tv Key Capitol Hill Hearings CSPAN September 18, 2015 9:00pm-11:01pm EDT
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abortion. the question is, should a woman who chooses to end a pregnancy have the right to do so. and that's a fair argument. and as i've said before, i happen to think the answer to that question is yes. i happen to think that middle aged men, which make up most of the united states congress and most of state legislators ought to be humble about telling women what they can and can't do with their bodies. with you i get -- but i get it. this is a fair debate. nobody is pro-abortion. however, it is the law of the land, two things -- number one, subsequent to rowe versus wade in the 1970s, it is the law of the land if a woman wants to have an abortion, she has a legal right to get it. you can, if you disagree with that, work to change that law. i would suggest that there are better ways to work than shutting down the federal government and hurting the economy an the american people but you can work to try to change that law. bup secondly, the only point,
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under the hyde amendment, zero taxpayer lawers, this is a matter of law that go into the abortions. the v.a. program and medical health care, the government does work in the health care, and under the hyde amendment, zero taxpayer dollars go toward abortion. so this comes down to what do we think about the attempts -- the practical attempts to make it almost impossible for a clinic to get started that performs abortion. as long as it is legal and women want to exercise their legal rights, i think it is wrong to instead of trying to change the law, to try to do things like get rid of planned parenthood and the clinics that provide these things, that is the way to go about this. if you disagree with borgs, i respect that, even if i don't agree with it. but the fact of the matter is taxpayer dollars don't go to the
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performance of abortions. obama care, by the way, also had a an exemption for churches. the catholic church, for example, which and -- and other religious institutions that oppose abortions, there was a wor work-around, so it wouldn't go to birth control, let alone a borgs, that would get through a work around so they don't have to directly provide that birth control. >> representative heims, we've heard a lot about tax reform, something that you are interested in. how would you reform the current system? >> gosh, i hope it is not just the republicans we're hearing about tax reform. tax reform is a problem, it is urgent for everybody, right. in all sorts of different ways. the tax code is about assin efficient and -- as inefficient and uncompetitive as it can be. it is way too long and
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complicated. it incentivizes the wrong thing. our corporations have hundreds of billions of dollars trapped abroad because we have a high corporate tax rate so why not keep the money in islareland or elsewhere and the code is riddled with exceptions and credits that allow businesses with a high tax department to bring the high corporate rate down. so the answer in brief, in my opinion, is make the code a lot simpler. get rid of so much of the gunk, the credits, the deductions, and in favor of a lower rate. get rid of the credits and deductions. many of which, what we call the tax expenditures, the credits and deductions, most of those go to benefit the top third or so of the income distribution in this country. so the wealthier people are actually getting the benefit of that complexity.
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that is not -- there are exceptions to that. the earned income tax credit which helps lower income people. but you have a code benefiting people that don't need the benefit as much as others so we have to start with scratch. a lower rate and less complexity in the code and that will make americans happy and our businesses a lot more competitive abroad. >> colleen from florida, texts into you, what happened to the irs scandal. it seems wrongs are brought forward and revealed and that is it and we never hear a resolution. >> gosh, i don't think there has been no resolution. the irs has been pretty badly beaten up over the last couple of years over what i think was some pretty irresponsible behavior in one of the units with respect to making judgments about which political groups they scrutin ize more than others. and in fact, just in the last couple of weeks irs people have been in front of congressional panels testifying. i saw the chief of the irs just yesterday in the capitol.
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the other thing that is important in the irs is that they are getting squeezed, badly. so people are angry at the irs and cut their budget. this is like the other thing we were talking about earlier, a little counter productive. you may not like the irs or taxes and most americans are in that camp but at the end of the day we need the revenue for armed sources, for social security and if you are angry at the irs and you don't have to know that that will result in less revenue collection and more fraud and less of an ability for that agency to be as good as it should be. >> brian is in waldorf, maryland, independent line. hi brian. >> good morning, gentlemen. i think it is rich to listen to everybody on the tv be shocked that mrs. yellen didn't raise interest rates. any intelligent person with a
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mortgage would recognize if you have a zero percent mortgage, why would you want to raise your rate. what makes you think this will raise the amount of interest on the debt she has to pay. and secondly, obama would never allow the interest rate to be increased on the people. he wouldn't allow the banks to make more money on charging people more interest. the interest rate will not go up at least at minimum, until after january 20th of 2017. there is no way that will ever take place. now, sir, i heard you say something that you wanted to have more of the so-called refugees, as you used the word, come into this country. now i take it you have no military knowledge as all. why would you want to allow an enemy, which we are at war with, come in free, without even a gun in their hand, to invade our country, to unleash 20,000 enemy troops into our country. why would you want to unleash that on us?
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and thirdly, a woman does have a free -- a right to choose. she has a choice to make. if you do not want to get pregnant, keep your pants on. >> that is brian in waldorf, maryland, representative heims. >> um, brian, of all of the things you said, most of which i don't agree with, the one that really troubles me the most is that you would suggest that the refugees who are fleeing war zones in places like syria are the enemy. i don't know about you, but i'm looking at the pictures of these people, these are bakers and policemen and firefighters from places likal eppo, who are leaving god awful war zones with their kids and crossing deserts and getting shot at and just want to survive. these are refugees. they are not the enemy. my faith said you look after the least amongst us so your characterization of the people, i couldn't disagree with most. and this country was founded, where i come from, south of me,
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is a huge statue in new york harbor that says on it something i think part of our american values, bring me your tired, your poor, your huddled masses and my family were poor and huddled masses and now we say sorry, not only will we slam the door on people who are terribly needy and in trouble and change the country to we slam the door on the rest of the world. i couldn't disagree with you more with the way you articulate that. and quick point on economics, they are set by the federal reserve. one of the traditions is that we've isolated the interest rates from the meddle of the of the president an the congress of the united states. so what happened yesterday was a good example of one of the strengths the country has is guys like me who may have an agenda or who lived at 1600
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pennsylvania avenue don't get a vote. >> as always -- >> on the next washington journal, adam brandon with freedom works will talk about the group's call for the removal of congressman john boehner from his position at house speaker. and the possibility of a government shut down. and later issues important to black women in campaign 2016. melanie campbell of the black women's round table public policy network and editor of essence magazine vanessa deluca will join us. washington journal live every morning at 7:00 a.m. eastern on c-span and we welcome your comments on facebook and twitter. our road to the white house coverage of the presidential candidates continues on saturday morning with a new hampshire democratic party convention live from manchester. speakers include five presidential candidates. former sect of state hillary clinton, bernie sanders, former governor of rhode island,
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lincoln chaffee and martin o'malley and lawrence lessic, saturday at 9:30 a.m. on c-span, c-span radio and c-span.org. the c-span campaign 2016, taking you on the road to the white house. good evening, ladies and gentlemen. i'm speaking to you tonight at a very serious moment in our history. the cabinet is convening and the leaders in congress are meeting with the president. the state department and army and navy officials have been with the president all afternoon. in fact, the japanese ambassador was talking to the president at the very time that japan's air ships were bombing our citizens in hawaii and the philippines and sinking one of our transported loaded with lumber on the way to hawaii. by tomorrow morning, the members of congress will have a full report and be ready for action. >> eleanor roosevelt is the
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longest serving first lady for an unprecedented 12 years all the while her husband unknown to the public was physically limited by the effects of polio. she dedicated her life to political and social changes aand her legacy continues today as she is discussed as the possible face of the $10 bill. eleanor roosevelt this saturday night on c-span's series, first ladies, examining the public and private lives of the women who filled the position of first lady and their influence on the presidency. from martha washington to michelle obama, sunday at 8:00 p.m. eastern on american history tv on c-span 3. >> dr. steven ostroff has been acting administrator of the food and drug administration since april. he recently testified on capitol hill about food safety protocol in the u.s.
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s in an hour and 20 minutes. >> good afternoon. i thank the witnesses as well as those in the audience. this hearing will come to order. this hearing will focus on the fda's efforts to improve and maintain the safety of our food supply. i thank you, commissioner, for for your presentation here today. thank you for participating in this hearing. we're delighted for that and dr. ostroff, i appreciate the warm working relationship we are developing. and i appreciate the conversations and dialogue we've had on a number of fda issues over the last several months. thank you personally and professionally for the way you are treating me and this new chairman of the subcommittee.
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one in six americans falls victim to food-borne illness each year. americans expect that food will be safe and the fda is largely tasked with maintaining that confidence. passage of the food safety modernization act in 2010 gave your agency significant new responsibilities in implementing a very sweeping set of changes to the food safety laws, probably, certainly the largest change in the last 70 years. our hearing today is timely, as it follows last week's publishing of the first two final rules for preventive controls on human and animal foods. in delivering these new regulatory responses, your private sector partners expect transparency and certainty from the fda. when i speak to small businesses and agriculture producers in my home state, their major concern is a government that limits job creation and stifles innovation through burdensome regulations. i'm pleased that the agency took
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many of the suggestions and comments from the agriculture community into account by reproposing portions of the fsma rules because they were unworkable for farmers, and i thank you for that. modernizing fda's regulatory and educating industry and consumers are controls are at the heart of fsma implementation, and that starts the compliance process. it's vital that fda continue in collaboration to issue proper regulatory guidance throughout this process. i also recognize that successful implementation, and 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 fsma's implementation with the resources that are at our disposal, and has done so since fsma's enactment in 2011. i think spending in the last five years has increased 8%,
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something that can't be said for many other federal agencies. but we know that you face additional challenges and additional tasks. we're interested in exploring how we can be more helpful. and as the continuing process, as the process continues for appropriations this year, fsma funding will undoubtedly play a significant role in our deliberations and establishing priorities. i look forward to discussing these and other topics with our witnesses today. we have a lot to cover this afternoon. i turn now to my colleague for any remarks he may wish to give. >> thank you very much, mr. chairman, thank you for holding this hearing. thank you, dr. ostroff for attending. the safety of our food supply is something our people take for granted. when people head to the grocery store, for the most part people don't give a second thought whether or not the food they pick up for their family will make them sick. america has and continues to have the safest food supply in the world.
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that of course doesn't mean that it's perfect. as anyone who has ever had a food-borne illness will testify to. we need to continually work to make sure we stay ahead of a changing marketplace. we don't think about strawberries or melons out of season, because we have access to food from all over the globe. to stay ahead of this is a monumental task and there are multiple federal agencies involved, including usda, which regulates 20% of our food supply, and fda, which regulates 80%. outside of the federal government, businesses and farms are we're working continually to make sure a domestic onion is always safe to eat, as well as an imported strawberry. the food safety modernization act, the law changed the way we look at the issue of food safety. prior to fsma, an outbreak would take place and we would spend our time and resources tracking it down. now we are working to make sure
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that we prevent that outbreak from occurring in the first place and giving fda the tools and the teeth it needs to do just that. it's a better way to do business. the law had about 50 specific deliverables, no small task for any agency. and although it took longer than many would like, fda published two of the seven major final rules next week and the rest will be out, as i understand, by next spring. we're at the point where the rubber meets the road and it will require a new way of thinking for food inspectors who have been trained to look for a specific problem rather than making sure those problems never materialize in the first place. it's not always smooth sailing and i know that folks have learned about food processing along the way. i think most people would agree that 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. it's timely, and i'm very interested to hear from our witnesses. >> dr. ostroff, again, welcome.
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you may commence your testimony. it is a significant number of pages. and i've extended the deadline from the normal five minutes to ten. >> well, thank you. >> so please proceed. >> thank you, senator moran and other members of the committee. i share your enthusiasm for the warm working relationship we've been able to develop in the last several months. we look forward to continuing to work with you, not only on food safety issues but all the other issues that fda deals with. so i'm steve ostroff, acting commissioner of food and drugs. i really, very deeply, i appreciate the opportunity to be here and talk about the food safety act, also known as fsma. i would like to thank you and for holding this hearing and the committee members for their ongoing interest in this particular topic and for the strong and growing working
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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 that this is food safety month. and i can't think of a better way to celebrate than by starting the process of bringing fsma's important new rules online, as we did last week, and by discussing with you today the critical next steps that must be taken to realize the goals of fsma. so although i've only been working at fda for two years, actually began my public health career considerably before that, 30 years ago when i was working at the cdc on food safety and food-borne diseases. particularly at that time the newly recognized and deadly pathogen e. coli 157. while working in washington state, close to oregon, over a two-year period, i personally interviewed every person or a member their family in the state diagnosed with that particular
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infection and visited a number of them in their homes. i subsequent did the same with people with other food-borne pathogens. i can say without question that i have a very deep appreciation for the suffering and consequences of food-borne illness and have carried that perspective throughout my career as a public health practitioner and as a physician. in fact, fast food safety was the reason that i joined the fda in 2013 at the urging of the person sitting to my left. despite today having much-improved technical methods to detect and investigate food-borne illness from when i started my career 30 years ago, along with some notable successes in reducing the incidence of certain pathogens, there simply remains too much food-borne illness. as you mentioned, nearly one in six americans fall victim to food-borne illness each year. that's 48 million people.
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of these, 128,000 are hospitalized and and 3,000 die. this burden 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 also quite frankly acknowledge that it is simply time to start preventing them. so over here on this side, cdc's food net data has shown that for many, many years now, the burden of illness due to the major food-borne pathogens remains essentially unchanged. as you can see, the illness burden from some pathogens goes up while for others it goes down. looking at the poster over here on the other side of the room, in total the line remains distressingly flat.
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so i say to you that it's 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 risk-based solutions that can benefit both consumers and industry. that is what we do at fda when we're confronted by such problems. i know that mike and his team have embedded this concept in their work to modernize the nation's food safety system through fsma so it can meet the challenges of a new global era. the enactment of fsma was inquestionably the product of foresight and the recognition of common interests. members of congress on both sides of the aisle came together
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with consumers and food industry leaders to enhance fsma's ability to protect the food supply in a modern diverse world of free flowing commerce. fsma stands for the proposition that the standard across the food system should be to have processes in place that we have learned work to prevent food problems that many food safety producers -- practices that many food safety producers are already implementing. this means having prevention oriented standards in place that are equally applied to domestic and foreign producers, reasonable verification of compliance with those standards, and accountability for those who are unable or unwilling to comply. fsma directs fda to build a mod ern food safety system based on these ideas. fda has fully embraced a dynamic
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collaborate approach to implementing fsma is working very hard to build partnerships and strengthen existing ones. this effort includes the food industry from farmers and manufacturers to transporters and importers whose capacity and responsibility under fsma for producing safe food is the absolute foundation of the new system. it also includes fda's food safety partners and other government agencies at the federal, state, tribal and local levels, and it also includes foreign governments which can play an important role to help assure that the foreign supplies to the u.s. market are being produced in safe fashion. and it includes consumers and patient advocates who have been victims of foodborne illness. because after all, they are ultimately the ones we are doing this for. two final preventive control rules we issued last week are critical linchpins for building our new food safety system. they focus on implementing
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modern food manufacturing processing for both human and animal foods, thus ensuring food companies are taking a 24/7, 365 day a year approach and working with the fda to pro vent -- prevent problems on the front end rather than waiting until a problem is recognized through identifying people with food born illness as you know happened in your state of kansas earlier this year. these rules are important in their own right but they are only the first in a number of steps towards building a comprehensive food safety system. three more rules will be finalized by the end of this year, those being the produce rule, foreign supplier verification process, and accredited third party certification. then the final two rules will be issued this spring -- sanitary transport and intentional adulteration. these form the network for food safety called for by fsma, all
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based on the principle of prevention. writing the rules is clearly ooh big step but it's 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 fsma mandated food safety system in the comprehensive way that congress envisioned right from the start that we will fail to achieve the fsma 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 i'm 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 the level of funding that we need to accomplish on ground what is set in statute and in rule. american consumers are depending
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on us and they expect this of us. 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 outlined the scenario by which these rules will be announced. what was the basis for their prioritization? is there something about these rules that make them more difficult, easier, significant to pursue in what do we expect in the future? >> well, i will just say that they're all important. the preventive control rules are probably amongst the most important of all of these rules and they are the ones that are expected to be implemented first, and so these are the priority to be issued. and the other ones will come shortly after that. >> the process you've been through, it will be the same
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process for the next promulgation. >> i will let mike answer that. >> the essential answer is yes, we will issue these. deadlines for these are set by the court. we are obligated to be able to meet all of them and we will meet all of them, i can assure of you that. >> just add that as the commissioner indicated, these rules from a wholistic package of standards that congressman dated to frame this comprehensive preventative system. and so we've been through a dialogue with our stakeholders that's addressed all of these rules because they have to fit together. we have to have a coherent package of regulations. we are at the end of the process for all seven rules having gone through the notice, comment, public meetings, dialogues. so now we are able to actually issue the rules in final. sequencing has something to do as well with just the capacity to get rules out the door and give a little breathing room between rules so that we are on
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track to get these rules out on that timeline and just as the commissioner indicated. >> mr. chairman, if i might, mike can just make a couple of comments about the implementation plan and that may help to put some of this in context. >> well again, this is a large topic. i'm sure your questions will draw it out in detail but we are embarking on implementation and are deeply cognizant of the challenges. hundreds of thousands of facilities, the complexity of supply chains. but we know we can meet this challenge because we have the alignment of stakeholders and we've done the work and dialogue and support of shake holders. some of the themes that we are pursuing undergirding the implementation that we think are crucial to success, first this commitment as we
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implement to provide clarity throughout reach and guidance about the new rules. what they require and to be supporting the industry in achieving what's expected through education, through technical assistance. we've said on any number of occasions that we will educate before and while we regulate and we absolutely need that. that's the first theme -- clarity and support for compliance. the second thing we need to do thematically is fundamentally revamp how we conduct our inspections, how we conduct our oversight and compliance activities so that we are targeting our efforts based on risk and actively fostering and supporting vot untearily compliance through front line oversight that's historically been enforcement and reaction oriented. now it needs to be prevention oriented. and supporting compliance. i need to add the caveat, fsma has given us rules to take swift action to protect
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consumers but the goal has to be compliance in food safety and not just enforcement in an end itself. the third theme is strengthening and expanding our partnerships with state, agricultural and health departments. this is absolutely essential. we have a mandate from congress to establish a national integrated food safety system and we fundamentally understand that fda cannot possibly implement this law successful by itself. it has to work with our state and local partners. finally i just -- we emphasize and i think this is crucial, the commitment that i think we all need to have to this integrated comprehensive implementation of fsma. this system is a system that doesn't work if we tease out parts or delay parts or don't integrate this in a holistic way. i think the import safety provisions are particularly a crucial part of this overall system of prevention. this is how we will get a level playing field for u.s. producers. we'll meet the expectation of consumers that the food that is
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imported into this country is as safe as food that is produced here. these are themes that we hope to come back to and we want our feet held to the fire with respect to pursuing this. in this way i think if we do this we can, as daunting as it may seem, with the hundreds of thousands of folks who are seeking to bring into a new system, we think we can do it sticking with these themes. thank you, mr. chairman. >> mr. taylor, thank you. commissioner, your charts particularly this one, what's the explanation -- what's the cycle that occurs here? you said there are ups and downs. we've had reductions and increases, both. is there a cause and effect that you could describe to me? why that is with one particular pathogen? >> yeah. that's a good question. i think if you look over here, one of the other things that i think is quite notable from this particular graph is that for many of these pathogens that
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many of the reductions -- the reductions being the ones that you see that are lower than 1 -- occurred during the very early years of implementation of some new food safety activities in the late 1990s. and that really, if you follow that along into the 2000s, for many of these it's been incredibly flat. now i think it is 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 it's 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. sort of the locally grown phenomenon has increased over that time period. so there are a lot of things that are challenging the food
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safety system and influencing the occurrence of foodborne disease. but i think the bottom line is that as these trends have changed over time, we've basically been treading water. and it's 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. >> and you believe this will bend that curve? >> i believe it will bend that curve. if you take a look at several of the major food safety problems that we've experienced this year, including the most recent one that we have seen with the cucumbers that were imported from mexico, the various provisions that are in fsma are specifically designed to address the challenges that we've seen in all of those outbreaks. and so we should be able to influence not only the outbreaks that are occurring, but more
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importantly i think the day in and day out sporadic foodborne illness which forms the -- bulk of this particular data. i think it's important to say that while we believe all of the activities encompassed under fsma will work to drive these numbers down, it doesn't absolve consumers of doing the right thing once this food gets into their kitchens, because a lot can happen even if the food as it comes into the kitchens is safe. so it is a comprehensive approach that must be taken to assure that foodborne illness doesn't occur. >> let me turn to senator merkley. >> thank you mr. chairman. in your testimony you note fda strategy is taking "an educate before and while you regulate" approach and note that you are currently working on guidance documents. this is very important considering the first two final rules are about 1,500 pages.
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substantial amount. these guidance documents will be critical for businesses to understand and comply with the new law and they need to be timely. so folks in oregon are asking when these documents will become available and i'll just give you a chance to answer their question. >> to best answer that question, i'm going to turn to the person who's actually writing them. >> i'm writing them as we speak. guidance is absolutely essential to the success of these rules. we are investing a lot of resources in that now, even as we've been preparing the rules themselves. one thing i would note, in the 1,500 or so pages, this is 8 1/2 x 11 double space but those pages are themselves guidance, an explanation of what the rules actually mean and how we expect them to be applied. that's the first place folks should go to really get an understanding of what the codified rule language itself actually is intended to mean in practice. but that is just the first step
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in guidance. as you know we are developing several -- number of guidance documents, some of which are the key foundational ones so there will be a comprehensive guidance on the animal -- the human preventative controls rule that will be almost kind of an operator's manual for those who are not yet implementing modern preventive controls like many in the industry already are. for those who aren't there yet, this is going to be a very helpful operating guide essentially for implementing the rules. they will be doing similar guidance for animal food and similar guidance for both animal food preventative controls and -- >> let me just cut to the chase and say, great, i'm glad it's going to have this guidance. when will folks -- >> these major guidances will be coming out early to mid next year, well ahead of folks' obligation to comply. and they will be open for comment. it will be an ongoing process of dialogue but our best thinking will be out there in a timely way for implementation. >> okay.
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great. i've heard from constituents and that there are concerns foreign businesses may not be as closely monitored as u.s. businesses and consequently there might be greater risks from foreign products than from u.s. products. additionally, it could put u.s. businesses at an economic advantage of the compliance costs for fsma. in your testimony you state that fda can't hold domestic producers to the new standards if we are not doing the same for importers and their foreign suppliers and visa versa. so i know you are aware of these concerns. this may all further when the verification program will be finalized next month. to the degree you can tell us now, how will the fda adequately ensure the safety of foreign food products and will that oversight be as rigorous as oversight for u.s. businesses? >> i'm going to allow mike to give you some of the details. all i can say is one of the fundamental tenets of fsma is that we assure that the safety
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of foreign sourced food is equivalent to domestically produced food. i think that we have that obligation to create that equity. we know to certain degrees the tools available to us to be able to deal with imported food have been limited. but this rule -- this law will not successful 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 that are bringing this food into the united states assure that the procedures that were in place to produce that food are equivalent to the procedures that are in place for food that is produced domestically. let me let mike give you more detail. >> so congress did provide a multi-faceted toolkit.
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for strengthening over site. the commissioners referred to the foundational part of that which is this foreign supplier verification requirement so that importers will now for the very first time have a food safety responsibility to be accountable to us for knowing their sources of supply and verifying that those foreign suppliers are producing under our standards. that's a paradigm shift if we can implement it well. it's combined though in the design of congress with much more overseas presence by fda. so more foreign inspections, more partnership with foreign governments, more investment in foreign food safety capacity where that will contribute to food safety here. we think this toolkit if implemented properly will work to provide that equal rigor. the question is implementation, can we make the investments needed to carry this out as intended. >> mr. taylor, you mentioned the foreign inspections. fsma mandated 600 inspections in 2011 with a doubling of the previous year's inspection level
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for the subsequent five years, which would mean that in fy 2015 we'd have about 19,000 foreign inspections, and i believe in fact the department plans to only conduct 1,200. so 19,000 versus 1,200. 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 there's not enough inspections to hold them accountable. your thoughts on that? >> you put your finger on a huge challenge. and that is how do we target our resources with resources we get to do this -- implement this law effectively for food safety. we have increased our foreign inspects from at least 300 before enactment in the 1,200 to 1,400 range currently, and those have been very important, but
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they are part of a larger system. so the inspections are not inherently preventative in terms of the foreign supply verification programs is required. as far as suppliers for -- we we have to get 88,000 imports up to speed. that's a priority for funding. we'd like to do more foreign inspections but we also think we can leverage of foreign governments through things like a system s recognition tool we've developed where for countries that have advanced food safety systems we want to recognize that and be able to rely, a mutual reliance sort of relationship where we can rely on their inspections and not duplicate their efforts. so there are multiple elements of this. one of the major investments we've made over the last few years with increased funding from congress is to strengthen our foreign offices overseas which again are going to play a vital role in us building relationships with foreign governments, outreach to foreign industry, all those things where
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we can leverage our limited resources to maximize prevention activity overseas. we'd love to continue to be in dialogue about how we increase the inspection numbers along with these other activities. >> you mentioned the one thing that 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 that we could carry out the requirements especially for foreign produced food. and with a number that is significantly lower than that, we will be challenged. i think that there is little question of being able to implement the various rules that will be coming out over the coming months in the way that we envision that they need to be rolled out. >> i think one of those areas that the funding is impacting is in filling the foreign office.
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you mentioned an increase, but i believe the vacancy rate i believe is 40% of foreign offices are vacant. is that primarily a funding issues or prioritization issue? >> i will say that it is expensive for us to be able to place people overseas. however, actually placing people full-time in these offices is only one of the strategies that we've been using to carry out those responsibilities. so we do cycle in people for short-term assignments to be able to assure that we can carry out the things that 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. i've long been interested in this, actually before my colleagues came on and had tried to be helpful in getting more ag
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inspectors at our border. but that's a long time ago. california, as you know, is a huge -- it's the number one agricultural production state. 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. you know, given my extensive time at the cdc, i'm pretty 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 incidence of some of the
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pathogens that you see on these lists. 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 that's 418 illnesses across 30 states. we have seen the most illnesses of any state. 89 illnesses, 17 hospitalizations and and one death. i'm concerned that year after year the centers for disease control reports that the united states has not made progress in reducing the number of foodborne salmonella infections that occur. i was listening, and also read ing your comments, how that's these now food safety recommendations you are finalizing will prevent outbreaks like this from mapping
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-- 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's producing these crops. >> well, i'll preface my statement by saying that that particular outbreak is still under investigation. and so we don't 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've experienced this year, one of them being the salmonella associated with the cucumbers, and a few months earlier a parasitic pathogen cyclospora associated with cilantro that was also imported from mexico. you know, there are some themes about the quality and implementation of measures
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to prevent problems from occurring in the first place. and that is at the heart of what we are trying to accomplish with the produce rule. so that produce rule establishes a number of standards that producers overseas and producers domestically could adhere to. >> could you give us an example of the standards? >> you know, some of them are the water that's being used to irrigate the crops. one of them has to do with the access of animals to various locations. there's another aspect that deals with the hygiene of the workers that are working on these particular farms. and so it's 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
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difference fsma will make is we've known for years what these practices are and fda has provided voluntary guidance but there have been no enforceable standards, whether for domestic or foreign producers, and thus no accountability for doing the right thing. what fsma does is create enforceable standards, then also verification that those standards are being met. it is that simple but it is a profound difference from where we've been before where it was incumbent upon fda to find and react to the problem in the absence of clear standards for prevention. it is a real game change. i think for cucumbers, that kind of example will make a huge practical difference. >> right. no, i gather produce is about 48% of salmonella, and that's under your jurisdiction. and the rest of it -- meat, chicken, pork -- is under usda, if i understand that correctly? do you coordinate in standards between the two of you or are are the standards different?
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>> one of the critical requirements of being successful with fsma is to be able to work closely with a whole variety of partners. and it is not only partners that are at the federal level but it is also down at the state and local level where a lot of the e and local level where a lot of the day in and day out work with farmers occur. so, yes, it's very important that we work quite closely with usda to ensure the success of what we do. >> with produce -- for example, i'm had campylobacter and i know how serious it can be and it was from eating not thoroughly cooked chicken. so i asked my staff to look into it. now this is not your jurisdiction but it's interesting to me that 40% of the ground chicken in markets have salmonella. and i talked to a large chicken grower in my state and i said "what about this?"
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and he said well everybody knows you have to cook chicken to 165 degrees until you eat it." i said "well, i didn't know." and i don't think everybody know s so it raises the question of how these two agencies interact. i think you have a good thing going in what i read on fsma and i like very much how you're 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 doesn't seem to me we make much progress year over year. but with respect to this what you mentioned, cilantro, cucumbers, ice cream, tuna, caramel apples and these five
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outbreaks alone are almost a thousand cases of illness and 12 deaths. do you think there's anything that usda can begin to learn from fsma? do you think it's relevant? >> again, we work very closely with usda without question. far be it from me to provided a vice to them related to things that we ourselves don't 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 that we are doing in fsma that usda is doing. because from the consumer's perspective, if they end up with salmonella, they end with salmonella and they're not interested as to what the source
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as s as to do what we do to keep it from happening. >> we have two big agencies, one handles the meat products and one handles the fresh produce and i've wondered is that the best way to do it i think you're taking action and i'm pleased to see that. i'm also concerned about antibiotics in products and what's been happening in the 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
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called narms that monitors not only the occurrence of various pathogens in a variety of food products, particularly meat sold at the retail level but also monitors the patterns of microbial resistance. we look at isolates that come from products that we regulate, usda. looks at isolates that come from products that they regulate and cdc also incorporates information from human isolates of those same pathogens so we can compare those patterns and look at those patterns over time. as you know, we also have been working quite hard to address the issue of microbial resistance from food-born pathogens. that's a whole other large component to their activities.
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especially by reducing the use of medically important antibiotics used in food-producing animals, particularly when used for growth 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 multiyear process to put those rules in place. you know, we have done this on a voluntary basis to have all of the marketers of these antibiotics for use in food animals make labelling changes to remove growth promotion as an indication for the use of these antibiotics and they have all voluntarily complied. the phase-in period to make those changes in the labels is to start at the end of this year
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and so we would look to see changes start to occur as a result of those practices and the other very important point of those environments is to make sure that the use of those antibiotics for other purposes is under the direction of a veterinarian. so both will be helpful in terms of addressing the problem. >> thank you very much, commissioner. thank you, mr. chairman. >> you're welcome, senator feinstein. thank you very much. just to educate myself in a more general way, let me raise a couple of topics that result in the questions of the testimony. one of the things i wanted to ask about is the cause of death. you cite the cdc statistics, th related to food-borne illness. is there a breakdown related to
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consumer preparation as to the food being tainted? do we know where the cause lies, consumer versus provider? >> it's not an easy question to answer when you're 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 variety of different pathogens, some of which is have -- some of which deal with items that are supposed to be cooked, sometimes you're dealing with raw commodities like in the produce space and so ultimately in most instances what you want to try to do -- and i think what fsma is designed to do is to keep it from being there in the first place. and i think if you can successfully do that in many of these commodity areas you will
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be able to have an impact in reducing these problems from occurring. >> so there's a redhaux cuction can occur in the likelihood of the problem that reduces the importance of consumer preparation in the food item. >> let me just say without question that you never want to send any suggestion that consumers can become lax in the way they handle their food because i don't 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. >> that was very artful. i'll re-ask my question which would be there is no way, is there, dr. ostroff that consumer preparation is not important regardless of what arrives in the consumers' home? >> you said it perfectly. >> thank you. you indicate -- first of all, i wanted to follow up on the point
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of imported food versus domestic food. he was asking for equity, an indication that you indicated in your testimony that there is an importance to making sure there's not an economic disadvantage to domestic producers, not a double standard is the way we'd say it in kansas. does that double standard exist today? is there a difference in the nature and likelihood of food-borne illness from imported food versus domestic food? >> since i've been answering most of the questions i'm going to turn that to my colleague. >> i think the answer is that under current law prefsma, congress has made it clear that the same safety is to be achieved whether foreign or domestic. the real difference and where there's a different challenge is in the ability to verify those standards are being met and we have very different challenges with imports than domestic because we have an inspection
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force here, we can go into facilities and hold firms legally accountable. we have a set of relationships with the states who go into these facilities all the time. there's no amount of foreign inspection congress will ever pay for us to do that would provide a comparable level of oversight through inspection overseas so that's why we've got that multifaceted tool kit, more foreign inspection but very much collaborating with foreign governments. so the difference is not the standards, they're the same standards, the question is how do you verify? the imports provide a different verification challenge. >> and under fsma, the ability to enforce those standards is going to in large part rely on the verdictfication of those importing food that their providers, the foreign suppliers, are in compliance? >> that's the foundation for the new system because the u.s.-based importer is legally directly accountable to us.
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we can hold them legally accountable for doing that job problemerly so that's where we have the direct legal handle but we can go over and inspect foreign to facilities. if we see a problem we can keep the food from coming in. we can work with foreign governments to foster good practices and rely on their inspection activity but the direct legal accountability for imports in terms of private sector responsibility is on that u.s.-based importer. that's why the foreign supplier rule and its proper implementation is so foundational. >> what does that mean the importer is most likely to do to sign that certification? what is that company going to do in a foreign country to make certain when they attest that standards are being met that they're being senate. >> so under the regulation we proposed and you'll see coming forward and i'm not here announcing the final content of the regulation but the elements of it are evident from the proposals we've put out in a supplemental proposal we put out last year. but the whole idea is -- and
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this is following the congressional mandate -- the importer must have a program, a documented program where they have identified their suppliers, they've come to understand their suppliers' capability for food safety, they've approved the suppliers, they know the practices is supplier is under taking and they look at records and they -- and under some circumstance, when justified by risk -- because it's intended to be a risk-based foreign supply verification program -- we would envision the u.s.-based importer doing an audit. having an audit conducted -- an on site audit of that foreign producer. so it's having a real program that we can then audit and obviously go behind that and sample product when it's coming in, go behind that and actually inspect the foreign facility if we choose to. but it that's accountability for the importer that's the new feature. >> the word "audit" has a different meaning than "inspect," isn't that true?
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so when they're auditing they would not be doing the same thing an inspector, an fda inspector would be doing in a foreign country. is that -- we >> well, it's different. when you talk about inspection we're used to looking at facilities and conducting a physical exam of a physical place. the aud did term applies to looking at auditing the program, checking the records, being able to get confidence from examining the records and talking to the importer that they are, in fact -- they know what they're doing rand doing the right thing. so it's a records-intensive audit activity that will be a major component of ensuring this is being done properly. >> mr. taylor, thank you. i have more questions but maybe a way to accommodate your schedule is to to to you, and if you're unable to stay for my final round i wouldn't be offended. >> thank you very much, mr. chairman. i wanted to draw attention to the report that you've all displayed, the 2014 food safety
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progress report for folks who are numerically challenged, you've boiled it down to happy faces, grim faces and very unhappy faces and the unhappiest of all is the face representing vibrio. and over on the other chart you've provided by you've showed that while every other disease has decreased since the 1998 till now time period, there's one disease that has increase in incidents and this's i have been reel. what is the story? what in particular should we know about the challenge this disease represents? >> well, i have been rio can also be a significant disease. it comes in a couple of different forms. there are several different pathogens that are encompassed under the label of vibrio and they are in general associated
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with sea foot products. we have seen now -- i think it's important to put into context that in terms of the overall numbers, the number of illnesses associated with vibrio was actually quite small and certainly a very small fraction of what we see in the united states from either salmonella or camp low back or the. some of this was largely confined to certain areas of the country and because of movements that occur we merging diseases it spread to other areas where it traditionally hasn't been, but it is a trent we've been seeing along the east coast. >> i was reading the 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 that are ram nant those ponds.
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is that import of shrimp from these a farms contributing to the vibrio expansion? >> i would have to get you specific information about whether or not that's contributing but by and large to my knowledge most of the vibrio related illnesses are not associated specifically with imported shrimp. >> thank you. back when we were working on this bill a young man and his father came out from oregon to testify. the father was a police officer, the son when he was three, his name is jacob hurley, he had experienced a life-threatening 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
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involved in that was the peanut corporation of america. if we look back on that particular well. publicized incident how would the preventative controls rule that we just passed made a potential significance difference in the risk of that disease? >> so that's an unusual case in many respects. in part because of the vast scale of the damage that it did and the thousands of products that had to be recalled because this firm was selling not only peanut butter in bulk but peanut ingredients that went into thousands of processed foods. it was a catastrophic event for the food system. it also involved intentional conduct by the&m9j÷ owner and operator of that facility and the well-publicized subsequent criminal prosecution and
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conviction. the -- what fsm larks do even in that situation is provide a much stronger basis for inspectors when they go in to facilities to not just look on the facility conditions, and pre-fsma with no access to the records of the a facility, under fsma, we'll be able to go in and make assessments of the system and detect and find records that might document positive inliteral results such as occurred in this case that would reveal a problem that needs to be addressed. so there will be the rare incident where purposeful criminal behavior happens and there needs to be swift remedies for that but i think even in these cases we will be more effective in our investigatory role in investigating and whether this goes on in facile thes that needs to be addressed forcefully and fsma gives us rules to address that
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forcefully. if we identify this problem through inspection, under fsma, we can suspend the registration of that facility and shut the facility down administratively and that's important in these extreme cases. >> as you note, there were exceptional circumstances, roof, mold, animal contamination, so on and so forth. kind of egregious behavior of some known problems. in terms of the inspections you mentioned and the ability to have teeth, that matters. but there's another element of the preventative control rules that involves developing a tracking system for ingredients that go into processed foods. can you comment on whether that you believe will make a difference? >> so fda has historically since the bioterrorism act in 2001 was enacted it's had authority to require firms to keep records of where their incoming materials
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came from and where their finished producted have gone one up one down recordkeeping. fsma adds somewhat to our authority in this area by giving us the authority to set stan dads for how that firm connects the dots between the incoming and outgoing so that will be a step and that's a rule making that is under way to put that in place. fsma, frankly, puts constraints on fda in terms of traceability because it precludes us from requiring essentially a farm-to-table pedigree, or the kind of tracing that is done by u.p.s. and fedex. we're precluded from acquiring that sort of use of technology to improve traceability. so from our standpoint traceability is crucial. it's how we can investigate outbreaks more expeditiously, get to the cause of problems and solve them but traceability will have to come into the modern era fully through public/private
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collaboration, finding ways to harness industry, innovation with the support and dialogue so we can be sure whatever they do helps our investigators as well as the firms themselves but there's work to be done in that area. >> thank you very much. appreciate it. >> the mumbling here was i will not take advantage of senator merkley's absence. i ask unanimous consent as soon as he leaves to -- [ laughter ] one of the things i read in your testimony that i wanted to highlight and ask you to confirm to me how serious you are about this and how confident i can be that it will remain the policy and that is you indicate approach to inspection is aimed first at fostering and facilitating compliance rather than finding and penalizing regulatory violations. that is a policy in my view that
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every regulatory federal agency should adopt. the goal is to make improvements in cooperation with the regulated and it seems to me and we've had this in other agencies previously in which they seemed to be that was the direction they were going but over time the joy of penalizing became too great and the attitude of cooperation disappeared. is there some assurance that you mean what you say in your testimony and that it will last as part of the nature of the food and drug administration as it implements and enforces fis ma? fsma? >> all i can say is that we do believe that the approach that is expressed in fizz ma which is to work collaboratively with regulated industry -- and when i say regulated industry we mean
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from the farm to the transportation into people's 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 to -- and i'm sure you're quite aware there's the carrot and the stick and we though that the skerrit quite an effective way to promote improvements in food safety but that does not mean that we are not going to use the stick when we need to use the stick. >> if i could just add why i believe this will remain the policy over time regardless of who happens to be sitting in these chairs. partly we've put in the writing. we've made this commitment to the industry and the public and people support this. externally but equally important for your purpose, the people at
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fda embrace this wholeheartedly. the people at the front line in our agency are public health people. that's a cool. and that's been the culture of our agency given the framework for food safety which has been a statute and program but with fsma, we're public health at the front line and our front-line people love that. they would much rather be getting good food safety outcomes and doing public health than trying to wrack up enforcement numbers. that's not the fundamental mentality of that cadre of people, including the young people coming into the agency. it's an extraordinarily exciting time for them and the agency. so i think the future is here in terms of the culture change going on and we're working to institutionalize that and embed that in the practices of the agency. >> i recognize when i asked that question it may sound as if you're trying to take care of business or formers but isn't the reality that we end up with
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a safer food supply system when this is the attitude? >> what we know and you know and if you talk to the people in the food business it's obvious. the vast majority want to produce safe food. at a personal level and in their intense business interest to do that. so our whole strategy is based upon that assumption. we need to work with that vast majority who want to comply, support that compliance, verify that it's happening and for those who aren't complying we will act swiftly and take whatever action is needed to protect consumers and in these extreme cases like peanut corporation of america, invoke punitive remedies as a deterrent. but i think working with those whose interests is aligned with ours on foot safety is how we'll get the best public health. >> if i can respond that before dr. ostroff speaks, the world i from in kansas, the rumor of food disease or animal-born diseases causes dramatic consequences to farmers, to ranchers. it doesn't taken a actual case,
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just the thought something may be wrong. so i'm not opposed to strictly, strongly enforsing penalties and putting bad actors out of business because they have a huge consequence to the consumer and safety of our food supply. but for those same businessmen and women, the same farmers and ranchers, they can't afford financially to have the rumor or reality that there's something wrong what they produce. >> and our strategic interests are fully aligned on that. >> i think you're right. we know the ramifications from food-borne outbreaks that occur years ago still ripple through certain kmot tease. the other thing i say is that the approach that we will be taking under fsma is a fundamentally significant change to the way we approach food safety and it's really critical because a number of things
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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 work force be able to implement the things that you were saying in terms of being able to work collaboratively with industry, being able to educate industry and being able to oversee and ensure what they are doing is up to standards takes resources and i don't 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 in some aspect of what we're doing. >> you couldn't help yourself. [ laughter ] and i'll be happy to visit about that 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, what will
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the role be for those states as a result of fsma and its implementation? what happens different at the kansas department of health and environment? >> well, you know, 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 very critical partners in implementing fsma as it's designed to be implemented. they are our front line 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 mind most is the produce rule that we will look very much towards working with the states to be able to provide the type of front line support to the
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farmers within their states to be able to appropriately implement the new requirements for fsma. so they are critical to the success of this endeavor. >> let me ask one question related to the animal feed rule and contract farmers, doctor you indicated to me and commissioner you indicated to me in advance of this hearing that what i was going to hear from folks throughout in that world would be all requests to make sure congress appropriated sufficient funds to implement fsma and that you had worked your way through many of the challenges and had imput from the stakeholders and i appreciate that and it seems that that is in large part the reality. one area i've heard concern about is the definition of what a farm or farmer is and you're shaking your head so maybe i don't need to describe the issue. is there something afoot that i ought to know about the direction that you're going?
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what i have heard is that there is concern from farmers who have no involvement in anything other than raising the livestock, the animal that this will come -- that fsma will affect their operations as well when all the processing and everything occurs downstream and, in fact, the feed, most importantly, is not grown or provided by by them, it's provided by upstream, buyers of contract, those they have contracted with. this -- is this an issue -- have i described it atdequately? you were once smiling, now you're frowning. [ laughter ] >> the specific way a farm is defined is critical to these rules, not only preventative controls but also the produce rule. so we have worked quite closely
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with those that will be impacted by this rule to make sure we can get it as right as we can. i will ask mike, he's been immersed in this issue for the last several years. >> i do know the issue very well and the fact that there's presumably still folks who have concerns shows there's an exception to every rule about stakeholder support. but i think what you're talking about is the situation in which they are vertically integrated poultry operations where a purdue or tyson will own the chickens, manufacture and own the feet, provide it to contract growers who -- >> growers only grow. >> growers only grow. if growers have a concern i need to hear. that the affected party is the operator of the foo t feed mill that's not being managed on or
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buy farm operation but rather by this big vertically integrated poultry enterprise. that feed mill is subject to the animal feed preventative control rule. the environment is very practical and are risk-based and don't address issues that don't need to be addressed in terms of ensuring the safety of animal feed but those feed mills are subject to preventative controls. if the common farmer is growing or processing their own feed on their farm in their feed mill for their animals, that's part of the farm operation and would not be subject to the preventative controls rule. so i would be happy to engage whoever that has concern and connect them with our center for veterinary medicine and work through whatever the question is. that's -- >> you answered the question better than ski it and that's the assurance they were hoping to hear. >> again, happy to talk to them
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if that would help. >> let me talk just a moment about the appropriations process. as i indicated in my opening statement, this will continue to be a priority certainly of mine and i think of this subcommittee and you mentioned specifically the amount of money the president's budget request and our ability to meet that at this point hasn't 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're interested in have viewing and reprioritizing based on what the needs are of fda and others 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 able is 8%
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increase for implementation of fsma at fda. am i saying that correctly? of course you do. let me ask how that money has been spent in implementation and how has the -- how has it been allocated? is it across food safety inspections? food born disease surveillance? detecti detection? how do you decide how to spend that money over the past five years? and i'll consult with my expert. >> so the total amount since 2010 that's been implemented -- that's been allocated specifically for fsma, i believe the number is approximately $162 million over that time period. it has been used in a whole variety of ways but as you probably recognize, there has
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been a tremendous effort on our foort appropriately lay the ground work to get these rules to a place where those rules are both implementable and will work and that's no mean task. as you know we have had 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 strayed association trade associations. we've 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, so that
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has heavily contributed to a lot of resources we have 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 we've made that i think are very significant as well. some of it includes increasing technical staffing so we can support the industry, our state partners, our own inspectors as they implement this so this is at our center for food safety and applied nutrition principally. we've doubled the investment in the states to close to $50 million over the last few years: we've been able with the resources we've got, including these increases, to meet the fsma mandate for high-risk inspections, the frequency mandate and exceed that and do that earlier than expected. we think that's been an important part of getting ourselves in a position to succeed under fsma.
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then the airport area has been an area of investment. we've significantly increased the number of inspections as i mentioned. we've expanded foreign offices. so there've been significant programmatic investments in capacity for ourselves and the states to implement fsma so we can succeed going forward. >> thank you. it's apparently one of those circumstances in which both are right. the desired outcome has been achieved. food has increased by 8%, fsma by 4%. finally, i think this is my final question. is there any opportunities -- let me ask that differently because there has to be. as you implement fsma, are their there opportunities for reprioritizing existing spending that are -- that that spending is no longer necessary because you're headed down a different path than the nature of the way
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fda operated in the past? so where did the -- are there any savings to occur as a result of the implementation of fsma? >> i think -- my commissioner is looking at me so i will stay something. yes, that's a no. because i want to try to explain. if you look at the overall funding of the foods program, about three quarters of it pre-fsma goes into field based activities that relate to food safety but doing it the old way. what we're talking about is adding incrementally to that base source to so we can redeploy that resource to doing food safety in the way envision bid by fsma. i want to get credit for the fact we're not continuing to do the old stuff and add on the new thing. >> that's the nature of my question. >> to so the answer is we're
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redeploying but it doesn't mean we can stop spending the money needed to support the work force. we have to invest in it so it can work in this modern prevention-oriented way in a more sophisticated rell tear framework. so it's redeplace of employment as opposed to adding resources on top of resources that are still deployed doing their own thing. th >> that's what i wanted to hear. so since you, dr. ostroff, wanted to answer no, i'll give you the opportunity to answer yes. isn't the truth that we can now as we do things differently you redeploy assets, resources directed in the old way of doing business to the new way of doing business? >> so this is not going to require fewer people to be successful. it's just going to require that those people do things differently than they've been doing them but the people that
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we need to be successful for fsma, we're not going to have people go away. in point of fact, given the various responsibilities 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 we've been doing with our field force and what we have been doing with our laboratories, those responsibilities don't disappear under fsma. >> dr. ostroff, thank you for your testimony. mr. tootle, anything you'd like to make certain is included in the record before we close this hearing? >> i will close by saying i'm the eternal optimist. you know, we -- the question that we made for this fiscal year for fsma implementation is
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critical to its suck said and to name have its maximal impact which we hope that it will have to change these graphs that you see here on the right and the left. every component of that request is vitally important to the success of this endeavor so we will have incredibly difficult choicing to make if wick not get that particular request 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 you've made at this point and we're very, very appreciative of the resources that did show up in the subcommittee and the full appropriation for fsma
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implementation. all i can say is there will be significant shortfalls that will result with that particular number which will make it very challenging for us to be able to put in place fright the get-go what we need to do to be successful in this endeavor. >> doctor, thank you very much. appreciate your testimony. thank you for being here. i appreciate the presence of my colleagues and for members of the subcommittee, either those here or not, any questions that they'd like to submit 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 fda within four weeks spent to that point in time and, again, thank you for your testimony, thank you for the way that you have answered questions today and that 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
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speakers include five presidential candidates, former secretary of state hillary clinton, vermont senator bernie sanders, former governor of rhode island lincoln chafee, former maryland governor martin o'malley and harvard professor lawrence lessig. on sunday, a conversation with jimmy and roselyn carter on current events and the carter center's peace and health initiatives around the world. on c-span 2's book tv, supreme court justice stevphen breyer talks about his recent book and the challenges facing the american judiciary, including the application of american law in international contexts. saturday night at 11:00, former vice president dick cheney and his daughter former deputy assistant secretary of state liz cheney on their book "exceptional" which looks at america's foreign policy and national security. on american history tv on c-span 3, saturday starting at noon eastern we're live from georgia for a commemoration for the 13,000 union soldiers who died during the civil war at the confederate military prison camp
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at andersonville. speakers include sergeant major daniel daily and historian leslie gordon. we'll take your questions before and after the ceremony by phone, if and twts twitter. sunday afternoon at 4:00 on real america, archival video of pope paul vi in 1955 and pope paul ii in 1979 as they address the united nations. get our complete schedule at cspan.org. the pope's upcoming visit to the u.s. c-span has live coverage from washington, the first stop on the pope's tour. on wednesday, september 23, pope francis will visit the white house starting with a welcoming ceremony on the south lawn followed by a meeting with president obama. on thursday, september 24, the pope makes history on capitol hill, becoming the first pontiff to address both the house of representatives and the senate during a joint meeting. follow all of c-span's live coverage of the pope's visit to
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washington. watch live on tv or online at cspan.org. next, a senate judiciary committee hearing on electronic privacy with government officials and representatives from the tech industry. they testified about proposals aimed at protecting e-mail and other data information online. this is about two and a half hours. >> today's hearing is intended to help inform the committee about the most recent views of a wide variety of stakeholders concerning the need to reform the electronic communication privacy act or, as we know it around here, ecpa and various ways of fixing it. the committee's last hearing on the topic was four and a half years ago. since then, numerous proposals have been advanced by members of the committee. in 1986, congress enacted ecpa
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to both protect the privacy of americans' electronic communication and to provide the government with a means to access these communications and related records in certain circumstances. however, dramatic changes in the use of communication technology have occurred since 1986. americans now depend on e-mail, text messages, social networking web site, web-based apps and countless other electronic communication methods on a daily basis. and more than ever these communications are being retained in some form due to dramatic reduction in the costs of storing data in the cloud. these communication dodges are enriching all of our lives. they're of great help to me in keeping in touch with my constituents in iowa and, for the most part, we have american
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technology companies to thank for this digital revolution. these companies are now a significant engine of growth for our economy by creating an increasingly global market for these communication technologies. but, of course, these technologies are also being used everyday by those who intend to do our society great harm -- terrorists, violent drug dealers, child predators, environmental criminals and you can go on and on. these technologies create a digital trail that is often essential to bringing these offenders to justice in light of these changes, there's a grange consensus that ecpa must be modernized to adapt to this new landscape and whatever updates to the law we make, of course, must be consistent with people's protections under the fourth
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amendment. the privacy and technology communities have criticized ecpa for failing to provide sufficient privacy safeguards for individuals' stored electronic communications. indeed, given the way americans use e-mail today, it hardly makes sense that the privacy protections for an e-mail should urn on whether it's more than 180 days old or whether it's been opened. at the same time, law enforcement officials have expressed concern with certain aspects of the current ecpa framework and how it currently works in practice and they are concerned that reform efforts to a statute they use everyday do not unduly hamper the ability to investigate violations of law. an example.
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the department of justice has expressed concerns about efforts to exchange ecpa notice requirements to provide targets with unprecedented amount of information that could compromise ongoing investigations. both the department and civil law enforcement agencies have expressed the need to address an emerging gap in their authority if the target of an investigation fails to respond to lawful civil process for e-mail evidence in the targets' possession. they con end that this gap could law offenses such as civil rights violation, security fraud and consumer fraud to go unpunished. in addition many state and local law enforcement officials are frustrated with the current timeliness and quality of responses by providers. unlike traditional search warrants, law enforcement
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agencies can not control how quickly they obtain evidence through ecpa warrants. they rely on the providers to conduct the searches for them. to these officials, any heightening of ecpa's legal standards should be accompanied by changes to the law that ensure that they receive the information they need timely. in addition, some officials have expressed concern that the voluntary nature of ecpa's emergency exception can result in unacceptable delay in important cases. for example, when a child is abducted. closely related to these concerns is the on going issue of encryption and the going dark problem which the committee recently held a hearing on. this is another example of a situation where agents may immediate the legal standards to obtain critical evidence but are
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not able to access it quickly enough or even at all. as i said at our last hearing on ecpa, the reform we discussed in 2011, if we're considering changes to legal standard under ecpa we should also be working to ensure these same problems are granding law enforcement the necessary access to address the going dark issue. i sent a letter to deputy attorney general last week to get an update from the department about how that process is proceeding. reforming ecpa's treatment of stored electronic communications therefore is a complicated and potentially far-reaching endeavor that sits at the intersection of privacy -- [ phone ringing ] that's bad, i'm sorry. stored electronic communications therefore is a complicated and
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potentially far-reaching endeavor that sits at the intersection of privacy rights to the public, the investigative need of law enforcement professionals, society's interest in encouraging and expanding commerce and the dictates of our important constitution. the key is to strike the right balance between these interests as ranking is member lahey declared at our last hearing on the topic, 2011, "meaningful ecpa reform must carefully balance privacy rights public safety and security i agree. i'm grateful for the presence of all the witnesses and i recognize senator lahey. >> thank you, mr. chairman. i remember when our foreign communications act was passed
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nine years ago. in fact, the final -- i was talking with a form er direct o of the fbi last month vermont when we worked out the very final parts of it in my capital office about 10:00, 11:00 at night, trying to bring law enforcement. but keep in mind, those calls were on land lines at that time. call waiting was novel. few had heard of e-mail but we did figure there would be new electronic communications and we thought ecpa could provide that but there are now many ways that nobody could have anticipated of communicating. and the privacy rules concerning this are simply outdated
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government agencies can obtain the contents without a fwarnt that e-mail is more than 180 says old well, we don't expect our private letters or photos that we store at home to lose fourth amendment protections simply because they're more than six months old neither should our text documents. now, tomorrow is a major historical date in iowa. it's senator grassley's birthday. [ laughter ] i think they declared it as a day of public rejoicing [ laughter ] but if i sent him a note -- which i've actually written -- to him and he puts that note in his desk, handwritten note in his desk, somebody's going to have to have a warrant to go and
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get it. i didn't put anything in there that justifies that warrant. [ laughter ] but if i sent him a text that's stored in the cloud, why should bit any different? why should somebody just be able to take it out. senator leahy and i introduced the ecpa protection act to bring the digital world inline with the physical world. patrick leahy. there are nine of them on this committee. in the house even more, 300 co-sponsors, both parties support the bill. an extraordinary coalition of industry and civil society support this is bill. americans for tax reform, the center for democracy and technology. heritage act. aclu. usually representatives of those people have to have an orb traitor to get on an elevator
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with them if they're all in there together but they all agree with this but the bill has been reported by a judiciary committee by a voice vote in each of the last two congress. i think to use a technical term, passing this is a no brainer. five years ago the u.s. court of appeals for the sixth circuit found the contents of e-mail as fully protected by the fourth amendment regardless of its age. that's effectively become the rule nationwide. major service providers no longer turn over the contents of e-mails or texts without a warrant or legitimate warrant exception. the ecpa amendments act simply as senator lee knows we simply codify current practice. now, some have raised concerns the bill would have for civil regulatory agencies such as the s.e.c. well, we want these agenciesbe in our constitution that says only certain agencies have to follow the constitution and others don't have to.
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s.e.c. has not been able to obtain e-mails without a warrant because of the 2010 federal court ruling and our bill doesn't change that. so i'm disappointed the commerce department was not asked to join the administration panel given its important perspective but i thank the chairman for having this, a bipartisan number of senators and house members have that joined on this tells us this is an important issue. thank you and happy birthday a day early. >> thank you. before i introduce the panel i would want to put some letters that we received outlining concerns of the current ecpa reform proposals from law enforcement agencies so fively name -- the national association of assistant u.s. attorneys, federal law enforcement officers
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association, the major county sheriff's association, the national district attorney's association. the iowa county's attorneys association. so i would ask without objection that these and i diggsal letters be entered into the record. our first witness is principal deputy assistant attorney general elena tirangel. she also serves as the heads of department of justice legal counsel. prior to joining justice she worked in the office of white house counsel and served as assistant u.s. attorney d.c. before that she was with the national partnership for women and families. she has an underground watt sto undergraduate degree from brown. our second witness, andrew
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ciranzi currently serves as director of the division of enforcement security and exchange commission. before joining s.e.c. he was a partner at has practiced white collar criminal investigations. prior to that, he served as assistant district attorney in new york. he received his undergraduate degree columbia. third witness, daniel salsburg is the chief council of the office o technology, research, and investigation. bureau of consumer protection at the ftc. previously he served at the bureau of consumer protection. before that, he was a senior trial attorney for commodity cftc. mr. salsburg received his undergraduate and law degree from the university of pennsylvania. i want to thank all of you for testifying.
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we'll do it in the order we did. so proceed, elena. >> thank you. >> chairman grassley, ranking member leahy, and members of the committee, thank you for the opportunity to testify on behalf of the department of justice regarding the electronics communications privacy act or ecpa. we appreciate the opportunity to engage with the committee on this topic, which is of particular importance to the department. i look forward to discussing with the committee how the department uses ecpa and how the statute might be updated and improved. ecpa has always sought to ensure that the government can perform its safety and criminal enforcement mission while safeguarding individual privacy. it is important that ecpa reform efforts remain focused on maintaining both goals. electronic communications play a vital role in government investigations. indeed as technology has advanced and as electronic data and storage have augmented traditional means of communicating and storing
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information, appropriate governmental access to data is more important. ecpa is critical to tracking down criminals in investigations into murder, kidnapping, organized crime, child exploitation, identity theft, terrorism, and more, but criminal investigations are only a subset of the circumstances in which ecpa applies. the statute applies when the government acts as a civil regular later, or even as a regular civil litigant. the we agree that notwithstanding several updates to ecpa the statute draws some lines that do not account for the development of technology and the ways in which we use electronic and stored communications today. for example, there's no principled basis to treat e-mail less than 180 days old different from e-mail more than 180 days old.
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similarly, there's no reason for the statute to give lesser protection to e-mail that have been opened than to emmails that remain unopened. personal privacy is critically important to everyone. all of us use e-mail, and we want it to be appropriately protected. and many discussions on enhancing privacy focus on a proposal for law enforcement to receive a warrant from a public service provider. criminal search warrants are only available if an
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investigator can show probable cause that a crime has occurred. the lacking warrant authority, civil investigators enforcing civil rights, environmental, anti-trust and a host of other laws will be left unable to obtain store content of communication providers. as information is increasingly stored electronically, the amount of critical information that is off limits to government regulators and litigators will only increase. efforts to update ecpa can reflect these considerations and ensure appropriate judicial oversight to communications. any proposals to changes should address the ability of civil litigators.
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the department also has several more technical yet important concerns that we believe merit consideration. although discussions about updating ecpa have often focused on this content information, there are other parts of the statute that would benefit from further examination. i would also like to speak briefly about government access to data stored abroad. the administration is studying these proposals, but the department has significant concerns about aspects of these proposals. the department of justice appreciates the opportunity to discuss all of these issues with the committee, and i look forward to your questions today. >> thank you. andrew? >> thank you, chairman grassley, ranking member leahy, and members of the committee. good morning. thank you for inviting me to testify today on behalf of the fcc. i share the bill's goal of updating ecpa's collection procedures, but the bill in its
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current form proposes significant risk to the american public by impeding the afblt the fcc and other civil law enforcement agencies to investigate and uncover fraud and other unlawful conduct. i firmly believe there are other ways to update that offer stronger privacy protections without frustrating the civil ends of law enforcement. the fcc's mission is to protect investors, maintain fair, orderly and efficient markets and to facilitate capital formation. our division of enforcement furthers this mission by investigating potential violations to the federal securities laws. a strong enforcement program is critical to the fcc's effort to protect investors from fraudulent schemes. and promotes investor trust and confidence in the integrity of our securities markets. electronic commune cases often
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provide critical evidence in fcc investigations as e-mail and other message content can establish timing, knowledge, or relationships or awareness that certain statements to investors were false or misleading. when we conduct investigations, we generally seek e-mails through the key actors through a an admin stistrative spina. the subpoena recipient may have erased e-mails, inserted damaged hardware, or refused to respond. individuals who violate the law are reluctant to produce evidence of their own misconduct. in still other cases, e-mail holders are not able to respond. it is at this point in this an investigation that we may need to seek information from an internet service provider or isp. the bill at issue would require government entities to procure a criminal warrant when acquiring e-mail content. because the fcc and other
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several law enforcement agencies cannot obtain criminal warrants, we would effectively not be able to gather electronic evidence directly from an isp regardless of the circumstances, even in instances where a subscriber deleted his e-mails or fled to another jurisdiction. depriving the fcc of authority to receive e-mail content from an isp would also incentive ize subpoenaed individuals to be less forthcoming. they may be emboldened to destroy or not produce them. these are not abstract concerns for the fcc or the investors we protect. among the type of scams we investigate are ponzi and pump and dump market schemes. as well as yep cider trading violations. in these types of frauds, illegal acts are likely to be communicated through personal e-mail accounts. parties are more likely to be noncooperative in their document productions. technology has evolved since ecpa was passed. there's no question the law should evolve to protect privacy
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interests, even when significant law enforcement interests are also implicated. but there are various ways to strike an appropriate balance between these interests as the committee considers advancing this important legislation. as part of that balance, any ecpa reform can and should afford a party's information that is sought from an isp in a civil investigation notice and an opportunity to participate in judicial proceedings before the isp is compelled to produce the information. indeed when seeking e-mail content from isps in the past, the division provided notice to e-mail account holders in keeping with long standing and recently reaffirmed supreme court precedent. in the legislation was so structured, the individual would have the ability to raise with the court any privilege or concern before the communications are provided to an isp. while civil law enforcements may have a limited avenue.
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to abscess existing electronic communications in appropriate circumstances from isps. such a judicial proceeding would offer greater protection to subscribers than a criminal warrant in which subscribers receive no opportunity to be heard before communications are provided. thank you again for the opportunity to be here today. we look forward to working with the committees on ways to modernize ecpa. without putting investors at risk and impairing the fcc from enforcing the federal securities laws. the i'm happy to answer any questions that you have. >> thank you, andrew. daniel? >> chairman grassley, ranking member leahy, and members of the committee, thank you. let me begin by noting that my oral statements and responses to questions are my own and they don't necessarily reflect the views of the commission or any commissioner. having said that, i very much appreciate the opportunity to represent the ftc's testimony. and explain how proposals to reform
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