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IFT’s Traceability Pilot Projects: Should All Food Be Treated Equally?
by Ted Agres
The Institute of Food Technologists’ (IFT) “Pilot Projects for Improving Tracing Along the Food Supply System—Final Report” covers two food tracing projects sponsored by the FDA. In its report, the IFT recommends that the agency establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not allow exemptions based on risk categories or the size of the firm involved.
In addition, the IFT recommends every company involved in the food supply chain should be required to develop, document, and exercise its own product tracing plan and to identify and maintain records of so-called key data elements (KDEs), such as lot or batch numbers, to make product tracking more efficient.
“We think these recommendations are sufficient and directly on point,” says Angela Fernandez, vice president of retail and grocery for GS1 US, a member of the GS1 international supply-chain information standards organization. “The pilots validated the reality of what’s happening inside of the food supply chain today. The recommendations address all of the challenges that companies are facing.”
The FDA is currently accepting public comments on the 334-page report through July 3, 2013, after which it will submit its own recommendations on food traceability requirements to Congress and then prepare proposed regulations—steps required by Section 204 of the Food Safety Modernization Act (FSMA). While the law requires the FDA to establish recordkeeping requirements only for “high-risk” foods, the IFT recommends that this should be extended to all food categories because “low-risk” products can quickly become “high-risk” when an unexpected outbreak occurs.
Tomatoes, Kung Pao Dishes, and Peanut Butter
In September 2011, the FDA tasked IFT with conducting two traceability pilots, one involving produce and the other processed foods. FDA selected tomatoes for the produce test because they’ve been implicated in a number of significant outbreaks from 2005 to 2010 and their supply chain can be complex. The agency chose frozen Kung Pao-style dishes containing peanut products, red pepper spice, and chicken for the processed food test because they contain multiple ingredients implicated in outbreaks and they too move through a variety of supply channels. Finally, jarred peanut butter and dry, packaged peanut/spices were included “to enhance the complexity of the pilots,” according to IFT.
IFT convened a group of federal, state, and local traceback investigators to establish an historical “baseline” of the time and effort involved in various investigations. In all, 45 food industry participants voluntarily submitted data to be analyzed in the pilots. IFT also selected 10 technology vendors from companies that had volunteered to showcase their capabilities using blinded pilot data. Deloitte Consulting and Auburn University helped conduct cost-benefit analyses. “This was not a laboratory experiment,” recalled Jennifer McEntire, PhD, a senior director at Leavitt Partners’ food safety practice who worked with IFT on the pilots and coauthored the final report. “We simply didn’t have the time to ask people to implement hardware, software, or procedural changes within their facilities. We assembled a diverse group of about 45 industry members and worked with the records they had, and examined the systems they used for recordkeeping,” Dr. McEntire wrote in a March 7, 2013 blog posting.
Using current technologies to analyze company-supplied data, IFT found that it was “tedious and difficult” to sort through hundreds of pages of documents. IFT also found that confusion arose when data definitions were lacking; delays occurred when item descriptions were inconsistent or wrong or when information was incomplete; and sources were hard to identify because companies often went by different names. The pilots highlighted many areas for improvements and in its final report, submitted to the FDA in August 2012, the IFT made 10 recommendations. They include the following.
Uniform recordkeeping requirements. FDA should establish uniform recordkeeping requirements for all FDA-regulated foods and not permit exemptions based on risk classification. While FSMA restricts FDA recordkeeping requirements to high-risk foods, the IFT anticipates that confusion will arise if companies maintain different standards. GS1 US’s Fernandez explains why. “If we have to maintain dual processes based on high-risk and non-high risk foods, people will have to have multiple methodologies in place. One-size-fits-all can be more efficient. It will also address future scenarios: A food is non-high risk only if it hasn’t been subject to a recall. If a new non-high risk product does get recalled, we won’t have to change tracing processes for it,” she said. This recommendation “bubbled up” from industry itself, Dr. McEntyre adds.
Product tracing plans. FDA should require each member of the food supply chain, regardless of its size, to develop, document, and exercise a product tracing plan. While product tracing plans are currently not required by federal agencies, some companies have them as best practices, IFT says. Product tracebacks are different from product recalls in that the details of the product of interest in a traceback are not known. Having and exercising a product tracing plan “will increase the speed with which a firm can respond to an investigation and reduce the likelihood of errors,” IFT says. And while FSMA limits the FDA’s reach in seeking data to “one up, one back” in a company’s supply chain, the IFT recommends the agency should request additional information from companies in hopes that “capable supply chain partners” will have the extra information and will make it available.
Standardized, structured, electronic recordkeeping. FDA should develop mechanisms for industry to provide key data elements (date, time, item, lot, or batch number) and critical tracking events (transportation or exchange of goods, transformation or creation or manipulation of products, and depletion or exit from system) during a specific food safety investigation. “The pilot project verified that if all the information is stored electronically, the tracing process can be sped up significantly compared to having to manually go through paper records and manifests by hand,” says Ed Treacy, vice president of supply chain efficiencies at the Produce Marketing Association (PMA). “Electronic records could be Excel spreadsheets. This should not be a burden on companies as there are very few companies that do not use computers in their business,” he tells Food Quality & Safety magazine.
Nevertheless, while having data in electronic format would be ideal, IFT believes industry shouldn’t be required to maintain electronic records, especially since small and large firms have different needs and capabilities. However, providing data in a standardized and structured way may be required of all companies, says IFT. In the baseline study, most traceback records consisted of printed and handwritten documents sent by fax to regulatory agencies. In the pilot studies, most records were submitted in Adobe Acrobat pdf format. But even then, a pdf of a handwritten note could not be analyzed in a structured and standardized way, the report noted.
“The key point is, different size companies in the food chain are going to capture and hold that data in different ways,” says Fernandez. “Not everyone has robust databases and electronic capabilities, but if they can make sure their records are capturing those elements around a product or transaction, however they choose to do so, that is going to help FDA when a product is identified around a possible outbreak.”
Technology platform. FDA should adopt a technology platform that will allow it to aggregate and analyze data reported in response to a specific request. Such a secure platform could be a central repository of information for investigators and for other regulatory agencies. It could reduce the need for companies to send their data to multiple agencies. Because such a platform would require submissions in electronic format, it may not become a requirement, Fernandez notes. “But some of the larger and mid-size firms do have these electronic records and it could definitely help in doing a traceback,” she adds.
Other recommendations. FDA should clearly identify the types of data that industry needs to provide during an outbreak investigation; coordinate traceback investigations and develop response protocols between and among state and local health and regulatory agencies; and offer extensive outreach and education around future regulations and expectations.
Costs and Benefits
The IFT report devotes 57 pages to cost-benefit analyses but determines that conclusions are not possible to draw because the pilots were narrow and represented, by definition, “an artificial view of reality.” Nevertheless, the report described several companies that had instituted traceability technologies. For example, a small produce grower in Mexico who shipped 100,000 cases annually installed a barcode tracking system. First-year costs, including equipment and installation, totalled $5,500. The company estimated ongoing annual costs of about $1,500 plus a half-cent per label. “That’s not bad at all,” says PMA’s Treacy. While other larger growers, producers, and shippers have spent anywhere from tens to thousands to millions of dollars implementing advanced control systems, these are large systems not specifically installed because of FSMA.
Overall, GS1 US, the PMA, and other members of the Produce Traceability Initiative (PTI) were highly supportive of IFT’s recommendations. “Many of us in the grower/packer/shipper community are pleased to see that the IFT recommends a uniform set of recordkeeping requirements, encourages current industry-led initiatives, and suggests the development of standardized electronic mechanisms for the reporting of traceability data,” said Sabrina Pokomandy, marketing and public relations manager for JemD Farms and cochair of PTI’s Communications Working Group, in a statement. “These recommendations are in alignment with the goals and vision of PTI and help us move forward with industry-wide traceability implementations.”
To submit comments on the IFT report, go to www.regulations.gov and enter docket number FDA-2012-N-1153-0002. Comments are accepted by July 3, 2013.
Agres is based in Laurel, Md. Reach him at email@example.com.