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World Trade

Organization







WT/DS320/R/Add.6

31 March 2008






(08-0904)










Original: English

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


Report of the Panel

Addendum

This addendum contains Annex F to the Report of the Panel to be found in document WT/DS320/R. The other annexes can be found in the following addenda:


– Annex A: Add.1

– Annex B: Add.2

– Annex C: Add.3

– Annex D: Add.4

– Annex E: Add.5

– Annex G: Add.7



ANNEX F
COMMENTS BY THE PARTIES ON THE REPLIES
OF THE SCIENTIFIC EXPERTS, CODEX, JECFA AND IARC
TO QUESTIONS POSED BY THE PANEL AND

COMMENTS BY THE PARTIES ON THE OTHER PARTIES' COMMENTS




Contents

Page

Annex F-1 Comments by the European Communities on the replies of the scientific experts to questions posed by the Panel (30 June 2006)

F-2

Annex F-2 Comments by the European Communities on the replies of Codex, JECFA and IARC to questions posed by the Panel (30 June 2006)

F-41

Annex F-3 Comments by the European Communities to the comments by the United States and Canada on the replies of the scientific experts to questions posed by the Panel (12 July 2006)

F-54

Annex F-4 Comments by the United States on the replies of the scientific experts, Codex, JECFA and IARC to questions posed by the Panel (30 June 2006)

F-101

Annex F-5 Comments by the United States to the comments by the European Communities on the replies of the scientific experts, Codex, JECFA and IARC to questions posed by the Panel (12 July 2006)

F-141

ANNEX F-1

COMMENTS BY THE EUROPEAN COMMUNITIES ON THE REPLIES
OF THE SCIENTIFIC EXPERTS TO QUESTIONS POSED BY THE PANEL

(30 June 2006)


A.General Definitions


Q1. Please provide brief and basic definitions for the six hormones at issue (oestradiol-17β, progesterone, testosterone, trenbolone acetate, zeranol, and melengestrol acetate), indicating the source of the definition where applicable.
EC Comments

Dr. Boisseau's reply does not consider any progress in toxicological knowledge concerning these hormones, and in particular estradiol, since the 70th and 80th JECFA reports. Since then new data concerning residues in tissue and their toxicological impact have been published. In his answer, he has only adopted a narrow regulatory definition. More specifically, as regards oestradiol, aromatization of androgens in estrogens is also very significant in adipose tissue. In his definitions, the sites of production in the human body is limited to the primary source and does not dwell on variability over the life span of an individual. Furthermore, his definition does not stress that Zeranol is a very potent estrogen. Zeranol is not a "natural estrogen" that humans are exposed to. In fact, great care should be taken to avoid the presence of fusarium molds in animal feed and especially in products for human consumption. As regards the implantation of these hormones, he uses simple present tense ("the ear is discarded") when precisely this is not known nor it is sure that it happens in practice in all cases. He should therefore have said that "the ear should be discarded at slaughter". Moreover, implantation can be made at the dewlap level, not only at the ear one, especially in case of multiple implantations. Furthermore, in some new recommendations of trenbolone use, it is possible to proceed to repeated implantation of steers or heifers.

Q2. Please provide definitions for the following terms as they relate to the hormones at issue, indicating the source of the definition where applicable: anabolic agents, steroids, steroidal oestrogens, parent compounds/metabolites, catechol metabolites, mitogenicity, mutagenicity, androgenic/oestrogenic activity, genotoxicity, genotoxic potential, carcinogenicity, and tumorigenicity. In your replies, please be sure to identify and describe any relevant differences between the terms.
EC Comments
Dr. Boisseau's reply that "In my e-mail of 26/04/06, I have indicated that I did not think that I am in the position to reply to this question" calls into question the reliability of his answer to question no 1 and indeed to the other questions. As the EC has pointed out during the selection procedure, Dr. Boisseau does not posses any expertise on these substances, as he does not appear to have carried out any specific research on these substances during his professional life. Dr. Boisseau has explicitly admitted it in his e-mail to the Panel secretariat where he wrote: "I did not join any publications as I have none on hormones".




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