 First of all, please join me in thanking Peggy Hamburg for that remarkable speech. Thank you so much. We're joined by three remarkable additional folks to our panel who I'll very quickly introduce. You have their bios. To my left, the ribbon Jeffrey, the third who is a senior advisor here at CSIS, spent 22 years on Wall Street very successfully and since then has done a remarkable sequence of things. And most recently was under secretary for economic, energy, and agricultural affairs at the Department of State. Prior to that was a senior director and special assistant to the president of the National Security Council with responsibilities for international economic affairs, played a key role as a representative of Pentagon at a key moment in the creation of the Coalition Provincial Authority, played a key role advising the president after 9-11 in the redevelopment of Lower Manhattan. And I could go on and on, but in any case, quite a remarkable array. Tom Boyke, you've seen the paper that he's written. Tom trained as a biologist and historian at Columbia, went on to a very distinguished tenure at the Stanford Law School, was president of the Law Review, went from there to the US Trade Representative's Office, where he was a senior director there on intellectual property issues. And was a very important personality in the negotiations with Korea and China in a very sensitive and complex set of issues around the intellectual property rights and safety issues. Henry Chen is the senior safety and regulatory officer at the Coca-Cola Company, the sort of gold standard for these safety issues. He served for 30 years at the National Association, National Food Processes Association. He's a chemist by training, completed his PhD at USC. Prior to that was an undergraduate at Berkeley where he returned as a post grad, so long loyalties to those two great universities. So let me try to kick off the first round of our discussion and ask a very broad question and ask Tom to sort of perhaps kick off the answer. And the question is we've heard Dr. Hamburg's discussion around the agenda that we face, which is a very complex daunting agenda and that the US is seeking to be more engaged along these multiple levels. Tell us a bit from where you, as you look out, what the major challenges are going to be in achieving success, both in terms of US policy, the kind of past efforts that we've had and what those experiences might tell us. And looking five years out or 10 years out, what might success look like for us? Maybe you could just offer some quick comments and we'll invite Henry and Ruben to weigh in and then we'll come back to Peggy for her thoughts. Sure, I'd be happy to. First, let me start by thanking Steve and CSIS for the invitation to participate in this great panel, as well as for their support in publishing my paper on food and drug import safety. I also want to say one honor it is to share the stage with Commissioner Hamburg and Ruben Jeffrey and Dr. Chinn in this discussion. Let me begin by saying that I very much agree with Commissioner Hamburg's characterization of the food and drug import safety problem as well as the need for a paradigm shift in the US government's approach to the issue. Unsafe food and drug products at this point are no longer just simply issues of domestic public health threats that can be addressed with stronger border control or port inspection. They really have become food and drug import safety has really become a global health problem. The burden, health burden, the heavy health burden of foodborne disease and contaminated and adulterated foods and drugs really experience internationally in importing and exporting countries alike. And for all the reasons that the commissioners cited, the exponential growth in the food and drug trade, the proliferation of sources of these products, particularly in developing countries with less regulatory capacity, as well as the complexity of the products in the supply chains. All these mean that no one national regulatory authority, not even one as good as the FDA, can alone ensure the safety of the food and drugs that we import. So you need a new strategy. And I think the overarching strategy that FDA has put forward is a good one. And it's consistent with strategies that have been successfully employed to address other types of global health threats that cross borders like infectious diseases that cross borders with trade and travel. First they have called for measures to improve control and monitoring at the point of production of these products and talked about traceability, accountability for local manufacturers, as well as cooperation and information sharing with regulators. Next, the commissioner has talked about the need to invest in indigenous regulatory capacity in developing countries so that they themselves ensure the safety and quality of the food and drugs produced in that jurisdiction. Richard talked about the case for the buy-in for exporting countries in this initiative around food and drug import safety, specifically talking about the benefits that accrue to the consumers in those countries themselves who really are consuming the same products, the same foods and drugs that we are consuming and are exposed to the same threats. And also talked about how improving the safety of these products improves the brand of those exporting countries. And last, she talked about the need to coordinate with regional and international authorities on this issue. So in a sense, this is a very classic public health strategy in dealing with transnational threats and I think it's the right one. I think the challenge to get your question about the success of this effort and its feasibility will be in the details and the implementation just to throw out a few issues now and then open it up for discussion. Around traceability, a lot of the question will ultimately be around the scope and compliance with those requirements. The 2002 Bioterrorism Act, for instance, provides for traceability of some foods but doesn't extend to foreign producers and compliance with it has been lousy. A recent OIG report has determined that you have roughly 40% compliance with that requirement. To the issue of regulatory capacity building, there's a bottomless need in developing countries for regulatory capacity building and I think the question will be from the FDA standpoint, what sort of political mandate will the FDA have from Congress? What sort of resources will it have in order to start to address those needs but also whether or not those resources will be deployed in a risk-based, sustainable manner? Historically, as I discussed in the paper, this has not been the case. You haven't seen FDA really have the ability to engage in this type of regulatory capacity building and the resources have gone to countries typically like Egypt or Columbia which are not necessarily the producers of high-volume, high-risk products. The third issue would be whether or not the move towards this strategy can be done in a way that's consistent with international trade commitments. I'd love to hear Jeffrey's thoughts on this as well. I certainly agree with the commissioner that the idea behind food and drug safety is reaffirming of trade. The question is in this economic environment and the domestic political environment around trade policy, whether or not the bills that emerge from Congress will be supportive of that goal. The last issue I would say is I think the commissioner is quite right in emphasizing the need for corporate support and accountability as being a foundation for moving forward with these efforts. I think the big question is going to be how and what blend of what will be the characteristics in the mix of carrots and sticks employed in order to foster that support and capability. And I really think moving forward on those types of four examples will determine where we are in five years on this problem. It really does, as the commissioner outlined, require a paradigm shift. Thank you. Reuben, would you like to add? Yeah, Steve, thank you. I want to add my thanks, Dr. Amber, to you for being here today and for your service to our country and importantly for really the extraordinary record of the FDA over time in keeping food and medical products and medicine safe in America. We're the exemplar in the world of kind of best practices in this regard and we'll get a lot of confidence under your leadership that will continue to be the case. So thank you. Just a couple of things to add to Tom's commentary and stress the magnitude of the implementation challenge here when it comes to import safety across the suite of products from food to medical products. It requires success over time is going to put a premium on communication, collaboration and coordination across a variety of fronts starting in our own government. Not that the interagency process doesn't always work seamlessly but there's certainly a lot of equities at stake in any one of these issue sets and the departments and agencies, there's FDA, there's agriculture, there's state, there's USDR that gets into the trade aspects and it's very important that we as a government continue to be lined up in terms of definition of priorities, sense of desired outcomes and then negotiating and implementation strategy. Secondly, at the international level, we've got a variety of fora through which we can achieve the objectives of food and medical product safety. First at the bilateral level and the issue sets are very different depending upon the particular trading partner. Take China as one of your 150 sources of imports, there the issues are one of scale and economics. Just the pure size of China is overwhelming, they have 200 million, 200 million farms, however defined, you can't inspect them all. So it's absolutely imperative to have the right understandings at the right levels as we've begun to do, we've made significant progress with the Chinese thing and we both recognize that we have a long way to go and prioritizing, pursuant to those agreements and Tom, you were involved in putting these together. There are now third party certifications of certain export facilities, we have inspectors there, they have some people here, and it's the beginnings of a process which will hopefully lead to greater confidence on both our parts of product integrity going in both directions. Africa, you alluded to this as well, Tom, challenge completely different. It's one of development and developmental capacity. Of agriculture, not to generalize in Africa, every country is different of course, is clearly important, the basic food supply, the health, the welfare of the people, and also in certain countries as a source of export earnings. So supporting these countries through our own bilateral efforts and through the development community writ large in improving their own domestic quality for their own benefit and then also translating into that, to the requisite protections where exports for exports coming into our market and other markets is an absolutely critical dimension to addressing the problem longer term. And it clearly goes beyond the purview of the FDA, the FDA can't begin to take in all these responsibilities but it speaks back to the importance of making sure we as a government have a government as a whole approach to this suite of problems. And then finally there are all these various multilateral forum and every region has a regional grouping of which we are a part. I don't need to name them all. You've got the G8 which historically or the G7 has taken on food security and health issues query whether or not some of these challenges will now get taken up by the G20. I would suspect that I am personally, I think that these are challenges given the stakes that are well worth the while of an institutionalized G20 process in the fullness of time. But how these organizations and groupings take on these challenges in a way that is supportive of solving the problem, i.e. assuring food safety while at the same time does not interfere with the normal flow of appropriate trade, commerce and investment activity. If you didn't have enough to do, that's just another layer of international considerations. Henry, would you like to add a few comments? Well, first, thank you for inviting me to be part of this distinguished group. I'll be a little bit out of place here. I wanted to emphasize a little bit of the remarks that were made by Reuben and also Dr. Hamburg that applauding FDA on the initiatives going forward, the food industry has always felt that a strong FDA is vital to food safety, but not only food safety, but consumer confidence in food safety because that's really obviously very important. Excuse me. The initiatives that Dr. Hamburg has talked about in terms of building local capacity, getting troops on the ground at the countries that come. We can hear you just fine up here. Yeah, go around. Let's see, Tom. Sorry about that. Hopefully, you heard my initial comments saying that the food industry is very supportive of FDA. We've been supportive of a strong FDA. We believe a strong FDA is vital to having consumer confidence in safety of the food supply. And the initiatives that Dr. Hamburg has outlined in terms of having additional capacities on the ground, building relationships in those countries, moving responsibility further down into the supply, further up into the supply chain. Those are all kinds of things that food companies do when they go into those markets. And so in many ways, what FDA is doing is mirroring what the most responsible companies are doing in those developing markets already. But having the clout of FDA and FDA bringing resources in certainly going to be a great improvement. And certainly, it will improve, and the FDA's intention to be collaborative. And I think the food industry will really want to share some of our best practices in terms of how we do audits of suppliers, how we qualify suppliers, how we trace our ingredients. We really would like to be able to share some of those best practices with FDA. Peggy, shall we come back to you for some of the reactions? Well, number one, I'm enormously encouraged by the level of support for what we're trying to do and the recognition of the complexity of the challenge, the time urgency of the challenge. But the fact that we simply must make this a priority and that if we're really going to address this problem over the longer term, we cannot lose time going forward now. It is just a very, very difficult undertaking on every level. I tried to lay out something about the nature and scope of the challenge in terms of the expanding global markets. But when you think about what are sort of the modalities in which an agency like FDA needs to implement, it's also very, very complex. Internally, it requires working with partners in government that historically we may not have always worked as directly with many of which we have, but aligning the trade and commerce issues, the diplomacy and international relations issues the issues with the Department of Agriculture and other components of government and finding a way to strike the balance between what are the compelling public health needs and what are the other priorities of government because clearly we want those interests to all align. The truth is they don't always align and so obviously as FDA commission or part of my responsibility is to always make sure that the public issues and concerns get fully on the table and addressed and that they get the primacy that they need and deserve, but framing those in the broader context of all of the tools and the infrastructure for actually implementing solutions in an international context. The second great challenge of the logistics of this I think is the global governance issues. We have developed and will continue to develop bilateral and multilateral arrangements. That gets us moving forward but it still is a fragmented piecemeal approach and I think what we really wanna strive for is increasing harmonization of standards and broader sharing of both information and technical expertise as well as just plain old resources. But there isn't really a clear governance structure for this issue. The World Health Organization obviously plays an important and vital role. There are FAO, the International Food Organization plays an important vital role. There are other dominant players like the European Union and the drug arena, their EMEA which is the FDA equivalent and there are other very strong regulatory authorities out there that sort of provide some informal governance but I think we do need to think about if we want to really institutionalize some of these approaches and really have a strong foundation on which to build going forward, do we need some innovation in that regard and it's made even more complex by the fact that these issues, we're talking here about both food and drugs and devices, not every regulatory authority is structured in the same way. In fact, we are the exception to the rule doing drugs, devices and medical products as well as now tobacco products and a few other important consumer goods. So that is a major challenge. What is really exciting to me despite all of the bumps in the road before us is that there is I think this strong appreciation of just how important these issues are and the fact that CSIS is both hosting this forum but has taken this major advance that you mentioned at the beginning of your remarks to really include this issue as part of the overall global health strategy and the fact that people in very different roles than health, people that work on economic development issues, people that work on trade issues, people that work on diplomacy issues are also starting to see that this is an issue that they need to fully engage on and they need to work with us. It gives me hope that moving forward we can accomplish a lot. And finally, industry is such a critical partner and as you said, we can learn a lot from industries such as Coca-Cola that have a long history and a strong track record in assuring the safety of the supply chain. And I think that when we think about how we're going to extend our global reach and work with key partners, industry is an essential partner in that effort. Thank you. Reuben, can you comment a little more about what kind of diplomatic strategy in this situation is gonna make sense? We're in a period of pretty rapid and very ambiguous transition where the G8, we're not sure where the G8 will migrate and what will it look like in two years when we're the host, if it still exists. And we've got a G20 that's rapidly taking shape and that's just one piece of the puzzle. Yeah, first, I wanna make an obvious point but related to the attention of not just Americans but the world community on this issue set. And that is simply that a consumer in China or an African country, no less than one in the United States in this world of rapid communication, they know a problem when they see it and they don't like it and they hold their governments accountable. And I think that's a good thing for maintaining momentum on an international process or series of processes. I think, Steve, your question's a tough one because there's not an easy answer here because there are a lot of in place mechanisms. There's institutional structures. You mentioned the UN ones. There are all these various regional ones. Different countries are organized in different ways in terms of how they regulate. We've gotta do a sort of simultaneously move on the existing fronts. And through those, one identifies the really big issues whether it's a particular product of concern or a particular region of concern. And as to those issues, we as a country and as a matter of diplomacy need to think long and hard whether or not it's better to elevate them to some wider group, whether it's the UN mechanism or the G20 or something else. But there has to be some kind of structure since any one organization can't deal with all of the issues because they're so broad, they're so diverse, they're so numerous, whereby we in our own minds prioritize what those issues are and bring them to the fore in these broader globally representative groupings. Again, be it the UN or the G20, so that there's some real concerted organized action on a common basis to address the particular issue. Sean, do you have anything to add on that? Sure. I think the comments have been really great. I agree with both Rubin and Commissioner Hamburg's discussion of efforts, particularly Commissioner's discussion of need for new diplomatic approaches. I think the last administration had a fairly mixed record in pursuing bilateral agreements around trying to improve food and drug safety. I think we achieved a memorandum of agreement of somewhat varying quality with China and the efforts to negotiate those agreements with India didn't get off the ground. I think that some of the issue will be moving towards and I think the Commissioner's comments in identifying this as a more global health issue I think will help in the sense of not no longer targeting countries as particularly bad actors maybe moving from more of a bilateral model of these contentious negotiations more to an international model I think will help. I think more attention needs to be paid to what is in it for these countries, the buy-ins. I think having resources to actually provide regulatory capacity building is certainly one of those carrots. There is a great FDA pilot program right now about the Secure Supply Chain Initiative looking at preferential access to drug manufacturers that meet verified quality standards. That's a good approach as well. But I do think you need a more integrated interagency approach involving USCR, Commerce and others in terms of moving forward this approach. That's both because of tapping other sources of expertise but also other sources of linkage. Other things that you can provide to move this debate forward. But I also think better use needs to be made of international for. I am a fan of pursuing initiatives in Codex around these issues moving towards more commodity specific production standards for high risk products would be a better way to go in my view than trying to pursue these on a bilateral basis. Henry, do you agree with that? Yeah, so I was just going to mention that Codex in the food area, obviously Codex is a forum for talking about the harmonization of international standards on foods. So there is that forum, probably one of the things that unfortunately Codex does have a reputation of not moving very swiftly. So one of the things that we could all benefit from is some way of moving Codex along a little bit more swiftly. You know it's interesting as we're talking about harmonization of international standards, I just came from a meeting I guess a week ago where they were talking about regulators in different countries were talking about their efforts at harmonizing their regulations. And we had a presentation from China talking about they're trying to harmonize regulations between China, Hong Kong and Taiwan. And they have some challenges. We had a presentation from governments in Southeast Asia trying to harmonize regulations between Singapore and Taiwan and the Philippines and all that. And so there's a lot of effort, a lot of attention going on in terms of harmonizing regulations. Unfortunately in some ways we got to where we are in terms of the different standards over a period of many decades. It will take maybe a little bit of time to unravel and harmonize, but I think we all agree that harmonized standards are the way to go. And this is where FDA comes in because FDA is really powerful in the sense that they are a science-based organization. And so the things that Commissioner Hamburg was talking about, that risk-based inspections, you're talking about traceability and having that risk-based, I think goes a long way. I mean, you don't wanna waste your resources on things that are low risk. But on the other hand, you wanna focus on those things that are high risk. So, and also in the area of talking about harmonization, it's interesting that as we are gathered here, there's another conference elsewhere in the city. Of course, I guess that's not too unusual for Washington, but that there is a conference that's going on called the Global Food Safety Initiative Conference where a large number of multinational companies and other food companies are gathered together talking about harmonizing or developing a standard to, or procedure to harmonize audit standards and those kinds of things. So. Thank you. Why don't we turn to our audience for some comments and questions. Just stand up or put your, yes, we, here and here on this side, let's start. We'll gather together three, yes, please. Just identify yourself and there's a microphone, Seth Gannon, who's been very instrumental, helping us put this together. Bring that over. Thank you. Hi, I'm Jared Favoli. Jared Favoli from Dow Jones. This question is for Mr. Chin. Trying to figure out, does Coca-Cola support the proposed food inspection user fees? Okay, hold on that for a minute and a second. Back here. Hi, Bill Thoe with the Booz Allen Hamilton. Have you taken a look? You talked a little bit about some of the penalties you're putting on the foreign importers. Have you looked at, from their perspective, what the trade-off is between the risk of getting those penalties and the cost to their business of improving food inspection? Because that's what will drive their business. Right down here in front. Thank you very much. Raghav Birgur from India, Asia Today. My question is for the commissioner. Excellent talk, of course. One, what sort of agreement do you have with India as far as food safety and imports of medicinal drugs are concerned? At the same time, Ayurvedic or herbal medicine are talking the town in America or around the globe today. If you have considered or if you have got any request from any Indian facilities. And finally, as far as terrorists are concerned, they try to hurt people in many ways. And now they may be looking through some food and medicines and so on. So what kind of, what sort of safety are you considering for the terrorist attacks? Okay, just one more Jim Harrington here. And then we'll come back to our panelists for responses. Thank you, Jim Harrington from the National Institute of Health for the International Center. You're an excellent talk, commissioner. Thanks so much. My question is on the bigger picture. What about a framework convention on food and drug safety? Not unlike the framework convention on tobacco control. Would that be something that would help harmonize and bring to bear the countries that actually would sign on that and ratify it? Okay. So, Henry, we have one specific question for you. Maybe you'd like to too, and then we'll turn to Dr. Hamburg on the broader ones. Well, actually, I don't think I'm, I'm not actually the right person to address that. That's something that our people on our government affairs people are better equipped to address. I'm the science and regulatory guy. I'm not the user fee guy. Okay. Okay, Amber. Well, maybe I can use that to give an answer on the other, because I think in a way what the gentleman from Blues, Alan Hamilton was discussing with the issue about relative incentives and disincentives to participate in the marketplace. And it is true that there are importers of varying sizes and certain demands and expectations and penalties on smaller importers does create a potential concern for them. I guess I would say that whether you're large or small, the products that you bring into this country need to be safe and the importer does have a clear responsibility and needs to be held accountable for being able to assure the safety of those products. I think that we need to be willing to work with those importers to help them better understand how to fulfill their responsibility in terms of the safety and security of the supply chain as we touched on earlier. Industry has a lot of interest and experience in this arena as well, because in the final analysis, the products aren't safe, and particularly if they cause serious problems in people in this country or anywhere else in the world, that's going to be even worse for the business of those importers. I think we view it as a partnership. We want to work together. We want to create the support and incentives to assure compliance rather than enforcement and penalties, but you need to have the enforcement and penalties that you can bring to bear when necessary. With respect to the question about U.S.-India, very, very important relationship both with respect to drugs and food imports. We have a lot of working relationships with India and we have two new offices in terms of an actual on-the-ground presence. I'd have to get back to you with respect to what, you know, specific signed agreements we have. I'm not certain of that, but there's been an explosion of activity in India in terms of medical products, generic drugs, of course, being very well-recognized, but also now, you know, more innovative products as well. And that relationship and our ability to work with those companies and have on-the-ground presence is very, very key. And India, as you well know, is a leader in certain food products, particularly spices, which are highly vulnerable to contamination. And so, again, you know, really working with India to make sure that the products are produced in ways that are in compliance with international and U.S. safety standards is absolutely key and in the interests of both of our countries. And I expect that we'll be working more and more closely with India over the time to come. And the framework conventions. The framework conventions, you know, it's an interesting idea. Interestingly, there have been very, very few international conventions around health with the tobacco framework convention being won in the Biological Weapons Convention being another. I kind of think this issue is not one that's cut out for a convention per se. I think that you would end up actually potentially causing more harm because the sort of specific things that you'd lay out would actually box you in rather than enable the kind of broader engagement and commitment that you need. But I think that the strategy of really trying to convene in a more international way and really support different kinds of fora for addressing questions of harmonization and coordination is very, very key. And we need to do more about that. And as we do that, I mean, I liked your notion of moving forward with the sort of structures and institutions that are already in place but thinking about how we might reformulate as we better understand our needs as we also experiment and learn about what works and what doesn't. But I think we need more global fora for talking about these issues and acting on these issues. And I think we need a sort of a multiplicity of different strategies, though. Sure. Just respond to a couple of those points on the liability and penalty side. It's an important issue. I will say that it's true that from a regulator's perspective, the costs of regulating imported products in their production are a lot higher. And there is a justification for having penalties to encourage better production, safer, higher quality production of those products in light of those higher costs imposed on U.S. regulators to try to ensure the safety of these products. I will say that being said, there is an important issue around least-developed countries for whom, for which rather, agriculture is a sole area often of comparative advantage. And the question of how these countries, small producers in these countries, can meet rising standards is a real one. And I do think there needs to be an attempt made to try to facilitate when things talk about in the paper, the possibility of collectives as a way of trying to pool resources to allow them to meet these standards. But it's a real issue. On the Framework Convention, I concur with the Commissioner that international approaches are important, but you do have both the SPS and the TBT agreement already with extensive provisions on harmonization around safety and safety for food and drugs. So I think you'd have a hard time moving forward with a convention on that same subject when you already have those agreements. We also in the U.S. have had a difficult relationship with these public health framework conventions to begin with. Tobacco being the obvious example. So I'm not sure that model is really would be the best, although the international approach I think is the right one. Yeah, listening to these various responses, it sort of underscores the need for leveraging the resources that exist. There's the FDA, there's the broader regulatory community in the U.S. through all these multilateral forum. And the private sector really does play a key role. I won't comment on user fees. I'll leave that to the government affairs people wherever. But the resource of the private sector to monitor supply chain, management, assure best practices, consistent quality throughout the supply chain to train people, professionals, young people from around the world in their companies and in the ways of doing safe and effective business and production is absolutely critical. So that partnership with government and governmental bodies is one that needs to continue, it's already strong, but needs to continue to be strengthened and reinforced. We're getting to the end here, so I'd like to, there's a woman right here in the middle here. Hi, Caitlin Christensen with the Global Health Technologies Coalition. It's evident that the health of non-U.S. populations is a major priority of this administration and enhancing national regulatory authorities in the developing world would be a significant step to improving global health. Another issue is the role that the FDA plays in the review of products that the FDA can and does play in the review of products that are intended for diseases found in the developing world or diseases not primarily found in the U.S. The European Medicines Agency or the European equivalent of the FDA has recently implemented a new process by which it approves or it reviews products intended for non-European populations in partnership with the WHO called the Article 58. I'm curious whether you see a potential role or similar process that the FDA might consider in that regard to help with the review of products for the developing world. Thank you. Let's take one more question comment, please. Commissioner Rob Quartel, former U.S. Federal Maritime Commissioner and father of the Container Security paradigm. I'm also chairman and CEO of Antelix, which built Predict. And when I walked in today, I didn't realize you were going to announce it. So as soon as I walk out, I'm going to link to your website from my website. But we're, A, we're honored to be involved with FDA and B, it took a great deal of courage to actually push through these kinds of technologies because they really are advanced beyond what people are typically used to. This is a conference, so my question is however, this is a conference about food imports. But I would be curious about what you're thinking about regulation of domestic products that you regulate as well, because many of the same technologies can be applied in this space as well. Thank you. Can we come back to the commissioner? Okay. Well, I'll start with the last question first. You know, I really think we need to think about many of these strategies, not as international and domestic, but as common problems in a, you know, dramatically fluid and interconnected world and the same kinds of strategies that we need to apply internationally, we need to apply at home, the shift from a reactive mode to a preventive mode, the focus on, you know, really assuring the safety and security of the supply chain, the notion of working in critical partnership with both industry and domestically with state and local health authorities you know, I think that we're talking about import safety in a sort of targeted way in part because it's been underappreciated and under addressed and because of the growing number of imports of all kinds of consumer goods into this country, there really is an urgent need to step up to the plate and really begin to do things differently and to acknowledge and respond to what is a very serious vulnerability and threat to health. That doesn't mean that domestically we don't have a job to do and we don't require some of that same paradigm shift and I think the overall message, you know, that I hope to convey is that FDA is a critical player domestically and internationally in promoting and protecting the health of the public and that in order to do so we need to be adequately supported. We need the appropriate authorities. We need to be in a position to truly leverage science and technology and we need to work in full partnership. The other question was about our role in helping to support access to medical products in other countries and of course we do have to operate within a very well-defined and scrutinized legal and regulatory framework and the approach being taken by Europe isn't one that we can just adopt here at home but we do have a commitment to trying to make medical products more available around the world. In the PEPFAR program we were able to go forward with an innovative approach what's called the tentative approval process but it's more than tentative and more than 100 products have been made available for use through the PEPFAR program in the developing world. So we will continue to work on those efforts. It is a priority and I think that, you know, another aspect of what we're trying to do through this import safety and the broader framing that we're applying to import safety is to support the capacity of other countries to be able to make innovative medical products and safe foods more available for their own communities. I think we're at the end of our time here so please join me in thanking Mr. Hamburger and our other panelists. Thank you so much.