Thought about todays hearing as it relates to cdc, it is this. With the recent incidents, we recognize the pattern at cdc where we need to greatly improve the culture of safety and i am overseeing sweeping measures to improve that culture of safety. Cdc works 24 7 and our scientists protect americans from threats, including naturally occurring threats like ebola and mers and drug resistant bacteria such as anthrax. But we must do that work more safely and we will. Theres a recap of the recent incidents that summarized in our report which has been completed and were just at the outset of our investigation of the influenza contamination. Id be pleased to go through the two diagrams weve provided to the subcommittee which outlined what we know to date. But in brief, the anthrax incident shows deeply troubling problems. A lack of proper protocol, incorrect inactivation procedures. Failure to ensure that we were transferring materials that were sterile when we thought they were sterile. Use of a virulent strain when a nondangerous form would have been appropriate. In the influenza crosscontamination, were still trying to understand how the crosscontamination occurred and investigating how there could have been such a long delay in notification. The risk to employees from the anthrax exposure was at most very small and the risk of release to the public was nonexistent. But that does not change the fact that these were unacceptable events. They should never have happened. In the past, as the committee has outlined, there were a number of specific incidents, and i do believe that cdc staff worked hard to address the specific findings of past investigations. But i think we missed a critical pattern. Instead of just focusing on those when we issued the anthrax report, we provided not only these two incidents but the prior episodes of what has happened because what were seeing is a pattern that we missed. And the pattern is an insufficient culture of safety. Were now implementing every step we can to make sure the problems are addressed comprehensively in order to protect our own workforce and to strengthen the culture of safety and to continue our work protecting americans. I have taken a number of specific steps. Ive issued a moratorium on the transfer of all biological materials outside of all bsl 3 and 4 laboratories at cdc. Ive closed the two labs that were involved in this situation until were sure they can be reopened safely. Ive appointed dr. Michael bell, a senior scientist, to be director of the Laboratory Safety reporting directly to me as the single point of accountability. He will review the moratorium and lift it lab by lab that can be done safely. Hell also facilitate expansion and use of that Safety Culture throughout cdc. Cdc scientists are world famous for their rigor and Scientific Investigation and we will now apply that same wrrigor to imflg safety in our labs. Im convening a High Level Working Group within cdc internally to advise us on every step of the process and an external Advisory Group of outside experts who are top in the world to take a fresh look and see what we can do to do better. Well look at every activation and transfer protocol and other protocols that improve them as needed. Well look at future incidents if they occur with a command structure which should have been used earlier in the anthrax exposure. I will ensure that appropriate disciplinary is taken as indicated by our investigations and will apply Lessons Learned from this experience to our function as a Regulatory Agency in our select agents regulatory program. In hindsight, we realize that we missed a crucial pattern. A pattern of incidents that reflected the need to improve the culture of safety at cdc. But as with many things, recognition is only the first step. Were taking a number of additional actions to establish and strengthen a culture that prioritizes the safety of our own staff and encourages reporting of actual and potential situations that may place that and others at risk. Openly assesses those risks and implements redundant systems to keep risks to the absolute minimum. Part of that culture will be increased reporting of problems or potential problems. One of the aspects of an effective culture of safety is rapid reporting of problems. So if we do uncover problems in the coming weeks and months, this may well be the result of strengthening our culture of safety rather than failing to address it. We have concrete actions under way to change processes that allow these incidents to happen. Reduced the likelihood of an occurinence the future and apply lessons broadly. Well do Everything Possible to live up to the high standards that congress and the American Public rightfully expect us to achieve. I look forward to your questions and thank you for inviting me to testify today and for your interest in this important topic. Make sure your microphone is on. Push it very close to your mouth. Thank you. Its not on. Green light. There you go. Thank you. Mr. Chairman and members of the subcommittee, thank you for the opportunity to testify today about the animal and Plant Health InspectionServices Inspection into the release of possible live anthrax at the cdcs campus. Im dr. Jere dick, associate administrator for afus within usda. They conducted a thorough inspection of the incident to learn how it happened and to determine appropriate remedial measures. We will continue to monitor the cdcs response to ensure all necessary corrective action is taken and that when work resumes at the laboratories it will be done in full compliance with the health and safety of the employees and the public at the forefront usda was designated by congress as the partner with cdc and the oversight of select agents because of our expertise and experience safely working with select agents over the past century through our efforts to precent dangerous disease agents from affecting agriculture and the environment. For decades, aphis has safely operated high Containment Laboratories that handle select agents, including those of concern for human health our personnel, our leading diagnosticians and experts in though effective working of high Containment Laboratories to ensure objectivity, aphis and cdc signed a memorandum of understanding in october of 2012. Which makes aphis the lead inspection for cdc entities. Since the mou was finalized, aphis has cared out 11 inspections of the four cdc labs. Aphis takes any potential release of a select agent or toxin very seriously with a goal of quickly ensuring that the release is contained and determining what led to the release to ensure no future incidents. On june 13th, cdc officials discovered a potential release of anthrax and notified aphis. Cdc voluntarily closed impacted labs on june 16th. Aphis made its inspection a priority and quickly began its work to ensure that all select agents were secured and that there were no other breaches in biosafety or biosecurity. Especially trained aphis Inspection Team of veterinar yaens and plant pathologist spent nearly two weeks beginning june 23rd conducting a facility review of the laboratoriey eies cdc personnel. Aphis briefed cdc officials on july 2nd outlining the efficiencies so they could immediately begin taking corrective actions. Aphis found the laboratory did not use inadequate activation protocol and did not ensure that the protocol was in fact, validated. The initial response to this incident by the cdc laboratories was inadequate. Both in securing as well as disinfecting laboratories. For example, individuals without approval to handle select agents were able to access space containing or potentially contaminated with anthrax at least four days after the incident was discovered. We also found that employees did not have appropriate training in some instances. We found no Clear Management oversight of the incident at the labs and no clear single manager overseeing the overall cdc Incident Response which resulted in employee confusion about how to respond. In addition, cdcs Occupational Health clinic was not prepared to respond to the potential exposure of a large number of workers. Aphis currently has in place a cease and desist order with select agents and the toxins at the two impacted select agent laboratories. We will require that corrective actions be taken to ensure the integrity of these research programs. We have directed cdc to provide aphis with his plan for coming into compliance by july 25th. And before allowing cdc to resume select agent work in the laboratories, aphis will conduct a reinspection to ensure that all corrective actions have been taken. Mr. Chairman, this concludes my testimony. Id be happy to answer any questions that you or members of the subcommittee have. Thank you, dr. Dick. Dr. Kingsbury, please point that microphone very close to your mouth. A lot closer than that. Bring it really bring it bring the mike really close, please. Really close. Thank you. Is that better . Yeah. Okay. Thank you very much for inviting us to come to talk to you about some of our past work on biosafety issues as mr. Waxman noted in his statement, weve been doing this work for quite a while. We started with the original anthrax attacks and weve gone on to a number of other issues over the years. Basically our past work has a couple of major themes. One of them is a lack of Strategic Planning and oversight of the whole picture of biosafety laboratories. Aphis and cdc are only a part of that picture. And since 2001, there have been an increasing number of biosafety laboratories both within that sector but across the whole government. There are six or seven different agencies involved. And no one entity has been charged with developing a strategic plan. We became particularly concerned about that as budgets began to shrink, rerk inizing the management and operation of these labs is an expensive venture. If they arent properly maintained, other kinds of problems can arise. Weve also observed that theres a continued lack of National Standards for designing, constructing, commissioning and operating these laboratories. There is guidance. The biosafety and microbiological and biomedical laboratories guidance is available, but its not required. And there is no process by which an entity needs to make sure that they are following that guidance. We think this broader government perspective about both how many of these laboratories we need and for what purpose and also a better framework for oversight is still needed. We have done some work since this episode became since the most recent episode became public. We did take a team to atlanta. I want to thank dr. Frieden for his staffs cooperation with us when we were there coming together with something im prepared to sit here and talk about on Something Like ten days notice is a bit of a challenge for us. But his staff was very good at providing everything we asked for. Im not going to add very much to that debate. I think the two previous witnesses have covered the details pretty well. The one thing i would add is while we agree there is a requirement to have Standard Operating Procedures that are reviewed at appropriate levels for biosafety, we believe its also important that those procedures be validated. And by that we mean independently tested so that we can be assured that if these procedures are follows, there will be no further episodes. So ill just add that one thought to the debate about the incident itself. Thank you, mr. Chairman. Ill now recognize myself for five minutes. Dr. Frieden, is anthrax a biological agent that has been or could be used in warfare . Yes. And the mishandling of anthrax can have some real consequences. If someone were sickened by anthrax, what would some of the symptoms be . Anthrax can cause a variety of symptoms but the most severe thunderstorms are respiratory anthrax which can cause severe illness or death. Now i have an image of some lab of some workers handling testing for anthrax, et cetera. One sees, this is not a lab but some other workers investigating. When i toured labs, there have been the number of levels there, whats required for breathing, for covering clothes, for before and after is pretty severe. Ive got to ask this question. This is a ziploc bag. I have to think what in heavens name would go through the mind some of scientist thinking a ziploc bag is enough to protect someone from anthrax when you have other instances of all that paraphernalia someone has to wear when deal with anthrax. Have you talked to these individuals and asked them why . I have been directly involved in the investigation. I will be directly involved in the remediation of the problem that we find. Many of the issues that are mentioned in the aphis findings relate to what was done with the material that was believed to have been inactivated. So once the laboratory had said, here is killed anthrax, it was handled by the staff in those lower Containment Laboratories as if it were not infectious. Our subsequent studies suggest that its likely that it was not, but the core error there was the failure to dr. Frieden, this is like saying, i didnt know the gun was loaded but somebody got shot. But you should always assume it is. For someone to say, i didnt think the anthrax was live isnt acceptable and i wonder if you have the ability to not only reprimand such personnel but to fire them, to suspend them from working with pathogens that are deadly or quite frankly, do they understand that the extent to which this went could have left them in a condition where they were charged with criminal nejigence . Do they understand the seriousness of this to the American Public health . I think furst your idea, mr. Chairman, of a twokey system as is used in other circumstances is quite appropriate here. Both within the high Containment Laboratories and to verify this stuff coming out is safe if it does come out because stuff has to come out of the laboratories to be tested or worked with elsewhere. In terms of disciplinary proceedings, what we want to do is strike the right balance. On the one hand we recognize the need to make sweeping improvements in our culture of safety and part of that means that staff need to feel comfortable any time saying, hey, there may be a problem coming forward. At the same time, if our investigation finds that there is negligence, that people knowingly failed to report or took actions that were likely to or should have known to endarge themselves or others, then we will take appropriate action. The people who were not approved were able to handle select agents were able to access space through june 17th, four days after the incident was discovered. Now my assumption is they are pretty smart people but its extremely disturbing to think they arent thinking of this. But let me ask this. Its been a week since you learned about the march 2014 cdc shipment of h5n1 shipment. Have you find out why theres a sixpeek delay and is there a coverup involved in this or is this bureaucratic hurdles are too high . What was the cause . Ive only gotten some preliminary information on that. I will make a general point, however. When we look at emergencies in Emergency Departments or intensive care units in the health care sector, the biggest problem isnt usually a failure to respond effectively when people recognize theres an emergency. Its a failure to recognize the situation is an emergency or someone that requires immediate attention. But we havent completed our investigation of that. Well look at all possibilities. Is there any occasion or alarm system that lets people know whens theres been a release or a problem there . There are multiple alarm systems within cdc. In this case it was a crosscontamination of a culture. Somehow, and we havent figured out how yet, a low virlens Avian Influenza was crosscontaminated in our laboratory with the high pathogenic h5n1. I have to get more alarms going off when you try to walk out of walmart with the shirt that hasnt been paid for. Is there any evidence of coverup hiere from employees nt wanting others to know weve seen at this point no evidence of a coverup but we see the need that to encourage reporting. Any time theres a problem or potential problem so we can assess it and take rapid action. I now recognize ms. Degette for five minutes. Dr. Kingsbury, let me just make sure i heard your testimony right. You testified that theres an increasing number of labs that are handling these bio agents, correct . Correct. And you said theres really no one agency in charge. Is that correct . Correct. Now you said that today but in 2007, the gao testified before this committee the same thing. No single Government Agency was responsible for tracking all of these labs. Thats correct. Thats correct, too. Dr. Frieden, are you aware of this finding by the gao going back all the way to 2007 . Yes, i am. And do you agree with dr. Kingsbury that there are an increasing number of labs handling these bioagents . If we look over the past ten years, its my understanding theres an increasing number. Do you agree that theres never been one agency in charge despite the red flags going up all of these years . There is a Clear Division of responsibilities between cdc and aphis in terms of select agent oversight, inspection and enforcement. Several years ago at my direction, we turned over the inspection of cdcs laboratories, select agent laboratories to aphis which conducted them to this point. But the overarching issue of lab safety touches many parts of both the Public Sector and nongovernmental sector. Are you saying aphis is in charge now since you put that into effect the last few years . In terms of the inspection of laboratories which are working with select agents, theres a Clear Division of responsibility between ourselves and aphis. Does that mean aphis is in charge . Yes or no. Aphis is in charge of investigating cdcs select laboratories. Not in charge of the overall enterprise. Do you think we need to clarify who is going to be in charge of the overall enterprise . Were certainly willing to look at every suggestio