Day 040 - 21 Oct 94 - Page 10
1 same consideration which you are dealing with in the
2 paragraph starting, "In 1983 the SCF"?
3 A. Forgive me, your Lordship. I did not quite catch the
4 question.
5
6 Q. If you look -- I have to turn away from you in order for me
7 to look at the bundle -- you have been referred to a
8 paragraph which starts, "In 1983 the SCF eventually
9 returned to Amaranth".
10 A. Yes.
11
12 Q. Is that the same matter you refer to in the paragraph
13 before when you say, "In 1983 the SCF awarded a permanent
14 ADI"?
15 A. Indeed, yes, it is.
16
17 Q. The last sentence of that shorter paragraph is: "In 1984,
18 however, JECFA reviewed essentially similar data".
19 A. Yes, indeed.
20
21 Q. Is that the document we are now looking at?
22 A. That is precisely this document and I am grateful for
23 your drawing my attention to it. I have obviously read
24 this document, but did not on that occasion provide a
25 precise footnote to it. This is indeed the document which
26 I read and am referring to.
27
28 MR. RAMPTON: No, you did not, and I am going to suggest a
29 reason why you did not in a moment, Dr. Millstone.
30 A. Sorry, I did not quite follow that. What is it that
31 I have not done?
32
33 Q. What you have not done, I will put it bluntly -----
34 A. I certainly have not provided a reference.
35
36 Q. What you have not done is to give due weight to what is
37 said in this 1984 JECFA Report. You have left the matter,
38 I suggest, in a state of equivocation with an implied
39 criticism of the SCF that the results of the long-term
40 study which they were awaiting in relation to renal
41 calcification were never forthcoming and yet they went
42 ahead just the same.
43 A. If you will forgive me, Mr. Rampton, I do not count a
44 90-day study as a long-term study. For a study in rats to
45 be long-term, I think it needs to be at least two years.
46
47 Q. That is my fault for describing a 90-day study as
48 long-term. You write: "... while requesting the results
49 of a further 90-day study to establish a no-effect level,
50 and to clarify the underlying mechanism". Then you go on a
51 sentence later: "Despite requesting the results of such a
52 study, the SCF has never subsequently commented on
53 Amaranth". I suggest to you, Dr. Millstone, that if one
54 looks at this JECFA document of 1984 one finds the results
55 of that 90-day study done at BIBRA; am I correct?
56 A. Would you be so kind as to point me to the place in the
57 JECFA document where I can find it?
58
59 Q. Yes, I will. This is, in fact, what is called a monograph
60 addendum to, no doubt, some previous report.