call the meeting to order today we are having a hearing in the subcommittee on the food and drug administration globalization act and on the recognize myself for an opening statement initially the draft of this legislation was released by chairman dingell miss just two pac and myself and it builds upon a jar thirty six ten introduce by chairman dingell as well as h r three one one five introduced by mr st ak h r three four eight four introduced by ms de gette and my bill h r three six two four distressed also incorporates findings from the subcommittee on oversight and investigations of the full committee the report released by the f d a science board's subcommittee on science and technology the administration's food protection plan and import safety plan and input from key stakeholders in the field this draft is significantly different from the bill we discussed last fall on food safety the committee staff worked very hard to incorporate all the comments and feedback we received during and since the last hearing and as a result we have before us today a more expansive discussion document due to its length and density of information we've decided to hold at least two hearings so that we have enough time to devote to each issue and today will focus on the food related provisions only something must be done to strengthen and improve the regulation and safety of our food supply too often consumers here on the news about a food product recall and too often we read about people getting sick after consuming every day foods like spinach and peanut butter these instances are taking enormous toll on consumer confidence in food items in two thousand and seven consumer confidence in the safety of food purchased in supermarkets reached its lowest level since one thousand nine hundred nine a public opinion poll conducted by the trust for america's health last year found that sixty seven percent of americans are worried about food safety meanwhile consumer confidence in the f d a itself is plummeting a harris poll conducted in two thousand and six indicated that only thirty six percent of americans believe the f d a is the f d a is doing a good job and that's down from sixty one percent in two thousand and this is not just about consumer confidence however these instances truly endangered the american people each year seventy six million americans get sick to unsafe food products every year three hundred twenty five thousand individuals will be hospitalized and five thousand will even die from food borne hazards it's estimated that the medical costs and lost productivity due to food borne illnesses cost us forty four billion dollars annually and these illnesses are completely preventable in my opinion all of this raises questions about our current food safety laws many of which were enacted in the one thousand nine hundred obviously laws that were written in the early twentieth century are no longer current particularly as the food industry becomes increasingly more global and rather than continuing to simply react to outbreak after outbreak of contaminated products it's about time that we put in place a stronger and more thorough system to prevent contaminated products from reaching store shelves we must work with players at every stage of food production from producers to processors to manufacturers to retailers as well as government entities and the scientific community in order to ensure the full and active participation required to protect our food supply in the united states today there are forty four thousand food manufacturers and processors and one hundred fourteen thousand food retailers if you factor in international societies that number increases dramatically and yet the f d a the agency that is tasked with overseeing eighty percent of the food supply has had to face eroding budget resources year after year not surprisingly this is forced the f d a to cut resources since two thousand and three the number of f d a field staff dropped by twelve percent and between two thousand and three and two thousand and six federal inspections dropped by forty seven percent as i understand it there is widespread acknowledgement that the f d a is woefully underfunded the f d a science board itself issued a report in which they deem the agency is powerless to improve and will be unable to complete its task without a significant increase in funding and it's up to us in congress to ensure that this is a as he gets the funding levels it needs to protect the american people now the draft before us will generate revenue adding to the funding the f d a receives through the appropriations process by requiring all food facilities to register on an annual basis with the f d a and pay a registration fee will benefit the agency in two ways first the f d a will have an up to date list of all food facilities both domestically and abroad and second it will generate the resources necessary to allow the f d a to conduct inspections of food facilities and other safety related activities tests they cannot currently perform the draft will also require each and every one of these facilities to have a comprehensive food safety plan that are available to the f d a particularly during onsite inspections and the safety plans are an important tool for preventing food safety problems for from occurring and quickly and appropriately addressing incidents of contamination should indeed something slip through the cracks the draft also creates incentives for companies to be in compliance with food safety standards while establishing strong penalties for bad actors will hear testimony this morning from industry experts on how the provisions related to food safety in this discussion drive could improve the safety of our nation's food supply and what areas within this travesty will need to be explo greater detail i want to thank all the witnesses i want especially welcome mike ambrosio who is from my home state of new jersey and also cal dooley of course as a former member of congress and a friend i now recognize my colleague mr deal for his opening statement thanks chairman i want to thank you for providing the subcommittee with the opportunity to evaluate this discussion draft addressing the drug cosmetic and device safety i think it goes without saying that a bill that is this comprehensive in nature would make very fundamental changes in the way the f d a regulates all of these items obviously with legislation which includes this kind of these kind of sweeping changes we must take adequate care to evaluate the bill's impact looking at the different components of this legislation separately i think helps to facilitate that go and i want to thank you for affording us this opportunity like i mentioned at our hearing on food safety last september i think we've all heard from constituents in our districts about their concerns of the safety of this nation's food supply and the products that we're importing into this country now more than ever however we're also starting to hear about the burden being placed by american families on account of rising food prices as we move forward in this arena i think we are going to have to be careful to have to carefully balance our desire to secure the nation's food supply without  unnecessarily include increasing food prices as we work to ensure american families can have confidence in the food products they consume i think it is critical for this committee to wrestle with the most cost effective way to achieve this spending more money does not necessarily result in safer food products more of or as we discussed at length last year during the reauthorization the prescription drug use or the act that we seem to be moving toward a total reliance the regulated industry to fund the regulating agency my limited understanding of some of the structures in this bill makes this seem more true not less there are many who are already on comfortable with the f dependent on funds from the prescription drug industry and now it seems that we're moving the food industry in the same direction these food safety issues are certainly important ones that we should be addressing and i look forward to the testimony of our witnesses about this draft and steps that congress should be taking to secure our food supply thank you for the time and i yield back to the chairman thank you mr deal recognize our vice chair mr green for an opening statement hearings on the state of food safety which found the f d a simply didn't have the money technology or manpower to fill its mission the findings of this committee the g a o and the science board or army say at least and most certainly indicate the f d a needs more resources to protect our food supply support legislation that would improve the ability to protect our food supply and demand the chairman our committee for the dedication improving safety i do ever have concerns regarding the port of entry provisions in a discussion draft appreciate the fact that the committee did make changes regarding the provision from h r thirty six but i still have some concerns with the section on the port of entry provisions in the draft and in the port of houston is vital to our economy and provides thousands of jobs in our district as well as southeast texas ports the largest port in terms of foreign tonnage and a large portion of that is related to our energy industry but the poor imported six hundred six thousand tons of imported food products in to handle an increased number of imports from under registered food facilities there for i respectfully question chairman the committee work for me to address the concerns of average guarding a port of entry provision i don't think we should pick winners and losers based on a decision that was made decades ago and not based in reality of where the food products are actually imported today and with that i look forward to working with you mr chairman and staff and my time thank you mr green next to recognize the ranking member the full committee mr barton for opening statement thank you thank you mr chairman we appreciate the regular order on this bill and the legislative hearing on a having said that the fact that you're having a legislative hearing is a good step up and we hope that we may have some input into the process i would say the bill before us  needs some improvements i would start with some basic principles in the bill is replete with user fees if you look at the price of food and how much it's gone up just in the last six months to a year i think we should tread lightly on imposing additional costs on our food industry because ultimately consumers pay those cost and yesterday's washington post had a front page story about hunger in the world and as food prices are exploding how it's going to be more and more difficult to deal with just some of the  basic food commodities also have a problem with the restriction of ports of entry as my good friend from texas mr green just pointed out we don't have an f d a laboratory in texas yet we do have a number of  very active ports and it would seem somewhat over micromanagement to restrict imports to certain to basically the places that have these laboratories already in that this is an important issue to him and he would like to move legislation you know my preference on the minority side is to be co operative but in order for us to be co operative we've got to be allowed to be co operative  barton the next recognize the chairman of the full committee and thank him for all his work in putting together this bill and making it a priority mr dingell first this is a very important hearing that we are conducting today second i want to commend you for the hearing but also for your leadership in this very important matter and for the way that we have worked together on a number of other important matters this year so far this committee has been vigorously investigating whether the food and drug administration has the resources and the authorities that it is to protect the public health i want to say that everyone will not consider introduced legislation today but rather a staff draft which will enable us to gather information about the feelings and concerns of our people and about industr on tainted foods with causes ranging from intentional adulteration to poor manufacturing processes we've found that there are enormous amounts of food and other commodities coming in which food drug cannot even begin to investigate the cause have been severe risk danger and hurt to our people i want to observe that from what we're going to learn at these hearings it is my intention to work with you mr chairman and other members of this committee first to meet the concerns of the members second to perfect the legislation and third to see to it that legislation is introduced upon which we may commen with great speed and vigor in the full committee and i want to observe that we have in this committee this year and last year been working very closely together across the aisle my colleagues on the republican side have made enormous contributions to the public interest and i'm proud of the way that we have worked together in these matters it is my intention that we shall continue to do so on this legislation we have found in our investigations and this is been confirmed by f d a as own science board that f d a lacked the resources and the authorities to adequately oversee the nation's food supply in the twenty first century i would note that they have similar abilities in the area of prescription pharmaceuticals and other areas of the concerns of that agency now it must be observed the agency has been less than forthcoming about its funding needs it is evident to almost everyone else however from the experts to our constituents and people who are being sickened and killed by the inadequacies of that agency that the agency is star for resources and that it cannot meet its basic responsibilities the discussion draft that we're considering today will focus on our efforts to seek real legislative conclusions to what is in fact a public health crisis first the discussion draft aims to increase the resource that the f d a needs to do its job as the f d a science board found as a result of years of chronic underfunding and i know this did food facilities appallingly low and notes that f d a has been forced not to increase food inspections but to cut them by seventy eight percent over the past thirty five years at precisely the same time that food importation has increased exponentially f d a estimates that at most it inspects domestic food manufacturers once every ten years once every ten years or culture could inspect dog food manufacturers often more often than food drug can inspect the producers and makers of food for our people a curious and indefensible such situation for foreign food facilities the situation is even worse at its current rate of inspection f would need more than two thousand years to visit every plant must change second because we can't just is spect our way out of the problem the draft provides a with resources and authorities to prevent food safety problems before they occur voting on legislation introduced by you mr chairman we ask those who supply americans their food to ensure the safety of their products and when prevention fails f d a must have strong read but tools looting authority to order recalls as our colleague was to get and others suggested many are reaping the benefits of globalization but we must make sure that all parts of the food chain here bear some responsibility as well finally the draft provides a range of incentives for good actors in the global system many companies with reputations to protect are on the cutting edge of food safety in the absence of effective f d a oversight they're using their purchasing power to urge improvements in safety from their suppliers those who do this must be rewarded and we will work to assist them so that they could build preventive protective measures into their products at the same time we must ferret out the bad actors who seek to game the regulatory system and pass and the lack of rare regulatory diligence led led to the death of people and pets and these are only a couple of small examples of what is going on german food drug device cosmetic safety are not partisan issues and it is our intention that they cannot be solved i look forward to working with all my colleagues on the committee specially our ranking member mr barton and my republican colleagues and also other members as we have previously worked together on legislation important to american people such as a consumer product safety modernization act the national health reauthorization and i hope that we can work together to craft good sensible legislation provides the necessary resources and authority for the food drug administration to fulfill its critical mission to protect the american people and i want my car here in the committee to know that it is my intention to work with them to see that their concerns whatever they might be are addressed that we could come forward with a bill that will be supported by the committee with great enthusiasm and german i thank you for thank you but also the access access to america's drug supply our delivery systems have changed dramatically with the globalization of food and the drug markets and we no longer have the luxury of monitoring only the operations within our border we now have the challenge of ensuring the safety of the syllabi in areas of the world where criminal interests are high and the regulatory systems are very weak over the past year focused on the safety of drugs coming into our country and completely diverting our highly regulated drug supply chain and i understand next week will we will turn our attention to the drug and device sections of the discussion draft before us  and so much has has advanced since one thousand nine hundred eight with regard to technology and we need to take advantage of that and move from the paper pedigree chairman dingell that you created that can be easily adult rated and move into the electronic pedigree and jim matheson and i have worked hard with all industries in the supply chain and work to do the very best and i think what would be very prudent what i'm asking both chairman of the full committee of the subcommittee that this be considered next week for hearings so we can receive input it is as chairman dingell you understand it was very complex when you laid out this framework it hasn't gotten any simpler and it is a very difficult subject to to explain to someone who knows nothing about it takes a lot of time and investment and i think a very prudent for us to incorporate that in our hearing next week and i would ask for your indulgence in consideration w gentleman from utah is recognized actually mr chairman and if i could wave my opening statement use that to my question time that's what i'd like to do thank you very much mr chairman thank you the way the committee has conducted itself with regard to food safety over the last year this is a really complex issue and it's one that demands a thoughtful and reasoned response and that's why we've had all the number of hearings we've had in the oversight and investigations subcommittee now we have the draft legislation and the hearing today and so i think it's really wonderful the process we're using i also want to thank chairman dingell and his staff for incorporating the absolutely absolutely no authority to order a mandatory recall and i think that a mandatory recall can give us to two good results the first one is obviously that if you have a recalcitrant producer who will not voluntarily recall products then you can mandatorily recall it but in addition i think this thread of a potential mandatory recall actually will put pressure on food manufacturers and distributors to make the food safe in the first place because in truth while mandatory recall is important we want to have the food safe before it's recalled to begin with and so i think that that that's an important provision of th was kind of an edgy leap to put it in there and i think it's important that that that be part of any strong food safety legislation the second thing i'd like to discuss which is not in the draft legislation and i think also would be very effective in legislation i've introduced h r thirty four eighty five the trace act and what that does is it sets up a food traceability system we all remember the outbreak of e coli been in spinach a couple of years ago and there was a voluntary recall but it took weeks and weeks to discover the source of the problem in the meantime food spanish producers all around the country with perfectly fine facilities and good produce lost tremendous profits what we learned in our hearings in the oversight investigation subcommittee is that in fact we have the ability to trace food in fact some of the organic food producers and other small family producers do have trace ability systems and if consumers could walk into a store and see a lot number or some kind of a number where we could trace that food back to the source we would have an ability then to make sure that our food products we could find where the problem was we could identify it and then we could do the recall or whatever we needed to do right away so i'm hoping i can work with you mr chairman and the rest of the committee to include the provisions of that legislation as well and any final bill that we introduced thank you very much thank you recognize mr murphy of pennsylvania for an opening statement thank you mr chairman this congress we have had six oversight investigation hearings regarding food safety and as the second hearing in a subcommittee looking at potential legislative remedies i think these hearings have given us substantial evidence of the need to increase safety of our food supply when you look at some of things have occurred such as seventy six million people contract food borne illness united states each year about three hundred twenty five thousand requests from hospitalization about five thousand die a cord into a two thousand and seven g study in the first two months of this year alone the department of agriculture's issue five recalls on top of fifty eight in two thousand and seven and thirty four the previous year with number increases substantially when you factor in f d a recalls and of course we just experienced the largest beef recall in u s history of one hundred forty three million pounds including fifty million pounds of mint sent to federal nutrition programs including school lunch programs we continue to have problems ensuring the safety of food imports in july of last year california issue a recall of imported chinese ginger after discovering have been treated with a dangerous pesticide with a shaky track record on products ranging from tires of toothpaste i think we can all agree allowing imported chinese food at lax oversight is a substantial problem and although america is an m b a of other nations in terms of what we have in food and farm safety the question remains how do we remedy the problem with our food supply without unduly taxing the nearly three hundred thousand foods the sold in this country i have serious concerns about the legislation before city but it begins the process of finding a legislative solution and i welcome that debate i've toured many facilities in my district and i know the type profit margins made them operate under registrations the additional regulations could severely impact these local businesses let's also keep in mind the expense to them and expense passed on to consumers with food u s food prices rose four percent in two thousand and seven and two thousand and eight spec to be even worse i guess cost twenty five percent more in february than they did a year ago milk and dairy products are up thirteen percent poultry is up seven percent higher corn to the u s d a flour used to make bread was selling at sixteen dollars one hundred weight last summer and it's up through the forty's and expect to go to some sixty dollars keep in mind also these overlap with their energy issues and the grain needed to fill the twenty five gallon tank with with ethanol would according to lester brown feed one person for a year the feeling that tank every two weeks the twenty six people so any impact we have upon cost of us food supplies and other food supplies are affected around the world keeping all these challenges in mind i look forward to working out a bill that addresses the weaknesses of our food inspection network without unduly burning small businesses and most importantly without unduly burdening every family and their cost of their grocery basket i look forward to the test as witnesses and i thank you next is the gentlewoman from wisconsin ms baldwin recognize for an opening statement thank you mr chairman and thank you very much for holding this port and hearing i want to commend you and chairman dingell and chairman stu pac for putting forward this discussion draft that addresses a very serious challenge we face with respect to food and drug safety the fact that our nation faces a very serious food safety concern is not in question we all know about many of the incidences that have been related by previous speakers tainted spinach peanut butter and just recently in march of two thousand and eight we had salmonella tainted canteloupe in several states including my home state of wisconsin that cost several people to fall ill but there are questions that do need to be asked and they include what additional authorities does the f d a need to ensure the safety of our food supply does the have sufficient resources to carry out appropriate food safety measures what steps can we take to prevent food contamination incidents before they occur and in an increasingly interconnected world how do we ensure that food coming in from other countries is safe and i think that the dingle polonius to pack disk discussion draft addresses these questions in a thoughtful and constructive manner i strongly agree that the f d a is in critical need of increased resources to ensure our nation's food supply we must take steps to make sure that this need for resources is met and i support the draft provisions that provide those most much needed resources i'm also pleased that the discussion draft includes a provision that would allow the f d a to partner with accredited third party laboratories to perform testing this partnership will expand the f d a as laboratory testing capacity and role result in more food being tested this  a smart way to harness the abilities of the private sector and a smart way to expand the f d a as food safety efforts without draining the already very scarce resources of the f d a lastly mr chairman i'd like to extend a special welcome and thank you to james lovett who is one of our witnesses today mr lovett is testifying on behalf of coal babs a company that has more than sixty years of food testing experience among other things that they do and it has a very large and impressive facility in my home district the hometown of madison wisconsin i'm pleased that they'll be able to communicate with us today and share their unique perspective in this debate and the role that they play in ensuring the safety of our nation's food and i look forward to today's discussion thank you again mr chairman for holding this hearing thank you next for an opening statement the gentleman from new york mr towns thank you very much mr chairman i would like draft of the food drug administration globalization act legislation this year i think it's safe to say that everyone in this room and for that matter everyone listening to are watching this hearing once our food system to be sa and save or that it currently yes it is clear to me that the first order of business is to increase the resources available to the f d a is this committee is pointed out on a number of occasions f d a is own science board refused to address the role of science in the agency's work without first addressing the historical lack of resources for the agency as a whole i do however have some issue with the user fee as set up by this legislation well i will which i will get to in a minute am also pleased that the bill tries to direct the f d a in the food industry to prevent problems before they occur that make sense from the point of view of the consumer who does not want to get sick to prove a point anyone's point as of as from the point of view of the industry that does not want to go bankrupt facing a major product recall the third item in this bill but i'm pleased about is the attempt to provide flexible authorities for the enforcement of food safety standards that's going to help improve industry standards and ensure compliance without the need for overbearing enforcement provisions i do however have a few concerns about the discussion draft that i think need to be addressed let me sum up this bill as it currently stands it would competitively disadvantage small food producers and processors and leave oregon in the position of having zero ports of entry for imported foods stabs and then in a virtually increasing energy use the to get our food but let me emphasize the issue is so important and your work on it to date is so little that i want to work hard to resolve these issues and arrive at a bill that i can support and that we can pass out of committee first if we must go the road user fees and the fees must be on a sliding scale or processors below a certain size should be exempt altogether from that fee two thousand dollars is cost prohibitive for many of my small food processes many people in oregon are turning toward local food producers and processors to get the freshest best food while using the least amount of energy to get it the way this user fee is set up puts those producers at a disadvantage i also believe that registration of these facilities may already be required by other federal legislation for example the of two thousand and do and i wonder about duplicating efforts second i have concerns about the country of origin labeling provisions i want to thank you for changing the provisions from unworkable to workable are almost there but not quite we need to work on the definition of process food since it varies from the bureau of customs and what is proposed in the farm bill we also need to clarify who is responsible for listing the ingredients on whose web site and is the ingredient listed per the time of year it's available or is it tied to a particular package there are lots of details to be worked out and i look forward to working with them and with you and your staff third i'm extremely concerned about the provisions that limits of eventually the importation of food only through ports with an f d a or f d a certified inspection and testing facility oregon does not have one not even at the port of portland which would mean that all of our food importation business would be sent to california or washington that means a lot of business to oregon ports but it also means in this cost of ever increasing gas prices that the cost of food will include the increased use of gas to get that food from california and washington to oregon i thought we were supposed to be encouraging the decrease of energy not passing apology a policy that requires unnecessary increased use of gas actually i'm very concerned that these policies combined the registration fees the importation requirements the labeling requirements will work against my small food producers in folks pride themselves on innovation and i would not want the pursuit of food safety to be the death for locally produced locally consume fresh foods i am more details from the food safety division of the oregon department of agriculture that i would submit for the record i look forward to working with you mr chair and my colleagues to resolve these concerns thank you thank you and i believe that concludes the members opening statement so we'll now turn to our witnesses and i would ask the the first panel which is the f d a representatives to come forward please thank you for being here today on our first panel  have dr steven sun loss who is director of the center for food safety and applied nutrition at the f d a and accompanying him is dr stevens stevens solomon who's deputy director of the office of regional operations in f d a as office of regulatory affairs let me mention that we have five minute opening statements is just one of you going to speak ok so five minute opening good morning and thank you chairman filone and members of the subcommittee i'm stephenson last director of the center for veterans center for food safety and applied nutrition at the food and drug administration and i appreciate the opportunity to discuss our legislative proposals as well as proposals developed by you and your colleagues on the committee to enhance f d a s ability to carry out its important public health mission food can become contaminated at many different steps along the path from farm to fork in recent years a has done a great deal to prevent both the liver and intentional contamination of food at each of these steps however changes in consumer preferences changes in industry practices and the rising volume of imports posed challenges that require us to adapt our current food protection strategies to address these challenges last november secretary of health and human services michael leavitt presented to the president an action plan for import safety which reflects the input of twelve departments and agencies and provides recommendations to enhance the safety of imported products in conjunction with the action plan f d a released a food protection plan which provides a framework to identify potential hazard and counter them before they can do harm together these plans provide an updated and comprehensive approach to ensure that the u s food supply remains one of the safest in the world the plans and compass three core elements prevention intervention and respon to the prevention element means promoting increased corporate responsibility so that food problems do not occur in the first place the intervention element focuses on risk based inspections sampling and surveillance at all points in the food supply chain the response element bolsters f d a s emergency response efforts by allowing for increased speed and efficiency consistent with the goals of the action plan in december h h s and the people's republic of china signed a memorandum  the safety of food and animal feed products exported from china to the united states the memorandum of understanding establishes a bilateral mechanism to provide greater information to ensure products from china meet u s standards for quality and safety the key terms of the agreement include enhanced ration and certification requirements greater information sharing faster access to provide to production facilities and the implementation of key benchmarks to evaluate progress the first formal bilateral meeting under the memorandum of agreement was held in beijing last month f d a has also made a commitment to station inspectors and other agency representatives in china to increase their ability to carry out foreign inspections and to facilitate cooperation between f d a and its counterpart regulatory authorities f d a is considering endeavors similar to this in other countries in the plans we identified several new legislative authorities needed to help us fully implement them for example f d a is requesting the authority to require entities in the food supply chain to implement measures soley soley intended to protect against intentional adulteration of the food supply by terrorists or criminals we are also requesting explicit authority to issue regulations requiring preventive food safety controls for high risk foods such authority would strengthen f d a as ability to require manufacturers to implement a risk based hazard analysis and critical control point or half the equivalent process to reduce food borne illnesses from these foods some of the other alleged the slate of the proposals include authorizing f d a to accredit and use highly qualified independent third parties to evaluate compliance for voluntary inspections allowing the f d a to move the inspection of high risk products of concern upstream by requiring the exploiting countries regulatory authority or third party inspector to certify each shipment for compliance with f d a standards prior to shipment giving f d a authority to issue mandatory recalls a voluntary recall is not effective authorizing the f d a to refuse admission of imported food inspection access has been delayed limited or denied and giving f d a enhanced access to food records during emergencies we commend the members of this committee and their staff  developing the discussion draft entitled the food and drug administration globalization act of two thousand and eight we recognize and appreciate the committee's efforts to include new authorities requested by the administration in support of the action plan for import safety and the food protection plan we are in the process of reviewing the discussion draft in detail and we look forward to working with you on this legislation at this time however we can make some general comments that guided the development of the import action plan and the for the for food safety and and which we believe should also guide the development of products safety legislation first any legislation should allow f d a to set requirements and priorities based on a strong scientific risk assessment f d a given the breadth and scope of the food products imported into the u s f d a cannot rely on inspections as its primary means of ensuring food safety any legislation  should build on the framework in the plans to build in safety measures to address risks throughout the products lifecycle and focus efforts on preventing problems first and then use risk based interventions to ensure preventive approaches are effective coupled with a rapid response as soon as contaminated food or feed is detected or when there is harm to people or animals the federal government should be striving to address food safety concerns while minimizing the potential effects on the increasing costs food while the administration is supportive of user fee programs in which regulated industries provide funding for additional performance and efforts or programs designed to recoup the costs of enforcement action such as fre inspections the administration will carefully review any proposed user fee to ensure that is it is being assessed against identifiable recipients for special benefits derived from federal activities beyond those received by the general public any legislation should be carefully designed to avoid creating real or perceived trade barriers any legislation should have said empower robust voluntary private sector efforts already underway with these in mind we believe that the proposed legislation should be more closely targeted and prioritized according to risk several of the legislative sections are not exclusively targeting high risk products some of these requirements would require such substantial resources that they would not be feasible further such resources could be tracked for more important food safety and food defense priorities in addition the legislation should more explicitly incorporate the administration's strategy of leveraging efforts underway by certifying bodies and foreign nations finally several provisions of this bill may need to be reviewed in light of us agreement obligations and we are reaching out to the united states trade representative for further insight on these thank you again for the opportunity to discuss f d a as legislative proposals as well as the proposal developed by the committee we look forward to working with you to obtain passages of the requested legislative authorities identified in the food protection plan and the action plan for import safety and i would be happy to answer any questions at this time thank you mr chairman thank you dr sun law recognize myself for five minutes for questions i have two questions i'm going to try to get in one about the funding and one about your authority so just bear with me so we can get both of those in the draft legislation incorporate some of the suggestions your agency made in its recently released food protection plan and those are strong concepts and things the f d a should be doing to protect the american people but we know for a fact that the f d a is underfunded commissioner vanished in bach even recently stated in an interview that you requested more than the two point nine five percent overall increase for the f d a that was for opposed by the agency has endured for the past decade so my first question in your professional judgment how much money does the f d a need to carry out the tasks laid out in your plan and also when this bill thank you mr chairman well first of is a lot of it has to do with the authorities that we're going to be given if we if we do acquire some of these authorities it will make a big difference on the amount of revenues and resources that we're going to need for instance if we have the authority to recognize third party inspectors then then we would expect that the that the number of inspections that that would really required by f d a even if it's a same week we would we would be relying on those third parties to do a lot of the inspection work for us that doesn't mean that there aren't costs associated with that we would have to certify those those third parties to make sure that they are inspecting in accordance with our regulations but it's very difficult at this point to say exactly how much additional revenues we will be needing until we have a clearer picture of what new authorities that we've already declared we need in order to do you want to make a distinction between your plan versus this bill and i mean i know this bill you're just seeing the you know in the last few days but what you want to talk about the cost of additional money under your plan at least under our plan again we would we would have to manufacturer in the world that it that imports of the united states would have to be inspected at at a fairly regular frequency either two or four years do you have to have cost estimates for your plan anywhere in the agency at this point you could give us inspections for plants that well let me just finish this because i want to get to the second question in me if you can at some point i'm sure some point are going to put some kind of cost on your plan you know get back to us because obviously the amount of funding is a big issue here in terms of how we pay for it in your testimony you mention three core elements that are vital to ensuring a safe food supply including concepts like prevention intervention and response and you know well prevention is very important to me and is a central theme in my bill on food safety i don't think we should be just reacting to instances of contaminated food but instead we should make sure things we should make sure those instances never happen in the first place at the same time in your testimony you're only asking for authorities in specific areas such as the power to protect against the intentional alteration of food and for high risk foods however the recent outbreaks have not been intentional nor have they soley affected high risk products and yet americans are still dying from people from food borne illnesses so my question is does the f d a currently have the authority to protect the american people from low risk non intentional outbreaks and if not what authorities do you need to do so to provide those protections thank you mr chairman we do have the authority to protect the public against both high and low risk what we are we're requesting in the food protection plan an import safety action plan was the authority to explicitly require that companies that have higher risk foods that they are producing have plans in place written plans in place that we can audit against to make sure that they are following a preventive program  so that that that food contaminated food does not get to the public now for for lower risk plants we would encourage those low risk plants to also have similar preventive measures in place we think that in order to make the maximum use of our resources that we should be targeting those firms that produce high risk profit essential you have the authority in your opinion for both right now but you're focusing on the high risk we're focusing on have we would like to have explicit authority to require firms that produce high risk foods to to have plans in place and documented so that we can expect inspect against those particular plants right now that act that  explicit for seafood and and i believe at least at least seafood and other high risk products there is no explicit authority for that ok thank you gentleman from georgia thank you box on the last one of the concerns that you've already heard expressed from members here in opening statements and one that my state would have a concern about too is the lack of f d a inspection facilities adjacent to our ports of entry would you briefly address that concern and how would you propose to deal with the concern about having inspection facilities available at ports of entry so laboratory facilities at ports of entry i can just depending upon what kind of food is imported in the united states it may not make a difference whether or not there is a laboratory there because that laboratory may not be doing the type of analysis that we would require for instance if it was seafood and the particular laboratory would only be looking at things like pesticide residues it would there would be no effect on having a laboratory right there we we believe that with the rapid transportation that's available today that products can be shipped entry to any of our laboratories within twenty four hours and that really doesn't represent a problem for us well obviously as you've already heard states are very concerned about their own competitiveness in terms of what might be mandated for inspections that will dictate laboratory analysis i think that is one of those concerns that all of us are going to have to be very aware of in terms of anything legislatively mandated in that regard so it is an area my state for example as i understand does not have a laboratory except in atlanta georgia which is very much in line from our ports so that will be a concern that you're going to continue here i think and it's something that as a practical matter all of us both at the legislative level and at the enforcement level need to look at very carefully and have a thorough a more thorough understanding in that regard could you expound just a little bit about the existing agreements with other countries in terms of you you indicated that the authority to rely on the country that you know the exporting country to certify slave d is an important element in this whole process how successful do you think that currently is what needs to be done if we need to beef up daddy end of it what needs to be done there thank you the currently the only agreement that have under way is with china and we've just begun that process and we have identified certain high risk foods seafood being one of them that we would require that the chinese government certified to our standards that those those products were safe before they ever left the port we are considering similar agreements with other countries for which we have concerns about their ability to ensure that the food is sa e what this what we have asked for in the import safety action plan has the authority to explicit authority to require certification from other countries as a condition of them being able to export to the united states obviously that could potentially impact trade agreements and other matters and you indicated that consultation with the u s trade representative office was one of the areas that need to take place and i agree with that  would you after you and your staff have been salted with us to you are would you be willing to come up and brief us staff wise and members who are interested on know what those kind of trade implications might and areas of concern that we should be aware of in that regard certainly i think that would be very helpful for us to have a pretty detailed understanding of the the interaction between all of these things as it relates to what sherman question as to food and drug administration the science board estimated that over the past thirty five years your inspection capability has fallen seventy eight percent because of cuts in funding in addition they estimated the u s to meet food manufacturers once every ten years they also estimated that you ma only ninety six overseas food inspections last your potential for one hundred eighty thousand or more facilities that needed inspection are these statements true i believe they are  now let us look at your situation you have the fortunate situation that you have received huge cuts so your ability has declined enormously over that period of time you now do not know what your additional what the additional burdens are will be imposed on on you by this bill will do i am asking you at this time to submit to us in writing at your earliest convenience a statement of what you need to carry out your current responsibilities and second what you will need under this bill to carry out the responsibilities imposed upon you can you give me a quick and dirty answer as to what you will need to bring yourself with your president responsibilities under law in terms of inspecting food producing establishment much i don't have a number for  protection plan and the import safety action plan and in the bill before that we're discussing today is going to be that we will take on a new role and that is as a certifying body that we will certify other whether it's a foreign government whether it's whether it's a state agency or whether it's a private industry private sector industry to inspect to our standards order to enable us to make a proper approach we will also include that question and you may give us more more detail than thoughtful answer on that now i'd like to address risk based system and information structure according to the science board f d a lacks information science capability and information infrastructure to fulfill its regulatory mandate they found that there is insufficient capability in modeling risk assessment and analysis are you familiar with that statement i'm familiar with the statements or the report goes on to state f d a infrastructure is obsolete fishing controls to ensure continuity of operations or to provide effective disaster recovery services and it they go on to observe the given the lack of defense dependable thank you chairman juan i've been watching the hearing on my television set as i was in a series of private meetings so i somewhat kept up with the what the hearing i haven't been here in person  y the department has not taken an official position because if you read your testimony one could interpret it that the f d a would would prefer instead of instead of a strict regular regulatory approach more of a risk based approach is that is that a fair statement and yes it is a fair statement that we would prefer to use our resources to apply to the highest risk areas rather than a broad across the board inspection program do you do you see a possibility since this is a discussion draft to have a meeting somewhere in the middle between the approach in the bill before us in the approach where you have limited assets and you apply  those as you study or more risk based approaches or possibility to meld those two together i would certainly hope so i would too would you care to comment on the third parties for certain functions as opposed to having everything be done directly by paid employees of the f d a well sir i think it's impractical impractical it specially when we're talking about foreign inspections  think that the f d a could possibly cover one hundred fifty different countries and somewhere between one hundred forty thousand and one hundred eighty thousand different manufacturers first of all it would require that we had agreements with all those foreign governments to go in and inspect but the reality of that situation is that if everybody took that approach then every country would be inspecting every other country and there would be a continuous string of inspections that would go on and i don't see how a company could actually produce food under those conditions because it would be constantly inspected by every country so we believe and i think it consistent with the proposed legislation that we rely on either foreign governments that to certify according to our standards or third party independent  to certify to our standards and that we would have an audit in function to make sure that they are in compliance with our standards is it fair to say that the approach you just outlined is if i understand  all countries but more and more we are looking to other countries that they we believe they are a quick on to our system and and utilizing the information that they gather from their inspection but there would be a precedent on the drugs out in some countries yet what's what's the what's your view of the proposal that all of food imports have to come in to certain ports that already of testing and sampling occur in various parts of the united states so even if we even if the import did come to a port where there was a laboratory there is no guarantee that that laboratory could actually run the analysis that we want and so we would still have to ship that sample to another laboratory in the united states that specialized in that particular testing so least from my view is that it doesn't gain us very much  requiring that the met that particular port have a laboratory my time is about to expire and my last question if i understand the bill correctly it also restricts the ability the f d a to reorganize  or relocate any of these food inspection laboratories in the twenty first century do you think that's good public policy to put that kind of restriction into law mr chairman i i think that we we and i don't know who put the lab there but i can imagine if it was a member of congress somebody from southern arkansas many decades ago and i understand him now they have that works and that's why if the bill make some changes it  registration or survey cation before to regulate food and drugs and are these labs able to handle the current workload or with this increased workload that you would have now i have to admit i've been on the docks at the port of houston and had f d a inspectors there with capability timeliness of doing work and we're continually evaluating how we can improve that testing is one component of trying to get assurances about the safety of food so we're handling our current workload we understand that there's more work that needs to be done and we're looking to obtain additional efficiencies by trying to improve the laboratory capability to pass the in the timely and the last thing is i know this bill provides additional funds for the expansion in and with the f d a with these funds intent is to add more labs in particular locations that have a high deal of important a great deal of imports that you would need  n would you consider locate them in areas that have that that have food imported trade levels right now i don't believe that we've made any kind of decisions about increasing the laboratory capability one of the things we are considering  recognizing independent laboratories and accrediting those laboratories to to conduct conduct analysis that we would that would supplement the work that is currently done in the f d a laboratories and i know the cost  that it cost so much to do this independent lab would be cheaper to be actually establish a an f d a lab in a location if you have enough business to do it certainly something that we would consider ok thank you mr chairman or your ba thank you mr green gentleman from indiana mr brewer for questions  killer do you think it is important to have a non delegation clause when it comes to the authority to issue a mandatory recall i'm sorry sir could you did you repeat the question do you believe it is important to have a non delegation clause when it comes to the authority to issue a mandatory recall ok thank you let me just say that in virtually every situation where we've asked for recall we have gotten compliance from from the regulated industry so it would be a very rare event if we asked for a voluntary recall and we were denied that recall  and in those extraordinary circumstances i don't have concerns that that delegation would be given to the commission or even the secretary because i believe that these would be fairly extraordinary circumstances why is it an important issue for you why is it in in court an issue that's an important issue because we believe that that there are there could be circumstances where the public's health was at risk and where we were not remove any any potentially risky food products from the marketplace to do that there are acceptable levels of risk that you have to take so when when you articulate to us that you prefer a risk based approach is can you elaborate a little bit further on why that is the  as we can to target those products that we believe have the greatest potential to cause harm to public health so it's purely from the the standpoint that we first of all want to have systems that we can identify where the high risk foods what is a high risk food was a high risk and then make sure that we are paying adequate attention to those high risk foods to ensure that they are safe where and not ignoring the lower risk products because in we are finding that some of the products that we thought were low risk in the past actually turned out to be higher risk than we thought but by really targeting our efforts to make sure that we are addressing the food that has the highest potential to cause harm to the public health when you come to judgment do you have interagency cooperation or entered departmental cooperation as with the department of homeland security interfacing of targeting systems in your risk based approach with regard to countries localities territories companies that are on on certain lists is that we're talking about we yeah we  have with homeland security we have come up with a risk paradigm to identify which products have the greatest potential for causing a catastrophe should the food become  entries were located with customs and border protection and homeland security at the national targeting center and our on with u s d a work side by side and looking at the assessment of entries are coming in and particularly from a concern about bioterrorism concerns making those assessments jointly and sharing information so that co location is very valuable to us other examples from homeland security relate to the pet food contamination when we worked to stop products coming in from china that we gluten in the rice protein concentrate our customs and border protection homeland security went out and did a nationwide pledge to see was there any evidence of this product this contaminant coming in from any other country so we focused on the initial product and homeland security focused on the rest of the border issues thank you very much thank you gentleman from wisconsin mr baldwin for questions thank you mr chairman dr some of you already addressed a couple of questions relating to the third party system that's being proposed in this discussion draft to enhance and augment experience with independent testers do you agree that they do sound an independent founded dependent scientific testing and also can you speak to what sort of accreditation process you would envision a undertaking to ensure that the testing done by third parties is rigorous and in accordance with the highest scientific standards thank you we we currently do rely on independent third party laboratories when for instance we have an import of lurd against a product coming into the united states we're acquire that those importing for have their product tested on entry to the united states and that they pay for that through an in independent third party laboratory and then we review the results of that so we do have some good relationships we do rely on them right now in terms of of accrediting there are certain laboratory accreditation standards that i believe we would be relying on in accrediting officially accrediting right now we don't a credit we would like to a credit we rely on the on the testing results of certain laboratories that we have confidence in but we want to take that to the next step and actually be able to accredit them there would  be very good accreditation standards in place and we would we would most likely rely on what is already out there what sort of what sort of accreditation processes are in place that you don't currently use but you might know i think i think there are some iso standards i think there are other standards i'm not familiar with all of them right now the other question i have is sort of trying to move f d a from  basically being in reaction mode for food safety issues and looking at what actions the f d a should be taking to prevent food contamination food safety incidents before they even occur and what could the f d a be doing right now to prevent future food safety threats what additional authorities do you think the f d a needs to be more proactive in preventive and  what are your comments on the draft legislation provisions that seek to enable f d a to act more proactively by requiring foreign and domestic food facilities to have safety plans in place to identify identify and mitigate hazards thank you what we have asked for in our food protection plan an import safety action plan is somewhat similar to what is in the proposed legislation  what we would under the under both of those plans we would require two things first for intentional contamination we would want our high risk food areas to have certain preventive measures documented in  place that we could inspect against so so that's a preventive measure the other one that we asked for is to for high risk food production facilities that they would have a ha like plans in place that we again could mandatory that we could inspect against to ensure that they were that they did have effective preventive programs in place thank you gentleman from pennsylvania mr pitts recognized for questions thank you mr chairman dr sun loft do you think requiring the labeling of the country of origin  every ingredient in a product will improve the safety of that product and if so are we just safety of the products that come into the united states from from other countries should be as safe as the domestically produced products we are asking for these new authorities to help ensure that but i don't want  i don't want people to feel that relying on a country of origin label is going to give them information about the safety of that particular product that it should meet the united states standards and what is your primary labeling only that it should not be viewed if there is a country of origin labeling that it should be viewed as a way for consumers to to to  make judgments on the safety of the product we don't believe that that country of origin labeling is in any way should be associated with the safety of foods imported from other countries what  is related to that well it would be something other than that and again we have not taken a position on anything else from from the point of view of the f d a that's the thing that we're concerned about the most is that food that's imported be conform to the same standards as domestically domestically produced food and therefore country of origin labeling does not provide any additional information are you concerned about possible confusion with the requirement for for labeling to the public and the concern about the difficulties of a manufacture to comply and the cost for for changing and gradients for instance if you have a product with twenty two and gradients one of them from brazil brazil has you know a drought so now they're going to argentina are you concerned about the constantly changing label the requirements again since the f d a is  not asked and then ministration is not after country origin labeling that's not something that we even considered at this point do you think it would be a mistake if food safety legislation tried to do what many food manufacturers have already put in place in regards food safety and replace it with a system that relies on inspections of all facilities and testing of all food shipments and i certainly we don't believe that that inspection sampling and testing involved would shipments is a is a feasible approach considering that we receive somewhere on the order of almost ten million import entries per year that that's at least at this time not even feasible to try and test our way into safety if we're going to have the safest food supply system possible don't we have to rely or put more focus on the manufacturers to prevent food safety issues yes absolutely and that's one of the that's one of the principles of both the food safety import safety action plan and the food protection plan is to put specially the prevention responsibility on the suppliers manufacturers do both corporate food manufacturers have safety systems in place to prevent becomes a matter of you may have many many small content companies that produce a small percentage of the food versus large companies that produce much larger a few large companies that produce a larger percentage but but we are like to work with you on another issue which is not currently included in the discussion draft before us but i think it is an issue that's very much within the purview of the f d a in food safety and i think it should be included in legislation we move here in this in the house  this is a problem stems from the lead content of certain ceramic very decorative food where such as plates in my home state of utah and i'm sure in districts throughout the country consumers are unaware that lead is a component of glazes and can leach out of ceramic where the glazes improperly fired or worn down from daily use children are at particular risk of let exposure and this risk is compounded when we're talking about food containers because kids frequently consume acidic juices that leach lead from ceramics now this issue recently hit home for  me a young mother in utah who is breastfeeding her baby used ceramic plates to heat her food in the microwave her infant became very sick and ultimately her doctors discovered that the baby was suffering from lead poisoning because of the plates used in the food preparation for her mother this mother was completely unaware of the potential health risks posed by certain ceramic ware products as i suspect many if not everyone in this room as well would be unaware of that risk mr chairman i brought with me a brief video clip of news coverage which i think will give my colleagues on the committee as well as our panel a better snapshot of this issue just as brief background you november of two thousand and seven over four hundred people lined up at the salt lake county government center to have bags and tubs filled with dishes along with toys and jewelry tested for lead levels once they found out that this is a problem the public has responded with great concern you'll see lines of people a video which showcases the magnitude of interest in the problem this runs for less than a minute but it helps highlight the story of this mother and her baby could we run and i mention the gentleman actually has an additional three minutes from what's up there because you have  killing my time here tonight don't worry about the time but what's going on i don't know she's setting it up  mcbride had complained that after only breast feeding her fussy constipated infant a pediatrician discovered high levels of lead in chloe's blood the only lead davis county health officials found in jen's home was in her dishes why does our state and federal government allow any lead in place without at least telling us plate after plate hundreds upon hundreds of them tested with kenyan consulting companies are after to see if there was any lead sometimes no lead detective but in one out of three dishes we checked today we found lead well as i said i want to give a brief traced to ceramic this is the last one that we are aware of in which there was a ceramic where was involved and we don't know if that was actually the cause of the increased blood lead levels in when a child was was in believe it's many of the plates company and is it a small percentage that actually get tested would have to get back to the correct as i understand there's a memory of understanding that the f d a has signed with the state administration of entry exit inspection and quarantine in china and in that memory of understanding you establish the certification system the ceramic were made in china it is imported the us will carry an inspection stamp on the box it has a c c i'd be stamped with the chinese organization it also carries an f d a stamps  going by these plates and i've seen them in the stores in utah there's an f d a stamp on the box but that stamp doesn't provide any information the consumer about lead content what protections does that stamp indicate to consumers when they see a stamp on a ceramic plate that's been sold in the us i may know this may not be the authoritative answer and i will get back to you if it's not what i believe that means we have so what i think is consumers when they see an f d a label on a box assume it's safe that would be what i do so i think that's what most people do and i think most consumers have no idea that lead exists and ceramic where at all would it be more useful least to have a label on the box that mentions that this product may contain lead i mean i've got a plate right here i can't tell that it's got lead but it's been tested it's got all kinds of lead in it i've got a plate right here that's sold by another company where they've stamped on it this lead free so you got some manufacturers that will tell you that they don't have lead in their product but both of these they came from overseas are going to have that f d a label on the box and that doesn't give me as a consumer much information at all so it seems to me it might be helpful if we could maybe at least inform consumers that there's lead in the product with f d a be open to something like that well the way that we rather than declaring something to be lead free we have we have established levels at which we don't believe about is the is the lead that can actually leach out of the plates most or many of the glazers do contain lead but if they are fired correctly in the process of manufacturing these plates then that lead should be sealed there into the plate and not be available for ingestion seems to me that and i'm not here to argue about the level that's safe or not safe i would suggest that in the testing that was done for hundreds of people in utah the levels were all over the story on the news back in you to i didn't know there was lead in this so mr chairman i'm very anxious to see if there's something we can do in this bill to make sure consumers are better informed about the possibility of well being these plates so that they can make their own decisions about using this type of pla e to microwave food and i appreciate working with the committee on this and i appreciate your indulgence with the extra time for questioning your back my talk thank you and we will certainly follow up on your request and next is the gentlewoman from north carolina ms miers for question thank you mr chairman i just had one question doctor what would you say is the most cost effective way in broad terms to improve food safety in this country without dramatically increasing the price of food which is already very high right and moving up well if i if i look at all of the legislative authorities that we have requested in the food production plan an import safety action plan i believe that third party certification where we can multiply our inspectorate by the use of independent third parties is the most effective way to improve safety recently signed a memorandum of understanding concerning food safety and facility registration with china were you aware and this may be happening in the other states as well that oregon department of agriculture has been working for the last couple of years with china on food processing facility inspection protocols what's your opinion of the role of states in food safety i was not aware of that country of origin food labeling that actually made it to the house in the senate and signed by the president and yet that's really never taken place the question is is that ever going to happen number one question and number two is as we look at food processing and in talking to some of my food processors in my district they were talking  or they may have a bad year for broccoli one place and so you get it someplace else the next year what do you think and how do you do this if you're going to label that can or put it on a website i mean what are they have who's web site what are they have to list is it the final manufacturer where you know that it's put in the can or put in the container or whatever they put it in is that going to make is that going to work first of all and will it will the public and more have that authority as well as the treasury i believe we do not we didn't ask for it there are as you indicated there there are complications in trying to do that with the many ingredients that may make up a food and the and the fact that those sources of ingredients can change overnight and we certainly as i said earlier do not want or believe it is in the best interest of the public to be viewing country of origin labeling as a way of determining whether or not to save because those products need to meet the u s safety standards just as domestically produced the key thank you very much thank you and i think that concludes  our questions thank you very much for your input and in those cases where we asked for a follow up questions if you could get back to us in writing as quickly as possible thank you again thank you both thank and i'd ask the next panel to come forward i want to welcome our second panel and let me introduce each of you starting on my left is mr michael taylor who is research professor of health policy for the department of health policy of the school o public health and health services at george washington university next is mr michael ambrosio who's vice president for food safety and quality assurance of the wait for an food corporation in the lives of both in my home state in new jersey and then we have mr james lovett who's a corporate senior vice president of covance laboratories this this says based in princeton new jersey but i know you mentioned well ok i know you mentioned wisconsin as well and then we have our colleague honorable cal dooley former congressman and president and c e o of the grocery manufacturers association good to see you again cal and finally is caroline smith the wall who's the food safety director for the center for science in the public interest has been working on these issues for many years good to see you as well as i mentioned we here five minutes opening statements from each of the witnesses those statements will be made part of the hearing record each witness may in the discretion the committee said meditational brief and pertinent statements in writing for inclusion in the record and i'll start again on my left with mr michael taylor who's recognized for five minutes thank you i think that mike may not be honor thank you again thank you very much mr chairman ranking member deal and members of the committee i appreciate the opportunity to testify today on the discussion draft of the food and drug administration globalisation  act last year as i think we've already heard this morning the government accountability office declared the federal government's food safety program at high risk of failure due to its outdated laws fragmented structure and inefficient use of resources this came after a decade recommendations from g a o and the national academy of sciences to modernize the system legislatively and organizationally so that it can be effective in preventing food safety problems instead of simply reacting to problems after the fact so mr chairman i applaud the subcommittee for tackling this critical issue and for focusing first on the obsolete food safety laws under which the food and drug administration parade's f d a has legal tools for addressing food borne illness and the safety of imported foods were enacted in  may may have been suitable for their time but they focus more on reacting to problems rather than preventing them and they are plainly inadequate to deal with today's global was food supply as we embark on modernizing these laws the committee the subcommittee to be clear first on the basic policy principles that should guide reform and i think you will find good agreement among experts on the following five principles and in fact we've heard most of them embraced in varying ways already this morning first it's critically important to treat food safety as a farm to table system wide problem and this simply recognizes that hasn't can be created and minimize that many points across the food system second we must make prevention of food safety problems the central focus of the system because this is the only way to protect public health and maintain public confidence third we must recognize that the primary duty for prevention falls on the food industry and we've as we've heard this morning it's the industry not government that produces food and all of the industry can make it safe for we must focus f d a on setting and enforcing standards that make the food industry accountable for prevention ensuring accountability by setting and enforcing standards is the unique and most essential government role on food safety fifth and finally we must strengthen f d a mandate for providing national leadership and international leadership on food safety and bolster the agency's tools for managing a science and risk based regulatory program this includes a stronger research mandate and working with state and local governments to build a nationally nationally integrated food safety system that makes good use of all its resources and i have the discussion draft on the table for discussion today embraces most of these principles to varying degrees first and foremost a discussion draft is i believe on the fundamentally right track and mandating safety plans and preventive controls for all food facilities domestic and foreign importantly it also recognizes that food safety in order for food safety plans and preventive controls to be effective in improving food safety hansing public confidence they must be linked the plans must be linked to food safety outcomes in the form of performance standards and in force by f d a to me this coupling of preventive controls the ject of measures of performance is the most essential element of meaningful food safety reform the discussion draft also addresses the important issue of food safety at the farm level with its what i think is a very judicious approach to establishing standards for fresh produce and include some innovative ideas for hansing oversight of imported foods overall i think the discussion draft is the right starting point as outlined in my written testimony however i do have questions about some provisions such as  proposal for certification of food facilities while i see its potential value for imports is done by credible third parties i think we have to focus first on strengthening the accountability of importers themselves for ensuring the safety of the food th import and further i do not think that f d a should be in the business of certifying food facilities in moving forward with this legislation i hope because of committee will also consider measures to strengthen food safety oversight at the retail level in collaboration with state and local agencies and to give f d a the research mandate and resources it needs to restore its scientific leadership on food safety mr chairman restoring f t s capacity for leadership is critical to food safety  public confidence in food safety we need to get f d a food safety policies right and then we need to back them up with the resources to do the job thank you again for the average testify and i look forward to questions thank you m grown from a small struggling cooperative into a strong regional player with significant operations in the new york metro area headquartered in quays b new jersey wake for and along with shoprite stores have become one of new jersey's largest employers with approximately thirty two thousand associates in new jersey and forty seven thousand overall in two thousand and seven retail sales totaled ten billion dollars wait for an operates two point five million square feet of warehouses and logistical distribution centers supplying over two hundred stores in new jersey new york pennsylvania delaware connecticut massachusetts and rhode island the wait for an organization is a law just the nation's largest on non farm cooperative in the united states and is comprise forty four members who and independently own and operate supermarkets under the shoprite banner mr chairman i applaud you your ranking member and the subcommittee for your efforts to improve whose safety we to believe the that improvements will best be achieved through a three tiered program that emphasizes prevention intervention and response this morning i represent several of wake friends recommendations for revising revising the bill but i ask that my in state my entire statement be included for the record media coverage of recent outbreaks recalls and food safety scares have contributed to a decline in consumer confidence and reveal new challenges for ensuring the food supply is safe in an ever changing marketplace i am pleased to note that in two thousand and eight with the federal government and the private sector working together to improve food safety consumer confidence has rebounded our retail industry trade association the food marketing institute working with weight for and and its other members has outlined a number of retail industry food safety efforts and goals in a report being released today mr chairman i would like to submit this paper the f m r i food safety paper the supermarket perspective for the record enhancing the safety of the food supply requires the active effort and strong support of suppliers food wholesalers and retailers as well as government this includes our commitment to train our own people our efforts to implement best food safety practices and outreach to consumers it's a farm to table challenge that needs a farm to table solution it's both a domestic and international problem we must address together wakefulness committed to working with the supply community to constantly improve the safety of the food they manufacture process and to this and participate in a safe quality food program as q f within a domestic retail setting training still manages work using food safety is important to currently wait for and makes extensive use of the super safe program the final link in the supply chain is the consumer wait for it has long provided consumers with practical science based guidance on the safe food handling at home to the point to shop for food safety education our customers expect the foods they purchase to be safe whether it's store produce manufactured or farm grown as retailers we have an obligation to make sure we are sourcing from suppliers who have food safety plans in place accredited third party certification companies are objective independent bodies at a highly qualified to evaluate manufacturing facilities and to test if warranted that the supplier meets or exceeds all federally mandy added food safety standards one such program is a q f which is managed by f m i and recognized by the global food safety initiative which also recognizes several of the certification programs wait for and uses s q l because s q l has a well documented validated food safety management system we are pleased to see that your bill recognises this concept but we would ask that you work with us to ensure that accredited third party programs do not become a substitute for f d a inspection and regulation these programs are best use to supplement and leverage f d a resources since f d a will never have sufficient resources to inspect every facility in recognition of rigorous infrastructure currently in place we encourage congress and every f d a to examine how other countries are using certification as part of the overall risk assessment plan we believe that the f should be given the authority to mandate a recall in those cases where a company responsible for adulterated food does not act properly to requalify who we also believe that supply should be required to give retailers immediate notification one recall action is taken in addition there are other several other initiatives we would like to support global sourcing safety rapid testing safety and this repro to use here again as a retailer wait for will be using s q l and a vigorous appeals process there are several other food safety and we have asked our industry trade association to examine more closely these are registration fees user fees and country of origin labeling mr chairman thank you for the opportunity to testify i remain available to the subcommittee for further discussion and information should you need contract research organizations headquartered in princeton new jersey coping with his operations and more than twenty countries and more than eighty seven hundred employees two thirds of whom are in the u s we conduct research and development for new medicines and provide laboratory testing services to food and other industries one of my responsibilities at covance is our food testing business i thank you for inviting me to participate in this discussion on food safety we strongly support the subcommittee's efforts to advance food safety in our country and we also support the third party testing provision in the draft discussion bill cove ants is a full service laboratory to the food industry offering comprehensive testing services are possibility in madison wisconsin is one of the largest food testing laboratories in the world our lab routinely analyzes more than fifty thousand samples per month it operates twenty four hours a day seven days a week it serves not just industry customers but also state and federal labs including the f d a i'd like to thank congressman baldwin congresswoman baldwin for support of our medicine facility and she's actually toured our facility there and i'd also like to note that we operate through testing laboratories in battle creek michigan and singapore that have similar capabilities let me turn to the current status of food safety testing at the f d a you know the sheer volume variety and complexity of f d a regulated imports coming into this country is stunning f d a agrees and its food production plan that quote increases in the volume and complexity of imported foods have tacked the limits of f d a as approach to handling imports and quote so has recommended a new approach that includes the use of highly qualified third parties we agree with the vision of the f d a and of the subcommittee about the potential contribution of third party testing labs this will provide several benefits first is faster implementation this country currently has significant private laboratory capacity capable of ramping up quickly to meet any new testing requirements desired by congress and the a second is efficient use of limited resources as was noted earlier it's not necessary for f d a to dramatically increase its own laboratory testing capabilities the capability exist already in the private sector and we can quickly meet new requirements third is access to state of the art testing facilities cove ants and many other qualified laboratories maintain highly trained staff and state of the art equipment with a high level of automation ensuring rapid and high volume sample throughput and then fourth is the ability of the f d a to maintain adequate oversight and control f d a has worked effectively with coke ants and other labs for many years on a variety of issues authorizing f d a to accredit third parties builds on the success but it shouldn't tail very strict accrediting requirements let's face it it's essential that the american public have a high level of confidence and their food safety and the testing of their food food testing laboratories whether private or public should be held to high standards we have some suggestions for appropriate accreditation standards for consideration first is f d a good laboratory practices or g l pease f d a already has published g o p s for third party laboratories for many years we're not starting from scratch with third party lab standards a should continue to use this highly reliable standard which is respected across the globe second is the international standards organization as was noted early i s o seven seventeen zero two five standard i so standards generally are used in manufacturing in the chemical petroleum industries and in food processing and other areas requiring i s o certification together with the f d a g o p program would help ensure stringent record keeping requirements third is a way see international official methods the majority of testing methods actually used today for food testing have been fully validated and standardized by a always see international they always say provides validation services for testing methods at a o c a o e c official methods are considered the gold standard of test methods around the world f d a laboratories themselves use the and they always see method one is available as covalent so in conclusion cove ants applauds the committee for including provisions of its draft bill authorizing the f d a to accredit third party labs we believe there is an appropriate role for and dependent third parties to improve the safety of our food supply and this use of third parties will also permit f d a to quickly and easily alter resource requirements based on changing needs and circumstances so i thank you for the opportunity to testify and would be pleased to answer any questions thank you mr leavitt congressman doing well thank you and i'm delighted to be joining all of you today and testifying on behalf of the grocery manufacturers association the national fisheries institute the snack food association american frozen food institute and the america american bankers association we are all committed and representing our members to be partners with you and others to ensure that we can advance reforms that well and hansa safety of our food supply in particular as we move forward with  considering what should be included in many forms we have several measures one we urge you to give f d a the power to establish safety standards for food ten vegetables two we urge you to require that every food company has a poodle safety plan that is based upon food safety risk analysis that document appropriate food safety controls and that is available for f d a to review three we urge you to require every food importer to police their foreign suppliers and document for a review their food safety controls and for we urge you to give f d a new powers to address bad actors who have declined to recall contaminated food products posing a risk of severe health consequences  we are pleased that bipartisan piece of legislation and bodying these components was introduced just yesterday by congressman costa and congressman putnam when we look at turn to the issue of the provisions that are in the  draft discussion draft bill we think there are many in there that are constructive but we do have some serious concerns about others we have strong objections to the registration fees the import duties and other fees that will essentially result in a billion dollars in taxes on food products which will show up and increase cost at the grocery store shelves you know you put this on top of the energy legislation that kate was passed by this committee that is also diverting twenty five percent of our corn crop and food to feel your further compound in the rapid escalation in food prices that we have never seen in recent time we're also very concerned about some of the per script regulatory approaches that would allow f d a inspectors to second guess food safety decision many of our member companies that are really i'm you know embodying the latest in technology and science to ensure that they the best this is not the route that we should be going down and when we come to the issue of the third party certification i think we have to be very concerned about basically having f d a give the authority and the power affectively a government agency to pass judgment on whether or not suppliers are manufacturers are in compliance with f d a regulation is that if again if you turn this around what we are going to be effectively doing is saying to import or any producer of food or an ingredient product regardless of where they are in the in the world could be france could be canada could be somalia is that we are going to require them to be certified by a third party eighty that we have supposedly sanction to pass judgment on whether or not they are compliant with our defined set of regulations and rules why are we why do we do expect is going to be the response to this do you not expect that canada that france that the u k that china that japan will also put in place similar protocols that would require every x border of a food product in this country to be accredited or certified by a group that they have sanction i really you know as a committee to give thirty is serious consideration about going down a path that will inevitably bruise and bided response that will have great harm on our ability to access the international markets which are so important to the to our industry you know the food industry is willing to accept that there are some needs to reform to ensure that we are allowing f d a to have the appropriate enforcement provisions when you have an instance of a need for a mandatory recall you know we support some of the provisions that it will clue this for when you have a class one need for a recall the other provision i'd like to touch on in closing is a provision that would allow a five hundred thousand dollars civil penalty to be assessed on a daily basis right now what happens when you have a potential food safety problem that is occurring is that there is a very collaborative interaction between the manufacturer and c d c the centers for disease control if you put in place the threat of a five hundred thousand dollars civil penalty you are going to really undermine that collaboration discussion that really leads to the most efficient and quick determination of what products pose a risk and getting them out of the market as quickly as possible our member companies do not need a threat of a civil penalty to ensure that they deploying the best practices committee to give serious considerations whether or not that would be an effective reform to enhance of safety of our food product thank you ms dual thank you so much chairman on behalf of our over nine hundred thousand consumer members of the center for science in the public interest i want to thank you for your leadership on food safety in the many representative deal representative barton representative dingell the many members of this committee who have worked long and hard on this issue in the last two years the impact of food borne disease has been fully described in hearings already before this committee and with this hearing i see that your committee is really starting the job of solving the problems in our food safety system but let's not forget the victims some of whom have testified before this committee victims like ashley armstrong who is three years of age suffered acute kidney failure and months of dialysis after eating eco light tainted spinach her costs the cost of her family were unspeakable hundreds of thousands of dollars in medical cost her her parents spent months in the hospital or more lou marshall who is eighty six years of age will ha was hospitalized and will spend the rest of her life in nursing care for meeting salmonella tainted peanut butter as the committee moves forward to consider this legislation these are a few of the victims i hope you remember and the illnesses that we must prevent search for ways to empower the f d a with the resources and the authority that i host sorely lacks today it seems like every week another food warning sends consumers to their pantries to look for the source of a melon or the production code on a recent recently recalled can or jar of food food outbreaks and recalls in recent years have caused a dramatic loss in consumer confidence and many many costs to the food industry as well as long advocated that congress take this step of creating a modern food safety system and we believe after analyzing sixteen years of outbreak data that this system we're operating under the proof is in the last few years is fundamentally flawed we need a new system we've supported a unified agency we've brought forward many concepts and ideas to this committee and others but it's critically important that the new system be based on public health well the f d a globalization act does not contain sweeping reform of the nature that we have proposed in the past nonetheless the improvements that it proposes are essential to address the gaps weaknesses in the f d a is current food safety program it builds upon the improvements of the bio terrorism act of two thousand and two but adds a fundamentally new structured f safety program it contains numerous improvements i'll just mention a few written process control plans utilizing performance standards that create a food safety foundation that has not before existed  it also contains a voluntary certification program for imported foods but one that has strong incentives to encourage companies to seek certification and that is modeled on programs already in place in the retail sector and it also has important new in forstmann authorities things like mandatory recall and civil penalties that the f d a needs to do its job in the spirit of the bill the inspection frequency as you have right now two years and four years are really not good enough and we would like to see those inspection frequencies increased to ensure that the food companies really know they have to comply the f d a globalization act really takes many ideas from many stakeholders people like the grocery manufacturers of america who put out their own plan c s p i who put out a white paper in the fall and the food and drug administration's food protection plan it really very successfully with many of these ideas together then this hearing really demonstrates that there is widespread agreement among these entities and also the the committee here on the need to improve f d a has oversight of the imports their inspection capability and their enforcement tools well ea stakeholder may differ on the particulars the f d a globalization act offers an unprecedented opportunity for congress to pass strong food safety legislation that in fact represents the best ideas for improving the current system thank you thank you and i want to thank all the panel will start with questions and i'll recognize myself financially for five minutes i'm trying to get one question in from mr taylor and then one from m ambrosio mr taylor you mentioned the need to strengthen the performance standards section in the discussion draft we've gotten some questions on this provision in particular as there appears to be confusion as to what performance standards are and what they should be some even feel that it would be impossible to create performance standards for all food someone like us to focus only on the top ten contaminants and you know those most risky products in your professional opinion what should we be aiming for as we expand the performance standards section of the bill i think this is a really important question to ask and i think tell do is comment sort of pose the issue i think i think i completely agree with carol that what we are not talking about is standards where the government is going in and telling companies how to produce a food and how to design the brakes in the car that's the old fashioned command and control approach to regulation which is a failure i ran the food safety agency u s d a which is based on that principle and i've seen it not working very well when i use the term performance standards i'm i'm referring to standards that address the outcome to be achieved think of we have these in the current system today we have pesticide tolerances for example that set  quantitative limit on the amount of a residue that can be present in food and companies then work to meet that that outcome they're not told how to do it they work to achieve it we also have standards in respect to m pathogens which is what i think we're really focusing on here today and of course the recent work that f d a has done a lot of styria trying to find a health based level of listeria that is that that protects public health in that the companies can then work to to meet that what i refer to as a food safety outcome that is an acceptable level of contamination so it's not about mandating how they do it it's ensuring on behalf of the public that these food safety plans are actually designed to achieve an outcome that is acceptable to the public  it's it is the sort of the modern approach to regulation is performance standards not commanding control of mandatory standards i would also emphasize that you know there are many many hazards in the food supply i strongly believe that f d a ought to be directed to take a risk based approach to focus on the most significant hazards in terms of impact on public health and figure out what are the selected commodity and pathogen specific patterns for which up a new performance standard can actually help drive progress on food safety so it should be targeted and it should be done in a way that is not prescribing how the industry does it but defines on behalf of the public what's an acceptable outcome in these high priority cases thank you the sam bros the i'd like to follow up on your comments on the concept of certification since your views on the matter seem to be different for mr dooley's my understanding is that many retailers including most of the largest like we're wait for him but also wagman safeway giant already now with the suppliers to be certified for safety by a third party entity in fact that under one particular certification system already being used by major retailers thirty thousand facilities were certified last year alone is it your sense that that is where the food industry is heading is it your view that certification complain important role in helping to augment f d a oversight thank you certification can play an important vital role in this the s q l model which is recognized by the global food safety initiative it's an international standard that parallels with the british retail consortium in the i f s when you look at it it's really without getting too technical and i can give you information with regard to technicality of the program but it truly is an enhanced tasa program when you look at it there are a lot of good things that manufacturers do but in this particular case when you look at a certification body that oversees what processes have been performed at those  manufacturing facilities it truly gives you a sense that there's a good management system that's putting place it really is walking the walk and talk in the talk i mean essentially when you go in there it's the manufacturing field syllabi that develops these plants and they live by it it has been proven it's worldwide it has been globally recognized for several years now it's thought it was a large situation happen on the west coast so when you look at it from a global perspective it is recognize of it parallels many other global food safety initiatives that are out there and it is recognized so you mentioned this particular one the safe quality food program i want to just elaborate a little more on how that operates with you well as i manage program and essentially it's what i had said it's a managed program that it's a really enhanced way of looking at things they look at it from the growers level if you want to look at produce for that matter and then they take it all the way to the processing and there are different levels of s q l for you get into s q f one thousand in two thousand and both address the needs of what you're actually looking at it's pretty much tailored to the specific discipline of the operation so if you're looking at a manufacturer if there's disciplines within the body of that program that address that if you're looking at a farmer it gives you the disciplines with regard to the growing conditions and if you're processing spinach as we had the incident back in zero six you'll see that that will go right into the with the f d a every two years do any of you oppose giving that authority statutorily he also testified that f d a cannot deny entry into the country of a food produced in a foreign facility where the facility operators hampered or deny the f b i s ability to inspect that facility he asked that we change the law to allow the f d a to deny entry of food produced in that facility do any of enough but more to the point all of these elements are are they're not opposed but they're not enough they will not solve the problems we've seen with spinach with peanut butter with imported pet food in food ingredients they will not solve those problems alone but i don't oppose them all right the foreign facility i assume everybody would generally agree that if they have denied or hampered f d a has authority to inspect we should at least give f d a the authority to deny products from those facilities coming in anybody opposed to that proposal he also requested in his testimony that f d a have the authority to order a mandatory recall in the event that a company does not conduct its own voluntary recall and i think the indication is that we haven't had that situation develop yet would any of you and that that authority in f d a be non delegate ball below the commissioner of f d a level would you all generally support that proposition and when we have been dealing with user fees in the past user fees have generally been considered to have been a bit for the people who are paying the fees in the case of pharmaceuticals to speed up the process of f d a review so presumably their product could get to market quicker what benefit to the payroll or of these these do you see in the proposal here ok sort of what i thought let me ask you oh yes ok yes ma'am i i think one of the issues of costs that has to be looked at is the price of not having a program and not having a program today and the fast food safety program actually cost consumers of the cost to the victims of these outbreaks which can be can be quite large but even if you have a mom case of illness and you are out of work for two days that cost you your employer so there are significant societal costs in addition though the industry itself has has faced significant costs from the failure and lack of a system the spin the industry has faced i think in liability costs alone it's one hundred million dollars which is that are effective as soon as possible well i think all of us would agree that we'd like to avoid these kind of bad situation developing if any of us had confidence that we could write a statute that would do that sort of we would do it i don't think anybody thinks we have the currently being proposed most and they're being proposed in the draft we would support perhaps a user fee that would be associated with an export certificate because that does provide a proprietary benefit but again when we look at this whole issue of public safety this should be a public charge much as public safety on your streets in your community of your neighborhoods and that if you move down the path of charging up from the people who you inspecting you also have the potential to undermine the credibility of the building and the integrity of this inspection service by having those who are being expected basically funding it and as you know that's one of the concerns that we've had  becoming so dependent on those fees for what's supposed to be an objective analysis thank you all my time has expired thank you mister thank you mr du gentlewoman from wisconsin baldwin thank you mr chairman i've been focusing a lot in opening statements and previous questioning on the discussion draft third party testing provision i will continue to do that with just a couple of quick questions for mr l the discussion draft contemplates additional food testing over what is currently occurring and i'm wondering looking forward to ultimate passage of a bill implementation of the bill what proportion of additional testing would you see third party laboratories taking on versus f d a itself your microphone thank you for your question congresswoman baldwin i think that third party labs can take on substantial testing it's not that there's a lot of empty laboratory lab sitting out there just ready to start running tomorrow because obviously for enterprise system doesn't work that way but companies like ourselves can ramp up laboratories very quickly just last year the sink the singapore laboratory that i mentioned we took a empty building and six months later had an iso seventeen o two five certified laboratory running testing on food and so you know this is rampant that can happen very quickly and i think that you know in the absence of very substantial procreation is to allow the f d a to build the large number of labs i think walton be needed you know the private sector can really make a big contribution here you mentioned in your testimony that currently your company covance works with the f d a government federal level state love a lot and private entities can you talk a little bit about the current partnership you have with f d a and then also explain to me how would the testing done by your company or a third party compare to the type of testing that's currently done by the f d a is it similar is it different please please elaborate yes  thank you again i'll take the second question first if you don't mind i think the testing is actually quite similar we both run away c methods when that's feasible or when they're available and we run similar methods on other occasions so i think the testing between a good government lab and a good private lab is basically the same in terms of work we've done with the f d a you know it's been you know myriad work over the years on a multiple of occasions often it's something where for example in the case of the federal when that first chemist but a dental file a federal supplements and food these were fully validated by the away see in the f d a and they were used together with data that we generated through our own testing the ultimate lead ban dietary supplements containing ephedra another example is a crawl in my when that became a concern we were contracted by the f d a to conduct a large market basket survey to a dental five how much acrylic my there actually was in a whole series of different kinds of foods and i think that's a good example where we were able to ramp up very quickly to do it was a very large volume of testing on short notice that would have been difficult for an existing government lab that's already very busy take on thank you thank you gentleman from pennsylvania mr pitts thank you mr chairman mr dooley or anyone else would like to respond given all the new requirements the import job for each testing of every single import what could we be passed on to consumers so you would see an increase and but it's hard to quantify you know just what the magnitude of that be we can quantify what the magnitude of the fees would be i mean you have in the legislation they think with the registration fees  six hundred million if you look at the ten thousand dollars per importer the is that what does that mean to mr ambrozy as stores that he has that they're importing directly you know maybe it's wine from france or cheese from from from europe or someplace are they going to be liable for a ten thousand dollars fee or is that little boutique store that you might have on main street that's an importer directly are they also going to be ten thousand we look at that as being another magnitude that could be as much as four hundred million on top of that and then if you go into the regulatory side of it that inevitably is going to increase some prices but the one thing i want to clarify is is that there is a lot of our companies today doing have in place the best practices and on that comes to the audit what we are concerned with is we have a proposal that would say that every private sector company that is has a set of preventive controls in place and if you're importing you have a supplier quality assurance plan that plan will inevitably include a third party probably certification or audit but that is going to be a price private contractual arrangement that they'll have with their supplier why we are so concerned and what we think will add additional cost here if you have f d a sanctioning one audit that might be out there is that you can create a restriction in the marketplace it will drive up the cost of audits that will also be passed on to that consumer and you also have the threat of again imposing these on other countries and their companies if they're in manufacturing that they're going to have a new cost there that they're going to respond and so i think we have to be very careful about going down this the increase in the cross food for this bill in conjunction with the ethanol mandate i you know we haven't done you know the you know the complete analysis on that we have currently have retained an economist is doing some modeling to get some more for labeling package meat and poultry products where that has been packaged using minute levels of carbon monoxide the rationale is that it may artificially keep the meat red longer and mislead  types of packaging that has the effect of preserving the redness of me longer extended period of time and you know this is an example when we when i mentioned in my testimony that we're very concerned about per script of controls being put in place this is a classic example of congress putting a prescript control on what type of technology can be used in the packaging of a meat product you know they are requiring a separate label that will basically make this very difficult to be used in the marketplace and the concern that we no health risk to consumers by its utilization ok i just have one more question the draft requires country of origin labeling for where the final product was produced along with the requirement to maintain a website with a list of all sources greedy and  can you comment on that provision in terms of your ability to do it and in terms of what it contributes to prove safety anywhere but which drew well first off you know you know what the grocery manufacturers are absolutely committed to it doesn't matter if that food product is your manufacture in the united states or if you are importing a food product or if you're importing a gradient from any country throughout the world that those have to be safe and that this idea that we're going to be able to develop a website where we can put on every ingredient in a particular product is going to be problematic i mean if you look at a pound of folgers coffee on the grocery store shelf it could have beings coming from twenty seven different countries so and countries so are we then to put on the web site this product could contain vegetables that came from these fifty countries at some point during the year and what is the value to the consumer by providing that information we would say there  i'm going to go to a second round in part because i think we expect mr dingell to come back so i can have some questions myself and then we'll go back and forth again for those who would like to go back to congressman dooley again in your testimony you you emphasize that we need to implement a risk based approach for the prevention of contamination and in our conversations with industry experts oftentimes though  they sort of indicate that that's not an easy thing to do can you elaborate on the side the and explain how it would factor in safety mechanisms for what usually would be considered low risk products like peanut butter which as you know was a was a recent cause of the salmonella outbreak well i think that you know and mr taylor probably can lab rate on this too is that there are some products that are processed in a manner which is there on the hair and really you know low risk there are some products  going to be more acidic that are going to be a lower risk there is going to be some products which are fresh and are semi processed that are going to be of higher risk and we need to have a regulatory system an inspection system that is developed where you are allocating more of your scarce resources if you're after day on those products that pose the greatest risk and i would even say when you look at the fee structure that you put in place it doesn't make any sense to charge up lat two thousand dollars across the board or should that be a risk based b does it make any sense to have an arbitrary number of inspections saying a plant has advanced back to every two years regardless of the risk of that product that is being processed once again you need to have a system which is identifying and herit risk of a product to consumers to have a food borne illness and then allocating your resources in a way that is going to make the biggest difference let me you know i still don't understand how you would propose to do this risk based modeling i mean i've been having a problem with that in many areas not just this one but let me go back to about a response to what you're doing when you're back to stablish even some of the performance standards that mr taylor referenced you are in fact and identifying that there are some levels in some products that are going to have the need to have a performance standard because you know that in a fire risk this is not that hard to do all right well let me following up then let me do was obviously relates to both what mr congressman dooley and mr taylor said i mean you heard mr taylor's views on the performance standards and you know basically this same question what would we look at in terms of performance standards and given the difficulty in my opinion in structuring a risk based model you know how do you factor th down on this issue of risk based risk based whether it's performance standards or inspection frequency one thing that we have seen over the last year is even the u department of agriculture which has a much more robust robust inspection system has been able to develop the data necessary to really catalog their facilities in terms of  risk it doesn't mean they're going to continue to work on it but the bottom line is they don't have that system in place today to do it we in terms of performance standards the way the  globalization act is structured right now allows for f d a to utilize performance standards where they see it's appropriate to leave discretion in the agency itself to use performance standards the mot the model of using performance standards to evaluate and measure how the process controls are working is an excellent model but again it can i would i would agree with your assessment we're not there yet we can't use it for every single food product but we can use it more effectively than we do today mr taylor points to hopefully clarify and add to this me the provision in the bill that would call for standards for fresh produce is an example i would argue of taking a risk based approach taking the evidence that we've got from the outbreak investigations that have shown that we do have a risk of contamination of fresh produce a certain bacteria and it is a need to put in place standards to prevent that and the standards would presumably be crafted scientifically to address the particular hazar whether it's seminal or recall in a way to measure the success of the efforts that were taken so the risk based approach is that is making the decision to focus efforts in terms of standard setting that inspection on this particular set  commodities because they pose public health risks i want to underscore the suggestion that somehow the food industry in running its business would take a risk based approach well in a way that's true but the food industry has a fundamental obligation which i think most companies take seriously to ensure that every food that they produce is safe you can make any food unsafe you allow contamination with pesticides or other chemicals and so so there's a foundational duty that the companies have to be sure that the broad for safety in the food in the food laws are met with the risk to produce really focus on how we target government efforts to get a public health benefit for the resources that are invested united states where food is imported into this country the draft legislation would require a certification for food facilities or the importer would be limited to the porch in which there's an f d a lab in that metropolitan area given that some labs are not located at major ports the number of ports where food could be imported could actually be lower than thirteen is it practical to say that we're going to have the number of ports available to import food less be less than thirteen and not have a devastating effect on our food supply who would like to thank you so much  terms of the you know narrowing the number of ports of entry from three hundred to thirteen i think that the intention of the bill is not the way the way i read it plainly is to have a system where it is voluntary to get certified but there is a strong incentive if companies want to continue to operate exactly as they do today which is they can go to any port of entry th certified and give a timeframe for allowing that certification to occur it can't occur overnight because there aren't probably enough certifiers in place the th ing that that certainly hit home for me as i listened to the f d a witness today was the fact that today they're not using their laboratories for the most part to check imported food very little imported food today is ever checked in a laboratory i believe it's like two tenths of one per cent so the new system will have to utilize laboratories whether they are f laboratories or private laboratories to do the testing that is needed for imports and that is not being done today anyone else like mr taylor i think the certification issues need a lot of discussion before this legislation moves forward and i think it's a very interesting idea and i think it has it has significant questions around it i would urge that we think about certification as a way  on a way to supplement a system that is based fundamentally on the duty of the importer to be able to document how it was that they are importing they are importing in the united states they should be able to document how it is that that food is produced in a way that meets u s standards as i understand the proposal that g m a put out last fall on imports that's what they recommend and the reason that's so important is because that's the legally accountable end of the here in the meet those importers i should say meet those duties and i think there are roles for third party certification and a lot of different ways to sort of provide that assure but i would build certification on top of a foundation of accountability for the importer to provide assurance that that the product reduced overseas is being produced in accordance with the same standards that we are able to enforce directly here in the united states mr raja we like testing is retailers however that's not what i really look at from my standpoint governing where i have to govern testing only validate a system i don't know how many items you would have to test and notify somebody to feel good about it if you look at salinas valley and you look at lettuce in that valley over there and i've been there several times how many heads of lettuce do you have to test in order for somebody to feel good about it it all goes back to the culture of those farmers and how they produce the item and how they harvest the item come into port so you can you can test and test and test but you might not see everything that you're testing testing only gives you a snapshot and invalidates the program and in the case of the biggest outbreak we have ahead on produce it was domestic it was an imported so i think we really have to look at what we're doing domestically first and then think about how we can take the good practices that we've learned domestically and then give the importers more of an opportunity to enhance their growing and manufacturing procedures just build on what mr ambrosio said i totally agree that testing only validates an existing program and it's really the overall program that assures food safety at the same time you know that just begs the question of how much testing is needed to really validate the program and i'm not sure that two tenths of one percent is enough so i think even to go to one percent would be a five fold increase which would be very substantial without you know delving into all the details of certification as it relates to the question you first  raised about linking ports of entry to the f d a labs i think that leveraging the resources of private labs which i think is going to be needed at the press well matter to increase the amount of testing at a rate that you know we're all go develop a plan to help build the scientific and regulatory capacity of major exporters to the united states do you want to just develop that i mean i know you made that statement but what it what do you  expect to be done to follow up on that i think it's you know this is where you really have to define that public private partnerships that can really help develop the capacity and many of the developing countries of the world to have the ability not only to stablish the appropriate standards and protocols but also the ability to enforce those and that's where there is i think the potential i don't want anyone to think that i am a critic of a standard for an audit i think those  audits ought to be a private contractual arrangement between the retailer the manufacturer and potentially the companies are providing those ingredients so there is the ability to help build out a private sector employers structure that could see the greater utilization of some of these audits that have higher standards that can be deployed and on some instances could be sanctioned by those governments to become the the the there we would clearly state that there is room for improvement we're committed to trying to implement the private sector reforms in the public rate forums that can achieve that and we also have to accept what are the source of borne illness look at th just fine how do you feel about that the industry and g m back in september of last year advanced our four pillars for enhanced food safety the basics in the components of that achieve those outcomes we also make it very clear that much like the medical device in the pharmaceutical industry we will support food drugs doesn't have the resources to do the job and you're here this morning or this afternoon now telling us that you don't need any help everything is fine mr dingell that is a clear message representation of my statements we have consistently stated that we are supportive and have been constructively engage with your staff with mr palauan staff with republicans and democratic members of this committee and offering our ideas and proposals and how we can that your industry will go any lengths to avoid regulations to protect the consumer we're going with your help but i hope we will have help and would do it without for help if we don't have your really do want your help and your cooperation your ideas as we move forward so thank you again let me just say in closing i want to remind the members that they may submit additional questions for the record to be answered by the relevant witnesses the question should be submitted to this committee clerk within the next ten days so you'll find out you know within the next ten days if there are additional questions that we'd like to have responses from in writing and without objection this meeting of the subcommittee is a