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EU probes alleged use of sewage in French feed
Risk of BSE in vaccines revealed
CJD in third young Seattle case: ex-meat packer
Update: the human face to CJD
Jamaica bans imports of EU animal products, feeds
Growth hormone blunder may have given Britain mad cow disease
US starting to pay blood donors
Belgium Agrees To Tests on Exports
States try to halt spread of chronic wasting disease
Foot-dragging at FDA on CJD as reportable disease

Growth hormone blunder may have given Britain mad cow disease

Sunday, August 8, 1999 London Observer Service
LONDON -- Britain's ``mad cow'' disease epidemic was caused by a scientific experiment that went wrong, some experts believe. The blunder has cost Britain $6.4 billion, claimed the lives of 43 people and triggered fears that the death toll could eventually reach several million.

Experts believe that hormones, taken from the brains of slaughterhouse carcasses, were injected into cows in a bid to create a new breed of super-cattle. But the experiment -- carried out in the 1980s -- backfired. The hormones, extracted from pituitary glands, were transmitted in an agent that spread mad cow disease and eventually infected humans as new variant Creutzfeldt-Jakob Disease (nvCJD).

Twenty years ago, a similar use of human growth hormone, extracted from the pituitary glands of cadavers and given to children with congenital dwarfism, was shown to have spread CJD among humans.

``The theory is simple,'' said Dr. Anne Maddocks, a retired senior medical scientist who specialized in infection control at St. Mary's Hospital in London. ``The promiscuous use of pituitary hormones in cattle led to BSE in the same way that they led to CJD in humans. The timing of the deaths in cattle and humans who were exposed to pituitary hormones is very compelling.''

Maddocks has spent a year investigating the theory, which overturns previous ideas that blamed the epidemic on changes in the preparation of sheep carcasses infected with the brain disease scrapie, which were fed to cattle. Maddocks is backed by Malcolm Ferguson-Smith, an award-winning Cambridge University scientist on the government's mad cow disease inquiry team.

Evidence supplied separately by Joanna Wheatley, a former researcher and now an organic beef farmer, also supports the theory. Wheatley says abattoirs were selling pituitary glands to vets and researchers. Cows then got the disease through contaminated brain extract in their hormone injections. Infected cattle were ``recycled'' back into the national herd when carcasses were used in feed or bovine medicine.

The theory is also supported by David Brody, the lawyer acting for families of victims of the BSE-related nvCJD, who are suing the government. Brody also represents families of those who died from CJD after receiving growth hormone treatment. ``One has to take this theory very seriously indeed,'' he said. ``There is a striking resonance to the timing of events and the thinking behind them, and the similarities suggest that serious questions need to be answered.'' A spokesman for Ministry of Agriculture refused to be drawn: ``It is a theory being considered, but it is only a theory.''

Although the ban on British beef exports was lifted in Europe last week, specialists warn that nvCJD could still kill millions of people. Sir John Pattison, the chairman of the government's scientific advisory body on the disease, said it would take a decade to know the full impact of the crisis.

``We, as a population, are in deep trouble,'' he said. ``That is why the range of possible numbers of variant CJD still goes from something not very different from the numbers we have at the moment to six- or seven-figure numbers.'' His remarks led another panel member, David Pepper, to warn that the chance of such comments causing ``alarm and despondency and maybe even worse are quite high.''

In another sign that scientists are still in the dark over the disease, a new warning has been issued by John Collinge, another scientist advising the government, suggesting that people having their tonsils and appendix out are at risk of contracting nvCJD. This is because the disease has been found in these parts of the body and can be spread through surgical instruments, he warns.

Comment (webmaster): This is a good scenario for initial amplification but not for origin -- where would the bovine pituitaries have gotten their BSE fibrils? It has also been established beyond all reasonable doubt that the main amplification came from feed, eg, the primates in France and zoo animals in England did not receive growth hormone shots. Bovine growth hormone given to dairy cattle has also been suggested as a possibility in the Stetsonville, Wisconsion outbreak of 1985.

Comment (Dr. Michael Hansen, Consumer's Union 11 Aug 1999 ):

"This article is overhyped in my opinion. While it's possible that use of rbGH or other pituitary hormone treatments in cattle may have caused some of them to get BSE, this theory obscures the fact that the main risk factor, I believe, is the refeeding of cows to cows. The theory implicity assumes, as you point out, that the original infectious agent came from cattle, not sheep (which there is no real evidence for as the source of the infectious agent anyway). That is the important point which needs to be focused on.

The problems I have with the cow pituitary hormones being a main cause of BSE are twofold. First, I don't think use of these hormones would have been all that widespread in the UK. Unlike the US, where there is a relentless pressure to have cows produce more milk (due to declining prices to producers), in the UK, with the CAP policy, there are milk quotas so there isn't that pressure to get cows to produce more and more milk. While some farmers may have illegally been using rbGH or other hormones, it's not clear that this was a very widespread practice.

Second, and perhaps more important, we don't know how infectious the injections would be. While injections would undoubtedly be more infectious than the oral route, you have to remember that cattle would be fed MBM virtually every day, while the number and frequency of injections is far less (probably by at least one to two orders of magnitude). Although it is true that human pituitary hormone lead to cases of CJD among children, only a very small percentage of the children exposed to contaminated hormones came down with the disease.

As of 1997, there were 16 confirmed cases on CJD in children in the US out of 8,000 that had been exposed through use of cadavar-source human hGH from NIH (i.e. I believe these numbers are from children that used batches of hGH that were shown to have been contaminated [children usually were injected daily for a number of years]--this info from Gibbs). Thus, only .2% of all the exposed children developed CJD. If the numbers were similar for the cattle, then only .2% of the cattle getting injections of hormones from batches that were contaminated with BSE would come down with BSE. Combined with the probable sporadic use of injectable hormones, this would probably not be a huge number of animals. I still think the main route of infection was oral and that cattle cannibalism was the primary culprit.

As for story itself, I wonder why it took so long for the reporters to write it up. Dr. Anne Maddocks laid out this theory in the statement she gave to the BSE Inquiry (statement No. 467, issued June 16, 1999 but put up on the BSE Inquiry website on July 6 . I haven't had time to read the full statement and the appendix but it seems to me from skimming it that she is trying to explain why BSE emerged in different places but at the same time. Seems to me that the cattle refeeding explains this quite well. An initial cow comes down with BSE spontaneously (perhaps had a mutation in the prion gene or in the promoter, or other regulatory element that lead to overexpression of the prion gene, etc.). That animal is rendered and fed to many other animals. But the titer of infectivity is too low for the disease to manifest itself (i.e. the incubation period vastly exceeds the life of the cow). These cattle are subsequently rendered, fed to more cows, and the titer of infectivity gradually increases, through cycles of refeeding, until the incubation period is shorter than the lifespan of the cow. At this point the disease appears all over the countryside due to the gradual amplification that has happened via refeeding.

As far as I can tell there aren't really any experiments going on to investigate this.

In sum, while I think the theory is interesting and possibly played some role in helping to speed up (however slightly) the rate of amplification, the main culprit in BSE was that it originated in cattle and was then amplified during refeeding. The hormone angle is subsidiary to this and probably should be investigated further, along with the notion that use of OP dips for ectoparasites (such as phosmet) dramatically increased susceptibility of cattle to BSE by sharply increasing the expression (i.e. densisty) of bovine prions in cattle brain--a modification of the Purdey theory.

BSE probably originated in cattle and was mainly amplified via refeeding. Given the sheep as origin of BSE agent, we'll have a hard enough time getting the press to focus on that, but it's simply an extension of the Gibbs hypothesis, which I think is essentially correct. Maddocks' and Purdey's theories should be looked at, but only in the context of this main view. Otherwise, we risk the press thinking that BSE was "caused" by use of cattle hormones, or pesticides."

Risk of BSE in vaccines revealed

 August 8 1999 Jonathon Carr-Brown   London Times
Four of Britain's most senior scientists downplayed the potential risk of the transmission of BSE to humans through vaccines to prevent a serious health scare. They insist that the secret warnings they gave to medical experts to make vaccines from materials that came from non-BSE-infected cattle were not fully implemented.

New evidence given to Lord Phillips's BSE inquiry reveals that the BSE working group, set up in 1989 by Margaret Thatcher and led by Sir Richard Southwood, be-lieved the risk of transfer through vaccines was "relatively high", not "remote" as its final report claimed.

The route by which BSE transfers to humans in the form of new-variant CJD is unknown. There is a possibility that one agent could be the thousands of vaccines used until 1993 that were made out of material likely to have come from infected cattle. The vaccines were used to treat diseases such as measles, rubella and tetanus.

In 1989, when knowledge of BSE was negligible, the Southwood report proved pivotal in the way other bodies overseeing medical products assessed the risk to the public. In particular, the Committee on Safety of Medicines cited the report when it decided not to destroy thousands of stockpiled vaccines made or cultured using bovine materials.

[Millions is more likely than thousands. These possibly tainted stocks continued to be used up until 1993 when they were gone from inventory. Children are of especial concern given that all are required to receive the shots and because of their long life expectancies. Britain could lose a whole generation from this -- why not simply purchase the vaccines from the US? -- webmaster]

It calculated that a vaccine health scare could lead to the almost guaranteed death of 170 unvaccinated people, which had to be set against the "remote" risk of anyone contracting CJD through a vaccine.

But in a twist to the inquiry, Southwood, professor of zoology at Oxford University, and his former colleagues - Lord Walton, a leading clinical neurologist; Sir Anthony Epstein, a former head of the department of pathology at Bristol University; and Dr William Martin, a distinguished veterinarian - were recalled by Phillips to explain why their report "presented a misleading picture of the working party's views".

Southwood admitted his inquiry did not regard the risk as remote, but "relatively high". Asked if he thought the risk from vaccines was greater than the risk of being infected after eating beef, Southwood replied: "Yes."

Yesterday Epstein defended the approach the Southwood inquiry took. "Those authorities were consulted in no uncertain terms," he said. "If they choose to disregard all of the warnings they received and hide behind the word 'remote' what can we do?"

EU probes alleged use of sewage in French feed

Aug 13, 1999 Reuters
BRUSSELS - The European Commission said on Friday it had written to the French government to ask it to respond to press allegations that French companies are using sewage in manufacturing animal feed. Commission spokesman Thierry Daman said the head of the Commission's agriculture department had sent a ``very urgent letter'' to the head of France's competition, consumer and anti-fraud authority to ask for a response to the accusations, made on German television.

``The head of our agriculture directorate has written a very urgent letter to the French authorities pressing for information on whether such sludge is used in animal feed and what measures have been taken to put a stop to such practices,'' Daman told a news briefing. Daman said accusations had been made that French feed manufacturers were adding sludge to animal feed, which had been recovered from factory purification filters. The sludge was alleged to include impurities from toilets, sewers and kitchens.

The letter from EU director-general for agriculture Guy Legras warned that the use of such substances was outlawed by a 1991 EU decision. If the reports were true, it ``would constitute a major risk for public health,'' Legras wrote.

He said he had recently seen reports from France about ``similar grave anomalies in knackers' yards during the production of meat and bone meal.'' Asked by reporters why the Commission had not reacted to similar reports in a French newspaper a month ago, Daman said the Commission believed at that time that the problem had been dealt with. ``The whole thing seems to be coming back in a global context,'' he said.

Belgium's recent dioxin-in-food scare has reignited a debate about what goes into animal feed, and led to renewed calls for a ban on the use of ingredients such as meat and bone meal.

CJD in 3rd yound Seattle case: ex-meat packer

Saturday, August 14, 1999 By Chris Maag Journal Reporter
Degenerative diseases usually take years to kill their victims. But when Gary Hollinquest lay dying in his bed at Harborview Medical Center in July 1998, the sinews in his arms and chest still bulged. "It took him so quick, he still had big muscles from working out,'' Hollinquest's sister Felicia said. [A French bodybuilder died of nvCJD from injecting bovine pituitary extracts. -- webmaster]

Hollinquest died July 27, 1998, of Creutzfeld-Jacobs Disease, or CJD, a fatal, degenerative disease of the brain. According to Ermius Belay, medical epidemiologist at the Centers for Disease Control in Atlanta, the traditional form of CJD affects about one person per million, a rate that has remained steady in the United States for at least the last 40 years. It's most common among older people; only 10 percent of CJD victims are below age 55.

A new form of CJD, apparently related to "mad cow'' disease, was discovered in England in 1996. The new strain was more infectious than the older variant, affecting 42 people in the last three years, and its average victim was younger than those infected with traditional CJD. "No cases of the new CJD have ever been found in the United States,'' Belay said.

But Hollinquest is the third Seattle-area man known to have died of symptoms commonly associated with CJD since April 1998, and he was the second to have CJD listed as the official cause of death on his death certificate.

William Lapp of Carnation died of CJD in April 1998. Issaquah resident Matthew Look's death certificate lists presenile dementia as his cause of death, but University of Washington researchers are still studying his brain tissue, testing for CJD.

The Centers for Disease Control have requested that that Seattle-King County Department of Public Health review the medical records of Lapp, Look and Hollinquest as part of its monitoring for CJD.

In addition, Jeff Duchin, chief of communicable disease control and epidemiology for the area public health department, confirmed that he is currently reviewing the records of a fourth man whose death raised questions of whether CJD was the cause.

The age of the local victims also concerns their survivors. Lapp was 40 when he died, Look 42 and Hollinquest 43.

"I think there are lots more cases than they are saying, and people are getting it at a younger age than they say,'' Felicia Hollinquest said.

Gary Hollinquest worked at the Iowa Beef Packing plant in Pasco from 1983 to 1984, according to Aileen Wunder, who dated Hollinquest for seven years. He worked on the "rib line,'' killing cows by shooting them between the eyes and then slitting their throats.

"He got cut a few times. We all got cut,'' Wunder said. "You have to separate the meat from the bone, so your knife always has to be really sharp.''

Representatives of Iowa Beef Packing could not be reached for comment yesterday.

Wunder also said Hollinquest, of Seattle, was a longtime intravenous cocaine user. It is unknown whether either his drug use or his work at the beef packing plant had anything to do with Hollinquest contracting CJD.

All his family knows is that Hollinquest died quickly. Doctors at Harborview Medical Center told Felicia Hollinquest in April 1998 that her brother had been admitted suffering confusion, disorientation and an inability to walk. She placed Hollinquest in a nursing home, where he deteriorated quickly. He was diagnosed with CJD in May and died in July.

"Before, he was the life of the party. He could sing beautifully, and he was a good uncle,'' Felicia Hollinquest said. "It just took him so quick.''

Reusing disposable medical devices

August 13, 1999 Lauran Neergaard Associated Press
A piece of metal broke off a catheter and lodged inside the heart of a 32-year-old Kansas woman earlier this year - and reignited a medical controversy. The catheter was disposable; it was supposed to be thrown away after its first use. Instead, critics contend it was resterilized and reused six times, a process that they argue stressed the device until it broke.

Unknown to most patients, every day hospitals recycle disposable medical devices. They range from simple products like surgical clamps to complex cardiac catheters, bronchoscopes, even angioplasty balloons. Proponents say this so-called reprocessing is a safe way for hospitals to save thousands of dollars. They argue that many devices are called disposable only so manufacturers can sell more of them, and correctly note that even brand-new catheters can break.

But critics point to the Kansas injury and laboratory discoveries of dried blood or tissue in supposedly resterilized devices. Some products, they say, simply are too fragile or have too many nooks and crannies where contamination could lodge to be safely reused.

Does that put patients at big risk? "The honest answer is no one can tell you,"says Sen. Dick Durbin, D-Ill., who contends the government doesn't have a good way to track the practice's safety, and thus is pushing the Food and Drug Administration to crack down. The concern isn't new. In 1997, the FDA said it was investigating reports of infections and other complaints with reused medical devices - and two years later, the agency still is investigating.

FDA's recent testing of recycled angioplasty balloons discovered they can harbor dried blood after attempted cleaning, and that repeated uses can stretch the balloons so they don't inflate properly. Then, last spring, the FDA learned of the Kansas injury, which disposable device makers used to lobby for curbs on reprocessing. But new catheters have been known to break, too, and companies that reprocess medical devices argue that saving hospitals from having to repurchase catheters that cost $1,000 each is important.

When a device can be safely reprocessed, "to throw it away is an unforgivable waste of scarce health care resources,"Pam Furman of the Association of Medical Device Reprocessors told a recent meeting on the issue. Reusing disposable devices is legal, although hospitals assume any liability - but the growing fight in Washington over the issue leaves consumers in the middle wondering what to think.

Independent health experts say consumers shouldn't panic, because reports of patient problems are so rare that there's no evidence recycled devices are a big risk. "I would just be absolutely amazed if this is a major public health problem and the (leading hospitals) have failed to realize it,"says Dr. William Jarvis of the Centers for Disease Control and Prevention.

The CDC, he notes, has had to investigate very few outbreaks linked to reused devices in the past decade. But it is about to study the issue in Brazil, where poverty means devices are reused hundreds of times more often than here, to better understand of how much reuse products can stand, and how best to sterilize them. Durbin, in contrast, has asked Congress' General Accounting Office to investigate reused devices here, and last week won Senate approval for $1 million for FDA to better monitor the practice.

"I would ask at this point"if your doctor plans to use reprocessed catheters or other very complex devices, Durbin said. "I think it's a legitimate concern." Device recycling's increase is inevitable because of growing health care costs.

And the FDA suggests the issue, like much in medicine, may boil down to evaluating reused devices on a case-by-case basis: Some may be fine to reuse 10 or 12 times as long as they're reprocessed under certain standards, while other devices might be too risky.

"We're not saying it's safe. ... We're not saying it's unsafe. We don't know. We're still looking at this,"said Larry Spears, FDA's director of medical device enforcement. Stay tuned, he says, because FDA will announce by October how it plans to further address the practice. "We're going to have to regulate based on risk,"he said. [This practise could spread CJD under certain circumstances -- webmaster]

The human face to CJD

25 July 99 webmaster
Families affected by CJD have put together some excellent web sites that coordinate information from cases scattered all over.

At the Many Faces of CJD website, over 40 moving personal accounts have been posted that give a glimpse into how this terrible disease affects individuals and their families. Many people shared their experiences in order to help new families cope with CJD and ultimately reduce future cases.

CJD Watch carries excellent data on the incidence of CJD. As the federal government itself actively seeks to minimize CJD, it became necessary for concerned families to collect incidence information directly and provide researchers with needed data and contacts that would otherwise be lost.

Blood recalls and withdrawals for CJD is an important topic that potentially concerns a great many people. The site does a remarkable job of distilling the complex and provisional information on risk, researching the unbelievable number of medical practices potentially introducing risks, and on tracking specific issues and politics of blood recall after it is learned that a donor had CJD.

CJD Voice is a most important support group site that offers message boards, state-by-state contacts, web chat, member stories, a mailing list, and government policty updates. A well-attended conference was put on in June, 1999 in Indianapolis. The site has received 33,873 visitors since 18 Feb 98 making it a major Internet resource for CJD.

These sites are making a very important contribution to education, outreach, and research on CJD -- let's wish the respective webmasters well as they work hard to keep these sites current and well-informed over the coming year.

Jamaica bans imports of EU animal products, feeds

Thu, Aug 12, 1999 By Earl Moxam Kingston, Jamaica, (Reuters)
Jamaica banned imports of animal products and feed ingredients from European Union countries effective Thursday, citing the risk of contamination from the cancer-causing chemical dioxin.

Agriculture Minister Roger Clarke told Reuters the Caribbean nation would immediately suspend issuing import permits for feed and animal products from all EU countries. He said the ban would remain in effect until the potential threat of contamination had been removed "and normality returns to the food safety status of the European Union." The decision was made on Wednesday at a meeting of the veterinary division of the Ministry of Agriculture, following consultations with the European Commission.

Jamaica's action came shortly after the governments of two other Caribbean islands, Montserrat and Grenada, put their countries on watch for the cancer-causing dioxin and PCBs in some food manufactured in Belgium, France and the Netherlands. An admission by Belgium's government in May that some meat produced there contained high levels of dioxin has triggered worldwide bans on importing Belgian meat, eggs and dairy products.

Clarke said Jamaica's importation of European meat and feeds was negligible, representing less than 2 percent of such products consumed in the country. "In fact no importation of these products have occurred over the past several decades from Belgium, hence our supplies of food and animal feeds should be considered safe," he said.

But he said Jamaica was not prepared to take any chances, and that staffing of inspection units would be increased at the island's ports. While the ban took effect immediately, Clarke told Reuters that imports already en route to Jamaica would not be turned back, but would be subjected to "rigorous testing."

Can these really be classified as volunteer donations?

1999/08/07 correspondence
"If you are able to donate blood, United Blood Services has a pretty good deal going. Each time you donate, you are award a "point". For a certain number of points, you can get free prizes. In the past year, I've gotten my kids insulated lunch boxes and myself a watch. They have quite a bit of other stuff as well (clocks, duffel bags, portfolios, wallets, etc.), and sometimes have "double-point" specials. And, you get cookies and juice after donating. What a deal!

The Red Cross gives me T-shirts, and I understand that some places are so short that donors are being offered frequent flyer miles. There's a place in Nashville that pays pheresis donors."

Comment (webmaster): The US used to pride itself on an all-volunteer system but here has started down a slippery slope with these premiums in lieu of cash. The historic reason for this is safety -- people selling blood are hard-up and at high-risk for numerous diseases, including new and unscreenable forms of hepatitus.

Central Blood Bank Announces Blood Recall

Fri, Aug 6, 1999 PR Newswire
PITTSBURGH -- Central Blood Bank announced today that it has been asked by the New York Blood Center (NYBC) to conduct a voluntary recall of 1,379 blood components distributed for transfusion between 1993 and 1996 to hospitals served by Central Blood Bank. This recall is based on U.S. Food & Drug Administration concerns that NYBC tests were not performed in strict accordance with standard procedures for these blood components.

Darrell J. Triulzi, M.D., Medical Director of Central Blood Bank, said the organization has begun notifying the hospitals involved, which will in turn identify the recipients and notify the appropriate physicians. Those physicians will contact the transfusion recipients if medically appropriate. Dr. Triulzi said it will take at least several weeks to complete the process of identification, notification and testing of recipients. Central Blood Bank will provide testing at no charge.

Dr. Triulzi said the notification from NYBC involved a recall of components from 4,540 blood donations. The donations were identified based on a recent statistical analysis of testing data performed by NYBC and the FDA. Dr. Triulzi said Central Blood Bank staff undertook a massive research effort and found that 3,602 donations (79 percent) were from people who have subsequently donated again and were negative for all viral markers. Central Blood Bank was then able to eliminate components from these donors and autologous donations from the recall process. The remaining 727 donations resulted in distribution of 1,379 transfusable blood components that are the subject of this recall.

Dr. Triulzi said the risk of infection from these transfused units is very small. "It is very reassuring that more than 3,600 donors have been retested, and no discrepancies with NYBC testing have been found," he said. "Testing is critically important to the safety of the blood supply, but it is one of several layers of safety that are in place. Other safety measures include donor education about risk behavior, interactive health histories taken face- to-face by a trained health professional, and the opportunity for donors to tell us if we should not use their blood for transfusion."

In October 1990, CBB contracted with the FDA-approved laboratory at NYBC to perform viral marker testing on blood donations collected by Central Blood Bank. That testing was carried out from October 1990 through April 1997, after which CBB switched to another FDA-approved testing facility.

In late 1996, an FDA inspection at New York Blood Center raised concerns that certain laboratory technicians may not have performed testing on blood in strict accordance with standard procedures, resulting in recalls and a late 1998 Public Health Announcement. NYBC has recalled blood components in New York City, Chicago and Memphis as well as Western Pennsylvania. The recalls have been monitored closely by the FDA.

Central Blood Bank is a nonprofit organization providing blood products to 40 hospitals in Allegheny, Armstrong, Butler, Mercer, Washington and Westmoreland counties in Pennsylvania and selected communities in northern West Virginia and eastern Ohio. In a typical year, Central Blood Bank provides 300,000 blood products to those hospitals.

Belgium Agrees To Tests on Exports

Associated Press Mon, Aug 9, 1999 By PAUL AMES 
Belgium backed away from a clash with the European Union on Monday and pledged to comply with EU demands for strict new tests on food exports to ensure they are not contaminated by cancer-causing dioxin. The decision to submit all food exports with more than 2 percent animal fat -- including waffles and mayonnaise as well as almost all meats -- to the costly and time-consuming tests reverses the position Belgium took over the weekend.

On Saturday, Health Minister Magda Aelvoet had said Belgium would defy the EU and apply the tests only to exports with fat content above 20 percent. Her statement appeared to contradict Belgium's earlier acceptance of the EU demands and put the country on a collision course with the European authorities. After government officials held talks Monday with the European Commission and industry representatives, Aelvoet backed down.

"The message from the food industry is very clear. We risk a total embargo if we don't follow EU rules," she told reporters. Belgium intends to appeal to the European Court of Justice. However, pending a ruling from the EU's supreme court, Prime Minister Guy Verhofstadt it has promised to follow the regulations, EU Commission spokesman Thierry Daman said.

Belgium has been wracked by dioxin contamination fears since May, when the government announced that high levels of the cancer-causing chemical had been discovered in eggs, meat and dairy products. The fear led to a wide range of products being pulled from supermarkets and international bans on Belgian food.

Although the Belgian government said it had traced the source of the scare to one supplier of fats used in animal feed, fears emerged last month that the contamination may be more widespread. Under pressure from the EU, Belgium agreed to tighten tests on livestock, meat and dairy products so only those certified as dioxin free will be exported. However, the government has sought to reduce the number of tests to avoid overwhelming its laboratories and causing expensive delays.

States aim to halt spread of chronic wasting disease

The Country Today  August 4, 1999 By Scott Schultz Regional Editor
STEVENS POINT, Wisc -- Chronic wasting disease -- the deer family's version of mad cow disease -- has been found in recent years in Western states' deer and elk herds and is seen as a threat to cervine herds throughout America.

What steps, if any, need to be taken to keep the disease from spreading to Wisconsin's herds is a challenge that Wisconsin farmers, animal health officials and wildlife specialists are considering. Western states' prevention efforts and what possibilities are available for Wisconsin were discussed during a July 27 symposium in Stevens Point.

Science has yet to pin down all the ways that transmissible spongiform encephalopathies are spread from animal to animal and how well the TSEs are spread between species. It is well known, however, that the disease causes lesions on an animal's brain and causes the affected animal to slowly "waste away," -- thus the name chronic wasting disease.

The disease has been found during the 1990s in captive and wild deer and elk populations in Colorado, Wyoming and South Dakota and has been identified in captive herds in Nebraska. It was first identified during the 1960s in a research facility at Fort Collins, Colo., and has affected up to half of the deer and elk at that facility.

Mysteries that remain about how the disease is spread, or even whether the same strain of TSE is getting to the affected herds, have made monitoring and control difficult. Adding to the problem is difficulty in identifying the disease. So far, the only way to find the disease has been through study of dead animals' brain tissue. There are clinical signs, such as the failure to thrive and a never-ending thirst for water, but researchers say the disease is well on its way to spreading once clinical signs appear in a herd.

"This is a disease that is going to be a lot easier to keep out of your state than it will be to do something about once it's here," said Mike Miller of the Colorado Division of Wildlife. "It's not trivial." The disease has been found in captive herds and in free-roaming herds in northeastern Colorado and southeastern Wyoming. No relationships have been established between the cases in captive herds and those in free-roaming herds.

Mr. Miller said computer models show the disease could spread and peak in 40 to 50 years in deer, until populations decline enough to stop CWD from spreading. As the disease spreads eastward, Mr. Miller said people should expect to see huge effects on whitetail deer populations. As herd numbers are decreased by the disease, Mr. Miller said one option would be to allow it to "naturally run its course."

Eradication of herds in areas where the disease is found is another option, but Mr. Miller said that is politically impossible, especially in Colorado, South Dakota and Wyoming areas with highly regarded elk and mule deer populations. He said people -- from animal rights activists to hunters -- likely would oppose eradication methods, and he challenges anyone to propose it in Colorado. "In our correct political environment, it's just not the thing to do," he said. The next management level would be surveillance programs that would allow for the quarantine of herds where the disease is found.

North Dakota, South Dakota, Montana, Colorado and Nebraska all have mandatory surveillance programs for captive herds and Minnesota has a voluntary surveillance program. Most of the states also are looking for diseased animals in their free-roaming herds.

The Wisconsin Board of Agriculture, Trade and Consumer Protection earlier this year passed a position statement saying the agriculture department will investigate ways to keep the disease out of Wisconsin. That could mean a voluntary or mandatory surveillance system eventually being put in place in Wisconsin.

State control programs could lead to the need for other states, such as Wisconsin, to implement a program if deer and elk farmers expect to market animals across state lines, said Glenn Ziebarth of the North American Elk Breeders Association. "There are enough states where it's mandatory that the market forces are going to drive it," Mr. Ziebarth said.

South Dakota's Fish and Game Department acted quickly once the disease was found there and put together a far-reaching surveillance and quarantine program. A confirmed case of CWD was found in South Dakota in December 1997, and a surveillance program was implemented in February 1998. The program was put into place after department officials met with South Dakota and federal wildlife regulators, veterinarians and cervine industry representatives.

Quick action was needed to control CWD's spread, said Sam Holland of the South Dakota Fish and Game Department. "The seriousness of CWD in the cervine industry was very apparent," he said.

Tests for CWD are done on all captive deer and elk 18 months old or older that die from any cause (slaughter included) in South Dakota. Five captive herds have been quarantined and the owner of one herd where CWD was found asked that his herd be destroyed and agreed to keep cervine animals off his farm for a year.

Herds are classified according to how long animals from the herds are found to be CWD-free. Five-year quarantines are required for herds that have contact with herds where CWD is found, an action that can be reduced by state regulators as monitoring occurs. South Dakota also has created an intrastate health certificate much like that required for interstate moves.

The testing process doesn't come cheaply for the state's deer and elk farmers. Veterinarians must be paid to take brain samples from dead animals (the sampling is done by inspectors in slaughterhouses), and there is a $31 per animal charge for the tests, which are done through the state's diagnostic laboratory. Further testing expenses occur with state-positive tests, as samples are then sent for National Veterinary Service Laboratory certification.

Although there are expenses, Mr. Holland said farmers should see them as a cost of doing business, and noted that farmers will benefit in the long run because the disease is devastating to herds. "What I've seen of this disease, I think it will 'break' the herds, unfortunately," Mr. Holland said. "I don't think you can 'test out' of this disease."

The South Dakota program also has targeted surveillance of free-roaming cervines, with hunters asked to submit harvested animals' heads for testing. The first hunting season of the program garnered less than the half-percent goal of samples that state officials had wanted, but Mr. Holland said no positive tests were found in those samples.

A surveillance program in Colorado is funded in part through a federal cost-sharing aid program. Mr. Miller said the program will spend about $500,000 per year in monitoring Colorado's free-roaming cervine herds. "The costs might be high because we're trying to get a lot done in a short time," Mr. Miller said.

Colorado studies show the disease moves steadily through elk herds, sporadically through mule deer herds and quickly through whitetail deer herds. Unlike bovine spongiform encephalopathy (mad cow disease), CWD doesn't seem to be a feedborne disease, according to Mr. Miller. However, it can be spread between animals at feeding sites, he added. "It seems to be transmitted from animal to animal," he said.

Mr. Miller said an occasional severe winter should help to control the spread of CWD, with deer that are sick from the disease dying before they spread CWD to other animals. Even then, evidence has been found showing that the disease can survive for long periods on dead tissue.

Comment (webmaster): A highly sensitive blood test in live animals is to be published in August 1999 in the J of Chromatagraphy B by MJ Schmerr and colleagues. This test can detect as few as 15 million prion monomer molecules. CWD has very likely spread to a great many facilities. In Wisconsin, where elk from Montana are grown for several years before being shipped back for captive "hunting" there would be a potential risk of transmission to dairy cattle on adjacent pasture or after pasture rotation.

Foot-dragging at FDA on CJD as reportable disease

5 August 1999
Commissioner Jane Henney
Food and Drug Administration
Parklawn Building, Room 1471
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner Henny:
Pursuant to the Administrative Procedure Act ("APA"), 5 U.S.C. S 553(e), and the FDA implementing regulations, numerous organizations and individuals have petitioned your office to take action regarding, inter alia, the potential human and animal health impacts associated with the spread of transmissible spongiform encephalopathy. See FDA Docket No. 99P-0033/CP1 (filed January 7, 1999). Since the filing of the petitions over almost seven months ago, your office has failed take any action concerning the issues presented by the Humane Farming Association (HFA), the International Center for Technology Assessment's Center for Food Safety and other petitioners. The agency's failure to respond to the citizen petition denies petitioners relief at the agency level and is a constructive denial of the petitioner's request. As such, petitioners intend to pursue other avenues, including judicial review, in order to assure that the agency responds to the issues raised by HFA and others.

Indeed, the agency inaction in this matter is subject to judicial review. Under the APA "agency action" is defined to include "the whole or part of an agency rule, order, license, sanction, relief, or the equivalent denial thereof, or failure to act" and gives courts the power to "compel agency action unlawfully withheld or unreasonably delayed." Thus, the APA authorizes courts to review agency decisions to refrain from taking action. When administrative inaction has precisely the same impact on the rights of the parties as denial of relief, an agency cannot preclude judicial review by casting its decision in the form of inaction rather than in the form of an order denying relief.

In addition, the agency's inaction is violative of established agency regulations. The FDA has established regulations in which a reasonable period for agency response to citizen petitions can be no more than 180 days. Regulations which are promulgated by an administrative agency in carrying out it statutory mandate can also provide standards for judicial review of agency action. Such self-imposed constraints may supply the "law to apply" to overcome the judicial presumption against reviewing administrative inaction. Thus, the agency must act in a "prompt" manner or be subject to further action. The agency's delay in answering the current petitions amounts to a refusal to act, with sufficient finality and ripeness to permit judicial review.

Furthermore, petitioners remind the FDA that excessive and unreasonable delay in addressing matters brought to its attention by the public saps the public confidence in an agency's ability to discharge its responsibilities and creates uncertainty for the parties, who must incorporate the potential effect of possible agency decision making in the future.

Petitioners request the agency to respond to the aforementioned petition by September 1, 1999. In the absence of an affirmative response, the petitioners will be compelled to consider litigation in order to achieve the full and complete action required to address this violation of federal law.

Sincerely,
Joseph Mendelson, III
Legal Director
Center for Food Safety
c/o International Center for Technology Assessment
310 D Street, NE
Washington, DC 20002

CC:     Docket No. 99P-0033/CP 1
        FDA Dockets Management Branch (Room 1-23)
12420 Parklawn Drive, Rockville, MD 20857.

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