Day 040 - 21 Oct 94 - Page 12

     
     1        requesting the results of such a study, the SCF has never
     2        subsequently commented on Amaranth", you might have
     3        included, "although JECFA in 1984 did comment on such a
     4        study".
     5        A.  Indeed I might have done, but the position is that it
     6        is a rather curious practice for the Scientific Committee
     7        for Food to leave an ADI in the state of being temporary
     8        when if they believed that evidence was available which
     9        would be sufficient for them to make it full and permanent
    10        for them not to comment on it.  But, while I recognise that
    11        JECFA have referred to this study and these data, I am
    12        certainly of the opinion that studies of this nature always
    13         -- I mean, the results of studies of this nature always
    14        stand in need of some interpretation and their significance
    15        is not entirely self-evident from a simple reading of the
    16        results.
    17
    18        So that, for example, firstly, in the BIBRA study conducted
    19        by Ford, Butler and Gaunt, the groups of rats comprised
    20        only 25, and the SCF might have taken the view that while
         that was considered sufficient for JECFA, it was not
    22        necessarily sufficient for the SCF.
    23
    24        Moreover, the rats in this study were first exposed to the
    25        Amaranth when they were, what for a rat, at any rate,
    26        counts as maturity, namely, 11 weeks of age, and not for
    27        the entire lifetime of the rat.
    28
    29        Now, it is quite possible that a toxicologist or a group of
    30        toxicologists, such as the Scientific Committee for Food,
    31        might say that when you are seeking to establish an
    32        acceptable daily intake, since the acceptable daily intake
    33        is supposed to be an intake which can be sustained for the
    34        entire duration of a human life or an animal life, an
    35        appropriate form of test is a test conducted from birth to
    36        death.
    37
    38        Therefore, there are possible limitations with this study
    39        which may or may not have concerned the SCF, but without
    40        their explicitly having discussed this, my point remains
         that they have not commented on it.  It is, indeed, correct
    42        that JECFA have reported it and JECFA have commented on it,
    43        and this is not a matter to which I have made explicit
    44        reference in my report.
    45
    46   MR. RAMPTON:  No.  You have not either made explicit reference
    47        to what may be the answer to what you have just told us
    48        about the age of the rats and their lifetime, have you?
    49        Would I be trespassing on your kindness if I asked you to
    50        read the whole of the next section? 
    51        A.  The long-term studies? 
    52 
    53   Q.   Yes, long-term studies, right down, please, to the top of
    54        internal page 7 on page 107, the right-hand column.
    55        A.  OK.  Are you asking me simply to read it without making
    56        any comments as I go?
    57
    58   Q.   I am asking you to read it to yourself.  Please tell me
    59        when you have finished, then I will ask you some questions.
    60        A.  Is there any reason why I should not make marks on the