Day 038 - 19 Oct 94 - Page 18


     
     1        negative evidence, and typically invoke or search for or
     2        hypothesize reasons for disregarding that evidence.
     3
     4        In doing so, it seems to me that they are, in effect,
     5        failing to do what they are supposed to do, which is give
     6        the benefit of the doubt to the consumers.
     7
     8        What they ought to do is -- well, let us take an example:
     9        Let us suppose you find an adverse effect at a relatively
    10        high dose in a laboratory animal;  an example might be one
    11        of the compounds at issue, the antioxidant butylated
    12        hydroxy anisole or BHA, also known an E320, the widely used
    13        antioxidant.
    14
    15        Now, it emerged from the study conducted in Japan that when
    16        fed at two per cent of the diet this caused tumours in the
    17        fore stomach of the laboratory animals.  Now, human beings
    18        do not consume this compound at anything like two per cent
    19         -- probably less than 100.  But when I read the discussion
    20        of this evidence in the reports of the Scientific Committee
    21        For Food and the Joint Expert Committee on Food Additives,
    22        which I trust we can abbreviate to the customary acronym
    23        JECFA, the JECFA Report and the SCF Report ----
    24
    25   Q.   Can you keep your voice up?
    26        A.  Sorry.  When I have scrutinized the reports of the SCF
    27        and JECFA, what I find is that there is an underlying
    28        assumption that the evidence cannot be a reliable guide to
    29        the effects that the compounds have on humans, and a wide
    30        range of possible reasons why they might sensibly be
    31        disregarded are introduced.
    32
    33        Now, given that human beings do not consume BHA at those
    34        levels, and given that it might possibly be the case that
    35        the symptoms that were exhibited by those laboratory
    36        animals arose by some gross overloading of their
    37        biochemistry, it seems to me the sensible thing to do would
    38        be to require further studies at lower doses, perhaps
    39        closer to those consumed by humans, but in correspondingly
    40        larger groups of rodents which might more effectively model
    41        the effects which the compounds are likely to have on human
    42        beings, lower doses in large groups.  But that is not what
    43        is done.
    44
    45        Therefore, what I find in the evaluations and
    46        interpretations of the evidence presented by these expert
    47        committees is what I can only characterise as systematic
    48        willingness to ascribe the benefit of the doubt time and
    49        again to the compound; assume it innocent until
    50        definitively proved toxic, rather than presumed to be 
    51        hazardous until proved safe. 
    52 
    53        You are looking for what is to be taken to be adequate
    54        evidence of safety in order to be admitted on to a list of
    55        permitted compounds.  I believe the threshold of acceptable
    56        evidence of safety is typically far too low or far lower
    57        than I am comfortable with, given that I believe the
    58        primary focus of policy making should be the protection of
    59        public health.
    60

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