Day 039 - 20 Oct 94 - Page 24
1 magnitude, of the contribution of nitrite when used as a
2 preservative to the total nitrite load of the human body
3 and to the total nitrosamine load of the human body. There
4 is no dispute that I am aware of on the question of whether
5 or not nitrites contribute to the formation of
6 nitrosamines, or whether the nitrosamines are hazardous; it
7 is just a debate about relative risk: Both the
8 relationship between nitrosamines deriving from nitrite
9 used as an additive and other sources in nitrosamines, and
10 the relative risk between long, chronic toxicity from
11 nitrosamines against the acute toxicity of botulism that
12 nitrosamines are there to prevent.
13
14 MR. MORRIS: This raises an issue which came up before about
15 inadequacies in the manufacturing process, and I think,
16 I may be wrong, but there is some European or standard
17 position which is that additives should not be a substitute
18 for inadequacies in the manufacturing process; is that
19 correct?
20 A. Words to that effect are from time to time incorporated
21 into official documents, yes.
22
23 Q. Then the implication is there cannot be inadequacies in the
24 manufacturing process because there are regulations
25 governing ----?
26 A. Yes, I may have included remarks on this matter in one
27 of the documents I prepared for you.
28
29 Q. Professor Walker's impression was that there are rules and
30 regulations of manufacturing, so it is not an issue.
31 A. Yes, but the rules and regulations governing
32 manufacturing are typically cast in very vague terms. They
33 refer to what is called -- well, in the British regulations
34 they typically refer to the -- they invoke the expression
35 "good manufacturing practice".
36
37 When I attempted to establish the meaning of this term,
38 I approached the relevant section of the Ministry of
39 Agriculture, Fisheries and Food and I said: "How does one
40 decide what is and what is not good manufacturing
41 practice?" Their reply was: "Manufacturers decide what is
42 good and bad manufacturing practice". Therefore, I think
43 we are in a position where all manufacturers deem their own
44 practice to be good. Therefore, we have nominally a form
45 of words in regulations which are almost entirely
46 ineffectual.
47
48 The position at the European level is pretty much the
49 same. The regulations refer typically to quantum status,
50 the amount which is sufficient, and it is left to
51 manufacturers to make a judgment themselves. I think it is
52 important to point out that there are more specific
53 regulations which govern preservatives where there are
54 clearly acknowledged hazards of excess consumption of
55 preservatives, and in respect of these preservatives in
56 particular quantity of maxima levels are embodied in the
57 regulations for the use of nitrites and nitrates, both in
58 the UK and throughout the European Community.
59
60 Q. You said sodium nitrate is used as a colour fixative?
