Day 040 - 21 Oct 94 - Page 11

     
     1        A.  Which would probably be the -- well, no doubt it is
     2        indeed.
     3
     4   Q.   If you look under Explanation, it says this:  "Amaranth was
     5        last reviewed"----
     6
     7   MR. MORRIS:  Which page are we on?
     8
     9   MR. RAMPTON:  Page 169 of the file:  "Amaranth was last reviewed
    10        by the JECFA in 1982 ... when new studies on metabolism and
    11        mutagenicity were considered; no evidence of potential
    12        toxicity was revealed by these studies.  The temporary ADI
    13        of 0-0.75 mg/kg body weight established by the 22nd meeting
    14        of JECFA ... was extended to 1984 pending the submission of
    15        data from long-term feeding studies.
    16
    17        Since the previous evaluation, additional data has become
    18        available and is summarised and discussed in the following
    19        monograph addendum."
    20
         Then you see:  "Biological Data:  Special studies on renal
    22        calcification".  You see:  "Groups of 25 mature (11 week
    23        old) male and female Wistar rats were fed diets designed to
    24        provide intakes of 0, 20, 40, 80 or 1250 milligrams of
    25        Amaranth per kilogram body weight per day for either 28 or
    26        90 days.  Over the 90-day period, the actual intakes were
    27        close to the target figures", so on and so forth.
    28
    29        Turn over the page, you see in the second paragraph on page
    30        170:  "It was concluded that the calcification occurs only
    31        in animals with developing senile nephrosis.  The
    32        no-effect-level in this study was 80 milligrams of Amaranth
    33        per kilogram of body weight per day for 90 days".
    34
    35        The reference is Ford, Butler and Gaunt (1983), and if you
    36        turn over to page 171 you see Ford, Butler and Gaunt as the
    37        third reference (1983), "Report of the effects of Amaranth
    38        on renal calcification in the mature rat - a 28 and 90-day
    39        study.  BIBRA Report No.453/2/83. Unpublished report from
    40        the European Colours Steering Group submitted to the World
         Health Organisation."
    42
    43        That is the 90-day study to which the SCF have made
    44        reference, is it not?
    45        A.  It may well be that one.  There may have been others of
    46        similar duration.
    47
    48   Q.   Tell me why in your report for this court, where serious
    49        business is being conducted, Dr. Millstone, did you omit to
    50        notice that? 
    51        A.  Forgive me.  I am not sure whether you are saying 
    52        I omitted to notice it or I omitted to mention it, but I do 
    53        not quite see that either apply.  My point, I think, in the
    54        text remains entirely correct, namely, that I have searched
    55        in vain through subsequent reports of the Scientific
    56        Committee for Food for any evidence that they have reviewed
    57        or commented on this; I expect you would----
    58
    59   MR. JUSTICE BELL:  Let me put it another way.  I think part of
    60        what Mr. Rampton is suggesting, if you have, "Despite