Volume 5: Animal Health, 1989-96
2. The ruminant feed ban, 1989-96
The chronological account
Developments in 1995 - a mandatory routine sampling regime is pursued

Developments in 1995 - a mandatory routine sampling regime is pursued

UKASTA continues to question the value of the CVL questionnaire

2.393 On 11 November 1994 Mr Wilesmith forwarded a draft copy of the proposed questionnaire for feedmills to Miss Nelson, and commented that 'we should only proceed with the mooted survey if there is sufficient documentary data available'. ¹

2.394 Following discussion of the draft at UKASTA Scientific Executive Committee and Feed Executive Committee meetings, Miss Nelson replied on 25 January 1995. She advised Mr Wilesmith that individual companies could only provide accurate information backed by written records for 1993 and 1994 and explained that:

For the four previous years, the information would become less accurate and, consequently, somewhat unreliable. Also it was very likely that some feed compounders could only provide information about the store or the broker who supplied the raw materials. It was doubtful whether information could be provided on the precise source such as factory of origin. Similarly, information on production processes could only accurately go back for the last couple of years. The Committees also believe that the collection of the data required would be quite onerous. ²

2.395 Miss Nelson noted that MAFF's November 1994 progress report clearly stated that infected ruminant protein was the cause of BSE and that no other source of infection had been identified. UKASTA questioned the value of information that could be obtained from the proposed survey and whether it was needed at all. ³

2.396 According to Mr Wilesmith, the CVL Epidemiology Department was denied access to the information it sought via the questionnaire after the feed compounders took legal advice. ⁴

Joint feed sampling proposal

2.397 On 30 January 1995 UKASTA representatives met Mr Howard, Mr Fleetwood and Dr Matthews to discuss future action on the monitoring of feedstuffs using the ELISA test. At this stage, under the voluntary regime, 745 samples had been tested from 284 farms, with only three positive results, which had been obtained prior to the technique's validation in December 1994. ⁵

2.398 It was agreed that UKASTA members, with an allocation of 20 samples to be tested each week at Luddington, would organise their own sampling programme. It was agreed that MAFF would continue with routine sampling following BAB visits to farms, but in accordance with a revised programme:

i) where farmers used feed produced by commercial compounders, whether UKASTA members or not, samples would not be taken on farm, but at the mills as part of MAFF's routine unannounced sampling programme; perhaps on average one visit to each mill per year.

ii) on these visits samples would be taken from all ruminant rations being produced at the time but the testing of these samples would depend on the testing capacity at Luddington.

iii) MAFF would take samples of feed on those farms where the feed was home produced. ⁶

2.399 It was agreed that one protocol should cover sampling procedures undertaken by compounders and MAFF. The text of the protocol was discussed and it was agreed that the new sampling procedures should be implemented as soon as possible - hopefully during March. ⁷

2.400 On 1 February 1995, Mr Howard wrote to Miss Nelson to clarify that senior officials still needed to approve the joint sampling proposal, but that there should be no problems. He also asked that UKASTA quantify their future demands on Luddington's testing capacity, which would be helpful when officials put forward a case to increase testing capacity. ⁸

2.401 Miss Nelson could not provide a specific indication of the number of samples that compounders were likely to submit. However, she suggested that companies would be checking their manufacturing processes and procedures. She said that once companies had identified 'critical control points' and satisfied themselves that the potential for cross-contamination had been minimised to the greatest possible extent, they would reduce the number of samples they submitted and rely on MAFF's random sampling. ⁹

2.402 On 10 February 1995 Mrs Terry Gurnhill of the Animal Health (Disease Control) Division distributed the note of the 30 January meeting and a revised draft protocol on sampling procedures. She asked recipients ¹⁰ to confirm that they agreed with the proposals so far. ¹¹

2.403 Dr Matthews replied on the same day that he believed the proposal was that random sampling at mills would only take place at UKASTA member mills. Non-UKASTA-member mills would only be tested if they had supplied feed to BABs discovered on farm. He also stated that one protocol could not cover the joint sampling programme, because for the private submissions it was for the company to decide on the frequency of the sampling. However, the sampling procedures could be identical. Dr Matthews suggested that the protocol for MAFF still required discussion. ¹²

2.404 Mr Wilesmith was also concerned about the proposals:

. . . there are a number of problems with what is proposed. The first, and probably most important, is the restriction to the sampling of commercial feedingstuffs at the mills producing the rations fed to animals on farms which have experienced 1990, and later, born BABs. There must be sampling and testing of feedstuffs on the farms at the time of the visit of the Veterinary Officer. This must not be restricted to feedstuffs produced by members of UKASTA. Any positives need to be followed up by further sampling on the farm and at the producing mill or mills. The problem here seems to be that non-UKASTA member feedmills are not involved; they are certainly not aware of what is going on.

. . .

In summary, we need to discuss more fully the use of the ELISA in the monitoring of finished feedingstuffs and their ingredients, especially as non-UKASTA members could be epidemiologically important in the cross-contamination problem. ¹³

2.405 On 21 February 1995, having read Mrs Gurnhill's and Mr Wilesmith's minutes, Mr Eddy suggested a short meeting to 'talk through this since I think there are a number of strands we now need to draw together'. ¹⁴

Mrs Browning informs Parliament of BAB situation

2.406 Meanwhile, on 31 January 1995 Mrs Browning had answered a series of written Parliamentary Questions on BSE. In response to a request for information on 'the numbers and circumstances' of confirmed BABs, she said:

As at 23 January 1995, 15,771 cases of BSE had been confirmed in cattle born after 18 July 1988. Of these 8,955 were born in 1988, 5,995 in 1989, 812 in 1990 and nine in 1991. The great majority of the born after the ban cases have probably been exposed to ruminant protein in feed. The normal range of incubation period makes it inevitable that further cases will be confirmed in some animals exposed to infected feed and born in the months following the feed ban. Although it is still possible that BSE can occasionally be transmitted maternally or horizontally, there is no unequivocal evidence that either has actually occurred. ¹⁵

2.407 Mrs Browning was also asked how many renderers, feed compounders and farmers had been prosecuted for contravening BSE regulations since 1988. She replied that two prosecutions had been taken - one in 1991 and the other in 1992. She did not indicate the nature of the prosecutions or whether they involved renderers, feed compounders or farmers. ¹⁶

SEAC reviews the voluntary testing regime

2.408 On 10 February 1995 SEAC considered Mr Wilesmith's completed case control study of BABs. Mr Wilesmith told SEAC that there was an absence of new trends or clusters of cases that might indicate a change in the nature of the epidemic. He expressed his concern about the number of BABs and said that the cooperation of feed compounders, which had not been forthcoming, was needed to investigate a possible continuing feed source. ¹⁷

2.409 SEAC was informed that the ELISA test had been in use for a few months and 'seems to be having a salutary effect'. One mill had changed its raw material delivery procedure to avoid cross-contamination and sampling protocols had been agreed with another manufacturer. ¹⁸

2.410 In a statement to the Inquiry, Mr Meldrum noted that:

I should add that at this time I was in discussion with at least one small compounder who found it difficult to accept that cross-contamination with meat and bone meal could occur with the result that cattle could be exposed to the agent of BSE through feed. It was very much later that they were forced to the conclusion that cross-contamination had occurred in their mill as a result of an ELISA positive result and an advisory visit to their plant from an expert in compounding. ¹⁹

2.411 In response to information that Luddington was working to capacity, SEAC suggested 'that there may be a case for expanding the capacity to do these tests'. ²⁰

2.412 The minutes of the meeting record that:

Dr Tyrrell concluded that there are a number of possibilities for cross contamination which appears to be the main reason for the BAB cases. It should be possible to develop the test so that it could be performed on a large number of field samples. Epidemiology must be continued and reiterated. Feed manufacturers and compounders need to co-operate so that risks can be measured. The Committee is very concerned that possible contamination of feed will continue the epidemic. It was felt that as 40% of suspect cases being reported now are BABs, MAFF must continue to look for a consistent, significant feed source. ²¹

UKASTA queries integrity of the ELISA test

2.413 On 22 February 1995 Mr Taylor and Mr Wilesmith attended a UKASTA meeting to discuss various aspects of the ELISA test. A number of feed compounders had been submitting feedstuff samples to Luddington since the start of the year. Of particular concern was that a sample of MBM 'almost certainly' containing ruminant protein had tested negative, whilst salseed, of plant origin, had returned a positive result. It was confirmed in the latter case that no oil derived from animal material had been used to lubricate the pressing machinery. A sample of salseed had also been examined by microscope and no animal protein had been found. Further, it was reported that although an undiluted salseed sample had tested positive, a ruminant feedstuff containing 20 per cent salseed had tested negative. Another inconsistency was that whey powders from one factory had given a positive result, while whey powder from another factory had given a negative result. ²²

2.414 It was agreed that the test gave a false positive for the salseed, but it was believed this problem could be overcome. The false negative for the MBM caused more concern, but again it was thought this could be remedied. A list of compound feedstuff constituents that had been tested was tabled, and UKASTA undertook to provide a list of other ingredients commonly used in the feed industry that also needed to be tested. It was hoped this would eliminate as far as possible false positive tests in the future. ²³

The Minister is updated on the BAB situation

2.415 In response to an earlier request, on 27 February 1995 Mr Eddy provided Mr Waldegrave with a BAB update. He noted that the ruminant feed ban had clearly cut the number of BSE cases substantially, however:

The challenge is to squeeze the disease out completely and that is more difficult because cases may arise from rare accidents or low levels of cross contamination which are hard to prevent and virtually impossible to investigate retrospectively because the disease has a 5 year mean incubation period. The long incubation period also makes it impossible to check whether the arrangements we now have and level of compliance by the industry are adequate: that will only become clear in 5 years or so. ²⁴

2.416 He reported that there were currently 16,957 confirmed BABs, with most born in the period immediately following the introduction of the ban when there was likely to have been a carry-over of feed. Mr Eddy said:

[T]he use of protein from specified bovine offal (SBO) in animal feed was not banned until September 1990 and if, as now seems likely, there was cross-contamination of ruminant feed by feed for pigs and poultry there could be some inclusion of low levels of processed SBO in cattle feed up to September 1990 and some carrying over of material in the pipeline into 1991. Experiments still underway exposing cattle to different amounts of brain from BSE infected cattle indicate that very small amounts of untreated infective material can cause disease in cattle, even smaller than the 1 gm often quoted. This suggests that even a low level of contamination of SBO in pig and poultry rations into ruminant feed could cause disease. ²⁵

2.417 Mr Eddy advised that of greater concern was the 'future level of late 1991 BAB's and in due course any post 1991 cases which cannot reasonably be attributed to SBO contamination of animal feed before September 1990'. He said there were 18 confirmed 1991 BABs, though more than 50 were histopathologically positive, awaiting confirmation whilst further detailed enquiries were made. If 1992 BABs occurred, Mr Eddy advised that they could reflect one of four factors:

(a) that infection is coming from sheep offals (which are not covered by the SBO ban and can still be used for production of meat and bone meal for use in feed for pigs and poultry).

(b) that the range of cattle offals covered by the SBO ban is too narrow. (Although research studies provide no evidence for this.)

(c) that the disease in cattle may be caused by other mechanisms such as maternal or horizontal transmission (this is not ruled out); direct contact with sheep (which can be ruled out on epidemiological grounds) or spontaneous disease as with human CJD though the incidence of CJD is so low that an equivalent mechanism in cattle would account for only a handful of cases each year.

(d) Failure to comply fully with the disposal requirements for SBO. ²⁶

2.418 Mr Eddy described the detailed epidemiological investigations that had been undertaken or were proposed for BAB cases and the associated difficulties. He concluded that in the absence of firm epidemiological evidence, 'one can only speculate' whether any of the four factors applied. ²⁷

Results of the attack rate experiment are reported to the Minister

2.419 On 28 February 1995 Mr Meldrum minuted Mr Packer with an update of BSE research results. He noted that results from the attack rate study (see paragraph 2.128) indicated that 'the amount of unprocessed brain needed to cause disease is very small'. Mr Meldrum also pointed out that:

The findings may help to explain why the feed ban was less effective than intended, and they will certainly cause UKASTA uneasiness. This supports our view that we should tighten up our controls on the disposal of the specified bovine offals; an issue we have discussed with Ministers. ²⁸

2.420 On 31 March 1995 Mr Packer forwarded Mr Meldrum's minute to Mr Waldegrave. He also forwarded a submission by Mr Howard proposing action in light of the research finding on dose. Mr Packer noted that the attack rate study 'is a very serious result meriting careful reflection and, if necessary, action'. ²⁹

2.421 Mr Howard's submission suggested that 'there is a risk that skulls still containing brain tissue may be rendered into meat and bone meal and subsequently incorporated into animal feedingstuffs'. Given the attack rate study's indication that a small dose of infective brain could transmit BSE, 'Veterinary advice is therefore that steps should be taken to avoid the risk that any brain attached to bovine skulls could find its way into animal feedingstuffs'. It was therefore recommended that the removal of the brain from the skull should be prohibited, thereby requiring the whole skull to be disposed of as SBO once head meat had been removed (see vol. 6: Human Health, 1989-96 for a full discussion of brain removal). ³⁰

2.422 On the presentational aspects, Mr Howard's submission advised:

Infection of cattle through feed continued to be a problem after the ruminant protein ban was introduced in 1988, and to a much smaller extent, even after the SBO ban was extended to animals in 1990. There is circumstantial evidence that ruminant protein which is used in pig and poultry feed may cross contaminate cattle feed being produced at the same mill. Although better house keeping will help to overcome this, it will not be practically possible to ensure that cross contamination never occurs, and it is therefore essential that additional steps are taken to make sure that ruminant meat and bone meal contains no significant infectivity . . .

The change should be presented as a measure to increase the effectiveness of the current legislation in response to the number of cases of BSE confirmed in cattle born since 18 July 1988. ³¹

2.423 On 5 April 1995 Mr Packer was informed that Mr Waldegrave agreed with the recommendations set out in Mr Howard's paper. However, Mr Waldegrave asked whether action on feedlines needed to be taken. In particular, he queried whether the attack rate study results meant that MAFF needed to do more to ensure that feedlines that had contained contaminated feed were now clean. ³²

2.424 Mr Meldrum responded to Mr Waldegrave's query on 19 April 1995:

The short answer is "no". The important thing is to prevent infected material continuing to enter feedlines, and additional measures have been and will be taken to achieve this (for example, enforcement of minimum rendering standards, and the tightening up of controls on the disposal of SBO). By contrast, the problem of infectivity already in the feedlines is insignificant, and any infected material will have been flushed out by uninfected material some time ago. There is no action I can recommend that we should take at this time except to continue to intensify the controls on the disposal of the SBOs. ³³

2.425 A manuscript note on the covering minute recorded that Mr Waldegrave was content with Mr Meldrum's recommendation. ³⁴

2.426 On 9 May 1995 Mr K Taylor forwarded a report on the BSE epidemic's progress to Mr Waldegrave. In his covering minute, Mr Taylor noted that there was a continued downturn in the BSE incidence in 5-year-olds, 'which is further evidence of the effect of the ruminant protein ban introduced in July 1988'. He advised that it was planned to publicise the information by an arranged Parliamentary Question and press notice, of which drafts were attached. The draft press notice stated:

The number of cases of BSE being reported at present is 45.3% fewer than at the same time last year and there is continued downturn in incidence of BSE in five year old animals. Both changes are attributable to the ban on feeding ruminant protein to ruminant animals which was introduced in 1988. ³⁵

Further progress on joint monitoring and enforcement programme

2.427 On 3 April 1995, owing to a backlog of material at Luddington, Dr Matthews had advised all DVOs that collection of samples from farms should cease until further notice. ³⁶

2.428 On 10 May 1995 Mr Howard distributed a note to Mr Taylor, Dr Cawthorne, Mr Eddy, Mr Fleetwood, Dr Matthews, Mr Wilesmith and Mrs Gurnhill. The note summarised the main action points that had been agreed at a meeting held on 2 May 1995. These points were:

(a) that officials should continue to encourage feedingstuffs manufacturers to submit samples of feed ingredients, or finished feed for testing at Luddington making full use of the allocation of testing capacity made available for them.

(b) that veterinary staff should continue with routine sampling for the present on farm.

(c) that plans would be drawn up for veterinary staff to visit feedmills to carry out advisory visits which would include explaining to manufacturers about the BSE controls, the situation on BAB cases, and how to avoid the cross contamination of ruminant feeds with ruminant protein. This proposal subject to agreement by senior management.

(d) that when agreed by senior management the proposals would be put forward for the Secretary to consider with a view to putting them to Ministers to keep them informed of the action being taken.

(e) that unannounced sampling visits to mills were preferable to on-farm sampling, subject to the agreement from the mill (already given by UKASTA on behalf of their members), and that in the long term on-farm sampling would be carried out only where samples were not collected from the mills supplying the feed. Such a change would follow the exercise of 1(c) above and in agreement with industry representatives. ³⁷

2.429 Five days later, on 15 May 1995, Mr Andrew Fleetwood, SVO in the Animal Health (Zoonoses) Division, formalised the proposals. He minuted Mr K Taylor, Mr Eddy and Dr Cawthorne ³⁸ and recommended that SVS officers 'visit premises compounding feedingstuffs for ruminants in order to check and advise on the systems used to segregate mammalian protein from those feedingstuffs'. ³⁹

2.430 Mr Fleetwood explained that the visit programme was needed because no explanation had been found for BABs other than the continued presence of ruminant protein in ruminant rations. He summarised the evidence that suggested this was so and advised that officials wished to supplement the existing sampling programme with 'a system of proactive checks designed to minimise the chances of rations becoming contaminated in the first place'. Mr Fleetwood said:

This has been recognised by the major members of UKASTA who have designed and promoted a system of quality controls for use at their compound feedmills. These controls are designed to minimise the possibilities of accidental cross contamination of ruminant compound feed, and should it occur, minimise the extent of the problem. UKASTA members are supplementing these measures by sending materials to Luddington VIC for spot checks. However, it is far from clear whether similar controls have been implemented by smaller compounders or non-UKASTA members, or how well the controls are working within larger mills. ⁴⁰

2.431 Mr Fleetwood continued:

It is assumed that most visits will be made to commercial compounders on the basis that home mixers are unlikely to mix rations for more than one species. The register of UKASTA members provides an obvious entry to commercial compounders, but officials believe that visits to non-UKASTA compounders are at least as important. ⁴¹

2.432 Compounders who gave evidence to the Inquiry suggested that when they became aware that cross-contamination was an issue in 1994, they reviewed their controls on the production of ruminant rations. For example, Dalgety Agriculture identified the handling of raw materials between the intake point at the mill and their delivery via raw material storage bins and weighers to the blending process as an area of concern. The equipment was identified as having a number of points where contamination could occur in material handled after MBM. The company subsequently invested in a blow line intake of MBM, which allowed MBM to be blown straight into storage bins and thereby avoiding conveyors and elevators. ⁴²

2.433 Similarly, J Bibby Agriculture conducted an intensive study of its mills when it was made clear that cross-contamination was an issue. As a result, MBM use was stopped in two mills and dedicated MBM blow lines were installed in remaining mills. ⁴³

2.434 In his minute, Mr Fleetwood said mills to be visited would be selected either on a random basis or on a known risk factor basis. Most visits would be made to commercial compounders because home-mixers were unlikely to mix rations for more than one species. Mr Fleetwood recommended that the visits' objectives should be:

1. an investigation of the mill so as to identify the critical points at which cross-contamination could occur.
2. an audit of existing operating procedures to determine whether risks have been adequately addressed.
3. the provision of advice in circumstance where risks are identified that have not been adequately addressed by operating procedures.
4. Briefing of mill operators on the current BSE disease position, and that accidental cross-contamination of ruminant rations is the probable cause of the BABs.
5. Advice to mill operators that samples of ruminant rations may be taken then or at a later date so as to monitor compliance with the feed ban. ⁴⁴

2.435 Mr Fleetwood invited the recipients to consider the proposals, and if they agreed, he recommended that further detailed planning should take place on instructions for visits and training of SVS officers. ⁴⁵

2.436 Dr Matthews responded by a manuscript note to Mr Fleetwood on the following day, noting that he thought the aims were:

- ideally to visit all mills;

- if not, then all mills producing ruminant rations,

- if not, all non-UKSATA mills producing ruminant rations (probably all). ⁴⁶

2.437 Mr Fleetwood replied that, as there were probably in excess of 1,000 mills and home-mixers producing ruminant feed, some sort of targeting would be required if MAFF resources were to cope. ⁴⁷

2.438 On 18 May 1995 Mr Howard raised a further point regarding his note of 15 May, which had been prepared following the meeting on 2 May. He said:

Regarding the continuation of routine sampling by field staff at the time of BAB investigations we agreed a new procedure. It was that the officer would establish whether the ruminant rations in use were from a UKASTA member or from a non-UKASTA member including on farm mixers. It was agreed that in the case of the former a sample would be taken from the mill (we hold the lists of UKASTA members) and if the latter, samples would be taken on farm as before. We agree that it was important to cover non-UKASTA members as the risks of cross contamination could be greater on these premises. ⁴⁸

2.439 Dr Matthews responded by a manuscript note. He said that he understood the intention to be:

1. UKASTA mills - unannounced random sampling

2. NON-UKASTA mills - with their approval - as UKASTA.

- if approval not forthcoming sample on farm when identified as a supplier to farm with 1990 BAB or later.

3. Home mixers - sample on farm either at time of report of a 1990 BAB, or if logistically possible as part of surveillance of all 'feed manufacturers'. ⁴⁹

2.440 Also on 18 May 1995 Dr Cawthorne responded to Mr Fleetwood's minute of 15 May. He said:

Can we assume that all UKASTA members have been through a process of self-examination and have identified critical points in their mills where cross-contamination might take place and have taken corrective action? If so, we need not visit all feedmills but could concentrate on non-UKASTA members producing ruminant rations.

The major problem as I see it is, from a standing start, identifying critical points in mills at which cross-contamination might take place, and training staff to carry out mill audits on corrective action. I don't see that this is something that SVS can do by itself, it will need assistance from UKASTA. The next question is where we will find the appropriate staff. We already have a pool of SVOs who have been carrying out mill audits in connection with salmonella. Might it not be possible to include a number of those in the core of SVS staff to get trained in this BSE procedure? ⁵⁰

2.441 His initial thoughts were that this was not a scheme that could 'be progressed on a broad front' until MAFF had more experience and information at its disposal. Therefore, if attention was focused on the small mills who were unlikely to be aware of cross-contamination problems, 'this should allow us to develop the policy at a sensible pace, learning as we go'. ⁵¹

2.442 In a manuscript note dated 19 May Dr Matthews replied that in relation to Dr Cawthorne's assumption, 'UKASTA actually stated that they would like contact with local plant management to be made, particularly with respect to raising levels of awareness concerning our expectations if we resort to unannounced random sampling'. ⁵²

First BAB born in 1992

2.443 On 16 May 1995 Dr Matthews informed Mr Meldrum that he had received the first positive result for a suspect born in 1992. The case had yet to be confirmed. At that time there were 73 confirmed BAB cases born in 1991, out of a total of 19,151 overall. A further 68 awaited confirmation. Dr Matthews advised that this meant that it would be several weeks before he could process the 1992-born case, 'although I fear that there will have to be an increase in the throughput rate soon in order to keep up with receipts'. ⁵³

2.444 Mr Eddy conveyed this information to Mr Waldegrave on the following day. He advised that since the case was yet to be confirmed, the information should not be put into the public domain. He said that if confirmed, the case would be disappointing but not unexpected. In light of the exemption from BSE export rules for animals born after 1 January 1992, it 'will need careful handling'. ⁵⁴

2.445 Also on 17 May 1995 Mr Eddy provided Mr Haddon with a 'contingency note' on the line to take for BABs born in 1992. In his covering minute, he said:

In our discussions my veterinary colleagues were anxious to make the point that we must expect to have 1993 and 1994 BAB cases as well as 1992 cases and there is something to be said for preparing the public, and the Germans, for this now rather than giving the impression, perhaps by omission, that 1992 would be the last year for BABs. I can see merit in this and have included a low key comment . . . But I do feel on balance that it may be better not to make too much of this point at this stage. In a year or so's time we may well have better statistical evidence and be able to say that the incidence of the disease in each birth year group is continuing to decline, and may well have more confidence in the statistical sense about the strength of any decline in 1991 and possibly even into 1992. At the moment we cannot really say very much and there is a risk that reference to 1993 and 1994 born cases could be potentially more damaging as a result. ⁵⁵

2.446 The 'contingency note' suggested that there was no reason to regard BABs born in 1992 differently from those born in 1991. It then sought to put the case in context by quoting various BSE incidence figures which indicated the ban had been 'extremely effective'. The note also cited changes made in dealing with mammalian waste as further assurance that there was no cause for alarm. It listed the measures in place to prevent transmission of BSE through feed as:

- the destruction of clinically suspect cattle;

- the seizure and destruction of specified bovine offal from clinically unaffected cattle, and the use of stains which allow the illegal use of such material to be detected;

- the ban on feeding mammalian protein to ruminant animals, and the use of tests which will identify ruminant protein which is illegally incorporated in ruminant feed;

- the prohibition of the use of rendering systems which have been shown not to inactivate the BSE agent. ⁵⁶

2.447 Dr Render, Private Secretary to Mr Waldegrave, subsequently advised Mr Eddy that Mr Waldegrave wanted the 1992 BAB case to be published once it was confirmed. However, he said that officials would need to consider carefully 'what we say in the EC and to Germany'. He also queried whether there were any contingency plans which needed to be set in place. ⁵⁷

2.448 On 23 May 1995 Mr Richard Carden, Head of the Food Safety Directorate, minuted Mr Eddy advising that publication of the case could cause consternation in the European Community and lead to arguments that trading arrangements for UK beef exports should be altered. Mr Carden thought that MAFF officials must be clear about what the repercussions might be and what their line of response would be to the European Commission, Member States and trade interests within the UK before the news went public. He asked to see the advice prepared for Mr Waldegrave before it was submitted. ⁵⁸

2.449 Following discussion between officials on how best to present briefing material to Mr Waldegrave, ⁵⁹ on 1 June 1995 Mr Haddon provided a final note to Mr Packer for onward submission to the Minister. It noted that there was no suspicion of maternal transmission for the 1992 case, which suggested that transmission via feed continued 'well into 1992, which is not unexpected'. The note proposed that the case should not be individually announced, but rather processed in the same way as other BAB cases, to avoid 'indicating greater concern on the Government's part about the risks to human or animal health that the case objectively warrants'. ⁶⁰

2.450 A question and answer brief was included in the briefing material. Under the heading, 'If Necessary', it included the following:

What is being done to stop cross contamination occurring?

The Government has recently gone out to consultation on new specified bovine offal (SBO) proposals which would require all rendering plants processing SBO to have the necessary facilities to hand and store SBO separately from non SBO material. We are also proposing to require all SBO to be processed in cookers dedicated solely for this operation and to require the processing of all SBO in dedicated rendering plants. This would prevent contamination of normal meat and bone meal with that produced from SBO, which is potentially contaminated. Discussions have also taken place with representatives of the feed industry who have assessed systems for potential cross contamination. Such contamination of cattle feed with mammalian protein (bovine, ovine or porcine) can [be] detected by an ELISA test currently available to test feed samples collected on farm.

Is there still contaminated feed on farms?

It is difficult to say. No positive feed samples have been detected since the new ELISA test was introduced and subsequently validated. What is clear is that the number of new BSE cases this year is down 45.1% on the same period last year and that the ruminant feed ban is having the intended effect in controlling the disease in the national herd. ⁶¹

2.451 Mr Packer forwarded the material to Mr Waldegrave on 5 June 1995. He pointed out that since there were no changes in controls between 1991 and 1992, the discovery of the 1992 BAB was not unexpected. He also suggested that Mr Haddon's proposals for public handling were 'about right'. However, regarding a background note included in the material, Mr Packer suggested that because it was envisaged that it would be sent to the German Government and the European Commission, 'I am not yet convinced it is quite right':

I wonder whether a more positive and reordered note might not be more appropriate. We might start by noting the success of one overall policy as evidenced by the reduction in mortality and perhaps go on to acknowledge perhaps more openly the existence of cross-contamination after 1990, which apparently occurred at a fairly low level. This would implicitly acknowledge the likelihood of further 1992 cases. We could then go on to point out that this problem had been/was being addressed by further control measures. ⁶²

2.452 In the event, Mr Packer decided that the 1992 BAB should be made public ⁶³ and a low-key parliamentary question was organised for Mr Waldegrave's approval. It was published on 9 June 1995. ⁶⁴

Further problems with the ELISA test

2.453 On 5 June 1995 UKASTA representatives ⁶⁵ met Mr Taylor, Mr Howard and Mr Wilesmith to discuss the ELISA test and sampling of ruminant feedstuffs. UKASTA's note of the meeting records that since the 22 February 1995 meeting, where UKASTA raised doubts over the test's integrity (see paragraphs 2.413-2.414), UKASTA had provided samples of 83 different raw materials for testing. It was reported that a number of vegetable products gave positive bovine, ovine and non-specific reactions. They discussed what further steps could be taken to address these problems. ⁶⁶

2.454 The MAFF officials advised that the Ministry was still collecting feedstuff samples from a proportion of farms where BSE suspects were being investigated. However, analysis of the samples was being delayed by further investigative work at Luddington, and few samples had been collected since Easter due to storage problems. The testing of privately submitted samples was also on hold. It was confirmed that since the test was validated in November 1994 (see paragraph 2.385), there had been no positive reactions to any compound ruminant feedstuff analysed. ⁶⁷

2.455 In general discussion on BAB cases, UKASTA's note of the meeting records that:

An explanation for the BABs was infection via the feed route, which accidental cross-contamination could be expected to account for. . . MAFF commented that in practice the system was not perfect and even if it were to be made so now the results would not be seen this century.

Reference was made to the 'attack rate' experiments which had yet to be finalised. Whilst it was necessary to wait and see what results were found on completion of the work, it was expected that a gramme or less of infected brain would be sufficient to cause BSE in cattle if eaten.

. . .

The clear objective of the feed industry was to put pressure further up the supply chain to ensure that no infective material could reach a compound mill. Also, in the interest of 'due diligence' a record of all the action taken with regard to minimising the risk of cross contamination should be maintained. ⁶⁸

2.456 UKASTA's note of the meeting also recorded that:

Further to the discussions at the next Scientific Committee, consideration was to be given to UKASTA issuing a circular to feed members stressing the need to minimise the risk of cross-contamination. This could cover not only the question of ruminant protein getting into ruminant feedingstuffs but also veterinary medicinal additive residues into feeds for non-target species. ⁶⁹

SEAC considers the 1992 BAB

2.457 SEAC considered the 1992 BAB during its meeting on 21 June 1995. The background paper prepared for Mr Waldegrave (see paragraphs 2.449-2.450) was provided for SEAC's information. The minutes record that:

It was recognised that the 1992 case was not a one-off and evidence suggested that the existing controls had not been fully applied in some slaughterhouses and in some feedmills. Dr Tyrrell said that for contamination of feed to continue there must have been failures at all three levels: the slaughterhouses, the renderers and the feedmills. ⁷⁰

2.458 Enforcement of the RFB in feedmills was discussed. Mr Eddy explained the difficulties that were being experienced with the ELISA test, which included the fact that the test had not been validated for all raw materials. He advised that there had been three positive tests from 936 samples. Two mills were involved, of which one had changed its practices 'instantly'. However, 'some mills had admitted as a result of the test that there was no way with their current set-up that they could prevent small scale cross contamination'. In conclusion:

Dr Tyrrell accepted that the test was not sufficiently robust for use in prosecutions but it was clearly helpful to have an independent test. ⁷¹

Plans for advisory visits to feedmills

2.459 In late June MAFF decided that the industry should be informed of its concerns regarding cross-contamination in mills. It was agreed at a meeting on 26 June that a letter should be sent to UKASTA members stressing MAFF's concerns about the potential risk of cross-contamination particularly at mixed mills. Mrs Gurnhill circulated a draft letter for this purpose on 28 June. She asked in her covering minute that Mr Fleetwood provide a list of critical control points in order to seek UKASTA's approval and endorsement of them. ⁷²

2.460 In a manuscript note dated 30 June Mr Fleetwood questioned whether the letter should not go to all feedmills. He commented that he 'would rather meet UKASTA and discuss critical control points with them before putting them in the letter.' ⁷³

2.461 On 3 July 1995 Mrs Gurnhill replied to Mr Fleetwood:

It was not my understanding that we were to write to all mills, I understood from our meeting that we were to write to UKASTA members only. I know that Dr Matthews agrees with you, but I wonder if this is the right approach initially as it could be difficult to persuade non-UKASTA members to adopt UKASTA recommendations on cross contamination. Perhaps it would be best to write to UKASTA members first and then as a second stage, when we can determine how successful our campaign has been, write to non-UKASTA members. ⁷⁴

2.462 Dr Matthews was sent a copy of Mrs Gurnhill's minute, and in a manuscript note on the following day to Miss Jill Wordley, temporary Head of Branch C (BSE Issues) of the Animal Health (Disease Control) Division, he commented:

. . . we can't afford to mess around with this. UKASTA will primarily be a source of technical advice so we need to meet soon. After that it is imperative that we write to all mills. We had assumed that UKASTA had kept their members aware of our concerns. We now know that they haven't. The non UKASTA members still don't know any details of our findings on low dose risks. The letters will only open the door. Visits to mixed species mills should follow and are far more important. ⁷⁵

2.463 Miss Wordley replied on the same day. She said

I think Dr Matthews is right. We could justly be [illegible] failed to give all mills the same information at the same time (particularly if there is any suggestion of insurance liability). Would the right procedure be as follows:

(i) prepare a draft letter including an initial draft of our understanding of the critical control points (if possible)

(ii) discuss this draft with UKASTA and amend in the light of their comments

(iii) send to all mills inviting them explicitly to comment. We might need to make clear the legal position i.e. they need to know if any information they give will be used to take enforcement action against them. ⁷⁶

2.464 Mr Fleetwood also responded to Mrs Gurnhill's minute on 4 July 1995. It was his understanding that the letter would be sent to all mills, not just UKASTA members. It was intended that the letter would present a list of 'critical points' at which cross-contamination could occur. Mr Fleetwood suggested a 'logical order around the mill':

1. cross contamination in vehicles delivering raw materials
2. common intake pits
3. shared conveyors throughout the mill
4. equipment that is shared between different rations - in particular mixers, grinders, screw presses, conditioners and coolers
5. re-working of faulty material and spillages
6. final product storage if it is used for different rations at different times
7. cross contamination in vehicles delivering the final feed. ⁷⁷

2.465 Mr Fleetwood stated that it 'may be worth making clear that this list is based on actual inspections of mills and is not a theoretical exercise'. He suggested setting up a meeting with UKASTA's Technical Committee to 'see what they made of the list, in particular whether it is sufficiently comprehensive and whether the risks can be ranked into any order of likelihood'. He noted that MAFF would be on 'shaky ground' if it attempted to advise how to address the risks, so it needed to be made clear that recipients of the letter would be expected to identify appropriate remedial action themselves. ⁷⁸

2.466 On 11 July 1995 Dr Cawthorne wrote to Miss Nelson to seek UKASTA's 'co-operation in taking the next step in raising levels of awareness about our concerns on cross-contamination of feed throughout the feed manufacturing industry'. He recounted that MAFF was concerned about the potential for small-scale contamination of ruminant rations by ruminant MBM, particularly in mills also producing pig and poultry feed. MAFF had not yet visited mills to quantify risks in specific plants, though they had expressed a desire to do so via Mr Wilesmith's proposed questionnaire. Dr Cawthorne also believed that discussions with UKASTA had established that MAFF hoped to visit plants to explain its intentions, should it consider it necessary to redirect the feed sampling programme from farms to mills. He understood that UKASTA members felt that personal contact with the officers who would be responsible for the sampling would be helpful, and would be ideal for discussing general risk reduction principles. ⁷⁹

2.467 However, Dr Cawthorne said that Commission Decision 95/287/EC (see paragraph 2.471) would overtake them, since MAFF would soon be required to use the ELISA test for monitoring at mills, specifically those producing mixed species diets. He commented that the resource implications were enormous and that MAFF did not have the testing capacity to start immediately. The first step would be to obtain legal powers to sample. ⁸⁰

2.468 Dr Cawthorne advised that MAFF still believed there was an urgent need to visit mills before statutory sampling commenced. He explained that MAFF hoped to make an initial approach to all mills by letter expressing its concerns. Dr Cawthorne therefore asked that UKASTA should help to identify the major critical control points, and appended the list that Mr Fleetwood had formulated for UKASTA's Technical Committee to discuss as soon as possible. ⁸¹

Announcement of 'tightening the rules on BSE'

2.469 On 19 July 1995 Mr Douglas Hogg, who had become Minister of Agriculture on 6 July 1995, announced by way of press release ⁸² and Parliamentary Question that he would soon make the Specified Bovine Offal Order 1995. ⁸³ His Written Answer highlighted the BSE epidemic's decline and noted:

The decline in the number of cases demonstrates that the ruminant feed ban, the key control measure, is proving successful in bringing the epidemic under control. It is estimated that the total number of cases is at least 150,000 fewer than would have occurred in the absence of the ban. However, we are continuing to see cases of BSE in animals born after the introduction of the feed ban in July 1988. This suggests that there has been some continued leakage of BSE infective material into animal feed. ⁸⁴

2.470 Mr Hogg's answer then outlined the steps that had been taken to try to remedy the problem, and also explained how the Specified Bovine Offal Order 1995 would make it even harder for SBO to enter the animal food chain. ⁸⁵

Commission Decision 95/287/EC requires routine testing in mills

2.471 Commission Decision 95/287/EC was adopted on 18 July 1995. Article 1(1) required that:

Official Elisa tests for the identification of ruminant protein in feed intended for ruminants shall be carried out for routine monitoring, in particular in plants which produce feed for pigs and/or poultry as well as for ruminants. ⁸⁶

2.472 In a statement to the Inquiry, Mr Meldrum noted that the Decision 'overcame the problem of right of access to feedmills which had not been overcome in the meantime'. ⁸⁷

2.473 Dr Matthews indicated in a statement to the Inquiry that although the capacity for ELISA testing had been increased, routine monitoring required MAFF to allocate its resources efficiently:

. . . we gathered data from the industry in order to target mills that represented the greatest risk - those that were recognised as being associated with a disproportionate number of BAB cases (simply as suppliers of feed - we had no knowledge that any particular feed was contaminated), and those that produced ruminant diets as well as feed for pigs and poultry. That programme commenced in February 1996 and capacity was expanded by the end of 1996 to 18,000 and again by the end of 1997 to the current capacity of 24,000 test per year. ⁸⁸

2.474 Before the Commission Decision was adopted, Dr Matthews had, on 17 July 1995, minuted Dr Cawthorne, Mr Meldrum, Mr Taylor, Mr Eddy and others to bring to their attention 'the difficulties of implementing' the Decision. He explained that although recent internal documents had been upbeat, he suspected there would be 'real difficulties in organising sampling at mills before the [EC] mission visit at the end of next month, and we need to be ready for delays'. Dr Matthews described action planned before the Decision, which involved writing to every operator listed by the Pharmaceutical Society of Great Britain for inclusion of medication. This amounted to about 2,000 premises with an estimated 500 of those being manufacturers, the rest home-mixers. He continued:

Because it is going to be impossible to visit all of the above, it is essential to target those that present the highest risk - the mixed species mill. These will be the subject of advisory visits. They should also be the prime target for sampling and testing of feed. We cannot cope with the workload involved in visiting all home mixers, but we should not forget them as a potential route of tranmission . . . They are likely however to be responsible for fewer cases than are mills should cross contamination occur. ⁸⁹

2.475 Dr Matthews discussed the number of samples that would need to be collected for the results to be interpreted with confidence, before describing the testing limitations. Of primary importance was testing capacity. Luddington could process 50 samples per week. To increase this to 100 would require an additional two to three staff and to increase the capacity to 150 would require four to five staff. Another laboratory would be needed to increase the capacity further. Dr Matthews indicated that although problems with false positive results appeared to have been resolved, MAFF would have to be wary of the test's integrity. He concluded that until visits to mixed species mills had taken place to quantify the size of the problem, and to identify needs and time-scales to resolve the problems, there was little point in increasing capacity. ⁹⁰

2.476 Dr Matthews's minute was subsequently discussed by Mr Meldrum and Dr Cawthorne, who agreed that all voluntary testing should be replaced by official testing, with attention focused on mixed species feedmills. The aim should be to have the testing up and running by the end of August, when the Commission mission was due to visit. In a minute to Mr Meldrum, Dr Cawthorne estimated the required number of samples per year and reiterated the testing capacity difficulties. He concluded:

Finally, there appear to be no legal powers under which we can enter mills and take samples for testing. We have discussed this matter with lawyers who say that the recent Decision agreed at the last SVC provides a basis for taking official samples but that this will need to be transposed into domestic legislation. We are therefore preparing instructions but again it is unlikely that these powers will be available to us by the end of August.

Despite our best intentions, it seems likely that circumstances will severely limit our ability to embark on a full and comprehensive programme of testing by the time the Commission arrive at the end of August. We will endeavour to have some sampling of mixed species mills under way by then and hopefully we should be able to present them with a draft SI as an indication of our intent. I hope you will find these arrangements acceptable in the circumstances. ⁹¹

2.477 Mr Meldrum replied on 25 July 1995 that he was keen for the present ELISA testing capacity to be doubled. He also said that Dr Cawthorne would have to do his best to identify multi-species mills by the end of August so that he could explain the intended sampling system to the Commission mission. Mr Meldrum expressed concern that the Legal Department would not have a new Order finalised by then, and asked Dr Cawthorne to query whether an Order could be signed before the visit took place. ⁹²

2.478 Mr Eddy received a copy of Mr Meldrum's minute and replied on the same day. He commented:

I think we all recognise the desirability of making this Order quickly but I do want to make sure that we are clear precisely what we want to do so that we can be sure that the legal powers are all provided. I do not want to be in the position we often find ourselves in, that we think we have got the powers to do something and when it comes to the crunch, Legal Department turn around and say we haven't. ⁹³

MAFF advises UKASTA on the implications of Commission Decision 95/287/EC and seeks assistance

2.479 On 21 July 1995 Dr Cawthorne advised Miss Nelson that Mr Meldrum had asked that the ELISA testing in mills required by Commission Decision 95/287/EC should begin as soon as possible. Dr Cawthorne explained that it had been MAFF's intention to write to feed manufacturers in August, drawing their attention to cross-contamination and asking those who produced mixed species feeds to identify themselves to MAFF so that they could be targeted for advice and testing. This was now unlikely to be achieved by the end of August 1995, so Dr Cawthorne asked whether UKASTA could assist MAFF in identifying mixed species mills that would be willing to have their products tested. ⁹⁴

2.480 Mr Reed replied in Miss Nelson's absence on 31 July 1995. He advised that UKASTA did not have the information that MAFF sought and added:

Before [seeking the information], I think it would be right to get through the discussions planned for 7 August and see what comes of them, as we would need to reassure our members not only as to the efficacy of the ELISA test but also on the purpose of the inspection and testing programme. In particular, our scientific experts still remain to be convinced that the ELISA test has been fully validated and risks of false positives eliminated. ⁹⁵

2.481 Mr Reed also sought to clarify assertions that BABs were caused by SBO-contaminated feed. In particular, he referred to Mr Meldrum's statement on 'Farming Today' on 20 July 1995 that 'We know there has been cross-contamination in feedmills'. Mr Reed argued that:

So far as we in UKASTA are aware, there is no evidence as a result of the on-farm testing programme that ruminant protein has been included in ruminant feed. How then can anyone know that there is a risk of cross-contamination involving ruminant protein at the feed mill? ⁹⁶

2.482 He explained that the media had questioned UKASTA about the results of the tests and what they might imply about cross-contamination in feedmills. UKASTA dealt with these by saying that they were not aware of any hard evidence, but were cooperating in the development of the testing programme to help give 'the best possible assurance at every level that ruminant protein cannot stray into ruminant feed'. Mr Reed suggested that 'This line will not be easy to sustain for long, so it would help to know whether MAFF views are dictated by hard evidence or by supposition'. ⁹⁷

MAFF meets with UKASTA to discuss cross-contamination in mills

2.483 On 7 August 1995 UKASTA representatives met Mr K Taylor, Miss Mary Coales, ⁹⁸ Dr Matthews, Mr Fleetwood and Mr Prince. Mr Reed expressed his displeasure at MAFF's recent public announcements on SBO. The note of the meeting records that he was 'anxious not to have any more nasty surprises from MAFF'. UKASTA had only discovered Mr Hogg's statement on SBO of 19 July 1995 from a journalist. Further, during a 'Farming Today' interview Mr Meldrum had said that he 'knew' cross-contamination was occurring in feedmills. Mr Reed said that UKASTA should be informed of any evidence. Mr Taylor sought to reassure UKASTA by 'emphasising the difficulty of managing announcements of this kind, and explaining the background to the need for tightening up on any possible small amounts of cross contamination in the feed chain'. ⁹⁹ UKASTA's note of the meeting records that:

MAFF advised that there was epidemiological proof rather than hard evidence that cross contamination took place at a particular mill on a particular day. There was also both published and unpublished research work which concluded that there was no other significant means of transmission of BSE than the feed route. The evidence for potential cross-contamination had been identified in the following areas:-

(a) residues of meat and bone meal at the intake point which were subsequently flushed into a bin for which they were not destined;

(b) the use of unidentified reworks. ¹⁰⁰

2.484 MAFF explained their understanding of dose which had been obtained from the attack rate experiment:

It was now public knowledge that the dose of infected material needed to transmit the disease was relatively small. MAFF advised that, from unpublished results of an incomplete experiment, it had been shown that BSE had developed in animals fed 10g of infected tissue. It was more questionable as to whether a dose of 1g would cause the disease. ¹⁰¹

2.485 UKASTA was informed that case control studies carried out to date were of little value in explaining feedstuff's role in the transmission of BSE. A study, anticipated to commence after 1 April 1996, was being planned using herds that had BABs compared with those that did not. ¹⁰²

2.486 Discussion turned to the proposed monitoring programme in feedmills. UKASTA had sent a draft protocol to Mr Howard on 8 February 1995, but it was agreed that a small working group should be established to develop a sampling protocol that satisfied the requirements of Commission Decision 95/287/EC. MAFF 'stressed the importance of being seen to be implementing the EC Decision by the time of the Commission's visit on 28 August'. ¹⁰³ UKASTA's note of the meeting records that:

[W]ith particular reference to the ELISA technique, MAFF intended to take powers to check anywhere in the chain. The premises to be visited would include both farms and commercial mills as well as distributors of feedingstuffs (both premises and delivery vehicles). ¹⁰⁴

2.487 UKASTA reiterated their concern that 'false positives' could give a misleading message to the public, and their fear that there could be claims from farmers if testing showed that there was cross-contamination in mills. It was also suggested that fault could lie with farmers who allowed animals access to feed intended for other species. MAFF agreed to cover this point in a letter to home-mixers. ¹⁰⁵

A letter is sent to manufacturers and mixers of animal feedstuffs

2.488 On the day after the meeting Dr Matthews sent a fax to all DVOs in England, Wales and Scotland, instructing them that on-farm sampling was to be reinstated immediately. Sampling had been suspended in April due to a backlog at Luddington (see paragraph 2.427). ¹⁰⁶

2.489 Also on 8 August 1995 a draft letter that MAFF intended to send to manufacturers and mixers of feedstuffs was forwarded to Mr Reed. ¹⁰⁷ Following the receipt of his comments on the next day, ¹⁰⁸

the final version of the letter was distributed in Mr K Taylor's name on 10 August 1995. It set out relevant background information and stated:

We would now like your help in 'fine-tuning' the controls at the feedingstuffs end of the chain. If you are manufacturing or mixing feedingstuffs for farm animal species, you may well be making use of mammalian protein, for example meat and bone meal, either on its own, or as part of a protein balancer, for the preparation of feedingstuffs for pigs and poultry. If you also make feedingstuffs for ruminants, we would ask you to make careful checks so as to ensure that feedingstuffs for ruminants do not become inadvertently contaminated with mammalian protein or substances containing that protein. I attach a list of examples of where such contamination could occur. Farmers are particularly asked to make sure that cattle do not have access to feed which is intended for pigs or poultry, and which may contain mammalian protein, and that feed for pigs and poultry is stored separately from ruminant feeds at all times. ¹⁰⁹

2.490 The attached list of examples of points at which cross-contamination might occur read:

Receipt and handling of raw materials

• Cross contamination in vehicles delivering raw materials
• Common unloading area/intake pit (for example cereals or vegetable proteins contaminated by meat and bonemeal or protein concentrate remaining in reception hopper)

Preparation of feedingstuffs

• Share conveyors in a feed mill
• Equipment shared between the preparation of different rations - in particular mixers, grinders, pelleting presses, conditioners and coolers
• Reworking of faulty material and spillages
• Use of an inappropriate ingredient (e.g. a protein balancer containing meat and bone meal in a cattle ration.)
• Failure to clean shared equipment between the production of say poultry feed and a following batch of cattle feed.

Storage of feedingstuffs

• Use of the same bulk storage for different rations at different times
• Cross contamination in vehicles delivering final feed
• Access by ruminants to feed prepared for a different species

Use of feedstuffs

• Use of feed intended for pigs and poultry in cattle or sheep ration, either on a regular basis or in an emergency. This includes protein balancers that may contain meat and bone meal. If unsure, play safe, and do not feed to cattle or sheep. ¹¹⁰

2.491 The letter concluded by asking those who produced feed for ruminants and pigs and poultry to contact their local DVO, so that they could be prioritised in the forthcoming programme of visits. ¹¹¹

UKASTA and MAFF meet to discuss implementation of Commission Decision 95/287/EC

2.492 As decided during their 7 August 1995 meeting, UKASTA met Mr Fleetwood and Mr Wilesmith on 11 August 1995 to discuss the implementation of Commission Decision 95/287/EC. UKASTA stated that legislation to implement the Decision's requirements should apply to all stages of the production process, from slaughterhouses through to commercial compounders and home-mixers. It argued that too narrow a focus, on the compound feed industry alone, would indicate a lack of adequate control and would not be as effective in plugging gaps in the system. A letter formally expressing this view was sent by Miss Nelson to Miss Coales on 24 August 1995. ¹¹² During the meeting MAFF advised that its understanding was that legislation was required to secure powers of entry throughout the chain. ¹¹³

2.493 UKASTA sought to clarify the meaning of 'routine monitoring' as used in the Commission Decision. MAFF considered that the objectives were to find holes in the system and to ensure continued compliance with statutory requirements. MAFF was working on the development of a structured sampling system to replace existing random sampling on farms. Its suggested sampling programme was:

- monogastric mill only - no samples to be taken;

- ruminant mills only - lower levels of sampling;

- multi species mills - sampling frequency to depend on production facilities at each individual site and whether meat and bone was used. ¹¹⁴

2.494 The draft protocol, 'Monitoring of ruminant feeds for the presence of mammalian meat and bone meal', which UKASTA had prepared at the beginning of the year, was discussed. It was agreed that it should be redrafted and used as guidance for sampling under the new legislation. ¹¹⁵

Further steps to implement the mandatory sampling regime

2.495 On 18 August 1995 Mr K Taylor forwarded a draft Animal Health Circular (AHC) to Mr Meldrum for comment. The AHC advised DVOs on the changes that were to take place in the sampling regime. In his covering minute, Mr Taylor noted that the Legal Department had yet to decide 'how powers to sample should be taken', and had not drafted any legislation. Voluntary on-farm sampling had therefore been re-instituted as a temporary measure, and it was intended to move towards mandatory sampling 'in a series of steps'. Mr Taylor told Mr Meldrum that he had written to over 3,000 mills registered with the Royal Pharmaceutical Society (see paragraphs 2.489-2.491) and that the draft AHC was the next step in the process. He concluded:

We have been advised that there is no point in testing more than 4,600 samples a year - perhaps less: it depends on the number of multispecies mills, and we do not yet have that information. It was originally envisaged that 18,000 or so samples would be taken annually, but it is clear that increasing the number of samples would make little difference to the confidence level for detecting a 0.1% contamination rate. ¹¹⁶

2.496 The draft AHC recounted the evidence that had led to Commission Decision 95/287/EC:

1. The continued absence of epidemiological and experimental evidence that maternal and horizontal transmission are playing a signficant part in the epidemic:
2. The experimental evidence, albeit incomplete, that oral challenge with a very small amount of bovine brain from a confirmed case of BSE will cause clinical disease in cattle:
3. The epidemiological evidence that there appears to be a correlation between the size of pig and poultry populations in a region, relative to that of cattle, and the incidence of disease in BABs. This does not appear to be a direct correlation with pigs and poultry kept on the same farm as suspects, but is considered to be associated with the fact that some feedmills will be producing feed for pigs, poultry and ruminants on the same premises. If the former contain meat and bone meal, there is a risk of cross contamination within the mill:
4. The evidence from some visits to mills generated by the on-farm sampling of feed suggests that there is real potential for cross contamination in many mills:
5. The evidence from the recent audit of SBO controls in abattoirs that historically at least there has been a small, but real, continuing animal health risk because some SBOs have not been handled properly and may have contributed to meat and bone meal used in monogastric diets. ¹¹⁷

2.497 It summarised:

[T]he conclusions drawn from the evidence above is that the potential dose of bovine brain needed to infect a calf is 'small'. It is difficult to translate that into quantities of meat and bone meal, but investigations so far have indicated that there is continued potential in some plants for accidental cross contamination of raw materials and finished feed. This does not take into account the possibility for deliberate inclusion of ruminant protein or for raw materials not to be composed of the ingredients specified by the suppliers, or the accidental feeding of diets intended for monogastric animals to ruminants. ¹¹⁸

2.498 DVOs were advised that they should be contacted by mills following their receipt of the letter sent on 10 August 1995. They were instructed that visits should be arranged to explain MAFFs intentions regarding the mandatory sampling regime, which was soon to be implemented. ¹¹⁹

2.499 Also on 18 August 1995 Miss Coales informed various MAFF officials that the Legal Department 'have confirmed their view that we already have the required powers to do sampling at all points of the feed chain'. A statutory instrument was not required to implement the mandatory sampling regime. ¹²⁰

2.500 It was believed that section 64A of the Animal Health Act 1981 conferred the necessary powers. It provided that:

[A]n inspector (on producing, if required to do so, some duly authenticated document showing his authority) may at all reasonable hours-

(a) enter-

(i) any land, building, or other place, or

(ii) any vessel, boat, aircraft, hovercraft or vehicle of any other description,

for the purpose of ascertaining whether the provisions of any order made under this Act in implementation of any community obligation have been or are being complied with, and

(b) carry out such inspections (including inspection of documents) as may be necessary for that purpose.