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 an