the meeting of the subcommittee is called to order and today we are meeting to review the food safety enhancement act of two thousand and nine discussion draft will recognize myself for an opening statement of original initially this draft discussion or this discussion draft was released by chairman waxman chairman emeritus dingell chairman stupak representative to get represent a sudden myself early last week and the draft bills on several bills already hearings on this topic in the last two years the information we learned during these hearings as well as during the numerous conversations we've had with stakeholder groups in the f d a has been incorporated into the draft before us today and i believe this traffic bill represents a strong well thought out approach to improving the f d a and its food safety activities we've heard time and again that our current food safety system is broken it's a system that relies heavily on the f d a rather than placing the responsibility on the manufacturers to ensure the safety of their products it's a system that is geared towards responding to food outbreaks rather than one that is aimed at preventing them and this system does not work and recent outbreaks of e coli in spinach and salmonella in peppers and peanut butter highlight that fact unfortunately these are not isolated instances each year seventy six million americans get sick due to unsay food products every year three hundred twenty five thousand individuals will be hospitalized and five thousand will die from food borne hazards it's estimated that the medical costs and lost productivity due to food borne diseases cost us forty four billion dollars annually and these illnesses are completely preventable the good news is that there seems to be agreement that something must be done then it might and that it must be done quickly the president has made food safety one of his priorities he's assembled a food safety working group to come up with principles on this issue chairman  mistress two pac and i have worked closely with key stakeholders on this discussion draft and as we move forward with the legislation we hope to continue those conversations as well as conversations with our conor parts on this committee the bill we're discussing today will modernize the food safety laws currently in place it places a strong emphasis on prevention and shift the responsibility for food safety on to those who actually make the food it also product for vides the f d a with the necessary resources and in force when authorities to ensure that all companies are in compliance with the new requirements this draft bill would require all food manufacturing companies to register annually with the f d a so that the agency has an up to date list of all facilities who sell products in the united  focuses on prevention by requiring companies to conduct a thorough hazard and risk analysis of the products that they're making it mandates that companies put in place preventive controls to mitigate and minimize those identified hazards and it requires companies to document all the steps they've taken to implement and verify the controls to ensure there effectively minimizing hazards the bill also addresses the shortfalls of our current traceback system by requiring the f d a to establish record keeping system that manufactures would be required to use this measure will allow the agency to quickly trace the source of an outbreak back to its origin and prevent and minimize the number of individuals affected by a food borne illness while shifting responsibility for food safety on to the manufacturers the draft also recognizes a crucial role the f d a needs to play in this realm this traffic was the agency to set standards for food safety and hold the food food industry accountable for meeting those standards it provides the f d a with stronger enforcement authorities such as recall authority and access to records the bill also increases the inspection frequency for food facilities requiring that the f d a inspect the syllabi at an established minimum frequency now we're going to hear today from industry experts about the various provisions in this discussion draft and i look forward to those conversations i hope that we can all continue to work in this collaborative manner as we move move to markup of who safety legislation in this committee i'm very pleased to to welcome dr margaret hamburg of the f d a today see we had a meeting last week while we were doing the energy markup we were in the back having some conversations and i was very impressed with her this is the first time should be testifying before this committee and i thank you for being here i also want to thank our other witnesses for appearing before us today i specially want to welcome back mike ambrosio he's of course from my home state good to see you again mike and i'm now recognize mr deal for an opening statement thank you chairman flown in for holding this hearing today and thanks to our distinguished witnesses who have joined us to review this draft of the food safety and has been act e two thousand and nine look forward to your testimony and to the questions that this panel that our committee will actually have of the panels as a resident of the state of georgia which has already received a focal point focus of the issue of food safety i know firsthand the perspective that our nation has on the issue of the lack of safeguards and fallback measures that many people expect of the twenty first century food supply chain in our country we all agree food safety is a priority and i support giving f d a the resources it needs to ensure our nation's food supply remain safe and reliable for american dinner tables across the country additionally implementation of preventive controls such as hazard analysis and critical point plan included in the draft under discussion is an important step forward in ensuring unsafe food products don't reach store shelves in the first place as we know preventing compromised goods from entering the market is the best line of defense to preventing food related illnesses alsa believe it's important to enhance f d a is ability to conduct own side inspections of food facilities the inspection schedule established under the draft does recognize risk profiles for food in terms of how frequently facilities should be in space but the regimen set forth in the discussion draft fails to address the cost benefit factor of conducting such frequent inspections and could possibly result in insufficient oversight of certain higher risk facilities due to time and manpower limitations of our inspectors it is my hope that our witnesses here today can provide input with regard to an appropriate inspection schedule which achieves the goal of ensuring safety for the american people without placing an undue burden and strain on the f d a which is already a challenge on the current food safety obligations this legislation authorizes an annual pay to play registration fee for domestic and foreign food facilities of a thousand dollars to supplement appropriations made by congress the f d a in discussion hour but we've not been able to determine from the majority from the majority or the f exactly how much funding is necessary to meet the requirements of this bill i believe it would be premature to impose significant the zone industry and in turn the american consumers without any reference as to how much funding is actually needed if the majority remains internally imposing such registration fees we must also be certain these fees are limited to cover the activities which are such as a minimal fee paid to the f d a for an application to cover the cost of review and processing if the goal is to improve food safety we must ensure that funds are not funneled into other activities that may or may not have anything to do with improving food safety a situation which i believe could occur under the language of the current proposal obviously these are issues among many others that i feel hopefully this committee will be able to address as we move this issue for word and i look forward to the hearing today and the results that come out of it apre shape chairman alone and is bipartisan efforts on this issue and look forward to having a product that all the members of this committee in support and thank you very mr chairman for the time thank you mr deal mr  very much mr chairman this subcommittee and our full committee is beginning the process today of passing critically important legislation designed to reach revamp our nation's food safety system the food safety it has from an act of two thousand and nine and this hearing marks a key milestone over the past few years a series of food borne disease outbreaks and spinach peanuts and peppers just today i'm a few have laid bare some major gaps in our antiquated food safety laws oversight work by g a o and by our own oversight committee has also helped us understand where we need to focus our efforts to bring our food safety laws into the twenty first century the draft legislation that is the subject of today's hearing is based on the f d a globalization act of two thousand and nine introduced by chairman emeritus dingell chairman  and i commend them for their work on that bill and their continued efforts in shaping this new bill i also want to recognize these just since we've received from the obama administration we work closely with the f d a to identify problems with the current food safety law and to find workable solutions we will not be passing legislation that sets up the agency to fail the bill requires that the agency set tough standards but we've given them the flexibility to prioritize and address the most important risks first the draft also incorporates helpful suggestions from ranking members barton and deal and representative shimkus i believe we can reach a bipartisan agreement and look forward to continuing to work with all the members of this committee in working with the f d a on this legislation one thing was abundantly clear the administration is absolutely committed to overhauling f d a s food safety program i think wills all see that commitment today when we hear from commissioner hamburg the recent food outbreaks have exposed glaring holes in f d a s basic food safety authorities f d a does not have routine access to any records kept by the food manufacturers f d a cannot require companies to conduct a recall of unsafe foods the agency can only ask and hope that the company complies f d a also lacks basic modern enforcement tools like administrative civil monetary penalties the food safety it has from an act will give f d a these and other critical of stories one of the most important changes that will occur under this bill is a focus on prevention the legislation does not anticipate that f d a alone will protect us from on safe food the hallmark of any effective food safety law must be a shared responsibility for food safety oversight between f d a and industry the act will strike the right balance in this shared responsibility the bill requiring manufacturers to implement preventive systems to stop outbreaks before they occur and will give the f d a the tools it needs to hold them accountable if they fail under the bill that v a will also have clear authority to issue and require manufacturers to meet strong in forcible performance standards to ensure the safety of various types of food i commend many of those in industry for recognizing the importance of this prevention model and coming to the table to support it let me turn briefly to one of the vote contentious issues in the bill the registration fees i wish we did not have to resort to industry fees to supplement funding for f d a as work however when it comes to f d a food program that shortfall in revenues is extreme the f d a his own science board told us that the f d a is so starved for resources that american lives are at risk we cannot realistically expect appropriations alone to provide sufficient resources to close that gap the recent outbreaks have also taken a major toll major toll on the food industry in the recent peanut outbreak kellog kellogg's alone lost seventy million dollars faced with such a dire situation i think it's reasonable to ask the food industry to chip in a rob robust food safety oversight system will provide a great benefit to industry by preventing future outbreaks and rebuilding consumer confidence let me be clear we are not asking industry to cover the entire cost of the bill or any single part of the bill like the cost of inspections the bill establishes a set fee of one thousand dollars per year per facility f d a is prohibited from increasing that fee in future years except to cover the cost of inflation since bill simply asked industry to chip in its fair share i also want to address another concern i've heard the presence of f d a on farms f d a has always had the authority of foods on farms and they've generally relied  and local authorities for food safety oversight on farms because they have a strong on foreign presence i'm confident the farmers have nothing to fear from this bill the bill calls for f d a to set its standards of regulation which a will go through a public notice and comment process our committee is in the is busy in the middle of three of this three month period last month we passed a comprehensive energy and climate change legislation soon we'll take up health care reform but food safety is so critical that i've carved out time right in between to pass this legislation over the next few weeks to work with all our committee members democratic and republican with the f d a with the affected industries to achieve a consensus on a food safety bill that we can pass out of committee we can't afford to wait any longer i look forward to hearing from our witnesses today thank  waxman the gentleman from kentucky mr whitfield well thank you mr chairman and we appreciate your having this hearing on this very important issue today we all recognize that f d a has many very important responsibilities and we've known through hearings for the last number of years that the resources available are always in question but we recognize also that there's a definite need for reform of f d a and and we're delighted that dr hamburg is here with us today to provide testimony and the other panel of witnesses as well and we look forward to working with the majority on this important legislation and having said that we do have some significant concerns about some provisions in this legislation particularly the risk based inspection portion particularly that relating to the low risk facilities also the traceability provisions that i understand for example would apply to every convenience store in the country in addition to that the recall provisions  this legislation the country of origin provisions particularly as it relates to the website requirements and then also of course the ability the power that we give the f and other instruments to obtain company records i think we need to look at those provisions much more closely but obviously this isn't orden piece of legislation we look forward to working with you and listening to the testimony of our witnesses today thank you thank you next is our chairman emeritus mr dingell and thank you for all you've done on this legislation mr chairman thank and thank you for holding today's legislative hearing on the food safety and hence next of two thousand and nine discussion draft we've worked together you and i with chairman stu pac and others over the years and i'm delighted to say that this have joined us in our work on this bill we're about to try and fund an agency which is hollow which does not have either the personnel or the revenue or the money or the resources what it needs to do its job and we're about for the first time since one thousand nine hundred sixty two when i was young member of this body to try and see to it that it gets its authorities updated today to deal with the real problems in the world of trade and in the world marketplace i'm pleased that we're taking the necessary steps to advance this legislation and address the important issue of food safety i'm hopeful that we will shortly be doing something with regard to pharmaceuticals i want to thank the witnesses who have joined us today and look forward to hearing their testimony and dr hamburg welcome to the committee congratulations on your confirmation i was encouraged by the administration's early recognition that food safety is a problem that needs to be addressed the administration food safety working group is a signal to how serious the president considers this issue and i want to thank you for the way that you and your staff have provided timely and full technical advice on the legislation i want to note that i'm hearing complaints from folks about the thing about the fi system i want to make a note that the only part of food drug that seems to be working is that which functions under produce and which has just is getting protection or the american consumers are receiving necessary safety in one hundred thirty eight the congress comprehensively addressed the issue of food safety seventy years later food  is still trying to protect a larger increasingly global supply with outdated statutes and inadequate resources as a result the american consumer confidence in the nation's food supply in the food and drug administration and quite frankly in this body the congress has declined an american consumers are being forced to pay a heavy price not only with recall after recall but also the fact that people are being sickened and killed by unsafe foods and also by pharmaceuticals and again i wish to hope that we will commence work on pharmaceuticals as soon as this year is a this business is attended to the food and has been x is a measured and effective response to the dire situation we're faced with today regarding food safety mr chairman the legislation is based on a bill you chairman stupak and i have introduced earlier this year and also on a bill that was introduced by me during the past during the past congress it includes good technical advice from f d a and valued input from the minority and other stakeholders and i want to make clear that i'm working with the minority try and resolve their concerns and that we are also working with the industry and i want to thank my friends in the industry for the goodwill which they have shown in working with us and i also want to thank chairman waxman for his leadership on this point i look forward to continued deliberations in the hope of producing speedily a bipartisan piece of legislation that will pass the committee and the house as i've indicated both in a correct and a speedy fashion amongst other things this bill will prevent safety problems before they occur it require manufacturers to implement food safety plans and that identified protect against foods food hazards it will see that food and drug has the authority to see to it that good manufacturing practices are here to here in the united states and elsewhere especially in places like china which is in fact the wild west in this particular matter it will advance t fire the science of food safety increases specs frequency of food facilities something which can happen more often on dog food manufacturers under the jurisdiction of the department of agriculture then it happens with regard to manufacturers who manufacture food products for the safety of our people it will enhance f d a as ability to trace the origin of tainted food in the event of an outbreak of or food borne illness and should be noted that the food and drug administration and the industry are totally incapable of providing speedy service in this particular it will enhance the safety of imported food f d a will be allowed to require that certain foods be certified as  safety standards and again to trace but also through drug we'll be able to finally get enough people at the doors of this country to see to it that that safety is properly enforced and the good manufacture practices are here to around the world for the protection of our people it will provide strong enforcement tools including mandatory food recall authority stronger criminal and civil penalties for bad actors subpoena authority and it will increase and strengthen food and drugs detention authority finally and i would argue more importantly the legislation addresses the very important question of resources the agency we will give the agency this already as it needs it we would do them a grave disservice if we did not give them the resources they need the legislation includes registration fee which will fund food safety activities at f d a the revenue from this be coupled with additional appropriations which we hope we can get out of those preparations committed the office of management budget well ensure that food and drug can do its job for those who argue there's no benefit for the industry to pay for safety activities at food and drugs are for the following us peanut industry could lose a billion dollars this year because the outbreak of salmonella that forced the biggest food recall in history that has just been ripped replicated by other recalls in the food industry tomato industry lost one hundred million dollars in sales during the two thousand it outbreak that ultimately was attributed to helping your peppers spinach growers took a two hundred million dollar hit to their industry during a two thousand and six bag spanish recall and let's not forget that wonderful chilean grape scare of one nine hundred eighty nine which food drug had neither the authority nor the competence to address as ask unanimous consent to revise and extend my remarks i have a few other things i'd like to say that i know  appreciate his comments about there being some discussions i do have to admit the discussions that we've had when we point out a point that is correct there except when there is a debatable point mr chairman there's a not seem to be any movement in compromise so i would encourage more discussions on some of these issues if we really want this to be a a bipartisan bill you know the other thing i have trouble with is draft hearings if we're going to have a legislative hearing let's have the legislation this is a draft legislation and if we had a great draft legislation hearing on climate change and then when the bill came before us that had three hundred additional pages in it and there's fear on our part that  this is a sneaky way to say we had a legislative hearing but you really don't have a legislation hearing if you don't have the legislation before you this is the democratic majority operandi we claim a crisis only government can be the savior government must get bigger and the middle class pays and that's the issue here and i was on on i in the last congress with bart stupak readily accepting the premise that we have to get inspectors into these facilities and we are ready to address an issue that thoughtful and respectful pays for the inspectors in facilities where they're not going into and it's not like we haven't done anything congress last congress approximately fifty seven million from the supplemental went to food safety the house passed a two thousand omnibus appropriated additional three hundred twenty five million for the f d a with one hundred forty million of the three hundred twenty five million would go for food safety programs in the president's two thousand and ten budget he included one billion a day no dollars to f d a for food safety so there there is a huge commitment already for massive federal funds to go to food safety now we have as our concern a i bill a draft that has much three hundred twenty five million for no explanation no earmarking no direction and that's where a lot of our questions will be today is why that amount what justifies that amount how are we going to sure that it's not going to be used for other purposes and the like so i would ask the leadership  after her not only here but up in the oversight subcommittee and during that time i have been continually talking to my good friends on the minority side because i want you to be aboard this should not be a partisan issue and when we go to the next step in this process i was sure the gentleman that most of the changes that will be made will be changes that will be made as a result of discussions with my friends of the  chairman next is the gentlewoman from colorado miss to get thank you mr chairman mr chairman this is the first step towards realizing a long held dream not just by me and other members of this committee but by the millions of americans who have been concerned about the safety of our food especially in light of the cascading litany of food borne illnesses that we've heard about from other members of this committee we've had a dozen oversight hearings and also legislative hearings we've had bills dropped by many members of congress for many years and i'm so excited under your leadership in the leadership of chairman  verge of enacting comprehensive food safety legislation the most important thing about this bill is it would be a definitive statement by this committee and this congress that food safety is a priority in the united states of america i want to highlight two of the sections of this bill and i want to thank you and mr dingell and others and mr stupak for including the provisions of my two bills in this draft mark because they're critically important in the future two ish roaring safe food for everybody the first one is traceability as you know mr chairman i've been working on these traceability issues for many many years and when i first started people said it couldn't be done but then as we realized with time not only can it be done and in slightly different ways within every industry but if we want to assure this integrity of the food system it has to be done that what i fondly call the salsa scare of last year is the perfect example of why we found people being sickened by salsa and they and and we couldn't figure out why this destroyed pretty much the entire profit of the tomato crop for that whole year because everybody thought it was tomatoes that had the salmonella as it turned out after months and months and months of increased sick this increased scrutiny we found out that no it wasn't the tomatoes at all it was how it ten years and they were from texas and what i found out is that we can go to this particular to kill or sector of the field and find those is going to be essential and i look forward to working with my friends on the other side of the aisle to make sure it's not onerous but i will say this it is not just in the interest of consumers it's in the interests of businesses who want to protect their profits to have traceability mandatory recall is the second provision of this bill that i've been working on for many years and i'm so grateful has been included and i want to say finally mr chairman all of this policy that we talk about it's all well and good but i can't help but think about young jacob jacob hurley who you might have seen he was in our last hour and i committee hearing jacob is from portland oregon and he got sick from eating peanut butter crackers his favorite food when his parents took him to the doctor they said they finally got him stabilized and he wouldn't eat so they told the parents have jacob just eat what he loves the peanut butter crackers the very food that had made him sick in the first place and the only way we found out about this was because the alert commissioner of of consumer protection in oregon showed up personally at his door and confiscated the peanut butter crackers we need to fix this we need to fix it now and i'm so grateful that we are thank you mr chairman thank  ma'am welcome to the committe humbert welcome and my first reaction to the discussion draft is going to lead to some questions that i have for you today it appears that the congress like times we like to pound our chests and and then show the american people that we're doing something well but we really end up creating legislation within our own areas of jurisdiction and we create problems we create things that are multi issues and redundancies and if we really wanted to couple substance with the words that i've heard here from some of my colleagues today we would be working with other committees of jurisdiction we would have a very comprehensive bill and so i'm going to be asking you questions ma'am about clear lines of the delineations and responsibilities between u s d a and f d a and who should who should really have what responsibility or should we as a nation put all food under one agency and work cooperate fully with the ag committee to do something like that what we have is a discussion draft that has been cleverly drafted only within the jurisdiction of our own committee and so what we end up doing is are we exasperating a problem and so i'm interested in your in your leadership you're representing an administration and so i'm interested in your best counsel to us and your willingness to work with the leaders of other agencies to truly protect the american people and the other point i make is that congress as of late has been beating up on f d a i would say the f d a the individuals that i've met and the ones that you have the privilege to lead are some pretty fine and capable and dedicated individuals in the last sixteen years seventeen years that i have been here whether it's been publicans and controller democrats we continue to pass legislation that leaves more and more responsibilities upon your core missions and so he's here as your challenge to maintain the gold standards not only with regard to pharmaceuticals but also in food you know we were about to send you legislation for a new mission on tobacco that's counter to your even cultural mission yet we're going to continue to make you the whipping post and so i'm really concerned about the more responsibilities we give you how much does that dilute your responsibilities and so those are some of the questions that i'm going to be posing to you and with that you'll back gentleman from georgia i thank the chair and i appreciate the leadership you're showing on this issue this is a matter of particular interest to me since as mr deal already pointed out two of the most egregious recent cases of tainted food in the food supply originate in my state of georgia and i think this bill represents a major step forward in trying to prevent this from happening again when things it's a particular bone of contention with me is that in the last outbreak we got evidence in this committee that the manufacturer had test results which were showing positive presence  of salmonella the food was he was standing out in the marketplace was tainted and yet they didn't report that to the f d a seems to me that what we need to have in addition to the good measures to be incorporated in this bill is an effective testing regime that has integrity in terms of sampling and integrity in terms of testing and we've got to make it easy folks to be able to do this to comply with this and mandatory for them to report the results of any testing that's why i think we can pick the bad actors out really early on and perhaps even do a better job of arresting trends at a very early stage detecting problems before they become serious above all want to make sure that we don't bring about the sergeant shorts syndrome and he was a comic character in hogan's heroes who made a big big lie out comic demonstration every now and then not knowing what was inconvenient for him to know what to make sure that folks don't have the option of opting out or have a disincentive to know what they need to know when they need to know it and that we know what they know when they need to know it so that's the balance i think we need to strike here look forward to working individuals sometimes working under the adverse conditions that we supply but certainly i know you're very proud of the organization of which you lead and i believe that pride is justified michel and i'm going to stipulate to all of the  the difficulties of the food and drug administration is encountering that have already been well documented and i would ask you know as consent to insert my entire statement into the record let me just concentrate on the aspect that we are now finally after  hearings on this getting down to the somewhat of the business of acting for the f d a and talking about legislation that would give the food and drug administration some tools but we're also giving them a time frame which may prove to be a very difficult time frame for implementation and we're also putting some additional burden on businesses at a time that our economy's in some difficulty the legislation proposed will mandate the largest change in food safety in at least two decades and it will give the entire food industry a compressed time to do so in a few short months they will have to turn the current system of paper based records into a like an electronic form of businesses will have to find the money to register as a food facility and additional user fees if we deem them appropriate in the future and they'll have to be able to fully trace the food to its place of origin all those may be a lot of the goals but i'm not certain that what we're proposing is a timeframe is adequate and then the food and drug administration itself in that shortened compressed time frame will have to hire enough inspectors to meet the new inspection standards create unique identifier number for every food facility be they domestic or foreign set up a new administrative law position for the new criminal and civil penalties and make certain that each state each center has a food safety plan all of this instantly demanded in one piece of legislation i would just point out when we did the consumer product safety improvement act last year h r forty forty we acted in good faith and we acted with some dispatch but we created some situations that are absolutely untenable we've had to go back and try to amend some of those we've driven some small businesses to the point of bankruptcy we've created a situation where our resale shops because they cannot measure the lead standard that we required are in a position that they don't know whether they can you know worried about bipartisanship a bill is bipartisan if it is bipartisan at the beginning and chairman dingell i appreciate the courtesy that you showed me in the last congress and involving me at least in some of the plume early discussions of the draft that you were considering but really when the draft comes to the committee for consideration it really ought to have had input from both sides and the fact that there are five or six democrats on the bill and no republican was there no republican on this side of the dyess with which you could sit down and talk and perhaps get to a point where there could be some general a remember we've done this before on other pieces of legislation we did it on the food and drug reauthorization act in june of two thousand and seven and i frankly do not understand why it is not worth the effort to make these pieces of legislation we're not talking about points for the next election we're talking about the regime that will be in place that will ensure the safety of the food for my grandson and marcia's grandchildren this is the legacy that we're going to be leaving and it is too important to be left to partisan politics and i thank you for the additional chunks of chairman all you back thank you the gentleman from california ms harm thank you mr chairman i'd like to welcome peggy hamburg an old friend a brilliant physician and superbly qualified person to this committee and and to her new role as f d a commissioner i think you bring  a lot to this job and will help this committee which has worked on this issue for the issue of food safety for years and years and years come to a a thoughtful  careful helpful decision on the shape of this legislation so welcome mr chairman i'm very comfortable with a discussion draft and i do know that it read that it reflects many many years of input from members i thought dingell's comment that it's almost old enough to vote was particularly apt that applies to me too and and i think that coming from a state like california which is the largest agricultural producer traceability and mandatory recall i agree and we could have saved a lot of pain lot of cost and a lot of health problems had we had those measures in place so i i just want to conclude by saying that we have a able and willing partner facing us this morning i think we have an able and willing committee on a bipartisan basis to engage with her and i'm very eager to see to make progress and to enact legislation close to the committee draft as soon as possible it's in our national interest and surely as we talk about grandchildren it's in our grandchildren's interest i yield back the balance of my time thank you gentleman from tennessee ms b thank you mr chairman and i want to welcome dr tim jones who is going to be on our second panel he's hiding over here in the back and he must be one of these baptist from tennessee he's going sit in the back to back row until  time for him to come forward but dr jones is an epidemiologist with the department of health in our great state and does a wonderful job for our state and i'm absolutely delighted that we're going to be able to hear from him today on the second panel so dr jones thank you for taking the time to come while the draft legislation before us today attempts to improve the safety and the efficacy of the nation's food supply it appears that there is still a lot of room for improvement and i'm appreciative that we are having the hearing and i am hopeful that we're going to be able to work in a bipartisan way on this issue i appreciate the majority's attempt to improve the country's food safety system but i think that we all know especially those of us who are mothers we know that you can inspect your way to food safety we know that this legislation is going to have to do more than  be reactive this legislation broadly increases the f d a authority to make it one of the largest federal agencies in the existant my concern is the growth of bureaucracy and what is going to happen as that bureaucracy grows what i do think is necessary and i think it is necessary that our system be risk based that it be prevented if and take that approach and that it effectively target bad actors it is imperative that resources are focused on issues of high risk and innovation to that are most effective however this bill places on do burden on small businesses and did they would be harmed by burdensome and expensive provisions that are found in this current draft of this legislation and the f d a has provided no evidence that it has improved internal processes in order to improve the review of the nation's food supply this is something we have talked about endlessly in this committee and in hearing so we're looking forward to having some questions on this there seems to be and you haven't proven otherwise and that there are established protocols and lines of communication between different jurisdictions you have not shown that there are best practices in date about thirteen months ago i asked for a list of best practices on intra agency communication and how you were sharing this information how you are working with your affiliates so that everyone can more easily pinpoint and get to the bottom of problems and bad actors and issues that are coming forward and yesterday the f d a and a announce that they are studying ways to make the agency more transparent this should have been done before we pass a bill that would give the agency millions of dollars in user fees and i'm going to yell my time back and submit my full statement for the record and look forward to the questions thank you gentlemen from the virgin islands miss christiansen thank you mr chairman and while come back dr hamburg i know new york has suffered a great loss but the nation needs you more i also think it's very fitting that as we've come back to congress and begin to put the nuts and bolts on our health care reform legislation that the first hearing that this committee is having is with f d a because i believe will begin that reform with an overhaul in the better resourcing of the food and drug administration from the food safety enhancement act of two thousand and nine that we're looking at in draft today and the family smoking prevention and control act of two thousand and nine we're looking at a new f d a and you have the challenge as well as the opportunity to remake this important institution in ways that it better serves the health of the american public while also fostering guiding and supporting the bringing of new and better treatments to us as well i have confidence in a better resourced f d a with more authority and want to one that's not overly prescriptive i don't want to be overly prescriptive on what we tell the agency to do but i hope that we'll be able to allow the agent agency to do its job based on clear authority adequate resources and sound science in the case of food safety this my first few months on this committee i've really been alarmed to find out what has happened that has put the public public health in jeopardy from salmonella to some questions about even the i r b process and several other areas so we're here to help you create a better stronger f d a and this hearing is part of that process and i thank you and all of the panelists for sharing their experience and expertise with us this morning so thank you gentleman from pennsylvania mr murphy th chairman and welcome dr hamburg pennsylvania's number one industry is agriculture and with there comes a lot of food processing honored to have when national companies located in pennsylvania like hershey's we have companies like welch's grows a lot of grapes there and more locally in the pittsburgh area regional distributors are grocers like giant eagle national distributors of olive products like delilah's and of course big names like delmonte and corporate headquarters of heinz and small companies like sarah's chocolate the cells around the country all of them have talked with us about concerns for this bill and certainly are very supportive of make sure we have strong f d a and where we want to make sure that happens few questions are raised and i hope i'll be able to remain for part of this hearing although i have to run to the floor and i apologize for that i missed some of this but a number of issues making sure that there is no one intended consequences of the bill that leads to increased price for consumers let's work on that on the registration fee particularly as it may affect some smaller businesses trying to work also on ground to the traceability need to be clear what exactly the obligations are for both the process and fresh food industry are we talking about traceability a final product or traceability of every ingredient ingredient when into the product for example of a local restaurant chain makes cookies or someone else makes cookies trying to track every single ingredient that comes up with a specific food color dye may be a problem for them and like to make sure we make that work for the safety of consumers but not in a way that impairs companies from doing their work and also not unintended consequences of giving the f d a copies of all test results could be less testing as companies go through lots and lots of test for products that never make it to market would it be to test the hundreds of samples each day have to be available or changed to the testing of products that are in the marketplace with regard to the country of origin labeling a disclosure to list every ingredient on a website will increase the could increase the cost in resources and not necessarily bring added value  general label such as some statement that this product may contain ingredients from one or more the following country also how about raising the importance of making sure that all and for some standards and auditors all enforcement officers and authors are well trained and calibrated to work to define audit standards there's also concern of what happens with the family farm that may sell to local grocery stores what level would they have to comply and would it be that the fees for them would be so high that they simply could not sell any products outside of their own farm store and is that impaired some small distributors how do we help them another issue for grocery store what if they make packaged food at their stores such  as some value added ground beef products made in their smita apartments what happens if they mix in other foods at the store how does that affect them in other ways so certainly in pennsylvania we want strong food safety bills we want ones of protection summers we want small businesses to be encouraged and large businesses to be supported but also encourage new startups but more than anything else this week we want the penguins to win the stanley cup  thank you gentleman from texas mr green machine and i want to thank you for holding the hearing today on discussion draft of the food safety legislation over the past year so there's been several high profile  incidents in the united states involving spinach cantaloupes peanut butter and tomatoes this committee's diligently investigate all these incidents these hearings on the f d a a clearly shown us that simply does not have the resources funding  thank you mr chairman i'll be very brief we support there being a legislative hearing and hearing on food safety we think it's time to address this problem in a bipartisan fashion if at all move with the legislation sometime this month republicans are ready to help if we can agree on a bill that provides the f d a with the tools that it needs to ensure the safety of our food supply but we will not support a new blanket authorities that are designed merely to empower the bureaucracy nearly everybody says that quote we cannot inspect our way to food safety in quote we need systems that reliably prevent  pipeline resources in those places that are most susceptible to contamination the draft forest poses several areas strengthen prevention of food illness outbreaks such as requiring all manufacturers to have food safety plans and also the creation of appropriate produce standards these ideas make sense and have near universal support we are concerned however that parts of the draft add more weight than quality to the regulations and in our opinion provide too much discretion to the f d a without any corresponding food safety benefit for example country of origin labeling it's not about food safety as a practical matter it will simply increase the cost of groceries at the store we know this because expert after expert assessed at the committee that this provision is absolutely no effect on safety there are several other specific concerns with the draft including the level in the scope of the registration fees i will say that the registration fees are less in this draft than they have been in some previous draft so that i can at least say that we're moving in the right direction having said that it doesn't appear i mean it does appear that the majority simply wants three hundred to four hundred million dollars in additional funds for the f we can see that that there's any clear purpose for that amount of funding having said that we look forward to the hearings and if we can work on some of these problems we're prepared to be positively engaged thank you mr chairman thank you for holding this hearing on this extraordinary important issue i want to extend my appreciation to the sponsor of this bill and all of those who for so long have been fighting the fight to fix our food safety system and make sure that the food that is on the table to feed our families is safe for their consumption and that which goes to them goes with them to school they can fear not that it will be safe for their children to eat i thank you very much for your long efforts in improving our food safety network along with representative dingell represents to pack and others throughout on both sides of the aisle  and look forward to working with you as you may know the very first bill that i introduced in the house i believe was a bill a call for mandatory recall authority for the f d a and there's a reason for that i mean we have seen these problems arise again and again and again within our food safety network and the american people i think would have been shocked as i was to learn that our government did not have the authority to issue mandatory recall when it became apparent that it was necessary ohio has suffered the effects of problems with our food safety system most recently the salmonella outbreak has claimed lives and to many throughout the the buckeye state and it's critical that we are moving forward with a comprehensive bill to finally address and ensure the safety of america's tables and  system thank you so much i yield back thank you gentleman from michigan mr rogers thank you mr chairman appreciate the hearing and congratulations commissioner for your your confirmation i look forward to working with you some difficult issues ahead i'm glad this committee is focused on food safety i think we can all agree that the f d a needs more resources to protect our food supply and strengthen public health and concerned however that this might be a ready shoot aim a vent we just passed a fairly onerous bill and added a lot of authority to the f d a that had a huge loophole in it that allowed to back all regulation to be borrowed from the general fund of the f d a so you have this whole of millions and millions of dollars of which are going to have to try to apply to new thousands and thousands of new regulators at the same time we're trying to improve food safety and i can't think of anything more important than our food supply i mean i can my hat's off you commissioner on the challenge of what you've just accepted as we all know the f d a is currently unable to inspect a majority of the nation's food facilities worse many high risk facilities have gone without inspection and oversight at all over the last two years we've seen the impact of this failure most numerous seminal and e coli outbreaks which have sickened thousands and even lead to death i hope that this bill can eventually be a bipartisan bill however many of the concerns that we have expressed have not been addressed and we have not had the opportunity to sit down and have a discussion before this bill has come before the committee and i think that's horribly unfortunate when you're talking about food safety and food safety issues the user fees in this draft are concerning to me as written the bill would require one thousand dollars in a registration fee per food facility but these funds totaling about three hundred seventy five million dollars which will be passed along to consumers which are regular families trying to pay their bills already there's nothing in there that dedicates this to new inspections so we've come up with a new tax regiment that doesn't benefit the f d a in getting it to the place where you need it most which is inspectors for food facilities and food supply makes no sense to me and that's something we absolutely have to change in this bill or madam commissioner you're going to be looking at a very tough hold to fill again there's nothing in here that tells you appropriators where to put that money so that you can best use it to accomplish the mission of which this bill will tell you it has to do without telling you where the money's coming from this is that's almost dangerous when you think about this plus the f d a tobacco regulation authority that allows them to take your money for food supply inspections and drug approval and use it for hiring new regulators for tobacco that's a real problem that we need to fix not only in this bill at least i hope we can producers are required to pay that this new tax they should abs salut we have the certainty that the funds are going to be used for food safety inspections i think that's common sense i think we can all agree on it i would hope to work with the majority to get that taken care of in addition the draft inspection schedule seems almost impossible to achieve today i hope commissioner that you can shed some light on what a practical risk based inspections schedule should should look like and i hope you can cover that today in your statement and through questions i also also have several other concerns the new broad recall authorities think recall authority is important but how it's done is incredibly important and expansive new civil penalty regime new labeling requirements that seem don't seem to have anything to do with food safety again i think all of these issues we can address if we work together in a bipartisan manner and i think come around something that we all believe needs to happen and that's more resources for food inspection and food safety regimes that the f d a has a primary responsibility for i look forward to working with you and thank  us that addresses very serious challenges that we face with respect to food safety before i begin my remarks i would like to submit for the record written testimony from the secretary of the department of agriculture trade and consumer protection in the state of wisconsin without objection so what are you mr chairman food safety is an issue of great concern to me and my constituents approximately one in the four people in this country are affected or or sick by food borne disease each year as americans we rely on government to keep us safe and as government we have fallen down on the job as we consider this draft legislation i know that our goal is to empower the f d a to prevent food contamination incidents before they occur i hope that we do so with appropriate and sufficient resources but also with precise coordination between other federal agencies the states and the private sector currently with its limited resources the f d a focuses it's spectrums on large manufacturers engaged in interstate commerce and it leaves much of the frontline work to the states this bill creates a risk based inspection system that significantly increases the frequency of inspections i want to make sure that we are not duplicating efforts and that we can empower states to perform their work on the ground with a just a call in financial support i urge the f d a to use this legislation to create a stronger more integrated food safety system that leverage a state and local resources another as as another result of limited resources f d a relies on many private sector firms to conduct food safety tasting testing testing on a contractual basis i'm pleased that the discussion draft includes a provision that would allow a laboratory accreditation process facilitating the f d a is use of third party laboratories to perform testing and i want to make sure that the conflict of language of interest language in the bill does not prevent some of the most experienced laboratories from maintaining their strong partnership with the f d a moving forward i look forward to hearing your testimony dr hamburg and that of the other witnesses today and i thank you again mr chairman for this hearing thank you mr chairman mr chairman public health officials estimate that seventy six million people become sick three hundred twenty five thousand actually hospital last and five thousand each year from food borne illnesses caused by contamination incidents like those in my own home state of georgia where the actions of a few bad actors and eyebright nown ineffective government oversight sickened more than six hundred seventy seven people in forty five states and calls at least now and this underscores the need for action i agree with my colleagues that more needs to be done to ensure that the food products american consumers buy are safe additionally i support the efforts of this committee as it reviews ways to streamline and improve the food inspection system in this country this is chairman i hope that these hearings will continue to laois the opportunity to reflect on the bright downs in our current system as well as the appropriate solutions to safeguard the health and welfare of all americans and commission i commend you for your recent appointment look forward to hearing from you and from the next panel of witnesses and with that mr chairman  thank you gentleman from iowa mr brayley thank you mr chairman and welcome dr hamburg i don't think anyone sitting over here has anything but good wishes for you and the enormous challenges you face and we wish you well and look forward to many fruitful and productive conversations with you as vice chairman of the oversight in investigation subcommittee has been very involved in the hearings that we've had up to this point on this important subject and i'm glad to see it's finally getting to the point of considering legislation that so critical to the health and safety of americans throughout this process we've seen examples of both good and bad actors in the food industry some companies like nestle usa set the standard with proactive food safety audits and showed us what can happen when companies do the right thing in reaching out and doing their own investigations on the other hand we heard extensively about peanut corporation of america and its unsanitary in unsafe conditions and about its action to misrepresent the results of audits that were done which put people at risk and cost people their lives that's why we're here today to talk about what we can do to improve the current state of the situation this food safety enhancement act will solve many of the f d a s current limitations and i'm glad that it requires increased inspections of food facilities teared inspection systems that distinguish between high risk facilities low risk facilities and warehouses and i also support the provisions to insure the safety of imported foods which is something i fought for since introduction of the fresh produce safety act last congress also very importantly i'm very proud that this bill has strong whistleblower protections and i believe that it will help man who's the c e o of kellogg how much the pca salmon l l outbreak had cost his company and he replied between sixty five and seventy million dollars the legislation before us today might have prevented that outbreak and save those costs more most important however is what we owe to the families of this country who have been injured or killed by unsafe foods and the desire to take real action to keep our food supply safe in two thousand and six a graduate of dubuque wallers high school in my district a marathon runner named jim joe cole contracted e coli from a spinach salad that she ate after seventeen days in the hospital she was released with just eight percent of her kidney function and she now has to see a doctor twice a year to monitor her kidneys jill and all other americans should be able to have faith that their food is safe and we're here today to try to restore that fake thank you mr chairman thank you  gentleman from maryland mr sarbanes thank you mr chairman welcome dr hamburg we're so excited to see you in this position and we look forward to your testimony on the proposed legislation  the comments been made a couple of times that we can inspect our way to food safety and that may be true but we cannot inspect our way to food danger which i think has been  unfortunately the hallmark of what's happened in recent past and so this bill that's proposed is going to put so much more emphasis on monitoring and 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 in other words these are things that the average citizen would imagine are already in place and i think would be surprised to learn are not in place and so there's so much about this bill that represents so the pent up needs and concerns of the american public that we need to address on the economics and there's been a fair amount of discussion about that already just in the opening statements the better we do on the front end of course with monitoring and inspection the last cost we're going to have on the back end both in terms of f d a needing to scramble to deal with outbreaks of foodborne illness but also the save cost to businesses and having to deal with the effects of that and i think that those save costs will far outweigh the investment that we put in on the front end and certainly justify many of the measures that are contained in this bill so we look forward to your testimony welcome the good luck to you that my time gentleman from connecticut mr murphy thank you mr chairman i look forward to a doctor hemorrhage testimony and members of the other panels i think we're  talking about here today setting very high very reasonable expectations for what we can do out of the f d a and i think that if that's our goal we can get a product that both parties can be proud of as the former chair of connecticut's public health committee i think i speak for a lot of state policymakers in our feeling of helplessness over the past five to dan years especially and i think you're going to find as this committee will find a lot of  incorporated into the underlying bill and i appreciate you paying attention to her work here as well look forward to your testimony thank you for being here you know back thank you gentleman from martin ms castor thank chairman and kudos as well to to rosa de lauro and bart to pac and john dingle our colleagues here that 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 and 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 it is relevant to all americans i wanted to remind my colleagues that the government accountability office remember keeps that very short list of major government problems that require broad transformation before  they can ever hope to be effective the list called the high risk series includes no two notorious government failures such as the financial regulatory system which led failed to prevent the largest financial collapse  generations and it includes the implementation of the homeland security department which has been plagued from the beginning by cost overruns and no surprise it also includes federal oversight of food safety  and here's an example from last year that 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 f d a intimated at the time not to consume florida tomatoes and that cost our state and agricultural producers and hard work unfolds over one hundred million dollars all of the time and effort spent hinting and suggesting that florida tomatoes where the problem only serves to delay the solution to the real problem and allow more america to get sick argument he understands the problem this committee has held several hearings and we understand that we must act expeditiously part of the problem lies in the lack of federal authority to affectively respond to a crisis when f d a does not have incontrovertibly approve of a specific food contamination it cannot today issue a mandatory recall instead it must rely on corporations to voluntarily choose to pull inventory from the shelves the f d a does not even have the ability to assess civil penalties this legislation before us give the f d a that long overdue enforcement authority the problems facing food safety and oversight are legion and they are difficult but they're not insurmountable and i'm confident that we will move the food safety and handsome an act of two thousand and nine quickly and provide american consumers with a safe transparent and reliable food supply i yield back my time thank you gentleman from california thank you mr chairman for having this important hearing on the food safety and handsome an act of two thousand and nine and i want to extend the warmest welcome and congratulations to dr hamburg she is a woman of exceptional talent of high intellect a person with great character and someone that has given much to our country already and comes  from one of the most outstanding families i think in our country i am so you can tell how elated i am that the president chose so wisely in appointing you is f d a commissioner and we all look forward to working with you to the extent that you succeed the country going to succeed i also think that that your tenure can be and will be the mark where the f d a returns to being the gold standard in terms of a public agency the american people believe in the f d a they want the f d a to succeed because what you do they can't do for themselves and the decisions that are taken can be the difference between life and death that's how profound the decisions are so i can't tell you how thrilled i am that you are the  one i'm pleased that the legislation that we're considering is going to improve the traceability of food because when tainted food is discovered it's critical that we know where it has come from where it's gone and what stores it's sold in if sales are limited to a certain area targeted recall could take place which would be more effective for consumers and businesses and i'm 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  to along with my colleague mr murphy from connecticut really want to salute those that have worked on this issue rosa de lauro has just been tireless and you know that she brings passion and intellect to what she does and so some of the ideas from her legislation are embedded in this i look forward to our conversation i i hope that what we are asking the f d a to do that you are really up to  it i think that we've lived on fees for a long time and i still have questions and would like to know directly from you whether you really think you're going to have the resources that are necessary to do this because if you don't then the print of the legislation or law will be wonderful to read like some constitutions around the world that are absolutely magnificent but they're not worth the paper that 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 and some think that there should be a standalone food inspection agency can the f d a actually do all of this do you have the resources for it i mean if there's pizza that has pepperoni on it versus pizza that doesn't have any meat on it should there be a split jurisdiction between agriculture and the f d a in terms of inspection i think the more splits there are the more that there's more of an opportunity for things to fall through the cracks i may be entirely wrong but i i still have some questions i don't think this is a perfect piece of legislation but i'm sure glad that we're considering the issue so i wish you nothing but the best i have great 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 thank you thank you gentleman from illinois mr chairman and congratulations dr hamburg i come to this issue with a lot of history and also this particular show with a lot of emotion my good friend nancy donnelly whose only child alex was lost because because of eating a call hamburger with e coli and then dedicated her life to creating an organization save tables our priority has worked tirelessly for for food safety and every time year after year we have people coming before us telling these devastating stories and every time we say we're going to do something so that never happens again and yet it does in february we heard testimony from peter hurley who's young son was made ill by eating austin peanut butter crackers they were found in millions of of homes and we were all shocked by documents presented at that hearing that showed that the peanut corporation of america knew that their products were tainted and yet released them into the food supply anyway so the discussion draft that's before us includes provisions that will seriously fill the many still many of the gaps in our current food food system and wanted to just mention a couple of things that i think ought to be considered for review there's just a brief mention in the in the bill dealing with the issue of an eye by adek resistant pathogens and the extent to which antibiotics that are used in livestock contributes to this resistance we don't necessarily always think about this is as food safety but i think it's a truly important issue we looked h one n one i know it was a virus but but nonetheless everybody is waiting for that kind of plague that we don't have the cure for because partly because of antibiotic resistance act and i believe the companies who have positive test results for possibly dangerous contaminants should be required to report those results to the f heard how p c a nobody knew about it and i think there are many other examples it's a question how the f d a effectively can ensure the food safety of our food if we don't even know where there might be a problem and finally i believe the collecting and disseminating of information about food safety and food borne illness 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 ensure that americans are adequately informed thank you so much i thank you and i believe that completes our members opening statements will now turn to our witness and let me say dr hamburg i appreciate your being here i want to welcome you we have as you know five minute opening statements become part of the record and then you may get some questions afterwards from members of the committee so thank you and if you begin chairman alone and members of the subcommittee i'm dr margaret 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 you chairman waxman chairman stupak chairman emeritus dingell and other members of the committee and your staff for your leadership and 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 this great agency and him and i am inspired by the president's personal commitment improving food safety including the progress being made by his food safety working group the president has backed up his commitment with resources proposing historic increases in funding for f d a food safety efforts i also appreciate the support of secretary kathleen sebelius and the department of health and human services and of secretary tom vilsack and the u s department of agriculture for major progress on food safety in addition a coalition of consumer group is fighting for improvements in the food safety system so that more families do not have to suffer tragic consequences from food borne disease major sectors in the food industry also support and are advocating for fundamental change but even with all this support and momentum our efforts will fall short unless congress modernize its food safety laws to deal with the challenges of the twenty first century that's why this hearing is so important from the perspective of f d a there are three key questions to ask about food safety legislation first does the legislation support a new system focused on prevention second does the legislation provide f d a 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 its responsibilities to comment on the discussion draft let me address each of these issues in turn for the first does the legislation support a new food safety system focused on prevention the draft legislation would indeed transform our nation's approach to food safety from a spawning 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 then implementing effective measures to prevent contamination does the legislation provide f d a the legal tools necessary to match its existing and new responsibilities in a new food safety system f d a has the fundamental responsibility of overseeing and verifying the implementation of preventive measures by hundreds of thousands of companies the agency also retains the existing critical role of protecting the public during an outbreak f d a needs new legal authorities to be able to succeed in these roles and protect the public health this legislation would provide these critical tools my written testimony provides several examples but i'd like to highlight one of the most important new authorities now section one zero six provides f d a with explicit authority to access to food records during routine inspections thereby addressing one of the most significant gaps in f d a existing authority the authority provided in this provision is essential to enable f d a to identify problems and require corrections before people become ill and it also enables the agency to verify during routine inspections that firms are maintaining proper distribution records records access and record keeping by all persons in the distribution chain are the 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 the legislation provide or anticipate resources for the agency to match its existing in new responsibilities the draft legislation makes an important investment in the resources needed for major progress after all f the a must have the resources necessary to meet its responsibilities otherwise the public will not benefit from the 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 that are also requested in the president's fiscal year two thousand and ten budget one of these is in section one  provides for registration fee this the 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 three hundred seventy thousand registered facilities and to enhance its other food safety activities section one hundred five proposes a rigorous inspection schedule for food facilities these requirements start eighteen months after the  to meet these requirements section one of five allows the agency to use inspections conducted by inspectors from recognized state local other federal agencies and foreign government officials a would like to raise three issues about section one zero five first the amount of resources required to achieve these inspection goals would far exceed even the historic increases in the president's fiscal year two thousand ten budget moreover it would be difficult if not impossible for f d a 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 f d a 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 a will gain better and for me nation to guide the agency's approach to inspection and oversight we will understand where we must inspect more frequently because of the high risk of certain foods facilities and processes and understand where we can protect public health without conducting inspections as frequently as a result f d a would support flexibility to modify the inspection requirements based on the best available data and risk third section one of five could do more to provide flexibility to f d a in meeting the inspection challenge the draft legislation allows the agency to rely on inspections by other federal agencies as well as by state local and foreign governments an additional promising mechanism for international inspections is certification by accredited third parties f d a would like the flexibility to explore the use of such an accreditation system and audit the performance of accredited third parties with strong standards and robust oversight by f d a this approach could help address the oversight challenge posed by the more than two hundred twenty thousand registered foreign  exporting to the united states this is a historic moment for food safety in the united states a moment for f d a and its sister agencies in the federal government to rise to the challenge of the twenty first century success means fewer hospitalizations and death fewer devastating recalls and greater health really 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 at f d a i look forward to assisting with the legislative process i welcome any questions you may have thank you dr hamburg will have a series of questions now the members in each of them gets five minutes and i'll start with myself under the bill all facilities both domestic and foreign seeking a market food in the u s must register each year and provide certain information about the facility to the f d a if the facility is not registered  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 a registration fee now my understanding is there was in two thousand and two that was bioterrorism legislation and under that  legislation food facilities were required to register but there was no requirement to update that registration so my question is rather reference that that registration under the two thousand and two bill has that system resulted in problems in terms of f d a is ability to accurately account for all facilities selling food in the u s and maybe you can tell us what problems exist and then the second part is do you believe that linking a fee to the requirement to register would help address whatever problems exist under this system that dates back to that two thousand and two bioterrorism decision thank you i think it is clear based on the experience since the bioterrorism act in two thousand and two that we do need the extended authorities that would be offered in this bill we know that when a facility registers once but doesn't have to register again that it does create problems in terms of our ability  fully understand the nature of the food related activities in that facility the you know corporation of america i think it is one good example when they first registered they weren't actually making you know better and then they they added that to their activities with with annual registration we would have a much better record in understanding of the activities and it would provide with the tools to be more responsible in our oversight and in our inspections with respect to the issue of fees 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 fees 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 he is an investment in a robust and effective food safety system that he w go to enable the f d a to provide certain specific services and put in place the broad and modernized food safety system that american consumers expect and need right now you let me go back to this city because in the president's budget he has seventy five million dollars in registration reinspection fees so obviously the administration's already shown support for the concept of a registration fee for for food facilities in the budget however in our bill with a thousand dollars per facility fee we would generate much more than the seventy five million that's in the president's budget so i wanted to explain if you could what was contemplated in the president's budget request of the seventy five million that that request to address the new authorities provided in this bill with the president's budget request was of course put together before the specifics of this proposed legislation was put forward to wasn't addressing all of the specific requirements laid out in this bill importantly 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 seventy five million dollar increase in  budget it was to include many elements that are a part of this legislation increased inspections but not to the degree that this legislation would call for the implementation of preventive controls strengthened laboratory testing a stronger integration of f d a and federal food safety efforts with the state and local activities which is ultimately very very essential to well there you know i know that the bill allows these fees to be applied towards a broad array of f d a food safety activities you know other words that allows the fees to be used to boost f t s ability to develop standards like performance standards or preventive controls do you agree that the fee should be applied towards all these activities that we mentioned in the bill i think we want to robust comprehensive program and those fees should be applied to putting in place that suite of activities the preventive controls or drill ect directly related to what companies must must do under the new legislation and i think it's very appropriate that the fees cover  that aspect for example the inspections obviously are directly related very important the fees cover that aspect and many other aspects of the portfolio of activities outlined in the legislation really are essential to what needs to be done to protect consumers and ultimately to protect the food industry so that the the public and consumers can be assured that the products are probably know senator kennedy and durbin and barr and gregg have introduced a food safety bill on the senate side and it has the administration endorse that bill has it endorsed this i'd be happy at a later time to discuss in more detail the bill on the senate side but as far as you know the administration has not endorsed the either but i don't believe so ok well the reason i brought that up there are some significant differences in the senate bill in the house bill and one area of difference relates to recall authority of the f d a and  under this bill the f d a would have the authority for recall if an article of food may may cause adverse health consequences that would be the legal standard may cause but in the senate bill it says that there must be a reasonable probability of serious adverse health consequences are death so those standards are significantly different and i was just asking you since you're now going to be responsible for this that first standard that's in this bill seem so general and so  nebulous in a way does that narva you are don't you think it would be better to have a more precise identified standard for recall well i certainly understand the concern that you're raising and i think that there may be opportunities for some word smithing certainly we would never seek to recall a product without  reasonable expectation that there was serious adverse consequences and harm related to that product recall its is no small issue both in terms of resources and efforts on the part of the f d a and also its implications on an industry and consumers who want access to those those products so i think it's it's an area that we we'd like to work with you on for language that we wouldn't want to be too overwhelmingly prescriptive because we want to have the flexibility in that kind of potentially emergency situation to move  forward well i agree i mean i think this is an area that we should look at because we know the ramifications of a recall the expense involved and certainly we want to have a balancing of protecting the public versus preventing a new expenses to companies as well so i'm glad to see that that is at least an area that you would be willing to talk about and i might also say the same thing would apply to these access of records there really is no standard at all in this bill but on the senate bill it says that if the f d a has a reasonable belief that an article of food prevents a threat of serious adverse health consequences death f d a would have access to be able to copy all records and so forth and so forth but under this bill it appears that  the f d a would just have blanket authority to request any records at any time without any sort of standard being met here i'd like to stress that i think access to routine records is extremely important to ensuring a safe food supply it is very important that when inspectors go into a facility they can examine certain aspects of what have been the procedures during a proceeding period of time and not just inspect what's happening at that moment had we been able to have better access to to routine records in the case of p c a which has been talked about already this morning we would have been able to see that there was documentation of contamination several years earlier which had not been been adequately addressed my time like to ask just one additional question it relates to jan schakowsky comment her on the statement about the use of antibiotics in the agricultural community and the fact that more and more people seem to be to certain antibiotics is that a concern of yours it's a huge concern of mine in terms of the growing problem of antibiotic resistance in this country and around the world in the implications that it has for our armamentarium of of antibiotics to address serious and life threatening diseases i think it's an area that merits a lot of attention by the f d a working in partnership with others it's it's a topic i'd be happy to come back and discuss in in more detail with you and it is very high priority for me in terms of overall goals to improve public health two food facilities in the united states a hundred fifty two foreign facilities in the same time i was out of nuffin specters how many should you have and what resources would you need to do the job i think we can do better do more frequent inspections we also need to do smarter inspections and we need not to rely simply on inspections as our tool for a safer food supply we agree on that i am keenly aware that there is a substantial cost associated with conducting foreign and domestic facility inspections how much do you need to do this properly in terms of personnel and money if you can give it now  that and it is clear that with new inspection requirements f d a is going to need new additional resources to meet that requirement is it not that is absolutely true the president has asked for additional resources for food safety activities that the agency requested i'm told about two hundred fifty nine million additional money is that is that correct yes it was the president intensities additional dollars amounting to one hundred sixty four point eight million in new budget authority and ninety four point four million in new fees registrations respect an export certification would be used for inspecting rather for president's budget requests for food safety is activities did not include any new requirements that may come with the food safety legislation or new spewed safety legislation and we're considering years that correct i'm sorry but could you repeat the president's request for new monies did not include monies to address the questions that you will be compelled to face under the new legislation is that correct it it addressed some components but not the full at all  question do you agree with the idea that we should prohibit the use of registration fees for inspection i think we need registration fees to enable the agency do its inspection all activities and other components of the food safety plan as matter of fact was a few successful activities that food drug at this particular time is what you do under purdue for which you are supported by fees is that not correct that import products under f d a as jurisdiction to the united states in any year i believe yes that question is no is no and this this legislation would enable us to get a much better handle on who is out there producing and very important and now these individuals are not required refuse to comply with certain requirements to ensure the safety of these products that they import they can handle any type of f d a related products and are not required to have any specific training so to do is that not correct that is correct we would like to make sure that that individuals importing food into the united states followed standards and guidelines that weeks packed with domestic food production the domestic draft the step the discussion draft establishes a program to require reporters u s custer brokers of foods drugs and devices mothers fathers to register with a and or to and require that good importer practices are maintained as a condition for maintaining registration do you agree with that require we would german thank you for your patience and i thank my colleagues i would note that the changes in the draft that we have before us today are those which have been largely done in consultation with us and in consultation with my minority college the next changes  your statement you you support the f d a is ability to trace foods more quickly during an hour outbreak so you would support a track and trace system with regard to foods that correct i would i think it is very important to our ability to respond quickly  to outbreaks of concern and you are since you you appear to be an indoor seeing the bill this draft discussion bill in front of us you also support than the f d a has ability to  increase inspections of food processing facilities would that be correct i think we'd need to do more inspections that as i said earlier i think we also need to recognize that it isn't simply increasing the number of inspections that will get us to the food safety system that we need but it's it's also instituting the preventive controls and relief shifting the way we think about food safety and also stronger partnerships with the locals and foreign governments and anguishing when you discover contaminated food you believe it's your responsibility then to prevent the distribution of that contaminated food into the marketplace not correct yes so you're asking for that ability to do a recall would that be correct yes and that once that contaminated food has been discovered do you believe that you should have the ability to order the destruction of the contaminated food it depends on the specific circumstance sometimes of the can contaminate food it might be possible to reprocess it and make it available in a safe way but if it is contaminated and putting consumers at risk  and and such a an option does not exist then that food should not be allowed to be provided to consumers since you support a federal tracking system for food would you also be willing to support a electronic pedigree system for an interim operable tracking system for pharmaceuticals you know i think that in both realms it is very important to know where things is this year and where they're going and yes well you know i'm reluctant if you're going to use contaminated lettuce over adulterated drugs i don't think so i'm not i'm i didn't see your question was i there or i my question is if you're going to support a pedigree system for the tracking of tracing contaminated food don't you also believe that it's important for us to electronic have an electronic pedigree for the tracking tracing of pharmaceuticals in in concept i think as i said that the traceabilit s and fed ex of which thirty to thirty five thousand packages pharmaceutical packages come into those mail facilities every day so do the math when you do your inspections about eighty percent of them are either either adult rated or there they're counterfeit knockoffs yet f d a claims if you want is the ability to destroy so you're you're so you're sitting here before this committee today saying that you now believe that you should have increased ability to inspect and to go after this contaminated food i want to make sure that you also believe that you should have the ability to destroy these counterfeit knocked off drugs because if you just do the math that's that's got to be in excess of three hundred fifty thousand counterfeit adulterated knockoff drug packages per day that's millions of packages per year that are harming people so let me go right right to you do you believe the f d a should have the authority equal authority to destroy these these counterfeit adulterated drugs as i indicated earlier this is the my seventh day on the job and i have been briefed in full on all these issues the problem of counterfeit drugs is a huge concern and i am eager to work with you thank you claire they care very much about what's happening right now they're sitting right now here's customs and right over here is f d a there's not even a wall yet customs has the ability to destroy but you claim you don't have the ability destroy please don't come before this committee and tell our entry that you think we ought to be able to protect you with regard to food but with regard to drugs i can't believe as a doctor you and i i'm not telling you that sir but i am in the u where these are issues that are at the heart of the f d a mission and as a physician extremely important to me are issues that i am determined to work on determined to work with members of congress to find appropriate solutions but i you know i am not comfortable at this time discussing the specifics of that program with them i haven't been i would be willing to work with you because i can't believe that this would be an issue that you would equivocate on or you will yield back thank you very much mr chairman and dr hamburg i want to add my welcome to the that of my colleagues to your appointment i know you're going to be working with this committee on a lot of different issues i want to talk to you about the traceback system because we have worked very closely over the years and most particularly on this latest iteration of the legislation on setting forth mandatory characteristics that would be contained in the tracing system that the f d a sets up through the regulatory process for example the bill requires that the origin and previous distribution history of food must be maintained and that history must be linked with the subsequent distribution history of the food and it also requires to me this is a really key component that the system be interoperable so for different types of food they can figure it out some people question whether it will be ever be feasible to implement this type of system and i'm wondering if you can give your opinion on the fisa bill lety of this type of a traceback provision well as you as you indicated is very very important and key to our success in being able to respond swiftly to outbreaks and make the appropriate interventions to protect the american public interoperability is absolutely key because it involves a whole range of different players along the the full lifecycle of the product and that's one of the great challenges i think as we move forward in developing and implementing a traceability program we need to work very carefully with exchange but that should be our goal absolutely and in the draft legislation that's exactly what we do is we give the f d a the author or the to work with industry and consumer groups to develop both the specific types of types of trace traceability requirements and we're not saying that that we have a one size fits all correct correct do you think that there's an economic case to be made to the industry for better case ability i think absolutely because with the opportunity to really do adequate trace back we can really target what are the components of a food or the specific proof food products that are causing the problem and remove those or or put in place the interventions to decrease the risk  that particular component of the the food lifecycle in that way we can both save lives and reduce illness but i think also reduce the costs to companies who as we've heard about this morning's you know have occasionally been in appropriately targeted when the traceback was inadequate and we didn't identify the correct product and also when there's a whole industry but it's only one processor manufacturer that's the problem then we can protect the rest of the industry by really honing in on the particular product risk and once we develop this system it should also may make identification and removal of the specific contaminated food much more speedy than it happened with and benefits consumer health and it benefits the economic interests of that sector just one last  question the draft legislation that we've prepared exams farms that sell directly to consumers or to restaurants from the traceability requirement to the farmers markets and so on do you think that that's an appropriate carve out for them i think that we have to recognize the burdens on smaller businesses but we also from a public health point of view have to assure that when there is a problem we can get access to the information that's needed to identify the source of a contaminated food so we need to work very closely with you know when one thing is that these farmers markets for example they're not broadly distributed their food is just local so if someone did get sick the state health department could easily trace it really makes it easier to do the outbreak investigate right thank you very much thank you gentleman from illinois ready thank chairman mr mccain i ask you a question process question first you're sure is there a possibility that the subcommittee may consider this legislation next week yes and if so i would ask senate submit questions for the record by the close of business tomorrow could we have witnesses respond to those questions by the close of business monday sounds like a good idea to me since we're likely to markup next week you have no problem with that i think that's very appropriate and we do know that objection that's what we'll do we know that's challenging but of course this is a draft and as i said the opening statement so we appreciate that and again we do appreciate us morning welcome on board and we're all working for really on the same team trying to get responsible legislation that protects human health while ensuring that these go to where fees need to go so i just have to one in this goes back in history today two decades ago when congress was deliberating how to improve the state clinical laboratory testing conference report stating that proficiency testing is considered one of the best measures of laboratory performance and arguably the most important measure since reviews actual test results rather than merely gauging the potential for good results as we examine the discussion draft and its call for accreditation standards for laboratories to perform analytical testing on food your opinion should proficiency testing be explicitly included here too i think that we would only want to work with accredited labs in the credits ation process addresses those those kinds of concerns the accuracy of the testing is key to making the right decisions and you know i think that as we move forward lavatory testing needs to be a strong component of what we do and so efforts to ensure the accuracy of testing results is absolutely key to protect businesses and to provide the public health system with the information it needs to take action on it and i would agree with that  think that's the closest to it yes is ok and that's fine but i think that's a critical component and if we're going to do this that proficiency test the process by which we you know test the test or so we have some  certainty let me go back and i know we've talked about this seventy five million in in the president's budget and that's three hundred seventy five million in revenue and i mention this in my opening statement before some of the discussion and i  understand that you know this legislation offers more authority and so that's why there may be a differing number than what the president proposed but i think a lot of us are going to be challenged by the fact  helpful before we move the mark up is you know show us the money show us show us where we came up with this amount and we've are as i said also there's already been a lot millions of dollars put into food safety over the past six months a lot of us are trying to understand word three hundred seventy five million we understand that there was a thousand per facility and you add up the facilities you get three hundred seventy five million but that doesn't answer the question as to where is that money is that money going to go to an expection regime and what does it cost to do in the factories and especially on this i've been really a strong spokesperson for risk based system now the risk based system promoted in this draft legislation is nowhere near what i believe a risk based system should be i think you should go after risky individuals and facilities that in essence offer no risk you ought incentivize them and this is been statements i made for a long time so i think even this risk based approach that we're saying can be modified somewhat  so is there a way to give us some give us a better handle do you have better numbers that support this discussion draft that three hundred seventy five million dollars actually means three hundred seventy four million more dollars worth the ability to inspect well we're aggressively i don't believe that three hundred seventy five million will cover the costs of the inspecting on the schedule outlined in the bill we actually would need considerably more resources to do that we know you know based on estimates vary but that the domestic inspections cost  a little over nine thousand dollars in a national inspections are probably threefold higher and the this number of facilities requiring inspection are  very very large number in the hundreds of thousands why numbers add up quickly and my time's expired and i apologize i would just say that there is going to be skeptics that say ok we've got three hundred twenty five million dollars on a fee schedule and it's not going to go for inspection will go to other aspects of the f d a and and it would help provide some clarity and mr irvine to stand on this because the chairman emeritus mentioned this once again that there that there's been gauche a sion with his republican colleagues i would call them information positions of the answer of no not really negotiations on addresses on the bill and i would encourage maybe a says going to be a member member discussion but if if we really want to claim that this we want to bipartisan bill we ought to have some just not dictates this is what we're going to do but this is where we need panel that they submit their questions that members submit questions by the end of tomorrow night which would be thursday night and that we have responses by the end of business day on monday ok mentioned that again i mean i don't know of maybe difficult to meet that schedule but you know what would the chairman yield and we understand that's a lot to ask but for us to move i think that's fine and well you know where abbe needed to imply was that we appreciate your taking seriously and wanting to move it forward with all right thank you gentleman from california ms harmon thank you mr chairman i've sat here for a few hours listening to this hearing and i i think  the content is very important and i do think this committee has developed an enormous record on this subject this is not new information for four members of this committee and i do think we will be able to move  room he was in some fashion implying that dr hamburg is not focused on drug safety my response to that is of course she is she's been here for ten minutes and the first topic up is food safety so  let's give her and this committee time to focus on that subject in the near future and you are not accusing each other of in some way of perhaps inadequate attention on the subject of food safety which is what we're talking about there is a section in the legislation about testing by accredited labs last year i recall a huge show worry about whether the prior administration was go back on the number of accredited labs and the impact that would have on major ports of entry like the ports of los angeles and long beach my district happens to be there that are are the place where enormous amounts of him for imported food enter the country so i just want to give you a chance dr hamburg not in terms of a yes or no answer but could you assure us that that  lab capacity is a priority of yours and assure us that there will be adequate lab capacity for the anticipated importation of food and and for the standards in this legislation to work absolutely laboratory testing isn't is an essential component of a strong science based food safety system and we do not have any play and to restrict our our laboratory capacity and i think you know as we move forward we will want to make sure that we are applying the best possible science including laboratory science to our our testing and screening activities i hope that there will be advances in laboratory science and technology that will enable us to to do our inspections in a in a more efficient and cost effective way but it's a it's a pillar of what we do and we will continue to support it and we may as resources become available and and needs suggest actually expand our capacity well i appreciate that and i'm not suggesting that that our current lab structure be frozen in time obviously if there are improvements either in location or in function we ought to embrace that but another one of the concerns that has been expressed is the ability to get the results from the lab to the f d a in a timely manner  do you think the current system is adequate in that respect and and are you thinking about improvements to that well we're eager to implement a system for reportable foods that will include laboratories reporting positive tests to f d a and i think that will be a very important additional element to our activities good was appreciated that too obviously in light of some of the recent outbreaks and their devastating impact  with all of the questions and listening to all of our opening statements in your testimony reference section one zero six that provides the more explicit authority for f d a to access food records during inspections do you think that that's enough or should we go further in the legislation to mandate that those records before we get to the you know i think what's outlined in the legislation is certainly a very good starting point we don't want to be inundated with information we don't want to put too much of a burden on an industry but we do need that access to records we need companies to keep appropriate records and we need to be able to have it to be able to inform our routine inspection allow activities to be able to work with the companies to make sure that they have adequate preventive controls in place and we need it certainly in the event of a serious outbreak a public health concern to enable us to swiftly get the information we need for action so you think that requiring them to have their plans and have their plans audited in conjunction with your authority to do to have access to the records should be sufficient you know i think we would want this to be a dynamic process as we learn more putting in place the programs and policies and then learning from experience but i think that the bill lays out a very sensible and doable approach ok and you also talk about the huge task of hiring and training inspectors and if i understand correctly you're asking for so more flexibility  n the legislation to be able to do that i asking for general flexibility or would a transitional timetable with time certain in the legislation work just as well  think we just have to recognize that this would be an enormous scale up of activity and that we need the time frame to enable us to do it right to recruit the people and train the people to work with industry to develop the systems that work so we'd like flexibility in that way and we would like more general flexibility so that we can can learn as as we go in terms of of the inspection schedule and some of the requirements in that regard ok my last question is kind of a general one i don't think it was asked before but even as late as yesterday someone asked the secretary the question about one single entity to secure food food safety with the authority over the food safety program for the country  i'm sure i don't think the secretary supported it i'm sure you don't support it but what can you say about if you've had a chance to look at how f d a and u s d a work together or  don't work as well together as they should what can you say about addressing the concerns that gave rise to the legislation that would put it in this single entity well it's a couple of responses to your important question one is that clearly as the new f d a commissioner i have a first in urgent priority to strengthen food safety within the f d a and i think that there are there many things that we can do to strengthen our program to improve accountability to raise the issue as as a high priority part of strengthening food safety within f d a is strengthening coordination with critical partners as well and that certainly means with u s d a and i look forward to a productive working relationship with them it also means strengthening the working partnerships with state and local public health organizations and it importantly also involves working with other international agencies and government foreign governments because i think we're going to see the percentage of food coming in from overseas increasing in the years to come and the globalization has a profound impact on the work of the f d a and i also do think that the authorities and tools that this new draft legislation could potentially provide to the f d a will be extremely important in in moving the federal government and the f d a in the direction that we need to for a robust and modernized that i'm confident you're going to do to improve food safety and this country as i mentioned in my opening statement a while has been hit hard by issues arising from to safety in the past year there's been a hundred and five cases of salmonella reported in ohio and sadly three deaths resulting from the most recent peanut based strain nellie napier with a constituent of mine who unfortunately died from salmonella poisoning that she can attracted a nursing facility and just in april of this year in cuyahoga county there were three incidences of illness from e coli and another at this time a seven year old girl so this is an urgent  issue for the people that i'm so honored to represent i mention that i introduce to protect consumers act which was a bill that would give the f d a mandatory recall authority and i'm happy to see that it is a part of this comprehensive bill  and i just like to get a little bit more of your opinion about the need for recall authority and this bill of course seeks to remedy the situation of the f d a not having the mandatory recall authority by laying out two different types of recall tori's first if the f d a believes there are certain food may cause adverse health consequences or death the f d a can recall require recall but in that scenario f d a must first give the company an opportunity to voluntarily recall its own products and if that doesn't work then the f d a can order a mandatory recall and then of course the second type of recall is an emergency recall if the f d a finds that a certain food presents a threat of serious adverse health consequences or death you may do that immediately can you just tell me about whether you think that the need and the approach the two tiered approach is is addressed in a good way in this bill and why it makes sense well i think the history is that voluntary recall is often effective in getting those potentially harmful products off the shelves and protecting consumers but that you do need that emergency mandatory recall function as a as a backup there certainly have been cases where the mandatory recall of a dangerous product has been delayed because of a reluctance on the part of of the company to to pull that product and there's has been a back and forth and lawyers involved and delays of  weeks putting consumers at risk so i think that to have the mandatory recall as a emergency measure is is very very important and sadly in a world where we  might also need to address intentional contamination of food that emergency mandatory recall becomes becomes a very very important tool if you know i think the reality is that it is having that as an enforcement tool probably makes it easier to also work with companies on the voluntary recall so i think it's a continuum that we need we need both with the general generally oh just on the same point just a follow up on this i have very little time but i'll yield just a follow up i one of the issues would be may cause that's kind of a low standard i think there's going to be concern about the may cause language in here and how do you define that yes well we discussed that earlier and i think perhaps there are some words missing that could be done on that thank you i think my colleague sure and if i could just follow up  n the the suggestion that has been made and some have argued that because mandatory recall is such a strong toll that only the commissioner should be able to exercise the authority to order a recall with no further delegation and i just wanted to know about your thoughts on the approach of having only the commissioner order a recall and how that would work for the f d a and frankly while i'm at it would such an approach work with regard to suspensions and subpoenas and what are your thoughts about those subjects well these are important and powerful authorities that shouldn't the use lightly however i think that experience shows that senior level officials can be intrusted with these authorities along with the the commissioner but it's certainly something that we would want to to work with with congress on in order to to put in place the system that people have the most confidence in i think you and i  i'm certain that we share concerns about expediency and making sure things happen in a quick time and i think that your answer on the way that the recall authority would work you having the manticora mandatory authority would give you an opportunity to to encourage even more strongly they would be necessarily encouraged the companies to comply and their own as well so thank you very much thank you mr green thank you m committee in reforming the f d a and then last year all the food safety issues that came up it seem like we're we're back at it again and i'm glad you're there in my opening statement i mentioned my concerns about the location a number f d a labs and i beach important tons of food yet we don't have any f d a lab and i had the honor meet my f d a inspectors on the docks at the port of houston but they are detailed out of laredo texas and i guess because it's such a large state in the need for lab somewhere i'm glad the bill does include the ability to contract with labs because that's we wanted inspections done is quick as possible does the place these labs and what considerations replacing in place like texas or even southern california i don't know southern california didn't have a lab with a long beach and that's my only question thank you sharon well you know i'm  fascinated that the laboratory issue comes up so much here because it's such a key issue and in my past experience as a public health official it's it's often the laboratory that the underappreciated component of public health needs so this this is this is very encouraging to me at the present time we don't have any plans to expand that basic you know never team laboratories that you mentioned although as i said to  congresswoman harman you know it with additional resources and an expanding need that might be a possibility we will be creating some additional high throughput laboratories and in all honesty i'm not i'm not certain  about the process by which those laboratories are being developed and sighted it's something i need to go back as as a very new f d a commissioner  and learn more about but the laboratory issue is is one that is essential as we've discussed i guess the reason it comes up so often is that over the last three years actually our our committee spent so much time on you know pharmaceutical safety food safety concern is that we're importing so much of our food like you said laredo texas probably the biggest land based force in the world and so much food comes from mexico we need the inspections it's timely as possible to move the produce or whatever the products of foodstuffs particularly but we also need to make sure that it's and the problem is it's not paid for but with this see that it's going to be assessed hopefully that will generate the resources both for the personnel and also for the facilities and i guess if you're having a contract with private labs that may be great but there are times that a public lab would would be faster and ultimately cheaper to the to the folks who pay the bills and so that's why i just asked the f d a to look at that that it i'm glad we're going to contract because we want the commerce to flow but  if there is a need to have a lab that would be more economical and just as fast as contracting the private labs then i would hope this funding source because i guess over the last three years our hearings have said if the ace their staff we don't have the staff we don't have the resources we're going to try to give you the resources in this bill and hopefully the higher the staff and have the facilities and let me also just assure you that that your constituents are not being compromised in terms of of the laboratory testing that that's needed to protect their food supply because samples can be be shipped to labs it doesn't it in the modern era it can be done in a timely and  safe way so so that the coverage in terms of laboratory testing is still available but i hear and understand your concern about the gap in terms of a onsite facility  in in your region well and i think the fear that some of us have is that we don't want to play favorites these ports compete for cargo and we don't want to be based on that there's not an f d a lab or it's slower to get this through one port as compared to the  here as chair of oversight and investigations and one the authors of the food safety enhancement act we've seen at about nine hearings in the last two years just on food safety and certainly as a major problem one of problems i found every time we had a hearing there was always a lack of information that the f d a did not have from either the manufacturer of the food or the pro producer of that food and it was always difficult to get information in the safety and hansen act authorizes the f issue subpoenas for records and other things relevant to a hearing investigation or proceed or relative to any other matter within the f d a has jurisdiction including matters under the public health service act and the federal anti tampering act do you believe subpoena power would be beneficial to the f d a it's very important for us to get access in a timely way to the information that we need and i think that the that authority will enable us to act more swiftly and effectively yes well we hope you would because i still i think we're still waiting for information from the two thousand and seven salmonella outbreak in peanut butter and from the georgia plant blakely georgia link we got all that information that are not part of a pretty particular hearing or investigation of a specific violation of the act there seems to be a fear that f d a will go on fishing expeditions constantly stent sending out birds on this quest for documents how would you address these concerns well i i think that we have enough work to do without going on fishing expeditions we would be seeking information that would be of vital importance to addressing that the tasks at hand it would it would be of great value to have the ability to access critical information to inform the inspection process as well as to inform outbreak investigations and i think that if we are going to be able to to really move forward to ensure the safety of supply this is is one of a number of and of tools that will enable us to really do what needs to be done and that's refreshing to hear because i've been pushing subpoena power for the f d a for ten years and get a witness to agree with me from the f d a but by the time i got back to my office the f d a had called me and say that's not the official position of the point i think it's important we look at all the documents and all the evidence and all the studies not just two studies when there's over one hundred other studies that raise concern and pino also on food safety on the lab labs and we actually had to put in legislation to make sure these field people critical work for the f d a and for the safety of american people stay on their jobs and you recently wrote back to me myself and chairman waxman indicating that there are no current or future plans to close or consolidate any of these thirteen field laboratories and they also went on and said that you're actually hoping you'll be able to hire at least seventy seventy new analysis for thirty labs to replace staff last this or the last few fiscal years so thank you for that and it without objection i'd like to place the record from the commissioner in the record this letter in the record without objection so ordered let me ask you one more question if i may risk based inspections schedule one the important requirements in the new food safety bill will be to put into place is passed is a risk based inspection schedule for food facilities under current law even risky facilities can go years between f d a inspections but our legislation has strict requirements to make sure f d a inspection inspectors actually get into the riskiest facilities as frequently as possible the risk its facilities must be inspected at least every six to eighteen months no food production or storage facility will go more than four years between inspections under current law there is there is not any requirement regarding how frequently these and facilities must be inspected his or there  is not and i think that you are desired to see to see a risk based strategy the put in place is absolutely key so that we can target resources on the highest risk does this bill give you the flexibility you need to modify the inspection goals based on available resources and the best available evidence on risk well as i said in my test of tony i am concerned about the requirements for inspection outstripping available resources and that's been a chronic problem for the f d a in terms of being able to fulfill its important mission i think that it's the no strategy outlined in the draft legislation is a wonderful aspirational goal i would love to be able to sit here and say that f d a could take it on and fully achieve it but there is a reality  of limited resources both dollar and human and i think that's where we need some flexibility to to really look at the numbers and really also begin to move swiftly  in the direction outlined in this bill but also try to to learn as we go so that we can can find ways to do our inspections in a more efficient targeted way and really focus on the the highest risk and really try to leverage other resources to achieve the goals as well through partnerships with state and locals partnership with with foreign governments and potentially with with third parties that are certified and overseen by the f d a to help us particularly with respect to the burgeoning number of foreign sites for inspection thousand facilities would provide enough resources to do the inspection and other work that the f d a sorely needs to the resources and the personnel to do it we understand that hopefully they'll be part of bill and thank you mr chairman thanks for your help on this bill issue because in the subsection three it says any other matter relative to the commissioner's jurisdiction under this act there's not a i would i would like there to be i'm a cause i don't i have a promise to make causing the other part of the bill or the draft we should at least have a make cause for offering us subpoena someone and so i would hope that we that would be something else we look at so i think there is some issues we want subpoena power but we want to be for a reason we just don't want to be at the at the whim of with all due respect dr hamburg the radio number let me ask you a question with regard to another area and that is the registration and fees collected from commercial importers and there's been a change in this graph from previous graphs that we have seen specifically why should drug and device manufacturers who currently already pay an annual establishment the be required to pay duplicative the and what entities are really encompassed within this commercial importation fee schedule well the the import the refers to the fees on the the individuals or the companies that are serving as the the link between foods that are our loan process manufactured overseas and being brought into the united states to be distributed consumers here and and so they're not necessarily representing a given manufacturer but but it's a very important function because it's that bridge between  what is happening on the international scene and what is coming into this country for you specifically with regard to the drug and device manufacturers who currently already register and already pay a fee would you envision that they're i don't i need to go back and look at this issue with respect to devices because i don't i don't know how that system is set up whether it's the manufacturer that is serving in that role or not so i i will be back and would you take a look more about that i think that's one that we really seriously need to look at i don't think we ought to be duplicating what you're already doing because you have jurisdiction they are i think that would be on fire let me ask you also quickly with regard to  tracing of food the tracing system that is put in place for you to issue regulations it appears that that would include the restaurants to be be able to have traceability and i'm told about seven out of every hand eating the stablish much are not part of chain operation they're just independent separate food operations i'm just curious as to whether or not you think that this would have a serious impact on the small business owners and do you think we ought to do cost benefit analysis before we impose that can of cost on these individuals but i think clearly we want to work with with restaurant owners and small businesses in order to make sure that the systems are not too cumbersome but it is very important that they keep records because if if there is a tainted food that is is in their facility the implications for the health of their business as well as for the health of their consumers is is is very significant indeed and i think that they would they would want to be able to assist in sharing their information about where the food came from so that the the traceback in occur and we can identify the source of an outbreak and control it so i think they very important link in the food supply chain and you know protecting health really depends on them keeping records let me ask you what is if the done to implement the current what i think is called a one one back traceability requirements what has been done to implement that well the the one up one back has been in place as i understand it for for a while now but it is it it has proven not to be adequate to really capture the the the full lifecycle of a product and that we really need as i mentioned earlier the the full supply chain to be documented and integrated interoperability not just fragments you know is really key to successful in swift investigation of outbreaks and the ability but you may know that i have a bill that calls for b p a to be banned from being used in food and beverage containers because of the risks that have been  identified we've also recently learned that food and chemical industries have launched a public relations campaign opposing any efforts to deal with this issue is the f d a concerns about a and what the f d a plan to do about those concerns well we are concerned certainly i'm aware of you know some of the the studies that have have raised issues in in animal populations and some of the information about b p a in many components of the the food supply are starting to see activities at the the local and the state level in terms of of action with respect to b p a and i i would hope that that f d a could really be providing leadership on some of these issues of of assessing  and analyzing risk we are taking another look at the b p a issue the chief the acting chief scientist at the f d a has been asked to take the lead on this because of course this is a decision where we have to bring the best available scientific data to bear we need to look at at all of the studies and examine them but it's an issue of great consequence for americans as  as a mother as well as as a physician it's an issue that i think we need to look at seriously and i look forward to be able to come back with some reports from this serious  look that's being taken and we've backed that it's going to be a task for him over the summer to lead this this review and by the end of the summer we beginning of fall we hope to be able to to put forward a fresh look at the b p a issue do you have any advice for parents who are concerned about their children ingesting this chemical well i think of course parents that are concerned can find alternatives that don't have b p a and for the most part i think that those alternatives are are are pretty clearly labelled and pretty available and i think anyone with concerns you know should should do so ok thank you for your work on this if you can keep us posted on the progress you're making on absolutely evaluation of it thank you so much chairman thank you and thank you very much dr hamburg as as we've said you know we do intend to move forward on this bill next week and we appreciate your input and whatever else comment you may give us by next monday  my intention is to we have one vote will come back and then we'll hear from our second panel thank you thank you thank you for your leadership on this important issue the subcommittee will reconvene and i see our second panel is already seated let me introduce each of you on my left is mr michael ambrosio who is the from the food marketing representing the food marketing institute and he is the vice president for quality assurance division at wake for and food corporation next we have ms pamela g bailey as president and chief executive officer of the grocery manufacturers association and then we have miss caroline smith to wall who is the safe food coalition food safety director of the center for science in the public interest dr tim f jones who  welcome you know it's five minutes and obviously your statements become part of the record if you if you want don't want to if you want to include material more than the five minutes and we all heard before i know some of you are wondering if you can meet the deadline but since we do intend to go to market next week we i agreed with what mister mr shimkus said about will give you any additional written questions by the end of business tomorrow we'd like them back by monday at the end of business so we'll start with mike tim mike ambrosio thank you for being here again thank you chance alone ranking member dealin members of the health subcommittee i am honored to appear before you today on behalf of the food marketing institute to present our views and suggestions on the food safety enhancement act this gushing draft f m i and its member company share the common goal of enacting legislation this year that would generally improve the safety of the food supply steps that actually prevent the presence of adulterants in the food supply or only all the only true way to improve the safety of our food i am i can borrow zero vice president of quality assurance wakeling for a current food corporation i have been in charge of food safety programs at wake for for thirty years founded in eighty six wake for and has grown from a small struggling cooperative into the nation's largest retailer own non farm cooperative in the united states we are headquartered in keys be new jersey wakes and along with that shop right stores employees all the forty thousand forty seven thousand individuals in new jersey new york pennsylvania delaware connecticut massachusetts rhode island in maryland today i am also representing f m r i a national trade association that has fifteen hundred member companies made up of food retailers and wholesalers in the united states and around the world f n i f m i members operate approximately twenty six thousand retail food stores with combine annual sales of roughly four hundred billion dollars representing three quarters of all retail food store sales the united states f m y s retail membership is composed of national and regional chains as well as independent grocery stores this morning i will present several of the families recommendations for revising the bill but i guess that my entire statement be included in the record in april in two thousand and eight i testif before the subcommittee on legislation that would have modernized the over and over hold the food safety systems up the food and drug administration since that time hole proposed profile food safety outbreaks and recalls involving tomatoes jalapenos peanuts and pistachios have not only made headlines but regrettably have caused illness and in some cases even death many of the themes and ideas that i share today will be similar to those that i shed in two thousand and eight but there are differences that reflect lessons learned and new weaknesses in the existing food safety system identified from these latest recalls as the purchasing agent for the consumer in the final link in the supply chain our industry understands it is vital to ensure that the f d a has had necessary authority credibility and resources to meet the challenges of today's global market place consumer confidence remains an essential factor in this debate food safety issues can be extremely complex and consume was very greatly in the knowledge of the science and other issues affecting the safety of our food supply however as food safety issues do a national headlines consumer awareness as well has a well concern about the safety of commercially prepared food and products purchased at the supermarket heightens mr chairman i applaud you missed  for your efforts to address changes that are needed to improve our food says safety system we support many of the proposals in the draft by emphasizing the need to have preventive measures be the foundation on which the food safety system should be built the draft also recognize that we need to focus on the majority of resources on facilities and products that pose the greatest risk of contamination that could result in food borne illness or injury we must continue to be sure that any changes meet certain criteria be supported by science have measurable benefits be affordable be realistic and be implemented without unintended consequences first we applaud you for not only designating entire section of the bill solely to prevention but also putting this first and the most extensive section of the bill from our perspective this is the appropriate emphasis in addition i would like to specifically comment on certain sections of the draft f m i recognize a strong public private partnership is needed to help ensure safety of the food supply although every penny counts in these high and tough economic times there is nothing more important than improving and ensuring the safety of our food supply we are willing to support a fair registration or uses the provided that it is utilized by the f d a in a transparent and accountable manner to improve the safety of our food supply through maine such as conducting research and consumer education programs we look forward to working with the committee to address our concerns about how the f d a may utilize any fees collected we support the requirement that every register food facility conduct their risk assessment and implement and maintain a validated food safety plan and identify potential resources of contamination and appropriate food safety controls and document those controls that would prevent eliminate and reduce potential hazards it here is to food safety plans goes a long way towards developing a culture within a company that is critical to ensuring food safety mr chairman thank you for the opportunity to testify we appreciate the work that has gone into the development of the food safety enhancement act discussion terrific with the go improving food safety and the food supply and helping to restore consumer confidence in the food safety system i look forward to your questions your remain available to the subcommittee thank you thank you i don't know if that's on the mike or you don't have a mike  i'm pam bailey and i'm president and c e o of the grocery manufacturers association which represents more than three hundred food beverage and consumer products companies americans enjoy one of the safest food supplies in the world but we recognize that nine product safety is the foundation of consumer trust we look forward to working with the quick committee to quickly enact food safety reforms that will restore consumer confidence and will continually improve the safety of our food supply although the food industry is alternately responsible for the safety of our products a strong government oversight is a critical part of our through the safety system that is why g m a supports much in the discussion draft including your proposal to set safety standards for fruit and vegetables your proposals to improve the safety of imported food and food ingredients and your proposals to give f d a strong enforcement powers to deal with bad actors including mandatory recall authority in particular we strongly support proposals to require all food manufacturers to conduct a hazard analysis to identify potential sources of contamination identify appropriate for the preventive controls and to document those preventive controls its food safety plan we believe that food safety plans are the cornerstone of prevention in that they will help ensure that safety is built in from the very beginning we have proposed certain my of occasions to some of these provisions to your staff and we look forward to working with you in particular we look forward to working with you to address your concerns about traceability we recognize that the discussion draft instructs f d a to assess the cost benefits and feasibility of traceability technologies and give f d a the power to exempt certain foods furthermore we recognize that discussion draft instructs f d a to conduct pilot projects in public meetings however we believe these studies meetings and pilot projects should be completed before f decides whether and how to assign the food industry the responsibility for tracking a food product and which coding in a dentist occasion systems may be best suited to this task as you anticipate in the draft the cost in feasibility of requiring every manufacturer to maintain the full pedigree of every ingredient in every food may outweigh the public health benefits to address concerns raised during the peanut product recall we urge you to consider whether intermediate distributors and brokers should include on the labeling of their bulk and greedy and the identity of the ingredient supplier in general we support proposals to give f d a stronger enforcement powers including the power to order a recall we believe that certain enforcement provisions of the discussion draft such as mandatory recall and suspension of registration should only be exercised by senior agency officials when there is a risk of serious adverse health consequences and should ensure that companies are afforded certain due process protections such as an administrative hearing as we saw during the recent recalls of tomatoes and how opinion peppers recalls can have a devastating financial impact and they need to reflect the best science and w agency judgment finally we strongly support efforts to provide f d a with additional resources g m a helped create the alliance for a stronger f d a and we have worked with other consumer industry groups to increase f d a spending if congress an an appropriate role for industry our industry is significantly increasing our own investments in food safety in we are prepared to make additional investments to continually improve the safety of our suits food supply and to comply with many of the new mandates that are envisioned in the discussion draft we are not opposed to all fees and i am confident that the committee can reach a bipartisan consensus on the agency's resource needs and an appropriate role for industry let me close by saying again that the food and beverage industry is committed to working with you to quickly enact food safety legislation which makes the prevention of contamination the foundation of our food safety system thank you thank you mr well thank you very much thank you for your leadership temple loan and also the leadership for many other members of this subcommittee and committee and i also thank you for you to you our ranking member deal for for the many hearings that we've sat through we've listened to the witnesses it's just this is this work has been going on before this committee for a long time and i think hopefully we are nearing an end my name is caroline smith the wall director of food safety for the center for science in the public interest but today i am representing ten consumer public health and victim's advocacy organizations that are members of the safe food coalition let me begin by saying that we believe this is a strong bill that will employees improve food safety it requires food companies to build into their process is the conduct of regular and they have to institute preventive controls to prevent problems from occurring it provides a modern framework for food safety oversight to replace the antiquated food safety laws that have him strong the food and drug administration it gives f d a essential new authority to carry out the mission of preventing illnesses and outbreaks and to inspect food plants much more frequently and it addresses the funding issues urgently needed to institute the program improvements doing this with a modest registration fee the heart of any effective reform effort lies in prevention which is in the bills hazard analysis and preventive controls section the bill provides f d a with new tools like written plans and access to processing records that will allow government inspectors to review the conditions in plants over time not just when inspectors are in the facility we recommended dition all strengthening of the bill by requiring companies or labs to report pathogens on final product samples to f d a whenever they are encountered in a facility this would give f d a an early warning of problems and my prevent another tragedy like the outbreak linked to the peanut corporation of america it is a common adage that you cannot detect what you don't inspect random and frequent inspection by public officials is a necessary component of an effective food safety system this legislation divides food companies into three categories based on risk and directs f d a to inspect the facilities ever six months to four years well this is a vast improvement over f c s existing program we continue to believe that more frequent inspections are needed particularly of high risk with silly these respect inspection is a concept that expands across the entire spectrum of food products not just those regulated by f d a the registration fee as proposed is quite modest and it a thousand dollars per facility it should provide somewhere between three hundred and four hundred million dollars in new revenue for food safety activities let's put this into context in the peter pan outbreak and add the average cost per victim reporting and illness was two thousand six hundred and fifty dollars and this is based on an estimate using the economic research service cost calculator so when there is an outbreak consumers of who are affected may pay over two twenty five hundred dollars or more these are individuals so clearly a thousand dollars fee on each facility to avoid these problems is more than reasonable especially when compared to the cost of individuals and families that you've had here before this committee testifying on on the severe impact of foodborne illness in addition i'd just like to note that companies themselves can run run advertising campaigns to promote the their products that run into the tens and even hundreds of millions of dollars to conclude i just want to say that polling has shown that the public has lost confidence in the safety of food the percentage of consumers confident in food safety fell to a about twenty two per cent according to the university of minnesota's food industry center this legislation provides a modern framework for f d a regulation of the food supply that will deliver many benefits to consumers though it does start stop short of structural reforms that we also think are essential we appreciate your leadership and we believe that these new authorities that you're proposing will over time prevent the outbreaks and illnesses and help restore consumer confidence earlier this year members of the energy and commerce committee made commitments to the victims of the peanut corporation of america outbreak finalize this legislation and to enact it thank you thank you dr jones mr chairman members of the subcommittee thank you for the opportunity to be here today recent high profile outbreaks demonstrate the huge challenges and opportunities for improvement in the nation's food supply in food safety infrastructure laws policies in the be frank philosophies developed decades ago no longer suffice to successfully meet these doing new demands the legislation we're discussing today is therefore a critical step in reviving the food safety capacities of the f d a i work in the state health department as an epidemiologist responsible for investigating food borne diseases and effect cleaning up the mess left when things go awry in the food safety chain i'm excited to see that this proposed legislation addresses many of the problems that i experienced first hand in my role both investigating and helping prevent  improving the traceability of food as called for in this legislation is fundamental to successfully achieving many of the other tasks described if traceback information had been more promptly available and shared faster i think that many of the problems associated with the recent tomato jalapeno incident could have been mitigated and likewise tracing peanut butter from one plant to four thousand different commercial products would have been utterly impossible with many other types of foods ensuring that all foods are traceable efficiently and accurately is critical to maintaining food safety contamination of produce and foods which are eaten uncooked are of particular concern because consumers have less control over the safety of those foods in their own kitchens setting standards for pre harvest food production starts to close a major current gap in the nation's food safety system suspected produce associated illnesses are particularly difficult to investigate from both the public health and regulatory perspectives while large food service corporations and their suppliers often have excellent quality control programs with impeccable records many other companies don't the portions of this bill requiring country of origin labeling improve distribution records and plans to regulate the safe production of harvesting of fruits and vegetables are important to help address these problems i'm pleased to see the agencies being career in courage to markedly increase the scrutiny of food handling and it is i'd like to emphasize the importance of basing inspections and product testing and any other interventions by the agency on sound science the bill does have important directives to improve testing in the science base of the agency's activities it's critical that from top to bottom activities are more efficient and effective and not just more frequent this builds requirement the agency's activities are risk based is particularly critical it's likely that as technology improves the value of traditionally defined inspections will change dramatically and i did urge that the agency retain sufficient flexibility and authority to adapt to changes rapidly and with this few barriers as possible i think it's important that any discussion of the food safety system to emphasize the importance of interaction between f d a and c d c along with state and local partners in meeting the directive to enhance the science of food safety and develop risk based approaches data from c d c and its partners on things like outbreaks disease surveillance and attribution of human disease to specific foods will be critical it's imperative that such data are developed and shared cooperatively to meet the needs of all the partners involved in the system and every discussion that i've been in participate pertaining to food safety the importance in current inadequacy of in effective information sharing is probably the most common single topic that's raised and pleased to see that an issue addressed in this bill improving the technological capacity to share information will be important in accomplishing this but perhaps even more important is changing the ingrained policies of not sharing information among partner agencies far beyond any logical limit even when the failure to do so threatens the public health to meet the mandates of this bill f d a will have to increase interaction in coordination with state and local agencies which will require funding and focused attention federal regulatory agencies frequently are prohibited from sharing proprietary information obtained during investigations flow of information both directions between f d a and c d c as well as state public health partners is critical examples of this include such things as distribution lists during recalls information on suspected products or producers and information on potentially exposed people the f d a c d c and other partner agencies must have both the authority and expectation actionable information with public health partners to the extent necessary to protect the public's health and i'll conclude with a final comment about the importance of ensuring f d a and its that its and its state and local partners have adequate resources to meet the responsibilities with which they are charged in this bill no one would argue that the f d a is currently underfunded overworked and essentially overwhelmed state and local food safety capacity must also be robust in order to maintain an effective food safety system adequate and consistent funding and resources must be dedicated to explicitly to sustain the food safety programs that f d a as well as the state and local partners who work with them to keep the food supply safe americans will eat a billion meals today and i can't think of a better investment than one that will keep every one of those meals safe thank you dr jones mr stenzel good afternoon chairman paul own ranking member dealin members of the  subcommittee i'm pleased to be with you as you know that the fresh produce industry has been a leading proponent of strong federal government oversight of food safety my name is tom stands on president and c e o of the united fresh produce association organization has been privileged to testify ten times in the last two years before this committee or other members of congress perhaps only runner up to caroline on this panel our board of directors in january two thousand and seven adopted a series of policy principles calling for mandatory science based regulation by the federal government today we could graduate you in the leadership of the full committee in presenting the draft of the food safety and handsome an act of two thousand and nine for consideration while my written statement contains a number of suggestions for strengthening the bill i'll focus just now on three key areas of concern let me start by repeating those policy principles i mentioned to protect public health and ensure consumer confidence produce safety standards must allow for a commodity specific approach based on the best available science must be consistent and apply couple to the identified commodity no matter whether it was grown in the united states or imported and it must be federally mandated with sufficient federal oversight of compliance in order to be credible to consumers we're pleased that these principles are recognized in the draft food safety and hansen act and looking specifically at the draft we strongly support the bill's intent in section one hundred four for f d a to focus on maximizing public health by implementing regulatory standards for those specific raw agricultural commodities that it believes are most critical the f d a has estimated that only five commodities have been associated with eighty percent of all produce related food borne disease outbreaks in the past ten years and that is where we must direct our resources in a highly diverse industry that is more aptly described as hundreds of different commodity industries one size does not fit all we support congress specifying that f d a have broad authority to regulate any produce commodities it determines necessary but with a clear mandate to develop rulemaking that focuses resources for maximum public health benefit on those specific types of commodities for which the secretary determines that such standards are necessary to minimize the risk of serious adverse health consequences we also recommend the section one hundred four strengthen the support for collaboration between h h s and the u s department of agriculture and all state agencies in all areas of education research and enforcement with regard to produce it's important that we bring the broadest knowledge and resource base possible to assist all stakeholders in understanding and complying with f d a set public health standards the only with section one o seven on traceability i want to assure the committee that the fresh produce industry is committed to farm to for traceability of our products  presented in detail testimony before the house committee on appropriations chairwoman de la rose ag subcommittee this earlier this year here we have under way a produce traceability initiative to provide electronic traceability for six billion cases of fresh produce that move annually within the united states this is a massive and extremely expensive long term undertaking but it's a commitment that we've made however we are concerned that the prescriptive nature of section one zero seven could actually  derail these important efforts to bring the most cost efficient and cost effective technology to bear on this challenge as you weigh various traceability provisions we urge that congress set the goal the mandate for food traceability but not overly  scriptive requirements such as those in this bill rather we believe congress would be more effective in mandating an intensive evaluation of technologies systems and pilot tests that will truly lead to the end result we all desire to that point this legislation should set a goal for total supply chain traceability across the food industry not single out individual food categories for traceability finally on the question of imports i believe the committee should carefully examine all of the provisions regulating imported foods to assure equal treatment and fair standards for imported and domestically produced foods there should be a principle maintained throughout all provisions in section two zero one we support the bill's intent to importers to register with f d a and comply with good importer practices the committee should make clear that this is the standard protocol for importing foods and that the limitations and restrictions invision in section one zero nine provide very extreme authorities to be used by f d a only in worst case scenarios when required to minimize the risk of severe adverse health consequences with regard to imports we also strongly support the concept of the safe and secure food importation program in section one thirteen and urge that the bill require f d a to implement such a program with clear direction that it shall be implemented rather than may be implemented finally let me mention one forty three and country of origin labeling the fresh produce industry is already required under the two thousand and eight farm bill to provide mandatory country of origin labeling it retail point of sale our industry has moved rapidly to ensure compliance with this law  urges that those products which are already covered be specifically exempted from any new depleted coverage under the f d a and c act let me conclude with a comment about public health the very department of health and human services that regulates our safety has the dual responsibility to promote public health but consider the fact that we need as americans to double our consumption of fruits and vegetables to meet this very simple u s dietary guidelines with that public health imperative fears of food safety have no place in the fresh produce department thank you for your leadership on this effort thank you and thank all of you will now take questions from the panel five minutes each and i'll start i wanted to start with mr will  there are many in the industry have that have called for prevention i should say a stronger emphasis on prevention and many feel that we need to share the responsibility for making food safe the f d a obviously does an important job but manufacturers in this also be responsible for the foods that they make and one of the ways the draft before us proposes to do this is through a new emphasis on prevention it requires companies to conduct has analysis to identify potential safety risks for the food they handle it then requires that the facility owner adopt preventive measures to reduce or eliminate these risks so mr well can you elaborate on how preventive controls such as those put forth by the bill will help make food safer and could you give us some examples of preventive controls and how they might be implemented or applied thank you chairman for a lot we the systems that are going to be applied in this spill are well tested  we have watched the implementation of what are called half up or hazard analysis critical control point systems in the seafood industry in the beef and poultry industries and in  the also in fresh juice and several other industries the problem with the approach that f d a has been taking up until now and the solution that your bill will bring to the agency is that they've been trying to apply these systems one by one industry by industry and i think what you see here is a unified unitary view among industry and consumer organizations that these systems are needed across the board they're run developed by the industry they're driven by the industry they design the programs but the government can use them tax we go in and conduct inspections which are much more meaningful than the ones they do today well let me ask each of you miss bailey and then go to the others quickly if you would respond whether you support these preventive approaches to food safety absolutely yes  talk to jens yes or we do all right i mean obviously we got consensus on the preventative approach being a critical part of the bill i wanted to ask about access to records  to one of the new requirements in the bill references access to records section one of six requires that food manufacturers and produces retain records relating to the foods they produce and upon request provide these records to the f d a f d a will in the event of a food borne disease outbreak or during an inspection have access to information how foods were produced manufactured transported or stored and initially johns can you describe for us how this type of records access would be helpful to the f d a in the event of a food borne disease outbreak well i mean i think access those records are critical in order for them to sort of pinpoint their interventions but i also think the ability for f share that data with other agencies that assist them in those investigations is critical and that's been a huge barrier for us they have worked on outbreaks where f d a had the names and phone numbers of people that had consumed contaminated product and would not or thought that they could not share that information with public health departments that are responsible for calling those people and telling them not to eat the stuff and that's just mind boggling to me i mean i think it's subtle but there are some addressing that issue in this bill you want to comment on some is due on whether you believe that this access to records provision will help protect public health the access to records provision gives the agency the ability to look at plants when they visit them they can look at them as they're operating over time today when an f d a inspector goes into a plant they just see the four wall the plant they may not even get access to any records in that facility they can look at production practices as they're happening on that day but with the access to records provision together with th preventive control system in this written food safety plan the the inspector will have be able to go and look back at where the company has faced perhaps challenges in its operation and how they've addressed them ok thank you you mr deal thank you mr steele i guess i'm going to start with you from the produce or side of it first of all in a general context  do you see any problem or potential of this legislation creating overlaps with f d a jurisdiction and requirements to do things versus current u s d a requirements to do things in our food supply we don't see any jurisdictional issues and public health in that sense f d a has the statutory authority now to regulate the fresh produce industry we do suggest strongly that down there be a good coordination with the u s department of agriculture in education in foresman certainly one of the keys to implementing this bill is going to be an effective structure with f d a working with u state and local agencies in compliance enforcement inspections that needs to be strengthened but there's not a jurisdictional issue of competing authorities monitor standing is that it the production level that good agricultural practices are the primary preventive to an mechanism for dealing with it the production level do you see perhaps that and updating or improvement on those agricultural practices standards as they apply to fruits and vegetables is important and is there anything here that would prevent that from taking place yes or a deal that is an extremely important part of the f d a is good agricultural practices are called to be updated in this draft legislation we strongly support that is the baseline guidance for all fruits and vegetables for those specific commodities in which f d a is deterministic if again level of risk then you move into the rule making procedure but that's one of the key things is the way we can best focus our public health resource on the greatest risk i said in my testimony that eighty percent of all the outbreaks have been associated with just five commodities so the basic good agricultural practices are very appropriate for all fruits and vegetables but let's focus the rulemaking on those specific commodities that require it  i believe you made the point that since we have mandated studies in pilot projects etc that those be completed before we start trying to write the rules and regulations is that one of the points you were making on tr yes it seems to me that if we're going to do the studies in the pilot projects we ought to do that before we write the regulations because presumably they will give us the information to guide us in the room making process so i think your point is well made in that regard insoles your industry has already put in place some traceability standards how do you see your current efforts in traceability how do they correspond to what's in this legislation i tell you this is proving to be a massive massive undertaking and we are committed to doing it even on a voluntary basis before any type of requirement but externally complex system of creating that operable system that can see the lifecycle all the way through of our products but some of the specific language in this bill the full pedigree of each product gives us great cause for concern even though we're moving down a path of hundreds of millions of dollars being invested in interoperable traceability systems we don't think they might meet exactly the terms of this bill so we would also strongly advise that f d a be mandated to get involved in that technology in the pilot test learn about each industry and then write the regulation it's premature to tell every industry exactly how it should be done until we have this greater learning  one of the scares that we've alluded to here was the mexican pepper scare that adversely impacted the tomato industry and i guess i would ask you again how how do we ensure that foreign producers meet the kind of standards that we would need would it require in your opinion some kind of foreign producer verification system of some sort i think the requirements in the import section are appropriate that importers will now be required to register with f e m a and as part of get good importer practices they will have to assure that their products have been grown in accordance with the standards we believe that is an appropriate step to be taken i don't think anyone in visions going searching around every farm around the world nor every farm in america to be honest with that that's simply not going to be the case the authority should be there for f d a if they need to investigate an issue  but the basic responsibilities going to lie with the importer where the food manufacturers and does your organization represent the organics producers yes or we have a number of organic suppliers in our group would you entertain us i have a statement and i think we cleared it with your staff from the frozen food institute to be inserted in the record without objection so what did chairman dingell miss german thank the industry or the consumers for a number of years that's right and as a result they have been unable to adequately fulfill their role in ensuring the safety of the nation's food supply example of something they've not been able to do without adequate resources that sounds like a very serious matter tell us what that means well good manufacturing practices serve the basis those are required both in food and drug pharmaceuticals that's right and so the preventive controls that we're talking about and half that for example are one step up from good manufacturing practices you want to have them updated and as we all know there's been enormous advances in manufacturing and food processing since one thousand nine hundred six relating to pathogen control environmental testing all of that the advancements and f d a has not been able to incorporate them into updated good manufacturing practices guidance for industry would you also surveillance and research that's right would you agree that they have not conducted a satisfactory number of inspections over the years this figure i got with which seems interesting f d a conducted six thousand five hundred sixty two domestic food facility inspections of two thousand eight hundred fifty two foreign food facility inspections in two thousand and eight the total number of registered facilities is three hundred seventy eight thousand but there are many more out there in the world who are shipping stuff to us is that a first date that's an accurate statement yes thank you and i'm sure you are you agree as you have said in your statement that f d a needs additional resources to do their job yes industry to work prosper chivas have a satisfactory food drug administration one which protects the consumers but also which doesn't overburden the industry and we look forward to continuing your efforts on that and i hope th for those discussions going forward  i'm troubled about foreign people who deliver food into the united states food and drug doesn't have the right number of inspections and inspectors at the border do they know that's right they did not i'm told they only ridge is back about one percent of the foods coming in tonight as states and the games are played off times where the third turned back rather where food about the fact that food and drug has no understanding with their sister agencies with customs with immigration so as a result lot of time surge factors will be at the porch and there's no food and drug folks there where to where to see to it that there's a proper agreement to make that makes it possible so that they would work together instead of ignoring each other's business there are i think that sounds like a good idea now i know that i   it's a it's a very vague term ok miss bailey may cause i'm not certain mr wall thank you the actual subsection says if the secretary has reason to believe that the use or consumption of or exposure to an article of food may cause adverse health consequences so the actual standards or is reason to believe and the may cause is is in there but if it really is is the standard which is very protective of public health thank you dr jones i agree with those comments and mr sensel i believe that it's a much more vague standard that and i hope we can work to clean up that language and i think there's an opportunity to do that let me ask this subpoena question again to those who may want to talk about that there are three criteria in section three eleven which i didn't allude to the first versus any hearing investigation other proceedings respecting a violation of the act i think most people agree any hearing investigation or other proceeding to determine if a person is in violation specific provision of this act i think an average person would say ok subpoena these babies the third one any other matter relative to the commissioner's jurisdiction relationship between the food drug and cosmetic act and these other legal statutes i think the language may be appropriate but maybe may not well may not come back maybe you got it ok thanks dr jones i'm a physician  hearten harm folks by the language found the language log very important and interesting things can be done as crafted mr stenson i think it's also quite a general standard and  minimum standards for safety this is a lot of the language stuff that i've been focusing on day why would we want the agency to issue minimum standards instead of the appropriate standards for safety mr ship thank you for raising that it's actually a subject i addressed in my written testimony i don't think we should be using such terms as minimum or expecting minimum standards we should have the agency write the standards that are most appropriate that all production producer should follow i can tell you this that as soon as we have minimum standards the first thing is going to happen is someone's going to say that's not good enough so if we're going to go down this path let's make sure the agency writes the most appropriate standards and that said whole debate that we always have a peer about some certainty industry needs certainty if we have vague language there is uncertainty and with uncertainty comes higher risk because of trying to comply that's ok i appreciate that and let me  what was surprising in the draft is and i was annoyed i last congress i can't talk about what was the hearings in previous congresses or what's going on this time but baby formula has popped into this debate and i know of no hearings on baby formula in the last congress when i was ranking and when i have there been any reported problems that was suggested there needs to be a reason to change way infant formula is regulated in the premises it's highly regulated already can you want to comment on that yes we are not familiar with the origin of that provision we noticed it in this draft we are of course aware of how highly regulated regulated baby formula is and we are interested in receiving further information but it obviously is very important as is the safety of the product and the availability to the mothers and children and taking care of my my time expired i would have gone on with a pilot program i think that's been discussed a little but i know mr ambrosio has some comments and i think a pilot program might be important and i you the problem that we have is there's an important vote in our other subcommittee so i'd like to adjourn for just five minutes so that the members can go and vote in the other subcommittee and we'll come right back so the subcommittee if you bear with us just in recess for five minutes ok this subcommittee will reconvene and ms to get thank you very much mr chairman i want to echo mr dingell thanks to every single witness here for working with us on this legislation all of your input has been very very important and none of you will be surprised to know i want to talk about the mandatory recall provisions of the bill and i want to start with mr well first of all do you think mr while that the current buyout provisions of the bioterror mack are sufficient to give us the mandatory recall that we need in a robust food safety system no i don't and why is that well the bioterrorism act actually didn't really give them mandatory recalls it but it does give them the authority to take certain actions like administrative detention and some other actions when when they meet a very thought so once thank you for that the case and the one step the one step up and one step back traceability was a good first step into this area but i think the provisions in in this bill are much improved on that what we've seen over the years since that law was passed is that the f d a itself has had trouble with identifying food products involved in major recalls and outbreak because it just doesn't go far enough forward or backwards correct right they dr jones you're nodding your head yes as well yeah i mean i think you know there's such a huge food production chain that if there's one point in the chain where records aren't good you can i mean t recommended the secretary be allowed to design systems based on the information gathered and not be mandated to develop a specific type of system prior to those efforts care act and and ms bailey in your testimony your written testimony you talked about the concept of including intermediate distributors and brokers in the labeling a book ingredients the supplier so that we could get that traceability correct that's right and mr stenzel your i've got to say the produce industry in this country has was really a b i shouldn't say this in front of everybody else but you folks were the ones that gave me courage to believe that we could do traceability because you're doing such a great job so i want to commend you i guess i guess the issue as i heard in all of your testimony today is some concerns with the specific language of section seven of the of the committee draft would that be accurate to say miss bailey that i'm right and and i just want to you know you talked in your in your verbal testimony today about the tomato recall and you were talking about mandatory versus versus voluntary recalls but but that made me think about traceability too because it doesn't really matter if the recall is mandatory or voluntary if the ability to do it quickly trace where contamination came from foods correct and and you know what what we've been seeing lately i was i was thinking about the latest the pistachios where they were saying just don't need any then i thought well what if you had to stash shows that were incorporated in granola or something like that that went a long way you could really devastated food agency miss bailey i wonder if you want to comment on that i think first of all we're absolutely sympathetic with your goal in the importance of and proving are traceability systems i think it's a matter of prioritizing how we go about it that's why we recommended there's there's first of all there's a difference between a single product like a strawberry or that is that is ready to eat versus ingredients that may be co mingled in right into addition exactly right and we saw in the peanut paste problem that when their brokers involved p c a would sell the paste to a broker who would then sell it to an end manufacturer and that's why we included the recommendation the right distributor label it now going forward what we have learned working with our member companies and other areas of the food industry it can be enormously expensive when you start to deal with commingled ingredient because commodity products and that's where we caution and we think the legislation has it absolutely right let's write a dent if i cost benefit because in the end resources are finite right but let me just say because my my time has expired that that i really hope all of you will come in and work with us on this particular tr language because from the from the very early days of my working on this issue what you're saying is exactly my view which is we need to have traceability throughout the industry but that we can't have a one size fits all traceability system or technology the key is those things be interoperable so if you have peppers and tomatoes mixed in a salsa that's one level of complexity if you have that salt incorporated in a processed food that's another layer of complexity and then if you had that put into something at a restaurant or a or any place that's another layer so we have to really work on that what i'm amazed about i had to take a deep breath because mr matheson and i and i guess now chairman dingell and gene green you know we've taken this trying to educate the committee here on electronic pedigree with regard to drugs yet now all of a sudden this is great interest to do something expansive on pedigree with food so i just want you to stop and ponder and think about this mr chairman because as we move to the drug safety bill the reason i went right at the f d a commissioner you can't say i've got this level of interest in making sure that they go after tainted food but with regard to drugs well that maybe that's a little bit different we're not going to send this message to the country that tainted food  bad lettuce that's really awful but we can have a different standard when it comes to bad laboratory i just i'm comfortable let me ask them some questions because i don't think i completely understand when i look at section one of six in section one of seven we we have sort of an all in and then under traceability we have some exemptions so i'm you know i come from a very small town i grew up on the typically river buffalo indiana we have to stop signs either side of a bridge that's the size of the town i come from so i think about small small businesses and i worry so when we think about access to records and we're going to see a requirement with regard to restaurants how are we going to in clude concessionaires they may anticipate that we would include concessionaires so when you go to m c i arena how about when you go to the college football game have our high school about little league you know we make deer chili at our little league games i mean we was always going to be included how about convenience stores how about you pull in the mom and pop gas station and they've they've created something you can get sausage i mean where what kind of requirements are we going to be placing and where do we stop presumably thought about you we as a committee need to need to be have better definition as to what who's in who's out total silence this congressman at the risk of your wrath i just don't think that food safety is something that is determined by scale size of company i run a trade association that has many very small members who are going to be extremely challenge to comply with this this regulation we also have very many big members but in last summer's outbreak we also found that some of the issues and some of the places where people were getting sick where the very smallest restaurants and we've got to be able to have a system that that takes care of there's food handling there's a swing food processing and food handling right yes or so the people up here on this diet love to talk about all these food born pathogens and all these sicknesses that everybody comes down to predominantly deals with the handling of food right now so much always the processing of food at a manufactured facility i almost feel like they're being used as a when the fact is other handling me and probably everybody here in the audience and around the country we've all gotten sick because somebody left the managers out overnighters or something well when i look at the traceability requirement we decide i guess farms for example they've got to keep their records or i guess little league has to keep their records or everybody is going to involved with food going to keep their records but we're go restaurants in farms would be required to maintain the safety records but direct sales by farms are exempt what about seafood so if we're going to exempt on the farm we exempt seafood how about that that trawler that goes right out there gets the seafood and he owns the restaurant and the trawler and process is the food should they be exempted just like we're going to exempt on the farm total silence those are the same kind of questions i have when we start picking and choosing where we draw the line especially if i could the language in that section at the end is is very important and i think goes to the heart of our concerns that there are a number of questions there has to be a sense of what these of all technologically what the cost benefit is and what the relation is to food safety if we're going to exempt farms should we exempt trout farm catfish farms how about fish caught on the great lakes what about seafood i think those are all questions that need to be answered and if i could offer the analogy might be this is very similar to electronic medical records in that it is a concept that makes good sense but it is not easy to achieve and there are many reasons why it's not easy to achieve technologically and well so it is easier for me to be able to achieve electronic pedigree the drug industry wanted specific companies yet i can't get cooperation here to do this but they say that what i'm trying to do is to complex what the heck is this this is this is a decentralized model of the degree i love to work with this terminal you're back at thank you ok we're done with our questioning and i'll just remind you again we heard this earlier about the times you may get written questions by the close of business tomorrow and we'd like you to answer them by the close of business on monday and again i want to thank you all this was very helpful i really can't emphasize enough that even though you know our plan is to go to mark up next week that we would very much like and we intend to you know consider a lot of the statements that were made today as we move forward over the next week and several members have commented on how valuable you know your testimony is going to be as we move forward without objection the meeting of the subcommittee is adjourned thank you