The subcommittee convenes this hearing entitled safety of the food supply continuing concerns over the food and drug administrations food recall process. Disease outbreaks from tainted food are Ongoing Public Health challenge. The centers for Disease Control estimates that each year one in six americans, 48 Million People get sick from food born illnesses, 128,000 are hospitalized and 3,000 die. The number of multi state food illness outbreaks is increasing affecting greater numbers of americans. And the number of vulnerable people, older, and immune compromised individuals is growing. The threat of food born illness persists even though we have gotten better at detecting and investigate outbreaks. And through the implementation of the hazard analysis and critical control point rules over the last two decades, cdc trend data indicates major reduction in the incidents of food born disease. Yet the problem remains significant. When contaminated food reaches store shelves, the fda is last line of defense. They need to protect consumers. In 2010, Congress Gave fda more power to retain the food. Fizz ma was enacted to provide fda with authority 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 a report that contains findings and recommendations for fda. The oig report looked at 30 volumtoll tier recalls. The fda used mandatory recall authority only two times since enactment of physicfizz ma and all over the last four years. In some cases fda was slow to evaluate Health Hazards. Took fda average of 47 days to complete an evaluation after learning of a planned food recall. The oig found that fda was slow in starting recalls. Average leebt between recall began once fda new of the safety issue was 57 days. The report also raises questions about the fdas ability to cope with uncooperative companies. In one company it took ten months after fda issued a warning letter about unlisted ingredients before the firm finally pulled the product. In another case recall of nut butter began more than five months after the fda had traced the out break to the source facility. There were 14 illnesses in 11 states during that time. A series of recalls of cheese products contaminated lister yeah took 81 days to complete. 9 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 lister a continued to allow the product to be distributed. Owner later pleaded guilty to fda crimes and went to prison. Justice was done but they needed to find a way to detect such destepgs owner. 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 their electronic data system called the recall enterprise system. The electronic data system did not include when they found out about the suspect Food Products. Worse, fda does not collect sufficient or accurate data so that the agency can measure performance it tell whether their food recall performance is improving. In addition to the oig findings, fda told Committee Staff in briefing there were concerns about the turnaround time it takes to get test results from fda labs used to make an evaluation of the seriousness of the food hazard. To ensure the fda labs are performing properly, they need to provide independent funding and permanent staff to office of Laboratory Science and safety. This office has not been fully stood up and been unable to inspect fda labs. Fda should follow the example of cdc. Their office of lab science and safety has dedicated funding and permanent staff to oversee cdcs own labs. The enactment of fizz ma provided fda man torety recall authority tan imposed more legal obligations on food manufacturers and distributors. Fda has the tools, but the oig findings and fda own assessments show that the fda needs to reform itself to get this right. Im heart end that the fda commissioner has recognized that 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 the time limits and scope of information provided to the public about fda regulated food recalls. I welcome and thank the witnesses and lube forward to their testimony. Ill now recognize the Ranking Member for the purpose of her opening statement. Thank you so much, mr. Chairman. As you know, food safety is not a new issue for this committee. Many of the challenges that we are going to hear about today are the same issues that we have dealt with over the past decade. All of those examples you mentioned were brought up hearings in front of this committee. For example, we held a hearing in 2008 on a major salmonella out break that affected over 1300 people in 43 states. As that case illustrated we lacked basic controls over food recalls, including trace ability. Fda and cdc originally identifi identifi identifi identified tomato as likely cause but later on they found out it was from hajalapeno. Yet that case demonstrated that the responses not as simple as just pulling off all the suspected products from the shelves, because entire industries should be devastated. When we had these hearings, where we thought it was the tomatoes, tomato industry was 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. It gave the fda more tools to prevent and to respond to outbreaks, including critically new authority to issue mandatory recall orders, and requirements for manufacturing firms to have recall plans in place. But now seven years after we passed the law, the office of Inspector General has a new report that points to some of the same issues that we have 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 recall. Sometimes there have been long delays in getting firms to recall all their affected product or even to provide the fda with basic information. In addition, in sufficient oversight of firms, fda has also weaknesses in its own recall responses. For example, its critical for the public to understand the risk that a food product may present. But oig found that fda was sometimes slow to eval kwat the Health Hazard posed by a contaminated product. This is not to say that these cases are easy and answers are always crystal clear. The fda is dealing with many recalls every year, each which presents its own challenges and complexities. That being said, i do think there is more the fda can do to improve the food Safety System. Oig report presents multiple recommendations for fda, such as improving its policies, and procedures for managing recalls and monitoring first. However, id like to hear more from oig about what specific steps they think fda should take. A foor more guidance manuals are not enough. We need to know what needs to be change to better protect the american public. As fda continues to implement provisions of sma, the committee needs to hear how the law is 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 form tear chairman of the Committee Walk into the room, bart stew pack. And congressman stew pack was one of the key players in enactment of this food safety. With that mr. Chairman ill yield back. Yields back. And i would like to welcome mr. Stew pack for his attendance today. Good to see you back and welcome you best. Now recognize chairman of the fu full committee. Thank you, mr. Chairman. A privilege serving with you. I take this issue very personally. In february of 2009, this subcommittee held the hearings on nationwide outbreaks of salmonella illness es linked to peanuts. One of the witnesses was peterson. When his son became sick, doctors said to give him his peanut food. His favorite food was Peanut Butter crackers. That was poisoning. When they tested it, packages were con tataminated. He became ill because the peanut products were 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 asked him whether he was willing to take the lid off and eat any of these products now since he was so cavalier about turning it loose on little kids like jake to eat. He refused, of course, sighting his fifth amendment rights. Thankfully jake over came his illness and great to see him last year. Now ha young teenager. He and his dad came back to visit us. More than 600 people in 44 states were sick end and unlike jake, nine people died. As a result, mr. Parnell is currently serving a 28 year sentence in prison for his actions. And while this case of pca is the exception and not the rule, fortunately, food born illnesses remain a major concern. Chairman harper ran through the numbers. Each year 48,000 are sick end, 3,000 die, it has been on the Government Accountability high risk list since 2007. And just in the past few months dozens of people in the United States and canada and two died from e. Coli leafy green. I was glad to see the fda commissioner commitment with yesterdays announcement that the fda will accelerate the release of information before they officially classified as recall items. We look forward to hearing from the fda today what it plans to do to 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 labs which do play a critical role. I thank you all for testifying today and recent work in december as well as early alert they issued in june of 2016. Recent work builds on the past work most notably two reports related to food recalls related in 2009 and 11. While the reports were issued prior to this act, many of the recommendations in the recent december report are similar, if not the same, as they were in 2009 and 2011. Further, the they raised concerns about fda food recall process in 2012. And while fda says its addressed many of the findings of the recent 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 fizz ma in 2010. Todays hearing will give us a Good Opportunity for fda to share specific plans to address the recommendations made by the oig including the time frame we can expect the time changes to be implemented. I dont see dr. Burgs, i know he was looking for sometime. If any one else would like the remainder of my time, if not ill yield back to the chairman. And i have another hearing i have to go to. So thank you again for the good work you do. I know we are on the same team. With that i yield back. Thank you, mr. Chairman. Now recognize the ranking number of the full committee, mr. Pa lone for 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 over sight of food recalls and the agencys authority to protect the nations food supply. Fda plays a critical role. In fiscal year 2017 alone, fda oversaw more than 3,600 recalls. This is no small task but we have seen cases that exposed weaknesses in fdas ability to respond to these threats. For example, as i already mentioned, in 2007 a Committee Investigation into a salmonella out break identified serious flaws in our food safety network. In 2010 the Committee Found they had limited authority and did not take swift action when needed. Witnesses preet he hadly told this committee that fda lacked sufficient authority to address weaknesses and our food Safety System. Thats why Congress Passed the fda safety fizz ma in 2011. And they gave fda new authorities to strengthen the food recall process. For instance, fda now has the ability to mandate recall when a product poses a serious Adverse Health consequence. This is a significant tool because we have seen cases of manufacturing firms reluctant to cooperate with the fda. And thanks to fizz ma firms are also now required to have recall plans in place to help prepare before contamination occurs. Fizz ma provided these new tools, but up to fda to make sure they are being put to good use. Thats why this hearing is so important. We need to know they are implementing. Rece recent inspector report says fda may not adequately oversee the recalls. They did not always monitor firms during a recall such as ensuring that firms initiate the recalls promptly. In some of the cases highlighted in the report particularly troubling for example between 2012 and 2014 nut butter sick end 14 people in 11 states. Fda identified the source in march of 2014. But products were not fully recalled until august of that year. 16 five days later. Inspector general also cited series of recalls of cheese products that were contaminated with lister yeah and led to one infants death and two lost pregnancies. And i know eve one on this committee will argue even one fatality is fa toor many. So while we recognize these are complex and tefr recall poses a unique challenges, these findings dem state the fda must exercise ju dish shus yet forceful over sight when the Publics Health is at risk. So i look forward how they are implementing it. I dont think anyone else wants my time. So ill yield back, mr. Chairman. Gentleman yields back. Opening Statement Part of the record, and without objection theyll be entered into the record. Id like to introduce our panel of witnesses for todays hearing. Today we have mist gloria jar vin who is the deputy Inspector General of Audit Services for the office of the Inspector General at hhs. We welcome you today. And mr. Douglas stern, the director of the office of enforcement and import operations and a fares at the fda. Welcome to you both. And thank you for being here today to help and to provide testimony. And we look forward to the opportunity to discuss the fdas food recall process. You are aware that the committee is holding an investigative hearing. And when so doing 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 ill 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. And you may both be seated. You are now under oath and subject to the penalties set forth in title 18, section 1001 of the United States code. You may now give a five minute summary of your written testimony. And we will recognize mist jar vin first for your testimony. Good morning, chairman harper. Ranking member deget, and other members of the subcommittee. I am gloria jarmen, Inspector General for Audit Services office of Inspector General u. S. Department of health and human ser he advises, i appreciate the opportunity to appear before you today. Conduct aids evaluations and in expected at food safety is a priority for oig. And remains key to our mission of protecting the health and safety of the American People. I am here today to discuss our recently published report on the food recall process at the food and drug administration. And our recommendations for improving that process. This audit review documentation for 30 recalls which were judgmentally selected from the 5750 reported to fda between 2012 and may 4, 2015. For the recalls we found that fda food recall process was not always efficient in ensuring the safety of the nations food supply. Specifically identified deficiencies in fdas oversight of information maintained in the data system. My testimony today focuses on key aspects of these three findings and their recommendations for improving the food recall process. First, determined that fda could not always ensure firm recall promptly and did not always evaluate Health Hazards in a timely manner. To improve oversight we recommended that fda establish set internal time frames for discussing the possibility of voluntary recall with a firm and initiating use of mandatory recall authority. In addition, we recommended that fda takes several actions to ensure that Health Hazards evaluations are done in timely ma