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Lester M. Crawford, Jr., D.V.M., Ph.D. - Tea Association of the U.S.A.

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.

Tea Association of the U.S.A.
Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.

Deputy Commissioner
U.S. Food and Drug Administration,
October 18, 2002
Good morning. I appreciate your invitation to discuss the role of the Food and Drug Administration in helping ensure the security of food in the wake of the terrorist attack last September. There is a lot being done and I'll be happy to tell you about it, but first, I want to tell a story that has some meaning for our present situation, and that many of you will find familiar.

The story I have in mind goes back to the latter part of the 19th century when Britania ruled the waves and the British tea importers had a monopoly on all the tea in China. Rather understandably, these importers kept the best tea for their very large domestic market, and sent the rest -- which frequently was second-rate or worse -- to the United States.

This was not the sort of products that American consumers cared to buy or the American tea merchants wanted to sell, but they had no choice: if they refused to accept a shipment of bad tea, they ran the risk of being blacklisted by the British suppliers, and getting no tea at all.

The Americans importers -- your predecessors -- finally got so frustrated that they went to Congress and asked for a law that would enable them to reject infested or impure tea -- a product that conceivably could pose a health hazard -- without incurring the revenge of their suppliers. And Uncle Sam did what governments are created for, by coming to the defense of American consumers and industry.

It promulgated two Tea Acts -- one in 1883, and an amended version in 1887 -- which made the U.S. the world's only country with official tea standards. From 1887 on, shipments of substandard tea were turned away from the U.S. ports -- not by the vulnerable merchants, but by the U.S. government. By now, I am sure, you understand why I recall this piece of history in connection with the unforgettable experience of last September 11. On that horrible morning, we were shocked into realization that for all of us, there is no more business as usual. This was most of all true for the U.S. government, which had to greatly intensify its protection of the public health by helping safeguard our food and other regulated products from contamination by terrorists.

As I will describe in a minute, not surprisingly, much of this critical concern has been once again focused on imported food -- not because of any qualms about the involved firms, but because food consumption is universal and its production, processing, storage and transportation abroad presents a potential target for terrorists. The Food and Drug Administration, which was assigned the lead role in this effort, joined forces with the Centers for Disease Control and Prevention, the U.S. Department of Agriculture and other federal, state and local agencies, and last fall launched a bioterrorism program that is unprecedented in its size and urgency in our agency's 96-year history.

Fortunately, in building a strong shield against the hazard of contaminated food, the FDA and its partners had a good basis to start from. As most of you remember, foodborne disease was a major public health issue throughout the 1990s, and FDA and others in the public health community responded by developing a solid foundation for a state-of-the-art, science-based food safety system that was designed to prevent or detect, identify, and confront foodborne outbreaks.

In the previous decade, much work was done to strengthen a surveillance system that included federal and state food laboratories and enabled them to rapidly exchange information and results of tests. The FDA had also advanced the implementation of good agricultural practice for produce and of the advanced HACCP quality control system for seafood and juice. In addition, the agency participated in campaigns to educate American consumers and foreign food producers and exporters about the A-B-Cs of food safety.

What the FDA and the public health community lacked was sufficient experience in confronting a massive attempt to contaminate food. In the mid-1980s, a religious cult in Oregon tried to throw a local election by contaminating salad bars in ten restaurants with Salmonella typhimurium, and around the same time, there was a threat of cyanide poisoning of grapes imported from Chile. Neither of those incidents caused any deaths or had nation-wide implications.

Since history was no guide, our agency had to rely primarily on information from U.S. intelligence agencies; science-based risk assessment and management; common sense; and, last but far from the least, the support from Congress, which by now has strengthened our counter-terrorism program with additional $480 million.

Although our goal is to help ensure the safety of all food on the U.S. market, it has been obvious that the most tempting targets for bioterrorists would include some of the 4 million shipments of produce and other food that's annually exported to our country from all over the globe. So while not disregarding the potential vulnerability of our domestic food, much of our effort has been focused on increasing the surveillance of imports.

Here is what has been done by our agency so far, in most cases in cooperation with our partners in the federal, state and local governments:

  • Most important of all, we're in the process of hiring 832 new employees.

Almost 600 of these mostly college-educated employees are being trained and assigned to the ports of entry and FDA field offices, where their main task will be monitoring the safety and security of imported food. We estimate that by the end of this year, we will be able to conduct 24,000 import inspections, nearly double the total in the past.

  • Our agency has produced two food security guidances -- one for domestic producers, and one for importers -- that suggest ways for improving protection against accidental or intentional contamination of food products.

In addition, the FDA has developed an Operational Risk Management document which is based on a six-step process used to improve the safety of aircraft, space vehicles, and nuclear power plants.

  • Last fall, our agency contracted for an assessment of the relative vulnerability of food and cosmetics to intentional contamination with biological, chemical and radiological agents. The report, which is still in the works, will be submitted to Congress in December, and its unclassified portions may be made public.
  • Over the past year,the FDA has sponsored and participated in various preparedness exercises, four of which required the agency to respond to a bioterrorism event.

The drills, which helped test and strengthen FDA's response plans, were carried out in cooperation with other federal, state and local authorities, and in two cases included representatives of regulated industries.

  • We have also enlarged our network for monitoring foodborne outbreaks. In addition to strengthening CDC's FoodNet and PulseNet and expanding eLexnet, the FDA and the USDA's Food Safety and Inspection Service have agreed to create PrepNet, or Food Threat Preparedness Network, for the coordination of homeland security activities to ensure food safety.

We are also developing plans for a Food Laboratory Response Network, which will be integrated with CDC's facilities to further enhance our ability to respond to a bioterrorist attack on food.

In addition to all these activities, Congress has recently expanded our counter-terrorism agenda by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which makes our safeguards for the security of food imports much more robust. Since this is probably your primary interest, I'll go quickly over the provisions that deal with imported food:

  • Registration: Domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. must register with the FDA by December 13, 2003. Exempted are farms, restaurants, retail food establishments, non-profit establishments that prepare or serve food, and fishing vessels not engaged in processing.
  • Maintenance of Records: With the exception of farms and restaurants, all firms engaged in the food business will have to maintain records that would enable our agency to determine the immediate previous sources and the immediate subsequent recipients of food under their control. Access to these documents, is intended to help the FDA to investigate credible threats that the food poses serious adverse health consequences or death to humans or animals.
  • Administrative Detention: The FDA may order the detention of food if an officer or qualified FDA employee finds credible evidence or information indicating it poses a threat of serious adverse health consequences or death to humans or animals. The Act requires our agency to notify the state with jurisdiction over the involved port of entry of the detention and what articles it includes, and to notify states of credible evidence that an imported food shipment presents a serious threat to the public health.
  • Prior Notice of Imported Food Shipments: Importers must provide the FDA with a prior notice of food shipments that includes a description of the article; the manufacturer and shipper; the grower (if known); the country of origin; the country from which the article is shipped; and the anticipated port of entry. If the FDA does not issue the necessary final regulation by December 13, 2003, the law specifies that the import notice must be provided to the agency no less than 8 hours and no more than 5 days prior to the shipment's arrival.
  • Debarment: The act authorized debarment of persons who have been convicted of a felony relating to the importation of food, or who have engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences to humans or animals. Food imported by a debarred person will be held at the U.S. port of entry, but it may be delivered to non-debarred persons who furnish proof that the food is in compliance with FDA standards.
  • Marking of refused imports and port shopping: The act authorizes the marking -- at the owner's expense -- of foods refused admission into the U.S. Refused food may be deemed adulterated if it is offered again for import, unless it is established that it has been brought into compliance.
  • Import for export: No article of food, food additive, color additive or dietary supplement may be denied admission into the U.S. if the importer submits a statement that the article will be incorporated into a product that will be exported from the U.S., and executes a bond to cover the cost of liquidating the articles, if necessary. However, the admission can be refused if there is credible evidence that the submitted statement is false.
  • Cooperation: The act also authorizes grants to, or cooperative agreements with, states, territories and Indian tribes that carry out examinations, inspections, investigations and other activities necessary to implement the law's provisions.

We'll have to publish several regulations for the implementation of this law, but we expect to have that job done by the mandated deadline of December 13, 2003.

Now, these are some of the ways we believe we can prevent or quickly respond to bioterrorism. There is no question that there is much more that could be done, and I want to invite you to help us consider what else we can do, and how we can do it, to prevent, or at least minimize the threat a intentional contamination of our food.

We need the best information about the terrorists' potential, preparations and plans, and perhaps you and your overseas contacts could be helpful in this area. We also need to carry out a new kind of research that would answer such questions as how an intentional food contamination could be launched, who would be most affected by it and how, and how to best prevent or mitigate the potential harm. There is no body of knowledge on this subject that I know about, but we can start the learning process in several ways:

  • For example, we can go back to our records and reexamine the past major foodborne outbreaks for lessons on what made these events possible, and how they could be intentionally reproduced. We also must scrutinize every new foodborne outbreak for possible signs that it is a rehearsal for a terrorist attack.
  • Another important project we must undertake is the development of analytical tests for the agents that are most amenable for introduction into the food supply. Cataloguing and funding the necessary research on these agents is essential for confronting bioterrorism.
  • Yet another approach we should test is gaming the food war -- conduct an exercise to test our responses to a theoretical attack of bioterrorism, the way our defense community war games other terrorist scenarios. In short, we very much want to get all the help you and other food producers and importers can give us. Of course, we have no illusions that there are any short cuts to victory over the current threat of terrorism, but if you ask me what I see happening down the road, I will remind you of the FDA tea program.

It was a good, effective program that kept bad tea our of our market. It worked so well that in the 1970s, when two subsequent administrations tried to shut it down, your industry volunteered to pay part of the cost of keeping the tea examiners in business. But within the two decades that followed, the tea imported for our market was so uniformly up to the Tea Act's standards that non-compliant shipments became just a bad memory, and the FDA's examiners became a a stuff of cartoons.

In 1996, Congress revoked the Tea Act as no longer necessary, and within two years, the program went out of existence. Its demise was so completely unmourned that the FDA docket for comments on the closure to this day has not received even a postcard.

Our current challenge is, of course, of a completely different order of magnitude. But over the long run, I am convinced that our counter-terrorism program will follow the same course as our tea program.

The Bioterrorism Act will work well, keeping our imported and domestic food secure and safe.

And with all of us united and working together, the time will come when our food imports will no longer be threatened. Our counter-terrorism program then will have outlived its usefulness, and our role in the war on terrorism will be relegated to history as yet another example of public health protection effectively rendered to meet the needs of the day. Thank you.