Supply Chain Traceability

The U.S. has been rated as “Average” in its food traceability regulations and practices, listed as “trailing most other countries” and falling well below the “Superior” rating of the countries of the European Union. Although the 2014 report from the Global Food Traceability Center (GFTC), which rated 21 countries, acknowledged the expectation that FSMA will improve U.S. food traceability capabilities, it added as well that this development is still in its early stages. (See a summary of the report results in Traceability Ratings by Country, table below.)

Whether or not one is in complete agreement with the report results, it is undeniable that the current “one forward/one back” traceability requirements of the U.S. need improvement, particularly when considering the increasing global nature of the food system and the complexities this entails for tracking and traceability of food products.

Sparta Systems Director, Product Marketing Kelly Kuchinski sees the report as being very accurate in its assessment of U.S. traceability systems, but, she said, even the European Union, with its “Superior” rating, is not perfect—one need simply recall the horsemeat in beef scandal of 2014 to see this.

Additionally, Kuchinski said of the U.S., “I see of lot of changes going on in the industry now” for which she sees two primary causes:

• FSMA – Although it took a terrorist attack on U.S. soil for the country to wake up and see something needed to be done, major food safety regulation changes are underway. However, Kuchinski said, there is some industry hesitation in implementing new processes because the traceability regulations have not been proposed, and the industry knows that FDA is unlikely to have the resources for full FSMA enforcement.
• Globalization – Because of the increasing globalization of the supply chain, Kuchinski said, “Businesses are losing a lot of control and visibility into their quality systems. Most can do one forward/one back, but after that they lose sight of it.”
   

A Risk-Based Approach.

DNAtrek Founder and CEO Anthony Zografos also sees this lack of visibility as an issue. Because of globalization, a finished food product is likely to have gone through 12 to 16 nodes along its supply chain, Zografos said. And the expectation is that there will be even more in the future because the complexity of the food supply chain is growing exponentially. As such, he said, the systems currently in use will not be able to provide the depth that will be needed for effective traceability.

As such, Zografos believes the industry needs to address supply chain traceability in a risk-based way. “We don’t need to trace through the entire supply chain,” he said. “We need to trace back to the highest risk nodes—not necessarily all the nodes.” To do this, we need to identify not only high-risk foods, but also high-risk points in the chain. As an example for produce, he said, “Is there risk at distribution? Yes, but it can be miniscule compared to risk in the field.”

Once the high-risk nodes are identified for a specific product, a recall or contamination traceability process can start with those nodes that were identified to be of highest risk, then move to lower risk nodes until the source is identified.

Kuchinski also sees such a risk-based approach as viable in supply chain management. To improve quality management verification of the supply chain, manufacturers could implement supplier score-card programs. Within the tracking system, each supplier in the chain would be assigned a risk level, then risk-based audits would be conducted based on the risk level. Those that are not assigned a high-risk level would still be audited at least once every three years, she said.

However, with today’s technological advances, suppliers need not be visited in person even when an issue occurs. Rather, systems that operate through secure cloud platforms enable real-time assessments through which a supplier’s processes and changes can be identified and issues tracked down. However, if an issue is repetitive, Kuchinski said, then it would be advisable to visit or at least discuss the issue in person.

Even when risk-based programs are applied to a supply chain, item-level tracking would be necessary and would need to be regulated and enforced—or at least standardized with collaboration between suppliers, processors, retailers, and regulators. As a prior industry marketing manager for GS1, Kuchinski said, “I understand the importance of standards, especially across a supply chain.”

Additionally, she said, the food industry can learn some lessons from the pharmaceutical industry, which is required to track to the item level. There must be a serial number for each item when it is packed and the numbers recorded at each level, Kuchinski said, “So when it is unpacked and resorted, each item has genealogy.”

One of the issues with this, however, is that pharmaceuticals are high margin, so the companies can afford to implement such systems, whereas most foods are low margin, so it would be more difficult for the companies to implement such systems. But, Kuchinski suggested, foods could be done to the pallet level.

EMA.

As evidenced by China’s melamine contamination of baby formula, the EU’s horsemeat in beef incidents, and ongoing issues with adulterated olive oils, detection of economically motivated adulteration (EMA) needs to be considered in traceability initiatives as well. “You need to have something in place to ensure there is no counterfeit product in your supply chain,” Kuchinski said.

Current traceability systems will not detect such issues, Zografos said, but “that is an area that needs to be addressed in traceability. Economically motivated adulteration has to be the same as traceability—they all have to be integrated,” he said. It is such a big requirement for a traceability system that, Zografos said, “It won’t work unless we implement a risk-based approach to address those issues.”

Whether discussing EMA or general traceability initiatives, Zografos said that producers he has spoken with don’t have confidence that their traceability systems can actually work and identify the source of a contamination. Rather, he said, “they do it because they have to.” Additionally, he said, because the manufacturers have to recall their product whether they are at fault or not—and face all the economic and brand consequences that that entails, many producers he spoke with saw no value in their existing systems. He does, however, see the FSMA initiative as attempting to bring about a balanced approach to traceability.
 

Electronic Tracking.

Although FDA is still identifying the tracking and traceability requirements that will be incorporated into FSMA, Kuchinski said, food manufacturers should be working now to ensure they have or implement thorough recordkeeping measures, integrating both their own operating procedures and those of their suppliers, to enable them to capture information and react quickly should an issue arise. “Keep all documentation for presentation to regulatory officials and have verification that you know of and are reacting and are preventing issues,” she said.

The Hazard Analysis Risk-based Preventive Controls (HARPC) of FSMA are very much like the HACCP plans that the industry has long implemented, Kuchinski said. As depicted in the infographic (at right), both HACCP and HARPC focus on proactive food safety, identify hazards, and include corrective action. The process differences lie primarily in the identification of critical control points of HACCP vs. preventive controls of HARPC; HARPC’s requirement for a “qualified individual” (which is yet to be defined by FDA); and the timing for re-analysis. Additionally, HACCP is an internal program specific to the plant, while HARPC extends further—up and down the supply chain.

However, we do not yet know if FSMA requirements will require electronic tracing up and down this supply chain. The Act allows FDA to require a product tracing system and additional recordkeeping requirements, but it does not allow FDA to require a specific technology for recordkeeping or tracing.

That said, Kuchinski said, the implication is that manufacturers will need to do electronic tracking, particularly if the pharmaceutical model is followed—or if it is to follow the same path as biennial facility registration for which is stated: “The Secretary (i.e., FDA) may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is five years after the date of enactment of the FDA Food Safety Modernization Act.” [Section 102. Registration of Food Facilities. Section (b) Suspension of Registration (5) Regulations (B) Registration Requirement].

“Since FSMA passed in January 2011, the requirement to submit electronically cannot take effect before January 2016,” Kuchinski said. “The FDA understands that collecting registrations, CAPA information, and other documentation electronically provides a record of submission dates and required documentation received to ensure compliance and completion of the registration process.”

But whether or not electronic tracking is required, FSMA final rules will include tracing legislation, which we can expect to improve the traceability capabilities of the U.S. food industry and, hopefully, in time, move the country up from a “trailing” position to a leading position in the global arena.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.