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 forw