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Rich Murray: vegsource.com: Nelson:
totally inadequate USA mad cow testing 4.2.1 rmforall
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USDA Mad Cow Strategy: Don't Look, Don't Find
by Jeffrey A. Nelson firstname.lastname@example.org
April 2, 2001 LOS ANGELES -- Compared to the actions taken by countries in the European Union, the United States government does not seem to be aggressive enough in protecting American consumers from bovine spongiform encelphalopathy (BSE), commonly known as mad cow disease.
The type of testing methods now used in the U.S. have been shown to miss prions detected by the more advanced testing methods employed in Europe. (A prion is a microscopic protein particle similar to a virus but lacking nucleic acid, thought to be the infectious agent responsible for BSE and certain other degenerative diseases of the nervous system.)
Germany, which long proclaimed itself "BSE-free" using the same type of testing the US currently utilizes, did not discover its first mad cow cases until it began using the more sensitive testing procedures.
The U.S. currently uses Western Blot analyses, immunohistory chemistry, and histopathology, which are more labor intensive and take longer than the newer tests. They require removing a portion of the brain, sectioning it, staining it with dye, and examining how the dye has interacted with the tissue.
The U.S. also is presently testing only 1 out of every 18,000 cows slaughtered, whereas countries like Switzerland test 1 out of every 60 cows.
Mad cow disease in humans is called New Variant Creutzfeld-Jacob Disease, or nvCJD. It is transferred to people via consumption of contaminated meat, and is a horrifying, fatal disease that attacks the brain, turning cells and tissue into a fibrous sponge-like material. The disease is usually first indicated by difficulty in walking and loss of memory. Eventually people with the disease will lose control of all their faculties. In the past, some spongiform brain diseases (which include nvCJD) have been misdiagnosed as another spongiform disease, Alzheimer's. Some doctors will not autopsy possible CJD victims because of its highly infectious nature; surgical tools cannot be sterilized if they come in contact with the disease.
Dr. Marcus Doherr is a veterinarian epidemiologist at the University of Bern, Switzerland, who received his Ph.D. from University of California at Davis. He helped design the Swiss mad cow testing program, regarded by many experts as the most advanced in the world.
Doherr says that if the U.S. has as high an incidence of mad cow as France, for example, the current USDA testing program would not detect it. "They're not testing enough animals," he says. "The USDA argues it's a good sample, but it isn't representative of the population it is trying to extrapolate."
Catch a falling cow?***
European countries have for some time been testing a far greater percentage of their cattle. And unlike the U.S., European countries are now testing animals which are headed into their food chain. The U.S. is currently testing a tiny number of "downer cows," cows which are selected for testing visually by USDA inspectors because of obvious illness.
Dr. Linda Detwiler, a veterinarian who chairs the BSE Working Group at the U.S. Department of Agriculture, defends current U.S. testing, asserting it is adequate to detect mad cow if it is in the U.S. "We are targeting fallen stock, and we know it's best to target those cows because in Switzerland, the country with the greatest scientific experience with spotting the disease, they found all their BSE cases in fallen stock, and none in testing animals going into the Swiss food chain."
Actually, that's not entirely correct. Dr. Markus Moser, a molecular biologist and guest researcher at Oxford University in England, heads the Swiss company Prionics, which developed a rapid-response test for BSE, called the Prionics Check Test. Moser says their test has found cases of mad cow in tests of "healthy" cattle which otherwise would have entered the food chain.
Moser does agree with Detwiler that BSE has been found in significantly higher percentages in fallen stock, making it reasonable to focus initial testing there. However, you can't compare the current U.S. testing to testing done in Europe, he says. The reason is because the U.S. has a very different definition of "fallen stock" than the Europeans.
"In Europe," says Moser, "'fallen stock' refers to any cow not regularly slaughtered, which gets sick or dies, breaks its leg and is destroyed, or doesn't go into the food chain for any number of reasons. No such cows can be disposed of in Europe without being tested for BSE."
But in the U.S., the term "fallen stock" appears to refer only to cattle that actually arrive at the slaughterhouse and are so obviously sick that they are pulled out of the line by a USDA inspector. "Who would bring a sick animal to an abattoir that they knew was going to be pulled out?" says Moser.
In fact, U.S. ranchers can dispose of sick cattle in a number of ways, such as selling them to rendering plants to be turned into animal food. Unlike Europe, the U.S. does not have the same laws insuring these fallen cattle are not disposed of without testing first for BSE.
Dr. Mike O'Connor is another expert who believes U.S. policy could be improved. O'Connor is a founder and the Technical Director of Enfer Scientific, in Dublin, Ireland. His company developed the Enfer rapid-response test for mad cow disease, now used in the UK.
"It's illegal to bury casualty cattle in Ireland," says O'Connor. "You can't just dispose of them however you want. They must be tested. That obviously doesn't happen in the U.S."
Dr. Roland Heynkes, a German molecular biologist who has studied spongiform diseases since 1990, including mad cow, says that German tracing systems also make it very difficult to bury fallen cattle without a BSE test. He adds that Germany now tests a much greater percentage of their cattle now than even Switzerland. "1 out of every 3 healthy cattle, as well as all fallen cattle over 24 months, are tested in Germany by law," he says. "In addition, there are large numbers of voluntary tests of younger cattle, and in contrast to Switzerland, it's impossible to avoid a BSE test in Germany when cattle are over 24 months old."
Dr. Dagmar Heim, the head of Switzerland's BSE testing and surveillance unit, points to the most dramatic illustration showing the difference between European and U.S. definitions of "downer cows." It's the number of cows the U.S. counts as "fallen" versus the number Europe identifies.
In Switzerland, she says, some 14,000 cows were identified and tested last year as "high risk/fallen" out of a total of about 800,000 slaughtered. By comparison, the US identified and tested only about 2,000 "fallen cattle" -- out of a total 36 million slaughtered here.
That's a difference between 1.75% of all cows in Switzerland being identified and tested as fallen cows, and .0056% (five-thousands of one percent) of all U.S. cows being identified as "downers" and tested.
If the USDA used the same "fallen cattle" definition as Europe and ended up testing 1.75% of its cattle for mad cow disease - as the Swiss do - the U.S. would be testing about 630,000 cows per year, rather than the 2,303 cows tested last year.
Moser says the USDA's claim that it is testing what the Swiss have identified as a "high risk group" - fallen cattle - is not accurate. "You're testing a very small sub-population of what Europe looks at, a tiny fraction of what we consider to be 'fallen cattle.' It's not the same at all."
Best mad cow disease test is "made in the USA" - but not used here According to a study published in 1999 in the scientific journal Nature, the most sensitive mad cow test is produced to date is made by a company called Bio-Rad, with headquarters in Hercules, California, near San Francisco. In 1998, the European Union formed a commission to evaluate mad cow tests, and the result was a joint effort between the French Atomic Energy Comission and Bio-Rad, which developed and in 2000 began marketing a test called Platelia BSE. Bio-Rad CFO, Tom Chesterman, says their rapid response mad cow test costs $17 per cow, with some 600,000 tests having been sold in Europe since the beginning of the year.
Two other tests reviewed in the Nature study were also shown to be highly effective; Dr. Moser's Prionics Check Test, and Dr. O'Connor's Enfer. All three tests are designed to provide quick response times, enabling meat packers to test animals and get results back before slaughtered carcasses in the plant's "chill room" reach 4 degrees Centigrade, the temperature at which they can be loaded onto trucks to go to market.
When asked whether the USDA was evaluating or considering using these newer tests in the U.S., Detwiler said they would look at them at some point in the future. The reason the USDA isn't looking more closely at these tests now is because "there's too much demand for them in Europe," and Prionics, for example, is currently "unable to send any testing kits to the USDA, "she says. "We can't start any evaluation if they can't deliver the European tests to us."
Moser of Prionics and O'Connor of Enfer find it surprising Detwiler would say this. "Our test has been commercially available since 1999," says Moser, "how many do they want?" He says their test is marketed by Roche Diagnostics in the U.S., which has for sometime been trying to get the USDA to take interest in it. "It's been available to the USDA for a long time, if they wanted it."
O'Connor of Ireland is also eager to get the Enfer test to the U.S. government. "There is no problem getting Enfer tests to the U.S.," he says, adding he would be delighted to have Enfer find a home in the U.S. "We are trying to get it in there with our marketing partner, Abbot Diagnostics."
Moser says that a "60 Minutes" producer recently contacted him for a story, and also told him Detwiler at the USDA had made the same assertion, that Prionics would be unable for several months to give the USDA a test to evaluate. "How could the USA not be able to get our test?" asked Moser.
Asked what the USDA thought of the Nature study affirming the effectiveness of the three rapid mad cow tests, Detwiler replied she wasn't familiar with the study and needed to read it. She added that she expected it to take quite some time for the USDA to evaluate the rapid tests, that it would likely be a long time before they might be approved.
"Approval is really a gray area," says Moser. "Yes, things often go through long processes to be formally approved, but the current method used by the USDA hasn't been approved by anyone."
Approval is also a gray area because the test isn't being given to live animals, which would normally require many safety tests, but is being administered to dead brain tissue. The only needed testing appears to be to determine whether or not the tests work - which the EU and a number of individual European governments have already tested and proven perform quite well.
Rapid testing was key to discovering BSE in Germany***
BSE was first discovered in Switzerland in 1990, with the Swiss government instituting numerous consumer protection measures since then to close off the country from known BSE-sources. In 1998, conventional testing appeared to indicate that BSE rates had declined dramatically. Prionics introduced their rapid testing method and began marketing it.
"Some here in Switzerland were resistant, saying we had BSE under control, why did we need to do this testing?" said Doherr. But others, including consumer groups pushed for the new testing to be done and so Swiss authorities with some reluctance decided to try it.
"It became very apparent there were a lot of BSE cases that were missed before we used the Prionics test," said Doherr. "We quickly realized that this rapid testing was a very valuable tool to see how the epidemic is progressing. There was a dramatic increase of BSE-infected animals detected." Doherr says nearly four times as many cases of BSE were found in Switzerland in 1999 when rapid testing was used, than were found in 1998 using only conventional testing (the same methods used today in the U.S.).
"This was huge news around the world," said Moser, whose company produces the test. "Everyone was in shock over this discovery." Moser says Prionics subsequently convinced Swiss authorities to do a test on 3000 normal cows, in addition to testing fallen cows. The results revealed mad cow was also in cows which had no obvious symptoms, and were headed into the food chain.
"Rapid testing was finding a lot of BSE in Switzerland," says Moser. Switzerland's beef industry was coming under fire, he says, but the Swiss argued that their beef was probably no worse than other EU countries, and the only difference was they had better testing.
They turned out to be right.***
Germany had long proclaimed it was BSE-free. They also used the same testing the U.S. government currently uses. "The Germans didn't see any BSE," says Moser, "So they said 'We're clean.'"
Heynkes notes that although the German government's position was that Germany was BSE-free, "several German BSE experts had warned for years that Germany was unlikely to be BSE-free."
Moser said after Prionics found greatly increased mad cow in the Swiss herd, his company tried to interest European governments in their test. "They were in a state of denial, saying they didn't have BSE here, that they had 'firewalls' around their countries, they had taken measures to keep their beef safe, were already testing, and so on." Moser said most governments weren't immediately interested in fast tests that would make it possible and affordable to test many cows very quickly.
So Prionics began marketing their rapid test directly to labs in Germany, and directly to meat producers. "And some of these companies felt they had a responsibility toward their customers," says Moser. A few privately were concerned that one day they might have legal liability if mad cow turned up and infected people.
"If they did some testing now, that would be a reasonable step," Moser says. Private labs then performed the Prionics test on a small number of cattle -- and found BSE in German cows for the first time.
"It snowballed from there, Germany did more rapid testing and found it had a big problem. It was a huge scandal," says Moser. All consumer groups in Europe had been pushing for more testing, and now DG24, the Health and Consumer Protection Directorate-General of the EU, issued rules for mandatory minimum testing in member countries, for all fallen cattle and cattle over 30 months of age.
Heynkes said that before the private testing in Germany revealed BSE, the German government had not wanted to test widely for mad cow. "But when the people refused to buy untested beef," he says, "the government had no other choice but to test." Heynkes says if U.S. consumers were really interested in knowing what the BSE-status is of the meat they eat, "they would only have to boycott untested beef for a few weeks" before wide testing would be forced by market forces to begin.
"The importance of this new rapid test is that a lot of other countries were claiming they had no BSE," says Doherr. "They were not implementing any consumer measures to protect their public. It was important that these countries were forced to use this test. It told them, 'You are wrong, you do have BSE, and you need to do something to protect your consumers.'"
Commercial forces have since taken hold, Moser says, and countries wanting to sell their beef to other EU countries have had to start widescale testing to assure their foodchain, or other countries won't buy from them.
Worthless USDA "firewall" strategy?***
Recent studies point to intensive factory farming techniques used widely in Europe and the U.S. as causing mad cow to develop in herds. Specifically, the practice of feeding cow protein back to cows is widely considered to promote and spread mad cow disease. Although the U.S. enacted laws to stop this practice in 1997, FDA monitoring in March of 2001 revealed that several hundred U.S. feed factories are violating these rules intended to prevent the spread of mad cow.
Additionally, the U.S. permits the feeding of other animal remains to cows, which new research suggests may permit continued spread of mad cow disease. This practice has been outlawed in Europe and elsewhere.
While keeping out meat and feed from countries known to have BSE is important, some experts say it's very possible if not likely that the disease can appear spontaneously in a country with farming techniques used in the U.S. and Europe, even in the absence of any outside "contamination." In this instance, the current USDA "firewall strategy" - preventing mad cow from appearing by blocking imports from BSE countries - would prove of little use.
European experience also shows relying on the judgment of people in slaughterhouses can be problematic, Moser says, as it requires a degree of interpretation. "If a vet is not well educated in spotting signs of BSE, they can easily miss them," he says.
Doherr agrees. "If a cow's production of milk drops significantly, in Switzerland we test it as a sign of mad cow." In the U.S., however, that cow is sent into the food chain. "BSE starts as a subtle chronic disease, and gets more intensive. But it's easy to miss at early stages if you're not trained," Doherr says. He says things as simple as a behavioral change, a cow afraid of movement, noises or light, or a cow being sensitive to touch - all signal BSE suspicion and trigger testing in Europe, but not in the U.S.
"If a cow kicks when you try to milk it, a U.S. farmer - who is told 'we don't have BSE here' - will not even think about it," says Doherr. "He'll just think it's time to replace that cow. People who think they have no BSE in their country are unlikely to recognize a case, let alone report it."
Moser also points to potential problems with the conventional immunohistory testing, the testing method used by Germany (which many now realize missed cases of BSE) and currently used by the U.S. While Moser believes the test isn't a bad method per se, he says it has potential problems.
"These tests depend on the quality of the tissue," he says. "If the brain tissue used in the test is not of good quality and is partly degraded, the test becomes problematic. In the U.S. they're only analyzing downers, and if the animal is lying down and dead for a day, the conventional method used in the U.S. doesn't have a chance to pick up BSE."
He adds that the conventional test itself requires interpretation by the lab technician in order to be certain of the result. "It takes a trained person to interpret that test accurately. You can overlook things," he says.
With his rapid testing technique, Moser says, results are unambiguous. "It's an objective method. You either have a positive or a negative."
O'Connor says rapid tests are not only faster, but more accurate than the government test. He says Enfer tests between three and five thousand cattle per night at their facility in Ireland, and have results back to the packing plant in the middle of the night so as not to slow down meat packing operations. BSE-positive cows are removed before entering the food chain.
"If we get a positive test, as we got a few last night, then we repeat the test," says O'Connor. "If we get two positive results on a cow, then we tell the meat processor to hold the carcass, and we send the sample to the government for their confirmation testing with immunohistory."
O'Connor says that in several instances the Enfer tests have come up positive, but the immunohistory test used by the Irish government later came back negative, indicating no BSE. O'Connor says Enfer has insisted the government look again, and the immunohistory interpretation subsequently finds that in fact the cow is positive.
"Our test is more sensitive than the immunohistory test," he says. "When there's a disparity, we've had the government double check, and they come back to us saying, 'Oh yes, you're right, this one was prion contaminated.'"
The testing used by the Irish government - which can give false negatives - is the same currently used by the USDA.
Health or political problem? ***
Moser says the American government is in a defensive position now. "They're only testing 2,000 cattle a year, and they feel that's good enough to prove that they don't have BSE in their country," says Moser. "So right now BSE isn't being treated like a potential health problem in the U.S., but a political problem. It's the same situation European countries were in."
Heynkes agrees, pointing out that Ireland tests more than twice as many cows in one night as the U.S. tests in one year.
Moser believes the USDA is in a "denial stage." "They don't want to really look at this. They were taken by surprise at what's happened in Europe, and they want time to breathe. Rather than be on the safe side, they don't want to introduce rapid testing right now," he says.
Moser thinks the U.S. is afraid wider testing might reveal mad cow is in the U.S., putting the government in a position where they would have to admit their surveillance has not been sufficient. "I've seen it before. You mention mad cow disease, and everyone freezes. The politicians go into hiding. No one wants to comment on this. It's absolutely amazing."
Moser also can't understand why USDA representatives would tell reporters his company, Prionics, is unable to get tests to the U.S. for several months. "It tells me they have no PR concept. They have no concept on how to deal with the situation. They want to beat for time. It's a statement that shows they're not prepared," he says.
Heynkes, the German molecular biologist, goes further. "I think in Germany she would have to resign after this lie." Heynkes refers to the January 2001 resignation of the German Agricultural and Health Ministers over what was widely viewed as their grossly inadequate reaction to the health threat posed from mad cow disease.
Heynkes agrees with Moser on the reason the US is not rushing to embrace rapid testing. "These tests have been used in practice several hundred thousand times now and already identified seemingly healthy - but BSE infected -cattle," he notes. The problem isn't about whether or not the rapid tests are accurate, he believes, but that "the U.S. government simply does not want to test and find BSE."
Moser of Prionics believes the U.S. government is exercising poor judgment in making extreme statements like "There is no BSE here."
"The problem is, if you get one sick animal, everything changes. The people will feel they've been lied to by the government. 'We're not BSE-free after all!'"
Moser says the U.S. should simply say that it's "unlikely" that we have it. "That way, even if the worst happens, the public is emotionally prepared. But the way the U.S. is handling it now, as soon as you have your first case - and I hope you don't, but it's likely you will - no one will buy beef in the U.S. the next day. It will destroy the U.S. beef industry because of the way it's being handled now."
Moser says this is what happened in Europe. "Then the politicians will say, 'People are hysterical, people are overreacting.' But they aren't over-reacting. They're reacting to having been told something false. They're reacting to having been given a guarantee in an area where it is impossible to give guarantees. So the U.S. is taking a dangerous and extreme position."
European questions apply to USA***
"Germany isn't a banana republic," says Moser. "It's a major Western democracy with advanced science and technology." It used the same science that the U.S. is currently using, he notes, and found no BSE. "The fact that they then used rapid testing and found big problems, this suggests that it can very well happen in another modern democracy."
Moser says he believes there is also a "psychological barrier" in BSE testing. "The veterinarians doing BSE surveillance in slaughterhouses were reluctant to go out on a limb too often and say, 'This looks like BSE,'" says Moser.
And in "adamantly BSE-free countries," there's a lot of pressure on the inspectors who are looking for BSE-suspect animals, he says. "Imagine what an inspector is triggering if he thinks BSE is spotted. If it's an error, okay, fine. But if it turns out to be BSE, the whole slaughterhouse will have to be shut down, the press will probably get wind of it, and it would be a scandal. Maybe he would lose his job."
Heynkes points to a German inspector, Dr. Margit Herbst, who claimed to have seen more than 20 BSE suspected cattle which were not adequately tested for mad cow. She went public with her concerns, and lost her job.
"But nothing changed," says Heynkes.
Moser says that once a few cases of BSE were spotted with more objective rapid testing, suddenlyEuropean inspectors were finding symptoms where they hadn't before. "After breaking that psychological barrier, suddenly everyone was finding BSE symptoms. Surveillance actually improved dramatically once the ice was broken."
Heynkes agrees. "The first German BSE case was extremely helpful because otherwise we would still have no useful cattle feed law now," he says. He notes that the government has had to make BSE science much more transparent and subject to examination and comment from non-government powers. "More and more the German government has to deal with an organized BSE science, making it harder for consumers to be misled."
Moser doubts there is an organized conspiracy between the meat industry and government to suppress mad cow findings. Rather, he thinks there's a human factor involved that "no one likes to see what's not nice to see" coupled with sorely inadequate testing.
Who's protecting our health?***
In most European countries, decisions about BSE programs and testing are currently being made by politicians. There has been much criticism for the way BSE issues were handled early on, and many Europeans now believe the interests of agriculture and the meat industry were much more important in the decision-making process than was the potential health of the people. In England particularly, recent reports have been highly critical that BSE was handled predominantly by agricultural and veterinary officials, when in fact it was a major potential public health issue, and should have involved the UK Ministry of Health.
In Germany it was the same way, with only veterinarians dealing with BSE questions at the beginning. Says Heynkes, "Things only improve when independent scientific bodies review the risks, and when government scientists are prepared to ask experts from outside for input on their drafts." The UK learned this the hard way, from its BSE crisis, and is what forced them to build up their Food Standards Agency, says Heynkes.
As in the UK at the early onset of the mad cow crisis, neither the U.S. Department of Health nor the Center for Disease Control is setting policy on BSE. This, despite that BSE policy could potentially have a major impact on public health. Instead, all policy and decision-making rests with the USDA, whose stated mission is not preventing disease, but to "Enhance the quality of life for the American people by supporting production of agriculture."
Says Representative Dennis Kucinich (D-Ohio), who wants the U.S. Congress to look into the issue of BSE testing, "Public health and safety requires demanding and immediately employing the latest and most accurate testing methods available."
For the moment, improving mad cow testing techniques is not the USDA's focus. According to Detwiler, who plans and supervises the USDA's BSE program, the thrust is on improving visual surveillance. This means educating people, says Detwiler. "Just like George Bush is flying around the country trying to rally people to his tax cut plan," she says, "I'm flying around the country to rally people to do better surveillance. Tomorrow I fly to Nebraska for an event."
But according to European experts, without instituting a working cattle identification and tracing system, the USDA's plans to tout increased surveillance will probably not not be enough. Only by making and enforcing laws which track cattle will the U.S. be able to prevent farmers from simply burying BSE-suspected cattle without being tested, says Heynkes.
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