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Preliminary Salmonella Saintpaul Outbreak Data

August 28, 2008

OPERATOR:  Good afternoon, and thank you all for holding. At this time your lines have been placed on listen–only until we open up for questions and answers. Please be advised today′s conference is being recorded. If you have any objections, you may disconnect at this time.

I would now like to turn the call over to Ms. Lola Russell. Please go ahead.

LOLA RUSSELL:  Good afternoon.  Again, this is Lola Russell with the Centers for Disease Control and Prevention′s media office, and today we will be holding a media briefing on the release of the “Outbreak of Salmonella Serotype Saintpaul Infections Associated with Multiple Raw Produce Items in the United States 2008”. It′s being published today in our Morbidity and Mortality Weekly Report and will be released afternoon today.

Our speakers today are Dr. Robert Tauxe, who is Deputy Director of the CDC′s Division of Foodborne, Bacterial and Mycotic Diseases – that′s Dr. Robert Tauxe, T–a–u–x–e. Dr. David Acheson – Associate Commission for Foods for FDA; and also available to answer questions will be Ian Williams, who is chief of CDC′s OutbreakNet team; Michael Chappell, acting Associate Commissioner for Regulatory Affairs, FDA; Melinda Plaisier, Associate Commissioner for International Programs FDA; and added to our speaker list will be Sherri McGarry, who is Emergency Coordinator, Center for Food Safety and Applied Nutrition with FDA.

I will turn this over to Dr. Tauxe, who will give a brief opening statement, followed by an opening statement by Dr. David Acheson. Dr. Tauxe?

DR. ROBERT TAUXE: Thank you very much, and than you for joining us today. Many thanks to my colleagues at CDC, the FDA, the Indian Health Service, state and local health departments, and others for their excellent work during this month–long multifaceted investigation. The focus of today′s briefing is CDC′s initial summary report on the recent outbreak of Salmonella Saintpaul infections published in this week′s Morbidity and Mortality Weekly Report. This report summarizes many of the major actions taken by CDC, FDA, the Indian Health Service, and health departments in response to the outbreak.

This was a very large and complex outbreak that appears to have begun in April, and most persons became ill in May, June, and early July. As of August 25th, a total of 1,442 persons had been reported ill with the outbreak strain. At least 286 people have been hospitalized, and the infection may have contributed to two deaths. The outbreak encompassed 43 states, the District of Columbia, and Canada.

Based on the available information and reports, it appears that this outbreak is over. This assessment is based on several things: First, the number of reported cases has been dropping since early July, and by the beginning of August was down to the number of cases we would expect to see anyway in the absence of a major outbreak. There are some cases of this infection that occur every year. In other words, the number of cases of Salmonella Saintpaul infections of this particular fingerprint patterns appears to have returned to the number we would typically expect to see this time of year.

In addition, we′ve been tracking clusters of Salmonella Saintpaul related illnesses that are associated with restaurants when a whole group of people become ill after eating at a particular restaurant.  The last such restaurant–associated cluster of illness occurred in early July, and none have been reported since; and this is also an important indication that this particular outbreak over.  I do want to note that while the available evidence indicates the outbreak appears to be over, CDC and state and local health departments are continuing to conduct surveillance for cases of infection with the outbreak strain.  We do expect a few more cases to be reported, but we′ll be monitoring them closely to be sure that this is not an increase in the number we would expect to see anyway.  We recognize that since the specific source of the contamination with Salmonella has not been identified, it′s important that we remain vigilant.

The initial summary report notes that the preliminary results of the investigation show that jalapeno peppers were a major source of contamination and that Serrano peppers were also a source.  And in addition, tomatoes were possibly a source, particularly early in the outbreak.

As has been previously noted, this outbreak had some unusual characteristics:  First, neither raw jalapeno nor Serrano peppers have previously been identified as a vehicle for a Salmonella outbreak in the United States.  Second, it involves more than one food item.  Multi–vehicle outbreaks are unusual, but have occurred in the past; and although most large food–borne disease outbreaks have been linked to a single food item, multi–vehicle outbreaks do occur.  Some years ago, a group of outbreaks was attributed to both parsley and cilantro grown on one farm.  In the current Saintpaul outbreak, contamination of multiple produce items might have occurred on a farm or during processing and distribution, though the specific mechanism of contamination has not been determined.

This outbreak highlights the recurring problem of outbreaks due to fresh produce and the importance of taking measures to reduce the contamination of produce wherever it might occur.  It′s important to work with industry to identify and correct the potential sources of contamination.  It also highlights the need to increase the capacity of the public health system to respond to food–borne disease outbreaks, capacities that would include swifter detection, swifter investigation, and swifter trace–back efforts. We will be working with our public health partners to examine the lessons learned from this outbreak and use those lessons to further strengthen the system.

I do want to remind everyone that fruits and vegetables are an important part of a healthy diet, and public health agencies and partners are working to enhance the response to outbreaks and to improve food safety measures for fresh produce and other sources of food–borne illness.

Finally, I want to mention that the epidemiologic investigations conducted by CDC and its public health partners depend greatly on the willing cooperation of many persons sick and well, and we would like to thank all of them for participating in our surveys and interviews.  We could not do this without public participation.  I would now like to turn to my FDA collage, Dr. David Acheson, who will also offer some comments.

DR. DAVID ACHESON:  Thank you, Dr. Tauxe.  This is David Acheson, Associate Commissioner for Foods at FDA.  I too would like to begin my comments with thanking our federal, state, and local colleagues for their assistance and diligence in working with us on this outbreak.

I′d like to begin by a brief comment on the state of FDA′s investigation. The FDA has completed its field investigation into the source of the Salmonella Saintpaul outbreak and is continuing to conduct a thorough analysis of all the data that we′ve generated during the course of that investigation.  As of today, the FDA is listing the advice to consumers to avoid eating raw jalapeno and Serrano peppers grown, harvested, or packed in Mexico. The FDA is taking this action consistent with CDC′s declarations that the Salmonella Saintpaul outbreak appears to be over. Because jalapeno and Serrano peppers grown in Mexico and associated with the Salmonella Saintpaul outbreak are no longer in circulation in US markets, the agency has concluded its field investigation.

As part of the Salmonella Saintpaul investigation, the FDA stepped up ongoing surveillance sampling of produce from Mexico.  As a result of that initiative, the FDA has identified shipments of produce from Mexico which tested positive for strains of Salmonella other than the Salmonella Saintpaul strain.  In the cases where contamination was discovered on imported produce, the FDA has refused the entry and imposed appropriate import control on a shipper–specific basis to prevent the entry of contaminated product into the US market.  These regulatory actions are an essential part of the food safety and food protection activities that the agency engages in on an everyday basis.

Finally, some thoughts on lessons learned and follow–up action:  The FDA believes strongly that there are some important steps that need to be taken to enhance protection against food–borne illness in the domestic supply of fresh produce.  Amongst these measures – and there are many of them contained in the Food Protection Plan – firstly we need congress to give FDA the authority to require industry to institute mandatory preventative control for high–risk foods such as certain types of fresh produce that have been repeatedly associated with serious adverse health events.  Secondly, we need to develop technology which will enable us to detect pathogens in fresh produce more quickly.  And finally, we need the industry to enhance their ability for product tracking, such as using an electronic tracking system so that we can more quickly trace the source of contamination.

In addition, we are evaluating the lessons learned from this outbreak in order to improve our response capabilities within FDA and make additional recommendations to the industry with a goal of improving preventative measures and increasing the efficiency of response.

That concludes my remarks.  I appreciate your attention.  Thank you very much.

LOLA RUSSELL:  First of all, I′d like to remind our participants today that we will only be taking questions from the news media during this media briefing.  Can we have our first question, please?

OPERATOR:  Thank you.  And at this time if you would like to ask a question, please press star (*), followed by one on your touchtone phone. To withdraw your request, you may press star (*), two.  And once again, to ask a question please press star (*), one.

Our first question comes from Maggie Fox with Reuters. Please go ahead.

MAGGIE FOX:  Hi.  I wanted to ask you about the relationship with Mexico. The Mexican authorities were evidently quite offended by the way this whole thing was handled.  Is there anything that can be done in the future to make those kinds of issues go more smoothly?

LOLA RUSSELL:  Dr. Acheson?

DR. DAVID ACHESON:  Yes, this is David Acheson, FDA.  I want to emphasize that our relations with Mexico have been collegial from the beginning.  We met with the Mexicans in the first few days of this outbreak and subsequently on a very regular basis, almost daily for quite some time…shared a lot of information with them…worked very, very closely with the Mexicans when we sent our teams down to inspect farms in Mexico; and, in fact, the Mexican authorities partnered with us on those investigations.  So they were right there with us, and we continued good dialogue.

I think that, unquestionably, the Mexicans are looking at ways to work with us, to improve systems, and we′re committed to that.  And we′re looking to work with them, with the Mexican authorities, to improve produce safety, both in terms for their domestic supply as well as any produce that may be imported into the United States.  So FDA is committed to continuing close collaborations and relationships with Mexico as we move forward.

LOLA RUSSELL:  Thank you, Dr. Acheson.  Next question, please?

OPERATOR:  Thank you. Our next question comes from Elizabeth Weise with USA Today.  Please go ahead.

ELIZABETH WEISE:  Hi. Hello all of you. Thank you so much for taking my call. I have two questions: First of all, if you′ve actually identified the farm in Mexico where you found the outbreak strain, why were all Mexican–grown jalapenos and Serranos implicated?  And my second question would be why are tomatoes still included in this?  It seems to be a real Occam′s Razor situation.  You actually found the outbreak strain on a single farm, which is pretty impressive in an outbreak investigation; I don′t believe it happens very often.  So why do you feel that tomatoes still should be – should have been implicated in this outbreak?

LOLA RUSSELL:  We′ll have Dr. Acheson answer the first part of the question, and then Dr. Tauxe will answer the second part.

ELIZABETH WEISE:  Thanks.

DR. DAVID ACHESON: With regard to the issue of where we found the contaminated products, you′re absolutely right.  We found the outbreak strain in Serrano peppers and in irrigation water on one farm. What is not completely clear from that is was that the sole source.  If you got Salmonella Saintpaul in a water supply on a farm, you′ve got to ask the question of whether that – how it got into the water, whether it was connected to canal systems and other irrigations systems that could have caused that contamination to go elsewhere. The question has been raised too of cross–contamination in distribution centers.  And that too is a possibility that, even though it may have been on one or multiple farms, it could have been cross–contaminated within distribution centers.

So it′s really – that′s why we′re not prepared to say definitively that particular geographic location was the source and that nothing else is a possible source.

ELIZABETH WEISE:  Just one quick follow–up:  How far apart was Farm A and Farm B?

DR. DAVID ACHESON:  Again this is David Acheson.  I don′t specifically know that, but I′m looking at Mike Chappell, as he knows that.  My recollection was it was approximately a hundred miles, but that′s not a fact. So we can check that and perhaps get back to you with that.

ELIZABETH WEISE:  Thanks.

DR. ROBERT TAUXE:  This is Robert Tauxe with CDC to address the question of why tomatoes are still on the list here.  As you remember, there was an initial epidemiological investigation in New Mexico and Texas that occurred very early, focusing on persons who got ill in May. And that investigation showed a strong association between illness and with eating tomatoes.  And we′re not sure, looking at it then or more recently, that those tomatoes were contaminated. And we′re not sure where they came from, and we may never know for sure.

There were subsequent investigations after the outbreak had spread to many different states and had appeared in a number of different restaurant locations as well which provided important information implicating jalapeno peppers and Serrano peppers later in the investigation; that′s after May.  And it′s very clear to us that much of the multi–state outbreak can be accounted for by those peppers that were then in circulation.  However, the early cases and the early focus in New Mexico and in Arizona and Texas left us with this strong association with tomatoes, and we continue to believe that that association could reflect real contamination at that point.

ELIZABETH WEISE:  So that would have been just early on?  So you′re not thinking that tomatoes were an issue throughout the length of the outbreak, but that something might conceivably have happened at the beginning with tomatoes?

DR. ROBERT TAUXE:  It′s the strong evidence that we had of an association with tomatoes came from early in the outbreak.

ELIZABETH WEISE:  Okay.

LOLA RUSSELL:  Next question, please.

OPERATOR:  Thank you.  Our next question comes from Ricardo Alonso Zaldivar from Associated Press.  Please go ahead.

RICARDO ZALDIVAR:  Hi.  Thank you, and thank you for taking my question.  The early focus on tomatoes, could it be because investigators were maybe just asking the wrong thing?  You hadn′t seen this kind of outbreak with jalapenos before; you had seen it with tomatoes, correct?  So could it be that they got a signal about tomatoes just because they weren′t asking a fuller question?

DR. ROBERT TAUXE:  This is Robert Tauxe with CDC.  Yes, that′s a very good question.  I think that the initial investigation into this outbreak considered a wide range of different possibilities that had been described as sources of Salmonella or that seemed likely at the time.  And an initial set of what we call hypothesis–generating interviews was conducted that asked people, among other things, whether they ate green bell peppers or red bell peppers or other types of peppers, and it did not go down an exhaustive list of all the other types of peppers.  But what was thought to be a relatively small proportion of those people answered yes to eating other peppers.

And on the basis of that, the full case control investigation was developed based on the most common foods that were reported by the people who had become ill.  And that′s the one that identified the strong association with tomatoes and also did not find an association with eating, say, salsa or guacamole, which are also popular foods there and were mentioned commonly.  I think if an association had been found with eating salsa or eating guacamole in that first investigation, our attention might have focused more on all the ingredients of salsa or guacamole.  But since there was not a specific association with salsa or guacamole in that first investigation or a risk identified separate from that of tomatoes, that was where that investigation took us.

RICARDO ZALDIVAR:  A quick follow–up:  So as you look at the totality of the evidence now, does the evidence on tomatoes seem to you to be relatively weak?

DR. ROBERT TAUXE:  I think that the epidemiological and laboratory information is very strong for the jalapeno pepper and is also strong for the Serrano pepper, which means we′re now talking about two different food vehicles with culture confirmation.  The information about the tomatoes was from the early study time period, and there was not a laboratory confirmation of it.  So its information that′s more restricted in time and does not have a confirmatory laboratory finding behind it.

LOLA RUSSELL:  Next question, please.

OPERATOR:  Thank you.  Our next question comes from Melinda Hemmelgarn, Columbia Daily Tribune.  Please go ahead.

MELINDA HEMMELGARN:  Hi.  Thanks for hosting this call.  I have a couple of questions.  One has to do with the irrigation water and the source of the fecal contamination that was getting into that water.  Was it from a feed lot?  Was it from human contamination?  And then the second question has to do with irradiation and the FDA′s new rule.  Do you foresee the day where all fresh produce will be somehow irradiated since we′re not able to really get our hands or arms around the issue?

LOLA RUSSELL:  FDA, Dr. Acheson, please.

DR. DAVID ACHESON:  This is David Acheson, FDA.  With regard to your question about the cattle and feed lot, I can certainly tell you that there were cattle in the proximity of the farm in which we found the positive Salmonella Saintpaul isolate. It would be speculative in terms of whether those cattle are carriers of Salmonella Saintpaul on an ongoing basis and how it may have contributed to the contamination of the water supply; but there were cattle in proximity, yes.

In the context of your second question on irradiation, as you′re all aware FDA has announced the approval of irradiation just very recently for two specific kinds of leafy greens, spinach and iceberg lettuce.  This should be seen as part of a solution to an ongoing situation.  It isn′t the silver bullet; it is just one more opportunity to provide an extra level of safeguard over fresh produce.  There is no intention currently of FDA to be going down a road of requiring such a treatment or anything along those lines, whether it be domestic or imported.  I think it′s just critical to emphasize that this is just one more step that can be taken, bearing in mind that the most critical part of protecting the food supply with fresh produce is appropriate preventative control, good agricultural practices on the farm.  That is key.  And this is not being put in place to work around that or to facilitate growers and farmers avoiding good agricultural practices; that has got to be clearly understood.

And the preventative controls that I spoke of in my opening statement are directed much, much more broadly than just irradiation.  It′s a much broader issue of requiring preventative controls with people who are handling fresh produce.

MELINDA HEMMELGARN:  Thank you.

DR. ROBERT TAUXE:  This is Robert Tauxe with CDC.  I would just like to echo what Dr. Acheson said.  I think irradiation is a very promising technology that we know can greatly reduce bacterial contamination on a number of food items, and we were glad to see the approval of that process for the leafy greens that was just announced by FDA last week.  And we think that irradiation of a number of foods, like pasteurization of milk, can be an important prevention technology when it′s integrated with all the other prevention steps.

LOLA RUSSELL:  Thank you, Dr. Acheson and Dr. Tauxe.  We′ll take the next question, please.

OPERATOR:  Thank you.  Our next question comes from Annys Shin with the Washington Post.  Please go ahead.

ANNYS SHIN:  Thanks for taking my question.  I just wanted to clarify, Dr. Acheson.  You said earlier that you think that FDA needs – congress needs to give FDA authority to require preventative controls for high–risk foods.  And I assume you′re meaning foods that have been linked to illnesses in the past.  But as Dr. Tauxe pointed out, jalapenos and Serranos hadn′t been linked to illnesses in the past.  I guess I′m wondering can you – is the understanding that FDA doesn′t have this authority now or only has authority with regard to foods that have been linked to illnesses in the past and do you need this extra authority for things like jalapenos and Serranos that haven′t been linked to illness in the past?  Could you clarify that a little bit?

DR. DAVID ACHESON:  Sure.  This is David Acheson.  Let me try to clarify that for you.  What we are asking for as part of the Food Protection Plan is explicit authority to require preventative controls in foods that would be considered as high risk.  And the definition of high risk in the Food Protection Plan were foods that have been repeatedly associated with serious adverse health consequences or death.  The reason that we did that was we needed to start somewhere with requiring preventative controls for those foods that are the greatest risk, and this is a risk–based strategy and is targeted to that.  Clearly, there are good agricultural practice guidance documents which we′re in the process of updating, and they need to be applied across the board.  There needs to be preventative controls across the board, but where are we going in terms of the legislative requirement?  It is focused, initially at least, on the areas of greatest risk, which obviously if other foods come online as being indicative of greater risk, that would be included also.

LOLA RUSSELL:  Next question?

OPERATOR:  Thank you.  Our next question comes from John Wilkerson, FDA Week.  Please go ahead.

JOHN WILKERSON:  Did you find any link between the two Mexican farms at all?

LOLA RUSSELL:  I′m assuming that′s for Dr. Acheson?

DR. DAVID ACHESON:  This is David Acheson.  No, we didn′t, other than the fact that they do go through the same distributor in Mexico. So the products from the two farms do both track through the same distributor.

JOHN WILKERSON:  Okay.  And what measures are needed to improve trace–back?  I know you′re working on guidelines. But, for instance, should there be better recordkeeping requirements and good manufacturing regulations?

DR. DAVID ACHESON:  This is David Acheson from FDA.  The trace–back requirements are complex.  And as you point out, we′re exploring various options.  The agency is planning public meetings in the fall, October–November timeframe, to explore this further with the stakeholders, industry and consumers and others who are interested in this.  I want to emphasize that during a trace–back, as we′ve discussed on previous calls, it was a question of the agency going to individual establishments and obtaining records.  Rarely were those records not available; that was not the problem.  It was that the records were frequently maintained as paper records, they weren′t electronic…not that all the industry is like that.  There are certainly elements of the produce industry that are maintaining electronic records, but the vast majority of the establishments we went to in this investigation weren′t.

So that was why things like interoperability so that one part of the chain connects to the next, consistency of naming products so that as, for example, tomatoes are moving through the system they don′t change their name as they work their way through the system, which was something that we had to deal with.  So those are the types of things that we′re looking for as multifaceted approaches around trace–back.

JOHN WILKERSON:  And were production records a problem?  Do the records show how – what comes into a facility links up with what is coming out of a facility?

DR. DAVID ACHESON:  Typically yes, they do.

LOLA RUSSELL:  Next question, please.

OPERATOR:  Thank you.  Our next question comes from Justin Blum, Bloomberg Business.  Please go ahead.

JUSTIN BLUM:  Hi.  Thanks for taking my call.  Dr. Acheson, can you explain in a little bit more detail why you decided to lift the warning not to eat raw jalapeno and Serrano peppers from Mexico?  How do you know at this point, without knowing exactly what the origin was, that once that′s lifted contaminated jalapenos and Serranos won′t reenter the US?

DR. DAVID ACHESON:  This is David Acheson.  That′s a very good question, and clearly none of us can provide a cast–iron guarantee that Salmonella Saintpaul won′t reemerge.  As we pointed out, we have not identified the total source for this.  We have identified a farm, water, and product on that farm that was contaminated.  We are basing this advice, as I said in my opening statement, about lifting the advice to consumers because it′s consistent with the Centers for Disease Control′s declaration about the outbreak appearing to be over and that the foods, the Serrano and jalapeno peppers, that would have been associated with illness from these facilities that we′ve inspected would no longer be in circulation.

As was pointed out earlier, we need continued vigilance looking for not just Salmonella Saintpaul but other Salmonella strains that may be on produce making Americans sick and taking the appropriate action.  And to that end, we are doing the assignments that I talked about in terms of continuing to test products/produce from Mexico looking for Salmonella.  And when we find it, are taking appropriate regulatory action.  But I don′t think that we can exclude the possibility that we may not see more Salmonella Saintpaul.

JUSTIN BLUM:  If I could ask a follow–up question.  I guess I′m still a little bit confused about why there′s less danger posed by those products now than during the time the ban was in place because isn′t it possible that the reason CDC is saying the outbreak appears to be over that you did have this warning in place and that stores weren′t stocking peppers from Mexico?

DR. DAVID ACHESON:  I think one has to realize that products like peppers and other things that are grown in the dirt, there is an inherent risk of them being contaminated with pathogens such as Salmonella. There is no way to guarantee that growing these products anywhere, domestically in the United States or in other countries, are going to be free of Salmonella.  That is an ongoing situation.  Salmonella to be found on fresh produce is something that we see periodically and we take appropriate action.

I think the point is that, with this particular outbreak, the peppers that would have been linked to it initially are no longer in circulation and that the outbreak appears to be over.

LOLA RUSSELL: Thank you, Dr. Acheson. Next question, please.

OPERATOR:  Thank you. Our next question comes from Sapna Parkih with Fox 5 WNYW.

SAPNA PARIKH:  Hi. Thank you for taking my question. My first one is actually a follow–up to the question about radiation. Could you please just comment on some of the concerns I guess that radiation of produce can lower the nutritional value and affect the food in other ways?

LOLA RUSSELL:  Dr. Acheson, please.

DR. DAVID ACHESON:  Yes, this is David Acheson.  The studies that were done at FDA before coming out with this statement about irradiation of fresh produce looked very carefully at the impact on nutritional value, and there was no significant impact on nutritional value or reduction in levels of vitamins or other important components for nutrition.  So all of those factors are weighed in before the decision is made.

SAPNA PARIKH:  All right, thank you. And the second question was some of the lessons learned I guess that you guys have mentioned, the need for electronic systems to help with trace–back and so on and so forth, is that something that you think should be a responsibility of the FDA or of the industry?  I guess where does the change need to happen?

DR. DAVID ACHESON: This is David Acheson from FDA. The change – industry has a responsibility to produce a safe product, and industry has a responsibility to know where that product is as it′s moving through the chain in the context of fresh produce, from the grower or the farmer right through to the retailer. That′s an important responsibility, the industry I believe recognizes is their responsibility to have. Part of that is, as I said, knowing where things are. So industry does have a responsibility to do this, and many take that very seriously and are doing it and have the capacity to do it. The point is that not all industry is doing it, and there need to be standards that will be set for ensuring that trace–backs, when we need to do them, can happen more expeditiously.

LOLA RUSSELL:  Thanks, Dr. Acheson.  We′ll take two more questions, please.

OPERATOR:  Thank you.  Our next question comes from Arthur Allen, Washington Independent. Please go ahead.

ARTHUR ALLEN:  Yes.  I′ve got a couple of questions.  First I was wondering does the distributor in Mexico that services both of these farms also process tomatoes?  This is the farm, one of which – on one of which the infected peppers were found. And if not, I′m wondering if tomatoes are still a suspect is it possible that – are we talking about two differently sourced outbreaks occurring here?

LOLA RUSSELL: Dr. Acheson?

DR. DAVID ACHESON:  I don′t know for a fact whether the distributor that I mentioned that was getting peppers from both of the farms also was getting tomatoes coming through that distribution system.  I can′t tell you specifically whether that′s the case, but we can look into that in terms of what our investigation there – what we learn from that and let you know.

ARTHUR ALLEN:  Okay.  One follow–up question: You mentioned early on that you had found truckloads or material contaminated with other strains of Salmonella.  Can you give us any idea of how many – did this happen multiple times or how many different shipments were involved, the quantity we′re talking about or the number of instances?

DR. DAVID ACHESON:  As we′ve been undertaking that assignment, we have been placing firms on import alert when they reach the criteria to go on import alert.  And there are a number of firms that we have done that for.  I′ll try and find you the exact number of that, but they′re all posted on our website, so they are publicly available.  Some of these processes have also resulted in recalls that were product that was in domestic commerce.  Now, that doesn′t mean that it′s domestically produced; it doesn′t mean it′s Mexican produced.  It′s essentially it′s in commerce and certainly as of August 21st we had initiated with the state 14 recalls as part of this.  And I found that number, and we again, as of August 21st, we have placed 17 firms on import alert as part of that assignment.

ARTHUR ALLEN: How does this compare to previous levels of recalls and import alerts, if you looked at a year ago, say, or six months ago?

DR. DAVID ACHESON:  In relation to peppers?

ARTHUR ALLEN:  These were all peppers?

DR. DAVID ACHESON:  No, they′re not all peppers.  I′m trying to focus your question.

ARTHUR ALLEN:  Yeah. No; I′m just trying to get a sense of, you know, how much more activity by FDA in terms of recalls and putting people on alert has resulted from the sort of increased vigilance that came as a result of this investigation.

DR. DAVID ACHESON:  Well, certainly we have increased our testing of Mexican produce, and I can′t tell you by what percentage because I don′t have those numbers right in front of me.  But we have increased our testing, and we have found the positives that I just explained. So because of the increased testing, then obviously the level is greater than it was previously.

LOLA RUSSELL:  Thank you, Dr. Acheson. Last question, please.

OPERATOR:  Thank you. Our final question comes from John Gever of Med Page Today.

JOHN GEVER:  Hi.  I wanted to return for a moment to the initial focus on tomatoes.  There was testimony in congress last month from a tomato industry executive who said that at the time of the outbreak only tomatoes from Florida were being distributed on the US market and – or excuse me…yeah, those were the only US tomatoes being distributed on the market.  And that′s because the initial cases were seen in Texas and New Mexico, which receive their tomatoes from – or most of their produce – from Mexico that the investigation could have focused on Mexican produce from the very beginning, which presumably would have allowed your investigation to move more quickly.  Could you respond to that?

DR. DAVID ACHESON:  The trace–back that we undertook on tomatoes took us very definitively to Florida and to Mexico.  As we were tracing back initially sporadic cases and then subsequently clusters, we were getting more than one lead going back to each geographic location.  And we discussed this extensively at the time on a number of calls.  In view of that, we sent inspectors and investigators to both areas, predominantly southern Florida and a particular area in Mexico to look at the farms that had been implicated as part of the trace–back.  So there was no indication at that stage of the investigation that it should have been focused one way or the other, and we weren′t about to take that chance.  The trace–back, which was the science behind this, was leading us to two geographic locations, so we went to two geographic locations.

The pepper story was different in that that – the trace–back there took us back to Mexico.

JOHN GEVER:  So you′re saying that in the initial cases there were some of these restaurants and other places where people consumed the foods, that the tomatoes did indeed come from Florida?

DR. DAVID ACHESON: That′s correct, yes.

JOHN GEVER:  Okay. And I had another question too, different subject.  The editorial adjacent to the MMWR report mentions a sluggish process for submitting Salmonella typing results to Pulse Net.  Why is that so slow?  It mentions a 17–day median time to submit the results.  Why is that so slow and what can be done to speed that up?

LOLA RUSSELL:  Dr. Tauxe will answer your last question.

DR. ROBERT TAUXE:  Thank you.  That delay in reporting is the time it takes between the day the person first becomes ill and the day that the DNA fingerprint pattern is posted to Pulse Net, and its average in this outbreak was 17 days.  Part of that is the time it takes for someone to actually consult a physician and have a test done and get diagnosed, and that′s probably not going to be made much shorter.  But the other part of it is the time it takes between the laboratory, the clinical laboratory, in a clinic or hospital identifying the Salmonella, getting it to the state public health lab, and then the public health lab running it and posting it.  And that time can be shortened if it can be made, for example, mandatory that clinical labs would rapidly submit Salmonella to the state lab and not save them up and submit them in batches and if the state public health laboratories were resourced to be able to do the Salmonella fingerprinting in real–time.  So that one can be – that part of the delay could be shortened. It would take faster shipping from laboratories to the public health laboratories and the capacity to do faster fingerprinting at the state labs.

JOHN GEVER:  And a general question about the editorial:  Does that represent the official agency view of CDC and FDA?

DR. ROBERT TAUXE:  The MMWR is a CDC statement.

LOLA RUSSELL:  Okay.  Thank you so much for participating today in our news media briefing on Salmonella Saintpaul Outbreak 2008.  If you have additional questions, please call me, Lola Russell, in the CDC press office or Stephanie Kwisnek in the FDA press office.  Thank you so much.

OPERATOR: Thank you, and this does conclude today′s conference call.  We thank you for your participation.  You may now disconnect your lines.

END

####

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