We will be back. I went to see if there are any other Opening Statements and i want to make sure we have plenty of time. Any othe other members Opening Statements introduced in the record without objection will be entered into the record. Let me introduce the witnesses for todays hearing. Doctor tim pearson will lea leaf the panel, the scientist in the Government Accountability office in july, 2008 and as such he is a member of the Senior Executive service of the u. S. Federal government and also serves as a director for the center for Science Technology and engineering. Thank you for being with us today and we look forward to your comments. Also would like to welcome from ththe centers of Disease Control and prevention with 30 years of Public Health and science and Emergency Response in medical Training Experience she now serves as the Deputy Director for the office of Public Health preparedness response thank you for being here. Next steve munro for the laboratory of science and Safety Centers for Disease Control and prevention from the background of microbiology and infectious disease. We look forward to hearing from the lab Safety Policies at the federal level and next up, doctor Mark Davidson who is the deputy administrator at the department of agricultures Veterinary Service program. The oversee the National Important activities as well as all agricultural select agent services. A. The chief army corps we think the Major General for being here and providing the expertise of the biological agents in the department of defense. You are all aware of the committee is holding investigative hearings and when doing so we take the testimony under oath. Do any of you have any objections taking testimony under oath . The chair advises you all you are entitled to be advised by counsel do you desire to be advised by counsel seeing none in that case with you rise and raise your right hand and i will spare you and plaques the testimony that you are about to give us the whol is thh and nothing but the truth. You are now under oath and subject to the section 1001 of the United States code. Make sure the microphone is on. The process of destroying the pathogens while retaining the characteristics for the research in developing the vaccines. The delicate balance and eliminating the pathogens and preserving its attributes for the study and research must be achieved. The safety is a top priority. The federal select agent oversees the containment labs jointly through the cdc in accordance with the committees longterm strategic interest in the programs oversight you asked us to begin the work before the may 2015 revelations concerning the dod labs ships made over the course of the bacterium that causes anthrax for almost 200 laboratories worldwide. Although regulating these labs he is and will remain a complex endeavor the nature and extent of the challenge had not yet been anticipated when you meet your request. There are three findings from the report. For the first week of the total number involving the incomplete inactivation is unknown. While the program reporte report the ten incidents occurred from 2003 through 2015, the gao identified an additional 11 that the program did not initially identify. These involve a variety of pathogens and inactivation method as shown in the figure before you. Because it cannot easily identify the incidents it doesnt know how or why they occur and that makes it difficult to develop guidance. Lighting behind the difficulty are the fact that currently no definition exists in the guidance and the they are not sd in this incident and is the result of researchers regulated by the program cannot consistently identify and report the incidents which means in turn that regulators cannot provide an accurate number of them. The second finding are the critical challenges that affect the inactivation and high containment labs. The challenges we identified are the gaps in scientific knowledge, the limited federal guidance on how to develop and implement the protocols and the inconsistent use of safeguards with respect to the gaps in the knowledge we found the resources are dedicated to the research and publication of research on the inactivation method. With respect to the limited guidance we found that while the particles are often developed sometimes they vary in the same department potentially increasing the biosafety and bio security risks with respect to safeguards b we found among othr things a general lack of emphasis on safety in several labs that we visited and this increases the risk of human error that can result in exposure to dangerous pathogens. The third finding is the cdc referred violations consistently to the Inspector General, nor consistently enforced regulations related to these incidents. For example, we found that the cdc didnt use the same set of criteria for referring the violations in the investigation and didnt document for referring or not referring violations. We found it wasnt clear why the incidents were referred and enforced and others were not for example the Program Required one private and two academic labs for the plans following the incidents but never required federal labs to develop the plans on similar occasions until the revelations in 2015. Without consistent criteria into documentation for thanddocumentg violations and enforcing regulations, the program cannot ensure that its regulatory approach to oversee the high containment labs is applied consistently. The nature of the extent and consistency provided we have identified problems and made recommendations concerning systemic issues including among others the lack of the strategic understanding of the nature and extent of the natural need for the containment labs and its a duplicate of policing oversight structure and the need for updated policies and stronger oversight. We recommend that among other things a single oversight entity be identified to determine the number of locations in missions to meet National Goals to counter the biological security threats and the aggregate risks associated in the proliferation and the type of oversight needed although some of the recommendations have been implementeimplemented key recomn regarding the need for the entity hasnt been addressed even while theyve continued in the general public and in this rapidly emerging infectious to use an ongoing threat and ongoie National Homeland security the time for getting both across the Research Enterprise is now. This concludes my remarks and im happy to respond to any questions that you may have. You are recognized. Cherney murphy, ranking member, distinguished members of the subcommittee, thank you for the opportunity to testify before you today regarding the contributions of the centers for Disease Control and prevention to the federal select Agent Program. Im the Deputy Director and chief medical officer of the office of Public Health preparedness and response at the cdc. Much has changed since i testified before the subcommittee last year regarding the response to the inactivation involving the proving ground. Since last november ive been privileged to lead the agents through significant change. Inspection reports are more timely, clear, riskbased and consistent. The regulated community is a stronger partner in achieving standards of biosafety and pathogens security and the response planning is more proactive and a and the agents k and oversight is improving but the word is by no means done and im pleased to introduce who joins the cdc three weeks ago as the new director of the division of select agents and who will continue the commitment to improving the federal select Agent Program with the inactivation of the pathogens into proposing ways to the Laboratory Practice and government oversight. We conquer with the recommendations related to the Agent Program and ive already initiated efforts to address them. As recommended in the report the department of health and Human Services is expecting to publish a final rule which will improve oversight of the inactivation protocol. We are also developing guidance to be released confidently that will assist the regulated community with implementation of the new requirement. We are improving the incident collection in the report by updating the form used to report the release of the agents and we expect incomplete inactivation as a potential cause of exposure to the agents will now be explicitly captured. We are working to improve consistency in how w and how wes the Inspection Findings to focus attention where it is needed most. We are using the process to better standardize the standarde application of the Enforcement Actions including the Inspector General as was recommended by the gao. They will increase the transparency of oversight. Research done saves lives by supporting the vaccines and drugs and tools needed to identify pathogens when disease can be treated or prevented. Scientific methods are diverse and complex and we must be careful not to overprescribed benefits and interfere with medical advances. We are increasing the regular complaints through collaboration and the community which shares a common interest in biosafety pathogens security and bears responsibility for assessing the risk of the work and applying appropriate safety measures. We also use the experience and judgment of our inspectors over 60 of whom hold phds in microbiology and the rest masters degrees to provide guidance on Risk Assessment and management as well as review the work of the scientists during inspection. We set specific requirements inf the rule change as we are doing with select agents. For 70 years the scientists and staff have been on the frontlines of Public Health tackling pandemics and a. Of the division of the agents is responsive and making improvements including the gao recommendations on the activation. The select agents save lives and we are balancing the need for the regulatory constraints with the benefit of scientific discovery. I assure you we have and will continue to work diligently and thoughtfully to evil the program and protect americans from biological threats. We welcome the input as we continue on this path. As good afternoon jimmy murphy, ranking member, members of the subcommittee. Thank you for the opportunity to testify before you today. I am the associate director for Laboratory Science and safety. I serve as a single point of accountability for the quality and safety of the liver for using the reporter agreed to the director. My office was created last year to provide oversight of the safety quality internal laboratory. Distinct from the regulatory role of the division of select agents. I exercise no authority over the programs regulations or the enforcement activities. My office does ensure that the laboratories t that work with select agencies comply with the regulations. Moreover the responsible for the concludes comprehensive oversight of biological, chemical and radiation safety whether or not they work with select agents. The laboratories play an indispensable role protecting the publics health. We screen newborns for bonuses and detect outbreaks that threaten communities and invent new ways to detect. The pathogens in the laboratories is a critical part of this work. Inactivation destroys the pathogens ability to cause infection and it occurs at lower levels of containment. This enhances the safety for the workers in expands the number of laboratories people to work on the pathogens that would typically require higher levels of containment. Inactivation enables the generation of vaccines, provides viruses diagnose diseases and protect the safety of the Laboratory Staff and the public. However, it is critical that when the laboratories inactivate pathogens, they do so safely, completely, and verifiably. The incomplete inactivation in the laboratory and 2014 with two major reforms including the creation of my position. I take seriously the importance of the inactivation of pathogens in the laboratories. I want to briefly highlight two ways that we are strengthening the pathogens activation of the safety review board charged with every protocol for the inactivation and the transfer of biological materials to lower levels of containment. It examines every part of the protocol and reviews every Standard Operating Procedure and ensures scientists that perform appropriate skills and training. Itits creation is the signature reform and represents a fundamental change in the oversight of the inactivation of the pathogens in the laboratories. The second way we aim to strengthen the laboratories in general is to enhancement in the rough guide. In partnership with the institute of health is a country has a guide on the biosafety practices and policies for laboratories working with pathogens. When the usda Animal Plant Health inspection services. This cdc jointly oversees the federal program. This insurers anyone possessing using are transferring biological select agent or toxins that have the potential to pose a Severe Threat to public plant or Animal Health minister transported safely and securely and retake very seriously scientists understand that the consequences of the toxins can have. We recognize the gravity we can assure you that it has strengthened our program although it will not completely eliminate all rest we have the safeguards and process to reduce the risk as low as possible in addition to the review the federal select Agent Program has participated in the Broad Spectrum review of the program to give us a robust set of recommendations for our oversight we have implemented a majority of the recommendations and are addressing the remainder this includes the five recommendations from todays gao report we are in the process of finalizing the proposed rule and regulated guidance to provide clarity for the community and the select Agent Program about the roles and responsibilities for the activation of select agents to clarify what is required to achieve achieve activation and laos danders to help researchers and others vowed the date deactivation protocol. Once in place to will hold those accountable for meeting the standards we are finalizing revisions to the standard form the program uses. We will complete confirmation of other causes of release to monitor and track issues that arise insuring accountability for those that work with select agents to analyze trends and reduce the risk of future incidents. We are in the final stages of developing the new system to ensure consistency. The three tiered system is based on severity and standardizes how the federal select Agent Program will respond to those violations. With that system that includes consequences to the new enacted asian and guidance enforcement under the program will be more consistent in our stakeholders will have a clear understanding of their responsibility. Again taking any potential relief very seriously by a sure you we are working closely with federal partners to develop strong cultures to the maximum extent possible with the security of these potential agents that allows these to continue this concludes my statement that will be happy to answer any questions you may have. Good afternoon. Did is an honor to appear before you today with a bias security measures. Including the the select agents. To provide valuable analysis to perform policies and procedures not as committed to working with partners i am responsible for Regulatory Compliance oversight. For high consequence pathogens. At the nih with the same operational standards working with the team of professionals we oversee laboratories on the main campus and hamilton montana. To conduct Research Diagnostics and vaccines including measures from infectious diseases. Activated pathogens are a component of this research with the nih in the testing protocols with collaboration of investigators reviewed by the biosafety officer and also the Biosafety Committee these policies and procedures are applicable to be removed from a height containment laboratory. With the molecules of guidelines with a biosafety laboratories. Edition and is regulated by cdc usda. Did is important that every effort is made to harmonize language with the validation and implementation of the protocols. The gao report calls for consistency of the data and for greater accuracy for a template subject to the guidelines internally keeping records of the destination and in the upcoming revision to document that shipment of the material with the Broader Research committee to sponsor biosafety month and throughout the month of Research Institutions are encouraged to focus on bioSafety Policies practices and procedures. This year we will encourage institutions couldnt to collaborate and to be in place. In this symposium and the workshop. And with the way forward. And with those modalities and successes and failures and the gaps. Want to assure the subcommittee we are committed to the safety of the public Whose Mission is to find new ways to reduce analyst and we are committed to keep the trust and strong leadership. Eightyfour the opportunity to testify. And distinguished members of the subcommittee thankyou for the actions concerning the safe handling of the biological agents u. S. Army medical Research Material with the Army Surgeon General for the biosafety program. The age irresponsible with the biosafety possible by a safety review today i will briefly describe the actions they accomplished since the last hearing and two for future validation besiegers of the governance procedures of biosafety purpose each responsible and is now establishing the process. And those of all biosafety matters with risky and oversight. As the dod interface insurers the standardization to enhance biosafety with the operations. The Production Facility for which the amtracs shipments were sent was sent to the Chemical Biological center in july. This was under a chain of command that has a robust experience under the research and arterial command. But since the establishment datasets facetoface with multiple teleconferences to review and assess by a safety concerns associated with the laboratories. If and to provide recommendations on accessibility for initiation of used to enhance that program. On the 25th of july they signed the Army DirectiveTitle Department of defense biosafety program. This establishes a policy to the Service Activities this replaces the previous moratorium with additional safeguards with production handley and shipment and a Critical Program associated materials. However the secretary of defense for inactivated anthrax as with the handley and shipment were working on several initiatives intended to enhance harmonization for practice sampras teachers across the network of laboratories initiated stories for the viability testing can be intact and activation study for out of praxis underway completed for a slated for completion october 2016. With the Quality Management system and the other initiatives the Development Team the scientific review and the unified oversight to enhance management. My written testimony provides a description. And the observations would inform to improve oversight. To improve guidance and validation to develop consistent enforcement would forward to cooperating with department of health and Human Services and did the department of agriculture responding to the investigation and im happy to answer your question. Now i will recognize myself for five minutes. We have been here before with these agencies and see the problems occur again the number of scientists with advanced degrees rules of accountability. But this is a Severe Threat to we have more cases of anthrax pathogens released more than a terrorist. But this global luckily we have not received but this serious but let me start off with this question. Stood the cdc put out a public announcement that theyre subject to personal action . Whenever there is an issue we recognize with those too dangerous pathogens my office in is involved. This could have been gross negligence can do the employees understand the seriousness of they did not respond but that disciplinary action all of the scientist to uphold the integrity and more action would be needed. And for all protocol. Based on the investigation they will pursue those actions. Those of our required dannay Reliability Program failure to comply and that is grounds for disqualification with the privilege to work with these agents. We appreciate the army to stand up and do that. We are here to protect the safety of our country. We dont want to hear anymore equivocating. We understand. And then coming on the same path. And we just are not clear. And help us to understand why should we trust you . What is different . Many aspects of our programs have changed our inspections have improved with the regulated community for practitioner yen trading have improved and response activities of the is the broader range of federal reports i think you can look to what has happened many changes of the gao recommendation coming out in the recent report. Rework very closely together to implement the changes through the different reviews we have found gaps needed to address and were very active with the work we have done with our inspectors through the steps were taking through the gao to address the regulations clear guidance of policies and we have to continue to. Gao reports specific tracts. Is there a specific way . Is the assets of . Is that concrete specifically set up with clear reporting . Is it is updated. I am not a time. With the report there is six additional recommendations of the high containment laboratories and have been on the subcommittee 20 years the last 10 years we have seen a number of recommendations that always tried to improve from the program so i have to ask the is the existing e structure spread across the different agencies provide the oversight we need despite the ongoing efforts . It will require considerable coordination is that correct greg. That is correct. I believe it is possible of course, gao does a good deal of work on coronation and general. Is is easy to conceive and challenging to do. To have those key thing is to address the court bashan. With that laboratory is fragmented to rely on self policing and those efforts if that provides adequate oversight what theyre testifying about today with an oversight entity . It is important to answer in context as it goes back to the post Oklahoma City bombing. From what we spoke with but bios security and there is work to be dead in the redo and to expose the challenges and a regulatory structure. And the National Security sense given those challenges to do you think it would be practical to have a news siegel oversight . For this committee were looking at the comparative structure about the sufficiency and efficacy of what were doing walking with parkers. You dont have the conclusion of this eagle entity or not . To make that would be a thing to seriously consider with the biosafety domain. What about that siegel entity for the oversight regulation . I cannot comment other than the system for the recommendations to make it better. Em like to ask the witnesses what they think of the concept of the centralized agency to oversee the program . Added is authorized to oversee those agents said toxins not of laboratory. To authorize the agency is that a good idea . That is a expectations but if. But the breath that we all bring to the disciplinary expertise and nike is the factors in. So each agency has a voice that the table with the guidance. Mr. Paige agree can coordinate. Within dod we have done that had consolidated oversight regardless of service so for us that makes sense. With full disclosure founder and ceo of a company with the campaign blabs so i am very familiar with what you are doing with the usda had to give kudos for the type of inspectors and to speak from the private sector would not have any real concern from the oversight so concerns fall and to the two areas the especially if youre trying to protect dna adjust kill that offer the sizzle straightforward hard to imagine that anything that was not activated if you try to protect the dna and it is trickier but if youre anything into bacteria with spores you test m to grow and activate what you said thought it might be days but it was once with our findings certainly with tuberculosis. Said to have a very rigid was active procedure with subsequently and the spores will pop. Could you speak to that of the bacteria side . The viability testing of agents following deactivation procedures is critical to be a part of the requirements. Sewed to disallow the treatment has not select agents. But with the viability testing with the prohibition as it is activated. I would encourage you to test that out months down the road. It can hurt but others like tuberculosis. We ship live viruses all the time. It is not uncommon in and the United States today. There is no prohibition but to some extent people think all pathogens should be activated but some researchers and relying on the safety protocols by a at large they realize how dangerous the materials are. And i worry with the private sector is doing things you can treat the virus protect the dna had inactivate. Had to look to license those technologies as opposed to trying to compete with the private sector to establish new activation nothing is like the zika virus so why would the government do something that is already available with the private sector quick. To ensure research the the Science Behind the laboratory setting. Had to activate those viruses. Your where the private sector can already do this greg. But it depends on the specific use so it is important to have a benefit that will work. I encourage you to make sure to look at the private sector. Fair enough. Gao made six recommendations to reduce the report of the incidence of the activation of dangerous pathogens that would like to hear from each of those agencies and the length of time it would take to implement. First to increase the viability testing to coordinate Research Efforts to help close the gaps across highway contain and laboratories and that this point the caps that need to be addressed that our unknown and what is the sycophants and when do we believe this recommendation. Had with the activation part of the of problem is there is a one perfect way to enact a a eddy pathogen there has been some coordination but the efforts to look specifically because we are aware with dod there is no comparable currently at cdc. Each individual areas with an activation to help people understand everything that could go into the activation protocol with the specific research and that they work with in the containment laboratories. Constantly and new pathogens at are discovered so the science will always follow that. As we are constantly pursuing this that nih we have a process and at viability testing. We have ongoing collaborations with other agencies. Conducting a series of experiments on the optimal dose of radiation the initial study has identified the met bid for standardization to produce the sterility that is the probability of one in a million. For the optimal activation of spores. But this is the issues level that is commonly used by the medical device industry. With those compounds aimed variables that will be used and continued to manage. Get would appear before those of recommendations with the inactive nation protocol they must first increase the Scientific Understanding to close the gap woody wood greed or all you hopeful this can be done in a timely way . And will g. A. O. Monitor that agencies for progress . Guess we believe it is possible extensive coordination is this is terry. And yes they will keep an eye on them. To be subcommittee over the past and focused to strengthen the nation 3299 to help us get the problem to incentivize procurement of vaccinations and treatments to combat the attack. However is a focused on the past during the preaches that as much as National Security and fortunately we have not had a blast leading to widespread contamination but i am just curious and want to explore with enforcement and to focus on federal government and industry is to develop countermeasures and if we use anthrax as the example that it is currently stockpiled, are the last workers for the scientist and staff given the necessary vaccines . Are they given vaccines . Most are. The military are the with civilian it is not a requirement. The personal protective equipment weekend not force them to take the vaccine for something something that they dont choose to do. What about those working in this space . And off a offering is the prophylactic and with the Occupational Health clinic in case there would be an exposure. That is what i wanted to followup are they on site in case of exposure for everybody . The workers that are working in a the laboratory with the incidence of 2014 with the potential there were workers exposed in other parts of the agency that means not an all cases have a stockpile of sight to treat every employee at the agency. What is the process in place quick. She would have access where if it was widespread release of an agent with that and to back. And that jurisdiction in this state of georgia to recognize the need for countermeasures to make a request to the secretary of hhs in those materials would be provided to this cdc through the states to insure that they receive what is needed. That sells like a lot of government entities. But it is all under the same mechanism. But you mentioned this data storage as well. So when you said it goes very fast, how fast approximately if there were to be exposure . Within hours. In the state of georgia for the cdc to carry out the work. If there were the exposure. Rioja access to the National Stockpile so we keep be enough on hand to address the potential initial exposure but it again with the same access to the stockpile. Five of the 21 incidents resulted of the equipment issues malfunctions or failures. Can you explain the alert system . I am not familiar with that specific equipment issues that you mention with the failure of an activation or the worker and general with the failure of equipment that notification goes through the cdc. And that all necessary protective measures are taken to protect the workers are agents. And if necessary we will bring in the state and local authorities. Are there oilers systems in place . With the functioning of dealer system. 3m of those involved and there was no equipment of of mixup and brought out of the lab. And relating to the equipment failure. To make six recommendations to address that activation issue of day are implemented to improve safety to mitigate the of risk involved tearfully except the recommendations . Implemented in a timely fashion . Statements and testimony i have no way to evaluate the energy or time. Then you expand on the importance of the safe handling of these pathogens . To develop clear and consistent activation with the respected guidance why is that important and what would it do to improve safety quick. And boils down to definitions in a very scientific and pristine way and what is central to this if you cannot identify or mitigate risk. Talk about the lack of clear definition with the usda was the uniform definition to reduce future incidents . It will not guarantee one of the of things that we found was a clear definition to bring the same this to the language talkedabout the agency in becketts the feet and not help. But when those incidents involving me in activation occur to analyze information to help identify the cause to mitigate the risk of future incident . How will that improve safety quick. That Safety Culture that we are endorsing windows so that you work through all of it scientifically. There should be some common understanding of that. And some of these recommendations whether its one agency or another is just a matter of safety from your o opinion. Were looking for an increase in this activity. In the greater validation verification efforts. In the viability testing to rest recommend that the agriculture and coordinate Research Efforts. We want to close the knowledge gap. In a quantifiable way what that would take that be something to identify what the gaps are and help those identified gaps and identify resources for that. Other than it does need to be done. More needs to be done according to the agencies. In the Scientific Community itself. Do you have any idea of how long it might take these scientists to close the gaps. No i dont have a specific time. It will be something worked on for years to come. No i dont have a specific time. Will be something worked on for years to come thank you mister chairman i think all of my fellow congressmen for being here. We are can have some members that had questions for afterwards also. I also want to make sure we have it unanimous consent to put into the record. Do you have protocol of a non select agent when you deactivate those. Does the cdc had the protocol quacks. Yes the review board reviews all protocols for any for agent. Including that. With the non select agents. And you have protocols now. From the diseases. Weve also have an interagency governmental penal thats reviewing all of the protocols. Co they make sense. That make based on the scientific evidence. I just want to say i want to thank all of the panelists the panelists for being here today. We will submit those. We thank you for the progressnd here. We dont want to hear about any other instances. Without this hearing is adjourned. Sound back [inaudible conversations] been [inaudible conversations] been [inaudible conversations] [inaudible conversations] [inaudible conversations] today fed chair jimmy gerling on the interest rates. Live coverage of the House Financial Services committee. They will discuss efforts to secure the voting process. Water live coverage on cspan. Org or listen live on the cspan radio app. Every weekend book tv features books and authors. Charles murray this saturday author of the book, in our hands, shares the universal basic income for americans. It is that some people need a pat on the back. In other people need a kick in the pants. John dickerson reflects on key stories. When interjects it real he was an outsider. He had been the general. There was a great worry because he was a flamboyant and successful general. The commonest and editorial writer. He is written over 30 books. Slave resistance and the origin of the United States of america. Race to revolution. The artist as revolutionary. So when japan bombed pearl harbor in place in black america was infrastructure of pro tokyo support. It is to say that he was able to convince many black americans that their destiny and fate should rest with washington. For a complete schedule go to book tv. Org. Kevin brady spoke about the Trans Pacific partnership trade you. In order to get congressional approval. Time is running out. Congress meant bradys a remark it is 45 minutes. [inaudible conversations] good afternoon ladies and gentlemen welcome back. Im president of the institute and it is my distinct from much today to get to introduce and host chairman kevin brady. Comes of the eighth district of texas