Under the Bioterrorism Act, the Food and Drug Administration and the Bureau of Customs and Border Protection require more stringent and detailed advanced notification and electronic presentation of cargo information. Source: ARC Advisory Group. Photo by Gerald Nino, courtesy of CBP.

However, the FDA must show credible evidence that the product poses serious adverse health consequences or death to humans or animals before requesting such records. The food industry has noted that the requirements of the rule are sometimes difficult for companies to understand. In its comments, the Food Products Association (FPA) stated that the rule includes complex new requirements for both recordkeeping and records access by FDA and that understanding and interpreting these new requirements will be a top priority for the food industry.

Jim Brown, vice president of Wonderware e-Compliance, says, "While many companies have the data in electronic form, they seem to have difficulty correlating this data into a report that helps the FDA provide a rapid response. Paper records make it even more difficult to correlate this data into the type of report expected by the FDA and the consuming public." Additional information on the rule is available on the FDA web site at www.cfsan.fda.gov/~dms/fsbtact.html.

What are FDA's intentions?

The final rule only requires persons who manufacture, process, or pack food to keep a record of lot or code number or other identifier, if the information exists. However, it is important to understand that the FDA states that the record must include all information "reasonably available" to identify the "specific source" of each ingredient that was used to make every lot of finished product. Keep in mind that "reasonably available" may vary from case to case. If the identifier exists on any company document, it is likely to be considered reasonably available. It could be an actual lot number from a supplier or simply a dated receipt of an ingredient. In a case where a specific source of an ingredient cannot be identified because of common storage silos or other limitations, all potential sources of the ingredient must be identified.

The FDA believes most companies already keep such information for business purposes. An initial FDA overview of the final ruling seemed to expand the product recipe reporting requirements to include ingredient quantities and procedures.

However, during public meetings the FDA indicated that only ingredients need to be identified in the record requirements. The recipe recordkeeping requirements have been and will continue to be a source of concern to food manufacturers. They are concerned about the potential loss of intellectual property and intellectual property rights and the impact over mandating will have on the industry's ability to meet the Bioterrorism Act's intent.

E-Seals, which are affixed in various ways to the doors of cargo containers, are computer microchips with radio antennas that can transmit data automatically over radio frequencies to reader networks. If the seal is tampered with, it automatically reports that information, along with its own identity and location, to a reader that relays it to authorities. The relays can occur in different ways, including to web-based software, cell phones or other PDA devices. Source: Savi Technology, EJ Brookes Company, RAE Systems.

Transporters and food safety

Today, RFID is seen as a necessary cost because of customer mandates. As RFID technology matures, the benefits will be apparent when the technology is applied through backward integration into the plant. Source: ARC Advisory Group.

Food safety has always been and continues to be the top priority of the entire food industry. Many companies have well-documented food safety programs that include good manufacturing practices, good sanitation and pest control practices, HACCP protocols, personnel qualification and awareness training, process validation, change management, and an effective product recall system. They have also begun to beef up their food security programs, including increased plant security measures and anti-counterfeit packaging activities.

Although the cost to benefit varies significantly from manufacturer to manufacturer, current maturing technology and standards should not be considered major obstacles to beginning the development of more effective tracking and tracing within the manufacturing process, across the global supply chain, and among trading partners. It is now a necessary part of improving food quality, safety, and security; improving business performance; meeting customer requirements; improving consumer confidence in a company's products; and mitigating business risk such as the threat of bioterrorism and the growth of the counterfeit foods market.

As Mark Armentrout, chief operations officer of Aginfolink, says, "If you look at where western consumers are today, you'll see that we care about our food and where it comes from. We care not just about nutritional value, but about the safety of the food, how it was raised or grown, and the humane treatment of both the animals and the people involved in the process." Aginfolink provides animal and meat tracking and tracing solutions from the actual animal all the way to the retail store. Although its solutions include RFID and DNA identification technology, its core competency is software and services that provide simple and secure methods of sharing data via private data sharing networks. Some of its clients include Iowa Cattlemen's Association, Kentucky Beef Network, Southeast Livestock Network, AGIL-DOMINAR in Brazil and Stanbroke Pastoral Company in Australia.

More robust "farm to the fork" tracking and tracing systems and sub-systems are needed to meet current and near future business requirements. Paper records systems are proving inadequate and are being replaced with electronic systems that enable the exchange of information among enterprise and production systems as well as trading partners. They provide workflow enforcement, multi-factorial data analysis and a basis for continuous improvement. Some of the major deployments include environmental monitoring, food quality, food safety, food security, personnel safety, asset protection and more. These deployments impact almost every organization in the enterprise. For example, a food safety program must include every individual who can impact food safety, including senior management, operations staff, those responsible for purchasing ingredients and other materials, maintenance, engineering, those responsible for hiring and training staff, and those responsible for the internal and external logistics of staff and equipment. Each person will have defined and documented technology and procedures used for prevention, recordkeeping, event management, validation, and change control.

Quality, safety or security?

The Avery Dennison ALX RFID Print/Apply system encodes and prints unique RFID labels and automatically applies the encoded labels to cartons, cases and pallets. During the encoding process, the system detects and then rejects miscoded or unreadable RFID labels. Source: Avery Dennison Printer Systems.