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Hearing Of The Agriculture, Rural Development, Food And Drug Administration And Related Agencies Subcommittee Of The Senate Appropriations Committee - 2009 H1N1 (Swine Flu) Virus


Location: Washington, DC

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SEN. KOHL: Good morning, and we thank you all for being here today. I would like to personally welcome Senator Brownback who's the new ranking member of the subcommittee. It's very good to have Senator Brownback and his knowledge and experience with us.

We also of course would like to welcome Secretary Vilsack and Dr. Sharfstein to this committee hearing.

In a normal year, gentlemen, your first appearance before this subcommittee would focus on the administration's budget request, which coincidentally is being released today as you know. But we're going to ask you to come back for that once we've had a chance to study the budget and use this previously reserved time to hear from you on the steps that USDA and FDA are taking in response to the H1N1 outbreak. And we thank you both for being here in that regard.

The past two weeks, Americans have witnessed lots of media coverage of the flu outbreak, and speaking with Secretary Napolitano yesterday, she indicated that it has not turned out to be as severe as we originally feared. The immediate sense of crisis fortunately seems to be passing. We are no longer calling for schools to close and the fear many people have in recent days should be subsiding at this time. But we still need to be vigilant as we all know, and if history is any guide the second wave has historically been even more lethal.

But as of today there is good news. The number of new cases in Mexico is slowing. It seems to be a milder strain than previously thought. Hospitalization rates are comparable to the regular flu. Existing drugs have been effective. And finally, there has been a good coordination among all levels of government here in the United States. And the messages given to the public have been consistent and timely.

But we all know there's more to be done. We need to work to spread accurate information about this flu and that it is not, quote, "swine flu." Our food supply is safe, and no one should be closing their borders to United States meat. Secretary Vilsack, that's one of your jobs.

We also need to make sure we have a vaccine for this as well as the seasonal flu that will come around in the fall, and to make sure that it's safe and that there's enough for everyone. Dr. Sharfstein, that will be your job.

So we look forward to hearing from you both after any statement from Senator Brownback that he wishes to make at this time.

Senator Brownback.

SEN. SAM BROWNBACK (R-KS): Thank you very much, Mr. Chairman. And it's a pleasure to join you here. I saw my colleague and the former ranking member Bob Bennett on the elevator on the way up, and he was handing me the reins as the ranking member. And I'm delighted to be here.

Being from the state of Kansas, this is an important topic for us; it's an important topic for all the country. But certainly the agriculture subcommittee is one that a lot of people watch, and I'm looking forward to serving with you and getting your advice on any of the NBA playoffs that you had. I'm sure you would know those as well as this topic.

This is a key topic in front of us on the H1N1. Early April doctors in California detected this new and unique influenza strain in two young children and immediately began working with officials at the Center for Disease Control and to determine the origin and make-up of this influenza strain. After identifying the strain as a novel H1N1 influenza and tracing it to a significant outbreak in Mexico, it became clear that health officials were dealing with a serious situation of global importance.

This outbreak is a true test of our public health response systems, and by all accounts it's working. The Department of Health and Human Services, working with state health departments, has been able to quickly identify and respond to this virus; antiviral drugs that are effective in treating this type of influenza have been shipped to all 50 states and provided to Mexico to assist with the situation there.

In addition, efforts are underway to develop a vaccine that would be ready for the fall flu season if it's necessary. Each sector of our public health infrastructure is mobilized to combat H1N1 influenza.

While we've appropriately-focused on the public health aspects of the situation, we must not forget that the initial naming of this virus has erroneously caused concern that pork products pose a threat to public health, resulting in a decline in the pork market. I know the Secretary, being from Iowa, is critically aware of that. And I have to say, Mr. Chairman, my background in the trade field and working with the initial opening up of foreign meat markets to the United States, to beef and pork exports, too often what we see taking place in a situation like this is another country using this as an excuse to block our products.

And we've seen this happen in a number of different health situations that are not a health concern to the population. And so we've seen to date 20 countries have placed trade restrictions on U.S. pork products that are healthy, that are safe, and I think these are just being used as trade barriers to our products, pure and simple.

Mr. Secretary, I am certain you share that view, and I'm certain you're on top of this to push to reopen these markets, because this just happens all too often. And as a result, our prices for pork in the United States have declined over 15 percent. So it has real impact, and already a difficult marketplace for our producers. It's a huge public health concern. Dr. Sharfstein, we'll look forward to your work and your comments on this. And it's one that we want to support your team and the efforts to make sure that we handle this the best possible and effective way that we can.

Thank you, Mr. Chairman.

SEN. KOHL: Thank you very much, Senator Brownback.

We have with us this morning Senator Mark Pryor who's a member of this subcommittee now. Thank you for being here, and you may make any statement you wish.

SEN. MARK PRYOR (D-AK): Thank you, Mr. Chairman. I don't have any statement, but thank you both for your help on this issue and I look forward to hearing from the panel. Thank you.

SEN. KOHL: Thank you.

Secretary Vilsack, we'll take your statement, please.

SEC. TOM VILSACK: Thank you very much, Mr. Chairman. And good morning to you and to Senator Brownback and Senator Pryor. I appreciate the opportunity to testify today before you on the 2009 H1N1 influenza.

I have with me today as well Dr. John Clifford, the chief veterinarian for the Department of Agriculture; as well as Jim Miller, under secretary for Farm and Foreign Ag Services; and Dr. Kenneth Peterson, assistant administrator for Food Safety and Inspection Service.

Before I begin, I would like to express my sympathy and that of the USDA and our concern for all those who have lost loved ones as a result of this flu, as well as those who have been sickened by it. I recognize that many Americans are worried about this virus, and I want to assure them and you that federal, state and local governments are working closely together to respond to the emergency, an emergence of this virus.

The appearance of the 2009 H1N1 flu virus in humans and the associated concerns for animal health underscore the interdependent nature of human and animal health and the need for a one-medicine approach to animal health surveillance. This emphasis is certainly true in USDA, and it's how we view our role in animal health safety, a role in which we are concerned not only with animal health but with the optimal health of people, animals and our environment.

Today I'd like to emphasize several points relating to the flu outbreak.

One, it's absolutely safe to consume pork products.

Two, USDA is involved in surveillance and vaccine development for swine.

Three, USDA is well-prepared should we detect the 2009 H1N1 flu virus in U.S. swine.

And, finally, USDA is working hard to keep markets open for pork products.

I've been saying since day one and will continue to reiterate that pork and pork products are safe and the American food supply is safe. Experts at the USDA and the Center for Disease Control have carefully examined this issue and found no evidence that this flu virus can be transmitted by food. It is important that consumers understand that you cannot contract this flu from eating pork or pork products. We are reiterating this message not only to the general public and industry but to our trading partners and organizations, such as the U.S. Commodity Futures Trading Commission and Chicago Mercantile Exchange, in order to assure markets that U.S. pork is safe and to protect producers' livelihoods.

Another point I want to reiterate is that there is no evidence that this virus is in U.S. swine. We continue to take steps to verify that there are no signs of this virus in our swine herd, including working with state animal health officials, private practitioners and our own federal veterinarians in the field. However, it's important to note that because of the inherent qualities of influenza, there could be transmission from humans to swine.

In fact, Canadian food inspection agency officials have confirmed that swine from a herd in Alberta, Canada, tested positive for the strain currently causing illness in humans. Canada has handled this situation appropriately and taken the necessary steps and precautions. No sick swine have left the farm, and animals and premises have been quarantined. We are working closely with our counterparts in Canada to keep abreast of the situation, and this emphasizes the critical importance that pork producers be vigilant and understand and accept appropriate biosecurity measures.

Vigilance is something we use at USDA, and we have an effective safeguarding system in place that utilizes surveillance, testing and monitoring to ensure diseases are kept out of the livestock industry. Just as our safeguarding system has been proven successful in the past, we are confident in our efforts, combined with those of our industry partners, that will alert us to any possible disease in U.S. swine.

USDA is prepared, and so while USDA's routine safeguarding efforts for animal disease are ongoing, we do recognize the need to be responsive to the heightened concerns surrounding this flu and are undertaking additional measures around surveillance and research to reassure consumers, producers and the public. To ensure early detection should the H1N1 flu be introduced into U.S. swine and because this particular strain has human health implications, we've accelerated implementation of a swine flu influenza surveillance program which we began developing in July 2008 in cooperation with the CDC and other stakeholders.

Dr. Clifford is here if you wish to talk more about this.

If we were to detect an unusual case of swine influenza, USDA would take a series of swift and appropriate actions to contain the virus and protect animal and human health while the virus was being identified.

Following the escalating media attention regarding the 2009 H1N1 influenza over the weekend of April 25th and 26th, the pork industry has encountered, as Senator Brownback indicated, an over 15 percent decline in the average cash based price for hogs. Prior to that weekend, USDA reported a weighted average-based price of $61.03 per hundredweight paid for Barrows and Geltz (ph) on a carcass basis. As of May 5th, that price decreased to $50.95 per hundredweight, a decline of over $20 per head for pork producers. By comparison, the average based price was $75.07 a year ago, or a 47.3 percent decline from the current price.

Although the decline in pork prices has not been as large, the wholesale pork carcass cutout value decreased by 5.5 percent from April 24th to May 5th.

Now let me turn your attention for just a minute to the international market for U.S. pork and other meat and poultry products. As you know, exports are vital to the success of the U.S. meat and poultry industry. For example, in 2008, total U.S. pork exports were $4.7 billion. When I first became aware of the 2009 H1N1 flu situation, one of the first steps I took was to instruct each of our Foreign Agricultural Services representatives in other countries to reach out to all of our major trading partners to keep their markets open. Through this network of overseas posts, FAS worked quickly to remind the appropriate foreign ministries and key foreign officials that discovery of this virus in humans is not a basis for restricting imports of commercially produced U.S. meat and pork products.

We wanted to make sure our trading partners knew that this is not a food safety issue and that we expected them to make decisions regarding the importation of U.S. pork based on sound science and internationally accepted rules. Because of our swift action, we have been able to significantly mitigate the impact on our international markets.

To reinforce our commitment, Ambassador Kirk and I put out a joint statement, again urging our trading partners to make decisions based on scientific evidence in accordance with our international obligations. We will continue to work with the U.S. Trade Representative's Office to send a strong and unified message in this regard.

One of our key markets we immediately contacted was Japan. Japan is the number one export market for U.S. pork, with trade worth over $1 billion a year. We are particularly pleased with the Japanese response which was very strong and unequivocal, a confirmation that U.S. pork products are safe and there's no reason to restrict into their country.

Official and unofficial bans were quickly lifted in numerous countries due largely to USDA's outreach. For example, all Central American markets that initially closed are reported to have been reopened to U.S. pork products.

I am disappointed that China and Russia have imposed restrictions in reaction to H1N1. These restrictions account for the bulk of the impacts on exports. China has a record shipment of $273 million, roughly 6 percent of our exports in 2008. However, the pre-H1N1 forecast expected 2009 shipments to be a bit lower. Russia has banned all meats from some states, thus impacting not only pork but also beef and poultry. Pork exports to Russia were valued at $414 million, accounting for 9 percent of our trade.

Our USDA posts overseas have taken every opportunity to reach out at every level of both the Chinese and Russian governments. The message they are delivering is clear: U.S. pork and pork products are safe, and these markets should be reopened consistent with international guidelines. We will continue to focus our efforts on reopening these markets.

In closing, I want to emphasize that USDA will continue to work with other government agencies, industry, and our counterparts around the world to monitor the situation and assure the public and our trading partners that U.S. pork is safe. I must reiterate that indeed our products and our pork are safe. We're moving swiftly to make sure that we understand the science behind this virus, have the tools in place to detect and identify it, and respond appropriately if needed.

You also have my assurance that USDA will continue to press our trading partners to remove restrictions on U.S. products and that restoring the international market for U.S. meat and poultry is a top priority.

That concludes my statement, Mr. Chairman. I look forward to working with members and staff of this committee, and I'd be glad to answer questions you might have later. Thank you.

SEN. KOHL: Thank you very much, Secretary Vilsack.

Dr. Sharfstein?

DR. JOSHUA SHARFSTEIN: Thank you, Chairman Kohl, Senator Brownback, Senator Pryor, for the opportunity to testify today. Let me also say to Secretary Vilsack that it is terrific to meet you, that FDA supports completely your message on the safety of pork products, and we share USDA's mission of ensuring a safe food supply for Americans. I also should say we've had, in my five weeks on the job so far, just a terrific relationship with your staff at USDA, collaborating on a whole range of food safety projects. And I think there's just so much exciting and worthwhile to be done through that collaboration.

Among its other responsibilities, FDA protects public health by facilitating access to safe and effective human and animal drugs, human biological products and devices.

This mission has been put to the test by the H1N1 situation in the last couple weeks. Since the beginning of the outbreak when we became aware on Thursday, April 23rd, FDA has worked closely within HHS, with our sister HHS agencies, with USDA, other government agencies, the World Health Organization, and foreign governments to address the serious challenge.

I appreciate the opportunity to discuss FDA's response, including our approval of several emergency use authorizations, and the efforts of internal FDA response teams.

I'm going to just start by explaining the most public thing that FDA did which was to issue several emergency use authorizations. This concept was part of the Bioshield Act of 2004. An emergency use authorization allows the use of an unapproved product or of an approved product for an unapproved use in a declared emergency. To authorize this emergency use, FDA must find that the agent -- in this case the flu virus -- one, can cause a serious or life-threatening disease or condition; two, based on the totality of the scientific evidence it is reasonable to believe that the product may be effective against the disease or condition; three, that the known and potential benefits of the products used outweigh the known and potential risks; and, four, there is no adequate approved and available alternative.

On Sunday April 26th, the acting HHS secretary issued a nationwide public health emergency declaration in response to human infections discovered from the 2009 H1N1 flu virus. In the days that followed, the acting secretary issued justifications justifying emergency use of certain antivirals, in vitro diagnostics, and personal respiratory protection devices. And FDA followed very quickly with several emergency use authorizations. Two of these were for medications, for Tamiflu and Relenza, two antiviral drugs.

So Tamiflu, FDA approved on an emergency basis the use of this medication for children under age one and gave the first dosing for that age group. In addition, under emergency authorizations both medications may be distributed with information pertaining to emergency use to large segments of the population without complying with the label requirements otherwise applicable to dispense drugs.

For example, both medications may also be distributed by a broad range of health-care workers, including public health officials and volunteers, in accordance with applicable state and local laws or public health emergency responses. It was this emergency declaration that allowed the stockpile to ship so quickly.

FDA worked literally around the clock over the weekend, and I signed those emergency authorizations at 3:00 in the morning on Monday morning so that our stockpile could begin to ship as they had scheduled.

The third one was for a diagnostic kit. It was the PCR flu panel diagnostic test that CDC put together to allow other labs other than the CDC lab to accurately diagnose this new infection. FDA approved this initially and then amended the authorization to allow the use of different sample types such as throat swabs and different reagents for this task so that the supplies remain adequate. This was also approved that first night so that immediately CDC could begin distributing this task with all the appropriate instructions to labs around the country.

The fourth one that we did right up front was around masks, and FDA issued an emergency use authorization permitting the use of N-95 masks by the general public from the strategic national stockpile in accordance with CDC's guidance on how these masks should be appropriately used.

Taken together, these authorizations helped CDC and state and local responders to take the actions needed to help meet the medical and public health threat, getting these products to patients and communities in need.

I just want to give you a little bit of a background on how FDA was able to do this so quickly and so effectively I think. And that is that we changed the management structure of the agency in order to handle the H1N1 situation. As soon as we became aware I asked Dr. Jesse Goodman, FDA's acting chief scientist, and deputy commissioner for Scientific and Medical Programs, to lead FDA's efforts. Dr. Goodman is an international expert on biologics. He used to oversee the Biologics Center at FDA during the period where they significantly increased the number of flu manufacturers selling into the United States. He has tremendous experience in flu vaccine development and evaluation.

He is leading an infinite management approach which is a different type of leadership approach than the usual kind of organizational chart at FDA. This approach, we put together seven substantive teams which are cross-cutting and include staff from across the FDA as needed. All the FDA centers are engaged in the work on H1N1. These teams work with the Office of the Assistant Secretary of HHS for Preparedness and Response, CDC, other HHS agencies, and national and international partners. The teams are the Vaccine Team, the Antiviral Team, the In Vitro Diagnostics Team, the Personal Protection Team, the Blood Team, the Shortage Team, the Consumer Protection Team.

The Incident Command kind of approach is what is used by emergency agencies. It was originally developed to fight fires and is now widely adopted across the federal government. It also includes an Operations Section, a Logistics Section, a Communications Section that coordinates external relations and has senior level health, international and legal advisers.

Very briefly I'm just going to tell you about what the teams are working on now. The Vaccine Team has a goal of facilitating the availability of a safe and effective vaccine to protect the public from the 2009 H1N1 flu virus as soon as possible in the event that it's needed. And this work goes all the way from the lab where FDA grows the virus, tries to genetically reengineer a reference strain of the virus that could be used for vaccine production, to getting reagents for to test the potency of the vaccine which involves sheep, the antibodies for that apparently produced from sheep, all the way to helping to design the clinical trials or advise on the clinical trials that would be used to test the potency of the vaccine and the effectiveness of the vaccine all the way through approving the final vaccine.

And that team is engaged with the NIH and VARDA which does the purchasing of vaccines for the federal government.

And then there's the Antiviral Team. This is the team that approved the Emergency Use Authorizations that first weekend for the two antiviral drugs, and they've been working very hard on identifying other products that may be needed under an emergency use. For example right now there are no intravenous flu medications that are approved for use. So that team is working with manufacturers for promising products to see whether it might make sense to do an emergency use authorization in case that would become necessary because there would be so many sick patients.

Like the Vaccine Team, this team is working closely with colleagues around the world. They got a lot of calls. This team put together the dosing for kids under age one based on their expertise in drugs, the science of drugs and the human body, and the rest of the world was very interested in following them, has been using their recommendations.

The In Vitro Diagnostics Team is the one that led the development of the tests, and they are regularly communicating with manufacturers about other tests that could get approved.

The Personal Protection Equipment Team oversaw the Emergency Use Authorization on disposable N-95 respirators, and it's working with manufacturers on the current demand for respirators, meaning the N-95 masks. And they are working with CDC on public communications.

We have a Blood Team. The main focus of the Blood Team is to ensure that the blood supply remains robust during this period. The people, if they were to get too many people sick, maybe the blood levels would drop. But they are also looking at if there's any potential that the virus could have any safety concerns for the blood supply. And so far there have not been any significant problems identified.

We have a Shortage Team which is solely devoted to identifying shortages, working with manufacturers of approved drugs to make sure that they can get their capacity up and going, thinking a couple steps ahead about where there might be bottlenecks in the distribution process, and how FDA can help.

And finally, the Consumer Protection Team, which has the goal of protecting consumers from fraudulent and potentially dangerous FDA regulated products or other promotions that claim to diagnose, prevent, mitigate, treat or cure the flu virus. And in fact they've already found a number of these where people are promoting things that are potentially dangerous in the guise of treatment for H1N1 influenza. They've taken enforcement action and the promotions have been halted.

I just want to take one second to thank the subcommittee for the funding in 2006, which really was critical to FDA getting to this point. FDA's current efforts are built on a foundation that has been really built over the last five years; 2004 there was a major flu vaccine shortage, and Congress and the administration at the time really took that very seriously. FDA worked very hard to increase the number of manufacturers in the market from where they were down to one ingestible flu vaccine manufacturer, there are now I think five. And that included a whole number of investments that were only made possible because of actual supplemental in Fiscal Year 2006, $20 million to FDA. That paid for a special review team that went out and inspected the vaccine facilities quickly to get them on-line faster, including a second major facility, domestic facility that Sanofi Pasteur and just got the approval from FDA yesterday.

And it's going to double their manufacturing capacity for injectible flu vaccine in the United States from 50 million to 100 million doses of seasonal flu vaccine a year. That facility approved yesterday is going to be available in case there is large-scale production of H1N1 virus vaccine. And it is no exaggeration to say that that supplemental appropriation, the foresight that the subcommittee had in moving that forward, is directly related to the fact that we're starting from a pretty strong foundation.

So to conclude, I would just say that it has been a real pleasure for me as someone who's relatively new, very new to FDA, to see what the agency is capable of and its response to this challenge. FDA is fully committed and engaged in protecting the public's health. Among us are laboratory scientists, medical reviewers, epidemiologists, product experts and field inspectors. We will bring every skill and resource we have to this critical mission.

Thank you very much for the opportunity to testify, and I look forward to your questions.


SEN. KOHL: Thank you. Dr. Sharfstein, if it takes four to six months as we understand it to develop an effective vaccine, we'd be into fall before we know it. Do you anticipate that you will be in a position to have a flu vaccine available by that time if necessary?

DR. SHARFSTEIN: The way I've been thinking about that question is to separate out into two separate issues. One is that manufacturing capacity and what the system can do, and the other is the virus and the unknowns about the virus. Because of the investments that have been made, the manufacturing capacity is very robust. The question is how the virus is going to behave and it's impossible to make predictions at this point.

The first stage is to get a very good reference strain of the virus that's growing well and can be used to turn into seed lots for a vaccine. And that's the stage we're in now. And that has to be completed to get the next stage. When you get the seed lots and there's pilot amounts of vaccine that can be made by the manufacturers, then it has to be tested for potency chemically and then tested in humans.

And those tests could show, boom, it works right away—you know, the humans do well, they have a good immune response to it, and now it's ready for a wholesale manufacturing if that's what we want to do. But it could also say, Wait a second, there's a problem with the immune response, and we've got to go back and figure out what we need to do to boost the immune response so that it actually works." And we don't know exactly how that's going to go.

So I know that there's a lot of interest in saying "It's going to be four to six months, it's going to be four months, what's the exact production?" But the truth is, each of these steps has its own uncertainties, and when you're dealing with a completely new virus you're not sure.

It could be that every step moves very quickly. It could be that there's a particular step, which causes a big challenge, and we have to figure out a way around it. So I think, the good news is we have the capacity. You know, once the technical things are solved, the capacity to produce the vaccine is there. But there are a lot of unknowns.

There's also the unknown of whether we would recommend a vaccine. You know, in 1976 there was the decision very quickly after a new flu virus was identified to make and also give the vaccine right away. The president announced that he wanted everyone to get a vaccine. It was February 1976 that the new virus was identified at the time, and the president announced I think in March he wanted everyone to be inoculated in the fall. That is not the approach that we're taking now. We want to be prepared with the vaccine but there may be a separate decision based on the way the epidemic is, other factors, what we know about the vaccine at the time.

We're going to wait to make a decision on whether to recommend it.

So I'm sorry that was as clear an answer as I would like to give. I think we're confident that the manufacturing base is there. We believe we are putting all the expertise we can into it, but there are going to be a number of uncertainties as we go through in order to be able to answer when the vaccine will be available and whether we'll even recommend it.

SEN. KOHL: Are you saying that we first have to determine what particular kind of a vaccination we need? And that will be determined once an outbreak starts occurring? And we can then figure out? But then in a sense it's too late, isn't it?

DR. SHARFSTEIN: No. I think what, we're at full-scale. Right now our efforts are full steam ahead to make a vaccine, but we don't know exactly what type of vaccine to make until we test it in people to find out whether it works. So for example how much of the flu virus antigen goes in each vial, we don't know that. If you have a certain amount of, like the material for a flu vaccine and you don't know exactly how much, you wouldn't know how much goes in each vial until we do the testing to see how people respond to it.

So there are a whole bunch of technical questions before you figure out what kind. And we're going to be working on that before the fall. So that's going on full steam ahead. But knowing, but how that resolves itself will determine whether a vaccine is available in September or October or November or how much of it's available, you know, and when. There's just these outstanding technical questions. It's really true in any flu season, but it's particularly true now because it's a brand new virus. People don't know exactly how it will behave in all these tests and until we actually do the tests.

SEN. KOHL: Um-hum. Secretary Vilsack, what more do you anticipate doing to be sure beyond statements and urgings that our foreign markets don't get closed to us?

SEC. VILSACK: Senator, we're in a combination of steps. First and foremost, I think it is important for us to continue reiterating at all levels that our pork products are safe and that there should not be any restrictions. So we are consistently, on a daily basis, particularly in China and Russia, conveying that message.

We are updating them on the science; we're updating them on what we know about this virus to reassure them that there is no scientific basis for abeyance.

Secondly, we are working with international organizations to ensure that statements from those international organizations are supportive of what we are saying, that our pork products are safe. Whether it's the WHO or the OIE or the FAO, we're working with a variety of international organizations to make sure that those statements are consistent and that they are repeated on almost a daily basis.

We're working with Ambassador Kirk to determine whether or not, as Senator Brownback suggested, whether or not there are other issues that this is tied to or tied in with and if so whether or not those can be rectified as well. So there is an ongoing process. We are working with our Canadian partners to also send a very strong and consistent message. That message is resonating. We're beginning to break through. Central American countries are a good example. We have continued to emphasize Japan's attitude about this because I think it's instructive to other Asian nations.

And so it's a combination of factors. And the more we know about this situation the more we continue to talk about it and educate and inform. At this point in time, that is the strategy that we're utilizing.

SEN. KOHL: Thank you.

Senator Brownback.

SEN. BROWNBACK: Thanks, Mr. Chairman.

A couple questions that seem to really bounce around a lot on the flu situation, Dr. Sharfstein, is the idea that this is going to, the potential for this to get worse in the fall. It's like you get a bump of flu and then it takes off once it gets to incubate or mutate. When will we get some sense, or do you get a sense about that at an earlier stage? Or does that just come on you? Do you get any, can you develop any thought as to whether that will indeed happen?

DR. SHARFSTEIN: That's an excellent question. I think that there are several ways to try to get a sense of it. One is sort of that the biological way to study the virus and see whether it's mutating, and so the CDC has been sequencing different viruses that people are getting from around the country, and they have not found dangerous mutations at this point.

Now, everybody knows that can change.

In addition there is surveillance of a number of hospital emergency departments, so the CDC was able to say when this all started in these states, these emergency departments are seeing more respiratory illness, and it's probably the flu. But they also were able to see that it was not that severe, very quickly.

I think the CDC will be right on top of any changes in the severity given the nature of the surveillance that they have. And some of their surveillance systems are getting literally information on every patient in certain emergency departments, confidentially without identifying information, but they're getting information that allows them to kind of draw a picture of how severe the situation is.

I think this is a situation where we have to hope for the best but prepare for the worst. And given the experience of the flu virus in previous seasons, the fact that it does get worse, and like Chairman Kohl said could come back with a ferocity in the fall, that's why all the agencies are really working full steam ahead on preparing a vaccine.

SEN. BROWNBACK: Does it come back with a ferocity because it mutates?

DR. SHARFSTEIN: It's a couple factors. It's going to probably pass around the world, so you'll see it, or you know one scenario is it doesn't exactly go away; it may go to the Southern Hemisphere during their flu season. That will actually be a key sign to see what it's like there before it comes back here. Part of it is that it could mutate. The other thing is that for some I think not entirely known reason the flu really does transmit better during flu season. And I'm not sure there's an exact answer to why. Some people think it's because people are in indoors more, and the cold, or it could be another factor. But if more people get it, the more vulnerable people get it, and there will be, you know, many more people dieing rather than a time when there's just less transmission overall.

So you know, I think the third thing is I've been testifying and meeting with Dr. Falchi from NIH who is a world expert on these things. And he's I think really making a point of being very humble when it comes to a new virus and what can happen. And you know, the fact that it's new means that we're not sure what could happen, and we've got to just be prepared and watch very carefully.

SEN. BROWNBACK: For both of you gentlemen, this is another zoonotic disease. I remember the last head of CDC telling me that 10 of the last 12 major health concerns we've had have been zoonotic where it's animal to humans, that it jumps and can go back and forth. Are we sufficiently invested in research on how to handle these zoonitic diseases that seem to be the most ferocious on us?

SEC. VILSACK: Senator, let me first of all say that in the summer of 2008 we began an extensive research project involving swine flu and various strains that we were aware of in an effort to try to learn more about the impact of this particular influenza. As a result of that work, we are in a position to sort of integrate into that work this recent strain, and we are going to accelerate our efforts to try to learn more about it.

So in a sense we began that research in July of 2008. We continue it. It's a two-year project. It's a combination work between us and CDC to understand more about the mechanics if you will of the flu.

I will say that it's fairly obvious that the amount of resource that's been dedicated to USDA and to animal research generally has been relatively flat in terms of investment over the last several years. And so that has required us to prioritize and to make decisions about what gets researched and how and of course we get a great deal of instruction from members of Congress about concerns that they have that are particular to their region and very important to agricultural production and livestock production.

We will hopefully have an opportunity with a new administration to sort of take a look at the structure of our research programs. One of the --

SEN. BROWNBACK: But you're going to have to do them back and forth. This is going to be both animal and human. The research needs to take place, and you're going to have to work with CDC and other places to make sure, because these -- they go back and forth.

SEC. VILSACK: And the flu project is in fact a joint project between CDC and USDA. So we are working in concert with CDC on that particular project, and there are a number of inter-agency agreements and memorandums that we've entered into. So that work has started, and it will continue. And we're going to make sure that we prioritize the research as best we can with the resources that are provided to us.

DR. SHARFSTEIN: I would say before I took this job I was the health commissioner in Baltimore City for three years. And in the public health world it's very clear that there needs to be a lot of attention to the issue that you're raising. The West Nile virus as you may know was really evident in birds, and it took quite a while for people to realize that there was something new going on in birds, and that that was actually transmitted over into humans. And I would say in addition to the basic research to understand that, the surveillance systems and bridging the surveillance systems between animal diseases and human diseases is something that at a public health level it's extremely important.

And you know, it's something that I think the CDC probably at the federal level has a big interest in, especially given the very kind of cautionary tale of what happened with West Nile.

SEN. BROWNBACK: Mr. Chairman, just one final thought to Secretary Vilsack. I've had other members raise to me that we have a number of agricultural workers coming into the U.S. from around the world but particularly from Latin America, and concern about the flu virus and I presume that's something you're going to be looking at or ICE will be looking at and concerned and watching, taking place. Right? I'd appreciate your thoughts on it.

SEC. VILSACK: Senator, first and foremost, I think it is fair to say that significant aspects of agriculture are dependent on seasonal workers, and it will be important for us to continue to be vigilant at the borders as Homeland Security currently is to ensure that people coming into this country from wherever they are coming in. As Dr. Sharfstein has suggested, this is a global issue, and so it really doesn't make any difference where they are coming from; they can be carriers.

So we need to continue to be vigilant at the borders at all points of entry for all people coming into this country. And I've been working with Secretary Napolitano to ensure that there is adequate training and adequate understanding of what to look for, and she has indicated to me that they are working very, very hard to make sure that people who are suspected of this are in fact stopped and potentially questioned and possibly quarantined for a period of time.

SEN. BROWNBACK: It's a tough issue because we need a lot of support and help within the agricultural industry, but it also has to be, you know, safety first.

SEC. VILSACK: It's a balance, absolutely. It doesn't do much good for the market if we have situations like this.

SEN. BROWNBACK: Yeah. Mr. Chairman, thank you.

SEN. KOHL: Thank you, Senator Brownback.

Senator Pryor.

SEN. PRYOR: Thank you, Mr. Chairman.

May I start with you, Dr. Sharfstein? On the World Health Organization, I guess they recently said that pork products from infected meat should not be consumed by people. Their comments as far as I understand it seem more cautious and maybe even at odds with what USDA, the Food Agriculture Organization, the World Organization and for Animal Health and others have said. Can you talk about the science of that for a minute?

DR. SHARFSTEIN: Sure. My understanding is that the WHO has been pretty clear. So I'm going to, I want to hear from you what your, more of what the specific concern is. But I understand that they said that influenza viruses are not known to be transmissible to people through eating processed pork or other food products derived from pigs; that this virus has not been shown to be transmissible to people through eating pig meat or other products derived from pigs; and that heat treatment commonly used in cooking meat will readily inactivate any viruses potentially present in raw meat products; and that pork and pork products, handled in accordance with good hygienic practices, will not be a source of infection.

So from what I've heard from the team inside FDA is that WHO has been pretty good on this.

SEN. PRYOR: So you guys are pretty much on the same page then?

DR. SHARFSTEIN: Yeah. Yeah. I think that there's been—I don't know if you know anything about that?

SEC. VILSACK: If I might clarify, I think yesterday there was a question that was hypothetically answered and responded to by someone from WHO that suggested as your question indicated. Today there has been a clarification made by WHO that is very consistent with what the doctor just indicated, which are that pork products are safe and safe for consumption and that there really is no scientific reason for banning pork or pork products. And we are working very, very hard, Senator, very hard, to make sure that all the international organizations are very consistent with their language. We've appreciated their renaming this after the media basically took the name "swine flu." We appreciate their assistance, but it was clarified today and it was an unfortunate circumstance yesterday.

SEN. PRYOR: That's great.

That's helpful because I must be working on yesterday's news, but thank you very much. And let me ask you, Secretary Vilsack, if I may, as a follow-up, right now as it currently stands how many countries are either banning pork from North America or are seriously contemplating that? Do you know?

SEC. VILSACK: Senator, I want to make sure I get the number right; 22 countries have banned pork products or pork either from our country totally or from various individualized states within the country. That number was larger. As I indicated earlier, Central American countries had indicated a desire to ban and they've reversed that.

We are continually working, as I indicated earlier in response to the chairman's question, we are continually working with the U.S. Trade Reprehensive, with international organizations, with our own field offices with our Foreign Ag Services, to convey a very consistent and clear message. And we are going to continue to do that.

And I think we are beginning to have some success, and I think the fact that there are several countries that have reversed bans or several countries that were considering them that didn't go through or perhaps modified what they were doing is an indication that we've had some success. But we've got more work to do.

SEN. PRYOR: Do you have an indication that that number 22 will go down in the next week or so? Or do you know that yet?

SEC. VILSACK: I don't know that. I hope that it does go down, and we have been as I said earlier we've been focusing specifically on China and Russia because those are the two large importers of our pork and pork products. We've been working daily with ministries in those two countries to provide them up-to-date information to respond to questions that they have. And we know that our Canadian counterparts are doing the same. And we hope that in the short term those situations and decisions which are not based on science and not based on international rules are reversed.

SEN. PRYOR: Thank you. I have just one more question, Mr. Chairman. And it's a follow-up, Secretary Vilsack. And that is, I know in the omnibus appropriation there was a Section 727 added on the House side that basically prohibits funding from being used to establish or implement a rule that would allow for importing poultry products from China. And I know you'd been in discussions with China about pork and imports, exports from the U.S. into China, about pork, and then there's the Section 727.

Do you have any indication that China is, part of their contemplation on this is just retaliation for 727?

SEC. VILSACK: Senator, I have no specific knowledge of that, but to amplify, we are working very, very hard with members of Congress who have concerns about food safety to reassure them that we can take steps and will take steps to make sure that products that are imported from China into our country are in fact safe. We're in the process now of preparing and providing some information to members of Congress at their request to begin that process of reassuring them. I will be meeting with the Chinese minister I think next week, and I'm sure that this will be a topic of conversation, as will the pork ban if it's still in place when the minister arrives.

SEN. PRYOR: Thank you both. Thank you, Mr. Chairman.

SEN. KOHL: Thank you, Senator Pryor.

Senator Bennett.

SEN. ROBERT F. BENNETT (R-UT): Thank you very much, Mr. Chairman. Mr. Secretary, Dr. Sharfstein, let me thank you, following up on what Senator Pryor talked about let me thank you for your effort to make sure that people understand that this does not come from eating pork products. We have a significant industry in the pork industry in Utah, and they have been affected by the publicity here. People think back of avian flu when people wouldn't eat chicken. Indeed, I traveled in parts of the world during that period of time, and you couldn't buy scrambled eggs for breakfast in some of the supposedly best hotels in the world because everybody was afraid of the connection to the birds. And they were slaughtering huge population of birds, chickens, whatever it might be, throughout Asia.

Can we keep that publicity up that we don't need to slaughter pigs, that we don't need to avoid bacon-wrapped burgers at Wendy's or wherever it is you buy that, that all of these things are not an enormous danger?

SEC. VILSACK: Senator, I can assure you that every day we are reinforcing that message, and we're doing it in the context of reminding the people of this country, when other countries ban or place unfair restrictions on trade, it not only impacts the pork producers in that respect, but it also potentially dampens consumer activity here in America.

And I want to take this opportunity, by virtue of your question, to remind all of America that there are hard-working farm families that are playing by the rules, working hard every day to put food on our tables, and through no fault of theirs, absolutely no fault of theirs, and because of a miss-messaging from, and a convenience on the part of those reporting all of this, they are now suffering a significant financial hardship and stress.

And we will reiterate every day: pork products are safe, safe to consume and safe to import. And we will continue to do that until this crisis is past.

SEN. BENNETT: Thank you. I appreciate that statement and the passion behind it because I share that.

Now, I understand the chairman raised with you the question how long it takes to develop an antiviral vaccine, before I came in. As part of your incident management approach you have a Shortage Team that attempts to spot shortages in the consumer market of antivirals. Can you give us an overall view of where you think some of the shortages are in? In addition to your answer to the chairman's question about timing, there's always the question about distribution. Again going back to the experience with avian flu, we had the concern that, well there's enough here, but there's not enough there. And could you just reassure us all, or inform us all if "reassurance" is too strong a word, of what the various problems would be and how quickly you think you could get them resolved?

DR. SHARFSTEIN: I'm happy to answer that. Let's talk about the medicines to treat flu and then the vaccine second?


DR. SHARFSTEIN: The medicines to treat flu, there's, the government invested, and I'm sure through your committee or through the Senate, a significant amount of money in building up stockpiles of antiviral drugs.


DR. SHARFSTEIN: 50 million or so courses for the United States. And so far we're not even touching the top of that in terms of use. A quarter of the states' supply has already been in the process or has already been distributed to the states. And so on the public side there is a tremendous amount of resources that have already been mobilized. And if the problem were to become worse, people who needed the treatment would be able to get it, up to quite--it would have to be an extremely severe problem for it to really be pressing that. And it doesn't look like it's going to be that anytime soon.

At the same time the manufacturers are actually ramping up production in concert with FDA where you know if they need to use a new distributor or something like that we're going out and just you know, making sure that they're all set so that they can keep doing that. And we actually had a whole bunch of product that just needs to be put into packs, so they have been doing that. So they are actually meeting, increasing production for the longer term and we have the stockpiles.

On the private side, which is what the pharmacies have, there have been spot shortages; so a particular area of pharmacy might sell out of Tamiflu as people might go and try to get prepared and have some at home or something like that. And there are some attempts to reduce that on the private side, and the companies are working with suppliers and our team helps them spot those shortages.

That what people should know is, even if they can't get it at their pharmacy right now, the public health department has a lot of it. And there is not an overall shortage of these antivirals right now at all.

On the vaccine side, it relates as I was saying before to the complexity of the vaccine. We have the infrastructure to make a lot of vaccine. And actually one of the smartest investments that was made by the federal government was actually in chickens. There are flocks that were purchased to make eggs just in case a pandemic might happen, and if there was no pandemic those eggs go into cakes and the government gets part of the money back.

And those chickens are sitting around making eggs, making eggs, and now it's like their moment. And those eggs are going to be able to be used. It was five years ago when there was the flu vaccine shortage. People were very concerned about the egg supply, and people thought, depending on the time of year if a pandemic hits it will take months to be able to get eggs to even begin to make the flu vaccine. But now we've got a ready supply of eggs. And because it's an egg- based vaccine for the most part still, those eggs can go right into the process.

The plant that FDA licensed yesterday can be used for that. And it really, the manufacturing capacity is there.

The question is going to be more about the virus, how it behaves in clinical studies, how it behaves in the grower tanks; and that's going to determine how many months it takes or how much vaccine is available, how quickly. There are some just unanswered scientific questions because it's a new vaccine.

But the good news is the manufacturing capacity, the eggs, all that's there; and we're working with NIH and CDC to think a couple steps ahead. We're helping think about, even though we don't have the pilot lots or clinical studies, what would a clinical study look like? Let's get it all set up in advance so that as soon as we have the pilot lots we can do it.

So we're going to try to facilitate everything we can and have the only delays, not really delays but the only steps be the scientific steps, and not we've got the eggs, we've got the facilities, we're going to have all the designs for the studies. All that will be ready to go. We just have to get the best minds and the best science working on the vaccine itself.

SEN. BENNETT: Thank you for that. I think that's a very helpful review for the public to understand. So let me summarize, and then you tell me whether I'm right or wrong. I liked the word you used earlier when you say we're very "humble" with respect to this, which means we're not predicting, 'Oh, everything's going to be under control, and we're smart enough to have everything figured out.' We're very humble, but at the same time it sounds as if we're really quite well-prepared, so that if it does in fact turn into a pandemic, as there are some indications that it might, that we are taking all the steps we need to take to deal with it. Is that a fair summary of what you're trying to tell us this morning?

DR. SHARFSTEIN: I think that's an excellent summary, much better than I said.

SEN. BENNETT: Thank you, Mr. Chairman.

SEN. KOHL: Thank you. I'll just try to follow that to another point. Are you suggesting that we will be prepared for an outbreak this fall if it occurs?

DR. SHARFSTEIN: I think that we are, I anticipate that there will be everything done to prepare for an outbreak this fall. But because of the humble issue, because we don't know exactly what an outbreak could look like and we don't know about what could happen in the vaccine production process whether this virus is going to behave differently, I don't want to give any guarantees. I do think that we have the infrastructure and the capacity so that if things play out like we think they will, that we will be able to have a good protection for almost any circumstance.

But, you know, I think we have to recognize that this is a new situation and you know just think about how much this has changed over the past couple weeks. When it first started, you know, it looked like one thing, and now people are thinking it looks like another thing, and it probably will take a couple more. People will look at it differently over the next few weeks. And we're just going to have to, you know, live with a little bit of uncertainty in this.

But I do think that the foundation for preparation is extremely strong. The resources we have, the manufacturing capacity, the partnerships with private industry, the expertise in the federal government, all these things are working very hard to, you know, do everything possible to be prepared.

And you know, that personally makes me have some degree of confidence about it. But I do think we have to balance that with the fact that this is a new virus.

SEN. KOHL: Secretary Vilsack, has there been a precipitous decline in the American market for pork products?

SEC. VILSACK: Senator, we have not seen a significant decline. And I appreciate the fact that American consumers have taken our message to heart. But anytime you have the kind of publicity that this particular influenza has received and the concern that has been spread globally about it, you always are concerned and worried that it might.

Clearly, pork producers have suffered and will continue to do so until we get this turned around. And so we are very, very conscious of the stress that this industry currently has, and we are in the process of obviously looking at ways in which we can be of assistance and help.

SEN. KOHL: How did it happen that this thing has been so mischaracterized to the American public?

SEC. VILSACK: I think part of the problem was, and Dr. Clifford could probably do a better job of explaining this, the makeup of this particular flu is multifaceted, and unfortunately in the early, early days of reporting the media latched on to one but not the only component of this flu as a way of describing it. And once it got described in that way, it became a bit difficult to redescribe it.

We have seen consistency within the federal government. We've seen consistency with our state partners. We've been in contact with state Ag commissioners and secretaries and they have reinforced the message. We've seen consistency from our nation's governors. We've also seen consistency now with the message from international partners as well. And we are going to continue to reinforce the message. But I think part of it had to do with sort of the makeup of the flu.

Doctor, if you'd like, if I might?

SEN. KOHL: Dr. Clifford?

DR. CLIFFORD: Thank you, Chairman Kohl. Actually, this particular virus, as Secretary Vilas has indicated, has different components. Many of these components have been found in swine, but this particular virus is made up of avian, human, and swine components. And when these things get into a particular species, then they get kind of, when they are first found they are tagged with that species as being 'swine flu' of 'avian flu' or 'human flu.' So this particular virus has both a Euro-Asian lineage that's been found in avian species that was transferred to pigs, and in the U.S. the North American part of this has been found in, has reassorted from humans, chickens and in swine, and has been in the swine population. So it's reassorted itself.

And where that occurred, we don't know. We don't know if it occurred in swine initially or not. But all indications are that there's been no findings of this particular virus in the U.S. swine population to date. There's been no reported cases of this in Mexico. And we just had the first case identified in Canada where it was associated with human passing to pigs.

So this appropriately should be tagged really more of a 'human' flu because it's passing from human to human.

SEN. : Dr. Sharfstein, I was looking at the notes here that there's a good possibility this fall when they ask people to get vaccinated for two different types of flu?

DR. SHARFSTEIN: I think it's premature to be thinking about what could happen this fall. I think that, I was talking a little bit before about 1976 when right after the, you know, new virus came on the scene all the health agencies and even the president were saying, 'We know exactly what's going to happen six months from now.' And I think everybody looks back on that as a mistake that was made by everyone, you know, who was involved in that they didn't adapt their thinking to the nature of the vaccine and the nature of the epidemic at the time.

And I think that we're going to have to walk through a bunch of decision-making points. How much vaccine, you know, gets made—it will be a decision that's made a little bit later once we know what the right vaccine to make is. And then as --

SEN. : You've got to make that within a time frame that you can produce the vaccine. And you're already probably producing, are you already producing a fall vaccine for a normal influenza?


SEN. : It's already being produced now?

DR. SHARFSTEIN: That's in full-scale production, probably more vaccine than, you know, we've ever had before.

SEN. : So you'll have to make the cut-point or the call on this on whether, for H1N1, by when?

DR. SHARFSTEIN: Well, I think right now they are producing the reference strain which is the strain that grows into the actual vaccine. The way you make the vaccine is, you take the key elements of this new virus that are new that need to be stimulating the immune system for the response. You kind of take those out, and you plug it into another flu virus that grows really fast and it's a good strain for a vaccine. So it's actually like it—you create this new virus to make, and then it gets treated and killed for the injectable or dealt with differently for the live attenuated.

So that process is going on now to develop the reference strain that could be used. Then you've got to make the pilot lots. Then you've got to develop your strategy.

And then there's a moment that comes when, and you'll have to take a look when you're at that moment: are you done with the seasonal flu vaccine supply? Are you in the middle? Is there still some seasonal to be done? Do we want to interrupt that, or not?

SEN. : When is that call, when is that decision point?

DR. SHARFSTEIN: The decision point probably is going to be in the next one to two months, I think.

SEN. : That you've got to make the call whether or not to vaccinate for H1N1?

DR. SHARFSTEIN: No. That call is not going to get made until the fall. But the call about whether to immediately switch over production is probably going to have to be made in the next one to two months.

SEN. : But what if the call is made we should do both, because we lose, what, 35,000 people a year in flu?

DR. SHARFSTEIN: Right. But we're going to have tens and tens --

SEN. : If you don't vaccinate for that you could have more people die of the normal flu?

DR. SHARFSTEIN: No. That's why it's going to be in part a tough decision. But you should know that the seasonal flu vaccine for this fall is well into production. Those doses will be there. You know, tens of millions of doses. So we're really only talking about the tail end there, whether we cut off the tail end of that production. Well, we're going to have a lot of seasonal flu vaccine no matter what this fall. It's a question of whether we have to cut off the tail end to switch over. That will be a call that will have to be made probably in the next one to two months. Then the decision to vaccinate is going to be made probably in the fall. Even, let's say the decision is made to make a whole lot of H1N1 vaccine. That's still different from the decision to recommend that people get it.

SEN. : Um-hum. I understand. I'm just, I'm trying to get -- what I hear you saying then is that you'll get your production for the normal flu season. You're going to try to do everything early.


SEN. : So you got it. And then if we switch over, that will be done in a month or two that you switch over to the H1N1 and the production machinery towards it.

DR. SHARFSTEIN: Right. I would say that the regular flu vaccine is already in production, and it's nothing different than what was already happening. This is the season for that. And then only when you're ready to go to production of the H1N1 does it become a decision. And that will depend on when we're actually ready. You know, as that decision approaches, we'll be able to look at the seasonal flu vaccine supply and say, Are we 80 percent done, are we 90 percent done, are we 100 percent done? And then it's not even an issue. But that decision will come when that decision needs to be made based on whether we're at that point with the production process.

SEN. : Thanks, Mr. Chairman.

SEN. KOHL: Gentlemen, does USDA or FDA have a role to play in the Southern Hemisphere with respect to manpower, supplies, and the flu?

DR. SHARFSTEIN: I can answer for FDA. Definitely. There are a couple different levels. One is that we're in contact with regulatory agencies around the world about the appropriate way to treat this and all the different products and the tests and the things that have been licensed, or authorized I should say, by FDA. And in addition through CDC we're going to be keenly interested in what is happening there in terms of what it means for how severe it could be in the United States in the fall. And that will affect a lot of issues that relate to the vaccine production.

SEN. KOHL: Secretary Vilsack?

SEC. VILSACK: Senator, we have specifically offered help to Mexico through the Food and Agricultural Organization in the United Nations, and we'll continue to offer that help. We also have APHIS contacts and communication and attaches in countries throughout the world. They are prepared to serve as local contacts to animal health service organizations and operations in foreign countries. And if we receive any requests for assistance and help as it relates to this, we will do everything we can to the extent we can to provide help and assistance and technical assistance.

And I'm sure that as we learn more about this from the research that's now taking place, we will be in a position to share what we know with scientists and researchers in other countries.

SEN. KOHL: Good.

Well, we thank you for being here today. It's been informative and instructive, and I think we have a sense of comfort that you're really on top of it, doing everything you can, and that you have a sense of confidence that we're going to be successful. Thank you for being here.

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