New traceability rule just dropped
Alexa, play Hall and Oates, "Private Eyes"
On Nov. 15, the FDA announced a final rule to improve traceability for contaminated food in the food supply. The rule is part of the “New Era of Smarter Food Safety” initiative that builds on the advancements of the Food Safety Modernization Act to rethink how FDA does food safety. (Interestingly, this initiative was supposed to roll out in 2020, but then the FDA got occupied with COVID, so it’s just now being implemented).
Traceability, like foreign matter contamination, seems pretty straightforward - you should have the ability to know where the thing you’re eating came from, or, at the very least, the FDA should be able to know where the thing that made you sick came from. But as any historian of food and agriculture can tell you, this exact challenge has bedeviled consumers and inspired marketers since at least the Progressive Era. Today, while companies now have internal mechanisms to trace individual ingredients and products that go through their system, much of that is obscured for the average consumer.
“Traceability” is an obvious weak link in the U.S. food system, especially in comparison to the farm-to-fork strategy of the European Food Safety Authority (Country-of-origin labeling is a related form of traceability, albeit for an entirely different purpose.) I and other scholars have attributed the European emphasis on traceability and the American emphasis on risk mitigation to historical differences in food safety scandals in the 1990s. The simplified version is that identifying the source of localized food safety outbreaks in Europe, particularly mad cow disease, proved crucial to eventually controlling those outbreaks. While traceability was important in American food safety scandals, such as the Jack in the Box E. coli outbreak in 1993, much more emphasis was put on implementing procedures to control and reduce the number of pathogens, for example, than understanding exactly which cow had E. coli, which by the end of the outbreak mattered very little. (Differences in the legal landscape matter here as well; in the U.S., tort law has proven to be an effective, if tragically necessary, means of holding companies accountable for the hazards of foodborne illness).
I often hear talk of the need for more traceability in conversations about livestock production in particular. In that space, traceability offers the potential for consumers to learn more about a whole range of issues not traditionally associated with food safety (animal welfare, working conditions in plants, etc.), but that nevertheless remain very important. An extreme version of traceability would be the Portlandia “is it local?” sketch, where you can visit the farm your chicken was raised on. The bad thing is that much of the U.S. food system isn’t set up for this in any meaningful way, and in fact, products like boxed beef and convenience foods specifically combine products from multiple locations or creatures into a single food item that can then be distributed equally widely.
As I mentioned in my posts about the formula recall, we want to imagine FDA as all-seeing and all-knowing. But, as I note in the book I’m working on, even the USDA, which posts inspectors in every plant (with exceptions for processing and further processing plants), is very limited on what they can “see” in part due to the way the laws were written. In a food system as complex as the one we have, where it’s arguably both impossible and ineffective to open every box or check every chicken nugget, food safety regulators have to come up with new approaches.
Hence, this new Food Traceability Final Rule, which hit the Federal Register today! The rule requires additional recordkeeping - and therefore, data - on foods that may pose greater risks to public health. You can see the full list of foods here, but my reaction when I looked at this list? Well, of course. In general, it’s a good rundown of foods that have historically been identified as higher risk — such as “finfish” (which is a technical way to describe what most Americans would call “fish”), soft cheeses, and oysters — and some foods that have more recently been in the news as the source of very scary food safety recalls (I’m thinking here of nut butters, leafy greens, sprouts, and melons).
Apparently this list has been in development since 2014, in response to a requirement baked into the Food Safety Modernization Act that requires FDA to develop such a list. This long and winding process of regulatory change started when the agency published a request for comment on their draft approach to designating “high-risk foods.” For the real nerds, there is an online tool you can use to explore the risk-ranking process that the agency eventually used to determine which foods were higher risk.
So what’s involved in “additional recordkeeping?” In plain language:
Required tracking of important data (“key data elements”) at important moments in processing and shipping (“critical tracking events”)
Use of a barcode or similar (‘lot code’) that follows the item from start to finish
Creation of a “traceability plan,” which includes a list of processes, procedures, points of contact, a farm map (!)
All records must be preserved in forms that prevent data loss, and must be in forms that can be made available to the FDA within 24 hours.
While this currently applies only to the higher-risk foods on the list, it seems plausible to me that this approach will gradually be expanded to lower-risk or all foods regulated by the FDA (as a reminder, that’s mostly everything except beef, pork, poultry, and catfish). At least from my vantage point, this seems like a major step forward. But it remains to be seen whether these new requirements will improve the agency’s ability to respond to recalls, or just create the perception of “red tape” and raise the ire of food processors. It’s also possible that some of these expectations are already required for other certifications or vendors, so this may not actually be that much extra work.
It does make me think back to the letters I read in the LBJ Library, written by fishing trade associations who opposed the creation of a Fish Inspection Act. I wonder what they’d think about all this.
Thanks for reading, and have a happy Thanksgiving! I haven’t seen any recalls of cranberry sauce this year, so that’s good.