Day 039 - 20 Oct 94 - Page 63


     
     1
     2   Q.   Thank you.  A similar proposition is true of most countries
     3        in the world, is it not?
     4        A.  Forgive me.  Could you be slightly clear as to which
     5        proposition?
     6
     7   Q.   The use of those compounds in the world at large is
     8        similarly regulated, is it not?
     9        A.  Similarly regulated in industrialised countries, yes,
    10        in OECD countries, yes.
    11
    12   Q.   For example, throughout the European Community?
    13        A.  Throughout the European Community there is just about a
    14        uniform regulatory system since 1st January 1993.
    15
    16   Q.   In the United States the use of such substances is
    17        governed, is it regulated by government?
    18        A.  It is indeed.
    19
    20   Q.   Through the agency of the Food and Drugs Agency, the FDA?
    21        A.  That is the relevant agency, yes.
    22
    23   Q.   The information upon which the governments of the Western
    24        world act in making regulations is fed to them, is it not,
    25        from a number of sources directly or indirectly?
    26        A.  You are asking me to agree with that?
    27
    28   Q.   I am.
    29        A.  Well, I would not take that precisely as it stands.
    30        I would want to qualify it slightly more carefully, because
    31        I am sometimes concerned at the mechanisms by which
    32        documents come to be incorporated into the dossiers which
    33        the toxicological experts review.  The system I find most
    34        impressive is the US system in which companies are legally
    35        obliged to submit all the evidence which they have
    36        concerning these compounds, and the scientific staff of the
    37        FDA make it their business to conduct independent searches
    38        of the toxicological database. The position in the UK is
    39        very different.
    40
    41   MR. JUSTICE BELL:  I think the question was simply that the
    42        information was fed to the bodies from a number of sources?
    43        A.  In some cases the information is fed, for example, the
    44        Committee on Toxicity, from very, very few sources and, in
    45        particular, the dossiers of documents typically come from
    46        the companies who are themselves seeking to market or use
    47        the compounds.  One of the distinctive feature about the
    48        British system as far as I can tell is that the Scientific
    49        Civil Service, the Department of Health and the Ministry of
    50        Agriculture, do not always themselves independently seek 
    51        out scientific independent data. 
    52 
    53   MR. RAMPTON:  Dr. Millstone, let us get around this semantic
    54        problem, if I may call it that, by taking a body which is
    55        supranational JECFA?
    56        A.  Yes.
    57
    58   Q.   Do you agree that it is supranational?
    59        A.  Yes.
    60

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