why those experts were selected in spite of not ha ving carried out experiments with the substances at
issue and does not see any need for further substant ial elaboration. The Panel notes that the United
States, in its comments of 19 October 2007, considered that any new objection on the experts by the
European Communities would be untimely. The Pa nel has nevertheless deemed it necessary to make
some clarifications, in response to the EC request, to paragraph 7.85.
6.24 The European Communities requests that we modi fy the first sentence of paragraph 7.87 to
better reflect the content of its letter of 28 March 20 06. We consider that the letter largely reiterated
points which the Panel already addressed in paragra ph 7.85 i.e. the involvement of experts in the
preparation and drafting of JECFA's risk assessments and their alleged lack of scientific expertise.
Besides this, the EC letter of 28 March deals exclusiv ely with conflict of interest, which is the subject
addressed by the Panel in paragraph 7.87. While th e Panel has modified the paragraph to reflect the
fact that the EC letter addressed other issues alre ady discussed in this report, it did not deem it
necessary to modify the rest of the paragraph, excep t to clarify the elements on the basis of which the
Panel considered that the experts concerned shoul d be deemed to be the best among the very few
individuals available.
6.25 Having reviewed the EC comments on paragraph 7.89 of the interim report , the Panel agrees
that this paragraph did not directly relate to the i ssue of the alleged conflict of interest of two of the
experts consulted by the Panel and has deleted it.
6.26 The European Communities argues that th e statements in paragraph 7.123 and footnote 396
are not accurate as some of the subsequent evidence did expand and confirm the scientific basis of

223 Annex E-2, pp. 115-116.
224 See also Dr. Boobis, Annex G, para. 511; Dr. Tritscher, Annex G, para. 515; Dr. Wennberg,
Annex G, para. 517.

Directive 2003/74/EC. The European Communities refers to the replies of Dr. Guttenplan and
Dr. Sippell. The Panel also notes the US comments of 19 October 2007 on this request for review
from the European Communities. In paragraph 7.123 and footnote 396, the Panel states that nothing
new was submitted after the adoption of Directive 2003/74/EC that differed in any fundamental way
from previous evidence. This is not contradicted by the EC comment that subsequent evidence
expanded and confirmed the scientific basis of its Di rective, including the EC reply to question 5 of
the Panel after the second substantive meeting. 225 The statements of Dr. Guttenplan referred to by the
European Communities226 do not support the EC argument. Dr . Sippell mentions in paragraph 611 of
Annex G that he changed his opinion on exposure to exogenous oestrogens and precocious puberty
because the acceptance of the significance of the ultrasensitive assays within paediatric endocrinology
increased tremendously after he published his review article in 1999. However, the ultrasensitive
assays he is referring to were not carried out or p ublished after the adoption of Directive 2003/74/EC.
In his written replies 227, where he discusses the u ltrasensitive assay techniques, Dr. Sippell refers to
Klein et al (1994) and Larmore et al (2002) and other studies dated 1999 or 2001. As a result, in the
opinion of the Panel, the statement of Dr. Sippell cited by the European Communities is not about
evidence that became available after the adoption of the Directive. Consequently the Panel did not
modify paragraph 7.123 and footnote 396.
6.27 The European Communities also ar gues with respect to paragraph 7.124 that it had reserved
its right to submit the finally published version of the study contained in Exhibit EC-107. According
to the European Communities, this study was submitt ed in time and should have been accepted. The
Panel notes that, when it submitted Exhibit EC-107 on 21 December 2005, the European
Communities specified that it "reserve[d] its right to s ubmit further evidence, if and to the extent this
appears necessary for the purpose of commenting on any further submissions by the other parties as
well as on replies of the panel's experts". The Pane l does not read this reservation as reserving the EC
right to submit the finally published version of th e study. Moreover, the Panel recalls that the
European Communities stated that it left it to the discretion of the Panel whether to forward the
published version to the experts.
228 The Panel, having regard to the comments of the United States of
19 October 2007, considers that it sufficiently explai ned in its report the reasons why the published
version of this study had not been sent to the expe rts. In particular, it considered that submitting a
modified study to experts at a relatively late st age of the expert consultation proceedings could
generate confusion.
6.28 The European Communities also considers with respect to paragraph 7.133 that the Panel
should accept that the European Communities submit the comments it wished to make in relation to
some factual errors made by the United States in its replies to the Panel questions posed after the
second substantive meeting. The Panel considers th at its decision was clear. If inaccuracies resulting
from US factual arguments had been reflected in the interim report, the European Communities could
have identified them in its comments or in its comments on comments. There does not seem to be any
need for the Panel to reverse its decision of 20 November 2006.
6.29 The European Communities also alleges, with respect to paragraphs 7.135 et seq., that one
paragraph was added to the transcript of the experts' hearing annexed to this report compared with the
version sent to the parties in January 2007. Ther e are, indeed, more paragraph numbers. However,
there is no additional text in Annex G as compared to the version sent to the parties in January 2007.
In fact, the difference results from a correction to the paragraph numbers of the transcript. In the
version sent to the parties for comments, there was a paragraph between paragraphs 29 and 30 that did
not have a number. This paragraph became the new paragraph 30 in the final version of the transcript,

225 Annex C, pp. 5-7.
226 Annex G, paras. 709 and 713.
227 Annex D, para. 319.
228 See EC's letter to the Panel dated 29 May 2006.

and as a consequence, all the other paragraph numbers shifted by one. On the same subject, two more
changes were made in paragraph numbers: paragra ph 827 of the draft transcript was divided into two
paragraphs, following a comment by the United States 229, and became paragraphs 828 and 829 in the
final version of the transcript. Finally, another paragraph lacked a number, between paragraphs 926
and 927. This paragraph corres ponded to a short statement by Dr. Boisseau clarifying that he had
asked a question to Dr. Boobis, not to the Eur opean Communities. This unnumbered paragraph
became paragraph 929. In conclusion, three add itional paragraph numbers we re added in the final
version of the transcript compared to the draft ve rsion sent for comments to the parties. The draft
version had 1069 numbered paragraphs; the final version has 1072 numbered paragraphs.
6.30 The European Communities also seems to request , with respect to paragraph 7.148 that the
Panel specify the nature of the "e ditorial adjustments" made in th e transcript. The Panel deems it
appropriate to recall that the tapes of the meeting of the Panel with the experts were given to a typist
who transcribed them. Two types of editorial adjust ments were made to the transcript. First, the
Secretariat proofread the transcript, identifying any words or passages the typist had misunderstood
and checking these passages against th e tapes. The type of errors identified were limited to
confusions regarding technical terms (e.g. "N-point" instead of "endpoint"; "safe defactual" instead of
"safety factor" 230 or "defactual threshold" instead of "de facto threshold" 231 ). Other corrections
involved minimal adjustments to sentences, for ex ample to remove repeated words and occasionally
adding punctuation marks. Once these corrections we re made, the transcript was sent to the experts
and subsequently to the parties in order to give each speaker the chance to verify that his or her own
interventions had been accurately reflected. The experts' comments consisted of further corrections of
technical words which had been improperly transcribed, or corrections of word order or colloquial
expressions to make the transcript more legible. This is the reason why the Panel considered that
these corrections did not go beyond "minimal editorial adjustments".
(b) Comments by the United States
6.31 With respect to the discussion of the procedural question of the opening of the Panel meetings
with parties and experts for public observation, the United States requests that we remove our
discussion of the term "proceedings" as it appears in Article 17.10 of the DSU. We note that the same
request was made by the European Communities. Since this reference was only an additional
argument, we accepted the parties' requests and re moved our discussion of the term "proceedings" in
Article 17.10 of the DSU.
6.32 The United States also requests that we modify paragraphs 7.151 and 2.7. We see no reason
not to adjust the description of the measure since it is actually the absence of recourse to the DSU by
the United States which seems to be at the orig in of the EC complaint. However, under the
circumstances, we also deem in n ecessary to specify that the issue stems from the fact that the United
States maintained the measure after the notifica tion of Directive 2003/74/EC to the DSB and we
modified paragraphs 2.7 and 7.151 accordingly.
6.33 The United States contests the conclusion of th e Panel in paragraphs 7.162-7.164 that the
European Communities narrowed the terms of reference of the Panel through the approach it followed
in its first written submission. For the United States , the EC approach is a "choice of legal strategy"
which is not binding on the Panel. The Europ ean Communities cannot constrain the terms of
reference of the Panel by adopting a specific approach to its claims in its first written submission.

229 See US letter dated 14 February 2007.
230 Annex G, para. 422.
231 Annex G, para. 707.

6.34 The Panel agrees that it is well established that a complainant cannot change the terms of
reference of a panel in its first submission or sub sequently. As stated by the Appellate Body in EC –
Bananas III:
"If a claim is not specified in the request for the establishment of a panel, then a
faulty request cannot be subsequently 'cur ed' by a complaining party's argumentation
in its first written submission to the panel or in any other submission or statement
made later in the panel proceeding."232
6.35 However, the Panel does not believe that this is the issue in the pre sent case. The European
Communities did not try to cure a faulty request. It ma de its claims more specific. As the Panel itself
noted233, there could be several ways to find a violation of Article 23 of the DSU. The European
Communities has clarified how it considered that this violation should be approached by the Panel.
As stated by the Panel on EC – Tube or Pipe Fittings234:
"In our view, it is in the nature of the Pane l process that the claims made by a party
may be progressively clarified and refined throughout the proceedings."
6.36 The Panel also quotes the Appellate Body in US – Carbon Steel .235 It seems to be accepted
that complainants can clarify their claims througho ut the proceedings. In this instance however, it
appears that the United States is concerned by the conclusion of the Panel that it is bound by these
clarifications or that they are part of the Panel's terms of reference.
6.37 Panels are free to address claims in the order that they deem appropriate. 236 However, if a
party specifies in its first written submission that a claim is raised in the alternative, can a panel
disregard this clarification? To a lesser extent, can a panel disregard the fact that the complainant
addressed the violation of a given provision in a particular way? Regarding the first question, it seems
that panels should be bound by a claim made "in the alternative" as acknowledged by the Appellate
Body.237 Regarding the second question, the reply mi ght be less clear and depend on the type of
"clarification" made by the complainant. In this case, the clarification had serious consequences on
how the Panel could address the claims listed in the terms of reference. It was not a violation of
Article 23 in general, but a viola tion of Article 23 as a consequence of a breach of Article 22.8 of the
DSU. The Panel also notes the arguments of the European Communities in its comments of
19 October 2007. The Panel recalls, in particular, that the rights of the respondent or its ability to
defend itself were in no way affected by the "narro wing" of its claims by the European Communities.
The Panel remains of the view that it is bound by th e EC approach to its claims and, accordingly, has
not modified paragraphs 7.162-7.164.
3. Comments of the parties regarding the Panel's findings of violation of Article 23.2(a)
read together with Articles 21.5 and 23.1 of the DSU and on the EC claims on
Article 23.1, read together with Articles 22.8 and 3.7 of the DSU
(a) Comments by the European Communities
6.38 The European Communities disagrees with th e interpretation the Panel makes, in
paragraphs 7.174 et seq., as well as in paragraph 7.272 of the EC claims as set out in its first written

232 Appellate Body Report on EC – Bananas III, paras. 141-143; Appellate Body Report on US – Lead
and Bismuth II, paras. 72 and 73.
233 See para. 7.176.
234 Panel Report on EC – Tubes and Pipes Fittings, para. 7.10.
235 See para. 7.161.
236 Appellate Body Report in Canada – Wheat Exports and Grain Imports, para. 126.
237 See, e.g., Appellate Body Report on EC – Selected Customs Matters, para. 308.

submission. The European Communities insists in its comments that "it did not argue [in its main
claims] that there was a violation of Article 22.8 itself, but rather one of Article 23.1". In other words,
the European Communities seems to suggest that th e Panel should not have addressed the conformity
of the US measure under Article 22.8 of the DSU – even though this article was listed in the EC
request for establishment of a panel – but only unde r Article 23.1. Yet, the European Communities
alleges a violation of Article 22.8 in various parts of its first submission and subsequently.238
6.39 In the opinion of the Panel, the use of the term "in conjunction with" or "read together with"
is not indicative that the European Communities only claims a violation of Article 23. In
Section III.E.3 of its first written submission, th e European Communities alleges a violation of
Article 3.7 even though in its conclusions it states that the United States' and Canada's unilateral
conduct "violates Article 23.1 of the DSU read in conjunction with Articles 22.8 and 3.7 of the DSU".
One cannot conclude either that the European Communities draws a conclusion of violation of
Article 22.8 from the violation of Article 23.1 since its allegation of violati on of Article 23.1 stems
from the obligation to withdraw the measure if the violation has been removed. Rather, one must
conclude the opposite, i.e. that the European Communities draws a conclusion of violation of
Article 23.1 from a violation of Article 22.8. Fo r those reasons, the Panel does not agree with the
argument made by the European Co mmunities at the interim review stage that it never made a claim
of violation of Article 22.8 of the DSU, and that its claims related only to violations of Article 23.
6.40 The European Communities also contests the qua lifications made by the Panel of its second
series of main claims (i.e. its claims of viola tion of Article 23.1 of the DSU in conjunction with
Article 22.8 and Article 3.7 of the DSU) as cl aims "premised on compliance by the European
Communities with the DSB recommendations and rulings in the EC – Hormones case" in
paragraph 7.181. The Panel notes that it has clearly explained in paragraphs 7.277-7.278 why it
believes that this claim was premised on complianc e with the DSB recommendations and rulings in
the EC – Hormones case.
6.41 Consequently, the Panel will not delete the sec tion of its report cons idering the allegedly
non-existent EC claim under Article 22.8 of the DSU.
6.42 The Panel, however, deems it appropriate to clarify paragraph 7.181, and to make the
modification suggested by the United States in its comments of 19 October 2007 with respect to
paragraph 7.359 in order to make clear that it is not reviewing the EC claim of violation of
Article 22.8 in isolation.

238 See, for instance:
– EC's first written submission, para. 73: "Under Article 23.1 of the DSU, the United States is
obliged to have recourse to, and abide by, the rules and procedures of this Understanding.
This encompasses, inter alia, Articles 22.8 and 3.7 of the DSU";
– EC's first written submission, section III.E.2, title: "The obligation not to apply suspension of
concessions or other obligations under Article 22.8 of the DSU";
– EC's first written submission, Section III:E.3, title "Violation of Article 23.1 and Article 22.8
of the DSU necessary entails a violation of Article 3.7";
– EC's first written submission, para. 122: "For these reasons, the United States, by violating
Articles 23.1, 22.8 of the DSU, also acted contrary to Article 3.7 of the DSU";
– EC's oral statement at first meeting, pa ra. 56: a "systemic claim under Article 22.8, in
conjunction with Article 23.1";
– EC's reply to questions of the United States af ter the first substantive meeting, para. 8: "More
specifically, the European Communities considers that the continued application of sanctions
despite the unchallenged EC compliance measure is in violation of Articles 23.1 and 22.8 read
together."
– EC's second written submission, para. 217.

6.43 The European Communities also argues that, even though the obligation of the respondent
clearly emerges from the Panel's reasoning, the Pane l should clarify its recommendations. This could
be done either by removing from the findings any consideration of the second series of main EC
claims (i.e. its claim of violation of Article 23.1 of the DSU in conjunction with Articles 22.8 and 3.7
of the DSU) or, if necessary, through suggesti ons under Article 19.1 of the DSU, or through
clarifications in the Panel's reasoning. A somewhat similar request has been made by the respondent
in its request for review of precise aspects of the interim report. However, the European Communities
suggests that the Panel should clarify that the United States must remove its suspension of
concessions, whereas the United Stat es requests that we note that, once our findings are adopted by
the DSB, recourse to dispute settlement in accordan ce with the rules and procedures of the DSU for
the purpose of Article 23.2(a) read together with Articles 21.5 and 23.1 of the DSU will have been
achieved in respect of this matter.
6.44 The Panel is mindful of its duty to assist the DSB in making recommendations or rulings
aimed at achieving a satisfactory settlement of the ma tter. The Panel notes that the parties have both
requested that the Panel make suggestions or conclu ding remarks aimed at clarifying what is expected
from the United States. The Panel notes, however, that their proposed suggestions or concluding
remarks are divergent. The Panel wishes to recall its conclusion in paragraph 7.251. This conclusion
is based on the terms of Article 23.1 and 23.2(a). Those provisions require that recourse should be
had to "the rules and procedures of the [DSU]" (Article 23.1) or, in the case of Article 23.2(a), that
recourse be had to "dispute settlement in acco rdance with the rules an d procedures of this
Understanding". Moreover, for reas ons explained in this report, the Panel does not believe that
recourse by the European Communities to disput e settlement exempts the United States from its
obligations under Article 23.1 and 23.2(a) of the DSU. The Panel has clarified this point in
paragraph 8.3.
(b) Comments by the United States
6.45 The United States requests the Panel to harmonize the lists of means of dispute settlement
which appear in paragraphs 7.247 and 7.350. While the Panel sees no reason not to expressly refer to
panel proceedings in paragraph 7.247 , it notes that paragraph 7.247 u ses the word "including" before
listing means of dispute settlement. Its list is, thus, not exhaustive. The Panel also believes that this
would be more necessary for the sake of completeness than for the sake of cons istency. Indeed, the
two lists relate to different ma tters. In paragraph 7.247, the Panel listed the means of dispute
settlement available to the United States to comply with the requirements of Article 23.2(a) of the
DSU to have "recourse to dispute settlement in acc ordance with the rules and procedures of [the
DSU". Comparatively, paragraph 7.350, addresses the means available to the European Communities
to obtain the termination of the suspension of c oncessions or other obliga tions. The addition of
recourse to a "normal" panel in paragraph 7.247 s hould not be taken to imply that the United States
would satisfy its obligation under Ar ticle 23.2(a) if any party to the dispute such as, for instance, the
European Communities had recourse to dispute settle ment. The Panel reads Article 23.2(a) and 23.1
as requiring that the dispute settlement procedure be initiated by the United States. Having also
regard to the EC comments of 19 October 2007 239, the Panel does not deem it necessary to modify
paragraph 7.247.
6.46 The Panel also accepted the US request to harm onize certain terms of paragraph 7.270 with
the terms of paragraph 7.251.
6.47 In its comments on paragraphs 7.308 through 7.359, the United States argues that, whereas it
is the case that a complaining party in WTO disput e settlement bears the burden of proof to make out
a prima facie case of the WTO-inconsistency of the defending Member's measure, that concept does

239 Paras. 14-16.

not equate to, nor does it imply that, there exists a presumption that the responding Member is in good
faith compliance with its WTO obligations. The Un ited States argues that questions of good faith or
bad faith do not form a basis for a presumption of consistency or inconsistency.
6.48 The Panel agrees with the United States that good faith in the performance of treaties and the
question of consistency are ultimat ely to be distinguished in the panel proceedings. A finding of
violation of a Member's obligations will ultimat ely be based on an obj ective assessment of the
conformity of the measure at issue. However, th e Panel considers that, whereas a party to a dispute
may ultimately be found in breach of its obligation irrespective of whether it is acting in good faith or
not, good faith remains the premise on which the presumption of compliance is based. In other
words, it is because a Member is s upposed to comply with its obligati ons in good faith that it can be
presumed to be in conformity with its obligations and that it is for the complaining Member in a
dispute to make a prima facie case of violation.
6.49 The United States argues, on the cont rary, that the burden of proof is testament solely to the
fact that there is no presumption of bad faith that attaches to measures taken by a WTO Member. The
Panel disagrees. The Panel note that the United Stat es does not cite to any re port in support of its
position. Comparatively, the Panel notes that the Appellate Body, in EC – Sardines, stated that:
"We must assume that Members of the WTO will abide by their treaty obligations in
good faith, as required by the principle of pacta sunt servanda articulated in
Article 26 of the Vienna Convention . And, always in dispute settlement, every
Member of the WTO must assume the good faith of every other Member."240
6.50 In that context, the Panel fails to see why bur den of proof should be based on an absence of
presumption of bad faith.
6.51 Likewise, the Panel does not understand why good faith should not form the basis for a
presumption of consistency because it is ultimately irrelevant for purposes of finding whether a
measure is consistent or not with the WTO. Sin ce WTO Members are to be assumed to abide by their
treaty obligations in good faith, it is normal that , until a prima facie case has been made by the
complaining Member, the responding Member enjoy this presumption of compliance in good faith.
Whereas this presumption goes to the substance or th e "merits" of the measures at issue, it does not
affect the ultimate finding of the Panel, which w ill be ultimately based on an objective assessment of
the matter, including all the relevant evidence submit ted by the parties. For these reasons, the Panel
sees no reason to modify its findings in paragraphs 7.308 through 7.359.
6.52 The United States also requests that we modify paragraph 7.360. According to the United
States, the fact that the Panel's terms of reference do not include provisions of the SPS Agreement
does not necessarily mean that the conformity of the EC Directive 2003/74/EC with the
SPS Agreement lies outside the Panel's mandate. The Un ited States refers to the Appellate Body
report in Argentina – Footwear (EC)
241 to conclude that the Panel would not exceed its terms of
reference by examining provisions not cited in the Panel request and would comply with its
obligations under Article 11 of the DSU.
6.53 The European Communities, in its comments of 19 October 2007 242 , disagrees with the
comments of the United States to the extent that, un like in the case referred to by the United States
where there was an express reference to another provision in the article allegedly breached, there is no
reference in the term "removed" in Article 22.8 to any other provision. The European Communities

240 Appellate Body Report in EC – Sardines, para. 278.
241 Appellate Body Report on Argentina – Footwear (EC), paras. 74-75.
242 Para. 21.

considers that if the US interpretation prevailed, the responding party would effectively be free to
refer to any provision of the covered agreemen ts and the terms of reference would become
meaningless.
6.54 The Panel considers that it has extensively explained why it believes that, while making
actual findings regarding the compatibility of the EC Directive 2003/74/EC with the SPS Agreement
is not part of its mandate, it h as jurisdiction to address the compa tibility of the Directive with the
SPS Agreement to the extent necessary to make findings in relation to Article 22.8 of the DSU, which
is part of its mandate. The Panel agrees with the Un ited States that this is part of its duty to make an
objective assessment of the matter pursuant to Article 11 of the DSU and a sentence has been added to
that effect in paragraph 7.377. The Panel also believes that its approach is consistent with the scope of
a panel mandate as confirmed by the Appellate Body.
6.55 The United States also requests that we modi fy the second sentence of paragraph 7.366 to
take into account the terms of Article 7.2 of th e DSU which provides that "Panels shall address the
relevant provisions of a ny covered agreement cited by the parties to the dispute " (emphasis added).
The Panel agrees with the United States that provision s invoked by the responding party, for instance,
as affirmative defence must be addressed by a pane l. The Panel notes, however, that the "matter"
before it is defined by the request for establishment of the Panel. The matter before this Panel is
whether the United States' measure has breached, inter alia, Article 22.8 of the DSU, not whether EC
Directive 2003/74/EC complies with the SPS Agreement. As a result, the US references to provisions
of the SPS Agreement are not claims. The Panel may address them, however, as part of its findings on
Article 22.8 of the DSU. The Panel has nevertheless clarified paragraphs 7.366 and 7.367.
6.56 Finally, the United States requests a modifica tion to paragraph 8.2 and the addition of
concluding observations. Regardi ng paragraph 8.2, having duly considered the EC comments on
comments, we nonetheless decided to replace the te rm "legislation" with the term "measure",
consistent with Article 19.1 of the DSU.
6.57 Regarding the addition of concluding observati ons, we do not agree with the United States
that, "once [our findings are] adopted by the Dis pute Settlement Body, recourse to dispute settlement
in accordance with the rules and procedures of th e DSU for the purpose of Article 23.2(a) read
together with Articles 21.5 and 23.1 of the DSU will have been achieved in respect of this matter."
For reasons explained in this report, the Pane l does not believe that recourse by the European
Communities to dispute settlement exempts the Unit ed States from its obligations under Article 23.1
and 23.2(a) of the DSU. The Panel has clarified this point in paragraph 8.3.
4. Comments of the parties on the compliance of the EC ban on meat and meat products
treated with the six hormones at issue for growth promotion purposes with the
SPS Agreement in relation to the Panel's findings on the EC claims on Article 23.1, read
together with Articles 22.8 and 3.7 of the DSU
(a) Comments by the European Communities
(i) Introductory comments
6.58
 In an introduction to its specific comments, the European Communities alleges:
(a) that the Panel has dismissed the 1999, 2000 and 2002 Opinions as not constituting a
proper risk assessment based on an alleged absence of specific evidence which, the
European Communities claims, is impossible to provide;

(b) that the Panel dismissed the Opinions as not having presented sufficient evidence to
call into question the conclusions of JECFA;
(c) that the Panel should have scrutinized JECFA's evaluations, which are based on old
studies which were not publicly available a nd were not communicated to the Panel or
the Panel's experts for review;
(d) that the Panel has reached its conclu sions on the EC implementing measure
(Directive 2003/74/EC) by relying selectively, for a number of important issues, on
the statements of two experts in a group of six. The European Communities recalls
that those two experts had participated in the drafting of the JECFA's assessments
contradicted by the EC Opinions and we re obviously defending their own work and
the methodology applied by JECFA and Codex. Comparatively, the other four
experts had overall validated and supported th e conclusions of the EC Opinions; and,
finally,
(e) that the Panel's methodology and reasoning are contrary to established principles on
burden of proof and standards of review of genuine scientific questions by WTO
panels and ordinary courts of law.
6.59 Regarding the argument under (a) above, the Panel will address this question when it
addresses the EC comments on the Panel' s findings under Article 5.1 of the SPS Agreement. As a
preliminary remark, however, the Panel wishes to clarify that it did not "dismiss the opinion of a
relevant committee constituted of highly regarded , independent scientific experts". The Panel
concluded that the European Communities had not evaluated specifically the possibility that the
adverse effects related to the association between excess hormones and neurobiological,
developmental, reproductive and im munological effects, as well as immunotoxicity, genotoxicity and
carcinogenicity coming into being, originating or resulting from the consumption of meat or meat
products which contain veterinary residues of oestradiol-17β as a result of the cattle being treated with
oestradiol-17β for growth promotion purposes. The Pane l also found that the scientific evidence
referred to in the Opinions does not support the EC conclusions on genotoxicity, or the conclusion
that the presence of residues of oestradiol-17 β in meat and meat products as a result of a cattle being
treated with this hormone for growth promotion purposes leads to increase cancer risk. Nor does the
scientific evidence support the EC conclusions a bout the adverse immunologi cal and developmental
effects of consuming meat and meat produc ts from cattle treated with oestradiol-17 β for growth
promotion purposes. This does not put into ques tion the results of the studies and research relied
upon by the SCVPH, nor the conclusions reached by the scientists, but simply the conclusions drawn
by the European Communities on the basis of the science.
6.60 Regarding the argument under (b) above, it is co rrect that the Panel considered that, in order
to determine whether relevant scientific evidence was insufficient within the meaning of Article 5.7 of
the SPS Agreement, it had to take the results of the risk assessments made by JECFA as a
"benchmark" of the existence of suffi cient scientific evidence. This is in line with the findings of the
Appellate Body in Japan – Apples that the relevant scientific evid ence will be insufficient within the
meaning of Article 5.7 if the body of available scien tific evidence does not allow, in quantitative or
qualitative terms, the performance of an adequate assessment of risks as re quired under Article 5.1
and as defined in Annex A to the SPS Agreement
243, as well as with the presumption of compliance
under Article 3.2 of the SPS Agreement.

243 Appellate Body Report on Japan - Apples, para. 179.

6.61 As far as the argument under (c) is concerned, the Panel explained in its findings why it relied
on JECFA's work without questioning it. 244 First, using JECFA's risk assessments as "benchmarks"
did not mean that the Panel had to examine the scientific evidence supporting JECFA's conclusions.
Second, none of the parties contested that JECFA and Codex work on the hormones at issue (with the
exception of MGA) constitute international standa rds, guidelines and recommendations within the
meaning of Article 3.2. Because sanitary meas ures which conform to international standards,
guidelines or recommendations are deemed to be consistent with the provisions of the SPS Agreement,
the Panel had no reason to scrutinize the evaluation made by JECFA. The only benefit of such an
evaluation would have been to determine whethe r JECFA's risk assessment met the conditions of
Article 5.1. However, the question before the Pane l is not to review the validity of international
standards: the Panel has no mandate to do that. It is not to review whether JECFA's risk assessments
are compatible with Article 5.1, but whether the EC implementing measure is compatible with
Article 5.1 as far as oestradiol-17 β is concerned or justified unde r Article 5.7 for the other five
hormones at issue. The Panel also notes in this respect that, whereas Members have, pursuant to
Article 3.3, a right to introduce or maintain sanitary measures which result in a higher level of sanitary
protection than would be achieved by measures b ased on the relevant international standards,
guidelines and recommendations, the way to do this is not by seeking to demonstrate that those
standards, guidelines and recommendations are flawed or outdated, which would simply show that
they have become insufficient and would not ju stify the EC measure, but by providing positive
evidence or information supporting the conformity of the measure at issue with Article 5.1 and/or
Article 5.7. It was, thus, for the European Communities to provide convincing evidence, in line with
the requirements of Article 3.3 of the SPS Agreement, to justify its definitive ban on oestradiol and
that relevant scientific evidence was insufficient for the other five hormones.
6.62 Regarding the argument according to which th e two experts involved in the drafting of
JECFA's risk assessments were defending their ow n work and the methodology applied by JECFA
and Codex, the Panel wishes to add to what it has already said above that, since JECFA's risk
assessments were used as the reference risk assessments for purposes of the analysis under Article 5.7
of the SPS Agreement, it was necessary for the Panel to be able to rely on the advice of experts
intimately knowledgeable about the su bstance of JECFA's risk assessments.
245 The purpose was not
to check whether JECFA's risk assessments were supported by sufficient scientific evidence or carried
out in accordance with Article 5 of the SPS Agreement, but to identify to what extent the concerns
raised by the European Communities in its submissions had been considered in the development of its
risk assessments by JECFA (e.g. how the risk to pr epubertal children had been taken into account by
JECFA). Second, the Panel recalls that JECFA is an international, indepe ndent entity composed of
highly qualified experts selected by the WHO or FAO according to strict procedures. 246 JECFA also
regularly reassesses its risk assessments, normally at th e request of Members of Codex, and evidence
before the Panel suggest that the European Co mmunities did not request JECFA to reassess the
hormones at issue on the basis of the new evid ence it had gathered. Instead, the European
Communities relied on its own risk assessment. Moreover, JECFA reaches its conclusions by
consensus. So the opinions expr essed by the two experts were given with regard to the consensual
view of JECFA on this matter, not just their own personal positions in the past. This does not mean,
however, that JECFA's work is these particular expe rts' own work: it is a joint work by several
experts. The experts that the European Communitie s claims were defending their work acknowledge
that the state of knowledge can evolve. For instance, Dr. Boobis stated that:

244 Paras. 7.643-7.647.
245 In order to assess the appropriat eness for the Panel to seek advi ce from experts involved in the
preparation of JECFA's risk assessment, it is also importa nt to recall that the experts are being consulted in the
context of an assessment of the EC implementing measure under Articles 5.1, 5.2, 5.7 and 3.3 of the
SPS Agreement, and of the presumption of conformity with the SPS Agreement.
246 JECFA's reply to question 14 of the Panel. See also Dr. Boobis, Annex G, para. 511; Dr. Tritscher,

"[S]cience moves on, and it would be co mplacent for a risk assessment body to
assume that it knew everything about a substance at a particular point in time. We
have to work within the available information, and the question we ask is: do we have
sufficient information at this point to conduct a risk assessment? – not: is the data
complete and are there no scientific questions remaining to be answered."247
6.63 The experts consulted by the Panel are used to considering and peer reviewing studies that go
beyond what they have published themselves or perhap s even contradict them. In other words, they
are not likely to feel any need to defend their ow n previous work results in the light of new,
convincing evidence or techniques that put such prev ious work into doubt. The Panel also notes that
other experts referred to JECFA's work in their replies, just as they also referred to studies
commissioned by the European Communities.248
6.64 The European Communities also argues that the remaining four experts "overall validated and
supported the conclusions of the [SCVPH] Opinion[s]". The Panel does not share this point of view.
First, not all experts expressed their views on all the issues. The experts who expressed their views
often agreed with each other. Second, the impressi on that a majority of experts overall validated and
supported the conclusions of the SCVPH Opinions is incorrect. With respect to the five provisionally
banned hormones, to different degrees, the experts agreed that new studies would be useful. This
does not mean, however, that they considered them useful for the reasons a dvocated by the European
Communities. The four experts agreed regarding the hazard related to hormones, or the risk attached
to high doses. But so did the two experts with JECFA experience.
6.65 As to the argument that the Panel's methodol ogy and reasoning are contrary to established
principles on burden of proof and standards of review of genuine scientific questions by WTO panels
and ordinary courts of law, the Panel wishes to recall its findings at pa ragraphs 7.380-7.386 and
7.412-7.427 on the standard of review and burden of proof . The Panel has also explained why it gave
particular relevance to JECFA's risk assessments and why, to the extent that the European
Communities disagreed with JECFA, it had to prove that its measure was based on a risk assessment
consistent with Article 5. 1 and Annex A(4) of the SPS Agreement, or that the relevant scientific
evidence was insufficient.
6.66 The European Communities argues that the statement originally found in paragraph 7.371 was
not accurate as the European Communities was alle gedly replying to a hypothetical question and
stated that it was not necessary to lo ok into the scientific issues. Th e Panel notes that the European
Communities stated in its reply to question 74 of the Panel 249 that "it did not believe that it [was]
necessary to look into the scientific issues". The European Communities did not formally object to
the Panel seeking scientific opinion even if the Panel proceeded with reviewing the SPS Agreement.
Indeed, the European Communities added in its reply to the same question 74:250
"However, the European Communities does not believe that the Panel would have the
expertise to decide on such issues itself, should the Panel decide to go down [the
road] of deciding the scientific issues at st ake. In such a scenario, the European
Communities believes that the consultation of scientific and technical advice would
be absolutely necessary."
6.67 The European Communities argues th at it was replying to an hypothetical question. Yet, the
European Communities uses the affirmative and not th e conditional in its reply when it states that

247 See Annex G, para. 346.
248 See, e.g., Dr. Guttenplan, Annex D, para. 145.
249 EC's replies to Panel questions after the first substantive meeting, Annex B, para. 274.
250 EC's replies to Panel questions after the first substantive meeting, Annex B, para. 275.

"New experts will have to be consulted". 251 The Panel concludes that, whereas the European
Communities was not of the view that it was n ecessary to look into the sci entific issues, it was
nevertheless in favour of the consultation of scien tific experts if the Panel decided to address the
scientific issues at stake. Paragraph 7.371 was modified accordingly.
6.68 The European Communities suggests that the Pane l contradicted itself in paragraph 7.377 of
the interim report when it stated, on the one hand, that parties had had sufficient opportunity to
comment on the other party's allegations and, on the other hand, in paragraph 7.133, refused to allow
the European Communities clarify the nature of a number of factual errors allegedly made by the
United States and Canada. In paragraph 7.133, the Panel took the view that the European
Communities should not be allowed to make furthe r comments, lest the other parties would also
comment and this would launch an endless exchange of arguments. The Panel notes that parties were
allowed to comment on the experts' responses and to comment on the comments of the other party. In
addition, the parties were allowed to comment on each other's replies to the questions of the Panel
after the second substantive meeting. This is fully co nsistent with usual pane l procedures. Moreover,
the European Communities could correct any fact ual error appearing in the interim report by
requesting the Panel to review precise aspects of the interim report, if the allegedly erroneous
information provided by the United States and Canada had been used in the findings. The Panel notes
that the EC request to correct some factual statemen ts made by the other parties was limited to factual
aspects, not to legal issues such as a llegations of inconsistency with the SPS Agreement, which was
the subject of this paragraph. The Panel nonetheless decided to clarify paragraph 7.374.
6.69 The European Communities argues that, in para graphs 7.376-7.377, the Panel states that its
approach was a "pragmatic solution" and the "most l ogical way forward" without further explanation.
The European Communities considers that the appr oach of the Panel is arbitrary and negatively
affects the interests of the parties and reverses existing case law and established practice. The Panel
first notes that the European Communities doe s not specify which "existing case law" and
"established practice" it refers to, and that it does no t make any reference to its previous submissions.
Second, the Panel notes that these paragraphs c ontain only additional arguments. The Panel has
amply justified its decision to address the compa tibility of the EC implementing measure with the
SPS Agreement throughout the preceding paragraphs. Th e Panel also explains the reason why it
follows this approach in paragraph 7.377, emphasi zing the need to assist the parties and the DSB in
solving this dispute and the need to determine whether there is a violation of Article 23.1 in
conjunction with Article 22.8 and Article 3.7 of th e DSU. The Panel's choice was directed by the
requirement to make an objective assessment of th e matter before it, in accordance with Article 11 of
the DSU, having regard to the particular circumstan ces of this case, as recalled in section VII.C.2.(a)
of this report.
6.70 The European Communities stat es that paragraph 7.404 and footnote 516 are factually
inaccurate. This comment can only relate to and be limited to the refusal of the Panel to let the
European Communities correct alleged factual errors in the comments of Canada and the United
States on the EC replies to the questions of the Pane l after the second substantive meeting. First, the
European Communities never identifie d the factual errors at issue. Second, the Panel explained its
position in its letter of 20 November 2006. The Panel recalls that it followed the standard practice of
panels in terms of procedure, allowing comments on replies to the questions of the Panel. The Panel
felt justified in not allowing further comments. Th e Panel stressed that the European Communities
could address these factual errors at the interim review stage, if they were reflected in the findings of
the Panel. It appears that the European Communities did not take advantage of this opportunity as no

251 The Panel also notes that the European Communities made an alternative claim of violation of
Article 22.8 of the DSU and Articles I and II of the GA TT 1994, in isolation from its claim under Articles 23.1
and 3.7 of the DSU which was based on an allegatio n of actual compliance with the recommendations and
rulings of the DSB in the EC – Hormones case.

such factual corrections were made. Thus, the Panel sees no reason to correct paragraph 7.404 and
footnote 516.
6.71 With respect to paragraph 7.410 , the European Communities argues that the statement of the
Panel is unsupported and is an error of law. We do not share the European Communities' opinion.
First, the Panel did not base its decision to include Article 5.2 of the SPS Agreement in its review of
the conformity of Directive 2003/74/EC exclusiv ely on the comment of the European Communities
quoted in paragraph 7.409. In paragraph 7.404, the Panel mentioned that it would "consider all
allegations and arguments raised by each party". Since the United States had alleged a violation of
Article 5.2, the Panel could look at it irresp ective of the EC position on this matter. In
paragraph 7.410, the Panel simply notes the absen ce of objection of the European Communities. It
was, therefore, not deemed necessary to modify paragraph 7.410.
6.72 The European Communities argues, with resp ect to paragraph 7.420, that the Panel
misconstrued its role by engaging in settling a scien tific debate and arbitrating the opinions expressed
by the scientific community by "picking and choosin g" from individual replies of experts without any
valid explanation. The Panel explained in its find ings in paragraph 7.71 why it deemed it preferable
to consult experts individually. The Panel had al so explained in its letter to the parties of 25
November 2005 how it understood its ro le in terms of assessment of scientific opinions. The Panel
believes that weighing the scientific evidence before it was necessary to reply to the two main legal
questions in relation to the SPS Agreement, i.e. whether the European Communities had performed a
risk assessment within the meaning of Article 5.1 for oestradiol-17 β and if the relevant scientific
evidence was sufficient within th e meaning of Article 5.7 as far as the other hormones were
concerned. In fact, the Appellate Body confirme d the discretion of Panels in weighing evidence in
EC – Asbestos .252 This is also part of the role of panels under Articles 11 and 13 of the DSU. The
Panel also considers that the role of the experts was to act as an "interface" between the scientific
evidence and the Panel, so as to allow it to perform its task as the trier of fact. If panels were not to
weigh the scientific evidence before them, then the DSU would have mandated the recourse to experts
review groups. The Panel also notes that the Appellate Body took the view in EC – Hormones , that
both the SPS Agreement and the DSU leave to the discretion of a panel the determination of whether
the establishment of an expert review group is necessary or appropriate. 253 The Panel explained its
approach in detail in paragraph 7.420 and thus does not believe that it engaged into "picking and
choosing" without any valid explanation. The Pane l notes that some replies to its questions were
more detailed than others and supported by bibliogr aphical references. The Panel believes that, in
case of divergence of opinions between the experts, and having due regard to the comments of the
parties and the clarifications provided by the expe rts at the meeting with the Panel, it was a sound
approach to take into account, in forming its own op inion, the opinions that were the most precise
and elaborate. Therefore, having also consider ed the comments of the respondent of 19 October
2007, the Panel did not deem it necessary to revise paragraph 7.420.
6.73 The European Communities considers that, in pa ragraphs 7.423-7.427, the Panel missed the
point made by the European Communities, namely that neither the United States, Canada nor JECFA
have provided conclusive proof that the methods used to generate the outdated evidence on which
they based and continue to base th eir risk assessment were validated. The Panel first notes that the
paragraphs at issue are part of an introductory section, not one where the validity of the evidence
actually relied upon by JECFA is being discussed. S econd, the purpose of the discussion contained in
the paragraphs at issue is clearly stated in para graph 7.427. The point made by the Panel is that a
study is not ipso facto irrelevant because it is old. The Pa nel makes two points in paragraph 7.427:
(i) that accuracy is a problem when one is at the limits of detection of the older methods and (ii) that
in any event an essential question is whether a given method has been validated.

252 Appellate Body Report on EC – Asbestos, para. 161.
253 See para. 7.74.

6.74 Second, the European Communities' comment rais es the question whether there is a need for
the United States and Canada to prove that JECFA' s risk assessments were based on validated studies.
In the opinion of the Panel, this is not a question that needs to be addressed in order to resolve this
dispute. JECFA's risk assessments were used as the bases for Codex recommendations which are,
pursuant to Article 3.1 and Annex A(3) of the SPS Agreement, "international standards, guidelines or
recommendations". Pursuant to Article 3.3, it is for the WTO Member wishing to introduce or
maintain sanitary measures which result in a higher level of sanitary protection than would be
achieved by measures based on the re levant international standards, guidelines and recommendations
to provide scientific justification in support of such measures. In that context, the question before the
Panel is not whether JECFA's risk assessments were based on validated studies 254, but whether the
European Communities' permanent ban on meat and meat products containing veterinary residues of
oestradiol-17β derived from cattle treated with this hormone for growth promotion purposes is based
on a risk assessment within the meaning of Artic le 5.1 and, for the five provisionally banned
hormones, whether there exists validated studies that sufficiently put into question the evidence on
which JECFA's risk assessments are based, so as to s upport a conclusion that the relevant scientific
evidence is insufficient to permit the assessment of risk.
(ii) General comments on the Panel's analysis regarding oestradiol-17β
6.75 The European Communities argues that the use of the term "measure" in paragraphs 7.443
and 7.518 to describe the Panel's function is unfor tunate because "it is clear that a panel does not
measure anything (which implies that there is something quantitative to measure), but simply
examines the conformity of the measure with the relevant provisions." 255 The Panel notes that it used
the term "measure" in the sense, as defined by the Oxford English Dictionary, to "judge or estimate
the greatness or value of (a person, a quality, et c.) by a certain standard or rule; appraise by
comparison with something else." 256 The Panel believes that judging or appraising something, in this
case the SCVPH Opinions, against a certain standard or rule, in this case Articles 5.1 (including an
examination of Article 5.2) and Annex A(4) of the SPS Agreement, is precisely examining the
conformity of the measure with the relevant provi sions. Therefore, the Panel will not change the

254 The Panel did not use the quotation from Dr. Wennberg in paragraph 7.426 to argue that JECFA's
studies were actually validated, but to stress that if a study used a validated method, there is no reason to reject it
simply because it is old. The problem with some of the more recent studies on which the European Communities
relies is that they have not been validated. The Europe an Communities also refers to statements of Dr. De
Brabander (Annex G, paras. 670, 675, 681 and 687) and Dr. Sippell (Annex G, para. 689). The Panel
understands from Dr. De Brabander's comments that there would be reasons to re-do certain assessments, inter
alia because the separation power of components has incr eased considerably since th e 1980s (see para. 681).
However, the Panel notes that Dr. De Brabander insists on the fact that one cannot say that the "old" data are not
correct on not valid un til they are checked with modern analytical methods, which, according to him, has not
been done. Dr. Sippell states that, for infant a nd young children, a standard commercially available
radioimmunoassay is not able to pick up the real concentrations, because there are numerous other cross-
reacting steroids. Dr. Sippell concludes that "one should really look at the new data". Whereas this statement
suggests that old data are not valid, Dr. Sippel stops short of formally concluding that they are not valid. We
also note Dr. Boobis' comment following Dr. Sippell's intervention (Annex G, para. 691):

"I would make the point that a method that is used to measure low levels of oestrogens in
infants is a different question from a method that is being used to measure residues in food.
The analytical challenges are quite different and the methods that were developed in the 1980s
for the residues were fit for that purpose, and that is what they were used for. If you ask the
question about the circulating concentrations, that is a different issue. So in terms of residues
the methods were suitable."

255 EC's comments on interim report, para. 50.
256 Shorter Oxford English Dictionary, 5th edition (1993), p.1730.

term. However, the Panel wishes to clarify here th at it did not intend to use the term "measure" to
imply any sort of quantitative analysis.
6.76 The European Communities also st ates that it did not understand the Panel's use of the term
"objective measures" in the paragraph of the inte rim report corresponding to paragraph 7.443. The
European Communities correctly points out an error in the paragraph. The fourth sentence should
read "The Panel must objectively measure the Opini ons against the relevant standard for whether a
risk assessment has been conducted, which can be found in the texts of Articles 5.1 (including an
examination of Article 5.2) as well as Annex A(4) of the SPS Agreement." Again, the Panel notes that
it is using the term "measure" in the sense of a qualitative appraisal of the SCVPH Opinions against a
standard or rule, namely the SPS Agreement.
(iii) Comments on "risk assessment techniques"
6.77 The European Communities argues that the discussion by the Panel of risk assessment
techniques in paragraphs 7.446 to 7.469 is irrelevant and unnecessar y given that no relevant
international risk assessment techniques for veterinary drug residues have been agreed upon.257
6.78 The Panel notes that Article 5.1 requires that Members take into account the risk assessment
techniques of the relevant international organi zations when ensuring that their sanitary and
phytosanitary measures are based on a risk assessment. Therefore, the Panel believes that an analysis
of whether such techniques exist and whether th e European Communities took them into account is
necessary and appropriate to an analysis of wh ether the European Comm unities has removed the
previously found inconsistency of its ban on the importation of meat and meat products treated with
oestradiol-17β for growth promotion purposes with Article 5.1 of the SPS Agreement.
6.79 The Panel notes in paragraph 7.449 that no specific techniques or guidelines had thus far been
formally adopted by Codex for use by nationa l governments in conducting risk assessments of
veterinary drug residues. However, there are relevant definitions of the phases of a risk assessment as
well as guidelines and practices for conducting a risk assessment in the general sense and the Panel,
therefore, analyses whether th e European Communities took these into account when it adopted
Directive 2003/74/EC.
6.80 The European Communities also argues that these passages convey the erroneous message
that the concept of risk assessment as defined in the SPS Agreement is the same as in Codex
Alimentarius.258
6.81 The Panel is surprised by this comment, because it states in paragraph 7.467:
"[T]he Panel must concur with the reasoning of the panel in Japan – Apples, that the
requirement to 'take into account' the risk assessment techniques of international
organizations:
'[D]oes not impose that a risk assessment under Article 5.1 be 'based
on' or 'in conformity with' such risk assessment techniques. This
suggests that such techniques should be considered relevant, but that
a failure to respect each and every aspect of them would not
necessarily, per se , signal that the risk assessment on which the

257 EC's comments on interim report, para. 51.
258 EC's comments on interim report, para. 51.

measure is based is not in conformity with the requirements of
Article 5.1.'"259
6.82 The Panel finds that this quotation adequately conveys the Panel's opinion that although the
risk assessment techniques of the relevant interna tional organizations must be considered by the
Members, they are not binding on Members and that not following them would not necessarily lead to
the conclusion that the risk assessment did not co nform with Article 5.1 and Annex A(4) of the
SPS Agreement. However, to avoid confusion, the Pa nel clarified paragraph 7.467 and added
paragraph 7.468.
6.83 The European Communities also ta kes issue with paragraph 7.455. In that paragraph the
Panel summarizes the arguments of the European Communities as follows:
"The European Communities agrees that the risk assessment techniques developed
by Codex are relevant and contemplated in Article 5.1's requirement to take into
account the risk assessment techniques de veloped by relevant international
organizations. However, the European Communities maintains that the risk
assessment criteria as developed by the WTO dispute settlement bodies are clearly
more relevant to the application of the SPS Agreement."
6.84 The European Communities argues that this pa ragraph is misleading because the European
Communities has followed the four steps of risk assessment described by Codex. The European
Communities asserts that it has followed the four steps because its legislation so provides, not because
it is required to do so under the SPS Agreement, since such techniques do not exist.
6.85 The arguments summarized in this paragraph are contained in paragraph 192 of the European
Communities' second written submission.
6.86 Paragraph 192 of the European Communities' second written submission states:
"[A]ll parties to this dispute agree on the relevance of the risk assessment techniques
developed by Codex recently. Indeed, Article 5.1 itself points to the relevance of risk
assessment techniques developed by rele vant international organisations.
Furthermore, the SCVHP has explicitly based its assessment on the three elements of
risk identification, risk characterizatio n and exposure assessment recommended and
applied by the Codex.
260 A few qualifications, however, apply. First, risk assessment
criteria as they have been developed by the dispute settlement bodies are clearly more
relevant to the application of the SPS Agreement than those developed by

259 Panel Report on Japan – Apples, para. 8.241.
260 In response to a question from the Panel, th e European Communities clarified the following: "As
regards the statement in para. 192 of its Rebuttal Submission, the European Communities is grateful to the Panel
for pointing out the error and oversigh t. The error is double because: first, the steps of a risk assessment as
defined by Codex are four (not three) and, second, the terminology used in para. 192 to describe the first three of
them is not correct either (see following para. 193 where the proper terminology is used for the first three steps).
The words used in para. 192 is an isolated oversight and does not re flect the position which the European
Communities has expressed in so many other places in its written submissions and the oral hearing. Indeed, with
its reply of 3 October 2005 to Written Question No. 24 fr om the Panel, in particular paragraphs 140-143, the
European Communities has properly described the four st eps of a risk assessment and the reasons for which it
thinks it has complied with them in this case. See also paragraphs 145-152 of its reply of 3 October to Written
Question No. 25 from the Panel. Moreover, a careful examination of the 1999 Opinion shows beyond doubt that
the European Communities has completed the four steps, albeit it made a qualitative exposure assessment for the
reasons explained therein." (EC's rep lies to Panel questions after the second substantive meeting, question 8,
para. 34, Annex C-1)

international scientific bodies. This follows naturally from the fact that it is the
former's duty and privilege to interpret the provisions of the SPS Agreement."
6.87 The Panel believes that the sentiment of the Eu ropean Communities' argument is adequately
summarized in paragraph 7.455 and will not alter the paragraph.
6.88 As to the European Communities' argument th at paragraph 7.455 is misleading because the
European Communities has followed the four steps of risk assessment as defined by Codex, the Panel
notes that it does not discuss in any way in paragr aph 7.455 whether the European Communities' has
complied with the four steps. In addition, the Panel notes in paragraph 7.458 that "the European
Communities argues that the risk assessment at the basis of Direct ive 2003/74/EC precisely follows
the four steps of risk assessment as defined by Codex ..."
6.89 It is irrelevant for the Panel whether the EC in ternal legislation mandates that the European
Communities follow the four steps or whether th e European Communities complied with its own
legislation. The Panel's analysis focuses on whether the European Communities "took into account"
the relevant risk assessment techniques of the re levant international organizations as required by
Article 5.1 of the SPS Agreement and, in paragraph 7.469, the Panel finds that it has.
6.90 The European Communities asks the Panel to more fully summarize its arguments in
paragraphs 7.502 and 7.503.
261 The Panel has, therefore, modified those paragraphs.
(iv) Assessment of the scientific arguments
6.91 The European Communities, ar gues that paragraphs 7.504 through 7.573 are incoherent and
confused. Specifically, the European Communities be lieves that they do not adequately present the
debate on the "threshold approach" which it believes is the central scientific debate. 262 The Panel
notes that the content of paragraphs 7.504 through 7.573 contains the reasoning of the Panel on
whether the Opinions satisfy the definition of a risk assessment set forth in Annex A(4) of the
SPS Agreement. This section of the Panel's reasoning is not the appropriate place to present a debate
between the parties about a particular scientific issue.
6.92 The Panel, however, is mindful that the par ties did expend a significant amount of argument
on the relevance of "thresholds" to the risk assessment process and that perhaps it would provide
further clarity to include more explanation of th e various arguments. Therefore, the Panel made
modifications to the summaries of the parties' argume nts. The Panel believes that the debate over the
"threshold" issue can be divided into two main co mponents. First, whether all four of the risk
assessment steps as defined by Codex should be foll owed when the substance under review exhibits
no threshold. Second, whether oestradiol-17β is such a substance that exhibits no threshold because it
is genotoxic in vivo and therefore would lead to adverse effects even at the doses found in meat as a
result of treatment of cattle with oestradiol-17β for growth promotion purposes.
6.93 The Panel also feels that it would be helpful to include some additional information provided
by the experts with respect to this matter. Th erefore, the Panel inserte d a new paragraph after
paragraph 7.464. The Panel also changed the first sentence of paragraph 7.467.
6.94 With respect to whether oestradiol-17 β, in particular, is genotoxic in vivo and has no
threshold, the Panel finds that the issue arises in two different contexts: first, in the context of what
such a conclusion means for evaluating whether th e SCVPH Opinions constitute a risk assessment
within the meaning of the SPS Agreement; second, in the context of the analysis of whether the

261 EC's comments on interim report, para. 52.
262 EC's comments on interim report, para. 53.

science supports the conclusions reached by the Eu ropean Communities with respect to the genotoxic
properties of oestradiol-17β. To address both of these issues the Panel edited paragraph 7.497.
6.95 The Panel also feels that it would be helpful to include some additional information provided
by the experts with respect to this matter. Th erefore, the Panel inserte d a new paragraph after
paragraph 7.529.
6.96 With respect to whether the science s upports the conclusion that oestradiol-17β is a substance
that exhibits no threshold, the Panel has adde d Dr. Cogliano's response to question 19 from the
Panel263 as paragraph 7.559.
6.97 The European Communities argues that paragraphs 7.518 and 7.519 of the interim report are a
misinterpretation of what the Appellate Body found in the original EC – Hormones case about the
concept of risk assessment and its significance in the SPS Agreement.264 The European Communities
does not provide any specific parts of the analysis th at it feels are a misinterpretation, neither does it
provide what it believes is the correct interpretati on. The Panel can only assume that the European
Communities maintains its position as summarized in paragraph 7.517.
6.98 The Panel based its reasoning in paragraphs 7. 518 and 7.519 of the interim report on several
passages in the Appellate Body Report on EC – Hormones . Paragraph 181 of the Appellate Body
Report reads as follows:
"The second preliminary consideration relat es to the Panel's effort to distinguish
between 'risk assessment' and 'risk manage ment'. The Panel observed that an
assessment of risk is, at least with resp ect to risks to human life and health, a
'scientific' examination of data and factual studi es; it is not, in the view of the Panel,
a 'policy' exercise involving social value judgments made by political bodies. 265 The
Panel describes the latter as 'non-scientific' and as pertaining to 'risk management'
rather than to 'risk assessment'. 266 We must stress, in this connection, that Article 5
and Annex A of the SPS Agreement speak of 'risk assessment' only and that the term
'risk management' is not to be found either in Article 5 or in any other provision of
the SPS Agreement. Thus, the Panel's distinction, which it apparently employs to
achieve or support what appears to be a r estrictive notion of risk assessment, has no
textual basis. The fundamental rule of treaty interpretation requires a treaty
interpreter to read and interpret the wo rds actually used by the agreement under
examination, and not words which the interpreter may feel should have been used."
6.99 The Appellate Body disapproved of the panel's use in the original EC – Hormones dispute of
the distinction between "risk assessment" and "risk management" because it had no textual basis.
However, this did not mean that the Appellate Bo dy endorsed an interpretation of Article 5.1 or
Annex A(4) of the SPS Agreement that included a risk management stage. In fact, it emphatically

263 Panel question 19, Annex D, p. 34 ("The Europe an Communities states that '... it is generally
recognized that for substances which have genotoxic potential (as is the case with oestradiol-17 β) a threshold
can not be identified. Therefore it cannot be said that there exist a safe level below which intakes from residue
should be considered to be safe. Therefore the fact that doses used in growth promotion are low is not of
relevance'. Does the scientific evidence referred to by the European Communities support these conclusions?
Would your reply have been different at the time of adoption of the EC Directive in September 2003? If so,
why? [see para. 201 of EC Rebuttal Submission (US case), paras. 120-122 of EC Rebuttal Submission (Canada
case), paras. 73 and 86-98 of Canada Rebuttal Submission, paras. 87-91 and 153-156 of US First Submission
and paras. 35-40 and 46 of US Rebuttal Submission]").
264 EC's comments on interim report, para. 55.

stated that the term "risk management" is not to be found in Article 5 or any other provision of the
SPS Agreement. The Panel, therefore, finds no basis for the European Communities' assertion that the
Appellate Body "confirmed that a risk assessment w ithin the meaning of Article 5.1 includes a risk
management stage which is the responsibility of the regulator to carry out and not of the scientific
bodies."267
6.100 This Panel, following the advice of the Appellate Body, has adhered strictly to the text of
Article 5.1 and Annex A(4) of the SPS Agreement in its interpretation. In analysing the European
Communities' compliance with Article 5.1 and Annex A(4) of the SPS Agreement, the Panel is also
cognisant of the Appellate Body's finding that:
"The listing in Article 5.2 begins with 'available scientific evidence'; this, however, is
only the beginning. We note in this connection that the Panel states that, for purposes
of the EC measures in dispute, a risk assessment required by Article 5.1 is 'a scientific
process aimed at establishing the scientific basis for the sanitary measure a Member
intends to take'. 268 To the extent that the Panel intended to refer to a process
characterized by systematic, disciplined a nd objective enquiry and analysis, that is, a
mode of studying and sorting out facts and opinions, the Panel's statement is
unexceptionable.269 However, to the extent that the Panel purports to exclude from
the scope of a risk assessment in the sense of Article 5.1, all matters not susceptible
of quantitative analysis by the empirical or experimental laboratory methods
commonly associated with the physical sciences, we believe that the Panel is in error.
Some of the kinds of factors listed in Article 5.2 such as 'relevant processes and
production methods' and 'relevant inspection, sampling and testing methods' are not
necessarily or wholly susceptible of investigation according to laboratory methods of,
for example, biochemistry or pharmacolog y. Furthermore, there is nothing to
indicate that the listing of factors that may be taken into account in a risk assessment
of Article 5.2 was intended to be a closed list. It is essential to bear in mind that the
risk that is to be evaluated in a risk assessment under Article 5.1 is not only risk
ascertainable in a science laboratory opera ting under strictly controlled conditions,
but also risk in human societies as they actually exist, in other words, the actual
potential for adverse effects on human health in the real world where people live and
work and die."
270
6.101 Therefore, the Panel finds that a risk assessmen t consistent with Article 5.1 need not be
limited to empirical or experimental laborator y methods commonly associated with the physical
sciences. However, the Panel also agrees with the Appellate Body's statement that a requirement that
a risk assessment be "a process characterized by systematic, disciplined and objective enquiry and
analysis, that is, a mode of studying and sorting out facts and opinions" is unexceptionable.
6.102 Nowhere in the texts of Article 5.1 and Annex A(4) does the Panel find support for the
European Communities' contention that a ri sk assessment within the meaning of the SPS Agreement

267 EC's second written submission, para. 191.
269 (footnote original) "The ordinary meaning of 'scientific' , as provided by dictionary definitions,
includes of, relating to, or used in science', broadly, ha ving or appearing to have an exact, objective, factual,
systematic or methodological basis', of, relating to, or e xhibiting the methods or principles of science' and of,
pertaining to, using, or based on the methodology of scienc e'. Dictionary definitions of science' include the
observation, identification, descripti on, experimental investigation, and theoretical explanation of natural
phenomena', any methodological activity, discipline, or study', and knowledge attained through study or practice'".
(footnotes omitted) United States' Statement of Administrative Action, Uruguay Round Agreements Act , 203d
Congress, 2d Session, House Document 103-316, Vol. 1, 27 September 1994, p. 90.
270 Appellate Body Report on EC – Hormones, para. 187.

includes "weighing policy alternativ es in light of the results of ri sk assessment and, if required,
selecting and implementing appropriate cont rol options, including regulatory measures." 271 What the
European Communities seems to be describing is how a government choos es an appropriate SPS
measure based on a risk assessment. The Panel does not find that this is contemplated by the texts of
Article 5.1 and Annex A(4) of the SPS Agreement.
6.103 To avoid any confusion or misunderstandi ng the Panel modified paragraphs 7.518 through
7.521.
6.104 The Panel is aware that the experts responded to the Panel's questions with respect to what the
European Communities had evaluated in its Opinions by using a terminology that is standard for risk
assessments conducted according to th e process outlined in the Codex Procedural Manual. Although
the scientific experts' responses may include term s such as "hazard characterization" or "exposure
assessment", the Panel is at all times aware that the relevant standard against which it is assessing the
European Communities' measure is that of the SPS Agreement. In order to emphasize this point, the
Panel added a new paragraph before paragraph 7.522.
6.105 The European Communities takes issue with the reliance of the Panel on certain statements by
the experts in paragraphs 7.522 to 7.528 and cites to various other statements by the same experts
which it claims stand for the opposite proposition. 272 The Panel takes note that Annex D, which
contains the replies of the experts to the Pane l's questions is 116 pages long and Annex G which
contains the transcript of the Panel's meeting with the experts is 170 pages long. This does not
include the various comments and comments on comments of the parties on the experts' responses and
on the transcripts. With this volume of informa tion, every comment by the experts could not be
included in the Panel findings and, fo r that matter, did not have to be. 273 Therefore, the Panel made a
decision to select quotations that are representative of a particular expert's opinion on a given topic.
The Panel has reviewed the specific paragraphs referred to by the European Communities in an
attempt to determine if it misunderstood or misrep resented a particular expert's opinion. It also
considered the comments of the United States of 19 October 2007.
6.106 With respect to Dr. Guttenplan, the European Communities objects to the Panel's reliance on
paragraph 145 of the experts replies to the Panel's questions and refers the Pa nel to paragraphs 366,
393, 713 and 716-718 of Annex G as well as his written reply to Panel qu estion 17 which is at
paragraph 176 of Annex D.274
6.107 With respect to the Panel's reliance on paragra ph 145 of Annex D, which is Dr. Guttenplan's
response to Panel question 13, cite d in paragraph 7.523, the Panel amended the para graph to better
reflect Dr. Guttenplan's complete response to the question.
6.108 Additionally, to more fully reflect Dr. Gutte nplan's written answer to question 52 of the
Panel, the Panel modified paragraph 7.528.
6.109 With respect to Dr. Guttenplan's other interven tions cited by the European Communities, the
Panel did not deem it necessary to make any additional changes in this section.
6.110 Paragraph 366 of Annex G refers to Dr. Guttenplan's opinion that oestrogen is genotoxic, but
that it may not be possible to "really estimate the ri sk at this point from such low levels of genotoxic

271 EC's reply to question 24 of the Panel after the first substantive meeting, Annex B-1, para. 137.
272 EC's comments on interim report, para. 56.
273 Appellate Body Report on EC – Hormones, para. 138; see also section VII.C.3.(d)(iii) of this report.
274 EC's comments on interim report, para. 56.

effects."275 Paragraph 393 of Annex G re fers generally to the issue of conducting risk assessments of
genotoxic substances with no threshold. 276 The Panel believes it has dealt with these issues in the
amendments mentioned above.
6.111 Paragraphs 713 and 716-718 of Annex G reflect Dr. Guttenplan's opinion that although,
because anything is possible, there may be a risk from consumption of meat derived from cattle
treated with oestradiol-17 β for growth promotion purposes, it is so low that it is not susceptible to
calculation. It also reflects an interjection by the European Communities asking Dr. Guttenplan to
confirm his statement that, although the risk is smal l and cannot be evaluated or calculated, it is not
zero.
6.112 The Panel does not believe that these statements ar e directly relevant to the Panel's reasoning
on whether the European Communities conducted a risk assessment consistent with the definition set
forth in Annex A(4) of the SPS Agreement. As the Panel has noted, the purpose of the risk assessment
is to evaluate the possibility that an identified adve rse effect comes into bei ng, originates, or results
from the presence of the identifie d additives, contaminants, toxins or disease-causing organisms in
food, beverages or feedstuffs. It is not to guara ntee that said possibility w ill be below the Member's
appropriate level of protection or indeed will be zero.
6.113 Finally, the European Communities cites Dr. Guttenplan's written response to question 17 of
the Panel. In that paragraph, Dr. Guttenplan st ates that the absence of catechol metabolites in meat
from treated animals does not imply that the meat is without risk for genotoxicity. Dr. Guttenplan
was being asked to evaluate a particular argument by Canada. The Panel does not read this statement
as implying that the residues of oestradiol-17 β in meat from treated cattle are definitely genotoxic.
However, even if this were the case, the issue of ge notoxicity is only relevant to the issue of whether
a threshold could be determined for this substance. Again, the Panel believes it has addressed this
point with the additions and edits suggested above.
6.114 The European Communities also refers the Panel to various interventions by Dr. Cogliano at
the Panel meeting with the experts, namely, pa ragraphs 400, 404, 406, 409, 870, and 1021-1025 of
Annex G. 277 In paragraphs 400, 404, and 406 of Anne x G, Dr. Cogliano provides the Panel with
general background information on the issue of th resholds and linear dose response curves. The
comments are not specific to the Opinions of the European Communities and therefore are not
relevant to the analysis the Panel is undertaking in this particular section. Paragraph 409 of Annex G
contains a question from the Chairman. The Pane l is unsure whether the European Communities
meant to refer to paragr aph 408 or paragraph 410. 278 In any event, in both those paragraphs
Dr. Cogliano provides general background informa tion on what is meant by a linear dose response
curve.
6.115 Dr. Cogliano, in paragraph 871 of Annex G279, states that the data are not sufficient to conduct
a "JECFA-style" risk assessment if oestradiol-17 β has no threshold. The Panel finds this statement
unremarkable for two reasons. First, the Panel is not evaluating whether the European Communities
has done a "JECFA-style" risk assessment, but whet her it has done a risk assessment consistent with

275 Transcript of the Panel meeting with the experts, Annex G, para. 366.
276 Transcript of the Panel meeting with the experts, Annex G, para. 393.
277 EC's comments on interim report, paras. 56-58.
278 Because the specific paragraph references by th e European Communities in its comments on the
interim report frequently tend to differ from the versio n in Annex G, the Panel believes that the European
Communities must have prepared its interim comments with a different version of the transcript than the one
contained in Annex G. In each instance of mistaken citation, the Panel has read the paragraphs in the transcript
surrounding those cited by the European Communities to ensure that it has correctly identified and is responding
to the concerns expressed by the European Communities.
279 Paragraph 870 is the Chairman giving the floor to Dr. Cogliano.

the definition set forth in Annex A(4) of the SPS Agreement. Second, the European Communities has
not argued that there is insufficient data to conduct a risk assessment of oestradiol-17 β, it has argued
that it has conducted a risk assessment of oestradiol-17 β that is consistent with the SPS Agreement,
that its measure is based on that risk assessment and that, consequently, it has acted consistently with
Article 5.1 of the SPS Agreement. Dr. Cogliano's statement, in the paragraph cited by the European
Communities, is not directly relevant in this context.
6.116 Paragraphs 1021 through 1025 of the transcript of the panel meeting with the experts report a
discussion where both Drs. Boobis and Cogliano confir m that the fundamental difference between the
JECFA study and the SCVPH Opinions is the willingn ess to assume a threshold and interpret the data
from that standpoint. The Panel has now cited these interventions in the new paragraphs 7.465, 7.466
and 7.530.
6.117 In its comments on the interim report, the Eur opean Communities argues that if the Panel had
properly looked at Dr. Cogliano's interventions in th ese paragraphs of the transcript the Panel would
have had to conclude that the European Communities' risk assessm ent has followed one side of a
legitimate debate while JECFA has followed another. 280 The European Communities seems to imply
that if the Panel recognizes this it would also c onclude that the European Communities' ban on the
importation of meat and meat products from cattle treated with oestradiol-17 β for growth promotion
purposes was based on a risk assessment within the meaning of Article 5.1 and Annex A(4) of the
SPS Agreement. The Panel does not see the issue in quite the same manner as the European
Communities. The issue is not whether a risk assessment following the four steps as defined by
Codex could or should have been completed. Th e issue is whether the European Communities has
conducted a risk assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement.
6.118 The Panel does not take a position on the science or on how to evaluate data when a particular
substance exhibits no threshold. 281 However, whatever approach the European Communities adopts
in its assessment of the risks, it is obligated to co nduct a risk assessment that is consistent with the
definition set forth in Annex A(4) of the SPS Agreement. The Panel finds that the SPS Agreement
requires an analysis that goes beyo nd the identification of a potential adverse effect. The analysis
must include an examination of the potential for that adverse affect to come into being, originate, or
result from the presence of the specific substance under review in food, beverages, or feedstuffs, in
this case oestradiol-17 β in meat and meat products derived fro m cattle treated with the hormone for
growth promotion purposes. The Panel will not prescribe a particular manner or approach for how the
analysis should be conducted, but the analysis must be conducted.
6.119 The intervention by Dr. Sippell in paragra ph 576 of Annex G cited by the European
Communities mentions a scientific study cited in the 1999 Opinion which posits that the radioimmuno
assays originally used to calculate daily endoge nous production levels of the hormones may have
overestimated these levels. The Panel addressed this i ssue, by inserting in paragraph 7.535 quotations
from the 1999 SCVPH Opinion on this issue directly, and a new paragraph 7.536.
6.120 Additionally, the Panel felt that more direct quotation from the Opinions with respect to the
other identified potential adverse effects would provide greater clarity. Therefore, the Panel modified
paragraphs 7.534 and 7.535.

280 EC's comments on interim report, paras. 57-64.
281 EC's comments on interim report, para. 78. Contra ry to the assertion of the European Communities,
the Panel does not endorse any one particular way to approach risk assessment.

6.121 The European Communities also refers to a statement by Dr. Boobis at paragraph 725 of
Annex G.282 The Panel has reviewed the surrounding pa ragraphs and found that, like Dr. Guttenplan,
Dr. Boobis had engaged in an exchange with th e European Communities about the concept of zero
risk. Again, Dr. Boobis confirms that science cannot provide absolute assu rance of the absence of
risk or an absolute guarantee of safety. Dr. Boobis also states "it is not clear to me how you would
ever conduct a risk assessment and guarantee that, w ithout ensuring zero exposure, and of course that
would cease all use of all compounds where there is any risk whatsoever, and they all have some
risk."283
6.122 As with the citations to Dr. Guttenplan's statements at the meeting with the Panel, the Panel is
unclear what the European Commun ities believes this reference to certain statements by Dr. Boobis
will add to the Panel's reasoning on whether it c onducted a risk assessment consistent with the
definition set forth in Annex A(4) of the SPS Agreement. The Panel notes again that the purpose of a
risk assessment is to evaluate th e possibility that an identified a dverse effect comes into being,
originates, or results from the pr esence of the identified additives, contaminants, toxins or disease-
causing organisms in food, beverages or feedstuffs, not to guarantee that said possibility will be below
a Member's appropriate level of protection or indeed will be zero.284
6.123 The European Communities argues that in paragraphs 7.557 to 7.566 the Panel relies solely
on the responses of Drs. Boobis and Boisseau and does not reflect the opinions of the other experts.285
6.124 The Panel notes that the relevant sec tion is from paragraphs 7.552 to 7.572 and that the Panel
cites Dr. Cogliano and Dr. Guttenplan in paragraph 7.568, and Dr. Guttenplan again in
paragraph 7.569. Nevertheless, the Panel has examined the written answers of the other experts to the
same questions of the Panel as well as the transcript of the Panel meeting with the experts and made
additional references to experts' statements.
6.125 The European Communities argues that the Panel is in error in paragraph 7.570 when it states
that the only study cited with respect to su sceptible populations was one having to do with in utero
exposure to DES, which is banned in the United States.
286 The Panel has reviewed the paragraphs in
the 1999 Opinion referenced by the European Co mmunities. Although the European Communities is
correct that other studies regarding susceptible popul ations are referenced in section 2.2.2.4 entitled
"Potential adverse effects of exogenous sex hor mones on growth and puberty upon exposure of
prepubertal children," the Panel, in paragraph 7.57 0, was specifically referring to the link between
cancer and consumption of hormone treated meat. With respect to that specific identified potential
adverse effect, the only study mentioned in section 2.3.2.4 under susceptible populations with respect
to oestrogen is one involving in utero exposure to DES. The Panel modified the third sentence of
paragraph 7.570.
6.126 Additionally, based on the European Communitie s' comment, the Panel also reviewed the
paragraphs in the interim report wh ich dealt with Section 2.2.2.4 of the 1999 Opinion. In order to
ensure that the Panel fully reflect s the science the European Communiti es relied upon in this section,
the Panel amended paragraph 7.533.

282 Paragraph 725 is an interjection by Canada. See transcript of the Panel meeting with the experts,
Annex G, para. 725.
283 Transcript of the Panel meeting with the experts, Annex G, paras. 723 and 729.
284 The Panel notes that the Appellate Body in para 186 of its report on EC – Hormones, asked "if a risk
is not ascertainable, how does a Member ever know or demonstrate that it exists?"
285 EC's comments on interim report, footnote 11.
286 EC's comments on interim report, footnote 11.

6.127 The European Communities argues with respect to paragraph 7.572 that because the Panel
based its findings on the views expressed by the "most convincing" experts, the Panel has failed to
make an objective assessment of the matter, failed to take properly into account the totality of the
available evidence and failed to give proper weight to different scientific views which are based on
genuine and legitimate scientific grounds. The Eu ropean Communities also argues that the Panel's
"most convincing" experts are the ones it had alleged had a conflict of interest.
6.128 The Panel bases its analysis in this section on its own reading of the plain language in the
Opinions which was corroborated by the views expr essed by the experts and this combination leads
the Panel to its conclusions. Additionally, the Pa nel disagrees with the European Communities that it
fails to examine the totality of the evidence or to give proper weight to particular scientific views. As
the Panel notes, it does not disregard any of the statem ents by the experts. However, the Panel could
not possibly provide full quotations of every answer or statement of every expert. The fact that the
Panel may have cited specific passages from speci fic experts does not mean that the Panel did not
consider and weigh all of the responses.
6.129 The Panel, after reading the Opinions, the expert s' answers to questions, the transcript of the
meeting with the experts, and the parties submis sions and comments, made a determination about
which experts had provided the Pane l with answers that responded to the questions asked in a clear
and consistent manner supported by expertise and evidence. This determination is the essence of
weighing the evidence. As the Panel noted in paragraphs 7.552 -7.572, the section to which paragraph
7.572 belongs, the Panel cited Dr. Boisseau, Dr. B oobis, Dr. Cogliano and Dr. Guttenplan. These are
the experts who answered the relevant questions and who had identified expertise in risk assessment,
toxicology, studies of carcinogens, and biochemistry. 287 The Panel regrets if it caused any confusion
by using the phrase "most convincing" and accordingly clarified paragraph 7.572.
6.130 The European Communities fails to see why the Panel, after having concluded that there is no
risk assessment, goes on to examine whether the scien ce supports the conclusions in the Opinions and
asks for more explanation than previously provided for. The Panel modified paragraph 7.538 in order
to provide additional explanation.
(v) Comments on the Panel analysis regarding the other five hormonal substances
6.131 The European Communities argues that paragra ph 7.605 is unclear and seems irrelevant for
the further analysis of the Panel. The European Co mmunities first argues that, in its oral statement, it
spoke about whether a risk assessment can reach a definitive conclusion, not whether or not it is
possible to perform a definitive risk assessment. Firs t, the Panel recalls that the EC reference to a
"definitive risk assessment" is found in the EC second written submission. 288 Second, the Panel does
not see any real difference between "reach[ing] a de finitive conclusion" and making a "definitive risk
assessment". Its reasoning in paragraph 7.605 thus applies equally to both statements.
6.132 Second, the European Communities considers that the Panel should have referred to what the
experts said at the hearing about the issue of whet her scientific data can ever allow for a definitive
conclusion to be reached. This seems to suggest that the European Communities no longer argues that
what matters in order to justify the application of Ar ticle 5.7 is whether a definitive conclusion can be
reached or whether a definitive ri sk assessment can be made. If this is correct, the Panel does not
believe that it is entitled to address new argument s at the interim review stage. The Panel
nevertheless reviewed the comments of Dr. Cogliano referred to by the Eu ropean Communities. In
paragraph 776 of Annex G, Dr. Cogliano suggests that there can be different types of risk
assessments, depending on the specificity of the risk one wishes to identify. The Panel fails to see in

287 Transcript of the Panel meeting with the experts, Annex G, paras. 54-72.
288 Inter alia in paras. 137, 143, 149, 153, 176 and 183.

what respect this statement affects its finding in paragraph 7.605. As recalled by the Panel in its
findings289, the type of risk assessment requested under Article 5.1 is a risk assessment within the
meaning of Annex A(4) of the SPS Agreement, which is not one of the types of risk assessment
identified by Dr. Cogliano. It is in the context of the completion of a risk assessment within the
meaning of Article 5.1 and Annex A(4) of the SPS Agreement that the Panel discussed the EC
argument regarding a "definitive risk assessment" or a "risk asse ssment reach[ing] a definitive
conclusion". The other comment of Dr. Cogliano referred to by the European Communities 290
suggests that data may be sufficient to do one type of risk assessment (e.g. "the JECFA-style ADI")
but not one based on a theory according to which it is not possible to identify a dose below which
there is no risk, because there is a risk at an y dose level, even the low doses one might find in
hormone-treated meat. The Panel notes in this rega rd that this is different from arguing that one
should be able to invoke Article 5.7 because one cannot make a "definitive risk assessment". As
mentioned by the Panel, the Appellate Body in Japan – Apples did not say that relevant scientific
evidence would become insufficien t if a Member could not perform a particular type of risk
assessment, but only if it would be unable to perform a risk assessment within the meaning of
Article 5.1 and Annex A(4) of the SPS Agreement.
6.133 Having also regard to the comments of the United States of 19 October 2007, the Panel did
not deem it necessary to delete or modify paragraph 7.605.
6.134 The European Communities make s a general reference to its second written submission and
takes issue with the assessment of the Panel in paragraphs 7.649 to 7.721 by stating that the Panel did
not properly and fully examine the reasons contained in the Opinions and relied exclusively on certain
statements of a minority of the experts it had chosen to advise it, while ignoring pertinent statements
of the other experts. The Panel notes that it addressed the EC comments on its findings where they
were directed at precise aspects of the interim report. This was the case regarding comments on the
Panel's reliance on the views expressed by some of the experts it consulted and for comments
regarding the existence of sufficient relevant scientific evidence. The Panel does not deem it
necessary to address those issues in general terms here.
6.135 The European Communities finds the Panel refere nce to a risk assessment "in substance" in
paragraph 7.628 to be "entirely unclear". In the opinion of the Panel, one can always follow each of
the Codex steps provided for the gathering and analysis of scientific evidence. However, in order to
be a risk assessment within the meaning of Article 5.1, that exercise must reach scientific conclusions
that are supported by the scientific evidence therein. 291 Thus, the possibility to complete a risk
assessment depends on whether the relevant scientific evidence is sufficient to support a conclusion
on whether the identified adverse effect arises from, comes into being, or occurs as a result of the
presence of the substance at issue in food, beverages, or feedstuffs.
6.136 The European Communities seems to suggest, in substance, that whether a risk assessment
can be completed depends on the level of protec tion chosen by a given Member. The European
Communities seems to link the conduct of the risk assessment with the desired outcome of a given
SPS measure; i.e., to ensure zero risk. The Panel believes that this is not what the SPS Agreement
requires. The Panel considers that the European Communities' interpretation is not supported by the
text of Article 5.7, which only refers to the insuffi ciency of relevant scientific evidence. There is no
indication that this insufficiency is to be assessed in relation to the Member's level of protection.
Otherwise the negotiators would have stated "in cases where relevant scientific evidence is
insufficient in the light of the level of protecti on chosen by the Member adopting of maintaining a
sanitary measure". Nothing in the context of Ar ticle 5.7 suggests this interpretation either.

289 See paras. 7.443-7.444.
290 Annex G, para. 871.
291 Panel Report on Japan – Apples (Article 21.5 – US), para. 8.136.

Articles 2.2, 3.3 and 5.1 provide relevant contextual support for the proposition that the purpose of the
SPS Agreement was to ensure that Member's SPS measures are "objectively justified" 292 by science.
This purpose would be defeated if a Member could invoke Article 5.7 whenever relevant scientific
evidence is insufficient to objectiv ely justify the type of measure that would achieve a particular
desired level of protection. The Panel modified paragraph 7.628 in order to clarify what it meant.
6.137 Regarding paragraphs 7.630 to 7.637, the European Communities argues that the Panel's
discussion does not do justice to the role genuine sci entific uncertainty plays in risk assessment. It
contests the Panel's exclusive reliance on the opinion s of Dr. Boisseau and Dr. Boobis and refers to
statements by experts other than those quoted by the Panel. As far as the Panel's reliance on
Dr. Boisseau and Dr. Boobis is concerned, it should be recalled that this is a risk assessment issue and
these two scientists were selected by the Panel inter alia because of their expertise on risk assessment.
Yet, Dr. Boisseau and Dr. Boobis were not the only ones with the same view. Dr. Tritscher's remarks
on the subject also support the Panel's conclusion.293
6.138 None of the interventions of experts cited by the European Communities in its comments
contradicts the conclusions reached by the Panel in its interim report, which are clearly spelled out in
paragraph 7.637. More particular ly, none of Dr. Cogliano's statements cited by the European
Communities contradicts the Panel. In the pa ragraphs cited by the European Communities,
Dr. Cogliano mainly explains the role of IARC and whether there is uncertainly about genotoxicity.
Similarly, in the paragraphs cited by the Europ ean Communities, Dr. Guttenplan says that there is
uncertainty about certain scientific issues, but he does not address the role of uncertainty in risk
assessment. Dr. Sippell addresses an issue unrelated to risk assessment. Dr. De Brabander addresses
the quality of data and improved methods. Regardi ng the alleged misinterpretation of some of the
statements of Dr. Boobis on the existence or not of genuine scientific uncertainty, it seems that the
paragraph referred to by the European Communities (Annex G, paragraph 1049) deals with a different
issue: that of scientific uncertainty in relation to U-shaped dose-response curves, not how scientific
uncertainty is treated in risk assessment.
6.139 The European Communities argues, with respect to paragraph 7.644 , that the risk assessments
performed by JECFA do not contain the specific evidence that the Panel allegedly found to be missing
in the EC Opinions and, therefore, cannot constitu te proper risk assessments. The Panel notes that
there is no reference to the JECFA risk assessment of oestradiol-17 β in the Panel's analysis of the
consistency of the European Communities' perman ent ban on meat and meat products derived from
cattle treated with oestradiol-17β for growth promotion purposes, because the European Communities
claimed that it completed its own risk assessment for oestradiol-17 β. The Panel thus conducted an
analysis of the SCVPH Opinions and sought to de termine whether they complied with the definition
of a risk assessment in Annex A(4) and whether the science contained therein supported the European
Communities' decision to institute a total ban. Unlik e the analysis under Article 5.7, with respect to
oestradiol-17β the Panel was not trying to determine whether there was sufficient scientific
information to conduct a risk assessment. The Panel r ecalls that the fault it found with the Opinions
was not that any particular piece of evidence was missing, but rather that the Opinions did not
specifically analyse the risk of the identified adverse effects arising from the presence of
oestradiol-17β in food, beverages, or feedstuffs. Th erefore, whether JECFA relied on the same
evidence as the European Communities in its analysis of oestradiol-17β is irrelevant. The Panel notes
that JECFA did take into account the dose levels in meat and meat products and attempted to calculate
the risk to humans from consuming typical amounts of meat. JECFA used a series of assumptions
regarding meat consumption, circulating levels of oestrogen in the blood for various sub-groups of the
population, etc. The European Communities may very well be right that there are other ways to
analyse the risk than those JECFA utilized. The Pa nel does not take a position on that issue. What

292 Appellate Body Report on EC – Hormones, para. 190.
293 Annex G, para. 348.

the Panel has said, is that such an analysis is required by Article 5.1 and Annex A(4) of the
SPS Agreement.
6.140 With respect to the Panel's reference to the con cept of "critical mass" in paragraph 7.648, the
European Communities request that we provide an explanation of where this criterion comes from and
whether it is in conformity with the findings of the Appellate Body in EC – Hormones.
6.141 The Panel used the term "critical mass" in full knowledge of its meaning. 294 It used it in the
sense of a situation where evidence becomes quan titatively and qualitatively sufficient to call into
question the fundamental precepts of previous know ledge and evidence. The Panel does not mean
that there must be sufficient evid ence to perform a new risk assessment. Otherwise, Article 5.7 of the
SPS Agreement would become meaningless. It used the term "critical mass" very much in its
common scientific usage, i.e. the new scientific info rmation and evidence must be such that they are
at the origin of a change in the understanding of a scientific issue. We do not see in what respect this
approach by the Panel, which applies to the speci fic situation in this case (i.e. one where a party
alleges that previously sufficient scientific evidence has become insufficient) would be contrary to the
findings of the Appellate Body in EC – Hormones.
6.142 The United States suggests in its counter-comments 295 that the Panel consider using the term
"weight of evidence" to explain its use of the "cr itical mass" criterion in conducting its analysis and
reaching its conclusions. The United States adds that the weight of evidence approach is standard in
science. Weight of evidence is explained by the experts primarily in paragraphs 487, 489, 493, 501 of
Annex G. At the experts' hearing, Dr. Boobis defined weight of evidence as:
"[T]he evaluation of the available information about a particular toxicological
endpoint taking into account factors such as the adequacy and number of available
studies and the consistency of results across studies. It is not an issue of seeking to
weigh one person's opinion against another." (para. 487)
and:
"This is not a question of what people think and minority opinions, it is a question of
looking at the data ... There is an element of interpretation of the quality of the study,
I accept, but that is why you have experts on the evaluation committee." (para. 501)
6.143 From the above it may be conclude d that weight of evidence is in the first instance concerned
with the quality of studies. "Badly done" studies ar e excluded so that the evaluation is based only on
studies that are "well done" i.e. studies carefully carried out using validated methods. In a second
stage, an assessor taking a weight of the eviden ce approach looks at the number of studies and the
consistency of results across studies. If one follows Dr. Boobis, in particular his comment in
paragraph 501 of the transcript (Annex G), the weig ht of the evidence approach may contradict the
views of the Appellate Body in paragraph 194 of its report in EC – Hormones because it would favour
the "mainstream" scientific opinion, whereas the A ppellate Body accepted that an SPS measure may
be based on a "divergent opinion coming from qualified and respected sources" and still be in
compliance with the substantive obligations of the SPS Agreement. This is why we do not wish to
replace the terms "critical mass" used in our report w ith "weight of evidence". In our view, a "critical

294 In mathematics and physics "critical" is defined as "constituting or relating to a point of transition
from one state, etc. to another". "C ritical size" or "critical mass" are defined as the minimum size or mass of a
body of a given fissile material which is capable of sustaining a nuclear chain reaction (Shorter Oxford English
Dictionary, 5th edition (1993), p. 558). In other words, the Pane l assessed whether it had been provided with the
minimum evidence necessary to conclude that knowledge has become quantitatively and qualitatively sufficient
to call into question the fundamental precepts of previous knowledge and evidence.
295 At para. 28.

mass" of scientific evidence and information could be small and may include situations where the
weight of the evidence has not shifted away fro m the existing prevailing knowledge, but where the
new knowledge is qualitatively and quantitatively suffic ient to create a situation where a Member can
legitimately decide that the pre-ex isting scientific evidence is no longe r sufficient to complete a risk
assessment within the meaning of Article 5.1 and Annex A(4) of the SPS Agreement.
6.144 The European Communities takes issue with paragraph 7.662. The European Communities
contests the Panel's approach in defining a list of general issues common to all five hormones. The
European Communities argues that it has identified exactly, for each hormonal substance, the sections
in the 1999 Opinion that deals i ndividually with that substance a nd suggests that the Panel's list of
"general issues" common to all five hormones is arbitrary.
6.145 The Panel first recalls that, as a general principle, panels are free to structure the order of their
analysis as they see fit. 296 The Panel does not deny that the EC Opinions addressed each hormone
individually. However, as explained in paragra phs 7.660 to 7.662, some issues were common to all
five hormones and the evidence provided was not alwa ys sufficiently specific to address a particular
issue in relation to each hormone individually. The Panel modified paragraph 7.652 to 7.663 and the
title to Section VII.C.3.(f)(vi) to reflect the fact that what is discussed are issues common to all
hormones for which hormone-specific evidence was not provided.
6.146 The Panel also clarified that certain insuffici encies identified in the EC Opinions had not as
such been discussed by the Europ ean Communities in its submissions. The Panel concluded that the
European Communities was not arguing that these pa rticular insufficiencies were what made it
impossible to complete a risk assessment. Ther efore, the Panel decided not to address these
insufficiencies. This may have prompted the EC comment that the Panel analysis on the individual
hormonal substances in paragraphs 7.722 to 7.830 was incomplete. The clarification brought by the
Panel demonstrates that it did not draw a random lis t of issues common to all hormones and explains
the reasons why a more limited number of issues was discussed compared with what had been
identified in the Opinions. The Panel has also clar ified this point in the sections relating to each
hormone individually and did not follow the request of the European Communities that it address each
and every issue of insufficiency raised in the Opinions.297
6.147 The European Communities contests the c onclusions of the Panel in paragraph 7.665,
footnote 792 as inaccurate, but without specifying why. In that footnote, the Panel refers to a new
method and new assays to detect small amounts of hormones in meat, mentioned in the 2002 Opinion.
From what is mentioned in the 2002 Opinion, the studies were on the subject of hormone levels in
meat, not in people. Whereas it might be possible to apply these method and assays to detect
endogenous levels of hormones in humans, the Eu ropean Communities does not argue this in its
comments, and this is not what the method and assays are about. It also appears that, according to the
2002 Opinion, the method and assays mentioned were not exactly successful or trustworthy. The
conclusion in section 4.1.1 of the 2002 Opinion, where the new method is discussed, reads: "[D]espite
a number of positive analytical results in this study, the low number of samples does not allow a
qualified validation of typical characteristics such as sensitivity, specificity, accuracy and
reproductibility." (2002 Opinion, page 9). The c onclusion of section 4.1.2, where the bioassays are
discussed, is that: "[T]he obtained results suggest that the use of recombinant yeast and rainbow trout
hepatocytes to detect oestrogenic compounds is not justified in view of their lack of sensitivity".
(2002 Opinion, page 9). It seems that, even if they were relevant in the context of paragraph 7.665,
this new method and assays do not contribute to a critical mass of evidence that would put into
question existing knowledge. The Panel, therefore, did not modify footnote 792.

296 Appellate Body Report on Canada – Wheat Exports and Grain Imports, para. 126.
297 EC's comments on Sections VII.C.3(f)(vii), (viii), (ix), (x), (xi).

6.148 With respect to paragraphs 7.667 to 7.670, the European Communities argues that the Panel
reduces the discussion to only two quot ations and draws a conclusion th at is not based on the debate
with the experts at the hearing. The European Communities argues that "much more was said about
this issue" at that hearing.298 The Panel notes, however, that the discussion related to the sensitivity of
children to hormones in general, without drawing an y direct link with any of the five hormones at
issue in this section, and to the validation of met hods, particularly of the new ultrasensitive assay (the
"Klein" methodology). The only hormone expressly discussed in relation to this assay was oestradiol-
17β. The Panel notes that it concludes in this secti on that (a) the studies using the new ultrasensitive
assay were limited to oestradiol-17 β; and (b) that the ultrasensitive assay had not been validated.
Thus, the Panel does not agree with the European Communities that its conclusions are not based on
the debate referred to above.
6.149 The European Communities requests that we cl arify the first sentence in paragraph 7.670.
More particularly, the European Communities requ ests that we specify whether this is a legal
argument or a scientific argument. The Panel consid ers that the finding that the evidence relates only
to oestradiol is not an argument but a factual cons ideration. The Panel considers that, since the new
detection method measured oestradiol only 299 and since no evidence was pr ovided that suggested that
extrapolation had been made or could be made to other hormones, the evidence is insufficient to
conclude, with respect to the five hormones subj ect to a provisional ban under Article 5.7 of the
SPS Agreement, that existing knowledge has been put into question.
6.150 With respect to the EC comment on the second sentence of paragraph 7.670, the Panel
confirms that, indeed, its understanding is that th e ultrasensitive detection method used by Klein and
subsequently relates only to oestradiol and has not been validated. This has been confirmed by
Dr. Boobis at the hearing. 300 As a result, the Panel cannot c onclude that existing knowledge and
evidence have been put into questio n by the results of the ultrasen sitive assay with regard to the
impact of the five hormones on prepubertal chil dren if the available evidence relates only to
oestradiol.
6.151 Even if the ultrasensitive assay had been validated and had demonstrated lower levels of the
five hormones at issue in this section – and not only oestradiol – in sensitive populations, the Panel
notes that the 1999 Opinion itself states that "[A] corollary is that perhap s the hormones residues in
beef, which are also low and which have also been determined by RIA are equally variable and over
representative of the actual hormone concentrations."301
6.152 In its comments regarding paragraphs 7.672-7.675 the European Communities considers that
the Panel's approach to the issue of dose response is flawed and circular.
6.153 The European Communities bases its contention th at the Panel's reasoning is circular on the
assumption that the Panel rejected the EC approach based on an absence of a dose response analysis.
Even though it rejected that approach in this particular case for oestradiol-17 β, the Panel did not
exclude that there could be situations where dose response would not apply. The Panel believes, on
the contrary, that it is the European Communities that is making contradictory arguments. The
European Communities cannot argue that "the Appella te Body clearly judged that a risk assessment
[could] be either qualitative or quantitative"
302 and that a dose response is not required in order to
complete a risk assessment and, at the same time, ar gue for the five hormones at issue that relevant

299 See para. 7.668 quoting Dr. Sippell. See, also, Dr. Sippell's statement in Annex G, para. 588.
300 Annex G, para. 572.
301 1999 Opinion, section 3.2, p. 30.
302 See EC reply to question 26 of the first series of questions of the Panel, para. 153, Annex B; see also
EC's second written submission, paras. 196-200.

scientific evidence is insufficient to perform a risk assessment because the data available do not allow
a dose response assessment. Yet, this is what app ears to be concluded in the 1999 Opinion as far as
the five hormones are concerned. The Panel nonetheless clarified the paragraphs at issue.
6.154 The European Communities argues that, in pa ragraph 7.677, the Panel declines to discuss
bioavailability on the basis that the studies relied upon by the European Communities do not relate to
the five hormones in question, but only to oestradiol and that there is no indication that the
conclusions can be applied to hormones other than oestrogens. The European Communities considers
that this assertion by the Panel is without foundation.
6.155 In order to reach its conclusion, the Panel examined most particularly the portions of the 1999
and 2002 Opinions quoted by the European Communities in its reply to question 28 of the questions
of the Panel after the first substantive meeting
303 and in its second written submission. 304 The two
extracts quoted by the European Communities addr ess only oestradiol, while making references to
oestrogens. Furthermore, the extract of the 199 9 Opinion quoted by the European Communities is
part of the section of the Opinion regarding oestradiol. The Panel notes that the European
Communities argued that "similar findings [had been] made for all the other five hormones".
305
However, the European Communities did not specify where such findings had been made. This
allegation has to be considered in relation to th e comments of the experts. The Panel nonetheless
deemed it necessary to clarify the section on bioavailability.
6.156 In its comments on the interim report, the Europ ean Communities also refers to the experts'
replies to question 43. The Panel first notes that th is question concerns bioavailability in general, not
the sufficiency of evidence regarding bioavailabili ty. The Panel has included quotations of the
relevant passages of the experts' replies in its findings. The Eur opean Communities also refers to
paragraphs 132 et seq. of the transcript of the hearing (Anne x G). The Panel reviewed the comments
of the experts on bioavailability and found that t hose comments address neither the bioavailability of
the five hormones at issue, nor the sufficiency or insufficiency of evidence on it.
6.157 With respect to paragraphs 7.685 to 7.700, the European Communities argues first that the
discussion on long latency of cancer and confounding f actors should have been in the Panel's analysis
under Article 5.1 of the SPS Agreement. We note that the Panel addressed this question to the extent
this was necessary for its analysis under Article 5. 1. The question of the latency period of cancer and
of the epidemiological survey of the occurrence of cancer in various populations was addressed in
paragraphs 7.567 et seq. The Panel also deemed it necessary to address the latency of cancer in its
section under Article 5.7 because the European Co mmunities argued that the long latency period of
cancer made it impossible to demonstrate positively th e existence of clear harm in relation to the
hormones at issue. The Panel first determined wh ether long latency of cancer was relevant for the
performance of a risk assessment for the hormones at issue. It then proceeded to determine whether
relevant scientific evidence in relation to the latenc y of cancer was insufficient to the point of making
it impossible to perform a risk assessment within th e meaning of Article 5.1 and Annex A(4) of the
SPS Agreement. In order to do this, it assessed whether it could be considered that a "critical mass" of
new information or evidence was now available wh ich could unsettle the way long latency of cancer
has been taken into account in risk assessment so far. The Panel clarified the part of
Section VII.C.3.(f)(vi) dealing with long latency of cancer and confounding factors in order to better
present its analysis.

303 Annex B-1, paras. 155-159.
304 Paras. 133-176.
305 EC reply to question 28 of the questions of the Pa nel after the first substantive meeting, Annex B-1,
para. 158.

6.158 The European Communities also argues that the section on long latency of cancer and
confounding factors is evidence that we applied a "double standard" of evid ence for the removal as
compared to the approval of the hormones at issue. We did not argue that JECFA or the respondent
performed the epidemiological studies necessary to demonstrate an absen ce of long term effect of the
hormones at issue in terms of cancer. We not e that the long latency of cancer has been
acknowledged. We also note that confounding factors make it difficult to assign a particular cancer to
specific circumstances of ingestion of hormone resi dues. We recall that JECFA's risk assessments
take into account the long latency of cancer thr ough the ADI. To the extent that the European
Communities disagrees with the approach followed by JECFA, it is for the European Communities to
provide a "critical mass" of evidence – not a "posi tive evidence" – that this approach is no longer
valid.
306 We conclude that, in these proceedings, the European Communities has not pointed at
evidence suggesting that long latency of cancer h as not been appropriately taken into account in
existing risk assessments.
6.159 The European Communities also takes issue with the Panel's discussion on the immunological
effect of the five hormones in paragraphs 7.701 to 7.708. The European Communities seems to raise
two issues in its comments. The first one is relate d to the question of whether a threshold approach
must be followed. The second one is whether the Pa nel dismissed the EC arguments on the basis that
the scientific evidence relates to oestrogens only.
6.160 Regarding the first issue, the Panel notes that all three experts who answered question 59 307
stated that there is no evidence of effects on th e immune system from doses such as those resulting
from consumption of meat from treated animals. If the point the Europ ean Communities wishes to
make in its comments is that the approach based on a "threshold" is not required to assess the effect of
the five hormones at issue on the immune system, th en the Panel fails to unde rstand why, under those
circumstances, the relevant scientific evidence on the effect of the five hormones on the immune
system is insufficient for the European Communities to perform a risk assessment for those hormones.
6.161 With respect to the second issue, the Panel notes that Dr. Boobis and Dr. Guttenplan address
the effect of oestrogen/oestradiol on the immune system (Dr. Boobis refers to "hormones such as
oestradiol"). As the Panel mentions in paragraph 7.704, the main reason for dismissing the EC
arguments on insufficiency of evidence regarding the effect of hormones on the immune system is the
fact that the evidence made available to the Panel re lates exclusively to the effect of oestrogens. The
European Communities has not identified any eviden ce that specifically addresses any of the five
hormones at issue in this section. The European Communities has not explained either to the Panel
why it thinks the evidence on oestrogens would be relevant for the other hormones. The Panel notes
in this respect that the Opinions do not identify an y evidence with respect to the five hormones that
residue levels in meat might have an effect on the immune system. The Panel nonetheless clarified
paragraphs 7.706-7.707.
6.162 Regarding paragraphs 7.709 to 7.721, the European Communities argues that the Panel quotes
Dr. Sippell as identifying adverse effects, but does not discuss his statement. The European
Communities adds that there is also no discussion of the other experts' views put forward at the
hearing.
6.163 Regarding Dr. Sippell's statement in paragra ph 7.714, the Panel has further discussed the
points raised by the experts on this matter in paragraphs 7.715 through 7.721.

306 In this respect, the Panel inserted a footnote in para. 7.648 to address the EC argument on standard
of proof.
307 Annex D, paras. 443-448.

6.164 With respect to paragraphs 7.700 to 7.713 of the interim report, the European Communities
argues that the Panel's discussion of the potential misuse and abuse in the administration of hormones
is in the wrong place, to the extent that this is an aspect of risk assessment, in the sense of Article 5.1
to 5.3 of the SPS Agreement, that is applicable across all iden tified potential risks and for all six
hormones. The Panel agrees with the European Communities that the question of misuse and abuse in
the administration of hormones may apply to all six hormones at issue and is an element that can be
taken into account in risk assessment, as set forth in Article 5.2 of the SPS Agreement and confirmed
by the Appellate Body in EC – Hormones. However, the Panel did not deem it necessary to address
this question in the section regarding the conform ity with Article 5.1 of the definitive ban on
oestradiol-17β, to the extent that the question whether misu se or abuse exists in the administration of
hormones did not have an impact on the issues addressed by the Panel under Article 5.1. 308 Indeed,
the question of misuse or abuse in the administration of hormones is relevant to the extent that it can
lead to higher concentrations of hormone residues in meat and meat products than would occur if
good veterinary practices were applied. As stated by the 1999 Opinion, it is an aspect of exposure
assessment. In this case, the Panel found that the European Communities had not evaluated
specifically the possibility that the adverse effect that it had identified in its risk assessment come into
being, originate, or result from the consumption of meat or meat products which contain veterinary
residues of oestradiol-17 β as a result of the cattle being treated with this hormone for growth
promotion purposes. Therefore, whether the concentrations of hormone residues in meat and meat
products could be higher as a result of misuse or ab use did not have to be addressed. The Panel does
not deem it necessary to move this section to another part of its findings.
6.165 Having regard to the point made by the Europ ean Communities that misuse and abuse in the
administration of hormones is an aspect of risk asse ssment within the meaning of Article 5.1 to 5.3,
the Panel reflected further on whether this issue re lated at all to the question of insufficiency of
relevant scientific evidence under Article 5.7. In the view of the Panel, the question of whether
JECFA properly took into account misuse and abuse in its risk assessments is irrelevant to the
question whether the European Communities can ta ke this matter into account in its own risk
assessment, since it has full discretion to do so pursuan t Article 5.2 and to the Appellate Body finding
in EC – Hormones. In that context, whether evidence exists of misuse or abuse in the administration
of hormones is not as such a scientific issue likely to make a risk assessment within the meaning of
Article 5.1 and Annex A(4) of the SPS Agreement impossible.
6.166 For these reasons, the Panel decided to delete th e section regarding misuse or abuse in the
administration of hormones from its final report and modified paragraph 7.603.
6.167 The European Communities argues that the Panel' s analysis on the issue of carcinogenicity of
progesterone in Section VII.C.3(f)(vii) is flawed . However, the European Communities does not
explain specifically in what respect it is flawed. The Panel therefore did not modify its reasoning.
6.168 The European Communities argues that the Panel' s analysis on the issue of carcinogenicity
and genotoxicity of testosterone in Section VII. C.3(f)(viii) is clearly incorrect and flawed. The
European Communities refers to a statement by Dr . Tritscher allegedly admitting that JECFA found
that there was scientific uncertainty about genotoxicity of testosterone.
309 The Panel consulted the
transcript and noted that Dr. Tritcher discussed the genot oxicity of oestradiol, not that of testosterone.
She did say that "all information is being looked at, in particular with compounds that have a
genotoxic potential", but she did not mention that progesterone had a genotoxic potential.
6.169 The European Communities argues that the approach and analysis of the Panel on the issue of
metabolism and carcinogenicity of trenbolone acet ate in Section VII.C.3(f)(ix) is flawed, inter alia,

308 It is nonetheless discussed in para. 7.483, in relation to Article 5.2 of the SPS Agreement.
309 Statement of Dr. Tritcher, Annex G, para. 463.

because JECFA's assessment defended by Dr. Boobi s and Dr. Boisseau dates back to 1988 and is
clearly outdated. The Panel has already discussed th is argument and considers that a risk assessment
does not become invalid merely because it is "old". The Panel believes that, in order to demonstrate
that a risk assessment is "outdated", a party must pr ovide studies showing that the data on which the
risk assessment is based are no longer valid.
6.170 The European Communities argues that the reasoning of the Panel regarding carcinogenicity
of zeranol is flawed, inter alia , because if the extrapolation to meat consumption mentioned by
Dr. Guttenplan was necessary, as the Panel seems to require in paragraph 7.799, this would have
amounted to a complete risk assessment in the sense of Article 5.1 of the SPS Agreement. The
European Communities argues that this is not the releva nt standard in the context of Article 5.7. We
agree with the European Communities that being able to perform a risk assessment compatible with
Article 5.1 is not the standard applicable in the cont ext of Article 5.7 and we do not consider that we
applied any such standard in this case. Indeed, the reason why the Panel paraphrased Dr. Guttenplan's
statement was not to say that th e European Communities could demonstrate that relevant scientific
evidence was insufficient only if it we re able to extrapolate some genotoxic effect of zeranol to meat
consumption. The point that the Panel wanted to make was that the extrapolation of the study
commented by Dr. Guttenplan would have entail ed, according to Dr. Guttenplan, a "myriad of
uncertainties". As a result, this study could ha rdly serve as a basis to put in question existing
knowledge. We clarified this in paragraph 7.799.
6.171 As regards the alleged application of a similar standard in paragraphs 7.803-7.804, the Panel
recalls that what has to be demonstrated for Article 5.7 to apply is that no risk assessment within the
meaning of Article 5.1 and Annex A(4) of the SPS Agreement can be performed. Our reference to
Dr. Guttenplan means that we consider, as mentioned in paragraph 7.637, that not just any form of
scientific uncertainty can justify a recourse to Article 5.7. As previously noted, we consider that when
scientific evidence has been sufficient, it may only be considered as insufficient if a critical mass of
scientific information and evidence exists, in terms of quantity and quality, to put into question
existing knowledge and evidence. We therefor e did not consider it necessary to modify our
reasoning.
6.172 In paragraph 7.812, the European Communities expresses its disagreement with the Panel's
approach consisting of applying a presumption of conformity with the SPS Agreement to JECFA's risk
assessment on melengestrol acetate (MGA), even t hough that risk assessment has not yet been
endorsed by Codex. The Panel has explained in paragraph 7.813 why some degree of relevance
should be given to JECFA's work, even though it is not formally a "standard, guideline or
recommendation" within the meaning of Article 3.2 of the SPS Agreement. The Panel also notes that
the European Communities does not sp ecify in which respect the Panel's analysis of the issue of the
residue data used by JECFA on carcinogenicity is fl awed, except for suggesting that the residue data
is "outdated", a question already addressed by the Panel in paragraphs 7.814 to 7.817.
6.173 Finally, the European Communities requests the Pa nel to clarify the meaning and extent of its
conclusion in paragraph 7.837. This paragraph simply states that, because relevant scientific evidence
is not insufficient, the European Communities cannot invoke Article 5.7. The corollary is that the
European Communities should be able to complete a risk assessment under Article 5.1. The European
Communities argues that the Panel should clarify fu rther how the risk assessment could be completed
in the presence of the gaps identified in the EC Opinions with respect to oestradiol-17 β. The gaps
identified in the EC Opinions for oestradiol-17β are:
(a) that the European Communities has not eval uated specifically the possibility of the
adverse effects related to the association between excess hormones and
neurobiological, developmen tal, reproductive and immunological effects, as well as
immunotoxicity, genotoxicity and carcinogenici ty coming into being, originating or

resulting from the consumption of meat or meat products which contain veterinary
residues of oestradiol-17β as a result of the cattle being treated with this hormone for
growth promotion purposes;
(b) The scientific evidence referred to in th e Opinions does not support the European
Communities' conclusions on genotoxicity, or the conclusion that the presence of
residues of oestradiol-17β in meat and meat products as a result of cattle being treated
with the hormone for growth promotion pur poses leads to increased cancer risk. The
scientific evidence does not support the EC conclusions on the adverse
immunological and developmental effects of consuming meat and meat products
from cattle treated with oestradiol-17β for growth promotion purposes.
6.174 Thus, the problems identified by the Panel are not related to the the fact that a risk assessment
cannot be performed, but rather that the Europ ean Communities did not conduct a risk assessment
pursuant to Article 5.1 and Annex A(4) and that the scientific evidence did not support the
conclusions which the European Communities re ached. The European Communities' comment
apparently underlines an approach to risk assessment that seems to consist of identifying a risk from a
particular substance and if there is any possib ility, no matter how remote, of that risk occurring
because of that substance, deciding that there is no need to further study whether the risk could arise
from the levels of that substance found in food , beverages, or feedstuffs. As discussed in
paragraph 6.112 above, the purpose of a risk assessm ent under Article 5.1 and Annex A(4) is not to
provide guarantees that risks will be below a particul ar appropriate level of protection or even zero,
but to objectively determine the possibility for the risk to arise from the presence of the substance
under review in food, beverages, or feedstuffs. The Panel therefore, does not believe that the
European Communities' approach to risk assessment, whereby the desired level of protection informs
the risk assessment rather than the risk assessment providing objec tive data to be utilized by a
government in determining how to achieve its appropri ate level of protection, is consistent with the
object and purpose of Article 5 of the SPS Agreement.
(b) Comments by the United States
6.175 The United States observes that the EC Opinions to which the Panel refers in the first
sentence of paragraph 7.482 address bioavailability and susceptibility of sensitive populations, but not
in vivo repair mechanisms. The United States refers the Panel to paragraph 46 of its second written
submission, where it noted that the Opinions ig nore the scientific evidence relating to human in vivo
DNA repair mechanisms. Therefore, the United Stat es requests that the Panel strike the phrase "and
in vivo repair mechanisms" from the first sentence of paragraph 7.482.
310
6.176 The Panel has reviewed paragraph 46 of the US second written submission as well as the
Opinions themselves and has found that the United St ates is correct that the SCVPH Opinions do not
mention the phrase " in vivo repair mechanisms". However, as also noted by the European
Communities in its comments of 19 October 2007, th ey do contain reviews of data on DNA adducts
and DNA damage and the Panel ma intains its conclusion that the European Communities did not
ignore the scientific evidence with resp ect to the effects of oestradiol-17 β on DNA. Therefore, the
Panel clarified paragraph 7.482 accordingly.
6.177 The United States also suggests that the Pa nel change the phrase "general risk" in
paragraph 7.537 as it may be confusing to the read er, because the Panel has carefully defined "risk",
but has not defined "general risk". 311 The European Communities, in its comments of 19 October

310 US's comments on interim report, p. 7.
311 US's comments on interim report, p. 8.

2007312, argues that the Appellate Body has already found, in EC – Hormones , that the EC risk
assessment at that time had indeed shown the "existence of a general risk of cancer".313
6.178 The United States' point about avoiding confus ion in terminology is well taken. The Panel
accordingly modified paragraph 7.537. However, the Panel will not use the term "identified the
hazard" as this too has very specific meanings as set forth in the Codex Pro cedural Manual and cited
in paragraph 7.448. Instead, it will modify paragraph 7.537 to read:
"All of the statements of the experts, a nd indeed statements from the Opinions,
indicate that the European Communities has evaluated the potential for the identified
adverse effects to be associated with oest rogens in general, but has not provided
analysis of the potential for these effects to arise from consumption of meat and meat
products which contain residues of oestradiol-17 β as a result of the cattle they are
derived from being treated with the hormone for growth promotion purposes."
6.179 The Panel also considers this correction to be in line with the finding of the Appellate Body in
paragraph 200 of its report on EC – Hormones referred to above by the European Communities.
6.180 When necessary, the Panel also made a number of minor editorial or typographical
corrections suggested by the United States. Howe ver, the Panel refrained from making the changes
suggested in two instances. With respect to the correction suggested in paragraph 4.234, the Panel
refers to paragraph 6.12 above. With respect to another correction suggested by the United States but
opposed by the European Communities (in paragraph 7.566), the Panel decided not to modify the
existing sentence to the extent that it paraphrase d a statement of Dr. Boobis. The European
Communities objected to any change by arguing th at it did not know what Dr. Boobis had actually
said since it did not have access to the tape recordi ng of the hearing with the experts. The Panel
notes, however, that the statement at issue comes from the written reply of Dr. Boobis to question 22
of the Panel, Annex D, paragraph 202.
VII. FINDINGS
A. P
ROCEDURAL ISSUES
1. Opening of the Panel meetings with the parties and experts for public observation
(a) Introduction
7.1 On 13 June 2005, at the first organizational mee ting of the Panel, the parties jointly requested
that the Panel's substantive meetings with parti es be open for public observation. Through written
questions, the Panel requested the parties to specif y the legal basis in the DSU for such a request.
Parties replied on 20 June 2005. On 30 June 2005, the Panel posed add itional questions to the parties
on the logistical implications of a hearing that was open to the public. The parties replied on
7 July 2005. The Panel held a second organizational meeting with the parties to discuss this issue on
8 July 2005.
314

312 Para. 23.
313 Appellate Body Report on EC – Hormones, para. 200.
314 The parties agreed to hold joint panel meetings in this case and that against Canada (WT/DS321)
and to harmonize the Panels' timetables.