Day 038 - 19 Oct 94 - Page 17


     
     1
     2        That apart, the question always then is, given that we have
     3        some evidence, for example, of adverse effects at
     4        relatively high levels of exposure, which is the position
     5        we typically find ourselves in, what assumption should we
     6        make about the shape of the curve representing the
     7        relationship between dose and effect?
     8
     9        Those who are keen to have a relatively liberal policy
    10        regime usually argue that one can reasonably assume that
    11        there is a threshold below which no significant adverse
    12        effects occur.  But there is no biological basis for that
    13        assumption.  Typically the postulation of a threshold, it
    14        seems to me, involves treating the absence of any evidence
    15        as if it were substantive evidence of the absence of an
    16        effect.
    17
    18        It is a leap of faith upon which a policy is sometimes
    19        grounded but for which there is no scientific evidence.  My
    20        understanding of the kinds of biochemical processes
    21        involved in toxic effects, and they are very wide ranging,
    22        imply that while normally the lower the dose the lower the
    23        effect, though not quite always, while generally the lower
    24        the dose the lower the effect, one cannot assume simply
    25        that one can identify or that there is a level to be
    26        identified below which all significant effects cease.
    27
    28        That, of course, complicates the policy making process,
    29        but, in practice, my reading of policy making is that it
    30        unrealistically and undesirably over-simplifies the
    31        position.  So, an assumption that there is a threshold and
    32        that it can be identified and that you can rely on rodent
    33        studies, and other laboratory animal studies, to identify
    34        that threshold, that is an assumption which is commonly
    35        made, but I do not find convincing.
    36
    37   Q.   Professor Walker explained that the additives that we are
    38        discussing in this court case in terms of their safety have
    39        been awarded an acceptable daily intake, or ADI, by the
    40        European Scientific Committee for Food as well as the Joint
    41        Expert Committee of the United Nations, Food and
    42        Agriculture Organisation and the World Health
    43        Organisation.  Why do you say that is not a sufficient
    44        guarantee of their safety?
    45        A.  Well, I have spent a great deal of the last 20 years --
    46        perhaps a disproportionate amount of the last 20 years --
    47        scrutinizing the judgments of these expert committees, and
    48        as much of the evidence on which they are supposedly based
    49        as I have been able to obtain.  The pattern I have found in
    50        their work is one in which, time and again, when the 
    51        results of animal studies and other studies on bacteria 
    52        failed to reveal any evidence of adverse effect, that is 
    53        spontaneously treated as if it was unproblematically
    54        reliable and not subject to a critical scrutiny.
    55
    56        When, on the other hand, they are confronting and
    57        evaluating evidence which appears to show adverse effects
    58        on the animal cell culture, tissue culture or bacterial
    59        culture of the tests, they seem to introduce an elaborate
    60        critical apparatus which they do not otherwise use, or

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