Grocery Manufacturers Association GMA
FDA-2012-N-0711-0063
Moreover, GMA and the food associations who have joined this letter believe that the Agency should not require any recalls for packaged food products that may contain trace amounts of an undeclared allergen at or below the established threshold as the risk to human health would be extremely low.
This comment alone ought to give the FDA pause in considering
any other commentary from GMA.
Because they are quite deliberately sidestepping any responsibility to allergic consumers by conflating risk to the GENERAL population ('extremely low') and that to highly sensitive allergic consumers (moderate to very high).
This suggests that they genuinely have no compunction about killing allergic consumers-- that some people don't, I don't know--
deserve (?) to be able to rely upon food safety and labels.
The notion that oils are hypoallergenic is also based on sampling methodology which is highly suspect, as the working group tasked with threshold determination back in 2004 rapidly discovered. Those with the lowest thresholds are at greatest RISK OF FATALITY-- not just in a dose dependent manner, as one might anticipate, but in a
non-linear fashion as well.
For those people, there may really not be a threshold above the current limit of determination. I daresay that with sesame, cashew, and peanut in particular, there may not be a threshold above the limit of
detection. What is problematic about ANY establishment of threshold for 'food safety/labeling' requirements is that it is based upon a confidence interval.
That means that SOME of the most vulnerable population (that is, those very low-threshold allergic consumers)
is going to be thrown under the bus. The only real question is--
how many of them?We don't even know the answer to this-- because there has never been a systematic effort to determine threshold for a wide enough swathe of clinical patients. Those WILLING to undergo DBPCFC's are not necessarily a good population sample for the whole population, and good luck getting an IRB approval to do an oral challenge on a
child who has been intubated after a
skin prick test.THAT end of the sensitivity spectrum is an unknown and undefined population. It just is. There's no way to get a good profile of those people without risking death for a few of them in the process.
So the real question is...
how badly do we want to know? What's it worth to us as a community?