FDA, foodborne illness outbreaks and inspections

FDA Must Shift Priorities. By Scott Gottlieb, M.D.
AEI, Tuesday, February 10, 2009

The Food and Drug Administration spent about 10 years to set a standard for how many peanuts needed to be in peanut butter before food companies could call the spread by that name, last amending that "peanut butter rule" in the 1990s.

More recently, a Georgia peanut plant was able to knowingly ship dangerously tainted peanut butter in one of the largest food contamination scares in the nation's history.

How can an agency that spends a decade carefully defining what's meant by the words "peanut butter" allow tons of the stuff to become contaminated with a deadly bacterium and evade detection, even though the foodmaker itself was aware of the dangerous adulteration?

Already, more than 1,550 products--from Little Debbie peanut butter crackers to Wal-Mart bakery peanut butter cookies--have been recalled after eight people died and more than 500 people (half of them children) were sickened. Salmonella had seeped into huge vats of raw peanut butter produced by a single manufacturer, the Peanut Corp. of America, investigators say.

FDA's approach to these two regulatory endeavors--setting the ingredient list for "peanut butter" and ensuring its safety--shows how the agency's priorities are out of proportion.

FDA has an entire office dedicated to debating what claims firms can make on food product labels. For example, when can products with fish oil carry claims that they reduce heart risks, or what defines the "standards of identity" that dictate when crushed tomatoes can be called "ketchup."

These regulatory tasks provide clarity for consumers--and rules of competition for manufacturers. The regulation itself is not without some merit. But what does it matter what percentage of peanuts makes up a spread when you can't even guarantee that it's free from deadly contaminants?

Go where danger lurks

What the FDA needs most of all is a risk-based regulatory mind-set. Resources, and focus, must be apportioned based on a top-down view of where the greatest consumer dangers lurk. That means riskless endeavors, such as defining what constitutes peanut butter, can be handled by private or academic entities working with FDA. There's precedent for this sort of collaboration.

This doesn't mean FDA already has all the resources and tools it needs to do the high-risk stuff--far from it. According to news reports, the actions of the Georgia peanut plant appear so deliberate that it's easy to say no amount of regulation could have prevented that harm. But greater authorities would have tightened the regulatory net around this and other bad actors.

More than a year ago, the FDA issued a "Food Protection Plan," asking Congress to give it authority to demand access to records that food producers keep. The plan has gone largely ignored. In the case of something like a peanut butter plant, if the producer manufactures on three lines and one is found to be contaminated, FDA can't demand that the firm divulge results of tests on its other two lines, even though there's a reasonable chance similar problems exist.

Firms with "positive" test results also aren't required to report those to FDA, even for deadly pathogens. They should be. But right now, even if the findings went back to FDA they would be fed into an outdated information system that makes it hard for the agency to sort through the reports. That computer system needs updating so that it flags the highest risk findings.

The lack of information tools also means that FDA can't easily trace the source of contamination. So every time there's a food scare, everything gets recalled even though only a fraction of products are actually contaminated. Industry could help with the creation of a better "trace back" system.

FDA also needs more direct control over food plant inspections. As a piece of political pork, Congress gives a lot of the money for inspections to states, which conduct the assessments (sometimes poorly) on FDA's behalf. The Georgia peanut plant was inspected by state, not FDA, regulators.

Better tests, better tools

Finally, FDA also needs money for developing better scientific tools to isolate contaminants. During the pepper recall last summer, the diagnostic test used by FDA to detect the contaminating bacteria took two weeks to read out a result. The FDA's food center can acquire all these new resources without being split off into a separate food agency, as some in Congress are advocating.

But an equally large part of FDA's problems doesn't relate to inadequate resources per se, but to the disparate and far flung nature of the agency's various functions itself, and the FDA's lack of perspective on how to focus on the most important from among those responsibilities. Regulators aren't marshalling resources in support of the things that matter most to ensuring consumer safety.

Congress exacerbates FDA's strain by foisting on it new responsibilities every time a consumer cause célèbre crops up. Now, many lawmakers want FDA regulation of the entire cigarette industry. Whatever the merits, this new responsibility would divert from more pressing FDA tasks such as, say, ensuring the safety of the nation's blood supply. Nor does a cigarette center fit FDA's historical mission of health protection and promotion.

Longstanding preoccupations, and mission creep, divert too much of FDA's attention from pressing tasks. FDA needs to more tightly focus itself on the areas that pose the biggest risks to consumers.

Scott Gottlieb, M.D., is a resident fellow at AEI.