The December 2006 E. coli outbreak is a stark reminder about how important it is for retailers offering foodservice to evaluate threats to their food supply chain and to develop ways to reduce the risk of a similar occurrence. In the event of any such public health crisis, access to business and operational records is critical both for mitigating the effects and shutting down the sources of the outbreak.

The harsh reality for retailers is that no matter where the contamination happens within the supply chain, the entity with the most to lose is the owner or operator of the location where consumers bought the contaminated food item. That is where the TV cameras will be pointing, and most consumers will remember the store name long after the source of the contamination is determined, even if it is not at the store level.

To gain an understanding of the various issues associated with this risk, take time to review the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. One of the most important elements of the bioterrorism act is the new U.S. Food and Drug Administration (FDA) record protection requirements outlined in Section 306, "Establishment and Maintenance of Records for Foods."

The new rules were designed to help the government track the source of contamination in the event of a terrorist event that targets the nation's food supply, but they may also be applied to inadvertent contamination. The recordkeeping rule propels organizations in the food supply chain to establish and maintain easily accessible paper or digital records that "identify the immediate previous source of all food received, as well as the immediate subsequent recipient of all food released."

This section of the bioterrorism act, completed in December 2004, contains new security guidelines for the entire food and beverage production industry, including agribusiness and animal feed supply. A number of organizations are required to comply with the bioterrorism act recordkeeping rule: food manufacturers, importers, processors, packers, trucking firms and transporters, distributors, wholesalers and retailers.

Records Protection Requirement
All businesses covered by this rule had to be in compliance within 12 months from December 9, 2004. The bioterrorism act allows FDA to pursue civil or criminal action to prosecute persons who fail to establish and maintain records as required by the final rule.

In a press release issued by FDA in December 2004, acting FDA Commissioner Lester M. Crawford explained the reason for the recordkeeping rule: "The ability to trace back will enable us to get to the source of contamination. The records also enable FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply."

In other words, if terrorists tried to sabotage the food supply, the records provided by the covered organizations would enable officials to first identify where in the supply chain the contamination occurred and then, if necessary, immediately remove the product from stores, warehouses or distribution centers. It is doubtful that officials investigating a food contamination incident would even be able to determine whether the contamination was accidental or intentional until, using the traceable records in the food supply chain, they pinpointed the source of the outbreak.

Because FDA generally is concerned only with traceability, its focus is any records containing information regarding the source of the food and its destination. Companies can maintain the required information in either paper or electronic format. According to the recordkeeping rule, the requirements apply in varying degrees to certain categories of businesses. For human food, records must be maintained in ranges from six months to two years, depending on the shelf life of the food. The maximum record retention requirement for transporters of all types of food is one year.

Safekeeping Records
One key aspect of the Section 306 rule is that records must be retained either at the establishment where the activities noted in the records occurred or at an otherwise accessible location. The rule states that when FDA has 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, any records or other information to which FDA has access must be available for inspection and copying as soon as possible, not to exceed 24 hours from time of receipt of the official request."

For more information, the complete Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is available at the FDA website.

Van Carlisle is president and CEO of FireKing. He can be reached at (800) 457-2424.