Q&A | David Acheson, former FDA associate commissioner - The Packer

Q&A | David Acheson, former FDA associate commissioner

04/27/2012 08:23:00 AM
Tom Karst

National Editor Tom Karst recently chatted with David Acheson, a former Food and Drug Administration associate commissioner for food protection, leaving the agency in August 2009.

4:05 p.m. Tom Karst: The length of time we are waiting on the FDA produce safety regulations is starting to become an issue. What do you make of that? Is that something you expected or is that a surprise to you?

Acheson4:06 p.m. David Acheson: No. I didn’t expect it. I was expecting to see something in February, to be honest with you. I thought January was a bit of a stretch, given just the scope of the four proposals that were sent to the OMB (White House Office of Management and Budget). I honestly thought we would see something in February or possibly early March. And now we are heading toward May and we still don’t have anything.

I have gone with our newsletter and said publicly that it wouldn’t shock me if this doesn’t pop until November, until after the election. The longer it waits, that’s where I’m seeing it head for political reasons, frankly.

4:09 p.m. Karst: I have heard some speculate that the OMB has some issues of how all the regulations mesh into the idea of not discriminating between domestic and foreign food. Is that a thorny issue, do you think, in how the law was written?

4:09 p.m. Acheson: It has got the potential for that, no question. I have not read the proposed rules any more than you have. So I don’t know whether it has created thorny issues but if you look at some of the language of the Foreign Supplier Verification Program, you can sort of look at it through (the lens) of a trade issue or WTO issue, given the way Congress wrote it. I’m thinking about maybe two or three specific areas.

One that struck me is lot by lot certification, which is specific language under Foreign Supplier Verification. Another one that struck me is annual on-site visits. Another one was a looser suggestion about testing and certification around testing. Now that one is a (bit) grayer.

But those first two, if you take them by face value — lot by lot certification and annual on-site certification. We don’t subject our domestic companies to that, so that incurs costs and that incurs delays and it incurs a potential trade issue. So I could interpret pieces of this — if the agency took the Congressional language at face value and put that as a requirement in Foreign Supplier Verification — that it could create a trade concern.


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