Transmissible Spongiform Encephalopathies Regulations 2006

rose to move, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 20 January, be annulled (S.I. 2006/68) [22nd Report from the Merits Committee]. The noble Countess said: My Lords, I declare my interests. With my husband, I am a partner in our small family farm. We have cattle, sheep, goats, pigs and poultry, all in small numbers and farmed extensively. We make goat cheeses and sell them, goats’ milk, lamb and pork through our farm shop. The last time that I moved a Motion praying to annul a TSE regulation was on 15 May 2002. I did that based on my concern that the TSE Regulations 2002 were over-prescriptive and neither reasonable nor proportionate. I do so again on this occasion, but would add that I do not believe that the regulations now before us are based on sound science. The noble Lord, Lord Livsey of Talgarth, moved an amendment to my prayer in 2002 calling upon Her Majesty’s Government,"““to keep the regulations under review in the light of scientific and technological developments relating to TSE””." I remind noble Lords, and the Minister in particular, that that amendment was agreed to but has not, as far as I can see, been carried out. There is very little difference between the regulations currently before us and those before us in 2002. Noble Lords may also recall that I went much more deeply into my reasons for doubting the science during our discussions on the Animal Health Act 2002. We have repeatedly been assured that the Government base all decisions on sound science, where applicable. Since the first regulations came into force, the science has moved on considerably, yet there is no indication that this knowledge has found its way into the regulatory arena. In fact, much recent research raises doubts about the origins of the so-called ““infectious agent””. These and other regulations are based on the widespread assumption that a rogue isoform of a protein designated PrP—called prion protein by some—causes TSEs. That hypothesis is unsupported by rigorous analysis and substantial data contradict it. In recent weeks, it has been announced that another type of scrapie, distinct from what some refer to as classical scrapie, has emerged. Professor Christopher Higgins—chairman of the Spongiform Encephalopathy Advisory Committee, or SEAC—was heard to say, on ““Farming Today”” on 27 February, that there was a classical scrapie but that there is now a new disease, which can be distinguished from both it and BSE and has been named ““atypical scrapie””. I am astonished. In 1986, Dickinson et al presented a paper at the second Paris symposium entitled ““Further evidence that scrapie agent has an independent genome””. In their summary they state that,"““Many distinct strains of scrapie have now been characterised in terms of their biological and neuropathological properties and a number of them have been re-isolated several times from different breeds of sheep and goats””." I understand that the neuropathogenesis unit in Edinburgh had, at that time, isolated more than 25 strains and characterised two-thirds of them in detail. Throughout the 1970s, Dr. Dickinson’s group correctly predicted a variety of aspects of TSE infectious agents and their diseases; for example, that infection with more than one strain of scrapie could involve competition between strains in production of disease. These accurate predictions were summarised in 1998 by Farquhar C.F. et al in Nature. Why is it that TSE researchers in Edinburgh, such as those at Moredun Research Institute, are refused information about which scrapie strains have been used as a basis for the design of the National Scrapie Plan? A number of researchers, including Hugh Reid, former head of microbiology at the Moredun Research Institute—which I shall call the MRI—Ian Aitken and Bill Martin, both former directors of the MRI, and Alan Dickinson, former director of the ARC and MRC Neuropathogenesis Unit, Edinburgh have been closely involved in TSE research, the last named for longer than anyone else worldwide. One of them recommended over 20 years ago that measures to reduce scrapie should avoid genetical extremes. Since then, many more details have been added to their understanding of TSE diseases, but the principles underlying that recommendation have not changed. They say that,"““In particular, the possibility still exists that some TSE strains may exist, or may arise, that will be able to replicate in the purportedly resistant genotype. In this event, the entire sheep population would then be at high risk””." That prediction is now proving to be correct because the ““atypical scrapie”” cases are in genotypes being selected by the National Scrapie Plan. In previous debates in your Lordships’ House I, too, voiced my concerns that this is what would happen. Most of those currently investigating the nature of TSE agents have chosen to work only with the quickest and highest infectivity titre rodent models and have assumed that extrapolation to other models would be valid. Furthermore, they have almost exclusively used the intracerebral route, which will never be a natural route of infection. That route may simply be the means of transferring amyloid primer and cerebral amyloidosis may be confused with a TSE infection. There is also concern that the methodology is not always explained in detail, which is essential as, for example, the likelihood of laboratory contamination with TSE agents and cross-contamination between strains is well known. There is now sufficient new and reassessed information to challenge the hypothesis that the proteinase K-resistant PrP present in TSEs is the real infectious agent per se. Can the Minister please explain why, in a situation such as that surrounding scrapie, BSE, CJD or foot and mouth disease, the Government seem to turn to scientists who are not regarded by their peers as experts in the area while ignoring those who are? Is it not in everybody’s interests to obtain the very best scientific advice, especially in areas where scientific uncertainties exist? Had we obtained the very best advice from the beginning, I wonder whether we would be in the position of requiring this legislation. I turn now to the regulations themselves. I expect the Minister to tell me that these regulations are merely transcribing EU regulations into our law. That may well be the case, but we should surely ensure that the words we enshrine into our law are capable of being interpreted reasonably and that their intention can be translated sensibly and proportionately. It is somewhat disconcerting to find that, as early as paragraph (4)(1) of Part 1, the only exception listed is for research animals. EU Regulation 999/2001 clearly states that the rules apply only to animals which will enter the food chain. They do not apply to show animals, special collections of animals or anything to do with cosmetic or medical work, provided they do not enter the food chain. I am confident that this is not made clear in the statutory instrument. Regulation 6 requires the Secretary of State and the local authority to,"““appoint inspectors for the purposes of enforcement of these regulations, except as specified in Schedule 6””." Nowhere is there any indication of the qualifications that would be required of the inspectors. That is deeply worrying, for they have extraordinarily wide and draconian powers. Regulation 18 lists some of them. Regulation 18(1)(a) requires that they must be strong enough to seize any animal. I understand that in this context ““animal”” means any animal except a human—so it could be an elephant, or a mouse. For Regulation 18(1)(b), (d) and (f) they must be detectives and scientists, or at least laboratory technicians, and for Regulation 18 (1)(c) they must be skilled stockmen or women. If they require the keeper of an animal to assist them with collecting and penning that animal, they must presumably be sensitive and have good communication skills. Regulation 18(1)(g) and (h) require the inspectors to have clerical skills, and to be competent computer technicians. Regulation 19(3)(c) also requires that they have the skills to kill or slaughter any animal. That may involve killing by intravenous injection or shooting with a captive bolt and pulping the brain for a farm animal, or shooting with a rifle for a wild one, with all sorts of other means in between. Noble Lords must agree that such a paragon of virtue, if such a one exists, would command an extraordinary salary. On the other hand, it might be that what is envisaged is a host of inspectors, each with a particular skill, who would appear as a team to enter any premises to ensure the Community TSE regulations, and these regulations, are being complied with. Perhaps the Minister will enlighten me as to which option the Secretary of State proposes to select. Is it really the Secretary of State’s intention that she should collect dead bovine or caprine animals personally? Is there any possibility that she might do so? If not, why include this in Regulation 1(1)(b) in Part 1 of Schedule 2? Why not simply say ““on behalf of the Secretary of State””? Also in this section, Regulation 5(2)(a) requires the occupier of a slaughterhouse immediately to dispose of,"““the carcase and all parts of the body of that animal (including the blood and the hide)””," while at Regulation 5(2)(b), unless he has a derogation,"““the carcase and all parts of the body (including the blood and the hide) of the animal immediately preceding that animal on the slaughter line and the two animals immediately following it””." What is the scientific rationale for the requirement that, in the event of a TSE-positive result, or of a no-test result, the slaughterhouse occupier must dispose of the carcass and all parts of the body, including blood and hide? For what scientific reason does this apply only to bovines, and not sheep and goats? Why, in the event of a positive test result, is compensation automatically payable, while in the case of a no-test result the decision to compensate the owner of an animal rests with the Secretary of State? Under what circumstances can the owner of an animal who is not the occupier of a slaughterhouse be responsible for events leading to a no-test result when the tests are done post mortem? I am beginning to wonder whether those who drafted these regulations would not benefit from the experience of working for a few days on a farm and in an abattoir. I turn to Schedule 4. Should we really be enacting legislation based upon out-of-date scientific knowledge? It is already accepted, as I have demonstrated, that previously held hypotheses about TSE-resistant and susceptible genotypes in sheep have been found wanting. Therefore, what is the point of sampling animals to establish their genotype, as required in Regulation 6(1)(b)? Upon what basis will the Secretary of State decide, under Regulation 6(3)(a) to (d), which animals, ova or embryos should be killed and destroyed, which are suitable for human consumption and which may be retained, if her decisions are not based on genotypes? As a goat-keeper, I feel strongly about paragraph 7(1), which requires a whole herd of goats to be killed and destroyed in the rare event of one animal with TSE being discovered on a holding. In reality, I am pleased to note that, for the two herds where scrapie has been found in goats, the rest of the herds have been reprieved for the time being, and I thank the Defra officials who made representations to the EU for derogation in those cases. It is good to know that common sense sometimes prevails. It is not my intention to divide the House on this occasion. I want the Minister to know that I am extremely concerned that all regulation in this field is based on a hypothesis—not even a theory—that none of the ““establishment”” scientific community can prove, despite millions of pounds of taxpayers’ money being thrown at the subject. I believe the answer is there among the experts in the subject. I seek two reassurances from the Minister, which I doubt I will get: first, that the will of the House on 15 May 2002 be observed; and, secondly, that a change of direction is in sight, and that future decisions will indeed be made on the basis of sound science. I beg to move. Moved, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 20 January, be annulled (S.I. 2006/68) [22nd Report from the Merits Committee].—(The Countess of Mar.)