hope that the company complies. fda also lacks basic modern enforcement tools like administrative civil monetary penalties. the food safety enhancement act will give fda these and other critical authorities. ..

>> let me turn briefly to one of the more contentious issues in the bill, the registration fees. i wish we did not have to resort to industry these to supplement funding for fda's work. however, when it comes to fda's food program, the shortfall in revenues is extreme or the fda's own science board told us that the fda is so starved for resources that american lives are at risk. we cannot realistically expect appropriations alone to provide sufficient resources to close that gap. the recent outbreaks have also taken a major toll on the food industry in the recent peanut outbreak, kelloggs alone lost $70 million. faced with such a dire situation

i think it's reasonable to ask the food industry to chip in. robust food oversight system will provide a great benefit to industry by preventing future outbreaks and rebuilding consumer confidence. let me be clear, we are not asking industry to cover the entire cost of the bill or any single part of the bill like the cost of inspections. the bill establishes a set fee of $1000 per year per facility. fda's prohibited from increasing that the future years except to cover the cost of inflation. the bill simply asked industry to chip in its fair share. i also want to address another concern i've heard the presence of fda on forms. fda has always had the authority on food on farms and they generally rely on state and local authorities for food safety oversight on farms because they have a strong nonfarm presence. i'm confident the farmers have nothing to fear from this bill. the bill calls for fda to set

its standards to regulation which means fda will go through a public notice and comment process. our committee is busy in the middle of three gauge three-month period. last month we passed a copperheads of energy and climate change legislation. so we will take up health-care reform, but food safety is so critical that i've carved out time right in between to pass this legislation. over the next few weeks i intend to work with all our committee members ,-com,-comma democratic and republic and with the fda with the affected industry to achieve insistence on a food safety bill that we can pass out of committee. we can't afford to wait any longer. i look forward to hearing from our witness today. thank you, mr. chairman. >> thank you, chairman waxman. the gentleman from kentucky, mr. whitfield. >> thank you, mr. chairman. and we appreciate you having this hearing on this very important issue today. we all recognize that fda has

many very important responsibilities, and we've known through hearings for the last number of years that the resources available are always in question. but we recognize also that there is a definite need for reform of fda, and we're delighted that doctor hamburg is here with us today to provide testimony and the other panel of witnesses as well. we look forward to working with the majority on this important legislation, and having said that we do have some significant concerns about some provisions in this legislation. particularly the risk-based inspection portion, particularly that relating to the low risk facilities. also the traceability provisions that i understand, for example, would apply to every convenience store in the country. in addition to that, the recall provisions in this legislation.

the country of origin provisions, particularly as it relates to the website requirements. and then also, of course, the ability or the power that we give the fda for subpoenas and other instruments to obtain company records. i think we need to look at those provisions much more closely. but obviously this is an important piece of legislation. we look forward to working with you and listening to the testimony of our witnesses today. thank you. >> thank you. next is our chairman, mr. dingell and thank you for all you have done on this legislation. >> mr. chairman, thank you, and thank you for holding today's legislative hearing on the food safety and hanssen acted 2009 discussion drive. we have worked together, you and i, with chairman stupak and others throughout the years and i am delighted to say that this

legislation is ready for enactment, and it is almost old enough to vote. [laughter] >> i want to say that i am delighted that chairman waxman and my good colleagues is to get mr. sutton and ms. sutton have joined us on our work on this bill. we are about to try and find an agency which is all, which does not have either the personnel or the revenue or the money or the resources which it needs to do its job. and we are about for the first time since 1962 when i was a young member of this body to try and see to it that it gets its authorities updated to deal with the real problems in the world of trade and in the world marketplace. i'm pleased that we are taking the necessary steps to advance this legislation and address the important issue of food safety. i'm hopeful that we will shortly be doing something with regard

to pharmaceuticals. i want to thank the witnesses who have joined us today and look forward to hearing the testimony. doctor hibbert, welcome to the committee. congratulations on your confirmation. i was encouraged by the early recognition of food safety is a problem that needs to be addressed. the administration food safety working group is a signal to how serious the president considers this issue and i want to thank you for the way that you and your staff have provided timely and helpful technical advice on the legislation. i want to note that i am hearing complaints from folks about the fee system. i want to make a note that the only part of food drug that seems to be working as that which functions under paducah and which has the advantage of having industry produced bidding and the funny. i want to know that the industry seems to prosper -- seems to be prospering mightily under that particular section and getting service from food and drug in a proper way, and that seems to be

about the only place that industry is getting protection or the american consumers are receiving necessary safety. in 1938, the congress comprehensively addressed the issue of food safety. 70 years later food and drug administration is still trying to protect the larger, increasingly global supply with outdated statutes and inadequate resources. as a result, the american consumer confidence in the nation's food supply and in the food and drug administration and quite frankly in this body, the congress, has declined. american consumers are being forced to pay a heavy price, not only with recall after recall, but also the fact that people are being sickened and killed by unsafe foods. and also by pharmaceupharmaceuticals. again, i wish to hope that we would commence work on pharmaceuticals as soon as this hearing -ish this business is attended to.

the food safety and hanssen act is a measured and effective response to the dire situation we are faced with today regarding food safety. mr. chairman, the legislation is based on a bill you, chairman stupak and i introduced earlier this year, and also on a bill that was introduced by me during the past days during the past congress. it includes good technical advice from fda and valued input from the minority and other stakeholders. i want to make clear that i am working with the minority to try to resolve their concerns. and that we are also working with the industry, and i want to thank my friends in the industry for the goodwill which they have shown in working with us. i also want to thank chairman waxman for his leadership on this point. i look forward to continued deliberations in the hope of producing speedily a bipartisan piece of legislation that will pass the committee and the house as i have indicated both in a correct and speedy fashion. amongst other things, this bill

will prevent safety problems before they occur. it will require manufacturers to implement food safety plans and that identify and protect against food hazards. it will see that food and drug has the authority to see to it that good manufacturing practices are adhered to here in the united states and elsewhere. especially in places like china which is, in fact, the wild west in this particular matter. it will advance the science of food safety, increase inspection frequency of food facilities. something which can happen more often on dog food manufacturers under the jurisdiction of the department of agriculture then it happens with regard to manufacturers who manufactured food products for the safety of our people. it will enhance fda's ability to trace the origin of tainted food in the event of an outbreak, or foodborne illness. and should be noted that this

food drug administration and industry are totally incapable of providing speedy service in this particular. it will enhance the safety of imported food, fda will be allowed to require that certain foods be certified as meeting u.s. safety standards and begin to trace. but also food and drug will be able to finally get enough people at the doors of this country to see to it that safety is properly enforced and that good manufacturing processes are adhered to around the world for the protection of our people. it will provide strong enforcement tools, including mandatory food recall authorities, stronger criminal and civil penalties for bad actors, subpoena authority and it will increase and strengthen food and drugs detention authority. finally and i would argue more importantly the legislation addresses the very important question of the resources of the agency. we will give the agency the authorities it needs and we would do them a grave disservice if we did not give them the

resources they need. the legislation include the registration fee which will find food safety activities at fda. the revenue from this the coupled with additional appropriations which we hope we can get out of those skinflint at the appropriations committee and the office of management and budget will ensure that food and drug can do its job. for those who argue there is no benefit for the industry to pay a fee for the safety activities at food and drug are offered the following. usb net industry could lose a billion dollars this year because of the outbreak of salmonella that forced the biggest food recall in history. that has just been replicated by other recalls in the food industry. tomato industry lost $100 million in sales during the 2008 a salmonella outbreak that ultimately was attributed to jalapeno peppers. spanish growers during a 2006 bag of spinach recall. let us not forget that wonderful chilean grape scare of 1989

which food and drug had neither the authority nor the confidence to address. i ask unanimous consent to advise and extend my remarks. i have a few other things i would like to say that i know everyone will want to read. thank you, mr. chairman. >> thank you, chairman dingell. the gym and from illinois. >> thank you, mr. chairman. doctor hibbert, welcome. i have seen chairman waxman has left the room. i appreciate his comments about there being some discussions. i do have to admit that the discussions that we have had when we point out a point that is correct, they accept. when there is a db of a point, mr. chairman, there does not seem to be any movement in compromiser i would encourage more discussion on some of these issues if we really want this to be a bipartisan bill. you know, the other thing i have trouble with is draft hearings. if we're going to have a legislative hearing let's have the legislation. this is draft legislation.

if we had the great draft legislation hearing on climate change and then when the bill came before us, it at 300 additional pages in it. there is fear on our part that this is a sneaky way to say that, we had a legislative hearing, but you really don't have a legislation hearing. if you don't have a legislation before you. this is the democratic majority offering i. we claim a crisis, only government can be the savior, government must get bigger, and the middle class pays. and that's the issue here. and i was on goldeneye on the last congress would mr. stupak readily accepting the premise that we have to get inspectors into these facilities. and we are ready to address an issue that is thoughtful. and respectable and pay for the inspectors and facilities where they are not going into. it's not like we haven't done

anything. congress -- last congress approximately 57 million from the supplemental went to food safety. the house passed a 2009 on the best appropriated an additional 325 million for the fda with 140 million of the 325 million would go for food safety programs. and the president 2010 budget, he included 1 billion additional dollars to fda for food safety. so there is a huge commitment already for massive federal funds to go to food safety. now we have as our concern a bill, a draft that has what, 325 million for no explanation, no earmarking, no direction. and that's where a lot of our questions will be today is why

that amount, what justifies that amount, how are we going to be sure that's not going to be used for other purposes, and the likes. so i would ask the leadership on the other side that if they really wanted a bipartisan bill, let's get some bipartisan negotiations, sincere negotiations. i would be honored to yield. >> i'm very fond of the gentleman. very well noticed and i have great respect for him and i have been talking as the gentleman well knows to the leadership on the minority side, both in the last congress and in this congress. i want this legislation to be bipartisan. i don't want the judgment to be surprised. i would go to my good friend that we have been having hearings after hearings after hearings not only here but up in the oversight subcommittee. and during that time i have been continually talking to my good friends on the minority side because i want you to be a board. this should not be a partisan issue, and when we go to the next that in this process, i will assure the gentleman that

most of the changes that will be made will be changes that will be made as a result of discussions with my friends on the minority side. >> and i thank the colleague and i look forward working with you. i go back, mr. chairman. >> next is the gentleman from colorado, just to get. >> thank you, mr. chairman. mr. chairman, this is the first step to realizing a long-held dream, not just by me and other members of this committee. but by the millions of americans who have been concerned about the safety of our food, especially in light of the cascading litany of foodborne illnesses that we have heard about from other members of this committee. we have had a dozen oversight hearings and also legislative hearings. we have had bills drop by many members of congress for many years and i am so excited under your leadership and the leadership of chairman waxman

and chairman dingell that we are finally on the verge of enacting comprehensive food safety legislation. the most important thing about this bill is that it would be a definitive statement by this committee and this congress that food safety is a priority in the united states of america. i want to highlight two of the sections of this bill, and i want to thank you and mr. dingell and others, mr. stupak, for including the provisions of my two bills in this draft mark because they are critically important in the future to assuring safe food for everybody. the first one is traceability. as you know, mr. chairman, i have been working on these traceability issues for many, many years. and when i first started, people said it couldn't be done, but then as we realized with time, not only can it be done, and in slightly different ways within industry, but if we want to ensure this integrity of the food system, it has to be done.

what i fondly call the salsa scare of last year is the perfect sample of why. we found people being second by salsa, and we couldn't figure out why. is destroyed or the much the entire profit of the tomato crop for that whole year to get as everybody thought it was tomatoes that had to salmonella. as it turned out, after months and months and months of increased sickness amah of increased scrutiny, we found out that no, it wasn't the tomatoes at all. it was jalapenos and they were from texas. and what i found out that we can go to a particular sector of the field and find those jalapenos, and we can do it quickly. so traceability is going to be essential and i look forward to working with my friends on the other side of the aisle to make sure it's not onerous, but i will say this, it is not just in the interest of consumers. it's in the interest of

businesses who want to protect their profits to have traceability. mandatory recall is the second provision of this bill that i have been working on for many years, and i am so grateful, has been included. and i want to say finally, mr. chairman, all of this policy that we talk about, it's all well and good, but i can't help but think about young jacob hurley who you might have seen. he was in our last oh and i committee hearing. jacob is from portland, oregon. and he got sick from eating peanut butter crackers, his favorite food. when his parents took him to the doctor, they said they finally got him stabilized and he wouldn't need so they told the parents, have jacob just eat what he loves, the peanut butter crackers are the very food that had made him sick in the first place. and the only way we found out about this was because the alert commissioner of consumer protection in oregon showed up

personally at his door and confiscated the peanut butter crackers. we need to fix this. we need to fix it now, and i am so grateful that we are. thank you, mr. chairman. >> thank you ms. degette. next is the gentleman from indiana. >> man, welcome to the committee. is it homburg or hamburg? hamburg. welcome. and my first reaction to the discussion draft is going to lead to some discussions that i will have for you today. it appears that congress a lot of times we like to pound our chest and then show the american people that we are doing something well, but we really end up creating legislation within our own areas of jurisdiction, and we create problems. we create things that are multi- pushes and redundancies, and if we really wanted to couple

substance with the words that i have heard here from some of my colleagues today, we would be working with other committees of jurisdiction. we would have a very comprehensive bill, and so i'm going to be asking you questions, ma'am, about clear lines of delineations and responsibilities between usda and fda. and who should really have what responsibility, or should we as a nation put all food under one agency and work cooperatively with the agony to do something like that. we have is a discussion draft that has been cleverly drafted only within the jurisdiction of our own committee, and so what we end up doing is are we exasperating a problem. and so i'm interested in your leadership. you are representing an administration, and so i am interested in your best counsel to us and your willingness to work with leaders of other agencies to truly protect the american people.

any other .. i make is as of late has been beating up on fda. i would say the fda, the individuals that i met and the ones that you have the privilege to lead are some pretty fine and capable dedicated individuals. in the last, gosh, 16 years, 17 years that i have been here, whether it's been republicans in control or democrats, we continue to pass legislation that leaves more and more responsibilities upon your core missions. and so here as you are challenged to maintain the gold standards not only with pharmaceuticals but also include, you know, we're about to send you a legislation for a new mission on tobacco that's counter to your even cultural mission. yet we're going to continue to make you the whipping post. and so i'm really concerned about the more responsibilities

we give you, how much does that dilute your responsibilities? and so these are some of the questions that i'm going to be posing to you, and with that i yield back. >> thank you. the gentleman from georgia. >> i thank the chair and i appreciate the leadership you are showing on this issue, and this is a matter of particular interest to me since mr. deal has already pointed out two of the most egregious cases of tainted food of the food supply originated in my state of the state of georgia. i think the story presented major step forward in trying to prevent this from happening again. one of the things, and the last outbreak we have evidence in this committee that the manufacturer had test results which were showing oxidant presents of salmonella. the food was then sent out in the market place was tainted and

yet they did report that to the fda. it seems to me what we need to have an addition to the good measures of incorporated in this bill is an effective testing regime that has integrity in terms of sampling and sampling in terms of. i think to do this, to comply with is an mandatory for them to report the results of any testing. that's the way i think we can pick the bad actors out early on and do a bad job of arresting trends in a early stage, detecting problems before they become serious. above all i'm going to make sure that we don't bring about the sergeant schultz syndrome here he was the comic character in hogan's heroes who made a big loud comic demonstration every now and then of not knowing what was inconvenient for him to know. so i want to make sure folks don't have the option of opting out or having disincentives to know when they need to know and we know what they need to know when we know it. i look forward to working with my colleagues on this as we try to incorporate provisions like that in this bill.

i yield back. thank you. >> thank you. the gentleman from texas, mr. burgess. >> thank you chairman. good to see you again. spent some time yesterday out at the fda's facility, and i will act on those comments of mr. boyer, you have a wonderful staff that you lead of there. they are obviously very, very dedicated individuals, sometimes working under the adverse conditions that we supply. but certainly i know you're very proud of the organization of which you lead and i believe that pride is justified. mr. chairman, i'm going to stipulate to all of the difficulties of the food and drug administration is encountering that have already been well document it, and i would ask unanimous consent to preserve my entire statement into the record let me just concentrate on the aspect that we are now finally after i don't know how many hearings on this, getting down to someone of the business of acting for the fda,

and talking about legislation that would give the food and drug administration some tools. but we are also giving them a timeframe which may prove to be a very difficult time frame for them to mentation, and we are also putting some additional burden on businesses at a time that our economy is in some difficulty. the legislation proposed would mandate the largest change in food safety and at least two decades and it will give the entire food industry a compressed time to do so. in a few short months they will have to turn the current system of paper-based records into an electronic form, businesses will have to find the money to register as a food facility and additional user fees if we deem inappropriate in the future and they will have to be able to fully traced the food to its place of origin. all those may be laudable goals but i'm not certain what we are proposing as a timeframe is adequate. and in the food and drug administration itself in that short and compressed time frame will have to hire enough inspectors to meet the new inspection standards, create identifier numbers for every,

set up a new administrative law system, and make certain that each senator center has a food city plan. all of this is demanded and won the legislation. i would just point out when we get a consumer product safety improvement act last year, hr 4040, we acted in good faith and we acted within some dispatch but we created some situations that are absolutely unattainable. we had to go back and try to amend some of those. we have driven some small businesses to the point of bankruptcy. we've created a situation where our resale shops because they cannot measure the lead standard that we required are in a position that they don't know whether they can sell the goods that they have been donated or not. so i urge others to take every new caution, the law of unintended consequences has a very short turnaround time in our current globalized world and we need to be cognizant of that. finally, worried about bipartisanship in a deal is bipartisan if it is bipartisan at the beginning. chairman dingell, i appreciate

the courtesy that you should be in the last congress and getting me involved in some of the parliamentary discussion of the draft that you are considering but really when the draft comes to the committee for consideration, it really got to have had input from both sides. and the fact that there are five or six democrats on the bill and no republican, there was no republican on this side which you could sit down and talk and perhaps get to a point where there could be some general agreement. we've done this before on other pieces of legislation. we did on the food and drug reauthorization act in june of 2007, and i frankly do not understand why it is not worth the effort to make these pieces of legislation based we are not talking about points of the next election. we're talking about the regime that will be in place that will ensure the safety of the food for my grandson and marcia's grandchildren. this is the legacy that we are going to be leaving, and it is too important to be left to