Day 038 - 19 Oct 94 - Page 18
1 negative evidence, and typically invoke or search for or
2 hypothesize reasons for disregarding that evidence.
3
4 In doing so, it seems to me that they are, in effect,
5 failing to do what they are supposed to do, which is give
6 the benefit of the doubt to the consumers.
7
8 What they ought to do is -- well, let us take an example:
9 Let us suppose you find an adverse effect at a relatively
10 high dose in a laboratory animal; an example might be one
11 of the compounds at issue, the antioxidant butylated
12 hydroxy anisole or BHA, also known an E320, the widely used
13 antioxidant.
14
15 Now, it emerged from the study conducted in Japan that when
16 fed at two per cent of the diet this caused tumours in the
17 fore stomach of the laboratory animals. Now, human beings
18 do not consume this compound at anything like two per cent
19 -- probably less than 100. But when I read the discussion
20 of this evidence in the reports of the Scientific Committee
21 For Food and the Joint Expert Committee on Food Additives,
22 which I trust we can abbreviate to the customary acronym
23 JECFA, the JECFA Report and the SCF Report ----
24
25 Q. Can you keep your voice up?
26 A. Sorry. When I have scrutinized the reports of the SCF
27 and JECFA, what I find is that there is an underlying
28 assumption that the evidence cannot be a reliable guide to
29 the effects that the compounds have on humans, and a wide
30 range of possible reasons why they might sensibly be
31 disregarded are introduced.
32
33 Now, given that human beings do not consume BHA at those
34 levels, and given that it might possibly be the case that
35 the symptoms that were exhibited by those laboratory
36 animals arose by some gross overloading of their
37 biochemistry, it seems to me the sensible thing to do would
38 be to require further studies at lower doses, perhaps
39 closer to those consumed by humans, but in correspondingly
40 larger groups of rodents which might more effectively model
41 the effects which the compounds are likely to have on human
42 beings, lower doses in large groups. But that is not what
43 is done.
44
45 Therefore, what I find in the evaluations and
46 interpretations of the evidence presented by these expert
47 committees is what I can only characterise as systematic
48 willingness to ascribe the benefit of the doubt time and
49 again to the compound; assume it innocent until
50 definitively proved toxic, rather than presumed to be
51 hazardous until proved safe.
52
53 You are looking for what is to be taken to be adequate
54 evidence of safety in order to be admitted on to a list of
55 permitted compounds. I believe the threshold of acceptable
56 evidence of safety is typically far too low or far lower
57 than I am comfortable with, given that I believe the
58 primary focus of policy making should be the protection of
59 public health.
60
