O'Brien: FDA's import rule will bring change - The Packer

O'Brien: FDA's import rule will bring change

12/20/2011 02:36:00 PM
Tom Karst

I had the chance to chat Dec. 14 with Tom O’Brien, Washington, D.C., representative for the Newark, Del.-based Produce Marketing Association.


4:00 p.m. Karst: How did you get connected to the fresh produce industry and the Produce Marketing Association?

4:00 p.m. O’Brien: In 1993, I joined USDA. I came as a political appointee with Lon Hatamiya, who was appointed to be administrator of the Agricultural Marketing Service. Lon and I had practiced law together in Sacramento. Before 1993, I was an attorney in Sacramento, California and am  a northern California native. So while I had a general law practice that occasionally handled food and even some agricultural matters, my introduction to agriculture came at USDA.

4:02 p.m. Karst: What was your title at USDA?

4:02 p.m. O’Brien: The last title I had was associate administrator at AMS. I was there from November of 1993 to February of 1999.

4:03 p.m. Karst: What did you like about working at USDA?

4:03 p.m. O’Brien: What I like in particular about where I was at USDA, was that it was really the intersection between the political appointees and the career employees and so you kind you have to be the one to translate between those two groups and make things work. I liked that quite a bit. I also liked being in AMS, where three fourths of its budget comes from user-fee programs. It is more entrepreneurial and leaner than some other agencies.

4:04 p.m. Karst: You kept an interest in agriculture and produce. What’s the scope of what you do for PMA?

4:05 p.m. O’Brien: I represent PMA in Washington. These days that is a lot of work on food safety. The farm bill also continues, since it wasn’t finished in the super committee. So it is both regulatory work and legislative work. I deal a lot with my old agency at USDA, and certainly other agencies: FDA, the Trade Representative’s Office, in addition to Congress.

4:06 p.m. Karst:  What do you like about working for PMA in Washington?

4:06 O’Brien: I began working for PMA in 2008. Long before I started working or PMA, I knew PMA from my time at USDA and also working for the governor of California. Because PMA knows the day to day workings of their members so well, they have a good sense of what are real issues and what are not real issues for their membership.
4:07 p.m. Karst: Food safety is looming larger and larger. What is your sense of the FDA produce safety regulation? What do you expect when that comes out?

4:07 p.m. O’Brien: I think it is important to remember that is not just the produce rule. You are right, that is huge. There is the produce rule, and around the same time it comes out there will be a proposed rule on preventative controls and a proposed rule on imports. So it is going to be busy first quarter and first half of the year. The most important thing will be to identify where the agency didn’t get it right and put together arguments and persuasions that will convince them that if they didn’t get something right they will take a new fresh look at it based on the comments and the hearings they will hold. So it will be interesting when it actually gets published to go through it. FDA has done a lot of work, a lot of outreach to PMA and others, but pretty soon we will get to see the details.

4:08 p.m. Karst: You talk about preventative controls. As you understand it, what will be the scope of that regulation?

4:09 p.m. O’Brien: If you remember a lot of the Food Safety Modernization Act keeps the sort of nomenclature of the 2002 Bioterrorism Act and the registration requirements. So there are farms and there are facilities. Facilities are mainly everything else that handles food, with some exceptions. But most of those facilities will have to have food safety plans, have identified risks and adopted preventative controls to mitigate those risks to food safety. It is not supposed to be very prescriptive. It is supposed to be based an individual look at his own facility, but that is my understanding of it. The produce rule applies to the farm side of things for produce, at least where the FDA feels there needs to be additional regulation.

4:11 p.m. Karst: Right. Then of course the import rule. What specifics will that rule bring?

4:12 p.m. O’Brien:  The law says that it is going to be up to the importer to have a system in place to verify that the food was produced in a manner consistent with U.S. laws. In some ways, a lot of those safeguards are already in the system, primarily from buyers and other private means. But this will formalize that and may take a very different tack than has been done in the past. In my mind, this might be the biggest change of anything coming out the Food Safety Modernization law, but we don’t know and we won’t know until we see it.

4:14 p.m. Karst: Just because there will be new steps to consider?

4:14 p.m. O’Brien:  That importers will required to have this system in place. Like I said, a lot already have them but this will formalize that.
 
4:15 p.m. Karst: You hear a lot now from USDA and FDA that they really talk to each other. Being a veteran of the agency, do you think that is really occurring and will that be a good thing for food safety efforts and implementations?

4:16 p.m. O’Brien: I think it is a huge change from what was going on at the USDA in the 1990s. When I was there we had the strawberries and hepatitis outbreak and the response to that really suffered because of the lack of communication between the two agencies, the lack of relationship. I think that is very different now, to the point where you have Leanne Skelton from AMS on detail at FDA and really providing that hands-on knowledge of how the industry works to FDA on a full time basis.



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