the meeting of the subcommittee on health will come to order and i recognize myself for opening statement initially we are here today to mark up a chart two seven four nine the food safety enhancement act two thousand and nine we've been working on this bill as many of you know for a long time both mr dingell and i introduced our first food safety bills eleven years ago and in the last few years especially this committee has been very focused on the issue holding hearings in both this subcommittee as well as in the oversight and investigations mr stupak subcommittee and i want to thank mr dingell as well as chairman waxman and mistress to pack for their commitment to this bill and for their tireless work on this issue and it has been tireless for a long time now obviously we must do something to address our nation's food safety system too often it breaks down too often contaminated or dangerous products make it onto grocery store shelves and into consumers homes and too often people get sick or even die due to unsafe food products during our hearing last week we heard about a three year old who suffered kidney failure after eating contaminated spinach a mother of young triplets who fell ill after eating contaminated baby food was in my office recently and this needs to stop and it needs to stop now the bill before us today is based on a discussion draft that chairman pack and i released a few weeks ago in includes provisions for mr from ms to gets food recall and traceability bills and incorporates input from the f d a and key stakeholder groups it also reflects some of the conversations we've had with ranking member barton ranking member deal and mr shimkus these conversations have been very productive and we intend to continue meeting on the remaining outstanding issues after this morning and as we move to full committee markup our bill today focuses predominantly on prevention unlike the current system of reacting to a food borne illness outbreak only after consumers have fallen ill this bill will require that companies put in place preventive controls to monitor the production lines and identify prevent or eliminate hazards should they arise it requires companies to have food safety plans detailing all the food safety activities the company is undertaking to ensure the safety of their products and to make those food safety plans available to an f d a inspector upon inspection the bill will also require all facilities that sell products in the united states to register annually with the f d a and to pay a registration fee the bill also empowers the agency these with authorities that are crucial to the food safety system under the bill the f d a will have the authority to set performance standards that companies must incorporate into their food safety plans it requires the f d a put in place a trace ability system for food products so we can easily trace that contamination from the consumer all the way back to the source of contamination it requires the f d a to win the f d a to inspect facilities according to a minimum inspection frequency and it provides the f d a with enhanced enforcement authorities including civil monetary penalties recall administrative detention seizure and subpoena now i believe that this bill will reform and modernize our antiquated food system i believe it will supply the f d a with the resources it needs to create a strong food safety agency and it will provide the authorities the agency requires to set standards and identify hazards and changes contaminants and finally it will give the agency the in forstmann authorities it needs to make sure that companies are complying with the bill and ensuring that the food they're making really is safe for consumers to eat again i'd like to thank my colleagues for all your work on this issue is an incredible amount of work on this issue for so many people on this committee and i look forward to comments on this bill as we move forward on our recognize mr deal for an opening statement thank you jim sloan i appreciate your holding the markup phone h r twenty seven forty nine t food safety enhancement act of two thousand and nine i appreciate the fact that you and your staff have made the issue of food safety a priority for the subcommittee and the fact that we've been able to work on a bipartisan basis and hopefully will continue to do that as we address this significant issue this committee has made tremendous progress in crafting a bipartisan bill over the last few weeks but there are some significant improvements that have been made but a few concerns that i have which remain one of those which is the most troublesome i think is one that we should address and that is the level of civil monetary penalties for unintentional violations which do not result in harm this bill would impose penalties up to five hundred thousand dollars on a food facility for such a violation without any form of a cap therefore due to an unintended and ultimately harmless violation of the law these in excess of millions of dollars could be imposed this would decimate companies particularly small businesses as a result is only reasonable that this committee include reasonable strict liability limits as well as a limit on civil penalties per proceeding and i hope that we can revisit this issue today and as we continue to move forward i would also like to highlight my concern with the frequency of f d a inspections of food facilities this legislation would require inspections of high risk a cell it is every six to eight months low risk facilities every eighteen months to three years and warehouse storage facilities every three to four years based upon so much based upon input from stakeholders and the financial burden which is scheduled placed on the f d a and the industry i believe this inspection regimen may not be realistic i agree that we must ensure that f d a conducts more thorough efficient and targeted inspections and by working with my colleagues in the coming week i hope we are able to arrive at an inspection schedule which is both cost efficient and highly effective i'm also concerned that requiring food facilities to maintain records in a standardized electronic format i have a number of smaller scale food facilities in my district and across the state of georgia many of which lack the sophisticated and costly computer infrastructure to enable electronic record keeping this would pose a significant hardship on thousands of companies across the country and i hope we can continue to work to avoid unintended consequences on this critical old enough to vote and i think it is therefore old enough for us to vote on i want to observe that this is a piece of legislation which is an example of how the house should work and how members should get together  bipartisan fashion i want to thank my colleagues on both sides for their work with us and i want to commend my colleagues on the minority side for their assistance we're considering a bill today h r two seven four nine the food safety enhancement act of two thousand and nine i'm proud to be the lead sponsor but i want to thank my colleagues who have joined in co sponsorship yourself for your assistance not a mistress to pack my dear friend from michigan and also has to get we started out a number of years ago on drafting legislation to fix food safety problems and also problems which exists with regard to safety of pharmaceuticals after years of hard work and cooperation of and with our republican colleagues we have been able to produce a strong piece of legislation which is proceeding now in a bipartisan fashion the legislation before says enjoyed a number of titles and a number of different bill numbers the goal has consistently remained the same to provide f d a the necessary authorities and resources to protect the nation's food supply and i would observe that both food and drug and the nation's food supply are in some substantial disarray we intend that that will be corrected that f d a will get the resources and the authorities which it needs to conduct its business of protecting the american people i want to thank mr waxman for his early acknowledgement of the need for this legislation and i want to thank also mrs sutton for her help in this with regard to this matter i'd like to congratulate and thank two of my staff members mr virgil miller cady campbell for their assistance and your staff mr chairman and that of the of the republican side i want to thank mr barton for the way he's worked with us and mr deal and also to thank has been helpful throughout the time that we have worked on this you will observe that the good faith of all parties is to be reflected in the manager's amendment which we will consider today we have closed the gap on a number of important i a few as observed by mr deal still remain i look forward to continue discussions prior to the full committee markup with the goal of producing a bill that will be bipartisan character and of which all members on both sides  i am pleased to report we've been able to reach agreement on issues of great importance which have been most contest most contentious one of them is the issue fees and then this i want to discuss the behavior of g grocery manufacturers association they have been gentlemanly cooperated and decent throughout this process and i want to express my appreciation to them for their assistance in this matter they have served the public interest in the interest of their own people and i hope that they are pleased with their their efforts because they indeed but b i've always been convinced that it doesn't matter what new authorities we give the f unless we give them resources to exercise these authorities carry out their responsibilities industry without regard to their historic opposition to fees has accepted that they have an appropriate role in ensuring that f d a has adequate resources and again i want to express my appreciation to them that role is detailed in today's manager's amendment and it will enable everybody to prosper from this including the consumers the industry and food and drug administration and ice my hope that the industry will get better service out of f d a because we're giving them the resources to arrive at better judgments more quickly while food safety is garnered our immedia attention i have to remind my colleagues that when we finish this we still have the problem of f d a as oversight of drugs devices and cosmetics we have legislation in the mill which is moving forward on all of these and which will be necessary to pass if we intend to have food drug be able to carry out its mission in proper fashion with regard to all the things underage jurisdiction the good news then is that we don't have to look far to find good legislation to address these issues and we have an appropriate legislative response to the food and drug administration globalization act and i would observe again that i along with you mr chairman and our dear friend mr stupak of introduced this legislation earlier this year we have been engaged vigorously in this matter and although occupied much and in health reform over the past few months we are getting this to the point where it is ready to make food and drug again the strong vigorish publicly oriented agency which i can remember a long time ago that used to be the legislation here is not working ridge not perfect we have work to do but he has to be appropriated appropriators who have been notoriously short in their effort and i could comfortably say however that it is that we have before us a better bill because of the contribution contributions made by the members of this committee both ranking member of the full committee mr barton thank you mr chairman and i want to say at the outset that after the opening statement i'm going to run over and and do a press event but i should be back for most of the market i want to thank you  irman waxman and chairman dingell for working with us today's issue i said like back in march that there really wasn't any daylight between chairman waxman and myself in terms of food safety what we needed to accomplishment accomplished we've had a somewhat rocky road between then and now but in the last week the majority has worked i think very cooperative and with the minority and the result is a a draft set of issues that we can work on today as subcommittee continue to work on the full committee serious substantive progress has been made and while i don't believe that the the manager's amendment today is this is the end result it's going to be the end all be all it is a good starting point one area where we've made great progress is resources for the f d a i was concerned that in the early drafts the level of fees was excessive and his squeeze both food producers and consumers we all agree that the f d a needs more money for food safety but we have disagreed on the level of funding that the f d a should receive the feeling which in the manager's amendment that's going to be offered today is a product of good faith negotiations not just between the minority and the majority but also between the congress and the stakeholders and i think progress has been made there is this is a public health problem i think the congress has a responsibility to appropriate more funds for the f d a for food safety it's still debatable proposition the exact level that should be season that and the level that should be appropriated to the appropriations process but i do say that good faith has been exhibited on all sides and we're making progress another issue in the draft that still need some work is the section on civil monetary penalties this trap would allow for the first time the could impose this fine for each article of food involved these fines if imposed in that way could easily run into the millions or tens of millions of dollars i think we need reasonable limits for strict liability violations as well as an overall per perceiving limit if they greet us violations in the f d a wants to impose a larger fine or a stronger penalty the f d a already has the authority to go to court and prosecute the individual or the company either civilly are criminally giving f d a for the first time it ministry of authority to impose civil fines of this magnitude on food producers is a significant new authority and we need to be very careful what we do here more work will have to be done between subcommittee and full committee on this issue inspection frequencies another issue with the draft we've heard a number of people testify before the committee that you can inspect your weight of food safety but that's what this draft intends to try to do it require an inspection of high risk facilities over six to eighteen months low risk facilities every eighteen months to three years in warehouses every three to four years these inspection frequencies are not feasible quien the f d a to inspect low risk a silly these and warehouses at that frequency will not improve food safety that's not just my opinion that's in pinion of numerous people who have testified before this committee and numerous stakeholders that are concerned about this issue f d a also at last week's hearing expressed some reservations about these frequencies i think that we should provide either in today's markup or it full committee more flexibility in frequency inspection mr chairman i've listed some of the problems i see with the draft but i several members on the republican side for working together to make this draft in this market possible today i want to give special commendation to chairman dingell he has worked like a trojan on this and prior congress and he continues to work in this congress i think it is one of his legacy issues that he will be remembered for and he he has been a total gentleman to me in the minority in reaching out to us both professionally and personally and i want to give him special commend commendation for what for his efforts on this issue with that mr chairman i will you go back and say that we look forward to this market today thank accomplishment for this committee we stand on the verge of passing a comprehensive broadly supported and bipartisan reform of our nation's food safety laws the committee released a discussion draft held our first  hearing just one week ago over the last week we work with members democratic and republican on and off the committee with consumer and safety food safety groups and with numerous represents from the food industry and with the  made a great deal of progress i know we still have some issues to work out and i'm committed to working with the members of the committee to resolve them my plan is to have a full committee markup next wednesday and i'm confident we'll have strong bipartisan consensus on tough new standards to protect the food supply there's a lot to be proud of in this bill it establishes a new preventive approach to avoiding foodborne illness it requires all facilities conduct hazard analyses assess potential food safety risks and develop plans to keep the food supply safe it establishes f d a food safety standards for produce it establishes a food traceback system so that f d a and public health officials can easily determine the causes of food borne disease outbreaks and gives the agency new tools to keep the food supply safe we make we're making a crucial breakthrough in this legislation by establishing a user fee system that provides dedicated funding for food safety activities under proposal that we develop with the republicans on our committee and with the grocery manufacturers association facilities will be assessed five hundred dollars annual registration fee these fees will provide f d a with the much needed infusion of resources to keep the food supply safe over the next week i want to make this bill even better and i'm confident that we can come to agreement on other key issues i want to acknowledge how far we've come with this bill and thank those responsible chairman emeritus dingell has worked on these issues for years his ideas have helped form the foundation of this bill and he and his staff have played a critical role in the negotiations over the key provisions in this bill chairman stupak great work on the oversight investigations subcommittee has helped identify key gaps in the regulatory system and he continues to be one of our strongest advocates for fixing these problems house of committee chairman polonia shown great leadership on this issue and i appreciate his work on last week's hearing and this week's markup i also want to acknowledge the work of representative sutton on the recall provisions of the bill and the work of representative to get on the traceability provisions finally i want to thank our republican colleagues ranking member barton and ranking member deal and representative shimkus for their willingness to get engaged with us on this bill and for their ideas to help make it better i'm looking forward to this i'm looking forward to this markup and to continuing to work with you and other member committee members as we move towards full committee markup of the strong bipartisan food safety reform bill next week i want to thank those who have been involved in this to say that and say thanks both sides have come to agreement compromise on many key issues such as country of origin labeling traceability and fresh produce standards i'm also encouraged by the progress made in other big items and i look forward to working continuing to work in a bipartisan manner towards a full committee markup to settle the rest of these outstanding issues chief among those is the fees for both facilities and importers civil monetary penalties some of these were addressed earlier the ability for change in the inspection regime for certain categories  review by the f d a recall authority and lastly clarifying our intent isn't to duplicate or over regulate those already already registered and follow strict safety standards such as meat and poultry farmers under the u s d a our wine and spirits industries under the alcohol tobacco and trade bureau so i look forward to working with you and thank you for moving us forward how you go back thank you the gentleman from tennessee mr gordon  waxman has committed just about everybody here and so i want to concur with with him in the accolades he gave to all the principles of done a good job overall i believe that we have a very good product here and i'm encouraged with about partisan effort to prove improve the bill and i hope these good efforts will continue we now in the full committee although i do still have some concerns and i concur with some of mr deal's earlier concerns and particularly i believe it would be useful to further clarify what type of food facilities are covered by the registration fee and other requirements in the bill i'm especially concerned that we may be inadvertently covering very small often seasonal mom and pop food processors th make homemade food items i think we all have numerous groups like this in our in our districts so i would like to work with the committee to clarify this issue as we move forward with this legislation and you're back my time thank you the gentleman from texas to burgess thanks chairman i appreciate that committee has worked so hard on this please forgive me if i don't share in the spirit of bipartisanship that is so much on display this morning because i don't know maybe it didn't filter down to the kids table here on the on the minority side but you know we had the we had the draft discussion last week that we had we had the discussion hearing last week and we had the draft legislation some significant problems with a draft legislation and then less than a week later we're back here with a markup receiving a manager's amendment literally just hours ago it has been it has been tough to make sure that this thing does what we would all like for it to do it you know sometimes was chairman almost seems like because we're republicans that we can't see into it the real concerns of the food safety safety universe but realistically many of us have worked on this for years many of us have worked closely with your colleague mr costa from california many of us have worked with the legislation that would senator kennedy's food safety bill over in the senate so all of us whether we're democrats or republicans are aware of this and concerned with the country's food safety needs i've felt for a long time that we need the ability to put an emergency stop button in our food imports so that when a food borne illness issue arises on a friday afternoon we don't have to wait until monday at nine o'clock for someone to get out of his or her chair and make a decision this is a commonsense idea that wasn't included in this bill i've introduced stand alone legislation to deal with this and i intend to attempt to amend the bill later on today to include that but mr chairman it is tough to sit here on this committee and watch these news stories on lou dobbs where we're not doing our work because the salmonella that devastated the tomato industry in this country last year was actually a problem with peppers and those were peppers coming across the southern border in texas and even after all of that was finally discerned we waited until after the weekend before we actually acted other concerns in section one zero seven regarding the traceability of food that were granted exemption for food produced on a farm and then sold directly to a consumer restaurant these farms would never have to trace how would this fix that problem that we had done in texas with the contaminated peppers last summer that was food that was sold directly from the farm to to consumers on this side of the border and it doesn't seem like this bill would actually have stopped that from happening and even some of the president's concerns are not being addressed appropriations eighteen months is not enough time for the food and drug administration to hire train and implement the aggressive food inspection provisions of section one hundred five this bill also supposed to strip out all of the references was just to be a fluids bill but references to food drug and device actually did appear in the discussion graph draft fourteen times yes thirteen of those fourteen were removed but in section two zero five regarding the suspension of registration which is a fairly significant enforcement action we still have the importation of food drugs and devices as a language in the bill for those who make an inaccurate or incomplete statement or submission of information and then finally  chairman at seven thirteen this morning we received the manager's amendment one hundred thirteen pages got through about a third of it so far again members need to be given the common courtesy of enough time to read and evaluate these very important pieces of legislation that we're trying to push through committee i'm optimistic because we are here this is a subcommittee mark and unlike other pieces of legislation that didn't go to regular order there is a there is the opportunity to amend and improve this legislation i intend to work with the committee to do that but  concerned about some of the ways that this is come to us all you back the balance of my time gentleman from georgia mr needs to be done to protect the health and welfare of our citizens as it relates the food we eat the bush administration issued several reports studies in two thousand and seven actually calling for a major overhaul of the system president  and his march fourteenth two thousand and weekly radio address called the food safety system and i quote a hazard to public ill is against this backdrop of bipartisan concern that i commend the efforts of this committee's leadership bot democratic and republican on their combined efforts to find a workable solution for the problems that currently plague our food oversight mechanisms that me and said i would like to encourage my colleagues to continue their efforts on a few outstanding issues first i would like to see this committee draw more distinction between the oversight responsibilities of the f d a and u s d a as they relate to food safety additionally the bill addresses one area  breakdown in our food safety net that is essential for a safe food supply facility inspection in testimony given before this committee just last week f d a new commissioner margaret hamburg got to hamburg testified that more frequent inspections are needed but we also need to do smarter inspections i would like to encourage this committee to work together to create a smarter inspection schedule that focuses resources where they are most needed instead of the inspection schedule that dr hamburg admits is not attainable with the present resources within the f d a mr chairman i appreciate the willingness of this committee to work and i bipartisan fashion to improve the food safety system in this country as most of us in this room know our committee will soon be taking up the issue of health care reform its mass and see or hope that we proceed with this lame spirit of bipartisanship on that issue as a committee as shown here today thank you mr chairman i yield back thank you the other gentleman from georgia mr barrow i thank the chairman an issue that i've been concerned about is the reliability of ongoing testing and testimony in our hearings are brought out the fact that both the sampling regime and the testing regime have to have integrity we're not going to know what we need to know when we need to know it i've been pushing and advocating throughout the process for some sort of mandatory reporting system so that the regulator knows what the processor knows when the processor knows it a competing is  as an incentive not to know what they need to know when they need to know it you don't want to give folks an incentive to dumb down the process and not test for fear they have to disclose some positives that they rather not disclose so i think they have to weigh these two things in the balance i've been working with the chairman emeritus of the subcommittee staff to try and bring into harmony proposal that would balance these two competing a set of ration so that we can have the twin goals of having the processor know what the processor knows when they need to know it and for the regulator to know that as well in real time i think that would provide a tremendous incentive toward better standards and best practices and i'm going to work with that hopefully we'll have something to add to the bill in the markup for the full committee but that mr chairman i yield back thank you thank you gentleman from pennsylvania m chairman first of all i like to thank you and your staff for removing the provisions in the discussion draft which applied to drugs and devices drug and device safety issues should be addressed just not in a bill dedicated to food safety and i understand the committee plans to take up those issues later this year i'm still concerned however with the risk based inspection schedule in section one hundred five the bill requires that category one high risk sillies be inspected at least every six to eighteen months category two low risk facilities be inspected at least every eighteen months to three years and category three facilities those that hol food such as warehouses be inspected at least every three to four years on the domestic side it is estimated there are thirty thousand high risk facilities forty five thousand low risk facilities and seventy two thousand warehouses and we do not even have a good estimate of the number of foreign facilities the sheer cost and manpower required to meet this inspection schedule is staggering and f d a is neither adequately funded nor staff to undertake such a responsibility it is my understanding that staff on both sides of the aisle have been discussing ways to adjust the inspection schedule while still ensuring that the nation's food supplies say the bill does require f d a to make recommendations to congress on adjustments to the timing of the schedule three years after an accident but i believe we can make those changes here in committee our side has offered a schedule that requires the high risk facilities to be inspected every year low risk of shelly's be inspected every three years once every three years and warehouses be inspected once every five years i would urge the majority to work with us on this matter and accept and thank you for bringing these important pieces of legislation together under the dingell bill and bringing it so early and this session to mark up this legislation which will strengthen the protections of a food supply is one of several that is needed to reform a broken and efficient system that currently does not adequately protect the public in the case of food safety we've heard the tragic stories many have been made ill because of the deficits in the system and some of tragically died the bill follows and several of the distressing hearings that we've had and does address many of the areas that we found were deficient and which allowed tainted food into us food supply companies to continue to distribute that food with impunity and safe foods and their suppliers to suffer severe economic damage because we could not trace the culprit in a timely and accurate manner the food safety enhancement act of two thousand and nine in that bill f d a is not only required to do more frequent inspections on a risk based criteria and provided with improved traceability and given stronger and necessary authority to order a recall but also through fees to get additional funding to support these activities and i'm not sure if i read it correctly but i think that i noted that lab test results now from accredited and independent laboratories would automatically be forwarded to f which is a concern that like congressman barr i raise that several hearings because i feel it's important for early notification of positive results and therefore lead time and timely action which can save individuals from illness and also save alive so i thank you for holding this markup on this important legislation and i want to want especially thank chairman emeritus dangle for his bold relentless and long champing of this legislation to improve this weak link in the chain that is our nation public health system and i look forward to working with you mr chairman ranking member deal and committee leadership and our colleagues to make yet this other step towards a stronger more responsive f d a and a stronger national public health the gentleman from colorado mr get thank you very much mr chairman not to sound like a broken record but we have had eleven hearings between now and i and this committee in the past two congresses and at the last congress we promised the families of those children who were who were poisoned by the tainted food that we would pass this  legislation i'm so proud of you surprised mr dingell i'm so proud of our friends on the other side of the aisle for really hunkering down and for getting this bill done it almost seems effortless now that we get to this day but the years and the years that we've been working on these food safety issues are finally coming to fruition and everybody's been working together to make this happen i want to specifically point to a couple of parts of the bill that i've had involvement in for another number of years the first one is giving the f d a mandatory recall authority people are shocked to learn that whenever tainted food is recalled in our country it's on a voluntary basis and oftentimes particularly when we have less than savory operators it takes a long time to find the proof and to recall that food so while i hope that the other provisions of the bill work to make to make sure that we don't have to recall food because it will be safe in the first place the fact is the f d a needs to have the ability to recall tainted food when all else fails and this bill will give them that that opportunity the second issue and one that's proved to be a little more difficult and thorny is the traceability provision but again this this this aspect is chris a call to being able to track down tainted food and to recall it in a speedy manner so that both the public health is preserved but also so the profits of the food companies are preserved rather than having these overbroad recalls the devastate whole industries will will now be able to pinpoint was accuracy where the food came from and remove it from the market mr chairman i want to thank you i want to thank mr dingell i want to thank our colleagues on the other side of the aisle i want to thank the food industry and i want to thank the consumer product advocates for working together on the traceability language it is wide it's far reaching it's going to mean a whole new level of detail in the food industry but it's the right thing to do it's the right thing to do for the consumers of american i think everybody has to work together to really make this happen and and so it's a great day for the u s congress and i also want to thank mr stupak in absentia for helping he's not here right now but he has he has been tireless in exploring these things and finding out the loopholes so thank you very much mr chairman i yield back thank you the gentleman from north carolina miss myrick thank chairman i will yield but i did want to say thanks to you and mr dingell and everyone who worked together to get this bill forward thank you the gentlewoman from ohio ms certain thank you chairman clone for holding this markup on this extremely important legislation which i'm proud to be one of the sponsors of i want to thank chairman emeritus dingell for all of his work through the years and bringing this to fruition in this comprehensive bill i also want to thank chairman waxman and chairman stupak and congresswoman de gette for their tireless efforts in making sure that the food on our tables is safe to eat you know unfortunately the headlines over food borne illnesses remain front and center in our national press and we've seen far too many outbreaks of food borne illnesses originating in everything from spinach beef peanuts alfalfa sprouts and the list goes on and those outbreaks continue to highlight the vulnerability of our food supply and the need for the safety reform legislation that we have before us the issue of food safety and food borne illness has taken a disproportionate toll on my home state of ohio over the past year there have been one hundred five cases of salmonella infection in reported in ohio and sadly three dusts from the most recent base strain nellie napier a constituent of mine died from salmonella poisoning which she contract at a nursing home facility and in april of this year in cuyahoga county to the north of me there were three incidents of illness from e coli and another death this time a seven year old girl and we know it's our obligation to protect our most vulnerable populations congress must ensure that the f d a is doing all that it can to protect our families and ensure our food safety i'm proud that the protect consumers act which i introduced earlier  this year and in the last session of congress to give the f d a mandatory recall authority when we learn that food is unsafe to eat has been included in this bill i greatly appreciate that it has been made a part of this legislation americans need to know that the food on their family's table and their children's lunch boxes are safe to eat whether the food is grown here or imported from abroad there must be strict regulation of the supply line that feeds our nation and i'm pleased that this bill seeks to improve the safety of food imports now we heard in our hearing last week that close to thirteen percent of the food we eat comes from abroad and yet the f d a inspects less than one percent of the food shipments arriving at our ports this dynamic needs to change and the certification provisions in the bill we are discussing today will help to do that i'm looking forward to the eventual passage of this bill as it is and that's is there a first up in securing our country's food safety mr chairman i look forward to working with you and chairman emeritus dingell and chairman waxman and all of the members of the committee to continue to reform our food inspection system and ensure the safety of our food supply know back thank you the gentleman from tennessee miss blackburne thank you mr chairman i want to thank you for the legislation today and i'm glad that we are at the mark and i still have concerns about this legislation and how it increases the f d a authority and will make it one of the largest agencies the largest federal agencies in existence and in my opinion we still have too little oversight from and too little accountability that come from this committee the f d a as we know is saddled with so many mandates and the newest is tobacco regulation and we i do feel and continue to feel that is going to play stress on what i see is a broken federal bureaucracy as i've said in the past the f d a needs to shift its focus from reacting to food safety breaches and instead implement policies to prevent those problems before they occur i think everyone knows that we're not going to inspect our way to food safety we have to be proactive and i do remain concerned about the burdens this legislation is going to place on businesses but particularly those small businesses and a couple of my colleagues have mentioned that already this morning i'm very concerned about the impact that is going to have on some of our small businesses with regards to inspections fees access to records traceability and some of the other provisions i believe that companies large and small put food safety at the top of their list it's a concern for them through quality controls to achieve the highest standards and assess risk these companies are committed to preventative measures that produce safe products the first time not after the fact and i would like to see the final draft of this legislation move more that direction but again i thank the chairman and both the majority and just want to observe that this markup in the hearings that preceded it demonstrate why following the regular order matters this bill is much better because of the many hearings we've held and i think it will be even better following this markup as new issues are brought to the table and i commend you and i commend others on both sides of the aisle for working seriously to make it the best bill bill we can field  nobody is arguing about the need to regulate food safety better coming from california which has the largest ag industry in the country we have as many other states have suffered from outbreaks of e coli problems with the stache ios and other things but i want to say that some things in this bill like a risk based system are in my view the right way to go and i don't know that we would have come to that if we hadn't had the careful review that we have i also command the sections on lab testing very important to the ports of l a and long beach adjacent to my district and the section subtitle beyond intervention which will help us create a food safety surveillance system that really works for the whole country all of these things matter let me just highlight one issue that i know will merit further consideration by the committee as the bill moves forward and that is an issue that has been raised with me and i know chairman waxman and perhaps others by customs brokers who are a major factor in my district they say that the new reporting requirements on importers should not directly apply to them because they are essentially performing a different role and there is a detail letter to chairman waxman about this which i would like to insert in the record without objection so thank you and i i just want to close with the comment that that their interest and the interest of others who are now  and i am quite confident that they will be heard and that if adjustments are needed in the legislation they will be fully considered so i want to thank you again mr chairman and thank all the members of the subcommittee for doing the job we were elected to do which is paying a lot of attention to serious legislation in our subcommittee and committee i yield back thank you thank you the gentleman from indiana was to make an opening now the gentleman from thank you mr chairman and let me add my voice to the people of congratulations to all the people who have been responsible for bringing this bill toss and i expedited the way in the work that has been done on both sides of the aisle that i think the best of the way the congress works this issue is a very personal one for me my good friend nancy donnelly law asked her son alex and nine hundred ninety three after he ate ground beef contaminated with e coli and i've been working on food safety well it's had an interview out forty years stories like nancy's are obviously heard too often in this in this chamber that's been mentioned over and over again and finally we have a serious proposal that will overhaul and improve the f d a as food safety initiatives first and foremost the mandatory recall authority is so incredibly important companies can't then refuse to recall products that could be harmful or deadly to consumers and unbelievably there was at least one company that refused to recall their products that were linked to the peanut corporation of america's nationwide outbreak of salmonella second it requires all food facilities to implement safety plans commonsense measure that will help prevent problems before they happen third it increases inspections of food facilities studies have shown that the american people support thorough and fre inspections of places where their food comes from and having a minimum inspection standard and a respect and inspection standard is critical to preventing the type of outbreaks we've seen and finally it approves our ability to trace where food come comes from identifying the source of an outbreak tracing it to any of the possible destinations will help identify problem companies and also protect those companies that are the problem companies  there are a couple of things that i would hope we could still add to the the bill one critical component that i believe needs to be included in the final bill is a requirement the companies that have positive test results for dangerous pathogens pathogens must report those findings to the food and drug administration and i know this is an issue that's been brought up hopefully we're continuing to to work on and that will have some new language  the in the legislation the other has to do with having the f d a consider the extent to which prolific antibiotic use in livestock is contributing to increased antibiotic resistance there is a sentence in the in the legislation that refers to that but i'm hoping that we could bolster it even more but i do have to say that overall i'm pleased with the product before us and look forward to working with the chairman and other members on both sides of the aisle to continue to strengthen this a very good bill and i thank you and i yield back thank you those that have been so persistent and dog and in pursuing the reforms that really need to be brought to our food safety system which i think is in tatters in our country and the record obviously shows it to the consumer groups that have worked so hard on this for so long and the families you are the ones that have never really given up and i think if i were going to give credit  the bulk of the credit would go to you for your advocacy this is been a long winding road today's to today's markup i recall at least a decade ago introducing in the well a decade ago what congress was that sweeping legislation to address the shortcomings in our food safety system dick durbin who was our house colleague had just gone over to the senate and i remember sitting up one night and listening to a c span hearing of the senate and there was testimony from inspectors that had actually been paid off to allow less than safe foods coming into our country and he introduced a bill in the senate i introduced a bill in the house carried that bill for two congresses and no one was interested in it the republicans weren't the national grocer's so see asian were in in in real opposition to it and the democrats were not interested either most frankly but it took recalls it took people becoming critically ill and people dying to get the congress to actually move and which reminds me that we are a reactive organization instead of proactive but whatever it is this is a very important day because what people ingest they have a right to expect that it is safe the united states of america should be the gold standard in food safety regulation and i would have preferred to have seen just a food safety agency in our country i worry that the fees that are going to be levied are certainly not going to meet what the cost of the entire undertaking is if we fall short in appropriations then different parts of the bill i think will be mandates but they won't be able to be carried out i think the f d a is heavily burdened with critical responsibilities today but that's not the direction of this bill and i want to see progress made on this front because it really has come to the point where it's a life and death situation for american citizens and that cannot be tolerated so i look forward to this markup i thank those that have worked on  it most especially the families and the consumer advocates you have my great admiration and gratitude and i think the entire committee says well thank you mr chairman thank you hearings and both on the health subcommittee and the o and i subcommittee and i'm glad we have this legislation before us own food safety enhancement act i support it greatly i still have some concern about the f d a labs that i expressed during our legislative hearing and actually for a few months last year and i look forward to working with both the f d a and also our committee to make sure we can fund those labs if we can't if we're not able to get the private sector to do what we need to do in the inspections and what that are you about not thank you mr matheson from utah well thank you mr chairman this is an important piece of legislation i'm pleased to see that we are moving forward i understand the magic amendment that was released this morning does resolve a number of issues that various folks have been raising i'd like to just raise a couple of issues that i'd like to see if we can work on as we move through subcommittee to full committee in the floor that i think would be helpful and enhanced the bill one is an issue that i raised during hearings in the last congress about the issue of lead in ceramic plates i would have thought this is a consumer product in an f d a issue but i found out the situation i found out about this for a story home where a young mother had a baby who got quite sick when they brought the baby into the to be checked they discovered the baby had lead poisoning and it was determined that the mother was using ceramic plates in a microwave and he in a food on that and then when the mother would nurse the baby the lead the transfer to the baby turns out that this is a problem with a lot of ceramic ware and it turns out that when ceramic ware is imported from other countries it has an f d a stamp on the box because we had a testing situation our county health departments back home to look at these boxes and you'd pull brand new plates out of these boxes with an f d a stamp on it and you could test him and see they had inappropriate levels of lead now when you see a government stamp that's supposed to mean something but in this case i'm not sure means enough and so if we could work on this if we go forward mr chairman maybe at least the labeling requirement to inform consumers the product may contain lead i think that would be a helpful step in terms of giving consumers better information to make good decisions because there are ceramic products out there that are specifically labeled as lead free but the ones that do have lead don't say they may have lead so that's an issue i just want to raise the mr chairman like to work with use move forward in this process let me mention just two other quick links i know you want to get to voting it's my understanding this legislation that there's some there's a call for the f d a is going to be allowed to prescribe controls for entire produce categories i think we need to understand the implications of that i'm not sure exactly what they are but i think that we ought to make sure we understand all the implications as we move forward on this finally i want to raise quickly the issue of antibiotic resistance i recently introduced legislation to address antibiotic resistance it's called the star act h r twenty four hundred and i've worked with the committee to include portions of that bill and other legislation and there may be an opportunity in this food safety legislation to consider some of those provisions so again i'd like to engage to you in a dialogue move forward with that again mr chairman thanks for our work on this it's a really important issue and i yield back my time thank you gentlewoman from putting together this legislation reflecting so much hard work over the years stakeholders from every sector involved in this issue from industry to consumer groups have commended your work to strengthen the f d a as ability to improve the safety of our food at our hearing last week i mentioned an issue of concern to me regarding coordination between the federal government and the states the legislation we are considering creates a risk based inspection system for food facilities and also authorizes the secretary of h h s to recognize state agencies as meeting the standards established for conducting inspections i asked at the hearing the the f d a how they plan to coordinate with states and in their response the f d a cited it's thirty years of experience working with states through existing programs but they did not acknowledge any plans to provide funding to states yet i will note that the fiscal year and ten budget justification that the f d a submitted to the appropriations committee in that they stated their desire to expand state capacity to perform risk based inspections by increasing the number of cooperative agreements and partnerships with states i'm hoping to work with you mr chairman to ensure that states receive the support that they need to consider to continue the excellent work they do on the ground my state of wisconsin licenses and inspects over thirty thousand food businesses and regulates many other aspects of the food chain from land to consumer nationwide state and local governments perform over ninety percent of all food safety inspections food sampling and food testing in the united states over two point five million inspections each year i want to ensure that food facilities are rich moving the rigorous inspections they need to prevent contamination and disease but i want to make sure that we are spending our money wisely and not duplicating our efforts last week i also expressed my desire to make sure that this legislation does not prevent some of the most experienced and savvy laboratories from maintaining their partnership with the f d a i also asked the f d a to clarify the record on this issue they responded that a third party laboratory that is not directly owned by a processor would be considered independent of that food processor for certain purposes and i just want to make sure that as we move forward that this manager's amendment has that will reflect that same interpretation i really appreciate working with you and your staff to address these concerns to perfect an otherwise very strong and long overdue bill and once again i congratulate you on your work on this legislation and appreciate your hearing my comments thank you gentleman from iowa mr britling mr chairman thank you for considering the food safety enhancement acted am glad to see that the subcommittee is marking up such important legislation to keep american families safe i support this bill because it will correct many of the f d a s current limitations and i'm pleased that the bill requires increased inspections of food facilities i'm glad that the bill differentiate between high risk facilities low risk facilities and warehouses and i'm also pleased to see provisions to ensure the safety of imported foods reflecting concerns i raised in a bill i introduced last congress the fresh produce safety act a bill that was brought about by a trip i took to our border inspection facilities in the gallus arizona and mexico where two thirds of produce sold in the united states and canada during the winter growing season comes through today's bill as many other strong provisions such as the whistleblower protection section and i believe the bill is as a big step forward in keeping america's food supply safe i also appreciate the committee's willingness to listen to my concerns during consideration of this bill especially on section zero one related to our treatment of carbon monoxide in food packaging the committee has been very responsive to concerns related to this provision and i am hopeful that we can continue to work together on this and consider ways to give the f d a authority to determine how carbon monoxide should be treated i also want to make sure that there is coordination among all government agencies involving food tracing and that we don't create duplicative requirements especially on farmers this bill establishes a food tracing system which the secretary will create and it requires a pilot program to test the system as well as multiple opportunities for public comment i support these provisions to include the public as a system is developed and i look forward to ensuring that the secretary is taking into consideration the current requirements of other agencies throughout implementation the food safety enforcement act will take significant steps toward ensuring the safety of the food we eat we should be focused on preventing problems before they start and this will bill will help us do that thank you mr chairman i yield back thank you and i believe that concludes our opening statements by the members so will now begin consideration of the bill the chair now cause of h r two seven four nine the food safety and hands of an act of two thousand and nine and the clerk will report the title of the bill h r twenty seven forty nine a bill to amend the federal food drug and cosmetic act to improve the safety of food in the global market and for that purpose without objection the first reading of the bill will be dispensed with a bill is now considered as read and without objection t bill will be open to amendment at any point and the chair now recognizes himself to offer a manager's amendment to a chart two seven four nine in the formative amendment in the nature of a substitute and the clerk will report the amendment recognize myself for a statement on the amendment in the nature of a substitute at this time this is a bar bipartisan amendment that takes into account suggestions by my colleagues on the other side of the aisle input from stakeholders as well as some smaller more technical changes and i'm pleased that we have been able to work in this fashion and that we've come to an agreement on the issues contained in this amendment i do recognize however that there are a number of outstanding issues that we have not yet addressed some of the members mention those in their opening statements and i hope that we will continue to work in a bipartisan fashion on those issues as we move to full committee markup as mr waxman has said next week i also want to mention that there are a number of questions from our hearing last week that have not yet been answered by our panelists we hope to get those answers to the members who requested them as soon as possible and with ample time left before the full committee markup next week this amendment addresses a number of smaller more technical issues but i do want to highlight for changes that i feel are very important the first pertains to the fees put forth by the bill is introduced after conversations with members on both sides of the aisle as well as long conversations with the key sta groups we've reduced this fee amount by half changing it from a thousand dollars per facility to five hundred dollars per facility we have included a cap on the fees so that no one organization will have to pay more than one hundred seventy five thousand dollars per year and finally in response to some concerns we heard during the hearing last week on how the revenue generated from fees would be allocated we changed the fee section to include a consultation in the form of a public meeting so that stakeholders will be able to weigh in on how the fee revenue will actually be spent now the second change puts in place due process protections as to who at the f d a can exercise select and foresman authorities this too was in response to concerns raised at these authorities should only be used in specific situations and that the decision to exercise them should be limited to certain individuals we also clarified the traceability language to make clear that before the f d a can issue  regulation on a traceback system they must take into account the views of the stakeholders the information gathered in the information gathering period as well as the results from the pilot study on traceability and finally we have included language that would allow the f d a to make accommodations for small businesses in the preventive controls sections we added language that directs the secretary to take into account small businesses when issuing guidance or regulations on preventive controls and also to issue guidance specifically for small businesses and how to implement preventive controls in accordance with the bill this is in addition to the already existing longer implementation period for small businesses and we added similar language in the fresh produce standards section where we direct the secretary to consider the impact of standards requirements on small farms in some this bipartisan m m and addresses many of the concerns we heard from members on this committee as well as from stakeholders again it has not addressed all the issues that we're working on and we hope to continue this very productive process with our minority colleagues as we move forward with a bill next week i support this amendment on the urge my colleagues on both sides of the aisle to do so and i want to thank everyone for all the cooperation we received on this now does any member seek recognition to offer well let me say does any the member would like to speak on the manager's  amendment down the river in kentucky yes miss mr chairman thank you i i just for clarification purposes would like to ask you just a few quick couple of questions to legal counsel if i could sure as you know in the rule areas we have a lot of small grocery stores convenience stores and one of the first question i want to ask you will all retailers be subject to mandatory recalls wetherell your question refers to call the recall authority granted to f d a under section one eleven yes of the legislation and your question was does it apply to all retailers also amended by the legislation that we are considering this morning amending this morning under section one twelve of the legislation before us and responsible party as amended by the legislation before us is o a person who owns operates or is or is an agent of a restaurant or other retail food establishment so yes retailers are covered under this so convenience stores whatever ok now second question in section one twelve certainly makes these retailers subject to the food registry which means that they will be required to contact the a if they become aware of a cell call reportable food which is defined in the act and i was just wondering and maybe this pertains to regulations established by f d a but  trying to contact the f d a and report the problem through does is there anything in the language of the bill that requires the f d a to have a eight hundred number for reporting purposes there's nothing in the legislation to that effect ok all right thank you mr and thank you does any other member seek to address the manager amendment gentleman from anybody gentleman from indiana i got a man at the desk well before we proceed let me just see if anyone else wants to address the managers and  chairman i just had a question for counsel two if i could are there any premises drawn around the size of the farm or the nature of the consumer as far as the traceability requirements under the bill for example could con agra sell one hundred thousand pounds of tomatoes to one of the school districts where that is a farm selling directly to the consumer and would that be exempt from the traceability requirements your question was are there  the parameters around the size of the farm as it relates to the records or any order any definitions are there that i'm missing and i apologize for that i don't have the correct i just got the new manager men with the copy that i had last night this was on page forty six and it to dress is direct sales by farms and says food is exempt from this requirement of this of this subsection if the food is one produced on a farm two sold by the operator owner or agent in charge of such a farm  the consumer or restaurant or grocery store so in other words could con agra a huge farm sell a hundred thousand pounds of tomatoes to the dead independent school district back home there is no specific language in the legislation that addresses the size of the farm saw that would be exempt from the traceability requirements that what do you reference that sale those tomatoes  the can you what was your question again mr burgess if in the example that you provided it will under section one of seven farms will be excluded if ye sell directly to the consumer but we really don't draw any parameters on i mean  intuitively i think of a small farmer it's selling at the farmer's market back home on saturday morning but that's a concept but what is what about the other concept a large industrial farm that is selling massive amounts of produce to a large consumer like a school district hospital where where is the traceability requirement for that really of what would be a very large commercial sale under the legislation the exemption that you are referencing only states that food is exempt from the requirements if such food is produced on a farm and so by the owner operator agent in charge of such farm directly to a consumer or to a restaurant or grocery store there is no additional language related in the legislation related to the actual size of the phone as chairman i would just point out that and i'm not certain if this represents a vulnerability in the bill but i would respectfully ask that we work on this between now and the full committee markup and see if we cannot refine this definition because it seems like that's a pretty large a gentleman you'll be happy to yield i i agree we should look at the language because the intention of this language is to really address farmers markets that are dealing small producers and farmers markets and so on and you're right if there's a large if there's a large corporate entity that selling to another large corporate entity directly we don't want to this to be too broad of a loophole so we certainly will be happy to work exemption i think that was the policy behind this but i think we have to look at it and rethink this in any way you think appropriate between now with the full committee thanks chairman i proceed to consideration all you'll back thank the gentleman from with regard to retailers in section one zero seven will retailers be subject to full pedigree traceability requirements of section one of seven all retailers and section one no seven of the legislation on page forty six there is a specific reference  food that relates to restaurants and grocery stores and the language specifically says that they so keep records documenting the farm that was the source of the food so that's the the only records that they would be required to will on issues on quarantines council will retailers be subject to quarantine follow on down you will find that that exemption is first of all applicable only to the foods produced on a farm seconds sold by the owner operator or agent in charge of such farm directly to a consumer or to a restaurant or grocery store if you come over to the top of page forty seven you will see then restaurants or grocery stores for food covered by an exemption under sub paragraph restaurants and grocery stores shall keep records documenting the farm that was the source of the food so you have a way which you are tracing this it is different it is intended not to burden the farmer but at the same time to see to it that you get the result we want which is traceability food and i think gentlemen i thank you with regard to the issue on quarantines and its impact upon retailers to counsel yes it is meant to apply also to retail of you know of any size under under section one thirty three there is no language that relates to exemptions for retailers the quarantine authority under this section released relates to geographic areas right thank you very much for your back thank you i will proceed now to amendments and the gentleman from india had in the memo and i recognize the gentleman thank you very much the memmott would be here number twenty three clerk will as read and i recognize the gentleman to comment on his amendment stream and i believe there is strong support from both sides of the aisle here in this committee to ensure that alcohol regulations remain under the jurisdiction of the tax and trade bureau the f d a in answers to questions that i had submitted to them the f d a supports t b s continued regulation of alcoholic beverages as set forth under the m o u between f d a and a t f as stated in the one nine hundred eighty seven m o u both agencies have authority with products both domestic and imported currently t t b ensures that alcoholic beverages are produced advertising market in accordance with federal law t t v also is charged with reviewing applications ensuring permits  operations regarding the production packaging and story storage of alcohol and ensuring that the labeling and advertising of alcoholic beverages are not misleading and that provide adequate information to the consumer in order to ensure that imported alcohol products are safe from contamination to t v conducts background checks and looks at each potential importers financial standing trade connections and business experience to decide whether or not the importer is likely to comply with federal law additionally tb requires quote certificates of label approval for every alcoholic beverage before it can be removed from customs customs custody or into domestic commerce and quote the t t p also requires pre imported samples or routine market basket testing where t v investigators pull product samples from all levels of the distribution chain and send it to their labs to verify the product is authentic and safe to be as a strong and extensive hold on the regulation of alcoholic beverage industry collecting approximately seven billion dollars in alcohol alcohol excise taxes every year f d a stated in response to my question that it supports as i said the m o u between the f d a and a a further stated that we believe there is no reason the draft legislation should alter the current regulatory framework they also believe that it doesn't it's important to note the t g v works closely with other federal agencies to ensure the safety of alcoholic beverages these agencies include customs and border protection to ensure the safety of imported alcoholic beverages the f d a to seek advice on health and safety issues and the u s d a when alcohol products bear an organic claim on their labeling and the u s trade representative when trade issues arrives and the federal trade commission regarding alcohol advertising additionally tedy the works with state agencies and has memorandums of understanding with foreign countries for this reason i believe that t v should continue to operate as the primary regulator of alcoholic beverages and i believe there is strong support on this committee for that to remain in place this is a classic if it's not broken don't break it so i believe that this is an agency that has an excellent track record mr chairman with working with many different agencies to protect the american people and i believe that that breaking this paradigm could cause a situation whereby we would be multiple issues and redundant my amendment is supported by obviously brewers distillers and wine and beer and wine wholesalers that should be no surprise  but i i think this is a an amendment instrument i'm hopeful that that you'll give it strong consideration and i yield back my time sheriff thank you yes mr  memorandum of understanding between f d a and the bureau of alcohol tobacco and firearms a t f under which a t f takes the lead on enforcement regulations with assistance from f d a in other words f d a does harm assessments this is something which is worked very well over the years and the amendment here seeks to expressly exempt alcohol from requirements of the bill  in most instances of food drug doesn't really have to be involved with regard to the question of safety but the i think the memorandum of understanding makes the amendment unnecessary and truthfully we don't know what the amendment exactly means i will note to my good friend that it's never been the intent to interfere with the way that alcohol is currently regular and i would assure the gentleman that in my opinion this legislation in view of the memorandum of understanding does not now the previous amendments to f f dca have not included such language so the amendment here i'm afraid would be causing us some problems with how it would be interpreted and how the court sure how the regulatory agencies would ultimately have their thoughts and actions interpreted and what we would finally wind up with affecting us as the matter goes forward and again i would repeat to my friend has dealt with this question in other instances and we did it when we addressed the question of sulfites of sulfates in food which was rather exciting thing because sulfites is sulfates were killing people in any of that is my view that there may be some specific issues here that need to be addressed and i'd like to assure the gentleman and feed withdraws the  amendment would be we'd be glad to work with him to try and see how his concerns could be met without affecting adversely the contents of the bill and i think that's the gentleman would cooperate with me on this we can example on labeling requirements where whereby it's outside of the m o u and f d a retains some of its authorities and those would be such as for wine coolers for example instead of wine if it's below a certain percentage of alcohol so while both of these agencies have jurisdiction over alcohol the m o u covers pretty much everything but there are some things that fall out what i was seeking to do and i work with work with the jam twee now and the full committee is that we have a system in place that is working very well and when you're seeking to bring them in now to these other requirements of record record keeping registration track and trace requirements he's in a system whereby it's always it's observe that food and drug does regulate a lot of things like food additives things that that fall into the category of medicine colorings of slavering which is i think is that guy which are heavily because i love full of alcohol because that's the only way you could get this get the particular substance into solution and i just don't want to just don't want to let want to speak in favor of the amendment just briefly chairman waxman i don't believe is in the room but he and i have had several discussions over the course of the last several months about  that because it's a republican idea or amendment that it's bad and it generically all agreed with that people can look at sets of facts the same set of facts and come to different conclusions and i think that's a situation that we have here herman dingle says that he's not trying to change the relationship between f d a and in the bureau of alcohol and tobacco tax  mr bush years says he's not a he's just trying to make sure that the existing relationship stays the same and since this is a bill about food safety and the classic definition of alcohol kind of generically it can be classified as a food but in reality most of the alcohol products are not so what bush trying to do is is maintaining that relationship and say that this memorandum of understanding that chairman dingell has referenced remains as is in chairman dingell says that he thinks this would undermine it and mr bush says that he thinks it would ratify it so here's and if mr bush wants to return withdraw this amendment that's his prerogative but i would hope between if he if he use to do so between now and full committee there really will be a meeting of the minds because this is an example of an amendment that is not miss civitas it's not nefarious it's not in any way intended to undermine the basic concept that's been worked out at the staff level in the member level it's it's meant to make sure that these products that are sold in all of our districts are regulated like they have been under the regulatory authority and has been worked out so i i see no harm in the amendment i respect chairman dingell and if he thinks there is potential harm i think we should work to solidify that to alleviate concern but hopefully some version of this would be in the bill the full committee and with that mr chairman i'd be happy you voted against the amendment i'm just saying that that there are questions here they've got to be answered and i want to work with general what does a bipartisan bill i want to and i want to satisfy the gentleman from india and i also want to see to it that that we don't make any surprises for ourselves later on anderson as we work together i think we get this thing fixed up to satisfy  votes after those three votes will come back immediately and begin with any other amendments to the manager's amendment except committee the meeting is in recess the subcommittee will reconvene and when we last left off we were considering amendments to the manager's amendment i would ask if any members seek recognition to offer an amendment to the manager's amendment recognizes the gentleman from missouri to offer an amendment i do have an amendment that i intend to offer and withdraw and hopefully we can continue to have further discussion of this particular issue this is an amendment that would  r blunt to explain the amendment mr chairman this amendment would exempt poultry and livestock formspring farms from certain provisions in the bill that i feel and  producers particularly small producers feel would be unnecessarily burdensome to the farmer this would this amendment would not make farmers comply with f d a s access to records and traceability of food all of these farmers are under some sort of u s d a compliance now also they generally comply with industry programs and all also have to comply with state laws the idea of an additional f d a inspector having new levels of access to farm records and farming program seems to me to be unnecessary it seems to me to be redundant and certainly a hardship for smaller operations this idea of traceability of all animal food all animal feed in a system having grown up on a dairy farm in a farm where we raised hawgs as well as had a dairy operation and a beef cattle operation you know many many farms still operate with the same  and pencil pencil and paper record keeping system that was used twenty five years ago traceability of all food makes it very difficult for the small producer particularly to compete and at the large producer level i'm competent is absolutely unnecessary at the large producer level they are already keeping track of those things from lots of animals to exactly what food products those animals have chairman i would offer this amendment i hope we have a chance to discuss it further but f d a access to on farm inspections and compliant records programs i think is unnecessary and i hope we can work on a bill that allows the producing community and family farmers at all levels to continue to produce livestock products and i missed him with that i'd withdraw my men less you have any questions or i think that you know we've gone to great lengths to ensure that the provisions of the bill don't alter the lines jurisdiction between you know agone health and human services so the main thing is who we would want to make sure that we don't infringe on u s d a s jurisdiction but i think we should continue the conversations and you know try to deal with this at the next level and so i appreciate that gentleman's offer to withdraw i appreciate that chairman i hope we can do that and sounds like you're the spirit of your comments is that duplicate reporting or unnecessary reporting is not the goal here and hopefully we can work together to ensure that that doesn't happen and will continue to work on this and i withdraw the amendment and i thank the gentleman and the clerk will report the amendment and then to the amendment in the nature of a substitute h r twenty seven forty nine offered by mr boyer of indiana the amendment has been or is being distributed i should say and without objection the member will be considered as read asked the gentleman to explain his amendment sherman i offer this amendment to clarify the bill to ensure that seafood and fish taken from other fish farms are included in the definition of farms which are exempt from the tracking and trace requirements under section one of seven i had a since the hearing in which the f d a commissioner testified and i brought up the questions to the second panel regarding  seafood our colleague rush barrett of south carolina mediately began to work with the south carolina aqua culture who also then works with the department of eggs in the state of south carolina he also works with the sea food alliance which would be the leading industries of clam fish shrimp and oysters and he raised some pretty strong concerns to me about the definition of farm and whether that as interpreted by f d a and how that would be utilized in the implementation in your draft and that's what i've done is i've offered this amendment to help clarify so everyone will know so when the follow up question whether definition of farms in your bill would include oyster beds rice farms cranberry farms fish farms crustacean farms the reply was by the f d a commissioner was yes if they meet the definition of farm a term which she defined under twenty one c f r one point three to eight as quote if the syllabi in one general physical location devoted to growing and harvesting of crops the raising of animals including seafood well i think that when you look at what's in the c f r in the reg and then try to lay it with the overlay or the framework for which you have in your  bill i have some mental challenges that i go through dr hamburg further stated that under the discussion draft we had a hearing last week it's not clear what linkage would be between the work of our no a colleague's a lety for leveraging the resources and capabilities of the two agencies through m o u's and other appropriate arrangements so they're trying to figure out how to work this through their present definition and further if they try to implement your bill if we're going to exempt our traditional farms from traceability requirements under the direct sales by farms and quote provision in section one of seven the bill we should make sure that farms and included the oyster beds wild fisheries aqua culture facilities freshwater fisheries salt and water fisheries including the press stations not only on land but also in the sea ng shrimp and good ole crawdads but we also have the shrimp and oysters i think about the thousands of fishing businesses that bring fresh fish in and sell directly to restaurants we must sure that these operations are not subject to the tracking requirements just as traditional farming operations are not subject to these requirements and so might this amendment builds on the comments of dr hamburg's remarks and simply clarifies seafood other fisheries would be exempt from the track and trace requirements of the bill and you'll back let me if recognize myself for five minutes you know i'm sensitive to what the what the gentleman the same because i let you know i represent a coastal district and we have i know that we don't have any fish farms that we have a lot of fishing but i believe that this is already covered you know and i you read that section which i believe would you know cover you know the situation you're describing but you know there may be aspects of the definitions that need to be clarified and and so i would be willing to consider you know discussing this further with the gentlemen as we move towards a full committee if he's willing to withdraw the m m n i i think it's covered but i understand where you're coming from and being that i represent a coastal district i would want to make sure that we're doing what we should so i would ask the gentleman if he would consider well given that mr chairman i will withdraw the amendment look for to working with you i thank the gentleman this is an amendment at the desk it would be under by mr rogers number twenty one clerical report the amendment this is a rogers amendment yes ok so i'm offering this amendment on behalf of mr amendment is being distributed and without objection the amendment will be considered as read and i would ask mr boyer to explain the amendment on behalf of mr rogers i think what mr rogers will be brought up when we when we did the bill regarding tobacco was used it was greatly concerned and i think all members have been concerned about the the stress that we the congress over the last twenty five years have placed upon f d a they have their core missions yet we continue to place many requirements upon them and we recognize that this is one of the agencies of government that is truly stressed and under resourced and recognizing amendment it would simply states the secretary of health and human services in the commissioner of food and drug shall not transfer any employee from the center of food safety and applied nutrition to any center agency or office responsible for regular regulating tobacco products so we want to make sure that people that we have can actually do the core missions of the f d a and do not transfer this over to the new functions regarding the regulation of tobacco with that i yield back  then recognize myself for five minutes first of all i definitely remember that during the tobacco who hearing in markup that the gentleman repeatedly expressed concern over the stress that might be placed on the a we have no intent of transferring any of the resources from the foods program to any other part of the f d a including the tobacco program in the fees in the bill are directed specifically to food safety activities also as i responded to this gentleman during the tobacco bill debate the dipak go program is fully funded with its own fees and resources however with that said you know we're happy to work with you on language to clarify this intent and to try to address your concerns which i know you've made many times and so with that i'd ask the gentleman i guess again on behalf of mr rogers to to given your spirit of cooperation on half mr rogers i withdraw his name and i thank the gentleman and the rogers amendment is withdrawn at this time any other member have any amendments the gentleman from georgia mr gingrey as chairman i have a then as may be necessary the amendment has been distributed and without objection again remember will be considered as read and i'd ask the gentleman from georgia to explain it thank you mr chairman i do have an amendment the full committee first i'd like to thank you mr chairman for working in a very bipartisan way in crafting this legislation this bill exemplifies the policy accomplishments that can be made when partisan politics are put aside in order to work for the true benefit of the american people particularly in the realm of food safety the amendment in the nature of substitute addresses a number of the concerns that were raised by my colleagues but despite the progress on this legislation i still have some concerns that may have a profound effect on our agricultural community and that's why i've chosen mr chairman to offer this amendment sections one o six and two zero three and the line bill give fairly bro inspection of party to the f d a and this may have a direct impact on our growers and lab stock producers in particular this has the potential of again on farm inspections to the jurisdiction of the f d a the u s d a united states department of agriculture agriculture and individual state agricultural departments already work diligently with their experts to inspect our farms to ensure their safety in my district alone the u s d a inspectors over twenty four hundred cattle farms nearly six hundred poultry farms and over eighty hog farms and i fear that authorizing funding for the f enter this same arena would be duplicative in nature and potentially cause an unneeded burden on agribusiness furthermore additional resources for the f d a and on farm inspections will likely divert those precious funds away from of them port areas of food safety that the f d a regulates so this amendment would simply add language that exist in companion legislation on food safety in the senate it would create through statutory language the needed distinction that would allow both the u s d a to continue to use its expertise in inspecting facilities is specially when it comes to the lab stock and the f d a of course to focus on the areas of food safety where that agency can excel is my hope that as this legislation moves forward we can continue the spirit of bipartisanship that is evident on this bill and work codified the distinction and collaboration between f d a and a that should exist for our farmers and laptop produces mr chairman thank you for your willingness to work on this important issue that will affect a number of farmers and laptop produces i look forward to continuing to work on this recognize myself for five minutes i do want to take a look at this and i do you know i have some i share some of your concerns i mean it's my understanding that the f d a has know already has farm jurisdiction but it often or i guess usually contracts that out to states and we don't want to change any of that so i'm glad that you're withdrawing at this time but we'll certainly take a look at it because  do i do share your concerns mr chairman thank you and with that i actually animists consent to withdraw the member and i look forward to working with you on the issue sank the gentleman and he has withdrawn his amendment that we have any other amendments to the substitute the ranking member mr barton mr chairman i want to offer an amendment that's called shadegg ninety five i'm offering it in the absence of mr shadegg he's not here my clerk will report mister so ordered and the gentleman is recognized for the purpose of his amendment this chairman and this is something and i highlighted in my opening statement and i'll be brief and with your  acknowledgment that you will work on this between now and full committee shattering are very prepared to withdraw this so we can continue to work on it but as i pointed out in my opening statement the draft it's before us for the first time would allow the f d a to impose civil penalties civil monetary penalties of up to five hundred thousand dollars on a third company for an unintentional violation that causes no harm to repeat that an unintentional violation that causes no harm we would give discretionary authority for the first time to the f d a to impose a civil monetary penalty of up to half a million dollars per violation and if you can depending on how the  decided to implement this if they did it on a per food per violation this single fine if they imposed the maximum fine could run into the millions or even tens of millions of dollars we would prefer that the entire provision be dropped but we're told at the staff negotiation level that there's there is a strong support on the majority side for for civil monetary penalty authority so this amendment if adopted in its current form would put limits reasonable what we consider to be reasonable limits on the civil monetary penalties the penley could be no more than ten thousand dollars for each violation for a violation that involves gross negligence or intentional conduct the f d a could impose penalties of up to one hundred thousand dollars for individuals in five hundred thousand dollars for a company it would also impose an cap per violation of one million dollars per per proceeding so this amendment is a halfway point it does allow the f d a the authority to impose civil monetary penalties but it puts what we think to be some very reasonable limits on those penalties and we would ask that the majority consider it if not now between now and the full committee with that i'd be happy to heal the chairman for whatever comments he wishes to m when i say i want to thank mr barnett this is definitely something that we like to work with you one i mean i just and so i appreciate you know both your offering it and offering to withdraw it because we will work on it as we move forward but i just did want to say that  we do think it's important that f d a have these penalties in place because right now they can impose penalties for certain drug and device offenses but not in cases where foods sillett he's failed to meet certain requirements and we had that p contaminated peanut case where there was clear evidence of misconduct but the f d a had no authority to impose civil monetary penalties on the facility or its managers so the civil penalties are important but i do recognize what the gentleman saying and  so as the gentleman has agreed to withdraw i will definitely work on this as we move forward with an understanding mr chairman i was drawn to him and i thank the gentleman amendment is withdrawn and let me ask if we have any other members to the managers a minute mr deal mr chairman i have one is called recordkeeping zero zero one clerk will report the deal amendment amendment to the the nature of a substitute character twenty seven forty nine offered by mr dio in section four fourteen b of the federal food drug and cosmetic act as amended by section one of six b strike as second that c is the secretary may require such persons to maintain such records in a standardized electronic format now we know that everything is moving in that direction but there are still those in the production and in the  processing chain that do not maintain all records in that format things like having a log for employees when they wash their hands or time temperature logs they're generally hand written and especially for smaller producers or processors many of their records are not an electronic format i would ash that you consider the withdrawal idea if there is an indication that you're willing to list try to refine this language because i think it may have some unintended consequences and i think we can work it out if you will be agreeable to doing that now would you certainly you know i heard your concerns mr deal and were very willing to work with you as we move forward on this thank you and i'll withdraw all the men mud and look forward to working with you on that before full committee markup ok i want to thank the gentleman the  amendment is withdrawn are there any further amendments ok hearing none we'll proceed we'll proceed to vote on the amendment the manager's a member of the amendment in the nature of a substitute the question now occurs on the amendment i'm sorry the question now occurs on the manager's amendment in the nature of a substitute all those in favor of the amendment will say i all those opposed say no in view of the chair the eyes have it and the amendment is adopted does any other member seek recognition at this time if not the question occurs on the chairman's amendment in the nature of a situ all those in favor signify corrections without objection so ordered let me just thank everyone i know this seems sort of anticlimactic at this point but tremendous amount of work went into this bill over the last few years and particularly by mr dingell is just to pack and some of the other members that are here as well as the republicans and it truly is bipartisan and we do intend to move forward as mr waxman said and move it to full commit next week but in the meantime we will try to address some of the concerns that were raised today and some of the amendments that were withdrawn so i want to thank everyone and all the staff again and the subcommittee is now a