On Tuesday, the FDA certainly took a step in the right direction by implementing the Reportable Food Registry, under federal regulations codified at 21 USC 350f. The FDA’s action essentially requires any food producer who knows of a microbial risk (e.g. bacteria or virus that can make you sick) in a food it produced, processed, packed, or held to report the problem to the FDA via the Reportable Food Registry. As a somewhat necessary evil in drafting legislation or binding regs, the FDA regulations contain some big words that will, unfortunately, leave dedicated compliance to the food producer.
Actually, I use the phrase "food producer who knows of a microbial risk" above more than a little loosely. The actual wording, set forth at 21 USC 350, requires a food producer to report "an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals."
Well, what constitutes a "reasonable probability?" I can think of more than one instance where a food producer, either in PR statements or through their attorneys in litigation, has offered the excuse to liability that "so and so’s E. coli [or any other pathogen] positive stool sample was only presumptively positive." In other words, initial testing detected the presence of the bacteria, but the bacteria was not conclusively (more loose words) identified as the pathogen de jure by further confirmatory testing.
The problem would unfold under the Reportable Food Registry very simply . . . something like this: lettuce producer A generates a positive test for Salmonella in a certain lot of product intended for shipment to grocery stores. Producer A’s positive test came from its own private lab, or any independent third party laboratory–doesn’t really matter. Producer A does not report the initial, presumptively positive test because it believes, realistically or not, that a presumptive positive does not constitute a "reasonable probability that the use of [the lettuce] will cause serious adverse health consequences." After all, it’s only a presumptive positive, not confirmed as something dangerous until the confirming test occurs.
Well, in this example, the confirming test does, in fact, occur, and it does, in fact, confirm that the bacteria that looked liked salmonella, walked like salmonella, and talked like salmonella was actually . . . salmonella. In the meantime, the product has been shipped and sold by the grocery stores. Consumers have eaten it and become ill. Producer A does finally report the confirmed positive test, but not until after all the damage is done.
I will point out here that this is not an impossible scenario. Just last month, a strange sequence of events occurred where more than two weeks passed after a positive test until Melon Acres farm recalled cantaloupes that it had received a salmonella-positive test on. Now the situation is not identical, but it illustrates the point that delays in testing, and reporting the results of tests, are not unheard of. I’m sure we’d all be shocked to know how many positive tests actually occur on the food we consume generally.
And lest we forget, we’re only a few short months removed from the massive salmonella outbreak associated with peanuts from Peanut Corporation of America. If you’re reading this, you’ll no doubt recall that PCA did not report or recall lots of product for which it received an initial positive test result for Salmonella. Read this for a brief refresher on this despicable situation.
In the end, just like the ultimate responsibility for producing safe food, the onus will rest squarely on the shoulders of the food producer to take necessary action to prevent people from getting sick from a product that the producer knows, or really should know, contains a microbial risk. I admit to being a little biased, maybe even jaded in my confidence that all producers will fully and honestly discharge their obligations under the FDA’s new regs. Time will tell.
According to the FDA press release: “The reporting requirement applies to all foods and animal feed regulated by the FDA (Excludes all beef, poultry, lamb and swine) …. The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States …. Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal …. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components (So, if companies limit or stop end product testing? What you do not know will not hurt you? Customer’s perhaps?) …. These people are termed responsible parties.” A responsible party:
1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party (So, if your supplier causes the contamination, you need to do nothing?) ….
Here is my major beef with this press release: “A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.” So, if a plant tests a sample of the product, but has not yet shipped it, no reporting required? Consider this, sample product testing does not assure that the product is NOT contaminate, only that the sample is. Sample product testing is a method of testing whether your manufacturing process is working. So, if you are getting positive sample tests, you have a problem – a problem that does not need to be reported? A few years ago, we had a case where a manufacturing facility tested end product for E. coli O157:H7 and found positives – for 30 days in a row. The company retained and destroyed those tested lots. However, it was a very small portion of a day’s production. Guess what happened? But, no reporting required?