The product traceability pilot projects required by the passage of the Food Safety Modernization Act have been completed and, not surprisingly, the overarching finding is that the current traceability systems that are typically being used today make it “very challenging” for the Food and Drug Administration to conduct a successful investigation following a food-borne illness outbreak.
At least this was among the finding of the Institute of Food Technologists (IFT), which conducted the pilot projects and released its more than 300 page report in early March. Tejas Bhatt, manager of Food Safety Programs for IFT, said the two separate pilot programs involved red round tomatoes and processed products (including chicken, peanuts and spices). Though the pilot projects were conducted separately, Bhatt said the findings were combined to present one report that had a main goal of offering recommendations to the Food and Drug Administration on how it can improve product tracing in a way that benefits all stakeholders.
Of the 10 specific recommendations that IFT made (see separate box), the majority dealt with ways that federal agency can improve its data collection and processes to improve product tracing. But the report also indicates that the industry itself has to do a better job of maintaining the identity of the producer as fresh or processed product moves through the supply chain.
Bhatt said IFT began its pilot projects “with a clean slate” and with no preconceived notions that current tracing systems were good or bad. The company presumed that they were the FDA and that a food borne illness outbreak had occurred. They conducted a total of 14 mock tracebacks. In the case of the tomato mock tracebacks, they knew that a specific tomato was involved and then the investigative team began the process of tracing it back to its producers. In the case of the processed product, they did not know what ingredient was involved or even which package of ingredients. “We wanted to know what data does the FDA need to begin a traceback investigation and how do they get it,” said Bhatt. “And then how does the industry store that information.”
He said the projects were designed to identify problem areas and determine solutions. He said a cost/benefit analysis was an integral part of the pilot project. “We spent a lot of effort looking at what was feasible (from a cost perspective). We wanted to know what was ideal but not achievable.”
Bhatt said his overarching view is that he was “very impressed” with what many companies are doing or trying to do to achieve traceability within the tomato sector of the fresh produce business. “We worked with 30-35 different companies all the way from small growers to large repackers,” he said.
He said an important part of the project was to determine the impact potential regulations would have on small businesses so it was very important to include small growers as well as large companies in the pilot projects. He said part of IFT’s charge was to come up with recommendations that were not impossible for a small business to implement. In fact, he said one of the top 10 recommendations was that the “FDA should encourage current industry-led initiatives.” He said that the findings indicated that industry-led efforts would be more successful than new top-down mandatory regulations from the agency itself.
In general, Bhatt said the study showed that the identity of the producers tends to get lost as product goes through the supply channel. Consequently, another recommendation calls for the FDA to require all firms along the supply chain “to identify and maintain records of CTEs (critical tracking events) and KDEs (key data elements) as determined by FDA.”
Still another recommendation calls for all companies to be required to have a product traceback plan. Bhatt said in conducting the pilot project, IFT discovered that most firms have product recall plans in place but not product traceback plans. “They are not the same thing,” he said.
While not specifically discussing whether there is need for new regulations, Bhatt said current regulations could be sufficient if they were followed. For example, the provisions in the Bioterrorism Act of 2002 require all companies to maintain records that can “determine the immediate previous sources and the immediate subsequent recipients of food.” Bhatt said this so-called one up, one down provision would make the FDA investigations much easier and quicker if everyone followed it and the records were clear enough to establish the link to the producer. The trouble is the pilot projects discovered that the link isn’t always there.
But he said there is a huge payback if whole supply chain traceback is enacted properly. The IFT report studied eight previous food borne illness outbreaks and determined that product tracing has the potential to both reduce the public health impact by up to 55 percent of total illnesses and reduce the economic impact by up to $14 million per outbreak.
Bhatt said there are many positive ROIs (return on investment) that produce companies can achieve by having a good product traceback system, including better inventory control, reduced risk, increased supply chain confidence and expanding markets.
Key findings from IFT's analysis of current product tracing practices indicate the following challenges associated with outbreak investigations:
• Tedious and difficult to sort through hundreds of pages of documents
• Confusion when data definition is lacking
• Inconsistent item descriptions
• Wrong or incomplete information cause delays
• Companies operating under multiple names are difficult to identify as sources
Although FSMA limits FDA to enacting additional recordkeeping requirements to “high-risk foods,” outbreaks during the last several years reinforce the fact that foods previously considered “low-risk” can quickly find themselves on the “high-risk” list. Consequently, IFT’s first recommendations was that “FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.”
Bhatt said IFT also noted issues with what FDA was asking for and why. For example, during a traceback FDA typically asks for bills of lading and invoices but what they really want is traceback data. Consequently, one of the recommendations calls for the FDA to clearly identify the types of data that industry needs to provide during an outbreak investigation.
In summary, IFT found that there are several areas (such as uniformity and standardization, improved recordkeeping, enhanced planning and preparedness, better coordination and communication, and the use of technology) in which industry improvements and enhancements to FDA’s processes would enable tracebacks and traceforwards to occur more rapidly.
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