Speech - Association of Academic Health Centers

Speech before

Association of Academic Health Centers'
11th Congress of Health Professions Educators

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of the FDA

June 7, 2004

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.

Thank you for the introduction, Denise (Holmes, director of Global Health at AHC), and good afternoon.

I am doubly pleased to be here today: as a former academician, I thoroughly enjoy a dialogue with the erudite and dedicated women and men who are training the world's best-educated health professionals. And as a food scientist and official of Food and Drug Administration, I welcome your invitation to discuss two timely and highly significant topics, which are the programs that protect our food supply against bioterrorism, and our livestock from the Mad Cow's disease, or BSE.

These safeguards are extensive, elaborate and are being carried out, day in and day out, by many federal, state, and local agencies, including, prominently, the United States Department of Agriculture. But under the Food, Drug and Cosmetic Act of 1938 our agency, the FDA, is responsible for the safety, wholesomeness, and truthful labeling of approximately 80 percent of all the food consumed in this country -- everything we eat except for meat, poultry and a few egg products that are regulated by the USDA. We are also mandated to ensure the safety of all animal feed, which has been the primary vehicle for the spread of bovine spongiform encephalopathy. FDA therefore is at the center of our government's robust efforts to protect us against the two signature scourges of our era, the threat of bioterrorism and BSE.

Safeguarding food and animal feed, incidentally, is only a part of the FDA's public health agenda. We're also responsible for the safety and effectiveness of all health care products, including drugs, vaccines, blood products, tissues for transplantation, and medical devices. In addition, we ensure the safety of equipment that emits radiation, and cosmetics.

But food safety is the oldest and in some ways most demanding part of our mission, and our agency has an unsurpassed experience in developing sophisticated, science-based measures to protect our public against food-borne disease. In the 1990s, for example, the FDA helped create a multimillion-dollar, nation-wide network of laboratories whose job is to identify and help counter such outbreaks. This system has been proved effective in reducing food contamination by several of the most common bacteria, including E. coli 0157:H7, Campylobacter, Shigella, Salmonella enteritidis, and Cyclospora.

These programs continue to serve their purpose, but they pale in comparison with the unprecedented efforts to secure our food supply following the terrorist attacks on the World Trade Center and the Pentagon in September, 2001. In the light of that outrage, food was recognized as a potential terrorist target: it is a life-sustaining, universally-consumed commodity; it is susceptible to contamination; and a significant amount of it -- up to 80% of our seafood, and 20% of fresh produce -- is imported from countries where we have no security presence.

Another hazard that certainly has not escaped our enemies is that in addition to causing casualties and a huge economic damage, contamination of food could provoke fear and panic far out of proportion to the actual harm. I need to remind you only of the "60 minutes" broadcast in 1989 charging that Alar, a growth-control chemical that was widely sprayed on apples, is a human carcinogen. Unfounded as it was, that allegation triggered a nationwide boycott of apples and apple products that cost the American apple growers $300 million.

Based on these considerations, the FDA was given the lead responsibility for a broad-based, multifaceted program to protect the security of our food supply. Incidentally, food security is not our only counter-terrorism job. FDA is also responsible for advancing the development and ensuring the supply of vaccines and drugs for the treatment of victims of such potential agents of terrorism as smallpox, anthrax, and plague. But it is the food security program that's our counter-terrorism Job One, and we are implementing it vigorously, with a heavy infusion of resources, and in close cooperation with an entire spectrum of other federal, state and local agencies.

The measures we've launched protect all food on the U.S. market, but their primary focus is the security of food imports. As I've mentioned, they make up an important part of our diet, and are growing by up to 15% a year -- last year, they reached 6 million shipments. As I'll describe in a minute, the hallmark of our bioterrorism efforts is the ingenuity, imagination and resourcefulness of the thousands of people engaged in counter-terrorism activities in the participating agencies. But the essential backbone and muscle of the FDA's defenses against bioterrorism have been provided by new resources and authorities granted to our agency by the United States Congress.

The first critical reinforcement, which was authorized within a few months of 9/11, was a $195 million supplemental appropriation for the recruitment of 655 new FDA employees, the great majority of whom are safeguarding our food.

Three hundred of these new staffers are now posted at 90 major United States ports of entry; 33 are criminal investigators; and 100 are chemists and analysts who have been added to the existing network of food-safety labs I've mentioned, plus a new Food Emergency Response Network that now includes 63 and federal laboratories from coast to coast. Our center for food safety and nutrition has a budget of $410 million -- as much as our centers for drugs and biologics combined -- and almost 3,000 employees, more than two-thirds of whom are based in the field.

Increased budget has enabled the FDA to significantly contribute to the creative ferment of many agencies -- including the Centers for Disease Control and Prevention, the Department of Defense, the USDA and the Environmental Protection Agency -- that has resulted in an array of barriers against bioterrorism. For example, we've issued guidances on security measures for every major type of food business and facility, both domestic and foreign. We initiated a scientific assessment of the vulnerability of our food to attacks with biological, chemical, and radiological agents. We've participated in counter-terrorism exercises; developed a fast food-pathogen detector; carried out hundreds of inspections of food facilities based on appraisal of their vulnerability to terrorism; and we've multiplied many times over spot inspections of imported food products.

We're spending $5 million working with the National Center for Food Safety and Technology; Joint Institute for Food Safety and Applied Nutrition; and National Center for Natural Products Research on research in three broad food and animal feed security areas. All told, we have more than 25 intramural research projects on food security.

After increasing our resources, Congress buttressed our counter-terrorism armamentarium by granting the FDA important new authorities in the Public Health Security and Bioterrorism Preparedness and Response Act, which was passed two years ago. The core of this seminal measure is four provisions that are designed to not only enable us to know the origin, and keep track, of food and animal feed that are on or about to reach the American market. The act also gives us the authority to prevent this food or feed, if necessary, from reaching our food stores and farms.

One of the provisions requires that all food and feed establishments, domestic and foreign, that cater to the United States market, register with our agency. This registration is now in process, and we expect it to eventually include up to 500,000 food and feed processors, warehouses, distributors, and others in the food and feed business.

Another provision of the law states that the FDA, which works closely with the U.S. Customs, must receive an advance notice of each foreign shipment about to be imported to the U.S.

The third major requirement of the Bioterrorism Act is that food and feed firms must maintain records that will enable our agency to quickly trace any food or feed consignment whose safety is suspect. And the fourth key provision gives our agency the authority to place such food or feed under administrative detention in order to ascertain its safety.

Since the law was passed, our agency has done a herculean job implementing it. We've set up Internet-based programs where firms can register and send, round the clock, prior notices of intended imports. We've developed the necessary rules and guidances, and conducted an extensive outreach to explain the Bioterrorism Act to food exporters in Canada, Mexico and South America. We're working with Canada and Mexico on food security systems and infrastructure at both borders.

By the end of this summer, this in-depth, comprehensive protective system will be fully in place and functioning. That does not mean that we've eliminated the possibility of a terrorist attack on our food supply. But we are far, far better prepared to prevent, mitigate, or cope with it than we were three years ago.

We are also greatly strengthening our capacity to prevent a devastating epidemic of Mad Cow's disease in our livestock.

This specter was perceived by some people in the discovery last December of a slaughtered cow in Washington state that had been imported from Canada, and found to be infected with BSE. Actually, the emergence of this disease in our country foreshadowed nothing even remotely resembling the epidemic in Europe nearly 20 years ago that caused the death of more than 100 people and a billion-dollar damage to the cattle industry.

Then, the cause of the epidemic was a mystery; today, we know that the disease is spread by feed containing rendered mammalian tissues contaminated with infectious proteins. Then, the public health authorities were at a loss how to respond; today, we have in place and are in the process of improving several firewalls that are designed to protect consumers, spot the disease, and prevent it from getting out of control.

These barriers date back to 1989, when the U.S. Department of Agriculture issued a ban on ruminant imports from countries affected by BSE, and initiated a BSE surveillance of U.S. livestock.

They include an emergency response plan developed over the years by the agencies that bear the main responsibility for BSE prevention, including USDA, FDA, and state authorities. Most of this planning and teamwork proved their worth last December in Washington.

Important barriers have been also erected to protect consumers against the risk of an incurable human variant of the Creutzfeldt-Jakob disease, which is associated with the consumption of meat and other products from BSE cattle. For example, in 1991, our agency began recommending manufacturers of biological drugs to not use bovine- or ovine-derived material from countries with BSE, and in 1997, the FDA broadened this guidance to include the manufacture of gelatin, cosmetics, and dietary supplements. USDA has prohibited the inclusion in human food supply of nervous system tissues that were known to be most likely affected by the disease.

FDA's best-known firewall, a ban on the inclusion of most mammalian protein in ruminant feeds, was put in place seven years ago. Enforced by state health authorities and our agency's inspectors, this measure has been widely acknowledged to be the most effective defense against extensive transfer of BSE. In November, 2001 the Harvard Center for Risk Analysis concluded after a three-year study that if BSE should emerge in the U.S., this firewall would make it highly unlikely that it would spread.

All of these programs and arrangements have been continually strengthened, tested and improved upon. For example, in late 2001 and 2002, FDA and other federal, state and local agencies participating in BSE programs conducted three response exercises that established lines of mutual emergency communication and coordination.

In 2002, Congress boosted our agency's BSE program with an additional $15 million, which enabled us to add 115 employees to the enforcement of the animal feed ban. We also strengthened consumer protection by recommending the deferral of blood donors who had lived in Europe during the BSE epidemic. This was to avoid the risk that their blood might be infected with the variety CJD, which has a long incubation period.

These and other measures were in place six months ago, when an analysis of the slaughtered Holstein in Washington showed that the animal had the Mad Cow's disease. It was a test for several our firewalls, and some of the lessons we learned were positive.

For example, the sick cow was identified as part of the surveillance of suspect cattle. The health of consumers was well protected: thousands of pounds of potentially infected meat was quickly recalled and kept off the market. The livestock was also safeguarded from harm: our inspectors located and supervised the destruction of the sick cow's rendered tissues before they could be included in ruminant feed. Epidemiological investigation determined the Holstein's origin, and most of the animals raised on the same Canadian farm were rapidly located and euthanized. The cooperation of the participating agencies was exemplary: in one instance, FDA specialists worked side by side with other federal and state officials inspecting 22 dairy farms, feed mills, slaughter houses, meat processors and other potentially involved facilities.

The FDA animal feed rule was another firewall that held: 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 appearance of the disease in our country clearly called for additional measures; moreover, some aspects of the emergency required thorough analysis in order to develop even more effective defenses against BSE. Some of the early ideas for improvement were presented in January, when our agency proposed several additional protections for consumers and the cattle industry.

At that time, we considered the possibility of banning several mammalian ingredients from human food, dietary supplements and cosmetics: materials from non-ambulatory diseased cattle; materials from cattle that had not been inspected; materials from inspected cattle that was found unfit for human consumption; specific risk materials such as brains, spinal cords and vertebral columns; and mechanically separated beef that could have come in contact with these risk materials.

We also indicated that we might no longer allow ruminant feed to contain mammalian blood, blood products, plate waste from restaurants, and poultry litter, all of which could potentially contain the infectious prions. Moreover, we said that ruminant feed should be manufactured only by dedicated equipment and facilities.

None of these proposals are chiseled in stone: both we and our stakeholders are questioning them and burning midnight oil looking for still better answers. But in the meantime, we're doing what we can to tighten up the protective systems that are already in place.

For example, we're stepping up FDA's efforts to achieve 100% compliance with the feed rule conducting 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%. But both we and our state counterparts who carry out these inspections want to get rid of the last missing percentage point.

Moreover, we plan BSE inspections not only for more renderers and feed mills, but also for truckers, firms that salvage pet food and feed, and farms that mix ruminant feed. We're going to increase sampling and analysis of marketed feed, including products imported from non-BSE countries; validate a simpler and faster method for the detection of bovine proteins in animal feed; and evaluate diagnostic kits for mammalian protein in feed.

I am not one given to Pollyannic predictions. Clearly, there is lot of work to be done to translate all of the experiences from Washington into cogent and compelling measures that will significantly step up our BSE defenses. But I see no reason why we should fall short of the goal. Our resources are much better than they used to be: FDA's current BSE budget is over $21 million, more than five times higher than it was only three years ago, and we're requesting additional $8.3 million for BSE activities in FY 2005.

It's also worth noting that time may be on our side. Scientists are exploring new avenues for preventing BSE by either eliminating or altering the cow's prion protein to prevent it from assuming the form that induces the spongiform encephalopathy. There is even a report from South Korea that a scientific team there has genetically engineered a cow that is believed to be BSE-resistant. This sounds like a promising development that one day might remove BSE from the catalogue of major public health hazards.

I will stop because I want to leave some time for your questions, but I hope that the my overview of our bioterrorism and BSE programs has made a point that should not be lost on educators, as well as the American public. The hazards I spoke about are real -- a risk-free existence, whether for humans or animals, will never be in our reach. But we are confronting the dangers of our era vigorously, and in a well-thought-out and systematic fashion. Our protections of the public health are strong, and getting stronger every day.

Thank you.

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