Impact of the Bioterrorism Threat

The events of September 11, 2001, and the aftermath anthrax incidents have refocused the food safety concerns and priorities of regulatory agencies. The threat of terrorism aimed at the food supply and assuring biosecurity have become nightly news stories. Can biosecurity be supplied by the regulatory agencies, or will responsibility largely fall on the growers, packers, shippers, and processors of our food? The question almost answers itself: the burden falls on the regulated industry to assure the safety of its products.

What would such an attack on the food supply accomplish? It is difficult to envision that widespread serious harm and death would result, at least no more than we experience in large outbreaks of foodborne disease. Nevertheless, even if relatively little harm to human health resulted, economic consequences could be great and consumer confidence in the food supply and the regulatory agencies shaken.

The Tylenol tampering episodes of the early 1980s provide a good model of the types of considerations and prophylactic steps the industry should be considering. The episodes energized Food and Drug Administration–regulated industries to implement meaningful anti-tampering plans, including new or modified drug forms and tamper-resistant packaging. FDA and the regulated industry developed a cooperative relationship as never before—and industry did the creative problem solving. In the current situation, FDA likely has its hands full in generally improving its state of preparedness and ability to respond to a bioterrorism emergency. Increased inspection of imported foods alone will stress FDA’s existing work force, and its program priorities will shift dramatically.

Although the level of sophistication in the response to potential bioterrorism will vary with the size of a given company, among other factors, there seem to be some common points for food growers, packers, shippers, and processors to consider in light of the current circumstances:
• In the absence of better knowledge about the nature and seriousness of a threat, the distinction between underreaction and overreaction is blurred.

• A strong focus on facility and personnel security is a must. Where possible, background checks for all personnel should be required. No one should have access to the finished food product who is not so authorized.

• Know who is delivering raw material to your facility, and who is transporting finished product out. Know what security precautions those entities are taking.

• Anti-tampering plans, if they exist, should be reevaluated. If they don’t exist, they should be developed.

• GAPs, GMPs, and HACCP plans should be reevaluated. Are they sufficient to protect from purposeful acts of food contamination? Do they cover the following points: raw material integrity, packaging integrity, air-flow systems, end-line activities, and storage and transportation?

• Consumer-complaint handling practices should be checked and fine tuned.

• Recall procedures should be checked and fine tuned. Know who you would contact at your local FDA office and how.

• Know who could provide quick access to analytical methods or microbiological or chemical analyses of your products on an emergency basis. Have those contact numbers readily available.

• Improve preparedness among all employees through regular training or drills. Develop a heightened understanding of the problem, its consequences, and the fact that increased awareness on the part of all is an important component of prevention.

• Know that procedural changes in handling a “possible problem” are called for in the face of a possible bioterrorism event. The balance of internal (company) investigation and FDA notification favors early agency notification. False alarms will be one price of vigilance.

• Be aware that FDA, the Centers for Disease Control and Prevention, and state agriculture and health agencies will likely be in a “help mode,” as previously seen in product tampering incidents. Everyone recognizes that terrorism is the fault of the terrorists, not of a farm or a food company.

The above list is certainly not intended to be all-inclusive of possible preventive steps. Large companies will likely have the resources to take a risk-analysis approach to their operation and use a team of experts to devise prevention strategies, intervention strategies, containment strategies, and educational strategies, all aimed at dealing with possible bioterrorism. The sharing of strategies and experience among companies with similar attributes, or sharing facilitated by trade organizations, will strengthen the whole of the effort, and should be encouraged by government. At all costs, complacency needs to be avoided, for, as time passes, the specter of possibly more and more sophisticated terrorist acts looms.

by DOUGLAS L. ARCHER
Contributing Editor
Professor, Food Science and Human Nutrition Dept.
University of Florida

by FRED H. DEGNAN
Partner, King & Spalding
Distinguished Lecturer, Catholic University
School of Law