Day 039 - 20 Oct 94 - Page 24


     
     1        magnitude, of the contribution of nitrite when used as a
     2        preservative to the total nitrite load of the human body
     3        and to the total nitrosamine load of the human body.  There
     4        is no dispute that I am aware of on the question of whether
     5        or not nitrites contribute to the formation of
     6        nitrosamines, or whether the nitrosamines are hazardous; it
     7        is just a debate about relative risk:  Both the
     8        relationship between nitrosamines deriving from nitrite
     9        used as an additive and other sources in nitrosamines, and
    10        the relative risk between long, chronic toxicity from
    11        nitrosamines against the acute toxicity of botulism that
    12        nitrosamines are there to prevent.
    13
    14   MR. MORRIS:  This raises an issue which came up before about
    15        inadequacies in the manufacturing process, and I think,
    16        I may be wrong, but there is some European or standard
    17        position which is that additives should not be a substitute
    18        for inadequacies in the manufacturing process; is that
    19        correct?
    20        A.  Words to that effect are from time to time incorporated
    21        into official documents, yes.
    22
    23   Q.   Then the implication is there cannot be inadequacies in the
    24        manufacturing process because there are regulations
    25        governing ----?
    26        A.  Yes, I may have included remarks on this matter in one
    27        of the documents I prepared for you.
    28
    29   Q.   Professor Walker's impression was that there are rules and
    30        regulations of manufacturing, so it is not an issue.
    31        A.  Yes, but the rules and regulations governing
    32        manufacturing are typically cast in very vague terms.  They
    33        refer to what is called -- well, in the British regulations
    34        they typically refer to the -- they invoke the expression
    35        "good manufacturing practice".
    36
    37        When I attempted to establish the meaning of this term,
    38        I approached the relevant section of the Ministry of
    39        Agriculture, Fisheries and Food and I said:  "How does one
    40        decide what is and what is not good manufacturing
    41        practice?"  Their reply was:  "Manufacturers decide what is
    42        good and bad manufacturing practice".  Therefore, I think
    43        we are in a position where all manufacturers deem their own
    44        practice to be good.  Therefore, we have nominally a form
    45        of words in regulations which are almost entirely
    46        ineffectual.
    47
    48        The position at the European level is pretty much the
    49        same.  The regulations refer typically to quantum status,
    50        the amount which is sufficient, and it is left to 
    51        manufacturers to make a judgment themselves.  I think it is 
    52        important to point out that there are more specific 
    53        regulations which govern preservatives where there are
    54        clearly acknowledged hazards of excess consumption of
    55        preservatives, and in respect of these preservatives in
    56        particular quantity of maxima levels are embodied in the
    57        regulations for the use of nitrites and nitrates, both in
    58        the UK and throughout the European Community.
    59
    60   Q.   You said sodium nitrate is used as a colour fixative?

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