.. >> adverse health consequences that would be the legal standard. but in the senate bill, and

there must me a reasonable probability of serious adverse health consequences or death. those standards are significantly different and i would just ask you since you are responsible for this, the first and third in this bill seems so general and nebulous in a way does that bother you or don't you take it would be better to have a more precise identified standard for recall? >> i certainly understand the concern you are raising and i think there may be opportunities for some words missing. certainly we would never seek to recall a product without some reasonable expectation that there was serious adverse

consequences and are related to their product. the recall is no small issue both in terms of resources and efforts on the parts of the fda and also implication on industry and consumers who want access to those products. it is an area we would like to work with you on four language. we would not want it to be to overwhelmingly prescriptive because you want the flexibility for the potential emergency situation to move forward. >> i agree. this is an area we should look at because we know the ramifications of a recall. the extent and fault and certainly we want to have a balance of protecting the public verses undue expenses to companies as well.

ironclad to see that at least is an area that you would be willing to talk about. i might also say the same thing would apply to the access of records. there really is no standard at all in this bill but on the senate bill if the fda has a reasonable belief it prevents a threat of serious adverse health consequences or death the fda would have access to copy all records and so forth and so forth. under this bill it appears the fda would have blanket authority to request any records at any time without any sort of standard be met. >> keira i would like to stress access to retain records is extremely important to ensuring a safe food supply. it is very important when

inspectors go into a facility they can examine certain aspects of what have men the procedures during a proceeding period of time and not just to inspect what is happening at that moment and had we been able better to access routine records in the case of pc a we would have been able to see there was documentation of contamination several years earlier which had been adequately addressed? >> my time is expired that relates days relates to the comment of the opening statement about the use of antibiotics and the agricultural community and the fact that more and more people seem to be establishing immunity to certain antibiotics is that a concern of yours? >> is in terms of the problems

of antibiotic resistance and the implications that it has four our armamentarium of antibiotics to address serious and life threatening diseases. it is something that merits a lot of attention from the fda working in partnership with others, it is a topic i would be happy to come back and discuss in more detail with you. it is very high priority for me in terms of overall goals to improve public health. >> thank you. chairman dangle? >> mr. chairman, thank you. welcome again dr. hamburg congratulations the first question is a yes or no, well, the inspections are an important part of addressing food safety problems isn't this correct?

>> yes. >> your agency does not have a good record when it comes to respecting food facilities last year you inspected 6,562 food facilities. in the united states 152 foreign facilities in the same time. was that enough inspections? how many should you have to do the job? >> i think we can do better with respect to the question exactly how many, i cannot tell you that now. >> i will submit your letter asking you these questions. >> i was warned you would do that. >> i asked the record remain open for my letter and the response of the administrator. >> so orders. >> would you support an increase frequency requirement? >> we clearly need to do more frequent inspections also smarter inspections and we'd

need not to rely simply on inspections as a tool for a safer food supply. >> we agree on that. i am keenly aware there is substantial with conducting foreign and domestic facility inspections, how much do you need to do this properly? >> in terms of personnel and money? if you cannot eat given know i will ask the record me kept open. >> it is a complicated answer we need a lot more money. >> we have the record remain open so it can be inserted that at a proper time. >> the record will remain open. you don't need to keep asking. >> also the fda will the new additional resources to meet that requirement? >> absolutely true. >> the present has us additional resources for food safety activities at the agency. i am told 259 million

additional money is that correct? >> yes. >> the president's intent with these additional dollars 64. 8 million of new budget authority 94 .4 million of new fees, registration, export certification would be used for inspecting or increasing the number of facilities inspections conducted by your agency? is that not correct? >> it would be used for that as well as other components of a more comprehensive modernized. >> it is correct their president budget request for food safety activity did not include any new requirements that may come with the food safety legislation or food safety legislation we are current -- considering here is that correct? >> can you repeat the question? >> the president request for new money did not include

money to address the questions you will be compelled to face under the new legislation? is that correct? >> it addresses some components but not all requirements that are outlined in the legislation. >> there are many who have resisted for food inspection frequency by the agency and ask two $70 for such activity be prohibited would you agree with that or disagree? >> i hate to do this but this style of questioning. >> sorry. i have a limited time. >> can you repeat the question? >> do you agree with the idea we should prohibit the use of registration fees for inspection? >> we need registration fees to enable the agency to do its inspection activities with the

food safety plan. >> one of the few successful activity is up the spectacular time is what is supported by fees? correct? >> correct. >> starving almost every other place? >> correct. >> can you state with any certainty and a number of people, customs, brokers, file rs to import products under the fda jurisdiction to the united states in the year i believe the answer is no. >> no. this legislation would enable us to get a much better handle who is out there producing and distributing food. >> the reason is they're not currently required to register with fda? >> that is a large part, yes. >> isn't it important to fda to have up-to-date and accurate accounting of who these people are? >> very important. >> these individuals are not required to comply with certain requirements to ensure

the safety of these products. that they import. they can handle any type of fda related products internet required to have any specific training to do. is that not correct? >> that is correct we would like to make sure it individuals importing food and the united states follow standards and guidelines the we expect with domestic food production. >> the domestic draft, the discussion draft establishes a program to required importers, customs brokers of foods, drugs, devices to register with the fda and require good importing practices are maintained as a condition for maintaining registration. do you agree with that requirement? >> really like importers to be registered. >> one more question i will

tell you what i know my time is up. madam administrator i will be submitting a letter, mr. chairman thank you for your patience i would no to the changes in the draft we have before us today have largely been done in consultation with fda and in consultation with my minority colleagues. and exchanges will originate the same way. thank you, mr. chairman. >> thank you chairman dingell. >> next is the gentlemen from indiana. >> given your statement, you support the fda's ability to trace foods a more quickly so you import a system with regard to food? >> i would. is very important for our ability to respond quickly to outbreaks of concern the. >> you appear to be endorsing

the bill, this draft discussion of the bill in front of us who also support the fda ability to increase inspections of food processing facilities. correct? >> we need to do more inspections as i said we also need to recognize this it is not simply increasing the number of inspections that will get us to the food safety system we need but also as a two big the preventive controls and shifting the way we think about food safety and stronger partnerships with the locals, foreign governments. >> when you discover contaminated food, you believe it is your responsibility to prevent the distribution of the contaminated food into the marketplace? >> yes. >> you are asking for the ability to do recall? correct? >> yes. >> ones that contaminated food has been discovered do you

believe you too have the ability to order the destruction of the contaminated food? >> it depends on the circumstances. sometimes it might be possible to reprocess and make it available in a safeway but if it is contaminated putting consumers at risk and such an option does not exist, then that food should not be allowed to be provided to consumers. >> since you support a federal tracking system for food, would you also be willing to support the yen and electronic pedigrees system for interoperable tracking system for pharmaceuticals? >> i think and both realms it is very important to know. >> is this a yes?

>> where they are going. >> is this a yes? >> i am reluctant ... >> you will choose contaminated blood tests over adulterated drugs? i don't think so. >> i don't think it was either o or. >> if you supported pedigrees system for tracking and tracing of contaminated food do you also believe it is important to have the electronic pedigree for the tracking and tracing of pharmaceuticals? >> and concept i think the trees ability is very important to ensure what consumers get ... >> all rights we have 11 international mail facilities, added three others, ed dhl, at ups and fedex. of which 35,000 pharmaceutical packages them into the facilities everyday so do the math when you do your

inspections, 80 percent are either adulterated or counterfeit, knockoffs yet fda claims they have the ability to destroy. you are sitting here before this committee today saying you now believe you should have increased ability to inspect and go after this contaminated food. want to make sure that you also believe you should have the ability to destroy these counterfeit knock off drugs because if you just do the math, that has to be excess of 350,000 counterfeit adulterated knockoff drug packages per day but is millions of packages of per year that are harming people. so let me go right to you, i do believe the fda should have the equal authority to destroy these counterfeit adulterated drugs? >> as i indicated earlier, this is my seventh

day on the job and i have now been briefed in full on all of these issues. the problem with counterfeit drugs is a huge concern and i am eager to work with you since you clearly care very much. >> right now they're sitting, your customs and right over here is fda there is not even a wall but it customs has the ability to destroy the you claim you do not. please do not come before this committee and tell our country that you think we should protect you with regard to food but with regard to drugs, i cannot believe the as a doctor ... >> i am not telling you that. >> then be clear. >> at the heart of the estate -- fda mission and as a doctor issues of our extremely important to me i am depart -- determined to work on with members of congress to find appropriate solutions but

i am not comfortable at this time discussing the specifics of that program at. >> i will be willing to work with the because i cannot believe this would be an issue you would be equivocate on. i yield back. >> the gentleman from colorado. >> thank you very much mr. chairman and dr. hamburg want to add my welcome to your appointments i know you will be working with this committee on a lot of different issues. why want to talk to you about the system because we have worked very closely over the years particularly on this latest legislation on is setting forth mandatory characteristics that would be contained in the tracing system that the fda sets up through the regulatory process. for example, the bill requires

the origin of previous distribution must be maintained and it must be linked with the subsequent distribution history of the food. also requires as a key component this system be interoperable for different types of food they can figure it out. some people question whether it will ever be feasible to implement this kind of system? i wonder if you can give your opinion on the feasibility of this type of a trace back provision? >> as you indicate it is key to our success to be able to respond swiftly to outbreaks and make the appropriate intervention to protect the american public. interoperability is key because it involves a whole range of different players along the full life cycle of the product and that is one of the great challenges. as we move forward in developing and implementing a

trace ability program, we need to work very carefully with industry and with the different components of the food production system. we need to do it in the context of public meetings and open exchange. but that should be our goal, absolutely. >> in the draft legislation that is exactly what we do. we give the fda authority to work with industry and consumer groups to develop the specific types of trees ability technology and the interoperability. correct? in other words, we're not saying, a different sectors of the food industry have different types of trees ability requirements. we're not saying we have a

one-size-fits-all, correct? >> do you think there is an economic case to be made for better trace ability? >> absolutely because with the opportunity to really to add acquit trace back we can target what are the components ordeal the products that are causing the problem and remove those or put in place the intervention to decrease the risk to that particular component of the food lifecycle and in that way we can both save lives and reduce illness but also reduce the cost to companies who we have heard about this morning we have heard inappropriately

targeted when the trace back was inadequate and we didn't identify the correct product and also when there is a whole industry, but only one process or manufacturer that is the problem we can protect the rest of the industry by honing in on the particular product at risk. >> was three develop the system is to make identification and removal of the specific contaminated food much more speak thin if it is consumer health-care benefits the economic interests of the sector. one last question and the draft legislation we have per faired exams farms that sell directly to consumers or restaurants from the tree's ability requirements with the farmers' market present is that a appropriate carve out for them? >> i think we have to recognize the burdens on smaller businesses but also from a public health point* if

you have to assure when there is a problem we can get access to the information needed to identify the source of a contaminated food. we need to work very closely. >> the farmer market is not broadly distributing their food it is local so us some when did get sick the state health department. >> it makes it easier to do the outbreak investigation. >> thank you very much. >> the gentle man from illinois is ready? >> mr. chairman can ask a process question? is there a possibility the subcommittee may consider this legislation next week? >> yes. >> i would ask for members to could submit question for the record by close of business tomorrow could we have witnesses respond by the close

of business money? >> it sounds like a good idea to me since we are likely to mark up next week. >> that is inappropriate approach. >> without objection that is what we will do. >> of course, this is a draft as i said so we appreciate that and we do appreciate your testimony and will come on board and we are all working on the same team trying to get responsible legislation that protects human health while ensuring that these fees go to where they need to go. i just have to. one, this goes back in history two decades ago when congress to liberated how to improve the clinical laboratory testing in this committee under the leadership of now chairman waxman and dingell and my former colleague

mr. madigan issued a report same proficiency testing is considered one of the best measures of laboratory performance and arguably the most important measures that have actual test results rather than gauge the potential for good results. as we examine the discussion draft as called for accreditation standards for laboratories to perform analytical testing on fruit in your opinion should proficiency testing specifically be included? >> i think we only want to work with accredited labs in the accreditation process but to address those kinds of concerns the advocacy of the testing is key to making the right decisions and i think as we move forward laboratory testing needs to be a strong

component of what we do. efforts to ensure a the accuracy of testing results is absolutely key to protect businesses and provide the public health system with the information it needs to take action. >> i would agree with that. think that is the closest to a yes i will get that is fine. it is a critical component if we're going to do this the proficiency test me a process by which we test the testers we have some certainty. let me go back. i know we have talked about the 75 million in the president's budget and the 375 million in revenue i mentioned in my opening statement and i understand this legislation offers more authority that is why there may be a different number than

what the president proposed but i think a lot of us will be challenged by the fact, and will be helpful before we move to mark up show us the money. show us where we came up with this amount. as i said also there happen millions of dollars put into food safety over the past six months. a lot of us are trying to understand where 375 million came out. we understand that was so many thousand per facility but that doesn't answer the question as to where is that money or is it going to go to an inspection regime? what does it cost to do the inspection regime? especially i have been a strong person for a risk-based system. the risk base system promoted in this draft, legislation, is nowhere near i believed a

risk-based system should be. think you should go after risky individuals pompano that in essence offer no risk you ought to incentivize them and this has been statements i made for a long time so even the risk-based approach can be modified somewhat. is there a way to give us a better handle? fifty you have better numbers that support this discussion draft at $375 million actually means $374 million worth of ability to inspect? >> regrettably i don't believe the 375 million will cover the cost of inspecting on the schedule outlined in the bill. actually would need considerably more source is to do that. we know based on estimates

that very, we know domestic inspections, cost, a little over $9,000, national inspections are probably threefold higher, and the number of facilities requiring inspection and are very, very large numbering in the hundreds of thousands. >> my time is expired and i apologize. i would just say there will be skeptics that say okay we have 375 million on a fee schedule that will not go to inspection. it will go to other aspects of the fda would it help provide and if i can and on this because the chairman mentioned this once again that there has been negotiation with the republican colleagues. i would call them