addressing the bill providing courage maybe this will be a member/member discussion but jeffrey really want to claim to have a bipartisan bill then we should have just not dictate this is what we will do but this is our be need to work together. i yield back my time. . .

wanting to move it forward swiftly. >> thank-you, the gentlewoman from california. >> thank you mr. chairman, i have sat here for a few hours listening to this hearing and i think the content is very important and i do think this committee has developed an enormous record on the subject. this is not new information or mayors of this committee and i do think we will be able to move legislation next week and i hope it will be bipartisan and i agree with mr. shimkus the new the mother should be opportunity to participate. i wanted to a knowledge a comment that mr. bowyer made it before he left to the hearing room, he was in some fashion implying that dr. hamburg is not focused on drug safety. my response to that is, of course, she is, she has been

here for tennis and the first topic is food safety so let's give her in this committee time to focus on the subject in the near future and not be accusing each other of some light of perhaps inadequate attention. on the subject of food safety, which is what we are talking about, there is a section in the legislation about testing by accredited labs. last year i recall thank you to worry about whether the prior administration was going to cut back on the number of accredited labs in the impact that would have on major ports of entry, like the ports of los angeles and long beach, my district happens to be there. that are the plays were enormous amounts of imported food and to the country, so i just want to give a chance dr. hamburg not in terms of yes and no answer session, but could do assure us

that lab capacity is a priority of yours and assure us there will be adequate lab capacity for the anticipated the importation of food and for the standard in this legislation to work? >> absolutely. laboratory testing is an essential component of a strong science based food safety system, and we do not have any plans to restrict our laboratory capacity and i think as we move forward we will want to make sure that we are applying the best possible science including laboratory science to our testing and screening activities. i hope there will be advances in laboratory science and technology that will enable us to do our inspections in a more efficient and cost-effective way, but it's a pillar of what we do and they will continue to

support it and we may as resources become available and aides suggest actually expand our capacity. >> well, i appreciate that and i'm not suggesting that our current lab structure be frozen in time. obviously if there are improvements in location or function we ought to embrace that, but another one of the concerns that has been expressed is the ability to get the results from the lab to the fda in a timely manner. do you think the current system is adequate in that respect and are you thinking about improvements to that? >> we are eager to implement a system for reportable foods that will include laboratories reporting positive tests to its fda and i think that will be a very important additional element to our activity is. >> good, i appreciate that, obviously in light of the recent outbreaks in a devastating

impact of human life and health, it's important to get that information out and accurate as soon as possible. mr. chairman, i don't have further questions, i am thrilled as she is here. i yield back. >> thank you. in the gentlewoman from the virgin islands, ms. christensen. >> thank you mr. chairman. i think your time is almost up. thank you for your patience with all the questions and listening to all of our opening statements. in your testimony your reference section 106 that provides the more explicit authority for a fda to access to records during inspections. did you think that is enough or should we go further in the legislation to mandate those records be forwarded to fda? >> you know, i think what is outlined is certainly a very good starting point.

we don't want to be inundated with information and we don't want to put too much of a bird and -- a burden on industry, but we do need that access to records. we need companies to keep appropriate records and we need to be able to have it to be able to inform our routine inspection activity is to be able to work with the companies to make sure they have adequate preventive controls in place and we needed it certainly in the advent of a serious outbreak of public health concerns to enable us to swiftly get the information we need for action. >> so you think that requiring them to have their plans and have their plans audited in conjunction with your authority to have access to the records should be sufficient?

>> dinow, i would think we would want this to be a dynamic process as we learn more putting in place the programs and policies and then learning from experience, but i think the bill lays out a very sensible and doable approached. >> okay, and you also talk about the huge task of hiring and training inspectors. fis understand correctly, you are asking for more flexibility in the legislation to be able to do that. are you asking for general flexibility or would it transitional timetable with a time certain in the legislation work just as well? >> i think we have to recognize that this would be an enormous scale up of activity and that we need the time frame to enable us to do it right to recruit the people and train the people to work with industry to develop

the systems that work. and so we like flexibility in that way and we would like more general flexibility so that we can learn as we go in terms of the the inspection schedule and some of the requirements in that regard. >> okay, my last question is kind of a general one. i don't think it was asked before but even as late as yesterday someone asked the secretary the question about one single entity to secure food safety with the authority over the food safety program and for the country. and i am sure, i don't think the secretary supported it and i'm sure you don't, but what can you say about if you have had a chance to look at how fda and the usda work together or don't work as well together as they

shouldn't, what can you say about adjusting the concerns that gave rise to the legislation that would put it in a single entity? >> well, a couple of responses to your important question -- what is clearly as the new fda commissioner i have a person i mention priority to strengthen food safety within the fda and i think there are many things that we can do to strengthen our program to improve accountability to raise the issue as high priority. part of strengthening food safety within fda is strengthening the coordination with critical partners as well and that certainly means with usda and i look forward to a productive working relationship with them and also means strengthening the working partnerships with state and local public health organizations, and is married and partly also involves working

with other international agencies and government, foreign governments, because i think we are going to see the percentage of food coming in from overseas increasing in the years to, and the globalization has a profound impact on and the work of the fda. i also do think that the authority is and tools that this new draft legislation that could potentially provide to the fda would be extremely important in moving the federal government and the fda in the direction that we need to for a robust and modernized the food safety system. >> thank you for your answers, thank you mr. chairman. >> thank you. the gentlewoman from ohio, ms. sutton. >> thank you mr. chairman and thank you dr. hamburg for your service and for all that i am confident you are going to do to improve food safety in this

country. as i mentioned in my opening statement, ohio has been hit hard by issues arising from food safety. in the past year there have been 105 cases of salmonella reported in ohio and sadly three deaths resulting from the most recent peanut butter strain. a constituent of mine who unfortunately died from salmonella poisoning -- a contract in a nursing facility, and just in april of this year and cuyahoga county there were three incidents of illness from e. coli and another death this time a seven year-old girl. so this is an urgent issue for the people i am so honored to represent. i mentioned that i introduced to protect consumers act which was a bill that would give the fda mandatory recall authority and i'm happy to see that it is a part of this comprehensive bill. and i would just like to get a little bit more of your opinion about the need for a recall

authority and this bill of chorus seeks to remedy the situation of the fda not having a mandatory recall authority by laying out to different types of recall authority is your first that the fda believe certain food because adverse health consequences are that that they can recall -- require recall, but in that scenario fda must first of the company an opportunity to voluntarily recall products and that doesn't work then the fda can order a mandatory recall and the second time every call is emergency recall if the fda five certainly it presents a threat of serious adverse health consequences are that. you may do that immediately. can you just telling about whether you think that and the need and the approach of the two tiered approach is addressed in a good way in this bill and why it makes sense? >> well, i think the history is

that voluntary recall is often an effective and in getting those potentially harmful products off the shelves and protecting consumers, but that you do need of that emergency mandatory recall bond senate as a backup. there certainly have been cases where the mandatory recall of a dangerous product has been delayed because of reluctance on the part of the company to pull the product and there has been a back-and-forth with lawyers involved and delays of weeks putting consumers at risk, so i think to have the mandatory recall as an emergency measure is very, very important and sadly in a world where we might also need to address intentional

contamination of food, that emergency mandate to a recall becomes very important tool. you know, i think the reality is that having that as an enforcement tool probably makes it easier to also work with companies on a voluntary recall so i think it's a continuum that we need, we need both. >> with a gentle lady yield on the same point, in follow-up? >> i have very little time but i will yield. >> to follow up, one of the issues would be may cause -- that is kind of a low standard. i think there will be concerned about the may cause language in here. and how you define that can i guess we discussed that earlier and i think perhaps there are some words missing that could be done on that. >> thank you, i think my colleague. >> sure, and if i could follow up on the suggestion that has been made it and some have argued that because mandatory recall is such a strong tool

that or the commissioner should be able to exercise the authority to exercise recall with no further delegation, and i just wanted to know about your thoughts on the approach of having only the commissioner order a recall and how that would work for the fda and frankly while i am at it, with such an approach working toward a suspension and subpoenas, what are your thoughts about the subject? >> these are imported and powerful authority is that should not be used lightly. however, i think that experience shows that senior level officials can be entrusted with these authorities along with the commissioner, but it is really something that we would want to work with congress on in order to put in place the system that people have the most confidence then. >> i thank you, and i am certain that we shared concerns about experience in making sure things happen in a good time. i think your answer on the way

that the recall authority would work, you having the mandatory authority would give you an opportunity to encourage even more strongly, they would be necessarily encourage, the companies come unto it comply on their own as well so thank you very much the mack thank you. mr. green. >> thank you mr. chairman and dennis dr. hamburg come i appreciate your patience today, but if you think this is tough you have the fda to work on a, which is i laugh because in a 07 we spent a great deal of our time both of the subcommittee and full committee in reforming fda and then last year with all the food safety issues that came up it's in my we are back out again. and i am glad you are there. in my opening statement i mentioned my concern about the location and number of labs and i know my colleague from southern california congresswoman harman mention the same thing. texas does have the longest

running border with mexico and the port of houston, and the port in long beach imported tons of food, yet we don't have a fda lab and i've had the honor to meet inspectors on the docks at the port of houston but there detailed out of loretta, texas. i guess because it is such a large state, the need for a lab somewhere, i am glad the bill does include the ability to contract with labs because we want the inspections done as quick as possible. does the fda intend to evaluate the current locations of 13 labs? whether these locations are meeting inspection demands, but also in the president's budget talks about three high-volume fda labs and how the fda decides where to place these labs? and what consideration placing in a place like taxes or even southern california? i did not know if they had

allowed with l.a. -- and that is my only question is of thank you mr. chairman. >> well, i am fascinated that the laboratory issue comes up so much here because it's such a key issue and in my past experience as a public health official it's often the laboratories that is the under appreciated the component of public health needs so this is very encouraging to remain. at the present time we don't have any plans to expand that basic, you know, network of laboratories that you mentioned in, although as i have sent to congresswoman harman with additional resources and expanding needed that might be a possibility. we will be creating some additional high throughput laboratories, and in all honesty i am not an certain about the process by which those laboratories are being developed

and cited in. it is something i need to go back as a very new fda commissioner and learn more about. but the laboratory issue is one that is essential as we discussed. >> i guess the reason it comes up so often over the last three years actually are committee spent so much time on pharmaceutical safety, food safety, and the concern is that we are importing so much of our food. like i said, laredo, texas is probable largest land-based force in the world and so much comes from mexico, we need in the inspections as timely as possible to move to produce. or whenever the products and foodstuffs particularly, but we also need to make sure that the problem is not pay for. but with this feed that is going to be assessed, hopefully that will generate the resources both for the personnel and also for the facilities.

and i guess if you are having to contract with private labs that may be great but there are times that a public lab would be faster and ultimately cheaper to the folks to pay the bills here, so that is what i just ask the fda to look at that and i'm glad we're going to contract because we want the converse -- commerce to fall but if there is a need to have a lot more economical and just as fast to contract with a private lab. then i would hope this funding source -- i guess over the last three years our hearings have said the fda's staff, we don't have the staff and the resources and we will try to give you the resources in this bill and hopefully the higher the staff and have facilities. >> men may also assure you that -- let me assure you that your constituents are not compromised in terms of the laboratory testing that is needed to protect their food supplies because samples can be shipped to lapse, and the modern era it

can be done in a timely and say why. so the coverage and terms of laboratory testing is still available, but i hear and understand your concern about the gaps in turn of the come -- in terms of an on site facility in your region cannot well, i think the fear some of us have is we don't want to play favorites. these ports compete for cargo and we don't want to be based on if there's not an fda lab or slower to get this through one part as compared to the other ports, i know i have run at a time but i appreciate the responsibility or taking on and hopefully will provide you with the tools that she needed. thank you mr. chairman. >> thank-you. in chairman stupak. >> thank-you mr. chairman and thank you commissioner barrett as chair of oversight and investigations and one of the authors of the food safety enhancement act, we have seen both nine hearings in the last

two years just on food safety and certainly is a major problem. one of the problems i found every time we had a hearing there was always a lack of information that the fda did not have the manufacture of the food or the producer of the food and was always difficult to get information. in the safety enhancement act authorizes the fda to issue subpoenas for records and other things relevant to a hearing investigation or proceeding or relative to any other matter within the fda's jurisdiction including matters of the public health service act and the federal anti tampering act. do you believe subpoena power would be beneficial to the fda? >> is very important for us to get access in a timely way to the information that we needed and i think that authority will enable us to act more swiftly and effectively yes. >> well, we hope you would because i think we're still waiting for information from 2007 the salmonella outbreak in

peanut butter from the georgia plant, i think we got it all that information yet there is some. to be concerned that the fda will abuse its subpoena power and our concern centered around a subpoena provision that authorizes the fda to issue subpoenas in matters under fda's jurisdiction that are not part of a particular hearing or investigation of a specific violation of the act. there seems to be a fear that it will go on fishing expeditions constantly sending out burdensome on this their request for documents. how to address these concerns? >> well, i think that we have enough work to do without going on fishing expeditions. we would be seeking information and that would be of vital importance to addressing the tasks at hand. it would be of great value to have the ability to access critical information to inform

the inspection process as well as to inform outbreak investigations and i think that if we are going to be able to really move forward to ensure the safety of the food supply, this is one of a number of tools that will enable us to really do when needs to be done. >> that is refreshing to hear because i have been pushing subpoena power for the fda for 10 years and to get a witness to agree by the time i got back to my office they would say that is not the official position so it is refreshing to hear that and i'm sure you won't use it for a fishing expedition. let me ask you this, chairman waxman and i wrote to you about redoing bp a well previous fda commissioner found no problem with its fda's on science review board says there was room for concern and we wrote to you and you wrote back that you have

agreed to review the safety of bpa so let me just say thank you on that point. i think it is important that we look at all the documents and evidence of the study is not just to studies when they're over 100 others that raised concern at this venal away and also on food safety in the lab situation. it has been my concern the last commissioner thought food safety was too close labs which i thought was the wrong idea so we have always fought a reorganization or closing of these labs and we actually had to put in legislation to make sure these feel people in critical work for the fda and safety of the american people stay on their jobs. and recently wrote back to me, myself and a chairman waxman indicating that there are no current or future plans to close or consolidate many of these 13 field laboratories and also went on and said that you were hoping you'll be able to hire and 70 new analysis or 13 laps to

replace staff lost over the last few you fiscal year so thank you for that and without objection out like to place the record from the commissioner in the record. >> without objection, so ordered. >> to me ask you one more question if i may. risk-based inspection schedule. one of the import requirements and the food safety bill will to put into place, is a risk based inspection schedule for food facilities. under current law and even risky facilities can go years between the fda inspections but our legislation has strict requirements to make sure fda inspections and to get into the risk facilities as frequently as possible. the riskiest facilities must be inspected at least every 6218 months, no food production or storage facility will go more than four years between inspections. under current law there is not any requirement regarding how

frequently these facilities must be inspected in. is there? >> there is not and i think your desire to see a risk-based added to be put in place is absolutely key so that we can target the sources on the highest risk. >> does this bill give flexibility to modify the inspection goals based on available resources and the best available evidence on risk? >> as i said in my testimony, i am concerned about the requirements for inspection and outstripping available resources and that has been a chronic problem for the fda in terms of being able to facilitate imports and mission. i think that it is the strategy outlined in the legislation is a wonderful aspirational call. i love to be able to sit here and say that fda could take it on end fully achieve it, but

there is a reality of limited resources both dollar and human and i think that's where we need some flexibility to look at the numbers and really also began to move swiftly in the direction as outlined in this bill, but also try to learn as we go so that we can find ways to do our inspections in a more efficient targeted way and really focus on the highest risk and really try to leverage other resources to the goals as well for partnership with state and locals partnership with foreign governments, and potentially with third parties that are certified and overseen by the

fda to help us particularly with respect to the burgeoning number of foreign sites for inspection. >> i'm sorry, but we -- >> the registration fee -- >> we are done with questions come and go ahead of iraq and was going to say hopefully the registration fee that would be putting in place with up to 400,000 of facilities would provide enough resources to do the inspection and other work that the fda sorely needs to the resources and the personal to do and and we understand that and hopefully that will be part of the bill. thank you mr. chairman and thanks for your help on the bill. >> thank you. mr. dl. >> i think my ranking member and i thank my colleagues because i will follow-up on this wordsmith and we talked about on the may cause. that's why we still have the same problem on the subpoena power issue because in this subsection three and says, and the other matter