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Lester M. Crawford, Jr., D.V.M., Ph.D. - Department of State

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.

The Secretary's Open Forum
Department of State
September 6, 2002
The Secretary's Open Forum Distinguished Lecture Series
Presents
A Conversation on Food Safety and Global Security
Featuring
Lester M. Crawford, Jr., D.V.M., Ph.D.

Deputy Commissioner
U.S. Food and Drug Administration
It is a very great honor to have been invited here today. I appreciate the invitation and want everyone here to know how much I value this opportunity. My esteem for the Department of State and its incumbent Secretary know no bounds. Much earlier in my career, I had the ennobling privilege of being on the same faculty as the founder of this forum. Dean Rusk was a towering figure at State and no less at the University of Georgia.

In late 1999, the State Department came to me at Georgetown University and asked if I would be willing to visit a number of countries for the purpose of explaining US policy on food biotechnology. Twenty countries and two years later, I concluded the assignment in Singapore with three enduring impressions. First, there is a great deal of international political chicanery masquerading as anti-American sentiment and food biotechnology and globalization are its most useful poster children. Secondly, the respect that the larger world holds for the FDA is, in fact, a national treasure of this country. And finally, the Department of State's care and handling of befuddled academics has to be second to none.

The terroristic events of last fall in this country have caused more attention to the food supply as a potential instrument for compromising global security. Today we shall deal with how realistic this concern is and what form such an event is likely to take. This will not be a recipe for food sabotage but, rather, a sober assessment of the situation.

First, what does history tell of us of the possibility of food as an instrument of terror? Happily, not much. In this country, an episode in Washington State wherein a religious cult attempted to affect a local election by contaminating salad bars with salmonella organisms is often cited. That attempt was, in a word, unsophisticated. Human feces from salmonella patients was the mostly ineffective vehicle. Then there was the threat of cyanide intoxication of grapes imported from Chile. Again, there was no real illness or loss of life. Nonetheless, the Chilean grape incident caused a considerable degree of concern if not terror. Both these incidents occurred in the 1980s and since that time, there has been nothing to report.

The same paucity of food-borne terroristic events mark a search for examples in other countries. There is no shortage of food-borne disasters but these have been accidental, often mindless, incidences. In Spain in the early 1980s, thousands of people died due to the substitution of non-edible oil for salad oil. And one need only summon up the spectre of bovine spongiform encephalopathy to realize how devastating a food-borne calamity can be.

The fact that few terrorist incidents involving the food supply can be found in the medical, scientific and popular literature might lead one to conclude that the use of food as an instrument of terror is unlikely. That would be looking at the world of today through the prism of the past. The terror of these times is based on a different note on a different scale.

Food could be used for terroristic objectives in three categorical ways. First, virtually all foods offer a convenient matrix for the introduction of microbiological or toxicological hazards. Secondly, few nations have more than a two year reserve of food. Even so, disruption of food production for only a few months would lead to chaos. Finally, food is sacred. What a parent feeds a child and what a nation consumes in the way of national staples such as rice in Southeast Asia or yams in parts of Africa are so much a part of the culture and such a large part of the diet that discontinuity of just these foods could lead to dramatic consequences.

All of which brings us to the crux of this concept-sphere-how to get into the mind of the terrorist. Or, put another way, how do we ascertain what is a victory for the terrorist? What we might consider the achievement of modest objectives might be precisely what was sought. It is indeed very hard for the rest of us to think like they do. But think like they do we must.

Food safety professionals from around the world come from a variety of disciplines. Food scientists and veterinarians probably comprise the majority but chemists, engineers, toxicologists, physicians and others are critically important in the maintenance of a safe food supply.

Until recently, I was on the Expert Advisory Panel on Food Safety for the World Health Organization (WHO), and I can tell you that progress in food safety around the world has been phenomenal over the last 20 years due in large part to the leadership of WHO and the United States.

But the orientation of food safety has decidedly not been in the direction of bioterrorism. And there are few, if any, bona fide experts on food bioterrorism in the world. What, therefore, is needed is the development of a sub-discipline in food bioterrorism that will spearhead the research that will lead to the body of science that is required. Initially, sub-disciplines are energized by a new cadre of professionals that cannot only think like bioterrorists but can design studies that result in better methods of detecting agents of terror in the food supply and of predicting the most likely scenarios of food-based terrorist acts.

President George W. Bush signed into law this summer the "Bioterrorism Preparedness and Response Act of 2002." In addition to many other effects, it defined as a matter of law the term bioterrorism which is taken to mean the use of living substances as a means or a template for inflicting terror. The food safety elements of this watershed legislation will govern the efforts of FDA, and other agencies, in protecting this country from food borne threats from foreign as well as domestic sources. Through 6 months of Congressional debate with a great deal of Executive Branch input, our nation reached consensus on what was to be done about the food supply.

In point of fact, the Act gives greater authority to FDA and other areas of federal, state and local governments for what is called bromatovigilance, the surveillance of the food and nutrient status of a region. The following are 8 major food provisions in the new legislation:

  • Registration-Requires registration of any factory, warehouse or establishment by the owner, operator or agent in charge of a domestic or foreign facility.
  • Maintenance of Records-Authorizes access to certain records when there is a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
  • Detention-Authorizes FDA to order the detention of food if the officer or qualified employee finds credible evidence or information indicating the article presents a threat of serious adverse health consequences or death to humans or animals.
  • Prior Notice of Imported Food Shipments-Requires prior notice of imported food shipments that includes the article, the manufacturer and shipper, the grower, the country of origin, the country from which the article is shipped and the anticipated port of entry.
  • Debarment (importers)-Authorizes debarment for persons convicted of a felony for conduct relating to the importation of any food or for persons who have engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.
  • Marking of Refused Imports-Authorizes the marking of refused food at the owner's expense.
  • Grants to States-Authorizes grants to states, territories and Indian tribes that undertake examinations, inspections and investigations and related activities. Authorizes grants to States to assist them with the costs of taking appropriate action after receiving notification under the preceding section.
  • Authority to Commission other Federal Officials-Authorizes the Secretary to commission other Federal employees to conduct examinations and inspections.

The Bioterrorism Act has already catalyzed an extraordinary network of communication and cooperation among and between the entire apparatus of food safety organizations and agencies. The Act also has firmly placed food safety as a legitimate concern within homeland security, national defense and related programs. The challenge now is to promulgate the enabling regulations and to accelerate the requisite research.

International cooperation and awareness are likewise at an all-time high. The United Nations food programs at WHO and FAO (Food and Agriculture Organization) will be the focus of much that is timely, useful and innovative.

At the end of the day, none of the above is going to be enough in and of itself. It is going to fall to the US to provide the necessary science and leadership in this area. Since most of the 180+ UN countries are not likely to be the subject of food bioterrorism and since some of those that are likely targets are insufficiently alarmed in my view, this country will have to do a great deal.

How will we start? Here are some possibilities:

  • Retrospective examination of major food borne outbreaks. Perhaps the most useful food bioterrorism school lies in the examination of past outbreaks with a view as to how these or similar events could be artificially reproduced.
  • Surveillance of food borne outbreaks as possible rehearsals for terrorist acts. Each ongoing outbreak should and must be considered in this context.
  • Development of analytical tests. Cataloging the select agents most amenable to introduction into the food supply and then funding the necessary research is highly important.
  • Food War Games. The food safety community must become involved in the algorithm development and doomsday scenarios similar to those that the defense establishment has concocted for other agents of terror.

Food safety matured to its present level of sophistication over the past 30 years due to the adoption of the Hazard Analysis and Critical Control Point System (HACCP). When the National Marine Fisheries Service, the Food Safety and Inspection Service and FDA converted HACCP to a regulatory tool in the late 1980s and early 90s a marked diminution in food borne disease and death occurred. HACCP is a straightforward risk management program that identifies the hazards, the sources of the hazards and then builds a preventive model that is easy to understand and simple to implement. The shining advantage is that it is a systems approach that structures food safety so that the food industry and inspectional authorities do not have to depend on intuition but work off a functional system that embodies both maximal diligence and the latest science to accomplish the goal of a steady improvement in the safety of the food supply.

HACCP now needs to be adapted to food bioterrorism programs especially including surveillance of imported foodstuffs. This will facilitate a focus by all interested parties on the most likely agents and modalities for accomplishing terrorism through the use of the food supply. This will require exquisite cooperation between the food industry, the food regulatory infrastructure and other countries and international organizations. It simply is not true that all potential hazards have an equal probability of occurrence. What the application of a HACCP-inspired approach to food bioterrorism control will do is allow the entire food community, including regulators to concentrate on the food borne incidents that are most likely to occur and to develop systems and inspectional programs that have the greatest probability to prevent food bioterrorism.

Lastly, the community has to develop the kind of seasoned leadership that is capable of creating an environment where results are likely and food biosecurity is foremost. As the food safety/security sub-discipline matures it must be wary of creating personnel and plans that become instruments of terrorism. This narrow line has been successfully trod in other areas of defense. We can do no less in food safety. Thank you.