Unfinished Business: Answering Your Questions About F&B Traceability

By Sam Lewis

Food Online and the Grocery Manufacturers Association (GMA) hosted a live web chat, Food For Thought: Everything You've Ever Wanted To Know About Traceability But Were Afraid To Ask. In this 45-minute live Q&A, Jennifer McEntire, Ph.D., vice president food safety & technology at United Fresh Produce Association joined Kristen Spotz, senior manager of food safety & quality assurance at GMA to talk all things traceability related to the food industry. While the session was educational and informative, there wasn’t enough time in the session to answer every audience member’s questions. Here, Jennifer and Kristen address the unanswered questions from the live web chat.

View the entire web chat  or read part one, part two, and part three of the web chat

Food Online: Bob is asking, “Does FSMA and or the FDA require traceability SOPs? We know they want the ability to recall product, but do they have specific guidelines for traceability?” He is also asking, “How to address assembled items, such as combinations of confections, or variety packs of snacks?”

Spotz: FSMA’s Preventive Controls for Human Food rule does not specifically require traceability SOPs. This rule does require a written recall plan for facilities that have identified a hazard requiring a preventive control. See section 117.139 of FSMA’s Preventive Controls for Human Food rule for requirements of the written recall plan.

McEntire: No. Currently, we’re still working under the 1 up/1 down regulation stemming from the Bioterrorism Act of 2002. However, the FDA does have the authority to require additional records for traceability of high-risk foods, so stay tuned!

Production/ assembly records should be able to show which “ingredients” (e.g. each variety of a snack) were packed together to form the finished unit, which should have its own unique identifier (batch or lot number, expiration date, etc.).

Food Online: Kristal is asking, “Can you give some information or suggestions on how to deal with brokers and distributors in terms of traceability?”

Spotz: The facility might need enhanced (more than one up and one back as required by the Bioterrorism Act) visibility in the supply chain if an entity further back in the chain controls a hazard. However, there are options in the preventive controls rule that others, in addition to the receiving facility, can perform the supplier verification activity.

In general, I think the brokers and distributors will see that receiving facilities are requesting more information and ultimately want more visibility to the supply chain as they want to ensure that supply chain risks are adequately managed. Your company will not be the only one requesting more information. The marketplace will ultimately demand more transparency.

McEntire: If you are subject to FSMA’s Preventive Controls rule and your hazard analysis shows that you need a supply chain control, you need to be able to identify the entity in the supply chain controlling the hazard. Brokers/distributors need to understand that you need that information in order to be in regulatory compliance.

Food Online: Alan is asking, “Regarding supply chain traceability, we are now having customers asking to go further back to our suppliers/farmers. Is that where FSMA is requiring from the end user?”

McEntire: It depends: If your customer is subject to FSMA’s Preventive Controls rule and their hazard analysis shows that they need a supply chain control because an entity (farm or facility) earlier in the supply chain is controlling that hazard, then they do need visibility back to that entity in the supply chain controlling the hazard. It’s based on the hazard analysis and does not necessarily apply to all suppliers; it also isn’t related to FSMA’s traceability provision (we are still waiting to see how the FDA addresses that part of FSMA).

Spotz:  As part of FSMA’s Preventive Control for Human Food rule, a facility might need to go further back in the supply chain to understand the entity that is controlling the hazard. However, the rule did not codify a specific requirement around traceability. It is important to recognize that customers might have certain requirements for doing business with them and this can be very different than requirements codified in FSMA.

Food Online: Roderick is asking, “How should we address bulk tanks, such as bulk oil tanks where we pump oil from railcars without emptying?” He is also asking, “What's an acceptable percentage of trace in regards to mass balance?”

Spotz: A facility still should be able to determine the volume of oil pumped from the rail car based on the flow-rate and speed of the pump. This volume of oil was than likely used as an ingredient to produce a certain yield of finished product. The goal with traceability should be to trace and account for 100 percent of the product (taking into account waste and scrap, plus the amount of finished product produced).

McEntire: You’ll want to have some identifier associated with that rail car and know when you began pumping and stopped pumping from it and relate that to how the product was used.

Regarding mass balance, you should work with your engineers to determine what is reasonable (e.g., how much residue is expected to remain). Clearly you want to be able to account for 100 percent of product, even if you know not all of it was used in product.

Food Online: Aubri is asking, “What about traceability for green coffee? We can go one back, but they can't sometimes. How do you feel about suppliers who don’t necessarily have thorough traceability due to the nature of the supply chain?”

Spotz: There could be a risk in using suppliers that don’t have thorough traceability or cannot identify or don’t have visibility to their supply chain. Traceability for certain commodities can be especially challenging. However, even in the case of raw agricultural commodities, there could be issues such as pesticide application and water quality for which visibility to the supply chain, while difficult, is important. Using suppliers that don’t have visibility to their supply chain could represent a risk.

McEntire: Supply chains can be complicated. Determine whether you need to go more than one back. These decisions should be risk based.

Food Online: Ben is asking, “In making the case for an investment in stronger traceability systems to executive management, what is a typical return on investment in a traceability solution? And what data or evidence should you present them to make your case?”

Spotz: The return on investment for more robust traceability systems can include enhanced supply chain and inventory control and greater market access. For example, some customers, as a requirement for doing business with them, might have more requirements around traceability for which investments in system improvement might make this customer requirement more obtainable.

McEntire: The IFT Global Food Traceability Center developed an ROI calculator. It is aimed at seafood, but is applicable to just about any food product. Check it out to understand how different variables in your operation will impact the ROI and how you can be present your case for investment in enhanced traceability capabilities.

Food Online: Another question from Ben, “How necessary is it to exchange data on the GDSN in traceability efforts?”

Spotz: GDSN, Global Data Synchronization Network, enables trading partners to globally share product data. However, there is no regulatory requirement to exchange traceability data on GDSN.

McEntire: There is no regulatory requirement. Companies should work with their supply chain partners to determine the best way to share standardized data.

Food Online: Kyle is asking, “How many traceability software products are out there? How different is each one from the next? Are there some which would be more of a fit for supermarkets/grocers versus distributors?”

Spotz: There are hundreds of traceability software products out on the marketplace and each offers its own advantages and disadvantages. The key should be that the program/software for traceability is easy to use so that the data can be readily extracted from the system in the time of a crisis such as a recall. In addition, the traceability software should “talk” to other business systems used at the facility.

McEntire: There are many types of solution providers who have different features and target markets. Any company considering making an investment should determine what they want the system to do BEFORE reaching out to any technology providers.

Food Online: Bob is asking, “Some retail stores, such as club stores, have point-of-sale records and can in fact trace a suspect lot code to customers. Do you see this as a future trend for traceability?”

McEntire: Right now, some retailers can track purchases based on SKU/PLU, but not at the lot level (because your average bar code can’t carry this information). However, there are other types of barcodes that can contain this information and moving forward people are exploring how this can be leveraged.

Food Online: Juan Manuel is asking, “Would you say that, at least in theory, it should be possible to design the traceability program or plan at the very early stages of product development, let´s say at the time the QFD is being done? If affirmative, how would you describe the process of identifying the traceability steps and which could be the best way to test the finished plan? via a mockup recall for example?”

Spotz: Yes, it is definitely possible.  Traceability should be considered as an input in the design process. A mock recall can be used to test your traceability system Remember that a traceability exercise is one component of a mock recall.

McEntire: Yes. During the product development process, you have the opportunity to identify Critical Tracking Events during the process/flow diagram. Truly testing the system involves more than selecting a lot code (finished product or raw material) and tracing it forward and backward, but that is certainly a good place to start.

Food Online: Javier is asking, “We receive COAs and sometimes the lot codes are dates of manufacture. A butter supplier has 2015 11 09 printed on the packages. The COA states 11/09/15, we have asked the manufacture to put the Lot Codes on the COA same as it is on the boxes and they refused. I asked them which number/date arrangement they use for recall/traceability purposes and they have not responded. Is there any standard on this, we want to use the Lot Code that is on the boxes of butter?”

Spotz: There is no regulatory requirement for the format of the lot code. There are industry leading practices and perhaps customer requirements for the format of the lot code and/or date code but there is no regulatory requirement.

McEntire: There is an ISO standard (8601) for dates, but it is a voluntary/industry standard, not a regulatory standard. The issue you describe is common and it will require alignment of the industry to develop a commonly-accepted practice. Is 11/09 November 9 or September 11? It depends on which part of the world you are in, and that can be problematic!

Food Online: Who will determine the resolution of traceability regulations domestically and worldwide and when is it likely to happen? The current method then was insuring knowledge of one step forward and one step back — is that still the process currently?

Spotz: The FDA has the authority, under FSMA, to issue rules requiring additional traceability recordkeeping requirements for foods deemed by the FDA has high-risk. So far we have only seen FDA’s draft approach and their final approach is yet to come. With regard to a worldwide approach to traceability this will likely be an industry-driven initiative.

McEntire: Yes. One forward/one back is still the current process. In terms of changes domestically, the FDA has the authority to require additional records, but has not yet acted on that. The agency is somewhat limited in what they can ask for, as per FSMA.

Internationally, ISO 22000 (and 22005) deliberations have discussed changing the traceability standard but this has not yet happened. Within GFSI, the standard is no more challenging (although some schemes assign timeframes within which information must be retrieved). Any revolutionary changes will probably be industry driven, rather than driven by regulations.