Volume 6: Human Health, 1989-96
6. Events from 1 April to 31 December 1995: human health returns to the agenda
MRM
Gelatine
The paper for SEAC on MRM
SEAC's consideration of the paper on 21 June 1995
Impact of SVS surveillance results on views about the safety of MRM
MAFF and DH agree that the MRM issue needs to be revisited
Discussion of MRM at SEAC's meeting on 23 November
MAFF's response to SEAC's recommendation on MRM
Discussion

6.196 In the first half of 1995, MRM was raised in the context of the production of gelatine from skulls and vertebrae for use in animal feed. While further details of SEAC's consideration of the use of gelatine in animal feed are given in vol. 11: Scientists after Southwood, 1986-96, in this section we describe briefly how SEAC's advice led MAFF to consider the possible implications for MRM. The main part of this section covers the second half of 1995, when SEAC revisited the extraction of MRM from bovine carcasses, leading to the ban, introduced in December 1995, on the use of spinal cord from cattle over six months old in the production of MRM.

Gelatine

6.197 SEAC had previously (in 1992) considered the use of gelatine in pharmaceutical products, and advised that SBO, as well as skulls and vertebrae, should not be used to make gelatine for pharmaceutical material used for injection, implantation or to be taken orally (see vol. 11: Scientists after Southwood, 1986-96). ¹ The use of gelatine in animal feed was raised in early 1995 when UK animal feed manufacturers asked MAFF to relax the ruminant feed ban, so as to allow gelatine to be included in ruminant feed. This followed advice from the EU Scientific Veterinary Committee (ScVC) recommending that gelatine be excluded from the EC ruminant feed ban (for further discussion see vol. 5: Animal Health, 1989-96). ²

6.198 Mr Eddy felt that SEAC should be consulted before any change was made to the ruminant feed ban. ³ Prior to a meeting of SEAC on the issue, Mr Eddy was advised of the views of various committee members, including Dr Tyrrell and Dr Kimberlin. In a minute dated 26 April to Mr Meldrum, Mr Haddon, Mr Baker, Mr K Taylor, Dr Cawthorne, Mr Raymond Bradley (Head of CVL Pathology Department), Mrs Jane Brown (Head of the Meat Hygiene Division) and others, Mr Eddy noted the position of Dr Tyrrell on the issue:

The position as put by Dr Tyrrell is that the risk of some nervous tissue contaminating bone exists with the backbone as well as the skull and if we are concerned about the use of skull to produce gelatin for animal feed we should be equally concerned with the use of the backbone . . .

. . . I am conscious of the fact that there is an obvious read across from this to the human health aspects and the collection of MRM from the spinal column. I think we ought to have a meeting in early May on this to decide whether I ought to go back to the Committee to try to get them to review the situation on backbones or whether we ought to take forward the steer from the Committee that any change on skulls should be reflected in tightening up on the vertebrae as well. ⁴

6.199 Mr John Howard (Animal Health Division, Head of branch dealing with BSE policy, casework and correspondence) commented in a minute to Dr Cawthorne and Mr Fleetwood, among others, on 27 April 1995, that one option of implementing SEAC's advice would be to add 'skulls and backbone' to the definition of 'specified bovine offal'. ⁵

6.200 Mr Fleetwood responded to Mr Howard in a manuscript note on the same day:

To add backbone to the definition of SBO would enormously increase the amount of SBO to be disposed of, introducing logistical problems and huge costs to industry.

Surely, cannot we say that the proposed SBO order will prohibit bovine skulls from going for gelatin production and thus, at a stroke, the product of greatest risk has been eliminated. In the circumstances, need we worry about backbone - SEAC were unequivocal on this anyway. ⁶

The paper for SEAC on MRM

6.201 MAFF had submitted a two-page paper on MRM for SEAC to consider at its 17th meeting in August 1994. ⁷ The paper had been prepared in the light of a recommendation made in July 1994 by the ScVC that spinal columns from cattle born before 1 January 1991 and slaughtered in the UK should not be used for MRM production, unless they came from animals which had never been in a herd in which a case of BSE had been confirmed during the previous six years. ⁸ However, the paper was deferred at SEAC's 17th meeting. A revised paper was proposed for the 19th meeting on 21 June 1995. ⁹

6.202 The paper sought the Committee's view on:

. . . the use of spinal columns from cattle born and slaughtered in the UK for the mechanical recovery of meat, i.e. meat for human consumption which is current practice.

The Committee will no doubt be aware of the possible read-across to gelatin production and consumer purchase of bone-in beef, (e.g. rib steaks) should a decision be taken to exclude some or all vertebrae from the production of MRM. The implementation of any partial exclusions would be extremely difficult to enforce. ¹⁰

6.203 After setting out some background on the recommendations from the ScVC, the paper went on to describe recent changes to legislation affecting the slaughter procedures for beef carcasses, and the effect of the transfer of responsibility for meat inspection to the MHS:

Concern has been expressed by some members in the past about adequate separation of SBOs from other parts of the carcass. With effect from 1 April 1995 responsibility for meat inspection in fresh meat premises was transferred from local authorities to the national Meat Hygiene Service (MHS). One of the main advantages resulting from transferring responsibility from the many local Authorities to the single MHS is that meat inspection standards can be applied consistently throughout the country. The MHS have been given instructions by MAFF on the need to enforce proper removal and disposal of SBOs. An unannounced audit is taking place in June, which, in particular, will check that the removal of the spinal cord is effective, and ascertain that the SBO controls are being properly implemented and will be monitored.

6.204 In conclusion, the paper stated:

The Committee will wish to note that despite the ScVC recommendation on MRM production the Commission have made no proposals in this area, and have given no indication that they intend to do so. Currently there are no restrictions on the geographical or anatomical origins of material used to produce MRM, although source bones must obviously come only from carcasses passed fit for human consumption. In practice skulls are not used for MRM production but vertebrae and long bones are used. A change in legislation which will soon be implemented will prevent the removal of brain and eyes from the skull, which will then have to be disposed of as SBO. It is important to ensure that spinal cord is removed from all carcasses slaughtered for human consumption.

The transfer of responsibility of meat inspection to the MHS will ensure that consistent standards are applied throughout the country. The MHS have been instructed to pay particular attention to the separation of SBOs and the audit checks proposed by MAFF will provide assurances that the SBO controls are being fully implemented. This should ensure that no carcass is permitted to leave the slaughterhouse for human consumption unless the spinal cord has been completely removed. ¹¹

6.205 The paper recommended that:

In the light of the changes which are to be made to the controls on SBO and the methods of enforcing these controls the SEAC is recommended to advise that the use of spinal columns from cattle born and slaughtered in the UK for the mechanical recovery of meat may continue. ¹²

SEAC's consideration of the paper on 21 June 1995

6.206 The minutes of SEAC's 19th meeting on 21 June record that Dr David Tyrrell, Chairman of SEAC, noted that the key question was whether the SBO controls were being effectively carried out and enforced. The minutes continued:

Dr Watson said that there was more likelihood of spinal cord being properly removed than brains from the skull. The impact of prohibiting the use of spinal columns on the industry would be enormous. In practice, there was a greater risk from spinal cord spraying onto meat. The question was once again one of policing. Mr Bradley noted that the head of the Meat Hygiene Service had been informed of the requirement to ensure that each side was inspected for the full removal of the spinal cord by meat inspectors.

Dr Tyrrell concluded that, provided in the slaughtering process the removal of spinal cord was done properly, the MRM process was safe and there was no reason for the Committee to change its advice. ¹³

Impact of SVS surveillance results on views about the safety of MRM

6.207 As described earlier in this chapter, SVS surveillance results in the second half of 1995 showed that in some instances spinal cord was not being completely removed from bovine carcasses.

6.208 Mr Meldrum mentioned in a minute dated 31 October 1995 that the instances in question were:

. . . potentially serious failings. Spinal cord is, of course, one of the tissues known to have the potential to harbour BSE infectivity. The backbone is frequently used in the production of mechanically recovered meat, and any remaining spinal cord would pass into the meat fraction. ¹⁴

6.209 Mr Meldrum discussed spinal cord removal and its effect on the perceived safety of MRM in written evidence to the Inquiry.

In summary over the period that I was the CVO there was considerable discussion about the safety of MRM and it was concluded that there was no reason to place any additional restraints on its production so long as the rules on the removal of the spinal cord were fully observed. I was not aware that there was any failure to remove the spinal cord from split bovine carcases until July 1995 . . . ¹⁵

6.210 However, in oral evidence Mr Meldrum stated:

I accepted that you would not be able to remove all the spinal cord on each and every occasion. It is not a perfect world . . . I also knew then and I also know now that on occasion small pieces of spinal cord may fall out of the spinal canal, be left attached, particularly in the head area if it becomes severed, and are attached and do not appear to lie in the spinal canal and can be missed. ¹⁶

6.211 On 3 November 1995 Dr Tim Render, Animal Health (Disease Control) Division, ¹⁷ minuted Mr Hogg, enclosing a draft covering letter (addressed to the Deputy Prime Minister) which repeated Mr Meldrum's earlier concerns. ¹⁸ The draft covering letter discussed the surveillance visits by the SVS to slaughterhouses and the instances of incomplete removal of spinal cord from carcasses:

This is a potentially serious failing, as it could risk exposing the public to SBOs. The backbone is used in the production of mechanically recovered meat and any spinal cord left attached to it would pass into the meat fraction. I know that the Chief Medical Officer is concerned about the implications. . . ¹⁹

6.212 The letter concluded with the action to be taken by the MHS in regard to surveillance, and noted that serious failings by slaughterhouse owners would be prosecuted.

6.213 On 16 November 1995 Dr Render advised Mr Eddy on the uses of MRM.

It can be used in any product containing chopped or minced meat. But in practice it is used in very few fresh, raw meat products and in few fresh cooked products. The main use is, apparently in products at the bottom end of the market, such as frozen sausages, burgers and pies etc.

6.214 He concluded that no information was available on the total amount of MRM produced and used. ²⁰

MAFF and DH agree that the MRM issue needs to be revisited

6.215 On 20 November 1995 a meeting was held between Dr Calman, Mr Meldrum and other officials from both MAFF and DH. MRM was a major topic for discussion. The note of the meeting, prepared by Mr Eddy, records that:

The CVO explained that this was a significant product for some meat plants but we were concerned because of the possible inclusion of small residues of spinal cord when the vertebral column was used for the production of this material. However the SEAC had visited slaughterhouses and had decided that it was not necessary to recommend a ban. ²¹

6.216 Dr Metters questioned whether 'even if the spinal cord was properly removed, there was a risk from other associated nervous tissue'. The note of the meeting records that he was reassured by Mr Wells's explanation that examinations of the cauda equina, peripheral nerves and dorsal root ganglia had been negative. ²²

6.217 Mr Meldrum discussed the SVS surveillance visits to slaughterhouses, which had revealed 'some problems related to spinal cord'. In response:

The CMO took the view that it was not possible any more to say that we could guarantee that potentially infectious material (spinal cord) could not get into the human food chain, albeit in small amounts. Clearly we have improved the situation in the last year or so but we cannot be 100% certain, particularly with the risk of inclusion of some spinal cord in MRM produced from vertebral column which would be used in cheap food. That is not to say that we believe that any member of the public may necessarily have been exposed to an infective dose but in presentational terms there is certainly a problem. The CVO agreed that we could not guarantee 100% removal of spinal cord although that was the target that had been set to the industry and the Meat Hygiene Service. ²³

6.218 Mr Meldrum stated, and the CMO and Dr Metters agreed, that in risk assessment there was a difference between MRM produced from cull cows and that from young cattle, which was less of a risk.

6.219 It was agreed that the issue of MRM needed to be readdressed and that it would be put to SEAC at its 22nd meeting on 23 November 1995, as part of the planned agenda item on the review of the results from the SVS surveillance visits to slaughterhouses.

6.220 Sir Kenneth Calman is to be commended for the vigour of his reaction on learning that segments of spinal cord were escaping the attention of slaughterhouse operatives and meat inspectors. By pursuing this matter with Mr Hogg, and subsequently Mr Meldrum and other MAFF officials, he was instrumental in ensuring that the question of MRM was brought back before SEAC.

Discussion of MRM at SEAC's meeting on 23 November

6.221 At SEAC's meeting on 23 November, Mr Eddy updated SEAC on the outcome of compliance check visits to slaughterhouses. He noted that a small amount of spinal cord had been found on 17 separate occasions in 16 plants. Overall, it had been estimated that about 0.4 per cent of carcasses might have some spinal cord left in them. ²⁴ Dr Will was 'appalled' at this information, given assurances previously given to SEAC that there was very little chance that the spinal cord would remain in the carcass. Dr Kimberlin agreed with Dr Will and felt that the situation was 'unacceptable'. ²⁵

6.222 The Chairman, Professor John Pattison, ²⁶ quoted the minutes of the 19th SEAC meeting in June 1995, at which they had decided that MRM was safe as long as the spinal cord was removed. Having learnt that not all spinal cords were being removed, he wanted to reconsider the issue of MRM. ²⁷ The minutes continued:

The Committee discussed at length what level of compliance is acceptable bearing in mind that it is important to consider relative rather than absolute risks. Dr Will stated that medicines would be withdrawn on lower risks. Mr Bradley warned against action that was alarmist and stated that as the epidemic declines the risk is actually falling. Professor Pattison suggested that the use of MRM be suspended until we find evidence that compliance is 100%. Dr Kimberlin thought it dangerous to consider a ban, which would be tantamount to an admission that we cannot guarantee removal of two easily removed tissues. ²⁸

6.223 After further discussion, including consideration of a draft statement prepared by the Secretariat, the Committee agreed the following statement, as recorded in the minutes:

Earlier in 1995 SEAC had considered that 'provided in the slaughtering process the removal of the spinal cord was done properly, the mechanically recovered meat (MRM) process was safe and there was no reason for the Committee to change its advice.'

In the light of the current audit reports showing failure to remove parts of the spinal cord in a small number of carcases the Committee expressed its grave concern.

It noted the further tightening up of controls but felt that unless and until it was clear that the removal of SBO, particularly spinal cord, was now being undertaken properly in all cases it would be prudent, as a precaution, to suspend the use of vertebrae from cattle aged over six months, in the production of MRM. ²⁹

MAFF's response to SEAC's recommendation on MRM

6.224 Mr Eddy put forward a submission on MRM to Mr Hogg on 24 November and copied it widely to other MAFF Ministers, MAFF officials and officials in Agriculture Departments in Scotland, Wales and Northern Ireland. He attached SEAC's conclusion on MRM in the light of the recent problems with removal of spinal cord in some slaughterhouses, and said:

On the basis of the current reports from slaughterhouses we must assume that there will be more cases of spinal cord left in carcases, at least until the message has got through to plant operators that we mean business. This leads me to conclude that we have no alternative at present but to suspend the use of vertebral column from cattle other than calves for the production of MRM. I have discussed this with the CVO who agrees but has said that in practice it will be impossible to police the six month age cut off for MRM so we will need to go for a ban on the production of MRM from all bovine spinal column. ³⁰

6.225 Mr Eddy recommended that an Order be made under the Food Safety Act. Furthermore, he suggested the consultation period should be no longer than three weeks because of the nature of the problem, and 'the fact that it is very much of the industry's own making through its failure to comply with the existing law'. ³¹

6.226 On 27 November 1995, Mr Hogg met Dr Calman to prepare for his meeting with Mr Stephen Dorrell, DH Secretary of State, ³² the next day. Mr Packer's minute of the meeting noted that, subject to Mr Hogg's and Mr Dorrell's views, Mr Hogg would announce, by written Parliamentary Answer the next day, that an Order would soon be made banning the use of bovine vertebral column in MRM. ³³

6.227 This minute formed the basis of a meeting between Mr Hogg 'and various other colleagues' ³⁴ on 27 November. Mr Hogg agreed that an Order should be made, that a Parliamentary Question should be answered on 28 November 1995 and that a statement should be issued incorporating a statement from the CMO. Consultation was also discussed, and it was decided that Mr Hogg would hold a meeting with interested parties on 30 November. Though a formal consultation period would not be ruled out, Mr Hogg would make it clear at the meeting that it was his intention to make an Order one week thereafter. ³⁵

6.228 Also on 27 November 1995 Mr Haddon forwarded a draft letter for Mr Hogg to send to the Prime Minister, John Major, immediately following his meeting with Dr Calman the next day, and a draft Parliamentary Question and Answer:

The proposed plan, as I understand it, is that the Minister should hold a Press Conference later tomorrow at which he will announce a short period of consultation on the proposed legislation banning the use of bovine vertebral columns for mechanically recovered meat as a precautionary measure. ³⁶

6.229 The next day, Dr Render sent a copy of the draft Order to various bodies, including the MLC, the National Farmers' Union (NFU) and the British Meat Manufacturers' Association (BMMA), asking for their comments on the proposed legislation. He also sent the same letter to plants producing MRM on 29 November. In the covering letter, Dr Render stated:

The Government is acting rapidly on this recommendation [from SEAC] in order to ensure that public health is protected from any remote theoretical risk from BSE. The measures are, of course, precautionary. There is no evidence of a link between BSE and the human disease CJD. ³⁷

6.230 Also on 28 November MAFF sent out a press release and responded to a written Parliamentary Question on the issue. The press release noted:

The SEAC expressed grave concern about the findings by the State Veterinary Service of a number of instances where slaughterhouses had left small pieces of spinal cord attached to carcasses after dressing. . . The SEAC welcomed the steps taken by the Minister to ensure full compliance with the controls on SBOs, but concluded that, unless and until there was full compliance with the requirement to remove the spinal cord, it would be prudent, as a precaution, to suspend the use of bovine vertebrae in the manufacture of MRM.

6.231 The press release recorded Mr Hogg as saying:

I am grateful to SEAC for its advice and have acted upon it as quickly as possible. This removes the risk of spinal cord tissue entering the human food chain. The new measures, like the others in place, are precautionary. They are designed to protect public health from any remote theoretical risk from BSE. I would reiterate that we have no evidence of any link between BSE and the similar human disease, CJD.

These new measures are a consequence of the failings in the handling of SBOs we have found in slaughterhouses. They do not reflect any concerns about the MRM process itself . . . ³⁸

6.232 A statement from the CMO was quoted, noting that there was currently no scientific evidence that BSE could be transmitted to humans. ³⁹

6.233 During oral evidence, Mr Hogg said that by the time SEAC gave its advice he had already decided that the SBO Regulations:

within the slaughterhouses either could not or would not be complied as to 100 per cent. Therefore when I received this report from SEAC, I was in no way surprised and was determined to act, which is what I did. ⁴⁰

6.234 Mr Hogg was also asked during giving his evidence to what extent he saw it as SEAC's role to advise on questions of policy as opposed to questions of science. He responded as follows:

They cross, do they not, they overlap? Certainly it was there to advise as to the science, but also there are conclusions that you draw, or they draw from their scientific assessments which have policy implications. You do not always comply with them exactly, for example in this case, they said, I think, that the danger was only a live one in respect of cattle over the age of six months . . . In fact we concluded that you could not have the six months threshold built in, because of difficulties over enforcement, and therefore we made it a total prohibition, so far as MRM was concerned. So that is an example of us going further than SEAC. Clearly they are scientific advisers, but they say things which have policy implications. ⁴¹

6.235 It was also put to Mr Hogg that it might be perceived that SEAC advised the Government that its policy was defective in this instance, and that it should have been MAFF, not SEAC, that addressed the defective policy. Mr Hogg responded:

That may be a fair criticism, but it may also be that their looking at this matter coincided with our looking at the matter . . . In fact, SEAC made a recommendation - perhaps because their meeting was shortly after the audit, it is quite likely, I cannot put it higher than that, we would have come to the same conclusion of our own, because they were relying on the same material we had, which was causing me very considerable concern. ⁴²

6.236 Mr Hogg chaired a meeting with industry representatives and MAFF officials on 30 November to discuss the proposed Order. Mr Hogg explained MAFF's reasons for the Order, what it would do and its plans for implementing it. ⁴³As noted by Mr Hogg in a statement to the Inquiry:

The industry representatives were on the whole unhappy with the MRM proposals, and raised a number of arguments against it. These included the issues of compensation, enforcement, the economic impact of the proposals and the adverse publicity that was being created. We discussed these issues fully and the representatives made it clear that they were not happy with my proposals. Despite this considerable pressure, I did not think that we had any choice but to follow SEAC's advice, and accordingly the Order was drafted. ⁴⁴

6.237 On 8 December Dr Render wrote again to interested organisations, enclosing a draft Order that had been revised in light of the comments that he had received following his previous letters of 28 and 29 November. He asked for further comments on the Order by 12 December. ⁴⁵ The Order was made on 14 December 1995 and came into effect on 15 December. ⁴⁶ It was to become the subject of an application for judicial review, and we deal with this in Chapter 7.

Discussion

6.238 Thus, at last, the decision was taken to ban the use of bovine vertebrae for the extraction of MRM. So far as preventing fragments of the spinal cord from getting into the human food chain was concerned, this was to a large extent a case of shutting the stable door. Measures were in hand that were to ensure effective implementation of the duty to remove all spinal cord from the carcass.

6.239 Much more significant was the benefit that the new regulation had in keeping dorsal root ganglia out of the food chain. Mr Wells had been premature when he informed Dr Metters that transmission experiments with dorsal root ganglia had been negative (see paragraph 6.216). The experiment was subsequently to show that dorsal root ganglia was infective.

6.240 We have discussed in the previous chapter why it was that the VFS failed to discover in the course of slaughterhouse surveillance in the years prior to l995 that spinal cord was not always cleanly removed from carcasses. We concluded that this was because the standard of inspection was less rigorous than the standard after the MHS was in place. We have seen how it was not until 1995 that the attention of the VFS was specifically focused on the importance of the total removal of spinal cord.

6.241 The discovery of occasional cases where spinal cord had not been cleanly removed provoked expressions of extreme concern by the CMO and by members of SEAC. We have asked ourselves how far this reaction was attributable to knowledge of the result of the attack-rate experiment and to growing concerns consequent upon the incidence of CJD in farmers and young people. We believe that these factors, and perhaps the change in the composition of SEAC, played a part in producing this extreme reaction. We do not see that the scale of the failures to remove spinal cord was other than a reader of MAFF's 1990 paper on slaughterhouse practices might have been led to expect. It is, as we have observed in Chapter 4, a matter of conjecture as to whether SEAC in 1990 would have responded to the failings that were discovered in the same manner as SEAC in 1995.

6.242 Whether, and to what extent, the extraction of MRM from the spinal column of cattle carcasses in the years up to 1995 has resulted in transmission of BSE to humans is also, as yet, uncertain. What is, we think, now clear is that this was the route by which infectious material was most likely to enter the human food chain during that period.