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Lester M. Crawford, D.V.M., Ph.D. - National Institute for Animal Agriculture

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Keynote address before the

National Institute for Animal Agriculture

Remarks by

Lester M. Crawford, D.V.M., Ph.D.

Acting Commissioner of the FDA

April 6 , 2004

Good afternoon, and thank you, Glenn (Slack, NIAA President/CEO), for the introduction. It's a pleasure and an honor to participate in this thorough and expert exploration of the new era that opened for our continent during the last 11 months, when we learned that bovine spongiform encephalopathy was present in Canada and the United States.

Certainly, the vigorous measures adopted in response to the May, 2003 finding in Canada, and its sequel last December in the U.S., signify a new level of concern and resolve to prevent the BSE threat from harming our people, our cattle population, and our economy.

And yet, in terms of the policies and activities carried out since we heard the troubling news about BSE on our continent, this new era differs primarily in degree -- rather than in substance -- from the strategies and actions with which the United States government had confronted the disease after it emerged in Europe in the 1980s.

Four of the five firewalls on which we rely today had been built, measure by measure -- largely by the U.S. Department of Agriculture and the Food and Drug Administration -- from 1989 on, when the USDA banned ruminant imports from BSE countries and started the BSE surveillance of U.S. cattle population.

After laying the foundations of these two protective barriers, USDA and FDA began developing the third fire wall, a response plan for containing the harm if BSE should emerge in the U.S. That joint project proved its worth after last December 23.

The fourth firewall, FDA's ban on the use of most mammalian protein in the manufacture of ruminant feeds, was put in place in 1997. By that time, the FDA had already laid the first building blocks of the fifth fire wall, which protects our consumers from BSE-contaminated products.

From 1991 on, our agency was recommending manufacturers of biologic products to not use bovine- or ovine-derived material from BSE countries; and in 1997 the FDA broadened this guidance to include the manufacture of gelatin, cosmetics, and dietary supplements.

In November, 2001 the Harvard Center for Risk Analysis' acknowledged the effectiveness of these BSE preventions by concluding, after a three-year study, that should BSE emerge in the U.S., it would be highly unlikely to spread.

Despite this assurance, it remained the policy of our government that the BSE safeguards should be continually strengthened, and they were. For example, during late 2001 and 2002, USDA and FDA conducted three BSE response exercises that established lines of communication and coordination with other federal, state and local agencies.

In 2002, USDA announced that it would increase its sampling for BSE to 12,500 animals, more than double the 5,200 samples examined the previous year, and it stepped up its testing of certain ground beef products for the presence of the banned central nervous system tissue. FDA, which during the same year was appropriated additional $15 million for its BSE program, hired 115 additional employees to oversee the compliance with the animal feed ban. The same year, FDA recommended the deferral of blood donors who had lived in Europe during the BSE epidemic, and who therefore might be infected with vCJD, the human disease associated with BSE.

And while building these defenses, the U.S. government took the lead in confronting yet another destructive potential of BSE, which is the disruption of international trade. Taking a lesson from the effects of the BSE epidemic in Europe, our government sought to persuade the international trading community that its response to BSE must be science-based, and carefully calibrated to be commensurate with the threat.

It was a rule the U.S. not only advocated, but also lived by. Following the BSE emergence in Canada, USDA took two steps to gauge the level of risk that development posed for the U.S.: it asked the Harvard Risk Assessment Center to reassess the risk of BSE spread in our country, and it joined the FDA in reviewing Canada's strong additional BSE safeguards. After Harvard reaffirmed that the hazard remained extremely low, USDA allowed last August resumption of low-risk Canadian imports, including boneless beef from animals under 30 months of age. Since then, USDA has proposed to allow also imports of live animals and certain other products.

This was the situation when we learned, just before Christmas, that a slaughtered Holstein cow, which turned out to have been imported from Canada, was infected with BSE. Suddenly, the Hannibal was no longer ante portas, and the responses of our government had to be targeted at the immediate threat to the health of our public.

Accordingly, the first and foremost of the four priority goals of the emergency operations that immediately went into effect was to protect the public health. USDA launched an epidemiological investigation to determine the sick cow's origin and locate, if possible, her offsprings and cohorts. After successfully tracing and recalling thousands of pounds of potentially unsafe meat, the Agriculture department euthanized all identified cohorts of the sick Holstein.

In the meantime, the FDA located the rendered material and saw to it that it was withheld from distribution, and destroyed. The emergency made heavy demands on all involved authorities -- federal, state and Canadian -- but the BSE firewalls had performed as expected. The sick cow was identified by the USDA surveillance of suspect cattle. The well-rehearsed contingency planning paid off: the USDA made daily calls to other involved agencies to share new information; FDA specialists assisted in the operations of the USDA emergency center; and FDA, USDA and State officials worked side by side inspecting 22 dairy farms, feed mills, slaughter houses, meat processors and other potentially involved facilities.

The FDA animal feed rule was another firewall that emerged intact: the rendering facilities that had processed the materials from the BSE cow were found to be in compliance with the agency's requirements. But the presence of BSE on our continent called for still stronger protections, and as you heard this morning, by the end of January, both USDA and FDA announced significant additions to their BSE defenses. The main focus of the measures taken by USDA was to heighten and shore up the fifth firewall, protecting the health of consumers.

On January 8, the USDA issued an immediate ban on inclusion of the following products in the human food supply:

  • meat from downer animals and animals that died on the farm;
  • products from BSE-tested cows before the tests are confirmed negative;
  • additional specified risk materials (including skull, eyes, vertebral column, the small intestine);
  • and additional mechanically recovered products (including dorsal root ganglia and clusters of nerve cells attached to spinal cord).

As another protection against the spread of infected material to the meat from the slaughtered cows, USDA also banned the use of air-injection stunning.

The FDA followed suit on January 26 by proposing to step up its protections against BSE transfer through ruminant feed, and against contamination of regulated products by BSE-infected materials. The agency said it would

  • remove from the animal feed rule exemptions for blood, blood products and plate waste;
  • prohibit poultry litter in ruminant feed;
  • and require dedicated equipment facilities for ruminant feed manufacture.

In addition, FDA proposed to ban the following materials from human food, dietary supplements, and cosmetics:

  • non-ambulatory diseased cattle; cattle not inspected; and inspected cattle found unfit for human consumption;
  • specific risk materials such as brains, spinal cords and vertebral columns;
  • and mechanically separated beef.

And even while attending to these top priorities, our government addressed with vigor two other issues that commanded and command our prompt attention. Both of them involve the potential impact of the BSE emergency on the acceptance of American beef on the domestic market, and abroad.

To maintain our consumers' confidence in the safety of beef, USDA and FDA opened to public scrutiny every event, measure and action associated with the BSE emergency, by reporting on them in detail on special Websites and data bases on the Internet, and by supplying the media with a wealth of material through interviews and press releases. So far, that effort has been successful, and most American consumers are showing no reluctance to buy beef products.

Considerably more difficult has been overcoming the ban on U.S. beef and cattle that was adopted by 50 U.S. trading partners after December 23. This has been a serious blow to our beef exports, which were expected to reach this year $3.8 billion (plus $65 million worth of live cattle) -- mostly to Japan, Mexico and South Korea.

To allay the concerns abroad, our government has launched numerous activities. One early step by Agriculture Secretary Veneman was to convene an international panel of experts and ask them to examine the U.S. firewalls and recommend their possible enhancement. Also early in January, USDA and FDA sent a mission to Japan and South Korea to explain the BSE incident and the rigorous safeguards in place. This outreach effort that was subsequently pursued by U.S. Trade Representative Zoellick in meetings with the Japanese trade minister and by Secretary Veneman in discussions with the cabinet ministers from Japan, Canada, Mexico and the Philippines.

In addition, USDA invited technical teams from Japan and Mexico to visit the U.S. and review the BSE defenses, and instructed the U.S. agricultural attaches abroad to inform foreign governments of the steps taken to assure the safety of U.S. beef.

USDA also republished last month a proposed rule to identify minimal risk countries or regions for BSE purposes, and allow for the importation of certain live ruminants and ruminant products from those countries and regions. Under the proposal, an important qualification for a country's or region's inclusion in the minimal risk category is the enforcement of restrictions, such as are in place in the U.S. and in Canada, on the removal of specified risk materials and exclusion of downers and unslaughtered dead cattle from the food supply.

In addition to all these measures, senior officials from U.S., Canada and Mexico have began intensive consultations on developing plans for a harmonized and science-based North American response to BSE. To advance this goal, the three countries have asked the World Organization for Animal Health to clarify its guidelines on trade among countries with BSE.

That's where are today. Where do we go from here? We'll do more of what we've done. We'll continue perfecting the protections for our population, our livestock, and our economy by reinforcing the BSE firewalls. As you heard this morning, USDA is in the process of implementing a series of measures it had planned, or began to execute, even before they were recommended in February by the international panel.

Most important is the strengthening of BSE surveillance in high-risk cattle population and random surveillance in the rest. USDA estimates that there are about 446,000 cows in the first category -- animals exhibiting central nervous system disorders, downers, and those that die on the farm -- and its goal is to test as many of these animals as possible during the next 12-18 months. The testing of 201,000 samples would enable the detection of BSE with a 95% degree of confidence of just 1 positive cow in 10 million. If the sample includes 268,000 cows, the resulting degree of confidence will be 99%.

In addition, USDA intends to collect 20,000 random samples from clinically normal but older slaughter cattle at 40 plants in 17 states that 

slaughter 86% of U.S. cattle. USDA is also working on the three other measures recommended by the international panel, which are:

  • the creation of two systems -- one for identification of dead and downer animals and for ensuring their proper disposal, and one for a verifiable national animal identification and tracking;
  • and enlargement of the national animal health laboratory network.

USDA's Animal and Plant Health Inspection Service (APHIS) has already received license applications for test kits for BSE that are less specific but faster than the "golden standard" immunohistochemistry test which is the official U.S. test for BSE. Some of these tests will be used in a USDA-certified, geographically dispersed network of state and university laboratories to examine the collected samples, and those with positive results will be sent for confirmation to the National Veterinary Services Laboratories in Ames, Iowa.

A measure of the importance that our government attaches to these activities is the inclusion in USDA's FY 2005 budget of $178 million to complete the renovation of these laboratories, and a $17 million increase for funding BSE surveillance. In addition, USDA will finance the strengthened surveillance system by transferring to APHIS approximately $70 million from the Commodity Credit Corporation.

The Food and Drug Administration will step up its efforts to achieve 100% compliance with its BSE rules. FDA and its state counterparts conduct, at least annually, targeted BSE inspections of all renderers, protein blenders, and feed mills processing products that could be tainted with BSE. There are 1,949 of these firms, and their compliance with the feed rule has been estimated at better than 99%. By the end of last year, only five of these establishments had been found to have violated the 1997 ban.

The agency plans to improve on this record not only by inspecting more renderers and feed mills, but also by extending BSE inspections to truckers, firms that salvage pet food and feed, and to farms that mix ruminant feed. Other FDA plans include increased sampling and analysis of marketed feed, including products imported from non-BSE countries; validation of a simpler and faster PCR-based method for the detection of bovine proteins in animal feed, and evaluation of diagnostic kits for mammalian protein in feed.

These are attainable goals: FDA's current BSE budget is over $21 million, more than five times higher than it was only three years ago, and the agency is requesting additional $8.3 million for BSE activities in FY 2005.

I want to conclude by making a point that might have been lost under the pressure of urgent activities during the BSE emergencies of the last year: the hazard of BSE today is a far cry from the specter it was less than two decades ago, when it was savaging European cattle industry and putting in peril human lives. Except for the loss of exports, which we trust will be temporary, the impact of the North American emergence of BSE has been far from overwhelming.

In fact, we've learned from it a valuable lesson, which is that the firewalls we'd built over the years are sound and strong. We can now be sure that the new measures adopted since January will make these policies still more effective.

There is also some comfort in knowing that time is on our side. Scientists are exploring new avenues for preventing BSE by either eliminating or altering the cow's prion protein so that it cannot, or is less likely to, assume the form that induces the spongiform encephalopathy. There is a report from South Korea that a scientific team there has used both approaches to genetically engineer a cow that is BSE-resistant. This is a promising development that one day may remove BSE from the catalogue of major hazards.

In the meantime, we need to keep working together, keep strengthening our protections, and if another case of BSE reappears in our hemisphere, confront it swiftly, vigorously, and on the basis of the best scientific evidence.