The subcommittee convenes this hearing entitled safety of the u. S. Food supply, and 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 that each year one in six americans, 48 Million People get sick from food borne illnesses, and 128,000 are hospitalized and 3,000 die. The number of multistate food illness outbreaks is increasing, affecting greater numbers of americans and the number of Vulnerable People over and immune compromise individuals is growing. The threat of food borne illness persi persist even though weve gotten better at investigating outbreaks and through the implementation of the hazard analysis and critical control point rules over the last two decades, cdc trend data indicates major reductions in the incidents of food borne disease, yet the problem remains significant. When contaminated food reaches store shelves, the fda is the publics last line of defense. The fda needs to be able to quickly and effectively help remove dangerous foods from commerce and protect consumers. In 2010 Congress Gave fda more power to recall tainted food. It was conducted to mandate a food recall. In addition to this law, previous audits by both the hhs office of Inspector General and the Government Accountability office made recommendations to fda to improve its food recall program. How has fda performed with food recalls in recent years with the new law and these recommendations . Over the last two years the hhs oig looked at this question and last month released the report that contains findings and recommendations for fda. The oig report looked at 30 voluntary food recalls overseen by fda between october of 2012 and may of 2015. The fda has used its mandatory recall authority only two times since the enactment of fisma and not at all over the last four years. The fda was slow to evaluate Health Hazards. It took fda an average of 47 days to complete an evaluation after learning of a plan or in progress food recall. The oig found that fda was woefully slow in starting recalls. The average length of a recall began once the fda knew of the issue was 57 days. The report also raises questions about the fdas ability to cope with uncooperative companies. In one case involving a Dietary Supplement Company it took ten months after fda issued a warning letter about unlisted ingredients before the firm finally pulled the product. In another case a recall of nut better began more than five months after the fda had traced the salmonella outbreak to the source facility. There were 14 illnesses in 11 states during that time. A series of recalls of cheese products took 81 days to complete and nine people got sick including one infant who died and two fetal losses linked to illness. During that time, the firm owner lied to the fda saying that the firm would suspend the manufacturing and distribution of cheese. However, the owner, despite knowing that the product tested positive for listeria continued to allow the product to be distributed. The owner later pleaded guilty to crimes and went to prison. The fda needed to find a way to detect such deception sooner. Fda did not have a reliable system for accessing the recall initiation date or the date fda became aware of potentially hazardous Food Products and it was the 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 and worse, fda does not collect sufficient or accurate data so that the agency can measure the performance whether the food recall is improving. In addition to the oig findings, the fda told Committee Staff in a briefing that there are concerns about the turnaround time it takes theyre used to make the evaluation of the seriousness of the food hazard. To ensure the fda labs are performing properly, its the office of Laboratory Science and safety. This office has not been fully stood up and fda should follow the example of the cdc. The office of lab, science and safety has dedicated funding and permanent staff to oversee cdcs own labs. The enactment of fisma provided recall authority and imposed more legal obligations of food manufacturers and distributors. Fda has the tools, but the oigs findings and fdas own assessments show that the fda needs to reform itself to get this right i am heartened that the fda commissioner has recognized that a handful of problematic recalls are too many because lives are at stake. I am also glad that the commissioner will look at ways to improve the time limits and scope of information provided to the public about fdaregulated food recalls. I welcome and thank the witnesses and look forward to their testimony. Ill now recognize the Ranking Member mr. Get for the purpose of her opening statement. Thank you very much, mr. Chairman. As you know, food safety is not a new issue for this committee. Many of the challenges that were going to hear about today are the same issues that weve dealt with over the past decade. All of those examples you mentioned were brought up in hearings in front of this committee. For example, we held a hearing in 2008 on a major salmonella outbreak that infected over 1300 people in 43 states. As that case illustrated, we lacked basic controls over food recalls including traceability. Fda and cdc originally identified tomatoes as the likely cause of the outbreak, but later on they found out it was because of jalapenos. This was frustrating to all of us because lives were at stake, the federal response was slow and inefficient and yet that case demonstrated that the response is not as simple as just pulling off all of the suspected products from the shelves because entire industries should be devastated. When we had these hearings where we thought it was the tomatoes, the tomato industry was absolutely devastated at that time and it turned out that the problem wasnt even tomatoes, but jalapenos. And so it was clear then as it is now that the fda needs the ability to respond to a multitude of different situations that pose risks to the Public Health. As you noted, mr. Chairman, in response to incidents like that we pass the fda food safety modernization act in 2011 and many of the members on this committee worked in a bipartisan way on that bill and it gave the fda more tools to prevent and to respond to outbreaks including critically, new authority to issue mandatory recall orders and requirements for manufacturing firms to have recall plans in place, but now, seven years after we passed the law, the office of Inspector General has a new report that points to some of the same issues that weve been worrying about in this committee for years. Despite the progress that weve made, here we find ourselves. Oig found despite more power to oversee manufacturing firms that produce potentially hazardous food. Fda is not doing enough to monitor firms during a recall. Sometimes there have been long delays in getting firms to recall all of their affected product or even to provide the fda with basic information. In addition to insufficient oversight of firm, fda his also we weaknesses in its own recall responses. Its critical that the public understand the product may present. Oig found that fda was sometimes slow to evaluate the Health Hazard posed by a contaminated product. This is not to say that these cases are easy and the answers are always crystal clear. The fda is dealing with many recalls every year, each which presen presents its own challenges and complexities. That being said, i do think theres more the fda can do to improve the food Safety System. Oigs report provides multiple recommendations for fda such as improving its policies and procedures for managing recalls and monitoring firms. However, id like to hear more of oig about what specific, meaningful steps it thinks fda should take. Guidance manuals are not enough. We need to know what actually needs to change to help better protect the american public. As fda continues to implement provisions of sma, the committee needs to hear how the law is working and what more the fda needs to do and how congress can help. I would like to take a moment of personal privilege, if i may. I just saw the former chairman of the Committee Walk into the room and congressman stupack was one of the key players in enactment of the food safety legislation. Welcome. We are glad to have you here. I am sorry that were still talking about this even years later. With that, mr. Chairman, i yield back. In the gentle lady yields back and i would also like to welcome mr. Stupak for his attendance. Its great to see you back and wish you the best. Now the chair would recognize the chairman of the full committee mr. Waldon for the purposes of an opening statement. Thank you, mr. Chairman. Bart, good to see you again and i enjoyed working with you when we did the oversight work and good to see you here. I take this issue personally. In february of 2009 this subcommittee held hearings on nationwide outbreaks of salmonellarelated products. One of the witnesses at that hearing was peter hurley from wilsonville, oregon. When peters then 3yearold son jake became sick doctors recommended they give him his favorite food just to encourage him to eat. Jakes favorite food was austin brand Peanut Butter crackers. Tragically, that turned out to be the very thing that was poisoning him. When oregon state officials tested the crackers, three of the six packages contained Peanut Butter contaminated by salmonella. Jake became ill because stewart parnell, the ceo of pca, knew that the peanut products were c contaminated with salmonella when he told the plant manager to, quote, turn them loose. At that same hearing i confronted mr. Parnell with this container, and i ask him whether he was willing to take the lid off and eat any of these products now since he was so cavalier about turning it loose on little kids like jake to eat . He refused, of course, citing his fifth amendment rights. Thankfully, jake overcame his illness and it was great to see him last year. Hes now a young teenager. He and his dad came back to visit us. More than 600 people in 44 states were sickened and unlike jake, nine people died. As a result, mr. Parnell is currently serving a 28year sentence in prison for his actions. While this case of pca is the exception and not the rule, fortunately, food borne illnesses remain a major concern. Chairman harper just ran through those numbers. Each year 48 Million People are sickened and 3,000 die from food borne illnesses and federal oversight of food safety has been on the account are Government Accountability offices highrisk list since 2007 and just in the past few months, dozens of people in the United States and canada were infected and two have died from what appears to be an e. Coli contamination and leafy greens and we are here to check on the food and Drug Administration and their work to protect the nations Food Supply Chain and to ensure health and safety for all americans and i was glad to see the fda commissioner Scott Gottlieb showed his commitment that the fda will accelerate the release of information about problematic products before they may officially be classified as recall items. We look forward to hearing from the fda today about what plans and benchmarks its developed to implement the law and recommendations from the oig. We look forward to the fda immremii implementing the expert recommendations to provide staff to the office that overseas the fda labs which do play a Critical Role in food recalls. I thank the hhs oig for testifying today and commend its recent report in december as well as the early alert issued in june of 2016. Where it builds on the pass work done by the oig and most notably, two reports related to two recalls in 2009 and 2011. The food safety modernization act and many in the december report are similar, if not the same as they were in 2009 and 2011. Further, the gao raised concerns about fdas food recall process in 2012 and while fda says that its addressed many of the findings of the recent oig report it is troubling that many of the recommendations from almost a decade ago stand today despite the Additional Authority given to the fda through fisma in 2010. Todays hearing gives a Good Opportunity to share specific plans to share the recommendations made by oig including the timeframe in which we can expect the changes to be implemented. I do see dr. Burgess. I know he was looking for some time. Anyone else would like the remainder of my time . If not, i will yield back to the chairman so we can proceed with the hearing and i do have another hearing i have to go to, so ill be in and out of this one. Thank you for the good work you do. I know we are here for americans can trust the food is safe to eat. Thank you, mr. Chairman. Now the chair will recognize the Ranking Member mr. Pollone for the purposes of opening statement. Thank you, mr. Chairman. This committee has a long history of overseeing food safety. Over the last decade weve had multiple hearings examining the food and Drug Administrations oversight of food recalls and the agencys authority to protect the nations food supply. The fda plays a Critical Role. Fda oversaw more than 3600 recalls and this is no small task, but we have seen cases that exposed weaknesses in fdas ability to respond to these threats. For example, as has been mentioned in 2007, a Committee Investigation into a salmonella outbreak identified serious flaws in our food safety network. In 2010 the Committee Found that fda had limited authority to ensure compliance and did not always take swift action when needed. Witnesses repeatedly told his committee that fda lacks sufficient authority to address weaknesses in our food Safety System and thats why Congress Passed the food safety modernization act and fisma had the overall food safety and gave fda new authorities to strengthen the food recall process. For instance, fda now has the ability to mandate a recall. This is a significant tool because weve seen cases of manufacturing firms reluctant to work with the fda. It has recall maps in place to help prepare before contamination occurs. Fisma provided these new tools and it is up to fda to mick sure theyre being put to good use and thats why this hearing is so important. We need to hear about how fdas implementing fisma and whether things have improved since we passed the law. A recent office of Inspector General report shed some light on that question and suggests that fda may still not adequately oversee food recalls. The Inspector General reported that fda did not always effectively monitor firms during a recall such as ensuring the recalls promptly. Some of the cases heigighlighten the report are troubling. For example, between 2012 and 2014, nut butter contaminated with salmonella sickened 14 people in 11 states. The fda identified the source of the outbreak in march 2014, but the products were not fully recalled until august of that year, 165 days later. The Inspector General cited cheese products that were contaminated with listeria and led to two lost pregnancies and i know everyone on this committee would argue that one fataality is one too many. So while we should recognize that these issues are complex and each recall poses a unique challenge, these findings demonstrate the fda must exercise judicious and forceful oversight when the Publics Health is at risk. I look forward to hearing how fdas implementing fisma and what challenges are made to protect the nations food supply. I dont think anyone else wants my time so ill yield back, mr. Chairman. The gentleman yields back. I ask unanimous consent that the Opening Statements be made part of the record and without objection theyll be entered into the record. Ill intus troduce the panel fo todays hearing. Gloria jarvin at hhs. We welcome you today and mr. Douglas stern, the director of the office of import operations of the office of regulatory,a fairs at the fda. Welcome to you both and thank you for being here today to help and to provide testimony, we look forward to the opportunity to discuss the fdas food recall process. You are aware that the committee is holding an investigative hearing and when so doing it has a practice of taking testimony under oath. Do you have any objection to testifying under oath . Both witnesses have indicated no. The chair then advises you that under the rules of the house and the rules of the committee you are entitled to be accompanied by counsel. Do you desire to be accompanied by counsel during your testimony today . Both witnesses have indicated no. In that case, if you would, please rise and raise your right hand, and i will swear you in. Do you swear that the testimony you are about to give is the truth, the whole truth and nothing, but the truth . Thank you. You may both be seated. You are now under oath and subject to the penalties set forth in title 18 section 1001 of the United States code. You may now give a fiveminute summary of your written testimony and we will recognize miss jarvin first for your testimony. Good morning, chairman harper, Ranking Member daggett and members of the subcommittee. I am gloria ja