 John, you had a question? I didn't have a question. I hope to be done. So for the student career experience program that I saw on the slides, how often are there positions of me? Let me talk about that at the end, and I'm going to be selfish about wanting to do that, not because I'm trying to keep you here until the end, because when we introduced that almost two years ago, was at the same time we started using a different authority. SCEP, student career something program. That's when we started the SCIP, federal career intern program, somewhat different from bringing people on, but I want to talk about them in totality and show you some numbers of how many people we brought on board as a result of the SCIP program. And I had a slide that showed that coming later on, so I'm going towards the end. So I have a question, but I'm going to go into a little bit of the structure, the organization structure of the FDA, because when I went online to the FDA website, I got something that's sort of central, but I couldn't figure out what your office is, who really uses it. Before we start, I don't have any slides talking about that, so let me take some time now to talk about that now. FDA is divided into, now I guess I could say seven overall centers, and I'll refer to them as centers. Center for food safety and applied nutrition, Center for veterinary medicine, Center for biologics, Center for devices and very much for health, Center for drug, Center for drug evaluation and research. There is a new center now, plus an NCTR, National Center for Tosclotical Research, that's in Arkansas. FDA has a new center now, and I'm going to talk about that one later on specifically, that's the Center for tobacco. So that sort of makes up the flow, and then there is the Office of Regulatory Affairs, we refer to as ORA, and that organization is where the field structure falls in. So we have the headquarter component to ORA, and then the field structure is divided amongst five regions, Northeast, Central, Southwest, South-East, and this region that we're in, the Pacific region. And within each of those regions you have district offices for the Pacific region district offices. My office, the Los Angeles district, there's the San Francisco district office, and the Seattle district office. Also on this region are two, we refer to as mega laboratories, and those are the Pacific regional laboratory Northwest, which is located, hence the name up in the Seattle area, and the Pacific regional laboratory Southwest. And that's the laboratory that's over here in the building where I'm located. So we fall under the field organization within the Office of Regulatory Affairs. So that's sort of the quick and dirty on the structure. On any given day, I couldn't tell you who's heading what unit, what division anywhere. There are so many changes, it's so fluid that that's a constant movement target. And there are a number of senior leadership positions within the agency, within headquarters in particular, that makes that revolving door even more difficult to know who's on first, who's on second, so to speak. So on the nutshell that's what that is. There are about 1,300-ish people in the field, field employees. We have about probably close to 700-ish in the Pacific region. Los Angeles district is the largest field office. And I don't mean in terms of large, as a size of a building that's across the area. I mean, largest in terms of the number of employees, largest in terms of the number of facilities that we have regulatory oversight over. And yeah, it's making it more personal. Largest in terms of the population to which we are within the Los Angeles district span of control. My office covers all of Southern California and the state of Arizona. And I'll show a slide on the number of respectors in those two geographical areas. So that's sort of a backdrop now, if you will, on the global structure. I mean, we could literally talk structure for days because it can be intricate. You've been in the area for a while. Can you say something about how your career trajectory came to this position? I could say it's fizzling out, but I won't. It's still growing. First of all, let me just say that I started working for FDA when I was 6 years old. So when I tell you I've been working for FDA almost 27 years, you'll know. I'm pretty mad. I've been over 26 years working for the agency. I started as a microbiologist working in the then named New York Regional Laboratory. And I did that for about nine years. I enjoyed science. I knew from here that I was going to do something in science because for me that is something that I had a love and fondness for. So I did that for about nine years. And I became a supervisor in our chemistry, in our food chemistry unit. And I was there for about three years maybe? Nine to 95, about three years. Following that, I became the director of our import operations in the New York District Office. So I was there for about five years. And from that position in 2000, I transferred out here as director of Los Angeles District Office. So when I look at it, I've been an FDA over 25 years and the agency is a little bit over hundreds. It's almost amazing. I was almost with the agency, almost a quarter of its history. And I always think back when I reminisce with folks who have been, especially the new folks when I tell them, because I remember we didn't have computers. I remember when the phones were lighted. I just remember a lot of those things. And as times have changed, certainly we have adapted and employing more and more technology. I won't go around the room here. For those who came in, I guess it's probably to get started here. At any time, if there's a question, please ask it. Either I'll do one of three things. I'll ignore you. I will answer the question. I'll say I'll get to that one later on in the topic if there's something that should be coming up. Although I said I will ignore you. I'm only kidding. I will not do that. Besides, you guys are all welcome to do it. So with that, it's an exciting time to be in public health. Exciting time because notwithstanding my fondness for science, it is something that affects all of us. Whether you're an accountant, whether you are a laborer, whether you are a doctor. Public health is something that touches us all. And I'm just fortunate to be an FDA where we are really, as I like to say, central to a lot of those public health issues that are going on. What I want to do is start off with a video. It's about five, six minutes and you sort of saw who it was before. And let me do it one more minute because the viewers will find and I'll introduce you. Oh, okay. Any other informal questions? I can tell you I'm going after I leave here. Later on this afternoon, we're heading up to Sacramento. And we'll be in meetings this week, or training ground for EPI, the enforcement studies. So it's EPI-ready training going on. Just for FDA staff? Yeah, FDA and with C. So we've been going up there, learning how to deal with food going up, working in investigations, so I can see if I really know what I think I know. Just by that comment, is the nature of your job now caused you to have to travel a lot? No, I always travel a lot. There's always travel. I mean last week I happened to have been in Sacramento as well for a meeting with our counterparts with the state. I happened to be going back this week, back to Sacramento because that's the location for the training. So travel seems to always be a busy part of the day. You may talk about this, but I'll also be in Sacramento on Thursday for the Green Chemistry Initiative towards the Department of Public Substances. And this morning I was asked to review a new picture on Biscuit Mount A. I'm not sure if that plastic comp has any effect in it, but the FDA has been criticized for the regulatory, maybe sometimes over-regulation, maybe under-regulation. In this particular case I can see public advocacy increasing and what one needs to see is that that's what drives policy, that is sciences. So giving you a fund for science, but also having to be the face of the regulatory agency. How do you jungle-ghost it? FDA is an organization based on sound science. I do know all too often politics interferes with that and there are, anybody can quote any number of examples in which politics appear to interfere with science. So the discussion that I'm going to have today is non-political. It's more the science of issues and where we are. I'll let the bureaucrats and the policy shapers deal with that aspect of it and my focus purely is science. And I certainly recognize when there are policy decisions that may appear and I stress that may appear to be not in line with good science. And I'm giving an example, not an FDA example, so I feel free to give an example. I feel free to give an example, it's not an FDA example. It's global warming. Everybody's science looks good, right? But they're on opposite sides of the spectrum here. And I don't know if it's policy, politics, or science governing that argument. That was a good non-getting trouble. That's a good two words there. I'm not falling on either side on just that those two words elicit a lot of discussion. Add emotions. Okay, some more people may join us later, but I don't want to keep you off later than usual. So it's one of the best-kept secrets that Irvine has. It is being hosted to a major facility that we couldn't go by administration. You can probably see the building anywhere from the campus right now. It's just across the San Diego Creek. And I remember when that building was coming up, there was promises of strong collaborations with campus. We've had several meetings in Symposia, and it's two of those that I met there at Alonzo Cruz. I think we, of course, have to do more, and I'm delighted that he's been able to join us today to add one more block in that wall that we're building together as a collaborative program, linking research to practice. He wrote a very strong letter of support for us when we were developing the NIH program, and we had many meetings with the nursing science faculty and pharmaceutical sciences all coming up with public health at the same time. As he mentioned earlier, and for the benefit of those who are just joining us, he's FDA's Los Angeles District Office Director, and his responsibilities include providing executive leadership to one of the lightest district offices within FDA's Office of Regulatory Affairs. So he's bringing science to these regulatory issues, avoiding politics as much as possible, but almost inevitably has to deal with it. Implementing, mining, and evaluating FDA's regulatory operations within the district, which includes Arizona, and all of Southern California, the Fourth of Los Angeles Long Page, and the International Mail Facility, giving that we open the quarter here receiving white powder and envelopes for some of our faculty. This is, of course, something that I'm very thankful for all of the techniques that have been developed in FDA and used to support public health. So it's my distinguished pleasure to welcome you and to interact with us, and he's going to stay around, I hope, still for months afterwards, so if we can't cover all the questions, you're free to join us at the Steelhead Room, so thank you very much. Thank you for that kind introduction, and I see the time, and I'm told we have about an hour, and I will try to adhere to that hour, some topics may be long and some may be shorter, but just note that at any time, if you have a question, please raise your hand because I would bet that that discussion will be more important when I have to say, so please don't hesitate on that. I want to start out with a small video, it clips about five minutes, and it is President Obama's nomination of the FDA commission, and this was back in March 14th of last year, but I think it provides a good introduction and backdrop to what I'm going to talk about today because I like the themes on which he's speaking and a lot of those things and things that we are speaking more and more in terms of how we're going about our regulatory procedures relative to public health, so I just thought it was a good introduction, and I was listening to see if he was going to say my name, but hopefully I could put this in place. Thank you. I've often said that I don't believe government has the answer to every problem or that it can do all things for all people. We're a nation built on the strength of individual identity, but there are certain things that we can't do on our own. There are certain things only government can do, and one of those things is ensuring that the foods we eat and the medicines we take are safe and don't cause us harm. That's the mission of our food and drug administration, and it is a mission shared by our Department of Agriculture and a variety of other agencies and offices at just about every level of government. The men and women who inspect our foods and test the safety of our medicines are chemists and physicians, veterinarians and pharmacists. It's because of the work they do each and every day that the United States is one of the safest places in the world to buy groceries or supermarket or pills in a drug store. Unlike citizens of so many other countries, Americans can trust that there is a strong system in place to ensure that the medications we give our children will help them get better and not make them sick, and that a family dinner won't end in a trip to the doctor's office. But in recent years, we've seen a number of problems with the food making its way to our kitchen tables. In 2006, it was contaminated spinach. In 2008, it was salmonella in peppers and possibly tomatoes. And just this year, bad peanut products led to hundreds of illnesses and cost nine people their lives. A painful reminder of how tragic the consequences can be when food producers act irresponsibly and government is unable to do its job. Worse, these incidents reflect a troubling trend that seemed the average number of outbreaks from contaminated produce and other foods grow to nearly 350 a year, up from 100 a year in the early 1990s. Part of the reason is that many of the laws and regulations governing food safety in America have not been updated since they were written in the time of Teddy Roosevelt. It's also because our system of inspection and enforcement has spread out so widely among so many people that it's difficult for different parts of our government to share information, work together, and solve problems. And it's also because the FDA has been underfunded and understaffed in recent years, leaving the agency with the resources to inspect just 7,000 of our 150,000 food processing plants and warehouses each year. That means roughly 95% of them go uninspected. That's a hazard to public health. It's unacceptable, and it will change under the leadership of Dr. Margaret Hamburg, who I'm appointing today as Commissioner of the Food and Drug Administration. From her research on infectious disease at the National Institute's Health to her work on public health at the Department of Health and Human Services to her leadership on biodefense at the Nuclear Threat Initiative, Dr. Hamburg brings to this vital position not only a reputation of integrity, but a record of achievement in making Americans safer and more secure. Dr. Hamburg was one of the youngest people ever elected to the National Academy of Sciences Institute of Medicine, and her two children have a unique distinction of their own. Their birth certificates feature her name twice, once as their mother, and once as New York City Health Commissioner. In that role, Dr. Hamburg brought a new life to a demoralized agency leading an internationally recognized initiative that cut the tuberculosis rate by nearly half, an overseeing food safety in our nation's largest city. Joining her as Principal Deputy Commissioner will be Dr. Joshua Sharfstein. As Baltimore's Health Commissioner, Dr. Sharfstein has been recognized as the national leader for his efforts to protect children from unsafe over-the-counter cough and cold medications. And he's designed an award-winning program to ensure that Americans with disabilities had access to prescription drugs. Their critical work and the critical work of the FDA they lead will be part of a larger effort taken up by a new food safety working group I'm creating. This working group will bring together Cabinet Secretaries and senior officials to advise me on how we can upgrade our food safety laws for the 21st century, foster coordination throughout our government, and ensure that we are not just designing laws that will keep the American people safe, but enforcing them. And I expect this group to report back to me with recommendations as soon as possible. As part of our commitment to public health, our Agriculture Department is closing a loophole in the system to ensure that diseased cows don't find their way into the food supply. And we're also strengthening our food safety system and modernizing our labs with a billion-dollar investment, a portion of which will go towards significantly increasing the number of food inspectors, helping ensure that the FDA has the staff and support they need to protect the food we eat. In the end, food safety is something I take seriously, not just as your president, but as a parent. When I heard peanut products were being contaminated earlier this year, I immediately thought of my seven-year-old daughter Sasha, who has peanut butter sandwiches for lunch probably three times a week. No parent should have to worry that their child is going to get sick from their lunch. Just as no family should have to worry that the medicines they buy will cause them harm. Protecting the safety of our food and drugs is one of the most fundamental responsibilities government has. And with the outstanding team I am announcing today, they have the responsibility that I intend to uphold in the months and years to come. Thanks. It's also a video clip. That was a video clip. I'm not talking about a video clip. Good morning. I liked that that was a video clip from the President's Weekly Video Dress that happened last March 14th. But it provided a good backdrop into some of the themes that I hope to touch upon this afternoon and certainly that we have been dealing with in FDA from the lettuce in 2006 that happened out in California to the tomato situation in 2008. That was again out here in California and certainly peanut butter. Although the manufacturer was not here, we still had a lot of activity as a result of following up on peanut processes, peanut butter, and all that. And just when you think you know an industry, something new happens with any factor that even comes with it. To advance this slide, I'm going to just hit this one. Okay, that works. I'm going to talk about today's food protection. The bulk of it would probably be on food protection and what we're doing as a result of that relative to public health. We're going to talk about enforcement and enforcement as a tool to achieve public health. I mentioned earlier the Center for Tobacco just quickly talk about that law and some of the things that that center is beginning to do. It is a new center and I do not know all that it will do ultimately. I already mentioned I talked about some local stuff, local highlights I'll call them. And the what's new and what's next. And although I say what's new and what's next, when I was looking at it this morning, I started to say, that's not really that new, but it may be new to you, so that's how I kept it. The what's new and what's next. Certainly going back up to food protection. Certainly FDA needs and needs to maintain a strong food protection plan certainly to address a lot of the challenges that we are being faced with today. The President mentioned forming a food safety working group and they are looking at some issues to try and strengthen the Food Protection Net within FDA. The plan needs to be one that is that addresses food for people and animals. Needs to address both domestic and imported food products and really needs to look at food safety and food defense. Put that word food defense sort of over here for now. I'm not going to come back with a little story about how it got to be food defense and not what it used to be called and how words matter. Certainly to achieve a meaningful protection of the food supply we must use threats of food-borne illnesses through what I call a global framework. Certainly is there any sustain anymore as domestic foods? I mean, I know California is a huge agricultural state which is its number one industry still. Coming from the east coast I used to think it was like Hollywood, Disneyland, but agriculture is its industry. So what are some of the challenges that we face in food protection? Certainly consumer demands 24-7, you know what, if I want a fresh lobster at 2 am just pulled out of the waters within 3 hours we could probably make that happen nowadays. That rapid consumer demand. Convenience foods are increasing and I'm saying this for myself. Do we cook anymore? I mean, I don't know I could put something in a microwave cooking budget. We really don't cook anymore, so convenience foods are certainly increasing in popularity. What we spend on food service certainly equals half of our U.S. spending just in our consumption of food. We're eating certainly more and more fresh produce and that is a good thing. Certainly more than 75% of the seafood eaten in the United States comes from foreign waters. Certainly over the course of the past 20 years we've been tripling our use of fresh produce. When we look at some demographic issue, 20-25% of the population is at high risk. At high risk we're certainly an aging company, an aging country. It's estimated by 2025 that a quarter of all U.S. citizens will be over 60. Certainly as medicine gets better and here is every advance is always going to be something that seems to always can hurt us. As medicines get better as transport technologies get better, as drugs are better at suppressing our immune system to deal with illnesses that we are dealing with that also opens up now a possibility for food-borne illnesses and food-borne diseases where in a healthy population they may be able to fight off that one E. coli bacteria by the immunocompromised group of individuals they may not be able to fight that off. And certainly I have here roughly 4% of the population immunosuppressed and from either disease or medication a lot of that certainly going on. Any food protection plan really needs to address three things, prevention intervention and response. Obviously prevention is at the top because we want to deal with things and build safety right at the beginning of a process or a production that we won't have to deal with on the back end. Prevention, really looking at our inspectional work and really using science to govern our risk-based science decision-making on what inspections will do, what classification of products warrant a higher level of review. And I'm going to say this is going to appear that I'm contradicting myself and constantly challenging ourselves on that because peanut butter is what I would have said a low-risk product. I mean does it even need refrigeration? Take it out, spread it out close it back up, stick it back in the cabinet. Low risk by almost what anybody would see but last year we had as I was mentioning earlier a number of people died as a result of refrigeration as a result of peanut butter, peanut products. So we always have to constantly evaluate and re-evaluate what we're calling a high risk issue and constantly challenge that because things will change. It's easy to see seafood as a high risk commodity because it's so temperature dependent. I mean seafood is one of the most highly perishable products out there because the moment it comes out of the water the competition starts whereas all the meat takes a little bit longer the moment it's out of the water it starts to decompose and certainly response. How fast we react to things in dealing with getting word out to individuals to the industry and really to those people who may have the products in their possession. Response is important because the sooner you respond the sooner you start engaging in a product bag with the hope of lessening the exposure to the problem to the general public. So response is quickly and early signals are even more important because that can help dictate how soon you respond. Classic coming up in food safety issues in food issues we always spoke food safety food safety, food safety, food safety you know keep hot foods hot, keep cold foods cold manufacture products using good manufacturing products have a good sound sanitation program in your facility all of those foundation for food safety. Following 9-11 we started thinking and looking at food a little bit different a little bit different we started saying now we need to speak food security I'm going to tell you the problem with that for a moment now we need, now manufacturers need to know their employees their employees background who's coming into the facility who has access to to toxins, to cleaning chemicals to the actual food production area because now we were a nation that was somewhat concerned that the next big one will happen in our foods department so we started talking food security we started talking food security not only in the United States but overseas of the countries hey Lonza, but that word says food defense I don't see where it says food security here is remember when I said earlier words matter we looked at food security as putting a fence around it locking the door knowing your employees but for many parts of the country they looked at food security and here's where it hit me they looked at food security having enough food to eat we're looking at it as put a fence around it lock it up our partners that we were really trying to work with were looking at it so much differently and so how do we evaluate, what are we really looking at having enough food to eat or something else and what we're really looking at was food defense the fence of the food supply was meant something different to other folks and not the same thing as food security they were able to wrap their collective understanding around food defense hands around that as opposed to food security which was given a different connotation so hence we're referring to it as as food defense okay there's some cross-cutting themes here certainly when we used to look at food safety issues it was we only cared about its manufacture and packaging pretty much done the marketing people had that thing it went out, we assumed it was going to be stored under inappropriate conditions and so now the focus really now is looking at the total lifecycle of that product from, you'll hear this phrase from the farm from to the plate when it's in the field looking at the total lifecycle and all what happens to that product in its whole chain of things with food which I grew up in the city so I call myself a city guy but when I'm standing in the middle of a farm up in Salinas Valley and all I see is rows of protos that's like oh my goodness how does this get to be the salad on my plate and it is a science on to itself certainly another cross-cutting theme is target resources that achieve maximum risk reduction I mentioned earlier I'm only about the science and using the best science to determine not only the type of analytics we're looking for and how rapidly we can find them but using the best science to help us dictate what's going to be those high risk activities that we're going to be focusing in rain products based on risk and I said earlier now, keep saying you gotta constantly do that constantly do that food manufacturers are coming up with more and more ways to sell us things and packaging and things I mean, not in any endorsement I'm just praying it's just only one product I know that I don't even know if it's still out there Starbucks had a product that you can buy a can and it's a self-heating can but you can buy the can and it's all for grocery sale and you can have hot Starbucks coffee wherever you want apply it back to some other food packaging that maybe you're trying to use that technology to cook food, not to be heat food, but to cook food when it doesn't get to the right temperature what if it stays in that quote unquote danger zone and pathogens start to grow so we always have to be looking at ranking products based on risk because the food service industries, I always say they're always dreaming of new ways to sell stuff and certainly market stuff remember that convenient food issue because I guess we can't be able to try to go to Starbucks now we gotta have it with us and I already mentioned focus on prevention and intervention obviously you want to build safety in from the start but at the same time you want to have a sound inspection process that will constantly be looking and searching out for problems through inspections and educational seminars in the life I already mentioned integration of food safety, food defense one is the GMP issues I mentioned about, the other one is the security aspect I'm using security loosely but the other aspect of making sure that we know where our product is where it's been where our poor, our raw manufacturing our suppliers are where they're goods from what do they do when they can't meet our own OEM, original specs marrying those two together and certainly using science and modern technology I think science has grown and continues to grow this is an IMH my opinion science will always be ahead of the law will always be because of the ingenious superiority of science always thinking of quicker, better, faster ways on doing things and I remember, we talk a lot zero tolerance to me that doesn't really mean anything because what was zero tolerance 20, 30 years ago oh, we can find that real easy now I always tell people zero tolerance is only the cautionary on the time I say because now we can go to the possibility level whereas before it was possible thousands, possible millions I remember possibility now we can go PBT, possible children level so science is always looking for the down to the genetic levels on organisms something that many people don't realize whatever there is an outbreak and whatever there is a major outbreak you have a lot of players involved the locals, the states CDC and FDA and let's say for argument's sake it's a E. coli 0157 outbreak when we are going about trying to determine how widespread it is and we're finding samples and we're getting samples from patients one thing that we're ruling that ties all those together is DNA technology because we are DNA fingerprinting those organisms and linking them to the outbreak something that whereas in the past it would have been just if we found the E. coli we couldn't tell with certainty if it was linked to the outbreak now we can determine if it's linked to the outbreak some people like to say we're starting to have that CSI effect it takes a little bit longer than 30 minutes an hour long show sometimes okay, home health impact of the food protection plan obviously better prevention is stronger we do chances of contaminated products getting out there if you build it up build the prevention and stronger intervention from the start clearly that's where you want to be but the best of times things are going to go may have some problem so certainly a faster response to be able to remove products faster and I'm going to talk about one of the things that we are doing relative to trying to get products move from get them off the shelf sooner I wouldn't give extra credit if anyone knows what RFR stands for in any class RFR stands for reportable food registry what the heck is reportable food registry I mentioned prevention and intervention response how soon we can be notified of a potential problem or dictate how soon we can get the potentially violent of product off the streets clearly so we know it's going to respond whereas in the past we would even find out through an inspection that we would do and you heard the numbers earlier about how few that were being done or sometimes we find out by a trade complaint either an in-house complaint or a competitor complaining or sometimes a manufacturer would just let us know what happened after they dealt with it so what the reportable food registry does is makes the responsible party don't worry about the legal definition of the responsible party it makes the person become aware of the situation essentially have to follow a report today letting us know especially there was a reasonable probability that that article of food and as animal and or human food can have a serious health effect and that's a monumental difference when you look at public health before we would have to go out searching for this and sometimes it would come to us, sometimes it would but now it puts the onus back on the manufacturer those who know if there's a problem makes them now have to make notice to us at FDA through the RFR process I can tell you this to affect September 8th I think that same day got our first reportable RFR and I get these emails every day on every day day pretty close to it on things that are being reported as problems that are happening out there not everything rises to a full response some of them are rather simple to deal with others have the potential for being more problem manager we are on conference calls literally every day there's a standing conference call every day looking at the RFRs that were reported that previous day I'll tell you a story about a funny one that I got I got one from that was filed in Arizona raising ground real close to it and it's essentially saying this is in a, I thought it was weird because it was in an apartment building in Arizona and essentially it was like the person in 4G is cooking tacos and stuff in her apartment and selling them I laughed the good thing is and I have to always look for the good thing and stuff that that consumer was aware of the RFR reporting care requirement bad thing is reported that's a local matter we don't necessarily deal in retail like that that was not an issue he was just filing a complaint against his neighbor I just laughed because I was like you didn't know about RFR public health is about how fast you can get things done how fast you can decipher the information that's coming to you it's about how quickly you can respond once you have an understanding of what's going on and it's about how quickly you can shift should be evidence or should be conditions one that response aspect is critical that badge by the way is the one that the commissioner has the big badging ceremony the commissioner gets number one when problems arise we need to take any number of actions to protect public health certainly initially the agency will work with manufacturers to correct problems voluntarily and that is probably the biggest win which we are achieving what I like to report to is voluntary compliance certainly if that fails legal remedies could include the manufacturer to recall a product should that not be the action that they decide to choose and depending on the severity of the problem we can prepare a seizure action which we would make a petition to the courts to have a product seize and federal monsters would affect that seizure and to recall was involuntarily done certainly products that are coming into the country that are imported into the country that may be problematic we can detain them and then ultimately refuse them or with refuse they can either export or destroy depending on if you think that that importer has a history of trying to we'll probably move the C so we can take control of those products especially if they have a history of trying to circumvent import procedures and certainly the agency can take firms and individuals to court to prosecute them when they are deliberately and woefully violation of the food drug and cosmetic that FDA you know always tells people to be between a rock and a hard place that's probably where we need to be between a rock and a hard place because it seems like if any one side is happy then that means that we're probably not doing something right we're not being the appropriate filter a strong FDA has credibility with the public a strong FDA is transparent in explaining its decisions and a strong FDA pursues creative solutions to problem and that's something that we will always attempt to do and certainly equally as important with the backdrop again with public health is that a strong FDA enforces the law every company under our jurisdiction certainly has a duty to comply with the provisions online and the food drug cosmetic act and its related regulation certainly to meet the standards those standards FDA publishes this regulation that companies move to adhere to I'm certainly it's like almost like being a police force doesn't matter how many police officers you have if the citizenry decided that they were not going to obey the law that police force would be overwhelmed so clearly most citizens are working to comply with the law as in our in our businesses certainly the commitment and compliance for many companies open terms of their corporate culture and as well as their investment and compliance system bodes well for the fact that we would never have the demand power to deal with every company if they decided to to violate the law our goal certainly is that for companies not only to make an implement commitment to prevent harm to American people but to do so and actively do so through a silent corporate culture but through a compliance program to achieve effective compliance on I'll say a few key elements certainly FDA must be diligent we must through regular inspections and regular routine inspection beyond their looking for problems sometimes problems can arise despite the best efforts of companies but when we find something we need to certainly be able to follow through with it and certain companies should have a realistic expectation that most aligned they will be core and that we will act upon that there are if I know a company very well probably because they have a lot of compliance issues with us and we need to be able to respond to those in kind FDA must be strategic we must put obviously greater emphasis and risk on those things that are riskier I said earlier now I repeat often we must constantly challenge that risk model to make sure that we are always capturing the most current risk FDA must be quick and I already mentioned that being able to respond to violations especially violations that jeopardize public health prevention intervention response and certainly FDA must be visible agencies must show industry consumers that not only are we on the job but we are doing things while we are on the job prevention, intervention and response okay Alonso can you show me how enforcement can be a benefit to the public health certainly it enables us to catch products to catch intercept unsafe products by holding violators accountable certainly moves to deter others moves to deter others for wanting to do the same action and clearly explain enforcement action and inform members of the public of potential dangers there's one thing to deal with a company and that their products are causing harm but we will have done little for public health but we don't inform the consumers as well so that they know if they have that product in their shells that they need to deal with it there are times in which we are dealing with B-calls that I have the same product in my house and you always debate, notice the way I don't keep it for myself because of how perishable it is enforcement actually can help industry as well because it creates a level playing field because they are incentive to want to do something that may be less than scrupulous and that they think that company A over here is being held to the same standards as company B so it creates that level playing field ultimately infected enforcement strategy creates public confidence and FDA oversight which in turn puts trust in the states of FDA regulated products from eroding such confidence is critical you heard mention on the video that United States insured one of the safest food safety systems in the world selling one of amongst the safest drug systems in the world because of we are working hard to prevent that confidence from eroding we do have our challenges as in most things in recent years GAO Government Accountability Office and others have suggested that FDA's enforcement efforts have not always lived up to the hype and certainly when you look at enforcement numbers is a pure indicate just the numbers over the past several years they have been going down and they have been hampered by any number of things certainly the pathways to enforcement was taken way too long the roadblocks that were there were just taken way too long remember the conventional response and how fast you respond how fast we put that firm on notice how fast we deal with corrective actions so okay I'm going to talk now for a few minutes about pathways pathways to enforcement and there are I'll mention five and I'll separate out the six ones the six things that Commissioner Hamburg introduced in the major talks he had given before FDLI Federal Drug Law Institute the six fundamental things that will have a big impact on public health with enforcement as a tool first FDA is going to set post-inspection deadlines when we find that the firm is significantly out of compliance we'll expect a prompt response from the firm generally looking at 15 working days and this will and we'll do this before we issue any warning level during that 15 working days we're preparing whatever regulatory regulatory enforcement tool is still being worked on during that time it may use what their corrective action is to maybe not issue that warning level or maybe to use it as a reason why we need to issue it and during that time we'll have that thing already in prayer second we're going to take a step to speed up the issuance of warning letters right now or in the past warning letters used to have to go to our office of chief counsel for their review and bless Alina will come back down to the district for instance for issuance but before that process was implemented the districts had direct reference on a lot of the warning letters that we issued so Alina is just saying unless you you can issue more of that so now we're going to move back now toward only those warning letters that limit limit warning to those of significant legal issues those that are in the process those that are taking a new interpretation on something those that are new and novel in its approach in addressing something those significant things will be going forward through to our office of chief counsel for regulatory review and certainly when we hope that more streamlined process will will keep consistency with our long standing practice of the districts being able to to issue direct reference warning letters for what I call the mortal team activities certainly one of the ones that will probably have a large multiplying effect on what we do certainly it's working more closely with our regulatory partners whether it's with trade organizations whether it is with our state counterpart whether it's with other government agencies you heard me mention earlier that last week I was up in Sacramento meeting with our counterparts in the state Food and Drug Branch we work very closely with them we do joint work planning we look at compliance issues together we have we work together on a lot of things and let me just mention one thing in particular we had this vision to form a food emergency response team so when there's an outbreak we have this team of highly trained investigators and scientists that will be responsible for investigating the outbreak we didn't know what we were going to call our team but we know what we wanted to do so some years later when we dealt with the spinach outbreak in 2006 that was that team that was the first major fault upon and now we have a name for that team it's California Food Emergency Response Team that group of individuals and I say highly talented individuals has received national attention so much so is being replicated by way of a grant a food grant and that forming now was six now it's nine RRTs rapid response teams so these nine states have grant money to work with their local district office on forming these these rapid response teams I don't want to say forming their calculus but these RRTs rapid response teams as our ability to be able to deal with and deploy these teams rapid to deal with outbreaks because you can imagine there's an outbreak that was traced back to lettuce and we go to the farm and we get to the farm and go well the farm is now like spallows no products are growing but yet we have to begin our investigation where the product came from and you really need people trained in farm and field investigations microbiologists and people others like that in terms of standard collection and evidence collection I always tell my people that we're collecting samples I says if you want to look at it like this because at any time we do someone can challenge this will be in court look at it like this look at this as us collecting evidence if you look at it like that you keep that in mind you're going to look to do it the proper way you're going to look at it like that moving forward on fixing enforcement pathways certainly MTA is going to prioritize its enforcement follow-up whenever we are in a situation in which we had to issue a warning letter or something they had a significant violation and we had to call a firm in and conduct what we referred to as a regulatory meeting we should prioritize what we do on our follow-up inspection and put that above a more routine inspection so we already know there were problems here before so now we need to follow-up and really think a look at where things are and see if they fulfill their commitment to corrective action and see how well those corrective actions have taken place so something in my own office we are having our case management meetings in which we're looking at the violated inspections in the past and where we're routinely managing them for our follow-up as I already mentioned on this one we prepared to act swiftly aggressively to deal with protecting the public we have been given certain tools if you will that we didn't always have so we got more tools following 9-11 as a result of the Bioterrorism Act of 2002 one of them being access to records and getting these administrative warrants when companies are feeling to allow us to get certain records we need to be able to be prepared to do those things rapidly not hesitate and the pretty please can we have access if we need the access use the authorities that we have to get that access especially if we're dealing with an event that we think has a serious can have a serious public health now I mentioned that there was these five and then there was a sixth one and a little different from the others the others were what we were going to do in the event that somebody didn't do something the issue of warning letter the sixth one is sort of my quality incentive incentive WIIFM was in it for me it relates to how firm how we respond to the firm after they make the necessary corrections now before they do their things and they made the correction there's nothing they don't have anything they don't have a receipt from us if you will that says okay you're clean so I see it's developing there you have it developing a formal warning letter closeout process that will essentially based on a re-inspection it'll certainly make sure that the corrective action and the violations have been dealt with and these closeout letters if you will certainly will help to keep the public informed and we'll indicate on our website once we get this up and formally running that these firms have received the closeout letter because right now our warning letters are public information they are posted on our website and anything that needs to be redacted from them which is usually not too much and anything at all do appear on the website there's no next step if you will that says that they make those corrective actions so this will be an attempt to try and we hope to think and incentive to to correct those to correct those things ultimately FDA success is going to be determined not necessarily the number of warning letters that are issued or sieges that happen or injunctive actions that happen but by the impact that we have on public health that impact can be through a voluntary recall could be through working through a manufacturer could be through a warning letter the connection between the law and public health is as true for any industry as it is for FDA and I always say FDA is at the intersection over its signs and the law means right there is where FDA is standing using good signs to help us deal with food drug cosmetic and its laws certainly when companies feel to meet those standards FDA needs to be ready to stand up and take the next appropriate step whatever they are deemed to be based on the problems that are being put before us I want to take some time now any questions on any of that food stuff I'm moving away from food stuff was this in response to companies complaining that years after they corrected something their negative impact a lot of companies are publicly trading and they certainly tell us that can have an impact on their board of directors and their shareholders and so forth our focus is the public health aspect with those issues remember I said that this is economics that's economics okay I mentioned tobacco it's a new center within FDA and that went to in tomorrow September 22 took effect I think in I want to say September 22 so just prior to it being enacted we got an assignment a compliance assignment to go out and to go to each district I think had to go to 5 to 10 smoke shops and look for flavored tobacco flavored cigarettes and I don't smoke so I had no idea what they were going to find I had no idea that they were flavored cigarettes one of the issues of this new build dealt with preventing use tobacco use and these flavored tobaccos has been seen as a gateway to introduce tobacco to younger and younger kids and so when they were bringing all these samples back and if you would close your eyes and someone put the cigarette in front of you you would almost want to take a bite of it because you'd think it's not chocolate or the freshest of strawberries or lime but it's not flavored these cigarettes were I don't know what it tastes like when you smoked it I can't imagine it tastes like strawberries or chocolate but that aroma was certainly there and certainly this tobacco control will obviously promoting public understanding of the contents and consequence of using cigarettes preventing use tobacco and helping adults to quit because I've mentioned ban on flavored cigarettes except one and I'm struggling to kind of find the one flavor that's not banned I want to say clove but please don't quote me but one flavor is not banned but most all flavor cigarettes are banned now I imagine everybody going to say you know I was in the smoke shop the other day and they had only some of the flavored tobaccos out there so anyway those samples that we took that we were collecting across the field was to get a baseline of the industry right before the implementation of this law we'll probably have another assignment sometime shortly to go out and take a look at and see if in fact that these manufacturers or these stores have stopped selling flavored cigarettes okay I mentioned earlier that we're looking at the president said that we were hiring and we have been for the past two years we have been hiring since our fiscal 08 we have brought on some 84 consumer safety officers that number is probably a little bit higher right now but when this line was repaired and we are still actively hiring to deal with all of the things that we have to deal with is that nationally or oh no that number is just mild nationally in last year I think it was some year before that I think it was called 700 some of the positions that new positions to us that we brought on board the quality program specialists Marlene she just actually started last Monday emergency response coordinator now we need to look at these emergencies and try to have a more uniform way in terms of how we contact staff how we deal with the oversight of these emergencies so now every district has an ERC emergency response coordinator I already mentioned we are still hiring investigators that are the consumer safety officers we are bringing on we are bringing on more investigators we got to bring on more compliance people these are the compliance officers of the staff that are dealing with the violated reports once they get them and we are bringing on additional investigators that means we need to have the infrastructure and the training in place and additional supervisor to be able to to deal with the new people that we got coming on so we are always hiring there and just today I was able to announce that we finally have on board or soon to be on board our director compliance branch that position has been making for a little bit over a year in my office and so I am pleased that we are able to get somebody to bring them on board around the shore I mentioned earlier before we really kicked off things I was going to show you the numbers of firms and this is always a soft number I tell people about 18 almost 19,000 regulated industry, regulated establishments and you see the breakout here just under half of them being foods the next largest amount being in devices Los Angeles district is a big huge device inventory the largest in the country most of the device manufacturers are here out in California a big industry certainly 10% in drugs and here's the ironic part I mentioned the largest field office is the ironic part we are not necessarily known as a drug district whereas that's the biggest firms the biggest cases out of the drug industry but we have more high-risk drug firms than those districts that are drug districts gives you a sense of the amount of numbers certainly animal feeds and in biologics and within biologics falls human tissue I want to break out human tissues later on because that's a big issue human tissues and you may recall I don't know I'm not sure if it was a day line story or a 60 minute story in which they were harvesting human tissues illegally and soon after that show I called the body snatcher assignment and we were looking at these tissue banks and how they're getting their tissue product because imagine a lot of control with tissue transplant imagine that they're hogging illegally the amount of diseases that that one transplant can cause got down the line so human tissues are big one Arizona I mentioned earlier that would cover Southern California Arizona these are just the numbers for for our friends today and I guess for the least of us here some of the things and now these are ORA also regulatory affairs highlights we have these goals performance based goals and their inspection based goals they've been increasing for us in certainly 20% over our 08 for last year we had 125 people just focus on PCA's peanut corporation of America and pistachio because around the time when peanut happened we had probably pistachios and the one nut that's always in my office I'm not talking about staff it's pistachios love pistachios to death I have to count them out before I eat them I'll wind up eating a whole pound in one city imagine my sugar and we start having the albums with pistachio manufacturers but over 125 people feel why we're dealing with peanut butter issues that's a lot of people on one issue and what I said we need to constantly evaluate how we put risk assessment issues hired over 400 investigators in 09 record number of over 1200 foreign inspections now here is where we are going to grow in terms of what we do we're going to be needing to do more and more foreign inspections year over year represents some 20% increase over the previous fiscal year certainly the number of legal and public health actions are increasing now that video you saw earlier was last March commission has been on board since then and we have been dealing with all of our issues reportable food registry issues we've been dealing with prevention and intervention response issues we have these nine rapid response team issues we are now moving rapidly on public health issues so as a result you would expect to see previous years level 9 probably expected as we continue that march on public health enforcement that it will continue to grow and revitalization initiative won't mean so much to you as in-house in terms of how we're looking at how we do our own business practices what are we doing are we doing things that we did 20 years ago that may not be relevant to what we are today so that major revitalization after it dealt with over 100 people in the field working on that on those efforts number recalls we have last year about 157 that's just in Los Angeles district office I don't have that national number that number would probably be in the hundreds of thousands remember the district is a big device area big device district the most of our recalls dealt in device issues followed by foods, drugs and followed by foods, biologics then then drugs recalls a classified based on severity 1, 2 and 3 class 1 recalls of the most public health significant ones followed by class 2 then by class 3 class 3 of the low risk the low risk of the 3 sort of what's to do I don't know if this is new maybe new to use mentioning FTA has been opening up a number of offices overseas Indian, South, Central and South America Europe and the Middle East and these offices as they open up they're really our initial entree into some of these areas and it's not putting investigators over there right away to go out and do inspections on these foreign seas a lot of these offices as they're opening up are really just making the contacts with the government organizations working on collaborative efforts as I mentioned earlier my regulatory partners are dealing with issues the Indian office and I remember this one well because unfortunately it was a result when they had the bombing in the hotel in Mumbai, India the commission and secretary were actually on their way to that office when the bombings occurred obviously they didn't finish the trip because of that so we have these offices overseas we have a dedicated cadre of people who are here who do foreign inspections it's difficult enough to do an inspection domestically so my hats off to these individuals who go into foreign countries and do these foreign inspections hey what's ahead certainly the house has passed the food safety enhancement act certainly requires passive hazard analysis and critical control point acronym has it FTA access to records ability to acquire mandatory recalls certainly set performance standards these are some of the additional tools that will certainly help us deal with the totality of enforcement and especially the food protection areas with the recall recalls now volunteer there are a few program areas in which FTA has the authority to issue mandatory recalls but not many sure we can lean on a company and do other things to try and entice them to issue them a recall but if a firm is dead set against issuing a recall we have to do other enforcement activities to try and deal with getting that bad product off the morning and certainly as I mentioned more and more recalls more and more foreign inspections we are looking to double the number of foreign inspections you did in the next two years to double that number because all of the reports, all of the studies all of the congressional oversight committees are saying we're not doing enough in the foreign arena and products that are coming over here but still a major import country so a lot of what we do and use is coming over here I think I'm at my last slide I think we have time for a few questions the second one that I said that I was going to do and I actually remembered after a month the student career scholarship program internship program why didn't we use that program I'll tell you why because almost at the same time as that rolled up soon after that this FCIP federal career internship program came out and it allows us an opportunity to hire directed from the schools so we don't have to go through the requirements of the SCET program SCET program is somebody who's sort of in school didn't quite finish yet and sort of will come into like an internship program around that time we were being told you need to hire 60 people and since the way the budget works you know you get the salary dollars up front and you need to get those 60 people on board but I didn't have time we're in and we're on six I think we were a lot more than that but we had to bring up so many people we didn't have the time to deal with two programs at the same time so we primarily focused purely on the SCIP program federal career internship program to bring people on board and it's essentially hiring somebody to one of their positions and investigating and they'll sort of be on their two year internship program okay that internship program you're an employee of the food and drug administration you are getting a promotion as warranted and going through training and all that other stuff as a normal employee or regular employee will come on board and after the two year internship program to be converted over to a permanent position so that's the SCIP program that's why we focused on that especially over the past two years we had so many people on board that we didn't look at SCIP I can tell you that Friday afternoon I was talking to my administrative officer and we have some administrative positions that we're trying to fill in the interim we were actually talking about SCIP as a possibility for us to be able to reach that gap I don't know what's going to ultimately happen but we really just started having that discussion but SCIP is still there we haven't used it yet because of our uses of the SCIP program our jobs are advertised on USAJobs.com or the .gov I can't remember which is which and so you will see those positions that are advertised there and it's open I think we have an opening we have it's advertised right now looking at first and more positions this year one question I remembered earlier any others I remember the I think it was dog food dog cat food yeah, melon and we were wondering how this foreign inspectionist will report and giving the severity of punishments in China for example but right now the office that you're opening up in China for example it's just to explore how this relationship will work the office has been open now over a year now we have two or three offices throughout China and initially they are serving as the asons they technically these employees are for the State Department but in these foreign places you mentioned melamine melamine is a it's a beautiful case of autopsy here even during the melamine situation obviously we were able to quickly determine the source of the problem because problems started happening soon after the domestic manufacturer changed suppliers one supplier A, everything was fine but the supplier B, cats and dogs started to drop dead so we were able to quickly hone in on there being a problem not necessarily knowing exactly what the problem was and ask through signs and intensely they came up that the problem was with melamine contamination it wasn't a plot to try and kill the dogs and cats of the world it was more of an economic game because the wheat gluten which is the basis for a lot of the pet food was the main protein source and the manufacturer paid more for that protein source so what the melamine does is they do a rather simplistic test to determine protein content and what the melamine does is give an erroneous false high content that's the reason why the melamine is put to the product the effect was out of the disasters to the pet food but here's the erroneous part and we knew the firm that manufactured so after about I don't know the timeline but after some period of time they finally allowed delegation from the U.S. to go over to the plant to do an inspection anybody can guess what we found we got there rubber they bulldozed the plant it demolished the plant just to demolish the plant so we weren't able to do an inspection there now you can search YouTube and you'll see you'll find videos on how these coal miners are still using melamine supplying it to the food industry I'm going hmm why don't we do that still out there after the pet food issue happened there were reports of the product getting into infant milk in China I think you may have heard of results from the National Associated Data so then we started looking at dairy products milk products and you name it chocolate products anything that had a milk or cocoa product in it from melamine so it's one of those things you wouldn't think of it as being a wheat food pet food you would think of it as a hybrid situation I always say you've always got to constantly establish and take a look at what's those risky products are for you thank you very much I know you're very busy waiting for it