And good morning. You the subcommittee today and him and him and the subcommittee today examines the center for Disease Control anthrax incident last month that potentially exposed dozens of from you potentially exposed dozens of researchers to live and you and anthrax because established cdc policies were not followed. You last friday, the director and you and you announced corrective actions being taken. Are you corrective actions being taken. The review identified a fundamental flaw the agency had no written plan to ensure the safety of workers and proper handling of live biological you agents. The department of agriculture agriculturetment of the disinfectant they used was expired. This is troubling, and completely unacceptable. The center for Disease Control is supposed to be the Gold Standard of the u. S. Public health system, and it has been tarnished. We rely on cdc to protect us, but the recent anthrax event and incidents have raised serious questions about the cdc ability to safeguard agents in its own labs. The director called the exposure a wake up call. This is not the first wakeup call. I am not even sure wakeup call is the proper term. It is a gross and dangerous understatement. It would be potentially very dangerous. A wake up call is catching something before the danger exists. Once a person is exposed to the serious pathogen, the danger is of a much higher magnitude. In 2006 bioterrorism labs sent anthrax on the mistaken belief it was enacted. Later, mistaken procedure led them to ship live agents to an outside lab. In 2009, they learned a strain that can cause a highly contagious infection has been shipped to outside labs since 2001 because researchers believe it was a last dangerous strain. One must question the scientific altercations of the scientists. These are not isolated incidents. From 2008 to 2010 the Inspector General issued three reports documenting concerns cdc labs were not ensuring physical safety of agents and ensuring personnel receive required training. An audit found a scientist discovered agents in a drawer in an unsecured lab, and another found agents in a freezer leftover from an outbreak investigation many years earlier. This is reminiscent of the recent discovery of smallpox files in storage on the nih campus. It was discovered by accident. In 2011, oig bound cdc did not monitor certain agents at federal laboratories. In addition to the Inspector General audit, several gao reports have raised concerns about oversight of high Containment Labs, including those at cdc. Despite the red flags, these incidents keep happening. We learned last friday scientists delivered an influenza strain that was contaminated with a very deadly flu virus. The crosscontamination was discovered may 23, but it took six weeks for this to be reported to cdc leadership. What we have here is a pattern of reoccurring issues, of complacency, and a lack of a culture of safety. This is not sound science, and this will not be tolerated. These practices put the health of the American Public address. It is sloppy and inexcusable. Dr. Frieden, i thank you for testifying today. I question if the corrective measures you have announced will solve the problem, and i look forward to the testimony. Taking personal actions will not address problems that appear to be systemic. Cdc needs to ensure that procedures are followed. You said you were distressed by the delay in notification over shipment. I want to know if you have reason to believe workers may be afraid to report incidents. Cdc will not solve human errors unless it gets as much information as possible. Since 2007, there have been 17 reports indicating a worker was potentially exposed to an agent or toxin. As far as we are aware, no one at cdc has become sick from improper handling, but these near miss events will continue. Sooner or later, someone will get very sick or die. The risks require failsafe mechanisms and redundancy similar to those used in contexts such as handling weapons. The subcommittee will review the oversight of laboratories and explore the possibility of an independent agency. I thank all the witnesses testifying, and now recognize the Ranking Member. Thank you very much, mr. Chairman. Last month the cdc laboratories in atlanta made a series of mistakes. They transferred anthrax to two other labs, potentially exposing dozens of individuals to anthrax. Luckily, no one has yet fallen ill. I am deeply troubled by what we learned about this incident. How did it happen . Cdc conducted its own internal investigation that identified numerous failures. There was no Standard Operating Procedure for the analysis conducted by the cdc scientist. There was no study plan. The Scientists Used a pathogenic strain of anthrax when a nonpathogenic strain could have been used. The Scientists Used unapproved sterilization techniques for pathogenic anthrax and then transported the material without confirming it was inactive. This was obviously an alarming series of failures, but there were other problems at cdc that made this incident worse. Cdc has provided to the committee a disturbing report from the u. S. Department of agriculture, animal and Plant Health Inspection service. After the incident, they conducted their own investigation of the facility. Inspectors identified Serious Problems in Lab Procedures and decontamination procedures. They reported the agency was inadequately prepared to handle the cleanup or treat those potentially exposed. I think we can all agree that reports on this incident are bad, but what is even more troubling to me is that in context they reveal a broad problem with cdc Safety Culture. We received report after report from gao, hhs, aig, and aphis offering a multitude of warnings and recommendations on operations of high Containment Labs. The report identified four other cases in the last decade where cdc shipped dangerous pathogens off site. The Democratic Committee staff repaired a memo describing the results from six different inspections at the cdc facility in2013 and 2014. Overall, in six inspections, aphis and invite dozens of concerns. 29 related to equipment, 27 related to security, and 39 related to recordkeeping. In some cases, the observations revealed that what appeared to be on the paperwork problems, but in other cases they found Serious Problems. Reports of scientists using torn gloves and exhaust blowing fumes in the wrong direction. None of these inspections gave cdc a totally clean bill of health. I want to make this part of the record, mr. Chairman. The record shows cdc had ample warnings and should have been focused on the problems in high Containment Labs long before the june anthrax release. I just dont understand why they did not heed those warnings. Dr. Frieden has indicated he was as surprised as anybody by the scope of the problem, and the fact he worked so surprise is a problem in and of itself. It shows there is a fundamental problem with the culture of identifying and reporting safety problems up the chain of command. Im sorry to say, these lab safety issues are not new to me or the committee. This is one of the detriments of having been on this committee for 18 years. We have had multiple hearings on this problem at the cdc over the years. In 2006 and 2007, we had terrible problems at the cdc facility in fort collins, colorado, just north of my district, where we had vectorborne diseases being very sloppily handled. Fortunately, we build a new facility since then in fort collins. A beautiful facility. And we are able to handle these diseases. But these issues are not resolving themselves, and so while you have a strong record at the cdc, i know you have answers and, we all appreciate it. But what we all need to know is we cannot legislate a culture change. It has to come from within the agency. Im glad to have gao and aphis witnesses here, because youre warnings were prescient and should have been taken more seriously. I can assure you, the warnings are being taken very seriously. Not just by the agency, but by the people here on this panel. I recognize mr. Upton for five minutes. Thank you. This is a very serious hearing, for sure. Two years ago after allegations about problems in cdc building 18, home of the deadliest agents and pathogens, investigations about compliance in the operation of its main lab facilities. In response to concerns, cdc director tom frieden sent the committee a letter. The letter outlined the agencys efforts to ensure better oversight in safe handling of select agents at cdc labs, including rigorous training, constant review of safety measures, and multiple layers of systems. The letter stated that a senior official who was not identified would be designated to report directly to the cdc director on safety at cdc labs. These measures sound very similar to the corrective actions dr. Frieden outlined last week to address the current lab crisis. Why should we believe this time that things are in fact going to be different . We asked cdc two years ago to invite each biosafety issue that had taken place since 2005. Cdc provided us with a list in 2012, but we now know from the internal investigation released last friday that the list was not complete. Improper shipments of pathogens in 2006, including anthrax, were not included in the cdc list of Safety Incidents that in fact was provided to this committee. Cdc staff has no knowledge that the incidents reported should have been included. We dont know why they werent. This raises the question of whether cdc leadership is receiving all the information about its own biosafety systems. As to the possible anthrax exposure, the delayed notice provided to leadership about avian flu shipments and the discovery of smallpox vials in a Cardboard Box on the nih campus, these issues no wonder seem isolated. A dangerous, very dangerous pattern is emerging, and there is a lot of unknowns out there, as well. When dealing with pathogens, unknowns are, frankly, unacceptable. What you do not know can hurt you. Why do these events keep happening . Cdc needs to solve this problem now as a team. The agency needs to get as much as possible from its workers about true safety, biosafety, the true state of biosafety at cdc and keep this committee and the American Public fully informed. There is zero tolerance for unlocked refrigerators and ziploc bags. Those days have to be over. I thank the chairman for yielding. I want to thank the panel for being here. As you can hear on a bipartisan basis, we have plenty of questions for you. We are deeply concerned about the incidents that have occurred at the federal labs that are run by the department of health and Human Services. Cdc, with the anthrax specimens, dr. , we appreciate the time you spend with us last week, but i think we have plenty of questions about the safety and the turf create you know, we would think that the priority would be safety and caring and making certain that you are tending to that culture of safety within these labs. Nih, with the vials of smallpox and the fact that this was in an unused portion of a storage room, who all would have access to that . And then, of course, the crosscontamination of the influenza sample. We have all talked about the three of these events, and the fact that they have occurred within this framework of time, the fact that there seemed to be a dismissiveness of the serious nature of these occurrences, the fact that the cdcs own report pointed out some of the contribute in factors in this and the lack of a Standard Operating Procedure and best practices, and the fact that this is not known among the employees at that agency, we know that there are some remediation measures that have been implemented, but the culture of safety or lack thereof continues to be a concern to us for Public Health. I yield back my time. Thank you, and we go to mr. Waxman. The possible release of these on the campus in atlanta, and i was on the committee, and we held hearings after the 2001 anthrax attacks. We looked at the safety of postal workers and the public in handling the mail, it and the Postal Service with the cdc response to those attacks, and we had hearings again in 2003 and 2005, where we found there were still gaps in biological detection of anthrax and in communicating test results to the public. Those hearings showed why cdcs work on identifying and containing Public Health risks on these types of biological elements is so important. But this work could also pose risks, and that is why this oversight hearing is important. In 2009, when i was chairman of the full committee, we held a hearing on the proliferation of high containment bio labs and the lack of oversight over such facilities. Mr. Dingell also held a hearing in 2007, so this is not our first introduction to this subject. At our request, we also looked into lab safety. It was reported in a number of studies, recently as 2013, the problems were associated with the governments fragmented, piecemeal dealing with these labs. No Single Agency has oversight over all high containment bio labs. There are no National Standards for operation, and we have no record of how many labs even exist. The health and Human ServicesInspector General also issued numerous reports on high Containment Labs and their handling of select agents. The Inspector General identified issues with the treatment of select agents and the safety of the individuals working with these dangerous pathogens. The ig recommended that the centers for Disease Control labs improve training for individuals handling select agents, improve recordkeeping, and take appropriate measures to improve safety. The American People count on the centers for Disease Control to protect them, and we want to be able to assure them that the cdc is conducting its research in safe and secure ways. Doctors efforts at cdc. We have worked with him on numerous issues over the last five years, and he has shown himself to be an effective leader and a strong communicator, and i appreciate the quick actions that he has taken in response to this incident. I am encouraged to see that dr. Frieden has appointed dr. Michael bell to oversee safety protocols and procedures. This investigation has shown us the cdc needs to change its Safety Culture, and i hope that dr. Bell can help instill a new mindset at the agency. Still, i am concerned that it took exposure of dozens of cdc staff to anthrax to finally spur cdc to action, so we want actions from the cdc about how this incident was allowed to happen in the first place, and i look forward to hearing from gao and others about the problems they have identified in the past, how cdc should implement their recommendations moving forward, and what role congress should play in making sure that happens. Mr. Chairman, this is not the first hearing on the subject. We have looked at it before. Weve now need to be sure that all of the recommendations we have had are put in place so we can stop Something Like this from happening again. Thank you, and we yield back my time. Thank you. I would like to introduce the witnesses in the first hearing. First, dr. Thomas frieden, accompanied by dr. Joseph henderson, the Deputy Director for Emergency Preparedness at the center of Disease Control. The doctor works with the plant inspection services, and dr. Nancy kingsbury works at the accountability office, and, dr. , did you want to introduce somebody else from your district . Mr. Chairman, thank you for the opportunity. I know this witness is on the second panel, and it will be a little while before we hear from the second panel, but it is an honor and a pleasure to introduce off of the second panel sean kaufman, part of a Company Called behavioralbased improvement solutions. His background is longterm employment with the cdc before forming his own company in my district, the 11th Congressional District of georgia, in woodstock, georgia, and i would encourage all members on both sides of the isle, if you have not had the chance i know we try to read all of the testimony, but sometimes we skip one or two along the way, but i will guarantee you that the testimony from mr. Kaufman really hits the nail right on the head in regards to the overall issue, and i will commend it to you, and i am proud to introduce him to you in anticipation of the second panel. Mr. Chairman, thank you very much, and i yield back. To the panel, you are aware that there is an investigative hearing, and they are used to taking testimony under oath. You any of you have objections to adding testimony under oath . It indicates no. The chair advises you that you are under the rules of the house and committee, and youre entitled to be advised by counsel. Do any of you wish to be advised by counsel during todays testimony . All of the witnesses indicate no. In that case, please rise and raise your right hand, and i will swear you in. Do you swear the testimony you are about to give is the whole truth and nothing but the truth . Thank you. All of the witnesses answered in the affirmative. Title 18, section 1001 of the United States code, and you may now give a fiveminute written summary of your statement. Dr. Frieden. Chairman murphy, Ranking Member degette. Chairman murphy, Ranking Membe