What do the changes to the final rule mean for the food and beverage industry?

On December 9, 2004, the FDA published its final ruling on the Establishment and Maintenance of Records. This final regulation implements Section 306 of the Bioterrorism Act, which directs the Health and Human Services Secretary to issue regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records.

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.
This regulation is the fourth regulation designed to increase the safety and security of the US human and animal food supply under the authority of the Bioterrorism Act. The intent of Section 306 is to provide the FDA with the ability to trace back and determine the source of contamination as quickly as possible. The records also enable the FDA to trace forward to quickly remove adulterated food that poses a significant health threat in the food supply.

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?

It is important to understand the changes between the proposed rule published May 9, 2003 and the final rule published December 9, 2004, as well as the FDA's intent behind some of these changes. The FDA identified the following significant changes in the final rule on Section 306, Establishment and Maintenance of Records. Compliance dates are now 12, 18, and 24 months for large, small, and very small businesses respectively. Some of the exclusions in the ruling have also been changed. All foreign entities are excluded, except foreign persons who transport food in the US. New exclusions have been added for non-profit food establishments and packaging operations. And the exclusion for retail facilities located in the same general location as the farm has been replaced with exclusion for all retail establishments with 10 or fewer full-time employees. The exclusion for pet food has been eliminated. Food contact substances, other than the finished container that contacts the food are also now excluded from recordkeeping requirements.

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

There is no longer a requirement to record a "responsible individual for transporter information." Road, water, rail and air transporters can now use existing bills of lading to comply with the rule. In addition, non-transporters may keep records on a transporter's behalf. Records retention requirements of one and two years have been changed to six, 12 and 24 months based on criteria similar to National Institute of Standards and Technology (NIST) definitions of perishable, semi-perishable and shelf-stable foods. Records availability requirements of four and eight hours have been revised to as soon as possible and are not to exceed 24 hours from the time of receipt of the official request. However, the FDA has made it quite clear it expects "as soon as possible" to ensure more rapid response to any situation that invokes the rule. This is consistent with the conclusions of the FDA's 2003 risk assessment study, "Risk Assessment for Food Terrorism and Other Food Safety Concerns." In it, the FDA states that "if an unintentional contamination of one food, such as clams, can affect 300,000 individuals, a concerted deliberate attack on food could be devastating, especially if a more dangerous chemical, biological or radio-nuclear agent was used."

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.
According to Scot McLeod, vice president for Ross Systems, "The need for automated traceability, as part of a comprehensive operational system of record, has become a basic requirement for most food processors. These systems facilitate compliance with government regulations and enable gains in efficiency and customer service. They also help food processors cope with the frequent challenges of food safety audits and mock recalls imposed by their customers." Paul Moylan, director of food industry solutions group for Rockwell Automation agrees. "Modern electronic tracking and tracing systems are providing our food manufacturing clients with tremendous improvements in productivity, cost reduction and customer satisfaction. They should not be viewed as a cost of regulatory compliance."

"There are many dimensions to food safety," continues Dave Quebbemann, director of marketing for Omron Electronics. "For example, incidents of inaccurate allergen and date code labeling are still all too common. However, manual and semi-manual systems are being replaced with more automated closed loop systems that ensure accuracy, reduce returns and recalls, and increase food safety."

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?

Developing an effective food safety program and continuing to improve it is made even more difficult because of differing opinions on whether something is a quality, safety or security issue. Even a personnel safety issue can be a product safety issue. However, two vital parts are training and programs. Personnel must be trained in all aspects of prevention, recordkeeping and event management. Their capability to apply what they have learned should be validated through extended on-the-job evaluation and sign off by their immediate supervisor.

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.
Dr. Craig Henry, vice president Food Safety Programs, and Dr. Allen Matthys, vice president State and Federal Regulations, of FPA believe that food quality, food safety, and food security should be separate programs. To them, how you achieve regulatory compliance and incorporate these programs into your own operation is specific to your site. In fact, the association provides food facility auditing services through the FPA-SAFE program. SAFE assists end users who are unable to conduct a detailed assessment and prefer to rely upon an audit to make a determination about a facility. Since its inception about four years ago, FPA-SAFE has experienced rapid growth, with more than 160 certified auditors performing 1,000 audits in the US and 14 foreign countries. More details about this service can be found on the association website atwww.nfpa-safe.org/default.htm.