PeteFree.comMad 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 United Kingdom delayed some critical aspects of its response to BSE
Despite impressive regulation in response to BSE, [70] it is possible to criticize the slow pace of intervention. [71] There were delays in recognizing the new disease, banning the cattle-derived meat and bone meal feed that spread it, initiating research, and in initiating surveillance of human health. [72] These delays undoubtedly increased the size of the epidemics.
BSE was diagnosed by the Central Veterinary Laboratory in November 1986, but only reported to the Minister of Agriculture in June 1987. [73] The Department of Health was informed only in March of 1988. The disease became reportable only in June 1988. [74]
Cattle-derived meat and bone meal feed was identified as the source of the pathogen in December 1987, but only banned for ruminants in July 1988. [75] (The ban was unenforceable, because there was no test for animal protein, much less BSE-infected meat and bone meal. Despite the existence of the feed ban, many "born after ban" cattle were infected. Consequently, government should have prioritized the development of a screening test, but this was not done.) [76] Affected cattle were slaughtered beginning that month, but compensation was set at only 50 percent for confirmed cases (as opposed to 100 percent for apparently negative cases) in August. Full compensation, intended to deter evasion of the bans, was finally provided in February 1990, three and a half years after the epidemic had been confirmed. [77]
In July 1989, the government prohibited the export of cattle born before the feed ban. In November, certain kinds of beef offal were banned from trade. Enforcement was so lax that a late 1995 study revealed that 48 percent of abattoirs were not complying. [78]
Finally, on March 28, 1996, the government introduced a plan to slaughter all cattle older than 30 months so as to ensure the safety of the food chain. [79] This decision came after vCJD was linked to BSE and a day after the European Union banned the export of British beef to any country. [80] Almost ten years had elapsed since the recognized beginning of the BSE epidemic.
The BSE Inquiry criticized some aspects of the United Kingdom response to BSE
It is not clear that the vCJD outbreak in people could have been avoided. But judging by the delays in coming to grips with BSE, it is probable that the size of the epidemic in cattle and people could have been reduced by more effective governmental action. The United Kingdom commissioned an inquiry [81] regarding the government's response to BSE up to the March 20, 1996. [82] The investigative panel approached the task from a modified precautionary perspective. Its report mildly criticizes the BSE effort.
The Committee's analytical paradigm required reduction of risk from BSE to a level that was "As Low As Reasonably Practicable" [83] (ALARP). ALARP, it said, is an exercise in proportionality, and proportionality requires weighing the cost and consequences of precaution against the risk the precaution is intended to avert. [84] In this balancing regard, the Committee view [85] conflicts with the EU Commission's perspective as expressed in February 2000. [86] The European Commission, although cognizant of costs, was unwilling to adopt a verbal formula that might appear to permit abandonment of the Union's Treaty commitment to the preservation of health and environment as ultimate priorities.
An abbreviated catalog of the Inquiry's criticisms of the United Kingdom’s BSE effort includes the following:
(a) Communication:
Failed communication between agencies created delays. [87] The Central Veterinary Laboratory failed to disseminate information on how many cattle were falling to BSE for the first half of 1987. The Ministry of Agriculture Fisheries and Food failed to inform the Department of Health of the BSE risk; consequently the slaughter and compensation policies were delayed in implementation. The same error led to delay in addressing the risk BSE presented to human medicines.
(b) Foresight:
Lack of foresight underestimated the risk prions would cause in the food cycle, [88] and led to unwarranted reliance on the scrapie theory of BSE origin. That, in turn, led to mistaken reassurances to the public that beef and beef byproducts were safe to consume. [89]
(c) Administration:
Administrative failings included excessive time taken in reaching decisions, a lack of rigor in evaluating how to effect the desired goal, followed by a lack of rigor in implementing, enforcing, and monitoring the regulation once it was imposed. [90] The Committee observed that wide consultation and meticulous redrafting led to delays due to "the best being the enemy of the good." [91] Egregious examples of this include the two-and-a-half years it took to advise schools on the dissection of bovine eyeballs and the up to three years it took to provide occupational warnings and advice to high-risk trades. [92] The lack of rigor in designing effective policy included the (a) mistaken idea that inadequacies in the food ban could be corrected once real-world effects showed they were there, (b) inattention given to the small size of the infective dose, and (c) inadequate consideration given to the problem of enforcement. [93]
(d) Government structure:
Structural problems led to poor communication and delays. The Ministry of Agriculture Fisheries and Food and the Department of Health had no interdepartmental structure for dealing with zoonotic diseases. [94] This problem was compounded when other agencies became involved, as with cosmetics, environment, and schools. [95] The Chief Medical Officer outranked the Chief Veterinary Officer, leading to obstacles for the latter in publicly expressing his views. [96]
(e) Flowcharting:
Inadequate flowcharting contributed to difficulties in foreseeing required interventions. No action was taken on an overt recommendation that a detailed investigation of the fate of all bovine-based products be done, so as to anticipate all possible modes of infection. [97] As a result, the Spongiform Encephalopathy Advisory Committee (SEAC) was surprised in 1994 when it discovered that residue at the bottom of tallow-rendering vats, which incorporated residue from infectious tissues, was being used in cattle feed. [98] Similarly, cattle gelatin was still being used in cattle feed as late as 1995. [99] And no consideration at all was given to the potentially harmful effects of infectious material in slaughterhouse or renderers' effluents. [100]
(f) Real world thinking:
Inadequate familiarity with the work-world led the SEAC to overlook the danger of mechanically recovering meat from potentially infected spinal columns. [101] A lack of familiarity with work procedures also overlooked the inclusion of lymphatic material in meat products which were intended for food. [102]
These errors were magnified by the inadequate consideration given to just how small the required infecting dose could be. [103] The latter mistake, in retrospect, was devastating. It includes a combination of inadequate precaution, sloppy epidemiological thinking, deficient familiarity with workplace conditions, and the failed application of pertinent experimental results. Governmental insensitivity to the dose question caused it to underestimate the problems inherent in slaughtering cattle, preparing food products, and manufacturing feed. [104] Similarly, the dose oversight may have had negative consequences resulting from initially inadequate guidelines, enforcement, and infrastructure for infected tissue disposal. [105]
(g) Law:
There were also statutory inefficiencies. The enforcement of BSE regulations on infectious tissues were left to local authorities, who lacked the financial resources to perform adequately, even if motivated. [106] The panel believed that the statutes in question should have incorporated a centralized monitoring scheme.
More generally, there was doubt that existing laws authorized the precautionary measures that were taken. The Animal Health Act authorized slaughter and compensation, but apparently only for animals that had been exposed to a zoonosis. [107] Since BSE had not been designated as a zoonotic disease at the time, and scientists considered its transmission to humans unlikely, Ministry of Agriculture lawyers doubted the validity of the slaughter-compensation scheme. [108] Similarly, animals not showing signs of BSE would probably not qualify as "being afflicted with the disease." [109]
The Inquiry had similar concerns about other statutes used to justify governmental action. These included The Food Safety, Consumer Protection, Environmental Protection, and Medicines Acts. [110] The Phillips panel doubted that the wording of the statutes clearly authorized precautionary action. [111] In the case of medicines, the law required case by case licensing action. [112] This meant that government could not generally prohibit the use of infected or risk material in the manufacture of medical products. [113] The power to suspend, revoke or modify existing licenses depended on notice and the right to respond. And emergency suspensions could not exceed three months. [114]
The Inquiry concluded that it was not surprising, under these statutory constraints, that government chose to issue voluntary guidelines rather than regulations. [115]
(h) Transparency:
The Committee observed that communication of the BSE risk to the public was particularly unsatisfactory. [116] The government response had been shaped by fear of provoking an irrational reaction from the public. The Committee concluded, "Our experience over this lengthy Inquiry has led us to the firm conclusion that a policy of openness is the correct approach." [117] Credibility requires trust, and trust can only be generated by openness. [118]
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Page 6 ─ Page 7 ─ Appendix ─ Footnotes