Day 038 - 19 Oct 94 - Page 44


     
     1   MR. JUSTICE BELL:  No, wait.  Are you going to tell him what the
     2        adverse reactions are or are you going to ask him?
     3
     4   MR. MORRIS:  Right.  Sometimes I am trying to move on to save
     5        time and then I cannot do it.  (To the witness):  If you
     6        just say what the problems are with Sunset Yellow and why
     7        you think it should not be available.
     8        A.  OK.
     9
    10   MR. JUSTICE BELL:  Bear in mind that I have read (because you
    11        have not changed this) what appears at pages 9 and 10 of
    12        your statement, Dr. Millstone.
    13        A.  Indeed, yes.  Can I just make it clear that in
    14        preparing this text, I have not been able to make an
    15        exhaustive search of all the literature, but I have
    16        reported here as what has readily come to hand.  But my
    17        grounds for concern about Sunset Yellow fall into two main
    18         -- under two main headings; firstly, acute adverse
    19        reactions, the existence of which has been acknowledged by
    20        the Committee on Toxicity.  As I indicate halfway down the
    21        page at page 9, that as long ago as 1979 they were
    22        referring to some evidence published in 1974 in The
    23        Archives of Dermitology indicating that Sunset Yellow
    24        provoked acute adverse reactions to skin, to eczema.  My
    25        recollection is that that -----
    26
    27   MR. JUSTICE BELL:  Where are you now in your statement?
    28        A.  Halfway down page 9, footnote 1.  Michaelsson's study
    29        was, I believe, a study of consumers rather than an
    30        occupational study of people handling the material in very
    31        large quantities.  So, it is evidence that ordinary
    32        consumers do react adversely to it.
    33
    34        More recently, I have cited on the next page, footnote 9, a
    35        paper by Gross and others indicating in that particular
    36        case, I believe, a double-blind challenge of
    37        gastroenteritis being triggered by Sunset Yellow which in
    38        the US is known as yellow dye No. 6.  So, that Sunset
    39        Yellow is capable of provoking symptoms of acute
    40        intolerance seems not to be contested, although there might
    41        be a dispute about how frequently that occurs.
    42
    43        The other concern I refer to has to do with gross changes
    44        at high doses in rodent studies with proliferative legions
    45        and tumours in rodents.  I mean, three per cent and five
    46        per cent are relatively high doses indeed.  They are
    47        dismissed by the Committee on Toxicity because there are
    48        relatively high rates of such tumours in the control
    49        groups.
    50 
    51        One of the chronic problems with interpreting toxicological 
    52        data is, what is the relevant comparator by which to judge 
    53        the significance of any change?  Sometimes a group of
    54        scientists will compare the cancer incidence in a group of
    55        animals to the concurrent controls, and at other times to
    56        the historical controls, the historical average for
    57        controls of that species kept under those kinds of
    58        conditions.
    59
    60        In this case it is disregarded because there is a relative

Prev Next Index