month with a look at 12 new supreme court cases. each week historians and experts join us to discuss the constitutional issues and personal stories behind these significant supreme court decisions beginning monday, february 26th, live at 9:00 p.m. eastern and to help you better understand each case we have a cam pan onguide written by veteran supreme court journalist tony morrow. landmark cases, volume 2. the book costs $8.95 plus shipping and handling. to order go to c-span.org/landmark cases. >> the office of inspector general late last year identified what it called deficiencies in the food and drug administration's oversight of the food recall process. the house commerce subcommittee on oversight and investigations held a hearing on the issue. officials from both hhs and the fda testified.

the subcommittee convenes this hearing entitled safety of the u.s. food supply, and continuing concerns over the food and drug administration's food recall process. disease outbreaks from tainted food are an ongoing public health challenge. the centers for disease control estimates that each year one in six americans, 48 million people get sick from food borne illnesses, and 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 over and immune compromise individuals is growing. the threat of food borne illness

persi persist even though we've gotten better at investigating outbreaks and through the implementation of the hazard analysis and critical control point rules over the last two decades, cdc trend data indicates major reductions in the incidents of food borne disease, yet the problem remains significant. when contaminated food reaches store shelves, the fda is the public's last line of defense. the fda needs to be able to quickly and effectively help remove dangerous foods from commerce and protect consumers. in 2010 congress gave fda more power to recall tainted food. it was conducted 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 the report that contains findings and recommendations for fda. the oig report looked at 30 voluntary food recalls overseen by fda between october of 2012 and may of 2015. the fda has used its mandatory recall authority only two times since the enactment of fisma and not at all over the last four years. the fda was slow to evaluate health hazards. it took fda an average of 47 days to complete an evaluation after learning of a plan or in progress food recall. the oig found that fda was woefully slow in starting recalls. the average length of a recall began once the fda knew of the issue was 57 days.

the report also raises questions about the fda's ability to cope with uncooperative companies. in one case involving a dietary supplement company it took ten months after fda issued a warning letter about unlisted ingredients before the firm finally pulled the product. in another case a recall of nut better began more than five months after the fda had traced the salmonella outbreak to the source facility. there were 14 illnesses in 11 states during that time. a series of recalls of cheese products took 81 days to complete and nine 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 listeria continued to allow the product to be distributed. the owner later pleaded guilty

to crimes and went to prison. the fda needed to find a way to detect such deception sooner. fda did not have a reliable system for accessing the recall initiation date or the date fda became aware of potentially hazardous food products and it was the fda's electronic data system called the recall enterprise system. the electronic data system also did not include when fda first found out about the suspect food products and worse, fda does not collect sufficient or accurate data so that the agency can measure the performance whether the food recall is improving. in addition to the oig findings, the fda told committee staff in a briefing that there are concerns about the turnaround time it takes they're used to make the evaluation of the

seriousness of the food hazard. to ensure the fda labs are performing properly, it's the office of laboratory science and safety. this office has not been fully stood up and fda should follow the example of the cdc. the office of lab, science and safety has dedicated funding and permanent staff to oversee cdc's own labs. the enactment of fisma provided recall authority and imposed more legal obligations of food manufacturers and distributors. fda has the tools, but the oig's findings and fda's own assessments show that the fda needs to reform itself to get this right i am heartened that the fda commissioner has recognized that a handful of problematic recalls are too many because lives are at stake. i am also glad that the

commissioner will look 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 look forward to their testimony. i'll now recognize the ranking member mr. get for the purpose of her opening statement. >> thank you very much, mr. chairman. >> as you know, food safety is not a new issue for this committee. many of the challenges that we're going to hear about today are the same issues that we've dealt with over the past decade. all of those examples you mentioned were brought up in hearings in front of this committee. for example, we held a hearing in 2008 on a major salmonella outbreak that infected over 1300 people in 43 states. as that case illustrated, we lacked basic controls over food recalls including traceability. fda and cdc originally identified tomatoes as the likely cause of the outbreak,

but later on they found out it was because of jalapenos. this was frustrating to all of us because lives were at stake, the federal response was slow and inefficient and yet that case demonstrated that the response is not as simple as just pulling off all of the suspected products from the shelves because entire industries should be devastated. when we had these hearings where we thought it was the tomatoes, the tomato industry was absolutely 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 and 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've 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 a recall. sometimes there have been long delays in getting firms to recall all of their affected product or even to provide the fda with basic information. in addition to insufficient oversight of firm, fda his also we

weaknesses in its own recall responses. it's critical that the public understand the product may present. oig found that fda was sometimes slow to evaluate the health hazard posed by a contaminated product. this is not to say that these cases are easy and the answers are always crystal clear. the fda is dealing with many recalls every year, each which presen presents its own challenges and complexities. that being said, i do think there's more the fda can do to improve the food safety system. oig's report provides multiple recommendations for fda such as improving its policies and procedures for managing recalls and monitoring firms. >> however, i'd like to hear more of oig about what specific, meaningful steps it thinks fda should take. guidance manuals are not enough. we need to know what actually needs to change to help better protect the american public. as fda continues to implement

provisions of sma, the committee needs to hear how the law is working and what more the fda needs to do and how congress can help. >> i would like to take a moment of personal privilege, if i may. i just saw the former chairman of the committee walk into the room and congressman stupack was one of the key players in enactment of the food safety legislation. welcome. we are glad to have you here. i am sorry that we're still talking about this even years later. with that, mr. chairman, i yield back. in the gentle lady yields back and i would also like to welcome mr. stupak for his attendance. it's great to see you back and wish you the best. now the chair would recognize the chairman of the full committee mr. waldon for the purposes of an opening statement. >> thank you, mr. chairman. bart, good to see you again and i enjoyed working with you when we did the oversight work and good to see you here. i take this issue personally. in february of 2009 this

subcommittee held hearings on nationwide outbreaks of salmonella-related products. one of the witnesses at that hearing was peter hurley from wilsonville, oregon. when peter's then 3-year-old son jake became sick doctors recommended they give him his favorite food just to encourage him to eat. jake's favorite food was austin brand peanut butter crackers. tragically, that turned out to be the very thing that was poisoning him. when oregon state officials tested the crackers, three of the six packages contained peanut butter contaminated by salmonella. jake became ill because stewart parnell, the ceo of pca, knew that the peanut products were c 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 ask 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, citing his fifth amendment rights. thankfully, jake overcame his illness and it was great to see him last year. he's now a young teenager. he and his dad came back to visit us. more than 600 people in 44 states were sickened and unlike jake, nine people died. as a result, mr. parnell is currently serving a 28-year sentence in prison for his actions. while this case of pca is the exception and not the rule, fortunately, food borne illnesses remain a major concern. chairman harper just ran through those numbers. each year 48 million people are sickened and 3,000 die from food borne illnesses and federal oversight of food safety has been on the account are government accountability office's high-risk list since 2007 and just in the past few months, dozens of people in the united states and canada were infected and two have died from what appears to be an e. coli

contamination and leafy greens and we are here to check on the food and drug administration and their work to protect the nation's food supply chain and to ensure health and safety for all americans and i was glad to see the fda commissioner scott gottlieb showed his commitment that the fda will accelerate the release of information about problematic products before they may officially be classified as recall items. we look forward to hearing from the fda today about what plans and benchmarks it's developed to implement the law and recommendations from the oig. we look forward to the fda immremii implementing the expert recommendations to provide staff to the office that overseas the fda labs which do play a critical role in food recalls. i thank the hhs oig for testifying today and commend its recent report in december as well as the early alert issued in june of 2016. where it builds on the pass work

done by the oig and most notably, two reports related to two recalls in 2009 and 2011. >> the food safety modernization act and many in the december report are similar, if not the same as they were in 2009 and 2011. further, the gao raised concerns about fda's food recall process in 2012 and while fda says that its addressed many of the findings of the recent oig 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 fisma in 2010. today's hearing gives a good opportunity to share specific plans to share the recommendations made by oig including the timeframe in which we can expect the changes to be implemented. >> i do see dr. burgess. i know he was looking for some time. anyone else would like the remainder of my time? if not, i will yield back to the chairman so we can proceed with

the hearing and i do have another hearing i have to go to, so i'll be in and out of this one. thank you for the good work you do. i know we are here for americans can trust the food is safe to eat. >> thank you, mr. chairman. now the chair will recognize the ranking member mr. pollone for the 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 oversight of food recalls and the agency's authority to protect the nation's food supply. the fda plays a critical role. fda oversaw more than 3600 recalls and 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 has been mentioned in 2007, a committee investigation into a salmonella outbreak identified serious

flaws in our food safety network. in 2010 the committee found that fda had limited authority to ensure compliance and did not always take swift action when needed. witnesses repeatedly told his committee that fda lacks sufficient authority to address weaknesses in our food safety system and that's why congress passed the food safety modernization act and fisma had the overall food safety and gave fda new authorities to strengthen the food recall process. for instance, fda now has the ability to mandate a recall. this is a significant tool because we've seen cases of manufacturing firms reluctant to work with the fda. it has recall maps in place to help prepare before contamination occurs. fisma provided these new tools and it is up to fda to mick sure they're being put to good use and that's why this hearing is so important. we need to hear about how fda's

implementing fisma and whether things have improved since we passed the law. a recent office of inspector general report shed some light on that question and suggests that fda may still not adequately oversee food recalls. the inspector general reported that fda did not always effectively monitor firms during a recall such as ensuring the recalls promptly. some of the cases heigighlighten the report are troubling. for example, between 2012 and 2014, nut butter contaminated with salmonella sickened 14 people in 11 states. the fda identified the source of the outbreak in march 2014, but the products were not fully recalled until august of that year, 165 days later. >> the inspector general cited cheese products that were contaminated with listeria and led to two lost pregnancies and i know everyone on this committee would argue that one fataality is one too many.

so while we should recognize that these issues are complex and each recall poses a unique challenge, these findings demonstrate the fda must exercise judicious and forceful oversight when the public's health is at risk. i look forward to hearing how fda's implementing fisma and what challenges are made to protect the nation's food supply. i don't think anyone else wants my time so i'll yield back, mr. chairman. >> the gentleman yields back. i ask unanimous consent that the opening statements be made part of the record and without objection they'll be entered into the record. i'll intus troduce the panel fo today's hearing. gloria jarvin at hhs. we welcome you today and mr. douglas stern, the director of the office of import operations of the office of regulatory,a fairs at the fda. welcome to you both and thank you for being here today to help

and to provide testimony, 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 it 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 will 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. 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 miss jarvin first for your testimony. >> good morning, chairman harper, ranking member daggett and members of the subcommittee. i am gloria jarvin, deputy inspector general of the u.s. department of health and human services. i appreciate the opportunity to appear before you today, conduct an audit and evaluations and inspection aimed at food safety is priority to oig and remains the key mission to protect the health and safety of the american people. i am here today to discuss our recently published report on the food recall process of the food and drug administration, and our recommendations for improving that process. this audit reviewed documentation for 30 recalls which were selected from the 1557 food recalls reported to fda between october 2012 and may

4, 2015. for the recalls we reviewed we found that fda's food recall process was not always effective and efficient in ensuring the safety of the nation's food supply. specifically, we identified deficiencies in fda's oversight of recall initiation and updates monitoring of recalls and the recall information captured and maintained in the fda's recall data system. my testimony today focuses on key aspects of these three findings and oig's recommendations to fda for improving the food recall process. first, our review of fda's oversight initiated recalls determined that fda could not always ensure the recalls promptly and did not always evaluate health hazards in a timely manner. to improve fda's recall, we recommended that the fda set internal timeframes for discussing the possibility of a voluntary recall with a firm and initiating the use of the

mandatory recall authority. in addition, we recommended that fda take several specific actions aimed at ensuring that health hazard evaluations are completed in a timely manner. success, our audit identifies several deficiencies in the monitoring and 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 recommend that fda take steps to ensure that audit checks are signed into levels specified into the audit program and that product distribution lists are complete and accurate. take specific actions to make sure that audit checks are completed in a timely manner and implement procedures for requesting status reports with the initiation of a recall and follow up with firms and do not provide timely and complete status reports.

third, our review of fda's recall data system determined that fda did not always track recall data and maintain accurate recall data. to have ensured the completeness and accuracy of data in its data systems and give fda's staff involved in managing recalls access to information about key events we recommended among other things that the fda ad to the data system, a feel for the date fda learns of a potentially hazardous product. the definition of the recall initiation date in its policies and procedures and ensuring consistent understanding of recall initiation date among recall personnel. in fahd's comments on our report it agreed with our conclusion that it needs to help ensure that recalls are initiated promptly in all circumstances. the fda said it will continue to consider the results of our audit as it moves forward to

operate a score team which stands for a strategic coordinated oversight of recall execution. this score initiative was developed to establish set team frames and expedite decision making to move recalled cases forward and improve electronic recall data. we appreciate the steps the fda has taken especially as the steps it plans to take to identify the vulnerabilities during the audit. oig work has demonstrated ways to improve the oversight of the food recall process and we will continue to work with the fda and congress to help ensure the safety of the nation's food supply. thank you for the opportunity to testify this morning and i am happy to answer your questions. >> thank you. the chair will now recognize mr. stern for five minutes for the purposes of the summary of his written testimony. thank you, and welcome. >> thank you, sir. good morning, chairman harper and ranking member daggett and members of the subcommittee. i am douglas stern, director was office of enforcement and import

operations and the 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 products. fda continues to improve practices to neck sure recalls are initiated and overseen and completed promptly and effectively to best protect consumers. in this regard, we appreciate the office offen spector general's focus on the subject. i would like to thank the committee for the opportunity to report on major changes fda has made in response to oig's investigation. when we learn about a food in the marketplace, we must keep people from getting sick and being harmed. fda has the ability to act in a variety of ways and the fastest and most efficient way is to make sure foods are recalled

quickly is to work with the companies while simultaneously providing the companies with timely and accurate information they can act on. making sure the fda has effective recall practices in place and we take immediate action to address unsafe foods and 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 recalls of food products. in the most recent fiscal year, fda oversaw more than 3,600 recalls. the recent oig review of the selected group initiated between 2012 and 2015 found some unacceptable delays in the removal of food from the market. this group included a number of challenges including criminal behavior from a firm that had

critical information, new technology used to link clinical samples to their source 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 in determining the proper action to address the problem. score, the strategic coordinated oversight, meets weekly about what actions to take. score's made a difference in addressing complicated, challenging and unusual incidents. the team has been involved in cases that range from lead contamination of a diet ear is up mrechlt, salmonella contamination of powdered milk and e. coli and soy nut butter to listeria, hummus, soft cheese and smoked fish. in addition to facilitating recalls and import alerts for the detention of products entering the u.s., score had the suspension of two food

facilities after recall. in addition to score, fda has put in place several additional procedural changes, last year after the review of the recall process, we developed a new strategic plan to improve the recall management. it is how the fda establishes monitoring of recall cysts and provides training and guidance to our staff to monitor effectiveness and increases the timeliness and the amount of recall information to the public. the procedural changes fda has completed since the oig investigation established a monthly monitoring system and regular audits and improve recall recommendations and audit check assignments and expand third-party recall audit and checks and provides information about recalls to fda and create a set of best practices for our state partners. fda will continue to implement additional changes that will continue to improve how we protect the public through the recall process and through consumer messages.

fda has improved its recall classification process and averages 13 to 15 days down dramatically from a year earlier. the agency is focused on providing more information to consumers in a number of ways. we now publicize recalls prior to classification. yesterday, we released a draft guidance to improve public awareness in additional recall areas and the commissioner announced that fda will identify a way to share additional information with consumers during recalls such as specific stores where recalled food may have been sold. fda's also currently pursuing major number tiffs that have implications for the oversight of recalls in the future. the food safety modernization act shifts the focus from responding to contamination to preventing it and it will change how companies will respond to food safety issues. in addition, the field operations have undergone a resoergz to meet today's challenges by specializing coordinates and other fda staff. thank you for the opportunity to discuss the fda's recall

processes. i would be happy to answer any questions yoi 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 to ask you some questions and the office of inspector general and the government accountability office dating back to 2009 has raised concerns about the fda's 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 shells. yet the december 2017 report from oig finds that monitoring recalls is still a problem for fda. why is this 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 answered a number of ways.

first, we do take this issue seriously and i've outlined in my testimony a number of actions that we have already taken any those included those that i just outlined in terms of establishing a group of senior leaders with audit process and additional procedures. i would say, too, that the oversight of the food safety system is a large-scale enterprise and we are actively working on fisma implementation which is the overall solution that we think will bend this curve in terms of food safety and it is something that we've been in great dialogue with with all of the other players involved in the food safety system. >> i think it would be safe to say that a goal of the fda through its implementation of fisma is to reduce the incidents of food borne illness in the united states. is that fair to say? >> yes, sir. >> is that fda goal documented somewhere and is there a timeframe?

>> well, i -- i think in terms of the hhs initiatives and agency initiatives there is language that speaks to that. i can say as somebody who is involved in fisma implementation myself. i'm on a steering committee and it is something that we are driven to do, and we have timeframes and at the same time we think it is important to get things right and we don't have to reverse back if we get a standard that's not correct and we are actively outimplementing a lot of the provisions of fisma and the rules have been written and so forth. so we have a lot of actions that have been taking place. >> does the fda view improvements to its food recall process as part of achieving this public health goal? >> we do. >> and are you satisfied that you're putting the metrics in place where we can actually do a quantitative view of what your improvement and process is going to be? >> yes, sir. we've taken a number of things

to -- to create more metrics and standards. we have an audit process in the steps that i've outlined that tracks during recalls the steps in between each of the critical control points to each of the steps that take place and we do think that that's important. there's always more we can do, and some of these issues can be complicated, but we do think that that's important. >> i know the public expects not to maybe do it that day, but the timeframe that you've got to shrink that. you believe that you're in the process to do that. to reduce greatly the number of days that it takes to complete the process? >> we do. okay. ms. jarvin, if i can ask you a few questions. what review of the hhs oic review is the most serious and why? >> as you know, there were several deficiencies identified

and we feel it is so important that there's better control over the oversight of firms and the initiation of food recalls and the health hazard evaluations are done sooner because we have several examples in our report where the evaluations weren't done in some cases over 100 days. i think on average it's at 57 days and it is so important that that's done so there's better information that the fda would have about what 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 and safeguarding 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 carry out its mission to protect the u.s. food supply? >> we are encouraged by what the fda has made and definitely more needs to be done and more time

because a lot of the things like mr. stern mentioned has been recently done and we not have had the opportunity to go back and assess the progress, but the fact that the teechl was set up by the senior executive score team is a positive step and the fact that there is a strategic step now for recalls is positive and the fact that they have the audit plan that mr. stern mentioned is also positive and yesterday they issued a draft guidance for improvement and recall process and all of those things could possibly be related to this legislation. so we see the steps are in the right direction. >> thank you very much for your testimony there. the chair will now recognize ranking member daggett for five minutes. >> thank you, mr. chairman. mr. chairman, i am encouraged to hear you say that, 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 its policies,

procedures and guidance. do you agree with that? >> yes. many of them do relating to the policies, procedures and guidance and initiating process is sooner as we mentioned long delays. >> so i'm wonder, what more actionable steps do you think fda should take to improve its recalls between just be in addition to just improving the policies and procedures? you mentioned initiating the guidance sooner? what can you expand on that? >> yes. i mentioned during the health hazard evaluation sooner because in the report, one of the examples that the chairman mentioned earlier is the issue that we mentioned in the early alert from june 2016 and one related to a cheese product and one related to nut butter where the period of time from the time that the fda became aware of the

hazardous product in the time that the firm initiated the recall and that's just the initiation and more has to happen after that to get the products off the shelves. for nut butter it was 161 days and for the cheese it was 181 days and that's not spikily wecy when we're seeing. we expect less time than that. >> the reason is, if food is contaminated more people are consuming -- >> yes. more illnesses and possible deaths. >> what's the agency's response to this? >> i would say a couple of things and first, as i outlined we changed procedures and policies and i would say one of the issues underneath here is to make sure that a problem is understood and that a recall is solving the problem and there were four different recall acts

that took place, and part of the question that gets to what action is taken is that sufficient? one of the reasons we put score in place and we feel that's critical and also the specialization of the field staff which has been going on for years is it's important for people to have the technical expertise to make those judgments and sometimes to order additional investigation. >> do you have difficulty getting people with the appropriate expertise? >> we have to make sure they're at the table and it gets more complicated. one of the things that happened during this period of time in the nut butter recall we started for the first time doing an entirely new technology. we have genome sek wensing and we need people to understand that, and we need people to understand the rules that were mentioned in fisma. 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 attracting those people? >> well, i -- >> yes or no will work.

>> we have a number of great people in the agency and we're always looking for more. >> would a stable budget help in that situation? >> a stable budget is helpful. >> okay. so -- so -- so one issue that as i recall, we really talked a lot about before we passed the act was this issue of mandatory versus voluntary recall, and will i'm wondering if you are finding, because the agency has the ability to implement mandatory recall, if that's helping expedite the voluntary recall process more? >> we believe it is helpful for a certain category because there is a certain point where we reach a firm and our discussions and the firm knowing that that power is there does affect the result. >> and has -- have you noticed

since the act passed the number of mandatory recalls have gone up? >> well, what often happens, more often than not is it reaches this certain point and there say voluntary recall, and you know, a lot of that -- so we do think that it has an impact by being there, and it's usually in terms taking a voluntary recall either because there is a mandatory authority or because they know there might be a communication from the agency. those two things are actually drivers in the self-interest --? nudging them along. >> yes. so -- so, you know, i really appreciate the oig's recommendations and i appreciate the agencies implementing them. if you think that there's more authority this committee needs to give to the agency to bolster that, and if you think there's more resources or stability of resources to do this hiring, let us know because we -- this is one of these bipartisan issues

and we care deeply about the safety of our constituents. thank you. i yield back. >> the gentle lady yields back. the chair recognizes mr. griffith for five minutes. >> thank you very much, mr. chairman. mr. stern, i know you're here doing the best you can and you're trying to make everything better, but there are really serious questions that i have related to a number of different thing, but i'm going to start with the nut butter situation because we touchedon a couple of those. if you look at the timeframe which is attachment a in the oig report, if you look at the timetable there on their chart, page 30 is what i have, 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. it clearly worked because you told them they were about to do and four days later they were, like, okay, okay. we'll do it voluntary.

what you said also in that regard, you said that part of the problem was the new technology and the whole genome sequencing and when you look at the time chart it raises all kinds of questions for me. so i want you to explain the whole genome in a minute, 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 facility. that was on march 24th. on -- and connected it with some of the diseases, some of the folks who had gotten sick. nothing was done apparently tacht and i don't know, but then the whole genome sequencing was completed on may 12th. so the discussion that you want

to make sure that you're doing the right thing and not disrupting as mr. getz said earlier, an entire industry with the recall that is not justified and 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 the american people who are watching this either live or later when they're having insomnia are going to ask is, okay, we want to make sure we're doing the right thing. maybe you can justify although there is a question mark there between march 24th and may 12th, but once you've got the whole genome sequencing and there's no distinguishing between the salmonella and the sick people and in your environmental, and i know i'm not using the

scientific terms and the sick people and in the nut butter, why didn't you act then? >> so there's a number of issues that make this complicated. >> okay. >> if i can go back a little bit. so there was a pfge pattern in march of 2014. it's important to understand that a couple things. >> folks back now don't know what is a pbfg.

>> this is pulse field gel electrophoresis, 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 pfge, 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 pfge 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 the 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. tonka 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 fsma 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 jarmon, can you offer some insight 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 dietary supplement, which was 303 days that they knew it was hazardous, 303 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. mr. stern, if the fda doesn't track things like this, how can you tell if firms are not moving swiftly enough and when to make more aggressive action? >> thank you for your question, 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 jarmon, 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 products are 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 status 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 oig 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 supply i'm not sure if we are equipped to see if it's airborne or manmade. and in the case of a bioterror attack timely response is crucial, but i know it can be difficult. so with that, mr. stearn, i'm interested in fda's efforts to protect the u.s. food supply from bioterrorism or economically motivated adulteration and what steps has the fda working group on economically motivated adulteration 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

fsma, intentional adulteration rule in which firms are to look at their own risks, related to potential adulteration 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 a supply chain and brought into the united states and then we have issue.

and then this system that's being created within fsma 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, fda as of december 2016 so i'm curious if something is 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, ms. 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 on 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. >> you thank the chairman and our witnesses. 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 and make 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, ms. 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 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 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 to 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, ms. 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.

c-span, where history unfolds daily. in 1979, c-span was created as a public service by america's cable television companies. and brought to you today by your cable or satellite provider. tonight on our companion network, c-span, senator bernie sanders environmental activist

bill mckevin and others call on the trump administration to adopt tougher policies from the fossil fuel industry. that is on the campus of george washington university in washington. and you can see it live on c-span. sunday night on after words, former speechwriter or president george w. bush, atlantic columnist, david frum, with his book "trumpocracy, the corruption of the american republic." >> this is a book about the city of how. this is the study of donald trump's power. how did he get it? how does he retain it? how does he get way with it?

trumpocracy is the system between trump and congress and the system between trump and the media that enable him and create an audience. the system that involves his -- the republican donor elite. the republican party that have sue come succumb to him and abo all, the core voters within the republican party who enabled him to win the republican nomination and go on to the presidency. >> watch after words, sunday night at 9:00 p.m. eastern on c-span 2's book tv. former florida governor jeb bush recently talked about education savings accounts, esas, in washington, d.c. we will also hear from advocates of private school vouchers about the role of esas in expanding private education.