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.