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Expert Q&A on Import Safety

Food Safety News was able to attend the Global Food Safety Policy Forum last week, and we thought our readers might find a Q & A from one of the expert panels from the import food safety discussion interesting.

Q: You throw out a very big number for what it would take for FDA to inspect all foreign facilities, 3.5 billion, but you also mentioned the number of facilities, which is something like 200,000. If you do the math, you come up with a cost of $18,000-20,000 per facility for an inspection, which seems like a rather high number. I am wondering if you could give us some information on how that number was derived and whether it takes into account anything in the food safety bills to have, say, an inspector on site, or to have a dedicated inspector or office in a country, or does this assume that every inspector has to fly to the other side of the world?

–Jean Halloran, director of food policy initiatives, at Consumers Union

A: Those are all very good questions. That’s an FDA figure. I think the average is about $17,000 per inspection. I can’t tell you exactly how they calculated that. I can tell you that when we presented that information David Acheson actually felt that that number was on the low side. I wish I could give you more details but perhaps FDA is a better source for that. But it is astounding and it does underscore the need for FDA to get all the tools that it can to conduct a more risk-based approach to its oversight.

–Lisa Shames, Director, Natural Resources and Environment, Government Accountability Office

I can give you a sense of the elements that go into that. I think that whether you’re traveling people overseas or whether you’re basing U.S. government employees overseas, it’s a costly operation. That’s one sort of basic point–more costly obviously than doing it here. But when we estimate the cost of the inspection its not just the hourly rate of the inspector, there is an infrastructure that is needed to support that, there is laboratory support, there is the ability to analyze inspection findings, to have all the elements of a meaningful inspection program. We’d be happy to sit down and walk through those elements, but it adds up fairly quickly.

–Michael Taylor, senior advisor to the Commissioner of the U.S. Food and Drug Administration

Q: I’d like one of you to comment on whether USTR and other agencies have looked at both bills to give an opinion as to whether or not the new import requirements would be in compliance with our WTO obligations. I ask that because we are supportive of many of the improvements in the bill, but because, in the case of dairy, we actually export 10 percent of our supply, and I know for many other food groups that number is even higher. Not being an expert in the technical aspects of the bills, has their been any government review to look at that aspect?

–Representative from the International Dairy Foods Association

A: The short answer is yes. There is an established internal administration process to look at all aspects of the bill…and I can assure you that–and I don’t know if any of our USTR folks are in the room–but they are not passive in analyzing and expressing their views, so we talk those issues through and have come to good conclusions.

–Michael Taylor, senior advisor to the Commissioner of the U.S. Food and Drug Administration

Q: My question is for Mr. Taylor. I was wondering when you commented on the thinking of FDA building a new [computer] system, is there any discussion about a system that would include and embrace inspection activities with USDA, CDP, and FDA? Or is the thinking just to build a new system for FDA inspections?

–Representative from Lockheed Martin

A: Well, the partnership with CBP is important, and it continues to be sort of part of the system as part of border element goes. We have an enormous interaction with USDA right now, interactions on food safety broadly, and really on all aspects. It is the reality that our jurisdiction is quite distinct from USDA’s. They have certain facilities that they are responsible for, which make up, actually, a very very small part of the overall flow of imported goods here, and they’ve got a different statutory framework they have to implement.

Even with the changes we hope Congress will enact, we will be operating under I think a much more comprehensive framework, but still be quite distinct from USDA, which you know is to a large extent about ensuring a level of inspection, or a mode of inspection overseas which is equivalent to what happens here. We don’t expect to be in that position at all. So we can certainly learn from USDA, but I think we will continue to be operating under a different set of ground rules, which reflect the global environment we are operating in, which is quite different than USDA’s.

–Michael Taylor, senior advisor to the Commissioner of the U.S. Food and Drug Administration

By law, USDA and FDA cannot share inspectors. There are separate budget lines, there are legal prohibitions. But there has been an effort to have high level discussions on the need to really create a more unified structure for inspection. One of the challenges that Michael Taylor is perfectly placed to address: at FDA, the inspection force–the same people inspect food plants, drug plants, and medical device plants. This leads to a lack of expertise, a lack of effectiveness of the inspection force, they’ve had an inadequate inspection force for many years.

–Caroline Smith DeWaal, director of food safety at Center for Science in the Public Interest

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