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Lester M. Crawford, D.V.M., Ph.D. - American Veterinary Medical Association

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.

Speech before
American Veterinary Medical Association
Executive Board & House Advisory Committee

Remarks by

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

April 5, 2004

Good morning, and thank you, Gerald (Rushin, AMVA lobbyist) for the introduction.

I think we've all learned since September 2001 not to underestimate our enemies.

One thing we can be sure about is that they followed closely the devastation that BSE wrought in the 1980s in the European cattle industry, and that they are hard at work contemplating how to deliver a similar blow to us by using various pathogens to contaminate our food supply and cripple our livestock industry.

As my colleagues have already made clear, our government is working just as hard to prevent anything of the sort from happening, and the Food and Drug Administration as the leading agency charged with protecting the public health, is doing its share.

FDA is responsible for regulating 80 percent of our food supply -- practically everything we eat except for meat, poultry and some egg products -- as well as all health care products for humans and animals, plus devices that emit radiation and cosmetics.

Our Center for Veterinary Medicine, or CVM, regulates all drugs, devices, and feed additives given to, or used on, all food and farm animals and pets.

The highest priority is to ensure the safety and wholesomeness of animal-derived human food, which is closely linked with the health of the animals and with their feed -- and this is an area where terrorism is of particular concern, because we import annually 280-290 million dollars-worth of feed, feed ingredients and fodder from countries all over the globe where we have no security presence.

It was because of this potential hazard that Congress passed in 2002 the Public Health Security and Bioterrorism Preparedness and Response Act.

This is an exceptionally important law that's designed to safeguard all food and feed on our market, and places particular emphasis on protecting the safety and security of imported food and feed.

There are four major provisions of this law, and they require that:

  • one, all firms, domestic and foreign, that are involved in selling food, feed and feed ingredients on the U.S. market must register with our agency;
  • two, that the FDA must receive a prior notice before the arrival of each food or feed shipment from abroad;
  • three, that all firms that handle imported food or feed must maintain documents that would enable us, if need be, to rapidly track down a suspect consignment;
  • and four, that upon locating a potentially seriously harmful shipment of food or feed, the FDA has the authority to place it under administrative detention pending the examination of its safety.

The law also gives FDA the authority to debar any person convicted of felony in connection with the importation of food or feed, and to mark up -- at the owner's expense -- any shipment of adulterated food or feed to prevent it from reaching our market through another port of entry.

These provisions went into effect last December, and we are now implementing them with the help of more than 600 newly hired and trained employees and in close cooperation with 6,000 officers of the U.S. Customs.

This is a great responsibility: We have a 7,500 mile-long border with Canada and Mexico that's crossed each year by countless cars, 11.2 million trucks and 2.2 million railroad cars.

The United States has more than 300 ports of entry, some of which receive annually 51,000 calls by foreign flag ships, others hundreds of thousands of commercial flights, and all of them admit 330 million foreign visitors.

To comply with the Bioterrorism Act, we've established a data base for the registration of what we expect to be about 400,000 firms that manufacture, process, pack, or hold food or animal feed for the U.S. market.

So far, we have received the required information from approximately 15,000 animal feed companies, about one-third of them foreign, and the rest domestic.

We've set up another data base where the shippers can notify both FDA and U.S. Customs and Border Protection of their intent to import a cargo of foreign food or feed.

This prior notice has to arrive at least two hours before the articles if they are shipped by trucks; four hours if they come by air or rail; and eight hours if the are arriving by water.

By the end of this summer, when the law's provisions are fully implemented, we expect to be getting 25,000 of these prior notices per day, 7 days a week.

By and large, we've got the preparatory work done, and now we are concentrating on educating the foreign and domestic food and feed firms on how to comply with the Bioterrorism Act's requirements.

Our veterinary center has several additional counterterrorism assignments:

For example, it is assisting State authorities in acquiring the scientific and analytical expertise and capability to respond to an animal feed contamination incident.

It is also developing, together with the Department of Energy and Iowa State University, a database that will enable veterinarians and others to respond to a bioterrorist attack on our livestock and other animals by taking such actions as quickly identifying qualified labs to analyze feed and animal tissues for chemical or biological agents; immediately contacting national experts in these fields to request help in diagnosis and follow-up; and recommending appropriate sampling techniques for laboratory analysis.

In addition, we are establishing a compliance programs for early detection of chemical and biological contaminants in the animal feed supply; and we're developing analytical methods to detect the presence of toxic substances in animal feed supplies.

We're also participating in national surveillance programs, such as FoodNet and PulseNet, for the detection of multi-drug resistant foodborne bacterial pathogens; and we're developing bio-security awareness guidelines for the feed industry.

All this is in addition to our routine programs, including the heightened surveillance of the feed industry and the ruminant feed to protect our livestock industry against the emergence of BSE.

These are just some of the highlights of the workload carried out by our veterinarians, by CVM, and by the inspectors and other specialists in the Office of Regulatory Affairs.

Regarding the FDA's vision of its future as the protector of animal and human health against attacks by terrorists, that role is spelled out in the Homeland Security Presidential Directive number 9. The goal of that directive is the establishment of an integrated surveillance system for the detection of any emerging threat to our agriculture and food supply.

On that subject, I've already mentioned the database we're developing together with the Department of Energy and Iowa State University with essential information for federal, state and local officials and others responding to an emergency threatening the feed supply.

In addition, we have begun a vulnerability assessment of the animal feed industry, and have assisted the Animal and Plant Health Inspection Service with their own risk assessment.

In addition, we'll be working with our sister agencies on several priority projects: one of them is on the development of common inspection methods for imported food and feed; and another on creating a National Veterinary Stockpile of therapeutic products that could be deployed within 24 hours of an outbreak.

We'll also take part in the establishment of university-based centers of excellence in agriculture and food security.

So if you ask me what's my vision of the future of the veterinary profession in this age of terrorism, my answer is that vets already are and will continue to be -- side by side with others in the health care community -- on the front lines of our defenses against terrorism.

They will be deeply involved in performing an invaluable service for our country, our way of life and our values by helping keep our people, our economy, and our animals healthy, secure and safe.

Thank you.