now. >> look, when it came out the other day that was confirmed by the auditor general we had a surplus last year, not just this year but a surplus last year, mr. kueter came out at the dust because they can veterans and cut seniors and they've got infrastructure. [talking over each other] >> spending in all of us areas has gone up. the way we balanced the budget was we did increase revenues. we did by cutting taxes. i guess what is a people is the a thinking of said before. witnessing in this fragile global economy everything is bigger with significant was insignificant juncture but what we're saying we're doing is were making sure we are investing in the things that will cause long-term growth and in things that help people in their pocketbooks to get education, to save to retire. higher taxes and permanent deficits is a risk that buys nothing for our people. >> mr. harper was elected on a

promise to make ottawa better, to change ottawa but, unfortunately, it is ottawa that has changed mr. harper. corruption has increased and that's part of his legacy but also it has become a more divisive place to a relationships with the provinces are more devices and meaner. i come out of provincial politics. i know it's part of my job if i become prime minister since sit down with the provincial premiers to work with them on important issues facing them. at the things we want to bring forward ike quality, affordable childcare. >> one of the things i think is clear is that i disagree with these two gentlemen on a number of things. but the main thing i disagree with him on his lack of ambition for our country to mr. harper wants you to think that are just as a possible. that's not true. in this country better is always possible. mr. mulcair talks of making things better but isn't going to act on it because he has no plan

to build the economy we need. >> thank you very much. so ladies and gentlemen, there you have it. this much-anticipated globe and mail debate on the economy comes to an end to you for a wide range of different views, and in a months time it will be voting today. i would like to thank everyone who'who has joined us and made s even possible. the mayor for hosting us in calgary. we believe in the national debate and i'm sure you agree that we got one tonight. our final word of thanks of course to the three leaders, mr. harper, mr. mulcair, mr. trudeau, we wish you all well. we know such a common interest in doing the best for candidate. you just have a different way of doing it. stay with us. we will be carrying the post debate terms later but first, james other globe and mail joins us now to become the postdebate

debate. i am the after and chief of the globe and mail. thank you and have a good evening. [applause] [inaudible conversations] >> today former cia director and retired general david petraeus goes before the senate armed services committee answering questions on u.s. middle east policy in combating i said. -- ices. >> the pope's visit to the u.s., c-span has live coverage from washington, d.c., the first up on the bookstore. today beginning at 3:45 p.m. on c-span we live with the president and mrs. obama to agreed upon upon his arrival at joint base entries.

>> the acting commissioner of the fda, dr. steve ostroff testified on food safety before

a senate committee. he talked about the budget and appropriations process and a proper funding is crucial to food safety. >> good afternoon. eyewitnesses as well in the audience notices hearing will come to order it will focus on the food and drug administration's effort to improve and maintain safety of our food supply, and i thank you, doctor osac complete presents today. mr. taylor, mr. tootle for participating. we are delighted with that and dr. ostroff, i appreciate the warm working relationship we are building and i appreciate the on a number of issues over the last several months, so thank you for the way you're treating me as the new chairman of the

subcommittee. you note in your testimony commissioner that nearly one in six americans are victims of foodborne illness each year. americans expected to they purchased at a grocery store or website will be safe and the fda is largely tasked with maintaining that confidence. passage of food safety modernization act in 2010 date the agency significant new responsibilities in implementing a very sweeping set of changes to the food safety laws, probably the largest, the largest change in the last 70 years. our hearing today is timely as it follows last week published of the first to find a role for preventive controls on human and animal food. in delivering these new responsibilities are private sector partners expect transparency and certainly from the fda. when i speak to small businesss and agricultural producers in my home state their major concern is the government that limits job creation and stifles

innovation through burdensome regulations. i'm pleased the agency took many of the suggestions and comments from the agriculture community into account by repurposing portions of the fsma rules because they were unworkable for farmers and i thank you for that. modernizing the greater good controls and educating industry and consumers are at the heart of fsma implementation. and the issuance of the preventive control rules starts the compliance process. it's vital if they continued in collaboration with industry and other agencies and issue proper guidance throughout this process. i also recognize that successful implementation, and this is the part you want me to say, mr. commissioner, i also recommend the successful application does not come without a cost. this subcommittee remains committed to investing in fsma's implementation within the resources that are at our disposal and have done so since

fsma's enactment in 2011 i think spinning of the last five years is increased 8%, something that can't be said for many other federal agencies. but we know you face additional challenges and additional task. and as the continuing process, the process continues for appropriations, fsma funding will undoubtedly play a significant role in our deliberations in establishing priorities. i look forward to discussing this and other topics with the witnesses today. weblog to cover the second editor not to my colleague, senator merkley, for any remarks he may wish to give. >> thank you for holding this hearing. thank you, dr. ostroff, mr. taylor, mr. tootle for attending the safety of a food supply something most americans take for granted. parents heading to the grocery store for the most part don't have to give a second thought whether not the first they're picking up will make the family

sick. america has and continues at the safest food supply in the world, but that, of course, doesn't mean it's perfect. as anyone who's ever had a foodborne illness will testify to, and we need to work to make sure we stay ahead of a changing global marketplace. we don't think anything about eating strawberries or balance out the seasons because we have access all of the colbert just ahead of us as a monumental task and their multiple agencies involved including usda regulates about 20% and 50 which regulates 80%. outside of the outcome of state agencies, private businesses and farmers are making sure the processes in place will make sure a domestic canyon is always safe to eat as well as an imported strawberry. the food safety modernization act which was signed into law in 2011 was the most sweeping update of our food safety policy nearly 70 years. the law changed the way to look at the issue of food safety. prior to fsma, we spend our time

tracking down. we are working to make sure that we prevent that outbreak from occurring in the first place and getting fda the tools it needs to do just that. it's a better way to do business. the law had about 50 specific deliverables, no small task for any agency, although it took longer than many would like, fda published two of the seven major final rose last week and the rest will be out by next spring. we are at the point where the rubber meets the road and it will require a new way of thinking for food inspectors have been trained to look for an existing problem instead of working with interest to make sure those problems never materialized. it's not always smooth sailing. i know folks at 50 have learned a lot about production agriculture and food processing. i think most people would agree you've done a good job working with industry to make sure that these new rules are effective while minimizing the disruption. thank you, mr. chairman for holding this hearing. it's time and other interested

to hear from our witnesses. >> dr. ostroff, again welcome and you me commend your testimony. it is a significant number of pages and i've extended the deadline from the normal five minutes to 10. so please proceed. >> thank you, senator moran and other members of the committee. and i share your enthusiasm for the very warm working relationship that we've been able to develop in the last several months, and we look forward to continuing to work with you not on a food safety issues but all the other issues that fda deals with. i'm steve ostroff, the acting commissioner of food and drug, had a really great deeply appreciate the opportunity for michael taylor at the same to my left to talk about the food safety modernization act, also known as fisma. i would also like to thank you for holding this hearing and for the committee members and ongoing interest in this particular topic and for the

strong and growing working relationship that has developed between the committee and fda to achieve our mutual goals of assuring the safest food supply in the world for american consumers. i hope everybody in this room knows that this is food safety month, and i can't think of a better way to celebrate than by starting the process of bringing fsma's important new rules online as we did last week, and by discussing with you today the critical next steps that must be taken to realizing the goals of fsma. so although i've only been working at fda for two years, actually began my public health cover considerably before that 30 years ago and is working at the cdc on food safety and foodborne diseases. particularly at that time the newly recognized and deadly pathogen e. coli 0517. while working in washington state over a two-year period i personally interviewed every person or a member of their

family in the state diagnosed with a particular infection and visited a number of them in their homes. i subsequent did the same with people with other illnesses from foodborne pathogens. so i can say without question that have a very deep appreciation for the suffering and consequences of foodborne illness and death carried that perspective throughout my career as a public health practitioner and as a physician. in fact foo that safety was the reason that i joined fda in 2013 at the urging of the person sitting to my left. despite today have a much improved technical methods to detect and investigate foodborne illness from when i started my career 30 years ago, along with some notable successes in reducing the incidence of certain pathogens, there simply remains too much foodborne illness. as you mentioned, nearly one in six americans fall victim to

foodborne illness each year. that's 48 million people. of these, 128,000 are hospitalized, and 3000 die. this burden of foodborne illness issued by each and every one of us, consumers and food producers alike. the economic costs are also quite sizable. since we know that the illnesses, the hospitalizations and deaths can be prevented, we must also, quite frankly, acknowledge that it is simply time to start preventing them. so over you on this side, cdc's food net data has shown that for many, many years now the burden of illness due to the major foodborne pathogens remains essentially unchanged. as you can see, the illness burden from some pathogens goes up while for others it goes down. but looking at the poster over on the other side of the room,

in total the line remained distressingly flat. so i say to that it is time to make that line start painting in the right direction. we believe that we now have the tools to be able to do that, and that too too is called the food safety modernization act. during my time at fda i have been thrilled to be able to participate in the process of modernizing our food safety system. this agency has stepped up to solve problems by identifying the best science and risk-based solutions that can benefit both consumers and industry. that is what we do at fda when we are confronted by such problems. i know that mike and his team have invented this concept into work to modernize the nation's food safety system through fsma so it can meet the challenges of a new global era. the enactment of fsma was unquestionably the product of foresight and the recognition of

common interest. members of congress on both sides of the aisle came together with consumers and with food industry leaders to enhance fsma's ability to protect the food supply in a modern, diverse world of free flowing commerce. fisma stand for the proposition that the standard across the food system should be done assess is in place that we have learned, worked to prevent food safety problems. problems that meaning food safety producers, practices and many food safety producers are already implementing the this means having prevention oriented standards in place that are equally applied to domestic and foreign producers, reasonable verification of compliance with those standards, and accountability for those who are unable or unwilling to comply. fsma directs fda to build a modern food safety system based on these essential ideas. fda has fully embraced a dynamic

collaborative approach to implementing fisma and is working very hard to build a new partnership and to strengthen existing ones. this effort includes the food industry from farmers and manufacturers to transporters and importers whose capacity and responsibility under fisma for producing seafood is the absolute foundation of the new system. it also includes the fda's food safety partners and other government agencies at the federal, state, tribal and local levels, it also includes foreign government which can play an important role to help assure that the foreign supplies of the u.s. market are being produced in safe fashion. and it includes consumers and patient advocates who have been victims of foodborne illness, because after all ultimately they are the ones that we are doing this for. the two final preventive control rules we issued last week our critical linchpins for building

our new food safety system. they focus on implementing modern food manufacturing processes for both human and animal foods, thus ensuring that food companies are taking a 247365 approach, and working with the fda to prevent problems on the front end rather than waiting until the problem is recognized for identifying people with foodborne illness as you happened in your state of kansas earlier this year. these rules are important in their own right but they're only the first in a number of steps towards building a comprehensive food safety system. three more rules will be finalized by the end of this year. those things produce rule, verification process and an accredited third party certification. the fine of two rules will be issued this spring, sanitary transport and attention adulteration put together these rules for the integrated

holistic network for food safety called for by fisma, all based on the principle of prevention. rules as good a big step, but it is only the first step. right now to exist on paper. the bigger challenge a hideous and limiting those rules and making them exist on the ground. we strongly believe that if we do not implement the new fisma mandated food safety system in the comprehensive way that congress envisioned right from the start, that we will fail to achieve the fisma gold with food safety, strengthen consumer confidence at a level playing field for u.s. producers. align mentioned earlier will not bend as it should and it must go. so i'm very proud of his work and i'm proud of our team. michael taylor alone has been a force of nature when it comes to fsma. so please continue to work with us to achieve the level of funding that we need to accomplish on the ground what is

set in statute and then we'll. american consumers are dependent on us, and expect his publisher colleges and i thank you again for your support of fda and for the opportunity to be a to discuss fsma with you. >> commissioner, thank you very much. let me begin just by asking, you outlined a scenario by which these rules will be announced. what was the basis for their prioritization? is there something about these rules that make them more difficult them easier, more significant to pursue? what do we expect in the future? >> i will just say that they are all imported. the preventive control rules are probably amongst the most important of all of these rules, and they're the ones that are expected to be implement it first.

the process will be the same process for the next promulgation? >> i will that mike answered that the real issue these, the deadlines for these are set by the court. we are obligated to go to meet all of them and we will meet all of them, i can assure you that spent as the commission indicated these rules form a holistic package of standard the congress mandated to bring this comprehensive preventive system. we've been through a dialogue with our stakeholders that will address all of these rules because they have to fit together. we have have a coherent package of regulations. we are at the end of the process in terms of going to the notice and comment, public meetings, dialogues, so now we able to issue the rules in final. so the sequencing has something to do as well with just the

capacity to get rules out the door and give breathing room between rules. so we are on track to get these rolls out on that timeline just as the commission indicated. >> so, mr. chairman, if i might, might can just make a couple comments about the implication plan and that may help put some of this in context. >> well again this is a large public an usher your questions will draw it out in detail, but we are embarking on implementation deeply cognizant of the challenges, hundreds of thousands of facilities, the complexity, the supply chain. but we know we can meet this challenge because we've got climate of stakeholders. we've done the homework, had the dialogue. the thing that would provide is an overview, some of the themes that we are pursuing, undergirding the implementation we think are crucial to success. it's crucial we stick with, the

first is this commitment as we implement to provide clarity to our reach and guidance about the new rules, what they report and to be supporting the industry in achieving what's expected through education, through technical assistance. we've said on any number of occasions we will educate before and while we regulate. we need the. that's the first thing, clarity and support for compliance. the second thing we need to do, thematically as you indicated is fundamentally weak them how we conduct our inspections, how we conduct oversight and compliance activity so that we are targeting our efforts based on risk and actively fostering and supporting voluntary compliance to provide oversight. that historically has been enforcement and reaction oriented come now needs to be prevention. i always need to add the caveat. as much as it won't work with interest, if the count the conditions for consumer been put

-- tousled essential to grab a mandate from congress established a food safety system, and we fundamentally understand that fda cannot possibly ever in this law successfully by its a big enough to work with our state and local partners. and, finally, i think this is crucial, the commitment i think we all need to have to this integrated comprehensive implementation of fsma. this system is a system that does work if we tease out parts or delay part or don't integrated this in a holistic way. the import safety provisions are particularly a crucial part of this overall system of prevention. this is how we will get a level

playing field for u.s. producers. we'll meet the expectation of consumers that the food that is imported is the safest route that is produced here. these are things we hope to come back to and we want our feet held to the fire with respect to pursuing thiscome and to think of we do this we can come as daunting as it may seem with the hundreds of thousands of folks were seeking to bring into new system we think we can do it sticking with these things. thank you, mr. chairman. >> mr. taylor, thank you. commissioner, your charge, particularly this one, what's the explanation, what's the cycle that occurs what you said there are ups and downs. without reductions in increases both. is there a cause and effect you can describe to me why vegas with one particular pathogen? >> -- why vegas spee-1 on the other things i think is quite notable from this particular graph is that for many of these

pathogens that many of the reductions to the reductions being the ones that you see that are lower than one occur during the very early years of implementation of some new food safety activities in the late 1990s. and that really if all that along into the 2000s, for many of these been it's been incredibly flat. i think it's important to recognize that food safety and food borne illness is an incredibly dynamic area. we have new challenges. we have an incredibly diverse food supply. i would venture to say it's much, much more diverse than what we had back in the 1990s when we started keeping some of these statistics increase in the proportion that comes from overseas has grown. this sort of locally grown phenomenon has increased over

that time period and so do a lot of things that are challenging the food safety system. and influencing the occurrence of food borne disease. but i think the bottom line is that as these trends have changed over time we've basically been treading water. it's time that we no longer tread water, that we actually do things that we know will work to make these numbers look different as we go forward. >> edgy believe that's where we will bend the curve? >> i believe that's what we will bend is perfect if you look at some of the major food safety problems with experienced this year, including the most recent one that we have seen with the cucumbers that were imported from mexico, the various provisions that are in fsma are specifically designed to address the challenges that we've seen in all of those outbreaks. and so we should be able to

influence not only outbreaks that are occurring, but more importantly i think that day in and day out sporadic food borne illness which forms the bulk of this particular data. i do also think it's important to say that while we certainly believe that all of the activities encompassed under fsma will work to drive these numbers down, it doesn't absolve consumers having the right thing once this to get into their kitchens. because a lot can happen even if the food as it comes into the kitchen is safe. so it is a comprehensive approach that must be taken to assure that food borne illness doesn't occur. >> let me turn now to senator merkley. >> thank you, mr. chairman. leads because when keynote at the eight strategies taking quote educate before and regulate unquote approach. i note you're currently working guidance documents.

this is very important considering the first two final rules are about 1500 pages, a substantial amount. these guidance documents will be critical for businesses to understand and comply with the new and the need to be timely, the folks in oregon are asking what these doctors will become available, and i'll just give you a chance to enter their question. >> i'm going to turn to the person who is writing them. >> i have a large an able team tackle writing it as we speak. guidance is essential to the success of implementing these rules and we are investing resources in that now. we printed it as we been preparing the rules themselves. one thing i would note in 1500 or so pages, double spaced but the vast majority of those pages our preamble, are themselves guidance and explanation of what the rules mean, how we expect them to be applied. that's the first place folks should go to really get an understanding of what the codified language itself is

intended to mean in practice. that is just the first step in guidance. as you know we are developing a number of guidance documents, some of which are the key foundational ones. so there will be a comprehensive guidance on the human preventive controls rule that will be almost kind of an operators manual for those who are not yet implementing modern preventive controls, like many in the industry are. those were not there yet this will be a very helpful operating type essentially for them making the rules. a similar guide for animal food and some of guidance for both animal food preventive controls spirit let me cut to the chase and say i'm glad it's going to have this guidance. when will folks speedy these guidance is only coming out early to mid next year, well ahead of folks obligations to comply. it will be open for comment.

>> i have heard from constituents into there are concerns that foreign businesses they not be as closely monitored as u.s. businesses and consequent there might be greater bee with some foreign products and from use products. it could put u.s. businesses at an economic disadvantage because of the compliance cost for fsma. in your testimony you state that the can't credibly hold producers to stand in for not doing the same for importers and afford suppliers. i know you're aware of these concerns. this may for the discus when a foreign supplier rule is finalized next month. to the degree you can tell us now, how will the anti-adequate assure the safety of foreign food products and will that be as rigorous as the oversight for u.s. businesses? >> i'm going to allow mike to give you some the details but all i can say is that one of the fundamental tenets of fsma is

that we assure that the safety of foreign sourced food is equivalent to domestically produced food. i think that we have that obligation to create that equity. we know that to certain degrees our tools available to us to be able to do with imported food have been limited. but this rule, this law will not successfully work and less we can assure total equity between food fetis that is produced oves with food that is produced domestically. and one of the critical elements of that is that the importers that are bringing this food into the united states i sure that the procedures that were in place to produce that food are equivalent to the procedures that are in place for food that is produced domestically. let me that might give you some

more detailed. >> congress did provide a multifaceted toolkit for strengthening oversight to the commission referred to a central, the foundational part of that which is best for and support their vacation and requirement so that importers will now for the first time have a food safety responsibilities, accountable to us or knowing their sources of supply and verifying that those foreign suppliers are producing under our standards. that's a paradigm shift if we can implement it well. its combined vote in the design of congress with much more overseas presence by fda. so more for inspections more partnership with foreign governments. more investment in for food safety capacity where that will contribute to food safety here. we think this toolkit, implement it properly, work to provide equal rigor. the question is implication, to make investment needed to carry this out as intended. >> mr. taylor intended. >> mr. taylor can you mention the for inspections and fsma

mandated 600 inspections in 2011 with a doubling of the previous years inspection level for the subsequent five years, which would mean that in fy '2015 we would have about 19,000 foreign inspections. and, in fact, i believe that the department plans to conduct about 1200. 19,000 mandated fsma versus 1200. this lack of foreign inspections is adding to the concern that really different standards are going to be, if you will, practiced in foreign countries because there is not enough inspections to hold them accountable. your thoughts on that? >> you put your finger on a huge challenge, and that is how do we target our resources with the resources we did to do this, implement this law effectively? we've increased our foreign inspections from less than 300 before enactment to the 1200-1400 range currently.

those have been important. they are part of a larger system and so the inspections are not inherently prevented in the sense of the foreign supply their vacation require the district so in terms of the import system we've got to get 88,000 importers up to speed in terms of doing their prevention oriented verification. so that would be a priority for funding that would like to do more for inspections but we also think we can leverage the inspection activities of foreign governments through mechanisms like assistance recognition tool that we've developed where for countries have advanced food safety systems, we want to recognize about and be able to rely can engage in a mutual reliance relationship where we can rely on the inspections and not duplicate the efforts. there are multiple elements of this. one of the major investments with increased funding from congress is to strengthen our foreign offices overseas which again will play a vital role in

us building the relationships with foreign governments, outreach to foreign industry, all those things where we can leverage our limited resources to maximize prevention activities overseas. so we would love to continue to be in dialogue about how we increased the inspection numbers along with these other activities. >> onthe one thing i do have to emphasize though it's about part of the request that we made in fy '16 for the full amount of funding which was 109 million was to be able to assure we could carry out the requirements, especially for foreign produced food. and with a number that is significantly lower than that we will be challenged i think that there's little question of being able to implement the various rules that would be coming out over the coming months in the way that we envisioned that they need to be rolled out. >> i think one of those areas that the funding is impacting is

in fulfilling those foreign offices. vacancy rate right now is 40% of the foreign office are vacant. is not primarily a funding issue or a prioritization issued? >> i will say that -- however actually placing people full-time in these offices is only one of the strategies that we've been using to carry out those responsibilities. so we do cycle in people for short-term assignments to be able to assure that we can carry out the things that we need to do in those locations. >> thank you. >> senator from california, senator feinstein. >> take you very much mr. chairman. i really appreciate the opportunity to talk with you, commissioner, for a few moments. i have long been interested in

this, actually before my colleagues came on, and had tried to be helpful in getting more content inspectors at our border, but that's a long time ago. california as you know is a huge, it is the number one agricultural production state. can you give me any percent for any measurement of salmonella in california produced produce? >> that probably is not a number that i would have off the top of my head. you know, even like extensive time at the cdc, i'm pretty familiar with the system that pages to collect the data, including that data that went into the food network port in which california is one of the participants in the system. and so that our data that are broken out by state for the

various submit sites in terms of the incidents of some of the pathogens that you see on this list. i cannot tell you whether or not it is the only commodity specific basis. >> okay, the latest salmonella for us is the cucumbers imported from mexico. and i gather that 418 illnesses across 30 states. and we've seen the most palaces of any state, 89, thus, 17 hospitalizations, and one death. i'm concerned that you after your centers for disease control reports that the united states has not made progress in reducing the number of foodborne salmonella infections that occur. i was listing and also reading your comments have these new food safety regulations, fsma, that you were finalizing will

prevent outbreaks from this come from happening with specifics. take thank you, as an example. how will you work both at the border in a foreign country with the business or the farm operation in mexico that is producing these crops speak with i will preface my statement by saying that particular outbreak is still under investigation, and so we don't all of the specific details that may have led to it happening. but having said that i think if you think of two of the major outbreaks that we've experienced this year, one of them being the salmonella associated with the cucumbers, and if you much bigger a parasitic pathogens, cyclosporine, that was associated with salon drove but also was imported from mexico, there are some things about the

quality and implementation of measures to prevent problems from occurring in the first place. and that is at the heart of what it is that we are trying to accomplish under the produce rule. and so the produce rule establishes a number of standards that producers overseas come and producers domestically need to adhere to. ..

>> we've known for years what these practices are, and fda's provided guidance, voluntary guidance, but there have been no standards and, thus, no accountability for doing the right thing. what fisma does is create enforceable standards and then, also, verification that these standards are being met. it's that simple, but it's a profound difference from where we've been before when it was incumbent to act on the problem. it's a real game changer, i think, for cucumbers, that kind of example, will make a huge practical difference. >> right. now, i gather produce is about 48% of sal no mel la -- salmonella, and that's under your jurisdiction, and the rest of it, meat, chicken, pork, is under usda, if i understand that correctly? do you coordinate in standards between the two of you, or are

the standards different? >> one of the critical requirements of being successful with fisma is to be able to work closely with a whole variety of partners. and it's not only partners that are at the federal level, but it's also down at the state and local level where a lot of the day in and day out work with farmers occur. and so, yes, it is very important that we work quite closely with usda to insure the success of what we do. >> with produce, for example, i know how serious it can be, and it was from eating not her to -- thoroughly-cooked chicken. so i asked my staff to look into it. now, this is not your jurisdiction, but it's interesting to he that 40% of the ground chicken in markets have salmonella. and i talked to a large chicken grower in my state, and i said

what about this? and he said, well, everybody knows you have to cook chicken to 165 degrees this you eat it. i said, well, i didn't know. [laughter] and i don't think everybody knows. so it raises the question of how these two agencies interact. i really think you have a good thing going in what i read on fisma. and i like very much how you're going about it. i worry very much about particularly chicken because chicken has become such a high item for people in terms of eating. and it doesn't seem to me that we make much progress year-over-year, year after year. but with respect to this, you mentioned cilantro, cucumbers, ice cream, tuna, caramel apples,

and these five outbreaks alone are almost a thousand cases of illness and 12 deaths. do you think there's anything that usda can begin to learn from fisma? do you think it's relevant? >> again, we work very closely with usda, without question. far be it from me to provide advice to them related to things that we ourselves don't regulate. all i can say is that, you know, they too are working quite arduously in putting in place additional strategies to be able to address those products that are under their jurisdiction. and there are a lot of similarities to things that we are doing in fisma to things that usda is doing. you know, because again, you know, from the consumers' perspective, if they end up with salmonella, they end up with salmonella, and they're not so

much interested in exactly what the -- >> that's the point. right, right. and we have two big agencies. one handles the meat products, and one handles the fresh produce products, and i've often wondered is that the best way to do it. i think you're taking action, and i'm very pleased to see that. i'm also concerned about antibiotics in products. and what's been happening in that human stream of consuming products that have antibiotics. could you talk a little bit about that and what your agency is doing? >> sure. as you know, this is also a very important as educate of food safety. and, you know, we have had a multiagency activity in place

called narms that monitors not only the to occurrence of various pathogens in a variety of food products, particularly meat that's sold at the retail level, but also monitors the patterns of antimicrobial resistance. we look at isolates that are are, come from products that we regulate, usda looks at isolates that come from products that they regulate, and cdc also incorporates information from human isolates of those same pathogens so that we can compare those patterns and look at those patterns over time. as you though, we also -- as you know, we also have been working quite hard to be able to address the issue of antimicrobial resistance from food-borne pathogens. that is a whole other large component to their activities,

you know, especially by reducing the use of medically-important antibiotics used in food-producing animals particularly when used for growth promotioning purposes. -- promotion purposes. and so we have put out a number of guidances and rules specifically designed to address reductions in the use of antibiotics for those purposes. this has been a multiyear process to put those rules in place. they, you know, we have done this on a voluntary basis to have all of the marketers of these antibiotics for use in food animals make labeling changes, to remove growth promotion as an indication for the use of these antibiotics. and they have all voluntarily complied. the phase-in period to make those changes in the labels is to start at the end of this

year. and so we would look to see changes start to occur as a result of those practices. and the other very important point of those requirements is to make sure that the use of those antibiotics for other purposes as under the direction of a veterinarian. so both of them, i think, will be very helpful in terms of addressing the problem. >> thank you very much, commissioner. thank you, mr. chairman. >> you're welcome, senator feinstein. thank you very much. just to educate myself in a more general way, let me raise a couple of topics that are a result of the questions and the testimony. one of the things i wanted to ask about is the cause of death. you cite the cdc statistic, the 128,000 hospitalized, 3,000 die related to food-borne illness. is there a breakdown of those deaths or hospitalization related to consumer preparation versus the food was tainted prior to preparation?

do we know be, do we know where the cause lies with the consumer versus the provider? >> it's not a very easy question to answer especially when you're sometimes talking about a relatively long period between the time that the exposure may have occurred and when, certainly, the illness occurs and when the death occurs. having said that, you know, we deal with a whole variety of different pathogens, some of which have, some of which deal with items that are supposed to be cooked. sometimes you're dealing with raw commodities like in the produce space. and so, you know, ultimately in most instances what you want to try to do and i think what fisma is designed to do is to try to keep it from being there in the first place. and i think if you can successfully do that in many of these commodity areas, then you will successfully be be with

able to have an impact in reducing these problems from occurring. >> so there's a reduction that can occur in the likelihood of the problem that reduces the importance of consumer preparation of the food item. >> let he just say without question -- let me just say without question that you never want to send any suggestion that consumers can become lax in the way that they handle their food, because i don't think that we would want to ever send such a message. i think what we do want to do is to be able to enhance consumer confidence that the food that comes into their kitchens does not contain pathogens. >> that was very artful. i'll re-ask my question -- [laughter] which would be there is no way, is there, dr. ostroff, that consumer preparation is not important regardless of what arrives in the consumer's home. >> you said it perfectly. >> thank you. [laughter] you indicate -- well, first of all, i wanted to follow up on senator merkley's point about

imported food versus domestic food. and he was asking for equity and an indication that you had indicated in your testimony that there is an importance to making sure that there's not a economic disadvantage to domestic producers, there's not a double standard, i think, is a way we'd say it in kansas. does that double standard exist today? is there a difference in the nature and the likely hood of food-borne -- likelihood of food-borne illness from imported food versus domestic food? >> since i've been answering most of those questions, i'm going to turn that over to my colleague. >> also under fisma the standards are the same. congress made it very clear in fisma that the same standards are to be applied, the same safety is to be achieved whether foreign or domestic. where there's a different challenge is in the ability to verify that those standards are being met, and we have very different challenges with

imported versus domestic. we can go into facilities, directly hold firms legally accountable. we have a whole set of relationships with states who go into these facilities all the time. we can really cover that. there's no amount of foreign inspection that congress will ever pay for us to do that will provide a comparable level of oversight to inspection overseas, and that's why we've got this multifaceted tool kit of foreign inspection but very much collaborating with foreign governments. the difference is not so much the standards, they're the same standards. the question is how do you verify. and the imports provide a different verification challenge than domestics. >> and, mr. taylor, under fisma the ability to enforce those standards is going to, in large part, rely on the certification of those who are importing food that their providers, the foreign suppliers, are this compliance. >> that's the foundation for the system because the u.s.-based importer is legally directly accountable to us.

we can hold them legally accountable for doing that job properly. so that's where we have the direct legal handle. but then we can go over and, again, inspect foreign facilities. if we see a problem, we can keep that food from coming in, we can work with foreign governments again to foster good practices and to rely on their inspection activity. but, yes, the direct legal accountability for imports in terms of private sector responsibility is on that u.s.-based importer. so that's why that foreign supplier rule and its proper implementation is just so foundational. >> what does that mean the importer is most likely to do to be able to sign that certification? what is that company going to do in a foreign country to make certain that when they attest that standards are being met, that they're actually being met? >> so under the regulation that we've proposed and you'll see coming forward -- and i'm not here announcing the final content of the regulation, but i think the elements are evident from the poems that we've put out in -- proposals that we've put out last year.

again, this is just following the congressional mandate. the importer must have a program, a documented program where they have identified their suppliers, they've come to understand their suppliers' capabilities for food safety, they've approved their suppliers, they though the practices the supplier is undertaking, and they look at records, and they -- and under some circumstances when justified by risk because it's intended to be a risk-based foreign supplier verification program, we would envision the u.s.-based importer doing an audit, actually having an audit conducted of that -- an on-site audit of that foreign producer. so it's having a real program that we can then audit and then, you know, obviously go behind that and sample products going in, go behind that and actually inspect the foreign facility if we choose to. but it's that accountability for the importer that's the new feature that's so crucial. >> the word audit has a different meaning than inspect, is that true?

when they're auditing, that importer is not inspecting. they would not be doing the same thing that an fda inspector would be doing in a foreign country, is that -- >> well, it's different because we're used to going in and looking at facilities and conducting a physical exam of a physical place. the audit term that we're using applies to looking at auditing the program, checking the records, being able to get confidence from examining the records and talking to the importer that they are, in fact, they know what they're doing, and they're doing the right thing. and so in that sense it's an, it's a very records-intensive audit activity that will be at least a major component of insuring this is being done properly. >> mr. taylor, thank you. i have more questions, senator merkley, but maybe a way to accommodate your schedule is to turn now to you, and if you're unable to stay for my final round, i wouldn't be offended. [laughter] >> thank you very much, chairman. i wanted to draw attention to the report that you've all displayed, the 2014 food safety

progress report. for folks who are numerically challenged, you've boiled it down to happy faces, grim faces and very unhappy faces. and the unhappiest of all is the face representing vibrio. and over on the other chart that you've provided, you show that while every other disease has decreased since the 1998 til now time period, there's one disease that has increased in incidence, and that's vibrio. what is the story? what particularly should we know about the challenge this disease represents? >> well, vibrio can also be a significant disease. it comes in a couple of different forms. there are several different pathogens that are encompassed under the label of vibrio, and they are in general associated

with seafood products. we have seen now -- i think it's important to put this context that in terms of the overall numbers, the number of illnesses associated with vibrio was actually quite small. and, certainly, a very small fraction of what we see in the united states from either salmonella or cam who back to have. some of this is associated with actual spread of the vibrio. in some instances it would largely confine to certain areas of the country and because of movements that occur with emerging diseases, it's spread to other areas where it traditionally hasn't been. but it is a trend that we've been seeing particularly along the east coast. >> i was reading an article recently about the ponds where shrimp are farmed on land in asia and where massive amounts of antibiotics are used to control the various diseases that are rampant in those ponds.

is that import of shrimp from these farms one of the factors contributing to the vibrio expansion? >> yeah, i would have to get you specific information about whether or not that's contributing, but by and large to my knowledge host of the vibrio-related illnesses are not associated specifically with imported shrimp. >> okay, thank you. back when we were working on this bill, a young man and his father came out from oregon to testify. the father was a police officer, the son -- when he was 3, his name is jacob hurley -- he had experienced a life-threatening case of salmonella from contaminated peanut butter. and he was one of among more than 700 who were sickened by contaminated peanut products in 2009.

i believe that the company involved in that was a peanut corporation of america. if we look back on that particular well-publicized incident, how would the preventive controls rule that we have just passed have made a potential significant difference this the risk of -- in the risk of that disease? >> so that, that's an unusual case in many respects in part because of the vast scale of the damage that it did and the thousands of products that had to be recalled because this firm was selling not only peanut putter in bulk, but peanut iningredients that went out into thousands of processed foods. it was a catastrophic event for the food system. it also involved intentional conduct by the owner and operator of that facility and the well-publicized subsequent criminal prosecution and conviction. you know, what fisma will do

even in that situation is provide a much stronger basis for inspectors when they go into facilities to not be reliant just on looking around at the facility conditions and pre-fisma with no access to the records of the facility, under fisma we'll have a hutch stronger ability -- much stronger ability as investigators to go into facilities and make assessments of the system and to be able to detect and find records that might actually document positive analytical results such as occurred in this particular case that would reveal a problem that needs to be addressed. so there's always going to be that rare instance where purposeful criminal behavior happens, and there needs to be swift remedies for that. but i think even in these cases, you know, we will be able to be more effective in our investigatory role in assessing systems and whether this sort of practice is going on in facilities and needs to be addressed with, addressed very forcefully. and fisma gives us new rules for addressing that sort of situation forcefully.

if we identified this sort of problem through inspection, under fisma we can actually suspend the registration of that facility and shut the facility down administratively, and that's an important tool in these sorts of extreme cases. >> as you note, there were exceptional circumstances like a rough mold, animal contaminations and so forth kind of egregious behavior of some known, regarding some known problems. but in terms of the inspections you mentioned and the ability to kind of have teeth, that matters. but there's another element of the preventive controls rule. i believe it's in preventive control rules, that involves developing a tracking system for ingredients that go into processed foods. and you just comment on whether you believe that is going to make a difference? >> yeah. so fda has historically since the bioterrorrism act in 2001 was enacted, it's had authority to require firms to hold, to keep records of where their

incoming materials came from and where their finished products have gone. one-up, one-down recordkeeping. fisma adds somewhat to our authority in this area by giving us the authority to set standards for how that firm connects the dots between the incoming and the outgoing. so that'll be a step, and that's a rulemaking that is underway to put that in place. fisma, frankly, puts some constraints on fda in terms of traceability because it precludes us from acquiring a farm to table pedigree or the kind of tracing that is done by ups and fedex. we're precluded from acquiring that sort of use of technology to improve traceability. so from our standpoint, traceability is crucial. it's how we can investigate outbreaks much more expeditiously, get to the cause of problems and solve them. but traceability is going to have to be coming into the modern era fully through public/private collaboration,

finding ways to harness industry innovation with the support of us and dialogue so we can be sure whatever they do helps our investigators as well as the firms themselves. but there's work to be done yet in that area. >> thank you very much, mr. taylor, dr. ostroff, mr. tootle. appreciate it. [laughter] >> the mumbling here is i will not take advantage of senator merkley's absence. [laughter] [inaudible conversations] finish -- i ask unanimous consent as soon as he leaves to -- [laughter] one of the things that i read in your testimony that i want to highlight and ask you to confirm to me how serious you are about this and how confident i can be that it will remain the policy, and that is you indicate the approach to inspection is aimed first at fostering and facilitating compliance rather than finding and penalizing regulatory violations.

that is a policy, in my view, that every regulatory federal agency should adopt. the goal is to make improvements in cooperation with the regulated. and it seems to me and we've had this in other agencies previously in which they seemed to be that was the direction they were going, but over time the joy of penalizing became too great, and the attitude of cooperation disappeared. is there some assurance that you mean what you say in your testimony and that it will last as part of the nature of the food and drug administration as it implements and enforces fisma? >> well, all i can say is that we do believe that the approach that is expressed in fisma which is to work collaboratively with regulated industry -- and when i say "regulated industry," we

mean from the farm to the transport into people's homes -- that we work collaboratively to encourage them and to work with them to do it right. and we know that ultimately doing it right has tremendous impact. that is not to say because, you know, you always have to -- and i'm sure you're quite aware, there's the carrot and the stick. and we know that the carrot is quite an effective way to promote improvements this food safety -- in food safety. but that does not mean we aren't going to use the stick when we need to use the stick. >> if i could just add why i believe this will remain the policy over time regardless of who happens to be sitting in these chairs. partly, we've put it in writing. we've made this commitment to the industry and to the public, and people support this externally. but equally important for your purpose, the people at fda

embrace this wholeheartedly. the people who are at the front line in our agency are public health people. enforcement is a tool, and that's been the culture of the agency given the statute we've had and the framework for food safety which has basically been an enforcement-oriented statute and program. but with fisma, we're now public health at the front line. and people love that. they would much rather be getting good food safety outlines than trying to rack up enforcement numbers. that's just not the fundamental mentality of that cadre of people including the young people coming into the agency, an extraordinarily exciting time for them and for the whole agency. i think the future is here in terms of the culture change that's going on, and we're working to institutionalize that and embed that in the practices of the agency. >> well, wouldn't it be fair -- i recognize when i ask that question, it may sound as if you're trying to take care of business or farmers, but isn't the reality that we end up with a safer food supply system when

this is the attitude? >> well, you know, what we know and you know and if you talk to people in the food business, it's obvious the vast majority want to produce safe food at a personal level, and it's in their business interests to do that. so our whole strategy's based upon that assumption, you know? we need to work with that vast majority who want to comply, support that compliance, verify that it's happening. and for those who aren't complying, you know, we will act swiftly, and we will take whatever action's needed to protect consumers. and in these extreme cases like peanut corporation of america, invoke punitive remedies as a deterrent. but, no, i think working with those whose interest is aligned with ours on food safety is how we could get the best -- >> if i could respond to that before dr. ostroff speaks. in the world i come from in kansas the rumor of food disease or animal-borne diseases causes dramatic consequences to farmers, to ranchers. >> somewhere right. >> it doesn't take an actual

case just the thought something may be wrong. so i'm certainly not opposed to strictly, strongly enforcing penalties and putting bad actors out of business. because they have a huge consequence, certainly, to the consumer and the safety of our food supply, but for those same businessmen and women, those same farmers and ranchers, they can't afford financially to have the rumor, the reality that there's something wrong with what they produce. >> and our strategic interests are fully aligned on that. >> okay. >> i think you're absolutely right. and we know that the ramifications from food-borne outbreaks that occur years ago still, you know, ripple through certain commodities. the other thing that i will say is that the approach that we will be taking under fisma is really a fundamentally significant change to the way that we approach food safety. and it is really critical, because a number of things that are income -- encompassed in the

funding request that we have made to congress is designed to insure that up and down the system we can reorient the work force to be able to implement the things that you were saying in terms of being able to work collaboratively with industry, being able to educate industry and being able to oversee and insure that what they are doing is up to standards. it takes resources. and i don't know any other way to say it. and we do know without question that unless we receive the total amount of the request, that something is going to have to give in some aspect of what

>> let me ask one question related to the animal feed rule and contract farmers. doctor, you indicated, commissioner, you indicated to me that in advance of this hearing that what i was going to hear from the folks out there in that world would be all requests to make sure that congress appropriated sufficient funds to implement fisma. and that you had worked your way through many of the challenges and had a lot of input from stakeholders, as you described. and i appreciate that, and it seems to me that that is in large part the reality. one area that i've heard concern about is the definition of what a farm or farmer is. and you're shaking your head, and so maybe i don't need to describe the issue. is there something afoot that i ought to know about the

direction that you're going? what i have heard, that there is concern from farmers who have no involvement in anything other than raising the livestock, the animal that this will come, that fisma will affect their operations as well when all the processing and everything occurs downstream and, in fact, the feed -- most importantly -- is not grown or provided by them, it's provided by upstream buyers of contract, those they have contracted with. this is an issue that -- have i described it adequately, or you were once smiling, now you're frowning. [laughter] >> well, no, because the specific way that a farm is defined is really critical to certain parts of these rules not only the preventive controls, but also to the produce rule. and so we have worked quite closely with those that will be

impacted by this rule to make sure that we can get it about as right as we possibly can. i will ask mike because i know he has been immersed in this particular issue for the last several years. >> i do know the issue very well. and the fact that there's presumably still some folks who have some concerns just shows there's an exception to every rule. stakeholder support for the rules. but i think that what you're talking about is the situation in which there are vertically integrated poultry operations where a purdue or a tyson will own the chickens, they will manufacture and own the feed, they will provide the contract growers who own the -- >> the growers only grow. >> the growers only grow. the growers, i don't -- if they have a concern that they're affected by this, i haven't heard that, and i do need to hear that. the affected party is the operator of that feed mill that is not being managed on or by a

farm operation. but, rather, by this big vertically-integrated poultry enterprise. that feed mill is subject to the animal feed preventive controls rule. the requirement's very practical and are risk-based and so don't address issues that don't need to be addressed in terms of insuring the safety of animal feed. but those feed mills are subject to preventive controls. if the poultry operator or any farmer, and this is the common practice for poultry, is growing or processing their own feed on their farm, in their feed mill for their animals, that's part of the farm operation and would not be subject to the preventive controls rule. so i'd be happy to engage whoever has the concern and connect them with our center of veterinary medicine and work through whatever the question is. >> you answered the question better than i asked it, and i think that's the assurance that they were hoping to hear. >> okay.

well, again, happy to talk to them if that would help. >> let me talk just a moment about the appropriations process. as i indicated in my opening statement, this will continue to be a priority, certainly of mine and, i think, of this subcommittee. ask and you mentioned specifically the amount of money that the president's budget request and our ability to meet that at this point hasn't occurred, but we worked hard to put more money into fisma implementation as we prioritize within the dollars that we have within our jurisdiction. and if those dollar amounts change, we're interested in reviewing and reprioritizing based upon what the needs are of fda and others to try to make certain we make the right priority decisions. but let me ask a couple of things about how the money has been spent in the past. as i indicated in my opening statement, the number i believe is an 8% increase over the last

phi years for implementation -- five years for implementation of fisma at fda. mr. tootle, am i saying that correctly? >> of course you do. [laughter] >> well, let me ask how that money has been spent in implementation, and how has the, how has it been allocated? is it across food safety inspections, food-borne disease surveillance, detection? how do you, how have you decided how to spend that money over the past five years? and and i'll consult with hi be expert. >> yep. so the total amount that, since 2010 that's been implemented, that's been allocated specifically for fisma, i believe the number is approximately $162 million over that time period. it has been used in a whole variety of ways. but as you probably recognize,

there has been a tremendous effort on our part to be able to appropriately lay the groundwork to get these rules to a place where those rules are both implementable and will work. and that's no mean task. as you know, we have had tremendous numbers of outreach activities to the various stakeholder groups. there have been somewhere in the range of 600 or so meetings that have occurred either public meetings, interactions with regulated industries, various trade associations. as you know, we've walked facilities and farms from one coast to the other. there has been a significant effort to actually do all the writing that it takes to get these rules to the place where they were. as you know, we issued a number of supplemental rules. and so that has heavily

contributed to a lot of the resources that we have used to get to the point where we can actually get to where we are now which is to start implementing. >> in addition, there are a number of programmatic and capacity investments that we've made that i think are very significant as well. some of it includes technical staffing, increasing technical staffing at the agency so we can support the industry, our state partners, our own inspectors as they implement this. this is at the center for food safety and applied nutrition. principally, we've doubled the investment in the states to close to $50 million over the last few years. we've been able with the resources we've got including these increases to meet the fisma mandate for high risk inspections, a frequency mandate, and exceed that and do that earlier than expected. we think that's an important part of getting ourselves in a position to succeed under fisma. and then the import area has

been an area of investment. we've significantly increased the number of inspections, as i mentioned. we've expanded the foreign offices, things we've talked about. so there have been some specific programmatic investment in capacity for ourselves in the states to implement fisma. it's part of an ongoing build-up so we can succeed going forward. >> thank you, mr. taylor. mr. tootle, it's apparently one of those circumstances in which both are right. [laughter] the desired outcome has been achieved. food has increased by 8%, fisma by 4. final, i think this is my final question. is there any opportunities, let me ask that differently, because there has to be. as you implement fisma, are there opportunities for reprioritizing existing spending, that spending is no longer necessary because you're headed down a different path than the nature of the way fda

operated in the past? so where did the -- are there think savings to occur as a result of the implementation of fisma? >> i think, yeah, the commissioner's looking at me, so i will say something. >> [inaudible] >> yeah. i think i'm going to give, yes, that's a no. because i want to try to explain, though, if you lack at the overall funding -- look at the overall funding of the food program, about three-quarters of it pre-disma goes into the field-based activities that relate to food safety, but doing it the old way. what we're talking about is adding, frankly incrementally, to that so we can redeploy all of that resource to doing food safety this the way envisioned by -- >> [inaudible] >> well, i wanted to give credit for the fact that we're not just continuing to do all the old stuff -- >> these the nature of my question. >> yes, sir.

so the answer is we're he deploying. but it doesn't mean we can stop pending the money that's -- spending the money that's needed to support that work force. we have to invest in it so it can work in a much more sophisticated regulatory framework. yeah, so it's redeployment as opposed to adding on resources on top of resources that are still deployed doing the old thing. >> that's what i want to hear, is that -- and since you, dr. ostroff, wanted to answer no, i'll give you the opportunity to say yes. [laughter] isn't the reality, isn't the truth that we can now as we do things differently, you redeploy assets, resources that were directed in the old way of doing business to the new way of doing business? >> yeah. >> so, you know, this is, this is not going to require fewer people to be successful. it's just going to require that those people do -- >> something different. >> -- things differently than the way they've been doing them.

but the people that we need to be successful for fisma will not, you know, we're not going to have people go away. and in point of fact, given the various responsibilities that we have under these rules, that we need every single one of those people to be successful in implementing this. and so from the standpoint of what we've been doing with our field force and what we have been doing with our laboratories, those responsibilities don't disappear under fisma. >> okay. dr. ostroff, thank you for your testimony, mr. taylor, thank you for being here, mr. tootle. anything you'd like to make certain is included in the record before we close this hearing? >> well, i will just close by saying i'm the eternal optimist, and, you know, we -- the request that we made for this fiscal year for fisma impleat