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IFT found challenges associated with each of the three main components critical to product tracing: accurate recording and storage of information on incoming products and ingredients (external tracing), tracing of ingredients and products within a facility (internal tracing), and accurate recording of information pertaining to products leaving a facility (external tracing). Given the nature of the information recorded at each of these points, it would be difficult to trace a product through the supply chain. Depending on the industry and the facility, the practices described in this section made linking the information pertaining to a specific product difficult or impossible.

Given the relatively small number of participants, the extent of commonality of key issues that complicate or prevent traceability observed across all sectors was striking. Appendix H. presents the results of poll questions, and analysis of responses, that were asked during an IFT webcast on traceability in January, 2009. Most traceability issues seemed to center around which data are recorded, the way in which data are captured, and the way data are exchanged within a facility and between trading partners. Overall, enormous variability in practices among the

representatives of the different sectors of the food industry was observed, and these differences were often not correlated with product, facility size, and other important distinguishing factors.

Data Recording – What is Recorded

A lack of consistent or complete information on existing paperwork, including the lack of unique identifiers, hinders the depth and precision of product tracing. If documents such as invoices, bills of lading, purchase orders or others are used, they often have dates, but may not have lot numbers or some other unique identifier, making the information often non traceable, or at most, traceable one step back or forward only.

Frequently companies mentioned the lack of certain key definitions as a challenge. For example, in manufacturing, the definition of batch or lot may vary; in warehousing/ distribution this term becomes convoluted with the assignment of internal “lot IDs” as described above.

Throughout the course of this task we found that at times, incoming lot numbers, even if available, are not recorded for a variety of reasons including “I don’t understand what they

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mean.”, “There is no standardization.”, and, “If I have a problem, I expect the supplier knows what he sent me.” Many companies expressed a concern that having to read each lot number on a case could slow down production and there was the same concern with having to read lot

information for products being shipped.

Many companies assign new internal “lot” numbers to materials received, and incoming lot numbers are often not linked with the newly assigned numbers. For example, if a pallet contained cases with different lots, the new number represented all lots (so it is impossible to differentiate between them). This practice was prevalent in all parts of the food industry—from ingredients being assigned a code by processed food manufacturers to warehouses and

distribution centers identifying and selling items based on an item number. The way in which internal codes are assigned and level of sophistication ranged from handwritten records to bar codes to RFID tags. A uniform encoding system that begins at the grower level should eliminate the need for assigning new internal “lot” numbers; however, the practice may be hard to break. One distributor mentioned that even after the PTI is implemented, they will continue to use item numbers since they are part of their accounting system, and are the numbers used by customers to order products.

This task required the examination of tracing to the point of sale and point of service. Therefore, we considered the limitations and benefits to labeling and tracking individual items sold to the consumer. Currently, there is a lack of product labeling that allows the transfer of key data elements. Information that identifies the product may be on paperwork but not on the product itself (although the availability of lot numbers on processed, packaged foods was high). Moreover, small packages may not have available label space and products such as loose

produce are often sold without a label, so their ability to be traced back is lost at the point of sale. Even if information was available on the individual consumer item, retail outlets cannot currently capture lot-specific information during transactions with customers.

Data Capture - The Way in Which Data are Recorded

The data elements shared between trading partners that vary from company to company. Since the expression of information on paperwork is not standardized, acceptance by electronic systems, especially those used by trading partners who may not be able to decipher or interpret the information, is difficult. Some data elements are machine or computer generated, and others are handwritten on documents. Without the use of consistent standardized data elements that must be recorded, the type of information that is ultimately captured is unable to pinpoint a particular product’s movement or characteristic and is lacking in precision.

IFT found a prevalence of companies who use paper documents to record information, rather than electronic records. Many companies also use a mixture of both paper and electronic recordkeeping. Concerns with paper records include accuracy (transposition of numbers and other human errors) and the lack of speed (can’t query; difficult to manually record information legibly in high throughput operations). Costs associated with electronic systems were often cited as a key concern and perhaps a reason why more companies do not use this form of

recordkeeping. Companies IFT spoke to mentioned the cost of changing IT systems, training people and purchasing hardware, and of “slowing down” an operation to switch to new software

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or to capture or provide additional information. Details can be found in Section 10.5.1 and in the Economics Report (Volume 2).

Data Exchange

Within companies, multiple electronic systems may be used that often can’t communicate (batching vs. warehouse management [WMS] vs. accounting systems). Furthermore, there were often no links between information received and shipped from facilities, causing a lack of internal tracing at companies.

Electronic systems were found to often have limited interoperability, prohibiting internal and external tracing. Legacy systems are prevalent, especially for large manufacturers who have acquired many companies/facilities. Custom systems which are designed in-house, often at large companies, are also prevalent. Making modifications to “off the shelf” systems is expensive so many companies avoid this route.

It was clearly conveyed that companies feel they are responsible for one-step forward, one-step back records, and that they are not responsible for knowing who supplied their supplier, or who bought from their customer. They clearly expect that their suppliers and customers (respectively) also keep one-step forward, one-step back or beyond records and therefore know where the product came from and went to.

There are several ways that trading partners communicate with each other and exchange

information. Many use electronic methods, such as advance shipping notices (ASN). Third party systems are also used to conduct business transactions. Although these systems exist, they are seldom used to transfer data elements important for product tracing, such as lot. Instead, the purpose of ASN is inventory control, and financial transactions aid in accounting. However, it seems that these systems can be used to exchange additional information.

Accuracy of Records

Quality of data, such as accuracy due to falsification of information to meet requirements/quotas and readability, may also be issues. When individuals were asked about accuracy of records, it was clear that manual entry of information could cause errors. Since manual capture of data is very common for all sectors interviewed, the potential for human error is high. For example, a bilingual workforce could potentially transpose month and day due to cultural differences. While Americans typically think 01/02/09 means January 2, 2009, people from Latin America, Europe and other regions in the world may interpret this as February 1, 2009. This lack of international uniformity in date expression can result in inadvertent “changes” in shipments out of first-in, first-out (FIFO) and may alter data capture and/or recording.

It was difficult for most individuals to quantify inaccuracy of records, but when a number was offered, it was typically around a 5% error rate. These errors ranged from transposing dates, to incorrect country of origin, to incorrect identification of a product. Companies were quick to point out that they check for these types of errors and require prompt correction (or else they reject a shipment) on incoming products/ingredients.

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First in, first out (FIFO) was often used for shipping in various segments of the food industry, such as distribution. FIFO is not a reliable system, especially for produce, because although it is generally adhered to as a default, sometimes customers know there is fresher product and insist on it, so that there is “lot jumping”. However, FIFO is specifically not used in repacking operations.

Other Common Issues

There seems to be a lack of understanding of the core elements of a product tracing system, and education around this issue might be useful. There is also concern over who the legal owner of data is and who is responsible for providing the data to FDA in the case of a request. The Bioterrorism Act limits FDA’s ability to review records to verify that they are kept, and

companies also noted FDA’s lack of enforcement authority in foreign countries. Enforcement of the current recordkeeping requirements is an issue, as evidenced by the following testimony Tom Stenzel, of the United Fresh Produce Association gave to the US House of Representatives: “We know of no instances where FDA has taken any regulatory action to cite a produce company or its customers for failure to provide adequate records as required by the Act.” … “I recommend that we urge FDA to enforce the current law before we all call it a failure. If in an outbreak situation FDA finds companies not in compliance, then take action. Take highly visible action. That’s what signals the importance of proper behavior to those in any industry who might be inclined to cut corners. And, if FDA needs additional authority to ensure that companies are in compliance before an outbreak, that should be part of the solution” (Stenzel, 2009).

There is no standardized format for product tracing information to be communicated between trading partners or submitted to FDA which increases the lack of interoperability between

various systems and records trade partners may use. This, in turn, increases the amount of time it takes to sort through various forms of information to find what is most useful during the course of a traceback investigation. It would be helpful for many companies to know exactly what information is most useful to FDA and other regulatory authorities, and therefore what they should focus on recording.

Small operators may have limited infrastructure (e.g., no IT staff) to record and manage data electronically. They are also more likely to have cash transactions and may not keep detailed records of these transactions. They are also more likely (esp. foodservice and retail) to shop at membership stores, such as Costco and Sam’s Club, to add to their own supply which limits their one-step back records.

Those who conduct mock recalls told us that could trace product in a relatively short period of time (typically minutes to hours). This is much more rapid than what is often observed during a traceback investigation. Upon further probing, and as a result of input from the food industry subpanel, it became clear that the “minutes to hours” estimate, although true, did not always represent the complete practices that were followed when a regulatory authority requested information. A few companies reported that they would locate and secure paper forms of

documentation to verify what the electronic trace told them (in the minutes to hours timeframe). This “double check” took substantially more time.

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Practices, issues, and other findings specific to each segment of the food industry interviewed are outlined below.