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BSE Inquiry first day: Judge asks for 6 month extension
BSE Inquiry: transcripts and commenting
Easing of British beef ban backed by veterinary panel
Canada seizes British meat
Was German BSE cow really a Swiss import?
Commentary by Danish rendering experts
Blood factor IX for hemophiliacs -- from transgenic sheep
FDA wonders if CJD-blood should really be recalled
MS-NBC show on BSE and CJD: off-site

BSE probe granted more time

 PA News  Mon, Mar 9, 1998  By John von Radowitz, Science Correspondent, PA News
Prime Minister Tony Blair tonight granted the BSE inquiry team more time to consider the growing mountain of evidence, it emerged today. Appeal Court judge Lord Justice Phillips, heading the panel of three conducting the inquiry, said on the first day of the hearings in London that he needed six more months. He said he would be asking Mr Blair for the extra time.
The judge said: "Having analysed the work to be done, I have concluded that it cannot be completed within a timescale that will result in a report at the end of the year. "I am not prepared to contemplate a report that is superficial because it has been too rushed, and I don't believe that those who are anxiously looking forward to receiving this report would wish us to sacrifice thoroughness for speed."
Under the original timetable Lord Justice Phillips was to have submitted his report on the findings by December 30. Tonight Agriculture Minister Dr Jack Cunningham confirmed in a Parliamentary answer that the Government had agreed to the judge's request. A revised date for delivery of the report had been set of June 30, 1999.

Lord Justice Phillips said it was only during the last month that he had come to appreciate the true scale of the task involved. Five government departments, with the Ministry of Agriculture and Department of Health at the forefront, had dealings with BSE over a period of about 10 years. During that time about 150 ministers had served in the relevant departments and he had written to them all. So far more than 100 scientists and 300 civil servants and ministers had been contacted.

The documentary evidence was "formidable". Investigators attached to the inquiry have been granted unprecedented access to government departments and sifted through thousands of files, logging information into lap-top computers. The job of gathering written evidence will continue throughout the inquiry.

The aim of the inquiry - the cost of which is expected to exceed 2 million - is to explore the root causes of "mad cow disease" and the way the crisis was handled by civil servants and ministers. Over the next four months politicians, scientists, civil servants, representatives of the beef and food industry, and relatives of victims of new variant CJD - the human disease linked to BSE - will be called to give evidence.

The hearings began today with opening statements from Lord Justice Phillips, counsel for the Ministry of Agriculture, Department of Health and National Farmers' Union, and a solicitor representing families of victims of nvCJD. Counsel for MAFF and the Department of Health expressed sympathy for the families of victims of CJD and said they would do everything in their power to assist the inquiry.

Stuart Isaacs QC, for the NFU, said: "It is impossible to estimate the human tragedy of the disease for its victims and their families. The NFU shares with the victims a wish to establish the facts surrounding BSE." Roger Tomkins, whose vegetarian daughter Clare is dying of nvCJD, will give evidence tomorrow.

David Body, solicitor for the victims' families, said his clients were not seeking scapegoats from the inquiry but believed that those who had made decisions on public policy concerning BSE should be held accountable for their actions.

"They want to ensure that nothing like the BSE epidemic ever happens again," he said.
Paul Walker, counsel to the inquiry, outlined the chronology of events up to and following the recognition of BSE. He told the hearing that although the disease was first identified in 1986, farmers had encountered animals suffering similar symptoms some considerable time earlier.
"Many farmers and others have written in to tell us that long ago there were many cases in this country and other countries that resembled BSE."
Animals suffering in this way were referred to as "Downer" cows and "Staggerers". These cases only occurred occasionally, however, and caused no anxiety to farmers or vets. The animals were simply put down and no attempt was made to examine their brains.

There were three main theories for the emergence of BSE, said Mr Walker. The chief one was that the agent responsible for the similar sheep disease, scrapie, was transmitted to cattle in rendered down ruminant feed. Changes in the rendering process which meant lower temperatures were used in the production of cattle feed made from sheep remains may have allowed the agent through.

Another theory was that BSE had always been there in a limited way, but turned into an epidemic when cattle were fed with material derived from the remains of cows with the disease.

A wholly different theory was that the disease was connected with the use of organophosphates to treat cattle suffering from warble fly. Other suggestions that a tiny, undetectable virus-like agent called a "virino" or an immune system problem may be behind BSE had also been put forward.

BSE was first identified as an entity in November 1986, said Mr Walker. Ministers were informed about the new disease by the Chief Veterinary Office in June the following year. In April 1988, Professor Sir Richard Southwood was invited to set up a working party to investigate BSE.

Sir Richard's report was received by ministers in February, 1989. It contained a warning of the remote possibility that BSE may be transmissible to humans, "presenting as CJD". Prior to this, on June 14 1988, the Bovine Spongiform Encephalopathy Order was passed banning ruminant-derived animal feeds.

In December that year the Zoonosis Order, 1988, designated BSE as a zoonosis -- a disease which may be transmittable from animal to humans. This enabled powers under the Animal Health Act, 1981, to be used to reduce the risk to human health from BSE. Mr Walker said some had accused officials of keeping information secret before the announcement on March 20 1996 that nvCJD was probably triggered by BSE-infected beef.

He said if facts were kept from the public it was the job of the inquiry to find out why. "There is no room for secrecy now," he said. After the first phase of the inquiry, which runs until July, there will be a two-month break before the second half during which people will be given the chance to respond to criticism.

As the hearings proceed, the evidence will be posted on the Internet. Lord Justice Phillips said he wanted the inquiry to be as open as possible and had permitted a radio link but he had decided not to allow television cameras into the hearings while witnesses were giving evidence.

He cautioned representative groups and the media not to come to premature conclusions in the course of the inquiry. Some witnesses had expressed fears that they may be exposed to trial by publicity.

Risk to humans 'remote until it happened'

March 10 1998	 Times BY MICHAEL HORNSBY, AGRICULTURE CORRESPONDENT
..... The first witness to give evidence will be Roger Tomkins, the father of Clare Tomkins, who contracted new-variant CJD last year despite having been a vegetarian for ten years. He and two vets, Colin Whitaker and David Bee, who examined what are now recognised to have been the first cases of BSE, will appear today.

One of the main tasks of the inquiry will be to examine why the ban on human consumption of potentially infected parts of cattle carcasses was not introduced until four years after the first diagnosis of spongiform encephalopathy in a cow in late 1985. The inquiry yesterday heard an eloquent appeal for justice from David Body, a solicitor representing the families of new-variant CJD victims, who read out a statement on behalf of the Human BSE Foundation, a body formed by the families last year.

The families said they were not seeking scapegoats but wanted to know the individuals responsible for giving advice and making decisions during the period covered by the inquiry, which ends on March 20, 1996, the date when the probable link between BSE and new-variant CJD was first publicly admitted.

Mr Body said a "central concern" was to establish whether officials had ever made a judgment that "the risk of human contamination [from BSE] could be regarded as remote until it happened" and that "some lives might be a price worth paying" to avoid economic damage to the farming industry.

BSE inquiry will break new ground

March 9 1998 Times  By Frances Gibb, Legal Correspondent
The British BS Iinquiry is expected to run for a year:
-- Main Inquiry site ... transcripts ... email feedback ... 0845 602 1013 by telephone to Lord Justice Phillips.

MORE than 300 ministers, former ministers and civil servants have been warned that they may be required to give evidence at the public inquiry into "mad cow" disease, which opens today. The inquiry, under Lord Justice Phillips, is expected to be one of the fullest and most thorough set up by a Government, rivalling the Scott inquiry. But it is also set to become a model for new, high-tech proceedings.

The inquiry, which could cost up to 10 million pounds, will be the first to have its own Website carrying daily transcripts and witnesses' submissions in advance of giving evidence, so that members of the public may alert the inquiry to any errors. It will also allow in cameras for the opening statements by the judge, by the counsel to the inquiry, Paul Walker, and others (although not for cross-examination of witnesses); and there will be a permanent radio feed, so that live broadcasts will be possible. The judge, lawyers and representatives of the victims or farming industry will have laptop computers.

LiveNote, the instant automatic transcription of what is said in court, will be used. This system, operated by Smith Bernal, was deployed in the trial of the Maxwell brothers, in which Lord Justice Phillips won plaudits for his efficient handling and insistence on new technology. As the words are said, they appear on a computer screen and can be immediately annotated or cross-indexed. At any time, all references to one witness or a date can be accessed.

The Scott inquiry spent a year trawling for documents and obtaining all the evidence before the hearings began. The BSE inquiry, announced before Christmas, has already received more than 500 submissions and more are being sought by special teams in Whitehall. It plans to go ahead with the first stage, the fact-finding hearings, as these are collated and analysed.

No draft findings be sent out to those involved before publication - what became known as Scott letters - to enable people to comment. That process delayed Scott by several months.

Today there will be opening statements from the judge, counsel to the inquiry and others, and then witnesses will give evidence, starting with a narrative account of the early cases of BSE and Creutzfeldt-Jakob disease - as one official put it, "what it was actually like for the families of the victims" - followed by scientific evidence.

The deadline for reporting is the end of this year and it is possible that Lord Justice Phillips may ask the Government for an extension of six months. Even at a total of 18 months, the inquiry would still take half the time of the Scott inquiry.

The non-statutory status of the inquiry means that it has no power to summon witnesses or insist on disclosure of papers. It does not expect to meet resistance; if it did, it could seek powers at a later date.

But Lord Justice Phillips is keen to make the atmosphere as public, as user-friendly and inquisitorial as possible. There will be no private hearings. The terms of reference are to establish and review the history of the emergence and identification of BSE and the new-variant CJD in Britain and of the action taken for ten years until March 1996.

The Scott inquiry was criticised for having no experience or knowledge of the workings of Whitehall. The BSE inquiry committee includes a senior civil servant, June Bridgeman, most recently deputy chairwoman of the Equal Opportunities Commission. Also included is Malcolm Ferguson-Smith, Professor of Pathology at Cambridge and a well-known geneticist.

The team has already produced an impressive array of working documents, including a glossary of scientific terms, a list of individuals involved, a BSE "time line" listing the main events, and a list of papers available for public inspection.

Lord Justice Phillips, who heads a panel of three to conduct the inquiry, has issued a special telephone number for anyone wishing to come forward with evidence: 0845 6021013. The judge has no powers to subpoena witnesses, but could be given extra powers if he fails to get the co-operation he wants.

On Tuesday, Roger Tomkins, whose vegetarian daughter Clare is dying of new variant CJD, will give evidence. On Wednesday the inquiry will hear from members of the first Government committee set up to consider the newly emerging BSE epidemic, under the chairmanship of Professor Sir Richard Southwood.

Professor Richard Lacey, who first warned of the human threat from BSE in the 1980s and was an outspoken critic of the previous Tory Government, will be questioned on March 17.

Treasury Files Searched As Part Of BSE Inquiry

Mar. 6/98 PA News John von Radowitz
Investigators attached to the U.K. BSE inquiry, which starts on Monday, were combing through files at the Treasury today as part of what this story called an unprecedented search of Government departments. Teams of "para-legals" (young helpers with legal training working under the supervision of experienced lawyers)have been set to work sifting through thousands of documents locked away in Whitehall vaults.

Armed with laptop computers, they are looking for anything which might shed light on events leading up to the beef crisis, and linking pieces of the jigsaw together. The aim of the deep probing inquiry, headed by Appeal Court judge Lord Justice Phillips, is to explore the root causes of "mad cow disease" and the former Tory Government's handling of the crisis.

Today it emerged that the inquiry, which will hear evidence from former ministers and senior civil servants, is expected to cost more than 2 million. Much of the money will ultimately come from the tax payer. The five Government departments involved (the Department of Health, Ministry of Agriculture and Welsh, Scottish and Northern Ireland offices) are meeting their own costs.

The story says that already the inquiry team has received more than 500 submissions from members of the public, ranging from letters to 200-page documents. The investigators have sought evidence from more than 100 scientists and members of the rendering food industry and written to more than 300 ministers, ex-ministers and civil servants.

The team has been given unfettered access to Government files, and so far has not encountered any resistance from ministers or officials.

Correspondent opinion

London 9 Mar 98
"The Philips enquiry starts Monday. The enquiry has been neutered by the fact that witnesses can't be forced to give evidence, if witnesses choose to give evidence they cannot be made to testify under oath, and there is no protection for witnesses from legal assaults by the agro-chemical industry or other punitive measures taken by those witnesses criticise (including their employers). Also, government papers from the last administration may be seen by the enquiry but their contents cannot be included in the enquiry's final report."

Was German BSE cow really a Swiss import?

 5 Mar 1998 Electronic Telegraph Toby Helm
Germany's claim to have had no cases of mad cow disease in domestically bred cattle is being called into question in Brussels following an argument with Switzerland over a beast called Anita.

The European Commission has asked for full details of the case after Swiss experts denied German claims that a cow infected with BSE found in Bavaria was Anita, an animal imported from Switzerland in 1995. After carrying out tests on the dead animal's brain, the Swiss say they found no genetic match with other members of Anita's family, including her father.

Senior officials in Brussels were cited as saying Germany will have to provide a full explanation of the cow's origins if it is to retain its record as a nation with no native cases of BSE and avoid cover-up claims.

Suspicions grew last night as strong rumours circulated in the Commission's agriculture directorate of another disputed BSE case in Germany. One senior EU official was quoted as saying, "We will have to sort all this out as the stories are beginning to get around."

Easing of British beef ban backed by veterinary panel

March 4, 1998   Associated Press 
BRUSSELS, Belgium -- A panel of veterinary experts on Wednesday tentatively backed the resumption of beef sales from Northern Ireland, but left the final decision to European Union farm ministers. Northern Ireland is the only area in Britain where computerized herd-monitoring tracks mad cow disease, a fatal brain ailment in cattle that prompted a ban on all British beef two years ago.

For that reason, the EU's executive commission proposed in January to exempt Northern Ireland from the ban. The EU Standing Veterinary Committee said it failed to reach a "qualified majority," sending the issue to a March 16-17 meeting of EU farm ministers. British Prime Minister Tony Blair said that easing the export ban "will mean that ... there is at least some light at the end of the tunnel."

In 1995, sales from Northern Ireland were worth $275 million and accounted for 28 percent of all British beef exports of 277,000 tons. The European Commission is not ready to recommend easing the ban on exports of British beef from areas other than Northern Ireland until these, too, implement computerized herd-monitoring. Scientists believe the disease, formally known as Bovine Spongiform Encephalopathy, may be linked to an equally fatal human brain ailment, Creutzfeldt-Jakob Disease, which has killed a 23 people in Britain.

To get the EU ban lifted, Britain has killed 1.8 million cows and plans to have computerized databases for all its herds this year.

Beef hopes rise as Europe lets in Ulster exports

March 5 1998 Times
BY CHARLES BREMNER IN BRUSSELS AND MICHAEL HORNSBY THE worldwide ban on British beef could be eased later this month after most European Union states voted yesterday to let Northern Ireland resume exports from herds that are certified free of BSE.

The vote by national veterinary officials from ten states failed to reach the "qualified majority" that would have immediately relaxed the export embargo, imposed almost two years ago at the height of the BSE scare. But British officials were confident that farm ministers would lift the ban in Brussels on March 16, when only a simple majority would be needed.

Tony Blair backed that assessment. He said in the Commons that the vets' vote was a breakthrough towards getting the ban on all British beef lifted.

"There has been a majority for the [EU] Commission proposals, which if upheld at the Agriculture Council next week - and I very much believe it will - will mean that the export certified-herd scheme is through," Mr Blair said. "And at long last, after long years of Conservative failure, there is at least some light at the end of the tunnel."

Jack Cunningham, the Agriculture Minister, said: "This is a very encouraging result." He and his team have been critical of what they see as politically driven opposition from Germany and other EU states. The minister told a parliamentary committee that it was "economically and politically convenient" for other EU states to sustain the ban. The Germans voted yesterday against the Northern Ireland scheme, along with Belgium, Luxembourg and Spain.

France abstained, saying it wanted more information on anti-BSE measures in Britain. Dr Cunningham said: "Had France voted in favour, we would have obtained the necessary qualified majority for final and complete approval of the scheme."

The unexpectedly high vote in Britain's favour appeared to have been partly promoted by a political compromise, in which the EU Commission last week proposed exempting states that claimed to be free of BSE from new restrictions on the sale of bone-in beef and other animal parts. The measure had been resisted in several states as unnecessary and burdensome. Diplomats also noted the general feeling that, after two years, memories of John Major's ill-fated "beef war" were fading and it was time to make a gesture towards Britain.

The proposed resumption of beef exports applies to deboned beef from cattle aged between six and 30 months which come from herds certified to have been free of BSE for eight years. Northern Ireland is the only region which meets the EU's stringent conditions because it has established a computerised system for tracking its cattle from birth. Other parts of the United Kingdom are setting up such systems.

An easing of the ban in Northern Ireland is significant. Before the ban came in at the end of March 1996, Britain exported about #520 million of beef a year, of which #234 million, or 45 per cent, came from Ulster.

Northern Irish officials estimate that 97 per cent of farms in the Province should be eligible for export under the certified herd scheme. There have been only 1,769 BSE cases in the Province, compared with more than 170,000 in Britain as a whole.

Government officials accept that it will take years before all restrictions are removed. British meat is still regarded with suspicion across the EU after the previous Government's announcement of a possible link with CJD. British negligence is widely deemed to have been behind the epidemic.

Tony Blair's political advisers have been banned from reading papers from the previous Conservative administration that have been supplied to the BSE inquiry. The commitment was demanded by John Major before he agreed to release Downing Street and Ministry of Agriculture files that related to BSE during his premiership. There was already a convention that ministers would not have access to the papers. A senior Conservative source said last night that former ministers had feared there might be leaks before the final report from Lord Justice Phillips. The inquiry starts Monday.

Remarks on the opinion of the Scientific Steering Committee meeting of 19- 20 February 1998. and a Proposal for recycling and disposal of animal proteins.

Jorn Jeppesen and Henrik Holst-Pedersen
KAMBAS, 4100 Ringsted, Denmark
General remarks

It has been generally accepted that safety against BSE/TSE must be done by:

          - Safe sourcing
          - Safe processing
          - Safe use
Beside this the Scientific Steering Committee (SSC) has adopted an opinion at its meeting of 19-20 February 1998.

As practical renderers we can agree on most of what has been stated, but we have to emphasize that in practice, it is impossible to take everything into account at the same time. It is of little value to make decisions that will require nonexistent separate processing plants or production lines, as this might take years to erect. Time is a very important parameter. If there is a risk it is of utmost importance to react quickly. On the other hand the practical solution must be safe and controllable.

Instead of giving separate comments to the SSC opinion we have chosen to come up with a proposal for recirculation and disposal of animal proteins. The proposal is simple, logic, controllable, can be put into operation quickly and will give a very high degree of safety against recycling of BSE/TSE infectivity.

Before presenting the proposal we will mention some generally accepted facts:

          - Sterilization under  pressure at 133 C, 20  minuttes at 3 
          bars  steam  pressure  of   particles  smaller  than  50  mm 
          (133/20/3)  has  shown  to  reduce the  infectivity  of  the 
          BSE/TSE-agent significantly. The reduction  is 6-9 powers of 
          ten.
          - Post mortem inspection  gives no additional safety against 
          BSE/TSE.
          - Small  amounts of BSE/TSE-infectivity might  be multiplied 
          in all types of animals.
          - Our knowledge  about species barriers is  limited and only 
          documented for  a few species.
          -  Ethical  attitudes  concerning animal  proteins  have  no 
          relevance regarding the risk of transmitting BSE/TSE.
          - Sterilization  (133/20/3) ensures complete  safety against 
          all traditional pathogenic microorganisms  in as well low as 
          high risk material ( directive 90/667).
          -  Testing  for  BSE/TSE   infectivity  is  for  the  moment 
          complicated and time consuming.  Testing for very low levels 
          of infectivity is almost impossible.
To come up with a logic proposal it has been necessary to establish some other principal points of views:
          -  Proteins derived  from meat  producing mammalian  animals 
          must   only  be   recycled   into  the   food  chain   after 
          sterilization (133/20/3).
          - Proteins from other species as  poultry and fish are to be 
          discussed.  In our  proposal  poultry  should be  sterilized 
          (133/20/3)   but   fish   meal   only   needs   to   fulfill 
          microbiological standards.
          -  Animals fed  nonsterilized  mammalian protein  (133/20/3) 
          must not be used in the food chain.
          - Ruminants must not be fed animal protein.
          - In  countries with  BSE/TSE, SRM must  not enter  the food 
          chain.
          -  Animals  showing  clinical   signs  of  BSE/TSE  or  with 
          diagnosed BSE/TSE must be incinerated directly.

Remarks to the diagram (enclosed)

The diagram illustrates our proposal. The diagram will speak for itself but below we have stated some comments on the various products included in the diagram.

Products for human consumption and edible by products

The safety is "safe sourcing". Any additional safety will mean processing like canning or other treatments. It seems illogical that products accepted for human consumption should not be accepted for petfood or similar products.

Using nonsterilized proteins (133/20/3) for pets and animals not used for meat production should be allowed when those animals are not recycled into the food chain. Concerning dogs and cats this will be easy to ensure.

Fur animals represent a problem as the carcasses are traditionally used for feed production after skinning. When the principle is implied here fur animals must eat sterilized proteins (133/20/3) if they are to be recycled. The alternative is skinning and incineration of the carcasses.

Gelatine bones

We are renderers and will not make comments on the safety of gelatine production. But fractions from gelatine production should be sterilized (133/20/3) before entering the food chain.

Dead animals.

Animals fed sterilized (133/20/3) animal protein can be used in the food chain. Animals fed nonsterilized protein (except fish meal) must not enter the food chain.

The question regarding the use of fallen animals for feed production is a purely ethical question. There is no increased risk of transmitting BSE/TSE by using fallen animals.

There is a growing market for products free of proteins and fats from fallen animals. Our proposal is to leave this question to the market forces. Taking this question into consideration now might seriously delay establishing safe solutions to the BSE/TSE problem.

Blood and bones

To exclude blood and "bones fit for human consumption" from sterilization (133/20/3) seems to us to be highly illogical as a lot of other mammalian proteins then should also be excepted from sterilizarion (133/20/3). It is difficult to understand that nonsterilized (133/20/3) ruminant blood can be fed back to ruminants while meat from pigs even after sterilization (133/20/3) is banned as feed for ruminants. As we have understood the present rules all bones must be sterilized (133/20/3). But there seems to be some doubt about this as some countries are not doing this for the moment. It is difficult to have a "beef on the bone ban" and to have the spinal column regarded as SRM in some countries and at the same time accept that "bones fit for human consumption" from all species including ruminants should not be sterilized. Bones can easily be sterilized (133/20/3) by post sterilzation of the dried bone product in steam atmosphere.

ELISA-test

By means of an ELISA-test it is possible to control whether animal proteins have been heated corresponding to 133 C. The test is strongly discussed. Our opinion is that the test gives reliable results, can be used and that most practical problems by passing the test is due to blind ends in the sterilizers, improper agitation or overfilling of the equipment.

Our proposal is without delay to claim the test. Later this should be followed by requiring certain levels of the test values for the products.

When all animal proteins (excl. fish meal) must be sterilized the problem with control of mixed products will disappear. Often the problem of meat meal not having proper ELISA-values is explained by for example mixing with nonsterilized (133/20/3) blood meal, poultry meal etc.

Poultry

Poultry only have a short life and therefore BSE/TSE can be expected not to have sufficient time for multiplication to be a risk. On the other hand poultry is often fed large amounts of animal proteins, and this is why our proposal requires the same sterilization for poultry proteins as for mammalian proteins. This will also make it easier to control the sterilization (ELISA-test).

Fish

Till now it is purely hypothetic that fish products can involve a risk concerning BSE/TSE and therefore our suggestion is that only fish fed nonsterilized (133/20/3) animal proteins (except fish meal) should be sterilized (133/20/3).

Fish meal will suffer dramatically from being sterilized (133/20/3) while other animal proteins are suffering much less from sterilization (133/20/3).

Animal fats

Animal fats will typically contain 0.1 -1% impurities consisting mainly of animal proteins. When sterilization of animal proteins (133/20/3) gives a reduction of BSE/TSE infectivity of 6-9 powers of ten it will be necessary either to sterilize (133/20/3) or filtrate the fat. Filtration might in practice be very problematic for some types of fat. Sterilization in steam atmosphere will be easier to perform, and it will give a higher safety than can be obtained by filtration. An ELISA-test of the impurities can be used for controlling the sterilization if sufficient impurities are present. Filtration will give filtercakes for disposal.

The SSC has proposed to have a nonsterilized fat for industrial use and a sterilized (133/20/3) for use as feed grade fat. This is inadvisable because two types of fat with exactly the same properties, but maybe with different prices will be present on the market side by side. The sterilization (133/20/3) of fat is not difficult to perform and should be requested. The quality loss during sterilization (133/20/3) is insignificant. If some types of animal fats should be prohibited as animal feed the fats should be denaturated and burned (as fuel).

Fertilizer

In nature BSE/TSE infectivity is only slowly broken down and fertilizer produced from animal proteins should therefore always be sterilized (133/20/3). There is a risk that meatmeal used on grass might be eaten by ruminants and restrictions concerning use must be considered.

Incineration

Due to lack of facilities this solution should be reserved to animals showing clinical signs of BSE/TSE or to SRM. Incineration is technically difficult to perform and might give rise to other environmental problems as NOx-pollution. It is of utmost importance that incineration is done under strict control of temperature and retention time. Erection of new facilities with big capacity for incineration will be costly and will take several years.

Species to species feeding

It is a simple and popular way to explain the BSE/TSE problem as a result of animal cannibalism. The word "animal cannibalism" is calling for ethical reactions and it is easy to postulate that a species barrier exists between all different species.

This field is very poorly investigated but we already know that between some species there seems to be no species barrier and in some cases infection is transmitted more easily between different species than within the the same species.

Our opinion is that the safety against BSE/TSE should be ensured by other means than taking a species barrier into account.

In practice a species to species ban will be almost impossible to work with at least for the time being as this will require erection of new separate facilities in the rendering plants and in the feedmills. A species to species ban will seriously delay solutions giving faster and bigger safety.

We are aware that some big international supermarket chains are discussing making their own quality standards where for example meat should be produced respecting a species to species ban. It should be left to the market forces to ensure the production of such product.

Canada seizes British meat

Times 9 March 98
Canada has begun a nationwide food inspection campaign after illegal meat-based products from Britain were seized from shops in eastern and western Canada. Imports have been banned since 1996. The Canadian Food Inspection Agency said the products - beef bouillon, soups and meat pies - were found in Calgary, Alberta; Halifax, Nova Scotia; Richmond, British Columbia; Montreal; and Toronto. Shop owners were told to destroy them.

British Meat Seized in Canada

6 Mar 1998 The Associated Press
OTTAWA - Illegally imported British meat products have been seized from eight stores by the Canadian Food Inspection Agency. The survey of retailers was prompted by the discovery of unapproved British meat products - including chicken, pork and beef products - in two British specialty stores in Calgary.

By Friday, similar products were found in stores in Halifax, Nova Scotia; Richmond, British Columbia, and four stores in and around Toronto. Officials said names of retailers and the dollar value of the seized products would not be released until the survey is completed.

The products were removed because there is no way of knowing whether the meat was prepared to conform to Canadian standards, said Lou Skrinar, an agency spokesman. The agency is trying to determine how the products made it into Canada without being discovered. Skrinar said it is likely the retailers were independently importing relatively small quantities that would not have raised suspicions at customs.

Canada, along with other countries, has banned British beef since a link was suspected in 1996 between eating beef infected with so-called mad cow disease. But that is only one factor in the current sweep, said Skrinar.

``This is not a BSE recall,'' said Skrinar, referring to bovine spongiform encephalopathy, the scientific name of the disease. ``It's about any meat product. Obviously the beef is going to be a little more sensitive, but it's being dealt with within the context of the illegal importation.''
Susan Rudner, British High Commission spokeswoman, said the commission is not sure how the products entered the country, but they are safe. ``There's no reason to believe these items are unsafe. These items are sold in the UK and wouldn't be sold there if the British government thought they were risky in any way.''

Factor IX for hemophiliacs

3 Mar 1998 Reuters 
LONDON - Genetic engineering company PPL Therapeutics Plc said on Tuesday it has commercially produced the human blood clotting protein Factor IX from the milk of transgenic sheep to treat Haemophilia sufferers. Shares in the company rose after the announcement to stand 5-1/2 pence higher at 215-1/2 at 1040 GMT.

Factor IX, known as Fix, is essential in the blood clotting process. Sufferers of haemophilia B have an inherited deficiency in the protein. It is used to control bleeding in haemophiliacs and as a preventative treatment for younger patients. PPL's ability to produce commercial levels of FIX from the milk of transgenic sheep could provide safe treatments, free of infectious agents such as HIV and CJD, for haemophiliacs.

``PPL's ability to provide large quantities of a safe and pure protein in a cost effective manner will be particularly important in the light of current concerns over the safety of products derived from human plasma,'' PPL said in a statement.

PPL, which collaborated in the production of Dolly the world's first cloned sheep, is one of the world's leading companies in the transgenic production of human protein for therapeutic and nutritional use. The company said the current value of the world-wide market for FIX is estimated at around 100 million pounds ($164.8 million).

Comment

Listserve opinion 9 Mar 98
The issue would be whether the sheep could possibly be incubating scrapie or viral diseases. However, human-derived factor may not be all that safe either: see FDA blood recall home page.

FDA Reconsiders Recall Policy: Does a Brain Disease Threaten Our Blood Supply?

Lead Story ABC OnLine 3/8/98 By Jenifer Joseph
The CJD Data Gap -- Madness and the Prion Link
There's a lot we don't understand about CJD, and the agent is still mysterious. But we're starting to hear about real injuries caused by the blood shortage.

Dr. Lawrence Schonberger, CDC CJD is diagnosed in one or two people in a million each year. But because it can take as long as 30 years for a person to develop symptoms, scientists say it is probably incubating in one in every 50,000 people.

Who Uses Blood Products?

-- Premature babies in intensive care 
-- Accident  victims 
-- Organ transplant patients 
-- Cancer patients 
-- Burn victims Children 
--Adults with  hemophilia, anemia and sickle  cell disease 
Twice a day like clockwork, Patrick Collins surfs an obscure Food and Drug Administration Web page that tracks blood-product recalls. Collins is a hemophiliac, born without a certain blood-clotting gene. His survival, and that of the rest of America's 25,000 hemophiliacs, depends on the safety of the nation's blood supply, so he's vitally interested in what he sees on the FDA recall page.

The rest of us might want to pay closer attention too. Since September 1996, almost all of the 51 recalls were ordered because the blood donors were subsequently diagnosed with Creutzfeldt-Jakob Disease (CJD). That's a rare but deadly human illness that is similar to BSE, or bovine spongiform encephalitis, also called mad-cow disease.

About 10 percent of the time, people with CJD either inherited it or contracted it after receiving human growth hormone or brain tissue transplants taken from CJD-positive cadavers. But the vast majority of CJD cases are what doctors call "sporadic," meaning they can't pinpoint the cause.

For that reason, recalling CJD-tainted blood is a wise public health move, says Leon Faitek, a hemophiliac and one of the FDA advisory committee's consumer advocates. "I'm very strongly in favor of the FDA policy," says Faitek. "In some ways, the blood supply is safer than it has been in recent history. But we're very concerned whenever a blood donor dies of CJD."

But surprisingly, the FDA is reconsidering its recall policy and may soon allow blood from donors found to have CJD to make its way into the health-care system.

The reason? The United States is in the midst of its worst blood shortage in recent history, and recalls affect nearly one-fifth of the blood supply. We simply can't afford to lose the questionable blood products, the thinking goes, CJD risk or not.

"The blood recall is causing more problems than it's solving," says Dr. Lawrence Schonberger, an epidemiologist at the U.S. Centers for Disease Control. "We're the first to admit there's a lot we don't understand about CJD, and the agent is still mysterious. But we're starting to hear about real injuries caused by the blood shortage."
An estimated 4 million Americans use blood products each year, for everything from emergency transfusions to in-vitro fertilization to cancer treatments. Many are in life-threatening situations. But CJD is also life-threatening.

Mad Cows and Englishmen

If you know about CJD, it's because of the panic in the past couple of years over a new human variant of CJD in Britain. It was suspected, but never proven, that eating contaminated beef caused the illness in people. Despite the attention focused on the problem in Britain, there is still no scientific consensus on what causes CJD and whether the human and animal variants are due to the same agent.

What is clear is that CJD is always fatal, killing its victims within months by filling their brains with microscopic holes. Complicating matters is that the disease can take up to 30 years to incubate, and there's no real screening test to determine who has it.

So the question of whether to recall blood from donors who died of CJD requires balancing the known risks to patients in desperate need of blood products against the theoretical risk of contracting CJD.

In January, hospital administrators came down on the side of immediate need, telling an FDA advisory group that medics have to have blood to treat gravely ill patients in emergency rooms now. Based on that testimony, the advisory panel voted 9 to 5 in favor of stopping the CJD-related blood recalls. The FDA won't say when or if any action might be taken on the panel's recommendation.

A Single Mouse

No scientist is willing to say there's zero risk of getting CJD from exposure to tainted blood. Right now, however, the risk seems mainly theoretical. "There has not been a single documented case so far where CJD was transmitted to another person through blood," says Dr. Laurie Harrison of the FDA.

The key word here is "person."

Dr. Robert Rohrer is a molecular virologist at the Veterans Administration Medical Center in Baltimore. He was the first researcher to show that mice could become infected with CJD from tainted blood. In 22 experiments, however, only one mouse fell ill with the disease. Though the mice studies show that it's possible to transmit CJD through blood, they don't necessarily demonstrate anything about human transmission.

"We don't know if CJD will transmit once in 22 cases or once in 22 million," says Rohrer. "But if there is a risk of people getting CJD >from blood, it's a risk we've been living with since the very first transfusion was performed half a century ago."
Since that time, he points out, we've had serious outbreaks of blood-borne diseases such as HIV or hepatitis C, but no such thing has happened with CJD.

Devastating Letters Prompt Action

A Florida couple who tried to have a baby through in-vitro fertilization has filed suit against a Virginia fertility clinic and a blood-products company, claiming they and at least 1,000 others may have been exposed to CJD from a contaminated blood product used at the clinic. No one knows whether the product was actually contaminated. But the couple, both surgeons, received a letter from the clinic saying their eggs and sperm had been stored in a blood byproduct traced to a donor who subsequently died of CJD. They decided to sue.

And in Canada, eight people launched a $3.6 million lawsuit against the Red Cross after they learned that blood transfusions they received might have been CJD-contaminated. Lawyer John Watts, who represents the Florida couple, acknowledges that the class-action suit will be difficult to try, given the lack of data available on the actual risk of infection. But it is that same information vacuum that the FDA must consider in determining a nationwide public policy on blood recalls.

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