Volume 6: Human Health, 1989-96
3. Introduction of the ban on Specified Bovine Offal
Consideration of baby food and cull cows
Circulation of draft baby food regulations
Further consideration by MAFF as to the implications of the baby food recommendation
Actions taken by pet food manufacturers and their impact
Mr Lawrence's submission on cull cattle
Proposed consultation arrangements for the draft baby food regulations

Circulation of draft baby food regulations

3.182 On 24 April 1989 Miss Alison Reeves (Food Standards Division, MAFF) circulated the proposed draft regulations on baby foods to colleagues and to officials in DH and in health departments in Scotland, Wales and Northern Ireland. The draft regulations included a draft covering minute and submission to the Parliamentary Secretary, Mr Richard Ryder (now Lord Ryder), on the need for the regulations. The draft covering minute included the following paragraph:

Ministers asked officials to prepare draft regulations following the announcement of their response to the Southwood Report on BSE . . . It is proposed that the number of different types of offal to be banned should be greater than that identified by the Southwood Working Party in order to include the organs which are considered "high risk" in terms of the presence of BSE or scrapie agent. ¹

3.183 The schedule to the draft regulations noted the types of offal to be banned: brains, feet, large and small intestines, lungs, oesophagus, rectum, spinal cord, spleen, stomach, testicles, thymus and udder. ²

3.184 On 25 April Dr Pickles contacted Miss Reeves regarding the above submission. She noted that:

In fact, you are not proposing to ban more offal than those suggested by Southwood, and any suggestion that in some way his recommendations needed later qualification would be unfortunate. ³

3.185 On the same day Dr Pickles also minuted Mr Tait (Health Services Division, HS4, DH) commenting as follows:

I had been consulted direct by MAFF on the content of the regulations and I am content. They are consistent with the commitment given at the time the Southwood Report was released. I do not believe we could justify any extension to the prohibition. ⁴

3.186 In evidence to the Inquiry Dr Pickles described her position, and what she regarded to be the position of DH, with regard to the Southwood Working Party's advice on offal. She said, '. . . we set up an expert working party and we accepted and welcomed their views' ⁵ and 'the general principle throughout [was] that we should follow the advice from our independent experts'. ⁶

Further consideration by MAFF as to the implications of the baby food recommendation

3.187 Circulation of the draft baby food regulations led to further consideration by MAFF as to their wider implications. On 5 May 1989 Mr Bradley sent a note to Dr Watson expressing his concerns about the proposed baby food legislation. The note opened with the comment: 'For info - and to ensure that we do not get the blame for legislation that can be criticised on a scientific basis.' ⁷

3.188 He continued:

An important omission is lymph node. This was not identified specifically in previous regulations but is a high-risk tissue if BSE follows the line of scrapie though titres are lower than for terminal hind brain. In regard to baby food the decision has apparently been made that it is excluded from use because 'it is not normally used for human consumption.' This may be true for baby food as currently prepared in the UK but not necessarily for imported food where "offal" may be variously interpreted and perhaps lymph nodes may be eaten. Even in this country in adult food prepared from bovine carcasses such items may be found in sausages and meat pies unless positive steps are taken to remove them.

3.189 He concluded that:

Any decision on baby food would have repercussions for adult food bans and pet foods - matters Alan Lawrence is dealing with. ⁸

3.190 It is convenient at this point to turn to developments on pet foods.

Actions taken by pet food manufacturers and their impact

3.191 The pet food industry first became aware of BSE in mid-1987. ⁹ In the months that followed, the UK's larger manufacturers of pet foods, such as Pedigree Pet Foods and Spillers, took a number of steps in response to the perceived risk posed by BSE.

3.192 In July 1988 Spillers stopped using bovine spleen in its products and replaced it with liver. At the same time, it changed its specification for ground bone to exclude the use of bovine heads and backbones with the intention of eliminating brains and spinal cord. ¹⁰ In October 1988 Spillers stopped using meat and bone meal (MBM) which originated in the UK and replaced it with poultry meal, imported pork meat meal and prairie meal (derived from maize). ¹¹

3.193 In July 1988 Pedigree Pet Foods commissioned Dr Kimberlin as an independent consultant to advise them on BSE. ¹² In particular, Dr Kimberlin was asked to review the state of scientific knowledge, advise on whether Pedigree's raw materials did or might carry the BSE agent, consider what level of risk attached to Pedigree's current recipes, and be available for consultation on any other aspect of BSE. ¹³

3.194 In February 1989 the Report of the Southwood Working Party stated that domestic pets could be susceptible to BSE: 'were the agent to reach them in an adequate dose by an appropriate route'. However, the Report also suggested that pets such as cats and dogs might not be susceptible to oral infection and that the high temperatures used in the canning process might have destroyed any infectious agent present. ¹⁴

3.195 In early 1989 Dr Kimberlin submitted his advice to Pedigree Pet Foods. In essence this advice was that certain bovine raw materials which Pedigree Pet Foods were then using did carry a potential risk, which could be avoided only if their use was discontinued. ¹⁵ In evidence to the Inquiry, Dr John Malin (Pedigree Masterfoods) explained that Dr Kimberlin was unable to be definitive, but nonetheless recommended that a limited number of risk materials which they were using should no longer be included in their raw material purchasing programme and recipes. ¹⁶

3.196 By March 1989 MAFF was aware that most companies manufacturing pet food were 'avoiding UK cattle nerve tissue, spleen and brains' in favour of sheep and in some cases poultry meat. ¹⁷ On 13 April 1989 Mr Donald Thompson met Mr John Garnett, Head of Food Policy Division, MAFF, 1986-90, to discuss BSE in pet food. At the meeting Mr Garnett ¹⁸ explained that Pedigree Pet Foods had commissioned research on BSE and were reviewing and collating research from other sources. He also advised the Parliamentary Secretary that Pedigree Pet Foods were prepared to let MAFF have the results of their research. ¹⁹

3.197 On 25 April 1989 Mr Garnett minuted Mr Meldrum that he was arranging a meeting with Pedigree Pet Foods for the purpose of discussing their research on BSE in pet foods with interested parties in MAFF. ²⁰ In a statement to the Inquiry, Mr Garnett said:

5.2 My minute of 25 April 1989 records that arrangements were under way to settle on a suitable date for Dr Kimberlin and others to meet MAFF representatives to discuss the outcome of his research. I remember being contacted by the PFMA [Pet Food Manufacturers' Association] a week or so later (I cannot recall whether it was by their Secretary or by the then President) with the news that Dr Kimberlin had reached some conclusions from his work which were potentially valuable beyond the petfoods context and that he felt we should try to fix the meeting sooner rather than later. I was asked if I could arrange a meeting between Dr Kimberlin and the MAFF scientists and experts as soon as possible. This led directly to the meeting on 16 May 1989. ²¹

Meetings between MAFF, Pedigree Pet Foods and Dr Kimberlin on 16 May 1989

3.198 On 16 May 1989 Mr Meldrum, Mrs E Owen (Food Standards Division, MAFF), Mr Garnett and Dr Woolfe had a meeting with Dr Kimberlin and Mr Donald Orm of Pedigree Pet Foods. ²² After this a further meeting was held between Mr Meldrum, Dr Kimberlin and Mr Orm. Mr Meldrum states that at this second meeting Dr Kimberlin gave him copies in confidence of the five papers he had prepared for Pedigree Pet Foods. ²³

3.199 The first meeting was essentially a presentation by Pedigree Pet Foods of a substantial amount of work which had been carried out to try to assess the risk of using, in pet food, animal protein which might be infected by BSE. In her note of the meeting, Mrs Owen did not attempt to summarise all that had taken place at the meeting; instead she referred to the papers written by Dr Kimberlin as being a full account of proceedings. ²⁴ Mrs Owen's minute noted:

From all this there would seem to be no great cause for concern about the way Pedigree are working to protect pet food. From the information presented there would appear to be more to worry about in the potential risk for the ultimate consumer particularly from MRM [mechanically recovered meat] and spinal cord used in some meat products. My first thoughts were that it would seem prudent to do a similar risk assessment exercise for human food. This would undoubtedly involve FSc [Food Science], Meat Group, Standards and Food Safety Divisions. ²⁵

3.200 Mr Meldrum made some handwritten notes of his discussion with Dr Kimberlin. ²⁶ Detailed background information was provided on scrapie and, in particular, on the work of Dr William Hadlow on the infectivity of tissues from cases of natural scrapie. Dr Kimberlin then described the work that he had done on the quantitative risk assessment for particular bovine tissues for BSE, placing brain and spinal cord in the highest risk category and ileum, lymph nodes, colon, spleen and tonsil in the second category as demonstrated in the table below. ²⁷

Table 3.1: Natural scrapie in sheep and goats: summary by titre categories ²⁸

Category	Titre Range (Log10/30 mg)		Tissues
	Sheep	Goats
I	3.8-4.1	4.6-5.0	Brain, spinal cord
II	2.7-3.2	3.0-3.6	Ileum, lymph nodes, proximal colon, spleen, tonsil
III	0.8-1.6	1.8-3.4	Adrenal, distal colon, nasal mucous, pituitary, sciatic nerve
IV	<0.8	<0.8	Blood clot, bone marrow, GSF, faeces, heart, kidney, lung, mammary gland, milk, ovary, saliva, salivary gland, serum, seminal vesicle, skeletal muscle, testis, thymus, thyroid ocerus

3.201 Dr Kimberlin also discussed other matters such as the importance of the route of exposure and the species barrier. Mr Meldrum said in his evidence that he found the meeting invaluable in the discussions that he had within MAFF and with Ministers on the proposed SBO ban. ²⁹ Indeed, he described his meeting with Dr Kimberlin as 'critical' because of the very detailed discussion about the categorisation of tissues in scrapie-affected sheep. It was clear to him that Dr Kimberlin thought it was a good idea to keep the more infective types of offal out of the human food chain. ³⁰

3.202 On 22 May 1989 Dr Woolfe forwarded Mrs Owen's minute of the meeting with Pedigree to Dr William Denner (Head of Food Science Division II, 1989-92, MAFF) with Mrs Owen's minute attached. Having considered the work of Dr Kimberlin, Dr Woolfe commented:

3. I have thought very hard about whether the Branch should carry out a similar exercise with meat and meat products for human foods. On balance I do not think we should undertake it, but a final decision has not been taken and you may wish to discuss this further. The reason for my reluctance is that I would have to use the same data as Dr Kimberlin, who has used as his basis, infectivity titres of different organs from sheep and goats with scrapie. The infectivity levels were determined by intracerebral injection into mice. The different organs can be placed in four categories of decreasing infectivity. For the purposes of human and pet foods only two and possibly three categories are important. Category I consists of brain and spinal cord and has the highest titres. Category II contains spleen and lymph nodes with an order of magnitude of titres lower. Category IV contains all the remaining organs, which had levels below the level of detection, and include heart, liver, kidney, skeletal muscle etc. In suggesting infectivity levels for different organs from preclinical and clinical animals for quantitative assessment, Dr Kimberlin has had to make intelligent guesses at the fact that even though the assay, which has an interspecies barrier, has not detected the agent, it might still be present in Category IV organs. In fact when all the effects are built in to figures, the infectivity levels are not insignificant in this Category.

4. Thus if one discounts the consumption of Category I organs, the determination of exposure of humans to the agent will therefore rest on consumption of Category IV parts of the carcasses. In the case of Pedigree, they have a heat process which can reduce levels of infectivity. But most human consumption of meat and meat products involves a cooking process which would not give any deactivation at all. Therefore, there would be no way of reducing such a calculated exposure of BSE agent to the public without recommending certain restrictions to Ministers. However, if challenged, the basis of our conclusions would still be intelligent guesswork rather than hard facts and would be difficult to substantiate.

5. I think that close contact should be maintained with Dr Kimberlin to see how his assessment is progressing and what conclusions can be drawn from the exercise. On the other hand, I think that the Ministry should be taking certain steps in the short term to allay public fears and the media interest, which has intensified the past week. These steps should ensure that spinal cord, brains and spleen should not be entering the human food chain either directly or through MRM, and will be given an adequate heat process if sold for animal feed. ³¹

Voluntary offal ban by major pet food manufacturers

3.203 We mentioned at paragraph 3.192 the steps taken by Spillers in 1988. In May 1989, following receipt of advice from Dr Kimberlin, Pedigree Pet Foods decided to remove certain bovine materials from its pet foods. In particular, it ceased purchasing from UK sources both spleen and those parts of the vertebrae which might include spinal cord. ³² Dr John Malin (Head of Research and Development, Pedigree Masterfoods) told the Inquiry:

The materials did not represent a major part of Pedigree's raw material supply and could be relatively easily and inexpensively replaced. Pedigree decided in May 1989 no longer to include them in its recipes, and told the [Pet Food Manufacturers Association] and MAFF of its decision. ³³

Mr Lawrence's submission on cull cattle

3.204 On 22 May 1989, after consultations within MAFF, Mr Lawrence sent to Mr Thompson the submission Mr Meldrum had asked him to prepare, but now limited to the disposal of brains and certain types of offal of all cull cows at the end of their working life. By way of background, Mr Lawrence explained that if the agent was present in cull cows with pre-clinical BSE it would most likely be found in the brain, spinal cord, spleen, lymph nodes and intestines. The submission continued: 'However the agent if present in such animals would be at a much lower level than that found in animals suffering from the disease.' ³⁴

3.205 The submission went on the explain that brain, spinal cord, spleen and intestines were prohibited from use in uncooked meat products, but could be used in cooked meat products under the generic title 'offal' on an ingredients list. However, if sold in a butcher's shop such types of offal would need to be sold under their individual names. Mr Lawrence stated that the Bacon and Meat Manufacturers' Association (BMMA), whose members produced about 80 per cent of the meat products sold in the UK, had advised MAFF informally that brain, spleen, spinal cord and thymus were not actually used in meat products. Some intestines were used for sausage casings but the mucosal surface, including lymphatic tissue (which might harbour the agent), was removed before use and 'such materials, therefore, must be considered a very low risk indeed'. ³⁵

3.206 The submission noted that a ban on the sale or use of such offal would not cause any problems to the trade but, unless any new information on BSE came out of the research projects being undertaken, there would not appear to be any reason to take further action at this stage, 'particularly since Southwood did not recommend it'. ³⁶ Mr Lawrence cited Southwood's conclusion that the risk to humans from BSE as presently perceived would not justify a labelling requirement for products containing brain and spleen. He advised that to take action would probably invite criticism as to why it was not taken earlier. Rather than reassure, it might alarm the public. Mr Lawrence continued:

10. Before any action were taken it would also be logical to seek the views of Sir Richard Southwood. The Department of Health would also need to be consulted. This may open up the door for further debate about scrapie and why similar measures are not being taken in relation to sheep and goats as well. The general public may also latch onto this aspect . . .

Conclusion

12. It would seem that action to prohibit the use of certain offals as uncooked or cooked meat products, either by statute or through a voluntary agreement with the meat trade, would have little impact on the industry. Even so, the Parliamentary Secretary will wish to consider whether action should be taken in the light of the fact that Southwood did not make such a recommendation and would need to be consulted about it, as would DoH; the prospect that, rather than reassure, it might alarm the public and re-open questions about the consumption of beef in general and, indeed, sheep meat and offal as well. The trade implications would also need to be considered very carefully. However, one positive step forward might be to ask the BMMA whether they intend to take any action in the light of the recent media attention on this issue. It is clearly in their interests to at least put the record straight, if their members do not in fact use these offals in the preparation of meat products. ³⁷

Proposed consultation arrangements for the draft baby food regulations

3.207 On 23 May 1989 Mr Cockbill put up to Mr Andrews a covering minute and a submission enclosing consultation proposals for the intended Baby Food (Prohibited Offals) Regulations to be forwarded, if Mr Andrews approved, to the Parliamentary Secretary, Mr Richard Ryder. ³⁸

3.208 The submission sought approval for the draft regulations to be circulated for public comment as required by section 118(6) of the Food Act 1984, before being submitted to Parliament. The Regulations would make it an offence to use or permit to be used any prohibited offal in baby food products or to sell baby food containing any prohibited offal. Prohibited offal would comprise the brain, spinal cord, spleen, thymus, feet, oesophagus, intestines, stomach, testicles, udder, lungs or rectum or any product deriving from these products. Mr Cockbill proposed that for ease of enforcement and consistency with other regulations under the Food Act, the list of prohibited offal be made wider than those described in the Southwood Report. ³⁹

3.209 The covering minute to the Parliamentary Secretary explained:

2. . . . All the organs considered 'high risk' in terms of the likely presence of BSE agent in sub-clinical infection (based on the analogy of scrapie) have been included in the ban, as recommended by the Southwood Report. Other offal listed has been included for the sake of consistency with existing regulations specifying offal. For this same reason, the draft regulations would control the use of mammalian offal and not just ruminant offal as addressed by the Southwood Working Party.

3. The proposals are unlikely to be controversial as offal (other than heart, kidney and liver which are not being banned) is not used in the manufacture of baby foods. However, the proposals are likely to attract a lot of public interest following the extensive media coverage given to this subject at the end of February and may stimulate suggestions that the ban should be extended to all meat products. We shall of course report the results of the public consultation to the Parliamentary Secretary. ⁴⁰

3.210 In his minute to Mr Andrews, Mr Cockbill reported:

I have already had some informal discussions with colleagues in Animal Health Division about possible reactions should the public consultation exercise result in suggestions for extension of the prohibition to all meat products. We have agreed that we must endeavour to ensure that, in the absence of any further scientific evidence which the public consultation exercise would be unlikely to reveal, we do not by any actions appear to cast doubt upon the conclusions of the Southwood Report. ⁴¹

3.211 On 25 May 1989 Mr Cruickshank minuted Mr Andrews. He had received a copy of a newsletter of the BMMA dated 18 May 1989 which indicated that the Association was advising its members to exclude bovine pancreas, thymus, brain, intestine, spinal cord and spleen from their products. He commented on Mr Cockbill's minute of 23 May:

I agree with the advice in Mr Cockbill's minute of 23 May that it would be best not to go beyond the recommendations of the Southwood Report. If we were to depart from the principle of basing our action on the best available scientific advice, it would be difficult to draw a line thereafter in the face of further pressures from the media.

If, however, Ministers are minded to take tougher action than Southwood recommended as a means of reassuring the public, it would appear to be possible to do so . . . without inflicting significant damage on the meat products industry. ⁴²

3.212 On 26 May 1989 Mr Andrews forwarded Mr Cockbill's submission of 23 May to Mr MacGregor. ⁴³ In his covering minute he advised:

If we consult on the basis proposed we have to expect pressure to extend the prohibition to the use of offals in human foodstuffs generally, and not just baby food. If we were to respond to such pressure we should of course be going beyond what Southwood said and opening ourselves to possible further pressures not based upon the scientific advice. On the other hand, if we were to judge that a concession to the pressure will be unavoidable it would be preferable to extend the scope of the consultation document rather than be forced to move later. ⁴⁴

3.213 Mr Andrews advised that Sir Richard Southwood and Sir Donald Acheson would need to be consulted before any decision on extending the ban on types of offal in baby foods was taken. He added that he had discussed the matter with Mr Meldrum, who would be putting forward his technical advice on the implications of going further. ⁴⁵

3.214 On the same day Mr Meldrum sent to Mr MacGregor the minute that Mr Andrews had told him to expect. His minute stated:

4. I am becoming increasingly concerned that Ministers are being forced to consider a ban on the use for human consumption of certain offals, such as brain, spinal cord and spleens, derived from both cattle and sheep, even though there is no scientific evidence to support such action. The argument for prohibiting the use of such material derived from adult cattle is more persuasive since we are dealing with a new condition in cattle and cannot be certain that the agent could not jump yet another species barrier and affect man. On occasions the agent will be present in brain of apparently healthy cattle that are in the incubative stage and the agent is also likely to be present on occasion in other materials such as spleen, lymph glands and nerves.

5. If the Minister feels we must do more than is suggested in the submission I believe we should consult Professor Southwood at the earliest opportunity. It could be argued that the brain, spinal cord and spleen of adult cattle should be removed from the human food chain for the reasons expressed above but to go further and extend this to sheep would re-open the whole of the scrapie issue and would signal that we were concerned about the human health aspects of that disease. In passing it should be noted that to remove the spinal cord from sheep carcass would present severe practical difficulties since few are split at the time of slaughter.

6. If we were to go further than Professor Southwood recommended it would create presentational difficulties and would demonstrate our willingness to move even further should there be sufficient public pressure to do so. Therefore we need to come to a firm decision now as to what materials should be banned for human consumption and thereafter hold the line until there is new scientific evidence leading to a further review. ⁴⁶