Health Law

A question about the FDA's Reportable Food Registry

By Marler Clark

 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 resutls 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.  

Full post as published by Food Poison Blog on September 09, 2009 (boomark / email).