IVD Technology Magazine
IVDT Article Index

Originally published November, 1997

IVD Technology News

BSE scare threatens IVD manufacturers

European furor over the outbreak of mad cow disease in Great Britain is threatening upheaval in the U.S. IVD industry.

In July, the European Union ordered a blanket ban on all products made from cattle parts that could carry bovine spongiform encephalopathy (BSE), which is suspected as the cause of the outbreak announced in 1996. The ban will affect blood coagulant, tetanus, and other IVD tests that use calves' brains as media.

Of even greater concern to U.S. suppliers is a further EU directive authorizing its 15 member countries to require that imports be government-certified as free from BSE-risk materials. That order could drag half the U.S. IVD exports into the mad cow disease fray, says John Place, director general of the European Diagnostic Manufacturers Association (EDMA, Brussels).

The ban came as no great surprise, given the level of European outrage over the incident. In 1996, Great Britain sent shock waves through Europe by disclosing that a BSE outbreak in British cattle from 1986 to 1995 might be linked to 10 human cases of a previously unrecognized strain of Creutzfeld-Jakob or mad cow disease. Characterized by plaque formations in the brain, the disease causes severe psychiatric symptoms and dementia. Most victims of the new strain are under 30 years of age and die within a year of onset.

Under fire for bungling the crisis, European officials have promised to rid the human food chain of BSE risk.

But IVD manufacturers are mystified that they were included in the ban, since their test products are neither ingested nor injected, but rather used in a laboratory or test-tube setting. "The only way these products could transmit BSE would be if someone drank them, and I doubt anybody would do that," says Carolyn Jones, director of technology and regulatory affairs for the Health Industry Manufacturers Association (Washington, DC). "I've gotten a lot of calls from IVD companies complaining and asking for information. They're very, very scared."

Industry officials say the EU order could seriously disrupt manufacturing and international trade, and for no good purpose. A rigorous surveillance program has turned up no cases of BSE in U.S. cattle, according to United States Department of Agriculture official Linda Detwiler.

"Personally, I do not know of any risk," says Detwiler, a senior staff veterinarian with the USDA's animal and plant health inspection service.

The EU justifies the sweeping ban by citing widespread public alarm over food safety. But critics respond that the EU is pandering to political interests and emotionalism.

The European Parliament recently threatened to censure its administrative arm, the European Commission (EC), and to fire its members if food safety isn't improved. Critics charge that commission members are caving in to hysteria to avoid being sacked.

In fighting the EU ban, the IVD industry is being joined by some powerful allies. The EU directive also prohibits imports of tallow and gelatin—beef derivatives that are used in the pharmaceutical and cosmetics industries. EDMA, which is composed of European and American companies, has sent a letter of protest to the EC. The U.S. government has threatened to challenge any ban on tallow before the World Trade Organization. And FDA has sent a delegation to the commission to "air its concerns," according to Kiki Hellman, PhD, a microbiologist in the agency's Center for Devices and Radiological Health.

If the EU's certification requirement is implemented, many industry officials worry that neither USDA nor FDA has the resources to carry out the program. Manufacturers could scramble to reconfigure their products, but how? Europe first banned brain, spinal cord, and spleen material from selected cows, and then went on to place restrictions on sheep and goat parts.

"Some products are produced both within and outside the EU," says EDMA's Place. "Companies produce them wherever it is cheapest to
do so. Manufacturers could change their products— use rabbits' brains instead of calves' brains, for instance—but then those might also be excluded."

Place says he would recommend that test makers use gene technology to modify their products, but the Europeans might resist. Despite the absence of any proven risk, European countries have refused U.S. exports of genetically modified soy oil and maize.

Manufacturers will be hard-pressed to rush new diagnostics through regulatory processes and onto the market before the ban kicks in on January 1, says Frederick Clerie, director of regulatory affairs at Bayer Corp. (Tarrytown, NY). Some diagnostics makers might have to pull their products from European shelves, at least temporarily, he says.

The practical ramifications of the ban are illustrated by the recent experience of Irvine Scientific (Santa Ana, CA). In a precursor to the EU ban, Ireland is requiring the company to certify that the cattle used in its bovine serum have been in the United States for 90 days. But that's impossible.

"Nobody holds cattle for that long," says Simon Roa, production director at Irvine Scientific. "Some of the cattle come from Mexico or Canada right before slaughter."

U.S. government and trade officials would like the EU to drop its certification requirement and exempt U.S. products from the ban. Earlier this year, the EU refused to certify the United States as BSE-free, in part because of a lingering concern about the recycling of waste animal protein into feed for cattle and sheep. FDA banned the practice, which is thought to amplify BSE contamination, last summer.

But some officials fear that appeals to reason won't fly in the present climate. "The politicians are going for zero risk," says Place. "The general public doesn't understand risk. People think that by adopting laws they can reduce the risk to zero, and they can't." — G. H.