Transcript of FDA-USDA Update on Adulterated Animal Feed


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Washington, D.C. - May 17, 2007

MODERATOR: Thank you very much, Rose. Ladies and gentlemen, welcome. I am Mike Herndon from the FDA's Media Relations Staff, and thanks and welcome to this briefing on the melamine investigation. We have speakers today from the Food and Drug Administration and the U.S. Customs and Border Protection and also have several FDA officials here, and officials from USDA, Customs and Border Protection available to answer any questions later on in this briefing.

Two speakers this afternoon are Dr. David Acheson, assistant commissioner for Food Protection with the FDA, and Vera Adams, executive director for Commercial Targeting and Enforcement, Customs and Border Protection. We will have a brief question and answer segment after the opening remarks.

Now at this time I will turn it over to Dr. David Acheson.

DR. ACHESON: There are a couple of areas that I just want to update you on today. The first relates to the information that we have on the status of the fish farms and the hatcheries, and the second is where we are on our inspections and investigations, both of the import side of things as well as the domestic protein surveillance assignment that we've done.

To begin with, the general overview, and this is information we provided before but let me just provide this as an overview, that Skretting, the Canadian fish feed maker, have recalled the fish feed containing melamine from all commercial fisheries and fish hatcheries that received it. And to remind you, this wheat gluten that Skretting received from China which was contaminated with melamine and melamine related compounds is from the same company that led to the pet food recalls.

Based on the safety risk assessment conducted by the various federal agencies, there's very low risk of harm from eating fish that consumed this melamine tainted feed. As we've said before, Skretting has 198 customers in the United States. Two of those are commercial fish farms, and the remainder are hatcheries, so 196 hatcheries and two commercial farms. And I'm going to say more about both of those in just a minute.

Of those two commercial farms, one is in Hawaii and the other is in Washington State, so to give you a little more depth on the fish farms themselves ? and I'm going to be speaking here initially just about the two commercial operations -- firstly with regard to the Hawaiian operation, testing on fish conducted for Kona Blue, the Hawaiian fish farm, by a private lab, but using the method developed and endorsed by FDA as well as direct testing by our own labs have proved negative for melamine. And I repeat, this is testing of the fish from that fish farm have been negative for melamine.

As a result of this, the company Kona Blue, has resumed harvesting its fish after they voluntarily suspended sales pending the results of these tests. Washington State is a firm called American Gold; they have also had their fish tested by us, by FDA, and those too have proved to be negative for melamine.

FDA was not able to test any of the feed at American Gold because it had all been consumed by the fish. So just to recap there, both companies, the one in Hawaii and Washington state have both had negative results on the testing of the fish themselves.

Finally, a point on the hatcheries. As we've said before, the fish in these hatcheries are tiny, the feed has been recalled, so they are no longer being exposed to the feed, and therefore that combined with the fact that they are tiny fish we believe there is no public health concern associated with these fish in the hatcheries. And the destiny for these fish in the hatcheries is ultimately to be released into a variety of public water, not going straight directly into commerce.

Turning now to the second main area on the inspection front, and first I want to focus on the import alert and give you a little bit of an update on that ? since April 27, a total of 46 shipments of vegetable protein products from China have been detained as part of this import alert. To date, none of the importers have proved that the shipments are melamine-free, so these products remain in detention. And before any of these shipments are released, FDA will review the analytical reports for technical accuracy, and we may collect and analyze samples of the product to confirm any submitted reports.

So currently there are still samples detained as part of this import alert, and as I've said they remain in detention until we are satisfied.

Moving on to the domestic protein surveillance assignment, and again to remind you this is an assignment that's been going on now for a couple of weeks; it is focused on domestic manufacturers who receive vegetable protein concentrates from China primarily. What we have done there is with the assistance of states and locals our inspector's investigators have gone into those companies, raised awareness about the importance of knowing everything there is to know about suppliers, and have collected samples for testing for melamine.

Currently we've collected 63 samples as part of this assignment from a variety of states. These include Arizona, California, Connecticut, Iowa, Minnesota and New Hampshire. Those are the states where we have collected samples to date, and I repeat Arizona, California, Connecticut, Iowa, Minnesota and New Hampshire. There have been no positive results for melamine on any of these samples collected so far. Of those 63, 37 of them were negative, 23 are pending, and 3 could not be analyzed because there was no method to do that, and that was because essentially they were a mixture of rawhide dog chews, clearly of low risk, and gel capsules. So that's why there wasn't a method for those three samples.

That in essence completes my brief summary. Thank you. I'll hand it back to Mike Herndon.

MODERATOR: Thank you, Dr. Acheson. Now I'd like to turn to Ms. Vera Adams.

DR. VERA ADAMS: Good afternoon, everyone. During one of the earlier media calls I discussed CBP's efforts to assess if further contaminated gluten products had entered the U.S. As a precautionary measure and to supplement federal efforts to detect and prevent the importation of specific products contaminated with melamine. CBP has undertaken sampling and testing of all imported wheat and corn gluten as well as rice protein concentrates arriving from all countries destined for human or animal consumption.

CBP began sampling shipments from China on April 30. On May 2, CBP expanded the scope of the operation to all countries. As part of the operation, CBP undertook sampling of the aforementioned group of products from each shipper as it entered the U.S. CBP's laboratories have been analyzing the samples for evidence of melamine and its analogs. I'd like to give you an update of this effort to date. Since the beginning of the operation, samples representing about 80 percent of all shippers of these products have been taken. CBP lab analysis is complete on about 80 percent of these samples. And to date, all have shown no findings for melamine or melamine analogs. We will report our complete findings once all the testing and sampling is complete.

And as a result of the large percentage of shippers already tested with negative results, CBP in consultation with FDA is evaluating the operation to determine if the sampling process can be amended and converted to some sort of random sampling protocol. CBP has undertaken this effort to assure the American public that every effort has and will be made to safeguard public health and safety.

CBP will continue to work closely with FDA to determine the appropriate sampling and testing going forward. Thank you very much.

MODERATOR: Thank you, Ms. Adams. At this time, ladies and gentlemen, we will take your questions. And as always, please limit yourselves to one question and one follow-up, and please state your name and affiliation. Rose, we'll take the first call.

OPERATOR: Thank you. At this time if you'd like to ask a question, press * followed by "1" on your touchtone phone. Please unmute your phone and record your name clearly when promoted. Your name is required to introduce your question. To withdraw your question, you press *2. One moment for our first question. Our first question is from Deirdre Henderson, Boston Globe. Your line is open.

REPORTER: Thanks a lot for doing this call. I was curious what you make of the Chinese government's statement earlier this week that they don't think the U.S. should take stringent action against any exporters of the wheat gluten and rice protein concentrate apart from the suppliers who have already been implicated with the melamine, the statement is that, "We hope the Americans will accurately and objectively deal with problems among individual companies and not take stringent measures against other Chinese companies producing the same type of products."

DR. ACHESON: Let me respond to that with regard to our import alert. The import alert, I really want to provide a bit of historical background as to where this came from. Clearly this began with a problem with wheat gluten and melamine and melamine compounds. It then expanded to rice protein concentrate. Historically there have been reports in other parts of the world with corn gluten contaminated with melamine. Based on that, the agency felt that it was important to put this import alert focused on vegetable protein concentrates from China. We still clearly believe that is the right action. You've heard the update on that. We will continue to do that until we are satisfied that the problem is taken care of. And essentially that's where we're headed because our primary mission here is to safeguard public health in the United States.

MODERATOR: Deirdre, did you have a followup?

REPORTER: Just a housekeeping. When you say these various fish and proteins have tested negative for melamine, is that at the threshold of the testing assay, or are they clearly negative? I guess what I'm saying is, are there traces of melamine that your tests aren't picking up?

DR. ACHESON: Well, a test is only as good as the lower limit of detection of the test, so if you've got a test that's sensitive down to a certain level, and if it's below that level it's going to come up negative in the test ? but that's true of any test; doesn't matter what test you're running. And it is below the limit of detection using our most sensitive methodology.

REPORTER: Thank you very much.

MODERATOR: Next question, please?

OPERATOR: Our next question comes from Cristy Keith, Universal Press Syndicate. Your line is open.

REPORTER: Hi, thank you. This is Cristy Keith from Universal Press Syndicate pet connection. You have stated previously that the FDA was actually sampling and testing pet foods being imported from China. Can you update us on that, how many samples have been tested, and have any of them been positive, and is that sampling still being conducted?

DR. ACHESON: I'm not aware of exactly how many of those we've tested. I certainly am not aware that any have come up positive. If there were, we'd have made that public. So that I can assure you. But in terms of just how many exactly we tested, I don't know the specific answer to that.

REPORTER: And is it still ongoing?

DR. ACHESON: Yes.

REPORTER: Thank you.

MODERATOR: Next question, please.

OPERATOR: The next question is from Julie Schmitt, USA Today. Your line is open.

REPORTER: Thank you very much. Is Customs sampling the shipments that the FDA is detaining?

DR. ACHESON: I'd refer that question to Customs and Border Protection.

DR. ADAMS: We are targeting using our own systems and identification of the products that are within the scope of this operation.

REPORTER: I think this probably is a question for maybe Michael if he's there. Who is the importer of the product that was recalled by cereal byproducts?

MR. ROGERS: I don't know that we're prepared to announce that. I think the headline we've said in the past is that most importantly all the positive samples for wheat gluten and rice protein concentrate have all linked back to two suspect sources in China. Those were the two suspect sources that were the target of our visit to China as well as working with AQSIQ. At this point I don't know what value it would be to walk you through the trace-forward information, but maybe that's something we'd provide at a later date.

MODERATOR: Thank you, Michael. Next question, please?

OPERATOR: The next question is from Nancy Cortis, CBS News. Your line is open.

REPORTER: Hi, there. I'm sorry, I didn't understand the answers to the last question about whether Customs is independently testing the product that's been detained, and I'm also wondering what you mean when you say that they haven't been able to prove that their product is melamine-free. How do they prove that their product doesn't have melamine?

MS. ADAMS: I'll take the first part of that question. Both CBP and FDA can target incoming shipments for things that we are interested in detaining and examining and inspecting. So we can put things on hold independently of FDA. In this particular sampling operation, we are sampling shipments and sending to our labs, having them examined, and then we are reporting those results to FDA. David, if you want to comment when FDA is satisfied and has reviewed those results, they will also list the detention they may have also placed on those shipments.

DR. ACHESON: Right. Just to add an answer to the second half of your question, those shipments are going to remain on detention until FDA is provided with an analytical report from an independent third party lab. That report needs to demonstrate that the product is free of melamine and associated compounds, and the testing that Customs and Border Protection are doing on those would fulfill that obviously.

If the shippers decide to use some other independent lab, which they are perfectly entitled to do, we would certainly require that those results be validated and we will review the analytical report, and we may if we've got doubts go ahead and collect a sample of our own to test it for ourselves.

REPORTER: Can you just remind me how many shipments are still being detained, and are there any shipments that were detained but have since been released?

DR. ACHESON: On the import alert, a total of 46 shipments have been detained, and none of those have been released yet but with regard to the FDA import alert. Now it's different with the assignment that Border Protection is doing, and you've heard the numbers there in terms of what's been tested and what's been released.