The Dark Side of Precaution: Preventing Prevention
The precautionary principle mandates intervention to save the environment and - most importantly - our health from degradation in the case of a pressing danger, even if all the scientific data are not yet on hand. It is invoked when we face threats from chemicals, radiation or other causes. The principle seems important, yet it is difficult to find an authoritative definition. The European Union has issued a communication in February 2000, which is all about how to apply the principle, but the writers manage not to define the term in the EU context.
The city of San Francisco, in its own implementation of the precautionary principle which I reported previously, gives a definition:Where threats of serious or irreversible damage to people or nature exist, lack of full scientific certainty about cause and effect shall not be viewed as sufficient reason for the City to postpone measures to prevent the degradation of the environment or protect the health of its citizens.
But now it appears that this very principle that is supposed to protect us from harm is being employed to eliminate our first-line defenses against those very threats.
Byron Richards' book - Fight for your Health - digs into and exposes the FDA's efforts to eliminate supplements in the US.
Nutritional sufficiency is a first line defense against the degradation of health. This is of course enshrined in the concept of the RDA, the recommended dietary allowances, which guard against the known deficiency diseases in about 98 % of the population and we might call that passive prevention. Go one step further, and you have the concept of optimal nutrition. Comparatively larger amounts of nutrients than those which prevent deficiencies will fight infection, prevent heart disease and keep cancer at bay, and we might say that this is active prevention. Toxic chemicals, including pharmaceutical medicines, tremendously increase our need for nutritive input.
Both in Europe and the US, the trend of legislation and regulation is going in the opposite direction: If bureaucrats have their way, we will have a greatly reduced choice of supplements and lower doses of nutrients available to counter the constant onslaught on our health.
The European Commission has passed legislation to regulate the market of food supplements. The approach of the European food supplements directive is highly prescriptive, that is, both dosages of nutrients and allowed ingredients are to be tightly regulated, provoking fears that many of the supplements people use will simply no longer 'qualify' and will vanish from the shelves of local health food stores. This is done in the name of the market, to facilitate trade, and any expected hardship for consumers is justified by the need for achieving "a high level of protection for human life and health."
In the US, the American food watchdog, the FDA, is doing things slightly differently, but the upshot of their actions and of certain legislation currently pending before Congress, will be quite similar to what we are experiencing in Europe right now. Byron J. Richards, author of a book that is a wake-up call to Americans seeing their health freedoms vanish, has explained how and why this is done in an excellent article: The FDA - a Wolf in Sheep's Clothing.
But let's see how this principle of precaution is implemented in Europe...
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The precautionary principle: a critique in the context of the EU Food Supplements Directive
Jaap Hanekamp, a Dutch scientist, closely examined the use of the precautionary principle in its European implementation and he published what he found in the journal Environmental Liability. He argues that since both deficiency and excess of nutrient intake can bring dangers, but since the danger of deficiency vastly exceeds the dangers of excess, the 'precautionary principle' is being applied in a very one-sided way. By focusing on the supposed dangers of excess and not taking the preventive use of nutrition into consideration, the principle becomes slanted, if not outright illogical."The Supplements Directive ... was implemented in order to safeguard human health in view of the potential toxicity of excess intake of micronutrient food supplements. However, (micro)nutrient food compounds differ from other chemical substances in foods in that they are essential for the human physiology, so that different adverse (toxicological!) effects can result from intakes that are too low as well as too high. Nevertheless, the focus of the directive is solely on the toxicology of excess."
The idea of legislators seems to be that, as long as RDA levels of nutrients are widely available, they have done their duty in promoting public health - but, says Hanekamp:"Established RDAs, and this is the emerging paradigm, may ... have become obsolete in that they are insufficient to prevent long-term DNA damage, resulting in, for example, cancer and aging. In summary, the perspective materialising from state-of-art scientific research in relation to any type of micronutrient is that the actual ‘mandatory’ amount of micronutrients for the human organism that maximises a healthy lifespan, in a number of cases turns out to be considerably higher than the amount needed to prevent acute deficiency diseases. It seems increasingly clear that RDAs are too restrictive an approach to micronutrients and their health attributes, which are not only a matter of preventing deficiency diseases but, more importantly, lie in the field of long-term benefits such as reduced cancer and cardiovascular incidents and decelerating aging."
Just as the sufficiency of RDA level nutrient intakes is an unconfirmed assumption, the effects of enshrining the principles of low level nutrition into legislation are not necessarily beneficial:"Whether or not supplements might add to the overall health of European citizens is, from a regulatory point of view, regarded as irrelevant. Thereby, the Directive assumes what actually should be proven, namely, that the health effects of an over-regulatory excess toxicity approach would be superior to alternatives. The concomitant assumption is that there are no health detriments from proposed (over)regulation. A choice is presented between health and money (economy), or even health with no loss at all, as a peripheral presumption is that the market will find a better and a cheaper as well as a safe way. Something (health) is gained with nothing lost (no adverse health effects from over–regulation). The burden of proof of safety corresponding to excess toxicity subsequently lies firmly with the marketing parties."
One might even go further than that. Since the adverse health effects of nutrient deficiency are generally more serious than the toxic effects of excess, and since higher intakes of certain nutrients have important protective effects beyond the generally recognized deficiency diseases, the precautionary principle, if correctly applied, would impose a wide availability of nutrient supplements, erring on the side of too much, rather than on the side of too little! Yet, as pointed out by Hanekamp, the application of the precautionary principle reverses the burden of proof for the safety of supplements, imposing on those who want to make supplements available, the burden to prove that their products do not have any detrimental effect. Of course it is impossible to prove a negative, so precaution, if focused exclusively on the possible toxicity of excess, will eventually bring things to a grinding halt, leaving us without front-line nutritional defenses." ... health risks due to micronutrients are habitually and historically related to deficiencies in the diet and not excess. This is so because minerals and the majority of vitamins are water-soluble and are readily eliminated by excretion as well as metabolism, the exceptions being vitamins A and D, which are lipidsoluble. The Supplements Directive in the preamble, states, however:An adequate and varied diet could, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities which meet those established and recommended by generally acceptable scientific data.Therefore, in view of this statement in the Supplements Directive, food supplements are regarded as superfluous products that are, by default, only in need of excess toxicology regulation; a varied diet is more or less a guarantee for sufficient micronutrient consumption and thereby human health."
Incidentally, what is that "normal diet" and who exactly is eating it, remains shrouded in a dense fog of mystery. No scientific study has shown it to exist, and if you ask around, I bet you won't find many who say "yes, I have been completely healthy for years, and it is because I eat a normal diet."
Hanekamp goes further and explains how precaution is used in the legislative context of nutrition:"Our contention is that within the precautionary context described above, the Supplements Directive is primarily focused on secondary risk management. Regulators and (scientific) experts in the main are being made increasingly accountable for what they do and thereby are becoming increasingly preoccupied with managing their own risks. Particularly, secondary risks to reputation are becoming as significant as the primary risks for which policies should in fact be devised.
The increasingly dominant regulatory culture of risk-aversion therefore engenders a food supplements policy singularly focused on excess toxicity risks, while simultaneously lecturing the Europeans to ‘eat a normal healthy diet’. Therefore, the directive avoids responsibility for the human health of European citizens.
Toxicity as a result of food supplements intake is a considerably more visible phenomenon, increased by the bias for negative information about possible health risks of products or activities. In comparison, deficiency diseases are not (and cannot be) related to any regulatory activities, as European regulators are not responsible for the individual dietary habits of European citizens, yet deficiencies have a far greater impact on public health."(Added emphasis is mine)
The European court of justice, instead of resolving the impasse, has made matters worse with its recent decision that confirmed the validity of the food supplements directive. The judgement justifies the use of lists limiting ingredients in supplements by the need for precaution (as quoted by Hanekamp):"In those circumstances and in view of the need for the Community legislature to take account of the precautionary principle when it adopts, in the context of the policy on the internal market, measures intended to protect human health … the authors of Directive 2002/46 could reasonably take the view that an appropriate way of reconciling the objective of the internal market, on the one hand, with that relating to the protection of human health, on the other, was for entitlement to free movement to be reserved for food supplements containing substances about which, at the time when the directive was adopted, the competent European scientific authorities had available adequate and appropriate scientific data capable of providing them with the basis for a favourable opinion, whilst giving scope, in Article 4(5) of the directive, for obtaining a modification of the positive lists by reference to scientific and technological developments."
Probatio Diabolica - Misuse of the Precautionary Principle to Preempt Prevention
For all our science and the legal mumbo-jumbo that justifies bad legislation, we forget to protect human health (abundant availablility of nutrients is certainly a positive factor) in order to protect ... human health! Talk about insanity.
Hanekamp puts this into more formal language:"This central quote of the ruling shows a number of things. First, precaution is only regarded within the context of the internal market and the protection of human health, where of course human health should prevail over economy. However, this view on micronutrients and the presumed risks involved a priori selects for scientific knowledge in league with the precautionary principle with its institutionalised mistrust and secondary risk management tendencies. More importantly, it ignores one of the basic tenets of European regulation, which in the case of micronutrients seems all the more ironic: ‘a high level of protection for human life and health’. As micronutrients cannot be characterized other than by way of a two-sided symmetrical benefits–risks profile (risk and benefits are on both sides of the micronutrients equation), the benefits of micronutrients must be an integral factor in the regulatory equation.
Secondly, the subsidiary and paradoxical role and functioning of science is highlighted in this quote. On the one hand, science should give definitive answers in relation to the issues of safety when a (new) micronutrient food supplement is brought to market. How this could be done when the precautionary principle is one of the basic principles is quite obscure. Indeed, how safe is safe enough, and what scientific results would be deemed sufficient? As said, and this cannot be emphasised enough, it can never be proven thatprobatio diabolica, which is impossible and thereby unlawful." (Added emphasis is mine)
micronutrient food supplements do not pose any risks to any consumers. As it is possible to prove that a particular risk exists, yet impossible to prove that any and all possible risks are absent, the precautionary principle is prone to generate a
Even with extensive quotes, I could only provide a glimpse into the full reasoning of the Hanekamp study and paper. Anyone interested in the detailed arguments can get the full text here.
In concluding, Hanekamp argues that the European Commission is ‘infected’ with an over-regulatory zeal, enhanced by the precautionary principle, adding that precaution empowers bureaucracy. To make the point, he quotes John Stuart Mill:
"Nevertheless, when there is not a certainty, but only a danger of mischief, no one but the person himself can judge of the sufficiency of the motive which may prompt him to incur the risk: in this case, therefore, (unless he is a child, or delirious, or in some state of excitement or absorption incompatible with the full use of the reflecting faculty,) he ought, I conceive, to be only warned of the danger; not forcibly prevented from exposing himself to it."
While I agree that there is a certain legislative zeal leading to over-regulation, perhaps more important in this case is the patently visible misuse of the precautionary principle. If correctly applied, the precautionary principle - which in essence is invoked to protect human health - should lead to wide availability of nutrients in super-high doses because that is what we need to protect health in the face of environmental and other stresses. If it leads to restrictions, which is the case in its present implementation, it is being selectively used with the aim of covering bureaucratic 'backsides' rather than providing protection to human health.
Mills, of course, was right when he stressed the responsibility of the individual in taking or avoiding risks. The EU and US legislatures should definitely take account of this and remember that perhaps we are not sheep, to do with as the shepherd pleases.
posted by Sepp Hasslberger on Sunday July 9 2006
updated on Wednesday July 12 2006
URL of this article:
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