[Part Two in an Exclusive Two-Part Interview with Dr. David Acheson, Leavitt Partners.]
As the dust settled after the passing of the Food Safety Modernization Act in January, many wondered, "What's next?" What can operators and manufacturers do to prepare? How far can the legislation really go without funding? How does the act compare with past food-safety overhauls?
We put these questions to Dr. David Acheson, managing director of food and import safety practice for Leavitt Partners, a firm that advises clients in the areas of health care and food safety. Previously, Acheson was associate commissioner of foods for the FDA, providing him an agency-wide leadership role for all food and feed issues.
[image-nocss] Having played an active role in developing and counseling FDA on food regulations, Acheson brings a compelling perspective on the latest regulatory changes.
Fare Digest (FD): Can you put the act in perspective of past legislation? What's the precedent?
This is by far the biggest change to the Federal Food, Drug, and Cosmetic Act since it was first written in 1938. So it's a vast shift and I think it's an interesting perspective on the way the government operates with unfunded mandates, which is essentially what this boils down to. We want you to do all this work but we're not going to give you the money. This is just personal opinion, but that's more likely the consequence of the current economic environment and the deficit than it is anything else.
There's always reticence to put more money into the FDA; they are an underfunded agency whichever way you slice it. And if you look at the bare bones of the system, the FDA has the responsibility of approximately 80% of the food supplyabout 150,000 registered firms in domestic, and about 250,000 foreign registered facilities in 150 different countries. It's a vast universe of stuff. You're essentially dealing with 300 million Americans putting food on the table two or three times a day, and a very significant part of every one of those meals is an FDA-regulated product.
The amount of money that they have to do this is approximately $1 billion. And if you think about it, the expectations that consumers have and the size of the task, $1 billion is nothing. It's not even pocket change; it's tiny. And yet we're now struggling to do the job well and they're saying it really needs to be another $1.2 billion added over the next five yearsthat's probably a realistic number, but frankly we should be funding the agency at that level anyway, considering what its portfolio is.
FD: How far away are we from a universal adoption of the Food Code, and will this act propel or deter that?
I see the two as very different challenges. As soon as you start to meddleand I use meddle in a gentle termwith state interests, you run into a potential buzz saw because the states don't like the feds messing in their stuff. And this gets down to pretty emotive type situations where the states say, "No, we want to have control of what's going on in our state." And the notion that the feds are going to regulate commerce going on in the state, it gets everybody upset.
A great example is raw milk. There are a number of states that allow the sale of raw milk under various levels of stringency in terms of safety, and the feds just absolutely deplore that. Given their druthers the FDA I'm sure would like to simply outlaw raw milk, period. And that flies in the face of a lot of state interests, politics, you name it.
I think what the FDA is best doing is sketching very clear standards, guidance, training, opportunities and education to support the states in implementing the most effective food safety strategy. That's my take on the political reality of trying to make this successful. I think if you tried to bring down a requirement for the Food Code at the state level you'd get so much pushback you'd spend the next five years dealing with the politics. Meanwhile people would be getting sick left and right. It's not realistic.
I'm all for consistency, and I'm all for setting a reasonable standard that people can rally around, but to some extent the Food Code has done that in that many states have adopted it in its entirety. But it still gives that opening for people to go off in a slightly different direction.
It creates difficulties for national chains who are saying, "I have to understand 50 different ways that they implement the Food Code." So I agree it's a challenge. In an ideal world it would be great to have that consistency, but I don't see it as an immediate, practical need or likely to happen.
With the Food Safety Modernization Act, we're going to see more leverage using state and local inspectors as surrogate federal regulators. This is going to require training of those inspectors, some sort of oversight, some sort of accreditation or auditing process going on at the state level. So we will see, I think, a much greater role for the statesexcept that they don't have any money either. It will empower them, and it will work towards building an integrated food-safety system for the states, which again is a good thing because you start to build consistency.
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