For months now, there have been growing signs of the determination of the Obama Administration to engage the FDA as never before in the prevention of risk – on food, drugs and devices. The latest iteration of this came today with the announcement by the agency of a new Reportable Food Registry.
The Registry is a product of recent legislation giving the FDA new authorities over the regulation of food safety. The Registry is an electronic portal through which the food manufacturers or processors must report a "reasonable probability that an article of food will cause severe health problems or death to a person or an animal."
Clearly that language is inspired by two recent safety occurrences – first the widespread presence of melamine in pet food
that is thought to have harmed untold numbers of dogs and cats in the United States in 2007. That resulted in a widespread recall
as well indictments and the filing of charges
against those alleged to be responsible – developments that did not get the widespread headlines won by the actual contamination and for which the agency did not get due credit. The other involved the great peanut scandal of 2009, to which there were many arms and legs, but one that stood out – Westco Fruit and Nut Company
. The company was asked to voluntarily recall its product and the company refused. The FDA seized product and one other company involved, the Peanut Corporation of America went bankrupt. So widespread was the contamination that the FDA created a widget
that one could download and put onto another Web site, a thoughtful and innovative tool.
According to the FDA, the requirement for manufacturers and processors to report contamination applies to all except for infant formula and dietary supplement producers who already have their own set of requirements.
If indeed manufacturers report, this requirement should shorten the span of time by which the FDA can act.
But one has to stop and ask oneself a few questions about how effective the new registry may be.
First, a manufacturer or producer is not required to report the problem if it is discovered prior to shipping and actions were taken to correct the problem. That sounds reasonable, but in the case of salmonella presence in produce, many manufacturers do not have in place systems that would allow them to trace and identify whether stock moved on and where, making it unclear what they should report as it is unclear what they actually know.
Secondly, what is a "reasonable probability" that a food might cause severe health problems or death? Certainly the presence of melamine or salmonella, but what about pesticide levels? What is reasonable? In its Guidance and Q&A on the matter
, the FDA says that anything that would trigger a Class I recall would be covered. Does every manufacturer know what that is?
And lastly, would the folks who brought us melamine in pet food and were indicted or the people who refused a voluntary recall or knew they would face bankruptcy really be likely to report their contamination concerns in the electronic portal, or would those disasters have happened anyway. It may not be possible, in the end, to regulate away greed and malfeasance.
Certainly the portal is a step in the right direction, but is one step in a much longer journey.