Day 040 - 21 Oct 94 - Page 21

     
     1        committee, review these same figures they will interpret
     2        them in precisely the same way, or that they can therefore
     3        take JECFA's judgment as final and definitive.
     4
     5   MR. RAMPTON:  That is not what I am saying, Dr. Millstone, at
     6        all.  You postulate hyperplasia observed in rats as a
     7        potential hazard in humans because it is a precursor, or
     8        may be a precursor, of cancer; is that correct?
     9        A.  Yes.
    10
    11   Q.   How long do rats live?
    12        A.  They live on average in a laboratory approximately 2
    13        and a half years.
    14
    15   Q.   These rats were administered doses of up to 1250 milligrams
    16        per kilogram body weight per day for more than two years;
    17        despite evidence of hyperplasia, no carcinogenesis was
    18        observed, was it?
    19        A.  It is interesting the way in which the comments are
    20        written here on page 7, it says:  "These studies indicate
         that Amaranth is not carcinogenic to rats exposed" and so
    22        on.  If I had been a member of the committee I would not
    23        have been comfortable with that comment.  I would have
    24        thought that it would have been more felicitous to say
    25        these studies indicate that Amaranth was not carcinogenic
    26        to these rats.  I mean, I made the point before that you
    27        get variations and differences in the results of different
    28        tests, even between different laboratories using the same
    29        variety of the same species, between different species and
    30        different varieties.
    31
    32        My reading of the literature is that while in this
    33        particular BIBRA study, in this particular group of rats,
    34        which were Whistar -- no, that was the 90-day study --
    35        these are on page 4 -- these are also Whistar derived rats
    36         -- we cannot conclude from that that Amaranth is not
    37        carcinogenic to Fisher rats or Charles River rats or any of
    38        the other types of rats used in laboratory experiments.
    39
    40   MR. JUSTICE BELL:  Listen to the next question.
    41
    42   MR. RAMPTON:  Do you wish to add anything, because I am passing
    43        on to something else now?
    44        A.  I do not believe I do at this stage.
    45
    46   MR. JUSTICE BELL:  If you are, we will take our break now.
    47
    48   MR. RAMPTON:  My Lord, I am pretty certain I shall finish before
    49        the adjournment.
    50 
    51                       (Short Adjournment) 
    52 
    53   MR. RAMPTON:  Dr. Millstone, still on Amaranth, please?  Turn
    54        back to page 11 of your revised report under the heading
    55        "Toxicological evaluation and possible health hazards" in
    56        the last paragraph on this page you write:  "One focus of
    57        the controversy has concerned the validity of the Russian
    58        work which had indicted Amaranth.  One of the crucial
    59        studies was conducted by the Russian scientist Adrianova
    60        and showed that 2% of Amaranth in the diet of rats caused