and we have very severe shortages in our workforce. we -- psychiatry is one of the oldest of the medical professions and i don't mean in terms of how long it's been around. >> you can watch all of this program online by going to c spann oreg span.org. we'll leave this now. we're taking you live to a house hearing look at food safety and a recent report by the health and human services inspector general they've identified deficiencies in the live food recall service. live coverage here on c-span 3. [ indistinct conversations ].

the subcommittee convenes this hearing entitled safety of the u.s. food supply continuing concerns over the food and drug administration's food recall process. disease outbreaks from tabted food are an ongoing challenge. the centers for disease control estimates 1 in six americans, 48

million people get sick from food bourn illnesses, 128,000 are hospitalize 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've gotten better at detecting and 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 incidence of food borne disease. yes 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.

the fda food safety modernization act was enacted to provide fda with the authority to mandate a food recall. in addition to that 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 vent 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 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. in some cases they were slow to enact hazards. it took them 47 days to complete an evaluation after learning of a planned or in progress food recall. oig found that fda was woe fully slow in starting recalls. the average length began once fda knew the safety 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 butter began more than five months after the fda had traced the samma nilla outbreak to the source facility. there were 14 illnesses in 11 states during that time. a series of recalls of cheese products contaminated with listeria took 81 days to complete. nine people got sick, including one infant who died and two

fetal lotio fetal losses linked to illness. during that time the firm owner lied to fda saying the firm koh would suspend the manufacturing and distribution of cheese, however the own are, despite knowing that the product tested positive for lis steer yar toind let the product be distributed. he later pleaded guilty to fda crimes and went to prison. justice was done but fda needed to find a way to detect action sooner. the 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 fda's electronic data system called the recalled enterprise system. the electronic data system also did not include when fda first found out about the suspect food products. worse, fda does not collect

sufficient or accurate data to so that the agency can measure it's performance to tell whether their food recall performance semiproving. in addition to the oig findings, fda told them they're concerned about the turn around times it takes to get fda labs it takes to make an evaluation of the seriousness of the food hazard. to ensure the labs are performing properly, fda needs to provide independent funding and permanent staff to its office of laboratory science and safety. this office has not been fully set up and has been unable to inspect fda labs. fda should follow the example of cdc. the cdc's office of lab, science, and safety is detected funding -- has dedicated funding and permanent staff to oversee cdc's own labs. the enactment of fisma provided mandatory recall authority and imposed more legal recall

obligations on food distribu distributors. fard has the tools but the findings and fda's own sextsds show that the fda needs to reform itself to get this right. i'm heartened 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 that the commissioner has ayou nounsed that the fda is looking at ways to improve the timeliness and scope of information provided to the public about fda-regulated food recalls. i welcome and thank the wits and look forward to their testimony. i'll now recognize the ranking member, mr. degette for the purpose of her opening state. >> thank you so much. 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 newspaper hearings in front of this committee. for example, we held a hearing in 2008 on a major som nilla

outbreak that affected 1800 people in 43 states. that demonstrated we lacked controls over food recalls. fda and cdc originally identified tomatoes as the likely cause of the outbreak but later on they found out to 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 the suspected products from the shelves because entire industry should be devastated. when we had these hearings where we thought it was the tomatoes, the 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 give the fda more tools to prevent and 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 pass 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 that despite more power to oversee manufacturing firms that produce potentially hazardous food, fda's not doing enough to monitor firms during a

recall. sometimes there have been long delays in getting firms to recall all their -- 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 evaluate the health hazard posed by a contaminated product. this is not to say that these cases are easy and the answer's 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's more the fda can do to improve the food safety system. oig's report presents multiple recommendations for fda, such as improving its policies and procedures for managing recalls

and monitoring firms. however, i'd like to hear more from iog about what specific meaningful accepts e steps it thinks fda should take. a few more procedural and guidance manuals are not enough. we need to know what needs to change to help better protect the american public. as fda continues to implement provisions of sma, the committee needs to learn how the law's 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 former chairman of the committee walk into the room bart stew pack. and he was one of the key players in enactment of this food safety legislation. welcome, i'm glad to have you here. i'm sorry that we're still talking about this seven years later. with that, mr. chairman, i yield back. >> gent lady yields back.

it's great to see you back and wish you the best. now the chair would recognize the chairman of the full committee mr. walden for the purposes of an opening statement. >> thank you, mr. chairman and bart, good to see you again. enjoyed serving with you when we did all that oversight work and it's good to see you here. i take this issue very personally. in february of 2009, this subcommittee held the hearings on national wide outbreaks of sam nil la related ill unanimouses. one of the witnesses that the hearing was peter hurley was wilsonville oregon. when peter's then 3-year-old son jake became sick, doctors recommended that they give him his favorite food just to encourage him to eat. well, jake's favorite food was austin brand peanut butter crackers. tragically, that turned out to be the very thing that was poisoning him. had they tested the crackers, three of the six packages contained peanut butter contaminated by sam nilla.

same become ill because stuart par nel, the ceo of pca new that the peanut products were contaminate when'd he told the plant manager to, quote, turn them lose. 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 refuse, of course, citing his 5th 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 become to visit us. more than 600 people in 44 states were sickened and unlike jake, nine people died. as a result, mr. participate ttl is serving a 28 year sentence in prison for his actions. while this case is the exception and not rule, food borne illnesses remain a major

concern. chairman harp eran through those numbers. 3,000 die from food borne ill ngss. federal oversight of food safety has been on 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 related to leafy greens. so we're here today to check in 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. i was glad to see the fda commissioner scott gottlieb showed his commitment to improving food safety with yesterday's announcement 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 bench marks it's developed to fully immeant the law and 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 fda labs which do play a critical role in food recalls. i think the hhs/oig for testifying today and commend its work with bomb the resent report in december as well as the early alert it issued to fda in june of 2016. this vent work builds on the past work done by the oig, most notably two reports related to food recalls that were released in 2009 and 2011. while the reports from '09 and '11 were issued prior to the food safety modernization 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 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's troubling that many of the recommendations from almost a decade ago stand today december e despite the additional authority giving to the fda in 2010. today's hearing, give us a good

opportunity for fda to share specific plans to address the recommendations made by the oig, including the time frame in which we can expect these changes to be implemented. i don't 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 chairman so we can proceed with the hearing and i also have another hearing i have to go to so i'll be in and thought of one. but thank you again for the good work you do. i know we're on the same team to try to make sure americans can trust their food is safe to eat. with that i yield back. >> thank you, mr. chairman. now the chair will recognize the ranking member of the full committee, mr. pallone 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 exam examining the food and drug administration's oversight of food recalls and the national's authority to protect the food sly. fda plays a critical role. if 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 already been mentioned, in 2007, a committee investigation into a sam nilla 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 this committee that fda lacked sufficient authority to address weak nsss in our food safety system, ands that why congress passed the fda food safety modernization actor fisma in 2011. and they officially reformed the overall approach to food safety and 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. had say significant tool because we've seen cases of

manufacturing firms reluctant to cooperate with the fda. and thanks to fisma firms are also required to have recall plans in place to help prepare before contamination occurs. fisma provided these new tools but it's up to fda to make sure they're being put to good use and that's high this hearing is so important. we need to hear about how fda's implementing fisma and whether things have been improved since we passed the law. a recent office of inspector general report sheds some light on that question and suggests that fda still may not always adequately oversee food recalls. the inspector general reported that fda did not always effectively monitor firms during a recall such as ensurg that firms initiate the recalls promptly. in some of the cases highlighted in the report are particularly troubling. for example, between 2012 and '14 as was mentioned nut butter contaminated sickened 14 people in 11 states. fda identified the source of the

outbreak in march of 2014 but the products were not fully recalled until august of that year, 165 days later. the inspector general also kielted a series of recalls of cheese products that were contaminated with lis steerya and led to one infant's death and two lost pregnancies and i know everyone will argue that even one fatality is far too many. while we recognize that these issues are complex and every recall poses a unique challenge, these findings say that the fda must exercise forceful over sight when the public health's at risk. i look forward to how they're implementing fisma and what challenges remain to protect our nation's food supply. i don't think anyone else wants my time so i'll yield back, mr. chairman. >> 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'd now like to introduce our panel of witnesses for today's hearing. today we have ms. gloria jar vin

who is the deputy inspector general for the audit services. we welcome you today. and mr. douglas stern, the director of the office of enforcement and import operations in the office of regulatory affairs 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 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 committee you're 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're about to give is the truth, the whole truth, and nothing but the truth? thank you and you may both be seated. you're 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 mr. jarvin first for your testimony. >> good morning, chairman harper. ranking member degette and other members of the subcommittee. i am gloria jarman, deputy inspector general for auditor service, u.s. department of health and human services. i appreciate the opportunity to appear before you today conduct an audits, evaluations and inspections aimed 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 audit report on the food recall process of the food and drug administration and our recommendations for imflaui improving that process. this document reviewed doomts take for 30 recalls which where are select from the 1557 food recalls reported to fda between october, 2012, and may 4th, 2015. for the 30 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, fda's 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 its food recall process. first, our review of fda's oversight a firm initiative

recalls fda could not always ensure that the firm's initiated recalls promptly and did not always evaluate health hazards in a timely man forte improve fda's oversight of recall initiation, we recommend that fda set internal time frames for discussing the possibility of a voluntary recall with a firm and initiating the use of this 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. second, our audit also identified several deefficiencies in fda's monitoring a firm's initiating recalls. fda did not always issue audit checks at the appropriate level. complete audit checks as assigned and complete timely and 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 levels specified in the audit program

and that product distribution lists are complete and accurate. take specific actions to help ensure that audit checks are completed in a 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 recalled data and maintain accurate recall data. to help ensure the completeness and accuracy of data in its 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 potentially hazardous product and clarify the definition of recall initiation date in its products and procedures and

ensure a consistent understanding of recall initiation date among key -- among recall personnel. in fda's comments on our report it agreed with our conclusion that it needs to help ensure that are recalls are initiated promptly in all circumstances. fda said it will continue to consider the results of our auditas it moves forward to operate its authority which stands for strategic coordinated oversight of recall execution. this score initiative was developed to establish set time frames, expedite decision making to recall cases forward and improve electronic recall data. we appreciate the steps the fda has taken as well as the steps it plans to take to address the vulnerabilities we identified on our audit. oig work has dem month vated ways for fda to improve its 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. again, thank you for the

opportunity to testify this morning and i'm happy to answer your questions. >> thank you, ms. jarman. the chair will now recognize mr. stern for five minutes for the purpose of the summary of his written testimony. thank you and welcome. >> thank you, sir. good morning chairman harper, ranking member degette and members of the subcommittee. i'm douglas stern, director of the office of enforcement and deputy director for regulatory affairs. we appreciate the opportunity to be 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's committed to continuously improving our practices to ensure that food recalls are initiated, overseeing and completed promptly and effectively to best protect consumers. in this regard, we appreciate the office of inspector general's focus on the subject and we'd like to thank the committee for the opportunity to report on major changes fda has

made in response to ogi's investigation. when we learn about a food in the marketplace that may be unsafe were we must act quickly to keep people from getting sick or being harmed. fda had the authority to act in a variety of ways, but often the fastest and most efficient way to ensure unsafe foods are recalled quickly is to work directly with the involved companies while simultaneously providing the public with timely, accurate information that 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 if the. >> if the foods area, fda's responsible for oversight and regulation of more than 300,000 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 3,600

product recalls. the recent oig review of a selected group of 30 food recalls initiated between 2012 and 2015 found some unaccepted delays in the removal of food from the market. this group included a number of challenges, including criminal behavior from a firm that hid 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 of 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 coordinated oversight of recall execution meets weekly and makes decisions about what actions to take. score's made a difference in addressing complicated challenging and unusual incidents. the team's been involved in cases that range from lead

contamination to a dietary supplement, contamination of a powdered milk, e-coli in soy nut butter and smoked fish. in addiction to getting recalls for the potential products entering the u.s., score helped expedite the suspension of two food facilities, actions that prohibit food distribution after recall. in addition to score, fda's put in place several additional procedural changes. last year after a comprehensive review of our recall process we developed a new strategic plan to improve recall management. plan helps to standardize how fda establishes a company's recall efforts, establishes monitoring of recall activities, provides additional training and guidance to our staff to monitor and assess recall effectiveness and increase dollars the timeliness and amount of recall information provided to the public. the procedural changes fda's completed since the oig investigation established a monthly monitoring system and regular audits, improve recall

assignments, expand third party recall audit checks and improve the pathway for foreign suppliers to provide recalls to fda and provide 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 recall process and consumer messages. it's also improved it's recall classification process and now averages thoirn 15 days down dramatically from a year earlier. furthermore, the agency is focussed on providing more information to consumers in a number of ways. we now public la size recalls prior to classification. yesterday we released a draft guidance to improve public awareness in recall areas and the commissioner amounsed that fda will identify a way to share additional information with consumers during recalls such as specific stores where recall food may have been sold. fda is also currently pursuing major initiatives that have implication for the oversight of rails in the future. food modernization act shifts

the focus from food safety system from responding to contamination to preventing it and will change how companies prevont and respond to food safety issues. in addition, fda they have under gone a challenge to meet today's challenges for coordinators and other staff. it gives me the opportunity to discuss the 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, to ask you some questions. the office of inspector general and the government accountability office in previous audit sports dating back to 2009 has raised concerns about the fda's monitoring of food recalls. such as verifying to make sure that retail greshry stores know about the recalls and the products have been removed from their shelves, yet the december

20 report from oig niends month storing 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, i would say we do take this issue seriously. i've outlined in my testimony today and in greater form in ny written testimony a number of actions that we have already taken are and those included those that i just outlined in terms of establishing a group of senior leaders an 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 the other players involved in the food safety system.

>> and i think it would be safe to say that a goal of fda through its implementation of fisma is through the uo reduce e of food borne illness in the u.s. is that fair to say? >> yes, sir. >> is that dmt somewhere and is there a time frame? >> 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 it is something that we are drifb do and have time frames if the at the same time we think it's 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 out implementing a lot of the provisions of fisma. inspections have started in a number of areas, the rules have been written and so forth. we have a lot of actions that have been taking place. >> did the fda view improvements

to its food recall process as part achieving this public health goal? >> we do. >> okay. and are you satisfied this you're putting the metrics in place that we can actually do a quantitative view of what your improvement and process is going to be? >> yes, sir. we've take ann number of things to -- to create more metrics and standards. we have an audit process in the steps that i've outlined which tracks during recalls the steps in between each of the sort of critical control points 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 thinks that's important. >> i know the public expects, you know, not to maybe do it that day, but the time frame 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 this process when there is a recall?

>> we do. >> okay. ms. jarman, if i can ask you a few questions. what efficiency identified in the report does the hhs/oig view as the most serious and why? >> as you know, there were several deficiencies identified. but we felt like it's so important that there's better control over over sight of firm's initial recalls and that the health hazard evaluations are done sooner because we have several examples in our report where the health hazard evaluations weren't done until, you know, in some cases over 100 days. i think on average it said fifrt -- 57 days. it's important that's done so there's better information fda would have of the harm of products. we think that's most important. >> the oig report stated that this review was conducted to determine whether fda's fulfilling its responsibility in safeguarding the nation's food supply now 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 progression 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 of senior executives, the score team, is a positive step. the fact there's a strategic plan 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 draft guidance for improving the recall process. and all of those things could possibly be related to this legislation, would so we see it as steps in the right direction. >> thank you very much for your testimony there. the chair will now recognize ranking member degette for five minutes. >> thank you, mr. chairman.

ms. jarman, 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 its 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. >> okay. >> as we mentioned long delays. >> so i'm wondering, what more actionable steps do you think fda should take to improve its recalls between just -- in addition to just improving the policies and procedures? you mentioned initiating the guidance sooner. what -- you can expound on that?

>> yes, i mongsed doing the health hazard evaluations sooner because in one of the examples that the chairman mentioned earlier the issue that we mentioned in our early alert from june, 2016, one related to a 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 off the shelf. >> right. >> for the nut butter that was 165 gays days. for the cheese it was 81 days. and that period of time while we aren't specifically saying in our recommendations what the period of time should be, we believe it's reasonable to expect less time than that. so -- >> and the reason is because if the food is contaminated, more people could be consuming it during that time, that's what chairman waldo was talk about. >> yes, and more illnesses and possible deaths. >> yes. mr. stern, what's the agency's response to this? >> well, i'd say a couple things.

first, as i've outlined, we've changed a number our policies. one of issues underneath here is to make sure that a 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, you know, part of the question that 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 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. because -- >> are you having difficulty get being people with the appropriate expertise? >> well, we got to make sure that they're there 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 which is

gmc sequencing. where he immediate people to understand that and understand the rules that have been mentioned in fisma. there are -- and so the level of specialization and the level of understanding of the supply chain needs to be high. >> i get it. >> yeah. >> are you having difficulty attracting those people? >> well. >> yes or no will work. >> we have a number of great people in the agency, we're always looking for more. >> okay. but 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 passed the act was this issue of mandatory versus voluntarily recall. >> right. >> and i'm wondering if you're 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 certain category because there's a certain point where we reach with a firm in 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 i -- what often happens more often than not it reaches this certain pointed and there's a voluntary recall. and a lot of the -- so we do think that it has an impact by being there. and it's usually in firms taking a voluntary recall either because there's a mandatory authority or because they know there might be a communication from the agency. you know, those two things are actually drivers in the self-interest. >> nudging them along. >> yes. so, you know, i really appreciate the oig's

recommendations and i appreciate the agency's 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 all -- this is one of these bipartisan issues we care deeply about the safety of our constituents. thank you, i yield back. >> thank you. gentle lady yields back. chair will now recognize the advice chairman of the subcommittee mr. griffeth for five minutes. >> thank you very much mr. chairman. mr. stern i know you're hearing doing the best you can and trying to make everything better, but there's some real 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, with you were talking about having the mandatory authority. if you look at the time frame, which say tach meant "a" in the oig report, if you look at the timetable there on their chart, it's page 30 of whattive have but you may have something

different, you all exercise or let them know that you might use mandatory on august 15th and they voluntarily recalled on august nine teeth so i think in response to ms. degette's question it clearly worked because you told them you were about do it and four days later they were like, okay, okay, we'll do voluntarily. the problem i have is on two things that you said also in that regard. you said that part of the problem was the new technology, the whole gee nome sequencing. but when you look at the time chart, it raised all kinds of questions for me. so i want you to explain the whole gee nome in a minute. >> right. >> 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 old irrelevant technology matched and uncommon strain of samma nilla to that facility. that was on march 24th.

on -- and connect today with some of the diseases, some of the folks who had gotten sick. nothing was done, apparently, at that point and there may have been some letters, i don't know. but then the whole gee nome sequencing was completed on may 12th. so the discussion that you want to make sure you're doing the right thing and not disrupting as ms. degette said earlier an entire industry with a recall that's not justified, you had that confirmation on may 12th. so may 12th, june 12th, july 12th. >> right. >> 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 you, okay, we want to make sure we're doing the right thing, maybe you can

justify, although there's a question mark there between march 24th and may 12th. but once you've got the whole gee nome sequencing and there's no distinguishing between the samma nilla in the sick people and in your environmental, and i know i'm not using the scientific terms, but in the sick people and in the nut butter, why didn't you act then? >> so there's -- there's a number of issues that make this complicated so if i could go back a little bit. >> okay. >> and so there was a link under the pfge pattern in march of 2014. it's important to understand that a couple things. >> all right folks back home don't know what is a pfg. >> this was pulse field. it helps link the clinical, that's the person, to what's happening at the facility. it's something that we've used, been relying on for a while. it's not perfect because it's

more limited in the amount of information that in terms of comparison of those organisms. and it shows that there's a strong link between what those organisms actually are because something like -- >> and that's what you linked up in march. >> that that's what we linked up in march. i will tell you that our expert analysis that was not enough to show causation at that point. >> okay. >> there was no link, and it was done differently than we usually do if the usually there's a food history that links where they ask people what did you eat. in this case, they went through some of the databank and they linked that up. they link today up with pfge and they linked it up with whole gee nome see kwengsing and they were excited about that when it happened because it has been something that we've used that's linking up to this database and it's something that really is very promising. but we -- there were delays in

this case and i should say first of all i think we could have done better in this case. i will tell you that when we did the whole gee nome sequencing we did it for the environmentals in may, it was not until august that we link today to the clinicals. and that was a -- that was a delay in terms of doing that whole gee nome sequencing link which was the trigger for that, you know, 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 the case, but i do think it's important to understand some of the complexities. 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 preventative models. but it was -- 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 all the all the product was negative. so the if i were testing was firm was pushing back on us with their own testing. thor to is a little bit more complicated. at the same time, we take the oig's point in this and 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 very approach in place where we need to make sure that the agency leadership and the staff are prepared to you know, know what's 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. >> the chair will now recognize the gentleman from new york for five minutes. >> thank you, mr. chair. this committee has heard that

fda must manage food rawles more effectively. that is why congress gave them new authorities in 2011. fda thoed us it is taking steps to improve that recall process. however, the oig's reports finds that fda's data on food recall is often incomplete or inaccurate. which makes it difficult if not impossible to tell how things having improved since congress gave the fda new tools. for instance, fda's recall data system does not track key milestones such as the date fda learned a product was potentially hassous. miss jarmon, can you offer insight why those data are important and how incomplete data make it difficult for fda to manage food rawles? >> yes, it's very important that the data in their recall systems is complete and accurate.

that way they can -- that's key to monitoring the food rawleca . there was no data for when fda became aware an item was potentially hazardous. without having that date there it's not possible for them to determine how long it took them to from the time they became aware that the product was potentially hazardous to the time that the food recall initiation occurred. in some cases some of the examples one where it was a dietary supplement where it was 303 days that the fda wam aware the product was hazardous and sent a warning letter to the firm was 303 days later when in that case the food recall initiation occurred because that date wasn't in the system. system was based on ten days because the dates in the system were not correct.

it's very important to make sure that the actions happen and faster. >> i thank you for that. oig points because when fda doesn't point out the date when a product is potentially hazardous they can't confirm they took a firm days of hazelnuts contaminated with salmonella. fda claims it would be time consuming to track this information. mr. stearn if fda does not track milestones like this how can you tell when firms are not moving swiftly enough to recall dangerous foods and when to take more aggressive action. >> thank you for your question. we do think it's important for the agency to record when there's 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're looking at try too make sure our procedures clarify and make sure that the records are correct when it has tipped over. and we're going to continue to work on that. >> thank you. in addition to incomplete data, oig also found fda can did not always collect timely and complete status reports from firms during a recall. miss jarmon, does that hinder fda's efforts to oversee trecals and how so. >> it's important after the firm initiates the recall fda is monitoring what is happening after that period of time. of course, when the initiation first starts, the products are still on the shelf. many cases the firm is still testing the effectiveness and verifying different things related to the product.

we found in some cases the status reports weren't received over 100 days until after this process, the firm had been communicated that started the recall. it's important that fda continue to monitor the firms in the recall process and the status reports is one way to do that. >> mr. stearn, does fda agree it needs to improve its collection of these status reports? what steps do you think we should take. >> let me say first, we'd like to have better status reports. it is entirely a voluntary process. right now historically and during this type, there's no obligation for a 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. fda, there will be an obligation in terms of how they conduct their recalls.

a third party audit for recall audit checks are critical. we had an extended discussion with oig about that and have expanded 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 where it needs to be. >> mr. chair, i yield back. >> the gentleman yields back. the chair will recognize the gentle lady from indiana, distinguished chair of the ethics committee, miss brooks for five minutes. >> thank you, mr. chairman. and thank you and the ranking member for holding this important oversight hearing today. as the committee is well aware, biodefense 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 fly, it's a security issue, as well as to how it impacts a threat to our

food system that could be devastating. much of our nation's corn, soy and hog supply 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 for potential outbreaks in the animal population that can jump to humans. should a bad actor seek to affect our food supply, our system, i'm not certain it is equipped to quickly determined if it's food born illness naturally occurring or if it's manmade. in the case of a bioerror attack, obviously timely response is crucial. i know can be difficult. so with that, mr. stearn, i'm interested in fda's efforts to protect the u.s. supply from bioterrorism or economically motivated an adult ration and what steps has the fda's working group on economically motivated an adult ration taken to improve protection of our food supply

and more directly how would fda as we're talking about these types of food recalls coming from manufacturers, how how hollywood fda respond if there could be a terrorist attack? >> first, there is as part of fisma, an intentional an adulter ration rule in which firms already to look at their own risks related to potential intentional an dealter ration from other parties. that's one component we do have a food defense group within fda that monitors some of the intelligence and works with some of the intelligence to try to make sure we're able to monitor what's coming in from outside of the country. largely in terms of food defense. and we also believe that having a preventive food safety system generally allows for closer

monitoring of what's coming in and making sure that folks understand what's happening in their own supply chains and that's the kind of danger that we've seen in some of these incidents that have happened historically is that sometimes there's something that happens in a supply chain and it's brought into the united states and then we have an issue. and the system that's being created within fisma helps to have people monitor what's happening throughout the supply clain which is helpful to combat those issues. >> i appreciate that, but now this is as of december, 2016. here we are in january 2018. the fda as of december 2016, i'm curious if something has changed, the fda still hadn't met a 2011gao recommendation to provide written advice to centers and offices on avenues to address economic an adulter ration. has that changed? has the fda created a document used to feet 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. 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 an adult kerrated products coming in it's usually where there's a lack of accountability within the supply chain. that is the most effective strategy. >> so you indicate there that there are a lot off 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 ho 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 the 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 an adulterration rule sul something that 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 gentle ladied from florida, miss caster for five years. >> thank you for calling this hearing today and thank you to our witnesses for work 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 lapsed between fda becoming wa aware of the 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 in. >> there's 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 firms cheese products and in

less than a week, there was a recall of that particular product. fda initiate add 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 bringing 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 an adultereighted 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 if i were was not manufacturing at that time based on what they said and not distributed. i think -- i say that at the same time 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 mind-set versus reacting. >> because it was when fda conducted its follow-up inspection october 7th it, again found the presence of listeria and at this point, this was 45 days after fda first learned about the contamination and however it took the firm another ten dayses before it voluntarily recalled all of the potentially capitaled product. at had point what, cog fda have done different to encourage or manage a fast earn fuller recall? >> this gets back to how some of these things can be complicated. the firm did an act when fda brought a 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 till going back on inspection. but you know, the firm said a lot of innings 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 pessage 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 issues it needs to use and like this one, we need to use them quickly into the chair will recognize the gentleman from new york mr. collins for new york. >> 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 re. >> caller:s driven by the fda.

>> virtually all are voluntary. >> the threat 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, sfaels, 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's -- it is in between though. 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 vol 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's interact with the firms and other components that do other things that are related to 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 tau review so your inspectors are not auditing recall plans today? >> well, right now, recall plans, before the passage of fis ma apartment 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 these 30 cases other cases that have happened where

there's a recall, we do follow up with that on inspection ordinarily in the next inspection to make sure and 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. fis ma helps standardize that. firm has 0 plan where there's a hazard to make sure there's some kind of plan to address recalls in particular. 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 in there every day are constantly making sure that ts are being crossed, is dotted. >> thank you. i got a note related to your earlier question. ware at about 1200 products class one out of our 36 a 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 dob 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 behave reason to, we have different types of surveillance testing. we have it at import and have it in the domestic raep and those all go off to our lab. we do a lot of testing ourselves. firms also have their own testing programs for various reasons. >> that you rely on, as well? >> that that is part of our oversight. >> 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. 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 hassous with spec reference to the knew trex 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. >>ing 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 of an 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 knew trex 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've 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 very system 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 a fda letter saying this is a warning letter, et cetera, et cetera, et cetera, i wouldn't think many companies would put a product on the market that they felt was deadly

or that would trigger that first tier any tier but particularly that first tier. but the question becomes, it is pretty reasonable or expected to assume ha 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 priortise that and we need to make sure we bring it forward. >> do you have sufficiently expansive regulatory authority to do that or do you need

statutory assistance. >> we're not asking for any authorities today. >> appreciate your answers. >> 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 con tap nation cases. unfortunately this is not the first time we're hearing about such outbreaks. 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 the 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 authority and significantly reformed the agencies ability to the prevent and respond to outbreaks. now we're here again discussing this issue. i want to find out how the law

is working. mr. stearn, overall, has fsma helped fda over seafood 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 the agency to respond to contaminated foods faster. however, the oig reported between 2011 and 2016, fda use that authority just twice. just yesterday, commissioner gottlieb stated and i quote it, what our recall authority and how we de -- authorities and how we wie 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 80s mandatory recall authority twice or a few times anyway. >> thank you for your question. our goal is to remove the product from the marketplace if it's unsafe. so the first -- that we start with that as a pcept. 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, an 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, i'll 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 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 of the times 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 i would say sometimes 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 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 ferm if they've sufficiently addressed it or not. >> the guidance yesterday, we released talking 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 sometimes 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 or the 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 -- or if we think it's appropriate even if a firm has done it because we have 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 rules firms have to have their own recall plan and -- >> is that approved by fda? the recall plan. >> well, it is not formally approved but 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 consume been and difficult as

the date may it be locked in different fda systems or obtained from sources outside of fda. what kind of sources outside of 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 mind a food safety issue they communicate to us. sometimes we have information that cops 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 that you information. >> yes, that happens. it happened in one of these cases. we worked with virginia did some testing that kicked off 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 capital 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. it's 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 supremely important. thank you very much. i yield back. >> the gentleman yields back. >> i want to thank you miss jarmon and you mr. stearn for taking it 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 0 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.

we appreciate you being her

and on the fda, "the washington post" writes the food and drug administration is taking steps to make it easier for doctors, patient anderson researchers to get access to clinical trial data amassed during the process of approving new drugs. commissioner scott gottlieb said tuesday. commissioner gout leave announced the actions just before a speech on fda transparency as a washington forum. the meeting attended by researchers and academics focused on 18 recommendations for making the agency's decision making less opaque.

the suggestions were part of a report called blueprint for transparency. you can read more at washingtonpost.com and we covered commissioner gottlieb's remarks at the washington forum along with other panels about fda transparency.p. that's available online at c-span.org. we'll have live coverage of two rallies in washington, d.c. this week. today, the march for life. and on saturday, the women's march on washington. anti-abortion activists will gather at the national mall for the 45th annual march for life rally marking the industry of the supreme court's roe versus wade decision legalizing abortion in the united states. watch live coverage of the march for life rally today at noon eastern on c-span3. and on saturday, live coverage of the women's march on washington 2018. march on the polls. it's the one-year anniversary of the 2017 women's march.

watch live starting at 11:00 a.m. eastern on c-span. today, the march for life on c-span3 and on saturday, the women's march on washington on c-span. this weekend on "american history tv" on c-span3 it, saturday at 8:00 p.m. eastern on lectures in history, depaul university profess ter mark pollat on 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. so this is during the civil war. the darkest hours of the civil war, 1864. lincoln who the artist shows with his leg slung over his chair like he's a country bump kin, right? his reputation for being so kind of innen elegant and crude, he says well, the packet 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 are 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 fact ultimate and 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. >> and sunday at 4:00 p.m. eastern on real america, the 1987 film "drug abuse, meeting

the challenge." >> anyone that says cocaine is not addictive they lie. >> when you do cocaine, you lie to yourself about being in control. >> cocaine is not hip. it's hype. anyone who tells you it's okay is a liar. >> watch "american history tv" every weekend on c-span3. >> next, an all women panel of foreign ambassadors to the united states talking about their lives and careers. they discuss overcoming challenges and offer advice to the next generation of women lead in other words global politics.