saturday noon eastern on book tv c-span 2 and sunday on eastern history tv working as we explore america. >> c-span where history unfolds daily. in 1979, c-span was created as a public service by america's cable television companies and is brought to you today by our cable or satellite provider. next a hearing on food recalls. last year the h h.s. inspector general released a report on deficiencies in fda oversight of recalls. representatives from the fd. and health and human services department testified.

>> the subcommittee convenes this hearing entitled safety of the food supply continuing concerns over the food and drug administration's food recall process. disease outbreaks from tainted food are ongoing public health challenge. the centers for disease control estimates that each year one in six americans, 48 million people get sick from food born illnesses, 128,000 are hospitalized and 3,000 die. the number of multi state food illness outbreaks is increasing affecting greater numbers of americans. and the number of vulnerable people, older, and immune compromised individuals is growing. the threat of food born illness persists even though we have gotten better at detecting and investigate outbreaks.

and through the implementation of the hazard analysis and critical control point rules over the last two decades, cdc trend data indicates major reduction in the incidents of food born disease. yet the problem remains significant. when contaminated food reaches store shelves, the fda is last line of defense. they need to protect consumers. in 2010, congress gave fda more power to retain the food. fizz ma was enacted to provide fda with authority to mandate a food recall. in addition to this law, previous audits by both the hhs, office of inspector general, and the government accountability office, made recommendations to fda to improve its food recall program. how has fda performed with food

recalls in recent years with the new law and these recommendations? over the last two years, the hhs, oig looked at this question and last month released a report that contains findings and recommendations for fda. the oig report looked at 30 volumtoll tier recalls. the fda used mandatory recall authority only two times since enactment of physicfizz ma and all over the last four years. in some cases fda was slow to evaluate health hazards. took fda average of 47 days to complete an evaluation after learning of a planned food recall. the oig found that fda was slow in starting recalls. average leebt between recall began once fda new of the safety issue was 57 days. the report also raises questions about the fda's ability to cope

with uncooperative companies. in one company it took ten months after fda issued a warning letter about unlisted ingredients before the firm finally pulled the product. in another case recall of nut butter began more than five months after the fda had traced the out break to the source facility. there were 14 illnesses in 11 states during that time. a series of recalls of cheese products contaminated lister yeah took 81 days to complete. 9 people got sick, including one infant who died, and two fetal losses linked to illness. during that time, the firm owner lied to the fda saying that the firm would suspend the manufacturing and distribution of cheese. however, the owner, despite knowing that the product tested positive for lister a continued to allow the product to be distributed. owner later pleaded guilty to fda crimes and went to prison.

justice was done but they needed to find a way to detect such destepgs owner. oig also found fda did not have a reliable system for accessing the recall initiation date or the date fda became aware of potentially hazardous food products. more than a third of the recalls reviewed had the wrong initiation date entered into their electronic data system called the recall enterprise system. the electronic data system did not include when they found out about the suspect food products. worse, fda does not collect sufficient or accurate data so that the agency can measure performance it tell whether their food recall performance is improving. in addition to the oig findings, fda told committee staff in briefing there were concerns about the turnaround time it takes to get test results from fda labs used to make an evaluation of the seriousness of the food hazard. to ensure the fda labs are

performing properly, they need to provide independent funding and permanent staff to office of laboratory science and safety. this office has not been fully stood up and been unable to inspect fda labs. fda should follow the example of cdc. their office of lab science and safety has dedicated funding and permanent staff to oversee cdc's own labs. the enactment of fizz ma provided fda man torety recall authority tan imposed more legal obligations on food manufacturers and distributors. fda has the tools, but the oig findings and fda own assessments show that the fda needs to reform itself to get this right. i'm heart end that the fda commissioner has recognized that even just a handful of problematic recalls are too many because lives are at stake. i'm also glad the commissioner has announced fda is looking at ways to improve the time limits

and scope of information provided to the public about fda regulated food recalls. i welcome and thank the witnesses and lube forward to their testimony. i'll now recognize the ranking member for the purpose of her opening statement. >> thank you so much, mr. chairman. as you know, food safety is not a new issue for this committee. many of the challenges that we are going to hear about today are the same issues that we have dealt with over the past decade. all of those examples you mentioned were brought up hearings in front of this committee. for example, we held a hearing in 2008 on a major salmonella out break that affected over 1300 people in 43 states. as that case illustrated we lacked basic controls over food recalls, including trace ability. fda and cdc originally identifi identifi identifi identified tomato as likely cause but later on they found

out it was from hajalapeno. yet that case demonstrated that the responses not as simple as just pulling off all the suspected products from the shelves, because entire industries should be devastated. when we had these hearings, where we thought it was the tomatoes, tomato industry was devastated at that time, and it turned out that the problem wasn't even tomatoes, but jalapenos. and so it was clear then, as it is now, that the fda needs the ability to respond to a multitude of different situations that pose risks to the public health. as you noted mr. chairman in response to incidents like that, we pass the fda food safety modernization act in 2011. and many of the members on this committee worked in a bipartisan way on that bill. it gave the fda more tools to

prevent and to respond to outbreaks, including critically new authority to issue mandatory recall orders, and requirements for manufacturing firms to have recall plans in place. but now seven years after we passed the law, the office of inspector general has a new report that points to some of the same issues that we have been worrying about in this committee for years. despite the progress that we've made, here we find ourselves. oig found despite more power to oversee manufacturing firms that produce potentially hazardous food. fda is not doing enough to monitor firms during recall. sometimes there have been long delays in getting firms to recall all their affected product or even to provide the fda with basic information. in addition, in sufficient oversight of firms, fda has also weaknesses in its own recall responses. for example, it's critical for the public to understand the risk that a food product may

present. but oig found that fda was sometimes slow to eval kwat the health hazard posed by a contaminated product. this is not to say that these cases are easy and answers are always crystal clear. the fda is dealing with many recalls every year, each which presents its own challenges and complexities. that being said, i do think there is more the fda can do to improve the food safety system. oig report presents multiple recommendations for fda, such as improving its policies, and procedures for managing recalls and monitoring first. however, i'd like to hear more from oig about what specific steps they think fda should take. a foor more guidance manuals are not enough. we need to know what needs to be change to better protect the american public. as fda continues to implement provisions of sma, the committee

needs to hear how the law is working, what more the fda needs to do, and how congress can help. i'd like to take a moment of personal privilege, if i may. i just saw the form tear chairman of the committee walk into the room, bart stew pack. and congressman stew pack was one of the key players in enactment of this food safety. with that mr. chairman i'll yield back. >> yields back. and i would like to welcome mr. stew pack for his attendance today. good to see you back and welcome you best. now recognize chairman of the fu full committee. >> thank you, mr. chairman. a privilege serving with you. i take this issue very personally. in february of 2009, this subcommittee held the hearings on nationwide outbreaks of

salmonella illness es linked to peanuts. one of the witnesses was peterson. when his son became sick, doctors said to give him his peanut food. his favorite food was peanut butter crackers. that was poisoning. when they tested it, packages were con tataminated. he became ill because the peanut products were contaminated with salmonella when he told the plant manager to, quote, turn them loose. at that same hearing, i confronted mr. parnell with this container. and i asked him whether he was willing to take the lid off and eat any of these products now since he was so cavalier about

turning it loose on little kids like jake to eat. he refused, of course, sighting his fifth amendment rights. thankfully jake over came his illness and great to see him last year. now ha young teenager. he and his dad came back to visit us. more than 600 people in 44 states were sick end and unlike jake, nine people died. as a result, mr. parnell is currently serving a 28 year sentence in prison for his actions. and while this case of pca is the exception and not the rule, fortunately, food born illnesses remain a major concern. chairman harper ran through the numbers. each year 48,000 are sick end, 3,000 die, it has been on the government accountability high risk list since 2007. and just in the past few months dozens of people in the united states and canada and two died

from e. coli leafy green. i was glad to see the fda commissioner commitment with yesterday's announcement that the fda will accelerate the release of information before they officially classified as recall items. we look forward to hearing from the fda today what it plans to do to address the recommendations from the oig. we also look forward to the fda implementing the other expert recommendations to provide proper funding and permanent staff to the fda office that oversees the labs which do play a critical role. i thank you all for testifying today and recent work in december as well as early alert they issued in june of 2016. recent work builds on the past work most notably two reports

related to food recalls related in 2009 and 11. while the reports were issued prior to this act, many of the recommendations in the recent december report are similar, if not the same, as they were in 2009 and 2011. further, the they raised concerns about fda food recall process in 2012. and while fda says it's addressed many of the findings of the recent report, it is troubling that many of the recommendations from almost a decade ago stand today despite the additional authority given to the fda through fizz ma in 2010. today's hearing will give us a good opportunity for fda to share specific plans to address the recommendations made by the oig including the time frame we can expect the time changes to be implemented. i don't see dr. burgs, i know he was looking for sometime. if any one else would like the remainder of my time, if not i'll yield back to the chairman. and i have another hearing i have to go to.

so thank you again for the good work you do. i know we are on the same team. with that i yield back. >> thank you, mr. chairman. now recognize the ranking number of the full committee, mr. pa lone for purposes of opening statement. >> thank you, mr. chairman. this committee has a long history of overseeing food safety. over the last decade we've had multiple hearings examining the food and drug administration's over sight of food recalls and the agency's authority to protect the nation's food supply. fda plays a critical role. in fiscal year 2017 alone, fda oversaw more than 3,600 recalls. this is no small task but we have seen cases that exposed weaknesses in fda's ability to respond to these threats. for example, as i already mentioned, in 2007 a committee investigation into a salmonella out break identified serious flaws in our food safety

network. in 2010 the committee found they had limited authority and did not take swift action when needed. witnesses preet he hadly told this committee that fda lacked sufficient authority to address weaknesses and our food safety system. that's why congress passed the fda safety fizz ma in 2011. and they gave fda new authorities to strengthen the food recall process. for instance, fda now has the ability to mandate recall when a product poses a serious adverse health consequence. this is a significant tool because we have seen cases of manufacturing firms reluctant to cooperate with the fda. and thanks to fizz ma firms are also now required to have recall plans in place to help prepare before contamination occurs. fizz ma provided these new tools, but up to fda to make sure they are being put to good use. that's why this hearing is so important. we need to know they are

implementing. rece recent inspector report says fda may not adequately oversee the recalls. they did not always monitor firms during a recall such as ensuring that firm's initiate the recalls promptly. in some of the cases highlighted in the report particularly troubling for example between 2012 and 2014 nut butter sick end 14 people in 11 states. fda identified the source in march of 2014. but products were not fully recalled until august of that year. 16 five days later. inspector general also cited series of recalls of cheese products that were contaminated with lister yeah and led to one infant's death and two lost pregnancies. and i know eve one on this committee will argue even one fatality is fa toor many. so while we recognize these are

complex and tefr recall poses a unique challenges, these findings dem state the fda must exercise ju dish shus yet forceful over sight when the public's health is at risk. so i look forward how they are implementing it. i don't think anyone else wants my time. so i'll yield back, mr. chairman. >> gentleman yields back. opening statement part of the record, and without objection they'll be entered into the record. i'd like to introduce our panel of witnesses for today's hearing. today we have mist gloria jar vin who is the deputy inspector general of audit services for the office of the inspector general at hhs. we welcome you today. and mr. douglas stern, the director of the office of enforcement and import operations and a fares at the fda. welcome to you both. and thank you for being here today to help and to provide testimony. and we look forward to the

opportunity to discuss the fda's food recall process. >> you are aware that the committee is holding an investigative hearing. and when so doing has a practice of taking testimony under oath. do you have any objection to testifying under oath? both witnesses have indicated no. the chair then advises you that under the rules of the house and the rules of the committee, you are entitled to be accompanied by counsel. do you desire to be accompanied by counsel during your testimony today? both witnesses have indicated no. in that case, if you would, please rise and raise your right hand, and i'll swear you in. do you swear that the testimony you are about to give is the truth, the whole truth, and nothing but the truth? thank you. and you may both be seated. you are now under oath and subject to the penalties set forth in title 18, section 1001 of the united states code. you may now give a five minute

summary of your written testimony. and we will recognize mist jar vin first for your testimony. >> good morning, chairman harper. ranking member deget, and other members of the subcommittee. i am gloria jarmen, inspector general for audit services office of inspector general u.s. department of health and human ser he advises, i appreciate the opportunity to appear before you today. conduct aids evaluations and in expected at food safety is a priority for oig. and remains key to our mission of protecting the health and safety of the american people. i am here today to discuss our recently published report on the food recall process at the food and drug administration. and our recommendations for improving that process. this audit review documentation for 30 recalls which were judgmentally selected from the 5750 reported to fda between 2012 and may 4, 2015.

for the recalls we found that fda food recall process was not always efficient in ensuring the safety of the nation's food supply. specifically identified deficiencies in fda's oversight of information maintained in the data system. my testimony today focuses on key aspects of these three findings and their recommendations for improving the food recall process. first, determined that fda could not always ensure firm recall promptly and did not always evaluate health hazards in a timely manner. to improve oversight we recommended that fda establish set internal time frames for discussing the possibility of voluntary recall with a firm and initiating use of mandatory recall authority.

in addition, we recommended that fda takes several actions to ensure that health hazards evaluations are done in timely manner. second, several deficiencies of firm recalls. specifically we found that fda did not always issue audit checks at the appropriate level. complete audit checks as assigned and collect timely and complete status reports from recalling firms. to improve fda's monitoring of recalls, we recommended that fda take steps to ensure that audit checks are signed at the level specified in the audit program and that product distribution lists are complete and accurate. to take specific actions to ensure that audit checks are completed in timely manner and implement procedures for requesting status reports at the initiation of a recall and follow up with firms that do not provide timely or complete status reports. third, our review of fda's recall data system determined

that fda did not always track key recall data and maintained accurate recall data. to help ensure the completeness and accuracy of data in data systems and give fda staff involved in managing recalls access to information about key events, we recommended, among other things, that fda consider adding to its recall data system or another fda system a feel for the date fda learns of a potential hazardous product. and clarify the definition of recall initiation date in policy and procedures and consistent understanding of recall initiation date among recall personnel. and fda's comments on our report it agreed with our conclusion, that it needs to help ensure that they are initiated promptly in all circumstances. fda said it will continue to consider results of our audit as it moves forward to operate as a score team which stands for

strategic core oversight of recall execution. this score initiative was developed to set time frames, expedite decision making to move recall cases forward, and improve electronic recall data. we appreciate the steps fda has taken as well as the steps it plans to take to address the vulnerabilities we identified during our audit. oig work has demonstrated ways for fda to improve its over sight of the food recall process. and we will continue to work with fda and congress to help ensure the safety of the nation's food supply. again, thank you for the opportunity to testify this morning. and i'm happy to answer your questions. >> thank you, miss jar mon. the chair will recognize mr. stern for five minutes for summary of his written testimony. thank you and welcome. >> thank you. i am douglas stern director of the import operations and office of regulatory affairs and acting deputy director for regulatory

affairs at the center for food safety and applied nutrition. we appreciate the opportunity to provide you with information -- oh, i'm sorry. is that better? we appreciate the opportunity to provide you with information about how we oversee recalls of fda regulated products. fda is committed to continuously improving our practices to ensure that they are completed promptly to best protect con supervisorsers. in this regard we appreciate the focus on ts subject and would like to thank the committee for the opportunity to report on major changes fda has made in response to their investigation. when we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. fda has authority to act in a variety of ways. but often the fastest and most efficient way to ensure unsafe foods are recalled correctly is to work with the companies

simultaneously providing the public with timely information they can act on. making sure fda has effective recall practices in place, and that we take immediate action to address unsafe foods are high priorities for the agency. fda has wide ranging oversight responsibilities. in the foods area fda is responsible for oversight and regulation of more than 300,000 registered food facilities and more than 12 million lines of imported food products per year. fda is also responsible for overseeing industry recalls of food products. in the most recent fiscal year fda oversaw more than 3,000600 food product recalls. recent oig review of selected 30 group recalls initiated between 2012 and 2015 found unseepable delays from removal of food from the market. this group included a number of challenges including criminal behavior from a firm that hid information, new technology, and

key questions about how broad a recall should be. one of the most significant steps fda has taken was in april 2016. fda established a team of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem. score, the strategic oversight of recall execution meets at least weekly and makes decisions what actions to take. score has bn made a difference in addressing complicated challenging and unusual incidents. the team has been involved in cases that range from led contamination of a diet product. score helped expedite the registration suspension of two food facilities, action that prohibit food distribution after a recall.

in addition to score, fda has put in place procedural changes. after year after a review of our recall process, we did a new plan to do recall management. plan helps to standardize the plan, and provides additional training and guidance to our staff, to monitor and effectiveness and increases timeliness and amount of recall information provided to the public. the procedural changes fda has completed since the investigation established a monthly monitor i system and regular audits. improve recall recommendations and check assignments. expand third party recall audit checks. improve the pathway foreign suppliers to provide information about recalls to fda. and in create a set of best practices for state partners. fda will continue to implement additional changes that will continue to improve how we protect the public through the recall process. fda has also improved recall

process and down dramatically from a year earlier. more information to consumers in a number of ways. we now pub size recalls prior to classification. yesterday we released a draft guidance to improve public awareness in additional recall areas and commissioner announced fda will identify a way to share additional information with consumers during recall such as specific stores where recalled food may have been sold. fda also currently pursuing major nsh tifr major initiatives. food modernization act shifts from responding to contamination to prevent tg and change how companies respond to food safety issues. in addition, fda field operations have recently undergone an organization to meet the special challenges. thank you for the opportunity to discuss fda recall processes. i would be happy to answer any questions you may have.

>> thank you very much, mr. stern, for your summary of your testimony. at this time the members will each have five minutes to ask questions of you. and i'll recognize myself for that purpose. and i'll start with you, if i may, mr. stern, and ask you some questions. the office of inspector general and government accountability office in previous audit reports dating back to 2009 has raised concerns about the monitoring of food recalls. such as verifying to make sure that retail grocery stores know about the recalls and the products have been removed from their shelves. yet the december 2017 report from oig finds that monitoring recalls is still a problem for fda. why is it still a problem? and why should the subcommittee believe that the fda is going to get it right this time? >> thank you for your question. sir, i answer in a number of ways. first we do take the issue

seriously. i outlined in my testimony today a number of actions we have already taken. and those included that i just outlined in terms of establishing a group of senior lead tears and audit process, and additional procedures. i would say, too, that ht oversight of the food safety system is a large scale enterprise and we are actively working on fizz ma implementation which is the over all solution that we think will bend this curve in terms of food safety. and it is something that we have been ingrate dialogue with with all the other players involved in this food safety system. >> and i think it would be safe to say that a goal of fda through implementation of fizz ma is through the to reduce the food born. is that fair to say? >> yes, sir. >> is that documented anywhere and is there a time frame? >> i think in terms of the h

h.s. initiatives and agency initiatives there is language that speaks to that. i can say as somebody who is involved in fizz ma impla plen tags myself, i'm on a steering committee, it is something that we are driven to do. we have time frames. at the same time, we think it's really important to get things right. we don't want to have to reverse back if we get a standard that's not correct. and we are actively implementing a lot of the provisions of fizz ma, inspections that started number of areas, rules have been written. so we have a lot of actions that have taken place. >> does the fda view improvements to food recall process as part of achieving this public health goal? >> we do. >> and are you satisfied that you are putting ht metrics in place where we can actually do a quantitative view of what your improvement process is going to be? >> yes, sir. we have taken a number of things

to create more metics and standards. we have a process that tracks during recalls the steps in between each of the sort of the critical control points each of the steps that take place. and we do think that that's important. there is always more we can do. and some of these issues can be complicated but we do think that's important. >> i know the public expects not to maybe do it that day, but the time frame that you've got to shrink that. you bloo eve that you are in the process to do that, to reduce greatly the number of days that it takes to complete this process when there is a recall? >> we do. >> okay. miss jar mon, if i ask you a few questions. what deficiency in the report do they view as the most serious and why? >> as you know, several deficiencies identified. but we feel like it's so important there is better control over oversight of firm's

initiation of food recalls and the health hazard evaluations are done sooner. because we have several examples in our report where the health evaluations weren't done in some cases over 100 days. i think on average it said 57 days. and it's important that that's done so there is better information fda would have where the harm is of the products. we think that's the most important. >> okay. the oig report stated that this review was conducted to determine whether fda's fulfilling its responsibility in safe guarding the nation's food supply, now that it has the authority to conduct mandatory recalls. does the oig see any evidence that the mandatory recall authority has been helpful to fda's ability to carry out its mission to protect the u.s. food supply? >> we are encouraged by the progress that fda has made. we see that there has been progress. but definitely more needs to be done. and maybe more time. because a lot of the things like mr. stern mentioned have been recently done and we haven't had

an opportunity to go back and assess the progress. but the fact that the team was set up with senior he can tiexes a strategic step. and planned recalls is positive. and audit plan is also positive. and that yesterday they issued draft guidance for improving recall process. and all of those things could possibly be related to this legislation, so we see it as steps in the right direction. >> that's right. thank you very much for your testimony there. chair will not recognize ranking member due get for five minutes. >> thank you, mr. chairman. i'm encouraged to hear you say, and mr. stern, i also believe it's true, that the fda is making efforts to improve their systems. the oig's recommendations largely relate to the fda improving policies, procedures, and guidance. do you agree with that?

>> yes. many of them do relate to improving their policies procedures and guidance. and initiating processes sooner, as we mentioned long delays. >> okay. so i'm wondering what more actionable steps do you think fda should take to improve recalls between just improving the policies and procedures? you mentioned initiating the guidance sooner. can you expound on that? >> yes. i mentioned during the health hazard evaluation sooner. like in the report one of the examples that the chairman mentioned earlier about the issue that we mentioned in our early a leather from june 2016 s one related to cheese product and one related to nut butter where the period of time from the time that fda became aware of the hazardous product and the

time that the firm initiated the recall, and that's just the initiation. more has to happen after that to get the products after the shelf. for the nut butter that was 161 days. for cheese 81 days. and that party while we weren't specifically saying in the recommendations what the period of time should be we believe is reasonable to suspect less time than that. >> so the reason why is because if the food is contaminated, more people could be consuming it during that time. >> yes. >> and more illnesses hand possible deaths. >> yes. mr. stern, what's the agency's response to this? >> well, i'd say ta couple things. first as i've outlined we've named a number of our procedures and policies. i'll say one of the issues is to make sure that problem is understood and that a recall actually is solving the problem. the cheese recall that was mentioned there was actually four different recall actions that took place during the course of that. so part of the question gets to, you know, what action is taken, is that sufficient.

one of the reasons that we put score in place, and we feel that's really critical, and also the specialization of the field staff which has been going on for years, is that it's important for people to have the technical expertise to make those judgments, and sometimes to order additional investigation. >> are you having difficulty getting people with the appropriate expertise? >> well, we have to make sure they are there at the table. and it keeps getting more complicated. one of the things that happened during this period of time, and the nut butter recall, we started fr the first time doing entirely new technology, sequencing, gene, we need people to understand the rules mentioned in fizz ma. and so the level of specialization and the level of understanding of the supply chain needs to be high. >> i get it. are you having difficulty tragicia tragici

tracking those people? yes or no will work. >> we are looking for great people in the agency always looking for more. >> would having a stable budget help in that situation? >> a stable budget is helpful. >> okay. so one issue that, as i recall, we really talked a lot about, before we pass the act, was this issue of mandatory versus voluntary recall. and i'm wondering if you are finding because the agency has the ability to do that, if that's helping expedite the recall process more? >> we believe it is helpful. because there is a certain point we reach with a firm and the firm knowing that that hour is there does effect the result. >> and have you noticed since the act passed, the number of mandatory recalls have gone up?

>> well, what often happens, more often than not, it reaches this certain point. and there is it a voluntary recall. and you know, a lot of it, so we do think it has an impact by being there. and usually in firms taking a voluntary recall either because there is mandatory authority or they know there might be a communication from the agency. you no he, those two things are actually drivers in the self-interests. >> nudging them along. >> yes. >> so you know i really appreciate the oig's recommendations and appreciate the agencies implementing them. if you think there is more authority this committee needs to give to the agency to bolster that, and if you think there is more resources or stability of resources to do this hiring, let us know. because this is one of these bipartisan issues we care deeply about the safety of our

constituents. thank you i yield back. >> thank you. chair will now recognize the vice chair mr. griffith for five minutes. >> thank you very much, mr. chairman. mr. stern, i know you are here doing the best you can and that you are trying to make everything better but there is some serious questions that i have related to a number of different things, but i'm going to start with the nut butter situation. because we just touched on a couple of those. one mandatory authority. if you look at the time frame which is attachment a in the report, you look at the time table there on their chart, page 30 of what i have, but you may have something different. you all exercised or let them know that you might use mandatory on august 15th, and they voluntarily recalled on august 19th. so i think in response to miss deget questions it worked because you told them you were going to do it and four days later we'll do it voluntary. the problem i have in that regard you said that part of the

problem was the new technology, the whole genome sequencing. but here's the question i have. there was enough information that something was going on that you all opened up an investigation in february, late february. six weeks later, you actually under using the older technology, matched an uncommon strain of salmonella to that that silt. th facility. that was march 24 and connected to some of the folks who had gotten sick. nothing was done apparently up to that point, there may have been some letters, i don't know. but then the whole genome sequencing was on august 12th.

entire industry with recall that's not justified, you had that confirmation on may 12th. so may 12th, june 12th, july 12th, august 12th all went by. eventually three months and a few days later, you then threatened the mandatory recall. >> right. >> so the question is, american people who are watching this either live or later when having insomnia are going to ask, okay, we want to make sure we are doing the right thing, maybe you can justify, although there is a question mark there between march 24 and may 12, but once you have the whole genome sequencing and there is no distinguishing between the salmonella in the sick people and in your environmental, and i know i'm using the scientific terms, but the sick people and in the nut butter, why didn't

you act then? >> so there is a number of issues that make this complicated. if i could go back. so there was a link under the pfg pattern in march of 2014. it's important to understand that a couple things. >> folks back now don't know what is a pfg. >> this is pulse gel, and that helps link the clinical to the facility. it's something we've been relying on for a while. it's not perfect because it's limited in the comparison of those organisms. and shows there is a strong link between what those organisms actually are. something like -- >> that's what you linked up in march. >> that's what we linked up in march. i'll tell you our expert analysis was not enough to show

causation at that point. >> okay. >> it was done differently. usually there is a food history, what did you eat, then link that back up, then look at the pfg, that didn't happen in this case. people did something new in this case, they went through some of the data bank and linked that up. they linked it up with ffge and whole genome sequencing and excited about that. and it has been something that we've used that is linking up to the database and something very promising. but there were delays in this case. and i should say, first of all, i think we could have done better in this case. i'll tell you that when we did the whole genome sequencing we did it for the environmentals in may. it was not until august that we linked it to the chemicals. that was delay in doing the sequencing link which was the trigger for that request for

mandatory recall and ts discussions with the firm that resulted in recall. there were things that i think could have been done differently in this case, but i do think it's important to understands some of the complex tis. this was not an obvious case on day one. and in fact a number of these cases it's not obvious on day one. it's very important that we accelerate our own investigation. it's important that firms have their own investigation and their own preventive models. but it was less than clear to the people who had that, you know, back in march, because there were environmentals which were concerning, but the links to the clinicals were less than crystal clear. like i said, it wasn't supported at that time by the food histories. and the firm tested all the product and it was negative. so story is a little more

complicated. but at the same time we take the oig point in this and we agree with it. we need to make sure. it's not okay if it takes this long even if it's complicated, that's why we have this approach in place where we feel we need to make sure that the agency leadership and the staff are prepared to know what is a red flag and act on it to make sure we get to the right result as soon as possible. >> i appreciate it. and yield back. >> gentleman yield back. chair will recognize from new york mr. ton ka for five minutes. >> thank you, mr. chair. this committee has repeatedly heard that fda must manage food recalls more effectively. that is why congress gave fda new authorities under fizz ma in 2011. fda has told us it is taking steps to improve that recall process. however, the oig's report finds that fda's data on food recall is often incomplete or inaccurate. which makes it difficult, if not

impossible, to tell how things have improved since congress gave the fda new tools. for instance, fda's recall data system does not track key milestones, such as the date that fda learned product was potentially hazardous. so miss jar mon, can you offer some in sight about why those data are important, and how incomplete data make it difficult for fda to manage food recalls? >> yes. it's very important that the data in the recall systems is it complete and accurate. that way they can -- i mean, that's key to monitoring the food recalls. and like we mentioned in our report, there was no data in there for when fda became aware that an item was potentially hazardous. and so in some cases, so without having that date there, it's not possible for them to determine how long it took them from the

time they became aware that the product was potentially hazardous to the time that the food recall initiation occurred. and in some cases some of it longer examples that we have, like one which was die tary supplement which was 303 days that they knew it was hazardous, 30 three days later the food recall initiation occurred. because that date wasn't in the system. if you look at the fda system it was ten days based on because they had the dates in the system were not correct. . so it's very important to make sure that the actions happen faster. >> right. i thank you you for that. oig points out because fda doesn't record the date when it learns a product is potentially hazardous, fda count determine, to instance that it took firm 151 days to actually initiate a recall of hassle nuts

contaminated with salmonella. they claim it would be time consuming to track this. if they don't how can you tell if firms are not moving swiftly enough and when to make more aggressive action? >> nauthank you for your questi sir. we do think it's important for the agency to record when there is a critical hazardous step. there are a number of issues in terms of our systems and how they interlink. we have different systems for different purposes and what kind of information that can be in there. we take this point. we are looking at trying to make sure that our procedures clarify and make sure that the records are correct when it has tipped over. and we are going to continue to work on that. >> thank you. in addition to incomplete data, oig also found that fda did not

always collect timely and complete status reports from firms during a recall. miss jar mon, does that hinder the efforts to oversee the recalls? and how so? >> yes. because it's important after the firm initiates the recall, that fda is also monitoring what's happening after that period of time so that in case of course when the initiation first starts, the parrot ukproducts a still on the shelf and verifying different things related to the product. and we found in some cases status reports weren't received over 100 days until after this process the firm had been communicated their story of the recall. so it's important that fda continues to check on this status and monitor the firms when they are in the recall process and the start us report is one way to do that. >> thank you. and mr. stern, does fda agree that it needs to improve its

collection of these status reports? if so, what steps do you think we should take? >> yes. well, let me say first that we would like to have better status reports. it is entirely a voluntary process. so right now historically and during this time there is no obligation for firm to provide us status reports. and we do think that that will be improved through the implementation of the preventive control rule which requires firms to have recall plans. so first time fda will be obligation in terms of how they conduct their recalls. a third party audits for recall audit checks we think are really critical. we did have extended discussion with oirks ig about that. we did expand that program. that gives us a lot more flexibility and turns around our recall audit check process much faster. and we do think consumer notices are appropriate because it sort of jumps over that whole recall

system and gets the message to where it needs to be. >> thank you very much. mr. chair, i yield back. >> gentleman yields back. chair will now recognize the gentle lady from indiana ms. brooks for five minutes. >> thank you, mr. chairman. thank you and the ranking member for holding this important oversight hearing today. as the committee is well aware, bio defense issues are something that i've been working on public health security is the top priority as we look at how we oversee our food supply, it's a security issue as well as to how it impacts threat to our food system that can be devastating. much of our nation's corn soy comes from my state of indiana. and i know and believe that our nation needs a stronger system of monitoring animal health, both for the threats to our nation's food supply but also potential outbreaks in the animal population and jump to humans.

and should a bad actor effect our food cysupply i'm not sure we are equipped to see if it's airborne or manmade. and in the case of a bio terror attack timely response is crucial, but i know it can be difficult. so with that, mr. stern, i'm interested in fda's efforts to protect the u.s. food supply from bio terrorism or economically motivated a dull tur ration and what steps has the fda working group on economically motivated a dull tur ration taken to improve protection of our food supply? and more directly, so how would fda as we are talking about these types of food recalls coming from manufacturers, but how would fda respond if there could possibly be a terrorist attack? >> thank you, ms. brooks. there are a number of points i would make. first, there is, as part of fizz ma, intentional adult ration

rule in which firms are to look at their own risks, related to potential a dull tur ration from other parties. so that's one component. we do have a food defense group within fda that monitors some of the intelligence and works with many some of the intelligence to try to make sure that that we are able to monitor what's coming in from outside of the country. largely, in terms of food defense. and we also believe that having preventive food safety system, generally, allows for closer monitoring what's coming in and making sure folks understand what's happening in their own supply chains. and that's the kind of danger we have seen in some of these incidents that have happened historically sometimes something happens in supply chain and brought into the united states and then we have issue. and then this system that's

being created within fizz ma helps to have people monitor what's happening throughout the supply chain, which is in part also helpful to combat those issues. >> i appreciate that. but now this is as of december 2016, and here we are in january 2018. the fda as of december 2016, i'm curious if something has changed, the fda still hadn't immediate a 2011 gao recommendation to provide written advice to centers and offices on avenues to address economic adulteration. has that changed? has the fda created a document used to meet the recommendation from 2011? >> i think i'm not aware of such a document. i do know there was a group that looked at this issue and found it very challenging. i've spent some of my career at fda looking at the heparin issue for several years. i worked with the committee on that. there's a lot of different ways this could happen. so i think in large part, the

answer that the agency is looking for is to look at standards that get applied throughout the supply chain because the places we've seen this enter, the places we've seen economically adulterated products coming in, it's usually where there's a lack of accountability within the supply chain. that's what we think is sort of the most effective strategy. >> so you indicate that there are a lot of obviously strengthening our systems against bioterror are incredibly complex, but can you talk with us about some of the impediments and challenges that your group and those who work in that group are experiencing so we can help break down those impediments. >> coordination of intelligence can be a challenge. we do have a group that works with cbp at their counter-terrorism center and i would say just generally, that's an issue because there's a lot of coordination that needs to happen and because it is

secure information, that can be a challenge. >> we've been working on that since 9/11. and it's now 16 years later. so you're saying there's still a challenge with your agency working with cbp on the supply chain? >> what i would say is it's one of the issues we deal with is try to make sure that the intelligence is where it needs to be. i'm not prepared to go probably any deeper than that at this point. i would say also the intentional adulteration rule is something the agency came out recently that does address that issue. >> thank you. i yield back. my time is up. >> the gentle lady yields back. the chair will now recognize the gentle lady from florida, miss caster, for five minutes. >> thank you for calling this hearing today and thank you to our witnesses for the work that you're doing. the issues we're talking about today have serious real world consequences. a single contaminated food product can have devastating

impacts across the country depending what it is and how it spreads. as an example, the oig report cited a 2014 recall of cheese products contaminated with listeria. that product contamination is particularly troubling because it led to one infant's death and two lost pregnancies. according to oig, 81 days elapsed between fda becoming aware of the adulterated product and the firm recalling all of the affected product. i understand that this case is particularly complex and fda was even given misleading information from the firm. but i'd like to walk through this recall and try to shed some light on the lessons learned. mr. stearn, fda learned about the contamination on july 28th. then spent a month inspecting, testing samples and requesting an update from the firm. you had previously mentioned

that it's always important that fda accelerate recalls. could you give greater detail on this case? how could fda have shortened that phase of the recall? >> one thing i would point out, there's actually a number of different recall actions that took place. there was actually four different recall actions that the firm took that oasis took during the course of the time period referenced. the first was there was a positive sample where one of the firm's cheese products and in less than a week, there was a recall of that particular product. fda initiated an inspection of the facility. we did act quickly to follow up with that. during the course of that inspection, there were environmental samples that were positive. we went in and did a lot of sampling in the firm. there were a number of things

that were positive and there was a frank discussion with the firm after that. the firm made a series of promises. the firm actually, first the firm said they would stop manufacturing. the firm also said they would stop distribution until they had consulted with fda and the firm said that they would bring in an expert and to do additional testing, and the firm also committed to do a recall of some product which they did initiate that was implicated by the environmental testing positives. and so you know, that happened and then after that, the firm continued to manufacture at a certain point and did distribution. and -- >> i also understand that after fda conducted its test it received a brief letter from the firm on september 11th that reportedly "lacked significant supporting documentation." but then the firm, as you said,

distributed potentially adulterated product after that. but then fda didn't conduct another follow-up inspection until nearly a month later. why didn't fda take swifter action after receiving the response from the firm september 11th? >> fda believed the firm was not manufacturing at that time, based on what they said and not distributing. i think -- i say that at the same time i say i think there's more the fda should have done in this case. and in some respects it gets to the issue of a preventive mindset versus reacting. >> because it was when fda conducted its follow-up inspection on october 7th, it again found the presence of listeria and at this point, this was 45 days after fda first learned about the contamination.

however, it took the firm another ten days before it voluntarily recalled all of the potentially contaminated product. at that point, what could fda have done different to encourage or mandate a faster and fuller recall? >> this gets back to how some of these things can be complicated. the firm did act when fda brought some sort of positive sample to it. they initially did a recall related to the first product sample. after there was an environmental, the firm made a series of promises which turned out to be lies. they were false. you know, and we didn't find out fully about that until going back on inspection. but you know, the firm said a lot of things that would be the kinds of things that fda would want to hear. we're going to stop manufacturing. > if they're not truthful with you or don't follow through, how do we hold them accountable? >> i'd say a couple things. it's important always to verify. even this firm's recall

activities i think should have been broader. there should have been a broader recall earlier. we had a product sample positive. we had environmental samples. we had bad practices that were documented in the firm. that's a pretty strong set. the firm made a lot of promises. the firm i think even given that more should have occurred. >> but the accountability answer. >> in terms of it, one thing i would notice that the owner was prosecuted. fda does have as office of criminal investigations. the deterrent message is important. and also, we need to verify, one of the reasons and oig mentioned recall audit checks, it's important we do those to make sure they happen. it's important we have follow-up inspections to make sure what was promised gets done. fda has verification procedures it needs to use, and in issues like this one, we need to use

them quickly. >> i yield back. >> the chair will now recognize the gentleman from new york, mr. collins, for five minutes. >> certainly food safety is a universal concern and this is not a partisan hearing at all. we're generally trying to get to an understanding of what does happen. so let me back off just a little. we say there's about 3,000 recalls a year. that's about ten a day. roughly how many of those are voluntary firm initiated and how many of those would be mandatory recalls driven by the fda? >> virtually all are voluntary. >> that's what i would expect. the threat certainly of the mandatory is there. since these are voluntary, whether it's under pressure or not, how quickly does the fda classify those as a class one, two, or three? >> so i think oig referenced some of the earlier data. most recently we were doing that within 13 to 15 days within the food program.

>> i'm assuming that if it is class one, you know, that's when somebody's hitting the buzzer with the red lights and so forth, that you do a lot more detailed work, analysis, urgency for a class one? >> it is a red flag. >> so roughly how many class ones a year do we get versus two or three? >> i think it's in my written testimony. i'd have to get back to you with the exact number. >> is it 10% or 80% class one? >> it's in between those two. so i don't have the exact number. it's -- i would hesitate to give a number when i'm not sure. but it is in between those. there's a significant proportion but it's not the majority. >> if it was 20%, that would be two a day, roughly. now, do you have the staff that you know, that is one person given oversight of that particular recall so you got two

every day that are class one voluntary recalls. is that a team that goes to work or a single person? >> we have recall coordinators that are throughout the country. one of the things we've done in our recent reorganization is we've specialized that staff so there's a recall coordinator who interacts with the firms and other components that do other things that are related to recalls. so -- but a lot of that is run by our field staff locally. >> so you know, your inspectors are in these facilities every day. >> yes. >> sometimes they literally have offices there. >> yes. >> we have to rely on the professional nature of the company itself. i'm thinking of quality manual, you, i'm sure, are always reviewing the quality manuals. as you said though, i was a little disturbed to see, you

don't currently mandate a recall procedure or plan with each company that you review so your inspectors are not auditing recall plans today? >> well, right now, recall plans, before the passage of fsma and the implementation of preventive control rule, there was not any kind of mandate that a firm have a recall plan. >> that would be a concern. >> so i will say when there is a recall and traditionally we will follow up and that happened in these, even in these 30 cases, other cases that have traditionally happened where there's a recall, we do follow up with that on inspection ordinarily in the next inspection to make sure, and we try to do that quickly to make sure there's some review of what occurred. the difference is, you know, what's the, you know, legal requirement, what standard do they have to do. we were talking about status reports. do they have to do status

reports. what do they have to do in a recall. fsma helps standardize that. the firm has to plan when there's a hazard to make sure there's some kind of plan to address recalls in particular, whereas before it was more reactive. >> common sense, if you don't have a plan, then it truly would be haphazard at best. so i would hope your inspectors were in there every day, constantly making sure the ts are being crossed, the is dotted. >> thank you, congressman. i got a note related to your earlier question. we are at about 1200 products class one out of our 36 -- little more than 3600. that's roughly a third. >> that's actually higher than i might have expected. i only have a few seconds left. how often does your lab do independent testing versus relying on the company data to assess the risk? >> we do part of the things you mentioned and some of these

where we have a -- there's a certain risk profile if it hits a certain risk profile, we do testing in the environment of that facility. in addition, if we have reason to, we have different types of surveillance testing. we have it at import and have it in the domestic realm and those all go off to our lab. we do do a lot of testing ourselves. firms also have their own testing programs for various reasons. >> that you rely on, as well? >> that is part of our oversight, to look at what they're doing. >> my time's expired. i appreciate your answers. i yield back. >> the chair will now recognize the gentleman from pennsylvania, mr. costello, for five minutes. >> thank you, mr. chairman. mr. stearn, as you know the oig report identified a number of deficiencies in the food recall process. and i wanted to direct your attention to figure one that shows the days it took firms to initiate the recall after fda

learned a product was potentially hazardous with specific reference to the nutrex research incident where it took 303 days to execute a recall after the warning letter was issued. first, is it correct in this particular case, it was found that the firm continued passing out free samples after receiving their letter? >> i am unsure about that specific fact. >> is that easily obtainable for you to provide us in short order? >> i could. >> i appreciate that. are fda actions after a warning letter typically delayed for 300 days? >> no. >> how often on average or is it customary or within the realm of acceptability for the fda to take an enforcement action after issuing a warning letter? what's the typical?

>> there's some variation by program. i say ordinarily, we go back within six months. in certain areas, clinical trials, for example, it tends to be longer because there's got to be enough data to actually monitor what's occurred. but this is -- this is not what ordinarily happens or what we should expect. >> are the delays of a recall more of a problem with dietary supplement products? >> i would say, you know, there are -- this is a good answer. one of the issues that occurred here in these dietary supplements, there's an ingredient dmaa. there's some controversy about that. there has been some litigation related to that. so -- and i could follow up, we could follow up with you in some ways. i would just say where some of the issues are scientifically challenging, the firm did challenge some of the science about the safety of the

ingredient in this case. >> and then final question on this line of thought. what lessons can you share that you've learned from the nutrex research case? >> i would say overall, in terms of the lessons, i think we would say it's important for the agency leadership to look very closely especially at high priority things that we have at class one. that is the kinds of things that have the highest risk. we need to do that prioritization and investigate mange sure we have systems in place to act where that occurs. >> do you -- were systems in place at that time and were not followed, or were the systems incomplete or insufficient? >> i think in this case, one of the issues that was related to the fact that this is not the

safety of dmaa or the unsafety of dmaa which is the ingredient at issue there is not -- there's i would just say there's a controversy or different ideas about that. and you know, to some extent we have to resolve that sometimes in the court system. >> to the extent that the -- that a warning letter triggers the type of litigious activity surrounding the safety of a particular element, does that give it higher priority or does that add to the priority or is that something within the systems that you have to address? >> i think we need to prioritize and you know, your question is a fair one. if we have -- there's a number of warning letters that come out that the agency has a lot of different issues.

if it's an issue that we find to be one that has potential harm to consumers, it's a higher risk issue, we should make sure that that gets addressed. >> yes, because it strikes me that i didn't do this kind of work as an attorney but if -- or if you were a gc for a company. if you have a product on the market, the product is doing well, you get an fda letter saying this is a warning letter, et cetera, et cetera, et cetera, number one, i don't think many companies would put a product on the market that they felt was deadly or that would trigger that first tier -- well, any tier but particularly that first tier. but the question becomes, it is pretty reasonable or expected to assume that you're going to get response that says wrong, we're going to take you to court or this issue is going to be litigated. that should not freeze you up in terms of addressing what you have identified as a potential

health issue. >> i would agree. >> so what do you do about that? >> we need to -- if again, i think as is the kind of issue that you flagged where there may be disagreement, if it's something that the agency finds is a threat to consumers, we have to prioritize that and we need to make sure that we bring it forward. >> do you have sufficiently expansive regulatory authority in order to do that, or do you need any statutory assistance? >> we're not asking for any authorities today. >> very good. appreciate your answers. yield back. >> the chair will now recognize the gentle lady from illinois, miss schakowsky for five minutes. >> thank you. i want to focus on fda's mandatory recall authority. the oig's report describes some concerning contamination cases

that unfortunately this is not the first time we're hearing about such outbreaks. in fact, this committee has been investigating fda's food safety efforts and recall practices for well over a decade. over seven years ago, fda told the subcommittee that mandatory recall authority would help it remove dangerous products from the market more quickly. congress then passed the fda food safety modernization act fsma which gave them the very authority and significantly reformed the agency's ability to prevent and respond to outbreaks. now we're here again discussing these issues. i want to find out how the law is working. mr. stearn, overall, has fsma helped fda oversee food recalls, particularly regarding inspection resources? >> yes, i would say so. >> you have had enough resources in order to do the job? >> i believe we have enough resources within what's been --

>> here's then -- congress gave fda this authority to help the agency respond to contaminated foods faster. however, the oig reported that between 2011 and 2016, fda used that authority just twice. just yesterday, commissioner gottlieb stated and i quote it, our recall authority -- authorities and how we deploy them are a cornerstone of our vital consumer protection commission. so mr. stearn, given that your recall authority is the cornerstone of the agency's consumer protection mission, can you explain why fda has only used its mandatory recall authority twice or a few times, anyway? >> thank you for your question. first, i would say our goal is to remove the product from the marketplace, if it's unsafe. so the first -- that we start with that as a precept. ordinarily if a company is

willing to do that, that's going to be the fastest way to make sure that that gets done. we have a number of, as i mentioned earlier, we do think that mandatory recall is one of the things that when we get to a certain stage with a company, generally convinces that company to recall if it's the right thing that it does play a role in the background in our discussions as well as some of the consumer communications that the agency uses. so i would say that's really one of the things in the background which is also to say there may be cases where it's appropriate and we should be using it if other actions aren't happening quickly enough. >> so the fda has to meet certain standards before it can invoke the mandatory recall authority, is that correct? >> that's correct. >> are there difficulties in meeting that standard or do you feel that having it there is a

threat is sufficient? is that what you're saying? >> what i would say is a lot of the issues get into the facts. there are some complexities about identification of products sometimes and the level of hazard within products. and in -- we ordinarily don't have issues with firms when there's like a pathogen in a particular lot of a product. a lot of the times that we have issues is what about the other products made at that facility. that happened actually in the cheese recall we mentioned earlier. and what level of evidence is needed for that. sometimes there's a kweshgs question, sometimes i would say there's a scientific or factual question about identification, the level of risk and so forth. so those are things that i think and again, back to why we have reacted to the oig's report the way that we have is that you know, our centerpiece really is score. is that our centerpiece is to

make sure that the leadership of the agency from different components when there is a red flag make sure we do whatever we need to do to get to the right answer quickly. when we get to the right answer, we believe we can make it happen quickly. >> there's some concern that fsma has not been fully implemented and enforced. is there anything we can do to speed up that process? >> we are actively working on fsma implementation now. i'm very much engaged in that myself. and i don't have anything today. i can bring that back to the agency if there's anything else to add. >> thank you. i yield back. >> gentle lady yields back. the chair will now recognize the gentleman from georgia, mr. carter, for five minutes. >> thank you, and thank both of you for being here. this is a very important subject particularly for us in the state of georgia. we had the unfortunate incident some years ago with the peanuts. that's still fresh in our minds. mr. stearn, when you released

the updated guidance yesterday on accelerating the recall process, part of it included stepping in if a company for the fda didn't -- for the fda to step in if a company hadn't sufficiently addressed the recall. how do you determine if they've sufficiently addressed it or not? >> the guidance yesterday, we released talks about public warning and notification. it talks about when we think a company should issue a warning and we describe how that should be done and when fda will issue public warnings as well as some changes in notification. this goes back to the issue we were talking about earlier in terms of the fda has to get to the right answer in terms of evaluating the issue as soon as possible. so if we understand the issue, we look -- we think it's best when we have a consistent message with a company that's responsible. there's not dueling messages. it's clear. and that's what we -- >> how often does that happen?

>> i mean, i would say the overwhelming number of times we can get to the right answer in terms of our communications with a company. there are times where -- and it's not the usual case. >> is the right answer always your answer, or -- >> i'm sorry? >> is the right answer always your answer, or does the company -- >> well, we do have a dialogue with companies. we do listen to them. some companies have -- i've been engaged in a number of technical conversations where a company has said things that have changed our minds. so that does happen. sometimes we're dealing with a company, though, where you know, their -- they don't understand the problem. we need to get a message to consumers. if they're not willing to do that, we have to be willing to do that. >> if that is the case, are there repercussions for that company? >> ordinarily, in most of our class one recalls the firm prepares a press release. we comment on that press release

and want to make sure it's actionable for consumers. if a firm will not or cannot do that, the fda will, or even if we think it's appropriate even if a firm has done it because we have to reach a certain population or there's a way to do it we think is necessary, fda will issue its own consumer communication. >> you issue it. are there any penalties to to the company or anything? >> oh, to the company? no -- >> if you have to step in and you have to exert that energy and you have to exert that authority, you know, there ought be ramifications. >> right. i mean, i do think one of the things i go back to which is not fully developed but under the preventive controls rule within fsma, firms have to have their own plan and -- >> is that approved by fda? the recall plan? >> well, it is not formally

approved, but it is, i say when we go in, we do have some oversight responsibility. they have an obligation to do it. we could, you know, exercise some regulatory oversight if a firm did not act appropriately in that regard. >> okay. let me ask you in december, the inspector general's office of hhs released a report on food recall, the process. and understand when the fda learned that a product was potentially hazardous, fda stated that tracking this data for all recalls would be time consuming and difficult, as the date may be located in different fda systems or obtained from sources outside of fda. what kind of sources outside fda are you talking about? >> we work with states a lot. sometimes states have their own -- there's a lot of state inspections, that states may find a food safety issue that they communicate to us. sometimes we have information

that comes from foreign governments. sometimes we have information that comes from third party sources. >> if that's information that is concerning, i mean, is there a time when the state feels like fda needs to know this, they send you that information? >> yes, that happens. in fact, it happened in one of these cases. we worked with -- virginia did some testing that kicked off the cheese recall we were discussing earlier. >> so you basically, you feel like you have all the information that you need? that's the question because i know you can't make a decision until you've got all the information. >> i think i would just say one of the challenges we have and i think it is a challenge is we deal with thousands of firms and there are a lot of different food safety issues. and these days we're also getting information from different sources. and that, in fact, happened in these cases. we need to find, we take the point, we need to find a way and part of the question is how. we need to find a way to make

sure we get all the relevant information in as soon as possible to make sure we get to the right answer. we take that point. i think technically, there are some challenges, there are challenges within our data systems. we have a lot of different ones. >> is there anything we can do to assist you with that? >> i would have to take that back to the agency. >> we're ready and willing, okay? thank you for the work that you do. it's extremely important, both of you. thank you very much. i yield back. >> the gentleman yields back. i want to thank you, miss jarmon, and you, mr. stearn, for taking the time to shed light where we are and recognizing the importance of this issue. we appreciate you being here today. i remind members they have ten business days to submit questions for the record. i ask that the witnesses agree to respond promptly to any questions that are submitted. with that, the subcommittee is adjourned.

this weekend on american history tv on c-span 3, saturday at 8:00 p.m. eastern on lectures in history, university mark polatt on president lincoln's portrayal in art and photographs. >> mr. lincoln, give me back my 500,000 sons, meaning the soldiers that have been lost in the war. this is during the civil war. this was in the darkest hours of the civil war, 1864. then lincoln, who the artist shows with his legs slung over his chair like he's a country bu bumpkin, right, his reputation for being so kind of inelegant and crude, he says well, the fact is, by the way, that reminds me of a story, which was another part of his reputation. he was always telling stories and homilies and tall tales and jokes, sometimes to a really irritating extent. >> at 10:30 p.m., from the american historical

association's annual meeting, a discussion on free speech on college campuses. >> intellectual diversity, i think, is healthier than many people suspect. now, that doesn't mean that there isn't an issue where certain students' views and certain groups have felt that they have received less active attention from the faculty and the administration, and i include conservative students in that group. they have received less public attention, and i think we need to meet those students where they are and to help them to develop a place in our public conversation where they feel more included. >> sunday at 4:00 p.m. eastern on real america, the 1987 film "drug abuse, meeting the challenge." >> anyone that says cocaine's not addictive, they liech. >> cocaine's not hip. it's hype. anyone who tells you it's okay

is a liar. >> watch american history tv every weekend on c-span 3. >> sunday on c-span's q & a, author and harvard law school professor noah feldman and "the three lives of james madison, genius, partisan, president." >> the constitution is madison's monument. in that way, the constitution is all around you when you come to washington, d.c. the whole three-part structure of government. the way that the government interacts, the way people speak to each other, the exercise of their free speech. all of that is his monument. sort of as was the case in st. paul's, where sir christopher rand's monument says if you seek his monument, look around you. similarly, if you seek madison's monument in washington, d.c., look around you. you will see it everywhere. >> that's sunday night at 8:00 eastern on c-span.