Ortiz v. Menu Foods, Inc. et al

Filing 19

REPLY re 9 MOTION to Remand to State Court filed by Yvonne Ortiz. (Attachments: # 1 Declaration of Thomas R. Grande# 2 Exhibit 1# 3 Exhibit 2# 4 COS)(Grande, Thomas)

Ortiz v. Menu Foods, Inc. et al

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Transcript of FDA Press Conference on the Pet Food Recall FTS-HHS FDA Moderator: Julie Zawisza April 19, 2007 3:00 pm CT

Coordinator:

This is a recording of the conference call scheduled April 19, 2007, at 3:00 pm, Central Time, with FTS-HHS FDA. Conference title is "Pet Food Update." Good afternoon and thank you for waiting. All participants will be able to listen only until the question and answer portion of the call. At that time, to ask a question, please depress star-1. This conference is being recorded. If you have any objections, you may disconnect at this time. I would like to introduce your speaker for today's call, Ms. Julie Zawisza. Ma'am, you may begin.

Julie Zawisza:

Thank you. Ladies and gentlemen, welcome. And I do apologize for this delay this afternoon. Thank you for joining us.

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Today, we'd like to bring you on FDA's investigation (to-date) of the contaminated pet food. We have three speakers here who I'll introduce in moment. Will someone please put your phone on mute? Thank you. The format for this afternoon is you will hear remarks from our speakers and updates and then we will take questions. Our three speakers today are as follows: Dr. Stephen Sundlof, the Director of our Center for Veterinary Medicine; Michael Rogers, Director of our Division of Field Investigations in FDA's Office of Regulatory Affairs; and Captain David Elder, Director of the Office of Enforcement in FDA's Office of Regulatory Affairs. At this time, I'd like to turn this over to Dr. Stephen Sundlof. Stephen Sundlof: Thank you, Julie, and thank you, everyone, for joining in the call. In keeping with our Commissioner's policy and emphasis on communications, we will be holding regular and predictable press calls and conferences to keep you better informed about the ongoing investigation. And I would like to bring you up on the latest developments now. Just as a side, we certainly understand how important pets are in Americans' lives. And we understand that a lot of the information that we are putting out is sometimes confusing. It doesn't contain all of the information that people would like and we apologize for that. But this is - we were trying to get
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information out as soon as we learn anything new so that we can prevent any further illnesses or deaths or losses of pets that we all care so much about. On Sunday evening, the Agency was notified by an import company named Wilbur-Ellis that they had received the shipment of rice protein concentrate from China that contained a bag labeled, "Melamine." Subsequent testing by the FDA detected melamine in the imported rice protein concentrate, and the importer, Wilbur-Ellis, has tracked and recalled the entire shipment of rice protein concentrate product. Rice protein concentrate is used as a protein source in some pet foods, although it does not appear to be widely used in North American products or as widely as wheat gluten. Wilbur-Ellis, the importer, shipped the rice gluten concentrate to five US pet manufacturer - pet food manufacturers. To-date, the presence of melamine has only been confirmed in two of the product lines - Natural Balance Pet Foods, and both of those product lines are from Natural Balance Pet Foods. As a precaution, though, all production dates for these products have been recalled. Natural Balance has confirmed that melamine has been found in some of its venison-base food, and has suspected rice protein because it was the only new ingredient in the food. Natural Balance tested the food after consumers reported dogs and cats suffering kidney failure. Natural Balance has voluntarily recalled all of its Venison and Brown Rice canned and bagged dog food, its Venison and Brown Rice dog treats, and its Venison and Green Pea dry cat food. The Pacoima, California company recently added rice protein concentrate to the dry venison formulas. As you are aware, melamine is the same industrial chemical that was found in wheat
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gluten imported from China and used in pet food made by Menu Foods, which recalled 60 million cans and parcels of dog and cat food in mid-March. FDA is bearing no resources as this work continues. Our field staff continues to sample 100% of wheat gluten coming into the United States from China, and is also sampling all rice protein concentrate. Additional products will be added as we receive information. Any product from the two firms in China who were the source of melamine - of the melamine contamination is stopped as it comes into this country and is examined physically. At this point in time, FDA's inspection and investigation staff continues to proactively and aggressively sample products coming through our borders, and has increased surveillance of products coming in from China. FDA recognizes that pet owners' concerns have not diminished by this recent development, but we are confident that all components of the FDA, our state and local counterparts and the pet and human food industry are working very closely together to identify and halt any further contamination. Thank you. And I will now turn this back over to Julie Zawisza. Julie Zawisza: Thank you, Dr. Sundlof. Ladies and gentlemen, a point of clarification. I said we have three speakers. We have three FDA officials here; Dr. Sundlof's prepared remarks are the only ones you'll hear today, but we have three officials here who will now take your questions. So, let us give you a moment to get in to the queue. Coordinator: Once again, if you would like to ask a question, please depress star-1. One moment please.
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Julie Zawisza: Coordinator: Julie Zawisza:

Operator, we'll take the first question when you're ready. Thank you. One moment. And I ask that you state your name and affiliation please and we'll take one question and one followup. And then, if we can get to everyone's questions, we'll start a second round. Do we have any questions?

Coordinator:

Diedtra Henderson of Boston Globe, you may ask your question. Hi, thank you for doing this.

Diedtra Henderson:

You talked about domestic efforts to do more sampling of product coming in from China. Can you give an update on the visa status for FDA officials who want to go over to China to do the investigation there? Michael Rogers: I'm not sure. Julie Zawisza: Mike Rogers will take that question.

Michael Rogers: This is Michael Rogers. We've expressed in the past the challenges associated with the authorities we don't have in China versus the inspection authorities that we do have in the domestic arena. To initiate a foreign inspection in China -- and the Agency is actively pursuing doing so -- we need the actual firms to be identified, but the process goes through the Chinese Government.
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The Agency has initiated a number of letters seeking the appropriate information to initiate those inspections. We fully expect the Chinese Government to cooperate and look forward to doing those inspections. Diedtra Henderson: And just a follow-up question.

There have been some reports of tainted corn gluten. Has the FDA heard obtained of corn gluten making it into the pet food, and is that one of the additional products that you mentioned, Dr. Sundlof? Stephen Sundlof: Yes. Well, we do have a report of contaminated corn gluten that was used in South Africa to make a pet food product, but we don't have any information that corn gluten was imported - contaminated corn gluten was imported in the United States for pet food production. Diedtra Henderson: Are you still there?

Stephen Sundlof: Yes. Yeah. Julie Zawisza: Okay, I think... Thank you very much.

Diedtra Henderson:

Stephen Sundlof: Uh-huh. Julie Zawisza: You're welcome. Thanks, Diedtra. Next question.

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Coordinator:

Carrie Peyton Dahlberg of the Sacramento Bee, you may ask your question. Well, my first question leads right after the one just asked.

Carrie Peyton Dahlberg:

Now that you're doing border checks or stepped up checks of rice protein and wheat gluten, what are your plans to do checks for other protein enhancers, such as the Chinese corn gluten as well as various soy powders and (flowers) and (isolates)? They could also be the targets of a (test to boost apparent) protein content. And my follow-up question is, as you've been doing these checks, have you found any other melamine? And how often? Michael Rogers: Well, I'll answer last first. Michael. Presently, we have no positive melamine samples associated with any other products except wheat gluten and rice protein concentrate. The agency is taking a number of proactive steps at the border, at domestic (Cantonese) to broaden our focus. If you'll recall, the Menu Foods investigation and this particular incident are separate recall events but very similar with respect to (fact patterns) and the common variable and all this appears to be the country of origin. From a product perspective, at our imports, at our domestic (Cantonese), at our manufacturers of both pet foods and other products, we're looking at those. I don't think it's appropriate to go into detail about what those steps are, but we're certainly actively looking at that.

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Carrie Peyton Dahlberg:

I'm sorry, I didn't quite hear my second question answered. As

you've done these additional border checks, have you found one melamine in - other than the samples that Menu and Wilbur-Ellis knew about? Michael Rogers: As I mentioned, Wilbur-Ellis is the importer of record associated with the positive melamine findings associated with the rice protein. And only - we only have positive samples of melamine associated with either wheat gluten or the rice protein concentrate. Julie Zawisza: Thank you. Next question. Coordinator: Julie Zawisza: Brian Hartman of ABC News, you may ask your question. Brian? Operator, let's go to the next caller. And then, if Brian gets back in the queue, we'll take him. Coordinator: Thank you. Andrew Bridges of AP, you may ask your question. Andrew Bridges: Hi. Thanks for taking my question. People have told me and I've seen it reported elsewhere by my colleagues in the media that melamine could possibly be used to spike products to make them appear to have a higher protein concentration than they actually do. Do what does the FDA know about that?
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Stephen Sundlof: Well, the... Andrew Bridges: And then also, in the Wilbur-Ellis case, what was the concentration of melamine found? Could it be explained by a reused bag or was it in higher concentrations? Stephen Sundlof: To answer your first question, we are aware of the fact that you could melamine would artificially increase the protein content. That's still a theory because we have not been into the Chinese manufacturer; we haven't been able to do those inspections yet. It's still only a theory and - but it certainly seems to be a plausible one. The concentration of the melamine and the material that was found in the bag labeled, "Melamine," I don't know if we have that information on what concentration. Julie Zawisza: Do we know, Dave or Mike?

Michael Rogers: We have a range. But again, I don't know if it would be fair to articulate what that range is right now and that we have ongoing samples that are presently in the queue. And so that - by the time we report it and it gets printed, it might be changed. Stephen Sundlof: Okay. Yeah, so I don't think we're in a position to speculate now as to whether or not that was just contamination from the bag or whether or not that was actually added to some substance in there to make it look like rice protein concentrate. But we should, you know, I think that information will be coming out as soon as we do some confirmatory assessments.

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Julie Zawisza:

Thank you. Next question.

Coordinator: Brian Hartman:

Brian Hartman of ABC News, you may ask your question. You know, I still don't think you - I heard an answer to the question from the Sacramento Bee about whether anything was found in border checks. Now, I know you mentioned this melamine from the rice. But if I heard you correctly, that was found because they tested the food after dogs and cats reported kidney failure. I think the question was whether any more was found in the border checks. And is anything else going to be recalled? These other companies - that we still apparently don't know the names of these four other companies that received this rice protein?

David Elder:

This is David Elder. I'll try to answer those questions. The finding of the positive melamine in the rice protein concentrate is a new development as of this week and the sampling criteria for rice protein concentrate has been added to the import screening criteria. So, the answer is no, any shipments that - of rice protein concentrates that have been offered for import, if there even were any, since earlier this week till now have not shown the presence of melamine. So the answer is that we've just started that screening criteria based on the information obtained regarding the positive. So, anything that comes in will be screened. And if we find it, obviously the shipment will be condemned and...

Brian Hartman:

Well, how about wheat gluten? Has anything you've tested showed positive for wheat gluten that you found coming at the border?
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David Elder: Brian Hartman: Julie Zawisza:

The answer to that is no also. Okay, thank you. Thanks, Brian. Next question.

David Elder: Julie Zawisza: Coordinator: Julie Schmit:

You had another question there too, Brian? All right, Brian, go ahead. Julie Schmit of USA Today, you may ask your question. Thanks for taking my question. I think Brian's other question was, if four other companies got this rice protein concentrate, should we expect them to recall products?

Julie Zawisza: David Elder:

Thanks, Julie. Yeah, this is David Elder again. I would expect the companies to recall products if food product - if pet food products were made from contaminated rice protein concentrate. And FDA is actively following that trail of where they went. And the investigations are ongoing. We have investigators in each plant following that trail; the companies have been notified. And we're investigating to determine what, if any, products were made and we would expect the companies, when
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presenting with the information that FDA has on the positive samples, to initiate the action. We're working with them to communicate the results and to determine what was made, where it went and to initiate the appropriate action as a result. Julie Schmit: Okay, thank you. And just a clarification, if - the melamine was found in a peat bag of WilburEllis but also other (base), correct? David Elder: Julie Schmit: Julie Zawisza: Yes. Thanks. Thanks, Julie. Next question. Coordinator: Susan Heavey: Susan Heavey of Reuters, you may ask your question. Hi. Thanks for taking my call. Dr. Sundlof, can you give us an update on the number of illnesses or deaths from the FDA's investigation so far. Stephen Sundlof: No. We continue to get thousands of phone calls reporting cases. And again, we have not had the opportunity to really sit down and work our way through that. We are consulting with the Centers for Disease Control and Prevention to help us in that effort as well as the American Association of Veterinary Laboratory Diagnosticians and the (band) - pet hospitals to try and make sense
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out of this whole thing. But at this point in time, we don't even have a good estimate of what that number might be. Susan Heavey: Okay, I think the number you gave last week on Capitol Hill was more than 14,000 calls so far. Stephen Sundlof: Yes, we were over 15,000. Susan Heavey: Over 15,000. And I may have missed this earlier, but the name of the five manufacturers that have received this rice protein, who are they besides Natural Brand? Stephen Sundlof: Right now, we're in the middle of that investigation, and so we're not releasing the names of those manufacturers other than the Natural Balance folks. So, as soon as we are able to confirm that they're either - that they - if they actually have manufactured with the rice concentrate - protein concentrate from Wilbur-Ellis, then we will announce the names. Julie Zawisza: That was Dr. Sundlof. Next question please. Coordinator: Patricia Sullivan of Washington Post, you may ask your question.

Patricia Sullivan: I'm trying to get a sense of how widespread the use of rice protein concentrate is in pet food manufacture. You said it's not as well used as the wheat gluten, but I don't have a sense of how many sort of recalls we might see.

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Stephen Sundlof: I don't have that information in front of me right now. We can certainly look into that and try and address that issue. But at this time, I don't have a good answer for you. Julie Zawisza: Okay, Pat. We'll have to try to get back to you on that.

Patricia Sullivan: Okay. Julie Zawisza: Thank you. Next question. Coordinator: Rick Perlstein: Rick Perlstein of The Nation, you may ask your question. Yes. Now that we know that corn gluten was found to have caused contamination at South Africa. Why aren't you sampling for that at the border? Stephen Sundlof: Well, my sense is that, you know, we are expanding the number of products that we are stopping at the border and testing and it may very well be that corn gluten is among those. But at this time, we haven't announced all of the different products that may be subject to retention at the border and subject for further testing. Julie Zawisza: Michael Rogers, you have something.

Michael Rogers: Yeah, we're taking a number of proactive steps in the domestic arena and at the port of entry. And I can tell you that they are not strictly limited to wheat

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gluten and rice protein concentrate. They include an attention to other products. Julie Zawisza: Thank you. Next question. Coordinator: Woman: (Unintelligible) of Detroit Free Press, you may ask your question. Hi. Thanks (for answering my call). I'm wondering, since there are four other companies that we don't know about yet and we don't know if they're going to recall products, what are you telling pet owners? And they - should they just stop buying pet food or should they just (start making) it themselves? What would you suggest? Stephen Sundlof: We have - we're suggesting as, before, to check our Web site. As soon as we get new information on recalled products, we are putting them on our Web site. We have reconfigured the Web site because we knew it was confusing to try and find all of the different brands of products that may be subject to recall. So, we've reconfigured it such that they're - you can - people can search on a single brand name and determine whether or not that's part of the recall list. And they browse by cat or dog's (brand of) food. So, certainly, before making a purchase of pet food, we strongly encourage consumers to check the Web site to make sure that that's not on the recall list. If they have products in their home that they are feeding, again check the Web site. As soon as we find out that a product is subject to recall, it will be on the Web site. And that's pretty much the information that we can offer the public at this time.
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Woman:

Should people be worried about the human food supply, too? (Maybe), (it's) something that...

Stephen Sundlof: Well, we certainly are looking into that. But in this case - in the case of this contaminated rice protein concentrate, we know that all the consignees of this company, the importer, Wilbur-Ellis, are pet food companies. So, at this time, it looks like it was - the intent was at least to make pet food out of it. Now, that doesn't mean that it can't - it couldn't have gotten diverted to other products. We are tracing it just as we do all of the wheat gluten at this time to determine whether or not it may have gotten into human food at this particular time. Now, we - where we trace it is to pet food. Julie Zawisza: Woman: Julie Zawisza: Coordinator: David Kerley: Thank you. Okay. Next question. David Kerley of ABC, you may take - ask your question. Thank you very much. It seems to be kind of (unintelligible) around the issue here. Since this started, the question was, was this an accident, was this intentional? If they are trying to spike the food -- you said that it's plausible -- is that now your focus of your investigation? Is this a company's attempt to improve their product that sell in United States that has killed and sickened all these animals?

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Stephen Sundlof: Well, our intent right now, David, is to go into the - get into China and to actually inspect these plants. It is - I think it adds to the theory when you see other products that are labeled as "Protein Supplements," and in this case, rice protein, and in the South African case, corn gluten, and in the previous case, it was wheat gluten. (Because) Melamine was found in all three of those, it would certainly lend credibility to the theory that this was intentional. But... David Kerley: But...

Stephen Sundlof: Go ahead. David Kerley: ...now, (if) (unintelligible) that it is intentional. Go ahead.

Stephen Sundlof: I said it would lend credibility to the theory that it may be intentional. And that's certainly one of the theories that we will be investigating when we do get into these plants in China. ((Crosstalk)) David Kerley: ...looking more and more like that, that these companies intentionally did it. Can you explain it from a food (science) purpose or reason why the company wanted to do it? Does it make the product more valuable or what is - why would you do this to these protein supplements to get them in the US and get them into the food? Not that they were - tried it to kill animals but apparently improve their product, right? Stephen Sundlof: Yes. I mean, there's - again, they - the motivation would be economic and that you can take a product that is low in protein and would not qualify for the designation, for instance, as wheat gluten, because it may not contain the kind of protein content to qualify, and a substance that, from a chemistry
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standpoint, makes it appear to have higher protein than it does so that it can be marketed and sold at the price of wheat gluten or rice protein concentrate or corn gluten but - that are labeled to - by definition must contain a certain level of protein. David Kerley: Thank you very much. Somebody's (light there is on). It's - and they're - (came up in the) signal just so you know. Julie Zawisza: David Kerley: Julie Zawisza: Thanks for letting us know. Is that better? It's fine now. Okay, thank you.

Michael Rogers: Yes. This is Mike. I'll answer that. As Dr. Sundlof had mentioned, what we expect to do with our inspections in China will answer some of those questions. It's a challenge to comment about intent without doing direct inspections of the sources in China. But the headline is, it shouldn't be there and raw materials and finished pet foods that contain traceable amounts of melamine are considered adulterated. As more information becomes available, we'll disclose that. But as we said, this is an ongoing investigation. Our goal is to work to inform the public. We're trying to take efforts to ensure the safety of the pet food supply.

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But there's also a targeted message here. And that message is there is an industry responsibility to know who their suppliers are, to exercise some diligence with respect to their suppliers of raw materials as well. Julie Zawisza: Thank you. That was Michael Rogers. Next question. Coordinator: Christie Keith: Christie Keith of Universal Press, you may ask your question. Hi. Yes, Blue Buffalo has just pulled one of its foods during this conference. Is that one of the other four companies that received the Wilbur-Ellis shipment? And do you expect further recalls to be announced today? And if so, what company? Julie Zawisza: David Elder: Christie Keith: Hold on one second. Could you repeat the exact question you're asking? Blue Buffalo just recalled one of its foods during this conference. Is it one of the other four companies that received the shipment from Wilbur-Ellis? And do you expect further recalls today? Man: David Elder: (Do we know what happened)? That is one of the companies that we're investigating. We're aware of that company.

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We are - there was a question a little while ago about do we expect further recalls and what are pet owners advised to do right now. And as we said, we are tracing every shipment of this rice protein concentrate that went from Wilbur-Ellis to the other pet food manufacturers. And we are not weeks away from decisions, we are hours or maybe a day or two away from decisions to make sure that we understand where these products went, what, if any, pet food was manufactured from it to advise the responsible firms of the findings and collect additional samples to conduct analyses. We're doing an investigation to get at the - all of the products that are affected by this. And as we continue to investigate, as you can imagine, we are following the trails wherever they lead. And other firms may emerge, we just don't know yet. It's very early in the investigation. We're tracing them, and as soon as have information, we are out in front sharing it because we think (it's been)... Christie Keith: You don't you have that information now that you know the other three companies and you're not sharing it? David Elder: We don't know what, if any, products were made yet. As soon as we find out what, if any, products were made - the responsible firms, as has been in a past case with wheat gluten, have been taking the appropriate steps to remove their products from the market. Christie Keith: Julie Zawisza: ((Crosstalk)) And so the... Thank you. That was...

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Christie Keith: ((Crosstalk)) Julie Zawisza: Christie Keith:

...have that information?

...say that again? Shouldn't consumers have that information now so we can use it on our decision making process?

David Elder:

We are not aware of all of the products that may have been made. We aren't we're aware of where shipments have gone at least through records. We are visiting the firms that the records indicate have received the shipments and we are investigating to determine what, if any, products were made from the shipments that the records show were received.

Julie Zawisza:

Once we know and we're sure, we absolutely will communicate any information like that publicly. But what our folks here are saying is we don't know yet. We don't have complete information.

David Elder:

When we have complete information, we share what we know when we know it. We are not going to share information that is speculative, that's preliminary. We're sharing information that FDA can stand behind.

Julie Zawisza:

That was Captain Elder. And next question please.

Coordinator:

Karen Roebuck of Pittsburgh Tribune-Review, you may ask your question.

Karen Roebuck: Hi. I have two questions.
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The first is that the USDA said that the FDA is investigating hog feed in relation to melamine potentially being found in it. And so that leaves the open the question has this made it to the human food chain? And also, I received a statement from the Chinese Government today and they're saying that Xuzhou do not export wheat gluten for food, only for industrial purposes. And I'd like your response to that as well. Michael Rogers: Yes. We received - (I'd address) your second question first. We received the same message back from the Chinese Government indicating that that the pet or that the wheat gluten that was shipped by (the one company) in China was not meant for pet food and therefore was not their regulatory responsibility. I'm not sure that that's accurate. We're - again, we need to follow up with the Chinese Government and get into China and actually do the inspection to determine what the real facts are. But regardless of how it got in here, it should not have been a component of any food for either animals or human. Regarding the USDA concern about hogs, we do understand that one of the companies that was manufacturing pet food had some pet foods that could not be used; it was not suitable for using as - in pet food. And so, it was sent to - I don't know if it was sent to another processor hog feed, but eventually we understand that it did make it into some hog feed and we are following up on that as well. Julie Zawisza: Thank you.

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Next question. Karen Roebuck: (Was it)... Coordinator: David Goldstein of Newsradio 710, you may ask your question.

David Goldstein: Yes, thank you. Have you tested the nitrogen spiking theory by directly testing protein content of the melamine-tainted sample to see if, by comparison, the protein level otherwise falls below grade? Michael Rogers: No, I don't believe we have. Julie Zawisza: Is that something new we do or would the companies do?

Michael Rogers: No, we (couldn't do that). Julie Zawisza: Okay.

David Goldstein: Is it - wouldn't it be something that would at least validate the theory? Michael Rogers: It would. Certainly, I think it's something - I mean, again, right now, our major concern is to make sure that no pets are affected that would not normally have to be. So, that's going to - it certainly would help us with the theory, I think, but right now we are more concerned about making sure that contaminated product is not available for pet foods and then we'll look at motive and - as the investigation proceeds.

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David Goldstein: But could you confirm also that that food supplements such as wheat gluten and rice protein concentrate are only imported in two grades, edible and nonedible? Michael Rogers: That I don't know. We're stopping all of that at the ports of entry. Julie Zawisza: Thank you. Next question. Coordinator: Nancy Cordes: Nancy Cordes of CBS News, you may ask your questions. Thank you very much. I'm wondering - this may be a fairly obvious question, but what does it say to you that this Chinese company had a bag labeled, "Melamine" sitting around to be able to put product into it? And what - how have they explained to you why they have bags with melamine stencils on them sitting around in their factory? Michael Rogers: Again, that's not something we're going to be able to determine until we actually investigate the plants in China. Nancy Cordes: And then my second question is, what do you think the chances are -- I mean, now that you're testing so many more products -- it showing up on all of these products? Do you have any theories on how long melamine has actually been going into these products and why reports of sicknesses only started happening now?

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Michael Rogers: We don't. I mean, from this - as I understand, from this - the rice shipment rice protein concentrate was the company's first - let me just say Wilbur-Ellis started receiving shipments from them, I believe, in April of 2006. And let me just check with our folks over here. Man: July.

Michael Rogers: July of 2006. Okay. So, that appears to be, at least at this point in the investigation - and please, recognize that information changes over time as it has with the wheat gluten, but it appears that that is at least the beginning of the relationship between the importer, Wilbur-Ellis, and this new company that they were purchasing the rice protein concentrate from. Nancy Cordes: Uh-huh. And can I just - the - my initial question, what does it say to you? I know you haven't been able to talk to them about this, but what does it say to you that they had a bag labeled, "Melamine" sitting around in their factory? Michael Rogers: It certainly raises some serious questions that we're going to have to find out what the answers were, and we will be asking those questions. Julie Zawisza: Thank you. Operator, how many callers are still on the line or in the cue? Coordinator: Julie Zawisza: I currently have about seven questions in cue. Okay.

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I don't - we will try - I don't know if we can get to all of them, but we'll do our best. Next question please. Coordinator: Diane Lade: Diane Lade of South Florida Sentinel, you may ask your question. Yeah, hi. Good afternoon. My question is prior to all these sort of happening and the sampling, is there any different procedure for inspecting large shipments of, say, wheat gluten that are coming into this country considered edible that it should be used for pet food versus human consumption or was that all the same inspection process? Stephen Sundlof: It's subject to the same requirements. Julie Zawisza: Diane Lade: Julie Zawisza: Is that it? That's it. Thank you. Next question. Coordinator: Abigail Goldman of LA Times, you may ask your question.

Abigail Goldman: Good afternoon.

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I know this is sort of been asked, but I really don't think we've gotten a good answer. Consumers have been frustrated by what seems to be a stream of recalls and the fact that pets continue to get sick. So, I'm not clear and therefore can't explain why you won't proactively tell people what these other companies are so that they can make decisions even if that's preliminary or still being investigated. Why risk that more pets would get sick by continuing to eat food that might be contaminated? Michael Rogers: Yes, this is Michael. Our efforts are to disclose the information that might relate to finished products reaching consumers on the shelf. As we referenced there, there are a number of companies that we've identified through our straightforward procedures that potentially received suspect products. This is an ongoing investigation. And our efforts will continue to then identify whether or not those firms that we believed received potentially contaminated product, actually used that product and whether or not those products are actually out there and available to consumers. When the Agency reaches that determination and that they're realistically possible, there's a parallel track. One, to interact with the firms to make them aware of that information, as well as to disclose that information to the public through calls like this as well as on our Web site. And you should expect that to happen. Abigail Goldman: So what you're saying is we don't know yet? We don't have enough information to credibly and accurately say, don't buy...
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((Crosstalk)) Michael Rogers: ...expressing the fact that we know at this time. Julie Zawisza: Thank you. Next question. Coordinator: Jon Rockoff of Baltimore Sun, you may ask your question.

Jonathan Rockoff: Hi. Thanks for taking my question. I was - this is kind of a little bit more about so what you hope to do in China and how your inspections there might either confirm or not the theory that there's nitrogen spiking going on. Michael Rogers: We'll be asking all of the logical questions that have come up as part of this exercise. What we know from our import records is that there are two sources of these products that exist within China. Our inspections that we expect to initiate with assistance of the Chinese Government will be to - be directed to identify the actual manufacturers that may have supplied these Chinese sources, their manufacturing practices and their raw materials and processes. We will be asking obvious questions that are designed to confirm our facts that we've discovered in the United States, and try to identify how these events have happened, and quite frankly, how long they might have happened, and whether or not these companies have other relationships and might direct us in other areas.

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Jonathan Rockoff: So, essentially, you want to - you just want to see where - how the melamine got into the product and whether that was intentional or not? David Elder: So what we want to do is to, when given permission, conduct inspections to fully investigate and get at the root cause of this. Jonathan Rockoff: Uh-huh. David Elder: As Michael said - this is David Elder speaking. As Michael said, we will ask all of the appropriate questions that anybody can think of and we will examine evidence and be on-site at the manufacturing establishment to observe practices, to look at equipment, to look at supplies. We'll conduct a thorough investigation to get at the heart of this. We're not going in there with any blinders on- we're going in eyes wide-open, exploring any theory and following any lead that is appropriate. Jonathan Rockoff: Uh-huh. Julie Zawisza: Coordinator: Jack Neff: Next question please. Jack Neff of Advertising Age, you may ask your question. Yes. Has the FDA looked into whether any US pet food manufacturers have received corn gluten from China? Michael Rogers: At this time, we have not. Again, this is the finding of the rice protein concentrate being contaminated with melamine that is causing us to start
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looking broader at other potential sources of melamine. And so, as the investigation continues, that certainly is something that may come up. Julie Zawisza: Thank you. Next question. Coordinator: Karen Roebuck of Pittsburgh Tribune, you may ask your question.

Karen Roebuck: Hi. Michael Rogers had said earlier that you were checking other products at the port besides the wheat gluten and the rice protein concentrate. And I was wondering what those were. And I'm also concerned about the human food chain and wondering what you're doing to see if any pork products in the market are possibly contaminated with melamine. If you could give us some more details on that. Man: The last question - I'll answer the last question first. Yeah, we will be working closely with USDA to determine what the final outcome - disposition of those pigs that may have gotten contaminated feeds will be. And we've done this on many, many occasions where we found contamination of animal feed or intentional use of unapproved animal drugs where we worked closely with USDA to determine whether or not those animals can go into the food supply. So, that's a process that is still ongoing. And we should have - we should know the answer to that in a short period of time.

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The other one - well, I'll ask Michael to respond to this the broader (sweep). Michael Rogers: As we stated, these are - these two events are separate events with very similar fact patterns, with a common variable -- the country of origin and a raw material a raw bulk material. Our efforts are certainly focused on those bulk materials that we have seen test positive for melamine. And that, as we have disclosed, is wheat gluten and rice protein concentrate. The Agency, from a proactive standpoint, is looking at opportunities for other bulk products from a number of sources and looking at whether or not initiating sampling efforts. At this time, though, unless one of those other bulk products raise a suspicion or is related to any particular company or we have a need to disclose that, I don't know if it's in the best interest to fully articulate where the Agency might be doing its surveillance work and investigation. Julie Zawisza: Okay. Ladies and gentlemen, at this time I'd like to conclude this briefing and I'd like to thank you for joining us today. Thank you to our speakers, Dr. Sundlof, Captain Elder and Mr. Rogers. We hope that you found this helpful and we really do appreciate the work that you're doing, getting this type of information to the public.

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As I'm sure, (you're hearing here), we're still in the heat of this investigation and we want the answers just as much as you do and as much as pet owners do. So, our intention here is to have regular briefings twice a week at this time, probably on Tuesdays and Thursdays, although we may have briefings sooner if we have briefing information that you need to have that we need to get to you. So I would in the interim to check our Web site regularly for updates and for a list of any other products that may be recalled. And if there are questions, call (Michael Herndon) at 301-827-6242 or send him an email. And in about two hours, there should be an instant replay of this telebriefing or phone briefing. And then, certainly, we'll also have the transcript posted. So, thank you again very, very much and have a pleasant evening.

END

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