">Mad Cows and Variant Creutzfeldt-Jakob Disease - The New Stature of the Precautionary Principle in European Law and Health Practice

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© April 2001 Peter Free

The core dispute between risk paradigms lies in allocating proof of safety

            The risk assessment choice is not between scientific, numerical risk assessment, on the one hand, and muddled, emotional thinking, on the other.  It is between differing concepts on how to deal with uncertainty.  The question is, when data is uncertain, who should bear the cost of exploration and tampering?

            Conventional risk analysis and precautionary analysis answer that question from different ends of the spectrum.  Conventional analysis waits to see proof of harm and then tries to fix or tolerate it.  It generally operates within disjointed frameworks defined by an immediate problem.  In effect, it throws the cost of error futureward to unidentified payers. 

            Precautionary thinking, on the other hand, tries to anticipate harm and preserve or build broad, desirable holistic endpoints.  It seeks to enhance or preserve preciousness.  In effect, precaution attempts to pay the costs of foregone opportunity upfront.  The first risk-management style arguably favors the individual actor, the second society.  The difference is not subtle.  It is demonstrated in how the two paradigms allocate the burden of proof of safety or harm.

UK versus EU responses to BSE epidemic illustrated the proof of safety dilemma

            The contrast between the United Kingdom's (UK) early conventional risk assessment approach to BSE and the precautionary one subsequently imposed by the European Union (EU) demonstrates the consequences of varying proof requirements.

            The UK initially treated the infectious BSE agent with less stringency than it might have, favoring a regulatory course that required moderate proof of harm before warning the public of the possibility of BSE disease in humans.  The rationale was that such a warning was unreasonable in light of the evidence available at the time, and it would have damaged the beef industry by inducing a panicked reduction in consumer buying and international trade.  The government effectively allocated the proof of harm in uncertain circumstances to the public, so that the economic good of the private sector could be maintained.  The approach has a laissez-faire, free market tone.  The cost was paid in damaged public health.

            The European Union, in contrast, acting on an inchoate version of the Precautionary Principle, allocated the burden differently by banning the importation of British animals and beef products and attempting to closely regulate agriculture and food safety.

            Who turned out to be correct?  Ten years after the British started on their fateful course, BSE surfaced in humans as a variant of always-fatal Creutzfeldt-Jakob disease.  Within this short period, and in a way seldom, if ever, experienced with toxics in the environmental arena, European proponents of the Precautionary Principle had the opportunity to say, "I told you so."

            The Union approach had allocated proof of safety to the private sector, in order to preserve the overarching goal of public health.  Arguably, its allocation of the burden of proof had been the wiser course.  The preciousness of human life, as opposed to profit, had been better preserved.

Mad Cow Disease’s jump to humans showed weakness of conventional risk analysis

            The European Union’s response to bovine spongiform encephalopathy (BSE, also called Mad Cow Disease) firmly established the place of the Precautionary Principle in European law and health practice.  Mad cows provided the world with a quasi-experimental confrontation between conventional risk analysis and precautionary management.  The subtle, but devastating, nature of the BSE pathogen revealed why the precautionary approach can be helpful in guiding responses to an interrelated and uncertain world.  Species-jumping mad cow prions [13] delivered this lesson with an immediacy that no other toxin has been able to do.

            The transmission of mad cow disease to humans in the form of variant Creutzfeldt-Jakob disease (vCJD) in the United Kingdom exemplified the cost doing business as usual when initial scientific data is lacking, but hidden molecular mischief is already under way.  For ten years, the United Kingdom approached BSE in a conventional way, only shifting to genuinely precautionary thinking when the disease visibly leapt to humans.  For a decade, Her Majesty's ministers and their scientific advisors believed that the absence of data on the new disease, combined with its similarity to one that affected only sheep, justified ignoring what they saw as a remote risk of disease transmission to humans.

            Post-transmission European responses to BSE illustrated the wisdom of being guided by a health-protective principle, subject though it is to criticism for lack of analytical content.  The European Union, with justification already set out in its founding Treaty, formally applied the Precautionary Principle in regulating the BSE epidemic.  The European Court of Justice approved this precautionary management style when the British challenged it.  Ultimately, both the United Kingdom and the European Union acted as if application of the Principle had merit in the real world.  This result will likely affect formulation of future European health, agricultural, and trade policy.  By affecting governmental action in such a large portion of the developed world, the Principle may come to influence (or annoy) other peoples.

Why these general traits are important in a technologically dangerous world

            These listed governmental traits are necessary for effective anticipation of (and reaction to) environmental and health risks because:

(a) molecular and ecological interactions matter and

(b) the world is too integrated to isolate oneself from the nasty effects of minutiae gone awry.

Modern risk analysis must anticipate complex interactions ─ BSE is as a paradigm

            The BSE epidemic, and its spread to people, is an example of the unavoidable complexity of appropriate risk management.  Epidemiological investigation of the transmission of mad cow disease illuminated connections between mundane activities.  “The ordinary can bite you,” is BSE’s precautionary message.  BSE's causative agent, the prion, presented humanity with a lesson in detail-specific holism that government and law cannot ignore.  The complex interactions which came to light during the BSE epidemic serve as a model of appropriate thinking about medical and technological complexities generally.  Modern risk analysis cannot ignore these lessons.

The practical effects of prion characteristics

            In summary, prion characteristics bested the British effort to control BSE for more than a decade.  Long incubation periods meant the disease was hidden.  The lack of an in vivo test to detect altered PrP made detection of silent infection impossible in cattle and people.  The presence of prions in the central nervous system of cattle meant customary slaughter techniques guaranteed that infectious tissue would make it out into the food chain.  Very small doses of infected tissue are sufficient to cause infection in the new host animal or person.  Cross-species infection is possible, and tends to generate new prion strains that, in turn, require new screening tests.  Prions do not necessarily manifest in the same peripheral tissues in different species; therefore experience with one animal is not necessarily indicative of what may happen with another.  Last, prion hardiness defeats common disinfectant techniques, including standard hospital autoclaving.  This presents a problem in appropriate sterilization of medical and surgical instruments after use on a patient who has either detectable and undetectable prion infection. [14]

Globalization and agricultural/industrial maximization contribute to the problem

            The industrialization and internationalization of agriculture and trade gave the hardy prion an entree to the global food chain.  The United Kingdom and the European Union both subscribed to maximizing food production. [15]  Recycling meat and bone meal byproducts, even to herbivores, made sense under this paradigm.  Scrapie-infected sheep brains were fed to cattle and these cattle, in turn, were rendered into cattle feed.  The rendering process was shortened, its temperature reduced, and a solvent extraction step eliminated to reduce costs. [16]  International trade in feed and animals then spread BSE.

            Similarly, maximizing productivity requires using the same equipment to manufacture feed destined for different animal groups.  Even after the ban on the feeding of cattle-derived meat and bone meal to ruminants, meat and bone meal intended for pigs and poultry contaminated the manufacturing line for cattle.  The United Kingdom solved this problem by banning mammalian meat and bone meal feed for all agricultural animals [17] when it was realized BSE might be transmitted to humans. [18]

            Efficiency and mechanization contributed their own set of problems to the crisis.  The use of captive bolt guns to stun cattle prior to slaughter had the potential to disrupt brain material and send it into the animal's blood stream. [19]  Although it was early recognized that BSE prions inhabited the central nervous system of cattle, mechanized meat removal techniques were used to remove meat from the spine of slaughtered animals.  The equipment was not discerning enough to avoid pulling off elements of the dorsal root ganglia from the spine. [20]  This separation problem was compounded when prions were discovered in other peripheral beef tissues. [21]  Meat intended for feed and human consumption was thereby contaminated.

            Maximization of product markets also complicated the governmental response.  Beef byproducts are used in a variety of nonobvious ways, [22] including use in baby food. [23]  Sausage casing comes from intestine; [24] rennet for making cheese and one form of tripe comes from the abomasum (fourth division of the stomach). [25]  These sources contain lymphatic tissue, a possible source of infectivity. [26]  Tallow, a byproduct of beef rendering, is used for edible fats, glycerin (for jellies and baking), animal and pet food, pharmaceuticals, [27] creams/ointments, and industrial products.  Gelatin, from animal hide and bones, is used in food, tablet coatings and capsules, cosmetics, china, glue, and photo chemicals. [28]  Bovine materials also go into the manufacture of a large array of goods including gum, toothpaste, leather-processing cleaning agents, fertilizers, fire extinguisher foam, handles, racquet strings, and paint. [29]  The magnitude of the BSE management task is illustrated by unusual uses of cattle products like school children's dissection of bovine eyeballs. [30]

 

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