OPERATOR: Good afternoon and thank you all parties for standing by. I would like to inform you that your lines will be on a listen only until the question and answer session of today's conference. The call is being recorded. If you do have any objections, you may disconnect at this time. I would now like to turn the conference over to Ms. Julie Zawisza. Thank you, ma'am. You may begin.

MODERATOR: Carol, thank you very much. Ladies and gentlemen, welcome to our media briefing this afternoon. I'm Julie Zawisza, assistant commissioner for public affairs. We are very pleased you could join us this afternoon. Today we'll be giving you an update on the contaminated animal feed, and we have one speaker, and then we have a number of FDA officials and a USDA official who will join us for questions and answers. Our speaker today is Dr. David Acheson, who many of you know. He's the assistant commissioner for Food Protection here with the Food and Drug Administration. And after he speaks, we'll go to the Q&A section and we'll have the following people available to answer your questions.

We have Dr. Kenneth Petersen who's assistant administrator for field operations with the Food Safety and Inspection Service at the U.S. Department of Agriculture. And we have from the Food and Drug Administration Dr. Stephen Sundloff, director of our Center for Veterinary Medicine. Captain David Elder, director of the Office of Enforcement. Michael Rogers, director, Division of Field Investigations. And Walter Batts, deputy director Office of International Programs.

At this time I would like to turn this call over to Dr. Acheson.

DR. DAVID ACHESON, FDA: Thank you, Julie. This is David Acheson, assistant commissioner for Food Protection at FDA. What I would propose to do on this call is to go over some old ground to make sure that we are all on the same page, and I'm going to cover five principal topics. The first is just to reiterate the whole story around wheat gluten and how some of it can wind up in pet food and some in human food. The second is to briefly mention an expanded recall from Menu Foods. The third is to discuss the human health impact of the findings in the investigations to date. The next is to discuss our current proactive strategy looking at both imports and domestics. And the third point is just to mention where we are on the investigation in China. So that's five points that I propose to cover.

For the first point just to put us all on the same page with regard to wheat gluten, and I want to just remind everybody that when wheat gluten comes into the United States it essentially can follow two predominant paths. It can either wind up in the pet food system or it can wind up in the human food system. In the current investigation, all the contaminated product ended up in the pet food system. As you are well-aware, this whole situation came to our attention because of sick and dying pets. That led to investigations to determine what was causing that problem. The problem was identified as wheat gluten initially. The wheat gluten was then investigated and found to contain melamine and melamine-related compound, and the belief is that the melamine and melamine-related compounds is what is toxic to the pet.

Once we knew that the contaminated wheat gluten had ended up in the pet food supply, the obvious question had any of those contaminated lots gone down the human side of the arm, had they gone into the human chain? We have done extensive investigations; follow-up, tracing forward and tracing back, into that system, and have found no evidence that any of those contaminated lots have ended up in the human food chain as an ingredient in human food. And I emphasize "as an ingredient." What I am talking about there is the wheat gluten is used in a range of human food including a variety of different breads and pastas and etcetera. None of the contaminated wheat gluten ended up in the human food chain as a direct ingredient.

Now as you all know, a portion of the contaminated pet food from the pet food arm of this scenario I'm painting to you was incorporated at some level into feed for hogs and poultry. Some of those hogs and poultry have entered the human food supply. I'm going to say more about the specifics of that in just a minute.

But I specifically wanted to just outline these two tracks, the pet food track and the human food track, and explain that all the contaminated wheat gluten has only gone down the pet food track and likewise the rice protein concentrate. It's all down the pet food track, and there is no evidence of crossover other than in the poultry and the hogs, which we'll get to.

Sticking with the pet foods, Menu Foods has announced an expanded recall. I am not going to go into the specifics of that. The information is on their website. Their belief is that this was due to a cross-contamination situation in which some of the previously contaminated product had cross contaminated some new product which came to their attention, so they have expanded the recall.

If there are specific questions about that, we have experts in the room who could answer those, but as I say the information on that is posted already.

Turing to my third point, the human health impact, we've again been over some of this ground on previous calls, but I want to go back over this again with you. Bearing in mind my first comments that this has all gone down the pet food side and the only connection to human food is when some of this pet food has been used as human food. Let me just reemphasize that our current belief is that the threat to humans from contaminated poultry or pork is extremely low, it's very unlikely that there is a human health effect here. The reason for that is several-fold, and essentially it's based on what we know of the levels of melamine that are toxic and what we know of the dilution effect of the pet food.

And what I mean by the "dilution effects" are that when the contaminated wheat gluten comes into the country only a relatively small proportion of the wheat gluten is containing melamine and melamine-related compounds, so it's varied between 5 and 8 percent of the wheat gluten is melamine. Of that, wheat gluten is not an exclusive ingredient to the pet food. It's mixed with other things, so it's further diluted as it is turned into the pet food.

When it comes to feeding that pet food to hogs and poultry, only a small portion of the pet food is used as the feed for the animals. That's the third arm of this. Once it's got into the poultry and the hogs, the small portion of the meat that's out on the market -- it's certainly all the pork, it's not all the poultry, it's a very small proportion of it -- will potentially contain very low levels of melamine. But again, the melamine that's present in that meat and poultry does not form an exclusive part; poultry and pork do not form an exclusive part of the human diet. People who eat poultry and pork do not eat exclusively poultry and pork.

So what we're doing to recap, and this is a little complicated, is that there is the series of dilution steps that take the original contaminated wheat gluten in terms of the way it's used to make the pet food in the first place, in terms of the way that pet food is used to make the animal feed, and then the amount of animals that the humans ultimately consume. What that result is, is a dramatic dilution of the contamination, taking it down to the point where we really believe the likelihood of a human illness is very remote.

I want to just clarify going back to my first point to make sure you all understand what I meant about pet food being used as human food. I'm not trying to suggest that people are consuming pet food as part of a three square meals. This is simply pet food that has gone through this pathway that I've just alluded to in which it ended up in poultry and hogs and therefore wound up in the human food chain. And again I know this is complex, and that's certainly part of our challenge, and obviously if there are questions around that, please ask for clarification.

The next point I want to mention is our proactive strategy, so we covered the basic areas of the pet food, the human food split, the expanded recall, where we are on the human health impact, and so the fourth point is our proactive strategy. And there are two key elements to that. Firstly, is what we're doing in the context of imports, and the other is where we are on the domestic side.

As we discussed before, FDA working with Customs and Border Protection, has an import alert in place that is focused on protein concentrate of vegetable origin and from China. What that means is that protein concentrate of vegetable origin from China are held at the border and are only allowed to enter U.S. commerce when we are satisfied that they are safe to proceed. There are some specifics around what that "safe to proceed" means which I'm not going to go into on this opening comment. But we have experts in the room who could address that if needed.

So what that is doing is, preventing any further input of contaminated protein concentrate of vegetable origin coming into the country from China.

On the domestic front, we have now initiated our assignment. It's now operational, in which working with states and locals our investigators are going out to manufacturers in the United States who use protein concentrate as an ingredient in foods and they are doing two main things. They are raising the awareness of those manufacturers about the importance of their supply chain, making sure that they know all there is to know about where they got their ingredients from; and secondly, if they have received ingredients from China and they are still on site and have not been used, that they are tested for melamine and melamine-related compounds. As I said, that assignment has just begun; it began this week. To date we do not have any results from that. But it will continue until we have pursued the domestic side for some considerable way to ensure that anything that is currently in the United States is safe to consume.

I want to just point out with regard to this proactive strategy in the testing we have done, just to give you a few numbers around that, we have currently tested approximately 700 samples that are either finished pet food or the ingredients. Of those 700, approximately 400 samples have tested positive; some of those have been multiple samples from the same lot resulting in a total of 92 positive lots.

So out of those 700 samples tested, approximately 400 have been positive for melamine and about 300 have been negative. All the positive samples have come from the two importers and companies that we already know about. And a number of the negatives have come from other companies. So what I'm saying here is that so far all the positives have tracked back to companies that we're already aware of, we're on top of, and that's what all the recalls have been about, and we're already beginning to get negative data on some other importers, other companies, obviously not currently under recall because they don't have melamine in them and they are not a problem. Those numbers I have confidence will expand over the coming weeks as we do more testing through the domestic assignment.

The final point I want to make is where we are in China. I don't have a great deal to say about that other than the HHS Human Health Services, FDA team are on the ground in China and they are working with the Chinese government on the investigation. At this stage I don't want to go into any further specifics on what the operation is in China. Suffice it to say that we are there and the investigation has begun. With that, I hand it back to Julie and take it from there.

MODERATOR: Thank you, Dr. Acheson. Carol, at this time we're ready to take questions from our listening audience, so we'll give people a moment to get in the queue. And ladies and gentlemen, we ask that you limit yourself to one question and one follow-up, and state your name and affiliation, please.

OPERATOR: Thank you. We will now begin the question and answer session, and if you would like to ask a question, please press #1. To withdraw your question press #2. Our first question comes from Abigail Goldman. Please state your affiliation.

REPORTER: Good afternoon. Abigail Goldman with Los Angeles Times. I have a couple questions. Can you confirm an arrest made in China related to this? And secondly if you are testing or holding imports from China but those imports are mislabeled as nonfood or fraudulently labeled as nonfood, what assurances do you have that you are preventing those ingredients from getting into either the pet food chain or the human food chain? Thank you.

MODERATOR: Abigail, this is Julie Zawisza. Your first question should be directed to the Chinese law enforcement authority. This is really a matter for them to speak to. Your second question I think Michael Rogers is going to take. Is that right?

DR. ACHESON: Sure. Thanks, Michael. I think basically the answer to that question is, if it's fraudulently labeled and arrives in the country under some other label and is not therefore identified saying it's coming in, say, as car parts, we are not necessarily going to know about that. But clearly if we find that, that in itself is something that we would follow up on. But we're not opening every container to make sure that it is what it says on the outside.

REPORTER: Let me clarify. Is that the situation here, or do you believe that was part of the situation here and part of the problem here?

DR. ACHESON: No. We believe this came into the country labeled as wheat gluten and it wasn't labeled as something else. We have no evidence that would suggest that is going on.

MODERATOR: That was Dr. Acheson, not Michael Rogers. Next question, please?

OPERATOR: The next question comes from Deidre Henderson. Please state your affiliation.

REPORTER: Hi. Thanks for doing this call. I'm with the Boston Globe. There's been a number of stories about Chinese agricultural practice, and I'm wondering if your investigators on the ground are seeing domestic use of melamine and melamine products in the animal feed, and would that have any implications for food that's coming into the U.S. from China, not just ingredients but seafood, poultry.

DR. ACHESON: That's a very good question, and clearly our investigators will be looking into many aspects including those kinds of things. At this point we're not in a position to make any comments in terms of what they're finding until they are back in the U.S. and the investigation is complete.

REPORTER: Thank you.

MODERATOR: Thank you. Next question.

OPERATOR: Joe Johns, please state your affiliation.

REPORTER: Hi. That's Joe Johns with CNN. Pretty straightforward question, could you give us some sense of sort of the data and the amount of data you've been able to recover on your testing in order to be able to say with any degree of confidence that the melamine did not actually reach into the human food chain except for those animals?

DR. ACHESON: I feel confident to say that the investigation of the contaminated pet food has been exhausted. We have followed that multiple different directions. The investigation continues, so I'm not going to say never, but that has been exhausted in terms of originally tracing back from the sick animals to what the problem was, then tracing forward from the contaminated wheat gluten into all kinds of different areas, and hence the host of recalls that you've seen.

So based on that, I'm very confident that none of those two contaminated batches have ended up on the human food supply.

Part of the reason for the domestic assignment that we're doing is to answer the second part of your question; that is, getting out ahead of the curve, looking in areas that we've not currently looked at, looking in areas where we don't have any evidence that there's a problem, but it's prudent for FDA to get out there and look in those areas even though there's no evidence that there's a problem. Hopefully when the domestic assignment is complete, we will be able to say with confidence what that showed. But that part of it is very early and very active.

REPORTER: A simple follow-up if I can just have one, and that is, it was said on one of these calls early on that the wheat gluten went into baby food. To what extent have you been able to look into baby food to find out if there's a problem?

DR. ACHESON: Well, I think there was a lot of speculation early on because wheat gluten and rice protein concentrate go in many different directions. But as I said, we have chased the contaminated lots in many different directions, and there's no evidence that it's ended up in baby food or for that matter in any other human food as an ingredient. The only connection with the human food is through the animal.

MODERATOR: Thank you. Next question.

OPERATOR: Randy Schmitt, please state your affiliation.

REPORTER: Associated Press. Dr. Acheson, when you were talking earlier about sending investigators out to look at the supplies of wheat gluten that are still in the hands of manufacturers, is that primarily pet food or is does that extend to human food too?

DR. ACHESON: Thank you for asking that question. I should have clarified that point. It's both. We are going to manufacturers on the pet food side, pet food side as well as the human food side.

REPORTER: Even though there's no evidence of human food contamination?

DR. ACHESON: Correct.

REPORTER: Thank you.

MODERATOR: Next question?

OPERATOR: David Curley, please state your affiliation.

REPORTER: ABC News. I've got a bunch, Julie, but -

MODERATOR: One, and then one follow-up, David.

REPORTER: All right. You say these contaminated lots did not get in the human food chain. Just sounds like standard practice for the Chinese. How long has this been going on? How do we know that a year and a half ago that wheat gluten wasn't in the human food chain, didn't get to us? And then do we have new poultry numbers yet? And why is it okay for melamine to be in human food but it's not okay for it to be in pet food?

DR. ACHESON: You've asked a whole host of questions there in your one question. Let me see if I can remember what you asked me. First of all, could this have been going on in prior years? Sure it could. We don't know that. We don't have samples from last year, the year before that, to test. We cannot rule that out. All we can say is that something was different this time where the contamination led to sick pets, and so it came to the attention of obviously pet owners as well as federal authorities.

We can speculate for hours as to why that was, what was different with this, we can speculate how long this may have been going on. The bottom line is, we don't know. In terms of the getting at one of your other questions of how do we know this hasn't gone into human food - I think that was one of your questions?

REPORTER: No, the question is, you've said on several of these calls this can't be in pet food. But you just said that it's 3 million chickens already gone into the human food supply and they may have had melamine in them, and apparently that's okay.

DR. ACHESON: That's the whole issue around the dilution factor. When pets eat pet food for the most part they would be consuming a single type of food as their exclusive diet. That's all they eat for their breakfast, lunch and dinner. And if that food is contaminated, they are going to get a pretty hefty dose of the problem. And they are eating the most contaminated part of this whole thing; they are eating the pet food which has got the greatest concentration of melamine and melamine-related compounds in it.

On the animal side, only a portion of that pet food is fed to the hogs. What I mean is, is that when farmers mix up the feed for the hogs for the day they might take, and I'm just putting some numbers on here, they may take one scoop of pet food and nine scoops of something else. So there's the dilution factor, and that's what is in hog meal.

Once it's in those hogs, we have no evidence that it bioaccumulates. The hogs and the chickens have been physically fine, there's been no evidence they have suffered any illness. The further even if there is any in the hogs or the poultry, the amount of poultry meat or pork meat that is consumed by humans is only a small proportion of the total daily diet, unlike the pets which typically have a specific type of pet food as their exclusive diet.

So there's two pieces to that. So when you compute all that out, the level of melamine and melamine-related compounds that the pets are going to get is going to be significantly higher than anything that would be left in the poultry.

REPORTER: Updated poultry numbers?

DR. ACHESON: Updated poultry numbers I'd ask Ken Petersen at USDA if he has any information on that.

DR. KEN PETERSEN: Okay, thank you. Dr. Petersen with USDA. Now the poultry numbers that we outlined on the call on Tuesday are still the numbers that we're working with, the 30 broiler farms in the one state of Indiana with the approximately 270 million hens that we believe went to slaughter back in March, and then -

2.7 million. I misspoke. 2.7 million head that we believe went to slaughter and out of the one state of Indiana.

And then the approximately 100,000 head of breeder birds that are still resident on the farm, so that's the poultry numbers from Tuesday's call and those are the numbers we're still working with today.

MODERATOR: Dr. Acheson has another comment.

DR. ACHESON: Just to get back to this question of what do we know what happened in the past, I stick with what I said before is that we don't know for certain but the one thing I forgot to mention is that we have looked at the incoming shipments for the two importers where we had the problem with the wheat gluten and the rice protein concentrate. We've looked back through 2007 and 2006 to see where that material went to, and it all went into the pet food side of the arm here. None of the wheat gluten or the rice protein concentrate that was imported by either of the two importers that we've recently had concerns about had anything that went as an ingredient into the human side of the food chain.

MODERATOR: I'm going to go ahead and move us along then because we have a number of other callers. Next question, please?

OPERATOR: Julie Schmitt. Please state your affiliation.

REPORTER: USA Today. Can you tell us anything about this smart pack recall? Are you aware of that?

MODERATOR: Julie, did you Smart Pac recall?

REPORTER: Yes.

DR. ACHESON: Sorry. Can you repeat that question?

REPORTER: This pet food company named Smart Pac has recalled one product in which it says it found melamine, but the product doesn't include any of the vegetable protein raw ingredients from China. Do you have any further information on that?

MR. DAVID ELDER: Julie, this is David Elder. The Smart Pac product was under recall. It was manufactured for Smart Pac by a company called Chenango Valley that has issued a press release, and that product did contain the rice protein concentrate as an ingredient, contaminated with melamine.

REPORTER: No. This is another product. This is something they just did last night.

MR. ELDER: Yes, but it's essentially the same reason as the contract manufacturer and it may not have been an ingredient, but there could have been a cross-contamination issue. But it was, we understand that it was tested, found to contain the same compounds, and we believe it's a cross contamination issue at that same manufacturer.

MODERATOR: Anything else, Julie?

REPORTER: Dr. Acheson mentioned 92 positive contaminated lots out of how many?

DR. ACHESON: What that was is, it was in relation to the 394, 400 or so positive test results that we've had. That represented 92 lots. I don't know whether we have, we don't have total lot number because if it's negative we're not going to go chasing it down. All I can give you is the positive information.

REPORTER: Thank you.

MODERATOR: Next question.

OPERATOR: Nancy Cortis, your line is open. Please state your affiliation.

REPORTER: I'm with CBS News, and I'm wondering if you have any comment on these new reports that it was apparently common practice for Chinese manufacturers to label food products as nonfood products in order to be able to elude Chinese inspectors, and if that is the case what new concerns now you have about other food products?

DR. ACHESON: I think part of the answer to your question is we need to see what the investigators come up with in China. Clearly there are a number of reports that things that are like that which are of interest, but I think we need to wait and see what the facts are and then make some determinations on how to respond to them. But clearly this whole episode has raised questions in areas that previously we were not thinking about so specifically.

MODERATOR: Thank you. Next question.

OPERATOR: Brooke Turnbulle, your line is open. Please state your affiliation.

REPORTER: Actually this is Dan Grutnech from CNN. My question is regarding the cross contamination. What exactly does cross-contamination mean because I've gotten reports from some vets that pets were still dying eating the food that was contaminated by cross contamination, but it seems like if they are just implying that a little food left over in a machine, that doesn't seem like that would be enough to kill these animals.

DR. ACHESON: Cross contamination can mean all kinds of things. To take a completely different example, cross contamination in a kitchen with e-coli 0157 is a frequent cause of human illness, so you can get bacteria crossing between raw meat and salad. This is a situation in which the manufacturer believes there was cross contamination in the facility. I don't have the specifics of the levels that they found of melamine, but they saw melamine and melamine-related compounds, and based on that they said, we need to do a recall.

How the cross-contamination happened and to what extent, I don't know.

REPORTER: But it seems like if the cross-contamination they are talking about is enough to cause the death in animals, then obviously they are implying that it's a very small amount. Wouldn't that then cross over that we should be worried about small amounts in human food?

DR. ACHESON: Well, cross-contamination is a statement of what happened. It doesn't speak to its quantitative nature. You can get massive cross contamination going on. Nor do I know specifically whether they were doing this because of this implicated lot that was cross contaminated was causing illness, or whether they were just doing this out of caution because they became aware of the cross contamination and they said, we don't want to take any chances here.

REPORTER: Are you aware of any human foods that are processed in the same factories as the pet food?

DR. ACHESON: No. There are not.

MODERATOR: Next question?

OPERATOR: Loren Edder, please state your affiliation.

REPORTER: Hi, with the Wall Street Journal, thank you. Is there any contaminated pork and poultry on the market right now currently today?

DR. ACHESON: I would ask Ken Petersen to address that please.

DR. PETERSEN: Okay, thank you. Dr. Petersen with USDA. No. When we described the other day the swine farms in the six states that were of interest and then of course the poultry farm that I just mentioned, for the poultry those 2.7 million head were chickens that had gone to slaughter. They had eaten contaminated feed on one or more days going back as far as February. But having looked at those animals and speaking to the dilution factors that Dr. Acheson mentioned, we have no reason to believe that those animals are of any risk to the public. And the same principles apply to any swine that have gone to market. The 6,000 head of swine that we mentioned last week I believe are still about the same 6,000 on farms that we were identified, and of those 6,000 it appears that perhaps 300 or so had gone to slaughter, and so the same notion of the dilution factors and given what they had been fed, would apply to those animals. So again we don't believe that those are of any risk to the public either.

REPORTER: I understand that you don't believe they are a risk to the public. I'm just wondering if you believe there's any meat that might have been contaminated by this feed on the market today.

DR. PETERSEN: No. We have no reason to believe there's any contaminated meat related to the melamine on the market today.

REPORTER: Okay. So you've ruled out a recall of any meat?

DR. PETERSEN: Yes.

MODERATOR: Net question please.

OPERATOR: Steve Hedges, please state your affiliation?

REPORTER: Chicago Tribune. Dr. Acheson, you mentioned the 394 positive tests for melamine. Can you explain what exactly that means, what levels of melamine were in those tests? And also, could you address whether your confidence it's melamine that was causing animals to fall sick and die or if there's some other possible ingredient that are causing illness and deaths?

DR. ACHESON: Let me just try to deal with your first question very quickly. It was variable, and it varied between 2 and 8 percent of the ingredients contained melamine or melamine-related compounds. Can you just reiterate your second question for me?

Q : There's been some speculation including some from the Chinese government that melamine did not cause the pets to fall sick and die because it hasn't affected other animals. I wondered if you're confident that it was melamine that caused the animals to fall sick and die?

DR. ACHESON: Yes. The toxicity studies that we're aware of would indicate that melamine alone is not particularly toxic unless you feed it in extremely high doses. That was a conundrum from the very beginning as to the explanation amongst many of the veterinarians is how could melamine be doing this? The discovery of the melamine-related compounds, which include a number of things, but one of them that there has been some mention of, something called cyanuric acid. The combination of melamine plus these other compounds appears to be more toxic than either one alone. So melamine alone or cyanuric acid alone is not particularly toxic. You mix the two together, it becomes more toxic, and the thinking is that when you put the two together there is a greater tendency for them to form crystals in the kidneys and lead to kidney failure. So we believe the current hypothesis is that it's a combination of the melamine with the other compounds that is the problem, not just the pure melamine itself.

I just want to correct something I said the first time around, I've just been corrected here, it wasn't 2 to 8 percent. It was 0.2 to 8 percent, just to correct those numbers. So our positive samples are approximately 400 positive melamine samples at ranges between 0.2 percent and 8 percent. I apologize for that.

MODERATOR: Thank you. Next question.

OPERATOR: Susan Heedy, please state your affiliation.

REPORTER: Hi. I'm with Reuters. You mentioned the investigation in China was ongoing. Can you tell us about how many investigators you have over there now and if you will be sending more, and if so, how many?

DR. ACHESON: No, I really can't say anything more about that.

REPORTER: Okay. And this may be a question for Dr. Sundloff. Last week the FDA said it had gotten reports of nearly 2,000 dead cats and about I guess 2,000 dogs. I know they are not confirmed yet, but can you give us an update on the numbers? I think also 17,000 complaints.

DR. STEPHEN SUNDLOFF: I think we don't have any new numbers from that, so I would have to ago back and tally the numbers again. We are continuing to add the - we have more phone calls than we've actually been able to log into our system, and so right now what we are doing is, we are trying to catch up with the backlog and get all those logged in and I imagine when we have our next press conference we can update the numbers. But right now those are still the same numbers that we reported on last time.

DR. MICHAEL ROGERS: I can update or provide some context to that number as we provide it. This group last week, we stated the agency has received more than 17,000 calls from consumers that allege animal illness or death associated with pet food products. Our preliminary review of those, and we've certainly entered a subset of those into our official data system, but the preliminary reviews suggest that as many as 50 percent allege an animal death associated with those pet food products. But as part of a long-term process, the agency will be evaluating those calls and determine their direct association to the implicated product.

DR. ACHESON: I want to emphasize that Michael Rogers said "allege." This does not mean it's definitive proof as I understand that.

MODERATOR: Thank you. Next question.

OPERATOR: Bill Tomson, please state your affiliation.

REPORTER: Hi, Bill Tomson with Dow Jones. I just wanted to get back to the pork and poultry meat that's on the market or apparently not on the market. Is it because it's not on the market, is it because it's already been eaten? And what about frozen products? How do we know there's none of that left on the market?

DR. PETERSEN: As Dr. Acheson indicated, the investigation is quite active, and so the farms that we mentioned are the ones that we're well aware of that appeared to have received the contaminated feed, and so those farms are the ones that either some type of control is being exerted at the state level. So those are the ones that we are aware of.

As was also mentioned, this relates to the pet food trace back, and pet food trace back is as I understand it winding down. They have pretty well gone to all these pet food manufacturers and through that process is how we became aware of some of this pet food making its way as a small component of animal feed.

But that investigation is still going on, so the farms we're aware of and the animals from those farms, those poultry or swine that have gone to slaughter, are the ones I mentioned. There's still other animals resident on those farms, and the local actions are preventing them from moving to slaughter. We are continuing to look for additional information in what additional information can inform us about the status of those animals particularly on the farm. But we have no reason to believe there's any risk to the public from those animals that are already, those birds or few hundred head of swine that were already slaughtered that made it's way into the marketplace.

REPORTER: But I just want to be clear. With 3 million head of chicken that were slaughtered in February, I want to make sure I'm clear on this - it's your belief those, you said they were processed and went into commerce, they've already been consumed by the public. And it's unclear whether the meat itself is tainted, but if it is it's already been consumed by the public?

DR. ACHESON: There's just no evidence of any harm to humans from that chicken or pork.

MODERATOR: Thank you. Next question.

OPERATOR: Andrew Martin, please state your affiliation.

REPORTER: Hi. I'm with the New York Times. I had a question about this current proactive program you're talking about, Dr. Acheson, and that is given the fact that you mentioned these vegetable protein concentrates veer off into all sorts of directions, how have you determined which manufacturing facilities to visit?

DR. ACHESON: Based on our import records and based on company registrations and other information that we have about who does what and what ingredients, that's been the basis of the dataset that's used to initiate this investigation. That's been combined with local knowledge of our state's locals and the local investigators in terms of who they know to visit. But essentially it's based on the data that we have of what ingredients go to which manufacturer.

REPORTER: Do you have any sense of the extent of that, how many manufacturers you're talking about and how long it might take?

DR. ACHESON: I'm thinking hundreds, but that's pretty much of a guess. It's in that range, and this is going to go on until we feel satisfied until we've got it covered. We are not setting the bar at 50 or 100 or 1,000. We'll keep doing this until we're confident that we've got our arms around it.

MODERATOR: Next question, please?

OPERATOR: John Rockoff, please state your affiliation?

REPORTER: Hi. I'm from the Baltimore Sun. I was just wondering whether you've found any melamine or related compounds in any other vegetable protein products besides the three you've identified so far, and whether you've identified any other importers who received tainted imports?

DR. ACHESON: Just to clarify, so far in the United States we've only found it in wheat gluten and rice protein concentrate. You may be thinking the third one is corn gluten. That's not been found to be a problem in the United States. That was found in South Africa several years ago. So we're only aware of two in the United States. Can we rule it out being in any others? No. That's why we're doing what we're doing at the borders and with the domestic assignment.

REPORTER: But you haven't found it in any of the others?

DR. ACHESON: That is correct. We have not found it in any of the others.

REPORTER: And what about any other importers besides Wilbur Ellis and Chemnutra?

A: No. We have, obviously the import alert has not been going more than several days, so but to date all the positives that we have found have been linked to those two companies that we were already aware of.

MODERATOR: Next question?

OPERATOR: Heather Harland, please state your affiliation?

REPORTER: NHK Japan. I had some questions regarding the import alert, and I just want to make sure I understand it properly. It's been reported in different ways and different media and looking at the documents, my understanding is there were three separate import alerts issued, one for each of the two Chinese companies involved, and then that would detail those products, and then the separate one which detains all vegetable proteins coming from China. But my understanding when I called the FDA they said in the case of the two Chinese companies there was an outright ban of products from those companies. It was also reported I think in the New York Times that all wheat gluten from China is indeed banned. So, then but my understanding is the import alert for all of China is different in that way, that it's not a total ban, it's merely a detention of those products, subject to further testing. So I just wanted to clarify that because the language in all those documents is identical but it seems as though the situation with all of them is different.

DR. MICHAEL ROGERS: Let me put into context - you listed a lot of facts, many of which were things, activities the agency took over a period of time. It's true when we encountered this problem we were initially focused on two suspect sources in China. As we announced last time though, the agency has taken more proactive approach and initiated a countrywide import alert which is that detention without physical examination for various vegetable protein products that includes from all manufacturers including the two suspect firms that are associated with all our positive samples. What this means for clarification is that these products are targeted at the border for 100 percent priority review and hold, which shifts the burden on the importer of record to demonstrate that their product is not contaminated nor adulterated. The present import alert, the countrywide import alert for various vegetable protein products is posted on the FDA website and provides additional guidance as to what firms need to do to go through this process.

MODERATOR: Heather, did that make sense, does that help?

REPORTER: Sure. Can I just ask one follow-up question because you said earlier that the wheat gluten was labeled as wheat gluten when it came to the United States because there have been reports that said it was labeled as textiles where it came to a third party textile manufacturer. It was not labeled as a food product when it came from China. Is that still true or did you determine that wasn't the case?

DR. ACHESON: No. As far as we are aware, it came in labeled as wheat gluten. Possibly some of that confusion may have been linked to the fact of the

exporter from China exports a variety of different products. They don't just export wheat gluten. They export a variety of things, and textiles may be one of them, and it maybe that part of the mixed message is the exporter exports a variety of different things, one of which was textiles. But we're not aware that it came into the United States labeled as textiles.

REPORTER: But you're still not aware of how it went out of China then? It's still possible it went out of China labeled as textiles. Is that possible or not?

DR. ACHESON: I'll ask Michael Rogers to address that.

DR. ROGERS: This is Michael Rogers. What we are referencing is how the shipments were declared in our import records as they were for import into the country. We don't have records, and we don't capture how products are declared leaving China.

MODERATOR: Next question, please?

OPERATOR: Steve Dale, please state your affiliation?

REPORTER: WGN radio, USA Weekend, Tribune Media Services. And one of you and I don't know which one mentioned that going back to 2006 conceivably - no. Let me say that correctly. Going back to 2006 is a fact that melamine was found not in the human food route but in the pet food route. If that's the case, pets have been suffering from kidney failure for a very long time. I wonder if it's possible that this has played a role in animal health, our companion animal health, for a very long time, or at least much longer than just the pet food recall, speaking of which as some of my colleagues have mentioned - let me just put it in very, I don't know about international trade at all, and I'm very ignorant about this. But it seems as though if there's any question whatever, any doubt whatsoever, rather than checking just possibly everything, why isn't there at least for the time being a ban on these products that are being imported into the United States on the protein concentrate? Why don't we just say, let's stop it until we're certain?

MODERATOR: I think there's some confusion here. And I want to make sure because this is a very important topic, I want to make absolutely sure that it's clear what we're saying and what the situation is. I'm going to ask Dr. Acheson and others to go back and explain this again.

DR. ACHESON: Let me try to clear up the 2006 issue that you started out with. Our investigation of imported product involved two specific aspects that I want to clarify with you. One is some testing and the other is some tracing in terms of where that product was used. In terms of the testing, certainly some of the product used in 2007 was positive, and some of the product in the latter part of 2006 was positive for melamine and melamine-related compounds. Based on the records that we have traced back, we've asked the question if you go back prior to the point at which we've got positives, and we don't know they are positives because it's all gone, but the record is there, we asked the question: where did that product go? And it all went into pet food rather than human food.

So if some of those samples early in 2006 had been positive, and we don't know they were because they've gone, what we can say with certainty based on the records that we reviewed is that if they were positive they went into pet food, not human food. Now you're asking why that didn't make pets sick. Well, we can't exclude that it didn't make pets sick. All we can say is that it didn't make them as sick as in 2007 because it didn't come to anybody's attention. But we cannot rule out that it didn't make pets sick.

REPORTER: So it's possible that pets have been infected by this in an undescribed way for awhile?

DR. ACHESON: It's certainly possible, but as I said it did not come to anybody's attention, but it's certainly possible. Then you're asking why there isn't an outright ban on this. Well essentially the import alert is not a ban because there are many people importing products into the United States, probably with no melamine in whatsoever. The purpose of this is to catch those that are coming in with melamine in them, stop it, and then following specific set of criteria that are laid out in the import alert, if it's negative and it can be proven to be negative for melamine then by all means allow it into the United States for use in U.S. commerce.

So the goal there is just not an out and out ban but to use a filter if you like to make sure everything is held up, examined, looked at, assessed, and then only let through the filter when we know it's okay.

REPORTER: Are you confident that filter is 100 percent foolproof?

DR. ACHESON: Nothing is 100 percent foolproof.

MODERATOR: We're going to go on to the next question please. Thank you.

OPERATOR: Karen Roebuck, please state your affiliation?

REPORTER: Hi. I'm with the Pittsburgh Tribune Review. Thank you for taking my call. I was wondering if any of the contaminated feed made its way to cattle or any animals other than chickens or swine, and how many farms are being quarantined in the U.S. or put on hold pending an investigation even if you don't know that you have stopped, even if you don't know that they are positive?

And also I'm hearing from readers who are concerned that once the pet food was recalled they started making chicken for their pets, and now since the pets are more susceptible to melamine and the related compounds, they are worried that they may just be giving them another contaminated product. Do they need to worry about that?

DR. ACHESON: You've asked a lot of questions there. Let me see if I can remember where you started out. Cattle, thank you. We're not aware that any of this went anywhere other than hogs, as we've described. No evidence whatever that it went into cattle. In terms of the numbers of farms, I'll ask Dr. Petersen to address that one.

DR. PETERSEN: The total number of farms has been static the last couple days, and it remains at 30 poultry-related farms, broiler-related farms, in the one state of Indiana, and then 8 swine-related farms in the six states, California, North Carolina, South Carolina, New York, Utah and Kansas. So those 38 farms total are the ones that are of interest today.

MODERATOR: Dr. Sundloff, could you address the question?

DR. SUNDLOFF: The question about concerns from pet owners because now they are preparing their own pet foods at home and they contain chicken and whether or not these animals are more susceptible to melamine, well first of all there's no indication that pets are more susceptible to melamine at this point. We still don't really understand how this whole syndrome affects animals. But one thing that we have tried to make a point of repeatedly is that we don't recommend that pet owners prepare their own pet foods, at least not over a long term, because pet foods are nutritionally balanced to meet all the nutritional needs of the pet. Just feeding chicken or single other ingredients is not always in the best interest of the pets. So the veterinary community in general is opposed to homemade diets unless you really know what you're doing and understand how to nutritionally balance a pet food, and most people, myself included, would not be able to do that.

MODERATOR: Thank you. Let's take the next question, and folks I know you are very interested in all this, but if you could limit yourself to one question and one follow-up we'd appreciate it so we can try to get through everyone this evening. Thank you.

OPERATOR: David Brown, please state your affiliation?

REPORTER: With the Washington Post. If this had occurred in human food supply, presumably there would be a case control study done early on to see what the, how strong the relationship was between various foods with the illness. Has anyone done that? Is there some analog to the epidemic intelligence service in the veterinary world so that we can get some sense of how much of a dose it takes to get this and sort of how different this is from the general epidemiology of renal failure in cats and dogs?

DR. SUNDLOFF: There is no equivalent to the EIS in the veterinary world. We are in close contact with a number of the veterinary professional organizations including the American Veterinary Medical Association, and the American Association of Veterinary Laboratory Diagnosticians. These are the folks that operate in the animal disease diagnostic laboratories and see a lot of these cases. And while there is no similar organization for veterinary medicine, in this case the correlation was so strong that it really doesn't require a case controlled study. We pretty much know which products were causing death and illness in the animals. They had that very dramatic effect. And so now we are trying to understand, you asked about the dosage and how much it would take. We still don't know the answer to that. We know that the wheat gluten contains variable amounts of melamine, but some of those concentrations were very high, as high as 9 percent I think is the highest number I've heard. And there are a lot of people right now trying to work on that issue as I mentioned the number of the veterinary organizations, certain colleges of veterinary medicine are also trying to conduct studies to understand better the relationship between melamine, cyanuric acid, and some of the other components that we found in the wheat gluten and rice protein concentrate.

So as things go on further we should have a better understanding of this, but right now we're still gathering information.

MODERATOR: Thanks. Next question.

OPERATOR: Steve Osbey, please state your affiliation.

REPORTER: Yes, thank you. The Greenville News. I'm having kind of a hard time understanding how such a small amount can do so much damage. You said that fewer than half the samples tested positive and then only between 0.2 and 8 percent contained melamine and melamine compounds. What portion of the pet food is wheat gluten or rice protein? And considering the low levels, is FDA investigating any other possible contaminants?

DR. ACHESON: I think I might have confused you a little bit. I apologize for that. We talked about a lot of numbers today and I think your question just illustrates the complexity of this whole investigation. When I mentioned 0.2 to 8 percent, what I was referring to is in the wheat gluten samples that we have tested that were positive, the question was what level, what was the percentage of the wheat gluten, the melamine content of the wheat gluten? What that means is, that in a specific sample of wheat gluten, in some it was up to 8 percent melamine and in others it was as little as 0.2 percent melamine. That's where those numbers came from.

The contaminated wheat gluten was then used in varying proportions to make the pet foods. And then it was those pet foods that were fed to the pets.

REPORTER: What proportion?

DR. ACHESON: I think it was probably fairly variable. I don't know whether Dr. Sundloff's got - I'm hearing about 5 to 10 percent of the pet food ingredient is wheat gluten. It's maybe on the high end. If you want the specific number on that I'm sure we can get that to you, but that's what the estimate is right now. I don't have a specific number.

REPORTER: That still sounds like such a small amount. So are you looking at other possible contaminates?

DR. ACHESON: What do you mean other possible contaminates?

REPORTER: Is there something else that might have caused this?

DR. ACHESON: We found no evidence of anything else causing this. The one thing that had changed in the formulation was the wheat gluten, which is why it focused on the wheat gluten. We looked at that for a variety of potential agents that could cause harm, and the melamine, melamine-related compounds is the only thing that's come up. I think as I tried to explain earlier, we don't believe the melamine alone is the cause of this. It is somehow the combination of the melamine and the melamine-related compounds. It seems under certain conditions in certain pets to form crystals in the kidneys and that's the problem. As Dr. Sundloff alluded to earlier, there's a lot of questions that we don't have answers to in terms of exactly how that happens and how frequently and the precise concentrations that is needed. But that's the current hypothesis as to how this happened.

MODERATOR: Thank you. We started late, so why don't we take two more questions, and that will get us right around an hour. Next question, please?

OPERATOR: Alan Bjerga, please state your affiliation?

REPORTER: Bloomberg News. So understand this, since you put in the import restrictions, you've done about 700 tests and about 394 of them have been positive, correct?

DR. ACHESON: Too many numbers in one press conference. The 700 samples that I said have been tested are not from the import alert. Those are total numbers of tests that we've done. The vast majority are related to the recalled products, and there are some others. So this is not just import alert. That's everything.

REPORTER: Okay, but all of the positives have been related to the two plants that you've had problems with?

DR. ACHESON: That is correct.

REPORTER: Okay. So do you think that shows that this is a limited problem?

DR. ACHESON: Today? Yes, but we would be complacent to not be proactive and get out there and look in other areas, which is exactly what we're doing through the import alert and the domestic assignment.

REPORTER: Thank you.

MODERATOR: Our final question this evening please?

OPERATOR: Elizabeth Weiss, please state your affiliation?

REPORTER: Yeah, it's Elizabeth Weiss with USA Today. Thanks for taking the call. Can FDA rule out other cross-contamination likely in other foods or plants?

DR. ACHESON: I don't quite understand your question.

REPORTER: We've talked about cross contamination would be a problem even in products which ostensibly don't contain wheat gluten or rice protein concentrate. But they were cross contaminated in the factories where they were made. Can we at this point rule out that possibility in other foods or other plants making different foods than these pet foods?

DR. ACHESON: Let me try to answer that in a slightly different way and hopefully it will address your question. I want to reiterate that all the contaminated wheat gluten and rice protein concentrate have only gone into pet food industries. They have not gone into the human ingredient foods. The only connection with the human food is through the poultry and the hogs as we've discussed. So even if there were cross contamination going on in a human food facility, it would be moot in the context of this argument because there's no contaminated wheat gluten or rice protein concentrate gone in there in the first place for the two plants that we know were problematic.

To get to your specific point, no of course we cannot rule out the cross contamination isn't happening in a food plant. Cross contamination is something that our investigators are always on the lookout for because it's always of a concern for example in the area of allergens. So it's an important thing that we look at. But hopefully you understand where I'm going with that is that because none of this has gone into the human food supply that we're aware of with all the extensive trace-forwards and trace backs, the question is kind of moot in the context of the human food.

REPORTER: And there don't exist anymore plants that make both human and pet food? I am presuming, but I just want to check?

DR. ACHESON: No. Not that we are aware of, and certainly the ones that were part of this outbreak the answer is no. I would like to say 100 percent there isn't some small person somewhere in the back room making human food. I don't know. A definitive never on that but I want to emphasize that everything we've investigated as part of this situation the answer is no.

REPORTER: Okay. Thanks very much.

MODERATOR: You're welcome. With that, ladies and gentlemen, I'd like to conclude this briefing and thank our speakers and our FDA officials and our official from the USDA Dr. Petersen for joining us today. If you have follow-up questions I invite you to call FDA and USDA. FDA's number is 301-827-6242. USDA's number is 202-720-5509. I suspect you already have those numbers, but I always like to give them out. We will plan another briefing on Tuesday afternoon at 4:00 p.m. We invite you to join us then, and until then if you again have follow-up questions just call us or send us an e-mail. Thank you very much, and have a nice evening.