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U.S. Department of Health and Human Services

Animal & Veterinary

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BSE Cow in U.S. Triggers FDA, USDA Cooperative Response, New Rules Announced

by Jon F. Scheid, Editor
FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 1

As soon as the U.S. authorities an- nounced on December 23 that a cow in Washington State apparently was infected with Bovine Spongiform Encephalopathy (BSE), the first case in the U.S., officials from the Food and Drug Administration immediately joined with those from the U.S. Department of Agriculture to implement existing and pre-tested response plans. Many officials gave up most of their intended Christmas and New Year's holidays. But through their work, meat from the infected cow was traced and recalled, and more importantly, the potentially infectious material from the cow was stopped from further distribution, and kept out of the food and feed supply.

Here is an overview of the events that started when the presumptive positive cow was first discovered, and a description of the responsibilities and functions of FDA and USDA—how they work together to ensure the safety of public health.


USDA and FDA have separate roles that, together, were able to protect consumers and the U.S. cattle herd. While USDA went to work to track down the source herd of the infected animal and to recall meat that could have come from the animal, FDA's primary responsibility was to be sure the disease didn't spread via feed.

Scientists believe that BSE is transmitted from animal to animal only through feed containing infectious material. Scientists believe that protein in rendered products made from an infected cow can contain the infectious agent. Therefore, the underlying principal of the BSE feed rule FDA implemented in 1997 is that ingredients that could carry the infectious agent cannot be fed to cattle or other ruminants.

After the BSE-infected cow was discovered, FDA immediately sent investigators to any facility that might have handled the byproducts made from the infected animal, working cooperatively with rendering companies. Ultimately, FDA inspected and traced products related to the BSE positive cow at 22 facilities, including feed mills, farms, dairy farms, calf feeder lots, slaughter houses, meat processors, transfer stations, and shipping terminals.

The investigators were able to track all rendered products—approximately 2,000 tons—that could contain material from the infected cow. None of it was used in feed.

One factor aiding the investigation was that all of the facilities that handled the byproduct were in compliance with FDA's 1997 BSE feed rule. Dr. Stephen Sundlof, Director of the FDA's Center for Veterinary Medicine, said during a December 26 technical briefing for the press about the BSE case, “We inspect all facilities that handle ruminant protein on a yearly basis, and currently all of the firms that are located in Washington State are in compliance.”

Implementation of the BSE Rule 

When FDA implemented the BSE feed rule in 1997, the first step for the Agency was an education campaign, followed up with inspection and enforcement activities.

FDA has provided nationwide educational seminars on the feed rule, developed a CD-ROM for training, held teleconferences, developed guidances for different segments of the animal feed industry and for State and Federal inspectors, and published a variety of articles. In addition, FDA has met with industry trade groups to discuss coordination of educational efforts with affected parties. CVM has made its compliance program guidance, which describes the inspection process for Federal and State inspectors, available on its website so the rules and the tools FDA will use to enforce them are readily available.

FDA and States have identified all the feed mills, renderers and other firms that handle material that is prohibited from cattle feed under the BSE rule (so-called “prohibited material”). These firms will be subject to inspection at least once a year, and more often if violations of the rule are found. These firms are most critical to feed safety because they are the first to handle feed that can carry the BSE infectious agent.

When FDA finds a firm with a significant violation, it assigns the firm a status of “Official Action Indicated,” which means that the firm must quickly address the violations and it will be subject to a prompt follow-up inspection.

Depending on the nature of the violation, a firm's products could be recalled, it could receive an FDA warning letter (which demands a response from the firm about how it will correct the violations), or it could find itself in court and facing a possible injunction.

From 1997 to the end of 2003, 47 firms had recalled a total of 280 products. 12 of the recalls occurred during 2003. Also, FDA has issued 63 warning letters. And the court has ordered one permanent injunction against a feed company.

The inspection and enforcement activity has resulted in a compliance rate greater than 99%.

New Rules 

On January 26, Health and Human Services Secretary Tommy Thompson announced four changes that will be made to the BSE feed rule that are designed to further tighten the restrictions to prevent BSE's spread.

  1. Mammalian blood and blood products will be prohibited from feed for ruminants. The previous exemption for pure porcine or equine products still exists, so porcine and equine blood meal collected at single species slaughter operations and proc­essed using dedicated equipment can still be fed to ruminants.
  2. Poultry litter will be prohibited from ruminant feed. The major concern is that poultry feed containing prohibited material can spill into the litter, and then be consumed by cattle. Poultry litter is made of bedding, spilled feed, feathers, and fecal matter collected in poultry houses.
  3. Plate waste will be prohibited. Plate waste is excess meat that was prepared for human consumption, collected from restaurants and proc­essed into a feed ingredient. Currently, inspectors have no way to determine whether processed meat in feeds came from plate waste or other sources. By eliminating this exemption, enforcement of the rule will be more effective.
  4. Feed production facilities must have separate equipment, facilities or production lines if they use prohibited protein for manufacturing feed for non-ruminant animals and also make feed for ruminants. This rule change will prevent cross-contamination of feed during processing.

Along with the new measures, FDA announced that it would boost inspections.

FDA itself intends to conduct 2,800 inspections, and States will conduct 3,100 contract inspections during 2004. States will also report on 700 additional inspections. FDA will be sure that 100% of all known renderers and feed mills that handle prohibited material are inspected.

Other Measures 

FDA announced other changes concerning consumer products.

FDA will prohibit the use of material made from “downer” (cattle unable to walk) or dead cattle in any FDA-regulated human food, including dietary supplements, and cosmetics.

Specified risk material, which is the material most likely to contain the BSE infectious agent and is made up of cattle brain, skull, eyes, or spinal cord of animals 30 months or older, and a portion of the small intestines and the tonsils of all cattle, regardless of age, will be prohibited from FDA regulated food and consumer products.

Also, mechanically separated beef, which comes from a process designed to remove bits of meat from bones, will be prohibited from FDA products, because it may contain specified risk material.


The two agencies within USDA most directly involved with the response to the discovery of a BSE-infected cow in Washington State are the Animal and Plant Health Inspection Service (APHIS), which has responsibility for animal disease surveillance, and the Food Safety and Inspection Service (FSIS), which has the responsibility for ensuring the foods USDA regulates are safe.

Under USDA's response plan, implemented in 1996, APHIS personnel conduct routine surveillance on cattle coming to slaughter as well as take samples from animals that display signs of central nervous system disorder at slaughter. Samples are sent to the USDA's National Veterinary Services Laboratory in Ames , Iowa . Any positive finding at that laboratory is considered a “presumptive positive,” and samples are sent to the United Kingdom 's Central Veterinary Laboratory, which is also known as the world reference laboratory, for confirmation.

The BSE positive cow was sampled as part of the routine sampling procedures. It was a “downer,” believed to be suffering from the after effects of a difficult calf delivery. The sample was put in the routine queue for testing at the laboratory in Ames . The infected cow was slaughtered December 9. The sample arrived at the Ames laboratory on December 11. The first positive test result was found on December 22. The laboratory did confirmatory tests on December 23, which also indicated that the cow was positive. Later that day, Agriculture Secretary Ann Veneman announced the “presumptive positive” finding.

The “presumptive positive” was confirmed on December 25 by the world reference laboratory in Weybridge , England .

With the finding of a positive cow, APHIS began a search for the birth herd of the infected cow and for any other animals that might have become infected with BSE.

BSE does not spread among animals by contact. Instead, the infectious agent is spread only through feed, scientists believe. So APHIS was looking for animals from the birth herd and other herds the infected animal had been in, because the animals from those herds could have been infected by consuming the same feed that infected the Washington State animal.

APHIS's epidemiological work progressed rapidly. Four days after Agriculture Secretary Veneman first announced the discovery of the infected animal, USDA had initial evidence to suggest that the animal came from Canada . Shortly after that, USDA discovered that the animal, born in April 1997, was older than the feed ban, which was begun in the U.S. and Canada in late 1997. The cow most likely received the infectious feed before the ban was implemented.

APHIS concentrated its epidemiological investigation on 81 cows imported to the U.S. from a dairy herd in Alberta , Canada , in 2001. Officials were able to trace a significant number of those animals and their offspring. Several were sacrificed and tested for BSE. All were found to be negative.

Meanwhile, FSIS began a “Class II” recall of meat that was produced at the slaughter plant the same day the infected cow was slaughtered. FSIS recalled 10,418 lbs. of meat distributed in Western and Northwestern states. FSIS did not believe the meat was unsafe, and the recall was done as a precaution, according to Dr. Ron DeHaven, USDA's Chief Veterinary Officer. “It's important to recognize that meat represents a minuscule risk, and it's only being recalled out of an abundance of caution,” he said during a technical briefing of reporters on December 27, 2003 .

Also, as part of USDA's response plan, the Department held technical briefings almost daily during the first two weeks following the discovery of the BSE-positive cow. At the briefings, technical experts explained recent developments and answered reporters' questions.

USDA rule changes 

In response to the discovery of the BSE-infected cow, USDA on December 30, 2003 , announced changes to its rules on meat.

  • Meat from downer cattle would no longer be permitted in human food.
  • Product from cattle tested for BSE would have to be held until tests confirmed that the cattle did not have BSE.
  • Specified risk materials, which include skull, brain, trigeminal ganglia, eyes, vertebral column, spinal cord and dorsal root ganglia of cattle over 30 months of age and the small intestine of cattle of all ages, would no longer be allowed to enter the food supply.
  • Material that could carry BSE infectivity could not be used in the process called “Advanced Meat Recovery,” which is an industrial technology that removes muscle tissue from bone and beef carcasses under high pressure.
  • Air-injection stunning, a process used in the slaughter plant, would no longer be allowed.
  • Mechanically separated beef would no longer be allowed in human food.

[The following charts and out-takes go with the ‘BSE Cooperative Response' article]

Compliance Rate for BSE Feed Rule Tops 99%

According to information from the BSE inspection database available on FDA's website, more than 99% of all firms that handle material prohibited from cattle rations are in compliance with the rule. Here are the statistics:

  • Total inspections reported by FDA and States (as of 1/23/04 ) ................. 26,000
    (About 70% of the inspections were conducted by State officials. FDA officials did the rest.)
  • A total of firms inspected (as of 1/23/04 ) ...................................................... 13,672
  • Total of firms handling prohibited material (as of 1/23/04 ) ......................... 1,949
  • Total firms with significant violation of BSE rule (as of 1/23/04 ) ....................... 5

FDA BSE Response Plan

FDA has an overall BSE emergency response plan that coordinates with other Federal agencies, especially USDA. Each Center within FDA has part of the overall FDA plan. CVM's part of the plan focuses on communication and coordination with other agencies (Federal, State, and local) and with regulated industry.

FDA and CVM had tested their plans several times before the Washington State incident, so the plans would be free of glitches. When the incident occurred, FDA's and CVM's response plans worked well.

Once the BSE-positive cow was discovered, FDA's BSE response plan called for the Agency to immediately establish an Emergency Operations Center that served as a single point of contact for FDA's response. The center maintained contact with the Office of the Secretary of the Department of Health and Human Services, with USDA's APHIS and FSIS agencies, and with other emergency centers as appropriate.

Also as part of FDA's emergency plan, FDA dispatched inspection teams to locate the byproducts that could have been made from the infected cow to make sure the material was not used in feed. The investigating teams were sent from FDA's Seattle District Office. The investigators successfully tracked down all byproducts that could carry the infectious agent, keeping the byproducts from entering the feed supply.

BSE in the U.S. – Timeline of Significant Events

December 9, 2003

Following standard protocols, USDA took samples from a Holstein cow, slaughtered at Verns Moses Lake Meats, Moses Lake, Washington, to test for BSE. The cow was a downer (non-ambulatory), but she had shortly before suffered complications from giving birth, and her difficulties walking were thought to stem from that. The samples were sent to USDA's National Veterinary Service Laboratories, Ames , Iowa . Because the animal had no signs of neurological disease at slaughter, the samples were not given high priority for BSE sampling

December 22, 2003

Preliminary tests at USDA's laboratory were positive for BSE, and the laboratory started further testing.

December 23, 2003

USDA's lab used the internationally recognized “gold standard” test on the samples, and confirmed the earlier positive finding. Agriculture Secretary Ann Veneman in a press conference announced the “presumptive positive” result for BSE—the first case of BSE in the U.S. USDA immediately began traceback measures to find the meat from the BSE-suspect animal and initiatived a “Class II” recall of the meat from the entire day's slaughter at Verns Moses Lake Meats for the day the BSE-suspect cow was slaughtered. 20 animals had been slaughtered that day. The recall was for 10,410 lbs. of meat.

USDA also begins to trace of all animals that could have been infected at the same time as the cow in Washington State .

December 24, 2003

FDA announced that it had dispatched several teams of investigators to find any FDA-regulated products that were or could have been made from the infected cow, including animal feed.

December 25, 2003

The world reference laboratory in Weybridge , England , confirmed that the cow was infected with BSE.

December 27, 2003

USDA announced that the infected cow was mostly likely imported from Canada , and was probably born in April 1997, which was before the BSE feed rules were implemented in the U.S. and Canada .

FDA announced that all the potentially infectious material that could have gone into feed was found before any of it was used to manufacture feed. An estimated 2,000 tons of material was traced and kept out of feed.

December 30, 2003

USDA Food Safety and Inspection Service announced a series of rule changes designed to keep suspected BSE animals out of the food chain. The rules included a ban on the use of downer animals and specified risk material.

December 31, 2003

FDA announced that it fully supports the safety policies announced by USDA.

January 6, 2004

USDA announced that DNA evidence proves that the BSE-infected animal came from a dairy farm in Alberta , Canada .

January 26, 2004

The U.S. Department of Health and Human Services announced measures it is taking to increase safeguards against BSE in the U.S. , including changes to the 1997 BSE feed rule and restrictions on the use of material of bovine sources that could be used in products for human consumption.