Transcripts For CSPAN2 Key Capitol Hill Hearings 20150921

Just outside the town, and those are the things im concerned to have you all been able to better coordinate with the First Responders and with the state coordinators, First Responders . We have. I have said to the railroads i think notifications of First Responders should be a priority, we have an emergency order that went into place in me 2014 i remain simplistic we have reiterated its importance with the railroads. Wrote them a letter reminded and expectation is there to be sharing that information with First Responders so that those individuals have as much information as possible. Are you getting pushback . To the states still say they dont have the info . It depends on the state. Some states have said they want more, were asking the railroads to please work with him to give them all of the impression they could possibly need. Some are satisfied, and then depending on whether that information is made public prickly depends on the state you put a working group together worked with robert executives and engineers and people on the front line and all the people on the rails trying to get input from them to try to better this or do the things that they simply are acceptable and candidates because yes, we have a task force is seeking to do that. Thank you. My time has expired. Thank you, senator manchin. I had senator wicker followed by senator klobuchar and senator blumenthal. Senator wicker. Thank you, ms. Feinberg. I think weve been kind today but i do think the committee on both sides of the aisle, the members are a little confused and frustrated by the lack of a specific proposal concerning the extension. Now, they chairman king and and clarified that apparently fra the chairman came in stand by the cruel american recommendation concerning extensions on a case make a basis. His natural position . What but as for integral america act was not a blanket extension but flexibly to work with railroads that we could prioritize where ptc would be turned on. So the statute is very black and white and offers literally really no wiggle room. So we asked for indie grow america act was flexible to work with railroads posted january 1st 2 turn up portions of ptc before waiting for an entire system spirit if i were a railroad and struggle to meet this deadline i would find that so uncertain that i dont know if i could develop a business plan. It seems to me that when that what that would do is come easily put up entirely to the discretion of the fra and the people trying to get this thing done good faith would be so frustrated that they would know where they stood. You know, it seems to me, ms. Feinberg, and were going to have to extend this for a period of time just to get people out there in the country the ability to know where they stand. And so to me it would be helpful, i dont think, i think we can all acknowledge that the grow america act will not be passed by the house and senate, passed out of committee, signed by the president before the end of this year. And so i would appreciate you coming back to us from the administration coming back to us about what vehicle we might have. Do we need to put it on the cr . If we do we need to move pretty quick and understand the cr, the folks design that are intending for it to be very clean and not have a lot of new provisions. Do we need to put it, cannot wait until the omnibus of the end of the year because it looks like thats where we are headed is this, is the reauthorization of the transportation bill in an appropriate way. But i would appreciate a specific recommendation as to the length of time that might be appropriate. Is at six months, a year, two years cracks you deal with this every day. Were trying to do with 100 things. I really would ask you to get back to us and provide some leadership there in terms of letting us know how industry can get this done. And i realize weve spent a lot of time on this topic so let me switch, let me be provincial then and ask you about gulf coast service. You know, the house and senate, we have been quite gotten a bill to the president desk yet, but i think, would you acknowledge that we have made it clear in legislation that it is the federal intent to have a working group formed to restore the gulf coast Passenger Service that we lost after Hurricane Katrina . Would you agree that that congressional intent is becoming clear based on the legislation so far . Yes, sir. And are you aware that a working group is proposed to develop and answer the question how we implement this . Yes, sir. And what you acknowledge that fira outrageous that we get the legislation is actually connected to form such a working group . Yes, sir. Ive met we just have on this. I am supportive of gold service being, of gulf shores service being restored. Weve had a good conversation and i will be down there next month. They are lovely and actually speeded where is the down there . Im sorry. I will be in louisiana and mississippi. Wonderful. You know, governor bright, senator cochran and i would like to host you on the right although the proposed route with the other members of the delegation, which amtrak president boardman and ceo csx ceo ward and others to assess the line. Are going to join us on that right if we can work out absolutely. Look forward to it. Wonderful. And i look forward to working with you on that. Thank you for your service. Senator klobuchar i believe this next. Thank you very much, senator wicker. Ms. Feinberg, congratulations. Any friend of senator manchin is a friend of ours. So first i wanted to talk to you about a block crossing issues. As i travel across minnesota i hear from people all over the state who has spent an excessive amount of time, sometimes hours struggling at it blocked rail crossing. Block rail crossings not only inconvenience drivers but they delayed emergency vehicles. Angela i was on the canadian border, major crossing but a very small town. Their rail crossing blocking is six to eight hours a day in the town. So in the drive act, we put a provision in their contractor sector of the transportation to develop highway rail crossing action plans including tools and data, safety, other things. That is the amendment that is into. Acting administrator feinberg hi,as this process moves forward what steps can the fra take to minimize blocked rail crossings. Antithank you the best practices in place . Thank you for the question. We are also very concerned about blocked crossings. We do not actually regulations in place that govern how long a train can block a crossing. But we frequently hear from communities in minnesota and elsewhere where you have folks who are waiting for some time while a train is blocking a crossing, he can sometimes lead to safety concerns as well when you have First Responders who are stuck on who are stuck on one side of the crossing and cant get to the other side of a crossing. So we preclude work with railroads individually to address specific problems. Weve also suggested that we do a study so that we can understand the effects of blocked crossings, but we are also worried about those and attempting to resolve them. So would be dictated by this bill, once i know well pass it eventually this year. Also i hear from communities that they dont have the capacity to prepare or to respond to a drill that are Hazardous Material spill. Firefighters and First Responders in some cases simply dont have the resources to purchase the equipment. What is the fra doing to ensure local units of government have these resources to be able to properly prepare and do you need any Additional Authority for the . I dont know that we need Additional Authority. We worked closely with our Sister Agency pipelines and hashes major hasan programs that will assist with training First Responders to making sure they had information that they need, the resources they need. There are training separately happened after training and testing facility in pueblo, colorado, which is actual facility for training. We will continue to look for resources where we can assist First Responders and appreciate your focus on it as a. And then one last question. I will in short and to be addressed in writing so my colleagues and ask questions before the vote. Would you support leaders from local government and First Responder serving on the redwood Safety Advisory Committee . That isnt happening yet and we think that would be helpful. Certainly. I will say that they are, theres more that can present at any point. They can come and reject those and we can make sure that they have a role in our meetings of process com and were happy to give it a look and make sure that they feel that their welcome and listened to at our meetings. We would like them on the boards we can discuss that later ill put the rest of my questions in writing and turn it over to senator blumenthal. Thank you. Actually, senator daines is next. Okay. There you are. Thank you anyway. Thank you. Appreciate that. Ms. Feinberg, congratulations on your nomination. Its nice to see you here again. Nation of montana is alternately 3200 miles of Railroad Track that moves our agriculture commodities, record amounts of crude oil, coal and other manufactured products across the rail system every day. Infector export the majority of our Energy Company of her wheat harvest goes to asia, and most of that by real the last summer there were challenges to rail capacity delays in shipping some for goods or car phone to ring a lot. A lot of concerns about this. This year i know the santa fe has made investments to increase capacity come and safety come and we expect smooth and efficient shipments of issues harvest as well as of those commodities. Additionally, we have the runs along the high line, muchneeded transportation and connectivity for a rural communities. Lasher noted 120,000 people boarded and i recall as a kid hearing stories about how my great grandparents would take Passenger Rail from shelby with the empire builder stops there, that someone, go back and forth when it first came out to montana a century ago. Needless to say its imperative to montana we continue to these passengers and commodities in a safe and efficient manner so my question will be the same horse we been beating here during this hearing which is regarding ptc. We all saw in the report released yesterday the gao has recommended again the congress extended december 31, 2015, ptc deadline. The largest railroad in my home state in montana is bnsf. They been working diligently. Have invested 1. 5 billion. Effect in another 500 Million Investment plan to implement ptc across the nation including on n the nearly 2000 miles of track in montana. This deadline is approaching. Descent highway bill contains an extension on a casebycase basis. I think we must continue to the passengers and, in a safe and efficient manner. Without israel connections we are in a trouble in montana. So my question is, administrator, what would you do in the immediate future to ensure our railroads do not come to a grinding halt on january 1, 2016, beyond the threat of fines . Well, senator, its good to see you again. I cannot, i cannot, i cannot give the railroad individual legal advice. I dont think thats an appropriate role for the fra administrator. We have said as good as we can possibly say that we will enforce the deadline. I know that many railroads are considering not operating starting on january 1 because they will not be in compliance with the ptc law, but would you have your cell phone we could forward the calls to montana tuc been taken state i am getting the calls. Yes, yes, im happy take yours as well stick im talking about from the people of montana because this will be a crisis. Im sorry. I interrupted you. Go ahead. I am also worried about a crisis that could ensue in january 1 as well. Weve tried to be as clear as we can possibly be. We will continue to try to assist this committee and the congress in a way that we can as you contemplate the possible extension of the deadline. And we work with you anyway that we possibly can speak we are down to about 100 days, plus or minus. Theres something called thanksgiving in the way. Theres the christmas holidays. So time is of the essence that given Everything Else going on in this town, a tennessee crisis trip it would be nice to avoid another crisis driven event. I completely agree. I do not have the authority to extend the deadline, the secretary of transportation does not. And we will work with this committee in any way that we can but are not able to do it ourselves. In your testimony making this a 1 billion loan from fra the new York Transit Authority to the template Safety Measures are often the focus of Passenger Rail is on the northeast corridor and understand the reason why because of the dense populations, but it sometimes perpetuates this urbanrural divide that we see across our country. As administrator what efforts would fra take to ensure that Passenger Rail service is not diminished in Rural America, places like montana . Well known for being made editable to Passenger Rail in these rural areas . The rrif program is certainly available and has come its frequently sort of the gets the most interest from short lines which tend to be functioning in these rural areas. I say west virginia, some from Rural America i contend that i am a strong supporter of the importance of Passenger Service between rural areas. We are working close with amtrak all the time. The northeast corridor is important to its 50 million people, 100 until zbig and Economic Impacts but it gets a lot of attention but it no way takes all of our attention, and we are laser focused on state routes as well. Thanks, ms. Feinberg. Thank you. Thank you, senator daines. Were still waiting for Passenger Rail to come to south dakota. Habit in wyoming. Montana and south dakota i think of the only 248 laura that dont have it. Senator blumenthal up and in senator cantwell. The vote has just been called. Ill be quick, try to get my main reason for speak is to say how carefully i support Passenger Rail in south dakota. [laughter] i agree. First of all, ms. Feinberg, i want to thank you for the fresh of breath air youve already brought to the fra. Due diligence and determination have made a significant difference already in the enforcement and the vigilance and vigor of oversight by an agency that had been asleep at the switch for much too long. There are still 64 recommendations i believe from the ntsb that have not been closed either Agency Budget made a lot of progress over a short period of time. And i hope that you will continue to focus not only on positive train control but im very significant other rail safety issues. Close call reporting, signal protection, Commuter Rail inspection practices, cameras, speed restrictions, fatigue, and so many other issues. I think your agency obviously can focus on more than one issue at once, and these other challenges are as important as positive train control, and a lot less expensive. So i hope that youll continue this effort because rail safety in the United States is sorely lacking. And will continue the catastrophes, often with fatal results and tremendous costs if the nation fails to do better, and you are at the tip of the spear so far as real safety is concerned. I hope you continue your efforts in that regard. Theres a vast difference in different kinds of extensions of ptc. I strongly support the railroad by railroad, year by year vigilant oversight approach. Which i believe was embodied in the coal act as opposed to the unlimited, indeterminate, openended approach which is currently embodied in the drive act. And i will oppose that kind of extension if it is incorporated in any sort of continuing resolution or shortterm fix. I believe that approach is simply an invitation to disaster. And i know that you have walked a fine line in your testimony today in a very understandable effort to be accommodating to the different views that are on this committee, but id like a commitment from you that you will vigorously enforce whatever ptc extension is adopted, if one is adopted by this committee and congress. Absolutely. We intend to vigorously enforce the deadline that is in front of us now and should be moved we will vigorously enforce valid. And i take it you would favor the limited and year by year, casebycase approach involving to go after thats bandied ministrations policy, is it not . Welcome the coal act, our purpose was to ask for flexibility for railroads that have made progress and when we are trying to prioritize ptc implementation in certain places. Certainly we are supportive of getting ptc and women as safe and as sufficient as humanly possible. I want to focus in the short time i have remaining on the need for greater oversight on the hartford line. I want to thank you and secretary fox for hosting the meeting including myself and the connecticut delegation and our governor. Id like you to commit as you did in a meeting that you will ensure that amtrak manages this project more ably and officially. You have my commitment that we will remain very vigilant over the project. Its one of those important projects in the country. And as was said in a meeting we are lucky to have good partners in connecticut that are actually prioritizing this kind of work and so we remain very focused on. There is an opportunity and obligation for more collaboration and cooperation here. The contention and disagreement that weve heard really are regrettable and ultimately will contribute to delay and cost overruns of this line, which are great . Yes, sir. Thank you very much. Thank you, thank you for the opportunity. Thank you, senator blumenthal. Senator campbell . Thank you. Weve talked many times about Railroad Issues as the northwest experiences more and more train traffic. Do you believe that Oil Volatility is an issue that needs to be addressed and that the dot working with dod should resolve this issue by doing the amount of testing required to say what pressure should be hundreds of state was i sort of think that it would be helpful to determine what role volatility place because you know the department of energy has partnered with our Sister Agency come with us to do a study of ppaca and crude which i think is what youre referring to to determine the volatility baca and so does it matter and how much which will guide a lot of our thinking and deal. I know that its astounding to me that neither fra nor penza thinks have the ability to regulate this vapor pressure, which we do in other areas this summer is waiting for a catastrophic accident and then say we should regulate this, but are you concerned that these vapor pressure readings as much as 18. 5 pounds per square inch, when in reality a lot of people have concerns about 10. Were not releasing north dakotas saying lets set the stand up 13. 5, or 1 13point soe of which i the concerned about, but they were funny theyre not even beating victim that is a revelation or oversight, whether the train traffic is actually meeting that standard the effects of people are finding much higher vapor pressures which i think volatility comes into play. Its hard for me to comment on what their authority is. Our authority is clearly the people that the product is called in when its on rails. I have been a loud proponent of asking the Energy Industry to play a role in assisting up with the safety of transporting crude oil across the country. I think its important for the Rail Industry to be accountable but i have been very vocal about my interest in having the Energy Industry have some skin in the game as well. The Energy Industry . Meaning meaning that shipper. Do you think the federal government needs to resolve the station wagon, whoever has the authority. I dont think the general public cares like what were all doing better as of late to this agency and then this doctrine and his regulation or it is volatile to pull. People want to know whether volatility is going to be addressed or not. You think the administration should address volatility . Is the studies that are being done by the department of energy just when you to address volatility for his place in the transport, we should do that, we should actually do that. Thank you. Thank you very much. Thank you, senator cantwell. I just want to point out for the record that grow act had an openended extension. There wasnt any deadline in the grow act. To drive act which passed the senate a few weeks ago has a threeyear deadline through 2018 for installation and then, of course, certification is dependent upon working with the dot. In addition to drive act also include a number of other safety related measures, including requiring inward facing cameras on all Passenger Rail roads, required speed limit action plans to address automatic train control modifications, of the Speed Enforcement issues, improving the safety o of the rl transport abbasids pictures with realtime information for First Responders and comprehensive oil spill responsive place. And it included a number of other safety issues such as sign of artist and track inspection. The drive act does have a number of safety provisions in their in addition to the ptc extensions. So, finsa thank you for adhering today, and we will keep the hearing record open ms. Feinberg, thank you for adhering today. We will keep the record open for two weeks. You would be asked to request is but the written answer to the can as quickly as possible. And as you can tell today a lot of focus on ptc. With a big problem. Youre coming in at a very important and critical time to try and help solve what most of us i think recognizes going to be a major crisis if we dont do some fairly quick action here. Your role is going to be important in the administration who is going to be important in trying to build the necessary Bipartisan Coalition that will take to pass legislation that gets us to where we need to go. So thank you for your time today and for your willingness to serve. And we will, in fact, adjourned the hearing. [inaudible conversations] while the house is out until thursday, the Senate Returns today to begin debate on the legislation that would ban abortions after five months. Live coverage together to been featured on cspan2. Senator Bernie Sanders was in New Hampshire over the weekend. Is one of the democratic president ial candidates. Among his stops was a town hall meeting in seabrook. We will have coverage from a town hall meeting tonight at 8 p. M. Eastern on cspan. The popes visit to the u. S. Cspan has live coverage from washington, d. C. , the first stop on the popes tour tuesday afternoon beginning at 3 45 p. M. On cspan where live with the president and mrs. Obama to greet the pontiff on his arrival. The act commissioner of the fda, dr. Stephen ostroff, testified on food safety before senate committee. He talked about the budget and appropriations process and how proper funding is crucial to food safety. Good afternoon. Witnesses this hearing will come to order. Todays hearing will focus on the fdas evident to maintain safety of our food supply, and i thank you, commissioner as ostroff, for your present here today. Were dr. Ostrove, i appreciate the warm working relationship we are develop and i appreciate the conversations and dialogue we have had on a number of fda issues over the last several months. So thank you personally and professionally for the way youre treating me as the new chairman of the subcommittee. You note in your testimony, commissioner, that nearly one in six americans fall victims to foodborn illness each year. Americans expect the food they purchase at a Grocery Store or restaurant will be safe next fda is largely tasked with maintaining that confidence. Passage of the food safety mood concernization actino 2010 gave your agency significant new responsibilities in implementing a very sweeping set of changes the food safety laws, probably the largest change in the last 70 years. Our hearing today is timely, as it follows last weeks publishing of the first two final rules for preventive controls on human and animal foods. In delivering these new regulatory responsibilities your privity private sector partners expect tran sharonry from the fda and when i speak to Agricultural Producers in hi home state their main concern is a government that stifles info vacation through burdensome regulations oomph pleased the agency took many of the suggestions and comments from the agriculture commune into account community into account by reapouringing the rules because they were unworkable for farmers and i thank you for that. Modernizing the fdas regulatory controls and educating industry and consumers are at the hart of the implementation and starts the compliance place. I also recognize that successful implementation this is the part you want me to say, mr. Commissioner i also recognize that successful implementation does not come without a cost. And this subcommittee remains committed to investing in implement addition within the resources at our disposal and has done so since the enactment in 2011. The spending in the last five years has increased 8 , something that cant be said for many other federal agencies. But we know that you face additional challenges and tasks and were interested in exploring how we can be more helpful, and as the continuing process, as the process continues for progresses this year, funding will undoubtably play a significant role in our deliberations and establishing priorities. We have a lot to cover tis afternoon and i turn now to my colleague, snore mark lee, for markley for comments. Thank you for holding this tearing, and thank you for attending. Safety of our food supply is something that most americans take for granted. For most part they dont have to give a Second Thought to whether or not they food theyre picking up for their family will make their family sick. America has and continues to have the safest food supply in the world. But that doesnt mean its perfect, as anyone who has ever had a food borne illness will testify to and we need to work to stay ahead of a changing global marketplace. We dont think anything about eat strawberries or melons out of season because we have access to food around the global. To say ahead of this, there are multiple agencies involved, including the fda; outside of the federal government state agencies, private businesses and farmers are working continually to make sure the processes and procedures in place will make sure that a domesticken onion is always face to eat. The food safety modernization act was the laws change the way we look at the issue of food safety. Prior to fsma an outbreak would tapes and we would suspend time tracking it down. Now we are working to make sure that we prevent that outbreak from occurring in the first place. And giving fda the tools and teeth it needs to do that. Its a better way to do business. The law had about 50 specific deliverables no small task for any agency. Owl though it took longer than many would like, fda published two of the major rules last week and the rest will be ute by next spring. Were at the point where the rubber meets the road and will require a new way of thinking for food inspectors. Its not always smooth sailing and i know the faction as fda learned a lot about production agriculture and Food Processing along the way. I think most people would agree you have done a good job working with industry to make sure that these new rules are effective while minimizing the disruption. So, again, thank you, mr. Chairman, for holding this hearing. Its timely and im very interested to hear from our witnesses. Dr. Ostrove, welcome, and you may commence your testimony. Ive extended the amount of time to ten. I share your thump for enthusiasm for the very warm working relationship we have developed the last several months, and and we look forward to continuing to work with you, not only on food safety issues but other issues that fda deals with. So im steve ostroff, the acting commissioner of food and drug, and i really very deeply appreciate the opportunity for mike taylor, who is sitting to my left, and me to be here to talk about the food safety modern nationation act, fsma. Id also like to thank you for holding this hearing and for the Committee Members in their ongoing interest in this particular topic, and for the strong and growing working relationship that has developed between the committee and fda, to achieve our mutual goals of assuring the safest food supply in the world for american consumers. I hope that everybody in this room knows this is food safety month. And i cant think of a better way to celebrate than by starting the process of bringing important new rules online as we did last week, and by discussing with you today the critical next step that muss must we taken to realize the goals of the act. So although ive only been working at fda for two years, actually began my Public Health career consider blow blue before that. 30 considerably before that when i was working at the cdc. At that time the newry recognized and dead he pathogen e. Coli. While working in washington state, over a two year period i personally interviewed every person or member of their family in the tate diagnosed with that infection, and visited a number of them in their homes. I subsequently did the same with people with other illnesses from foodborn pathogens, so i can say without question i have a very deep appropriation for the suffering and consequences of foodborne illness and have carried that perspective throughout my career at a public. He peninsulaer and as a physician. In fact, food safety was the reason i joined fda in 2013, at the urging of the person sitting to my left. Despite today having much improved Technical Methods to detect and investigate foodborn illness from when i start mid career 30 years ago, along with notable discusses in reducing the incidence of sergeant pathogens, there simply remains too much foodborne illness. As you mentioned, nearly one in six americans fall victim to foodborn illness each year. That is 48 million people. Of these, 128,000 are hospitalized and 3,000 die. This burden of foodborne illness is shared by each and every one of us. Consumers and Food Producers alike. The economic costs are also quite sizable. Since we know that the illnesses, hospitalizations and deaths can be prevented, we must always, quite frankly, acknowledge that it is simply time to start preventing them. So, over here on this side, cdcs food net tata has shown for many years now the remains essentially unchanged. As you can see, the illness burden from some pathogens goes up, while for others it goes down. Look foster over here on the other side of the room, in total, the line remains distressingly flat. So i say to you that its time to make that line start bending in the right direction. We believe that we now have the tool to be able to do that, and that tool is called the food safety modernization act. During my time at fda i have been thrilled to be able to participate in the process of modernizing our food Safety System. This agency has stepped up to solve problems by identifying the best science and riskbased solutions that can benefit both consumers and industry. That is what we do at fda, when were confronted by such problems. I know that mike and his team have imbedded this concept in their work to modernize the nations food Safety System to meet the challenges of a new global era. Enactment of fsma was unquestionably the product of foresight and the recognize of commons and. Members of congress on both sides of the aisle came together with consumers and with Food Industry leaders to enhance the protection of food supply in a modern, diverse world of freeflowing commerce. Fsma stands for the proposition that we that the standard across the food system should be to have processes in place that we have learned work to prevent food safety problems. Problems that many food safety producers practices that many food safety producers implementing. This means having prevention orient standards in place that are equally applied to domestic and foreign producers, reasonable verification of complains with those standards, and accountability for those who are unable or unwilling to comply. Fsma directs fda to build a modern food Safety System based on the central ideas. Fda has fully embraced a dynamic collaborative approach to implementing the act and is working hard to build new partnerships and strengthen existing ones. This effort includes the Food Distribution from farmers and manufacturers to transporters and imports, whose capacity and responsibility under the act for producing safe food this foundation of then new system. Also includes fdas Food Safety Partners and other Government Agencies at the federal, state, tribal, and local levels, and also includes foreign governments, which can play an Important Role to help assure the foreign supplies 0 the u. S. Marketing being produced in safe fashion. It includes consumers and Patient Advocates who have been victims of foodborne illness because, after all, ultimately, theyre the ones that we are doing this for. The two final preventive control rules we issue another last week are critical linchpins for building our new food Safety System. They focus on implementing modern Food Manufacturing processes for both human and animal foods, thus ensuring that foot companies are taking Food Companies are taking a 24 7, 365 day a year work approach in working with the fda to prevent problems on the front end rather than waiting until a problem is recognized to identify people with foodborn illness as you know happened in your state of kansas this year. These rules are important in their own right, but they are only the first in a number of steps for building a comprehensive food Safety System. Three more rules will be finalized by the end of this year, those neglect produce rule, foreign supplying verification process, and a credited thirdparty certification, then the file didnt final rules will be issued in spring, sanitary transport. These form the integrated network for food safety called for by the act, all based on the principle of prevention. Writing the rules is clearly a big step but only the first step. Right now they exist on paper. The bigger challenge ahead is implementing those rules and making them exist on the ground. We strongly believe that if we do not implement the new act implemented food Safety System in the acongress envisioned right from the start, we well fail to achieve the acts goals of food safety, strengthen Consumer Confidence and a level Playing Field for u. S. Producers. The line mentioned earlier will not bend as it should and it must go. So im very proud of this work, and i am proud of our team. Mike taylor alone has been a force of nature when it comes to fsma. So please continue to work with us to achieve level of funding we need to accomplish on the groaned what is set in statute and rule. American consumers are depending on us, and they expect this of us. So i will just end by thanking you again for your support of fda and for the opportunity to be here to discuss fsma with you. Commissioner, thank you very much. Let me begin just by asking you outlineslines the scenario y which the rules will be announced. What was the basis for the prioritization, it there something about the rules that make their moment difficult, easier, more significant to pursuit . What do we expect in the future . Well, i will just say that theyre all important. The preventive control rules are probably amongst the most important of all of these rules and theyre the one that are expected to be implemented first, and so these have the priority to be issued, and the other ones will come shortly after that. And the process you have been through, we will it will be the same process for the next promulgation . Well, mike can answer that. The essential answer is, yes. These the deadlines for these are set by the court order. Were obligated to meet all of them and we will meet all of them, i can assure you. Just add exthese rules from a holistic pact of standards that congressman debted to frame the system, and have been through a dialogue with stakeholders that addressed all of the rules because they have to fit together. So we have to have a coherent package of regulation. So were at the end of the process for all seven rules in terms of having gone through the notice and comment, public meetings, dialogues, and so now we are able to actually issue the rules in final, and so the sequencing has something to do with capacity to get rules out the door and give a little breathing room between rules. So were on track to get the rules out on the timeline, and and just as the commissioner indicated. Thank you very much, mr. Taylor. So, mr. Chairman, i if my might. Make a couple of comments about the Implementation Plan to put this in context. Well, again, this is a large topic im sure your questions will draw it out in detail, but we are embarking on implementation deeply cognizant of the challenges, the hundreds of thousands of facilities, complexity of the supply chain, but we know that we can meet this challenge bus we have the alignment of stakeholders health done the homework, had the dialogue. I think the thing i would just provide is the suggestion that some of the themes that we are pursuing undergirding the implex addition we think are crucial to success just crucial we stick with this. First is the commitment to provide clarity throughout guidance about the new rules. What they require and be supporting industry in achieving what is expected through education, through technical assistance, and if we said on any number of occasions we will educate before and while we regulate, and we mean that. Thats the first theme, clarity and support for compliance. The second thing we need to do is, as you have indicated, is fundamentally revamp how we conduct inspections and oversight and compliance activities so we are targeting our efforts based on recollection and fostering voluntary compliance through oversight. It has been enforcement and reactionoreend. Now needs to be prevention oriented and supporting compliance. I always need to add the caveat. I with encounter positions where consumers are affected, but the goal has to be compliance and food safety, not just enforcement as an end in itself. The third theme ill emphasize is strengthening and expanding our partnerships with the state,ing a call health depths. We have mandate from congress to establish a nationally integrated food Safety System and the fundamentally understand that fda cannot possibly implement the law successfully by itself it it has to work with state and local partners. And finally, i just emfew says this crucial the commitment that i think we all need to have to this integrated comprehensive implementation. This doesnt work if we tease out parts or delay parts or dont integrate in heel his stick way. Import safe provisions are a crucial part of the system of prevention. This is how we will get a level Playing Field for u. S. Producers, well meet the expectations of consumers that the food imported into this country is as safe as food that is produced here. So, these are themes we hope to come back to and we want our feet held to the fire with presuspect to pursuing this, and if we do that we can daunting as i may seem with the hundredsd thousands of folks to bring into the system, we think can do it. Mr. Taylor, thank you. Commissioner, your charts, particularly this one, whats the explanation . Whats this cycle that occurs sneer you said there are ups and dops, we have had reductions and increases, both. There is a cause and effect you can describe to me, why that is with one particular pathogen . Its a good question. I think if you look over here, one of the other things i think is quite notable from this particular graph is that for many of these path ogenerals that many of the reductions, the reductions being the ones you see that are lower than one, occurred during the very early years of implement implementatie new food safety activities in the late 1990s, and if you follow that along into the 2000s, for men its been incredibly florida. Its important to recognize that food safety and foodborne illness is an incredibly dynamic area. We have new challenges, we have an incredibly diverse food supply. I would venture to say its much, much more diverse than what we had back in the 1990s, when we started keeping some of these statistics, increasingly the proportion that comes from overseas has grown. The sort of locally grown phenomenon has increased, and so there are a lot of things that are challenging the food Safety System and influencing the occurrence of affordborn disease but i think the bottom line is as the trends have changed over time we have been treading water. And its time that we no longer tread water; that we actually do things that we know will work to make these numbers look different as we go forward. You believe that will bend that curve. I believe the act will bend that curve. If you look at several of the major food safety problems we have experienced this year, including the most recent one that we have seen with the cucumbers that were imported from mexico. The various provisions in the act are specifically designed to address the challenges that we have seen in all of those outbreaks. So we should be able to influence not only the outbreaks that are occurring but more importantly, i think, the day in and day out sporadic foodborne illness which forms the bulk of this particular data. I do also think its important to say that while we certainly believe that all of the activities encompassed under fsma will work to drive these numbers down, it doesnt absolve consumers of doing the right thing once the food gets into their kitchens because a lot can happen even if the food is safe, and so it is a comprehensive approach that must be taken to assure that foodborne illness doesnt occur. Let me turn now to senator merkley. Thank you, mr. Charm. Doctor, in your testimony you note that fda strategy its taking and, quote, educate before and while you regulate, unquote, approach, and note that youre currently working on guidance documents. This is very important considering the first two final rules are about 1500 pages of substantial amount. And these guidance documents will be critical for businesses to understand and comply with the new law and need to be timely. So folks in oregon are asking when these documents will become available and just give you a chance to answer the questions. To best answer the question, im going to turn to the person who is actually writing them. I have a large team back home writing them as we speak. Guidance is absolutely essential to implementing the rules and were investing a lot of resources in that now, even as we have been preparing the rules themselves. One thing i note in the 1500 or so pages, this is eight and a half by 11 double spails but the vast majority of the pages are preamble, are themselves guidance and explanation of what the rules mean, how we expect them to be applied. So thats the first place folks should go to really get an understanding what the codified rule language is intended to mean in practice. That is just the first step in guidance. So as you know we are developing several a number of guidance documents, some of which are the key foundational ones so there will be a comprehensive guidance on the animal the human preventive controls rule that will be almost kind of an operators manual for those who are not yet implementing modern preventive controls like many in the industry already are, for those who arent there yet this is going to be a very helpful operating guide essentially for implementing the rules. But we do a similar guidance for animal food and similar for both the animal food preventive control just cut to the chase and say im glad its going to have this when will folks the major guidance us will be coming out early to next year, well ahead of folks obligation to comply, and witness be an jung process of dialogue but our best thinking will be out there in a timely way for a implex addition. Gary. I heard from con state opportunities and their concerns that foreign businesses may not be as closely monitored as u. S. Businesses, and consequently, there might be greatest risks from foreign products and could put u. S. Businesses at an economic your statement that fda cant credibly hold domestic producers to the new standard if wore not a degree the same for imports. And i know youre aware have to these concerns. This may get further discussed when the foreign supplier Verification Rule is finalized next month, but to the keying you can tell us now, how will the fda adequately ensure the safety of for Food Products and will the oversight be as rigorous as the overfight for u. S. Businesses. Im going to allow mike to give you some of the details but all can say is one of the fundamental tenets of fsma is that we assure that the safety of foreign sourced food is equivalent to dome domestically produced foot. I think we have that obligation to create that equity. We know that to certain degrees our tools available to us to be able to deal with imported food has been limited, but it this rule, this law will not successfully work unless we can assure total equity between food that is produced overseas with food that is produced domestically, and one of the critical elements of that is that the importers bringing the food into the United States assure that the procedures that were in place to produce that food are equivalent the procedures in place for food that is produced domestically. Let me let mike congress did provide a multifaceted tool kilt for strength king import oversight and the commissioner referred to the foundational part of that which is this foreign supplier verification and requirement so that imports will now have a food safety responsibility, be accountable to us for knowing their source of supply and verifying that those foreign suppliers are producing under our standards. Thats a paradigm shift if we can implement it well. Its combined in the design of congress with much nor overseas presence by far. More partnership with foreign governments, more investment in foreign food safety capacity where that will contribute to food safety here. We think this tool kit, if implemented properly, will work to provide the equal rigor. The question is can we make the investments needed to carry this out as intended. Mr. Taylor, you mentioned the Foreign Inspections. And fsma mandated 600 inspections in 2011 with a doubling of the previous years inspection level for the subsequent five years, which would mean that in fy2015 we would have 19,000 Foreign Inspections, and in fact, i believe that the Department Plans to only conduct 1200. So, 19,000 in fsma versus 1200. This lack of Foreign Inspections is adding to the concern that really different standards are going to be, if you will, practiced in Foreign Countries because theres not enough inspections to hold them accountable. Your thoughts on that. You but your finger on a huge challenge how much do we target our resources with the resources we get to do this implement this law effectively food safety. We have increased our Foreign Inspections from less than 300 before inabilitiment to in the 1200 to 1400 range currently and those are very important, but they are part of the larger system, and so the inspections are not inherently preventive in the sense that the Foreign Supplier Verification Program requirement is. So in terms of priorities for implementing the import system, we have to get 88,000 importers up to speed in terms of doing their prevention oriented verification. So thats a priority for funding. Wed like to do more Foreign Inspections but a think we can leverage inspection activity of foreign governments threw mechanisms like a systems recognition tool we developed where, for countries who have advanced food Safety Systems, we want to recognize that and be able to rely and engage in a mutual reliance relationship so we can rely on their inspections and not duplicate theyre effort. So there are multiple elements of this. One major investment, increased funding from congress, is to to strengthen our foreign offices overseas which are going to play a vital role in us build legalizationships with foreign governments, outreach to foreign industry, all those things where we can leverage our limited resources to maximize prevention activity overseases so, we would love to continue dialogue how inincrease inspection numbers. You mentioned one thing i do have to emphasize, though, is that part of the request that we made in fy 16 for the full amount of funding which was 109 million, was to be able to assure we can carry out the requirements are especially for foreign produces. We will be challenged of being able to implement the various rules that will be coming out over the coming months in the way that we envision they need to be rolled out. I think one of those areas that that the funding is immigrant impacting is filling the foreign offices. The vacancy rate is 40 of foreign offices are vacant. Is that primarily a funding issue or a prioritization issue . I will say that it is expensive for us to be able to place people overseas. However, actually placing people fulltime in these offices is only one of the strategies that we have been using to carry out those responsibilities. So we do cycle in people for shortterm assignments to be able to assure that we can carry out the things we need to do in those locations. Thank you. Senator from california, senator feinstein. Thank you very much, mr. Chairman. I really appreciate the opportunity to talk with you, commissioner, for a few moments. Ive long been interested in this actually before my colleagues came on and had tried to be helpful in getting more ag inspectors at our border, but that is a long time ago. California, as you know, is a huge the number one Agricultural Production state. What can you give me any percent or any measurement of salmonella in california produced produce . That probably is not a number that i would have off the top of my head. Given my extensive time at the cdc im familiar with the systems that they use to collect the data, including the data that went into the food net report in which california is one of the participants in that system, and so there are data that are broken out by state for the various food net sites in terms of the incidents of some of the pathogens you see on these list us. I cannot tell you whether or not it is done on a commodity specific basis. Okay. Now, the latest salmonella for us is the cucumbers imported from mexico, and i gather thats 418 illnesses across 30 states. And we have seen the most illnesses of any state. 89 illnesses, 17 hospitalizations, and one death. Im concerned that year after year, the centers for Disease Control reports that United States has not made progress in reducing the number of foodborne salmonella infections that occur. I was listening and also reading your comments how these new food safety regulations, fsma, that youre finalizing will prevent outbreaks from this from happening with specifics. Take the cucumber as an example. How will you work it . Both at the border in a foreign country, with the business or the farm operation in mexico that producing these crops . Well, ill preface my statement by saying that particular outbreak is still under investigation, and so we dont know all of the specific details that may have led to it happening. But having said that, i think that if you think of two of the major outbreaks that we have experienced this year, one of them being the salmonella associated with the cucumbers and a few months earlier a parasitic pathogen that was associated with cilantro that also was imported from mexico. There are some themes about the quality and implementation of measures to prevent problems from occurring in the first place, and that is at the heart of what it is that we are trying to accomplish under the produce rule, and so that produce rule establishes a number of standards that producers overseas that are and producers domestically can you give us an example of the standards . Some of them are the water that is being used to irrigate the crops. One of them has to do with the access of animals to various locations. Theres another aspect that deals with the hygiene of the workers that are working on these particular farms. And so its a whole variety of requirements that will be in place under the produce rule that any producer who is importing food into the United States will be expected to meet. If i just may add, the different fsma will make we have known for years what the practices are and fda provided volunteer tear guidance but no enforceable standards, whether for domestic or foreign producers, and thus no accountability for doing the right thing. So what fsma does is create enforceable standards and verification the standards are being met. Its a profound difference from where we have been before where it was incumbent on fda to find and reaction to the problem in absence of clear standards for prevention. Its a gamechanger. That example will make a huge practical difference. I gather produce is about 48 of salmonella and thats under your jurisdiction, and the rest of it meat, chicken, pork,s is under usda, if i understand that correctly. Do you coordinate in standards between the two of you or are the standards different . One of the critical requirements of being successful with fsma is to be able to work closely with a whole a variety of matters, not only partners at the federal level but down at the state and local level where a lot of the day in and day out work with farmers occur. And so,ey, it is very important that we work quite closely with usda to ensure the success of what we do. With produce, for example, ive had i know how serious it can be, and it was from eating not thoroughly cooked chicken, and so i asked my staff to look into. This is not your jurisdiction, but its interesting to me that 40 of the ground chicken in markets have september nell la, and salmonella, and i talked to a large chicken groner my state and said what about this . He said Everybody Knows you have to cook chick chicken to 165degree until you eat it. I said i didnt know. And i dont think Everybody Knows. So, it raises the question of how these two agencies interact. I really think you have a good thing going in what i read on fsma, and i like very much how youre going about it. I worry very much about particularly chicken because chicken has become such a high item for people in terms of eating, and it doesnt seem that toe me that we make much progress year after year, but with respect to this, you mentioned cilantro, cucumber, ice cream, tuna, carmel apples and these five outbreaks align are almost a thousand cases of illness and 12 deaths. Do you think theres any that usda can learn from fsma you think is relevant . Again, we work very closely with usda without question. Far be it for me to provide advice to them related to things that we ourselves dont regulate. All i can say is that they, too are working quite arduously in putting in place additional strategies to be able to address those products that are under their jurisdiction, and there are a lot of similarities to things that we are doing in this ma to things that usda is doing. Because, again, from the consumers perspective, if they end up with salmonella and theyre not much interested in what to the source is, what we do to keep it from happening. Right. Right. We have two big agencies that one handles the Meat Products and one handle the Fresh Produce products, and ive o. Wondered is that the best way to do it . I think youre taking action, and im very pleased to see that. Im also concerned about antibiotics in products, and what has been happening in that human stream of consuming products that have antibiotics. Could you talk about that and what your agency is doing . Sure. As you know, this is also a very important aspect of food safety, and we have had a multiagency activity in place that monitors not only the occurrence of very pathogens in a variety of Food Products, particularly meat that is salted at the retail level, but also monitors the patterns of antimicrobial resistance. We look at isolates that are come from products we regulate, usda looks at ice lats that come from isolates that comes from products they regulate and cdc also incorporates information from human isolates of the same pathogens so we can compare the patterns and look at the pattern overtime. As you know we also have been working quite hard to be able to address the issue of antimicrobeat resistance from foodborne pathogens. Thats a whole other large component of our activities. Especially by reducing the use of medically important antibiotics used in food, producing animals, particularly when used for growing promotion purposes. So, we have put out a number of guidances and rules specifically designed to address reductions in the use of antibiotics for those purposes. This has been a multi,year process to put those rules in place. We have done this on a voluntary basis to have all of the marketers of these antibiotics for use in food animals make labeling changes to remove growing promotion as an indication for the use of these antibiotics, and they have all voluntarily complied. The phasein period to make the changes in the labels is to start at the end of this year, and so we would look to see changes start to occur as a result of those practices. The other very important point of those requirements is to make sure that the use of those antibiotics for other purposes under the direction of a veterinarian. So both of them will be very helpful in terms of addressing the problem. Thank you very much, mr. Collisioner. Thank youmr. Chairman. Youre welcome. Just to educate myself in a more general way, let me raise a couple of topics as a result of the questions and testimony. One thing i wanted to ask about is the cause of death. You cite the cdc statistics, 128,000 hospitalized, 3,000 die related to foodborne illness. There is a breakdown of those deaths or hospitalizations related to consumer preparation versus the food was tainted prior to preparation . Do we know where the cause lies with the con versus the provider . Consumer versus the provide center. Its not a very ease request question to answer, especially when youre sometimes talking about a relatively long period between the time that the exposure may have occurred and when certainly the illness occurs and when the death occurs. Having said that, we deal with a whole a variety of different pathogens, some of which have deal with items supposed to be cooked, sometimes youre dealing with raw commodities like in the produce phase, and so ultimately in most instances, what you want to try to do i think what fsma is designed to do is keep it from being there in the first place, and if you can successfully do that in many of these commodity areas, then you will successfully be able to have an impact in reducing these problems from occurring. So theres a reduction that can occur in the likelihood of the problem that reduces the importance of consumer preparation of the food item. Let me just say, without question, you never want to send any suggestion that consumers can become lax in the way they handle their food, because i dont think that we would want to ever send such a message. I think what we do want to do is to be able to enhance Consumer Confidence that the food that comes into their kitchens does not contain pathogens very artful. I will reask my which would be there is know way, is there, that consumer preparation is not important, regardless of what arrives in the consumers home. You said it perfectly. Thank you. You indicate well, first i want to follow up on the point about imported food versus domestic food and he was asking for equity, and indication that you had indicated in your testimony that there is an importance to making sure theres not a economic disadvantage to domestic producers, not a double standard, i think is the way we would say it in kansas. Does that double standard exist today . Is there a difference in the nature and the likelihood of foodborne illness from imported food versus domestic food . Since ive been answering most of the questions ill turning that one over to my colleague. I think current law, under fsma, the standards are the same. Congress made it very clear that the name standards for to be applied, the same safety to awhiffed whether foreign and difference. The different challenge is the ability to verify the standards are being met and have different challenge with import versus domestic. We he can legally go into facilities and hole firms accountable. A sit of relationships with states who goo into the facilities. Theres no amount of foreign inspection that congress will ever pay for us to do that would provide a comparable level of oversight through inspection overseas and thats why we have this multifaceted tool kit of foreign supply vacation, more foreign inspection, but very much collaborating with foreign governments. The difference not so much the standard. The question is how do you verify, and the imports provide a different verification challenge than domestic. Mr. Taylor, under fsma, the able tone force the standards is going to in large part rely on the civics e certification of those who are importing food that their proceed u providers, the foreign suppliers, are in compliance. Thats the foundation their the system because the u. S. Based importer is legally, directly accountable to us. We can hold them accountable for doing the job properly. Then we can go over and again inspect foreign facilities. If we see a problem we can keep the food from coming in but the direct lead abilitiability for immigrant portlands in terms of private sector responsibility is on the u. S. Based imimporter so the rule is foundational. What does that mean, the importer most likely to do to sign the certification. What do they could to make certain that when they attest that standards are being met, they are actually being met. Under the regulation we proposed and youll see coming forward im not announcing the final content of the regulation but the elements of it are evident from the proposal we put out last year. The whole idea is that the again is this is just following the congressional mandate the elm porter must have a documented program where they have identified their suppliers, come to understand their suppliers capabilities for food secretary approved their suppliers, know the practices of supplier is undertaking and they look at records and they and under some circumstances, when justified by risk, because its intended to be a riskbased foreign supply verification program, we have a the importer doing an odd did of the foreign producer. So its having a real program that we can then audit and then obviously go behind that and sample products when its coming in, go behind that and actually inspect the foreign facility if we choose to but this. The word audit has a different meaning than the word inspect. So when the importer is auditing, that importer is not inspecting that would not be doing the same thing that an fda inspector would be doing . Its different. Inspection, we look at facility and conduct a physical exam of a physical place. The audit term were using applies to looking at auditing the program, checking the records, being able to get confidence from examining the records and talking the importer they know what theyre doing and doing the right thing. And so in that sense its a very records intensive audit activity. That will be at least major component of ensuring this is being done properly. Thank you. I have more questions, but maybe a way to accommodate your schedule is to turn now to you and if youre unable to stay for my final round i wouldnt be offended. Thank you very much, mr. Chairman. I want to draw attention the report that you have all displayed, the 2014 food safety Progress Report for folks who are knew nearly challenged you boil it down to happy faces, grim faces, and very unhappy faces, and the unhappiest of all is the face representing vibriol and on the other chart you provided you show what while every other disease has decreased, since the 1998 till now time period, theres one disease that has increased in indense and thats vibriol. What particularly should we know about the challenge this disease represents . It can be a significant disease that comes in a couple of different forms. There are several different pathogens encompassed under the label of vibroo and they are engine associated with seaFood Products. We have seen now i think its important to put in context that in terms of the overall numbers, the number of illnesses associated with vibrio is actually quite small, and certainly a very small fraction of what we see in the United States from either salmonella. Some of this is associated with actual spread of the vibroio in some instances it was largely confined to certain areas of the country, and because of movements that occur with emerging diseases it spread to other areas where traditionally has not been. But it is a trend that we have been seeing particularly along the east coast. I was reading an article recently about ponds where shrimp are farmed on land in asia, and where massive amounts of antibiotics are used to control the various diseases rampant in those ponds. Is that import of shrimp from these farms one of the in factors contributing to the vibrio expansion . I would have to get you specific information about whether or not that contributing, but by and large, to my knowledge, most of the vibriorelated illnesses are not associated with imported shrimp. Thank you. Back when we were working on the bill, a young man and his father came out from oregon to testify. The father was a police officer. The son, when eh was three, this name is jacob, he had experienced a lifethreatening case of salmonella from contaminated Peanut Butter, and he was one of among more than 700 who were sickened by contaminated peanut products in 2009. I believe the Company Involved in that was a Peanut Corporation of america. If we look back on that particular were publicized incident, how will the preventive controls rule that we have just passed have made a potential significant difference in the risk of that disease . So that is an unusual case in many respects. In part because of the vast scale of the damage it did and the thousands of products that had to be recalled because the firm was selling not only Peanut Butter in bulk but peanut ingredients. It was catastrophic event for the food system. It also involved intentional conduct by the owner and operator of the facility, and the were publicized subsequent criminal prosecution and conviction. What fsma will do, even in that situation, is provide a much stronger basis for inspectors when they go into facilities to not be reliant just on looking around at the facility conditions and, pre fsma with no access to record of the facility. Under fsma we have a stronger ability to go into fate facilities facilities and make assessments and find records that might document positive analytical results such as occurred in this case that would reveal a problem that needs to be addressed. So, theres always going to be that rare instance where purposeful criminal behavior happens and there needs to be swift remedies for that, but i think even in these cases, we would be able to be more effective in our investigatory role in assessing systems systed whether this practice is going nonfacilities and needs to be addressed forcefully and gives us new rules for addressing the situation. If we identified this sort of problem through inspection, we can actually suspend the registration of that facility and shut the facility down and thats an important tool. There were exceptional circumstances, leaky roof, mold, animal con contamination, egregious behavior and known problems. In terms of the inspections you mentioned, and the ability to kind of have teeth, that matters. Theres another element of preventive controls rule, i believe its that involves developing a tracking system for ingredients that go into processed foods. Can you comment on whether you believe that is going to make a difference . So, fda has historically since the act in 2001 was enacted had authority to require firms to hold to keep records of where their incoming materials came from where and where their finished products have gone, one up, one down, record keeping. Fsma adds somewhat to our authority in this area by giving us the authority to set standards for how that firm connects the dots between the incoming and the outgoing. So that will be a step, and thats a rulemaking that is underway to put that in place. Fsma puts constraints on fda in terms of traceability because precludes us from require a foreign to table pedigree or the tasing done by ups and fedex. Were precluded from requiring that sort of use of technology to improve traceability, so from our standpoint, traceability is crucial. How we can investigate outbreaks, get to the cause of problems and solve them, but traceability has to come through publicprivate collaboration, harnessing Industry Innovation with the support of us and dialogue so we can be sure whatever they do helps our investigators as well as the firms themselves. But the work to be done yet in that area. Thank you very much, mr. Taylor. Dr. Ostroff, thank you. I will not take advantage of senator merkleys absence. I ask nance consent as soon as he leaves to one thing read in your testimony u testimony i wanted to high light and ask you to confirm to me how serious you are and how confident i can be it will remain the policy, and that is you indicate the approach continue specifics is aimed first at foster and facilitating complains rather than finding finding and penalig regulatory compliance. That is a poll state every regulatory federal agency should adopt. Would regulate industry. When i say regulated, we named from the farm to the transport into peoples homes, that we work collaboratively to encourage them and to work with them to do it right. And we know that ultimately doing it right has tremendous impact. That is not to say because you always have come and im sure youre quite aware, theres a carrot and the stick. We know that they cared is quite an effective way to promote improvements in food safety, but that doesnt mean were not going to use the stick. If i could add why believe this will remain the policy overtime regardless of weapons the city in these chairs, partly we put it in writing. We have made this commitment to the interes industry to the pubd people support this your externally, but equally important for your purpose, the people at fda embrace this wholeheartedly. The people who are at the front line in her agency our Public Health people. Enforcement is the to invest in a culture given the statute we had and a framework for food safety which is basically been in enforcement oriented statute and program. But with fsma where no Public Health at the front line. Our frontline people of the. They would much rather be getting good food safety outcomes and doing Public Health than trying to rack up enforcement numbers. Thats just not the fundamental mentality of a cadre of people including the people coming into the agency. Its an exciting time for the manhole agency. I thin think the future is injuf the culture changed thats going on and were working in many ways to institutionalize that and embed that in the practices are the agency. I recognize when asked that question, it may sound as if you are trying to take care of business or farmers, but isnt the reality that we end up with a safer food supply system when this is the attitude . What we know and you know and talk to people in the food business its just obvious that Basque Country want to produce seafood at a personal level and itits their business interestd in our whole strategy is based upon that assumption. We need to work without aspect of you want to apply to support the complex, or fights happening. Those who are not complying, we will act swiftly adequate of action is a to protect consumers. Extreme cases invoke punitive remedies at a determent deterrent. Working with those whose interest is aligned with ours on food safety is how we look at this Public Health outcome spent if i can respond to that, in the world i come from in kansas, the rumor of food disease or animal borne diseases causes dramatic consequences to farmers, ranchers. Right. It doesnt take an actual case. Just the thought that something may be wrong. Im not opposed to strictly, strong enforcing penalties and putting bad actors out of business because they have a huge consequence certainly to the consumer and the safety of our food supply. But for the same businessmen and women, those same farmers and ranchers, they cant afford financially to have the rumor, the reality that theres something wrong with what they produce. At our strategic incidents are fully aligned. We know the ramifications from foodborne outbreaks that occur years ago still ripple through certain commodities. The other thing that i will say is that the approach that we will be taking under fsma is really a fundamentally significant change to the way that we approach food safety. It is really critical because the number of things that are encompassed in the funding request that we have made to congress is designed to ensure that up and down the system we can reorient the workforce to be able to implement the things that you would think in terms of being able to work collaboratively with industry being able to educate industry and being able to oversee and ensure that what they are doing is up to standards, takes resources. I dont know any other way to say it. We do know without question that unless we receive the total amount of the request that something is going to have to give him some aspect of what we are doing. You couldnt help yourself. And ill be happy to visit about the topic. Let me finish up a couple other items. When it comes to the state of kansas, the state of oregon, the state of california, one will the role before those states as a result of fsma and its implementation . What happens different if the Kansas Department of health and in private . The approaches that are being taken at the federal level, those same types of changes will also occur at the state level. The states and localities are really very critical partners in implementing fsma as it is designed to be implemented. They are our frontline eyes and ears. They carry a lot of the workload in not only working with their regulated industries at the state and local level, but particularly in certain areas, and the one that comes to my nose is the produce rule. That we will look very much towards working with the states to be able to provide the type of frontline support to all of the farmers within the states to be able to appropriately implement a new requirements. And so they are really critical to the success of this endeavor. Let me ask one question related to the animal feed rule and contract farmers. Doctor, you indicated, commissioner, you indicated to me in advance of the hearing that what i was going to hear from the folks out there in that world would be all requests to make sure the Congress Appropriates sufficient funds to implement fsma. And that you had worked your way through many of the challenges and have a lot of input from stakeholders as you described i appreciate that and it seems to me that is in large part the reality. One area that ive heard concerned about is the definition of what a far more farmer is. You are shaking your head estimate i dont need to describe the issue. Is there something afoot that ought to know about the direction that youre going . What i have heard, that there is concern from farmers who have no involvement in anything other than raising of livestock, the animal, that this will come, that fsma will affect their operations as well when all the processing and everything occurs down stream and, in fact, the feed most important is not grown or provided by didnt get it is provided by upstream buyers of contract, those they have contracted with. This is an issue, have i described adequately . You were once smiling, know you are frowning. Well, no, because the pacific way that they form is defined is really critical to certain parts of these rules, not only preventive controls but also to produce rule. So we abort quite closely with those that will be impacted by this rule to make sure we can get it is about as right as we possibly can. I will ask mike because i know hes been immersed in this particular issue for the last several years. I do know the issue very well. And the fact that theres presumably some folks have some concerns to shows that there is an exception to every rule, but a stakeholder support for the rules. But i think what youre talking about is a situation in which the our vertically integrated poultry operations were a purdue or a dyson will own the chickens. They were manufacturing and own the de facto provide the contracted growers who owned speak their growers only grow. The growers only grow. If they have a concert that they are affected by this, i havent heard that added unique event. The affected party is the operator of that feed mill that is not being managed on or buy a farm operation, but rather by this big vertically integrated poultry enterprise. Thats the deal is subject to the animal the preventive controls rule. The requirements very practical and our riskbased, its a dont address issues that dont need to be addressed in terms of assuring the safety of animal feed. Those females are subject to preventive until. Difficult to operator or any farmer, this is the common practice of poultry is growing for processing their own feed under form to enter feed mill for their animals, as part of farm operation and would not be subject to the preventive control rules. Id be happy to engage whoever has the concern and connect them with our veterinary medicine works or whatever the question is but thats basically the way the rule he asked and t should the question better than i ask you. Happy to talk to them if that would help. Let me talk just a moment about the appropriations process, and i indicated in my Opening Statement this will continue to be a priority certainly of mine and i think of the subcommittee. And you mentioned specifically the amount of money that the president s budget request and our ability to meet that point hasnt occurred, but we worked hard to put more money into fsma implementation as we prioritize within the dollars that we have within our jurisdiction. And if those dollar amounts change, we are interested in reviewing and reprioritizing based upon what the needs are of fda and others to try to make certain we make the right priority decisions. But let me ask a couple of things about how the money has been spent in the past. As i indicated in my Opening Statement the number i believe thats an 8 increase over the last five years for implementation of fsma at fda. Mr. Tootle, am i saying that correctly . [inaudible] of course, you do. [laughter] let me ask of that money has been spent in implementation, and how has, hows it been allocated . If the across food safety inspections foodborne disease surveillance, detection . How have you decided how to spend that money over the past five years . And i will consult with my expert. So the total amount since 2010 has been implemented, thats been allocated specifically for fsma i believe the number is approximate 162 million over that time period. It has been used in a whole variety of ways, but as you probably recognize, there has been a tremendous effort on our part to be able to appropriately lay the groundwork to get these rules to a place where those rules are both implementable and will work. And thats no mean task. As you know weve had a tremendous numbers of outreach activities to the various stakeholder groups. There have been somewhere in the range of 600 or so meetings that have occurred. Either public meetings, interactions with regulated industries, various trade associations. As you know weve walked facilities and farms from one coast to the other. There has been a significant effort to actually do all the writing that it takes to get these rules to the place where they were. As you know we issued a number of supplemental rules. And so that has heavily contributed to our lot of resources that weve used to get to the point where we can actually get to where we are now, which is to start implementing. In addition there are a number of programmatic and capacity investments that weve made that i think are very significant as well. Some of it includes Technical Staffing company increasing Technical Staffing at the agency as we can support the industry, our state borders and our own inspectors. Weve doubled the investment in the states to close to 50 million over the last few years. Weve been able with the results we got including these increases to meet the fsma mandate for highrisk inspections. Frequency mandate and exceed that, he did earlier than expected. We think thats been an important part of getting ourselves in a position to succeed under fsma. And in the import area has been very of investment. Weve significantly increased the numbers the number of inspections the we expanded the foreign offices. So theres been some significant programmatic investment and capacity for sales and estate to be able to implement fsma s. Part of an ongoing buildup so we can succeed when forward. Thank you, mr. Taylor. Mr. Tootle, its apparently one of the circumstances in which both are right. The desired outcome has been achieved. Food has increased by 8 , fsma by 4 . Fire, i think my final question, is there any opportunities, let me ask you to go to because it has to be. As you implement fsma, arthur opportunities for reprioritizing existing spending that thats been you so longer necessary because you are headed down a different path than the nature of the way fta operated in the past . So where do, are there any savings to occur as a result of the implementation of fsma . I think, my commission is looking at me so i will say something. [inaudible] im going to give, thats another i want to try to explain though, if you look at the overall funding of the foods program, about three quarters of it, pretty fsma goes into the field based activities that relate to food safety but doing it the old way. What were talking about is adding frankly implementing to that base so we can read about all that resource to doing food safety in the wake envisioned by fsma. So it is i want to give credit to thank were not just content to do all the old stuff and odds on the new thing. Thats the nature of my question. The answer is we are redeploying but it doesnt mean we can stop spending the money needed to support that workforce. We have to invest in it so they can work in a modern prevention oriented with a much more sophisticated regulatory framework. So yes, its redeployment as opposed to adding on resources on top of resources that are still deployed doing the old thing. Thats what i want to hear is that thank you, dr. Ostroff, wanted to answer know i will do the opportunity to say yesterday isnt a reality, is that the truth that we cannot as we do things differently, you redeploy assets, resources that were directed in the old way of doing business to the new way of doing business . So you know, this is not going to require fewer people to be successful. Its just going to require that most people do Something Different than they been doing them. But the people that we need to be successful for fsma will not, you know, were not going to have people go away. And in point of fact, that given that theres responsible is that we have under these rules, that we need every single one of those people to be successful in implementing this. So from the standpoint of what weve been doing with our field force and what weve been doing with our laboratories, those responsibilities dont disappear under fsma. Dr. Ostroff, thank you for testimony. Mr. Tootle come anything youd like to exert is included in the record before we close this hearing . I will just close by saying im the eternal optimist. You know, we, the request that we made for this fiscal year, for fsma application from my perspective this absolutely critical to its success. And, you know, jamaicas have its maximal impact, which we hope that it will have to change somebodys of grass that you see you on the right and the left, every component of that request is vitally important to the success of this endeavor. And so we will have some incredibly difficult choices to make if we cannot get that particular request. And so i recognize that you have been an Ardent Supporter of the success of fsma, and we certainly are totally appreciative of the efforts that youve made to this point. And we are very appreciative of the resources that did show up in the subcommittees in the fold appropriation for fsma implementation to all i can say is that there will be some significant shortfalls that will result with a particular number which will make it very challenging for us to be able to put in place right from the get go but we need to do to be successful in this endeavor. Doctor, thank you very much. Appreciate your testimony. Appreciate you being a. I appreciate the presence of my colleagues, and for members of the subcommittee to those who were hit overnight, any questions they liked his bid for the record should be turned into the subcommittee staff within one week, which is wednesday september 23, and we would appreciate having a response back from fta within four weeks subsequent to that point in ti time. And became thank you for testimony. Thank you for the way that youve answered questions today and presented testimony, and please express my gratitude to the folks at fda for the outreach that has occurred in the development of these orders of control. With that the committee stands adjourned. Thank you, senator. [inaudible conversations] [inaudible conversations] [inaudible conversations] while the house is out until thursday, the Senate Returns today to begin debate on legislation that would ban abortions after five months. Live coverage begins at 2 p. M. Eastern on cspan2. The popes visit to the u. S. Cspan has live coverage from washington, d. C. , the first stop on the popes tour tuesday afternoon begin at 3 45 p. M. On cspan we are live with the president and mrs. Obama to greet the pontiff on his arrival. Wednesday morning on cspan, cspan radio and cspan. Org the welcoming ceremony for the pope as the obamas officially welcomed into the white house. Live coverage at 8 45 a. M. Eastern. Later at for that mess and canonization at the basilica of the National Shrine of the Immaculate Conception thursday morning at 8 30 a. M. Cspans live coverage from capitol hill as pope francis pixies to become the first pontiff to address a joint meeting of congress. Friday morning live coverage from new york as the pope speaks to United Nations General Assembly on cspan3, cspan radio and cspan. Org. Later at 11 30 a. M. The pontiff called a multireligious service after 9 11 memorial and museum world trade center. Follow our coverage of the popes historic trip to the u. S. Live on tv or online at cspan. Org. F from unborn babies, the most recent video was released just a few days ago. In these videos the blatant disregard for human life wasl underscored by a cavalier attitude on full display by planned parenthood executives. They flippantly and callously discuss the selling of body partss from babies who never had a chance for life. Ark, ugl without ya doubt these videos show a dark, ugly side to our humanity. How people can so become so desensitized that they dont shk recoil in shock at these videos and what they depict is beyond me. All i can conclude is that people somehow have ignored the right to life at the potential for life at these babies represent. Under and the catchphrases like choice. These videos rightly shock the conscience of many in our country star and even support of planned parenthood to publicly denounce them as disturbing. And yes, they are but they are more than that. As our nation unites behind this very basic understand of our moral mandate to defend those who cannot defend themselves, will have unique opportunity to make an important stride to support an agenda that promotes life over death. Next week the senate will consider a piece of legislation called the pain capable unborn Child Protection act, legislation i have cosponsored along with five with 45 cosponsors in the senate that would prohibit nearly all abortions after pregnancy has reached five months nationwide. Malcolm many states including my state have a ban on abortions once the baby becomes viable outside the womb. A friend of mine who is a neonatologist has told me privately what anybody can find on the internet or anywhere else, which is roughly at about 20 weeks, the baby becomes viable outside of the womb. And so this legislation will prohibit abortions after that baby becomes viable, which is under this legislation five months. At five months and unborn childs fingerprints and taste buds are developing. And it is at this stage when many doctors and experts believe that an unborn child can experience pain. Banning nearly all abortions after five months at the point unborn children can feel pain should be an obvious, moral imperative for all of us. Now i understand the issue of abortion divides our country, and some believe that abortion should be available on demand at all points during a pregnancy. But weve taken an important step here in the Congress Just a few years ago when banning the barbaric practice of partialbirth abortion, the actual delivery of a child alive and then literally killing the child is part of an abortion once they are born alive. So regardless of whether you are prochoice or prolife, hopefully we can come together and draw a line, a very clear line at liability of that baby. And i would like to point out how vital this legislation is for those who like the to believe we are to be advancing a culture of life in this country. Very simply the pain capable unborn Child Protection act would save the lives of thousands of unborn children a year. And thats why this legislation has garnered support of groups Like National right to life and a susan b. Anthony list. This chamber is long overdue in taking a hard look at the practices depicted by planned parenthood in these videos come and examining our own conscious and our nations policies that affect the unborn. I think of support to point out that contrary to what some in our country would be laid, that United States has been one of those liberal and most permissive countries in the world with regard to abortion. Matteroffact, the commonsense consensus of most democracies, most civilized countries around the world is that abortions after five months are unequivocally wrong, and there are actually only seven, seven countries in the world that allow abortions after five months, after viability of the fetus. Sadly, the United States is one of those seven. And we should be proud of the fact that we are right there alongside of china, north korea, and vietnam. Virtually, almost all other civilized countries in the world, even if they allowed a lack of access to abortion from they have drawn an important line at viability, at five months. America can and must do better than this. Every life is a precious gift of god, and we must protect those who cannot protect themselves. And we had to live now to the floor o of the u. S. Senate about the gavel and starting today with a debate on the Abortion Pill this bill. No vote expected today. Senators are expected to take procedural vote one hour after convening tomorrow. And on thursday the senate joins house for joint meeting of congress to hear an address by hope france is the you can watch that live on cspan at 10 a. M. The chaplain let us pray. Sovereign god, teach us to live in and for your peace as our senators permit your peace to guard their hearts, may make decisions that honor you. Remind them that true