Navigating the Food Safety Modernization Act, part one in an exclusive two-part interview with Dr. David Acheson, managing director of food and import safety practice for Leavitt Partners
[Part One 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, we 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?
[image-nocss]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.
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): What are you hearing from manufacturers and operators on the Food-Safety Modernization Act?
A mixed bag, to be honest. Some of the larger companies I'm working with feel like they're in pretty good shape to deal with all this and it really isn't going to cause much of a wrinkle in their daily operations. I think some of them probably haven't yet grasped what the requirements for a food plant are going to look like. The record-keeping parts of this and the building of a plan that might be looked at by a regulator is something they haven't really come to terms with.
You get down to the next layer and all the little companies are starting to ask: Do you think we're going to be in compliance? Are we going to have to make a lot of changes? What are we going to have to do differently? You've thought about HACCP (Hazard Analysis Critical Control Point), but do you actually have your plan to the point where you're willing to put it in front of an FDA inspector if asked for it?
The retail and restaurant end is looking at the act and saying, "There's not much of this that's going to affect us." But then you ask, "Are you a registered importer? Are you the importer of record?" If the answer is yes, well, then a lot of this will impact you. There's the supplier verification program, there's potential for having to produce a certificate for high-risk foodit's yet to be determined what that will look like.
The FDA clearly has a ton of work to do to begin to put together the guidance documents and the rules so they can get even close to meeting the timelines. Some have said, "If they don't get money this isn't going to move," and I disagree with that. Writing a regulation isn't expensive; enforcing it is. So I think what we will find is that the regulations get written and get moving pretty quickly. But the capacity to enforce them will not follow without money, and you have to enforce it to be inspected.
The inspection frequency that's in the actthey've essentially said they're going to split it between high-risk and low-risk facilities. If you're high-risk, the FDA has to get in there at least once in the next five years and then set up a regular once-every-three-years schedule. If you're low-risk, they're going to get in there once within the next seven years, and then set up a once-every-five-years schedule. That is a huge difference from where the agency is now. They do get into high-risk places pretty regularly, but low-risk or medium-riskhowever you define that, and the agency has to do that toothere are places that I have interacted with that have said they haven't had an FDA inspector in in over a decade, if ever. So that's going to be a shift for many folks.
FD: Are retailers and manufacturers in wait-and-see mode, or are there things companies can be doing?
No, it's not [wait-and-see]. I think you can get a pretty good read of the language that's in the act. There will be granularity and fine-tuning once the regulations are written, but I think you can get 75% of the way there by just looking at the act.
It's potentially going to move pretty quickly, and the "let's sit back and see how this plays out" notionthat's not my best advice. Or "let's keep our fingers crossed that they never get any money so nothing will change"I think that can be more dangerous. I simply don't think that's a smart way to go.
There are two big chunks to this. One is risk for a firm or brand around failing to be compliant with the new requirements. That's a risk, if you're not compliant. The other risk, which is an increasingly important risk, no doubt in the private sector, is just the greater awareness that consumers have about food safety. Consumers will walk away from a brandwhether it be a branded product or somebody's retail outfit or restaurantif there even seems to be a food-safety problem. We are seeing that more now as a force for changing behavior in the private sector than we did before.
What we're now seeing is the collateral damage from that sort of an event can be significant in terms of financial impact. So that's a whole other parallel universe that's going on that's starting to shift behaviors in a positive direction for food safety that's simply going to be augmented by wherever the regulations end up.
Watch for next week's Fare Digest for Part Two of our interview with Dr. David Acheson.