Sunday, May 18, 2008

BSE Inquiry DRAFT FACTUAL ACCOUNT DFA

Subject: BSE INQUIRY DRAFT FACTUAL ACCOUNTS
Sunday, May 18, 2008 BSE Inquiry DRAFT FACTUAL ACCOUNT DFA BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's

May 18, 2008

Greetings,

I thought I might document the DFAs i had in my files (what parts i have documented). damn shame i let them slip by me. ...TSS

Subject: BSE Inquiry draft report part 1 From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 14 Jan 1997 20:44:26 +0100 Content-Type: TEXT/PLAIN Parts/Attachments: TEXT/PLAIN (734 lines)

Part 1 of 2

TEMPORARY COMMITTEE OF INQUIRY INTO BSE

19 December 1996 DRAFT REPORT

Part B:RESULTS OF THE INVESTIGATION OF THE TEMPORARY COMMITTEE OF INQUIRY INTO BSE

Rapporteur: Mr Manuel Medina Ortega -----------------------------------

The decision of the European Parliament, adopted on 17 July 1996, footnote 1 which set up the present temporary committee of inquiry into BSE mandated the committee to 'investigate alleged contraventions or maladministration in the implementation of Community law in relation to BSE'.

In accordance with this mandate, the examination of the allegations of contraventions or maladministration has been divided into five chapters: three concerning responsibilities and negligence in respect of the UK, the Council and the Commission respectively; one concerning the possible determination and attribution of responsibilities as between the Council and the Commission; and a final chapter assessing the Commission's political responsibility.

I.1. RESPONSIBILITY AND NEGLIGENCE IMPUTABLE TO THE UK

All accounts thus far have coincided in singling out the UK as bearing the greatest degree of responsibility: even the Permanent Secretary, Mr Packer, and the Chief Veterinary Officer, Mr Meldrum, have accepted part of the blame for the development of the BSE crisis. The main elements demonstrating negligence on the part of the UK may be summarized under the following headings.

1.It failed to ensure an effective ban on the feeding of meat- and bone-meal to ruminants:

a)the production techniques used for making feedingstuffs did not include sterilization and deactivation of the BSE or scrapie agents, and failed to prevent cross-contamination with mammal-derived proteins of all types of meal intended for livestock (the latter, although outlawed for ruminants, were still being used in the production of feedingstuffs for other animal species);

b)the absence of control measures (until August 1996, there were no legal penalties in the UK for the storage or administration of such feedingstuffs) encouraged the continued illegal administration to ruminants of existing stocks of feedingstuffs containing ruminant-derived proteins.

The above is corroborated from the attestations of (among others) Mr Hoelgaard (Director, DG VI), Mr Pocchiari, Mr Dormont and Mr Riedinger. In addition, according to the documents forwarded to the committee, the subject has been discussed on numerous occasions on the Scientific Veterinary Committee (SVC). The European Renderers' Association (EURA) expressed its concern over the functioning of feedmills in the UK at a number of meetings in 1990. In this connection, one may draw attention to paragraphs 4 and 5 of the communication sent by EURA to the SVC on 27 February 1990 (Annex 1):

'4. From investigations in other countries in the EEC it appears very difficult to secure a complete separation in the feedmills between feed produced for ruminants and other feedingstuffs. 5. From the rendering industry it seems strange, that although brains, spinal cord, spleens and other organs recognized as material with high potential of BSE-agent, these wastes are still processed in a rendering plant and used for feeding purposes, although in principle not for ruminants. The possibilities for mistakes in the feed-industry exist. The use of such end-products as for instance fertilizer could be recognized as a necessary alternative'.

2.It failed to respect the national prohibitive legislation outlawing imports of flour from the UK, or, at the least, failure to take action to control the exports concerned. This implies failure to observe the principle of cooperation which should govern relations between all Member States. The data supplied by Mr Packer, Permanent Secretary at the Ministry of Agriculture, Fisheries and Food, are highly significant. In 1989, just after the ban on feeding meat-based meal to ruminants in the UK, exports to the EU rose to 25 005 tonnes (as opposed to 12 553 in 1988). In 1990, when, it may be assumed, the national import bans were already in force, 10 072 tonnes were exported, and subsequent figures were: 2720 tonnes (1991), 1494 (1992), 2226 (1993) and 2343 (1994) (see Annex2). On this point, there is a contradiction between, on the one hand, the statements by Mr Packer and Mr Meldrum, who admit to inadequacies over labelling but claim that regulation for international trade purposes was a matter for the EEC rather than the Member States, and, on the other, the Commission's justification of its failure to act on the grounds that no suitable legal basis existed. One cannot, however, accept Mr Meldrum's argument that the UK should therefore be exonerated from all responsibility (he claims that the UK government had written to the relevant Member State and third country authorities, informing them of its BSE problem and urging them to ban the feeding of mammal protein to ruminants).

3.It put pressure on the Commission not to include anything related to BSE in its general inspections of slaughterhouses, as regularly carried out between 1990 and 1994 in the context of their adaptation to the internal market. This point may be illustrated by Mr Hoelgaard's declarations at the hearing of 28 October 1996. Mr Hoelgaard's words may usefully be reproduced verbatim (see pp. 13 and 14 of the minutes of the hearings): 'I, therefore, do not know why this kind of inspection, that is slaughterhouse inspection with BSE on the side, did not continue in the subsequent years, although there is one piece of information which is perhaps relevant and which I have only recently become aware of. At the end of the inspection a discussion took place with the UK veterinary services on 29 June 1990. When BSE was raised by the inspectors about the deficiencies, Mr Keith Meldrum, Chief UK Veterinary Officer, apparently reacted angrily, stating that the Commission inspectors had no authority to investigate BSE matters; that BSE was not a technical but a political matter; the UK provided the best certificates in the world and the Ministry of Agriculture was reluctant to install computers in abattoirs due to issues of cost and confidentiality'(Annex 32).

4.It tightened this pressure on the Commission, as described in paragraph 3, via the substantial numerical presence of British officials and scientists acting, to a greater or lesser degree, within the orbit and under the control of the UK Ministry of Agriculture. The Commission has justified the massive presence of UK nationals on the committees on the grounds that BSE effectively concerned the UK alone. Nonetheless, the BSE subgroup of the Scientific Veterinary Committee has almost invariably been chaired by a UK national, and one may therefore reasonably harbour doubts as to its objectivity and impartiality. The minutes, in addition, are drawn up by a temporary Commission official of British nationality. The records of attendance attached to some of the minutes which we have received are sufficiently indicative (see Annex 3): -meeting of 5 February 1990: 9 participants (4 British); -meeting of 28 May 1990: 9 participants (5 British); -meeting of 28 September 1994: 10 participants (4 British); -meeting of 19 June 1995: 9 participants (4 British).

5.It made a biased reading of the advice and warnings of the scientists. The views of certain scientists who could be considered as more critical were not taken into account, and the serious and imminent risk of the disease spreading to humans was recognized only on 20 March 1996. The necessary research effort was not carried out, nor were correct priority fields for research defined; indeed, obstacles were put in the path of scientists adopting more critical attitudes to the inadequacy of the precautions being taken. At all events, the responsibility for negligence must be considered to be shared with the EU: the UK has spent only £ 60 m on BSE research, according to Ministry of Agriculture figures, and the EU has spent ECU 3 745 000 (see Annex 4).

6.It did not honour its undertakings made at the extraordinary Council meeting of 6 and 7 July 1990, held to deal with the initial BSE crisis. The conclusions of the minutes of that Council meeting state: 'The Council notes the United Kingdom's intention to introduce a surveillance mechanism of herds in which BSE has been detected, including inspection in approved slaughterhouses of cattle and carcasses from these herds. The results will be transmitted to the Commission and Member States for evaluation by the Standing Veterinary Committee.' (Annex 10). This is particularly serious, since the UK at no moment acted on its undertaking to identify the herds affected, which would have been a necessary first step towards eradicating the disease.

7.It did not implement the legislation by which bovine animals should have been identified and branded and their movements registered. Formally, there were strict and specific obligations, set out in the 'Bovine Animals Order 1990' (SI 1990/1867), which came into force on 15 October 1990 in implementation of Commission Decision 90/261. Article 1(2) of this decision stipulates that the UK is to make exhaustive use of computer registers for ensuring identification of animals. The terms of this decision were, furthermore, strengthened in 1995. In addition, Article 11 of Directive 92/102 on the identification and registration of animals obliges the Member States, in the case of bovine animals and as from 1 February 1992, to operate computerized registers and an identification system complying with the requisites laid down in the directive.

8.It failed to implement the provisions of Directive 89/662 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market. According to this directive, the country of origin (the UK, in respect of its exports) is obliged to ensure strict compliance with the conditions of health policy and inspection for all animal products leaving its territory for the Community market. The same directive sets out specific obligations in case of epidemics, including the submission to the Commission of a programme including the controls to be carried out. One can only be surprised by Mr Packer's declaration that his government should be exempted from blame, on the grounds that there are no proofs of non-compliance: if no checks are carried out, contraventions are very difficult to prove.

9.It took a blocking attitude within the Community institutions, with the aim of pressing the Commission and Council to lift or ease the embargo. This is clear from the minutes of the Commissioners' meeting of 5 June 1996 (Annex 5), in which Mr Fischler stated his intention to adopt the decision on the partial lifting of the embargo: the matter should be viewed in relation to what has come to be seen as the UK's abuse of its rights and blackmailing attitude towards the Community institutions, contrary to the obligations of each Member State as laid down in Article 5 of the EC Treaty. It is stated in the minutes concerned that the Commission asked Mr Santer to write to Mr Major to inform him of its intentions and call on him to review his decision concerning non-cooperation in the EU's decision-making process.

10.It did not display sufficient zeal in monitoring the maintenance of the embargo on meat and by-products. This is clear from Mr Fischler's letter of 10 September 1996 to the UK Minister of Agriculture and Mr Hogg's reply of 25 October 1996 (Annex 6). Mr Fischler's letter sets out the Commission's concerns in relation to the inspection mission carried out in the UK from 22 to 26 July 1996, when a visit to the port of Dover revealed the non-existence of the checks on shipments of beef products to the Member States required by Decision 96/239/EEC.

11.It did not abide by the agreements reached at the Florence summit: the selective culling programme was suspended, and no alternative proposal was formally put forward. The Florence agreements provide for the possibility of modifying the culling programme in the light of new scientific data; however, whatever the circumstances, a new programme substituting the old one has to be submitted and approved by the Commission and the Standing Veterinary Committee. According to the Commission's replies of September 1996, the selective culling programme had still to be approved by the British Parliament. We do not, to date, possess any documents formally attesting to progress having been made in implementing the programme, although it appears that culling is continuing in the UK, which has recently told the media that it intends to undertake a large-scale cull which could even go beyond the initial Florence proposals. At all events, there is still a procedural problem, insofar as British actions in this field should be agreed jointly with the EU, not carried out unilaterally: they should accordingly be approved by the Standing Veterinary Committee and the Commission, if the embargo is to be lifted at the earliest opportunity.

12.The UK Minister of Agriculture, Mr Hogg, demonstrated an unwillingness to cooperate, refusing to appear before Parliament's committee of inquiry. This is clear from his letters to the committee dated 25 September 1996 and 10 October 1996 (Annex 7). According to the report drawn up for the committee by Parliament's Legal Service on 8 October 1996 (Annex 8), 'a Permanent Secretary' attached to a British ministry could not be considered in legal terms to be a 'member of the government' within the meaning of Article 3(2) of the joint decision of the European Parliament, the Council and the Commission (No 95/177) of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament's right of inquiry.

13.All in all, since 1988 the UK authorities have introduced a considerable amount of legislation covering the various aspects of protection against possible BSE risks. The problem, therefore, lies not in any lack of appropriate legislative measures, but in the attitude of the government, which has failed to ensure the proper application of those measures and has not carried out the necessary checks. In addition, doubtless under pressure from the meat industry, the UK government has, in its turn, exerted pressure on the Commission's veterinary services with the objective of keeping the matter within the national orbit, thus avoiding Community inspections and preventing publicization of the extent of the epidemic, since this would have provoked unilateral action by some Member States on public health grounds.

I.2. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITY AND POSSIBLE NEGLIGENCE ON THE PART OF THE COUNCIL AND COMMISSION

The determination and attribution of responsibility as between the Community institutions, namely the Council and the Commission, is an extremely complex question, for a number of reasons:

1.One reason is the nature of the problem itself. It was initially thought that BSE was a variant of scrapie which had infected cows instead of sheep. On the basis of the parallel with scrapie - an illness which was well-known and considered harmless to humans - it was supposed that BSE was an animal health matter alone. However, once it began to look increasingly certain that BSE was a phenomenon different from scrapie, which could, in addition, jump the species barrier (having also been detected in cats), the matter took on a new dimension: it was no longer merely a veterinary and animal health problem, and the protection of consumer health became the first priority.

2.One must also bear in mind the decision-making system on veterinary matters and the respective roles of the Scientific Veterinary Committee and the Standing Veterinary Committee. As a rule, the Commission bases its legislative proposals on the opinions of the Scientific Veterinary Committee, whose members are appointed by the Commission on the basis of nominations by the Member States. This committee acts as a consultative organ of the Commission. A Commission proposal drawn up on the basis of recommendations by the Scientific Veterinary Committee is then forwarded for adoption to the Standing Veterinary Committee, which operates as a regulatory committee of the 'safety-net' (contre-filet') type - i.e. the Commission proposal is adopted provided it obtains the necessary majority. If that majority is not obtained, the Commission has to take the matter to the Council. It may happen that a sufficient majority for rejecting the Commission proposal is not reached in Council: at this point, the Commission is empowered to adopt the proposal under its own responsibility, in the absence of a decision from the Council that it should be withdrawn. This was the adoption procedure which applied to Commission Decision 96/362 lifting the embargo on semen, tallow and gelatine. It follows that responsibility must be seen, in general terms, as being shared, on a non-absolute basis, between the Council, the Commission, the Standing Veterinary Committee and the Scientific Veterinary Committee. The complexity of the commitology system makes it even more difficult to apportion responsibility, be it with respect to the institutions or to the committees.

3.Another factor is the operation of the principle of subsidiarity in public health matters. On this subject, it is essential to distinguish between the situations prevailing before and after the entry into force of the Treaty of Maastricht. Since 1 November 1993, competence in the field of public health protection has been a joint matter for the Union and the Member States, pursuant to Article 129 of the TEU. Nonetheless, as is pointed out in the report drawn up for this committee by Parliament's Legal Service on 25 November 1996 (Annex 9), legislation already existed before Maastricht obliging the Commission to take account of health protection implications in the context of the proper functioning of the COMs under the CAP. The Commission's powers in the field of public health protection have recently been confirmed by the Court of Justice (see: ECJ decision of 12 July 1996 - Case C-180/96; decision of the President of the Court of First Instance of 13 July 1996 - Case T-76/96).

4.Public health protection competences are compartmentalized between a number of different Commission departments (as regards possible food product risks). The BSE affair has been handled variously by: DG VI (Agriculture), DG III (ex-Internal Market, now Industry), the Consumer Protection Service (currently DG XXIV), and the Directorate for Health and Safety (DG V).

This compartmentalization has hampered the coordination and efficiency of the services concerned, and points up the lack of an integrated approach, such as would have been possible were there a body similar to the Food and Drug Administration in the US or the health administrations in the Member States.

I.3. RESPONSIBILITY AND NEGLIGENCE ON THE PART OF THE COUNCIL

Given the Council's character as a representative organ of the Member States, it should be assumed that implicit reference is being made here to the general responsibilities of the Member States, without prejudice to the question of the specific responsibility of the UK, which, in view of its importance, has been dealt with in a separate chapter. In relation to the activities of the Council and the Standing Veterinary Committee, we have been helped by the testimonies of Mr Yates, the Irish Minister of Agriculture, in his capacity as President-in-Office of the Agriculture Council, and Mrs Amendrup, assistant director of the Danish national veterinary services and member of the Standing Veterinary Committee.

Mr Yates endeavoured to define the sphere of competence of the Council, pointing out that legislative powers in the veterinary field and, even more so, in that of public health are shared between the Commission, the Council and the Member State governments. However, he argued, the Council was responsible for a specific activity of political guidance and impetus, and was also obliged to cooperate closely with the Commission. He stressed that the Council was not to be held responsible in a number of important areas, stating: '... dissemination of information about BSE, publication of research findings about BSE, controls on the production and export of recycled animal protein and controls on the temporary ban on exports of cattle, beef and meat-based productions do not fall within the Council's sphere of responsibility, as they come under the powers of the Commission or the Member States'. Prior to the March 1996 crisis, the Agriculture Council had specifically examined BSE at its meetings of 6 and 7 June 1990 and 18 and 19 July 1994 (see Annex 10). Both meetings were called to deal with the threats of unilateral measures by certain delegations (France and Germany) which were calling for tougher guarantees on meat imports from the UK. In addition, at several other Council meetings, according to the minutes supplied to us, certain delegations expressed the following requests:

- BSE should be included on the agenda, for assessment of the most recent scientific data (German delegation to the Council, 25 and 26 April 1994, 30 and 31 May 1994 and 20, 21, 22, 23 and 24 June 1994) (Annex 11);

-the Council of Health Ministers should be asked to participate in possible public health protection measures (German delegation to the Council, 28 and 29 March 1994) (Annex 12);

-there should be reinforced controls on feedingstuffs given to ruminants and on the use of potentially dangerous tissue in the manufacture of cosmetics and medicines (French delegation to the Council, 28 and 29 March 1994 and 25 and 26 April 1994) (Annexes 11 and 12);

-action should be taken on the request of the French delegation, forwarded to the Council of Health Ministers, for extension to all the Member States of France's unilateral measures banning the use of at-risk bovine tissue in the manufacture of cosmetics, medicines and baby-foods (meeting of 30 and 31 May 1994) (Annex 11).

Following the statement by the UK government of 20 March 1996 concerning new scientific data, the Agriculture Council held two extraordinary meetings, on 1-3 April and 29 and 30 April 1996 (Annex 13). At these meetings, it recognized the seriousness of the situation and urged the adoption of a number of urgent measures for health protection and support of the beef market.

The subject was discussed again on numerous occasions throughout 1996, with the Council awaiting the statements of the UK delegation concerning the evolution of the situation, with a view to resolving the crisis. On 30 March 1994 the Council of Health Ministers met to discuss the proposal by the German delegation concerning discussion of the possible risks of transmission of BSE to humans. The German delegation insisted on making a separate statement, in which it urged the adoption of further protection measures (Annex 14). Over 1994 and after March the Council of Health Ministers discussed the subject several more times. One may cite, as visible proof of the attention which has been paid to the subject in various policy areas, the discussions in the Council of Research Ministers, at its meeting of 7 October 1996, as well as the statements by Commissioner Cresson included in the minutes of the Commissioners' meeting of 9 October 1996 (Mrs Cresson reported on the disappointing outcome of the discussions in the Council of Research Ministers on this subject, and drew attention to the inconsistent position of the ministers, who had called for a greater research effort but had refused to provide the necessary resources) (Annexes 15 and 16). Following this Council meeting, the Commission submitted a communication to the Council and Parliament (COM(96)0582) allocating an additional ECU 50 m for BSE research. The subject was to be re-examined at the Research Council meeting of 5 December 1996.

The following statements may accordingly be made:

1.Responsibility for the problem is divided between the authorities concerned with agriculture and animal health and those concerned with public health protection. This applies at both EU and national level, with the division of responsibilities varying from one Member State to another. The situation is aggravated by the effects of the principle of subsidiarity, which has operated in this field, following the entry into force of the TEU, since November 1993, and by the fragile state of progress in the exercise of Community powers in the public health field.

2.With the exception of the statements by certain delegations since March 1994, as referred to above, the Agriculture Council did not deal with BSE at all between June 1990 and its meeting of 18 and 19 July 1994, at which the subject returned to the agenda, in response to the threats to the marketing of British meat in the wake of the complaints of the German government demanding tougher guarantees for the extraction of nerve and lymph tissue from deboned meat and a longer non-contamination period for herds before the export of carcasses. At this meeting, the Council endorsed the Commission's proposals.

3.The absence of a debate in Council, either to examine the state of affairs or to verify compliance with the June 1990 conclusions, in view of their importance, may be considered to imply neglect by omission on the Council's part; or it may be interpreted as passing the responsibility to the Standing Veterinary Committee. The 1990 conclusions mandated the Commission to adopt a number of measures to control and monitor the disease, to examine the risks arising from the manufacture of feedingstuffs for ruminants containing animal proteins, and to launch a wide-ranging programme of research. In addition, the Council had taken note of the undertakings of the UK delegation concerning the inspection of slaughterhouses and the identification of cattle. It is surely surprising that the Council should at no moment have acted to ascertain the degree of compliance with these conclusions, and that it should not have asked to be informed of the results of any inspections carried out by the Commission or the national authorities.

4.As is clear from the testimony of Mrs Amendrup and the documents in our possession, the question of the Council's responsibility should also be considered in relation to the actions of the Standing Veterinary Committee. This committee is made up of representatives of the Member States (the heads of the national veterinary services), and acts, in a certain sense, by delegation of the Council. According to Mrs Amendrup, a number of technical debates took place on the committee, based on the evaluation of the documents supplied by the Scientific Veterinary Committee. Once a subject had become of significant political interest, it was forwarded to the Council. The Standing Veterinary Committee should, it may be argued, have, on certain occasions, called for the debate on the subject to be transferred to the Council, in view of its major political significance, going well beyond purely technical considerations.

5.It is extremely difficult to evaluate the actions of the Standing Veterinary Committee: as it seems, no minutes are kept of its meetings, other than brief summaries, which have not been forwarded to the present committee of inquiry, despite repeated requests to this effect by its chairman. The sole available information consists of the minutes of the meetings drawn up by the Danish delegation and forwarded by Mrs Amendrup.

6.The view that the Council has tried to leave the responsibility in the hands of the Commission is confirmed by Mrs Amendrup's statement that in practice, other than in exceptional circumstances, the Council only considers veterinary subjects, whether affecting animal health or public health, when their political interest is such as to exceed the 'technical' competences of the Standing Veterinary Committee. The fact that this committee, in its turn, bases its work on the opinions of the Scientific Veterinary Committee, which is essentially a consultative committee of the Commission, and on which, as far as BSE is concerned, the British influence has been considerable, points up the ineffectiveness of the existing system of committees with respect to the protection of public and consumer health.

7.Another aspect which we have been able to establish, on the basis of information provided by Parliament's Committee on Budgets, is the Council's position with regard to the budgetary procedure: the tendency has been to reduce the sums initially earmarked by the Commission in the preliminary draft budget, for the headings relating to programmes for the eradication of diseases and measures concerning veterinary and phytosanitary inspections and controls. This is in contradiction to the Commission's pledges made in response to Parliament's positions in the various debates over the last few financial years.

I.4. RESPONSIBILITY AND NEGLIGENCE ON THE PART OF THE COMMISSION

From the examination of the testimonies received by the present committee, the Commission's written replies and the documentation supplied to us, we may state that, in general, the Commission's actions may be characterized as follows:

1.It has given priority to the interests of market management, as opposed to the potential human health risks existing in the light of the numerous scientific uncertainties concerning the possible effects of BSE on humans. There is a considerable body of material confirming this attitude. The most important evidence includes the following:

-the attitude of the then Commissioner, Mr MacSharry, in the days leading up to the extraordinary Council of 6 and 7 June 1990, including public threats to take out infringement proceedings against Member States introducing unilateral measures against British beef exports, or even to take such Member States to the Court of Justice (as confirmed in internal Commission notes - see Annex 17). In addition, Commissioner Van Miert, in his testimony, has confirmed his disagreement with Mr MacSharry on a number of points during the preparation of the extraordinary Council;

-the attitude of Mr MacSharry at the extraordinary Council, at which, as stated in the note of 28 October 1996 from Mr Berlingieri to Mr Hoelgaard (Annex 18), the then Commissioner received from Mr Mansito, Assistant Director-General for Agriculture, a proposal drawn up by the veterinary services of DG VI (Annex 19) to the effect that, in view of the existing difficulties relating to animal identification and checks, exports of British beef should be permitted only in deboned form. The third paragraph of Mr Berlingieri's note states: 'This approach has been presented to the Commissioner by Mr. Mansito, yourself and myself in the Council on 7 June 1990. The reaction has been quite rough and we have not got any longer the possibility of discussing it because we had been excluded from the meeting room';

-the instructions issued on 18 September 1990 by Mr MacSharry to Mr Legras, Director-General for Agriculture, which have been publicized in the press in the form of an annotation by Mr Legras: 'BSE: Stop any meeting' (Annex 20). Mr Legras states in his testimony of 1 October 1996 that this instruction should be interpreted as a manifestation of bad temper on the part of Mr MacSharry; however, in view of the Commission's management approach to the issue and the former Commissioner's admitted interest in averting disturbances of the beef market, this supposed interpretation is scarcely credible;

-the exchange of correspondence between Mr Legras and Mr Perissich, Director-General of DG III, on baby food (Annex 21).

2.It has tried to follow a policy of downplaying the problem which can, at certain moments, be interpreted as amounting to a policy of disinformation, with the aim of averting disturbances on the beef market. In this connection, the background note of 12 October 1990 (Annex 22) by Mr Castille, then an official of the Consumer Policy service (now DG XXIV), on the statements by representatives of DG VI at the meeting of the Standing Veterinary Committee of 9 October 1990 constitutes evidence of the Commission's attitude to the matter. It may be deduced from Mr Legras' annotation, as reproduced in Annex 20 and quoted in the third indent of the preceding paragraph, that the representative of DG VI was acting under instructions from his superiors. It should be pointed out that no proofs exist that the statements in question were made in the terms of Mr Castille's note, and the Commission representatives, in their testimonies to the present committee, offer the following qualifications:

-there was no need to discuss BSE at every meeting of the Standing Veterinary Committee, since, given that it was a notifiable illness, the Member States were automatically kept informed;

-the Commission wanted to be informed of the results of the work of the British scientists before its publication, so as to be able to make its evaluation immediately, since this work could contain new elements tending to favour changes in the existing legislation.

At all events, according to Mr Legras' testimony, the note has never been officially contested by DG VI. That the Commission's handling of the BSE affair has been lacking in transparency is obvious from the contradictions existing in the ex-Commissioners' and DG VI officials' testimonies and in numerous pieces of written evidence which have appeared in the press or have been supplied by the Commission to the present committee.

3.There has been a lack of cooperation and coordination among all the departments with responsibility for food products (DG VI - agriculture; DG III - internal market/industry; DGV - health; DG XXIV - consumer protection). This is confirmed by the testimonies of Commissioner Van Miert and Mr Perissich, the former Director of DG III.

Mr Van Miert says there was a lack of coordination between his office and that of the then Commissioner MacSharry during the preparation of the extraordinary Agriculture Council of 6 and 7 June 1990.

Mr Perissich informed us of the initial difficulties which he encountered in DG VI in relation to his initiatives on baby food, which, however, later bore fruit in cooperation and joint activity on the part of the Scientific Committee for Food (DG III) and the Scientific Veterinary Committee (DG VI).

4.Too much weight was placed on the role of the Scientific Veterinary Committee. This is clear from the testimonies of the senior DG VI officials, especially that of Mr Legras, Director-General for Agriculture, who has repeatedly stated that the Commission could not go beyond the recommendations of the Scientific Veterinary Committee since, should it try to do so, it would not have the support of the Member States on the Standing Veterinary Committee. It may be deduced from this that the Commission was unwilling to make a further political effort to take public health protection measures going beyond the recommendations of the Scientific Veterinary Committee: this is particularly serious in view of the strong pressures exerted by the British members of that committee.

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Further, there are no clear channels of communication between the Scientific Veterinary Committee and the Standing Veterinary Committee. This means that there are no guarantees that a scientific position of the Scientific Veterinary Committee will necessarily be adequately represented on the Standing Veterinary Committee; responsibility for ensuring the flow of information appears to lie with the Commission. In this connection, it is surprising that the Commission does not possess detailed minutes of the meetings of the Standing Veterinary Committee; if there are no minutes of the decisions and debates, it is scarcely possible to carry out effective monitoring of the policy lines expressed by the delegations on the Standing Veterinary Committee.

5.Criticisms may be made of the workings of the Scientific Veterinary Committee. This committee consists of experts appointed by the Commission from a list of names put forward by the Member States. In principle, the criteria for appointment have to be based on professional qualifications, and there is therefore no criterion of nationality balance in its membership.

In the BSE affair there has been, at the least, a lack of transparency. This should appear clearer if one recalls that BSE has been the subject of an ongoing analysis by the BSE Subgroup of the Scientific Veterinary Committee. This subgroup has, almost throughout, been chaired by a UK national (first Mr Plowright and then Mr Bradley), and has included a substantial number of British scientists. Mr Bradley, who from 1969 to 1991 was head of the UK's Central Veterinary Laboratory and was subsequently an adviser to the British Ministry of Agriculture, has acted as rapporteur on BSE at the full meetings of the Scientific Veterinary Committee;

it emerges, furthermore, from some of the minutes of the committee meetings that a number of members have suggested that Mr Bradley may have withheld information (see minutes of the meeting of the public health section of the Scientific Veterinary Committee, 11 May 1995 - Annex 23).

Mr Marchant, a temporary Commission official entrusted by DG VI with the day-to-day management of the BSE affair, who was formerly an official of the British Ministry of Agriculture, has been responsible for drawing up the minutes and providing Commission administrative support for the BSE Subgroup, in close cooperation with Mr Bradley. The letter of 31 January 1992 in which Mr Bradley provides Mr Marchant with instructions, which is in the possession of the present committee (Annex 24), clearly reveals the nature of the professional relationship between the two. It is a typical example of correspondence between two officials (one from the Commission, one from a national government), rather than an instance of cooperation between an independent scientist and a Community institution.

In addition, the arrangements practised by the Commission for reimbursing expenses incurred by participants in the meetings are such that, as is recognized by Mr Pocchiari in his testimony, scientists from certain Member States may be unable to attend the meetings on a regular basis for cash-flow reasons, thus only being able to monitor matters at a distance.

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6.The Commission has no provision for consulting independent, multidisciplinary advisory committees; had this been the case, it would have been easier to make a correct assessment of the evolution of the epidemic and the possible public health risks.

The chairmen of the animal health and public health sections of the Scientific Veterinary Committee, Mr Meurier and Mr Del Real, have expressed strong reactions in a communication to the present committee, arguing that the collaborators and the work of their committee should be treated with respect and trust. However, the recent creation, in the wake of the March 1996 crisis, of the multidisciplinary 'Weismann' and 'Interservices' committees (on the respective initiatives of Commissioners Fischler and Bonino) may be interpreted as a response to the need to fill a gap not covered by the previously-existing system of committees.

7.It has not encouraged the expression of views by scientists holding minority opinions: in principle, the opinions of the Scientific Veterinary Committee are adopted by consensus. In this connection, one may examine the disagreement which arose between Mr Somogyi and the Director-General for Agriculture, Mr Legras.

It is nonetheless also necessary to consider the testimony and documentation provided by Mr Legras in reply to Mr Somogyi's charges. The third paragraph of the report of the meeting of the Scientific Veterinary Committee (animal health and public health sections) of 3 November 1994 states that Mr Somogyi's dissenting view was communicated through the Commission representative, and that his letter, containing comments addressed to Mr Legras, was annexed to the minutes of the meeting (see Annex 25).

Another instance of the difficulties involved in registering the positions of the participants in the meetings of the Scientific Veterinary Committee is provided by the note of 28 November 1996 from Mrs Berge (of DG VI), which is in the possession of the present committee (Annex 26). This note states, inter alia: ' ... this is a consensus document and it is impossible to get the agreement on every point, since opinions are sometimes diverging'.The note from Dr Ahl (Annex 27) may be interpreted along similar lines. 8.It has not made efforts to adapt its staffing policy to the real needs arising from the establishment of the internal market.

This is clear from the note of 26 February 1991 from Commissioner MacSharry to his fellow Commissioners, the fourth paragraph of which describes the staffing situation in the inspection departments as 'particularly fragile' (Annex 28). The Commissioners did not act on Mr MacSharry's requests.

However, in the documents relating to staff requirements in DG VI, and, in particular, in a report on the internal situation of the veterinary services which has been made available to the present committee, while reference is repeatedly made to the urgent need for more human resources for tasks arising from the internal market or relating to certain priority illnesses such as foot-and-mouth disease, we have not found any reference to the need for staff to improve the monitoring of BSE.

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to be continued....

Subject: EP BSE Inquiry report (part 1 of 3) From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 25 Feb 1997 21:28:09 +0100 Content-Type: TEXT/PLAIN Parts/Attachments: TEXT/PLAIN (1030 lines)

BSE Inquiry report (Part 1 of 3)

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7 February 1997 A4-0020/97/A

REPORT

on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts

Part A:

I. RESULTS OF THE INQUIRY

II. RECOMMENDATIONS FOR THE FUTURE

III. MINORITY OPINIONS (published separately)

Temporary committee of inquiry into BSE

Rapporteur: Mr Manuel Medina Ortega

C O N T E N T S

Page

Procedural page 3

I.RESULTS Of THE INQUIRY

EVIDENCE OF NEGLIGENCE, RESPONSIBILITIES AND PRESUMPTIONS OF MALADMINISTRATION 4

1. INTRODUCTION:

A) BRIEF OF THE COMMITTEE OF INQUIRY 4

B) DIFFICULTIES ENCOUNTERED IN THE COURSE OF THE WORK OF THE COMMITTEE OF INQUIRY 5

C) MISHANDLING OF THE CRISIS DURING THE PERIOD WHEN THE DISEASE WAS AT ITS HEIGHT 5

2. RESPONSIBILITIES IMPUTABLE TO THE UK GOVERNMENT 6

3. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITIES AS BETWEEN THE COUNCIL AND COMMISSION 15

4. RESPONSIBILITIES OF THE COUNCIL 18

5. RESPONSIBILITIES OF THE COMMISSION 22

6. POLITICAL RESPONSIBILITIES OF THE COMMISSION 36

ANNEXES (published separately)

II. RECOMMENDATIONS FOR THE FUTURE 38

III.MINORITY OPINIONS (published separately)

At its sitting of 18 July 1996 the European Parliament adopted, pursuant to its powers under Rule 136 of its Rules of Procedure, the decision to set up a temporary committee of inquiry into bovine spongiform encephalopathy.

On 3 September 1996 the temporary committee of inquiry held its constituent meeting and appointed Mr Medina Ortega rapporteur.

At its sitting of 26 October 1996 Parliament decided to prolong the mandate of the temporary committee of inquiry for a further three months.

At its meetings of 3 and 19 September, 1-2, 8-9, 21, 24 and 28-29 October, 4, 11-12, 14, 18-19 and 25-26 November and 3, 9-10, 12 and 16-17 December 1996, the temporary committee of inquiry organized hearings with witnesses and experts in the field, and held a number of internal evaluation meetings.

At its meetings of 13, 15, 20-21 and 28 January and 5-6 February 1997 the committee examined the draft report.

At the last meeting it adopted the results of the inquiry and the recommendations unanimously.

The following took part in the vote: Böge, chairman; Santini and Kofoed, vice-chairmen; Medina Ortega, rapporteur; Barthet-Mayor, Bébéar, Dell'Alba (for Barthet-Mayor, pursuant to Rule 136(4, second paragraph)), Gillis (for Plumb, pursuant to Rule 136(4, second paragraph)), Goepel (for Böge, pursuant to Rule 136(4, second paragraph)), Graefe zu Baringdorf, Happart, Jensen (for Roth- Behrendt, pursuant to Rule 136(4, second paragraph)), Jové Peres, Laignel, Martin P., Martinez, des Places, Redondo Jiménez, Rosado Fernandes (for P. Martin, pursuant to Rule 136(4, second paragraph)), Roth-Behrendt, Thyssen (for Bébéar, pursuant to Rule 136(4, second paragraph)), Trakatellis and Whitehead.

The minority opinions (of the following Members: Happart, P. Martin, Martinez, des Places, Plumb and Whitehead) will be published separately from the results and recommendations of the committee of inquiry.

The results of the inquiry and the recommendations for the future were submitted on 7 February 1997.

I RESULTS OF THE INQUIRY

EVIDENCE OF NEGLIGENCE, RESPONSIBILITIES AND PRESUMPTIONS OF MALADMINISTRATION

1. INTRODUCTION

A) BRIEF OF THE COMMITTEE OF INQUIRY

The decision of the European Parliament, adopted on 18 July 1996 (note 1), which set up the present temporary committee of inquiry into BSE mandated it to 'investigate alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts'.

The committee's exercise of the functions entrusted to it is, according to its brief, to be carried out 'without prejudice to the jurisdiction of the Community and national courts'. It is, therefore, not for Parliament to determine individual responsibilities which must be the subject of actions brought before criminal and civil courts by the victims of the crisis. The attribution of political responsibility, and whether the committee should propose initiatives to that end to the plenary of Parliament, is another matter altogether.

In accordance with this mandate, the examination of the allegations of contraventions or maladministration has been divided into six chapters. The first chapter is introductory in nature and concerns the brief of the Committee of Inquiry and the difficulties encountered in the course of its work. The second concerns the responsibilities of the UK. The third attempts to establish the possible determination and attribution of responsibilities as between the Council and Commission. The fourth and fifth concern the responsibilities of the Council and the Commission respectively. The sixth and last concerns the Commission's political responsibilities. Section II sets out recommendations for the future.

It has become clear from the work of the Committee of Inquiry that the determination and attribution of responsibility as between the UK Government, the Council and the Commission is an extremely complex question. This difficulty is increased by the fact that BSE is a new and very strange disease. The pathogen has not been definitively identified and there is no live test for the condition..

B) DIFFICULTIES ENCOUNTERED IN THE COURSE OF THE WORK OF THE COMMITTEE OF INQUIRY

All Community officials who gave evidence to the Committee of Inquiry did so in accordance with Article 3(3) of the joint Decision of 19 April 1995 of the European Parliament, the Council and the Commission on the detailed provisions governing the exercise of the European Parliament's right of inquiry. Accordingly, officials gave evidence not as individuals but on behalf of their institution, acting in accordance with the Commission's instructions.

This presented an obstacle to the work of the Committee of Inquiry. In the first place, obtaining written replies was extremely slow. In addition, and more seriously, the Commission used blocking tactics, concealing the truth on various sensitive issues. The UK Government also adopted blocking tactics, right from the moment when its Minister for Agriculture refused to appear before the Committee of Inquiry. Consequently, the need to complete the work of the Committee of Inquiry within the deadlines laid down meant that a number of questions remained unanswered.

The pressure of time and the wording of the 1995 Interinstitutional Agreement made it impossible to attribute individual responsibility for maladministration. The Committee of Inquiry confined itself to the institutional framework, although it remains aware that, in addition to political responsibilities, there may also be administrative responsibilities which can be attributed to individuals who work and hold or have held office in the various institutions.

C) MISHANDLING OF THE CRISIS DURING THE PERIOD WHEN THE DISEASE WAS AT ITS HEIGHT

The main evidence of mismanagement of the BSE crisis can be traced to the period 1990-1994. In order to obtain a global view of events and attribute responsibility, consideration must be given both to the successes and failures of that period.

75% of the cases of BSE recorded in the UK occurred between 1990 and 1994. Towards the middle of 1990, France and Germany sought to introduce trade restrictions on British beef. Although these two countries were able to invoke the provisions of Article 36 of the EC Treaty, Commissioner MacSharry threatened to bring proceedings before the Court of Justice. In 1990 various internal notes were written which point to the existence of a policy of disinformation by the Commission. Although the Commission has denied on various occasions that such a policy was in force, written proof exists (see Annexes 20 and 22), as confirmed in the years that followed by a series of events which demonstrate how the problem was concealed.

- In 1990 scientific evidence was found that the infection could cross the barrier between species. There was evidence that the disease could be transmitted to cats and pigs. This was a serious development and should have prompted efforts to speed up the scientific research. However, from 1990 onwards the scientific research produced scant results.

- Between 1990 and 1994 veterinary checks on BSE in the UK were suspended.

- Between 1990 and 1994 Community legislative activity in the field of BSE was suspended, with the exception of the regulation on embryos.

- Between 1990 and 1994 the Council held no debates on BSE.

Consequently, although the Commission denies the existence of the policy of disinformation suggested by the written notes, the facts show that:

- the most important sources of information were not available; and

- the Council and Commission began to neglect their duties.

These two facts are connected, since if the flow of information is cut off and the Commission fails to fulfil its role in initiating legislation, the Council is sidelined. It is clear that the policy of disinformation was not confined to misleading public opinion, but played a full part in relations between the Community institutions.

The question of information is therefore of vital importance. There are two main sources of information, namely the results of veterinary inspections and the scientific evidence obtained from research. As far as veterinary inspections are concerned, it should be pointed out that, although the Commission sought to conceal the truth and attribute to the European Parliament the suspension of BSE inspection missions to the UK, this was a decision taken by the Commission in response to British pressure.

Research can be carried out when some stimulus exists, in other words where there is a problem and when there is sufficient raw material to carry out such research, in this case the organs of diseased animals. Although both these conditions were present in the UK during the years when the disease was at its height, no scientific findings were made. This is a further area where responsibility can be seen to lie with the UK.

A crucial factor before the legislative process gets under way is the work of the Scientific Veterinary Committee and the Standing Veterinary Committee. Once the sources of information had been cut off, both committees had little scope for action. Although the matter was taken up at a later date, it must be said that the BSE subgroup of the Scientific Veterinary Committee was chaired by a British official and that a large number of those who attended the meetings were of the same nationality.

2. RESPONSIBILITIES IMPUTABLE TO THE UK

BSE stemmed from the introduction from the United States of the 'Carver-Greenfield' system of manufacturing meat-and-bone meal. The UK Government, unlike those of other Member States, authorized the change in the system for manufacturing meat-and-bone meal. This led to the emergence of BSE. It also created conditions favourable to the spread of other diseases. In other states, when the process was changed, the introduction of a sterilization period was required.

Most of the testimonies and the greater part of the evidence supplied to the Committee of Inquiry suggest that the UK bears the greatest degree of responsibility. Even the Permanent Secretary, Mr Packer, and the Chief Veterinary Officer, Mr Meldrum, have admitted that mistakes were made in the management of the BSE crisis. The main elements demonstrating negligence on the part of the UK may be summarized under the following headings.

1. The UK authorities and the rendering industry

a) The UK authorities and the rendering industry paid insufficient attention to the risks involved in rendering a high proportion of sheep remains into meat-and-bone meal when scrapie was endemic in the British sheep population and the Carver- Greenfield rendering plants provided inadequate safeguards for the destruction of infectivity, although existing research results suggested that transmission to other species was possible.

However, by choosing to adopt new production techniques for animal meal, deemed more profitable, some manufacturers in the animal feedingstuffs sector bear a greater share of responsibility for the dissemination of the pathogen.

b) The UK authorities and the rendering industry continued to assume that, since scrapie was harmless to humans and BSE was a variant of scrapie in cattle, BSE must be purely an animal health matter

As early as 1979 a UK Royal Commission under Lord Zuckerman, set up to examine pathogenic transmission in general in the rendering process, warned about the wisdom, from an epidemiological viewpoint, of feeding rendered animal remains to ruminants.

c) In June 1987, British ministers were already aware of the existence of BSE and of the fact that scientists could not determine whether it could or could not be transmitted to other species or to humans. However, they decided to do nothing until 18 July 1988 when the ban on cattle feed was applied (this ban did not affect existing stocks). In December 1988, the UK prohibited the use of milk from suspect cattle for any purpose other than that of cows feeding their own calves. That action proves clearly that, in 1988, the British authorities suspected that there was a risk to public health if people ate meat from animals affected by BSE

2. The UK Government failed to ensure an effective ban on the feeding of meat-and-bone meal to ruminants:

a) the production techniques used for making feedingstuffs did not include sterilization and inactivation of the BSE or scrapie agents, and failed to prevent cross-contamination with mammal-derived proteins of all types of meal intended for livestock (the latter, although outlawed for ruminants, were still being used in the production of feedingstuffs for other animal species);

b) the absence of adequate control and recall measures (until August 1996 there were no legal penalties in the UK to back up the ruminant-protein feed ban) led to a failure to ensure the total disappearance of meat-and-bone meal (MBM) from ruminant feed;

c) The UK Government did not ask its own scientific advisers about the consequences of using stocks of meat- and-bone meal as animal feedingstuffs elsewhere where other ruminant animals might be exposed to it. Sir Richard Southwood told the Committee that he was not asked about these consequences:

' ... if you ask me whether in 1988 the working party [of which I was chairman] would have considered there was a risk to herds in other countries if UK-produced meal (with meat-and- bone meal) was exported I am totally confident that we would have answered in the affirmative. Knowing that the meal was almost certainly the cause of the outbreak in the UK it is clear that it was irresponsible (whatever the law) to make it available as cattle food elsewhere.'

The above is corroborated from the attestations of (among others) Mr Hoelgaard (Director, DG VI), Mr Pocchiari, Mr Dormont and Mr Riedinger. In addition, according to the documents forwarded to the Committee, the subject has been discussed on numerous occasions on the Scientific Veterinary Committee. The European Renderers' Association (EURA) expressed its concern over the functioning of feedmills in the UK at a number of meetings in 1990. In this connection, one may draw attention to paragraphs 4 and 5 of the communication sent by EURA to the Scientific Veterinary Committee on 27 February 1990 (Annex 1):

'4. From investigations in other countries in the EEC it appears very difficult to secure a complete separation in the feedmills between feed produced for ruminants and other feedingstuffs.

5. From the rendering industry it seems strange, that although brains, spinal cord, spleens and other organs [are] recognized as material with high potential of BSE-agent, these wastes are still processed in a rendering plant and used for feeding purposes, although in principle not for ruminants. The possibilities for mistakes in the feed-industry exist. The use of such end-products as for instance fertilizer could be recognized as a necessary alternative'.

3. It failed to respect the national prohibitive legislation outlawing imports of meal from the UK, or, at the least, it failed to take action to control the exports concerned. The liberalization of intra-Community trade cannot justify this serious failure to observe the principle of cooperation which should govern relations between all Member States. The data supplied by Mr Packer, Permanent Secretary at the Ministry of Agriculture, Fisheries and Food, are highly significant. In 1989, just after the ban on feeding meat-based meal to ruminants in the UK, exports to the EU rose to 25 005 tonnes (as opposed to 12 553 in 1988). In 1990, when, it may be assumed, the national import bans were already in force, 10 072 tonnes were exported, and subsequent figures were: 2720 tonnes (1991), 1494 (1992), 2226 (1993) and 2343 (1994) (see Annex 2).

It is disturbing, to say the least, that UK animal feed producers continued to export their product to third countries (exports to the EU doubled after the ban in 1989) in spite of the then alleged links to BSE and unclear labelling of the origin of the ingredients. It is surprising that the responsibility of producing a defective product, and thereby causing a catastrophe on the beef market, has not been laid more firmly at the feet of the animal feed producers in the UK. Furthermore, the increase of exports of British animal-based meal at low prices following the ban imposed by the British Government on their use in the UK for feeding ruminants may be treated as a case of dumping.

On this point, there is a contradiction between, on the one hand, the statements by Mr Packer and Mr Meldrum, who admit to inadequacies over labelling but claim that regulation for international trade purposes was a matter for the EEC rather than the Member States, and, on the other, the Commission's justification of its failure to act on the grounds that no suitable legal basis existed. One cannot, however, accept Mr Meldrum's argument that the UK should therefore be exonerated from all responsibility (he claims that the UK government had written to the relevant Member State and third- country authorities, informing them of its BSE problem and urging them to ban the feeding of mammal protein to ruminants).

Given the fact that large amounts of possibly infected ruminant feed were exported to other EU countries, and that in evidence the Committee heard that up to 57 000 animals were also exported between 1985 and 1989 to EU Member States, it was the opinion of the Commission’s representative to the Committee, Mr Hoelgaard (Director, DG VI) and Dr Galo, of the National Veterinary Laboratory of Portugal, that there could be as many as 1600 cases of BSE in other Member States.

4. It put pressure on the Commission not to include anything related to BSE in its general inspections of slaughterhouses, as periodically carried out between 1990 and 1994 in the context of their adaptation to the internal market. This point may be illustrated by Mr Hoelgaard's declarations at the hearing of 28 October 1996.

Mr Hoelgaard's words may usefully be reproduced verbatim (see pp. 13 and 14 of the minutes of the hearings): 'I, therefore, do not know why this kind of inspection, that is slaughterhouse inspection with BSE on the side, did not continue in the subsequent years, although there is one piece of information which is perhaps relevant and which I have only recently become aware of. At the end of the inspection a discussion took place with the UK veterinary services on 29 June 1990. When BSE was raised by the inspectors about the deficiencies, Mr Keith Meldrum, Chief UK Veterinary Officer, apparently reacted angrily, stating that the Commission inspectors had no authority to investigate BSE matters; that BSE was not a technical but a political matter; the UK provided the best certificates in the world and the Ministry of Agriculture was reluctant to install computers in abattoirs due to issues of cost and confidentiality' (Annex 32).

The lack of BSE-related inspections between 1990 and 1994 seems symptomatic of an assumption by the British witnesses before the Committee that they knew all there was to know and could handle the problem without outside 'interference'. There was also an attitude of 'benign neglect' of the issue (a willingness to let a British problem be dealt with by the British) on the part of the Commission and, through the veterinary committees, by the other Member States.

One cannot but deplore the fact that top-ranking officials in DG VI in particular bowed to the wishes of Mr K. Meldrum, Chief UK Veterinary Officer, i.e. that Commission inspectors had no authority to investigate BSE matters in the UK even though these same inspectors had uncovered BSE-related deficiencies in some slaughterhouses.

The tape-recording of the meeting of the Standing Veterinary Committee of 5 September 1999 also provides evidence of Mr Meldrum's lack of awareness of the problem:

'Given that there is no risk to human beings, what we are now proposing is once again based on an extremely cautious approach, because there is public concern. People are worried about this new disease and, to tell the truth, it is more an issue of consumer confidence than consumer protection.

But we say that there is no risk, or indeed any proof of such a risk.'

5. The influence of British thinking on the Commission was obviously increased by the preponderance of British experts and Ministry of Agriculture officials on the BSE Subgroup of the Scientific Veterinary Committee. This initially derived from the fact that the UK had far more experience of BSE than any other Member State. With other diseases the experts came predominantly from the Member State concerned (for example with swine fever).

Nonetheless, the BSE Subgroup of the Scientific Veterinary Committee has almost invariable been chaired by a UK national, which made considerations of objectivity and impartiality particularly important. The minutes, in addition, are drawn up by a temporary Commission official of British nationality. The records of attendance attached to some of the minutes which we have received are sufficiently indicative (see Annex 3):

- meeting of 5 February 1990: 9 participants (4 British) - meeting of 28 May 1990: 9 participants (5 British) - meeting of 28 September 1994: 10 participants (4 British) - meeting of 19 June 1995: 9 participants (4 British)

The preponderance of UK scientists and officials, therefore, meant that the Scientific Veterinary Committee tended to reflect current thinking at the British Ministry of Agriculture, Fisheries and Food.

6. It made a partial and biased reading of the advice and warnings of the scientists. The views of certain scientists who could be considered as more critical were not taken into account. Some members of the Southwood Committee have said publicly that the minutes of its meetings were drawn up by a UK Ministry of Agriculture official and contain omissions and discrepancies.

The UK Government only recognized the serious and imminent risk of the disease spreading to humans on 20 March 1996. Research was for too long influenced by the belief that the disease was a form of scrapie in cattle: this meant there was insufficient research in the area of transmissible spongiform encephalopathies and their possible connection to Creutzfeldt-Jakob disease in humans.

The necessary research effort was not carried out, nor were the research fields properly defined so as to obtain information rapidly and determine the risk to humans; indeed, obstacles were put in the path of scientists adopting more critical attitudes to the inadequacy of the precautions being taken. At all events, the responsibility for negligence must be considered to be shared with the EU: the UK has spent £ 60 m on BSE research, according to Ministry of Agriculture figures, and the EU has spent ECU 3 745 000 (see Annex 4).

Although the UK Government has said that it has always accepted scientific advice, Professor Southwood has confirmed that in 1988 his working party was especially concerned with the possible risk to infants from the presence of homogenized meat products in infant food, and recommended that specific bovine residues (SBO/SBM) should not be permitted in infant food. It took the UK Government over a year to accept this recommendation (see letter from Professor Southwood to Mr Böge, PE 220.549).

7. The UK Government did not honour its undertakings made at the extraordinary Council meeting of 6 and 7 July 1990, held to deal with the initial BSE crisis. The conclusions of the minutes of that Council meeting state: 'The Council notes the United Kingdom's intention to introduce a surveillance mechanism of herds in which BSE has been detected, including inspection in approved slaughterhouses of cattle and carcasses from these herds. The results will be transmitted to the Commission and Member States for evaluation by the Standing Veterinary Committee.' (Annex 10).

This is particularly serious, since the UK at no moment acted on its undertaking to identify the herds affected, which would have been a necessary first step towards eradicating the disease. In addition, the failure to monitor trade in animals between BSE-free and BSE-affected herds is still hindering a proper eradication policy.

The fact that the UK at no moment acted on this undertaking puts it in breach of Article 5 of the Treaty.

8. It did not implement the legislation by which bovine animals should have been identified and branded and their movements registered. Formally, there were strict and specific obligations, set out in the 'Bovine Animals Order 1990' (SI 1990/1867), which came into force on 15 October 1990 in implementation of Commission Decision 90/261. Article 1(2) of this decision stipulates that the UK is to make exhaustive use of computer registers for ensuring identification of animals. The terms of this decision were, furthermore, strengthened in 1995.

In addition, Article 11 of Directive 92/102 on the identification and registration of animals obliges the Member States, in the case of bovine animals and as from 1 February 1992, to operate computerized registers and an identification system complying with the requisites laid down in the directive.

On 7 June 1990 restrictions were introduced on the export of meat from herds where cases of BSE had been detected in the previous two years (Commission Decision 90/261/EEC, amending Decisions 89/469/EEC and 90/200/EEC). Shortcomings in the British registration system led to the appearance of 'cesspool' farms (a question debated in the UK parliament). These farms, which already had a high incidence of BSE, bought animals in the first stages of the disease and received compensation for the slaughter of the diseased cattle. The farms which sold the sick animals eluded the restrictions by concealing their true health situation.

This undermined the reliability of statistics on the disease and made it difficult to study and control it. In addition, it reduced the effectiveness of the Community regulations, subjecting consumers to a risk that could have been avoided. The failure to apply the rules on branding, registration and control raises doubts as to the validity of any selective cull programme of the kind envisaged at the Florence summit.

The fact that the UK did not comply with this legislation puts it in breach of Article 5 of the Treaty. It is also to be regretted that the Commission did not use the means of redress provided for in the Treaty, in particular Article 169 thereof, in order to ensure the actual implementation of Community legislation.

9. It failed to implement the provisions of Directive 89/662 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market. According to this directive, the country of origin (the UK, in respect of its exports) is obliged to ensure strict compliance with the conditions of health policy and inspection for all animal products leaving its territory for the Community market. The same directive sets out specific obligations in case of epidemics, including the submission to the Commission of a programme including the controls to be carried out.

One can only be surprised by Mr Packer's declaration that his government should be exempted from blame, on the grounds that there are no proofs of non-compliance: if no checks are carried out, contraventions are very difficult to prove.

The fact that the UK did not comply with this legislation puts it in breach of Article 5 of the Treaty. It is also to be regretted that the Commission did not use the means of redress provided for in the Treaty, in particular Article 169 thereof, in order to ensure the actual implementation of Community legislation.

10. It took a blocking attitude within the Community institutions, with the aim of pressing the Commission and Council to lift or ease the embargo. Clear evidence of the explicit threat of political repercussions should the export ban on gelatin not be lifted is provided by the letter of 3 May 1996 from the British Prime Minister to the President of the Commission and from the reply of 8 May 1996 from Mr Santer (Annex 3, part B). Mr Major's letter to Mr Santer specifically urges the Commission to lift the embargo on gelatin, tallow and semen, calling on the Commission to submit a proposal to the Council to this effect. At one point the letter says: 'May I therefore underline the imperative need for the ban on gelatin, tallow and semen to be fully lifted and the stage clearly set for further rapid relaxation and a lifting of the whole ban on a speedy timetable. The first requirement for this is a proposal from the Commission. I hope very much that you will ensure that such a proposal is put forward for next week's meeting, as Franz Fischler told us he intended. We will put our full weight into persuading other Member States to support it'.

President Santer told the Committee in his hearing before it that he regarded the attitude of the British Government as a form of blackmail, amounting to an abuse of the rights and obligations of a Member State as laid down in Article 5 of the EC Treaty.

The approach taken by the Commission in response to UK pressure is clear from the minutes of the Commissioners' meeting of 5 June 1996 (Annex 5), at which Mr Fischler stated his intention to adopt the decision on the partial lifting of the embargo: the matter should be viewed in relation to what has come to be seen as the UK's abuse of its rights and blackmailing attitude towards the Community institutions, contrary to the obligations of each Member State as laid down in Article 5 of the EC Treaty. It is stated in the minutes concerned that the Commission asked Mr Santer to write to Mr Major to inform him of its intentions and call on him to review his decision concerning non-cooperation in the EU's decision- making process.

The outcome of the pressure brought to bear on the Commission and the Council by the UK, in that the UK was able to secure at the last moment the support of delegations which had previously been strongly opposed to a partial lifting of the ban, was the adoption by the Commission of its decision on the partial lifting of the ban. This turn of events was condemned by a number of Members during the debate with Commissioner Fischler in Parliament on 6 June 1996.

It should be remarked that the outrage caused by the embargo is in marked contrast to the UK’s muted response to earlier bans on British beef by the United States and other countries including Australia, Canada and even the UK's own Crown Colony of Hong Kong.

11. It did not display sufficient zeal in monitoring the maintenance of the embargo on meat and by-products. This is clear from Mr Fischler's letter of 10 September 1996 to the UK Minister of Agriculture and Mr Hogg's reply of 25 October 1996 (Annex 6). Mr Fischler's letter sets out the Commission's concerns in relation to the inspection mission carried out in the UK from 22 to 26 July 1996, when a visit to the port of Dover revealed the non-existence of the checks on shipments of beef products to the Member States required by Decision 96/239/EEC.

Similar instances of negligence by the UK had occurred earlier. The British Government, the principal victim but also bearing the bulk of the responsibility for the damage caused by this epidemic, must admit that it was negligent in some obvious areas; after underestimating the risks of BSE for years, having fought for the lifting of the embargo on gelatin for political reasons (Annex 3, part B), and yet not content with this lax approach, the British Government did not comply with the prohibitions on meal issued in 1989 and between 1990 and 1994, since beef and veal under prohibition and derived products were subject to inadequate inspections.

12. It did not abide by the timetable reached at the Florence summit: the selective culling programme was suspended, and no alternative proposal was formally put forward. The Florence agreements provide for the possibility of modifying the culling programme in the light of new scientific data; however, whatever the circumstances, a new programme substituting the old one has to be submitted and approved by the Commission and the Standing Veterinary Committee. According to the Commission's replies of September 1996, the selective culling programme had still to be approved by the British Parliament. The programme was finally acknowledged as necessary and practicable at the end of 1996 and is now in progress. It was, then, not until 16 December 1996 that the British Government decided to carry out the culling programme agreed in Florence. At all events, there is still a procedural problem, insofar as British actions in this field should be agreed jointly with the EU, not carried out unilaterally: they should accordingly be approved by the Standing Veterinary Committee and the Commission, if the embargo is to be lifted at the earliest opportunity.

The fact that the UK did not fully comply with the undertakings it gave at the Florence summit for a period of six months put it in breach of Article 5 of the Treaty.

13. The refusal by the UK Minister of Agriculture, Mr Hogg, to give evidence to the Committee of Inquiry represents a breach by the British Government of the Member States' obligations under Article 3(2) of the Interinstitutional Decision of 19 April 1995). This is clear from his letters to the Committee dated 25 September 1996 and 10 October 1996 (Annex 7). According to the report drawn up for the Committee by Parliament's Legal Service on 8 October 1996 (Annex 8), 'a Permanent Secretary' attached to a British ministry could not be considered in legal terms to be a 'member of the government' within the meaning of Article 3(2) of the above- mentioned joint decision of the European Parliament, the Council and the Commission on the detailed provisions governing the exercise of the European Parliament's right of inquiry.

The unwillingness of the British Government to release documents and thereby help to clarify where responsibility for the BSE crisis lies severely hampered the work of the Committee of Inquiry. Moreover, the unwillingness of the UK Minister of Agriculture to appear before the Committee displays a blatant lack of interest in defending the interests of UK farmers.

14. All in all, since 1988 the UK authorities have introduced a considerable amount of legislation covering the various aspects of protection against possible BSE risks. The problem, therefore, lies not in any lack of appropriate legislative measures, but in the attitude of the government, which has failed to ensure the proper application of those measures and has not carried out the necessary checks. In addition, doubtless under pressure from the meat industry, the UK Government has, in its turn, exerted pressure on the Commission's veterinary services with the objective of keeping the matter within the national orbit, thus avoiding Community inspections and preventing publicization of the extent of the epidemic, since this would have provoked unilateral action by some Member States on public health grounds.

To sum up, the attitude of successive British governments may often be interpreted as a refusal to 'play the game' of the proper and transparent cooperation which must govern relations between the Member States of the European Union, even beyond the terms of the Treaty.

Finally, the Committee recognizes that there are regions of the UK that have low incidence of BSE, and have had strict monitoring and traceability of animals.

3. DETERMINATION AND ATTRIBUTION OF RESPONSIBILITIES AS BETWEEN THE COUNCIL AND THE COMMISSION

The determination and attribution of responsibility as between the Community institutions, namely the Council and the Commission, is an extremely complex question, for a number of reasons:

1. One reason is the nature of the problem itself. It was initially thought that BSE was a variant of scrapie which had infected cows instead of sheep. On the basis of the parallel with scrapie - an illness which was well-known and considered harmless to humans - it was supposed that BSE was an animal health matter alone.

However, once it began to look increasingly certain that BSE was a phenomenon different from scrapie, which could, in addition, jump the species barrier (having also been detected in cats), the matter took on a new dimension: it was no longer merely a veterinary and animal health problem, and the protection of consumer health became the first priority.

2. One must also bear in mind the decision-making system on veterinary matters and the respective roles of the Scientific Veterinary Committee and the Standing Veterinary Committee.

As a rule, the Commission bases its legislative proposals on the opinions of the Scientific Veterinary Committee, whose members are appointed by the Commission on the basis of nominations by the Member States. This committee acts as a consultative organ of the Commission.

A Commission proposal drawn up on the basis of recommendations by the Scientific Veterinary Committee is then forwarded for adoption to the Standing Veterinary Committee, which operates as a regulatory committee of the 'safety-net' (contre-filet') type - i.e. the Commission proposal is adopted provided it obtains the necessary majority. If that majority is not obtained, the Commission has to take the matter to the Council. It may happen that a sufficient majority for rejecting the Commission proposal is not reached in Council: at this point, the Commission is empowered to adopt the proposal under its own responsibility, in the absence of a decision from the Council that it should be withdrawn. This was the adoption procedure which applied to Commission Decision 96/362 lifting the embargo on semen, tallow and gelatin.

It follows that the responsibilities must be seen, in general terms, as being shared, on a non-absolute basis, between the Council, the Commission, the Standing Veterinary Committee and the Scientific Veterinary Committee. The complexity of the commitology system and the lack of transparency of the procedures inherent therein make it even more difficult to apportion responsibilities, be it with respect to the institutions or to the committees, and enables one institution to shift political and administrative responsibilities on to another.

The Standing Veterinary Committee enjoys by delegation powers which are the preserve of the Council. Nevertheless, the Commission convenes the committee and draws up its agendas. Provision is made at the Commission for posts in Unit B.II.2 for officials to act as the secretariat of the Standing Veterinary Committee with regard to animal health matters and the Scientific Veterinary Committee with regard to public health matters. In 1995 these posts had not yet been filled. It is known from the testimony of Mrs Amendrup that the Standing Veterinary Committee was subject to political pressures and was only partially aware of the information coming out of the Scientific Veterinary Committee.

Although the powers of the Standing Veterinary Committee were delegated by the Council, it is the Commission that exerts control over it. However, the committee's work is based on the opinions of the Scientific Veterinary Committee, and it is clear that the UK was able to control this latter committee through the convening of the meetings, the agendas and attendance, and the drafting of minutes.

Ceding control of the committee to another body and failing to monitor it could be seen as mismanagement on the part of the Council. In any case, the greatest share of responsibility must lie with those bodies which sought to exercise control over these procedures.

3. Another factor is the operation of the principle of subsidiarity in public health matters. On this subject, it is essential to distinguish between the situations prevailing before and after the entry into force of the Treaty of Maastricht. Since 1 November 1993, competence in the field of public health protection has been a joint matter for the Union and the Member States, pursuant to Article 129 of the TEU, but the EU has not to date been able to introduce a Community public health policy.

Nonetheless, as is pointed out in the report by Parliament's Legal Service dated 25 November 1996 (Annex 9), legislation already existed before Maastricht obliging the Commission to take account of health protection implications in the context of the proper functioning of the COMs under the CAP.

The Commission's powers in the field of public health protection have recently been confirmed by the Court of Justice (see: ECJ decision of 12 July 1996 - Case C-180/96; decision of the President of the Court of First Instance of 13 July 1996 - Case T- 76/96).

It is unacceptable, therefore, that the subsidiarity principle should be used as a pretext for shifting from one institution to another responsibility for errors such as the failure on the part of the Council or Commission to implement or monitor Community law. However, this happened repeatedly during the work of the Committee of Inquiry.

4. Public health protection competences are compartmentalized between a number of different Commission departments (as regards possible food product risks). The BSE affair has been handled variously by: DG VI (Agriculture), DG III (ex- Internal Market, now Industry), the Consumer Protection Service (currently DG XXIV), and the Directorate for Health and Safety (DG V).

This compartmentalization has hampered the coordination and efficiency of the services concerned, has facilitated the shifting of responsibility for maladministration between the various services of the Commission, and points up the lack of an integrated approach, a phenomenon exacerbated by DG VI's arrogating primary management of the BSE issue to itself. A coordinated policy would have been possible were there a body similar to the Food and Drug Administration in the US or the health administrations in some Member States, or even had a European Health Agency been created.

Nevertheless, it must be remembered that there were staff in all the directorates and services mentioned who should have dealt with the question and should have sought to prevent and eliminate any risks to animal and human health. Lack of coordination and malfunctioning are no excuse for the shortcomings in management and dissemination of information for which responsibility lies at individual and administrative level rather than at institutional level.

4. RESPONSIBILITIES OF THE COUNCIL

Given the Council's character as a representative organ of the Member States, the responsibilities that can be attributed to it at institutional level should be examined. There are some Member States to which individual responsibilities can be attributed. This is true of the United Kingdom, which, in view of its importance, has been dealt with in a separate chapter. Other Member States, such as France and Portugal, or Community institutions have set up committees of inquiry. These will be responsible for determining where responsibility lies in the states concerned. This does not mean that there were not other Member States responsible to a lesser or greater extent for the management of the crisis, but it is appropriate that such responsibility should be determined by the relevant parliamentary bodies.

In relation to the activities of the Council and the Standing Veterinary Committee, we have been helped by the testimonies of Mr Yates, the Irish Minister of Agriculture, in his capacity as President-in-Office of the Agriculture Council, and Mrs Amendrup, assistant director of the Danish national veterinary services and member of the Standing Veterinary Committee.

Mr Yates endeavoured to define the sphere of competence of the Council, pointing out that legislative powers in the veterinary field and, even more so, in that of public health are shared between the Commission, the Council and the Member State governments. However, he argued, the Council was responsible for a specific activity of political guidance and impetus, and was also obliged to cooperate closely with the Commission. He stressed that the Council was not to be held responsible in a number of important areas, stating: '... dissemination of information about BSE, publication of research findings about BSE, controls on the production and export of recycled animal protein and controls on the temporary ban on exports of cattle, beef and meat-based productions do not fall within the Council's sphere of responsibility, as they come under the powers of the Commission or the Member States'.

This committee, however, takes the view that the Council cannot evade its responsibility in this way. In view of the shortcomings, as set out in this report, in the work of the Standing Veterinary Committee, which also acts on behalf of the Council through the representatives of the Member States, the Council shares responsibility for the inaction and delays in connection with the control of the epidemic in the UK, the wrong decisions and poor coordination as regards health protection, and the disinformation supplied to the public.

Despite clear evidence of the failure to comply with the export bans and control measures which it itself had imposed with a view to protecting public health, the Council took no effective steps to enforce those bans and measures and failed to make representations to the Commission to ensure that they were complied with. With a view to the completion of the internal market, the Council also gave the economic interests of the meat industry political priority over health protection. It was particularly culpable in giving in to the British efforts at political blackmail between 1995 and 1996.

Prior to the March 1996 crisis, the Agriculture Council had specifically examined BSE at its meetings of 6 and 7 June 1990 and 18 and 19 July 1994 (see Annex 10). Both meetings were called to deal with the threats of unilateral measures by certain delegations (France and Germany) which were calling for tougher guarantees on meat imports from the UK.

In addition, at several other Council meetings, according to the minutes supplied to us, certain delegations expressed the following requests:

- BSE should be included on the agenda, for assessment of the most recent scientific data (German delegation to the Council, 25 and 26 April 1994, 30 and 31 May 1994 and 20, 21, 22, 23 and 24 June 1994) (Annex 11);

- the Council of Health Ministers should be asked to participate in possible public health protection measures (German delegation to the Council, 28 and 29 March 1994) (Annex 12);

- there should be reinforced controls on feedingstuffs given to ruminants and on the use of potentially dangerous tissue in the manufacture of cosmetics and medicines (French delegation to the Council, 28 and 29 March 1994 and 25 and 26 April 1994) (Annexes 11 and 12);

- action should be taken on the request of the French delegation, forwarded to the Council of Health Ministers, for extension to all the Member States of France's unilateral measures banning the use of at- risk bovine tissue in the manufacture of cosmetics, medicines and baby-foods (meeting of 30 and 31 May 1994) (Annex 11).

Following the statement by the UK Government of 20 March 1996 concerning new scientific data, the Agriculture Council held two extraordinary meetings, on 1-3 April and 29 and 30 April 1996 (Annex 13). At these meetings, it recognized the seriousness of the situation and urged the adoption of a number of urgent measures for health protection and support of the beef market. The subject was discussed again on numerous occasions throughout 1996, with the Council awaiting the statements of the UK delegation concerning the evolution of the situation, with a view to resolving the crisis.

On 30 March 1994 the Council of Health Ministers met to discuss the proposal by the German delegation concerning discussion of the possible risks of transmission of BSE to humans. The German delegation insisted on making a separate statement, in which it urged the adoption of further protection measures (Annex 14). Over the rest of 1994 after March the Council of Health Ministers discussed the subject several more times.

One may cite, as visible proof of the attention which has been paid to the subject in various policy areas, the discussions in the Council of Research Ministers, at its meeting of 7 October 1996, as well as the statements by Commissioner Cresson included in the minutes of the Commissioners' meeting of 9 October 1996 (Mrs Cresson reported on the disappointing outcome of the discussions in the Council of Research Ministers on this subject, and drew attention to the inconsistent position of the ministers, who had called for a greater research effort but had refused to provide the necessary resources) (Annexes 15 and 16). Following this Council meeting, the Commission submitted a communication to the Council and Parliament (COM(96)0582) allocating an additional ECU 50 m for BSE research. The subject was to be re-examined at the Research Council meeting of 5 December 1996.

(end of part 1 of 3)

Tom.....

27 Month delay in nyala case

Draft Factual Account #5

10. On 28 June 1986 Mr Jeffrey examined tissue sections taken from the brain of a nyala which had been kept at Marwell Zoo.(S Jeffrey para 6; YB86/7.8/1.1 ) This examination, and subsequent consideration of the report, are described in the CVL DFA.

51. On 10 June 1987 Mr Bradley sent a BSE update to Dr Watson. It discussed, amongst other things, the nyala case and subsequent paper, the work of Mr Wilesmith, the upcoming BCVA meeting and the work of Dr Kimberlin.(YB 87/6.10/1.1 )

63. On 22 June 1987 Mr Bradley sent a memo to Mr Wells detailing actions taken to date. It noted that publication has been discussed with the CVO and halted and that there were now at least 9 suspect herds and a case in a gemsbok at Marwell.(YB 87/6.22/2.1 )

74. On 1 July 1987, Mr Bradley wrote to Mr Jeffrey to tell him that his article on spongiform encephalopathy in a nyala was not authorised for publication, and that while he made comparisons with scrapie, the CVO was unlikely to give his approval.(YB87/6.29/3.1; YB87/7.1/2.1; YB87/7.1/3.1-3.10 ) This is further discussed in the CVL DFA.

153. On 11 December 1987, Mr Jeffrey's paper on the nyala was submitted for publication in the journal Veterinary Pathology. The paper had first been drafted the paper in autumn 1986. (S 64 Jeffrey para 10) The title of the paper was changed from 'A scrapie-like disorder in a nyala' to 'A spongiform encephalopathy in a nyala.' Other references to scrapie were also amended.( S Jeffrey para 10; S 65 Wells para 55; YB87/11.11/2.1; YB87/11.17/3.1; YB87/11.23/2.1. )

Spongiform encephalopathy in a nyala (Tragelaphus angasi).

Vet Pathol 1988 Sep;25(5):398-9 Jeffrey M, Wells GA Lasswade Veterinary Laboratory, Midlothian.

166. In January 1988, Mr Wilesmith was informed of the June 1987 case of SE in the gemsbok. He discovered from the Winchester VIC that both the >nyala and the gemsbok had received rations containing MBM and this provided further support for his hypothesis.( S Wilesmith para. 37)

Draft Factual Account #4

28. On 28 June 1986 Dr Jeffrey examined tissue sections taken from the brain of a nyala which had been kept at Marwell Zoo. (S Jeffrey para 6; YB86/7.8/1.1 ) The nyala had shown unusual nervous symptoms two weeks prior to being put down on welfare grounds. These symptoms included 'weaving with the head and neck, holding the head on its side and frequent nibbling near the tailbone.'(YB86/6.23/1.1 ) The sections were originally necropsied by Mr Geoff Holmes at the Winchester VIC.(YB86/5.29/1.1; YB86/6.18/1.1 ) The nyala (tragelaphus angasi) is not an antelope but belongs to the same family (species group) as cattle.

29. Dr Jeffrey observed that the brain showed taxonomic lesions of spongiform encephalopathy and that the similarity of the lesions to natural sheep scrapie was striking, and indeed he thought that in comparison to natural sheep scrapie the lesions were particularly florid.(YB86/7.2/1.1; S Jeffrey para 9 ) The sites (neuroanatomical location) and cellular location (grey matter neuropil and neuronal cytoplasmic vacuolation) were distinctive and characteristic of the TSEs. Dr Jeffrey sent a slide of the nyala brain to Dr Richard Kimberlin at the NPU in the latter quarter of 1986 who 'vividly recollect[ed] seeing the results down the microscope because the pathology was so striking'.(YB 98/11.18/1.1 )

30. Following a field visit to Marwell Zoo on 21 July 1986,(YB86/7.24/1.1 ) a report was compiled by Mr Holmes at Winchester VIC and a scientific paper prepared for publication in a journal.(S Jeffrey para 10 ) Dr Jeffrey conferred with Mr Wells, his line manager at the CVL, in the preparation of the paper.(S Jeffrey para 9; S Wells 1st para 55 ) Dr Jeffrey was not sure of the exact date he submitted the paper to the Animal Health and Veterinary Group (AHVG) for publication but said it was some time in Autumn 1986.(S Jeffrey para 10; YB86/11.00/1.1 ) Dr Jeffrey did not form any conclusions about the origins of the disease in this animal, but he discussed the case with the CVL Epidemiology Department, and they agreed to keep a 'watching brief' on the situation.(S Wilesmith para 11)

89. On 17 June 1987 the Annual Report of the CVO for 1986 was published, having been submitted for publication on 1 June 1987.( M24 Tab 2 at 69 ) The Report described the discovery of a 'Scrapie-like disease in a captive nyala' and noted that 'Transmissible spongiform encephalopathies have been reported in man, sheep and goats (scrapie), mule deer and mink.'

91. On 19 June 1987 Mr Bradley sent Dr Watson a BSE Update. Amongst other things it was noted:(YB 87/6.19/3.1-3.2 )

"The final draft Vet Rec paper has been prepared and submitted for authority to publish. This has been rejected by CVO whilst scrapie is mentioned. For this and other reasons the paper is temporarily withdrawn until further information is available"

92. On 19 June 1987 Dr S.H. Done diagnosed spongiform encephalopathy in a gemsbok from Marwell Park.(YB87/6.19/3.2; YB876.8/3.1; YB87/6.10/3.1; YB87/6.25/1.1 ) This was the zoo was from which the SE-infected nyala had come. While the nyala was from the same species group as cattle, the gemsbok is an African antelope.

100. On 1 July 1987 Mr Bradley wrote to Dr Jeffrey to tell him that his article on spongiform encephalopathy in a nyala was not authorised for publication, and that while he made comparisons with scrapie, the CVO was unlikely to give his approval.(YB87/7.1/3.2; YB87/6.29/3.1; YB87/7.1/2.1 ) The initial title of the paper was 'Scrapie-like disorder in a nyala'.( S Jeffrey para 12 ) At the request of Tolworth, the title of the paper was eventually changed to 'Spongiform encephalopathy in a nyala'.( YB87/11.00/1.1 ) Because of the original references to the scrapie-like nature of the disorder the paper was delayed for publication and was not published until September 1988.( J/VP/25/398 ) Dr Jeffrey told the BSE Inquiry that he resisted the move to alter his paper because it 'would have been negligent to try and publish that without a reference to scrapie'.(T25 at 32 )

157. On 17 November 1987 Mr Bradley minuted Dr Jeffrey noting that the title to his nyala paper was likely to be unacceptable to "senior management" for "veterinary political reasons". He also recommended that where comparisons were made with scrapie the emphasis ought to be altered.(YB 87/11.17/1.1 )

433. On 23 October 1989 Dr Watson told Mr Wells that the CVL were to supply material from the kudu and nyala to the NPU for transmission to mice. Dr Watson said this was an important transmission experiment designed to establish the relationship between the disease in zoo animals and cattle.(S Watson 1st para 134 ) Mr Bradley provided Dr Watson with a list of tissues that were to be sent to the NPU on 24 November 1989.(YB89/10.24/4.1 )

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BSE Inquiry site Draft Factual Account 13 extracts related to zoo animals:

19. On 24 January 1990 Mr Bradley sent to Dr Watson a summary of the main points of a meeting held with the Minister the same day.(20) The minute noted: "The Minister played Devil's advocate in relation to: ... 5. MBM exports unethical. All should be labelled & a letter should be sent to all countries to which MBM was exported should be sent." [No such letter was sent.]

28. By 12 February 1990 the nyala and kudu tissues and the placenta had been inoculated into mice at the NPU.(33) After his investigations into the alimentary tract, ... Mr Bradley said in a minute dated 12 February 1990 that:(36) "It is very clear that it is important to initiate studies now in a much wider range of tissues and in multiple specimens than can be accommodated in the annual quota of 30 for the next two years." Mr Bradley attached a table showing the progress of infectivity studies:..fixed nyala brain, fixed kudu brain, buffy coat.

57. On 17 September 1990 Mr Bradley circulated a minute with regards to an offer by Dr Schellekers of the Netherlands to collaborate on attempting to transmit BSE to chimpanzees.(YB90/9.17/1.1) Mr Wells and Dr Rosalind Ridley, who was conducting the marmoset experiment, told Mr Bradley that they did not feel there was any greater justification for an attempted transmission in chimpanzees than marmosets.(S Bradley 3rd para 40 ) Mr Bradley passed on this view to the CVO.(YB90/9.23/1.1; YB90/9.26/3.1 ). [This is ignorant beyond belief.]

67. In Spring 1991 Mr McGill performed a review of 200 brains that had, using the obex histopathological method, been deemed BSE-negative.(110) This diagnostic approach, that had been developed for use within the VIS, used a single section from the medulla to look for spongiform change. In his review Mr McGill examined other parts of the brain.(111) In his statement to the BSE Inquiry Mr McGill said:

Upon closer examination, three of the 200 'BSE-negative' brains proved positive for spongiform changes diagnostic of BSE.(112) This represents an overall diagnostic accuracy of 99.85%, exceeding the 99.6% previously published for the same standard diagnostic technique. Despite this, at the behest of MAFF managers, the emphasis of the study and its provisional title had to be changed, from accurately representing the whole negative 10%, to a study examining this 10% minus any mention whatsoever of BSE-affected cattle going undiagnosed. I therefore had to reluctantly locate and analyse three new BSE-negative suspect brains.(113)

76. In mid-1991 it was decided that a proposed survey of 300 deer brains would proceed.(124) As with the hound survey, there were difficulties in collecting the material in a manner optimal for histopathological examinations.(See YB92/11.4/2.1) During the period 1986 to 1996, 26 deer brains were referred for examination to the Consultant Pathology Unit at the CVL, but none of these showed evidence of an SE.

103. On 16 July 1992 a meeting was held at CVL to discuss the research proposals relating to the studies on SEs in a greater kudu at a zoo. (S Bradley 3rd para 65 ) Three main experiments were proposed: to determine the distribution of agent in tissues; to study the epidemiology; and to strain type isolates from a brain of a new case of spongiform encephalopathy. Formal proposals were later drawn up and Mr Bradley became the Project Officer for the experiments.

108. Mr Bradley and Mr Dawson met staff at London Zoo on 23 March 1993 to discuss tissue selection for the proposed transmission studies on BSE-infected kudu material.(166) The Zoo did not want to keep the kudu, but moving them to the CVL was ruled out because of inadequate facilities to care for them. The investigations into the distribution of the SE agent in various tissues began in June 1993.

121. On 9 October 1993 Mr Wilesmith and others published a paper on the additional cases of TSE in the herd of greater kudu at London Zoo.(S Wilesmith 2nd para 95 ) On the basis of feeding histories, the authors concluded that horizontal transmission had occurred. However, subsequent investigations based at the zoo revealed that the affected animals were most likely to have been infected from the feedborne source.

143. On 3 July 1994 Mr Bradley was informed that two more kudu were to be culled.( Bradley 3rd para 86 ) He visited the London Zoo on 21 July 1994 to review the progress of the studies on TSEs in zoo animals. Necropsies were to be carried out on the kudu and tissues collected for further transmission studies. At this stage the mice that had been inoculated with kudu tissues in August and September 1993 had not succumbed to spongiform encephalopathy. The Zoo authorities wanted to move the kudu because of the possibility of bad publicity.(YB95/2.10/1.6) This was discussed at a SEAC meeting on 2 February 1995. The meeting agreed that the risk to Zoo visitors was minuscule or non-existent. Mr Bradley's case control study indicated that infected feed was the most probable cause of the BAB kudu SE cases.

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46. On 28 June 1990 Mr Bradley informed Mr Wells that a survey of hounds was to commence.(68) The hound survey arose because the Tyrrell Committee had recognised that domestic pets might prove susceptible to the unconventional agent of BSE and recommended monitoring the health of animals fed offal, carcases or meat and bone meal.(M11a Tab 8 )

47. A total of 444 hound brains of mixed breeds from 101 kennels across the United Kingdom were collected and examined. Histopathological changes consistent with a florid spongiform encephalopathy similar to that reported in cats was not observed. However, the report of the survey identified serious flaws in the survey's design. Mr Wells said in a minute to Mr Bradley in October 1991 that 'the survey as designed has little to offer scientifically'.(YB91/10.17/1.1)

54. On 20 August 1990 Mr Wells confirmed the parenteral transmission of BSE to a pig.(YB90/7.20/2.1) The pig was inoculated in February/March of 1989 and was slaughtered in July 1990.(S Wells 2nd para 40) An interim report was prepared for SEAC(84) and a press conference was held on 24 September 1990 to announce the parenteral transmission of BSE to pigs.(85) The transmission of BSE to pigs was a major factor in the ban on SBOs being extended to all animal feed. Experiments were also conducted by orally dosing pigs with BSE infected material but when the pigs were killed after seven years they were not found to be incubating the disease.(S Wells 2nd para 40 )

55. By August 1990 a total of 10 cases of FSE in domestic cats had been confirmed.(S Wilesmith 2nd para 109 ) Mr Wilesmith designed a questionnaire to be completed by the veterinarians who clinically identified FSE for the purposes of an epidemiological investigation. In addition to this investigation, the University of Bristol was subsequently granted a MAFF contract for a study in collaboration with the NPU to ascertain whether the condition in cats was transmissible to mice and, if so, to undertake strain typing of the agent.(S Wells 2nd para 104; YB 92/6.19/5.1 ) Mr Wells was appointed Project Officer to monitor the study. When the study was completed it showed that the disease in cats was transmissible and that similarities in the biological characteristics of FSE and BSE on transmission to mice indicated that the two diseases probably arose from a common source.(J/VR/134/449 )

64. In February 1991 Mr Mark Robinson began studies on the transmission of BSE to mink.(S Wilesmith 2nd paras 117-118 ) This study was done in collaboration with the United States Department of Agriculture (USDA), the Agricultural Research Service (ARS), and the Department of Veterinary Science at the University of Wisconsin, USA. The results of this study were discussed at the 10th CVL/NPU BSE R&D meeting held on 27 April 1993.(YB93/4.27/1.1) The results indicated that mink were susceptible to BSE, and in contrast to previous attempts to transmit scrapie to the species, were susceptible by the oral route of challenge.(J/JVIR /75/2151)

99. On 11 April 1992 Mr Bradley prepared a paper for the Lamming Expert Committee on Animal Feedingstuffs.(153) Some of the areas covered in the paper were tallow, the danger of BSE to pigs, the effect of the species barrier, tissue infectivity of lambs and calves, scrapie incidence and the danger of dogs developing SEs.

116. In July 1993 studies involving the oral exposure of pigs to scrapie were started the CVL.(179) Such studies were recommended by the expert committee on feedingstuffs chaired by Professor Lamming, because it was found that pigs had been orally exposed not only to BSE but also to scrapie. The pigs were orally exposed to scrapie-infected brain material in November 1993 and while the experiment remains in progress, no pigs have been shown to have developed the disease to date.

123. In December 1993 Dr Ken Charlton of the Animal Disease Research Institute, Nepean, Ontario, Canada, visited the CVL bringing material from a suspect case of BSE in Canada. The CVL confirmed that the case was a BSE case and reported it to the Canadian authorities.(189) in 1994.

152. On 13-16 February 1995 ... ...BSE to pigs - Further work to clarify the finding of non-specific vacuolation in the brains of control pigs was needed.

...BSE to chickens - Sub-passage in chickens and mice of various tissues from experimentally infected birds was needed to clarify the findings of neurological signs without neuropathology in inoculated birds.

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bibliography:

Vet Rec 1997 Sep 13;141(11):270-1 Baron-T, Belli-P Madec-J-Y Moutou-F Vitaud-C Savey-M Spongiform encephalopathy in an imported cheetah in France. CNEVA-Lyon, Laboratoire de Pathologie Bovine, France.

Proc Soc Exp Biol Med 1996 Apr;211(4):306-22 Narang H Origin and implications of bovine spongiform encephalopathy. [tiger]

Vet Rec. 1994 Nov 12;135(20):488. Benbow G. Spongiform encephalopathies in zoo animals. comment

Vet Rec 1994 Oct 29;135(18):440 Swainston J. comment

Vet Rec 1994 Sep 24;135(13):296-303 Kirkwood JK, Cunningham AA Epidemiological observations on spongiform encephalopathies

Vet Rec 1994 Feb 12;134(7):167-8 Kirkwood JK, Cunningham AA, Austin AR, Wells GA, Sainsbury AW Spongiform encephalopathy in a greater kudu

Vet Rec. 1993 Oct 9;133(15):360-4. Kirkwood JK, et al. Spongiform encephalopathy in a herd of greater kudu

Vet Rec. 1993 Jan 16;132(3):68. Cunningham AA, et al. Transmissible spongiform encephalopathy in greater kudu

Vet Rec. 1992 Nov 7;131(19):431-4. Willoughby K, et al. Spongiform encephalopathy in a captive puma

Aust Vet J 1992 Jul;69(7):171 Peet RL, Curran JM Spongiform encephalopathy in an imported cheetah

Vet Rec 1992 Apr 25;130(17):365-7 Kirkwood JK, Wells GA, Cunningham AA, Jackson SI, Scott AC, Dawson M, Wilesmith JW Scrapie-like encephalopathy in a greater kudu

Acta Neuropathol (Berl) 1992;84(5):559-69 Jeffrey M, Scott JR, Williams A, Fraser H Ultrastructural features of spongiform encephalopathy

Vet Rec. 1991 Oct 5;129(14):320 Synge BA, et al. Spongiform encephalopathy in a Scottish cat.

Vet Rec 1991 Sep 14;129(11):233-6 Wyatt JM, Pearson GR, Naturally occurring scrapie-like s

Vet Rec. 1991 Jun 1;128(22):532. Pearson GR, et al. Feline spongiform encephalopathy.

Vet Rec. 1991 Mar 30;128(13):311. Kock R. Spongiform encephalopathies in ungulates.

Vet Rec. 1991 Feb 2;128(5):115. Gibson PH. Spongiform encephalopathies in ungulates. comment

Vet Rec 1990 Dec 15;127(24):586-8 Leggett MM, Dukes J, Pirie HM A spongiform encephalopathy in a cat.

Done JT. Vet Rec. 1990 Nov 10;127(19):484. Spongiform encephalopathy in pigs.

Vet Rec. 1990 Oct 27;127(17):418-20. Kirkwood JK, et al. Spongiform encephalopathy in an arabian oryx (Oryx leucoryx) and a greater kudu.

Vet Rec. 1990 Sep 29;127(13):338. Dawson M, et al. Primary parenteral transmission of bovine spongiform encephalopathy to the pig.

Vet Rec. 1990 May 19;126(20):513 no authors listed Spongiform encephalopathy in a cat.

Vet Rec 1990 May 12;126(19):489-90 Gibson PH Spongiform encephalopathy in an eland.

Nature. 1990 Mar 15;344(6263):183 Aldhous P. Antelopes die of "mad cow" disease.

Vet Rec 1990 Apr 21;126(16):408-9 Fleetwood AJ, Furley CW Spongiform encephalopathy in an eland.

Vet Pathol. 1988 Sep;25(5):398-9 Jeffrey M, Wells GA Spongiform encephalopathy in a nyala (Tragelaphus angasi) Lasswade Veterinary Laboratory, Midlothian

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Subject: Re: BSE Inquiry report delayed until 31 Mar 2000 From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Wed, 26 May 1999 19:58:30 +0200 Content-Type: text/plain Parts/Attachments: text/plain (59 lines)

Tom wrote:

And I don't like the sound of this at all: "From the end of May, Draft

Factual Accounts (DFAs) will no longer be available on the BSE Inquiry

website." It is a poor idea to take things down from the web even if they

are someday more or less replaced by revised factual accounts, because

people want to see and respond to what the lawyers were able to get

altered.

Maybe there will be better time for that kind of metastudies later on, Tom. IMO, if one wants to respond to affect the completeness of the factual accounts in a decent fashion to the good Inquriy staff, an earlier and more proactive approach from interested members of the public is necessary -- building on the first versions of the draft factual accounts, and of course, the evidence itself, which has come out of Phase 1.

I archived all the draft factual accounts already onto servers in Asia and

am ready to mirror the lost data the day that these go down in Britain.

Roland:

I fully agree that this documents should stay available on the british

server and I really can not imagine why they want to remove this

information from the web. Can you please tell me, how many MB

I need to copy the whole stuff on my PC?

The draft factual accounts in their present form take up less than 2.5 MB (html). I can't work myself up over that they are taken down from the server. Otoh, it is just 2.5 MB. The first version of the draft factual drafts will of course be replaced by complemented/corrected versions as should be expected from their name, form and content. I am quite pleased that it has been announced, that 'medicines' will be the subject of an additional draft factual account. This is good, necessary and quite relevant for one predictable area of inquiry during the Phase 2 proceeding.

The accumulated web-published evidence on the BSE-Inquiry site is quite large, appr. 34 MB html (appr equally divided between witness statements and transcripts of the Phase 1 hearings, total indexes to which are at



http://209.41.3.198/witness/ +


http://209.41.3.198/witness/htm/


and


http://209.41.3.198/transcripts


respectively. The draft account index is at


http://209.41.3.198/dfa/ .

I plan to get a few metalinks pages up on the web soon, which have proved useful for my personal interest, working on downloaded stuff on my home base. Essentially they are just one way to structure links to transcripts and statements according to the key involved persons and their placement in the hierarchies of MAFF and DOH. On the Inquiry web-site the evidence is basically arranged according to the time schedule of the Inquiry. Don't expect anything fancy, these structured metalinks pages will be raw _drafts_, and they will bl.... be replaced without warning, whenever and if I can spare the time.

Best regards,

Torsten Brinch

===============================================

Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' From: tom Reply-To: Bovine Spongiform Encephalopathy Date: Wed, 6 Sep 2000 18:20:09 -0800 Content-Type: text/plain Parts/Attachments: text/plain (110 lines)

######### Bovine Spongiform Encephalopathy #########

Just when I was thinking the Internet had reached a terminal condition of shallow pages and broken links, some young people come along and invent a really effective Internet search engine:



http://www.google.com/


This works quite well to search the entire


http://www.mad-cow.org site (or find 393 web sites such as GenBank that link to it, or 936 sites that cite it in text) back to 1996 as well as the BSE Inquiry


http://www.bse.org.uk/



Thus for louping ill (unnecessary cites suppressed):


http://www.bse.org.uk/witness/htm/stat537.htm


Witness Statements 537 - Coulthard

29.Pituitary FSH from pigs has been used in the USA prior to its use in the UK and much more extensively there and Canada.... 30.Thousands of embryos were exported from this country to the USA prior to the ban being imposed... 42. No cow pituitaries were used in the preparation of FSH [follicular stimulating hormone] products compared with the case of louping ill vaccine for scrapie.




http://www.mad-cow.org/~tom/fda_late.html#ill



In the 1930's: 18,000 UK sheep were inoculated against louping ill, a brain inflammatory illness spread by ticks. Despite formalin-treatment of the inoculated agent, the procedure gave rise to 1,500 cases of scrapie. Louping is a Scottish word for fleeing or leaping, related to loping. In humans, louping ill is called Russian spring-summer encephalitis, a meningo-encephalitis with muscular tremors and spasms followed by varying degrees of paralysis.... [John Lanchester 2 Dec 96 New Yorker]




http://www.foodsafety.org/consumer/ht/ht294.htm





In what the story calls a grand historical irony, this landmark series of experiments was being confirmed at the same time in England as a result of an outbreak of scrapie in several hundred sheep that had been immunized against louping ill with a vaccine prepared from tissue from the brain, spinal cord, and spleen of sheep that were belatedly discovered to have been exposed to natural scrapie infection.[6.Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520] The transmissible nature of the scrapie agent was thus established beyond any doubt. [P Brown, 1755 and All That: A Historical Primer of TSE.

We need to look at the full text of the article and its cites to see how they actually made the vaccine, whether they exported vaccine-infected sheep to Canada and the US, and what became of the vaccinated flocks. Perhaps there is still sample available, Moredun Institute is still around.

Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520 (not covered by Medline) Gordon, Bronlee and Wilson 1939 [full cite is available only in a letter we don't have)

Terry was reading Draft Factual Account 17



http://www.bse.org.uk/dfa/dfa17.htm




236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282] 237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked ŒWhat is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?¹ Part of the answer stated: ...

There has been one instance of inadvertant [sic] transmission of the

scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and

Wilson 1939). One of the three batches of vaccine made in 1935 at the

Moredun Institute contained the scrapie agent resulting in 7% of the

recipients of the 18, 000 doses in the batch developing scrapie. This

vaccine was made from formalin-inactivated sheep brain, and brought to

the attention of research workers that formalin, at a concentration of

0.35% for at least 3 months, which inactivated conventional viruses, did

not totally inactivate the scrapie agent.

----------------------------

4. Questions we might want to have answered are:

the highest risk would be from parenterals prepared from brain (eg

rabies vaccine). Any species in which transmissible spongiform

encephalopathies have been described would be suspect (“natural”

infections in sheep, goats, cattle, deer, mink, but can be transmitted

to hamster, mouse, guinea-pig etc). Are sterilisation processes

adequate for the most resistant strain of scrapie agent or for CJD

agent? Should companies be asked to include investigation for inclusion

of scrapie agent (eg mouse innoculation [sic]) in at least some batches?

If BSE behaves like scrapie, then we might expect other nervous tissue,

spleen, lymph nodes and placenta to be contaminated. Infection has been

described in other tissues too, eg gut wall, and we can not [sic] be

sure blood is free. Do we know what bovine materials are used in which

products, both as the active ingredient and in production? Bovine active

ingredients in human products include insulin, vasopressin, bone, immune

globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and

fetal calf serum must be used in preparation of very many products. For

each of these products would any “BSE agent” be destroyed or eliminated

in processing? If not, and the product is administered parenterally or

topically into an open wound, might there be a risk? [For oral

products, there would only be a trivially increased load on top of that

taken in food in omnivores/carnivores including man. But for some

herbivores, this might allow the agent to be introduced into yet another

species].

--------------------------

Medicines and medical devises;

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############



Subject: Louping-ill vaccine documents from November 23rd, 1946
Date: Sat, 9 Sep 2000 17:44:57 -0700
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de

######### Bovine Spongiform Encephalopathy #########

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.

In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."

The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.

Advances in Veterinary Research

by

W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.

Agriculteral Research Council, Field Station, Compton, Berks.

Louping-ill, Tick-borne Fever and Scrapie

In 1930 Pool, Browniee & Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.

Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.

Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.

This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramtic twist which led almost to catastrope. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made neccessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the grannular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.

Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have ben a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently produceing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occuring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ???oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.

From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.

Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-

(1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer.

Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.

As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.

The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease.

==================================================================

Greetings List Members,

pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA



http://www.whale.to/v/singeltary.html



http://www.whale.to/v/cjd2.html





Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Sun, 8 Oct 2000 17:18:47 -0700 Content-Type: text/plain Parts/Attachments: text/plain (121 lines)

######### Bovine Spongiform Encephalopathy #########

Hello Torsten and Group,

Torsten Brinch wrote:

What might be more interesting could be the document

referenced as 89/7.3/4.1 in Dr. Pickles' witness statement,

if you have it. What you posted was apparently the corresponding

4.2 and 4.3.

the document in question '89/7.3/4.1', i submitted this document to the BSE-L already. plus, if interested the minute was posted at the following url, with other data on sutures etc...



http://www.vegsource.com/talk/madcow/messages/7569.html



all it consists of, is what you posted below. the minute you speak of, where Dr. Pickles minuted Mr. Maslin on 3 july 1989. This is document 89/7.3/4.1. then you have 4.2 and 4.3 which are the by-products list.

you are correct, this is what i was reading when i referenced this minute. so in answer to Rolands question the by-products list would have come from MAFF and submitted to HSE, and is referenced at 48.1 statement 115 as Torsten said, and thanks again;



http://www.bse.org.uk/witness/htm/stat115.htm




what happened was, i got the documents mixed up and posted separately, the minutes a month or two ago, and the by-products list recently. sorry for the confusion, should have kept them together. but if someone could only see the pile of B.S.eee i have gathered, well, on second thought, it probably would not matter, it was just a thought...

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

Terry wrote:

thank you Torsten. and i can't for the life of me keep this document

in correct order, to resubmit to the group. is there an online version

of this document, other than just the reference numbers? if not, if

anyone has any suggestions, please write my private email and i will

try to scan again, but the letters are to small, unless there is some

setting to change. or maybe just fax to tom or someone???

Although the text you posted did appear rather bungled,

I think anyone with interest in the content will be able

to glean it accurately despite all the tabulator and

linebreak noise. I don't think you need to do more to

get it out.

What might be more interesting could be the document

referenced as 89/7.3/4.1 in Dr. Pickles' witness statement,

if you have it. What you posted was apparently the corresponding

4.2 and 4.3.

"July 1989

48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I

asked for more information from MAFF on which UK pharmaceutical

manufacturers used spinal cord, thymus and small intestines

[YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for

licensed and unlicensed products and devices for human medicinal

use, for their information. "

From the Draft factual account 17:

***

On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle

by-products and BSE. The minute said: "I was interested to see

the list of by-products sent to the HSE. Those of particular concern

included:

- intestines: sutures ( I thought the source was ovine but you are

checking this)

- *spinal cord: pharmaceuticals

- *thymus: pharmaceuticals

Are you able to give me more information on which UK

manufacturers use these materials? Our proposed ban

on bovine offal for human consumption would not affect

these uses, I assume."

A handwritten note on Dr Pickles' minute from Mr Mark Hawkins,

Higher Executive Officer at MAFF, to "John" said:

"A few companies make sutures out of intestinal

linings, worth around 3300 k p.a; probably some sheep used as well, but minimal. Virtually all spinal cord goes for rendering, with just a

very small amount going for pharmaceutical use.

About 30 % of thymus production goes for pharmaceutical

use (approx 3132 K p.a). Incidentally, some spleen also

goes for pharmaceutical uses (approx 3170 K p.a.

The main company involved with pharmaceuticals is Y

[company referred to as Y] (MLC is trying to find a contact).

Is Hilary serious about her final sentence? I would have thought

that a) the staining would make these materials unusable (this

is also MLC's view) and b) if they are unfit for consumption,

they are certainly unfit for medication. Has she forgotten

iatrogenic CJD?"

On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said:

"Having seen Mr Armstrong's print-out of the responses from

the BSE questionnaire, the Z Catgut product seems to be the

only UK source material and we would need a very strong

justification to allow it to remain on the market.Until now

we had been of the view that many of the other catgut products

were UK sourced as well. This is now shown not to be the case

and I think Z and we have a problem!"

***

Best regards,

Torsten Brinch

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############


Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER From: Torsten Brinch Reply-To: Bovine Spongiform Encephalopathy Date: Sun, 8 Oct 2000 21:06:58 +0200 Content-Type: text/plain Parts/Attachments: text/plain (79 lines)

######### Bovine Spongiform Encephalopathy #########

Terry wrote:

thank you Torsten. and i can't for the life of me keep this document

in correct order, to resubmit to the group. is there an online version

of this document, other than just the reference numbers? if not, if

anyone has any suggestions, please write my private email and i will

try to scan again, but the letters are to small, unless there is some

setting to change. or maybe just fax to tom or someone???

Although the text you posted did appear rather bungled, I think anyone with interest in the content will be able to glean it accurately despite all the tabulator and linebreak noise. I don't think you need to do more to get it out.

What might be more interesting could be the document referenced as 89/7.3/4.1 in Dr. Pickles' witness statement, if you have it. What you posted was apparently the corresponding 4.2 and 4.3.

"July 1989

48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I

asked for more information from MAFF on which UK pharmaceutical

manufacturers used spinal cord, thymus and small intestines

[YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for

licensed and unlicensed products and devices for human medicinal

use, for their information. "

From the Draft factual account 17:

***

On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle by-products and BSE. The minute said: "I was interested to see the list of by-products sent to the HSE. Those of particular concern included:

- intestines: sutures ( I thought the source was ovine but you are checking this)

- *spinal cord: pharmaceuticals

- *thymus: pharmaceuticals

Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume."

A handwritten note on Dr Pickles' minute from Mr Mark Hawkins, Higher Executive Officer at MAFF, to "John" said:

"A few companies make sutures out of intestinal linings, worth around 3300 k p.a; probably some sheep used as well, but minimal.

Virtually all spinal cord goes for rendering, with just a very small amount going for pharmaceutical use. About 30 % of thymus production goes for pharmaceutical use (approx 3132 K p.a). Incidentally, some spleen also goes for pharmaceutical uses (approx 3170 K p.a. The main company involved with pharmaceuticals is Y [company referred to as Y] (MLC is trying to find a contact). Is Hilary serious about her final sentence? I would have thought that a) the staining would make these materials unusable (this is also MLC's view) and b) if they are unfit for consumption, they are certainly unfit for medication. Has she forgotten iatrogenic CJD?"

On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said: "Having seen Mr Armstrong's print-out of the responses from the BSE questionnaire, the Z Catgut product seems to be the only UK source material and we would need a very strong justification to allow it to remain on the market.Until now we had been of the view that many of the other catgut products were UK sourced as well. This is now shown not to be the case and I think Z and we have a problem!"

***

Best regards,

Torsten Brinch

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Subject: Re: TREATMENT OF BY PRODUCTS OF BOVINE SLAUGHTER From: tom Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 10 Oct 2000 16:52:53 -0800 Content-Type: text/plain Parts/Attachments: text/plain (164 lines)

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Terry wrote:

thank you Torsten unless there is some

setting to change. or maybe just fax to tom or someone???

Although the text you posted did appear rather bungled,

I think anyone with interest in the content will be able

to glean it accurately despite all the tabulator and

linebreak noise. I don't think you need to do more to

get it out.

-=-=-=-

Agreed, these postings work fine and are a valuable contribution. But note that the Inquiry used systematic URLs for these witness statements, so just plug in the 3-digit number, here 115 to see Pickles' statement and then jump with the browser find to 'Having seen" or use http://www.google.com/ to see commentary on it.

tom



http://www.bse.org.uk/witness/htm/stat115.htm



Searched the web using http://www.google.com/ for Hilary Pickles spinal cord.

Witness Statement 71b - Mr Raymond Bradley

... tallow. Mr Cockbill wrote to Hilary Pickles (a medical doctor from DoH ... through abattoirs.

However, brain, spinal cord, spleen, lymphoid tissues and ...



www.bse.org.uk/witness/htm/stat071b.htm



WITNESS STATEMENT OF ALAN JOHN LAWRENCE

... John Wilesmith and Dr Hilary Pickles available to provide

... of the Report) Dr Pickles recognised that the

... refers to brain, spinal cord, spleen and intestines



... www.bse.org.uk/witness/htm/stat076.htm



Prion disease

... brain and eyes in the scull, spinal cord and tonsils of cattle), are collected

... worried. A memo from Dr Hilary Pickles at the department of health ...




www.mad-cow.org/~tom/mar99_mid_news.html




48. July 1989

48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I asked for more information from MAFF on which UK pharmaceutical manufacturers used spinal cord, thymus and small intestines [YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for licensed and unlicensed products and devices for human medicinal use, for their information.

48.2 I advised CMO that we did not need to enter into the debate on funding the Tyrrell Report's research proposals as almost all of these fell to MAFF to organise although I felt that DH should be involved in any discussions with Dr Tyrrell relating to which of the high priority work should be given highest priority and on the future of the Tyrrell Research Committee [YB 89/7.3/3.1-3.2]. I also set out some pros and cons in relation to the future of the group for CMO to consider. I drafted a reply to Mr Andrews' letter for CMO agreeing to an interdepartmental meeting with Dr Tyrrell and indicating that either Dr Metters or myself would attend.

48.3 A consultation letter on the proposed offal ban was prepared by MAFF and I suggested some changes to it before it was sent out by MAFF, having also copied it to others for comment [YB 89/7.5/2.1-2.14]. An early version of the letter had excluded sausage casings from the ban without explanation. Accordingly I asked MAFF for written confirmation that all lymphoid tissue was stripped in the preparation of sausage casings from bovine intestines [YB 89/7.7/4.1]. An assistant to CVO informed Dr Metters on 18.7.89 by telephone that CVL had investigated the lymphoid constituents of bovine intestines and concluded that neither tripe nor sausage casings need be included in the ban. We accepted these assurances at that time [YB 89/7.19/7.1-7.2 & YB 89/8.3/3.1-3.2]. CVO wrote to Dr Metters to confirm MAFF's reasoning in writing at my request [YB 89/7.24/2.1-2.2].

48.4 During July, I also received a pre-publication copy of the proposed HSE document on the handling of BSE carcasses and made a contribution on BSE to the forthcoming CMO's annual report [YB 89/7.24/4.1].

What might be more interesting could be the document

referenced as 89/7.3/4.1 in Dr. Pickles' witness statement,

if you have it. What you posted was apparently the corresponding

4.2 and 4.3.

"July 1989

48.1 Having seen a list of bovine by-products sent by MAFF to HSE, I

asked for more information from MAFF on which UK pharmaceutical

manufacturers used spinal cord, thymus and small intestines

[YB 89/7.3/4.1-4.3]. I copied this to colleagues responsible for

licensed and unlicensed products and devices for human medicinal

use, for their information. "

From the Draft factual account 17:

***

On 3 July 1989 Dr Pickles minuted Mr Maslin about cattle

by-products and BSE. The minute said: "I was interested to see

the list of by-products sent to the HSE. Those of particular concern

included:

- intestines: sutures ( I thought the source was ovine but you are

checking this)

- *spinal cord: pharmaceuticals

- *thymus: pharmaceuticals

Are you able to give me more information on which UK

manufacturers use these materials? Our proposed ban

on bovine offal for human consumption would not affect

these uses, I assume."

A handwritten note on Dr Pickles' minute from Mr Mark Hawkins,

Higher Executive Officer at MAFF, to "John" said:

"A few companies make sutures out of intestinal

linings, worth around 3300 k p.a; probably some sheep

used as well, but minimal.

Virtually all spinal cord goes for rendering, with just a

very small amount going for pharmaceutical use.

About 30 % of thymus production goes for pharmaceutical

use (approx 3132 K p.a). Incidentally, some spleen also

goes for pharmaceutical uses (approx 3170 K p.a.

The main company involved with pharmaceuticals is Y

[company referred to as Y] (MLC is trying to find a contact).

Is Hilary serious about her final sentence? I would have thought

that a) the staining would make these materials unusable (this

is also MLC's view) and b) if they are unfit for consumption,

they are certainly unfit for medication. Has she forgotten

iatrogenic CJD?"

On 4 July 1989 Dr Adams minuted Dr Raine about BSE. He said:

"Having seen Mr Armstrong's print-out of the responses from

the BSE questionnaire, the Z Catgut product seems to be the

only UK source material and we would need a very strong

justification to allow it to remain on the market.Until now

we had been of the view that many of the other catgut products

were UK sourced as well. This is now shown not to be the case

and I think Z and we have a problem!"

***

Best regards,

Torsten Brinch

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Subject: Some factual accounts about Mrs. Richardson's early observation of BSE From: Marc Barbier Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 27 Oct 2000 15:11:32 +0200 Content-Type: text/enriched Parts/Attachments: text/enriched (371 lines)

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A message just to bring some more information about the way Mrs. Richardson's testimony is 'more or less contested' in the UK Enquiry report.

See here under the extract 1. of the document "Early days", a draft factual account of the actions of MAFF and DH in relation to events up to the decision to establish the Southwood Working Party. This DFAL is one of the big amount of documents that the Enquiry is supposed to have used to deliver an opinion on the way the BSE was assessed and managed.

It appears in this document that a controversy exist about what Mrs.Richardson may have said or not, and almost about what has been heard or not from her (see extract 3) . As far as the CVL DFA is concerned it seems that it exist some oppositions within the CVL organisation. see (Extract 2).

It seems to me that the institutional deafness is not only a matter of policy-making in the present but also in the way factual accounts of the past are used in this kind of report of enquiry. Too many people seem to have forgotten what they might have said or not done.

MARC BARBIER

---------------extract 1. of the DFAL "Early days"----------------

THE EARLY DAYS

This is a Draft Factual Account of the actions of MAFF and DH in relation to events up to the decision to establish the Southwood Working Party. SCDFA refers to the Slaughter and Compensation Draft Factual Account (DFA 6), CVLDFA refers to the CVL Draft Factual Account (DFA 4) and the RFBDFA refers to the Ruminant Feed Ban Part 1 Draft Factual Account (DFA 7), all of which should be read in conjunction with this document.

1. On 22 December 1984, Mr David Bee, a veterinarian, was called to examine Cow 133, belonging to farmer Mr Peter Stent of Pitsham Farm in Sussex. She had an arched back and had lost weight. Mr Bee returned to the farm on numerous occasions to see more cattle with unusual symptoms.

2. On 11 February 1985, Cow 133 died, having developed head tremor and lack of co-ordination. By the end of April 1985, five more cows had died on the farm.

3. During Spring 1985 Mr Bee contacted Mr Watkin-Jones of the local Veterinary Investigation Centre (VIC) at Winchester, Hampshire, regarding the problems at Pitsham farm. The animals were showing aggression and were difficult to milk. Mr Bee said that they had a peculiar gait and arched backs.

4. In April 1985, veterinarian Mr Colin Whitaker was called to Plurenden Manor Farm, Kent, to examine some of Mr R Sternberg's cows showing symptoms including changes of behaviour, aggression and lack of co-ordination.

5. On 2 September 1985 a cow with these symptoms was sent from Pitsham Farm to Winchester VIC for slaughter. The VIC sent the brain and other specimens to the Central Veterinary Laboratory (CVL) at Weybridge, Surrey. This was the fourth Stent cow to be referred to the CVL, however the previous three referrals had not included brain samples.

6. The samples, received on 10 September 1985, were first examined by Ms Carol Richardson, who was the pathologist on duty. This, the subsequent examinations of these samples, and the conflict of evidence about the conclusions reached, are dealt with in the CVL DFA.

7. When Mr Watkin-Jones forwarded Mrs Richardson's report to Mr David Bee, Mr Stent's vet, he wrote:

"I enclose a histological report carried out by my colleague Carol Richardson. I have discussed her findings with her at some length and she comments that the pathological changes found would be consistent with bacterial toxin."

8 Ms Richardson did not remember having a conversation about the case with Mr Watkin-Jones.

9 Mr Bee did not accept this diagnosis. He believed there had been a fungal toxin in the cattle feed. He told the BSE Inquiry that on 4 October 1985, 'a fungal toxin called citrinin had been found in the feed. In any case, by this time, new cases had ceased to develop. I imagined that the problem had run its course'.

10 On 28 June 1986 Mr Jeffrey examined tissue sections taken from the brain of a nyala which had been kept at Marwell Zoo. This examination, and subsequent consideration of the nyala, are described in the CVL DFA.

11. Since his first callout in April 1985, Mr Whitaker had seen several more strange cases at Plurenden Manor Farm. Cattle had been exhibiting symptoms which included changes in character and in behaviour. The cattle became more nervous and aggressive. They also experienced a gradual deterioration of voluntary physical control, including lack of co-ordination and ataxia (inability to move). Mr Whitaker sought assistance from the local VIC at Wye. On referrals from Wye VIC by Mr Carl Johnson, three brain samples from the herd of Mr R. Sternberg of Plurenden Manor Farm were received at CVL (two on 27 November 1986 and one on 23 December 1986).

12. BSE was first recognised as a new disease by pathologists at the CVL in December 1986, and by 19 December 1986 CVL had identified possible repercussions for the export trade and for humans.

13. In the period after its (BSE) recognition in December 1986 and prior to BSE being made a notifiable disease on 21 June 1988 the VI Service collaborated closely with the CVL in identifying suspect BSE cases on farm, characterising the clinical signs of the disease, collecting brains from suspect BSE cases and passing these to CVL for detailed histopathological examination, and undertaking visits to farms with suspect cases of disease to collect information in support of the studies being undertaken by epidemiologists at the CVL. The VIS had primary responsibility for surveillance in the early days of the disease, and until it became a notifiable disease, the involvement of the field staff (VFS) was limited.

14. A few days after it was first identified in December 1986 Dr Watson telephoned Mr Howard Rees, MAFF's Chief Veterinary Officer (CVO), to inform him of the new disease. Watson reported that a case of spongiform encephalopathy had been diagnosed in a Fresian/Holstein cow on a farm in Kent. Mr Rees met with Dr Watson in early December to discuss the incidence and implications of BSE. At that time there was just one isolated case, and no way of testing live cattle to see if any others on the farm were infected. The belief was that BSE had a long incubation period, and therefore they had no idea how many cases would develop. No conclusions could therefore be drawn as to the possible course of future events.

------- Extract 2. of the CVL Draft Factual Account---------

Pathology Department

11. Mr Ray Bradley was Head of Pathology at the CVL from 1 August 1983 to October 1991. In addition, from June 1987 Mr Bradley was the CVL's BSE R&D Co-ordinator.

12. Mr Bradley set up a rota system in the Pathology Department in 1984, about which Ms Carol Richardson, a pathologist in the department, wrote in her statement to the BSE Inquiry:

left"In the Pathology Department, the policy of species specialisation initiated in 1945 was reversed in 1984 so that pathologists were expected to know everything about everything. All seven pathologists began to look for other work. By 1986 two had transferred within the Ministry and two had left for other employment; there were no replacement staff recruited and the remaining pathologists were left to cover the same workload and to take on cases in which they had limited experience. This lead to an overall lowering of expertise and fragmentation within the Department with very little intercommunication".

13. In his statement to the BSE Inquiry Mr Bradley explained the structure of the Pathology Department before and after his appointment as head of Pathology, which included the introduction of the 'rota system':

left"Historically the Department had been organised into two separate units, one dealing with research and the other dealing with service work for the Veterinary Investigation Service. Each of these units was then sub-divided into two sections along species lines, one dealing with pigs and the other dealing with ruminants. The system was relatively inflexible and for example, those employed in the service section often had little or no opportunity to become involved in research (and it was the opportunity to become involved in research which attracted many people to work at CVL). The system also meant that people specialised in a species although it had become generally recognised by 1983 that there was little to be gained in specialising in a species beyond the clinical level. This was because science had advanced to the point where it made more sense to specialise in organ systems because a specialist neuropathologist could acquire in-depth knowledge and use the same specialised techniques for the examination of pig brains and ruminant brains, but a pig or ruminant specialist could not develop the in-depth knowledge of all the organ systems with which he would be confronted.

When I was appointed Head of the Department, some thought was given as to how the efficiency of the Department, and in particular the Department's surveillance role for new diseases and consultation service for the VIS, could be improved. The intention was to ensure that new diseases were recognised as quickly as possible and improve the consistency and speed of reporting of pathological examinations carried out for the VIS. Consultation and discussion took place with members of the Department to see how these objectives could best be met and plans were then drawn up and the reorganisation effected.

The new concept following the reorganisation was to develop specialisation in organ systems, as is the norm for human medicine and this was along the lines on which the veterinary learned societies were organised. Various sub-units specialising in particular organ systems were set up along with a consultant pathology unit (CPU) which operated the consulting service for the VIS. The CPU was staffed on a rota system and all members of the Department took turns working in the CPU. The idea was that cases which came into the CPU would be referred to people specialising in that particular area, but where that was not possible for any reason the person on duty in the CPU would deal with the case. The fact that everyone was involved in the CPU was intended to improve communication in the Department, to ensure cases were referred to those best qualified to deal with them and provide a back up to deal with cases which could not be referred for whatever reason to allow a rapid response to the VIS. In my experience, the new system was more flexible and allowed CVL to provide a better service to the VIS."

14. The Consultative Pathology Unit (CPU) was staffed by six pathologists drawn from various sections of the Pathology Department on rota. Ms Richardson expressed her concerns about the rota system to the BSE Inquiry - she preferred a system that focused on particular species of animals rather than focussing on organ systems across species. She stated that "By working with species, you do get a feeling for that particular species, and exactly the problems that can be encountered in that species." Ms Richardson also said that the introduction of the CPU meant that the time she had to devote to research was reduced from 50% of her time to 10%. By way of contrast Mr Gerald Wells, who was appointed head of the CPU in November 1984, thought that the introduction of the CPU was an improvement as it provided a means of experiencing new or unusual problems and gave individual members of staff access to a greater diversity of material.

----------- Extract 3 of the CVL DFA about The controversy about the examination of BSE------

Examination of a case of BSE

20. On 10 September 1985 specimens from a cow owned by Mr Stent of Pitsham Farm were referred to the Central Veterinary Laboratory (CVL) by Mr Watkin-Jones at the Winchester VIC for histopathological examination. This was the fourth Stent cow to be referred to the CVL. Referrals from the VICs were dealt with on a rota system by the CPU.

21. Ms Richardson examined the sections on 13 September 1985. The history of the Stent cases was that seven out of a herd of 130 cows had been showing nervous symptoms over the previous five months; most had gone for casualty slaughter and no gross abnormality had been seen in the viscera. The Pathology Department had examined pieces of liver, kidney, heart and lung from three previous cases (2 adults and 1 calf) from this farm. Among the samples from the three cattle they had found chronic mild hepatitis, acute hepatic necrosis, moderate pulmonary oedema and chronic mild interstitial nephritis. Ms Richardson described her examination of the sections in the following terms:

left"I examined the frontal cerebrum first and progressed caudally scanning each section from dorsal to ventral surface. In this case there seemed to be a mild vacuolation of the cerebral neuropil. At this time Gerald Wells had been investigating the possibility that prolonged exposure of nervous tissue to 70% alcohol could produce neuropil vacuolation. Such prolonged exposure would occur over the week-end but I checked with the technician to ensure that such exposure had not occurred in this case before resuming my examination. I noted finding a mild multifocal non-suppurative peri-vascular infiltration with some eosinophils and in the caudal cerebrum mild focal gliosis. No abnormality was found in the thalamus (cranial midbrain) but mild neuropil vacuolation of the reticular formation in the colliculi. The medulla (a pathognomic site for scrapie in sheep) showed moderate neuronal and neuropil vacuolation. I found no abnormality in the cerebellum but the section of lumbar spinal cord showed mild neuropil vacuolation of the dorsal horns. There were two types of lesion in the section of kidney; a chronic mild /moderate non-suppurative interstitial reaction with tubular regeneration and fibrosis; a peracute reaction of a mild multifocal tubular necrosis with hydropic change (protein reabsorption). … Although I had never seen this type of lesion before in a cow I had frequently seen the combination of neuronal and neuropil vacuolation with this distribution in scrapie. To me, this was scrapie in a cow."

Conflict of Evidence

22. Ms Richardson said that she sought Dr Martin Jeffrey's opinion before writing the report. She explained how she left the slides and a request for a re-examination on Dr Jeffrey's unattended work-bench and when she returned she found a note that said 'bovine scrapie'. On her way out of Dr Jeffrey's room Ms Richardson said that she met Dr Jeffrey who said to her that Gerald Wells had examined two cases and was expecting another two. Dr Jeffrey does not remember this discussion.

23. The report was sent to Mr Watkin-Jones on 19 September 1985. Ms Richardson's diagnosis was 'Moderate spongiform encephalopathy - acute' and 'Mild renal nephrosis - peracute'. In the section of the pathology report for remarks she wrote: 'These acute changes suggest a toxicity of some description. The non-suppurative reactions are far more chronic, mild and non specific.' Ms Richardson asked a technician to cross-reference the case with the two cases that Mr Wells had seen. She recalled the technician telling her that Mr Wells had not reported any cases. Ms Richardson said she heard nothing further about the case. When Mr Watkin-Jones forwarded the report to Mr David Bee, Mr Stent's vet, he wrote:

left"I enclose a histological report carried out by my colleague Carol Richardson. I have discussed her findings with her at some length and she comments that the pathological changes found would be consistent with bacterial toxin. "

24. Ms Richardson did not remember having a conversation about the case with Mr Watkin-Jones.

25. Mr Wells re-examined the case at Ms Richardson's request. His re-examination of the sections was generally consistent with Ms Richardson's original diagnosis in that he agreed with her overall observations and that the observations on the sections were not artefactual i.e. caused as a result of post-mortem changes or in the preparation of sections. Mr Wells concluded that this was not a case of a specific disease but could possibly be the result of chronic bacteraemia or endotoxaemia. Ms Richardson said in her evidence to the BSE Inquiry that she would not have agreed with this assessment: bacteraemia would be 'either the production of bacterial toxins within the bacteria that we call endotoxins or actual production of toxins, exotoxins' and the clinical signs were not similar.

26. Mr Wells reviewed the cases from Stent Farm following a telephone conversation with Mr Watkin-Jones on 26 September 1985. None of the samples for the three earlier cases included brain tissue and the main post-mortem finding in these cases was internal bleeding. Mr Wells said in his statement to the BSE Inquiry that in the light of the history of the Stent herd, which indicated the occurrence of complex metabolic problems, the September case did not suggest that a new disease had been identified, though with hindsight, this was the case. He believed that the fact that seven out of 130 cows were nervous, did not equate necessarily to the occurrence of a specific neurological disorder.

27. In his statement to the BSE Inquiry Mr Wells noted:

left"Had Carol Richardson felt strongly that the observations she originally made were those of scrapie in cattle, I would have expected that she should have come back to me to discuss the matter subsequently or take the matter further herself."

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Subject: Re: exports of MBM from the UK From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 10 Nov 2000 14:31:39 -0800 Content-Type: text/plain Parts/Attachments: text/plain (85 lines)

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Hello Karin,

here is some that the United States imported, 'GREAVES'. but, there may be a source reference, that may be of some help to you, (maybe not), but thought i would pass it on in case it was. ===============

Meat and bonemeal is not specifically classified for overseas trade purposes. The nearest equivalent is listed as "flours and meals of meat or offals (including tankage), unfit for human consumption; greaves". UK exports of this to the US are listed below:

Country Tonnes

1980

1981 12

1982

1983

1984 10

1985 2

1986

1987

1988

1989 20

1990

Data for exports between 1975 and 1979 are not readily available. These can be obtained (at a charge) from data retailers appointed by HM Customs and Excise: BTSL (Tel: 01372 463121) or Abacus (01245 252222).

Overseas trade statistics Stats (C&F)C

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA



mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO wrote:

######### Bovine Spongiform Encephalopathy #########

Hello list members!

I have only just started to read the first volume of the BSE Inquiry report.

It was already known from Draft Factual Account nr. 25 that the feed ban had

been notified very late (1990) by Mr. Meldrum to non-EU- member-countries,

and I thought this was going to be an important point of criticism of the

Inquiry. I even thought, very naively, that 'risky exports' might be the

subject of one of the 16 volumes.

I was obviously wrong. If you are interested in this aspect of the Inquiry,

you should read chapter 3, the ruminant feed ban, _exports_ , especially

(paragraphs 217 and 218).



http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752



.... (218) : "In February 1990 Mr Gummer, by now the Minister of

Agriculture, Fisheries and Food, insisted that Mr Meldrum take the further

step of writing a letter of warning to Chief Veterinary Officers of all

countries which imported MBM from the UK. There is scope for arguing that Mr

Meldrum should have done this earlier. We think the argument is academic.

The only country outside the EU where it is suspected that cattle were

infected with BSE as a result of importing MBM is Switzerland, and it seems

that the MBM in question reached Switzerland via Belgium. If this occurred

after the ruminant feed ban, both Belgium and Switzerland were aware that

ruminant protein was suspected to be the cause of BSE. Accordingly we have

seen no need to pursue this issue further.

Those interested might also have a look at _figure 7.1_ on exports of MBM

from the UK:



http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106



I am very worried that several third countries may have imported BSE, and do

not have the financial capacity to start BSE surveillance programmes or

slaughter policies or even nvCJD surveillance.

Best regards

Karin Irgens



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Subject: exports of MBM from the UK From: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 10 Nov 2000 20:56:36 +0100 Content-Type: text/plain Parts/Attachments: text/plain (43 lines)

######### Bovine Spongiform Encephalopathy #########

Hello list members!

I have only just started to read the first volume of the BSE Inquiry report.

It was already known from Draft Factual Account nr. 25 that the feed ban had been notified very late (1990) by Mr. Meldrum to non-EU- member-countries, and I thought this was going to be an important point of criticism of the Inquiry. I even thought, very naively, that 'risky exports' might be the subject of one of the 16 volumes.

I was obviously wrong. If you are interested in this aspect of the Inquiry, you should read chapter 3, the ruminant feed ban, _exports_ , especially (paragraphs 217 and 218).



http://www.bseinquiry.gov.uk/report/volume1/chapte35.htm#643752



.... (218) : "In February 1990 Mr Gummer, by now the Minister of Agriculture, Fisheries and Food, insisted that Mr Meldrum take the further step of writing a letter of warning to Chief Veterinary Officers of all countries which imported MBM from the UK. There is scope for arguing that Mr Meldrum should have done this earlier. We think the argument is academic. The only country outside the EU where it is suspected that cattle were infected with BSE as a result of importing MBM is Switzerland, and it seems that the MBM in question reached Switzerland via Belgium. If this occurred after the ruminant feed ban, both Belgium and Switzerland were aware that ruminant protein was suspected to be the cause of BSE. Accordingly we have seen no need to pursue this issue further.

Those interested might also have a look at _figure 7.1_ on exports of MBM from the UK:



http://www.bseinquiry.gov.uk/report/volume10/chaptef2.htm#260106




I am very worried that several third countries may have imported BSE, and do not have the financial capacity to start BSE surveillance programmes or slaughter policies or even nvCJD surveillance.

Best regards Karin Irgens

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Subject: SV: SV: Changes to UK Rendering System? From: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 1 Dec 2000 22:11:59 +0100 Content-Type: text/plain Parts/Attachments: text/plain (58 lines)

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Hello John Although MRM was probably one of the most important sources of contamination of human foods until it was banned in 1995 in the UK, the MRM problem has nothing to do with rendering and MBM for animal feed.

Besides, I doubt that it would be very practical to _extract_ brain and spinal cord after "crushing and shattering" of heads and spines !

According to the BSE Inquiry's final report, MRM was produced by :

..." high pressure being applied to bones to separate them from anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers an pies. The major source of MRM was the spinal column"...

The BSE Inquiry certainly drew attention to this process. I think they even wrote a "draft factual account" on MRM last year.

Best regards, Karin

-----Opprinnelig melding-----

Fra: john hazelwood [SMTP:j_hazelwood@YAHOO.COM]

Sendt: 1. desember 2000 18:17

Til: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE

Emne: Re: SV: Changes to UK Rendering System?

TRUE But The UK invented MRM in the mid-nineteen

seventies, that is the industrial processing of whole

heads of cows and sheep plus skeletal waste on a huge

scale. The process was made viable by the collection

of hundreds of heads etc. That were then crushed,

shattered and centrifuged to extract the brains,

tongues, eyes, and spinal chord from the bone matrix.

A material was made from this slurry that could be

added to pies, sausages, burgers and baby filler as

cheap filler. The balance was used as a protein

supplement in animal feed.

Could you have a better way of spreading infectivity

? Did the BSE Inquiry describe or draw attention to

this process? I understand there was a HMSO

publication on MRM in 1980 but as yet I have not been

able to obtain a copy.

Best regards john

__________________________________________________



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Subject: Re: SV: SV: Changes to UK Rendering System? From: john hazelwood Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 5 Dec 2000 08:43:56 -0800 Content-Type: text/plain Parts/Attachments: text/plain (152 lines)

######### Bovine Spongiform Encephalopathy #########

Hello Karin

Although MRM was probably one of the most important sources of contamination of human foods until it was banned in 1995 in the UK, the MRM problem has nothing to do with rendering and MBM for animal feed.<<<< Besides, I doubt that it would be very practical to _extract_ brain and spinal cord after "crushing and shattering" of heads and spines !<<< According to the BSE Inquiry's final report, MRM was produced by : ..." high pressure being applied to bones to separate them from anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers and pies.<<< The major source of MRM was the spinal column"...<<< The BSE Inquiry certainly drew attention to this process. I think they even wrote a "draft factual account" on MRM last year.


<<< ######### Bovine Spongiform Encephalopathy ######### Hello John Although MRM was probably one of the most important sources of contamination of human foods until it was banned in 1995 in the UK, the MRM problem has nothing to do with rendering and MBM for animal feed. Besides, I doubt that it would be very practical to _extract_ brain and spinal cord after "crushing and shattering" of heads and spines ! According to the BSE Inquiry's final report, MRM was produced by : ..." high pressure being applied to bones to separate them from anything that was still adhering. The resultant slurry was used in a range of meat products for human consumption, including lower grade sausages, burgers an pies. The major source of MRM was the spinal column"... The BSE Inquiry certainly drew attention to this process. I think they even wrote a "draft factual account" on MRM last year. Best regards, Karin -----Opprinnelig melding----- Fra: john hazelwood [SMTP:j_hazelwood@YAHOO.COM] Sendt: 1. desember 2000 18:17 Til: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE

Emne: Re: SV: Changes to UK Rendering System?

TRUE But The UK invented MRM in the mid-nineteen

seventies, that is the industrial processing of

whole

heads of cows and sheep plus skeletal waste on a

huge

scale. The process was made viable by the

collection

of hundreds of heads etc. That were then crushed,

shattered and centrifuged to extract the brains,

tongues, eyes, and spinal chord from the bone

matrix.

A material was made from this slurry that could be

added to pies, sausages, burgers and baby filler

as

cheap filler. The balance was used as a protein

supplement in animal feed.

Could you have a better way of spreading

infectivity

? Did the BSE Inquiry describe or draw attention

to

this process? I understand there was a HMSO

publication on MRM in 1980 but as yet I have not

been

able to obtain a copy.

Best regards john

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Subject: Re: SV: SV: Changes to UK Rendering System? From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 5 Dec 2000 11:25:56 -0800 Content-Type: text/plain Parts/Attachments: text/plain (191 lines)

######### Bovine Spongiform Encephalopathy #########

Greetings John, Karin, and other list Members,

3. The issue of the use of heads for MRM processing has been raised on several occasions during the Inquiry hearings. Mr Soul told the Inquiry that “heads are not really suitable for the production of MRM...because the enamel of the teeth was such as to damage the machine.”[3] Mr Hibbett agreed with the Chairman that heads would go off for MRM production after removal of the brain; he had not come across the suggestion that “the machine could not cope with the teeth”.[4] Mr Oberst (MLC) thought that “if they went in at all it was in a very small number of cases.”[5] Mr Clark (then a Deputy Senior Meat Hygiene Inspector for South Holland DC) told the Inquiry that "I believe that heads are not used in the production of MRM...As far as I am aware heads would damage the machinery...and they would not be used.”[6]

4. Mr Maslin replied to Ms Jones on 12 December 1989 (copying to recipients of her minute), having discussed the matters raised with Mr K Taylor. He explained that: ‘On the splitting of heads, or spinal columns, we agree with your reaction. Some contamination is bound to occur but we have already gone further than Southwood suggested in tackling an already remote risk from offals. Through the prohibition we have taken all practical steps and an amendment to the Regulations is neither necessary nor practical.’[7]

MRMs



http://www.bse.org.uk/dfa/dfa14.htm



kind regards,

Terry S. Singeltary Sr., Bacliff, Texas USA

john hazelwood wrote:

######### Bovine Spongiform Encephalopathy #########

Hello Karin

Although MRM was probably one of the most important

sources of contamination

of human foods until it was banned in 1995 in the UK,

the MRM problem has nothing to do with rendering and

MBM for animal feed.<<<< >

Yes I understand the difference how ever the process

was cost /profit driven any MRM that was surplus ( the

balance) was passed back for use in animal feed - they

would not waste it!

Besides, I doubt that it would be very practical to

_extract_ brain and

spinal cord after "crushing and shattering" of heads

and spines !<<< >

Sorry I should have been more explicit - I was trying

to emphasise that this material included BRAIN etc.

and was a part of the general mush or "slurry" that

was extracted for HUMAN/animal consumption. -- Surely

this was the best practical way of processing the

WHOLE HEAD from a cost /profit point of view.

According to the BSE Inquiry's final report, MRM

was produced by :

..." high pressure being applied to bones to separate

them from anything that was still adhering. The

resultant slurry was used in a range of meat products

for human consumption, including lower grade sausages,

burgers and pies.<<< >

So they only tell a part of truth!

The major source of MRM was the spinal

column"...<<< >

So OK They just did not mention that the "head meat"

and that BRAIN was a VERY significant component prior

to 1989 at some of the plants.

The BSE Inquiry certainly drew attention to this

process. I think they even wrote a "draft factual

account" on MRM last year. <<< >

Not the process I described and they have done there

best to cover up the inclusion of BRAINS in MRM .

*******************************************************

Bovine heads.

4.26 Although a representative of the Chartered

Institute of Environmental Health (CIEH) suggested

that heads were used in the MRM process. The weight of

evidence was against this proposition.

WHO SAYS SO?

*******************************************************

Best regards, JOHN

--- mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:Karin.Irgens@DYREHELSETILSYNET.NO wrote:

######### Bovine Spongiform Encephalopathy

#########

Hello John

Although MRM was probably one of the most important

sources of contamination

of human foods until it was banned in 1995 in the

UK, the MRM problem has

nothing to do with rendering and MBM for animal

feed.

Besides, I doubt that it would be very practical to

_extract_ brain and

spinal cord after "crushing and shattering" of heads

and spines !

According to the BSE Inquiry's final report, MRM was

produced by :

..." high pressure being applied to bones to

separate them from anything

that was still adhering. The resultant slurry was

used in a range of meat

products for human consumption, including lower

grade sausages, burgers an

pies. The major source of MRM was the spinal

column"...

The BSE Inquiry certainly drew attention to this

process. I think they even

wrote a "draft factual account" on MRM last year.

Best regards, Karin

-----Opprinnelig melding-----

Fra: john hazelwood [SMTP:j_hazelwood@YAHOO.COM]

Sendt: 1. desember 2000 18:17

Til: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@UNI-KARLSRUHE.DE

Emne: Re: SV: Changes to UK Rendering System?

TRUE But The UK invented MRM in the mid-nineteen

seventies, that is the industrial processing of whole

heads of cows and sheep plus skeletal waste on a

huge scale. The process was made viable by the collection

of hundreds of heads etc. That were then crushed,

shattered and centrifuged to extract the brains,

tongues, eyes, and spinal chord from the bone matrix.

A material was made from this slurry that could be

added to pies, sausages, burgers and baby filler

as cheap filler. The balance was used as a protein

supplement in animal feed.

Could you have a better way of spreading

infectivity ? Did the BSE Inquiry describe or draw attention

to this process? I understand there was a HMSO

publication on MRM in 1980 but as yet I have not

been able to obtain a copy.

Best regards john

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http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html

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Subject: Re: SV: SV: Changes to UK Rendering System? From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Tue, 5 Dec 2000 11:39:50 -0800 Content-Type: text/plain Parts/Attachments: text/plain (253 lines)

######### Bovine Spongiform Encephalopathy #########

Karin and John,

forgot to add this;

57. On 22 June 1990, the APS/Parliamentary Secretary (Mr Curry) sent a minute to Dr Denner, copied to Mr Capstick, Mr Meldrum, Mr Crawford, Mr Baker, Mr Griffiths, Mr Lawrence and others, in which he explained that at a demonstration of the MRM process which Mr Curry had seen at a slaughterhouse, traces of spinal tissue had been found in the product and as a result the Parliamentary Secretary was ‘very unhappy about MRM’.[53] A suggestion had been made to Mr Curry that an efficient method of removing the spinal tissue would be to apply a suction pump to the spinal canal after the head had been removed and before the carcase was split. The Parliamentary Secretary asked for a short note on the feasibility of such a method.

58. On 25 June 1990, Mr Bremner sent a minute to Mr Meldrum, copied to Dr Denner, Mr Crawford, Mr D Taylor and Mr Griffiths. Mr Bremner reported that he was ‘very surprised’ that the Parliamentary Secretary had seen traces of spinal tissue in MRM and that ‘it is so unlikely that I suspect he was misinformed’.[54] Mr Bremner explained that what the slaughterhouse operators had said was that ‘they were not happy to sell MRM because of the risk of contamination of the vertebrae with the spinal cord. Unfortunately not all the spinal cord was being removed by the meat inspectors although only small pieces were left’. He went on to say that although the idea of using a suction pump was being pushed by the operators, he found it difficult to imagine how it would work, and that ‘my own view was that if the meat inspectors had done their job correctly, there would have been little risk and if the vertebrae were excluded from MRM, there should be no further risk’.

59. In a manuscript minute dated 28 June 1990, Mr Meldrum asked Mr Bremner to find out from his trade contacts whether any suction pumps were actually available on the market.[55]

60. Dr Denner wrote to APS/Mr Curry on 26 June 1990 regarding the visit to Canvin International Ltd. His minute was copied to PS/Minister, Private Offices, Mr Capstick, Mr Packer, Mr Meldrum, Mrs Attridge, Mr Wentworth, Mr Crawford, Mr Baker, Mr Griffiths and Mr Lawrence amongst others.[56] Dr Denner explained that:- ‘There are two separate issues arising from the Parliamentary Secretary’s (Mr Curry) visit to the abattoir. The first is the efficacy of removing spinal cord from the carcase, which is a mandatory requirement of the Bovine Offals (Prohibition) Regulations 1989. This issue is related to other problems of abattoir practice such as the removal of the head meat and brains from cattle heads, and the prevention of cross contamination from spinal fluids and tissue during carcase dressing. The second problem is the safety of MRM prepared from spinal column bones. Since legislation already exists for the removal of spinal cord, any further consideration must stem from the risk posed by using spinal column with the spinal cord removed in MRM piston type machines. Any policy decision on BSE must be based on the best technical evidence available to be consistent with previous MAFF policy. The CVO is already organising a study to improve abattoir practice of splitting carcases. The use of a suction tube for removal of spinal cord after splitting the carcase is an effective technique already in use in some plants producing MRM from lamb spinal column bones. This may be one of several possible techniques that can be studied. I understand the Tyrrell Committee will discuss the use of spinal column in the preparation of MRM at their next meeting on 2 July. Subject to their recommendation, Food Science Division would be prepared to commission a study into verifying whether central nervous system fluid or tissue is extracted into MRM during the preparation in piston type machines when spinal column with the cord removed is used. The results of such a study would give Ministers the basis for any further action.’

61. The APS/Mr Curry replied to Dr Denner on 2 July 1990[57]. She explained that:- ‘The MRM [at Canvins] was produced using a machine which used a piston under hydraulic pressure. The traces of spinal tissue were identified by eye by Canvin’s vet. However, Mr Bremner - who accompanied the Parliamentary Secretary on this visit - said that it was possible that the material in question could have been cartilage tissue. Mr Bremner felt that the machine was not working properly as the MRM it produced was in larger pieces than normal.’

MRMs


http://www.bse.org.uk/dfa/dfa14.htm



kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA

john hazelwood wrote:

######### Bovine Spongiform Encephalopathy

#########

Hello Karin

Although MRM was probably one of the most important

sources of contamination

of human foods until it was banned in 1995 in the UK,

the MRM problem has nothing to do with rendering and

MBM for animal feed.<<<<>

Reply-To: Bovine Spongiform Encephalopathy Date: Fri, 26 Mar 2004 15:22:01 -0600 Content-Type: multipart/related Parts/Attachments: text/plain (1957 lines)

Bovine Spongiform Encephalopathy (BSE) - Updated Vaccine Information

Posted: 3/24/2004

Bovine Spongiform Encephalopathy (BSE)

horizontal rule

snip...tss...2008

Opinion (webmaster): This is good step forward to name the compaines and specific vaccines though it is a pity that England doesn't keep records of who received what vaccine the way normal countries do. The previous two mass outbreaks of TSE attributed to vaccines involved louping ill in the 1930's and a 1999 vaccine in Italy, both produced in sheep or goat brain. An Indian physician has also expressed concern about a widely used human rabies vaccines produced in scrapies-endemic sheep brain in India; CJD surveillance there is minimal. No details are provided above on what part of the bovine is used in producing the vaccines, apparently fetal calf serum or bovine serum albumen are used in human cell culture to grow the viruses. The vaccines had been previously discussed in a Phillips Inquiry memo: bovine blood serum, ox heart infusion, casein (milk protein), fetal calf serum, beef muscle infusion, veal, and unspecified sheep use.

Extract from Phillips enquiry, draft factual account 17, 8 Oct 99

14 February 1989 Dr Adams minuting Dr Harris Vaccines: We have contacted all the major vaccine product licence holders whose products are likely to be used in children. Many manufacturers use bovine material. As can be seen, this information is diverse and incomplete. Each company stressed that they could not give an accurate assessment without detailed researches, given the complexity of sourcing/purchasing arrangements. All the licences are detailed in appendix 1 [unavailable]; the overview is as follows:

1. D have polio, measles, mumps, rubella, rotavirus vaccines. All use bovine serum from a UK source and bovine commercial product from unknown source. Some agent comes from the USA and New Zealand.

2. I gave most information (see Appendix 2 [unavailable]). All their vaccines apart from yellow fever, cholera and typhoid contain bovine material: Oral polio; up to 1988, foetal calf serum was used from UK and New Zealand (pooled); since 1988 foetal calf serum only from New Zealand. Large stocks are held.

Rubella; bulk was made before 1979 from foetal calf serum from UK and New Zealand. None has been made as there are some 15 years stock.

Diphtheria; UK bovine beef muscle and ox heart is used but since the end of 1988 this has been sourced from Eire. There are 1,250 litres of stock.

Tetanus; this involves bovine material from UK mainly Scottish. There are 21,000 litres of stock.

Pertussis; uses bovine material from the UK. There are 63,000 litres of stock.

They consider that to switch to a non-UK source will take a minimum of 6-18 months and to switch to a non-bovine source will take a minimum of five years.

3. E have measles, mumps, MMR, rubella vaccines. These are sourced from the USA and the company believes that US material only is used.

4. J have a measles vaccine using bovine serum from the UK. There are 440,000 units of stock. They have also got MMR using bovine serum from the UK.

5. K have influenza, rubella, measles, MMR vaccines likely to be used in children. Of those they think that only MMR contains bovine material which is probably a French origin.

6. L have diphtheria/tetanus and pertussis on clinical trial [redacted]; These use veal material, some of which has come from the UK and has been made by I (see above).

7. M have influenza vaccines which are made up in egg medium.

8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to certain bovine ingredients).

9. N have acellular triple vaccine in which I material of UK bovine source has been used.

As far as I can see Company I is the sole supplier of pertussis vaccine which uses bovine casein digest. You should also be aware that DH has made arrangements for meningococal vaccine to be available, on a named patient basis, from D and K. Both companies use bovine media in production." The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath): No vaccines or other injectable medicines in use in the United Kingdom contain bovine serum derivatives as ingredients in the finished products.

Comment (Kelly ): "It seems clear that no bovine derivatives are used in FINISHED products, however they are often used in the culture process. Does this also present a possible risk? Below is the packaging insert for one routine vaccine (inactivated injectable polio vaccine)made by Pasteur Merieux S?ms & Vaccins S. A. Lyon, France (now called Aventis):"

IPOL? Poliovirus Vaccine Inactivated, produced by Pasteur M?eux S?ms Vaccins S.A., is a sterile suspension of three types of poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). IPOL?is a highly purified, inactivated poliovirus vaccine produced by microcarrier culture. This culture technique and improvements in purification, concentration and standardization of poliovirus antigen produce a more potent and consistent immunogenic vaccine than the IPV available in the US prior to 1988. The viruses are grown in cultures of V.R. cells, a continuous line of monkey kidney cells, by the microcarrier technique. The cells are grown in Eagle MEM modified medium, supplemented with newborn calf serum tested for adventitious agents prior to use, originated from countries free of bovine spongiform encephalopathy. For viral growth the culture medium is replaced by M-199, without calf serum.

... Neomycin, streptomycin and polymyxin B are used in vaccine production, and although purification procedures eliminate measurable amounts, less than 5 ng neomycin, 200 ng streptomycin and 25 ng polymyxin B per dose may still be present. The residual calf serum protein is less than 1 ppm in the final vaccine. The vaccine is clear and colorless and should be administered intramuscularly or subcutaneously.

The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4 BOVINE SPONGIFORM ENCEPHALOPATHY 1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989.

snip...end...2008...TSS



https://lists.aegee.org/cgi-bin/wa?A2=ind0403&L=BSE-L&P=R48065&X=46104545F4D3582B66&Y=flounder9%40verizon.net



Subject: How many NHS patients identified by the National Blood Service as having received blood from a donor who later developed vCJD were people with haemophilia Lord Morris of Manchester From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Thu, 21 Dec 2006 11:32:40 -0600 Content-Type: text/plain Parts/Attachments: text/plain (781 lines)

Subject: How many NHS patients as having received blood from a donor who later developed vCJD were people with haemophilia Date: December 21, 2006 at 9:13 am PST Health: vCJD Lord Morris of Manchester asked Her Majesty’s Government:

How many NHS patients identified by the National Blood Service as having received blood from a donor who later developed vCJD were people with haemophilia. [HL750]

19 Dec 2006 : Column WA291

The Minister of State, Department of Health (Lord Warner): No patient with haemophilia or other bleeding disorders have been identified as having received blood from a blood donor who subsequently developed vCJD, nor have there been any reported cases of vCJD associated with receipt of plasma products.

However, all haemophilia patients who received plasma products between 1980 and 2001 sourced from UK donor plasma have been designated as “at risk of vCJD for public purposes”. All plasma products are now sourced from non-UK plasma. The United Kingdom Haemophilia Centre Doctors’ Organisation is collecting data that will provide an estimate of the number of haemophilia patients who have been exposed to plasma products which may be implicated with vCJD.

Lord Morris of Manchester asked Her Majesty’s Government:

What is their response to the findings of Professor John Collinge in the December 2006 edition of the Lancet on the transmission by infected blood of variant CJD; and what action they are planning to take. [HL751]

Lord Warner: The Lancet article refers to the third known case of vCJD transmission via blood transfusion from a vCJD-infected donor. This case was originally notified to the department in January 2006 and announced by the Health Protection Agency in a press release on 9 February 2006, a copy of which has been placed in the Library.

There are 24 living patients in a group of people who had received blood components from donors subsequently known to have developed vCJD. They were all notified in 2005 or earlier, through their GPs, of their risk status and have been provided with information and support. The Health Protection Agency contacted the GPs earlier in the year to notify them of this third case and the agency has ensured that the GPs are fully informed and briefed about the subsequent Lancet publication.

The department has implemented a series of measures to reduce the risk of vCJD being transmitted through the blood supply. Shortly after vCJD was first identified in 1996, the possibility of human-to-human transmission through blood was considered, and the department implemented precautionary measures to reduce what was, at that time, a theoretical risk. These measures have been strengthened since evidence of transmission via blood began to emerge from animal studies, and following the first case of transfusion-associated transmission in humans, reported in December 2003. An important additional step, introduced in March 2004, was to exclude from blood donation those people who had themselves received a blood transfusion since January 1980. Other precautionary measures include:

from December 1997, blood components, plasma products or tissues obtained from any individual who later develops vCJD, were withdrawn/recalled;

19 Dec 2006 : Column WA292

in July 1998, it was announced that plasma for the manufacture of blood products, such as clotting factors, would be obtained from non-UK sources;from November 1999, white blood cells, which may carry a significant risk of transmitting vCJD, were removed from all blood used for transfusion;in August 2002, it was announced that fresh frozen plasma for treating babies and young children born on or after 1 January 1996 would be obtained from the USA; in July 2004, the exclusion criteria for blood donation were extended to include previously transfused platelet donors, and donors who were unsure if they had previously had a blood transfusion;in September 2004, the department announced further precautionary measures for patients who had received certain batches of plasma products;in July 2005, the use of USA-sourced fresh frozen plasma was extended to all children up to the age of 16;in July 2005, the department announced further precautionary measures for those patients who donated blood to three people who later developed vCJD. The department continues to keep all the evidence in relation to transmission of vCJD by blood under close review.



http://www.publications.parliament.uk/pa/ld200607/ldhansrd/text/61219w0004.htm#06121940000034



http://www.whale.to/v/singeltary7.html



http://www.microbes.info/forums/index.php?s=6f1dd87fff0c5b970fc8b8fe838f7ee5&showtopic=377&pid=477&st=0&#entry477



Subject: Re: VACCINES/CHILDREN/TSE'S -- 'CONFIDENTIAL' Date: Wed, 6 Sep 2000 18:20:09 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1

######### Bovine Spongiform Encephalopathy #########

Just when I was thinking the Internet had reached a terminal condition of shallow pages and broken links, some young people come along and invent a really effective Internet search engine: http://www.google.com/ This works quite well to search the entire http://www.mad-cow.org site (or find 393 web sites such as GenBank that link to it, or 936 sites that cite it in text) back to 1996 as well as the BSE Inquiry http://www.bse.org.uk/

Thus for louping ill (unnecessary cites suppressed):



http://www.bse.org.uk/witness/htm/stat537.htm




Witness Statements 537 - Coulthard

29.Pituitary FSH from pigs has been used in the USA prior to its use in the UK and much more extensively there and Canada.... 30.Thousands of embryos were exported from this country to the USA prior to the ban being imposed... 42. No cow pituitaries were used in the preparation of FSH [follicular stimulating hormone] products compared with the case of louping ill vaccine for scrapie.



http://www.mad-cow.org/~tom/fda_late.html#ill



In the 1930's: 18,000 UK sheep were inoculated against louping ill, a brain inflammatory illness spread by ticks. Despite formalin-treatment of the inoculated agent, the procedure gave rise to 1,500 cases of scrapie. Louping is a Scottish word for fleeing or leaping, related to loping. In humans, louping ill is called Russian spring-summer encephalitis, a meningo-encephalitis with muscular tremors and spasms followed by varying degrees of paralysis.... [John Lanchester 2 Dec 96 New Yorker]



http://www.foodsafety.org/consumer/ht/ht294.htm



In what the story calls a grand historical irony, this landmark series of experiments was being confirmed at the same time in England as a result of an outbreak of scrapie in several hundred sheep that had been immunized against louping ill with a vaccine prepared from tissue from the brain, spinal cord, and spleen of sheep that were belatedly discovered to have been exposed to natural scrapie infection.[6.Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520] The transmissible nature of the scrapie agent was thus established beyond any doubt. [P Brown, 1755 and All That: A Historical Primer of TSE.

We need to look at the full text of the article and its cites to see how they actually made the vaccine, whether they exported vaccine-infected sheep to Canada and the US, and what became of the vaccinated flocks. Perhaps there is still sample available, Moredun Institute is still around.

Gordon WS. Advances in veterinary research. Vet Rec 1946; 58: 516-520 (not covered by Medline) Gordon, Bronlee and Wilson 1939 [full cite is available only in a letter we don't have)

Terry was reading Draft Factual Account 17


http://www.bse.org.uk/dfa/dfa17.htm

236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282] 237. On 6 June 1988 Mr Lawrence wrote to Sir Richard Southwood and enclosed some brief answers to the questions that had been tabled at the meeting on 19 May.[283] In relation to Q6, which asked ŒWhat is meat and other material from scrapie infected sheep used for - does it include pet food and material for biological products?¹ Part of the answer stated: ...

There has been one instance of inadvertant [sic] transmission of the

scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and

Wilson 1939). One of the three batches of vaccine made in 1935 at the

Moredun Institute contained the scrapie agent resulting in 7% of the

recipients of the 18, 000 doses in the batch developing scrapie. This

vaccine was made from formalin-inactivated sheep brain, and brought to

the attention of research workers that formalin, at a concentration of

0.35% for at least 3 months, which inactivated conventional viruses, did

not totally inactivate the scrapie agent.

----------------------------

4. Questions we might want to have answered are:

the highest risk would be from parenterals prepared from brain (eg

rabies vaccine). Any species in which transmissible spongiform

encephalopathies have been described would be suspect (“natural”

infections in sheep, goats, cattle, deer, mink, but can be transmitted

to hamster, mouse, guinea-pig etc). Are sterilisation processes

adequate for the most resistant strain of scrapie agent or for CJD

agent? Should companies be asked to include investigation for inclusion

of scrapie agent (eg mouse innoculation [sic]) in at least some batches?

If BSE behaves like scrapie, then we might expect other nervous tissue,

spleen, lymph nodes and placenta to be contaminated. Infection has been

described in other tissues too, eg gut wall, and we can not [sic] be

sure blood is free. Do we know what bovine materials are used in which

products, both as the active ingredient and in production? Bovine active

ingredients in human products include insulin, vasopressin, bone, immune

globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and

fetal calf serum must be used in preparation of very many products. For

each of these products would any “BSE agent” be destroyed or eliminated

in processing? If not, and the product is administered parenterally or

topically into an open wound, might there be a risk? [For oral

products, there would only be a trivially increased load on top of that

taken in food in omnivores/carnivores including man. But for some

herbivores, this might allow the agent to be introduced into yet another

species].

--------------------------

Medicines and medical devises;

Subject: 2 known incidents of iatrogenic scrapie Date: Thu, 7 Sep 2000 09:51:14 -0800 From: tom Reply-To: Bovine Spongiform Encephalopathy To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@uni-karlsruhe.de References: 1

######### Bovine Spongiform Encephalopathy #########

One really has to wonder what went on in veterinary products produced during the peak BSE years. At this point, there are only 2 known incidents, both involving sheep brain vaccines.

I found a better source for needed references for iatrogenic scrapie in a nice review by Ray Bradley at http://www.iica.org.ar/Bse/6-%20Bradley.html. Disclosure has been meagre on the 1998 vaccine incident in Italy. Note 3 of the 5 references are totally off Medline and the other 2 fail to have abstracts or links, due to journal ineptness, burial in conference proceedings, and age of article.

If anyone has the first 3, I would appreciate a fax 542-484-0669 US.

tom

GORDON , W.S., 1959. Scrapie panel. In: Proceedings of 63rd Annual Meeting of the US Livestock Sanitary Association, 63, 286-294. [no medline record]

GORDON, W.S., 1946. Advances in Veterinary Research: Louping ill, tick-borne fever and scrapie. Veterinary Record, 58, 516-525. [no medline record]

GORDON , W.S., BROWNLEE, A.& WILSON, D.R., 1939. Studies in louping-ill, tick-borne fever and scrapie. 3rd International Congress for microbiology, 362-363. [no medline record]

-=-=--=

CAPUCCHIO, M.T., GUARDA,F., ISAIA,M.C., CARACAPPÀ, S. & DiMARCO,V., 1998. Natural occurrence of scrapie in goats in Italy. Veterinary Record, 143, 452-453. [title only]

AGRIMI, U., GLUSOPPE, R.U., CARDONE, F., POCCHIARI, M. & CARAMELLI, M., 1999. Epidemic transmissible spongiform encephalopathy in sheep and goats in Italy. Lancet, 353, 560-561. [title only]

IATROGENIC DISEASE IN ANIMALS



http://www.iica.org.ar/Bse/6-%20Bradley.html



Ray Bradley Private BSE Consultant Veterinary Laboratories Agency, United Kingdom

There have been two reported incidents of iatrogenic disease in animals, both involving scrapie. One was in Great Britain (Gordon, Brownlee and Wilson, 1939, Gordon 1946, 1959) the other in Italy (Capucchio et al, 1998, Agrimi et al, 1999). Both resulted from infection being introduced into vaccines, louping ill vaccine in Great Britain, Mycoplasma agalactiae vaccine in Italy. Each of these vaccines was prepared from tissues that included sheep brain. In both episodes it seems most likely that natural scrapie infection was present unknowingly in some brains used for the purpose. Once prepared and having passed all the conventional vaccine tests large numbers of sheep in Great Britain, and goats and some sheep in Italy were inoculated. After the necessary incubation period large numbers (> 1,000 in each case) of inoculated animals came down with scrapie. In the meantime some inoculated clinically healthy goats and sheep may have entered food and feed chains or have been used for other purposes. In the British outbreak there appears to have been no consequence for humans who may have consumed infected sheep. It is too early to say what may be the consequences in Italy but measures have been taken to reduce any risk there may have been. .........end

Louping-ill vaccine documents from November 23rd, 1946 FULL TEXT

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

SNIP...FULL TEXT ;



http://whale.to/v/singeltary.html



Subject: Louping-ill vaccine documents from November 23rd, 1946 Date: Sat, 9 Sep 2000 17:44:57 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To: BSE-L@uni-karlsruhe.de

######### Bovine Spongiform Encephalopathy #########

THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946

NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND

ANNUAL CONGRESS, 1946

The annual Congress, 1946, was held at the Royal Veterinary College, Royal College Street, London, N.W.I. from September 22nd to September 27th.

Opening Meeting

[skip to scrapie vaccine issue...tss]

Papers Presented to Congress

The papers presented to this year's Congress had as their general theme the progressive work of the profession during the war years. Their appeal was clearly demonstrated by the large and remarkably uniform attendance in the Grand Hall of the Royal Veterinary College throughout the series; between 200 and 250 members were present and they showed a keen interest in every paper, which was reflected in the expression of some disappointment that the time available for discussion did not permit of the participation of more than a small proportion of would-be contributors.

In this issue we publish (below) the first to be read and discussed, that by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E., "Advances in Veterinary Research." Next week's issue will contain the paper on "Some Recent Advances in Veterinary Medicine and Surgery in Large-Animal Practice" by Mr. T. Norman Gold, M.R.C.V.S. In succeeding numbers of the Record will be reproduced, also with reports of discussions, that by Mr. W. L. Weipers, M.R.C.V.S., D.V.S.M., on the same subject as relating to small-animal practice, and the papers by Mr. J. N. Ritchie, B.SC., M.R.C.V.S., D.V.S.M., and Mr. H.W. Steele-Bodger, M.R.C.V.S., on "War-time Achievements of the British Home Veterinary Services."

The first scientific paper of Congress was read by Dr. W. S. Gordon, M.R.C.V.S., F.R.S.E. on Monday, September 23rd, 1946, when Professor J. Basil Buxton, M.A., F.R.C.V.S, D.V.H., Prinicipal of the Royal Veterinary College, presided.

Advances in Veterinary Research

by

W.S. GORDON, PH.D., M.R.C.V.S., F.R.S.E.

Agriculteral Research Council, Field Station, Compton, Berks.

Louping-ill, Tick-borne Fever and Scrapie

In 1930 Pool, Browniee & Wilson recorded that louping-ill was a transmissible disease. Greig et al, (1931) showed that the infective agent was a filter-passing virus with neurotropic characters and Browniee & Wilson (1932) that the essential pathology was that of an encephalomyelitis. Gordon, Browniee, Wilson & MacLeod (1932) and MacLeod & Gordon (1932) confirmed and extended this work. It was shown that on louping-ill farms the virus was present in the blood of many sheep which did not show clinical symptoms indicating involvement of the central nervous system and that for the perpetuation and spread of the disease these subclinical cases were probably of greater importance that the frank clinical cases because, in Nature, the disease was spread by the tick, lxodes ricinus L. More recently Wilson (1945, 1946) has described the cultivation of the virus in a chick embryo medium, the pathogenic properties of this culture virus and the preparation of louping-ill antiserum.

Between 1931 and 1934 I carried out experiments which resulted in the development of an effective vaccine for the prevention of louping-ill.* This vaccine has been in general use since 1935 and in his annual report to the Animal Diseases Research Association this year, Dr. Greig stated that about 227,000 doses of vaccine had been issued from Moredun alone.

Dr. Gordon illustrated this portion of his paper by means of graphs and diagrams projected by the epidiascope.

This investigation, however, did not begin and end with the study of louping-ill; it had, by good fortune, a more romantic turn and less fortunately a final dramtic twist which led almost to catastrope. After it had been established that a solid immunity to louping-ill could be induced in sheep, a group of immunized and a group of susceptible animals were placed together on the tick-infected pasture of a louping-ill farm. Each day all the animals were gathered and their temperatures were recorded. It was anticipated that febrile reactions with some fatalities would develop in the controls while the louping-ill immunes would remain normal. Contrary to expectation, however, every sheep, both immune and control, developed a febrile reaction. This unexpected result made neccessary further investigation which showed that the febrile reaction in the louping-ill immunes was due to a hitherto undescribed infective agent, a Rickettsia-like organism which could be observed in the cytoplasm of the grannular leucocytes, especially the neutrophil polymorphs (MacLeod (1932), Gordon, Browniee, Wilson & MacLeod. MacLeod & Gordon (1933). MacLeod (1936). MacLeod collected ticks over many widely separated parts of Scotland and all were found to harbour the infective agent of tick-borne fever, and it is probable that all sheep on tick-infested farms develop this disease, at least on the first occasion that they become infested with ticks. When the infection is passed in series through susceptible adult sheep it causes a sever, febrile reaction, dullness and loss of bodily condition but it rarely, if ever, proves fatal. It is clear, however, that it aggravates the harmful effects of a louping-ill infection and it is a serious additional complication to such infections as pyaemia and the anacrobic infections which beset lambs on the hill farms of Northern Britain.

Studying the epidemiology of louping-ill on hill farms it became obvious that the pyaemic condition of lambs described by M'Fadyean (1894) was very prevalent on tick infested farms Pyaemia is a crippling condition of lambs associated with tick-bite and is often confused with louping-ill. It is caused by infection with Staphylococcus aureus and affected animals may show abscess formation on the skin, in the joints, viscera, meninges and elsewhere in the body. It was thought that tick-borne fever might have ben a predisposing factor in this disease and unsuccessful attempts were made by Taylor, Holman & Gordon (1941) to reproduce the condition by infecting lambs subcutaneously with the staphylococcus and concurrently produceing infections with tickborne fever and louping-ill in the same lambs. Work on pyaemia was then continued by McDiarmid (1946a, 1946b, 1946c), who succeeded in reproducing a pyaemic disease in mice, guinea-pigs and lambs similar to the naturally occuring condition by intravenous inoculation of Staphylococcus aureus. He also found a bacteraemic form of the disease in which no gross pyaemic lesions were observed. The prevention or treatment of this condition presents a formidable problem. It is unlikely that staphylococcal ???oid will provide an effective immunity and even if penicillin proved to be a successful treatment, the difficulty of applying it in adequate and sustained dosage to young lambs on hill farms would be almost insurmountable.

From 1931 to 1934 field trials to test the immunizing value and harmlessness of the loup-ill vaccine were carried out on a gradually increasing scale. Many thousands of sheep were vaccinated and similar numbers, living under identical conditions were left as controls. The end result showed that an average mortability of about 9 percent in the controls was reduced to less than 1 percent in the vaccinated animals. While the efficiency of the vaccine was obvious after the second year of work, previous bitter experience had shown the wisdom of withholding a biological product from widespread use until it had been successfully produced in bulk, as opposed to small-scale experimental production and until it had been thoroughly tested for immunizing efficiency and freedom from harmful effects. It was thought that after four years testing this stage had been reached in 1935, and in the spring of that year the vaccine was issued for general use. It comprised a 10 percent saline suspension of brain, spinal cord and spleen tissues taken from sheep five days after infection with louping-ill virus by intracerebral inoculation. To this suspension 0-35 percent of formalin was added to inactivate the virus and its safety for use as a vaccine was checked by intracerbral inoculation of mice and sheep and by the inoculation of culture medium. Its protective power was proved by vaccination sheep and later subjecting them, along with controls, to a test dose of living virus.

Vaccine for issue had to be free from detectable, living virus and capable of protecting sheep against a test dose of virus applied subcutaneously. The 1935 vaccine conformed to these standards and was issued for inoculation in March as three separate batches labelled 1, 2, and 3. The tissues of 140 sheep were employed to make batch 1 of which 22,270 doses were used; 114 to make batch 2 of which 18,000 doses were used and 44 to make batch 3 of which 4,360 doses were used. All the sheep tissues incorporated in the vaccine were obtained from yearling sheep. During 1935 and 1936 the vaccine proved highly efficient in the prevention of loup-ill and no user observed an ill-effect in the inoculated animals. In September, 1937, two and a half years after vaccinating the sheep, two owners complained that scrapie, a disease which had not before been observed in the Blackface breed, was appearing in their stock of Blackface sheep and further that it was confined to animals vaccinated with louping-ill vaccine in 1935. At that stage it was difficult to conceive that the occurrence could be associated with the injection of the vaccine but in view of the implications, I visited most of the farms on which sheep had been vaccinated in 1935. It was at this point that the investigation reached its dramatic phase; I shall not forget the profound effect on my emotions when I visited these farms and was warmly welcomed because of the great benefits resulting from the application of louping-ill vaccine, wheras the chief purpose of my visit was to determine if scrapie was appearing in the inoculated sheep. The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:-

(1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer.

Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine.

As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus.

The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease. ==================================================================

Greetings List Members,

pretty disturbing document. now, what would stop this from happening with the vaccineCJD in children???

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA



http://www.whale.to/v/singeltary.html



http://www.whale.to/v/cjd2.html




although 176 products do _not_ conform to the CSM/VPC guidelines.



http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf



8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients).



http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf



http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf



more on the 1968 medicine act, they forgot to follow



http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf




Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)




http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf




http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf




2.3.Iatrogenic exposure

Iatrogenic exposure of scrapie has probably occurred twice. The first report determined that

the vehicle was a louping ill vaccine prepared from sheep tissues and this infected a large

number of sheep sheep (Gordon, 1946, Greig, 1950). The second was more recent and in this

case a vaccine against Mycoplasma agalactiae prepared from sheep tissues was incriminated

(Agrimi et al 1999, Capucchio, 1998) but not all outbreaks could be linked to the use of the

vaccine. In this episode goats were predominantly affected10.



http://ec.europa.eu/food/fs/sc/ssc/out170_en.pdf



http://ec.europa.eu/food/fs/sc/ssc/out247_en.pdf


5.3.3 The greatest risk, in theory, would be from parenteral injection of material derived from bovine brain or lymphoid tissue. Medicinal products for injection or surgical implantation which are prepared from bovine tissues, or which utilise bovine serum albumin or similar agents in their manufacture, might also be capable of transmitting infectious agents. All medicinal products are licensed under the Medicines Act by the Licensing Authority following guidance, for example from the Committee on Safety of Medicines (CSM), the Committee on Dental and Surgical Materials (CDSM) and their subcommittees. The Licensing Authority have been alerted to potential concern about BSE in medicinal products and will ensure that scrutiny of source materials and manufacturing processes now takes account of BSE agent.



http://www.bseinquiry.gov.uk/files/ib/ibd1/tab02.pdf




The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read

(scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL

Mr Cunningham CMP3 From: D O Hagger MBI Dr Salisbury MED/IMCD3 Mr Burton PD/STB/PG1B B/17/2 Date: 15.02.1989 Mr Dudley PD/AD4

BOVINE SPONGIFORM ENCEPHALOPATHY

1. The purpose of this minute is to alert you to recent developments on BSE as they affect medicines and to invite representatives to a meeting in Market Towers on 22 February 1989.

2. The report of the Working Party on Bovine Spongiform Encephalopathy (BSE) was submitted by the CMO to the Secretary of State for Health and Minister for Agriculturer on 9 February.

3. The summary at the end of the report records, inter alia: 'we have drawn the attention of the Licensing Authority to the potential of transfer of BSE agent in human and veterinary medicinal products. In paragraph 7 of his submission (Annex A), the CMO notes:

"I am also putting work urgently in hand to satisfy myself that everything possible has been done to ensure .... that transfer of the BSE agent in human and veterinary medicinal products does not occur."

4. The Veterinary products Committee meets on 16 February and The committee on Safety of Medicines on 23 February when each will be considering a draft of some joint guidelines for manufacturers of medicinal products which use bovine material as an ingredient or an intermediate in the manufacturing process (Annex B).....

6. Although a wide range of medicines may be implicated - and the present proposal is to write to companies for more information - an "instant" telephone survey of manufacturer of vaccines used for children has already been undertaken in response to a request from Dr Harris. The results are in Dr Adams' minute of 14 February (Annex C) - the proviso in his second paragraph, last sentence should be noted. 89/02.15/11.1

89/02.15/11.2 MF580439/1 0584 SOUTHWOOD REPORT: BSE AND MEDICINAL PRODUCTS

1. I attach a list of questions on BSE and medicines compiled with the aim of providing question and answer briefing to DH and MAFF Ministers upon publication of the Southwood Report. I have suggested names of those who may be able to provide answers. All recipients are invited to consider which if any important areas have been missed. Also attached is copy QA briefing being proposed by MAFF. I understand MAFF have produced General QA briefing on the reports as a whole. ..

MF580439/1 0585 Question

1. Which medicines are affected? (person to provide reply) Dr. Jefferys

2. Are the risks greater with some medicines than others? Dr. Jefferys

3. Why are medicines affected? Dr. Jefferys

4. Are some affected products available over the counter from pharmacies or shops? Dr. Purves

5. Are only UK products at risk? Dr. Jefferys

6. Are existing stocks safe? Dr. Jefferys

7. Are pre 1980 stocks available? Mr. Burton

8. Are these alternatives to the use of bovine material? Dr. Purves

9. Why can't we throw away suspect stock and import or manufacture safe medicines? Dr. Jefferys

10. Which patients are at risk? Dr. Jefferys

11. Are some patients particularly vulnerable? Dr Jefferys

12. What risks exist to those who have already used these medicines? Dr. Jefferys

13. HOW might patients be affected? Dr. Jefferys

14. Can BSE be transmitted to patients by medicines? Dr. Jefferys

15. How long will it be before risks are quantified? Dr. Jefferys

100 89/02.17/10.2 MF580439/1 0586

16. What research is going on to find out if medicines can transmit this disease and if any patients have been affected? Dr Jefferys

17. Could recent cases of Creuuzfeld Jacob Disease have been caused by transmission of BSE through medicines? Dr. Jefferys

18. What action is the Licensing Authority taking to ensure proper scrutinising of source materials and manufacturing processes? Dr. Jefferys/Dr. Purves

19. Are the guidelines practical? Dr. Jefferys/Dr. Purves

20. Will the guidelines remove the risk? Dr. Jefferys

21. How will the guidelines be enforced? Dr. Jefferys/Dr. Purves

22. How soon will they come into force? Dr. Jefferys

23. Will the guidelines be published? Mr. Hagger

24. What is being done to reassure patients, parents etc? Mr. Hagger/Dr. Salisbury

25. What advice is being given to doctors, pharmacists etc? Mr. Hagger

26. What advice is the Government giving about its vaccination programme? Dr. Salisbury

27. Is the vaccination programme put at risk because of BSE? Dr. Salisbury

89/02.17/10.3

Q. Will government act on this?

A. Yes - thymus is not used in preparation of baby foods but it is contacting all manufacturers to seek their urgent views on use of kidneys and liver from ruminants. Will consider any necessary measures in the light of their response.

VETERINARY MEDICINES

Q. Can medicines spread BSE to other cattle/animals?

A. The report describes any risks as remote.

Q. How can risks be avoided?

A. In liaison with the DOH the Veterinary Products Committee is examining guidelines for the veterinary pharmaceutical industry which will be issued shortly.

Q. What will Guidelines say?

A. In essence they call for non-bovine sources to be used if possible, including synthetic material of biotechnological origin. Where this is not possible the industry should look for sources which are free of BSE and which are collected in a manner which avoids risk of contamination by the BSE agent.

89/02.17/10.4 MF580439/1 0588

A. Bovine source material is used in [garbled, cannot read...TSS] and some other medicines.

Q. How many medicines are involved?

A. Computer records show that about 300 of the 3,050 veterinary medicines licensed in the U.K. are manufactured directly from bovine source material. However, other medicines may be produced from bovine sources and a letter is going to all license holders so that a comprehensive list can be drawn up.

89/06.19/8.1 BSE3/1 0191 Hr J Maslin (MAFF) Ref: Maslin3g

From: Dr H Pickles Med SEB/B Date: 3 July 1989

CATTLE BY-PRODUCTS AND BSE

I was interested to see the list of by-products sent to the HSE. Those of particular concern included:

* small intestines: sutures (I thought the source was ovine but you are checking this)

* spinal cord: pharmaceuticals

* thymus: pharmaceuticals

Are you able to give me more information on which UK manufacturers use these materials? Our proposed ban on bovine offal for human consumption would not affect these uses, I assume.

Id No. 1934/RD/1 89/08.10/6.1 117A

BOVINE SPONGIFORM ENCEPHALAPATHY MEETING HELD ON 21 AUGUST 1989 AT 2;15 IN ROOM 720 Miss M Duncan (Chairman) Mr W Burton Dr E Hoxey Mrs J Dhell Ms K Turner Dr S Whittle Mr N Weatherhead ... 5. The MCA had sent 2700 questionnaires out, 1,124 had made valid returns; of these 122 use animal material of some kind and there are 582 products involved. ... 6. The MCA/BSE working group will meet on 6th September. Their aim is to review responses from professional officers in MCA who have suggested seven categories of importance (with 1 being the most important} for medical products:

ID 2267/NRE/1 89/08.21/10.1

1. Products with Bovine brain/lymph tissue administered by injection.

2. Products with bovine tissue other than brain/lymph administered by inection.

3. Tissue implants/open wound dressing/surgical materials/dental and ophthlamic products with bovine ingredients.

4. Products with bovine ingredients administered topically.

5. Products with bovine ingredients administered orally.

6. Products with other animal/fish/insect/bird ingredients administered by injection/topically/oral routes.

7. Products with ingredients derived from animal material by chemical processing (eg stearic acid, gelatine, lanolin ext.

The BSE working group will decide which of these are important, and should be examined more closely, and which categories can be eliminated.

The responses by the companies were presented by Ms Turner and were categorised by MCA standards, the products that were discussed were all low volume usage products eg sutures, heart valves.

8. As the responses included some materials of human origin it was decided that more information should be sought about CJD. There had been 2 recent deaths reported associated with human growth hormone. These were being investigated.

9. Re-editing of the Paper on "Incubation of Scrapie-like Agents"

It was suggested that the document could be sent out to companies with the non-standard sterilization Document. The document could have severe implications on the companies whose products have a high risk factor as decided by the MCA working group....

11. The Need for a list of High Priority Implantables The commitee decided that no list is necessary as all implantables, including ones from a human source are of high priority. Concern was shown over Killingbeck who use human material but had not yet responded. The company will be chased for a response. Concern was shown over the fact that there may be other scrapie-like organisms in other animals and further enquiries should be made.

2334q/RD/4 89/08.21/10.7

BOVINE MATERIAL USED IN THE MANUFACTURE OF SURGICAL IMPLANTS AND BLOOD CONTACT MEDICAL DEVICES

Glutaraldehyde, formaldehyde, and ethylene oxide are used in the sterilization of these devices.

However, glutaraldehyde 4,10,12,19 formaldehyde 5,10,11,13,19 and ethylene oxide 19,23 are all reported to be ineffective methods for sterilization of material infected with the agents of CJD or scrapie.

Previous advice and research using the agents of CJD and scrapie, has concentrated on the decontamination of equipment; protection of health care workers from contaminated human material; human growth hormone; and dura mater. The methods developed may not be directly applicable or transferable to material of bovine origin for use in human implantation.

2334q/RD/7 89/08.21/10.10 BSE11/2 020 SC1337

DEPARTMENT OF HEALTH AND SOCIAL SECURITY Richmood House 79 Whitehall, London SW1A 2NS Telephone 01-210-3000 From the Chief Medical Officer Sir Donald Acheson KBE DM DSc FRCP FFCM FFOM

Mr K C Meldrum Chief Veterinary Officer Ministry of Agriculture, Fisheries and Food Government Buildings Hook Rise South Tolworth Surbiton Surrey KT6 7NG

3 January 1990

Dear Mr. Meldrum,

BOVINE SPONGIFORM ENCEPHALOPATHY

You will recall that we have previously discussed the potential risks of BSE occurring in other Countries as a result of the continuing export from the UK of meat and bone that may be contaminated by scrapie or possibly BSE.

I remain concerned that we are not being consistent in our attempts to contain the risks of BSE. Having banned the feeding of meat and bone meal to ruminants in 1988, we should take steps to prevent these UK products being fed to ruminants in other countries. This could be achieved either through a ban on the export of meat and bone meal, or at least by the proper labelling of these products to make it absolutely clear they should not be fed to ruminants. Unless some such action is taken the difficult problems we have faced with BSE may well occur in other countries who import UK meat and bone meal. Surely it is short sighted for us to risk being seen in future as having been responsible for the introduction of BSE to the food chain in other countries.

I would be very interested to hear how you feel this gap in the present prcautionary measures to eliminate BSE should be closed. We should be aiming at the global elimination of this new bovine disease. The export of our meat and bone meal is a continuing risk to other countries.

Signed Sincerely Donald Acheson

Did the US import fetal calf serum and vaccines from BSE-affected countries? 3002.10.0040: FETAL BOVINE SERUM (FBS) U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 2,727 233 131,486 8,502 Australia . . . . . . . . --- --- 19,637 2,623 Austria . . . . . . . . . --- --- 2,400 191 Belgium . . . . . . . . . --- --- 17 32 Canada . . . . . . . . . 900 110 30,983 3,220 Costa Rica . . . . . . . 500 20 4,677 169 Federal Rep. of Germany --- --- 105 21 Finland . . . . . . . . . 1 8 9 83 France . . . . . . . . . --- --- 73 7 Guatemala . . . . . . . . --- --- 719 42 Honduras . . . . . . . . --- --- 1,108 88 Israel . . . . . . . . . --- --- 24 165 Netherlands . . . . . . . --- --- 1 5 New Zealand . . . . . . . 26 5 65,953 913 Panama . . . . . . . . . --- --- 1,195 64 Switzerland . . . . . . . 971 8 1,078 23 United Kingdom . . . . . 329 82 743 756 Uruguay . . . . . . . . . --- --- 2,764 98 ------------------------------------------------------------------ 3002.20.0000: VACCINES FOR HUMAN MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 25,702 26,150 550,258 378,735 Austria . . . . . . . . . --- --- 45 225 Belgium . . . . . . . . . 14,311 12,029 248,041 199,036 Canada . . . . . . . . . 1,109 1,527 15,798 16,305 Denmark . . . . . . . . . 80 234 246 682 Federal Rep. of Germany 1,064 4,073 12,001 6,329 France . . . . . . . . . 3,902 4,859 87,879 92,845 Ireland . . . . . . . . . --- --- 120 478 Italy . . . . . . . . . . --- --- 2,359 81 Japan . . . . . . . . . . 445 1,903 11,350 11,298 Netherlands . . . . . . . --- --- 94 6 Republic Of South Africa --- --- 2 1 Spain . . . . . . . . . . --- --- 60 30 Switzerland . . . . . . . 716 353 9,303 4,271 United Kingdom . . . . . 4,075 1,172 162,960 47,148 ------------------------------------------------------------------ 3002.30.0000: VACCINES FOR VETRINARY MEDICINE U.S. Imports for Consumption: December 1998 and 1998 Year-to-Date (Customs Value, in Thousands of Dollars) (Units of Quantity: Kilograms)

<--- Dec 1998 ---> <--- 1998 YTD ---> Country Quantity Value Quantity Value ================================================================= WORLD TOTAL . . . . . . . 6,528 237 87,149 2,715 Canada . . . . . . . . . --- --- 2,637 305 Federal Rep. of Germany --- --- 104 5 Netherlands . . . . . . . 138 64 472 192 New Zealand . . . . . . . 6,390 173 83,882 1,895 United Kingdom . . . . . --- --- 54 318



http://www.mad-cow.org/00/may00_news.html



Procedures Manual

Bovine Spongiform Encephalopathy (BSE)

Ongoing Surveillance Plan

Ongoing Surveillance Plan Implementation July 20, 2006

snip...

Personal Safety

If BSE is transmissible to humans in the occupational setting, the most likely routes would be through contact with infective tissues through wounds or open lesions on the skin, contact with mucous membranes (eyes and mouth), or exceptionally, by swallowing.

.....snip...end



http://www.aphis.usda.gov/vs/nvsl/PDFs/BSE%20Ongoing%20Surveillance%20SOP%207-20-06.doc




SO, looks like to me the most likely route of transmission of TSE to humans might be through inoculations that would contain the TSE agent.

IF you look at all the successful transmission studies in the lab with TSE agent, inoculations was the most successful route. ...

Terry S. Singeltary Sr.

P.O. Box 42

Bacliff, Texas USA 77518

=============================================

Subject: Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S. From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy Date: Sat, 21 Apr 2007 20:46:06 -0500 Content-Type: text/plain Parts/Attachments: text/plain (2171 lines)

greetings,

i thougt some might want to read some old data on this topic ;

36. On 5 June 1989 I sent a minute to the CMO’s Private Secretary [169] (YB 89/06.05/3.1)



http://www.bseinquiry.gov.uk/files/yb/1989/06/05003001.pdf



reporting on progress. This was unusual for me but I assume I did this I had minuted him previously and because of the degree of involvement the CMO had in the issues. The minute explained that most responses to questionnaires had been received and were currently being reviewed, and a preliminary scan of the data so far available had not identified any information requiring immediate special action. Further, the MCA were applying the new guidelines to licence applications and renewals. The use of bovine insulin in a small group of mainly elderly patients was noted and it was recognised that alternative products for this group were not considered satisfactory. (I seem to recall that later some of these patients did become quite ill when transferred to other forms of insulin.)

37. I received a copy of Dr Metters’ minute to Mr Clarke of 7 June 1989 on further measures MAFF were proposing to take to extend the offal ban [170-172] (YB 89/06.07/6.1-6.3).



http://www.bseinquiry.gov.uk/files/yb/1989/06/07006001.pdf



This advised of the effect this would have of drawing attention to the continued use of bovine material in medicines and brought to Mr Clarke’s attention my minute of 5 June 1989. The following day Dr Metters sent a minute to the CMO’s private secretary which he described as a follow up minute for officials only and it was copied widely to colleagues in the Medicines Division [173-174] (YB 89/06.08/7.1-7.2).



http://www.bseinquiry.gov.uk/files/yb/1989/06/08001001.pdf



http://www.bseinquiry.gov.uk/files/yb/1989/06/08007001.pdf




38. On 9 June Dr Metters similarly updated the CMO on developments [175-186] (YB 89/06.07/6.1-6.3 ; 89/06.07/7.1-7.2 ; 89/06.05/3.1 ; 89/06.09/5.1-5.4) .



http://www.bseinquiry.gov.uk/files/yb/1989/06/09005001.pdf




The same day in a minute to Mr Wilson and various other colleagues [187] (YB 89/06.09/14.1)




http://www.bseinquiry.gov.uk/files/yb/1989/06/09014001.pdf



http://www.bseinquiry.gov.uk/files/yb/1989/06/27008001.pdf




I relayed the information about the proposed offal ban and also sought comments on the recommendations on pharmaceutical research issues that had been provided in draft by the Tyrrell Committee. (The report was submitted to Ministers on 13 June 1989.) On 7 September Dr Pickles sent me a minute regarding the Tyrrell report and its implication for medicinal products [196-197] (YB 89/09.07/3.1-3.2).

Subsequently there was a fair amount of correspondence between the Departments and their ministers about funding Tyrrell’s research proposals. I was not involved in this issue.

39. Questionnaire responses were analysed and outstanding replies were requested so that papers were ready for the BSE Working Party chaired by Professor Collee to consider them at a meeting on 6 September 1989 [188-195] (YB 89/09.06/10.1-10.8). I did not attend but I would have seen the minutes or the recommendations, which would have been available for the CSM’s meeting on 28 September 1989 [198-205] (YB

89/09.28/10.1-10.8). (I was not involved in the deliberations over the sourcing of bovine material for a particular licensed surgical suture because this was the remit of the CDSM which, at that time, fell outside my area of responsibility.) The recommendations of the BSE Working Party were:-

"1. That no licensing action is required at present in regard to products produced from bovine material or using prepared bovine brain in nutrient media and sourced from outside the United Kingdom, the Channel Isles and the Republic of Ireland provided that the country of origin is known to be free of BSE, has competent veterinary advisers and is known to practise good animal husbandry.

2. The Joint CSM/VPC guidelines should apply to all bovine material sourced from UK, Channel Islands and the Republic of Ireland and any other area known to have BSE. Companies which at present cannot comply should be encouraged to do so as soon as possible. The timescale should be agreed with the Licensing Authority for each individual product as appropriate.

3. No licensing action is required at present with respect to products containing material from animals other than cattle.

4. The Licensing Authority should continue to review scientific progress in

the field of BSE, so as to be in a position to take licensing action in the future should this be necessary."

The CSM endorsed these recommendations.

40. I discussed the action to be taken following the CSM meeting with Dr Jefferys, Dr Adams and Dr Purves around 13 October as documented in a memo from Dr Jefferys to Mr Love of that date [206] (YB 90/10.13/6.1). We agreed that the further advice of the BSE Working Group was needed and a meeting was planned for January 1990.

41. I later received a copy of a minute dated 14 November from Mr Robertson, who at that time was responsible for administrative issues relating to the CDSM (and therefore for products such as sutures which were considered by the CDSM) to Mr Davey, the private secretary to the Minister for Health and copied to the private secretaries to the other relevant ministers and to the CMO, regarding the possibility of media comment following a scientific conference on BSE to be held at the RSM the following day. The minute reiterated the advice of the Southwood report that the risk to man from medicinal products was theoretical and remote, referred to the CSM/VPC guidelines on manufacturing issued in March 1989 and confirmed that the CSM and MCA were continuing to monitor the position [207-209]. (YB 89/11.14/13.1-13.3)

1990

42. I did not attend the January 1990 meeting of the CSM BSE Working Group [210-233] (YB 90/01.10/7.1-7.7 ; 89/09.06/15.1-15.3) 221-233 (L2 Tab 3B) or the February CSM meeting [234-237] (YB 90/02.21/10.1-10.8); as a result of the MCA reorganisation (see below) my responsibilities had changed and these matters were no longer in my area. I cannot remember whether I would have seen the papers circulated for these meetings. By about February the new shadow businesses had been formed in the MCA, I had become co-ordinator for Business E (which was to take on responsibility for the Medicines Commission and the Medicines database but otherwise had no responsibilities for licensing matters, the CSM or other committees, or BSE) and Mr Bewley, the CSM Secretary, had become part of the management trio for Business A. In the Department's Distribution of Business, however, I continued to be shown as MB1 until October 1990 and so continued to receive some Departmental correspondence. Where I received material that was not for Business E or, later, B I would have passed it on to the appropriate person for action.

43. On 13 March the European Commission gave a decision regarding BSE, banning the export of certain bovine tissues and organs for human consumption and certain other bovine tissues and organs (including foetal calf serum, lymphoid tissue and cell cultures) for uses other than human consumption. Dr Metters subsequently sent a minute to Mr Bewley, copied to me, commenting on the possible effect of this decision on UK pharmaceuticals. He asked whether the CSM BSE Working Party had considered whether licensed products that still used bovine constituents should be asked to transfer to non-UK bovine source material [238] (YB 90/03.26/6.1). Mr Bewley (ex-MB1C but now Business A and Secretary to the CSM) responded to Dr Metters by a minute of 27 April 1990 (copied to various people including me) [244-254] (YB 90/04.27/5.1-5.4) which provided an update as to the current position on the few licensed medicines using bovine material sourced from the UK including stocks of vaccines; all new products were required to meet the guidelines. Dr Metters was also informed of the advice of the BSE Working Group. In a further minute of 1 May, Dr Metters indicated that he had noted the recommendations of the Working Group; he commented that even though any risk of transmissions of BSE through vaccination was remote, it would be desirable to replace existing vaccine stocks with New Zealand sourced products as soon as possible [255] (YB 90/5.1/8.1). He requested to be kept abreast of developments and would have discussed the issue with CMO if he had considered this appropriate.

44. On 26 April 1990 I attended a CSM meeting [239-243] (YB 90/04.26/9.1-9.5) at which a letter from the British Diabetic Association concerning the safety of bovine insulin was considered and a response approved confirming there was no insulin sourced from cattle in the UK or Ireland and that the situation in other countries was being monitored. By this time, I would have been aware of my impending appointment to Business B (Abridged Licensing) and that I would be establishing new links with the CSM.



http://www.bseinquiry.gov.uk/files/ws/s476.pdf




Bovine insulin

From: "Terry S. Singeltary Sr."

Hello , it might be beneficial for you to read the DFA 17. it has some valuable information in it, but some is outdated. there is disturbing news on the DOSE, and just how much infectivity it takes to infect an individual. i will post next. meanwhile, the url to DFA 17 is below the short article........

regards, Terry

--------------

207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records:

6. Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources. In addition, cell cultures for many vaccines used a bovine serum medium. Dr Harris undertook to speak to the Director of NIBSC about biological products. 13. Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF. Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin. In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened. 14. In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals. The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.

----------------

Medicines and medical devises;

----------------

235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed. She also asked about the species used in the manufacture of any licensed rabies vaccines.[281] 236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]

-----------------------

‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.

----------------------------

4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). ..........

Subject: Re: Bovine Insulin CJD/BSE $ Ignorant Doctors (Part 2) Date: December 6, 2000 at 8:05 am PST

In Reply to: Bovine Insulin CJD/BSE $ Ignorant Doctors posted by TSS on December 6, 2000 at 8:03 am:

4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].

--------------------------

271. The second part of the paper, entitled ‘Bovine Spongiform Encephalopathy – Action by Medicines Division’ states: 1.Product Licence Situation The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin. It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.

-----------------------------

3.1 Parenteral use There are three products in this category: i. Insulin ii. Bovine collagen implants iii. Bovine fibrin implants. The latter two are used in surgery and are the province of the CDSM.

------------------------------

6.2 Parenteral products

The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use.

In addition to this for parenteral products in general:

i. All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin. ii. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents. iv. While the agent of BSE is not known it is not possible to advise specific inactivation processes.

7. Recommendations for action

i. No licensing action should be taken against oral products. ii. All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents. iv. All licences for new products from bovine material should comply with the above. v. The Review/CDSM Sections should carry out a search for preparations containing bovine material. vi. There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds. vii. The ADR database should be searched for ADRs to bovine products. viii. The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.’[319]

------------------------------

hope this helps out.

HUMAN/ANIMAL TSE's ARE A 'WORLD' PROBLEM.....

TSS

BSE Inquiry Draft Factual Account 17




http://www.bse.org.uk/dfa/dfa17.htm




Q-3. What are FDAs concerns regarding the importation of beef insulin for my personal use?

A. There is a possible threat of bovine spongiform encephalopathy (BSE) or "mad cow disease" transmission through the use of beef insulin if derived from tissue contaminated with BSE agent.



http://www.fda.gov/cder/drug/beefinsulin/default.htm#Q-3



http://www.bseinquiry.gov.uk/files/yb/1990/04/30006001.pdf



http://www.mad-cow.org/00/may00_news.html




Human vaccine prepared in animal brains



http://www.mad-cow.org/00/nov00_late_news.html#fff



http://www.whale.to/v/singeltary7.html



http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh



COMMERCIAL IN CONFIDENCE NOT FOR PUBLICATION SUB COMMITTEE ON BIOLOGICALS. COMMITTEE ON SAFETY OF MEDICINES

CSM/SEAR/88 10TH MEETING. BIOLS/88/6TH MEETING

This paper was discussed by the Biological Sub-Committee on 2 November 1988, when the following recommendations were made;

1. No immediate licensing action should be taken against oral products, in which bovine material has been used.

2. All bovine materials should come from cattle from appropriately certified healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products.'

3. Manufacturers of parenteral products should show that their manufacturing processes are capable of eliminating scrapie-like agents.

4. All licences for new products from bovine materials should comply with the above.

5. There should be an article in MAIL requesting manufacturers to identify products in which bovine materials have been used. Bovine albumin and foetal calf serum should come from appropriately certified healthy herds.

6. The above should be drawn to the attention of the review/CDSM sections along with the need to search for preparations containing bovine material.

7. The above should be drawn to the attention of the ADR Section and SEAR along with the need to search the ADR database for reactions to bovine products.

REMARK.

1. The Licensing Authority's attention was drawn to the need to give ongoing consideration to whether action was required on bovine insulin and heparin products.

88/11.02/5.1



http://www.bseinquiry.gov.uk/files/yb/1988/11/02005001.pdf



'political risk of worrying large number of diabetic patients'



http://www.bseinquiry.gov.uk/files/yb/1988/05/24003001.pdf



207. On 17 March 1988 Dr Watson and Mr Alastair Cruickshank, Under Secretary of MAFF, attended a meeting with the CMO and senior medical officials at the DHSS to discuss BSE.[249] The minute of the meeting records: 6. Biological products were produced of bovine origin and this applied to a significant proportion of insulin despite genetically manufactured sources. In addition, cell cultures for many vaccines used a bovine serum medium. Dr Harris undertook to speak to the Director of NIBSC about biological products. 13. Mr Cruickshank thought it necessary to assess the risk in humans in order to justify the cost of any control measures taken by MAFF. Although it would be possible to monitor diabetics, it could take 20 years or more before we would be able to assess whether any risk existed from bovine insulin. In the meantime, with some 40 or so new cases in cattle a month, the disease would become newsworthy and it was important that both government departments arrange appropriate action before this happened. 14. In conclusion it was agreed that urgent advice was necessary on biological products and the disposal of sick animals. The options would be outlined to Ministers (of both government departments) and they would be asked to agree the setting up of an expert advisory group.

----------------

Medicines and medical devises;



http://www.bse.org.uk/dfa/dfa17.htm



----------------

235. On 2 June 1988, Dr Pickles responded to Mrs Alderman requesting a further database search and asking about bovine insulin, which was not on the list of products, although licensed. She also asked about the species used in the manufacture of any licensed rabies vaccines.[281]

236. Mrs Alderman replied on 3 June 1988, listing products containing bovine insulin and noting there were two rabies vaccines listed but the species used in manufacture was not shown.[282]

-----------------------

‘There has been one instance of inadvertant [sic] transmission of the scrapie agent to sheep through louping ill vaccine (Gordon, Bronlee and Wilson 1939). One of the three batches of vaccine made in 1935 at the Moredun Institute contained the scrapie agent resulting in 7% of the recipients of the 18, 000 doses in the batch developing scrapie. This vaccine was made from formalin-inactivated sheep brain, and brought to the attention of research workers that formalin, at a concentration of 0.35% for at least 3 months, which inactivated conventional viruses, did not totally inactivate the scrapie agent.

----------------------------

4. Questions we might want to have answered are: the highest risk would be from parenterals prepared from brain (eg rabies vaccine). Any species in which transmissible spongiform encephalopathies have been described would be suspect (“natural” infections in sheep, goats, cattle, deer, mink, but can be transmitted to hamster, mouse, guinea-pig etc). Are sterilisation processes adequate for the most resistant strain of scrapie agent or for CJD agent? Should companies be asked to include investigation for inclusion of scrapie agent (eg mouse innoculation [sic]) in at least some batches? If BSE behaves like scrapie, then we might expect other nervous tissue, spleen, lymph nodes and placenta to be contaminated. Infection has been described in other tissues too, eg gut wall, and we can not [sic] be sure blood is free. Do we know what bovine materials are used in which products, both as the active ingredient and in production? Bovine active ingredients in human products include insulin, vasopressin, bone, immune globulins, fibrin, dermal collagen, albumin. Bovine serum albumin and fetal calf serum must be used in preparation of very many products. For each of these products would any “BSE agent” be destroyed or eliminated in processing? If not, and the product is administered parenterally or topically into an open wound, might there be a risk? [For oral products, there would only be a trivially increased load on top of that taken in food in omnivores/carnivores including man. But for some herbivores, this might allow the agent to be introduced into yet another species].

--------------------------

271. The second part of the paper, entitled ‘Bovine Spongiform Encephalopathy – Action by Medicines Division’ states: 1.Product Licence Situation The computer list shows 53 product licences extant for preparations of bovine origin and of these 42 are for insulin. It is not clear how complete this list is, particularly on the review side where there may be grounds for concern, especially with regard to products for cellular therapy.

-----------------------------

3.1 Parenteral use There are three products in this category: i. Insulin ii. Bovine collagen implants iii. Bovine fibrin implants. The latter two are used in surgery and are the province of the CDSM.

------------------------------

6.2 Parenteral products The major problem here appears to be with insulin. The use of bovine insulin is rapidly declining and maybe restricted to those patients who have antibodies to the human preparation, or who cannot tolerate it. In this case bovine insulin is life saving, and the risk to benefit would currently be in favour of retaining its use. In addition to this for parenteral products in general: i. All cattle used for the preparation of these products should come from certified healthy herds, and not to have been given food supplements containing material of animal origin. ii. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing procedure is capable of inactivating scrapie-like agents. iv. While the agent of BSE is not known it is not possible to advise specific inactivation processes. 7. Recommendations for action i. No licensing action should be taken against oral products. ii. All bovine products should come from cattle from healthy herds, which have not been given food supplements containing material of animal origin. No brain or lymphoid tissue should be used in parenteral products. iii. Manufacturers of parenteral products should show that their manufacturing processes are capable of inactivating scrapie-like agents. iv. All licences for new products from bovine material should comply with the above. v. The Review/CDSM Sections should carry out a search for preparations containing bovine material. vi. There should be an article in MAIL requesting manufacturers to identify bovine preparations used in the manufacturing process. Bovine albumin and foetal calf serum should come from healthy herds. vii. The ADR database should be searched for ADRs to bovine products. viii. The Committee is asked to consider whether to take any action against bovine insulin or whether the risk/benefit ratio is appropriate.’[319]

------------------------------

hope this helps out........TSS

Rick Wolf wrote:

From: "Rick Wolf"

My mother who died of CJD in 1998 was an diabetic requiring insulin

since the 1960s. She used a bovine based insulin for many years. I

read in the newpaper yesterday that blood banks are screening

people who may have used bovine base insulin before 1985 because of

potential risk of CJD/TSE.

Does anyone have any more info on this? For those that lost a loved

one to CJD, did they use bovine based insulin?

Robin

----------------------------------------------------------------------

Eileen MacArthur wrote:

From: Eileen MacArthur

Terry...

Just got your info on beef insulin..what a blow to read it in

print. Strange we always suspected a connection with it to Mom who died July

17/98. She took it for 27 years...now I really am wondering. I too take

insulin but not that one.

Eileen

Reading your emails about vaccines brought something to mind.

Although my mom was the one that died on Dec. 10, 98 from CJD....... my dad died on June 20, 83 from complications with diabeties. I remember dad saying insulin was made from pork. Is this still true?

Could diabetics be at a higher risk for CJD?

Terry, would you know anything about this? Just wondering......

Thanks, Suzanne riptss

Terry...

Just got your info on beef insulin..what a blow to read it in print. Strange we always suspected a connection with it to Mom who died July

17/98. She took it for 27 years...now I really am wondering. I too take insulin but not that one. Eileen

Greetings Voice members, after reading over Paul Brown statement to Robin, I find them most interesting, hope he is correct... Terry

____________________________________________________________

Another thing....I asked Dr. Brown about the Hep. B. shot and it being manufactured in the U.K. and Belgium and here was his reply......

Dear Robin:

Thanks for the name and address.

As for vaccines, I'm not an expert, but Hepatitis B can under some circumstances be transmitted from person to person without needle or sexual penetration, and so for public health purposes I suppose it is justified to require vaccination.

As for risk of CJD, you would not need to worry, even if the vaccine was stabilized with albumin from a cow with BSE! Blood from BSE-infected cattle is not infectious, and even if it were, the albumin extracted from it would not be infectious. Both of these statements are based on experimental evidence.

Hope this helps Paul

----------------------------------------------------------------oooops...........tss

9663 Re: [CJDVoice] Your help again [CJD QUESTIONNAIRE PART 3] ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. Nov 18, 2001 9:09 pm 19662 Re: [CJDVoice] Your help again [CJD QUESTIONNAIRE PART 2] ... the date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement therapy ... Terry S. Singeltary Sr. Nov 18, 2001 8:59 pm



http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=100&cnt=10



http://health.groups.yahoo.com/group/cjdvoice/message/22712



http://health.groups.yahoo.com/group/cjdvoice/message/22711



http://health.groups.yahoo.com/group/cjdvoice/message/22695




22717 CJD QUESTIONNAIRE... updated version II...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. flounder@... madson1 Nov 5, 2002 12:51 pm 22716 RE: [CJDVoice] CJD QUESTIONNAIRE...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. No known routine medications to my knowledge._ _ _ Prompt for hormone therapy or nutritional supplements including ... Helen Severietti helen@... Nov 5, 2002 12:51 pm 22715 CJD QUESTIONNAIRE... updated version...TSS ... date, name of the medication, the reason for taking it, and route of administration) prompt for prescription drugs, including insulin and type. _ _ _ Prompt for hormone therapy or nutritional supplements including oral contraceptives and hormone replacement ... Terry S. Singeltary Sr. flounder@... madson1 Nov 5, 2002 11:46 am



http://health.groups.yahoo.com/group/cjdvoice/msearch?query=insulin&pos=80&cnt=10



Tracie Kedzierski wrote:

Terry,

The only problem is that having it on our messageboard conflicts with the information I have on our home page about the surveillance project and the report form I send out to the families.-----it is confusing. In fact..I'm sorry but we (The Foundation) have to pull it off.



http://health.groups.yahoo.com/group/cjdvoice/message/22778



http://health.groups.yahoo.com/group/cjdvoice/message/36030



CWRU CJD QUESTIONNAIRE HISTORY


http://cjdquestionnaire.blogspot.com/



years ago, ARMOUR use to sell a BOVINE based thyroid drug. i don't believe they sell it anymore. i think it was called thylar or something. wonder how many women used that one ??? its documented in the voice archive years back somewhere. ...terry

Q. The Claim: Synthroid is the Best Thyroid Hormone Replacement Drug

If you are hypothyroid, your doctor will probably prescribe Synthroid. This levothyoxine (synthetic thyroxine) drug, made by Abbott Labs, is the top-selling thyroid drug in the U.S., commanding some two-thirds of the market for thyroid replacement. Synthroid is, however, often more costly than its competitors. Some doctors won't hear of prescribing anything but Synthroid however, and claim unequivocally that "Synthroid is the best." Is That So? A. Levothyroxine is the synthetic form of T4, one of the two main hormones the thyroid produces. The most widely prescribed levothyroxine product is the brand name Synthroid. Given that levothyroxine is the conventional medical world's accepted treatment for hypothyroidism, most patients will find themselves prescribed

levothyroxine, and usually Synthroid. Synthroid's manufacturer has at times claimed their drug to be better than its competitors, but research proved Synthroid to be merely bioequivalent -- or equal, in terms of what function they perform in the body -- to their competition, rather than better. This claim of superiority, therefore, actually has no merit. Many doctors, however, still erroneously believe that Synthroid is "better," after being subject to years of this misleading advertising message. All the major brandname levothyroxine products, Synthroid, Unithroid, Levoxyl and Levothroid, have different fillers and binders, so people may have different allergic responses to the different brands.



http://pagead2.googlesyndication.com/


So, if you react to one levothyroxine, your doctor might want to try other brands to see if you react to those brands as well.

Some people who are on levothyroxine also need the addition of the second key hormone, T3. Among that group, some people do best with the T3 drug Cytomel. Anecdotally, however, some patients have reported allergic reactions to Cytomel. The option, compounded or time-released compounded T3, has been used successfully by other patients, but there have been concerns about these products, due to inconsistent production. Other doctors and patients prefer a product known as Thyrolar, a synthetic combination of T4 and T3. Some patients do best on natural desiccated thyroid drugs, such as Armour thyroid, or, in some cases, people find the hypoallergenic formula of natural drug, Nature-throid, works best for them. (Pork allergies, however, may make these products problematic for some patients. There are some patients and practitioners who are also concerned about these products due to fears of prion-related diseases such as Mad Cow Disease, despite manufacturer assurances that these products are safe.) So is Synthroid, or any thyroid drug, better than the others? I think Dr. Richard Shames, a Boca Raton, Florida holistic practitioner and co-author of Thyroid Power and Fat, Fuzzy and Frazzled? -- who has treated thyroid conditions for a quarter century -- has the best advice for patients. "In 25 years of practice, I have found that it doesn't necessarily matter which kind of thyroid hormone you start with so much, as which kind you end up with after trying several different types to see which one works best for you. Initially, I typically recommend whatever type they have either heard about, have a "gut-feeling" about, know family members who have a good response to a particular kind of medicine, or have a philosophical inclination for one kind or another. Sometimes it it the combination of two or three of the above medicines that proves to be the magic solution for a particular person. If the initial item tried does not give 85-95% improvement, I then encourage the person to either add something to their first choice product or discontinue it and start something totally new. It is my firm belief that the state of the art in finding the optimal medicine is still trial and error." The answer is, the best drug is the drug which safely makes you feel your best. And there's no predetermined formula to tell which drug will be the best for you, until you try them, find optimal doses, and see how you do over time.

Mary Shomon, About.com's Thyroid Guide since 1997, is a nationally-known patient advocate and best-selling author of 10 books on health, including "The Thyroid Hormone Breakthrough: Overcoming Sexual and Hormonal Problems at Every Age," "The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss," "Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You...That You Need to Know," "Living Well With Graves' Disease and Hyperthyroidism," "Living Well With Autoimmune Disease," and "Living Well With Chronic Fatigue Syndrome and Fibromyalgia." Click _here_


(http://thyroid.about.com/mbiopage.htm)


for more information on Mary Shomon.




From: Terry S. Singeltary Sr. (wt-d4-166.wt.net) Subject: Re: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW Date: August 16, 1998 at 14:14:48 EST

In Reply to: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW posted by Terry S. Singeltary Sr. on July 28, 1998 at 14:12:38:

I am having a hard time getting information on ingrediants of these drugs. Nobody wants to cooperate. Although I have found the names and ingrediants of some with DESICCATED ANIMAL (T4/T3). ARMOUR Thyroid tablets for oral use are natural preparations derived from porcine (Pork) thyroid glands. From the late 1890's until relatively recently, physicians worldwide have treated hypothroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Admimistration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were "GRANDFATHERED" into the system, consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain betwee 90% to 110% of the standard chemical content. Also Thyrolar contains synthetic T3. There is also Cytomel. I believe all these contain desiccated animal. I am still searching. Maybe the Thyroid Society could find time to list these drugs and their Ingrediants. None of the Drug company's will cooperate. You start talking about dessicated animals in these drugs and asking for ingrediants from people and they lose their tounge./

MADCOWDEADMOMMADSON/TERRY

PLUS, ARMOUR MADE A BOVINE THYROID MEDICATION SOME TIME BACK CALLED "THYRAR" MADE FROM DESSICATED BOVINE THYROID GLAND...

Subject: Mad Cow / Mad Pig and Thyroid Risks Date: November 10, 2000 at 2:24 pm PST Mad Cow / Mad Pig and Thyroid Risks

Could food supplements and medications be inadvertent media for the spread of prion based brain diseases? Multiple sources would suggest this is possible, even likely, due to the use of animal gelatins. This probability goes up even more when the medication itself is a glandular extract.

Importance

BSE / Mad Cow / TSE (Transmissible Spongiform Encephalopathies) are NOT a small topic!

Nobel Prize awarded to Carleton Gajdusek for Kuru/TSE research Nobel Prize awarded to Stanley Prusiner for TSE/Prion research Pulitzer prize winning author Richard Rhodes wrote "Deadly Feasts" on the controversy ISBN 0-684-84425-7 (Mentioned on 259 web pages) Oprah dedicated a show to BSE/Mad Cow, was sued by Texas cattlemen, Courts upheld her 1st Amendment right to Freedom of Speech! Cows, Sheep, Pigs, Mink, Humans have all caught and died of TSE's Prions can not be killed by mere boiling or cooking Over 200,000 deaths/year by 2015 predicted by Prof. Lacey (below) Over 30,700 web pages mention Mad Cow (AltaVista) Web pages on Chaperonins, chemicals possibly preventing the mis-folding of proteins which are the basis for TSE's and Alzheimer's, jumped from 2 to over 6,000 in one year!

Clearly, Transmissible Spongiform Encephalopathies, such as BSE and CJD (one human form,) are a topic of some controversy, one we should all become more aware of.

Mad Cow Censorship

Some questions were raised on the Thyroid mailing list out of StJohns.EDU regarding where the various natural thyroid supplements come from, and how safe they may be with respect to Mad Cow Disease. The basic text of this article was conveniently "discarded" by the moderator, as it seems are a number posts questioning the safety of natural thyroid extracts, or discussing non-prescription alternatives to them. Such pro-prescription medication biases are not new to certain moderated mailing lists... some of which may be rabidly pro something, others against, at the whims of biased or subsidized moderators. (The biases of that list are mild, compared to some other lists, such as an ozone list several years back.) Always look for biases when considering internet, and any other information sources.

Researchers on BSE / TSE say this kind of censorship is not new. Dr. Harash Narang, a British microbiologist and CJD researcher, says he first detected variant CJD in humans back in 1988. He claims that he was ordered to stop work on BSE in 1990, and subsequently "laid off". He believes that British authorities have blocked and undermined such research and detection efforts. (British press articles)

Thyroid Supplements and Mad Cow / BSE

There are natural thyroid extracts, such as Armour Thyroid, and synthetics such as Cytomel and Synthroid. The natural ones are taken from the thyroid glands of animals, such as pigs.

On page 220 of Rhodes' book, Nobel Price winner Dr. Carleton Gajdusek is quoted saying pigs are routinely slaughtered before the disease would become evident in them. Carleton Gajdusek is one of the foremost researchers of Kuru and other "Transmissible Spongiform Encephalopathies", TSE, of which Bovine Spongiform Encephalopathy, Scrapie, CJD, and Kuru are variants.

In the book, Dr. Gajdusek is quoted: "the disease hasn't turned up in pigs only because you don't keep pigs alive for seven or eight years; they're killed after two or three years at the most. When we kept pigs we'd inoculated in our laboratory for eight years, they came down with scrapie. [a TSE variant] Probably all the pigs in England are infected. And that means not only pork, it means your pigskin wallet. It means catgut surgical suture, because that's made of pig tissue. All the chickens fed on meat-and-bone meal; they're probably infected. You put that stuff in a chicken and it goes right through"... And in America, beef cattle are killed at or before age two, before they are likely to show outward symptoms. (Page 228)

Mad Cow in America

In America, chicken excreta is fed to cattle as a good source of nitrogen. (Page 258.) As for the American FDA's ban on feeding meat and animal by-products to cattle, Rhodes writes "That's a ban with exclusions big enough to drive a cortege of hearses through." Their own TSE advisory committee urged the FDA take stronger measures. (Page 257.)

According to the book, Bovine Spongiform Encephalopathy has been detected in America, and not just in cattle; the American form is yet another variant TSE, which does not cause the staggers and other behaviors found in British cattle, but results in a more "sedate" collapse of the victim, referred to as "downer cattle". The nature of the brain damage is also distinct; a spongiform with differently shaped and oriented vacancies. Other forms have been transmitted via eating wild squirrels, and wild bear. Some zoos have lost animals to TSE's.

Human Epidemic

Dr. John Pattison, Chairman of the British government's Spongiform Encephalopathy Advisory Committee (SEAC), Dean of the University College of London Medical School, believes 500,000 people may already be incubating CJD in Britain. [Dr. Alsleben.] Dr. Alsleben, in his excellent Mad Cow web site, states that prions can be found in white blood cells contaminating milk, and even in the animal grease used in lipstick. (URL at end) Professor Richard Lacey of the Microbiology Department of Chapel Allerton Hospital, Leeds, points out on page 222 of the book that "there was no certainty that the source of infection had been cut off."... "'If it seems that the incubation-period average for CJD in humans begins to be about twenty five years, maybe thirty years,' he told me grimly, 'then the peak human epidemic will come around the year 2015. If the current numbers of variant CJD cases [the main human TSE,] increases by fifty percent per year compound, as they well might, that would take it to about two hundred thousand cases a year by then'. Human cases, that is 200,000 deaths per year" (In Britain.)

Others suggest that 5% OR MORE of the Alzheimer's cases in America may be due to CJD and other TSE variants. If so, are we already seeing the beginning of a growing tide of TSE related deaths?

Limiting Factors

It is noted that amongst the Fore, the cannibals who got kuru, another TSE variant similar to CJD, only some one percent of the population seemed affected.

This one percent figure suggests a genetic bias, and some genetic biases have been detected. This may serve as a model for predicting human death rates. Evidence suggest a one in a million rate of spontaneous occurrence among susceptible species. Once inserted into a food chain that recycles animal protein, one in a hundred may get it.

In America, that one percent would translate to well over two and a half million slow, expensive deaths, a far worse epidemic

than AIDS! But... not the end of civilization as we know it.

One is reminded that there have been many plagues in human history; plagues like the Black Plague, the Justinian Plague, and many others. Humanity has thus far survived, even if reduced in numbers. No need to panic; just act wisely.

Prions and Counters

Several Prion variants have been found, some of which act quickly, some of which act far more slowly, so the 25 year estimate may be considerably off. There is also recent research on chaperonins, biochemicals that assist in folding proteins, which may be related to resistance to prion diseases. (Prion diseases are believed to involve folding of proteins, and what is similar to crystal growth of the mis-folded proteins.) See http://www.mad-cow.org/ and look up chaperonin at http://www.AltaVista.Digital.com , a term that only had two pages on the web last year, and now has over six thousand!

Will we find a cure for Spongiform Encephalopathy? Unlikely, since the spongiform phase is caused by massive death of neural tissue; tissue which can not regrow. That said, we might yet find ways of preventing the degeneration where it has not already occurred. So caution might be well advised.

Incubation

Twenty five years incubation time is a long time.... If one ends up with thyroid supplements in one's late thirties, it might be age 65 when some of the more noticeable effects begin to become evident. Those with less resistant genetics may display effects much sooner. Others may die of other dis-eases before the effects of TSE would become clearly visible. And most... may even avoid coming down with the disease.

And yet... Science News ran an article on Alzheimer's research in which some researchers claimed they could often detect the condition decades early simply by noting the manner of speech and writing of a person. People with pre-Alzheimer's conditions seem to rely more on lists and relationships, than logic and cause-and-effect reasoning about the world. They also tend to write shorter, simpler sentences long before clinical neurological deficits become evident. (Research was done using nuns, comparing their original statements of intent to become nuns, with their conditions decades later.)

Is Alzheimer's a form of TSE? Some would say yes, others would say no. And still others have suggested many cases of Alzheimer's are really TSE, but not all. The lesions in the brain are similar, but not identical.

Weigh the Risks

We must all weigh risks v.s. benefits ourselves. I am not a doctor, I can not advise you; you have to think for yourself. Like Oprah, I have stopped eating beef; as well as all other animal meats and animal products like gelatin. I dump the contents of all my gelatin capsules into a spoon, and discard the empty capsules. I also avoid "ranched" fish like catfish and salmon. Is that enough? I don't know. With luck, I may never find out.

A one percent rate sounds considerably better than other estimates I have run across. However, the real question I have is, what are the subtle effects long before the final destruction? If these prions are indeed the rod-like structures researcher Patricia Merz describes on page 156, then they would likely impede cellular machinery long before they became long enough to break cell membranes and kill the cells. Thus it is possible that long before that final break, subtle neurological effects could

become evident. Dr. Merz findings of prions in spleen tissue and elsewhere is quite disturbing, as it suggests prions may travel freely in the blood of these animals, and thus would imply that all tissue is likely to harbor some prions, not just brain tissue. Thus, over 25 million of us may be at grave risk to our health; and our relatives, at risk for extreme emotional and financial stresses as they contribute to our care as we slowly go mad and die of CJD.

Your health is your responsibility, not your doctor's. It is you who must decide what behaviors, and risks, are acceptable to you.

Books and Resources

"Deadly Feasts", by Pulitzer prize winner Richard Rhodes. ISBN0-684-84425-7. Worth reading! http://www.mad-cow.org/ Mentioned by Rhodes as a valuable current record on this developing topic. Dr. Harry Alsleben, a preventative medicine researcher, calls this "Our Greatest Biological Catastrophe", His excellent web site is dedicated to warning people about prion diseases; and exposing the policies that warn "officials", while attempting to minimize public concerns and short term financial impact to industry. What is more, he use to sell animal collagen products. He stopped and accepted the financial loss when he learned about BSE. I salute him for his responsible actions. Resources from PBS - Nova The Brain Eaters episode on Mad Cow disease. (Presumably, this site will not be up forever.)



http://www.mall-net.com/mcs/madcow.html



From: Terry S. Singeltary Sr. (wt-d4-166.wt.net) Subject: Re: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW Date: August 16, 1998 at 14:14:48 EST

In Reply to: THYROID MEDICATION, PIGS , PIG FEED, AND MADCOW posted by Terry S. Singeltary Sr. on July 28, 1998 at 14:12:38:

I am having a hard time getting information on ingrediants of these drugs. Nobody wants to cooperate. Although I have found the names and ingrediants of some with DESICCATED ANIMAL (T4/T3). ARMOUR Thyroid tablets for oral use are natural preparations derived from porcine (Pork) thyroid glands. From the late 1890's until relatively recently, physicians worldwide have treated hypothroid patients with tablets containing desiccated (dried and powdered) animal thyroid glands. These tablets contained both levothyroxine (T4) and triiodothyronine (T3). In 1958, the first synthetic levothyroxine tablets were marketed in the United States. Because thyroid hormones were on the market before the Food and Drug Admimistration (FDA) laws were in place, manufacturers of these hormones were not required to meet the extensive testing requirements of safety and effectiveness required of all new drugs introduced after 1938. In other words, thyroid hormone replacements, such as synthetic levothyroxine, were "GRANDFATHERED" into the system, consequently, there are no FDA approved procedures or standards for testing these preparations other than specifying that each pill contain betwee 90% to 110% of the standard chemical content. Also Thyrolar contains synthetic T3. There is also Cytomel. I believe all these contain desiccated animal. I am still searching. Maybe the Thyroid Society could find time to list these drugs and their Ingrediants. None of the Drug company's will cooperate. You start talking about dessicated animals in these drugs and asking for ingrediants from people and they lose their tounge./MADCOWDEADMOMMADSON/TERRY

PLUS, ARMOUR MADE A BOVINE THYROID MEDICATION SOME TIME BACK CALLED "THYRAR" MADE FROM DESSICATED BOVINE THYROID GLAND...

TSS

WONDER if any of our loved ones had taken "THYRAR" ??? (way back)

don't ask, don't find, cjd questionnaire. .............TSS

mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:BSE-L@LISTS.AEGEE.ORG

Bovine Spongiform Encephalopathy

BSE-L is a discussion forum for scientists who are interested in Bovine Spongiform Encephalopathy (BSE). BSE-L has been created on 20th July, 1994 by Siegfried Schmitt. Impressum: http://www.kaliv.de/impressum.html

DRAFT FACTUAL ACCOUNT

LISTS.AEGEE.ORG ( BSE-L: 28 matches.. )

mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=46104545F4D3582B66&Y=flounder9@verizon.net&q=draft+factual+account&s=&f=&a=&b=

LISTS.AEGEE.ORG ( BSE-L: 42 matches.. )

Item # Date Time Lines Subject 017701 2007-04-21 20:46 2210 Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S. 015613 2005-03-04 17:09 1001 Re: BSE 'may have entered baby food in 70s' 015611 2005-03-04 08:18 594 BSE 'may have entered baby food in 70s' 014989 2004-10-28 15:03 1080 Re: IFST updated Information Statement on BSE and Variant 014138 2004-03-31 22:02 538 'Babyfood CJD killed lad' ? 011869 2002-10-12 12:56 490 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011864 2002-10-11 16:51 642 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011867 2002-10-11 13:21 314 Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011863 2002-10-11 09:04 248 BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE 011785 2002-09-23 22:03 830 deer hunters and farmers and TSEs (a comparison) & a small survey of sCJD/CWD? 011493 2002-06-27 12:00 961 TSS/CWD/NEWS + state by state overview of game farms 010721 2001-08-11 16:01 210 ''Baby Foods'' and CJD * June 23, 1999 BSE Inquiry 009325 2000-12-04 16:20 285 'BSE/EXPORT COVER-UP' a review of 'the wrong' priorities $$$ 008889 2000-10-27 15:11 393 Some factual accounts about Mrs. Richardson's early observation of BSE 008452 2000-08-10 12:52 94 Re: ProMED (new var.), iatrogenic dental transmission risk 008440 2000-08-09 09:47 340 United States gets 'free' ride on level II of the GBR's $$$ 007229 1999-12-16 09:34 86 Re: U.S.'s application for assessment of BSE-status that was sentto the E.U.??? 007153 1999-11-29 14:06 73 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007144 1999-11-28 11:46 179 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007142 1999-11-27 18:54 588 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007140 1999-11-27 12:03 402 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007133 1999-11-26 10:36 303 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007126 1999-11-25 22:30 214 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007125 1999-11-25 13:17 82 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007124 1999-11-25 11:21 90 Re: Girl, 13, shows CJD symptoms. [re-baby food] 007016 1999-11-03 20:37 68 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007017 1999-11-03 20:31 80 Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] 007010 1999-11-03 08:36 141 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007008 1999-11-03 00:07 127 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007006 1999-11-02 11:49 142 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007003 1999-11-02 00:22 74 Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006998 1999-11-01 09:28 90 DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006940 1999-10-14 16:36 44 Drugs may have been made from BSE infected cattle 006312 1999-04-16 00:04 385 Monkey business at Marwell Zoo 006091 1999-02-14 20:21 116 Re: DFA 11 "The Touch Test" 006085 1999-02-13 10:46 91 Re: DFA 11 "The Touch Test" 006066 1999-02-11 00:04 90 Re: DFA 11 "The Touch Test" 006065 1999-02-10 05:56 55 Re: DFA 11 "The Touch Test" 006062 1999-02-09 11:37 49 DFA 11 "The Touch Test" 006027 1999-01-28 05:28 59 Re: History of BSE in UK 006022 1999-01-27 00:08 74 Re: History of BSE in UK 005892 1999-01-04 07:46 147 Inquiry Draft Factual Account of Southwood Committee

Item #17701 (21 Apr 2007 20:46) - Re: 100 Diabetics warned about mad cow exposure tissue came from cattle in the U.S.

Hello , it might be beneficial for you to read the DFA 17. it has some valuable information in it, but some is outdated. takes to infect an individual. i will post next. meanwhile, the url to DFA 17 is below the short article........

Item #15613 (4 Mar 2005 17:09) - Re: BSE 'may have entered baby food in 70s'

99. Mr. Lawrence wrote a

industry involved, as

opposed to Heather and the Baby Food industry.

For obvious reasons, if the DFA's are accurate, and the statements

within from the

Working Party and the Gov. and the statement from the

manufacturers of Baby Foods,

where they are stating in DFA 9;

"152.

There is no evidence of written assurances from the manufacturers

cord, spleen intestines and thymus;

What would you understand this

to mean? Firstly, the DFA paragraph 152 does _not_ say "the

manufactures could not supply this information to the Gov". It says

that there is no written evidence that they did -- not the same thing

at all. I do _not_ understand the DFA paragraph 152 to mean "the

statement made by the manufacturers to the Gov." and nor should you.

Item #15611 (4 Mar 2005 08:18) - BSE 'may have entered baby food in 70s'

99. Mr. Lawrence wrote a letter industry involved, as >opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the >Working Party and the Gov. and the statement from the manufacturers of Baby Foods, >where they are stating in DFA 9; >"152. There is no evidence of written assurances from the manufacturers spleen intestines >and thymus; > >What would you understand this to mean? Firstly, the DFA paragraph 152 does _not_ say "the manufactures could not supply this information to the Gov". It says that there is no written evidence that they did -- not the same thing at all. I do _not_ understand the DFA paragraph 152 to mean "the statement made by the manufacturers to the Gov." and nor should you. Paragraph 152 refers to

Item #14989 (28 Oct 2004 15:03) - Re: IFST updated Information Statement on BSE and Variant industry involved, as >opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the >Working Party and the Gov. and the statement from the manufacturers of Baby Foods, >where they are stating in DFA 9; >"152. There is no evidence of written assurances from the manufacturers

Item #14138 (31 Mar 2004 22:02) - 'Babyfood CJD killed lad' ?

I would like to point out in DFA 9

Item #11869 (12 Oct 2002 12:56) - Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE

I would like to point out in DFA 9

Item #11864 (11 Oct 2002 16:51) - Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE

I would like to point out in DFA 9

Item #11867 (11 Oct 2002 13:21) - Re: BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE industry involved, as opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the Working Party and the Gov. and the statement from the manufacturers of Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers

Item #11863 (11 Oct 2002 09:04) - BABY FOODS MAY HAVE BEEN CONTAMINATED WITH SRMs/MRMs and BSE

I would like to point out in DFA 9

Item #11785 (23 Sep 2002 22:03) - deer hunters and farmers and TSEs (a comparison) & a small survey of sCJD/CWD?

DFA 16

Item #11493 (27 Jun 2002 12:00) - TSS/CWD/NEWS + state by state overview of game farms and issues the permits required for possession. Department of Food & Agriculture (DFA) becomes the lead over captive cervids only if a disease outbreak occurs which could impact livestock (TB and

Item #10721 (11 Aug 2001 16:01) - ''Baby Foods'' and CJD * June 23, 1999 BSE Inquiry

I would like to point out in DFA 9



http://www.bse.org.uk/dfa/dfa09gs.htm



BSE INQUIRY DFAs


http://bseinquiry.blogspot.com/



Sunday, May 18, 2008

BSE Inquiry DRAFT FACTUAL ACCOUNT DFA

BSE Inquiry DRAFT FACTUAL ACCOUNTS DFA's


http://bseinquiry.blogspot.com/2008/05/bse-inquiry-draft-factual-account-dfa.html



Sunday, May 18, 2008 BSE, CJD, and Baby foods (the great debate 1999 to 2005)


http://bseinquiry.blogspot.com/2008/05/bse-cjd-and-baby-foods-great-debate.html



Sunday, May 18, 2008 MAD COW DISEASE BSE CJD CHILDREN VACCINES


http://bseinquiry.blogspot.com/2008/05/mad-cow-disease-bse-cjd-children.html




Item #9325 (4 Dec 2000 16:20) - 'BSE/EXPORT COVER-UP' a review of 'the wrong' priorities $$$ 46. Mr Wilesmith's early work, the involvement of NPU, and the establishment of a BSE Group are dealt with in the CVL DFA.

Item #8889 (27 Oct 2000 15:11) - Some factual accounts about Mrs. Richardson's early observation of BSE Mrs.Richardson may have said or not, and almost about what has been heard or not from her (see extract 3) . As far as the CVL DFA is concerned it seems that it exist some oppositions within the CVL organisation. see to events up to the decision to establish the Southwood Working Party. SCDFA refers to the Slaughter and Compensation Draft Factual Account (DFA 6), CVLDFA refers to the CVL Draft Factual Account (DFA 4) and the RFBDFA refers to the Ruminant Feed Ban Part 1 Draft Factual Account (DFA 7), all of which should be read in conjunction with this document. examinations of these samples, and the conflict of evidence about the conclusions reached, are dealt with in the CVL DFA.

brain of a nyala which had been kept at Marwell Zoo. This examination, and subsequent consideration of the nyala, are described in the CVL DFA.

----------- Extract 3 of the CVL DFA about The controversy about the examination of BSE------

Item #8452 (10 Aug 2000 12:52) - Re: ProMED (new var.), iatrogenic dental transmission risk I remember reading, (please don't ask me to reference, because i am seeing double now), but it was in one of the DFA's and the threat to children via baby-foods. But i remember someone stating in the DFA, of the risk from infected gums in children, teething in children, and the lesions of the gums, and the potential

Item #8440 (9 Aug 2000 09:47) - United States gets 'free' ride on level II of the GBR's $$$

RE-DRACONIAN MEASURES; DFA 5

Item #7229 (16 Dec 1999 09:34) - Re: U.S.'s application for assessment of BSE-status that was sentto the E.U.???

Also, if you will read DFA-25 about exports, paragraph 69;

Item #7153 (29 Nov 1999 14:06) - Re: Girl, 13, shows CJD symptoms. [re-baby food] sought by MAFF from the baby food manufacturers. And it is in _that_ context, that the DFA says that any such written assurances have not been found in the papers submitted to the BSE Inquiry.

Item #7144 (28 Nov 1999 11:46) - Re: Girl, 13, shows CJD symptoms. [re-baby food]

Firstly, the DFA paragraph 152 does _not_ say "the manufactures could not supply this

I do _not_ understand the DFA paragraph 152 to mean "the statement made by the

Item #7142 (27 Nov 1999 18:54) - Re: Girl, 13, shows CJD symptoms. [re-baby food]

opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements wit hin from the Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturer At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9

Item #7140 (27 Nov 1999 12:03) - Re: Girl, 13, shows CJD symptoms. [re-baby food] opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the Baby Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9

Item #7133 (26 Nov 1999 10:36) - Re: Girl, 13, shows CJD symptoms. [re-baby food] opposed to Heather and the Baby Food industry. For obvious reasons, if the DFA's are accurate, and the statements within from the by Foods, where they are stating in DFA 9; "152. There is no evidence of written assurances from the manufacturers s At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9

Item #7126 (25 Nov 1999 22:30) - Re: Girl, 13, shows CJD symptoms. [re-baby food] At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9

Item #7125 (25 Nov 1999 13:17) - Re: Girl, 13, shows CJD symptoms. [re-baby food] At 11:21 AM 11/25/99 -0600, Terry wrote: I would like to point out in DFA 9

Item #7124 (25 Nov 1999 11:21) - Re: Girl, 13, shows CJD symptoms. [re-baby food]

I would like to point out in DFA 9

Item #7016 (3 Nov 1999 20:37) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,

Item #7017 (3 Nov 1999 20:31) - Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime

Item #7010 (3 Nov 1999 08:36) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,

Item #7008 (3 Nov 1999 00:07) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,

Item #7006 (2 Nov 1999 11:49) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,

Item #7003 (2 Nov 1999 00:22) - Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A.,

Item #6998 (1 Nov 1999 09:28) - DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., Terry S. Singeltary Sr., Bacliff, Texas USA -- Greetings, I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments

Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a

Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract

Item #6940 (14 Oct 1999 16:36) - Drugs may have been made from BSE infected cattle Also, the new DFA 17, Medicines and Medical devices, has been published at the BSE Inquiry site below,

Item #6312 (16 Apr 1999 00:04) - Monkey business at Marwell Zoo YB86/7.8/1.1 ) This examination, and subsequent consideration of the report, are described in the CVL DFA.

unlikely to give his approval.(YB87/6.29/3.1; YB87/7.1/2.1; YB87/7.1/3.1-3.10 ) This is further discussed in the CVL DFA.

6; YB86/7.8/1.1 ) This examination, and subsequent consideration of the report, are described in the CVL DFA.

CVO was unlikely to give his approval.(YB87/6.29/3.1; YB87/7.1/2.1; YB87/7.1/3.1-3.10 ) This is further discussed in the CVL DFA.

Item #6091 (14 Feb 1999 20:21) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:006201be5736$1fe05a80$272d9c3e@pentium>

Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of The complete reference is actually (49) . M37/91/3.15/1.1-1.4 and it is the only reference in DFA 11 prefixed "M".The Committee of Inquiry will know, but I have no idea what M37 stands for (at a guess, Memo 37?? But then why isn't it in the 1991 YB?). The reference (49) relates to paragraph 34 of DFA 11 which reads

Item #6085 (13 Feb 1999 10:46) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"

Bear in mind that each DFA is an collation of evidence on a specific topic

given by different Inquiry witnesses, and, as the introduction to each

states, "The Draft Factual Accounts are intended to help the Committee of

Inquiry in their further work." All of the references in a DFA are to

statements, evidence transcripts, and documents which the three members of

Item #6066 (11 Feb 1999 00:04) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:002201be54b5$2da11de0$eebd9ec1@pentium

DFA 11 "The touch test", one of the four latest additions to the BSE

Inquiry Web site, is in fact a bringing together of all the evidence at the

Presumably there will be a sequel DFA relating to the evidence relating to

the post-1993 period and his claims for ante-mortem tests for BSE and CJD.

Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of

Item #6065 (10 Feb 1999 05:56) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"

DFA 11 "The touch test", one of the four latest additions to the BSE

Inquiry Web site, is in fact a bringing together of all the evidence at the

Presumably there will be a sequel DFA relating to the evidence relating to

the post-1993 period and his claims for ante-mortem tests for BSE and CJD.

Item #6062 (9 Feb 1999 11:37) - DFA 11 "The Touch Test" Organization: consultant Subject: DFA 11 "The Touch Test"

DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the

Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.

Item #6027 (28 Jan 1999 05:28) - Re: History of BSE in UK Emily Green, formerly a cookery writer, has merely put together her story from a newly issued DFA on the BSE Inquiry Web site, one of six that I drew attention to in a message here yesterday.

Item #6022 (27 Jan 1999 00:08) - Re: History of BSE in UK Emily Green, formerly a cookery writer, has merely put together her story from a newly issued DFA on the BSE Inquiry Web site, one of six that I drew attention to in a message here yesterday. But she displays

Item #5892 (4 Jan 1999 07:46) - Inquiry Draft Factual Account of Southwood Committee In response to the Inquiry request for comments on the three Draft Factual Accounts so far published, I have sent the following comment on the DFA on the Southwood Committee -- I haven't had time to study the other two yet misunderstanding and debate in the intervening years. It is the first sentence of sub-paragraph 2 of paragraph 9, shown in the DFA section 371--

We now have, in evidence to the Inquiry, quoted in the DFA, incontrovertible proof that, in its deliberations, the Southwood Committee the benefit of public understanding, I suggest that, after section 371 of the DFA, a note should be inserted, drawing attention to the Southwood Committee's understanding of the meaning of "dead end host" as exemplified

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LISTS.AEGEE.ORG ( BSE-L: 12 matches.. )

Item # Date Time Lines Subject 007016 1999-11-03 20:37 68 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007017 1999-11-03 20:31 80 Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] 007010 1999-11-03 08:36 141 Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] 007008 1999-11-03 00:07 127 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007006 1999-11-02 11:49 142 Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] 007003 1999-11-02 00:22 74 Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006998 1999-11-01 09:28 90 DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] 006091 1999-02-14 20:21 116 Re: DFA 11 "The Touch Test" 006085 1999-02-13 10:46 91 Re: DFA 11 "The Touch Test" 006066 1999-02-11 00:04 90 Re: DFA 11 "The Touch Test" 006065 1999-02-10 05:56 55 Re: DFA 11 "The Touch Test" 006062 1999-02-09 11:37 49 DFA 11 "The Touch Test"

Item #7016 (3 Nov 1999 20:37) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,

Item #7017 (3 Nov 1999 20:31) - Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reportsofBSEoutbreaks in Germany,France,and even in the U.S.A.,a prime Item #7010 (3 Nov 1999 08:36) - Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany, France,and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports ofBSEoutbreaks in Germany,

Item #7008 (3 Nov 1999 00:07) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,

Item #7006 (2 Nov 1999 11:49) - Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France, and even in the U.S.A.,a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: Re: DFA 18 Cosmetics...[There have been reports of BSEoutbreaks in Germany, France,

Item #7003 (2 Nov 1999 00:22) - Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: Roland Heynkes Subject: Re: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A.,

Item #6998 (1 Nov 1999 09:28) - DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., a prime market for Jersey cattle] From: "Terry S. Singeltary Sr." Subject: DFA 18 Cosmetics...[There have been reports of BSE outbreaks in Germany, France, and even in the U.S.A., Terry S. Singeltary Sr., Bacliff, Texas USA -- Greetings, I have been reading over the latest DFA 18, about cosmetics, and the possible route of BSE, through this source. Several interesting comments

Page 24, DFA 18, -- "the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a

Page 60, DFA 18, cosmetics -- 4. If it is possible for humans to contract

Item #6091 (14 Feb 1999 20:21) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:006201be5736$1fe05a80$272d9c3e@pentium>

Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of The complete reference is actually (49) . M37/91/3.15/1.1-1.4 and it is the only reference in DFA 11 prefixed "M".The Committee of Inquiry will know, but I have no idea what M37 stands for (at a guess, Memo 37?? But then why isn't it in the 1991 YB?). The reference (49) relates to paragraph 34 of DFA 11 which reads

Item #6085 (13 Feb 1999 10:46) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"

Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of

Item #6066 (11 Feb 1999 00:04) - Re: DFA 11 "The Touch Test" Organization: consultant Subject: Re: DFA 11 "The Touch Test" In-Reply-To: <mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:002201be54b5$2da11de0$eebd9ec1@pentium>

DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the

Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.

Bear in mind that each DFA is an collation of evidence on a specific topic given by different Inquiry witnesses, and, as the introduction to each states, "The Draft Factual Accounts are intended to help the Committee of Inquiry in their further work." All of the references in a DFA are to statements, evidence transcripts, and documents which the three members of

Item #6065 (10 Feb 1999 05:56) - Re: DFA 11 "The Touch Test" From: "Roland Heynkes @ T-Online" Subject: Re: DFA 11 "The Touch Test"

DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the

Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.

Item #6062 (9 Feb 1999 11:37) - DFA 11 "The Touch Test" Organization: consultant Subject: DFA 11 "The Touch Test"

DFA 11 "The touch test", one of the four latest additions to the BSE Inquiry Web site, is in fact a bringing together of all the evidence at the

Presumably there will be a sequel DFA relating to the evidence relating to the post-1993 period and his claims for ante-mortem tests for BSE and CJD.

mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:https://lists.aegee.org/cgi-bin/wa?S2=BSE-L&X=40522815A4EA0CEA99&Y=flounder9@verizon.net&q=DFA&s=DFA&f=&a=&b=

The BSE Inquiry / Statement No 527 Mr M B Baker Issued 30/09/1999 (not scheduled to give oral evidence) STATEMENT OF M B BAKER 1. I am replying to a request from the BSE Inquiry for information on my involvement in the issue of guidance to educational establishments on the dissection of bovine eyeballs. In particular this statement addresses concerns that there was undue delay on the part of the Department for Education and Science (now the Department for Education and Employment) in issuing guidance to schools after SEAC had recommended on 2 July 1990 that the practice of bovine eyeball dissection should be avoided [YB90/7.2/3.4]. 2. My comments relate specifically to a draft of a ‘Draft Factual Account’ (‘DFA’) which the Inquiry’s secretariat sent me, and of which I understand a revised version is to be published. I told the Inquiry secretariat that to the best of my recollection the version of the account that I saw seemed to me accurate and comprehensive, though the events occurred between six and nine years ago and my memory was not infallible. 3. I was a Head of Division (Grade 5 Officer) in Schools Branch 3 (responsible for school curriculum and assessment matters) during most of the period covered by the draft factual account and until my retirement from the Department and the public service in February 1994. My involvement with the subject of the account – guidance on the dissection of bovine eyeballs – 2 began in July 1990 and ended in June 1993 when responsibility for the subject was transferred to another Branch of the Department. 4. I was the senior officer who at the time was given and accepted responsibility for the issue of advice to schools on the dissection of bovine eyeballs. It is clear from the draft factual account that there was delay in the issue of such advice, and I do not disclaim my major share of responsibility for that delay. 5. I accepted that responsibility when the handling of the bovine eyeballs business was reviewed within the Department by senior colleagues at the end of 1992, in response to ministers’ concerns about the delay in issuing advice. It was then concluded that I had made significant errors in judgement in dealing with this piece of business; in particular in not ensuring that the matter was brought to the early attention of Ministers, and in taking a view on questions of public sensitivity that were probably a matter for Ministers. The outcome for me was a reprimand and a caution as to my future conduct. 6. Against this background, I shall not attempt a detailed defence of myself and my actions or inaction. However, I want to help the Inquiry as far as I can, so I attach a commentary on the main chronological phases of the story. It is subject to the same qualification: that my memory is fallible. 7. The main purpose of this commentary is to indicate the work preoccupations of myself and my Division over the periods in question. With hindsight, it is clear that the issue of advice to schools should have been regarded as urgent 3 and given a high priority. However, that was less clear to me and others at the time – before any new variant of CJD associated with bovine spongiform encephalopathy had been identified. The advice we had been given was that infection by the BSE agent through accidental inoculation in the course of dissecting bovine eyeballs was a remote theoretical risk. There was no epidemiological evidence of the transmission of the disease to humans, and the scientific literature seemed to suggest that transmission was highly unlikely. I recognise that we were not competent to make our own judgement on these matters and should never have been trying to do so. But my point is that I never believed in any real risk to pupils and saw the issue of advice to schools as an ultra-precautionary measure. 8. At that time the Branch, and my Division within it, was under very heavy and unrelenting pressure to introduce a statutory national curriculum and associated assessment measures, subject by subject, to an exacting and inflexible timetable determined by Ministers. At t e beginning of the timeframe of the DFA this had just been further complicated by a decision to revise completely the statutory orders for science and mathematics almost as soon as they had come into operation: a task that fell on Mr Jacobs and his team under my oversight. Later unexpected work requirements falling on myself and my Division included a review of the English curriculum order and an overhaul of the GCSE examining arrangements. 9. In this context, I saw the subject of precautionary guidance on bovine eyeball dissection as a distraction from our main agenda, and gave it a lower priority. 4 With hindsight again, it is now obvious that I attached too much weight to the reservations expressed by HMI and medical advisers about the public sensitivity of the subject and the possible implications of causing alarm or dismay. Such reservations should not have delayed a submission to Ministers, but rather formed a part of that submission. That was my major mistake, and I attribute it to the fact that as a result of my policy preoccupations I was giving insufficient attention to the subject. Of course those preoccupations reflected my perception of the DFEE Ministers’ own priorities. Health Ministers would have had different priorities, but the fact is that for a long time officials of the Department of Health did little to bring pressure on my Department. It was not until very late in the story (October 1992) that they made quite clear the importance their Ministers attached to the issue of guidance to schools on the dissection of bovine eyeballs and pressed us strongly for action. It was only then that I realised that there was a clear political imperative and public commitment to action. COMMENTARY ON THE DRAFT FACTUAL ACCOUNT July 1990 to 1991 The story began, so far as the Department and myself were concerned, with the approach by our Senior Medical Officer, Dr Ernaelsteen, who told us of the decision of the Tyrrell Committee. We were not directly approached with any request for action by officials of the Department of Health. 5 It seemed to us, or at least to me, that there was an initial issue whether it was necessary and appropriate to give advice to schools at all, and we consulted HMI in accordance with established Departmental practice. As to the nature of that advice, there was much discussion with officials of DH and MAFF, and a certain amount of vacillation and indecision. Should we also be advising against the use of sheep’s eyeballs? Should we advise on alternative resources (pigs, horses – and what about calves?) Should teachers continue to be able to demonstrate the dissection of eyeballs to their pupils? And there were arguments about the dangers of ingestion (as opposed to parenteral inoculation). During this period I was preoccupied with bringing to a successful conclusion the establishment of History in the National Curriculum: possibly the most contentious of all our tasks. The team under Mr Jacobs concerned with the bovine eyeball guidance was given the unbudgeted task of reviewing the national curriculum orders for both mathematics and science, which involved working overtime and at weekends. May 1991 to May 1992 By May 1991, although the first stage of consultation appeared to be complete the process had lost impetus. HMI had circulated extracts from the scientific press and were questioning the need to proceed. My Division was heavily engaged in priority curriculum tasks. Mr Jacob’s team was still engaged in the review of the mathematics and science orders. I had been given responsibility for the establishment of music in the National Curriculum, was trying to salvage an expensive curriculum materials development project on ‘Language in the Curriculum’, and was fighting a rearguard 6 defence of the English curriculum order against critics inside and outside Government. By about April 1992 it would seem from the DFA that we should have been in a position to issue the advice so long in gestation. However, delay itself had bred indecision and vacillation. HMI expressed doubts about the educationa advantages and the political implications of issuing advice at that point in time. And in May Dr Ernaelsteen expressed the view that the issue of advice was no longer timely, and the advantages would be outweighed by the disadvantages. June to September 1992 In my mind the exercise had taken a new direction, and the task was now to draft a submission to Ministers advising them against the issue of advice on the dissection of bovine eyeballs. However, the wording of a submission was obviously going to be tricky, and I found the draft put up by Miss Casbon unconvincing [YB92/6.8/3.1-3.3]. I did not find the time to produce my own draft. I now had other problems. In June I took over responsibility for the conduct of GCSE examining, which raised questions for urgent resolution about compatibility with National Curriculum assessment. Then the publication of GCSE results in August was followed by a published report from HMI calling in question the integrity of examining standards, and Ministers demanded immediate action. 7 September 1992 onwards In September and October officials of DH made clear to us the importance that their Ministers attached to the issue of advice to schools on bovine eyeball dissection. I learned for the first time of Mr Gummer’s commitment to the House to act on all the Tyrrell recommendations on BSE. From then on we acted with speed. Issued on behalf of the witness by: The BSE Inquiry Press Office 6th Floor Hercules House Hercules Road London SE1 7DU Fax: 0171 803 0893 Website: http://www.bse.org.uk email: mhtml:%7B33B38F65-8D2E-434D-8F9B-8BDCD77D3066%7Dmid://00000131/!x-usc:mailto:inquiry@bse.org.uk 8



http://www.bseinquiry.gov.uk/files/ws/s527.pdf



11.52 We acknowledge the difficulties faced by those called on to make public comments in relation to BSE and the delicate balance between providing necessary information and not creating unwarranted alarm. However, we thought Dr Kendell’s arguments were inconsistent. Whatever action was being taken to tighten up enforcement in December 1995, and in particular to ban MRM, it remained the case that seven years had now passed during which gaps or failures in enforcement had impinged on the food eaten by millions of people. As quoted above, Dr Kendell told us that by 1995 he did not regard the possibility of transmission to man as remote. He had not been following the scientific experiments on BSE, and we saw no evidence that Professor Collinge’s latest experiments on mice would have carried such weight with him at this point as to remove his concerns. 11.53 Having decided to make his statement, Dr Kendell should not have done so without making it plain that the safety of eating beef was dependent on strict compliance with the precautionary measures introduced by the Government in response to the emergence of BSE. At this point in the heated and increasingly polarised public debate, Dr Kendell’s statement is unlikely to have changed anybody’s basic perceptions. However, as we have observed elsewhere, such public statements by a CMO have a special authority of their own and their terms are crucial. They become keystones for judgements not only in the world at large, but within Government Departments and by Ministers, who rely on them as an authoritative basis for policy-making. Notes to editors or supplementary observations in newspaper interviews are ephemeral and not the considered and substantive core material being communicated. Indeed, they can sometimes contribute to the message becoming diluted and wrenched out of context.



http://www.bseinquiry.gov.uk/pdf/volume9/chapter11.pdf



to be continued. ...TSS



Sunday, May 10, 2009


Identification and characterization of bovine spongiform encephalopathy cases diagnosed and not diagnosed in the United States


http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html


Thursday, December 04, 2008 2:37 PM


"we have found that H-BSE can infect humans."
personal communication with Professor Kong. ...TSS


see full text ;


http://bse-atypical.blogspot.com/2009/02/atypical-bse-north-america-update.html



Friday, November 30, 2007


CJD QUESTIONNAIRE USA CWRU AND CJD FOUNDATION


http://cjdquestionnaire.blogspot.com/



Sunday, April 12, 2009 BSE MAD COW TESTING USA 2009


FIGURES Month Number of Tests

Feb 2009 -- 1,891

Jan 2009 -- 4,620


http://www.aphis.usda.gov/newsroom/hot_issues/bse/surveillance/ongoing_surv_results.shtml



see full text ;


http://madcowtesting.blogspot.com/2009/04/bse-mad-cow-testing-usa-2009-figures.html



Monday, May 4, 2009


Back to the Past With New TSE Testing Agricultural Research/May-June 2009


http://madcowtesting.blogspot.com/2009/05/back-to-past-with-new-tse-testing.html



Saturday, April 11, 2009

CJD FOUNDATION SIDES WITH R-CALFERS NO BSE OR HUMAN TSE THERE OF IN USA 'don't be fooled'



Greetings CJD Voice,

PLEASE be aware, R-CALFERS don't believe the USA has mad cow disease. R-CALFERS believe that the only problem in North America is in Canada, and that it's all Canada's fault. R-CALFERS ALSO believe that no human TSE in the USA is caused by eating beef. R-CALFERS only believe in the UKBSEnvCJD only theory. so in my humble opinion, they kinda mirror the CJD Foundations beliefs. dont' be fooled. fool me once, shame on you, fool me twice, shame on me. oh, it looks pretty, but please, i urge everyone here, do not be fooled. 569 members of CJDVOICE and only a few in a click communicates amongst themselves with the cjd foundation (the new one, not cele's old cjd foundation). why was this not posted on the cjd foundation web site (i may have missed it, but could not find it on homepage)? are they not proud that they have now sided with a cattle group that refuses to acknowledge the problem with mad cow disease in the USA, or a human TSE there of ? or maybe this is why it took over a decade or more to get a cjd questionnaire that would ask real questions pertaining to route and source of agent, as opposed to just how and by whom it was diagnosed?


i do not now, and will not ever support a partnership with R-CALF about any TSE, until they stand up and look at themselves in a mirror and admit that the USA is in the same boat as Canada, and that the USA also has a mad cow problem. the sham that took place in 2004, the so called extensive USA BSE surveillance program, was just that, a sham, and proved to be just that. the feed ban was just as much a sham, and proven to be so.


do not be fooled cjdvoice, please do not be fooled.


Bullard and r-calf et al, should stop worrying about Canada, and worry about their own back yard. stop covering up mad cow disease and using the SSS policy. if they would have taken care of business back in 1997, we would not be discussing this. Until a BSE Inquiry is addressed here in the USA against the USDA/FDA et al, and a true enhanced BSE Surveillance and testing program be put forth, we still will never no how many mad cows the USA really have $$$ the last enhanced BSE surveillance program was put forth, even the top prion Scientist said it was terribly flawed, and still is.


i said it a long time ago, ALL CATTLE FOR HUMAN AND ANIMAL CONSUMPTION SHOULD BE TESTED FOR 5 YEARS IN A ROW, before we know to a true extent, just what kind of problem we have. and all the rules and regulations on the mad cow feed ban will not work, unless they are strongly enforced, with severe ramifications when the rules are broke. stupidity is not acceptable anymore. ...



see full text ;



http://prionunitusaupdate2008.blogspot.com/2009/04/cjd-foundation-sides-with-r-calfers-no.html


Sunday, April 12, 2009

r-calf and the USA mad cow problem, don't look, don't find, and then blame Canada


http://prionunitusaupdate2008.blogspot.com/2009/04/r-calf-and-usa-mad-cow-problem-dont.html


Docket No. FDA2002N0031 (formerly Docket No. 2002N0273) RIN 0910AF46 Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed


http://madcowfeed.blogspot.com/2009/04/docket-no-fda2002n0031-formerly-docket.html


CJDVOICE AND CJDFOUNDATION MEMBERS,

FOR all these reasons, is why i oppose the CJD Foundation decission to side with a cattle company that over the years, was as responsible for exposing the USA consumer to mad cow disease as was Canada, and then submit a letter that was written and in support of blaming only Canada. This letter the CJD Foundation supports and ask you to write, is only in support of R-CALF and a closed market to Canada beef, ALL THE WHILE IGNORING AND NOT SAYING A WORD OF PAST AND PRESENT FAILLURES OF THE SAME THING HERE IN THE USA. don't be fooled CJDVOICE. if you support this letter the way it was written, you are only fooling yourselves. you are being played like a pawn. write your own letter/comment, tell them the rest of the story. THIS IS NOT ABOUT CANADA ! the only reason we don't find mad cow disease in the USA, is because they did everything they could do in NOT finding BSE in those some 800,000 cattle that were tested. even Paul Brown called it flawed. dont be fooled cjdvoice and cjd foundation members, don't be fooled. ...

CANADA DID NOT KILL MY MOTHER, AND HER DEATH WAS NO SPONTANEOUS EVENT, OR HAPPENSTANCE OF BAD LUCK. ...

r-calf talks the talk NOW, but they need to practice what they preach at home. clean up their own backyards, stop worrying about Canada. the USA and Canadian cattle market, feed market, import and export between the two, were so intertwined, it was one market. Canada is just being honest, they are testing to find, and finding. the USDA et al did just the opposite, and or years and years that was o.k. with R-CALF. Canada's feed ban is stronger that the USA's feed ban. the only reason the USA is not finding mad cow cases of any phenotype is because of the SSS policy of shoot, shovel, and shut the hell up. ...



Sunday, May 10, 2009

Identification and characterization of bovine spongiform encephalopathy cases diagnosed and not diagnosed in the United States



http://bse-atypical.blogspot.com/2009/05/identification-and-characterization-of.html



Thursday, March 19, 2009


MILLIONS AND MILLIONS OF POUNDS OF MAD COW FEED IN COMMERCE USA


http://madcowfeed.blogspot.com/2009/03/millions-and-millions-of-pounds-of-mad.html



Sunday, May 10, 2009


Meeting of the Transmissible Spongiform Encephalopathies Committee On June 12, 2009 (Singeltary submission)


http://tseac.blogspot.com/2009/05/meeting-of-transmissible-spongiform.html



TSS

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