Day 039 - 20 Oct 94 - Page 10
1
2 MR. JUSTICE BELL: If I may say so, that is sensible because
3 these three categories -- not to beat around the bush --
4 were ways of dismissing the matter. They could be
5 dismissed as comparatively rare, not very serious and
6 reversible, or as produced only by a very high dose, or on
7 the basis that there was no satisfactory evidence of them.
8
9 So, I do not want to really say any more. Mr. Morris, you
10 must take your witness, but what you are going to be asked,
11 if there is something in human reactions which concerns
12 you, tell us about it.
13 A. While we are on the subject of categorisation,
14 yesterday I offered a categorisation in respect of all the
15 additives on the positive list which was different from
16 either of the two we have just outlined. Yesterday you
17 indicated that if I could locate these compounds under my
18 headings of probably reasonable presumption of safety or
19 may pose a hazard to a small proportion of the population
20 or may pose a chronic hazard to the entire population and
21 so on, you indicated yesterday you might like me to use
22 that categorisation.
23
24 MR. JUSTICE BELL: You use your own. I am anxious we spend less
25 time talking about the form of the evidence and more time
26 on hearing the evidence.
27 A. OK. Might I then just comment briefly, back to Sunset
28 Yellow, notwithstanding my previous remarks that I did not
29 have anything to add, because the effect in the animals
30 reported at the bottom of page 9 of my text was a reaction
31 occurring only at a very high dose, but my remarks were
32 intended to convey the suggestion that that was not of
33 itself sufficient reason for disregarding it, but were
34 grounds for thinking it was worthy of further
35 investigation, despite the fact that the regulatory
36 authorities have chosen to disregard it.
37
38 MR. JUSTICE BELL: Just pause there. Mr. Rampton, Professor
39 Walker's high dose, though, related to observed human
40 reactions.
41
42 MR. RAMPTON: I do not even know about "observed". He was not
43 asked about that. Whether it was his view that that sort
44 of reaction in humans could occur at high doses and whether
45 that was an inference from the existing data drawn from
46 human and animal experiment or whether there are data drawn
47 from actual observations in humans at high doses, I am not
48 clear.
49
50 MR. JUSTICE BELL: But when I said "high dose" it was not that
51 it had been observed in high doses in animals; he was not
52 considering ----
53
54 MR. RAMPTON: No.
55
56 MR. JUSTICE BELL: -- animal reactions; he was considering only
57 human reactions.
58
59 MR. RAMPTON: That is because of the way in which the abstract
60 is framed.
