FSIS Recalls

DR.RICHARD RAYMOND: Thanks, Amanda, and my welcome also to all of you who joined us on kind of a late notice for this, what we think is an important teleconference. Before we get into the Topps recall and statistics there and our future plans for E. Coli control, I want to talk a little bit about the bigger, broader picture of E. Coli and what the agency has been doing this summer.

We saw a number of increased number of E. Coli 0157:H7 positive samples that were collected earlier in May and June, and we also saw some increase in recalls associated with the pathogen. And because of that the Food Safety Inspection Service initiated a number of steps in June to address why there has been an increase in the positives and also how to control this pathogen.

FSIS has already taken a number of steps to move towards understanding the increase in the E. Coli positive samples, but there are others that are still under development. For example, in July the agency doubled its E. Coli sampling and found no positives during that time period, and we continue with increased testing at this time.

Another aspect of our response we're planning has been to examine the efficiency and the effectiveness of outbreak investigations in recalls. We know that we can do better, and we are actively engaging with our public health partners at the federal, state, and local levels to determine what we can do better with our collaboration and coordination efforts to protect the public's health. With our partners we have been planning a two-day seminar to assess how we do business and learn how we can do better in this area.

Now we want to take this opportunity to provide you an update on the Tops recall and future efforts of the agency to prevent occurrences such as this from happening again. Dr. Daniel Engeljohn will talk more in a few minutes about some proactive steps this agency intends to take to reduce E. Coli numbers. We are continuing our epidemiological and case investigation right now in coordination with eight states in recording illnesses and the Centers for Disease Control and Prevention, and will provide updates as new information becomes available.

As part of our investigation, we are looking into the FSIS inspection activities in this plant in order to ensure that our inspection workforce has the tools, the training, the data, and the oversight to ensure public health protection. The assessment found that the plant's E. Coli 0157:H7 controls were inadequate and FSIS subsequently issued a notice of suspension for the raw ground processes on September 26. As of today the company has ceased all operations.

There has been some confusion about the timeline of this recall, and we want to be very clear and transparent about the steps that we have taken and try to eliminate some of that confusion. And at this point in time I'll turn it over to Dr. David Goldman, our assistant administrator for the Office of Public Health Science, to discuss the epidemiological investigation timeline.

DR. DAVID GOLDMAN: Thank you, Dr. Raymond. Let me add my welcome to those of you who have joined us on this afternoon. And I appreciate the opportunity to explain to you in a little bit of detail the timeline for the actions that the agency took, beginning with report of illness, which is where we often start our active investigations.

This case was somewhat different in that we began with an illness that was reported by a consumer. We have a consumer complaint monitoring system, and we had an illness reported through that system on August 31st. That was the illness reported to us by a patient, actually her father in Florida, as possibly caused by E. Coli.

According to our protocols, that very same day we logged it into our system, and we asked one of our field investigators to go collect leftover product from that person's freezer in Florida, and that same day this product was sent to one of our regulatory labs in Athens, Georgia, for testing.

On September the 7th, our agency reported out a positive E. Coli 0157 test result from the product left over from that patient's freezer. Let me be clear right at the beginning here, at this point we were not able to take recall action based on this initial test because there are often many strains of E. Coli that can contaminate products. In this case we did have 0157, but we wanted to do as we ordinarily do, further testing to characterize this pathogen and determine definitively that it was linked to the patient's illness.

So we initiated the next line of testing, and many of you may be familiar with the sub typing called pulse-field gel electrophoresis, known in its short form by PFGE. This is the so-called DNA fingerprint of a pathogen. It is not the initial test done, but a secondary test done to characterize the pathogen more completely as I just mentioned.

We initiated this test on September 7th, and this test takes several days to complete. In this particular case, it took our lab 7 days to complete this test because the gel had to be run several times. So we in essence ran the test several times in order to get a result that was authoritative and definitive.

Meanwhile, on September 8th, again in our lab, in our regulatory lab in Athens, Georgia, we had also received a sample from the plant itself, the Topps plant. This product was from an intact box. We took samples just as we had with the other sample, and got back a negative test on this particular product. I should say that our protocol calls for 13 subsamples to be tested. We treat each of them as an individual sample, so from this same product that had presumably caused this illness, we had 13 negative tests.

On September 14th, as I mentioned a minute ago, we finally received the result of our PFGE fingerprint testing, and by that time the Florida Department of Health Officials had uploaded their PFGE test from the patient and CDC's Pulse Net confirmed that they were a match. And so at that point we had information that linked the patient to the exposure, and in this case, again, it was leftover product that was opened in the patient's freezer, and we proceeded from that point.

When we are considering what actions to take, there are several things to consider. You'll recall I just mentioned that the box of frozen patties in the family's freezer had been opened. Because of that, we termed this a "non-intact packaging," and because of that we cannot say with absolute certainty that the contamination occurred in the processing plant, not in the home. So at this point in this process between September 14th and September 25th there were several meetings between scientist investigators in our agency to review these findings.

And in accordance with our past protocol, the agency did not immediately reconvene the Recall Committee. On September 20th, FSIS learned of two additional illnesses in New York state. At that point, we were told that the illnesses were associated with Topps product. FSIS was advised on that date, which was over a weekend, that the PFGE test results were not yet complete.

On September 22nd, we did get a report that the PFGE test results were complete in New York state, and that the two illnesses were connected with the products associated with those illness by PFGE fingerprinting, but yet they were different from the E. Coli fingerprint from the Florida case.

So at this point we had three different PFGE patterns related to three different products from the same establishment causing three different illnesses.

Our investigators worked to solidify the link between the processing plant and attempted to explain the three different E. Coli fingerprints. On September 24th, New York state alerted FSIS to the fact that its state officials had already tested a box of hamburger patties that they obtained in a supermarket and was unopened, and that this box also tested positive for E. Coli 0157:H7. The next morning, FSIS reconvened its Recall Committee and the recall was issued.

So there were several factors in this particular case, and as happens in other cases as well, that complicated this investigation. I want to tell you however that the agency is not completely satisfied with the time that elapsed between our first notification of the PFGE confirmation and the issuance of the recall. Since September 25, in addition to managing the recall, our scientists and Recall Committee members have been reviewing the data related to this recall as well as our own protocols to determine how we might improve the way we conduct these recalls in the future.

We've determined in fact that there is room for improvement, and we intend to act on the findings of our review immediately.

At this point I want to take the opportunity to remind everyone, to remind the consumers who read your news articles that they should continue to look in their freezers for this product. They should consult our website, and that you should link to our website so that they can see the products that were subject to the recall.

And I want to also remind all consumers that they should always engage in safe cooking practices in their households and cook to a safe temperature by a thermometer to 160 degrees for ground beef.

At this point I'd like to turn the session over to Dr. Dan Engeljohn who is our Deputy Assistant Administrator for the Office of Policy.

DR. DANIEL ENGELJOHN: Thank you, Dr. Goldman.

I'm going to identify some actions that the agency is going to take immediately. First, the agency will require all beef plants to demonstrate, using a checklist, to verify controls announced in 2002, that they have effectively controlled the hazard of E. Coli 0157:H7 contamination during the slaughter and processing of products before, during and after the products leave the plant. This applies to both suppliers and to grinders.

We are notifying all slaughter and grinder establishments that it is their responsibility to ensure that these measures are in place.

To supplement current hazard analysis surveillance activities, the agency will assign specially trained investigators to begin surveillance of corporate practices in addition to current individual practices to control E. Coli 0157:H7. These data will identify those corporations whose controls are insufficient and may pose a threat to public health.

We will be establishing a stronger threshold for taking a recall, a regulatory action, sooner, when there is evidence of illness linked to FSIS-inspected product taken from a consumer's home, and enforcement and investigation analysis officers dispatched to conduct a food safety assessment upon notification of any positive sample results.

MODERATOR: At this time, Operator, if you could give instructions if individuals have questions they would like to ask the panel.

OPERATOR: Certainly, thank you. If you would like to ask a question at this time, please press *1 on your touchtone phone. You will be prompted to record your first and last name. Please unmute your phone before recording. If you decide to withdraw your question, you may press *2. One moment please for the first question. The first question comes from Andrew Martin of New York Times. Sir, your line is open.

REPORTER: Hi. Dr. Engeljohn, weren't these measures already in place? I mean I thought this risk-based assessment that the USDA moved to a couple years ago was specifically designed to make sure this sort of thing, to minimize the likelihood of this sort of thing happening.

MODERATOR: If you could also identify the news agency?

REPORTER: I'm sorry. Andy Martin from the New York Times. Did you get the question?

MODERATOR: Part of it. If you could speak up.

REPORTER: I'm sorry. My question was, wasn't the USDA's, the fact that they changed to a risk-based system for examining meat a couple years ago supposed to – I mean many things that Dr. Engeljohn just talked about I thought were already in place. Can you explain that?

DR. RAYMOND: We have not instituted any risk-based inspection systems in processing or slaughter per se for our inspectors. We consider HAACP [Hazard Analysis and Critical Control Points] to be a risk-based plan. We consider our salmonella initiative to be risk-based. We consider our listeria interim final rule to be risk-based, but none of that really applies to this particular issue.

DR. ENGELJOHN: If I could also add some further clarification, since we announced our policies in 2002 related to E. Coli 0157:H7, we have been focused upon whether or not the establishments have controls in place. This would be upon looking at their food safety systems to see if in fact they reassessed or in fact whether or not they actually have identified controls.

What we are announcing today is in fact something new in which we will be looking more definitively at the underlying support for those controls so that we will have a more thorough assessment of what actually was done and whether or not those controls are effective. So we will be capturing that information and using it to guide us as to if and when we should take more immediate enforcement action.

MODERATOR: Thank you. Next caller.

OPERATOR: Next caller is David Curley, ABC News. Mr. Curley, your line is open. Mr. Curley?

REPORTER: I'm here. Can you hear me okay, Amanda?

MODERATOR: Yes.

REPORTER: David Curley, ABC. A couple of questions. Dr. Goldman, on Sunday I thought you told me that this came from the CDC and what has changed between then and now that this actually came straight to USDA? And if I understand Dr. Engeljohn correctly, in essence what you're saying is that these plants have not instituted the plans that they say that you told them to back in 2002. And I have one other follow-up, but why don't we start with those two?

DR. GOLDMAN: Could you clarify your first question for me, please?

REPORTER: Well, I asked you on Sunday if there was a delay, and you said that no, actually conducting an illness investigation is quite complicated and they brought things to our attention. You were talking about the CDC, which was a response to the earlier question. And now I hear you saying that this Florida illness came directly to you.

DR. GOLDMAN: Okay. In this particular illness investigation, we started with a case that came to us outside the usual mechanisms, through our Consumer Complaint System. We did, as this evolved, begin to deal with individual states through the CDC. And so I don't think I said there was a delay at any particular step except that I just now said that we have decided we can do better.

REPORTER: Okay. I just want to be clear because on Sunday you said you got it from CDC. Today you're saying it came the other way.

DR. GOLDMAN: I'm not clear what got what from CDC.

REPORTER: All right. You know, the first complaint. We can do this off-line. I don't want to hold everybody else's time up.

And then the other question, Dr. Engeljohn?

DR. ENGELJOHN: Yes. And as I understood your question, it was that you thought we already had these things in place and that we would have been verifying them since 2002. And what I would say about that is that since 2002 there have in fact been substantive improvements within the industry with regards to control for E. Coli 0157:H7. However, what we've found of recent, and in particular with the recall that was identified at the beginning of this interview, is that there are some non-uniform application of the policies that we are identifying, some lessons learned in terms of some ineffective programs that were in fact addressed but not to a level that would be demonstrated to be effective. And so this is what we're going to focus on at this point.

REPORTER: Is that a lack of oversight by FSIS since the new rules of 2002?

DR. ENGELJOHN: And what I would say is that in developing the science related to this and what we believe to be a necessary minimum controls, we have not provided additional clarification as to what our minimum expectations would be. Our expectation would be to identify more complete expectations of the industry.

REPORTER: And could you just – you said three of these cases of different profiles, DNA profiles. I must have missed the middle one. I understand the first and last ones. What was the second one?

DR. ENGELJOHN: There were three cases that were part of the initial recall. One was the Florida case, and the other two were from New York.

REPORTER: And the DNA on New York's were different, the two different, both cases were different?

DR. ENGELJOHN: Three cases, three different PFGE patterns, yes.

REPORTER: Thank you.

MODERATOR: Okay, thank you. Next caller.

OPERATOR: Thank you. The next caller is Alan Bjerga, and please state your news affiliation.

REPORTER: Yes, Alan Bjerga and Bloomberg News. Just quick update as far as the latest numbers as far as the number of confirmed cases of people that have been linked to this. And then my broader question is, in the first response you were talking about looking to see if there's adequate support for these controls. What do you mean by "support?"

DR. GOLDMAN: I'll answer the first part of your question. As of yesterday there were 29 cases, and I'm not certain that there have been any added to the list today. There's a posting on the CDC website from yesterday, and I'm not sure if they've updated that, but there were 29 cases there.

REPORTER: And what do you mean by "support" for controls?

DR. ENGELJOHN: The support that we are primarily focused upon is to know specifically which interventions are used and at what effective level they're used. With regards to sampling, what type of testing is done and whether or not that type of testing is supported by a rational basis as to why they test, what they do, and how much they test. And so it would be capturing information specifically to inform us about the degree of control that they would have, that in its totality would have an effect on controlling for E.Coli 157:H7.

REPORTER: Okay. And this is the X biggest. Where does this rank in the size of recalls in the nation's history? I've seen different numbers.

DR. ENGELJOHN: Number five.

REPORTER: Okay. Thank you.

MODERATOR: Thank you. Next question.

OPERATOR: Thank you. The next question will come from Bill Tomson, Dow Jones. Sir, your line is open.

REPORTER: Hi. This is Bill Tomson with Dow Jones Newswires. I just want to make sure I'm understanding this right. When you say there's nonuniform applications in things like "supported by a rational basis," what you're saying is that people weren't, companies weren't doing what they needed to do and USDA wasn't explaining to them or checking up to make sure they were doing what they were supposed to be doing. Right? Am I understanding it correctly?

DR. ENGELJOHN: I think there are a couple aspects to that. There is the issue of are the establishments doing what they said they would do. And then second of all, is the system that they designed fully supported by documentation and information to show that it would be effective? There are many different types of operations that are in place to produce ground beef, either through the slaughter process or through the grinding. Some produce their own slaughter source materials; others have to buy it. And so there are a variety of mechanisms in place that operators would use.

The issue becomes one of, is there consistency, and is there a rationale for why they are doing what they are doing? And as an example, there may be circumstances where product coming into the facility is treated one way for a one supplier and differently for another. And so our issue will be to look at specifically the support for the decisions that are made.

REPORTER: But haven't you been doing that already? I mean, why is that new?

DR. ENGELJOHN: Well, I would say up until now what we have found is that generally the programs have been highly effective. But I will say that we are coming to the end of a high prevalent season where there, in fact, would be a higher contamination rate, and it could simply be that due to the circumstances of the season that the issues related to finding out these concerns are more evident now than what they normally would be.

In any case, what we have found, such as through this recall, is that there were practices being employed for which the standard for which the establishments could have or should have been following was not either clear to them or to the oversight that we have for those programs.

DR. RAYMOND: I want to kind of add on to what Dan has said. We had three really good years where the number of E.Coli infections related to ground beef were declining or very low. We had three really good years where the amount of product that we sampled was extremely low as far as coming back positive for E.Coli. Something happened this summer. It's different. It was a high prevalence season, but we saw the sample numbers go up, we saw the recall numbers go up, we saw human illnesses attributed to ground beef go up.

It's our responsibility to make sure that all those plants out there that are making ground beef have these systems in place. And that's what this basic evaluation form is for is to make it, we will put down in writing and we will be able to see who has what, and we'll be able to see where we need to put our resources, our EAO officers possibly, our frontline supervisors, whatever we need to do to help plants get their systems back in place where they should be. This is kind of a wake-up call.

REPORTER: Thanks.

MODERATOR: Thank you. Next caller.

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

REPORTER: Thank you very much. I think, Dr. Raymond, you mentioned in your opening remarks that there's some concern about whether the FSIS inspectors at the Topps plant had the tools or something like that to be properly inspecting the plant. Can you explain a little bit more? It is kind of curious that a plant that would have an inspector in it quite frequently would then have a problem that would result in a recall of a full year of product. I mean, why wasn't that noticed before?

DR. GOLDMAN: That's one of the things we want to look at, to make sure that our inspectors all do have the tools, the training, the data and the oversight to ensure that they do what they need to do to protect the public's health. And in this particular instance that's one of the things we're evaluating through the front line supervisor, the district office and other persons involved.

REPORTER: Do you know, how frequently was the FSIS inspector or inspectors in this plant? Were they there every day all day, or –

DR. GOLDMAN: They were there daily but not continuous as is the case with most processing plants.

REPORTER: All right. And just to follow up on the period between September 14 and the recall, somebody talked about there was tests I guess to check to see if there was contamination in the home. And that's going to be one area I guess you're no longer going to be doing, or can you can explain hat a little bit more?

DR. GOLDMAN: We don't do environmental testing in the homes for E.Coli. We test product. I think, I guess I'm not sure where you got that reference.

REPORTER: Well, what was going on between the 14th and the 25th when you had the match and then the recall wasn't for 11 more days?

DR. RAYMOND: Dr. Goldman gave you a pretty detailed, step-by-step. I'll try to put it in maybe just a little higher level. On the 14th is when we found out that there was PFGE pattern in the samples that were taken from the patient's freezer that matched the patient's testing. There were negative tests in the 13 samples that we obtained from product made on the same day by that company that was in intact boxes. There's always a possibility although it may be remote of contamination of product in the home rather than product in the place of manufacturer and then into the food supply. It's unlikely. The agency has always had a policy that if there's a non-intact, meaning a box or container has been opened to where it could have been contaminated, if that's the only link to the plant that has not been adequate, sufficient evidence to do a recall, particularly when you have negative product of intact boxes in other sources. That's just been the standard protocol.

So after the 14th, really nothing was done. It was on the 20th when we were notified by New York State Health Department that they had some cases of E.Coli they thought might be related to Topps product, and then as David walked through the timeline, it was on the 24th that they called us and said they had an intact box of the Topps product that did test positive for the E.Coli and it was linked with one of their cases.

Their second case up there also was not linked to an intact product, but at that point in time the agency said, there's enough evidence here that we have a problem that we can link that case back on the 14th. We need to change our policy of saying if it's not an intact box we will not link it. There was just too much evidence here to avoid that, and that's what we did the recall that included three production dates. And that's one of the areas that we will take a strong, hard look at in the future. Should there be certain types of products not intact, like frozen, should they be considered stronger evidence or not? We'll need to look at each individual case. There are sometimes where it may be fairly evident that we should be doing a recall; there may be other times it would be very difficult to do a recall based on – it was three different sources of hamburger for instance all molded into one big batch. You can't do a recall based upon non-intact product like that. It's a policy that we will be changing here.

REPORTER: Next caller?

OPERATOR: The next question is from Steve Kaye. Please state your media affiliation.

REPORTER: This is Steve Kaye, IBN Cattle Buyers Weekly. Gentlemen, I just want to return to what possibly happened in the plant. I assume that the establishment in question had a HAACP plan but wasn't following it. So my question is, shouldn't FSIS's inspectors be aware that Topps wasn't following its written HACCP plan?

My second question is, the size of the recall was obviously or apparently because Topps was commingling product from one day to the next. Is FSIS in light of what has occurred considering making it a requirement that all plants that produce ground beef products completely separate one day's production from another?

DR. ENGELJOHN: I'll take the last part of that first in terms of the issue related to linking product one day to another. Many operators do purchase products to grind, and they need to grind that over multiple days. The issue really becomes one of what is the source material that's being used and the rational basis for segregating it?

Segregating product one day to the next doesn't address the microbiological issues which is, what is the likelihood that product from one day to the next is actually contaminated?

The focus of the agency and by the industry over these last couple years has been to put in place programs to ensure that there are in fact effective interventions during the slaughter and dressing process and in the manufacturing of boneless trim. And then having verification testing programs to increase confidence that if there was low level contamination there that it would be found.

This organism is one that is very sporadic in its occurrence, and it is generally not uniformly spread throughout the product. It usually is just what we would call point-source contamination generally on just one point on the contact surface of a product.

So the likelihood of finding it by testing is very low. That's why the issue is, what type of control program is in place and whether or not the plant has an effective means to demonstrate that their program is effective.

That can be done in a number of ways. In this particular case the plant did have a control program in place. The issue becomes the strength of its supporting documentation, which is something that our inspectors at this particular time do not actually have the type of training to be able to review the supporting documentation to make a determination about the strength of the validation. And that's what we use our specially trained enforcement investigation and analysis officers to do. And they are the ones who are trained to be able to look at that support documentation, the evidence that the plant has generated over time to demonstrated ongoing effectiveness, and they can make decisions about the effectiveness or the control programs. And that is what happened in this particular case.

REPORTER: Thank you.

MODERATOR: Thank you. Next caller.

OPERATOR: Thank you. The next caller is Tanya from WAWS of Jacksonville, Florida.

REPORTER: Yes, I'm here. One of my concerns was when we were received the fax it was late I believe on the 25th. It came in through our regular fax, and the information that was sent out did not give any specifics as far as how many states were affected, and from a perspective of sending people to bed, viewers with information, we were telling them it was a nationwide recall, but we didn't know if it affected Florida, and we spent the day into the night. First the fax was sent out and there was not a 24-hour person on hand. There was an E.Coli hotline or something that you could call with the Ag Department. But we found ourselves getting calls well into the morning trying to figure out what the status was and speaking with Topps and speaking with our individual Florida Health Department. Most of the information that we felt was gathered was gathered through good reporting and not through just making sure that everything was clear and there was just a sense of secrecy.

And I know that was not the intent. From a viewer's perspective we went to several doors and we were the ones that told them that there had been a recall. Wal-Mart was the only one locally that was aware, and they had pulled theirs off the shelf because of the Florida incident.

But it just seems like there should have been more transparency and to send out such a fax so scary. What are you guys going to do in the future to make certain that as much information can be given out to viewers rather than starting a panic? And that's what that did.

DR. RAYMOND: As I said in my very early opening remarks, we actually started a process in place to figure out how we can do investigative outbreaks more efficiently and effectively with all our public health partners, and that includes how we announce recalls.

This process was started back in June after another incident that I was not totally satisfied that perhaps we had been the most effective and efficient that we could. And I don't mean just us; I mean all of our partners combined. And we have met with the Association of State Health Officers, city/county health officers, state epidemiologists, public health labs and association with Food and Drug officials, and they all agree to an agency to an association that we can do better. And one of the ways to do better is to get together for a couple days and kind of point fingers at each other and figure out where we can make improvements. That is what we intend to do.

REPORTER: Great. Thank you.

MODERATOR: Tanya, you are from WAWS?

REPORTER: WAWS-WTEV. We're the Clear Channel duo in Jacksonville, Florida.

MODERATOR: Thank you.

OPERATOR: Ready for the next question, ma'am? That comes from Joe Perrone of the Star Ledger. Sir, your line is open.

REPORTER: Yes. Joe Perrone from the Star Ledger. Can you say how many slaughter plants and grinding plants are affected or will effectively have to certify that they are meeting the latest standard? And also have any inspectors or any of your employees been reassigned or faced any disciplinary action as a result of this situation?

DR. ENGELJOHN: I would say a rough number would be 1,500 establishments would be affected that produce beef, either slaughter or process. And I think as I understood your question, how many do we believe would need to take steps to change? Is that your question?

REPORTER: Yes.

DR. GOLDMAN: Well that we will find out. The issue for the agency is that at this time as you know we are in those plants every day, we do conduct our thorough investigations when we do have concerns about plants, but based on the evidence that we have collected. And so from a day to day perspective we believe they are operating as intended. However, what we are doing through other actions we've announced today is to make more clear and explicit what our minimum expectations are and to capture specific information that are conducted in each of those operations and then from that make decisions about which ones don't meet a minimal level of expectation that we are in fact looking at putting in place. So I would say we're raising the bar to some extent as to what we would expect to have in terms of documentation and control. And that we will find out once we complete this checklist.

REPORTER: Have any of your inspectors been reassigned or disciplined as a result of this recall?

DR. ENGELJOHN: We're still in the investigation process. We don't generally talk about disciplinary actions anyway.

MODERATOR: Thank you. Next caller.

OPERATOR: Thank you. The next caller is Andrew Martin, New York Times.

REPORTER: I just wanted to clarify something. Why was the plant, the Topps plant closed down and when will it open?

DR. PETERSEN: This is Dr. Petersen with our Office of Operations, and the Topps plant as you may know was, we suspended the assignment of inspectors on September 26. It was basically from when we sent in our specially trained investigators, they looked more comprehensively at the overall design of the plant's food safety system. And design means what is the science that they are applying to their program, and are they executing that science?

And when we looked at records over a period of a couple months we had some questions about whether they were consistently following their program. And they weren't' able to really answer those questions and so that really led to the suspension and it also really led to, you look at the recall and most of the illnesses were from June and up until beyond that, but the recall of course was for a full year.

And the fact that it was for a full year means that we had questions that they could not answer on whether they were effectively implementing their program over a protracted period of time. By "implementing it," I mean they have records that show what they do, and their records document that they receive test results from plants and are they receiving those test results, and following that program? So this is information that they collect on an ongoing basis. And there were some inconsistencies in what their plan said they would do and what they actually appeared to be doing, and that's what led to both the suspension and the recall going back a whole year.

REPORTER: Okay. And are you aware of what Topps did or didn't do after 2005 incident involving e-coli in Albany?

DR. PETERSEN: I don't have the specifics on that. We are aware of it. I mean that was, that situation was much more isolated. There was a case. There was no direct link as far as the epidemiologic information that led us to obviously initiating any recall. The plant, obviously we looked closely at the plant at that time and their practices at the time they made some minor fine adjustments to the program, and somewhere between then and now they must have made some changes to their program that they were not consistently implementing.

REPORTER: Thank you.

MODERATOR: Thank you. Next question.

OPERATOR: Thank you. David Curley, ABC News, you may ask your question.

REPORTER: Hi, there. First what happened with the "DNA testing?" Why did it have to run several times because you lost a week there? Isn't that like a two-day test?

And then back to Topps, they were doing solid meat. You've now shut that down as well, and when did that happen?

DR. GOLDMAN: To take the first part of your question, I can't tell you exactly why we had trouble with that particular gel. I just know that was reported by our lab. And yes, you can under ideal circumstances get a PFGE in a couple of days, but I do want to point out that we depend as public health departments do as well on the CDC's Pulse Net to confirm that there are or are not matches between those. That usually takes an additional day once the PFGE is obtained itself.

DR. PETERSEN: On the other part of their program, this plant like many others has several HAACP programs and so the HAACP program that was producing ground beef was obviously the one and the only part of their plant that was associated with any illnesses, and of course that was the only product that was subject to the recall.

And then as we go in and look more closely at their what you call whole muscle, what we call raw not ground, meaning everything other than ground beef, looking at that program we had similar questions really about what they were doing with some of the materials and where some of those materials were going, some of the decisions they were making, some of the scientific support they had for that part of the program.

And so today we put them on notice that we have some questions that they need to answer.

REPORTER: So are they shut down as of today or was it two days ago?

DR. PETERSEN: Yes, as of last week, you know Wednesday the 26th, of course their ground beef operation was suspended. Their other operation, we're getting a little bit in the weeds on enforcement, but we give them the opportunity depending on the seriousness of the violation to, they can operate for a brief period of time while they are responding to our questions, and that's what's happening with their raw not ground, meaning their non-ground-beef program.

They have elected not to operate, and they are electing to just respond to all of our questions in one submittal.

REPORTER: So you did not shut them down. They've elected not to operate. They could still do raw meat if they wanted to.

So they could, yes. Again, that was not the part of their operation that was linked to any illnesses. There's no evidence that there's any direct public impact. Like other establishments like them, we go in, we have some questions, and under normal due process procedures we give them a brief period of time to answer questions.

DR. RAYMOND: I think you got it right but I just want to make absolutely certain you do. They cannot produce ground beef.

REPORTER: I understand.

DR. RAYMOND: Okay.

MODERATOR: We have about 10 more minutes for the call, so if there's anyone on the line that has not yet had the opportunity to ask a question go ahead and ring in now.

OPERATOR: We do have someone on-line, Tom Johnston, please state your media affiliation.

REPORTER: Hi. Meating Place Magazine. Thanks for taking my call. The question I had was, after reading reports today that it was an 18-day delay was, in the case of an illness how long does it normally take to issue a recall? And in the case of recall that's not associated with an illness how long does that take? If you have like an average of how long that takes and just sort of why?

DR. RAYMOND: I'll let somebody else try to do the averages. First of all, let's just make it really clear. It was not an 18-day delay. It was 11 days after we got the PFGE pattern that matched between the open box in the freezer and the patient. Now we can discuss the 11 day in detail, but it was not an 18-day as previously reported. That was a mistake in the previous article today.

Average length of time, it's going to vary on the complexity of the illness. Sometimes when you have one person with an illness it's very difficult to even attribute it to a product, and other times they can say I ate hamburger three days ago and you go pull hamburger from the freezer and you can do these tests and if they all go well you may have an answer in eight or night days and you can do a recall.

Sometimes you have multi-state outbreaks. It takes awhile to tie them all together. On the other hand, if we test a product and it shows E.Coli and its out in commerce we can institute a recall immediately.

REPORTER: Thank you.

MODERATOR: Thanks. Any other questions?

OPERATOR: Yes. Thank you. Steve Hedges. And please state your media affiliation.

REPORTER: Hi. Steve Hedges with the Chicago Tribute. Dr. Goldman, I had a couple questions. One is, my understanding of trying to confirm E.Coli was that you needed the product that the patient or the consumer had actually used to identify the E.Coli. So I'm confused by the fact that the -- I wanted to know why that was not sufficient in this case, and also did USDA go into stores to try to find product to test themselves, or did you just rely on the samples sent by Topps to USDA?

MODERATOR: Your question in the beginning was about problems we had going into the consumers home and then if we go into retail establishments. Is that correct?

REPORTER: No, Dr. Goldman said the E.Coli could be introduced in the home, and that was a concern, so you needed a second source of confirmation but my understanding in these cases it's often difficult to find the food that the patient has consumed and to link it that way. I don't understand why testing the meat from the freezer isn't sufficient to confirm it.

Secondly, did USDA go out and try to find independent samples of the Topps hamburger?

DR. GOLDMAN: Yes. The first part of your question had to do with the possibility that contamination might be introduced somewhere other than the producing establishment, which is where we have our jurisdiction. And if we have evidence that has taken place, then we do move that information to a Recall Committee and take action.

But we do not, so if we find product left over in a patient's home then yes we do as we did in this case, we will test it to determine whether or not it has E.Coli, and that becomes part of the information that we begin to review as we did in this case to determine whether or not we have evidence that the product left over in the freezer caused the illness. And as I said earlier, the additional information we get from PFGE, is absolutely links those two things together and excludes possibilities, however remote they may be, that contamination came from somewhere else in the home.

The second part of your question had to do with whether we looked for product that has a similar or same lot code as that which we think has caused the illness, and yes we do. That's part of what we did in this case. Again, the only unusual feature of this case is that we found there was product left over in the establishment, but in other situations we actually go look for product with the same lot code that's in commerce, meaning in a supermarket. And we'll pick that up and test that if we can find it. And I'll remind you that in this particular case the sample that was sent from the establishment in an intact box was tested with our outbreak protocol, meaning 13 subsamples and all of those were negative. So that was an important piece of information that we received the day after we got the confirmation of the leftover product that was positive. So there were in essence two conflicting pieces of information about contamination of that product.

And one additional piece of information, in the case in Florida, the patties were served as part of a meal to others in the household and we had information again in our communications with Florida and with the family themselves that the other members of the household that ate these products did not become ill from consuming the same products.

MODERATOR: We have time for one more question.

OPERATOR: Thank you. Jennifer Zuid (sp), CNN. You may ask your question.

REPORTER: Hi. Jennifer Zuid from CNN. I just wanted to know, will there be a press release issued with the statements that were made at the beginning of this conference call?

MODERATOR: There will be a transcript made available later this evening on the USDA website which is http://www.USDA.gov.

REPORTER: Great.

MODERATOR: And I'd also like to mention that CDC was not able to join us on the call, but if you have specific questions you can contact their press office representative, Lola Russell, at 404-639-3286. And we thank you all for joining us this afternoon, and have a great evening.