Day 038 - 19 Oct 94 - Page 44
1 MR. JUSTICE BELL: No, wait. Are you going to tell him what the
2 adverse reactions are or are you going to ask him?
3
4 MR. MORRIS: Right. Sometimes I am trying to move on to save
5 time and then I cannot do it. (To the witness): If you
6 just say what the problems are with Sunset Yellow and why
7 you think it should not be available.
8 A. OK.
9
10 MR. JUSTICE BELL: Bear in mind that I have read (because you
11 have not changed this) what appears at pages 9 and 10 of
12 your statement, Dr. Millstone.
13 A. Indeed, yes. Can I just make it clear that in
14 preparing this text, I have not been able to make an
15 exhaustive search of all the literature, but I have
16 reported here as what has readily come to hand. But my
17 grounds for concern about Sunset Yellow fall into two main
18 -- under two main headings; firstly, acute adverse
19 reactions, the existence of which has been acknowledged by
20 the Committee on Toxicity. As I indicate halfway down the
21 page at page 9, that as long ago as 1979 they were
22 referring to some evidence published in 1974 in The
23 Archives of Dermitology indicating that Sunset Yellow
24 provoked acute adverse reactions to skin, to eczema. My
25 recollection is that that -----
26
27 MR. JUSTICE BELL: Where are you now in your statement?
28 A. Halfway down page 9, footnote 1. Michaelsson's study
29 was, I believe, a study of consumers rather than an
30 occupational study of people handling the material in very
31 large quantities. So, it is evidence that ordinary
32 consumers do react adversely to it.
33
34 More recently, I have cited on the next page, footnote 9, a
35 paper by Gross and others indicating in that particular
36 case, I believe, a double-blind challenge of
37 gastroenteritis being triggered by Sunset Yellow which in
38 the US is known as yellow dye No. 6. So, that Sunset
39 Yellow is capable of provoking symptoms of acute
40 intolerance seems not to be contested, although there might
41 be a dispute about how frequently that occurs.
42
43 The other concern I refer to has to do with gross changes
44 at high doses in rodent studies with proliferative legions
45 and tumours in rodents. I mean, three per cent and five
46 per cent are relatively high doses indeed. They are
47 dismissed by the Committee on Toxicity because there are
48 relatively high rates of such tumours in the control
49 groups.
50
51 One of the chronic problems with interpreting toxicological
52 data is, what is the relevant comparator by which to judge
53 the significance of any change? Sometimes a group of
54 scientists will compare the cancer incidence in a group of
55 animals to the concurrent controls, and at other times to
56 the historical controls, the historical average for
57 controls of that species kept under those kinds of
58 conditions.
59
60 In this case it is disregarded because there is a relative
