Day 039 - 20 Oct 94 - Page 31
1 the document with a proposed regulation. Then there will
2 be a period when they call for comments. Then they will
3 make a final ruling on it. But they clearly are anxious
4 about it and anxious to determine whether or not the
5 provisions of the Delaney amendment apply.
6
7 Q. To go through the things that Mr. Justice Bell referred to
8 on page 21, do you want to refer us to reference 53?
9 A. Yes.
10
11 MR. JUSTICE BELL: It is 53 (b) in my bundle anyway.
12 A. Yes, the paper by Nitzan and others, direct adverse
13 effects, acute adverse effects on young children.
14
15 MR. MORRIS: If we go to the summary on page 279 of that
16 document: "A small outbreak of toxic
17 methemoglobinemia occurred among infants in a paediatric
18 ward. Investigation revealed that the most likely source
19 of toxicity was an approved fat preservative which had been
20 added to a soybean infant formula by the manufacturer. This
21 fat preservative contained three phenolic compounds having
22 highly effective antioxygenic properties (butylated
23 hydroxyanisole, butylated hydroxytoluene and propyl
24 gallate). The outbreak ceased when the offending agents
25 were eliminated from the food preparation".
26
27 MR. RAMPTON: My Lord, again I intervene. I fear, again on the
28 grounds of saving time, it looks now inevitable, I am
29 afraid, that Dr. Millstone will have to come back
30 tomorrow. I do not want him to have to come back next
31 week. I do ask what relevance the study in infants in
32 hospital and finding a substance in soya beans has to do
33 with McDonald's catering organisation.
34
35 MS. STEEL: It is not about soya beans; it is about the
36 additives added to the oil.
37
38 MR. RAMPTON: In infants' food.
39
40 MR. MORRIS: For Mr. Rampton's education, I would have thought
41 that if an additive added to one particular product had an
42 effect, then it may be relevant if it was added to a
43 different product; it may also have an effect as well.
44
45 MR. JUSTICE BELL: I think the point is that this paper deals
46 with its effect on babies between the ages of 6 and 15
47 weeks, and the suggestion has been that they were rarely,
48 if ever, customers at McDonald's.
49
50 MS. STEEL: I think it is relevant because, obviously, this was
51 something that was discovered by accident. It is less
52 likely to occur. You discover something like that by
53 accident in a group of higher age, because they are not all
54 likely to be fed the same thing at the same time.
55
56 MR. JUSTICE BELL: I think you can really keep it pretty short,
57 because you have to bear in mind that the leaflet was
58 produced, partly anyway, to be handed out to people who
59 were going to read it and use McDonald's, the parents of
60 those who might use McDonald's. You have to ask yourself
