MAD COW NEWS

VENEMAN ANNOUNCES ADDITIONAL PROTECTION MEASURES TO GUARD AGAINST BSE

WASHINGTON, Dec. 30, 2003—Agriculture Secretary Ann M. Veneman today announced additional safeguards to bolster the U.S. protection systems against Bovine Spongiform Encephalopathy, or BSE, and further protect public health.

“For more than a decade, the United States has had in place an aggressive surveillance, detection and response program for BSE,” said Veneman. “While we are confident that the United States has safeguards and firewalls needed to protect public health, these additional actions will further strengthen our protection systems.”

Agriculture Secretary Ann M. Veneman announced additional safeguards to bolster the U.S. protection systems against Bovine Spongiform Encephalopathy, or BSE, and further protect public health.

Veneman said the policies announced today have been under consideration for many months, especially since the finding of a case of BSE in Canada in May 2003. The policies will further strengthen protections against BSE by removing certain animals and specified risk material and tissues from the human food chain; requiring additional process controls for establishments using advanced meat recovery (AMR); holding meat from cattle that have been tested for BSE until the test has confirmed negative; and prohibiting the air-injection stunning of cattle.

While many cattle in the United States can be identified through a variety of systems, the Secretary also announced that USDA will begin immediate implementation of a verifiable system of national animal identification. The development of such a system has been underway for more than a year and a half to achieve uniformity, consistency and efficiency across this national system.

“USDA has worked with partners at the federal and state levels and in industry for the past year and a half on the adoption of standards for a verifiable nationwide animal identification system to help enhance the speed and accuracy of our response to disease outbreaks across many different animal species,” Veneman said. “I have asked USDA’s Chief Information Officer to expedite the development of the technology architecture to implement this system.

Additional Information Additional BSE Information and Resources

“These are initial steps that USDA will take to enhance our protection system,” Veneman said. “I am appointing an international panel of scientific experts to provide an objective review of our response actions and identify areas for potential additional enhancements.”

Specifically, USDA will take the following actions:

Downer Animals. Effectively immediately, USDA will ban all downer cattle from the human food chain. USDA will continue its BSE surveillance program.

Product Holding. USDA Food Safety and Inspection Service inspectors will no longer mark cattle tested for BSE as “inspected and passed” until confirmation is received that the animals have, in fact, tested negative for BSE. This new policy will be in the form of an interpretive rule that will be published in the Federal Register.

To prevent the entry into commerce of meat and meat food products that are adulterated, FSIS inspection program personnel perform ante- and post-mortem inspection of cattle that are slaughtered in the United States. As part of the ante-mortem inspection, FSIS personnel look for signs of disease, including signs of central nervous system impairment. Animals showing signs of systemic disease, including those exhibiting signs of neurologic impairment, are condemned. Meat from all condemned animals has never been permitted for use as human food.

Specified Risk Material. Effective immediately upon publication in the Federal Register, USDA will enhance its regulations by declaring as specified risk materials 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, thus prohibiting their use in the human food supply. Tonsils from all cattle are already considered inedible and therefore do not enter the food supply. These enhancements are consistent with the actions taken by Canada after the discovery of BSE in May.

In an interim final rule, FSIS will require federally inspected establishments that slaughter cattle to develop, implement, and maintain procedures to remove, segregate, and dispose of these specified risk materials so that they cannot possibly enter the food chain. Plants must also make that information readily available for review by FSIS inspection personnel. FSIS has also developed procedures for verifying the approximate age of cattle that are slaughtered in official establishments. State inspected plants must have equivalent procedures in place.

Advanced Meat Recovery. AMR is an industrial technology that removes muscle tissue from the bone of beef carcasses under high pressure without incorporating bone material when operated properly. AMR product can be labeled as “meat.” FSIS has previously had regulations in place that prohibit spinal cord from being included in products labeled as “meat.” The regulation, effective upon publication in the Federal Register, expands that prohibition to include dorsal root ganglia, clusters of nerve cells connected to the spinal cord along the vertebrae column, in addition to spinal cord tissue. Like spinal cord, the dorsal root ganglia may also contain BSE infectivity if the animal is infected. In addition, because the vertebral column and skull in cattle 30 months and older will be considered inedible, it cannot be used for AMR.

In March 2003, FSIS began a routine regulatory sampling program for beef produced from AMR systems to ensure that spinal cord tissue is not present in this product. In a new interim final rule announced today, establishments have to ensure process control through verification testing to ensure that neither spinal cord nor dorsal root ganglia is present in the product.

Air-Injection Stunning. To ensure that portions of the brain are not dislocated into the tissues of the carcass as a consequence of humanely stunning cattle during the slaughter process, FSIS is issuing a regulation to ban the practice of air-injection stunning.

Mechanically Separated Meat. USDA will prohibit use of mechanically separated meat in human food.

On Dec. 23, Veneman reported that a cow in Washington State has tested positive for BSE. A swift and comprehensive investigation is ongoing to trace the animal to a herd of origin, which is believed to be located in Alberta, Canada, as well as track additional animals that have entered the United States. (For the latest update on the investigation, visit www.usda.gov.)

For more than a decade, the United States has had in place an aggressive surveillance, detection and response program for BSE. The United States has tested over 20,000 head of cattle for BSE in each of the past two years, 47 times the recommended international standard.

Since 1989, USDA has banned imports of live ruminants and most ruminant products from the United Kingdom and other countries having BSE.

In 1997, the FDA prohibited the use of most mammalian protein, the main pathway to spread the disease should it be in the United States, in the manufacture of animal feed intended for cattle and other ruminants.

An independent analysis by Harvard in 2001 and again in 2003 shows that the risk of BSE spreading in the United States is low and any possible spread would have been reversed by the controls we have already put in place.

Technical Briefing and Webcast with U.S. Government Officials On BSE Case

Tuesday, Dec. 30

Welcome to today's technical briefing on the BSE situation. Today we are going to start off with an update by Dr. Ron DeHaven. He's the chief veterinary officer for USDA. We'll have a statement by Dr. Daniel Engeljohn, executive associate for policy from Food Safety Inspection Service. And then we'll have a statement by Dr. Lester M. Crawford. He's the deputy commissioner for the Food and Drug Administration.

I just want to point out a couple of things. Because of the number of people on this call, we would ask that you ask one question, no follow-ups. Also at the table here is Dr. Kenneth Petersen. He is the executive associate for regulatory operations at FSIS. He will be available as well to answer questions as needed. So the way it will work today is we'll let the statements go, and then we'll take three questions from the audio bridge; then we'll take three here, and then alternate. Dr. DeHaven will point you out. Wait for the mike to come to you. And then, with that, I think we're ready to begin. Dr. DeHaven?

DR. DEHAVEN: Thank you very much. Again, thank you all for being here. Ed mentioned that we will be making some statements. And, actually, I'm going to defer to my friend and colleague, Dr. Lester Crawford from Food and Drug Administration, and let him make the opening statement. Dr. Crawford?

DR. CRAWFORD: The Food and Drug Administration fully supports the safety policies announced today by the U.S. Department of Agriculture, which build on the principles and procedures that FDA and USDA have developed since 1997. These protective measures will add an additional layer of protection to the American public. In order to obtain these goals, FDA will evaluate the impacts of the new policies on the agency's resources, so that we can devise and implement the most effective and efficient additional layer of protection to the American public.

FDA will devote additional resources in order to do these increased responsibilities for protecting the safety of the food and feed supply. FDA will continue to rigorously enforce its measures to protect the public health against the BSE hazard. In the last six years, the agency has sponsored workshops, teleconferences and other outreach programs to stimulate cooperation of state, local and cross-border authorities in a vigilant surveillance for BSE. It has issued import alerts and bulletins to detain all products with processed animal protein from countries with BSE. It has requested blood centers to exclude blood donations by individuals who might be carriers of the BSE agent. And it has urged manufacturers of drugs, vaccines, medical devices and cosmetics to use only materials derived from cattle that are BSE free. The main focus of FDA's BSE prevention program has been regular inspections of all renderers and feed mills in the United States, more than 99 percent of whom have achieved full compliance with the 1997 FDA rule that prohibits the inclusion of most animal protein in feeds for cattle and other ruminants. The effectiveness of FDA's surveillance was most recently confirmed by the fact that all of the firms involved in the current BSE investigation were found to be in compliance with the FDA rule, and that the agency working with state and industry officials was able to halt the distribution of all of the meat and bone meal from the sick animal.

I cannot close without complimenting Secretary Veneman and the Department of Agriculture, who have been in complete communication with FDA. We have worked together and our agency applauds her leadership in this regard. We recognize that USDA is the lead agency. We want you to know that we feel like we are in complete communication, and we are working together on this, and in the end we will bring this to a satisfactory conclusion as fast as we possibly can.

Lastly, FDA has contained, as we have previously announced, all of the suspect rendered material. It is under our control, and it is being held at the present time.

DR. DEHAVEN: Dr. Crawford, thank you, and thank you for being here with us today.

Just a brief update on our investigation stemming from, again, a single positive cow slaughtered on December 9th, and she tested positive for BSE on December 23rd. Documentation is now available indicating that she was approximately six and a half years old at the time of slaughter, and our primary line of inquiry does lead to a farm in Alberta, Canada. The age of the animal is particularly important in that it does provide an explanation as to how she became infected, in that as a six-and-a-half-year-old with an approximate birth date of April 1997, she in fact would have been born before the feed ban went into place, either in Canada or the United States.

Multiple samples for DNA testing are in various stages of being submitted to two laboratories, one in Canada and one in the United States. We continue our trace-back and trace-forward investigations. We believe that the positive cow was one of 82 animals from the same Canadian herd that were permitted into the United States. We are conducting a painstaking records review to determine the transit, timing and current location of these 82 head of cattle. We do know that several are on the same premises where the positive cow was located immediately before she went to slaughter.

The positive cow we know had three calves while she was in the United States. The first animal, or first calf, was stillborn. The second is currently a yearling heifer, and is located on the index farm. And the third, a bull calf, is in a group of calves at another location, a calf feeding operation which is also under a state hold order.

I want to emphasize that these hold orders are not imposed because BSE is a contagious disease, or in any way to prevent the spread of this disease, since we know from the science that the disease is not spread by casual contact animal to animal. Rather, these hold orders are in place to ensure that we maintain the location of all animals that are of consequence and otherwise relevant to our ongoing investigation.

Just on a side note, if I could, I am hearing from my colleagues in the state of Washington that because of the incredible interest in this issue, there had been reports that reporters are visiting multiple dairy farms throughout the state. And while BSE cannot spread by this way, other diseases can be spread by people and equipment who move on and off the farm. So I would urge all farmers and visitors to take appropriate biosecurity precautions, and please let's respect the privacy and property of these individuals.

Finally, I just want to reiterate that the science supports our assertion that the meat is safe and nothing that we have announced today changes any of that. Over the last few days we have indicated that we are carefully considering appropriate changes to our system. Clearly that's a prudent thing to do given this new find in the United States, as well as the find in Canada in May of this year.

Today's announcement by the Secretary is clearly a result of that review. These actions do not in any way suggest that the meat produced in the current system is unsafe. For years we have had a feed ban in place. The high-risk materials from this positive cow were removed. And meat produced on the day that this positive cow was slaughtered is being recalled. Just like the meat recall, we are making these further enhancements to our system out of an abundance of caution.

I would again like to express my thanks to the owner of the index herd who has been extremely cooperative, as has the owner of the slaughter plant where this animal was slaughtered, the importers involved in the movement of these animals, and of course state officials in the state of Washington, and my friends and colleagues with the Canadian Food Inspection Agency. All of them have provided tremendous assistance as we proceed with this investigation.

And, again, my thanks to the news media. We have been working hard, or you have been working hard, to ensure accurate reporting of this very complex and rapidly evolving situation.

With that, let me provide an opportunity for my colleague from the Food Safety Inspection Service, Dr. Dan Engeljohn, to make a statement.

DR. ENGELJOHN: Thank you, Dr. DeHaven. The Secretary of Agriculture has very broad authority to be able to swiftly and effectively take the policy actions that she announced earlier today. Here at the Department of Agriculture we have the Federal Meat Inspection Act, which the Food Safety Inspection Service administers. Through the Food Safety Inspection Service -- we are the public health regulatory agency here at USDA -- that ensures that the food supply -- in particular the meat, poultry and eggs -- are in fact safe, properly labeled and, importantly, that they are fit for human consumption.

With the policies that the Secretary announced today, we will put in place, or intend to put in place, regulatory policies that will ensure that the federally-inspected facilities will have written procedures that will document how they intend to segregate these high-risk tissues from those which present lower risk or no risk at all. As the Secretary mentioned, we are going to focus on tissues that contain the potential for high infectivity. And because healthy-appearing animals may in fact have infectivity in those tissues, we'll concentrate on those tissues even in healthy-appearing animals. As the Secretary mentioned, we'll look at the small intestine and the tonsils of all cattle. We intend to prohibit the use of the brain and spinal cord and the vertebral column in cattle of older age that may have higher infectivity because of their age.

With those actions, I'd like to turn the microphone back over to you, Dr. DeHaven.

DR. DEHAVEN: All right. We'll open it up for questions. And, as was first mentioned, we'll go to our telephone bridge for the first three questions. So, operator, if we could please have the first question...

Followed by Q&A with reporters.