the comments have been made a couple of times that we can -- cantons buy their way to safety and that may be true but rican not inspect our way to food danger which i think has been unfortunately the hallmark of what has happened in recent past and so this bill, it will put some as marcuses on monetary and an inspection on the front end which is going to make a tremendous difference. when you look at the provisions that are contained in this proposed legislation so many of them go under the heading of no-brainers. another risk these are things that the average citizen and would imagine are already in place and i think would be surprised to learn are not emplace so there is so much about this bill that represents the pent-up needs and concerns

of the american public that we need to address. on the economics and there has been a fair amount of discussion about that already testing the opening statements, the battery to on the front end, of course, with monitoring and inspection of the less cost we're going to have on the back end a both in terms of fda meeting to scramble to deal with outbreaks of foodborne illness, but also the save costs of businesses not having to do with the effects of that and i think that those save costs will form of away the investment that we put an end on the front end and certainly justify many of the measures contained in this bill. so we look forward to your testimony, unwelcome and good luck to you. i yield back my time. >> gentleman from connecticut, mr. murphy. >> thank you mr. chairman, i look forward to dr. hamburg testimony and members of the

other panels. what we're talking is setting very high but reasonable expectations for what we can do it out of the fda and i think if that is our goal we can get a product that both parties can be proud of it. as of the former chair of connecticut's public health committee i speak for a lot of state policy makers in a feeling of helplessness over the past 5210 years especially and i thank you are going to find in this committee will find a lot of allyson in state public health networks and they're going to be very supportive of this transformation you are under going to try to assist in their efforts which have been difficult over the past several years. leslie mr. chairman i am appreciative to you and mr. dingell and others for including in this bill several aspects of the work that my colleague in connecticut's chairwoman of the agricultural subcommittee of the appropriations committee rose

said the lore has been working on this issue. parts of this bill relative to inspection frequency for the riskiest foods out there, enforceable standards for foodborne pathogens, are parts of her efforts inc. in the underlying bill and i appreciate you paying attention to her work here as well. i look forward to your testimony, thank you for being here. >> thank you, the gentlewoman from california, ms. castor. >> thank you mr. chairman and kudos as well to rosa delauro and chairman stupak and john dingell who have worked for many years to improve food safety in america and welcome to dr. hamburg, based upon your background obviously you enjoy a challenge. the food safety is an important challenge for our country. of all the issues we deal with in this subcommittee food is the most ubiquitous and relevant to all americans.

i want to remind my colleagues that the government accountability office remember keeps him that a very short list of major tenant problems that require brawn transformation before they can ever hope to be effective. the list all of a high risk series includes notorious government failures such as the financial regulatory system which failed to prevent the largest financial collapse in generations, it includes the implementation of a home and security department which has been played from the beginning by cost overruns, and no surprise and also includes the federal oversight of food safety. and here's an example from last year that really hurt in my home state of florida. tomatoes last year from florida were blamed for a nationwide salmonella outbreak that was eventually traced to jalapeno and serrano peppers from mexico.

in the meantime fda intimated at the time not to consume florida tomatoes and that cost our estate and agricultural producers and hardware consultants over $100 million, all of the time and effort spent tinting and suggesting that florida tomatoes or the problem only serve to delay the solution to the real problem and allow more to get sick. our committee understands the problems this committee has held several hearings ended understand that we must act expeditiously. part of the problem lies in the lack of federal authority to effectively respond to a crisis. when fda does not have incontrovertible proof of a specific food contamination, is cannot today into a mandatory recall. instead it must rely on corporations and voluntarily choose to paul inventory from the shelves.

the fda does not even have the ability to assess civil penalties. this legislation before us gives the fda that long overdue enforcement authority. the problems facing food safety and oversight are legion and there are difficult, but they are not insurmountable and i'm confident that we will move the food safety enhancement act of 2009 quickly and provide american consumers with a safe, transparent, and reliable food supply. i yield back my time. >> thank you. gentleman from california, ms. eshoo. >> thank you mr. chairman for having this import hearing on the food safety enhancement act of 2009 and i want to a stand of the warmest welcome and congratulations to dr. hamburg. she is a woman of exceptional talent, high intellect, a person

with a great character and someone that has given much to our country already in comes from one of the most outstanding families i think in our country. you can tell how elated i'm that the president chose so wisely and appointing you as fda commissioner and we all look for to working with you to the extent that to succeed, the country is going to succeed. i also think that you're tenure can be and will be the market where the fda returns to being the gold standard in terms of the public agency. the american people believe in the fda, they wanted to succeed because what you do, they can't do from themselves and the decisions that are taken candid the difference between life and

death. that's how profound the decisions are. so i can tell you how thrilled i am that you are the one. i am pleased that the legislation we are considering is going to improve the traceability of food because when tainted food is discovered it is critical that we know where it has come from, where it has gone and what stores in this old man. if sales are limited to a certain area targeted recall could take place which would be more attractive for consumers and businesses and i am also pleased to see that the mandatory country of origin labeling for food is included in the bill. i think in today's environment this is really essential information for consumers to know where their food comes from. this is a long and complex bill and i to along with my colleague, mr. murphy from connecticut, want to salute those who have worked on this

issue. rosa delauro has been tireless and to know that she brings passion and intellect to what she does and so some of the ideas from her legislation our embedded in this. i look forward to our conversation. i hope that what we are asking the fda that you are up to it, i thank you have lived on fees for a long time and i still have questions i like to know directly from you whether he really think you're going to have the resources that are necessary to do this. because if you don't, then and the printing of the legislation or law will be wonderful to revive some constitutions around the world that are absolutely magnificent but they're not worth the paper they're written on. we have fallen off the edge of a cliff in terms of what's coming into the country and what's happened to the american people. we have to get this right this

time. some think that there should be a stand-alone for inspection agency. can the fda actually do all of this? do you have the resources for it? i mean, if there is pizza that has pepperoni on a curse is pizza that doesn't have any meat on it should there be a split jurisdiction between agriculture and the fda in terms of inspection? i think the more splits there are the more of an opportunity for things to fall through the crack. i may be entirely wrong, but i still have some questions. i don't think this is a perfect piece of legislation but i'm glad we're considering the issue. so i wish to nothing but the best. i have great confidence and respect for you and i'm very proud that the president chose to pick the best in the country for this job. a thank-you.

>> ping kia. gentlewoman from illinois, this schakowsky. >> thank-you, mr. chairman, and congratulations, dr. hamburg. in -- i come to this issue within lot of history and also this particular issue with a lot of emotion. and my good friend, nancy donnelly, whose only child, alex, was lost because of the eating hamburger with e. coli and then dedicated her life to creating an organization -- safe tables our priority -- has sort tirelessly for food safety. year after year, we have people coming before us telling these devastating story is end every time we say we're going to do something it never happens again

and yet it does. in february we heard testimony from peter hurley whose young son was made ill by eating austin peanut butter crackers that were found in millions of homes. and we're all shocked by documents presented at that hearing that showed that the pca knew that their products were tainted and yet released them into the food supply anyway. as of the discussion draft that is before us includes provisions that will seriously avila the many gaps in our current food system. i wanted to just mention a couple of things that i think ought to be considered for review. if there is just a brief mention in the bill dealing with issue of antibiotic resistance pathogens and the extent to which antibiotics are used in

livestock could tibbets to this resistance. i don't necessarily always think about this as food safety, but i think it is it true import issue. i know a to one and one was a virus but everyone is waiting for that kind of plague that we don't have the cure for partly because of antibiotic resistance. second i believe that companies to have a positive test results for a possibly dangerous contaminants should be required to report of those results to the fda. we heard how pca, nobody knew about it and i think there are many other examples. it's a question of how the fda effectively can insure the safety of our food if we don't even know where there might be a problem. and finally, i believe that collecting and disseminating information about food safety and foodborne ellis to consumers is a critical component of any

food safety plan. i'm encouraged by the provisions of the bill but i think there may be more that we can do to assure that americans are adequately informed. thank you so much. >> thank-you and i believe that completes our members opening statement. so we will now turn to our witness. let me say, dr. hamburg, i appreciate your being here and i want to welcome new. we have as you know five minute opening statements to become part of the record and you may get questions afterwards from members of the committee so they give and if he would begin. >> chairman pallone and members of the subcommittee, and i am a dr. hamburg commissioner of the food and drug administration. thank you for the opportunity to appear before you today to discuss the urgent need for reform of our nation's food safety system. i commend to chairman waxman,

chairman stupak, chairman emeritus dingell and others and your staffs for the interception hard work in developing this draft legislation. the food safety bill under consideration represent significant reforms needed to modernize our food safety system. i am honored to have been chosen by president obama to lead to this great agency and i am inspired by the president's personal commitment to improving food safety including that progress being made by his food safety working group. the president has backed up his commitment with resources proposing historic increases in funding for its fda's food safety efforts. i also appreciate the support of secretary kathleen sibelius and the department of health and human services and a secretary tom vilsak in the u.s. to permit of agriculture for a major progress on food safety. in addition, a coalition of consumer groups is fighting for

improvement in the food safety system so that more families to not have to suffer tragic consequences from foodborne disease. major sectors in the food industry also supports an avid coating for fundamental change. but even with all of this support and momentum our efforts will fall short unless congressç modernizes food safety laws to deal with the challenges of the 21st century. that's why this hearing is so important. but the perspective of fda, there are three key questions to ask about food safety legislation -- first, does of the legislation supports a new system focus on prevention. second, does the legislation provide fda the legal tools necessary to match its existing and new food safety responsibilities. and third, does the legislation provide or anticipate resources for the agency to match

responsibilities. to comment on a discussion draft levee address these issues intern. for the first, does the legislation support a new food safety system focus on prevention? the draft legislation would, indeed, transform our nation's approach to food safety from responding to outbreaks to preventing them. it would do so by requiring and then holding companies accountable for understanding the risks to the food supply under their control and implementing effective measures to prevent contamination does the legislation provide fda the legal tools necessary to match its existing and new responsibilities? in a new food safety system, fda has but one of the responsibility of overseeing and verifying the implementation of preventive measures by hundreds of thousands of companies. agency also retains the existing

critical role of protecting the public during an outbreak. fda needs new legal authorities to be able to succeed in these roles and protect the public health. this legislation would provide this critical tools. it my written testimony provide several examples but i would like to highlight one of the most important new authority is now -- section 106 provides fda with explicit authority to act as with records during routine inspections thereby addressing one of the most significant gaps in its beef existing authority. the authority provided in this provision is essential to enable fda to identify problems and require correction before people become ill. it also enables a agency to verify during a routine inspections that firms are maintaining proper distribution records. records access and record-keeping by all persons in the distribution chain and a key mechanisms of providing

regulators with information on plant operations, product safety and product distribution. such information is necessary to verify compliance and to identify problems. lastly, does of the legislation provide or anticipate resources for the agency to match existing and new responsibilities? the draft legislation that makes and imports investment in the resources needed for major progress. after all, fda must have the resources necessary to meet his responsibilities otherwise the public will not benefit from a promise of a modern food safety system and the agency will fail to meet the expectations of the president, congress and the public. the bill authorizes three fees requested in the president's fiscal year 2010 budget -- one of these is in section 101 providing for registration fees. this fee is of critical importance to enable the agency to improve and expand its food

safety activities including to increase its inspection coverage of the approximately 370,000 registered facilities and to enhance its other food safety activities. section one of five it proposes a rigorous inspection schedule for facilities, requirements start 18 months after the enactment. to meet these requirements section one of five allows the agency to use inspections conducted by inspectors recognized state, local -- other federal agencies and foreign government officials. fda apply to raise three issues about section 105. first, the amount of resources required to achieve these inspection goals would far exceed even the historic increases in the president's fiscal year 2010 budget. moreover, it would be difficult if not impossible for fda to

hire and train thousands of additional staff so quickly even while relying on inspections by state, local and other federal and foreign government officials. as a result fda encourages the committee to modify this action to take into account the operational and resource challenges involved. second, as we develop a new food safety system, fda will came better information to guide the agency's approach to inspection and oversight. it will understand where we must as bator frequently because of a higher risk of certain foods, facilities and processing is, and understand where we can protect public health without conducting inspections has frequently. as a result, fda was support flexibility to modify the inspection requirements based on the best available data on risk. third, section 105 could do more to provide flexibility to fda in meeting the inspection

challenge. the draft legislation allows the agency to rely on inspections by other agencies as well as state, local and foreign governments. an additional promising mechanism for international inspections is certification by accredited third parties. fda would like this flexibility to explore the use of accreditation system and on a performance of accredited third parties. with strong standards and robust oversight piatt fda, this approach could help address of the oversight challenge posed by the more than 220,000 registered foreign facilities exporting to the u.s.. this is an historic moment for food safety in the u.s., and moment for a fda and its sister agencies in the federal government to rise to the challenge of the 21st century. success means fewer hospitalizations and deaths,

fewer devastating recalls, and greater health to the american people. the draft legislation is a major step in the right direction. i commend the committee for its leadership and on behalf of the hundreds of dedicated staff devoted to food safety as fda, i look toward to assisting with the legislative process. i welcome any questions you may have. >> thank you dr. hamburg. we will have a series of questions now from the members' committee to them as five minutes and i'll start with myself. under the bill, all facilities both domestic and foreign seeking a market in the u.s. must register each. provide certain information about the facility to the fda, it is not registered it's illegal to market food from that facility in the u.s. and in order to register each facility would be required to pay a thousand dollars per year as registration page. my understanding is there was in 2002 bioterrorism legislation and under that legislation food

facilities were required to register eight -- but there was no requirement to update that registration so my questions reference to that registration under the 2002 bill. has that system result in problems of the fda's accounting for facilities selling food in the u.s. and maybe you can tell us what problems exist and on the second part is do you believe that linking a fee to the requirement to register would help address whenever problems exist under this system that dates back to that 2002 bioterrorism legislation? >> thank you. i think it is clear based on the experience since the bioterrorism act in 2002 that we do need it extended authorities that would be offered in this bill. we know that when a facility register's once but doesn't have to register again, that it does create problems in terms of our ability to fully understand the

nature of the food related activities in that facility. this before is one good example, when the first registered a they were actually making peanut butter and then they added that to their activities with an all registration, we would have a much better record an understanding of the activities and would provide us with the tools to be more responsible in our oversight and in our inspections. with respect to the issue of these, i think it's a very important component of any food safety plan that congress would enact. we absolutely need to have the resources to do our job. i understand that these represent a burden on companies and i wish that we were not dependent on that mechanism in

all cases, but i do think that that fi is an investment in a robust and effective food safety system. the fees will go to enable the fda to provide a certain specific services and put in place the broad and modernized food safety system that american consumers expect any. >> now let me go back to this fi because of the president's budget, he asked $75 million and registration reinspection fees so obviously the administration has shown support for the concept of a registration fee for food facilities in the budget. however in our bill with thousand dollars per facility fee, we would generate much more than the 75 million tons in the president's budget so i wanted you to explain if you could what was contemplated in the

president's budget request of the 75 million -- at the bessie to request the new authority to provide in this bill -- to that seat to request? >> the president's budget request was, of course, put together before the specifics of this proposed legislation was put forward so it wasn't addressing all of the specific requirements laid out in this bill. apparently including the inspection schedule. in my written testimony there is an appendix that actually lays out some of the food safety highlights in the president's bill and some of the targeted areas for that $75 million increase in the budget. it was to include the many elements that are a part of this legislation coming increase inspections by not to the degree this legislation would call for. the implementation of preventive controls. strength in laboratory testing.

a stronger integration of the fda and federal food safety efforts with the state and local activities which is ultimately a very essential. >> i know that the bill allows these views to be applied toward a broader array of that fda's food safety activities and allows them to be used to boost fda's ability to develop standards like performance standards and preventive controls. do you believe they should be applied for these activities that we mentioned in the bill? >> i think we want airbus comprehensive program and those fees should be applied to betting in place -- putting in place, the -- and they are directly related to what companies must do under the new legislation and i think it is very appropriate in that the fees cover that aspect. for example of the inspections

obviously are directly related, very important that they cover that aspect. and many other aspects of the portfolio of activities outlined in the legislation really are essential two what needs to be done to protect consumers and ultimately to protect the food industry so that the public and consumers can be assured that the products are safe. >> thank you, thank you very much. mr. deal here and i am sorry, mr. whitfield. >> thank you, mr. diehl had to leave the. dr. hamburg, as you probably know, senator kennedy and senator durbin have introduced a food safety bill on the senate side and has a the administration and doors to that bill or hasn't endorsed this bill or endorsed any