Transcripts For CSPAN2 Food Supply Safety 20180123

The subcommittee command center and entitled safety of the u. S. Food supply continuing concerns over the food and Drug Administrations food recall process. Disease outbreaks from tainted food are an Ongoing Public Health challenge. The centers for Disease Control estimates feature one in six americans from a 40 Million People get sick from foodborne elements as, 120,000 are hospitalized in 3000 died. The number of multistate food on the multistate food illness outbreaks of the increasing effect in greater numbers of americans and the number of Vulnerable People over an immune compromised individuals is growing. The threat of foodborne illness process even though weve gotten better at detecting and investigating outbreaks and through the implementation of the hazard analysis and critical control point rules and trend data indicates major reductions of foodborne disease yet the problem remains significant. Weve contaminated food the fda in the quickly and effectively help remove dangerous foods from commerce and protect consumers. In 2010, Congress Gave fda more power to recall tainted food and modernization act enacted to provide fda with the authority to mandate a food recall. Admission to this from a previous audits by both the hhs office of Inspector General and the Government Accountability office made recommendations to sga to improve its food recall program. How has fda performed the food recalls in recent years at the new law and its recommendations . Over the last two years the hhs oig looked at this question in 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 2012 and may of 2015. Bsd has used its mandatory recall authority only to time since vietnam meant and not at all over the last four years in some cases the fda was slow to evaluate Health Hazards. It took fda an average of 47 days to complete in the valuation after learning of a planned or in progress food recall. The oig found that fda was woefully slow and dirty in the recalls. The average length before recall began once fda knew of the safety issue with 27 days. The report also raises questions about the fdas ability to cope with uncooperative companies in one case involving a Dietary Supplement Company took 10 months after fda issued a warning letter about unlisted ingredients before the firm finally pulled the product. In another case the recall of nut butter began 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 contaminated with nine people getting sick including one into fetal losses linked to illness. During that time, and the firm ally to the fda saying the firm would suspend the manufacture and distribution of cheese. However, the owner despite knowing the product tested positive for listeria continue to allow the product to be distributed. The owner later pleaded guilty to fda crimes and went to prison. Justice is done, but if you need to find a way to detect such deceptions sooner. The oig also found fda did not have a reliable system for accessing the recall initiation date or the date fda became aware of potentially hazardous Food Products. More than a third of the recalls reviewed had the wrong initiation date entered into fdas 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. Worse, if he does not collect sufficient or accurate data said the agency can measure its performance to tell whether the food recall performance is improving. In addition to the oig findings, fda told Committee Staff in a briefing there were concerns about the turnaround time it takes to get test results and fda labs use to make an evaluation of the seriousness of the food hazard. To ensure the fda labs are performing properly from afternoon is to provide independent finding a permanent stop to its office of Laboratory Science and safety. This office has not been fully stood out and has been unable to inspect fda labs. Fda should follow the example of the cdc. The cdc office of lab science and safety has detected funding has dedicated funding and a permanent staff to oversee cdc zone labs. The enactment provided fda mandatory recall authority and impose more legal obligations of food manufacturers and distributors. Fda has the tools with the oig findings in fda own assessments show that the fda needs to reform itself to get this right. I am heartened that the fda commissioner has recognized even just a handful of problematic recalls are too many because lives are at stake. Im also glad the commissioner has announced fda is looking at ways to improve a time limit 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 will now recognize the Ranking Member companies to get, for the Opening Statement. Thank you, mr. Chairman. As you know, food safety and challenges we are going to hear about today are the same issues we dealt with over the past decade. All of those examples you mentioned were brought up in hearing 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 i case illustrated, we lack basic controls over food recalls including traceability. Fda and cdc originally identified tomatoes as the likely cause of the outbreak for later on found out it was because of jalapenos. This is 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 industries should be devastated. When they had these hearings where we thought it was the tomatoes, tomato industry was absolutely devastated at that time and it turned out that the problem wasnt even tomatoes, but jalapenos. It is clear then as it is now that the fda needs the ability to respond to a multitude of different situation that pose risks to the Public Health. As you noted, mr. Chairman, the response to incidents like that would 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. He gave the fda more tools to prevent and respond to outbreak, including critically new authority to issue mandatory recall orders and requirements for manufacturing for recall plans in place. Right now, seven years after we passed the law, the office of his or general has a new report that points to some of the issues we been worrying about in this committee for years, despite the progress weve made, here we find ourselves. Oig found despite more power to oversee manufacturing firms that produce eventually hazardous food, fda is not doing enough to monitor the recall. Sometimes there have been long delays to recall affected products or even to provide the fda with basic information. In addition to insufficient oversight, fda has also weaknesses on recall responses. For example, it is critical for the public to understand the risk that a food product may present. A oig found fda would sometimes slow to evaluate the Health Hazard posed a contaminated product. This is not to say that these cases are easy and the answer is always crystal clear. The fdas dealing with many recalls every year, each which presents its own challenges and complexity. That being said, i do think there is more the fda can do to approve the food Safety System. Oig report presents multiple recommendations for fda such as improving its policies and procedures for managing recalls and monetary firms. However, i would like to hear more from oig about what specific meaningful steps it takes fda to take. If you are procedure documents and manuals are not enough. We need to know what actually needs to change to help better protect the american public. Fda continues to implement provisions of fma, the Committee Meets to hear how the laws working, what more the fda needs to do and how congress can help. Id like to take a moment of personal privilege if i may. I just saw the former chairman of the Committee Walk into the room, bert stupak and congressman stupak was one of the key players in enactment of the food safety legislation. Welcome. We are glad to have you here. I am sorry we are still talking about the seven years later. With that, mr. Chairman, i yield back. I would also like to welcome mr. Stupak. I wish you the best. The chairman of the full committee, mr. Walton, for the purpose of an Opening Statement. Thank you, mr. Chairman. Enjoyed serving with you when i get all the oversight work and its good to see you here. I take this issue very personally. In february 2009, the subcommittee held hearings on nationwide outbreaks of salmonella related illnesses linked to products from the Peanut Corporation of america. One of the witnesses at the hearing was peter hurley from wilsonville, oregon. When peters 3yearold son jake became sick, doctors recommended to give him his favorite fruit to encourage them to eat. Jakes favorite food was boston brand Peanut Butter crackers. Tragically that turned out to be the very thing placing him. When they tested the crackers, three of the six packages containing Peanut Butter contaminated by salmonella. Jake came ill or stuart parnell, ceo of dca knew that the peanut products were contaminated with salmonella when he told the plant manager to quote, turn them loose. At the same hearing, i confronted mr. Parnell and 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 them loose on little kids like jake judy. They refused of course citing his fifth amendment rights. Thankfully, jake overcame his illness and it was great to see him last year. Hes now young teenager. Ps dad came by to visit us. More than 600 people in 44 states were second. 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 a pc is an exception and not the rule, foodborne illnesses made a major concern, chairman harper ran through the numbers for each or 40 Million People are sick and 3000 die from foodborne illnesses. Federal oversight of food safety has been on the Government Accountability offices high risk since 2007. In the past two months dozens of People United states and canada were infected into a guy from what appears to be an e. Coli contamination related to the figurines. We are here today to check on food and Drug Administration and their work to protect the nations Food Supply Chain and to ensure health and safety for all americans. I was glad to see the fda commissioner skop gottlieb show his commitment and the fda will accelerate the release of information about problematic products before they may officially be classified as recall items. Look forward to hearing from the fda about what plans, benchmarks 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 his work with the recent report in december as well as the early alert issued to fda in june of 2016. This builds on the password done by the oig, most notably to reports later to food recalls released in 2009, 2011 colonel the reports were issued prior to the food safety modernization act come in many recommendations in the report are similar if not the same as they were in 2009 and 2011. Further, gao raised concerns about the recall process in 2012 and while fda said its address many findings of the recent oig report comments traveling many recommendations from almost a decade ago stand today despite the Additional Authority given to the fda in 2010. Todays hearing he was a Good Opportunity for fda to share specific aims to address recommendations made by the oig including the timeframe we can expect changes to be implemented. I dont see dr. Burgess. I know he was hoping for some time. Anyone else would like my time. If not i would go back so the chairman can proceed with the hearing and i have another hearing i have to go to hear thank you again for the good work you do. I know we are in the same team here to help Americans Trust to their food is safe to eat. Without i yield back. Thank you, mr. Chairman. The chair will recognize the Ranking Member of the subcommittee, the full committee, mr. Pallone for his Opening Statement. Thank you, mr. Chairman. This committee has a long history of overseeing food safety over the last decade weve had multiple hearings examining the fruit and Drug Administrations oversight of food recalled in the agencys authority to protect the nations food supply could fda plays a Critical Role. In fiscal year 2017 alone, fda oversaw more than 3600 recalls and this is no small task but we have seen cases that expose weaknesses in fdas ability to respond to these threats. For example, as already mentioned in 2007, the Committee Investigation to a salmonella outbreak identified serious flaws in our food safety network. 2010 the Committee Found the fda has limited authority to ensure compliance does not take such action when needed. Witnesses repeatedly told the committee fda . Sufficient authority to address weaknesses in our food Safety System and that is why Congress Passed the fda food safety modernization act or transport and the overall approach to food safety and gave no authority to strengthen the food recall process. For instance, fda has the ability to mandate recall on the product poses a serious Adverse Health consequences. This is a significant toll because we seen cases of manufacturing firms likely to cooperate with the fda. Thanks to fmsa conference are required to have recalled plans in place to help repair before contamination occurs. Providing these new tools to be sure theyre pretty good use and that is where the hearing is so important. To hear how fdas implementing and whether things have been improved since we passed the law. The recent office of her general report sheds some light on the question as to just fda still may not always adequately oversee food recalls. The Inspector General reported fda did not always effectively monitor firms during the recall such as ensuring firms initiate the recalls promptly. Some of the cases highlighted in the report are particularly troubling. For example between 2012 and 2014 as was mentioned not better contaminated with salmonella sickened 14 people in 11 states and identified the source of the outbreak in march 2014 and the products are not fully recalled until august of that year. 165 days later. The Inspector General cited a series of recalls of cheese products contaminated with listeria and led to one death into lost pregnancies. I know everyone on this committee will argue even one fatality is far too many. While we recognize these issues are complex and every recall poses a unique challenge, these findings must exercise judicious but forceful oversight in the Public Health is at risk. I look forward to hearing how fdas implementing fmsa and protect our food supply. I dont think anyone else wants my time so i went to that, mr. Chairman. Agenda manuals back. I ask unanimous consent the members written Opening Statement be made part of the record. Without objection entered into the record. I now introduce our panel of witnesses for todays hearing. Today we have ms. Gloria jurgen county deputy Inspector General of Audit Services for the office of Inspector General at hhs. We welcome you today. And mr. Douglas stern, director of the office of enforcement and import operation for the office of Regulatory Affairs at the fda. Welcome to you both and thank you for being here today to help provide testimony and we look forward to the opportunity to discuss the fda food recall process. You are where the committee is holding an investigative hearing and in so doing it has a crack is taking testimony under roads. You have any objection to testifying under rose . Both witnesses have indicated no. The chair then advises you under the rules of the house and the rules of the committee, youre entitled to be accompanied by counsel. Do you desire to be accompanied by counsel 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, all truth and nothing but the truth . Thank you. You may both be seated. You are now under oath and subject to the penalty entirely 10, section 1001 and a five minute summary of your written testimony and we will recognize ms. Jarmon first for your written testimony. Morning, chairman harper, Ranking Member to gatt and other members the subcommittee. I implore you jarmon, deputy Inspector General, office of Inspector General u. S. Department of health and human services. I appreciate the opportunity to appear before you today, conduct an audit of valuation inspection and get food safety is a priority for oig and remain key to our mission of protecting the health and safety of the American People. I am here today to discuss the recently published report on the food recall process of the food and Drug Administration recommendations for improving a process. This audit review documentation for 30 recalls which were judgmentally reporting to fda between october 2012 in may 4, 2015. More than 30 recalls reviewed sounded fda food recall process was not only effective and efficient in ensuring the safety of the nations food supply, specifically identifying decision in the fda oversight of recall initiation monitoring the recall in the recall information captured and maintained in the fda recall data system. My testimony today focuses on key aspects of these three findings and oig recommendations to fda for improving the recall process. A review of fdas oversight initiated because determined that fda could not always ensure that firms initiate recalls promptly and did not always evaluate Health Hazards in a timely manner. To improve fda oversight of recall initiation, we recommend fda said an internal timeframe discussing the possibility of a voluntary recall of what the firm in initiating the use of this mandatory recall authority. In addition, we recommend fda takes several specific actions aimed at insuring Health Hazard evaluations are completed in a timely manner. Second, i did identify several deficiencies in the recalls, specifically we found fda did not always issue audit checks at the appropriate level. Complete audit checks as assigned collect timely and complete status reports from recall firms. To improve fda monitoring in recalls, we recommend fda take steps to ensure they are signed at the level specified in the Audit Program and the product distribution are complete and accurate. Take specific actions to help ensure the audit checks are completed in a timely manner and implement procedures for requesting status reports of initiation of a recall and follow up with firms that do not provide timely or complete status reports. Third, review of fdas recall system determine fda did not always track recall data and maintain accurate recall data. To help ensure the completeness and accuracy of data in this data systems and gave fda staff involved in managing recall access to information about key events, we recommend among other things fda consider adding to its recall data system or another fda system concealed for the date fda learned of a potential hazardous product and clarify the definition of recall initiation date in policies and procedures and ensure an ending of recall initiation date among recall personnel. In fdas comments on the report, it agrees with our conclusion that it is to help ensure recalls are initiated promptly in all circumstances. Fda said it will continue to consider results for audit estimates or to operate for strategic coordinated oversight of recalls execution. This initiative was developed to recall cases forward and improve electronic recall data. We appreciate the stuff fda has taken as well as the steps it plans to take to address the vulnerability is identified in the audit. Oig work has demonstrated ways for fda to improve its oversight of the food recall process and we will continue to work with fda and congress to help ensure the safety of the nations food supply. Again, thank you for the opportunity to testify this morning and im happy to answer your questions. Thank you, this jarmon pay the chair will recognize mr. Stern for five minutes for the purpose of the has written testimony. Morning, chairman harper, Ranking Member to get members of the subcommittee. And douglas stearn, office of the import operations and office of Regulatory Affairs and the acting Deputy Director for Regulatory Affairs for food safety. We appreciate the opportunity to provide you im sorry. Is that better . We appreciate the opportunity to provide you with information how we oversee recalls of regulated products could fda committed to continuously improving practices to ensure food recalls are initiated, overseen and completed promptly and effectively to best protect consumers. In this regard we appreciate the office of Inspector General focus on the subject and would like to thank the committee for the opportunity to report on major changes fda has made in response to oig investigation. When we learn about foot in the marketplace that may be unsafe, and must act quickly to keep people from getting sick or being harmed. Fda has authority to act in a variety of ways but often the fastest and most efficient way to ensure unsafe foods are recalled quickly is to work directly with the involved companies simultaneously providing the public with timely Accurate Information they can act on. Making sure if you have the effect practices in place can take immediate action to address unsafe food are High Priorities of the agency. Fda has wideranging oversight responsibilities. In the food area, fda is responsible for oversight regulation of more than 300,000 regulated food facilities in 12 million lines of imported Food Products per year. Fda is responsible for overseeing industry recall of Food Products. The most recent fiscal year recent fiscal year, fda oversaw more than 3600 food product recalls. The recent oig review initiated between 2012 and 2015 found some unacceptable delays in the removal of food from the market and the 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 within april 2016. Fda had a team of Senior Leaders charged with murdering complex or unusual food safety situation and determining proper action to address the problem. The score s. C. O. R. E. Meets at least weekly and make decisions about what actions to take. S. C. O. R. E. Is any difference in dress and complicated unusual incident to the team has been involved in cases that range from lead contamination of a dietary supplement, salmonella salmonella contamination of powdered milk, e. Coli and soy nut butter to wisteria and hummus, soft cheese and smoked fish. In addition to facilitating recalls for the detention of products entering the u. S. , and s. C. O. R. E. Help to food facilities actions that prohibits the distribution after recall. In addition, fda put in place several additional procedural changes remaster after comprehensive review of our process we develop a Strategic Plan to improve recall management or the plan how to standardize the lefty assesses the recall effort come establishes monitoring of recall activities, provides additional training, guidance to staff and increases the timeliness and amount of recall information provided to the public. Procedural changes fda has completed since the oig investigation establishing that the Monitoring System and i has to prove recall recommendations and audit check assignment comics and thirdparty recall audit checks and improve the pathway for foreign suppliers to read information about recalls to fda and create a set of best practices for state partners. Fda will continue to implement additional changes that will continue to improve how we protect the public through the recall process. Fda has also improved its recall classification process and now averages 13 to 15 days, down dramatically from a year earlier. Furthermore, the agency is focused on providing more information to consumers in a number of ways could we now publicize recalls prior to classification. Yesterday released a guidance to improve Public Awareness and additional recall areas and the commission are also not the fda will identify a way to share Additional Information that consumers are in recall such a specific stores or recalled food may have been sold. I would be happy to answer any questions you may have. Thank you very much for your summary of your testimony. At this time the members will each have five minutes to ask questions of you. I will recognize myself for that purpose. I will start with you, if i may, mr. Stern. The office of Accountability Office and previous audit reports back in 2009 had raised concerns about the fda monitoring of food recalls. Retail Grocery Stores know about the recalls and remove product from the shelves yet that 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 will get it right this time . Thank you for your questions. I would answer it a number of ways. First, i would say we do take the issue seriously. I have outlined, in my testimony today and in my written testimony, a number of actions we have already taken. Those include those i just outlined including establishing a group of Senior Leaders, an audit process and additional procedures. The oversight of the food Safety System is a large scale in a price and we are actively working on implementation which is the overall solution that we think will been this curve in terms of food safety and its something weve been in great dialogue with. I think would be safe to say the ritz implementation is to reduce the incidence of foodborne illness in the United States. Is that fair to say. Assert. Is that goal documented somewhere, and is there a timeframe . In terms of the initiatives and agency initiatives, there is language that speaks to that. I can say, as someone who is involved in implementation, im on a Steering Committee and its something we are driven to do. We have time frames, at the same time we think its important to get things right. We dont want to have to reverse back if we get a standard that is not correct. We are actively implementing a lot of the provisions, inspections that have started and roles that have been written. We have a lot of actions that have been taking place. Do they view improvements to the food process as achieving the health goal . We do. Are you satisfied that youre putting the metrics in place or we can actually do a quantitative view of what your improvement and process is going to be. Yes, sir. We have taken a number of things to create more metrics and standards. We have an audit process in the steps that ive outlined which tracks during recalls the steps in between each of the critical control points, each of the steps that take place, and we do think thats important. Theres always more we can do and some of these issues can become located but we think its important. I know the public expects not to maybe do it that day, but the timeframe, youve got to shrink that. Do you believe you are in the process to do that, to reduce greatly the number of days it takes to complete this process when there is a recall . We do. If i can ask you a few questions miss sharman, what does the hhs, oig view as the most serious, and why . As you know, there were several decisions weve identified but we feel like its so important that there is better control and oversight in the initiation of food recalls and that they are done sooner. We have several examples in our report where the Health Hazard evaluations when done until, in some cases, over a hundred days. On average i think its 57 days. Its so important its done so theres better information the fda has about what is the harm of the products. The oig report stated this review was done to see whether they are fulfilling their responsibility in safeguarding the nations food supply now that it has mandatory recalls. Is there any evidence that th this has been helpful to carry out its mission to protect the u. S. Food supply . We are encouraged by the progress of the fda has made. Weve seen 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 havent had an opportunity to go back and assess the progress but the fact that the team was set up, the score team, is a positive step. There is a Strategic Plan for recalls and that is positive for the fact that they have the audits is also positive and yesterday they issued draft guidance for improving that process. All of those things could be related to the legislation so we see it as a step in the right direction. Thank you very much for your testimony. The chair will recognize the Ranking Member for five minutes. Im encouraged to hear you say, and mr. Stern, i also believe that the fda is making efforts to improve their system systems. The oig recommendations largely relate to the fda approving its policies, procedures and guidance. You agree with that . Yes, many of them do relate to improving their policies and guidance and initiating processes sooner. We mentioned long delays. So im wondering, what more steps do you think the fda should take to improve its recalls in a distant between improving the policies and procedures. You mentioned initiating the guidance sooner, what can you can you expand on that . Yes, durin doing the Health Evaluation sooner, in our report, the examples mentioned earlier about the issue we mentioned in june 2015, 1 related. [inaudible] where the time when fda became aware of the hazardous products and the time that the firm initiated the recall, and thats just initiation. More has to happen after that to get the products off the shelf. That was 165 days. For cheese it was 81 days. In that. Of time while we are specifically saying what the period of time should be, we believe its reasonable to expect less time than that. The reason is because if the food is contaminated, more people could be consuming it during that time. Thats what the chairman was talking about. And more illnesses, and possible death. What is the agencys response to this . I was a couple things. We have changed a number of our procedures and policies. One of the issues is to make sure the problem is understood and a recall is actually solving the problem. The cheese recall that was mentioned, there actually four different recall actions that took place. Part of the question that gets to what action, is that sufficient . One of the reasons we put score in place is because we feel its really critical. Also the specialization of the field staff which has been going on for years and its important for people to have the Technical Expertise to make those judgments and sometimes to order additional investigation. Are you having difficulty getting people with the appropriate expertise . We have to make sure they are at the table. He gets more collocated. One of the things that happened in the nut butter recall we started doing an entirely Different Technology which is sequencing and we need people to understand that. We need people to understand the roles that have been mentioned. The level of specialization and understanding of the supply chain needs to be high. I get it. Are you having difficulty attracting those people . A yes or no will work. We have a number of great people in the agency. Were always looking for more. Would having a stable budget help in that situation. A stable budget is helpful. So, one issue, as i recall that we really talked a lot about before we passed the act was this issue of mandatory recall. Im wondering if you are finding that because the agency has the ability to implement, if thats helping expedite the voluntary recall. We believe it is helpful. Theres a certain point where we reach a firm in our discussion and the firm, knowing that that power is there does affect the result. And have you noticed since the act passed, the number of mandatory recalls have gone up . What often happens, more often than not is that it reaches a certain point and there is a voluntary recall. We do think it has an impact by being there and its usually in firms taking a voluntary recall either because theres mandatory or because they know there might be an indication from the agenc agency. There nudging them along. I really appreciate the oig recommendation and i appreciate the agencys implementing them. You think theres more authority this committee needs to give to bolster that . Do think theres more resources or stability of resources to do this hiring . Let us know because this is one of these bipartisan issues. We care deeply about the safety of our constituents. Thank you. I yield back. The chair recognizes the vice chairman of the subcommittee, mr. Griffis for five minutes. Thank you very much. Miss stern, i know youre doing the best you can and trying to make everything better but there are some serious questions that i have related to a number of different things. I will start with the nut butter situation but we just touched on a couple. You were talking about mandatory authority. You all exercise or let them know that you might use mandatory on august 15 and they voluntarily recalled on august 19. It clearly worked because you told them you are about to do it and four days later they said okay will do voluntary. The problem i have is you said that part of the problem was the whole genome sequencing but when you look at time chart, it raises all kinds of questions for me. I want you to explain the whole genome in a moment. Heres a question i have. There was enough information that you opened up an investigation in late february. Six weeks later youre actually using the Older Technology and matched an uncommon strain of salmonella to that facility. That was on march 24. They connected it was some of the folks who had gotten sick. Nothing was done, i dont know, but then the whole genome sequencing, the entire industry, you had that confirmation. They all went by and eventually three months and a few days later you then threatened the mandatory recall. The question is, the American People were watching this live or later when theyre having insomnia are going to ask okay, we want to make sure were doing the right thing, maybe you can justify that theres a . There between march 24 and may 12 but once youve got the whole genome sequencing and theres no distinguishing between the salmonella in the sick people and in your environmental and in the nut butter, why didnt you act then . There is a number of issues that make this complicated. Let me go back a little bit. There was a link under the pattern in march of 2014. Its important to understand a couple things. Folks back home dont know. This helps link the clinical to whats happening at the facility. Its something that weve used them been relying on for a while. Its not perfect, theres a strong link usually there is a food history where we asked people what did you eat and then we look and that didnt happen in this case. People did something new. They link it up and theyre very excited about that. I think we could have done better in this case. It was the trigger for that request for mandatory recall. There were things that couldve been done differently in this case, but i do think its important to understand some of the complexities. This was not an obvious case on day one, and in fact, a number of these cases its not obvious on day one. Its very important that we accelerate our own investigations of and that the firms have their own preventative models. It was less than clear to the people who have that back in march because there were environmentals which were concernings, but the links to the clinicals were less than crystalclear. Like i said, it wasnt supported at that time by the food histories, and the firm tested all their product and it was all negative. The firm testing, the firm was pushing back on us with some of their own testing. The story is a little bit more complicated but at the same time, we take the oig points and we agree with that, we need to make sure, its not okay if it takes this long even if its complicated thats 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 whats a red flag and act on it to make sure we get to the right result as soon as possible. I appreciate and youll back. The gentleman yields back. The chair recognized the gentleman from new york for five minutes. Thank you. This committee has repeatedly heard that fda must manage food recalls more effectively. That is why Congress Gave fda new authorities in 2011. Fda had told us it is taking steps to improve that recall process. However, the oig report finds that fdas data on food, recall is often incomplete or inaccurate, which makes it difficult or impossible to tell how things have improved since Congress Gave the fda new tools. For instance, fdas recall data system does not track key milestones which is the date that they learn the product was potentially hazardous. 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. Its very important that the data in the recall system is complete and accurate. That way, thats key to monitoring the food recalls and, like we mentioned in our report, there was no data in their firmware fda became aware that an item was potentially hazardous. So, in some cases, without having that date there, its not possible for them to determine how long its taking or 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 those longer examples that we have like a dietary supplement where it was 303 days from the date fda became aware that a product was hazardous and sent a warning letter to the firm, it was 303 days later when the food recall initiation occurred and that date wasnt in the system. They had dates in the system that were not correct. Its very important make sure the action is happening faster. Thank you for that. Oig points out that because they dont record the date when it learns a product is potentially hazardous, it took 151 days to initiate a recall when it was contaminated with salmonella. It would be timeconsuming to track this information. Mr. Stern, if they do not track milestones like this, how can you tell when firms are not moving swiftly enough to recall dangerous foods and went to take more aggressive action. Thank you for your question. As of now, 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 can be in there. We take this point, were looking at making sure our procedures clarify and make sure that the records are correct when it has tipped over, and we will continue to work on that. In addition to incomplete data, oig also found that fda did not always collect timely and complete data reports from firms during a recall. Does that hinder fdas efforts to oversee the recalls . How so . Its important, after the firm initiates the recall that the fda is also monitoring whats happening during that. Of time so that the course when the initiation first started, the products are still on the shelf. In many cases the firm is still testing the effectiveness. We found the status reports were received over a hundred days until after this process and the firm had communicated the recall. Its important that fda continues to check on the status and monitor the firms when they are in the recall process and the status report is one way to do that. Thank you. Does fda agree on the status reports, if so, what steps do you think we should take. Let me say, we would like to have better status reports. It is entirely a voluntary process so right now and historically, there is no obligation for a firm to provide us status reports and we do think that will be improved through the implementation of the preventative control rule which requires firms to have recall plans and so for the first time fda will have an obligation in terms of how they conduct the recalls. A thirdparty audit we think are really critical, we did have an extended discussion and we have expanded that program, that gives us a lot more flexibility and it turns around our recall audit check process much faster and we do think consumer notices are appropriate because it sort of jumps over that recall system and gets the message to where it needs to be. Thank you very much. I yield back. The chair now recognizes the gentle lady from indiana, the chair of the ethics committee, mr. Brooks for five minutes. Thank you. Thank you for holding this important oversight hearing today. As the committee is well aware, the bio defense issues are something ive been working on. Public Health Security is a top priority as we look at how we over see our food supply. Its a security issue as well on how it impacts our food supply. Much of our nations corn supply and hog supply comes from my state of indiana. I know and believe that our nation needs a stronger system of Monitoring Animal Health both for the threat to our nations food supply but also for potential outbreaks in the animal population that can mutate and jump to humans and should a bad actor seek to affect our food supply system, im not certain its equipped to quickly determine if its food borne illnesses naturally occurring or manmade. In the case. [inaudible] honestly timely response is crucial, but i know it can be difficult. With that mr. Stern, i am interested in fdas effort to protect the food supply from bioterrorism or economically motivated adulteration and what step has the fda working group on economically motivated been taken to affect our nations food supply. How would fda, as were talking about these types of food coming from manufacturers, how would fda respond if there could possibly be a terrorist attack. Thank you. There are number of points i make. There is an intentional adulteration rule in which firms are to look at their own risks related to potential or intentional harm from other parties. That is 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 make sure we are able to monitor whats coming in from outside the country, largely, and in terms of a food defense and we also believe that having a preventative food Safety System generally allows for closer monitoring of whats coming in and making sure that folks understand whats happening in their own supply chains and thats the kind of danger that weve seen in some of these incidents that have happened historically. Sometimes theres things that happen in a supply chain and its brought into the United States and then we have an issue. The system is being created within has people monitor whats happening throughout the supply chain which is also helpful to combat those issues. I appreciate that, but, this is as of december 2016, and here we are in 2018. The fda, as of december 2016, im curious if something has changed. The fda still hadnt met a 2011 gao recommendation to provide written advice to centers and offices on avenues to address economic adulteration. Has that changed . Have they created the document thats been used from 2011. Im not aware of such a document. I do know there is a group that looked at this issue and they found it very challenging. I spent a lot of my career looking at the issue for several years but i worked with committee on that. There are a lot of different ways this could happen. 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 weve seen this enter or the places weve seen adulterated products coming in, its usually with a lack of accountability within the supply chain. Thats what we think is the most effective strategy. So you indicate 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. Coronation of intelligence can be a challenge, we do have a group that works with the Counterterrorism Center and i would say, just generally thats an issue because there is a lot of coronation that needs to happen and because it is secure information, that can be a challenge. We been working on that since 911. It is now 16 years later and so you are saying there is still a challenge with your Agency Working with cbp on the supply chain. What i would say is, one of the issues that we deal with is trying to make sure that the intelligence is where it needs to be. Im not prepared to go any deeper than that at this point. I would say also the intentional adulteration rule is something that the agency has come out recently that does address that issue. Thank you. I yield back. The chair now recognizes the general lady for five minutes. Thank you, mr. Chairman and Ranking Member for calling this hearing and thank you to our witnesses for the work you are doing. The issues we are talking about today have serious, realworld 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 the 2014 recall of chief products contaminated with listeria. That product contamination is particularly troubling because it led to an infant death and to 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 this case is particularly complex and fda was even given misleading information from the firm, but i would like to walk through this recall and try to shed some light on the lessons learned. Mr. Stern, fda learned about the contamination on july 28. They then spent a month inspecting, testing samples and requesting an update from the firm. You had previously mentioned that its always important that fda accelerate its recall, 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 was a number of different actions that took place, there was actually four different recalls that the firm took during the course of this time that was referenced. The first, there was a positive sample where one of the firms used products and in less than a week there was a recall of that particular product. Also they initiated an inspection facility so we did quickly 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 after that and they made a series of promises. They actually, well first they said they would stop manufacturing. They also said they would stop distribution until they had consulted with fda and they said they would bring in an expert and do additional testing and they committed to do a recall of some product which they did initiate that was implicated by the environmental testing. And so, that happened and after that the firm continue to manufacture and did distributio distribution. I also understand that after fda conducted the test they received a brief letter from the firm on september 11 that reportedly said lacked supporting documentation but then the firm distributed adulterated product after that but then fda didnt conduct another followup inspection until nearly a month later. Why didnt they take swift action. Fda believes 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 theres more that the fda should have done in this case, and in summer specs it gets to the issue of a preventative mindset versus reacting. Because when fda conducted its followup inspection on october 7 it again from the presence of listeria, and at this point it was 45 days after they first learned of the contamination however took the firm another ten days before voluntarily recalled all of the potentially contaminated products. At this point, what could they have done differently to either encourage or mandate a faster, fuller recall. One of the things, this gets back to how these things can be complicated, the firm did ask when fda brought some sort of positive sample to it. They initially did a recall related to the first product sample, after the resin environmental, they made a series of promises which turned out to be lies, they were false, they and we didnt find out fully about that until going back on inspection. But, the firm had said a lot of things that would be the kind of things that fda would want to hear. Were going to stop manufacturing. But if theyre not truthful with you or they dont follow through, how do we hold them accountable. Know its a couple things. First its important always verify and, even this firms recall activities 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. Thats pretty strong that the firm made a lot of promises, i think, even given that more should have occurred. But the account ability answer. And so, in terms of it, one thing i would note is that the owner was prosecuted, fda does have an office of terminal investigation so the deterrence message is important. Also, we need to verify, one of the reasons, oig mentioned about recall, its very important we do those to make sure those things happen. Its important that we have followup inspections to make sure what was promised gets done. Fda has verification procedures it needs to use and if its a highrisk issue like this one we need to use them quickly. Thank you. I yield back. The chair now recognizes the gentleman from new york, mr. Collins, for five minutes. Thank you. Certainly food safety is a universal concern in this is not a partisan hearing. We are generally trying to get to an understanding of what happens. Let me back off just a little. We say there are about 3000 recall the year. , roughly how many of those are voluntary firm initiatives. The threat of the mandatory is certainly there. How quickly does the fda classify those of the class 12 or three. I think oig reference some of the earlier data. We were doing it within 13 15 days. You do a lot more detailed, urgency for class one. It is a red flag. Comedy class once to beget. Year versus two or three . I think, its in my written testimony. Have to get back to you with the exact number. Is a 10 or 80 class one. Its in between those two. I dont have the exact number. Id hesitate to give a number it is a significant proportion do you have a staff, is one person given oversight of that recall . Is it a team that goes to work or a Single Person . We have recall partners throughout the country. One of the things weve done in our reorg is we specialized that staff. Theres a recall coordinator who interact with the firm. Theres also other components that do other things that are related to recalls. Sometimes they literally have offices there we have to rely on professional nature of the company itself. As you said, i was a little disturbed to see you dont currently mandate a recall procedure or plan with each company you reduce . Right now, recall plans, that before the passage of preventative control role, there was not any kind of mandate that a firm have a recall plan. That would be a concern. When there is a recall, traditionally we will follow up and that happened in these cases where theres a recall, we do follow up with that on inspection to make sure and we try to do that quickly to make sure there is some review of what occurred. The difference is, whats the legal requirement, what standard do they have to do is mark we were talking about status reports. You have to do status reports . What do they have to do. Can you help standardize that . The firm has to plan whether theres a hazard to make sure there is some kind of plan to address recalls in particular. Where before it was more reactive. Common sense, if you dont have a plan than it truly would be haphazard at best. I would hope you inspectors are in their everyday constantly making sure that the tees are crossed and eyes dotted. Thank you. Related to your earlier question, i have a note. Thats actually higher than i might have expected. I only have a few seconds left, how often do they do independent testing versus relying on the company data . There is a certain risk profile if so, we will do testing in the environment and in addition, if we have reason to we have different types of surveillance testing, we have a net import and in the domestic rom and those all go off to our lab. We do a lot of testing ourselves. Firms also have their own testing programs. It is part of our oversight to look at what theyre doing. My time has expired. I appreciate your answers. All you back. The chair will now recognize the gentleman for pennsylvania for five minutes. Thank you. Mr. Stern, as you know him of the oig report identified a number of efficiencies 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 the fda learned a product was potentially hazardous with specific reference to the research incident where it took 303 days to execute a recall after the warning letter was issued. First, is it correct that in this particular case it was found that the firm continued passing out free samples after receiving the letter . I am unsure about that specific fact. Is that easily obtainable for you to provide us in short orde order. I could. I appreciate that. Are fda actions after warning letter typically delayed for 300 days . No. How often, on average is it customary or within the realm of acceptability for the fda, what a typical time. There is some, i think we ordinarily go back within six months, and certain area Clinical Trials tend to be longer because there has to be more data to monitor. Are the delays of a recall more of a problem with dietary supplement products. There is an ingredient and theres some controversy related to that. I could follow up, we can follow up with you in some ways, but some of the issues are scientifically challenging. The firm did challenge some of the science about the safety of the ingredient in this case. Okay. And final question, on this line of thought, what lessons can you share that youve learned from the research. I would say, overall, in terms of the lessons i think we would say its important for the Agency Leadership to look very closely, especially a high priority things that we have is class one, the kind of things that have the highest risk. We need to do that prioritization and we need to investigate and make sure that we have systems in place. 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 is related to the fact, that the safety or the on safety which is in the ingredient at issue, i would just say theres controversial or different ideas about that and to some extent we have to resolve that in the court system. To the extent that a warning letter triggers the type of litigious activity surrounding the safety of a particular element, does that give a higher priority or add to the priority or is that something in the systems that you have to. I think we need to prioritize, and your question is a fair one, there are a number of warning letters that come out. The agency has a lot of different issues, if its an issue that weve signed to be one that has potential harm to consumers as a higher risk issue, we should make sure that gets addressed. Yes, because it strikes me, i didnt do this work as an attorney, but if you have a product on the market, the product is doing well, you get an fda letter that says this is a warning letter, et cetera, number one, i dont think Many Companies would put a product on the market that they felt was deadly or would trigger that first year or any tier, but the question becomes, it is pretty reasonable or expected to assume you are going to get response that says wrong, we will take you to court or this will be litigated, and that should not freeze you up in terms of addressing what you would identify as a potential health issue. I would agree. What you do about that. We need to make, again, the kind of issue that is flagged where there may be disagreement, if its 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. You have Regulatory Authority in order to do that or do you need any statutory assistant. We are not asking for any authorities today. Very good. I appreciate your answers. The chair now recognizes the gentle lady from illinois for five minutes. Thank you. I want to focus on the mandatory recall authority. The oig report describes some concerning contamination cases and unfortunately this is not the first time we are hearing about such outbreaks. In fact, this committee has been investigating the food safety efforts and recall processes for well over decade. Over seven years ago fda told the subcommittee that recall authority would help it remove dangerous products from the market more quickly. Congress passed the modernization act which gave fda this authority and significantly reform the agencys ability to prevent and respond to outbreaks. Now we are here discussing these issues again so i want to find out how this law is working. Mr. Stern, overall, has it helped fda oversee food recalls particularly regarding inspection resources. Yes. So you have had enough resources in order to do the job. I believe we have enough resources within. [inaudible] Congress Gave fda this authority to help the agency respond to contaminated foods faster however the oig reported between 2011 and 2016 fda use that Authority Just twice. Just yesterday the commissioner stated our recall authority and how we deploy them are a cornerstone of our vital Consumer Protection mission. Given that your recall authority is the cornerstone of the agencys consumer mission, can you explain why fda has only used this mandatory recall authority twice or a few times . Thank you for your question. First our goal is to remove the product from the marketplace if its unsafe. The first, let me start with that as a precept, and ordinarily, if the company is willing to do that, that will be the fastest way to make sure that gets done. Now we have a number, as i mentioned earlier, we do think mandatory recall is one of the things that we get to a certain stage with the company, and it generally convinces that company to recall if its the right thing, but it does play a role in the background in our discussions as well as some of the consumer to medications that the agency uses. I would say that is one of the things in the background which is also to say there may be cases where its appropriate and we should be using it if other actions are happening quickly enough. So the fda has to meet certain standards before it can invoke the mandatory recall authority. Is that correct. Correct. Other difficulties in meeting the standard or do you feel having it there as a threat is sufficient. What i would say is a lot of the issues get into the fact that there are some complexities about identification of products and the level of hazard within product. We ordinarily dont have issues with firms when there is a passage in a particular product. A lot of times we have issues is what about the other products made at that facility that happened in the cheese recall. We mention that earlier. At what level of evidence is needed for that. Sometimes there is a question, sometimes theres a scientific it or factual question about identification, the level of risk and so forth and those are things that i think, back to why we have reacted to the oig report the way we have is that our centerpiece really is score, to make sure that the leadership of the agency from different components, when there is a red flag, to make sure we do whatever we need to do to get to the right answer quickly. We get to the right answer we believe we can make it happen quickly. There is some concern that they have not been fully implemented and enforced. Is there anything we can do to speed up that process . We are actively working on the implementation now. Im very much engaged in that myself and i dont have anything today. I can bring it back to the agency if there is anything else at. Thank you. I yield back. The chair now recognizes the gentleman from georgia, mr. Carter, for five minutes. Think both of you for being here. This is honestly a very important subject, particularly for us in the state of georgia. We had the unfortunate incident a number of years ago with the peanuts and that is fresh in our mind. Let me ask you, when you released the updated guidance yesterday on accelerating the recall process, part of it included stepping in as a company, for the fda to step in if a company had been sufficiently addressed the recall. How do you determine if they sufficiently addressed it or not. The guidance yesterday, we released talks about public mourning 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 changes the notification this goes back to the issue we were talking about earlier in terms of the fda having to get to the right answer in terms of evaluating the issue as soon as possible. If we understand the issue, we think its best when we have a consistent message with a company that is responsible. Theres not doing messages, its clear. How often does that happen. I would say the overwhelming number of times we can get the right answer in terms of our medications with the company. There are times, and its not the usual case. Is the right answer always your answer . Or. We do have a dialogue with companies. We do listen to them. Some companies, ive been engaged in a number of technical conversations where company has said things that have changed their mind. That does happen. Sometimes we are dealing with a company where they dont understand the problem, we need to get a message to consumers and if theyre not willing, we have to be willing to do that. If that is the case, either repercussions for that company. Ordinarily, in most of our recalls the firm prepares the press release, we comment to make sure its actionable for consumers. If a firm will not or cannot do that, the fda will, or if we think its appropriate even one affirmed does it because we have to reach a certain population where theres a way to do it that we think is necessary, fda will issue its own consumer to medication. Other any penalties to the company. [inaudible conversations] [inaudible conversations] [inaudible conversations] so the senate is back in session in about 15 minutes at 2 15 p. M. Eastern. Senators will resume their consideration of jerome p