Transcripts For CSPAN2 Key Capitol Hill Hearings 20240622

And i am proud of you. I know you are currently residing in florida but you are a true puerto rican. I know you are fighting for equality, and that is the solution. The democratic thing to do the right thing to do economically and financially for puerto rico insofar as the immediate crisis is concerned. Congress could give puerto rico a tool that is not available in puerto rico, and that is chapter nine of the bankruptcy code. It allows companies to reorganize themselves under the protection of the bankruptcy court, so that they can meet their payment obligations. It allows them to restructure in an organized and legal way. That is why i am fighting for that in congress. But the permanent solution would be to allow puerto rico to join the union. Pay federal taxes. But at the same time, get the same benefits from the federal government. Then puerto rico would prosper with that kind of profit status. There would be a transition, but we would have no Political Risk and we would drive the sick thrive the same way to states have thrive in the union. Host one last call from atlantic city, democrat. Caller hello. First of all id like to pay homage and respect to the 65th infantry reserve. They actually volunteered for world war i. These people are not mandatory to fight our wars. They fight in our cause. We have the same cause. That is number one. Number two, mr. Pedro i believe you are not going to be a little pay this debt. I believe your banks will collapse, and i believe puerto rico will become a science experiment. Are you prepared for this . Guest i did on but do not agree with this assessment. I believe puerto rico has a bright future. On an immediate basis we are facing a fiscal crisis, and we have a lot of debt. It basically amounts to the level of our economy. That is high. But we can manage. We can make sure that we keep innovation for development, that our authorities are reorganized but we do not keep breathing rates would to be terrible for economic development. At the same time we can streamline our government and make sure that we live within our means. Puerto rico as i said, has a lot of potential. Many doctors from puerto rico are wellknown. That is the biggest resource our stem professionals. Our beauty, our location. Our culture. We can do much better than we have. We just need the u. S. Government is to treat a fairly. Allow us to prosper. It was equality and we will host on the debt issue governors schumer senator schumer and blumenthal are warning that if puerto rico is not allowed to restructure its debt it could trigger a humanitarian crisis. What sort a few military crisis . Guest it would be chaotic if you do not have the legal structure to adjust your debt when need be. They are referring to mass migration, more than we have. In the past, we have lost a 250,000 people in just five or six years. If it continues at this level puerto rico will be seriously downsized, even more so. It is going to be very hard to make it viable. We want american citizens who resided puerto rico to stay there. They would rather live in puerto rico than anywhere in the states. But because the economy is lagging, its not working. The system is not working. That is why we need to change it. That is what they are referring to. I hope the chapter nine deal i introduced in the house, etc. Blumenthal and schumer introduced in the senate will get its day in congress and it will become law. It will deftly help puerto rico. Host pedro pierluisi, thank you very muc the Defense Department says live anthrax was sent to 192 laboratories, more than double the number reported in june and the list includes 50 states and seven foreign countries. The house energy and subcommittee is two hours and 10 minutes long. Good morning. Welcome to our hearing once again dealing with anthrax. The subcommittee examines continuing concerns over the federal select Agent Program. At the grounds that occurred at a tenyear timeframe. Its like deja vu all over again. Last year we held a similar hearing on an incident that potentially exposed dozens of researchers due to the fact that established the seizures were not followed. The director testified that we will take every step possible to prevent any future incidents and months after a hearing in after white house ordered safety stand down and a sweep of all federal labs come and the cdc revealed that there had been a transfer of a bola and this is all deeply troubling. Despite the growing number of red flags these incidents keep happening and we have learned that an army lab has shipped this across the globe. At least 192 labs have received shipments of live anthrax. And the stability testing used to validate and ensure that these were inactivated failed to detect the live anthrax spores. What is most troubling is that they use this potentially deadly process for years. As i said this is completely unacceptable. The dangerous safety lapses are threatening the Nation Security and Public Health and the committee hopes learn today what is being done to prevent future safety lapses and will this be any different. Last week the department of defense released a report following an internal review surrounding a light shipments of anthrax and according to its report the dod was unable to definitively determine the root causes for how and why they shipped live anthrax. Yet in the report the department acknowledged that all its labs routinely operate outside the validated experimental data. So in other words it seems that the department of defense labs have been irradiating larger numbers of spores and they cannot guarantee the activation of those numbers especially at the doses of radiation given. This begs a lot of questions beginning with why for so long. Who is responsible for making the decisions about which process to use including how many spores and at what level to radiation. And then as they are reevaluated and what is the cdcs role in developing these processes. According to a recent headline the cdc has announced that it will conduct another review as to how it regulates safety and security. And what we have is a lax culture of safety they said that this was a wakeup call, but it appears that they have hit the Snooze Button once again, what it is or it take to change it and when. None of us wants to be here a year from now disgustingness in heaven for bed a loss of life. The u. S. Government Accountability Office conducted a comprehensive comprehensive work on the oversight of high Containment Labs and the gal has been issuing recommendations calling for a governmentwide strategy for high Containment Labs and the need for National Standards for designing and a and commissioning. Yet these recommendations have not been implemented. Which is one of the reasons were here again today to discuss another safety lapse that threatens National Security and the Public Health. Id like to thank our witnesses were testifying here and i look forward to hearing your testimony and learning from you. Please be candid and straightforward as we try to find ways to improve the safety and procedures in our labs. This committee, the subcommittee, is not going to relent on the oversight of compliance with select Agency Regulations and will further explore the possibility of an independent agency to oversee these labs. And i recognize the Ranking Member from colorado for five minutes. Naked. Thank you, mr. Chairman. We have been hearing 2,072,092,000 and thousand 14 and now 2015. So you might as well mark your calendar now. Part of that is important because the federal government needs to work on obtaining Public Health risks but the work itself contains risks and thats why we do have to continue our oversight. Last years hearing on this transfer, i talked about the high Containment Lab that we had in fort collins which some years ago we have identified a terrible lapse and i was able to work with my former republican colleague bob schaffer from that district to get a new lab bill and im proud of that work but we have to continue to be able to assure constituents that similar facilities across the country are providing no risk to workers or the broader community. As you have said frankly the details of this incident do not inspire confidence. We are talking about a longterm series of inadvertent shipments and live anthrax from this ground in utah which is cozily one of the most sophisticated facilities in the world. This incident only came to light in the month of may because a private company contacted them after discovering what they thought was an activated anthrax that was actually live. Since that time we have learned that 86 laboratories and is then transferred this to an additional 106 laps in the absolutely received this for over a decade, miraculously nobody seemed to have fallen ill as a result of this series of incidents, but like you mr. Chairman, im concerned that this activity was going on for so long before one lab raised questions for the department to take action. And im even eager to hear answers as to how this is allowed to happen in the first place and what they are doing to ensure it never happens again and they found that theres insufficient scientific literature to develop this for the inactivation of the force. It is therefore relying on procedures that did not permanently or completely sterilized this. This is not my area of expertise but it seems troubling on its face. How have we conducted research on this dangerous pathogen for the past decade without clearly understanding how to inactivated. We need to conduct a serious examination of whether we used similarly questionable protocols for other select agents and he has included this from his lap. This seems like an important first step, but i want to know how that affects the research lab and furthermore i want clarification as to how to we have 200 separate labs all across the country working with anthrax, do we need to have 200 labs working with anthrax or as a possible that we should limit the number of labs and therefore limit the risk while still being able to do this important research. I want to hear today about whether the breakdowns are indicative of problems even across the high Containment Lab and they must be held to the highest standards. In this recently raised questions as to whether we can handle select agents. And improper shipments and we are just going on borrowed time. I hope all of you have answers today about what we are really doing to make serious changes to the system and include the recommendations that the gao has made. I would also like to hear from our witnesses about the role that congress should make in making sure the program operate safely and with that i yield back. Does anyone wish to make any comments . The cdc article, i would like to have you looked at it for the record. And i think it is relevant to todays hearings. I now recognize mr. Cohen for five minutes. Thank you, mr. Chairman. I hope today we can get to the bottom of what happened and what resulted in live anthrax being shipped 192 labs in all 50 states and seven foreign countries. [inaudible] i am deeply relieved that no one has fallen ill as a result and im hopeful that this will remain the case as we continue to track all of the labs are perceived ease and the personnel that handled them, this incident also raises questions about the safety of high Containment Laboratories across the country. Every day hundreds of labs as well as academic institutions and private companies handle dangerous pathogens with this program these labs perform an important work and they play a Critical Role in biodefense by conducting research to improve our defenses against biological attacks and strengthening our Public Health response capabilities. They are required to abide by a set of regulations with what they pose. They are required to restrict access to those individuals who have undergone Security Risk assessment and cement physical security safeguards and Incident Response planning. They must also ensure that Laboratory Work includes safety and security measures. They are also subject to registration and inspections by the cdc division of select agents and there are Civil Penalties associated with the protocols in possession and misuse subject to severe criminal penalties. This includes highly toxic genic avian flu as to whether we need to strengthen our federal oversight when it comes to working with dangerous pathogens. And what are they doing to prevent similar situations i look forward to hearing about the findings and recommendations from the review and how they can be used to enhance safety and security at all of our nations high Containment Laboratorlaborator ies. I also want to note that the gao has an important body of work and i look forward to hearing from them about the recommendation and Safety Measures across high Containment Labs. Im glad that nobody appears to have suffered any injury because of this latest into them. But the next time this may be from something more dangerous such as highly infectious pathogens. So i hope you can learn from this latest incident and we will take seriously the important recommendations made by recent and ongoing investigations by the gao and others who make this program safe. Obviously we look forward to the discussion and how we can improve oversight and what this committee can do to facilitate that process. I again thank the chairman and the Ranking Member as we proceed and i yield back my time. The gentleman yields back. We will go to our witnesses. As you are aware we are doing so and it has had the ability to take testimony under oath. The chair then advises you that do any of you deserve to advise that council today. Do you swear that the testimony that you give is the truth and nothing but the truth . All of our witnesses have answered and so now youre under oath and subject to the penalties of the United States code. You may now give a five minute summary of your written statement, Pay Attention to the lights here and we will start with you for five minutes. Thank you chairman Ranking Member. [inaudible] the Deputy Assistant secretary of defense for chemical and biological defense. The use of activated or dead anthrax is part of the dod programs in doing this with a development and testing of Protection Systems and Production Equipment and diagnostic and contamination capabilities your first learned of this under consideration on may 22 2015 when the centers for Disease Control and prevention was alerted by a private company sparking growth of live anthrax and a sample that was activated in utah. The cdc immediately began an investigation working with the dod laboratories and state officials and the fbi. And the same batch have been notified and expected to stop working with the samples, also the laboratories to produce this were directed to stop producing and shipping and working with any anthrax other than purposes related to this matter. This includes other batches containing live spores and on june 2 the department of defense notified all known recipients whether it was confirmed to contain live anthrax or not. Theres no there is no known or suspected cases among workers at any of the laboratories of producer was viewed inactivated anthrax and theres no known risk of General Health with this Laboratory Work and the workers themselves. Thirtyone u. S. Citizens, 23 dod were placed on prophylactics and this was completed yesterday. Returning to the subject of the laboratory that produced and activated the anthrax come on may 29 at that the kerry secretary of defense directed that the for laboratories test all previous anthrax that was in their inventory to identify any live spores. The testing is now complete and the results are as follows. Since 2003 they are radiated a total of 149 batches of live anthrax spores. Of the 96 samples that were available to test, 17 tested positive and that includes samples that contained live spores. This includes an additional 106 labs receiving secondary transfers for some of the directors of the lab. This brings the total to 192 and three territories of on puerto rico and the u. S. Virgin islands area recently completed review resulted in several key findings including but the primary systemic issue is the lack of specific validated standards to guide the development of protocols and processes and Quality Assurance measures. The resulting recommendations are grouped into three broad categories being enhanced Quality Control programming and establish testing protocols that are based on relevant data and improved Program Management department is ensuring that this doesnt occur again and this includes the moratorium that will continue. The top priority is the safety of all involved and we remain committed to complete transparency of information as we go forward. They give her the opportunity and i welcome your questions. Before you speak, i just want to note that we havent had a chance to review a lot of the testimony because it wasnt until 9 00 oclock last night and the Committee Rules we asked me for 48 hours. So we didnt have time to review it. So when we get the testimony its difficult for us to review it and i dont want to think that they are trying to frustrate our purpose here but i want to indicate to you if you could pass the word on for future testimony that we want that 48 hour limit to adhere to. So would like to hear from you for five minutes and we thank you. Thank you. Distinguish members of the subcommittee, we want to thank you for this opportunity to testify before you today and wed like to share with you what they have done to respond to the inadvertent release of spores or anthrax and to provide perspective on the select agencies programs that the cdc supports. We were 24 7 to save lives and protect people. This includes our Emergency Operations center in the faces of uncertainty about this. We understand how concerning this incident has been in the primary focus continues to be making certain that people are safe and that the anthrax materials are secured and ultimately disposed of. This raises serious and challenging issues and its important to note that Scientific Research and laboratories is a vital component of our Nations Defense against naturally occurring diseases and bioterrorism. This research is complex and sometimes dangerous. While its not possible to illuminate all risks, those of us working in this field across the country and around the world must do all we can to minimize the risk. Heres what we know today about the incident. There have been no confirmed cases associated with this. The persons believe that they have accepted treatment will have completed a chemoprophylaxis yesterday and no complications have been reported. And we are developing a a Research Agenda with questions about activation as to relegate to conduct the research. Under direction were initiating a review that will complement ongoing work over the past year. With new leadership for a thorough review to insure the up reading is mandated in light to recent evidence. Working with dangerous pathogens than the scientist to work with them also have a covenant to Public Health and safety remus to achieve a balance to protect workers and the communities around the walls supporting scientific ideas with the safety comes first. Was in characteristics of cdc still reject is a commitment to improvement the regulations have been refined including numerous federal advisory and the public and this has led to revisions concerning personal reliability Incident Reporting coordination of inspections of federal partners and tracking shipments. Below much work has been done to enhance the effectiveness of the Regulatory Oversight more work remains to be done. Where improvements can be made to better the program we will make them. Whether a disagreement on the best path for root we will contribute our expertise to this and worked diligently with 81 of biological threats sinecure recognized for five minutes very active morning chairman and Ranking Member and members of this subcommittee i am chief counsel to be as vector General Department of health and Human Services for quite appreciate the opportunity to appear before you today. While the cdc said lerner says select Agent Program o it is off route authorized to have stiff penalties and riyadh it evaluate and offer suggestions for programmer premier. Cdc reviews all the violations and refers criminal matters to the fbi. With other matters in a further investigate to determine whether to exercise authority or suspend or revoke the registration or have remedial action and. If cdc says a civil violation may have heard it will refer to oig for enforcements. To see penalty over the circumstances of the particular case. In our experience violations pose risks to Public Health and safety. Today oig totals 2. 4 million. Two cases that in april 2007 touche shepard anthrax to Research Facility that included a certification was not viable. The Research Facility tested the material and found the presence of a low concentration of viable anthrax we found they ignore the results viability tests that show viable anthrax was present. Later, november in 2010 the Government Laboratory received a shipment that included a vital of day neurotoxic in small amounts are exempt from regulation the packing slip indicated it was the exempt amount but it was a regulated amount then they self reported to unauthorized shipments of this aged. As a federal entity to have enforcement challenge anyone would shift to within the government but that may not mean better compliance consistent with our approach oig issued a notice of violation letters. They both stated that oig that they were violated the agency and should examine current policies and practices to take corrective action to monitor safeguards on the ongoing basis. Yesterday oig received another referral from cdc and we are reviewing the matter now. Over the years. [applause] has audited private entities and auditing the six federal laboratories to provide audit results to the head of the relevant agencies to put the matter of notice they are expanding the audits and evaluation and we will focus on oversight of the select Agent Program and hhs leopard laboratories. Through hour. I am pleased to be here today to discuss g. A. O. Work of high Containment Laboratories. Biosafety and security practices are intended to reduce exposure to biological agents and prevent their loss of theft or misuse. The recent shipments of live anthrax bacteria from dod to u. S. And International Laboratories similar to the last your exposure to live anthrax bacteria shows multiple breakdowns with establish policies and inadequate oversight of the federal consumer laboratories it is another example of ongoing safety lapses that continue to occur often with the say in koch says prior incidents. We have been lucky so far. Researchers work with highrisk biological agents that could result in serious infections that have the potential to be used with biological weapons. Those to develop vaccines and countermeasures to understand the emerging infectious diseases. That also have the potential for high consequences. And to have that transmission of blood dash transmissible pathogen not only with Laboratory Workers but the epidemic could be triggered for consequences far beyond what we saw today. Gao is currently conducting to examine the issues and the preliminary findings show dod and cdc have begun to address it to address fundamental flaw is is, reporting and tracking of bio safety and security after they have occurred. They said this is the first from the department level. Dod has been revising its procedures but that will only cover a subset. And they are working to make sure future events are prevented. Similar the cdc will address weaknesses in the 2014 anthrax incident with its own laboratories but the agency has not yet completed recommendations for Laboratory Oversight for example, the internal work Group Recommended cdc develop agency wide policies to have consisted requirements for biosafety for all Agency Laboratory and in response to develop the transport policy but not other agency wide policies such as Laboratory Documentation and divergences protocol. The incidents you are examining today are part of all large series of safety lapses gao since 2007 has reported on these issues of multiple recommendations to improve federal oversight of Containment Laboratories they agreed with our recommendation and have conducted activities to respond but have not implemented the key recommendations for a single federal entity with responsibilities for oversight of all container laboratories recommended the establishment of a single federal entity to conduct government buys Strategic Planning including assessments of risk and to develop National Standards for deciding constructing and maintaining such laboratories we continue to believe such the entity or other mechanism to ensure higher level oversight is needed in the face of the proliferation of high continue laboratories and the ongoing failures to fix their problems on their own. In closing is indicative of failures to have multiple levels of control including cross check training and procedures and validated protocol to prevent such accidents from occurring this completes my rice and will be happy to answer questions you or the subcommittee may have. I now recognize myself for five minutes of questioning. You said you will work diligently and and thoughtfully with all federal partner sharing our commitment from biological threats please let the cdc know that i do not believe that many more. The article from the usa today said the cdc refused to produce up policy from the usa today regarding with the lab Safety Office when was that written . You have any idea . Thank you chairman i was asked to appear here today and i apologize for the lateness of the testimony. You know, anything about this report . I know the article came out last night i did not know about that report that after this here we will provide answers. We would like the report and when it was written and that would be valuable. I trying to dump this down if i could of coffee in a microcosm of the tickets, but that one dozen cups of coffee table model be heated. So we know that about radiation on mass. But if i luckier from on the graph that on the upper left dots that the radiation levels say it is operating at of the realm of the acceptable limits. And the report states favored to the operate out of data for the findings it sells like it does exist as it operates outside of that. Is that correct . Cancer. Who is responsible for setting this bores or doses of radiation . Or are those protocols reevaluated retrieve the . That is what were looking into. The review was focused on compliance to follow the protocols that they had to show a willful disregard. To show that it was not willful. The graph shows that working outside of that gray box that should have been the foundation looking at the accountability issue how is that made outside that realm . All the labs were outside that area. That is something we need to know because you like to think there is a scientific rule set up that they are following and all the labs are following that. In response to the most recent shipments hesitate a referred for Civil Penalties for these actions . That is the second part of the investigation looking at the accountability issue. Iran the process. Was there eighth systematic process and also or to a acknowledged to take it seriously and added fact the cdc staff responded that all examples were security and destroyed them people that may have been exposed were protected we continued to consider chair take advice then nature of the program. To you set standards on a regular basis or at all . You worked with dot in a variety of ways. When we had our hearings for General Motors is somebody made the decision this big or this big they referred to that as the shrug and it is that area women know the flight here to the scientific standards when things begin to slip out were not looking at various but to slip by overtime and luckily nobody has died yet but we have dodged the bullet for a long time. I am out of time. Dr. Cross you talk to your testimony how people could be infected and even an epidemic could be started if you had a very blunt agent. Corrected edition we have National Security implications regarding the mishandling of these agents. That is also a concern. If they got into the wrong hands. You had a lot of recommendations that have not been fully implemented yet . The primary one is to have a more centralized oversight. To have the single entity to set the standards for all agencies . Dr. What is your agencys opinion of the single federal entities . I will say within the department we will do that interlay. Why havent we done that . Why havent you implemented that in cooperation with your fellow agencies . We are in discussions now on these issues. You dont disagree with the idea of . What is your agency view . The cdc works with usda as if we are with one program. Redo a joint inspections whenever a changes proposed were considered it is discussed with the actors. That is nice but what about dot . The oversight function i am trying to understand your question. What dr. Cross agency has recommended is one single Oversight Agency to set forth the protocol for the dispensing of these agents. So i am asking each agency if you would object it makes sense to have one protocol the matter which the lab has said. Would do shoreview . My view it is a complex decision that there are constraints to having one standard for all procedures. What would those be . With anthrax there is many different uses. But in any case if you are sending it around you dont want it to be live. That is not subject to debate so few could have one agency to come up with the protocols of oversight of how you will make that not to be live and dispense of that you would not object to that. We believe the select Agent Program would be the appropriate body to do that. Could that have oversight of the dod . Absolutely. Cater to cooperate to make that happen . We will cooperate in any way. That seems to be an excellent recommendations. Here is Something Else having been on this committee for a long time with the federal labs not just deal a with anthrax but the nuclear labs have the same problem to understand to have a culture of safety. Is there anything we can do to systematize the culture of safety . I spent 10 years at the Dupont Company is spending 10 years to make gunpowder so that Safety Culture is there so with industry best practices. How long have you been there . Just about one year. Day you have some ideas so we can increase the culture of safety . I know the cdcs director take this issue incredibly seriously that will involve. You need to supplement your testimony is important for i have another question but i would like a written answer. Why all the problems of this particular incident seemed to have come out of though one lab. Was a problem with how they were canceling the anthrax that is what you are investigating rainout but it still looks like the crux of the problem. But im just curious so why would we shipped the inactive cells to laboratories . What she you gave by a shipping something that is dead . One of the aspects the shell around the original lives for the original structure is still there that is important that is the basis for the diagnostics the closer we can get to that the better we are. To do something the gentlelady from colorado mentioned that we are doing this is an 200 laboratories around the country . Is that a true statement . We have live amtraks in 200 laboratories . The statement 192 labs there received this material were not intended to receive though ive amtraks there are 281 registered entities within the program registered for user transfer i struggle with that to understand why there are 200 especially given the circumstances. But how would you grade the duty handling of this matter . Since the incident was reported they have moved pretty quickly to identify where the samples were sent although that was still developing over the last few days. How would you grade them . Passing or acceptable . I think their response was discovered has been probably the b but the fact it went on so long is a failure. And the fact they have four different laboratories with four different men did with four different chains of command that dont talk to one another. Dr. Hassell, since anthrax probably is the most dangerous agent we can handle i suppose more dangerous than an ebola, is getting that is probably the biggest threat we have to National Security so in this case, has anyone tried to grow above live anthrax after they receive the products . With 200 laboratories . Have they try to reactivate . It was to show the presence of the spores her gore dont understand your question. I apologize. I only have one minute left. Is the same anthrax used in 2001 . It is absolutely not. This is a wild type in a liquid formulation with extremely small numbers of spores that is a very different situation. So do you feel that our National Security is more at risk because of the process we have been handling this over the last 10 years . I dont believe that these samples created such a risk i do believe they were secured quickly and destroyed that there were small numbers of spores it was naturally occurring. My thought process initially why were real shipping is 274 in nations . Does someone have a written authorization is that a proverbial email and who authorizes the shipment of zaph and under what process do they explain how they want to get it . Why would be shipped to seven foreign nations . Those could be duty dod facilities but they were allies. We dont have enough in america . I have run out of time. Unfortunately that led to todays hearing citizen the first incident. The sec and office of Inspector General with the safety lapses is the result of the same kinds of problems that you hear about today is that correct dr. Hassell . Yes, sir. Based on the previous problem should they have made a better effort to see if the process worked . That is my initial impression we will look at that to see if there are simplifications so we can report back. They announced flashier they inadvertently transferred by the anthrax. As dod tried to check their own process to make sure that was inactivated properly . No sir. Why not . Im not sure that is a good question. What are the steps leading up there should be better indicators to take action to detect this earlier. They think the reason for the hearing is it is strange that the cdc made a mistake with the dod facility but somebody did not say lets check to make sure dod is doing it right. Particularly because of the problem but nobody decided to do that . It does not appear so. Beyond the particulars the fact that such shipments can actually occur raises questions about the select agents at the other labs. Dr. Hassell, based on the continuing problems what assurance can you give the subcommittee bill longstanding safety problems or at other facilities that handle biological agents . We are trying to see if there are lessons to learn from this to answer the questions such as the previous question internally but other indicators say we should ask questions about other operations across the whole complex. What is dod doing to check by a Security Policies and procedures to be sure they are adequate . Were undertaking an effort now under the chain of command. We will make sure the standards to ensure internally that is standardized across all of laboratories to use that as of business a basis. Of those lead to different activities. One size may not fit all the there are definite lessons to learn and whenever possible. How is tease dod ensuring the concerns about this years are communicated to your senior of leadership some of those recommendations made previously we will be more vigorous and the instruction mentioned earlier in process will include aspects to bring all reporting for virtue higher levels the 2007 incident would not just remain today that would not just state there but come all the way up to Central Office within the department year in the process now to pull in all the Inspector General reports and cdc reports from all laboratories up to my office to see if there are indicators to be learned. Following my colleagues from western ginger we have been fortunate that they have not led tear broader publichealth for Security Problems i hope the incident shows as they call the action not just for anthrax but others select agents of all facilities. We dont want to have someone here again to see if the issues are being corrected and. They give to the witnesses for being here today. Dr. Sosin, basically what we are doing to hardened that infrastructure in locations where these may be understudied because we have heard a recurring theme that i have been on this committee on a number of years. We want everything to be perfect by human beings are involved that are sometimes not perfect. I was just a regular guy in private practice when the attack happened in 2001 reading with absolute horror what happened when those five individuals were infected and died in the virginia and room doctors experience he did not look that said but just like the last 100 but we found out you could be a lot sicker than what you looked as clinical deterioration begins you could almost be too late to although it is possible if you start early. Id like ebola it is treatable with a relatively common antibiotics. Sold bearing in mind from the ebola experience one year ago cdc was telling us last july we have a ready up to speed on ebola we dont have to worry. We dont have to worry to come to this country they have done what they need to do and that did not have been. This is not quite the same thing but you know, you have sites this is under study and unfortunately elapse can occur so you have paid 35 mail mile radius they were notifying the people on the front lines like the emergency room doctors this is something were working on in your community . Thank you for that question. With respect to pardoning infrastructure, yes. There are support programs that the state and local level to redress anthrax and other bio terrorism threats as you pointed out. Not know the routine treatments but advanced medical countermeasures such as the antitoxin and to treat those later stages that were brought to bear in this instance from prophylaxis. The state authorities are informed of the institutions of their jurisdiction as up part of the Public Health piperidines for portland dash program theres an active are reached in the absence of an incident that we are quick to respond as we did with this incident with information how to diagnose or monitor or treat could you provide the committee those materials . Absolutely. And what radius where the breach occurred in that geographic radius . They were not sent to Emergency Departments although we were considering it they were sent to the laboratories and state health departments. That is the point they thought there begetting activated strains inactivated but then they leave work if i have a lowgrade temperature and does not feel right they go down to the facility they look well and told they are deathly ill. These were isolated at a laboratory we were working with them directly to monitor them. Forgive me if i am not qualified that the problem is you did not know what you did not know and the people in the community the doctors and nurses or caregivers seeing patients would not have known this is what they were up against. My concern is how to read get that information out there to make them aware . To even know that is a consideration fair enough but before that they looked like the last 1500 patients that came through the door with a viral syndrome for pro to have a question i need to ask. Maybe you can provide an answer in writing but looked at the referrals for evaluations of the program the cdc nih army missile called Research Institutes seem to be the top three. So if you have the enforcement policy but you dont find federal agencies . To date we have not. But you rob banks because that is where the money is if multiple violators seem to be coming from those three groups so can you give back to me in writing to discuss what you were doing to consider providing the same penalties that any other lab in the country would have to do if they had a breach of these agents. Yes. To be clear most of the referrals in those incidents have not involve federal entities but there have said bp to instances of we would be happy to provide an answer. With multiple vendors that is the problem. To instill penalties thank you. We heard about the importance of keeping labs say fans sector to explore how both publican private have failed to meet critical Safety Standards both the cdc and hhs or office of Inspector General have roles of enforcement. The cdc division can refer entities for Civil Penalties horror as a violation. Cdc could deny or suspend or require a allowed to enter into a planning criminal charges could be made in cases of misuse of unauthorized possession or transfer. Could you briefly walk us through the difference in for some adoptions and how you determine the appropriate response for violations . Thank you for your question for girl you correctly pointed out the administration did options choose to spend or deny or revoke registration and. The process itself is intended to screen and a sure there are a Good Laboratory practice and leadership and appropriate use for the select agent material. That process and a variety of other steps are intended to assure the entity itself is taking the appropriate steps that it needs to do take. The decision to suspend or revoke is taken very seriously on balance with the nature that you talk about here. These are important bio defense facilities doing important work and the history of the program is to work collaborative the to identify a specific problem to address them but they are an option with suspicious activity were a referral to oig. We received a referral from the cdc from the multiple attorneys to review the allegations with the scientist and expert to make sure we understand. If we believe there has been a violation we will contact the entity that is the subject of the matter to give them the opportunity why the penalty could not be appropriate. We take that into account with consultation of cdc to go forward with the case am looking at those cases that we have had to make a judgment where the case should be valued at. Does your office richie and the Work Together to take action against those in violation . We communicate together to make sure we understand the facts in these matters to determine what to do to go forward. Dr. Sosin what types of violations would occur . I can tell you the process of revoking a registration is undertaken through careful efforts to halt the of laboratory address the concerns and improve its practices and that revocation would come only after the inability to make those changes or their decision to go longer be interested to do that work i could get further clarification of the specific measures if you would like. How often has that happened . I believe two times. Have also like to see the of violations. But are you seeing any trend at the cdc with Enforcement Actions from the office of Inspector General or the Lab Registration . The federal select Agent Program is constantly evolving with the approaches such as the corrective action plan process. They are relatively new so the trend is hard to evaluate but at the request of this subcommittee specific actions have been laid out with a response and we should have that information youre looking for. Cry of out of time but please give the panel the same trend that you cite would be helpful. Fake you mr. Chairman and to our witnesses for your patience. We have another hearing going on in this morning. Dr. Sosin i have the copy of the testimony from this Committee Last year. And he was testifying about the lead june 2014 anthrax incident and i will read from the testimony, these incidents never should have happened with the oversight that allowed them to happen was totally unacceptable. We will explore that a broader application to incorporate the Lessons Learned from them to proactively prevent a future incidents at laboratories across the nation that work with the risk pathogens so i want to know, i can you explain why we did not seem to learn the lessons . And you talk about why there is another comprehensive review of safety and security of the bio terror labs and why was not congress notified . Why is another review necessary . Were the problems that the cdc not corrected . And who is going to conduct the new review . And ultimately whod do we hold responsible for this . Thank you for your questions. I think it is important to recognize the Oversight Program is not ac dc laboratory itself functions separately but nevertheless in hindsight there has been reason to look more closely at anthrax with activation. No question that is necessary and to look for the moratorium the materials will be lifted to have a policy how to validate. Wait to. That was supposed to be done so why was it not . Who is responsible that it did not get tended to last year . The work of a complex Microbiological Laboratory has thousands of procedures. So no one person is in charge . It is done by committee . Isaiah current nature of the federal select Agent Program sets broad standards to achieve high Laboratory Performance so which does not review each individual individual specific procedure. But arent they called for notifying congress to the procedures called to notify congress if you have to do a review or if you have another incident . That is not a part of your business process . I apologize if congress was not notified regarding the review that we take internally at the federal select Agent Program. That review is not a review of cdc lab sam procedures. Let me ask you this. Im sorry. Going back to his testimony where he said it never shed a happened with lack of procedures totally unacceptable when is this not done last year . Many things were done but this was not addressed. That is the answer i wanted yes or no. Either it was or was not. That is what we want to know. This is what is so frustrating to the taxpayers who are footing the bill because you feel like you have immunity and you dont have to move forward to do the job because you have the continuing appropriation you just dont do with intel is convenient you mess up once or twice or 86 times and it is no skin off your back because nobody is responsible. Because you operate by committee because we ask you to do something and report back to us but you sit around to say we will get around to it later . May be ready to give you a round to win it to get the job done we will have another hearing to lick to look at this as something that is frustrating purple you should realize that there was a mistake and immediately move forward to correct the procedures and policies. And then should change the way that things are done. I know i am running out of time. Is important to clarify that cdc error with anthrax was addressed was a different situation but as the federal select Agent Program the anthrax in activation and hindsight we should have will address those procedures before it is used again. I am sure you can understand. Regarding of it dod review and the science reveals around the protocol one of the route causes of dugway incident was scientific uncertainty of the process to inactivate those borders you said that led to the creation of protocols. And although it is only recently raising questions about the inadequacy of these procedures, the department knew of this for quite awhile. Dr. Hassell the department was aware of the inadequacy of the process using gamma irradiation, why didnt the department have better verification procedures to ensure that this bores were properly inactivated before shipping . That is a good question because it separates to the two issues of in activation and viability testing. Three guarding the and activation, several scientific publications in the of peer review journals to show different curves for killing anthrax but now we need to pull those together to get the consensus with cdc to figure out. Why wouldnt you do that before if the department knew of this uncertainty . This seems it was localized. Each individual laboratories set its own standards. So it was not raised up to a central body. And those standards were not acceptable speckling for verdun will have to be done in concert. Is the dod reviewing all protocols to make sure there are not similar gaps for the in activation for other pathogens . We will be doing that. For anthrax and other toxins . To take a the Lessons Learned to be applied across the board. How confident are you that people will take at seriously . Or how you come to reconcile . Certainly would air on this side of safety . Absolutely. Anthrax is hard to kill so that is the biggest challenge up front that shed give us the biggest challenge on the activation and viability testing after words because what we learn from both of those we will take for word. So who will be the responsible party reaching go back to save the had a hearing an agency said we will address this if we have to have another hearing, how do we identify . Because there is a problem with no personal accountability. Dont you agree . Yes maam. Looking at accountability some of those people will be identified we will provide that. Applied to ask questions about the cdc role in the select Agent Program. Why is there such variation house day enact anthrax . As mentioned in the earlier there are a variety of materials that come from ted anthrax and though laboratories and some research your prediction production have different purposes as well so of the cdc historically has a validated procedure either published and followed or validated within the laboratory with proof of stability testing but the accountability the exemption of anthrax becoming the event because it is dead is a requirement of the federal select Agent Program and tell the have a procedure that we can safely do that. You can see we are very concerned. We do expect similar variations for other select agents and how to readdress that . As pointed out by eight dr. Hassell the nature of baseball or is difficult to kill and in this instance the department of defense was trying to kill the organism without disrupting it that creates a challenges safety. Now the path is to set that margin if we go back to the chairman the dod shows the dosing between the kill curve and it was not happening your there were production runs that were growing effort anthrax that should have highlighted the procedure was not adequate but Going Forward we will make sure there is a safety margin to assure retake the right margin. Mr. Griffin . Dr. Hassell we have folks out there receiving this you answer the oppression from the the of dod facilities were they all facilities that was completely controlled by United States government. Note. Some of these would have gone to facilities not controlled by the United States governments own house searches and can we be those that were receiving live samples over 10 years did not discover this before they told us that have been growing their own samples to siphon off some . So to say you killed or acquired all of last anthrax house searching can maybe it doesnt sound like we can be very certain that if they take some of that to use in other ways . The non dod facilities are some of the most trusted allies. We do many things acrosstheboard. They are trusted but if they wanted to do research on biological weapons this would give them an opportunity to rallies to acquire the base material. Isnt that true . It is true but theyre already doing that work were looking for that common material across the board said everyone was testing on the same material to compare the results. They do have those programs already. How far with those facilities to have better protocols than we do that maybe we have a worker that will generate those lives cells that they may have given to a Foreign Agent . In some of those cases they have the material down it was soon to be dead. We do have records of has been destroyed. What you found but yes or no . The answer is yes. Moving on. Dr. Sosin, you said the sec acted reasonable to track down the of five anthrax and you said you would give them the letter me once discovered that you were not notified until yesterday to investigate the problem that was discovered in may . Correct so we have at least 60 days before you were notified. Yes. I dont consider that b for acting reasonably. Do you . We are not on the front line of the emergent situation that would be that fda so it is normal for the cdc to do an investigative work on its own before it would refer a matter to us because the evidence is more thorough. 60 days is reasonable . Yes. Okay. As a part of that they do their investigations but dont you think it is interesting you were notified yesterday . Maybe that hearing would speed up that time a little bit . I have no information. When you filed your testimony is said to have not received a referral for potential violations regarding dugway regarding the 2008 and 2010 incidents . Limit resubmitted at friday we had not received any further information it is a good way to spur attention with the government. I wish we didnt have to do is so often as the acting director for injury prevention and control i noticed in the report earlier from the acting director what is the relationship between your two areas and why is everybody acting . Im sorry that information about my acting director it is over a decade but dr. Rowe is the associate director for Laboratory Science with the emerging eve infections. Ed is an active role because we are trying to hire topnotch laboratory a scientist. Day you answer to him . I work with him. You are now recognized for five minutes. As the investigation into the dugway incident continues learning that more labs have received fell live shipments in addition to the 86 shipments so now talking about nearly 200 labs i want to understand if is necessary to have so many with dangerous biological agents with the opening statement. So you have an opinion on the labs that are working . I dont think we know. We have information. With the high Containment Laboratory is. Control for a subset and we do know from anthrax my apologies. With a federal agency to have planning and oversight for a high Containment Lab to develop National Standards. Is important that there be a comprehensive set of labs that are needed there has been increased with the federal agencies extending bell labs that they have and to a lot of private entities they are very expensive and as we have heard today to develop their own validation procedures there is not necessarily the assurance of consistency and while that could be performed that kind of reporting is a of problems theyre not going to organizations. So we are concerned there has not been a consistent set of standards in place of what the needs are or the plant for rare though laboratories ought to be built and maintained and what the cost is over the long term and if that is in line with said the disparity you have feedback that operates the high Containment Labs to establish that entity . It is not clear where that organization should be located. It is difficult to retrofit on top of the enterprises to have control as Companies Want to compete for contracts and some of going back to retrofit that is complicated we do dash have traction to centralize this. I will ask again do you believe the establishment might address the gaps to help establish uniform standards and procedures. Having more consistent lines of authority would be helpful and 86 with the dugway incident have pointed out those different laboratories for in different chains of command never coming together. That there was not toplevel knowledge than what was going on. And ray will be happy to work with you. And mr. Chairman this is not the only Government Agencies to testify to establish policies saree that we messed up. That there is no accountability in your view and dr. Hassell you have been a your job for one year. So i dont know what they did before may it is a decadelong process provided tired hearing about how free are establishing new policies this is anthrax we should have had policies for decades. This is ridiculous. There is almost contempt and people walked out of the room they did not get us this time. But this is just ridiculous. So how can there not be standardized protocols in the federal government after decades and decades . How can that not have been . Have been . You talked about how they standardized. How could it not . I can answer for dod the different shades of command is a fundamental problem they meet to high up in the organization and. In fairness you have only been here one year you cannot be accountable ted years ago. I increase. But i know that now i taper some responsibility to work with other people to make sure there are standardized the lot of the moratorium until i am confident we have the proper basis for operation and have achieved the right level of standardization. I appreciate that but the reality is people are losing their jobs if this is standardized. Dr. Sosin, you said the du solve this problem . Recently said you know, how in your testimony. I know how. How many people across the government are inspired to lost their job that cdc or dod . Where food is still doing the same thing even though theyre literally have a National Security risk of anthrax around the world and as mr. Griffith found out that does not matter. How many are protected because they are part of a federal the reunion that is not allow them to be held accountable. I would like you to see how accountable the staff are at cdc retake this incredibly seriously. There are regulations and rules for the transfer of live anthrax this particular incident was is exempted material that is not considered a select agent and then choose tried to put in more policies. For the people responsible lose their job. Before they can be considered killed three needed validated procedure. I have been acknowledged in hindsight this organism and the vulnerability you should have done this before. The reality the federal government has not known what constitutes a dead anthrax until this came up . In the laboratory see if there is gross. I yelled back. Mr. Chairman it is unfortunate that we have to have another hearing like this but there was a quotation in usa today that says the root cause is a lack of accountability. Is installed there reported and i think many of us have expressed frustration not only with the agencies represented here the two agencies subject to the problems, but across government and the veterans administration. That has allowed coverups and though the three people have been fired of of 300,000. That is one of the root causes it is too hard to fire a federal employee. The individuals at the dugway proving ground water their procedures at that facility . I dont have that information it is mostly civilians. Of those which are unionized . Im not sure. Aim appreciating if you have that response have you taken action against any of those . If we do take action you want to make sure it is taken at the right place to make sure a person should be accountable is held accountable. That is nice but how many mistakes are happening right now because there is no accountability . Do you know, today we are not shipping other life agents. You know that. How can you know, . Because the anthrax is so hard to kill. That has been stopped. Anything else . Where are they a other former abilities . Dr. Sosin . How can you be sure we dont have any of other incidents going on like this today . Search and she is hard to provide with the process to insure the stability there is no evidence the materials presumed inactivated are not inactivated we have noted evidence of a signal single event that doesnt mean we dont take this seriously or consider whether additional procedures need to be implemented. This is going on now with respect to anthrax and reconsider in a broader context. For the committee say, walk through the ownership of the different elements. That respects your to agencies. Who owns what part . What parts of you own . But the federal select Agent Program is oversight oversight with the improvements made through execution of this Program Includes screening with the suitability to me as an appropriate facility has Good Laboratory practice to work with the material also the fbi review of personnel reliability it availability will use that to look bad by a security and safety. And a process to detect and respond including the notification of jurisdictions that have these facilities in sight to go in and investigate to identify the people at risk and look at what caused them and as well as the Public Sector institutions . Iraq. Where do you find best practices . Dr. Hassell was talking rug going to the private sector. Where are we finding them today . It is the combination of both i said we go look at the private sector that doesnt happen mermaz a first reaction. The department of defense and nih are outstanding facilities during critical worked these are enhancements where these will have been because of the broad range of practices i do have additional questions i will submit for the record. Mr. Chairman, i appreciate you being here i am sure you are having a blast and insuring your time here but it is frustrating to see what has taken place with those protocols how long does it take to looking into this . It is hard to follow that. Is it the practice of of the dod to send out a death certificate with select agents . It has been. To go long has that been going on . I apologize i am not sure i am not sure how long that is part of the process. I am not sure at what point that was initiated. I can find out. We know what has been building on. Why is it the private lab that found the anthrax not have a death certificate with it . To make it was originally tested they did not see growth. If it is shipped out, you said the practice is to have a death certificate why wasnt there one shipped to the private lab . Demand for that particular operation was a blind test. With anthrax . To read to see if people could detect the presence of was a sweep to identify markers. We knowingly shipped live anthrax . It did not have a death certificate is a you going to be shipped life anthrax to a private lab because it did not have a death certificate . We did not supply the death certificate because they would know what it was. So was there a death certificate . Yes. The originator act dugway performs that test. What is the difference to show that it was live . It was very similar. That is what we are looking at the key differentiator. Who is that . Dr. Sosin . Who is responsible for assuring those procedures that it is dead . Going forward. No. Who was responsible at that time . Whose group was set . Dugway they developed that. Who was over there who default underneath . Who oversees dugway . The army. Narrow it down to help me figure out who a is responsible that chain of command for the death certificate for the procedures that show the agents are true the dead. Ben schaede of command in the laboratory . To find out if it is shipping out to. Though it is over finding of for sure those procedures that the agent is dead . You dont know. Kenny ransom depression dr. Sosin . I cannot. Not specifically. This raises my last question during to the Background Information i could not figure that out. There are so many people that touched this there is no clear line chain of command as a Business Owner you have to be responsible to no one can be fired because no one takes responsibility because no one has responsibility we just assume everyone is doing their job yet to reship out live anthrax and no one takes responsibility for that . You said you would leave or a lock down so it cannot be shipped one tell you declared a line of command and procedures for go right . How long will that take him . The minimum was six months. A minimum . If you agree just find out the players you could put somebody in charge. I have to do scientific studies. We have live amtraks ship domino based responsibility but nobody could answer. It is time for somebody to take responsibility. I yield back. Mr. Chairman maybe i should step back. But completed different than a virus is the spores it is easy to kill the virus. So there is biological agents with what bin issues going on and the concern is might we have that with Something Else like smallpox or whenever . To help the committee differentiate the bacteria to give the confidence level. You use that to penetrate the spore . So the way that you can prove it is dead is to take a sample that you did not make that clear. And to put it in culture for a month and should have been in culture six months is that safe to assume as you did not run their culture test long enough . It grows within todays generally. And if you take Something Like anthrax that could pop up in five months time and somebody is creating a death certificate after two months year are saying it is dead. Im sorry if you put that in the enquirer made it turner in germinates. So in a fertile environment you would expect to see that growth. Guy could pay to differ on this but i see that where it does not grow in one month or two months but then it shows up. I would suggest respectfully that i believe the biggest problem that was sent irradiated with enough intensity so was not killed but to validate it was ted they put it into a culture to see if it would grow if it was in culture 48 hours with the death certificate i can tell you the problem right now it was not in culture long enough. Best practices in industry you will see that batch said in the refrigerator or freezer six months and you will have that spoor six months not 48 hours and if it is in that culture six months it is deader than a door nail to have more assurance and it is different than a virus so i just think some of that confusion is going on because you do the death certificate at the lab after it has been repeated radiated and held in isolation until the culture just has run to say i did not see anything now the entire batches good to go. That is what happened then it was shipped out exempt because it had the death certificate but that is up to the lab decide how long they will grow the culture . At this point the stability testing is a Laboratory Procedure but there will be additional requirements as a result of this incident. That is what i would encourage you to do the problem starts the you do trust the labs to be on the top of their game with past practice but i can assure you best practice in private industry is six months, six months of testing not 48 hours. That is best practice coming out of private industry. I yield back