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House of Lords debate 7 March 2006


Transmissible Spongiform Encephalopathies Regulations 2006

The Countess of Mar 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.)

Baroness Byford: My Lords, I am grateful to the noble Countess, Lady Mar, for bringing these regulations to the attention of the House tonight. She has explained and gone into her concerns in great detail. I do not propose to repeat all that she has said because that would make this a very long session, but I do thank her.

I have questions for the Minister on two particular issues she has raised. First, in her contribution, the noble Countess asked why TSE researchers in Edinburgh, such as the Moredun Research Institute, are refused information about which scrapie strains have been used as a basis for the design of the national scrapie eradication plan. We should have an answer to that. Secondly, we should seek clarification from the Minister on the qualifications that would be required of the inspectors. I apologise for my voice, as well.

When the 2002 TSE regulations were debated, concern was expressed that they were over-prescriptive. The Minister restated the Government's confidence that these regulations were appropriate, but I question that again tonight. The issues raised by the noble Countess reinforce that. She inquired again of the Minister if he is confident about the soundness of the science on which decisions are being taken.

I am sure the Minister would agree that atypical scrapie is a sporadic eruption of the disease that can occur in even the most resistant genotypes. I understand that knowledge of it is still growing, but that it is still incomplete. It does, however, happen where there is no connection by breeding or any other occurrence of the disease. While the atypical disease has similarities to classical scrapie, it is not necessarily precisely the same, hence its title "atypical". I would like the Minister to comment on that.
I shall turn to the nitty-gritty of these regulations. On Regulation 17(1), how is an inspector to know when or whether domestic premises are being used in connection with these regulations? If entry is going to be made, I presume, although I did not see it, that a warrant would be obtained first. In all the other regulations we have talked about, a warrant is normally sought when entry is to be made into a domestic dwelling. Could I have it confirmed that this is also appropriate here?

On Regulation 22, how can Defra justify penalties of this magnitude in the face of the Prime Minister's announcement 10 days ago that he will introduce fines of up to £1,000 for assault or harassment of NHS staff, when here there is a possibility of a prison sentence as well? In Regulation 1(1) of Part 1 of Schedule 2, 1(1) of Schedule 3 and 1(1) of Schedule 4, is there any significance in the use of the phrase "under his charge", compared with "under his control" in the other two? What is the difference?

In Regulation 6(3) in Part 1 of Schedule 2, why is the charge to be met by the occupier if the no-test could relate to a sample that cannot be tested for any reason, as in Regulation 5(3) in the same schedule? At page 17, paragraph 2, does the,

"determination of whether or not",

mean the same as "confirmation that", and if not, will the Minister explain how one determines a suspicion? At page 29, paragraph 6(2), which deals with compensation, would the valuer's fee have to be paid by the owner, even where the suspect feed had been contaminated before it was delivered to the owner? Would it have to be paid by the owner even if it were proved after the slaughter of the animal that the inspector's belief that the feed was contaminated was erroneous?

I turn to page 19 and ask the Minister to look at the compensation table. It was only the 10 February that we passed that statutory instrument. The noble Baroness, Lady Farrington, was the Minister who responded at that time. I raised the question of why pedigree beef animals at the younger age received no compensation when clearly in all other sectors at that age compensation was paid. I raised it in the debate then on 10 February but I have had no word at all from the department. I would expect that the matter could be clarified tonight. I fail to understand why a pedigree animal does not qualify for payment. It is beyond me. I beg to support the Minister in the questions that she has raised tonight.

Lord Hylton: My Lords, once again I declare my interest as a farmer and as a dairy producer of milk. I would like to thank my noble friend Lady Mar for giving us the chance of this debate and for the rigorous way in which she examined the regulations. I welcome the element of consolidation included in the regulations and in general the control and eradication provisions, subject always to the application of the most recent, relevant and accepted science, a point my noble friend made so forcefully.
I agree with her that it is more than possible that the powers given to inspectors are too wide; in particular inspectors should be required to return all records taken away within a reasonable time. That is not written in the order. Going a little further, Her Majesty's Government should ensure that there are sufficient abattoirs to serve all the main livestock areas in the country. That is necessary both for healthy and for fallen and casualty stock following the concentration that has been going on in recent years in places of slaughter. It is also necessary both on economic and on animal welfare grounds. Will the Government therefore put the matter firmly on the agendas of rural development agencies and of the other quangos supposed to be addressing rural problems? RDAs could be given the task of assisting new, small and medium-sized abattoirs to open in areas of need.

I turn to a wider point concerning animal health. Is there anyone in the Cabinet who appreciates just how heavy has been the impact of cattle diseases on farming and therefore on the whole of the rural economy? Britain used to be the livestock rearing place of the whole world. Successive epidemics of BSE, foot and mouth disease and TB have ended that, alas. The general public have been momentarily alarmed by media reports of animals with diseases and often of the sluggish official responses. But, I ask, how many people really understand the cumulative effect of those outbreaks? There is plenty of evidence in terms of farmers who have committed suicide, for example, and of the continuing consolidation into ever-larger farms.

I have already referred to TB, now very prevalent in cattle in the south and south-west of England and in all Welsh border counties. A decision will soon have to be taken about eradicating badgers around the TB hotspots for cattle. Do we want to kill badgers or to go on killing cows, only to have the healthy remaining stock reinfected? The present policy is costing the country many millions as well as disrupting production and breeding. Will the Government also investigate whether rats can act as TB transmitters; for example, between badgers and the cattle themselves?

I end by asking a cautionary question. Are we as fully prepared as we can be for Asian bird flu? It is creeping nearer to us all the time. It raises issues of possible vaccination, which could turn out to be important for animal health much more widely across the board.

Baroness Howarth of Breckland: My Lords, I rise to speak against the annulment of the regulations, although I am grateful to the noble Baroness for raising the issue and giving us an opportunity to speak about the issues. I declare an interest as a member of the board of the Food Standards Agency and the deputy chair of the Meat Hygiene Service. I am going to take a broad view of the debate and will not attempt to answer any of the detail, although in another place I hope that the noble Baroness will take advantage of joining the seminars that are going to take place about TSEs. It is my understanding that the atypical scrapie is newly identified—she shakes her head; I say that to her because if she has greater understanding, she would be valued at those seminars and I urge her to join. As she knows, she is always extraordinarily warmly welcomed in the agency.

However, as a member of the FSA board I have seen the move from a nation appalled by the BSE crisis—my sympathy is with the farmers and the terrible tragedies that they have suffered over the years—and the consequent lack of confidence in food issues generally to one where I believe that we are moving forward confidently to testing and where our surveys show greater consumer confidence across the food chain. All the Food Standards Agency surveys are showing that confidence steadily increasing.

Consumers and public health are central to this important set of regulations. It covers all the key controls that protect the public from the risk of BSE—I shall return to that issue—including the feed ban, specific risk material controls (SRM) and the testing of cattle aged over 30 months. All provide vital protection against vCJD—a truly horrific disease involving a slow death and no cure.

I have spoken and worked with relatives of those who have died and who would not wish to take even the proportionate negligible risk. There is consensus among experts in the field, including the advisory committee, SEAC, that vCJD resulted from transmission of infection from BSE in cattle to humans via infectivity in food.

I know that in the past the noble Countess has talked about the therapeutic use of organophosphates, but experts over the years have looked at that, and in 1997 SEAC concluded that more evidence would be required to justify further consideration of a role for organophosphates in the development of BSE. The BSE inquiry by the noble and learned Lord, Lord Phillips of Worth Matravers, concluded in 2000 that the theory that BSE is caused by organophosphate pesticides was not viable. Professor Horn's review of the origin of BSE stated in 2001 that that theory could not be reconciled with the epidemiology and was not supported by research. All the research that has been reviewed by the Food Standards Agency supports the conclusion that BSE comes from the transmission from food to humans. I am sure that anyone in the Food Standards Agency would be prepared to write to any Member of the House who would like that to be outlined in more detail.

Policies have to be based on evidence, and the Food Standards Agency must base its views on evidence. If new evidence comes forward, we will review that. The evidence means that it is essential to maintain the confidence of consumers, both in the UK and elsewhere—particularly elsewhere at the moment—that they will be protected. The FSA advised that the OTM rule should not be lifted unless the BSE system that replaced it would be robust. That may be seen as difficult, but it is essential that consumers' health and welfare is protected. That was recognised and shared by stakeholders, including the meat industry. Indeed, on the whole, the slaughtering industry has been a willing partner in setting up the testing system which is now working well in over 40 abattoirs throughout the UK. The controls have been set out at EU level, but without these regulations they could not be properly enforced and that would presumably leave us with the expensive OTM rule. The cost of continuing that would run into huge sums for this country.

Things have moved on and we are no longer the BSE risk of Europe. Following extensive consultation in 2004, the FSA advised Ministers that, based on risk and proportionality, a move from the OTM rule to testing would also meet the test of protection of public health—but only if the system was robust and was checked by an independent advisory group, bearing in mind the history of this country's BSE.

Following the work of that group, the FSA concluded that,

"a reliable testing regime for OTM cattle has been successfully designed and trialled",

and that,

"arrangements are in place to ensure that, should the BSE testing regime be implemented, it would be able to operate across the UK to the highest standards".

But the independent group also considered that a recommended method of practice should be in place before plants could legally slaughter OTM cattle. The testing provisions of the TSE regulations simply implement those recommendations. I am sure the Minister will recognise the balance of care and proportionality that the FSA has brought to the issue and I commend the regulations to the House.

The Duke of Montrose: My Lords, I declare an interest as the owner of a large number of what are regarded as TSE-susceptible animals and as a participant in the voluntary scrapie eradication programme.

There seems to be a long history to this debate. Fortunately, the situation is not as fraught as it was when we debated the original 2002 regulations, when we were all very conscious of the dangers, not just from BSE but from foot and mouth disease, and the Government had an obligation to implement the European TSE directive in the absence of an updated animal health Bill. We can all be grateful that we are not faced with a similar situation just now.

However, there seems to be a curious similarity between this measure and the former one; in spite of the extensive effort by the Government to include more than 13,000 organisations in the consultation exercise, only 13 responded. That is an interesting reflection of what happened last time. Either the whole thing is far too complicated for most people to get their head around or the Government have got everything absolutely right.

There are still areas where we would be grateful for some elucidation. Noble Lords may remember that when the House was discussing the scrapie provisions in the Animal Health Bill, I moved an amendment seeking to restrict the compulsory slaughter of sheep in the scrapie eradication programme to those regarded as most susceptible of the five deemed categories. This was on account of evidence that among hill breeds, in particular the Scottish Blackface, only nine per cent qualified for the "most resistant" variety. The purpose of the amendment was to try to ensure that, as science progressed, we would still have the chance to review the next steps that the Government might propose, with the hope that, at the same time, we would begin to understand the particular attributes attached to the different groups and be able to ensure that, by breeding, the essential breed characteristics could be maintained.

We now have a chance, after four years, to revisit this topic, but the approach taken in the order appears to be based upon exactly the same scientific basis. I have received information that a ram in a Welsh mountain breed, with the highest category of scrapie resistance, was proving very unsatisfactory in terms of his progeny's survivability on the Welsh mountains. Tonight the noble Countess, Lady Mar, has suggested that various strains of scrapie do not obey the same rules as those adopted by the Government. Some of the animals classed as most susceptible may be those that can provide resistance. Perhaps there is a case here—though it would not be a subject for tonight—for the Government to retain a pool of genetic material from those that we are culling. I would be most interested to hear the Minister's response on these issues.

We should still congratulate the Government on the UK's achievement of this massive reduction in the incidence of BSE. The dream that we will eliminate it is still there. The fact that two months ago they were able to end the Over Thirty Months Scheme in relation to slaughter—and I take it that the noble Baroness, Lady Howarth, was merely referring to the Over Thirty Months Scheme in relation to inspection, which is still in place—will mean huge savings and that we are operating the same controls as the rest of Europe. These controls ensure that, as far as possible, there is no risk to consumers. That essential fact must be maintained. At the same time, I hope the Government will continue to address the finer details of rules and regulations to see whether further savings in cost and red tape can be made.

I recently received a communication from the Scottish Association of Meat Wholesalers, one of those bodies that replied to the Government's consultation, and that paid particular attention to the EU TSE road map, which allows for future developments in our control and elimination of this disease. It raises the point that a possibility for alleviating cost lies in the fact that the present classification of specified risk material includes the whole intestine, whereas BSE has only been isolated in the distal ileum. It was found that if the SRM rules were directed only at this part of the intestine, it would save the European industry £77 million each year.
Can the Minister tell the House how much research the Government are aware of as being carried out in this country? This is important if we wish to see the best progress within the EU road map?

Lord Greaves: My Lords, following the noble Baroness, Lady Byford, and other noble Lords, I thank the noble Countess, Lady Mar, for initiating this debate and laying this Motion to annul, which allows us to have this discussion this evening. This is a complex and difficult issue for lay people to get their minds around; nevertheless, it is a very important one. That has been indicated by the way, as the noble Duke said, it keeps coming back to be debated in this House.

This is a calmer and less hectic occasion than the last time the noble Countess sought to annul a regulation. That took place during the ping-pong on the Animal Health Bill, when emotions were roused and the noble Countess was roundly accused of all sorts of things, maligned and, at one stage, accused of undermining the constitution of the very country by what she was trying to do. The country survived her attempts to do that, as has the noble Countess, and we are here to discuss it again.

Before I turn to some of the issues raised, I want to thank and applaud the Government for some of the more positive aspects of these regulations. In its 22nd report of the current Session—it does beaver away—the Merits of Statutory Instruments Committee said that the regulations,

"effect a welcome consolidation of a number of instruments dealing with controls to eradicate transmissible spongiform encephalopathies in cattle, sheep and goats".

The consolidating aspect of these regulations is to be welcomed, as is what is described in one of the supporting memoranda in our briefing papers as an "innovative" approach by the Government in setting them out clearly and in a sensible way, which is easier to amend in future, and in writing them in plain English. I am not sure that everyone who reads them will understand them immediately; nevertheless, I believe that that has happened. It is interesting that, in using plain English in a sensible presentational layout, Defra is commended as being innovative. Perhaps it should lend some of its staff to other departments. At the moment, I am dealing with the Electoral Administration Bill, which is an absolute minefield of non-plain English and non-sensible layout.

Also, as I understand it, these regulations have been condensed into 42 pages instead of the 221 pages of the 2002 regulations. That is surely not only a step forward but an indication to civil servants everywhere who draft these things that it is possible to say things more concisely without saying less. These things are to be welcomed, and they are not trivial because nowadays much legislation is a minefield of gobbledygook.

When the House discussed the 2002 regulations, my noble friend Lord Livsey of Talgarth moved an amendment to the noble Countess's Motion and then the Minister, the noble Lord, Lord Whitty, moved an amendment to her Motion. It all got incredibly complicated and, apparently, constitutionally difficult. My noble friend would have liked to be here this evening but, unfortunately, he has been suffering from bronchitis and he is not quite as resilient as the noble Baroness, Lady Byford. The noble Baroness may be of a more resistant genotype than my noble friend; he apologises for not being here.

I shall give the gist of what my noble friend said four years ago. First, he made a general complaint that, once again, this was making law by subordinate legislation in complex areas that would benefit from a more detailed approach. If we could subject a statutory instrument of this kind to a Grand Committee-type afternoon's discussion, that would be beneficial to everyone. Again—this is a general point—if we are reforming the procedure of the House, we have to find ways in which complex and difficult issues such as this can be better debated, rather than through a Motion like this on the Floor of the House. So I repeat the comments that my noble friend made four years ago.

My noble friend also said—this has been echoed by a number of speakers this evening—that these regulations are rather over the top and gold-plated. In particular, I echo the comments of the noble Lord, Lord Hylton, about the powers of the inspectors. That is precisely the kind of thing that we should be able to scrutinise better and to which we should be able to persuade the Government to make changes, which is very difficult.

My noble friend's amendment referred specifically to appeals, on which the position is better now than it was four years ago. I remember the ping-pong on appeals that occurred during the passage of the Animal Health Bill. The noble Baroness, Lady Byford, and I managed to get some small improvements to the Bill at the bitter end of the ping-pong, and I think that there may be a better recognition of that kind of thing in these regulations.

The final part of my noble friend's amendment dealt with what he referred to as,

"the never-ending march of technology".

A number of speakers have made that point this evening. Four years ago, the House passed a resolution, with the support of the Government, which called upon Her Majesty's Government,

"to keep the regulations under review in the light of scientific and technological developments relating to TSE".—[Official Report, 15/5/02, cols. 382-83.]

Underlying what a lot of people have said this evening is a belief that the Government have not really been doing that. Perhaps the Minister could tell us what changes have been made to the regulations and how they differ from the 2002 regulations in response to the Motion that the House agreed to at the time. What have the Government been doing to keep up with the never-ending march of technology and, in particular, to respond to the changes in science that have been taking place?
I listened to the noble Countess, Lady Mar, in awe. The House is very—what is the word I am looking for? I am trying to compliment her, but I cannot think of the word. We really benefit a great deal from having her here to ask these questions. I do not know how much of what she says is right and how much is wrong; it is very difficult for a layperson to know such things. However, I know that she is asking a lot of the right questions, which I think deserve an answer.

As far as TSE in sheep is concerned—and the whole business of genotypes, more susceptible strains and less susceptible strains—I think that we are back to the questions that concerned many of us a great deal when we were discussing Part 2, if I remember rightly, of the Animal Health Bill. It is all very well breeding out certain genotypes in order to eliminate scrapie, if that can happen; it may be that it cannot happen and that new forms of scrapie will come that, because the other forms have been bred out, attack the other kinds of sheep. However, the real danger, which is quite clear to us all, is that in breeding out those genotypes you may also be breeding out the desirable characteristics of those genotypes, which have evolved over hundreds and thousands of years and which in future may not be there in response to a wholly different kind of attack on the sheep flock. That has been the concern about the Government's approach and, frankly, that concern remains. However, that is a more general thing, which does not necessarily affect these regulations immediately.

On the top side, the noble Baroness, Lady Howarth, explained how huge progress, in my view, has been made in tackling BSE. I understand the points that she made, but we cannot avoid the fact that in 1992 there were 37,000 cases of BSE in this country, whereas now the number is down not quite to single figures but to double figures each year. It is 20 years since BSE was diagnosed, discovered, invented or whatever happened then. I believe that a good enough case has been made for the connection between BSE and Creutzfeldt-Jakob disease in human beings for us to take the action that we are taking. Even if the two have nothing to do with each other, eliminating BSE in cattle is worth while in itself. I believe that progress has been made in that area. We all look forward to the lifting of the restrictions on the slaughtering and sale of cattle, to which the noble Baroness referred.

I welcome the regulations with two cheers, I think, in so far as I fully understand them. In particular, I welcome on behalf of these Benches the questions that the noble Countess raised and I very much look forward to hearing the Government's response.

Baroness Farrington of Ribbleton: My Lords, it may be helpful if I just inform the House that the fire alarm went off in the Barry Room kitchen. There is no cause for concern. Those of us who have a good sense of smell had smelt the fact that it had gone off.

The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Bach): My Lords, I join in the thanks to the noble Countess for introducing this debate by way of a Motion to Annul. I am staggered by the expertise that there is—not, of course, just from the noble Countess, but from around the House—on what is, as the noble Lord, Lord Greaves, said, a very complex matter.

Hearing about battles that were fought four years ago, I feel like a newcomer to a reunion party that noble Lords are holding tonight. I was the only person who was not part of those or even present—though I see I did vote on that occasion as I have looked in Hansard. I have not read every word of the debate as it went on for nearly three hours, if Hansard is correct.

We recognise that TSEs are a public health issue and that variant Creutzfeldt-Jakob Disease is a truly terrible disease. I know that noble Lords would like, first of all, to pay tribute to the victims of the human variety and their families. BSE and scrapie are also, of course, very important animal health issues.

These regulations revoke the TSE (England) Regulations 2002. They provide the necessary powers to administer and enforce the directly applicable requirements of the European Union Regulation 999/2001 which lays down the rules for the prevention, detection and eradication of TSEs.

I hope that noble Lords will forgive me if I remind the House why we need these regulations. The EU regulation sets out the objectives for TSE monitoring, control and eradication. However, it does not always say how these objectives should be delivered or set out what should be done if individuals do not co-operate. That is what our national legislation does. The 2006 TSE regulations set out in detail how the requirements of the EU regulation will be delivered and provide the necessary powers to enforce them.

I am grateful to the noble Lord, Lord Greaves, for referring to the Merits Committee, because if he had not I was going to do so. In their consideration of the regulations, committee members reported that the regulations,

"effect a welcome consolidation of a number of instruments dealing with controls to eradicate TSEs",

and were glad to hear of our claims that these regulations were written in clearer and more understandable English than some other regulations. The new regulations are much simpler and clearer than those they replace. Noble Lords will have noticed that they are also half the length.

The new structure of the regulations divides them into common provisions and schedules covering the main areas of control for TSEs. This structure makes the regulations much easier to use and understand. They are largely a consolidation and updating of the existing provisions in this area. They are both reasonable and proportionate and are not gold-plated. However, they do introduce a number of limited changes and I have been asked by the House to deal with one or two of those.

A common appeals procedure has been introduced, replacing the various appeals procedure that existed under the 2002 regulations. This was an issue which the noble Countess raised last time and it was of general interest to the House.

Schedule 3 of the regulations includes a new table compensation system for cattle killed under BSE control and eradication measures. This table is in line with that introduced by the Cattle Compensation Order (England) 2006 and brings BSE compensation into line with Defra compensation arrangements for TB, brucellosis and EBL in cattle. Changes have also been made to the compensation rates for female sheep or goats and lambs or kids in Schedule 4, following a consultation in autumn 2005.

The regulations also slightly amend the requirements for testing cattle aged over 30 months intended for human consumption. These requirements were originally introduced by the regulations of last year and are included in Schedule 2 of these regulations.

A robust system of testing was set down as a prerequisite by the FSA before cattle aged over 30 months could enter the food chain. I was grateful for what the noble Baroness, Lady Howarth, said about that. Industry was consulted widely before the introduction of the controls. The evidence indicates that the controls are not discouraging abattoirs entering this market.

The introduction of the OTM testing regime has led to a return of older beef to the food chain and is a very welcome boost in difficult times to the food industry and beef farmers. Farmers are generally receiving prices from the market that are well in excess of previous Over Thirty Months Scheme rates for their older cattle. It was encouraging too to hear what the noble Baroness, Lady Howarth, said about consumer attitudes to BSE.

As I said previously, these provisions simply provide the powers and controls that are necessary to ensure that the directly applicable European legislation is enforced properly. A concern was raised on the previous occasion—four years ago—that the regulations gave inspectors the power to kill any TSE-susceptible animals. In revising the regulations, we have given regard to these concerns. The schedules clearly identify where the provisions apply to bovines, sheep or goats respectively.

I turn to some of the questions that were raised. Some of the questions were detailed, quite understandably so, and I shall write a general letter to the noble Countess with answers to those questions which I do not answer in the next few minutes.

A number of noble Lords, including the noble Countess, the noble Baroness, Lady Byford, and the noble Lords, Lord Hylton and Lord Greaves, referred to the qualifications of inspectors. Regulations are enforced by these inspectors, who are either from the State Veterinary Service—they are of course qualified veterinary surgeons—or the Meat Hygiene Service, which oversees abattoirs. They are either vets themselves or qualified meat technicians.

I turn to powers. I know that the noble Baroness, Lady Byford, is very interested in this topic. We have met it in various Bills that we have debated at the Dispatch Box in this Session. I was referred in the course of debate to Rule 17(1) relating to powers of entry. This rule represents no change from previous regulations. The rule states that an inspector shall, on producing a document which shows his authority, have a right at all reasonable hours to enter any premises. These premises will include domestic premises provided that they are used for a purpose in connection with these regulations. If the domestic premises are outside the scope of these regulations, the inspector would be acting ultra vires unless he or she had obtained a warrant before entering.

It is a strong power—I do not want to deny that. No warrant would be required if, for example, the office of the farm—if we are talking about a farm—was in the dwelling house. If it was not found there and it was not reasonable to expect that it might be found there, the inspector would be acting outside his powers. The powers are quite clearly laid down in Rule 17. It is an example of the English used being more understandable.

The Countess of Mar: My Lords, there are two separate definitions of "inspector" in the regulations. The first refers to an inspector who is appointed under Regulation 16; the second refers to a veterinary inspector, which means a veterinary surgeon. Paragraph 18 refers presumably to what the Minister has just told us will be meat hygiene inspectors. Will these hygiene inspectors really carry out all these duties?

Lord Bach: My Lords, I am advised that they will. So I have dealt with inspectors as I intended.

The EU regulation sets out the scope for TSE control and eradication action. Where it is necessary to kill animals for control purposes, the EU regulation specifies which animals must be killed. Our national regulations give us the power only to deliver these requirements. The detailed provisions in the schedules set out when the powers will be executed, but that does not mean that an inspector can require animals to be killed without good reason. Actions must be in accordance with the EU regulation and these regulations. Thus an inspector may exercise their powers only in the circumstances set out in the schedules and in the EU regulation. It is worth noting that the control measures set out in the EU regulation are currently being discussed within the context of the EU Commission's strategy document, The TSE Roadmap.

Changes to controls are being considered in several areas to reflect the encouraging reduction in BSE cases across Europe. We are actively involved in this process. It supports the proposal that, in a case in which scrapie has been confirmed and BSE has been ruled out, it should not be necessary to cull the affected flock. The UK supports the proposed tolerance for acceptable trace residues of fishmeal in ruminant feed. This will alleviate significant problems which requirements for strictly dedicated production cause until the political issues of lifting the ban on fishmeal in ruminant feed are resolved in the European Parliament.

The noble Countess, Lady Mar, is a distinguished contributor on these issues, but there is a difference of opinion about the origins of BSE. Indeed, it is accepted that the origins may never be known. But I draw the House's attention to the independent review carried out last year by Professor William Hill, who confirmed that the elimination of food-borne sources was a key to the eradication of BSE. He recommended risk-based controls, and that monitoring should be maintained on animals and feed.

I shall return to answering some of the questions that have been asked today. The noble Countess mentioned what I believe is called the "one before and two after" rule. This is an EU rule, but I can announce that the Veterinary Laboratories Agency is carrying out a new risk assessment of this control. I hope that will give the House some satisfaction.

The noble Countess expressed concern about goats. The EU regulation sets out the control measures that must be taken when scrapie is reported, and the provisions of the domestic regulations provide inspectors with powers to enforce them. We believe that the EU controls are disproportionate for cases of scrapie in goat herds that are dairy flocks, where animals are not sent for breeding. In such cases, we have applied controls pragmatically, restricting and monitoring affected herds rather than culling them. Other member states are carrying out similar actions in herds with confirmed cases of scrapie.

The noble Countess, Lady Mar, and the noble Baroness, Lady Byford, talked about access for the Edinburgh scientists. I will answer that in the letter that I will write. The noble Baroness mentioned controls based on sound science. Controls are based on the best available science, and this is supported by the Government's independent experts—the Spongiform Encephalopathy Advisory Committee.

The noble Baroness also asked why there was no differentiation of penalties in these regulations. Our answer is that the legislation does not impose the penalties on individuals; the courts do. The penalty provisions set only maxima; that is all they can do. The courts have—they must have—a wide discretion when dealing with an individual case. So there is no inevitable lack of proportionality in any particular case.

Baroness Byford: My Lords, the whole question of fines that are being imposed particularly under Defra Bills has concerned me for several months. Many cases serve to produce evidence; they are not what I call life threatening, as some of the other instances are that come before the House for debate.

In many cases we question this because the proportionality of some of the fines that could be imposed seem to us to be exceptionally high by comparison with other everyday examples, as I call them, that I could give. That is why we keep raising the issue. In some cases, where it is not considered urgent or imperative, it appears that the Government propose to bring forward very big ranges.
The Countess of Mar: My Lords, certain members of the Statutory Instruments Select Committee have expressed their unhappiness about the way in which the penalty legislation is being brought in through secondary legislation, with no debate. That is causing serious problems and people are very worried about it. Perhaps the Minister would reconsider that.

Lord Bach: My Lords, I take these points seriously. These are maximum sentences. The courts are very capable of dealing with the majority of cases that are not the worst and, therefore, do not attract the maximum sentence. I shall try to deal with that point also in the letter, as it is important.

The Duke of Montrose: My Lords, perhaps I can go back to the point the Minister was making about connections with the Edinburgh scrapie body. Do the Government accept that there are various different strains of scrapie and that they have slightly different characteristics?

Lord Bach: Yes, my Lords, we do. I shall continue with the questions. On compensation for pedigree cattle, I shall go back over the record and include the answer in my letter, as I shall with the detailed and proper questions that the noble Baroness asked about specific parts of the regulations. Why is there no compensation for a "no" test? I am advised that a "no" test is normally caused by poor sampling or poor processes and, as such, it is felt that taxpayers should not be liable for compensation for abattoirs' poor sampling.

The noble Lord, Lord Hylton, raised some interesting points, not all of which I shall deal with tonight. On small abattoirs, at Defra we have limited funding for RDS grants and there is a large call on that funding, as the House would expect. The chairman of the Food Standards Agency has announced that she would like to see a review of abattoirs in sensitive areas. However, it is most important to ensure that all abattoirs meet controls that are put in place to protect public health. The call for the protection of small abattoirs has been noted.

The noble Lord, Lord Hylton, also mentioned bovine TB. Everyone would agree that that represents a severe problem for all of us. I reminded him that the consultation on badger culling ends later this week, on Friday, so I am unable to comment at this stage. All responses will be considered in due course, and I hope noble Lords with an interest in this have written in. I do not want to say any more about bovine TB tonight.

On avian flu, precautionary measures are in place and we consider them appropriate and sufficient for the time being. Exercise Hawthorn, to test the organisation, structures and systems in place in the event of an outbreak of AI, is planned for next month. We do not yet require birds to be housed and we shall continue to allow fairs, markets and racing to take place under licence. We believe that our refusal to panic is the right approach to this matter, but it means that we have to be ready if and when avian flu comes to this country. I believe we are ready.

The noble Duke, the Duke of Montrose, mentioned research into specified risk material—SRM—in relation to testing. We are encouraged that the TSE road maps are based on science and are proportional.

He asked about retaining a pool of genotypes. With industry, we have set up an archive of semen from rams of susceptible genotype under the national scrapie plan. That will make possible the establishment of viable breeding populations in sheep in future if that proves necessary.

I hope that I have answered most of the questions, although I have not dealt with atypical scrapie. In general terms, we take account of advice from the Spongiform Encephalopathy Advisory Committee and EU scientific communities. What is the European Commission doing about atypical scrapie cases? In its TSE road map, which sets out future proposals for the control of TSEs in Europe, it acknowledged that the current control measures might not be appropriate in atypical scrapie cases and planned to review the policies during 2006. I say to the noble Countess, Lady Mar, that, to date, we do not believe that there is any evidence to indicate that atypical scrapie is, in fact, BSE. We consider that there is an urgent need, however, to gain a better understanding of the true significance of atypical scrapie, which must be based on sound scientific evidence.

I have spoken for so long that the Deputy Chief Whip has come into the Chamber. I must wind up my speech. I have described the regulations as best I can. Let me mention the vote that will be held in all likelihood tomorrow morning in the EU's Standing Committee on the Food Chain and Animal Health on lifting the UK's export ban. Obviously, it would send the wrong message were we to annul the regulations tonight, thereby leaving us with no ability to administer and enforce the EU rules on BSE and scrapie, but the noble Countess, Lady Mar, has been good enough to tell the House that that is not her intention. I am sure that I speak for the whole House when I say that everyone hopes very much that the EU will vote to lift the export ban tomorrow, so that British beef will again be able to find its rightful place in Europe.

The Countess of Mar: My Lords, I am grateful to all noble Lords who have taken part in this debate. The noble Lord, Lord Greaves, said all the things that I should have said, but did not have time to say, about the nice aspects of the regulations and how they have been brought together. I am grateful to the noble Baroness, Lady Byford, and the noble Duke, the Duke of Montrose, for the questions that they posed, and I look forward to receiving the answers from the Minister. I also thank the noble Lord, Lord Hylton, for his support. Let me say to the noble Baroness, Lady Howarth, that I have never said that organophosphates caused BSE, but I said, and still say, that they might be a contributory factor, in that they affect the immune system.

I have huge sympathy with any parents who have had to look after children with new variant CJD. I just want to know what is really at the bottom of these diseases, and that is why I keep questioning the science. When we look at the amount of money that has been spent on BSE and the huge measures that have been taken, and compare it with what has been done on TB, we see that there is a clear discrepancy on the research front. As to the wonderful meat hygiene inspectors, has anybody asked them whether they are prepared to do all these jobs? I just hope that they will never have to carry out these duties. With that, I thank the Minister for his contribution and for being so patient. I beg leave to withdraw the Motion.

Motion, by leave, withdrawn.