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

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