FDA open mike
Cunningham pledge on beef ban
EU targets unnamed German firm in BSE probes
Cunningham pledge on beef ban
E.U. Fischler Rules Out U.S. Exemption From Meat Rules
EU's planned tallow import ban unscientific - U.S.
Illegal exports threaten hope of easing beef ban
EU to appeal WTO hormone ruling
Paul Brown JAMA article
Narang sues ex-employers in `mad cow' dispute
CWD and hunters square off in Colorado
Michael Hansen Tue, 23 Sep 1997 Consumer Policy Institute/Consumers Union ph: 914-378-2452 fax: 914-378-2928The US Food and Drug Administration's (FDA) TSEs Advisory Committee will meet on October 6 & 7, 1997, from 8:30am to 5:00pm both days, at the Holiday Inn-Bethesda (Maryland), Versailes I & II.
On October 6, the committee will discuss FDA regulatory controls to address transmission of CJD by human dura mater products.
On Oct. 7, the committee will discuss appropriate FDA actions concerning CJD-implicated "secondary" products (i.e. products in which a CJD- implicated plasma derivative was either added as an excipient or used as a reagent in the manufacturing process).
The meeting is open to the public and oral statements/presentations from the public will be scheduled between about 8:45am and 9:30am. If you want to make a formal statement/presentation, call William Freas or Jane Brown (ph: 1-301-827-0314) before October 1, 1997.
PA News Tue, Sep 23, 1997 By Geoff Meade, European EditorAgriculture Minister Jack Cunningham today vowed to continue the fight for a nationwide lifting of the ban on British beef exports. He told farm ministers' talks in Brussels that the Government wanted a deal which did not limit the end of the ban to specific regions of the country.
Brussels has indicated that the ban could be removed in Northern Ireland -- the only part of the UK considered to have sufficient safeguards against the spread of mad cow disease thanks to state-of-the-art computer records of cattle movements. But Mr Cunningham is anxious to ensure that any agreement to lift the ban -- now in place for more than a year -- automatically applies to other regions as updated computerised systems for the tracking of herds and BSE infection come on stream.
EU agriculture ministers were meeting as the Brussels Commission ordered the closure of German meat processing plants after routine checks by Commission officials uncovered what are believed to be consignments of British beef. Veterinary inspectors visiting the unnamed processing plants, coldstores and cutting centres between September 8 and 12 found meat which raised suspicions because of inadequate labelling.
"There are reasonable suspicions that it is of British origin and therefore violated the embargo," a Commission spokesman said this afternoon.The Commission is now trying to establish where the consignment came from in Britain and how it left the UK -- just a week after the Government was threatened with European legal action for failing to take sufficient action to monitor and enforce the ban. The EU's food health commissioner, Emma Bonino, contacted the German federal authorities yesterday, insisting on the closure of at least two meat plants.
Brussels has given the authorities one week to comply and officials say they cannot name the plants until the deadline has expired. It was only yesterday that Mr Cunningham held private talks in Brussels with his German counterpart Jochen Borchert, discussing the enforcement of the ban. Today, as his country came under the spotlight over beef exports, Mr Borchert told his colleagues that a total lifting of the ban on British beef was not possible while consignments, possibly contaminated, were escaping UK monitoring and reaching the Continent.
Later Dr Cunningham said he would continue to press the Commission to approve a scheme to lift the ban on meat from all "certified herds" which had never been in contact with BSE.
"I want to see a scheme which embraces farmers throughout the UK," he said.But he refused to rule out the possibility that exports could resume in Northern Ireland before the rest of the country. Britain fears that if it accepts a scheme which only applies to Ulster the EU could drag its feet on lifting the ban in the rest of the country. Officials are pressing for a plan which could be extended to England, Wales and Scotland once they have their own computer system up and running.
Dr Cunningham rejected the Commission's call for him to submit a new proposal based on advice by EU vets that meat from certified herds in Northern Ireland could be exported. He said it was the Commission's job to draw up a proposal to put to member states. However, he said Germany's representative at the meeting had given a "very negative reaction" to "any scheme for British beef being approved at all".
Franz-Josef Feiter, chief policy advisor to the Agriculture Minister, made clear that Germany would oppose any relaxation of the ban while British beef was still being smuggled abroad.
"He wondered how you could control exports in a region given that you can't even control them today under a total ban," said an official at the meeting.More than 2000 tonnes of British beef have been smuggled into Germany, France, Holland and other European countries.
But Dr Cunningham said: "It's not just a UK problem. There are not only willing sellers here. There are willing buyers elsewhere in Europe. These are European-wide frauds."And he warned that any attempt by Germany to use beef smuggling to block lifting the ban would breach the agreement thrashed out at last year's Florence summit.
"That's adding a new condition to Florence which I'm not willing to accept," he said.Britain won support from Dutch Agriculture Minister Jozias van Aartsen.
"I have trust in the way the UK government is handling the BSE issue," he said.
Reuters World Report Tue, Sep 23, 1997BRUSSELS - The European Commission has asked German federal authorities to close down a German company by Friday after its inspectors uncovered evidence of fraud concerning British beef imports, a spokesman said on Tuesday. EU Consumer Affairs Commissioner Emma Bonino said earlier that Brussels had asked for the closure of "about three" companies. But later she clarified her comments to say actual closure had been demanded in only one case.
In the other cases it had asked Bonn to step up controls, the spokesman told the Commission's daily news briefing.
"There are several cases. One is closure. For the others, an imprecise number, it is to reinforce controls," the spokesman said.After briefing a European Parliament inquiry committee into mad cow disease Bonino had told reporters the Commission had "sufficient grounds to call for closure" following inspections by Commission officials between September 8 and 12.
But in Bonn, a spokeswoman for the German Health Ministry told Reuters it had received no orders to close a company but had been notified that authorities might need to take "short-term" action in some parts of Germany. She said Brussels had drawn the German government's attention to one company in particular but not demanded closure.
"We received a letter. It did not demand the closure of a firm explicitly, but it drew our attention to one firm in particular," she said.The demand -- which can be rejected by the German authorities as long as they justify their decision -- was made in a letter sent on Monday night to Bonn, the Commission spokesman said. He said the Commission inspections had uncovered "tens of thousands of tonnes" of what was suspected to be British beef, because labels had been removed.
"It seems that the labels were taken off, so the origin is equivocal, so there are reasonable suspicions that it's of British origin, therefore in violation of the export ban," he told the European Commission's daily press briefing.The companies involved included cutting plants, cold storage and processing plants, the spokesman said. Bonino said it was unclear whether the beef was intended for the domestic or international market, although it was clear that much of it was destined for Russia. Last week the European Commission decided to open legal proceedings against Britain over beef exports discovered in other member states this summer, in breach of an 18-month-old worldwide ban.
The ban was imposed in the consumer scare unleashed after the British government revealed that there could be a link between mad cow disease (bovine spongiform encephalopathy) and its human equivalent. British Farm Minister Jack Cunningham has spoken of "sophisticated international fraud" in relation to the British beef.
Dow Jones Tue, Sep 23, 1997BRUSSELS --The European Union Commission won't exempt the U.S. under any conditions from a forthcoming ban on products deemed at risk of harboring "mad cow" disease, the Commission's top agricultural official said Tuesday. E.U. Farm Commissioner Franz Fischler said the U.S. won't be exempted from the Jan. 1 ban because U.S. meat products could contain bovine spongiform encephalopathy, or mad cow disease.
But Fischler said Australia and New Zealand could be exempted from the ban because the likelihood that their meat products harbor BSE appears to be smaller. The E.U. ban will be on the use for any purpose of the head and spine of cattle, sheep and goats more than 12 months old and the spleen of all sheep and goats.
The U.S. has said the ban would block millions of dollars a year of its tallow exports and billions of dollars a year of its pharmaceuticals exports to the E.U. unless it introduces stricter meat processing rules. The remarks by Fischler came at a press conference after a meeting of E.U. agriculture ministers. At the meeting, Fischler outlined the recent opinions of two E.U. scientific committees about the possibility of exempting E.U. trade partners from the ban.
One possibility for an exemption was for the Commission to grant a country BSE-free status.
"Australia and New Zealand might be awarded this status," Fischler said. "But it will not be possible in the case of the U.S."
September 24 1997 Times CHARLES BREMNER IN BRUSSELSTHE Government's drive to persuade Europe to lift its beef ban suffered a setback yesterday when the European Commission reported the illegal presence of British beef in Germany, stiffening German opposition to any easing of the 1996 embargo.
Emma Bonino, the Consumer Commissioner, said she had instructed the German authorities on Monday to close one meat processing company and take action against two others after Commission inspectors found "several dozen" tonnes of beef that they suspected had been shipped from Britain. The European Union found thousands of tonnes of illegal British exports on the Continent last spring.
Yesterday's news ignited a fresh bout of anger in Germany, the country most hostile to any easing of the ban. It also fuelled German resolve at a farm ministers' council in Brussels to resist moves now under way to allow the resumption of beef exports from BSE-free herds in Northern Ireland.
Franz-Josef Feiter, a German Deputy Farm Minister, said Germany had strong reservations about easing the ban. He wondered how, with inadequate checks on exports, the authorities could ensure that British beef came only from Northern Ireland.
The remarks testified to the big political hurdles still ahead as Britain tries to follow up a finding by EU scientists last week that exports could resume for beef from certain herds but only in Northern Ireland. The province was the only British region with an adequate computerised record of its cattle.
Jack Cunningham, the Agriculture Minister, insisted yesterday that the Government wanted the measure to apply to "certified herds" across the United Kingdom. "There was a very strong negative reaction from Germany," he said.
He did not rule out proceeding on a regional approach. "We will try to influence that decision to get the best deal for all UK farmers ... but half a loaf is better than no bread." However, he was at odds with the Commission over the next step. Franz Fischler, the Farm Commissioner, said it was now up to Britain to apply for an exemption for herds from Northern Ireland. The British minister insisted that it was the Commission's job to act.
The Commission said it was prepared to move quickly with proposals for legislation once the British decided to apply. Under the Florence agreement, concluded between John Major and fellow EU leaders in June last year, the Union promised to relax the ban if all scientific conditions are met. However, the consent of a majority of members is required. The Netherlands and Ireland indicated yesterday that they would support a resumption. Italy said it wanted veterinary officials to decide the issue before ministers. There was little support from other states. Dr Cunningham recognised the degree of resistance, saying he expected "battles ahead".
Before yesterday's news, German emotions were already running high in the aftermath of the discovery last summer that thousands of tonnes of British beef had been circulating on the Continent. The Commission threatened legal action against Britain last week for failing to ensure adequate controls at abattoirs. Signora Bonino, who was put in overall charge of the BSE affair earlier this year, stoked the fire yesterday when she complained to the European Parliament that the Commission lacked resources to monitor compliance with the ban. EU inspectors had found national controls to be inadequate "so there is no guarantee of a watertight separation between the British and the non-British meat supply," she said.
September 23, 1997 Reuter Information ServiceBRUSSELS - The European Union confirmed Tuesday it will appeal a World Trade Organization decision that an EU ban on imports of hormone-treated meat is contrary to free-trade rules. Speaking after a two-day meeting of EU farm ministers, Luxembourg Agriculture Minister Fernand Boden said ministers backed the European Commission's decision to appeal the ruling.
"We feel strongly about food safety and have asked the European Commission to take all necessary steps to get a favourable decision," Boden told a news conference. The eight-year old EU ban on imports of beef produced with the aid of synthetic growth hormones mainly affects imports from the United States, which won the WTO ruling in July. According to the U.S. meat industry, the ban has cut sales to EU countries by between $100 and $250 million a year. The EU stance has the backing of all member states and consumer groups across the 15-nation bloc.
Under WTO rules, once an appeal is made, the trade body has up to 80 days to issue a final ruling. If the EU loses, then the WTO Dispute Settlement Body could ask the Union to pay compensation for lost trade. Should Brussels refuse, the DSB could authorize U.S. trade retaliation equivalent to the same amount.
Reuters World Report Tue, Sep 23, 1997 By Julie VormanWASHINGTON - The European Union's plan to include U.S. beef tallow in an import ban was "an extremely serious issue" and lacked any scientific basis, U.S. trade officials said on Tuesday. The European public's fear of an outbreak of mad cow disease and of a similar disease in humans has elevated an obscure area of commerce into the potential cause of a major trade war.
EU Farm Commissioner Franz Fischler told reporters in Brussels on Tuesday that the United States could not be exempted from a ban on beef tallow imports scheduled to begin in January. Imports of beef-derived gelatin and bull semen would also be banned.
"This is an extremely serious issue with potential to disrupt billions of dollars in trade. The regulations being contemplated have absolutely no scientific basis," a spokeswoman for U.S. Trade Representative Charlene Barshefsky said.The United States contends it should be excluded from the EU's planned restrictions because it has the strictest food safety standards in the world. Washington is also seeking an EU declaration that mad cow disease -- known to scientists as bovine spongiform encephalopathy (BSE) -- is not present in the United States.
Paul Drazek, special trade adviser to the Agriculture Department, said U.S. negotiators were holding daily talks with European officials to try to find a way to exempt the United States from the ban. The U.S. system of monitoring the health of cattle herds and checking for any cases of BSE was viewed "favorably" by an EU scientific panel, Drazek added. U.S. cattle groups said the EU was unwilling to base food sanitary standards on scientific evidence.
"There is very minimal, if any, risk" from the rendered tallow or tallow derivatives used in cosmetic products, said Chuck Lambert, chief economist with the National Cattlemen's Beef Association. And the tallow used by pharmaceutical manufacturers was reduced to fatty acids that posed no health risk, he said.The EU's scientific committee has already established that tallow derivatives processed according to certain specifications are safe, according to U.S. officials. The EU proposed the ban because of consumer fears that some imported beef products might carry BSE and cause the similar and fatal Creutzfeld-Jakob Disease (CJD) to humans.
Washington asked EU headquarters in Brussels to examine the U.S. incidence of diseases such as BSE and scrapie, known as TSEs (transmissible spongiform encephalopathies).
"I can confirm there is no way the United States can be granted TSE-free (status)," EU Farm Commissioner Franz Fischler told a news conference after a two-day meeting of EU farm ministers.Last week an independent committee of EU scientists said that although it had not found BSE in the United States, it could not guarantee the country would stay free of it. The issue is not yet settled, since Brussels is still considering scientific advice on the different methods of making tallow, the nearly colorless and tasteless solid fat extracted from the natural fat of cattle and sheep. It is not known when a final decision on a possible exemption will be made.
Paul Brown, MD JAMA Abstracts - September 24, 1997Some human cases of the transmissible neurodegenerative disorder Creutzfeldt-Jakob disease recently seen in Great Britain are thought to have resulted from eating beef infected with the agent of bovine spongiform encephalopathy. Reasons for and against this presumption are explained, and the question of a similar situation occurring in countries other than Britainăin particular, the United Statesăis discussed in terms of the existence of scrapie (in sheep) or unrecognized bovine spongiform encephalopathy (in cattle), the practice of recycling nonedible sheep and cattle tissue for animal nutrition, and precautionary measures already taken or under consideration by government agencies. However, no cases have been identified in U.S. from eating infected beef
Paul Brown, M.D., of the National Institute of Neurological Disorders and Stroke at the National Institutes of Health in Bethesda, Md., considers reasons why there may or not be a link in the transmission, as well as the question of why a potential outbreak of mad cow disease in Europe has not been found in the U.S.
Mad cow disease is a spongiform encephalopathy, or a fatal neurodegenerative disease, that can affect both humans and animals. The most common human form of the disease is Creutzfeldt-Jakob disease (CJD), which may be hereditary, transmitted through the environment or have no known cause. Signs of the illness begin with loss of memory or confusion, but behavioral aberrations or problems walking are the initial symptoms present in about one-third of patients.
Information cited in the article indicates that sheep infected with scrapies transmitted the disease to cattle through meat and bonemeal nutritional supplements that included recycled sheep carcasses. The disease in cattle is known as bovine spongiform encephalopathy (BSE).
In the 1970s, both the U.S. and Britain eliminated a step that would have reduced contamination of scrapies in animal feed. But while Britain saw an epidemic of BSE, the U.S. did not. Within a recent three-year period, 21 people in Great Britain and one person in France were diagnosed with a "new variant" form of CJD syndrome. Because CJD has a 10-to-15 year incubation period, it is believed that the disease possibly came from eating contaminated beef in the 1980s before the magnitude of the BSE problem was recognized and steps were taken to prevent human exposure.
Dr. Brown has three theories:
Strains of scrapies in the U.S. are sufficiently different from those in Great Britain and are incapable of breaching the species barrier to cattle. Compared with Britain, the U.S. has a smaller proportion of scrapie-infected sheep-derived tissue in the animal mixătoo small to cause BSE. There is an epidemic in the U.S., but it has not been recognized.Dr. Brown writes:
"In the U.S., concern about the possible present (or future) existence of BSE has provoked numerous discussions between the Food and Drug Administration, the Department of Agriculture, sheep and cattle farmers, and the rendering industry to consider sourcing and processing safeguards to prevent on outbreak of disease. Several precautionary measures have already been taken, and it is likely that additional regulations will be forthcoming."Those measures include:
A continuing embargo instituted in 1989 on the importation of all cattle and cattle products originating in Britain or other countries with possible indigenous BSE. Restrictions on the movement of sheep from infected to uninfected flocks. A ban on mammal-to-ruminant feed (with some exceptions) instituted in June 1997.Under evaluation are recommendations to eliminate recycled animal tissue for livestock nutrition, restrictions on high-risk tissues (brain, etc.) for human consumption, restrictions on bovine-sourced biological products ranging from myelin (used in the treatment of multiple sclerosis) to gelatin (used in products from drug capsules to cosmetics).
Dr. Brown writes: "Although we cannot now undo the consequences to human health of past exposure to BSE, we must continue to clarify the risk of that exposure and, in particular, to obtain evidence for or against the presumptive connection between BSE and [the new variant form of CJD] ... Because the laboratory can only provide clues to the problem posed by new variant CJD, we must turn to classic field epidemiology for a definitive answer: only through continued surveillance of CJD in Great Britain and other countries (regional surveillance has just been initiated in the U.S.) will the suggested connection between BSE and CJD eventually be proved or disproved ... Statistical modeling suggests it may take 2-3 more years of observation before alternatives become clear."Dr. Brown says microscopic examination of brain tissue indicates that the new variant CJD is dominated by so-called daisy or florid plaques. Injection of BSE-infected tissue into monkeys produced similar plaques. But while that observation indicates a possible connection between the new variant CJD and infected beef, he questions why scrapie-infected sheep have never been shown to have caused a single case of CJD in humans anywhere in the world. Other questions remaining include: why the infection has never been detected in muscle or milk (the two most widely consumed livestock products) from animals infected with BSE, scrapie or any other spongiform encephalopathy; and why nearly all new variant cases on CJD occurred in young people even though the food products were consumed nearly equally by the British population.
PA News Wed, Sep 24, 1997 By Cathy Gordon, PA NewsA research scientist seeking to prove a link between "mad cow disease" and the human brain disorder Creutzfeldt-Jakob disease is set to launch a High Court battle tomorrow against his former employers. Dr Harash Narang today said he would issue a High Court writ alleging "malicious falsehood" at the Royal Courts of Justice in London at 2pm against the Public Health Laboratory Service Board and two other named defendants. He will be accompanied by families of CJD victims and their supporters. The Board had no comment to make today.
Dr Narang believes he was sacked from his 40,000 pound-a-year post as a microbiologist with the Public Health Laboratory Service at its lab in Newcastle upon Tyne in 1994 because of his belief in a link between the diseases. The following year he lost his claim for unfair dismissal when a tribunal ruled his post had become redundant because of a two per cent cut in Department of Health funding.
Dr Narang, 54, who believes there is no doubt that BSE can be transferred to humans, also claims to have discovered a test for mad cow disease in living cattle. He worked for the Public Health Laboratory Service, a government body responsible for researching matters affecting the health of the nation, >from 1977 until 1994 and developed tests for Rubella and Aids. He has set up the CJD Campaign Group with the families of victims of the disease.
25 Sept 97 CorrespondenceHere we go again. Another unconfirmed report that the incidence of CWD in Larimer County has reached 6.5% for deer, and 1% for elk. From a Colorado correspondent:
"The newest theory is that the Colorado Div. of Fish and Wildlife themselves infected the deer herds in Northern Colo. in the late 60's and early 70's, as the Division was doing studies on supplemental winter feeding on deer at their research facilities near Ft. Collins. This would explain the geographical incidence. They are said not to be checking the game units elsewhere in the state apparently, though one of the elk herds apparently moves as far south as New Mexico.
Deer don't digest grass hay that well being browsers and so have to be fed a high protein supplement; the cheapest feed was probably rendered animal. The claims that the deer picked it up from sheep grazed areas is ludicrous as there are many hundreds of thousand of sheep grazed on other tracts in Colorado yet there is no reporting by the Division of CWD elsewhere in the state.
Last year, I got a bull elk and I cut the antlers off... Brains and goop on my hands, cuts from previous butcherings etc... Scary
The hunter safety info they are giving out minimizes the risk, stresses gloves, and does not talk about eating infected but normal appearing animals. By Risk Assessment they mean loss of game tag sales to local and out of state hunters; these directly fund the Division."
U.S. Meat Groups Pan E.U. Mad Cow Decision, Urge Protest
harboring the illness, U.S. meat groups said. The decision to include the U.S. in the ban, which is expected to take effect Jan. 1, was announced Tuesday by E.U. Farm Commissioner Franz Fischler, who said U.S. meat products could contain bovine spongiform encephalopathy, or mad cow disease. The ban would specifically affect products like tallow, which is produced from the heads or spines of cattle, sheep and goats, and could cost the U.S. millions of dollars a year in tallow exports and billions of dollars a year in pharmaceuticals exports, according to the U.S. government. Tallow is used primarily to manufacture pharmaceuticals and cosmetics.
But no U.S. cattle have been diagnosed with BSE, and administration officials should approach the World Trade Organization to protest the E.U. move, said the American Meat Institute, which called the ban 'the latest in a long list of E.U. non-tariff trade barriers.'
'The E.U.'s recent directive banning the use of specified risk materials in tallow is not scientifically based,' the A.M.I. said in a statement. 'In the absence of BSE, there is no basis on which to ban specified risk materials.
'Even more outrageous is the E.U.'s suggestion that it cannot grant the U.S. BSE-free status,' the A.M.I. added. 'Aggressive government actions dating back to the mid-1980's have prevented BSE from penetrating U.S. borders. A.M.I. encourages the Clinton administration's efforts to challenge the E.U. directive before the World Trade Organization.'
It was unclear, however, if the U.S. plans to protest the move. Although spokesmen from the U.S. Trade Representative's office in Washington have criticized the European Union's inclusion of the U.S. among countries affected by the ban, they have not declared specifically that they would challenge it before the World Trade Organization. Officials from the U.S. Trade Representative's office did not immediately return a telephone call Wednesday morning asking for comment.
Chuck Lambert, chief economist for the National Cattlemen's Beef Association in Washington, said the inclusion of the U.S. in the ban 'is one more indication of the E.U.'s disregard for science when we try to resolve these issues.'
'The Europeans are true to form. There's no science to justify their position,' Lambert said.And Chuck Levitt, a livestock market analyst with brokerage Alaron Trading Corp. in Chicago, said the E.U.'s move could set off a trade war.
'I don't think anyone realizes how serious this is,' Levitt said. 'It could be a serious, serious matter, because all the cosmetics we send to Europe have tallow derivatives. This could invoke a trade war if it goes through.'U.S. cosmetic industry representatives said they were disappointed by E.U. Farm Commissioner Fischler's comments, but hoped the U.S. could persuade the E.U. to provide exceptions for some products.
'This is disheartening, but it's not the end of the road,' said Lou Santucci, vice president of the international division for the Cosmetic, Toiletry and Fragrance Association in Washington. 'I'm hopeful that the E.U. will grant an (exception) for properly processed derivatives.'