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Inside the FDA: Q&A With David Acheson

PART II: On the pending food safety legislation, the impact on small farmers, and the agency’s capacity to inspect the food supply: A conversation with Dr. David Acheson, former Associate Commissioner of Foods at the FDA.

Dr. David Acheson knows the federal food safety system inside and out. An expert in food safety and infectious diseases who has become well-versed in regulatory policy, Acheson understands the science and the politics behind how the U.S. Food and Drug Administration (FDA) works.

david acheson article pic.jpgIn 2002, Acheson became the Chief Medical Officer at the FDA’s Center for Food Safety & Applied Nutrition (CFSAN) and served in several different leadership capacities before eventually becoming the Associate Commissioner of Foods in 2008.

Acheson–‘your stomach’s best friend,’ according to the Washington Post–played a critical role in creating the 2007 Food Protection and Import Safety Action Plans, both of which proved to be important first steps in the agency’s response to a string of high-profile food recalls, ranging from E. coli in spinach to melamine-tainted pet food.

Last summer Acheson transitioned to the private sector to work for Leavitt Partners, a consulting firm founded by former U.S. Health and Human Services (HHS) Secretary Michael O. Leavitt, where he continues to work on food and import safety issues.

Food Safety News had a chance to chat with Acheson about how the FDA’s food safety system works, where it can be improved, and on whether the pending food safety legislation can cure the agency’s woes.

PART II


Q: Will the passage of an FDA food safety reform bill, if it looks similar to H.R. 2749 and S. 510, be a major turning point for the food safety system? Is this going to be as life-changing as some are saying it will be?

A: No. It wont, it won’t. There is a lot more to ensuring a food supply than writing laws. Food safety is cultural. In order for food safety to be successful, the food industry culturally needs to understand the importance of it. 

No amount of chest beating in Washington is going to address what a pepper farmer is doing in Mexico or what a shrimp farmer is doing in Thailand, or in Ecuador. 

There needs to be the regulatory bar so that the agencies can hold people to a certain standard–there is no question that needs to be in place–and the new regulatory approaches will help lay that in place. That needs to happen, there needs to be requirements for preventive controls across the board, there is no question about that, I felt that when we were writing the food protection plan.

But simply writing laws and regulations doesn’t solve the problem. I believe there is a perception that as soon as these regulations are passed we’re going to see the end of outbreaks, we’re going to see recalls going down, and food almost safer overnight. It won’t happen. It will be a gradual process. Arguably, it wouldn’t surprise me if we saw more outbreaks and more recalls, simply because we’re getting better at finding them.

That is going to create a lot of questions for people who will ask–heck we passed this legislation in this session of congress, assuming that it happens, why hasn’t it solved the problems? That is simply a fundamental lack of understanding that most people have about the complexity of this system. 

It just doesn’t fix that quickly.

Q: Well what if we have more and more recalls–because we’re better at detecting contamination–but fewer outbreaks (if we could trace back food more quickly to prevent illness) wouldn’t that be major progress?

A: Yes, oh no question. Yes. The devil is in the details. On traceability–you’re absolutely right. I’ve had some extraordinarily frustrating times as a regulator because of the lack of ability to trace product back. 

The tomato outbreak last year was the classic example. It was frustrating that you just couldn’t tie this thing down, and it was taking days, step by step, inch by inch, to trace it back. You’re absolutely right that traceability will cause recalls to be shut down more quickly, thereby reducing exposure, thereby reducing foodborne illness. I’m a complete advocate for all of that. But passing the legislation to say we require traceability is easy. It’s applying it so that it is working for that little pepper farmer in Mexico is where you really have a challenge.

Q: Real quickly, on that, since you’ve been on front lines of trying to trace back products, what should be the minimum requirement? Do you think barcodes for everything or one step up, one step down? 

A: No it’s got to be a system that operates from one end of the chain to the other. It has got to go from the farmer to the retailer or the restaurant to be effective because often the problem occurs on the farm, not exclusively, but often, particularly when you’re dealing with fresh produce. Virtually always the problem is recognized, at least when people get sick, at the retail and restaurant end. It needs to be extended so its going from farm to fork and it needs to be fully interoperable.

Q: Another part of the pending food safety legislation is to mandate an increase in the frequency of inspections, especially for high risk facilities. You’ve talked before about how difficult it is to build capacity at FDA. Do you foresee the agency being able to actually inspect to a level at which it’s a deterrent in the near future? Since you can’t inspect everyone, deterrence is the goal, right?

A: Right. Let me answer that by saying inspection is not the whole answer to the problem. Inspections are important, but I’ve said many times publicly that I don’t believe you can inspect your way to food safety. It just is not possible.  If you take the extreme example and look at what FSIS does (and they have at least one inspector in every facility all the time its operating), does that ensure a safe product? No, it doesn’t. Problems happen and inspections don’t catch it.

Now, where FDA is, there are certainly not enough inspections done. And that gets to your deterrent point. It is not acceptable for a food company to think that an FDA inspector is only going to show up once a decade. That is just not adequate–that is no deterrence whatsoever. So, for sure you need to ramp up the frequency of inspections, but let’s not confuse that with ‘ramping up inspections is going to result in dramatically safer food.’ It is one piece of this culture shift that I mentioned earlier. Producing safe food…it requires a company saying ‘this is important to us.’

It isn’t going to happen by the FDA inspector showing up once every year versus once every five years. But I don’t want to leave you with the impression that I think we shouldn’t be increasing the number of inspections, we should. But to your point, could that happen quickly at FDA? No, it can’t. It takes a significant amount of time to hire people and to train them to do inspections well.

Q: What role, if any, should FDA play in helping to shift the industry culture toward food safety?

A: FDA traditionally has played the role of the watchdog and the policeman, and not the teacher. What the agency needs to do–and it is completely under-resourced to do this–is to take on the dual role of capacity-building trainer and inspector, it has to do both. 

Q: There is a lot of small farmer opposition to the food safety legislation, the small producer and small farmers are afraid of what they see as burdensome regulations…

A: I think the small guys are looking at this and thinking ‘we cant do this…we’re not sophisticated enough to do it.’  That might apply to some really small people, in which case they shouldn’t be selling food. 

The bar we have to set is that if you want to sell food to the public, there is a minimum standard to which you need to be held. Nobody is exempt from that, I feel very strongly about that.

There is the naiveté that local equals safer and I just so don’t subscribe to that. Even if you’re growing stuff in your own backyard you don’t, frankly, know what the local rabbit has done on the produce the night before you ate it.

I think exemptions will get us into trouble. They will undermine food safety, and they will be incredibly difficult to implement because everyone is going to want an exemption.

Now that sounds a little bit hard, and maybe somebody reading this might interpret what I said as that I don’t have a heart with regards to small business but that’s not true at all. I think small businesses have a critical role to play and we should be encouraging them through federally sponsored education programs so that they can continue in their small business and they can do it right. That’s the solution here. 

Q: Do you feel optimistic about where the federal food safety system is going, are we moving in the right direction?

A: Yeah, we are. We’ve got a ways to go with food safety, but if you look at where are now compared to where were 10 years ago. There are many who could say, “how could you say that?” when we’re seeing more outbreaks, more foods implicated than had never been implicated before–I think that shows th

at the system is working. I don’t believe that peanut butter suddenly decided it would host Salmonella in 2007. I think peanut butter has been making people sick for years, we just didn’t know it.

See PART I of the interview, on FDA agency turf battles, the shift between administrations, and the politics of regulating the food supply, here.

© Food Safety News
  • I don’t believe the FDA is a watchdog or a policeman. My opinion is that they have been a fireman. The FDA has a tremendous amount of authority, today, and it is not utilized. I don’t know why and they won’t tell me. It leads me to believe that someone has told them not to enforce the law.
    For example, the Bioterrorism Act of 2002 passage regarding “one-up, one back traceability within 24 hours” has not been enforced since regulated in 2005. In four years of class one recalls, no company that was inspected due to the recall has been able to fully comply with these standards according to the FDA. Penalties, fines, closure, bad press – NONE. I asked the question in Oakland at an FDA informational meeting last year.
    What does that mean to you?

  • Cindy

    What a tool, typical Bush era administrator who thinks that only the big guys should be selling food. Whose pocket do you think this guy is in?

  • “There is the naiveté that local equals safer and I just so don’t subscribe to that. Even if you’re growing stuff in your own backyard you don’t, frankly, know what the local rabbit has done on the produce the night before you ate it.”
    How would this situation be helped by forcing me to stick a barcode on my home-grown produce? I for one am not expecting exemptions, but I don’t agree with the logic that says there should be absolutely NO exemptions. Identity-preserved produce (i.e. the Farm name is on the produce item all the way to the consumer) should be exempt from onerous traceability requirements.
    Will the small local growers be exempt? Sadly, not a chance…

  • “There is the naiveté that local equals safer and I just so don’t subscribe to that. Even if you’re growing stuff in your own backyard you don’t, frankly, know what the local rabbit has done on the produce the night before you ate it.”
    How would this situation be helped by forcing me to stick a barcode on my home-grown produce? I for one am not expecting exemptions, but I don’t agree with the logic that says there should be absolutely NO exemptions. Identity-preserved produce (i.e. the Farm name is on the produce item all the way to the consumer) should be exempt from onerous traceability requirements.
    Will the small local growers be exempt? Sadly, not a chance…

  • kozowh

    Q: Why are there no (legal) mom and pop pharmaceutical producers? A: They can’t comply with the FDA requirements.
    And while food production is different than drug manufacturing we should think about the differences between how to control contamination occurring in large producers vs. small. One size will not fit all. But both types of production are. Personally, I think that neither type of operation is doing an adequate job.