Day 039 - 20 Oct 94 - Page 70
1 are singularly unsensitive and, therefore, if you find an
2 effect at a high dose and you want to know whether it might
3 give prima facie indication of an adverse effect that might
4 occur at a relatively lower incidence at a lower dose in a
5 very large population, 55 million people, the appropriate
6 way to respond would be to increase the size of the dose
7 quite -- sorry, increase the size of the animal groups
8 correspondingly.
9
10 Now, you have tried to press me a few questions back on the
11 motivations of the members of these regulatory committees
12 and why they did or did not share my perspective. My
13 suspicion is this: As I indicated, I do not have direct
14 evidence since I am not a participant in closed meetings,
15 but it is clear that industrial companies would be
16 extremely uncomfortable at being asked to test these
17 compounds in significantly larger groups of animals because
18 that would substantially increase the costs, and they would
19 see that as economically undesirable.
20
21 It might be that, for all I know, one of the reasons why
22 these committees have not called for the kinds of studies
23 that I am calling for is because it would be financially
24 disadvantageous to companies whom from time to time might
25 sponsor them.
26
27 But if the objective of the exercise were the protection of
28 public health rather than helping companies negotiate their
29 way through the regulatory hurdles, then I think the
30 approach I am advocating would be adopted.
31
32 Q. I would like to pursue the question that I asked you. Can
33 you go back then, please, to page 8 of this document, page
34 260 of the file, which is the JECFA report about BHA?
35 I have heard what you said about large groups. Whether his
36 Lordship thinks it is a convincing answer is another
37 question. But, as a matter of realities, I want you to
38 attend to what actually happened in some of these studies.
39
40 Look, first of all, at Ito's study of 1986 and Tamano also
41 1986 -- the first complete paragraph on page 260 -- that is
42 to say, after the break in the left-hand column?
43 A. Can I just look back at the heading of this section?
44 OK, please continue.
45
46 Q. "In a similar study ... other workers reported that after
47 104 weeks exposure to [a variety of dosages] from 0 to 2
48 per cent BHA given by powdered diet to groups of 50 male
49 F344 rats", then it goes on about body weights. Then it
50 tells us about hyperplasia at the end of the first four
51 lines on the next page, does it not?
52 A. Yes.
53
54 Q. Before I ask you a question I want to read on: "This work
55 was confirmed by a study in which male F344 rats" -----
56 A. I am not with you. Which line are you on now?
57
58 Q. The first complete paragraph.
59 A. Of the next page, OK.
60
