Report from the Sub-comittee on the environment and health

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In relation to <strong>the</strong> weighing up of risks, <strong>the</strong> main content of <strong>the</strong>
precautionary principle can be construed in <strong>the</strong> form of a question: “Who
is to suffer <strong>the</strong> consequences of <strong>the</strong> uncertainty that must exist
scientifically concerning <strong>the</strong> polluting effect of a specific type of
behaviour?” This is illustrated by <strong>the</strong> following three concrete examples
of application of <strong>the</strong> precautionary principle:
1) Carcinogens (The Delaney Clause)
The best known and most frequently mentioned example is undoubtedly
<strong>the</strong> American health and food legislation’s so-called Delaney-Clause,
which states that colour additives, o<strong>the</strong>r additives or pesticide residues
must not be authorised in <strong>the</strong> USA if, at any level, <strong>the</strong>y have been found
to induce cancer in experimental animals or man. This rule was already
controversial at <strong>the</strong> time of its introduction in 1958, in part because it
was expressed as a requirement of “no risk”, which, scientifically, is
regarded as unachievable unless <strong>the</strong> requirement is linked to a direct ban
on use in <strong>the</strong> individual cases or every assessment of additives/pollution
is interpreted as a requirement of negligible or “de minimis” risk. The
discussion of this interpretation of <strong>the</strong> precautionary principle is still
going on. In <strong>the</strong> USA, <strong>the</strong> situation is that <strong>the</strong> requirement concerning
actual banning of carcinogens is enforced in <strong>the</strong> case of real additives,
including food additives, whereas pesticide residues (cf. Amendment
PL104-170 of 3 August 1996) are, ra<strong>the</strong>r, assessed on <strong>the</strong> basis of <strong>the</strong> “de
minimis” rule, interpreted as a lifetime cancer risk for one individual out
of 1 million (1 × 10 -6 ). Viewed as <strong>the</strong> risk rate, i.e. numerically, most
experts, including FDA officials, describe this – largely unchallenged –
as “negligible, trivial, insignificant or even non-existent”.
2) Spraying of seed-bearing and fruit-bearing crops
Right back in <strong>the</strong> first decades with growing use of spraying, i.e. <strong>from</strong>
around 1955 to <strong>the</strong> mid-1970s, it was established in most countries,
including Denmark, that rules for pesticides and instructions for <strong>the</strong>ir use
should be provided in accordance with <strong>the</strong> individual countries’
agricultural needs. This was normally verified by means of controlled
spraying tests carried out under <strong>the</strong> special ‘climatic and cultivation
conditions’ of <strong>the</strong> country in question.
Tests of this nature were carried out in Denmark in <strong>the</strong> period 1963-1975
by <strong>the</strong> National Plant Pathology Research Institute in cooperation with
<strong>the</strong> National Food Institute (now <strong>the</strong> National Food Agency) with a view
to authorisation of <strong>the</strong> products by <strong>the</strong> Ministry of Agriculture’s Poisons
Board. The results of <strong>the</strong> tests often showed that substantial parts of <strong>the</strong>
Danish fruit, vegetable and berry production at that time could be kept
free of detectable pesticide residues provided <strong>the</strong> spraying times, waiting
times before harvest and similar were fixed at ‘before flowering ends’
and ‘before seed-setting’ etc. This was largely accepted as a well-defined
basis for ‘Good Agricultural Practice’ and thus met <strong>the</strong> requirements and
wishes already formulated at that time concerning no (or only negligible
or “immeasurable”) residues in crops ready for eating.
Many of <strong>the</strong> regulations and recommendations given by <strong>the</strong> Poisons
Board and, later, in DEPA’s authorisation schemes, thus contained
significant elements of a restriction on use that went beyond <strong>the</strong> risk
assessment requirements formulated for purely health and environment