From the Dec. 9 transcript of the USDA-FDA traceability hearing, questions to USDA official Peterson and FDA brass Elder. From the transcript:


DR. GOLDMAN
: The first question is to ask each of you to compare the records access that FSIS inspectors have and FDA inspectors have When in a plant or firm.


DR. KEN PETERSEN: Okay. For FSIS records access, really two different scenarios. The easy one is in plants that we directly regulate, basically plants where we say has a grant of inspection. They produce meat and  poultry or egg products. Any of their records, and I gave you some of the requirements, but basically any of their records associated with any of their decision making related to hazards in those foods, we have access to any time, day or night, 24/7. If I need to get in and look at records on weekends, they're expected to allow me to do that. So in plant, not a problem. So the inspectors, on their day-to-day duties, they look for execution.

What is a plant doing on a daily basis? I have other people who look at more of the theoretical design part of their records, but the day-to-day inspectors focus on what do the plants say they're going to do and what are they actually doing. The other records we access, that was really more the focus of Bill Smith's discussion, is records of retailers, brokers, wholesalers and, of course, they're not subject to the HACCP regulations, and so the records they would have is a little bit different. As you heard from Bill, the specificity of the record requirements on them is different and, in fact, it's a little less robust.

There are some avenues we want to pursue typing up, and he mentioned a couple of them, most specifically details on grinding logs in grinding that occurs outside of an official federal establishment. On more than one occasion, we've had a bottleneck on an epidemiologic traceback because grinder logs were insufficient at a grocery store or some other firm downstream. They're insufficient to get us back to the producing facilities. So in plant, free reign basically for whatever I need, downstream because the requirements aren't as specific, I still have access to those records, but there's a lot of variability downstream.

 DR. GOLDMAN: Okay. David.

 MR. DAVID ELDER: Okay. I'll give this a shot. My disclaimer is I'm not a lawyer. I often play one in real life, though. So we don't have routine records access at FDA during food facility inspections, but there are some exceptions to that. During HACCP inspections, and we have HACCP regs for seafood and juice, we have records access. We have records access in low acid canned food manufacturers and infant formula manufacturers.

We don't ever have access to records, certain category of records, like financial records. We don't have routine records access in other food processors other than HACCP, infant formula, low acid canned foods, unless the statutory threshold that was created under the Bioterrorism Act of 2002 has been met, and that statutory threshold is basically that we have a reasonable belief that a product is adulterated and presents a threat of serious adverse health consequences or death, and then we go through an internal review process to say that, okay, that statutory threshold has been met. So in this situation, we have access to records that help us determine whether the food is adulterated and whether food on the market presents a serious adverse health threat.


DR. GOLDMAN: Okay. Thank you both for that perspective from the two agencies. Again a question that might be addressed by both of you, in turn, if the contents of a product sold to a consumer is transferred from its original packaging, and in so doing loses its identity, what do the regulatory agencies consider the responsibility of the manufacturer with respect to traceability in that instance?

 DR. PETERSEN:
On the FSIS side, transferring, if a product comes in, we'll say an official establishment, if it comes produced by one firm, let's say coarse ground beef, a second firm makes it into fine grind beef, the second firm I have, the establishment number has to go out on that particular package. So we would know that information. That second grinder would also have to, as I mentioned earlier, have some records on what they received and that kind of thing.

Where that scenario changes is again what was discussed in really what Mr. Smith was getting at. Say a grocery store, they take that fine grind product, they put it in trays that you, and all of us go in the store and purchase, and you, the consumer, doesn't directly know where that was really produced, you know. Obviously the store put it out for sale, but you don't know who their producing plant was.

The grocery chain would have variable levels of detail. Some have explicit detail. Some have detail that they receive from these people, these firms on such days, and you may not be able to lock it down to particular trays of ground beef that was sold , say between 1:00 and 4:00 p.m. So you would know what they purchase, you would know from some store records what they ground during the day, but you couldn't necessarily, and  again it varies, window them down to specific timeframes of production, which is a little bit different than we see in an official establishment.


 So leaving an establishment, there's a number on it. We know who it is. Somewhere downstream they can take it from

that and make it for direct retail sale. They can't change it and then further, you know, put it in the chain. They have to make it for direct retail sale at the consumer level.

MR. ELDER: If I understand the question correctly, I'm not familiar with the section of our statute or our regulations that requires a manufacturer to know the final packaging of all of the products that they originally manufacture. That is to say, if they manufactured a product, shipped it to a customer who repackaged it and sold it in new packaging to the consumer, I'm not aware of any section of our statute or regulations that requires that original manufacturer to fully know and understand that. It's certainly a good practice.vIt would be a recommendation of ours. I'm just not sure that it's grounded in law or regulations that they know that.

DR. GOLDMAN
: Okay. Thank you. I might have not been clear on the question, but the other part of the question, and I think the particular point raised by the questioner was if a product is taken home by a consumer and repackaged in foil or whatever and put in the freezer, subdivide it somehow, does that change the responsibility of the manufacturer in any way?

DR. PETERSEN
: For us, basically, no. I want to know, and we had some discussion on purchase card information. I can get into the store, I can kind of --but basically, no. We're going to pursue the source production as far as accurate records will take us, and  we will keep looking. If there's say people getting sick and you have multiple case patients, multiple interviews, you start to get a commonality of information that can help you take it back to a producing plant. It doesn't always happen, but we're going to ursue the information chain from the consumer's freezer. It's an unmarked package. If we can find out when they were in the store, we will get that information. If we can find out when the store sold it, where they bought it, we will take it back, but somewhere in there, sometimes it does break down.

DR. GOLDMAN
: Anything to add, David, there?

 MR. ELDER: I don't think so.

DR. GOLDMAN: Okay. There's one last question. This is just directed at FDA from the questioner anyway. Does FDA conduct the same traceback activities if the evidence of contamination arises from a source different than  illnesses? So there's some other evidence that comes to you apart from an outbreak or illness investigations, and would your traceback efforts be any different?

MR. ELDER: Yeah, FDA gets signals of potential product problems from a variety of sources. It can be a consumer complaint. It may not necessarily be illness associated. It could be through FDA's routine sampling program. We could get information from USDA. If they were doing an inspection of a plant that manufactures both FDA and USDA regulated products and they found a problem with the USDA product, we would initiate an inspection, working closely  with USDA on the part of the plant that produces the FDA regulated product.

There's a new requirement that went into effect a couple of months ago called the Reportable Food Registry which was part of the Food and Drug Administration Amendments Act of 2007 that requires entities in the distribution chain, when they become aware of an adulterated product, to report it to FDA, not necessarily through any illnesses or injuries, but because of their own internal testing or some other means, they've determined that there is a product that is adulterated. I

t's the Reportable Food Registry. We have calls every single day to understand those reports that are coming in, and we've reacted to them in terms of following up, working with our state regulatory partners, conducting inspections, and as I said, there are a number of routine surveillance programs, sample collections, information from other sources that send signals into the agency and to which we react. I can't tell you that every signal, through the fact finding, turns out to be a true signal of a real product problem, but every single signal is reviewed in some form, and some of those do result in FDA inspections and recalls of products.