Transcripts For CSPAN3 Federal Officials Testify On Bioresearch Laboratory Security 20160927

I think there is something to that. The way i would summarize it would be to say the United States is still the most powerful country in the world, but the margins of our lead are contracting. And what that means in terms of policy is that big problems in the world cannot be solved without the United States, but the United States can no longer be solving them alone or be dictating to others exactly how they get solved. So the premium in these coming years for the United States, i think, as the leading power in the world, is going to be on Coalition Building and alliance management. When we think about terrorism, think about cyber terrorism and big ideas of the chinese around the world i think the nature of our leadership is changing. It has to change. Ive written a lot about u. S. Power. At the end of the day when you add it all up, all the factors of power in the world, compare china, russia, United States, the United States still comes out ahead in almost everything, innovation, demographics and so forth, strength of our military and all that, but its a different model of leadership that we are going to be faced with, i think, given we are now working in a world that is a kind of balance of power world with rivals who dont agree with our concept of order. And yet rivals with whom we share some important interests, both russia and china, and we look at our traditional partners in europe, for example, where weve always been able to turn and have a reliable, someone has our back or is with us and following us. There you have centrifigal pressures. You can take immigration was the principal driver of brexit. If you start to see the eu come apart, its who knows whether thats going to happen . But we have to put it out there as something to think about. That is a very different world that the United States has dealt with for the last 70, 80 years. A different type of leadership that is more follow this event available online. We are going to take you live to a house subcommittee hearing, energy and commerce subcommittee hearing. Thats tim murphy of pennsylvania, the chairman of the subcommittee looking today at the security of bioresearch labs across the country. Live coverage here on cspan3. I would like to thank the geo for their hard work and report for todays hearing. I would like to thank the department of the army for their participation today. Thank you for being here. Disastrously, recent incidents at bioresearch labs revealed lackadaisical methods used to activate anthrax. Such negligence continues to put human rights at risk. The proving ground shipped live anthrax thought to have been successfully killed to contractors, subcontractors in private labs in all 50 states. And nine Foreign Countries for more than a decade. Dangers presented by such a careless mistake are unacceptable. Thankfully no one was harmed so the arm dodged a catastrophe in this manner. Without Major Overhaul how deadly agents like anthrax are handled and research is conducted at the risk of repeating this mistake remains viable. In 2014, the subcommittee held a hearing on the shipment of live anthrax thought to have been activated. The anthrax was shipped from a high Containment Lab at cdc to another lab with a lower level of biosafety. The trans ferret potentially exposed over 80 cdc employees. Internal cdc review at usda inspection found multiple failures, unapproved knack vags techniques, a virulent strain of anthrax was unnecessarily used in research. Lab staff, lack of training, lack of Standard Operating Procedures, inability to find anthrax samples and disinfectant use was expired. These instances drove direct action from the white house, federal laboratory standdown ordered in the summer 2014. However, disappointingly, even with consciousness raised about lab safety, bioresearch labs persisted in questionable inactivation practices today. The cdc in ft. Collins sent a shipment of zika, dang and chicken virus to atlanta. The viruses were used for diagnostic tests under emergency use authority. Despite cdc forth collins knowledge of the inactivation had not been confirmed, the shipment was sent. Dangerous live viruses, including zika were handled and shipped accord the country. Cdc ft. Collins told atlanta, dont open the package until inactivation was confirmed and ultimately, thankfully the package was not opened. This continued problem of mistakingly shipping live anthrax and other pathogens led the committee to make a bipartisan request to evaluate issues relevant to inactivation. By coincidence, the request was made two weeks before the discovery of the massive anthrax inactivation problems at dougway. Today the gao will present its findings and recommendations on the inactivation of dangerous pathogens. Failed inactivation has been long overlooked by regulators in the Research Community. The go brings several important findings. The gao found the federal select Agent Program operated by the department of health and Human Services agriculture does not require laboratories to identify incidents involving failed inactivation in its reporting resulting in inconsistent and incomplete reports. From 2003 until 2015, the select Agent Program reported 10 incidents being, a gao documented an additional 11 situations in which select agents were not effectively inactivated. Since this select Agent Program lacks standard practices for identifying such instances, we simply dont know how often they occur or why. This is extremely disturbing. In the report, the gao noted a need for better and more consistent followup with problems of inactivation are discovered. As one example, two incidents at cdc under investigation by the usda in 2014 were not referred for further investigation. The lack of consistency by select regulators and cdc leave this subcommittee and the public with zero confidence in regulators ability to protect the safety of the american public. The gaos most alarming discovery is today we still dont know what it takes to effectively and reliably inactivate certain pathogens. The chemical or radiological dosing is not actually effective. In other cases, the process for verifying the inactivation is not reliable. It is extremely troubling after 15 years of efforts we lack competency ensuring the safety of the public from dangerous and sometimes fatal bacteria viruses. Its been 15 years since we became aware of the need for select Agent Program, and clearly there is a lot of work to do. I want to commend the army for its response to the shocking shipments and cooperation we received from both nih and fda. Both worked to identify improvements needed and to implement these changes, including creating new offices and committing adictional resources. I welcome and thank all the witnesses testifying today and recognize our Ranking Member. Sadly, there are six minutes left on the vote on the floor. I will consolidate my Opening Statement and ask unanimous consent to put the full statement in the record and other statements of the eeb members and register my displeasure with this process this morning, not letting members fully speak. As the chairman said, we are continuing to examine the issue of inactivation and whether we have the profit scientific processes to ensure pathogens are inactivated before shipping or releasing them this gained public attention following the armys dugway proving ground incident where researchers for years had been shipping live anthrax to labs across the world inadvertently. Researchers must inactivate pathogens for a variety of reasons. For example, federal agencies, universities and others inactivate disease causes agents so Vaccine Development and diagnostic testing can occur in lower safety labs. This work is critical for promoting medical advancements and bolstering Public Health preparedness. Its a part of this committees ongoing bipartisan efforts to accelerate the path of cures and medical breakthroughs, but as valuable as this research may be, it can be very dangerous. All of the agencies here today share the responsibility for making sure that harmful pathogens are being handled without posing a risk to the public. Now its true weve all taken inactivation events very seriously all the agencies here have been acting to try to implement reforms to ensure past mistakes arent repeated. Im eager to hear about those efforts, but i also want to know what more needs to be done to address the possible risk to Public Health. The gao is here to testify about their body of work. And what theyve done is identify a number of issues around the reporting and referral of incidents regarding incomplete inactivation. For example, the number of incidents of incorrect inactivation is unknown. The select Agent Program failed to identify at least 11 inactivation incidents in the last 12 years. How many more are there . We dont know. I really am interested in hearing from the witnesses about their plans to implement the gaos recommendations, and how we can go further. Im also interested to hear about the scientific gaps that exist for the inactivation process for pathogens. High Containment Labs across the country still have not adopted a uniform approach to the inactivation of dangerous pathogens, which of course increases the risk that this may happen again. This is something we just simply have to get right. And so i think research is really important to National Security, and the process of working with these pathogens must minimize all potential risks. I guess were lucky that nobodys been injured or killed from exposure to these agents in the last few years, but just because weve had good luck doesnt mean that we should take this for granted. And i know nobody here does. I know nobody here does. So im looking forward to working with everybody here and im looking forward to working with you, and the other members of the committee, mr. Chairman, to make sure that in fact we get this right. With that, ill submit the rest of my statement for the record and the other Opening Statements of the other democratic members. When they return, if the members want to give theirs, the Ranking Member does. You are recognized for one minute. Thats exactly right. We are going to have to run to the floor. I do want to welcome you all. As the chairman has said and Ranking Members, we have been here before on this issue, july 16, 2014 we had a hearing on this issue. I have visited the cdc to bloc at processes and procedures and it is such a concern to us, even in your own report. You have found what is at the core of this problem. The lack of approval, the lack of written instructions. There is not a best practices processes in place. So the gao, were delighted to have you here. And want to talk with you about three of your findings. The tracking, the gap, scientific gaps that exist and then the federal select Agent Program and the inconsistencies there. So we thank you so much for being here, mr. Chairman. I thank you for your attention to the issue. Thank you. The panel, we are going to run down and vote. A half hour or so for the voting. Well be back so you get a slight reprieve and well be right back. Thank you. The subcommit eave energy and commerce taking a break on their hearing. Look being at bioresearch labs, the result of a recent gao report on the need for stronger oversight of dangerous pathogens in high Containment Laboratories. The hearing will resume. There is a series of votes on the house floor right now. Once that wraps up or just before that, the committee, subcommittee should gavel back in. Well have it live when it does resume here on cspan3. While we wait for that, just wrapped up, well show as much as we can of todayS White House briefing. Well, well, well where to start . What do you decide well start . Do you have any observations from the president about the debate last night . Did he keep at least one ear on all or part of it . As predicted, the president did have the debate on Television Last night in the indian treaty room of the residence while he was reviewing his nightly todo list. The president had an opportunity to talk about this with Ryan Seacrest earlier this afternoon. His main takeaway is that the candidate he strongly supports is the candidate that performed quite strongly in the debate last night. She made a very powerful case, particularly at beginning for building on the economic progress this country has made in digging out of the worst economic down turn since the great depression. She laid out a strategy thats focused on cutting taxes for middle class families, asking those at the top income scale to pay more. Closing tax loopholes that only benefit the wealthy and well connected. Focusing on investments in Early Childhood education and college education. Growing our economy from the middle out. That is precisely the Economic Strategy president obama pursued and that is the strategy that has yielded the longest streak of consecutive monthly job Growth Numbers in our nations history. We saw in the census data released a couple of weeks ago that in 2015, the Median Income in this country rose higher than it ever has, at least on record, in one year. And that poverty declined as much in one year as it has in about 50 years. So the president has pursued a strategy similar to the one secretary clinton advocated, and our country has benefited enormously from it. He certainly was pleased to hear her deliver such a persuasive case about why thiss a strategy that is Worth Building on. What did he think when the subject turned to Donald Trumps tax, not release them and how it made him starter to not pay federal income taxes. There is any reaction from the president to that or from you . You said you dont want to stand up every day and react to everything donald trump says. The president is also in a position where he has more latitude to respond to these kinds of declarations. I think what ill just leave it to is the president is somebody who, when he was running for president , made a conscious decision to abide by the standard thats been observed for more than a generation, which is he made a decision to release his tax returns. Even while serving in office as president , he continues to release his tax returns on an annual basis. Im not aware of any federal law requiring it, but if every president ial candidate in both parties dating back to the 70s has done it, its something the voters can expect. The president believes that transparency is good for the process and good for voters as they make a really important decision about the future of the country. Senate democrats are threatening to block the cr because it doesnt look good for flint, michigan. Does the white house support the Senate Democrats in their attempt to block this bill this afternoon . The president has made clear for months that Congress Needs to act to provide resources to this community of flint. The president had an opportunity to visit that Community Back in the spring and he met with the mayor and he talked to some residents. He talked to federal officials who were responsible for coordinating their response. And what he saw was a community that had been let down by their government. And weve been advocating for months that congress has the responsibility to step forward and provide resources to assist that community in their recovery. Now the executive branch, the administration has certainly fulfilled our responsibilities. President mobilized fema. Fema handed out hundreds of thousands of liters of water. We have seen rampedup assistance to meet the basic Health Care Needs of children that potentially were negatively affected by drinking the water. And there have been an effort to try to address some of these problems at the community level, but there is a significant investment in infrastructure in flint thats required to address this problem. Congress has the responsibility to step forward and provide those resources. The president s been calling them to do that for months. So included in the proposed text, at least based on what ive been told, are steps congress has taken to provide relief that the families in louisiana and maryland and other places that have been hit by historic flooding. Those are communities that need to be rebuilt, as well. The president was among the first to call on congress to act to provide resources to louisiana. And the president believes congress should do the same thing for flint and other communities that are dealing with challenges. Republicans say they will take care of flint, michigan, in separate legislation. Does the white house not believe them when they say theyll take care of that . As ive acknowledged on many occasions standing here, im certainly no expert in the legislative procedure, but based on way understand of the situation, there is some funding for flint included in the senates version of the Water Resources bill. The house version does not include funding for flint. This is a little ironic because the speaker of the house says he opposes adding funding for flint to the continuing resolution, and believes it should be handled in the Water Resources bill. But its not included in the Water Resources bill thats advancing through the house. And then he has the nerve to suggest that its democrats who are the ones causing problems. So i guess a little clarity about republicans commitment to addressing this issue is needed. After waiting for six or seven month for this funding to come through, that clarification would be eagerly welcomed by the white house, but most importantly, by the people in flint. You talked about the economic case secretary clinton laid out. Last night we saw her on the offensive on issues like race and the birther issue and temperament. Im wondering what the president said what he thought about the tone of the debate and sort of some of the attacks we saw . The president made the observation on a number of occasions, there is a tradition in this country of confrontational brand of politics. I think what the American People are looking for in their leaders are people who are tough enough to enter the arena and stand up for what they believe in, and to make a forceful case for what they believe in and to respond to even some tough criticism of their priorities and their agenda. The president certainly engaged in that process over the last eight years or so. Hes got the scars to prove it. I know there was an expression from at least one candidate last night who was concerned that people werent being nice to him, but look, this is supposed to be a vigorous debate. When you consider the stakes in this election, the president would anticipate and expect a tough debate on the issues. Thats what we saw last night. Out of curiosity, why did the white house or why did he choose to go on Ryan Seacrest to talk about the debate, give his response or reaction . What was the decision behind that audience . Well, the reason the president wanted to go on Ryan Seacrest show today is today is National Voter registration day. The president devoted most of his appearance on that program to encouraging people to register to vote. The president also taped an interview with steve harvey that will air tomorrow where he made a similar case. Thats why he did those radio shows. Its not surprising, or it wasnt a surprise to anybody at the white house he was asked by both those hosts for a reaction to the debate last night. Quickly, im wondering whether the white house has concerns or questions whether the company waited too long to notify users about what happened . I will say i cannot speak to the details in terms of what yahoo has indicated occurred in the context of this hack, but i refer you to my colleagues at the department of justice and Homeland Security who have jurisdiction here and may be able to provide you some greater clarity about what theyve concluded. On the president s schedule today is a fundraiser in d. C. For the hillary victory fund. That is an lgbt discussion. Im sure the president has the goal of raising a lot of money at the event, but does he have any sort of achievement in mind in terms of the message he wants to convey to those in attendance . Chris, this is a rather small event so its not open. The president will spend his time in discussion with those who are attending the event and talking about things you heard the president talk a lot about before, the stakes in this election, how important it is for democrats to stand up for our values and fight in support of a candidate thats seeking to advance them. The president s already spoken a lot publically about his strong support for secretary clinton. I would expect him to reiterate that pitch once again at the event this afternoon. One of the things we did not see during the Obama Administration was the equivalent of the lgbt cabinet member. If one of the attendance members brought that up, what would you imagine the president would respond . I think the president s quite proud of his record of ensuring that there are senior officials in his administration let me say it this way. The president is quite proud of appointing senior officials in his administration that reflect the diversity of the country. Thats true when you consider the president S White House staff, when you consider senior officials who serve at agencies across the government. Its also true when you consider the appointments that the president s made to the federal ben bench. Whether you evaluate that diversity based on race or religion or sexual orientation, the president s record surpasses that of his predecessors. And hes quite proud of that legacy. He also believes its a legacy that can be built on. Ill let secretary clinton speak to what her plans are for the kinds of appointments she would choose to make if she were elected president. Okay . April. Josh, last night many people are hands down saying Hillary Clinton was the victor, to include people from the republican party, but at the same time with this victory, does the white house still believe theres still an open window for donald trump to still possibly become number 45 . The president believes its important for people all across the country not to be complacent when the stakes are so high. And thats why the president was encouraging people to register to vote today on National Voter registration day. Its also why the president is going to spend a good portion of his october encouraging people all across the country to get out to the poles and make their voices heard on this election day. The president believes thats an important thing to do. Vice President Biden used very Strong Language today talking about some of Donald Trumps comments from last night, particularly when it came to donald trump saying it was a Good Business deal when there was a housing crisis in america, he was benefitting from peoples problems. The Vice President used the word hedouble hockey sticks. I dont want to curse in the briefing. I appreciate your restraint. Thank you. Did the president feel as upset about that, that someone who potentially could be in the oval office has profited off peoples pain, the american publics pain . Listen, i think the president believes that is a worthy question for voters to ask themselves. President obamas career in public life is different than that. President obama had spent his early stages of his career as a community organizer. Helping people in communities that were facing significant economic head winds protect their community. And whether or not that is thats what made the president an advocate for expanded Health Care Access and Affordable Housing programs and stronger education programs. And the president worked closely with faithbased organizations, helped citizens to organize and position their government. So when faced with these kinds of challenges in the past, president obama wasnt seeking a profit, he was trying to help people. He pursued that same kind of approach even as the leader of the free world. And many of the policies hes been focused on as president of the United States, particularly early in his presidency, were about ensuring that middle class families would get a fair shake and a fair shot. Thats why he fought so hard to create the Consumer Financial protection bureau, the only financial regulator in washington, d. C. , that has a Mission Statement focused on consumers and middle class families. Thats why the president fought so hard to expand access to quality Affordable Health insurance for every american. Thats why the president s focus in improving the economy is growing the economy from the middle out. Thats been his approach throughout his career. He believes thats an approach Worth Building on. Secretary clinton has a similar story to tell, when you consider her professional career. Ill let her talk about that. But i think it is certainly appropriate. I think the president made this clear in the context of his president ial, when he was a candidate on the ballot he made clear that he intended to pursue a different approach, or pursue an approach different than the one advocated last night by the republican nominee, but an approach consistent with president obamas focus on middle class families and those families trying to get to the middle class. Hes demonstrated throughout his career. Lastly, when both candidates were asked about how to heal the racial divide that has been quite evident in this election cycle, donald trump said it was about law and order, and then he goes into talking about stop and frisk. What does this administration feel about that . Particularly when you started not long ago having conversations on race, and hes talking racial profiling and law and order. Whats the thought about that . Again, as was noted during the debate, there are a lot of constitutional questions that are raised by that policy, and theres even a federal judge who weighed in and made clear that stop and frisk policy used in new york was one that was inconsistent with the constitution. Ive observed before, its a little strange to hear somebody who claims to feel so passionately about protecting the constitutional right to bear arms treat the constitutional right protecting against illegal search and seizure so cavalierly. President obama believes both those Constitutional Rights are worth protecting. Thats certainly consistent with his approach to these kinds of issues. I think whats also true is, and ill leave it to officials in new york to speak to this, but since that stop and frisk policy was ended, they have seen an improvement in their crime rates. So can you draw real firm conclusions about the impact of that policy based on just a year or two of data . Ill leave that to the experts. Those are the facts. I think theyre worth considering as you evaluate the approach being advocated by at least one candidate for president. Is the president preparing to send more american troops to iraq or syria . I dont have any announcements at this point about additional commitment of resources to our efforts against isil and iraq and in syria, but you heard the president speak many times about his approach to these issues, which is every time the president gets his National Security Team Together to discuss our ongoing strategy against isil, they have a discussion about which aspects of that strategy are making the most progress. And we enjoyed some important progress in recent weeks. There is additional progress thats been made on the ground against isil, both in iraq and in syria. The noose around the isil leadership in mosul and raqqah continues to tighten. Thats a testament to the efforts of the forces on the ground supported by the United States and our coalition partners. We also made progress in applying pressure to the isil leadership. Earlier this month or over the last month there are a couple of strikes that were taken by the United States that took two senior isil officials off the battlefield. These are two individuals who were, who had a central role in plotting isils external operations. That doesnt just enhance the National Security of the United States, that also makes it harder for isil to carry out attacks in europe and other places where the United States is invested in our allies National Security. But as the president has these conversations with his National Security team, they arent just looking to see which aspects of that strategy are showing progress. The president regularly asks, could we make more progress in we devote Additional Resources to that effort . And when the answer to that question is yes, the president worked closely with his team to find those resources and devote them to that nefrt a timely fashion. Dont have any announcements at this point. Well keep you posted in that changes. Is there a daily beast report the Senior Special envoy to syria was told two days before the latest air strikes against the socalled White Helmets the attack was coming. Can you confirm the u. S. Government at that level had advance warning . I have not seen that report. Why dont i check on that and well follow up with you directly. On the cr, if congress cant get an agreement by the end of the week, will the president sign a twothree day extension needed. I havent heard that option be floated. The president is not interested in seeing the government funding lapse, but its not an executive branch responsibility. This is a legislative branch responsibility. Republicans have a substantial majority in the house and senate. Its the responsibility of house and Senate Republican leaders to pass a bipartisan budget bill that arrives on the president s desk in time for him to sign it before funding runs out on september 30th. So i recognize that right now republicans are and the congress are scrambling to figure out how to get this done. Some of that may be attributable to the fact they took seven weeks off earlier this year. Maybe thats time that would have been better spent actually focusing on putting together a responsible bipartisan budget proposal. One other thing. Today the dc circuit is hearing oral arguments in the power plan. Can you outline any of the administrations arguments . Ill leave it to my colleagues at the department of justice to make the legal case to the d. C. Circuit. Obviously, weve got a lot of confidence in the case that they will make. The administration was acting on a strong legal and Technical Foundation in issuing or putting forward the policy that the administration announced last year. And the president is convinced that this is a policy that is important to living up to the commitments that we made in the context of cutting Carbon Pollution in the way that will be good for the longterm health of the planet. The president is also convinced this policy will be good for the u. S. Economy. We know investments in clean energy have created or supported tens of thousands of jobs all across the country, and weve had success in significantly expa expanding the amount of energy that is produced through wind and solar and other renewable forms. Ill also point out there are significant Public Health consequences for this policy. Our scientists estimate implementing this policy to reduce Carbon Pollution by 32 by 2030 would avoid 3,000 premature deaths, 90,000 childhood asthma attacks, and eliminate 300,000 missed work and school days each year by 2030. So there are a lot of Important Reasons why the president has prioritized this approach to cutting Carbon Pollution, and the administration is quite confident in the legal power of the arguments that well make before the d. C. Circuit about why its within the scope of the president s authority to make that kind of policy decision. Okay . Margaret. Josh, senate does appear poised to override that president ial veto of the 9 11 bill that would allow the families to sue saudi arabia. Why do you think that its this particular issue that allowed the first president ial veto override . I think there are a couple of reasons for that. The first is, we have not seen the United States congress be particularly effective at passing legislation. The president hasnt issued that many vetoes, period. I made this observation on a number of occasions. Over the last couple of years, we havent seen Speaker Boehner or speaker ryan work effectively with leader mcconnell to pass legislation that advances the conservative agenda. Its not as if in the last year and a half youve seen Congress Pass bills that would cut taxes for american businesses or cut expending, cut Government Spending or increase funding for the military or any of the other conservative priorities that they spend a lot of time talking about. But not actually legislating. So the fact that the president hasnt vetoed that many bills i think is a damning indictment of the effectiveness of republicans in congress. Thats just a fact. I think that is why its not just democrats dissatisfied with the performance of the United States congress, there are plenty of republicans who are unhappy they cast votes. They elected a republican majority in the United States congress and what do they have to show for it . Not very much. Thats part of it. I think the other part of it is that you have seen democrats on capitol hill who work very effectively to try to champion ideas that the president supports as well. And having a lot of Democratic Unity in fighting for some of the priorities that the president cares about has allowed us to make some progress in areas that are democratic priorities. One example would be the budget agreement they reached last year, a twoyear budget agreement that the hope had been that that would preecht any budget drama this year. Well see if that remains to be true. But the president has strong views about this legislation and the impact that it would have, not just on the u. S. Relationship with saudi arabia, but with countries around the world. It would increase the risk that is facing our Service Members and our diplomats and intelligence professionals. And that is a view that the president stated on a number of occasions. It is a view that has been its an argument that was also made by, in a letter, by president george w. Bushs attorney general and his National Security advisor. They have raised significant concerns about the impact that this bill would have on our Service Members and our diplomats. And some of americas closest allies including in europe have raised concerns about this bill entering into law. So the president feels strongly about this. Hes also aware of how challenging the politics are. Some democrats are helping to make this happen and bucking what the white house is asking them to do. Dont you think there is something very emotional on this particular issue that is getting democratic support to reject what the white house is asking them to do . I dont deny the political and emotional power of these arguments, but look, the president has spoken powerfully on a number of occasions about the sacrifice thats been made by the families of those in the United States who lost loved ones on 9 11. And the resilience that they have shown has serve d as a genuine inspiration to the president personally. I think what is also true is the politics of this are tough, but look, nobody questions the president s commitment to protecting the country and protecting the interests of americas 9 11 families, primarily because hes the president that ordered the mission against bosama bin lade. Hes the president that fought hard to make schaar 9 11 responders and rescues got access to health care they need when they risked their lives to try to save their fellow americans, but also to rebuild that site. The president is able to take the political heat because hes got the strong track record on this issue. But again, ill let individual members of Congress Speak for themselves. Weve heard from democrats and republican whose have indicated some openness to the position that weve articulated. They expressed some concerns about the potential impact of this bill. Well just have to see if those private concerns end up in the public votes they cast. Do you think you might have enough votes to block this from happening . Im not going to make any predictions about a congressional outcome here. Im giving you a sense of the kind of argument that the Obama Administration is making to members of the congress. This is the same argument that was included in the letter from a Bipartisan Group of National Security experts, including president george w. Bushs attorney general and National Security advisor. This is the argument we heard from our closest allies. This is consistent with the argument that we saw in a letter today from jeffrey immelt, the chief executive at ge, who raised significant concerns about the further erosion of this concept of immunity and the impact it could have on american businesses. There are widespread longstanding concerns that have been articulate d and the question remains whether or not members of congress will demonstrate the courage of their quicks and vote their conscience. Two administrations said there is no link between senior saudi officials and the terrorists who carried out these attacks. So given that, and you standing by those findings, why do you think it is such a risk that if these cases make it to court that they could find otherwise . Our concern is not rooted in a prediction about the outcome of these individual court cases. I have no idea what judges will ultimately conclude. I havent reviewed the evidence families or others may present. Our concern is rooted in the erosion of this foundational principle of international law. And the concern is rooted in the idea that the United States of america is more deeply engaged in more countries around the world than any other country in the world. So carving out addictiontional exceptions to sovereign immunity puts the United States at risk than any other in the world by the fact we are more engaged around the globe than any other country in the world. Thats the concern that the president has. And again, its not just the president making this argument. It is National Security experts in both parties, leaders in the private sector and leaders of some of our closest allies are expressing the same concerns. What do you say to the families, who in their view, believe the white house is standing in the way of justice . The president is very sympathetic to the argument that the 9 11 families make. The president is very interested in making sure that those families understand this Administration Stands with them. This is an administration that sought justice for their loved ones. This is the administration that fought to ensure that our rescue workers got the health care that they deserve. This is the president who every year has paid tribute to those who are lost on 9 11. So the president understands the passion thats on both sides of this issue. Its the its to consider the broader impact that this bill as its currently written would have on our National Security and the standing around the world and on our dip la mat and Service Issues that represent the United States around the world. One final question and syria and any updates and National Security counsel and meetings and the siege under way in aleppo . I dont have any updates but this is a situation that continues to be of deep concern by the president and the National Security team and its something that were going continue to monitor. Thank you. I have three issues that we can knock down before we go to the fourth. It may take a bit longer being the debate. First, my understanding is that the Senate Leadership has indicated that the action in that chamber is a mismeasure and will be tomorrow, if thats your understanding is that the intensification of the white house and only by the president . Well, i dont have any specific president ial conversations to talk about at this point. Yes, we will have the opportunity to do that. On the event today and the concerning of the outreach, if one studied the list, and that goes to the summit thats associated or sfunny or die . This is an outlet thats had a lot of success in building a large audience among young people. The president has gone to places like buzz feed and even between two ferns to make a case that young people should consider signing up for health care and the marketplaces, so it makes sense its the engagement that we got from funny or die. Besides seeking out for the outreach, does it say anything about the state and theyre getting the news and if you have been around a long time or any sets of history you would see that it jumps out at you and someone with the program like funny or die is a white house summit and what does it say . Its a commentary of the media and environment. The people get there and have an opportunity to get their news and to be informed and theyre confident that they will do that in the four months here while in office. We would be remissed to use another legal term or malpractice to fail to engage in those kind of o outlets that we know have substantial audience that were trying to reach and so thats part of what were doing today. This is also a medical term. Finally before we tackle the debate again the secretary speak today about many of the resources that his agency is making available to state Election Officials and offices to protect the integrity of the elections at the state level in terms of society and how confident is the administration about the integrity of the electoral process . Well, james we continue to be confident for a variety of reasons. From, i think one of the most Important Reasons is that many of because the elections are administered by state and local officials, theres not one central repository that lends itself to easily corruptioning or influencing a National Election and so the fact that you have administrators using systems in many different states to the record let me introduce and we will lead off the panel and its in july and 2008 as such he is a member of the Senior Executive service of the u. S. Federal government and also serves as a director for jo Center Science and thank you for being here and the comments. I would like to welcome dr. Daniel for the disease and Center Prevention with over 30 years of Public Health and Emergency Response and medical training. Next is steve monroe for the center for Disease Control and prevention and the background in micro biology and look forward from hearing from the policy levels and next up introducing dr. Mark davidson thats associate Deputy Director at the Veterinarian Service and he over seas the Programs National import and export as well as all agent services. We thank him for being with us today and look forward to the testimony. Joining us we have jeff potts and he serves as the bio manager and over seas the coordination of all high containment and within the Research Department and we thank mr. Potts and then commanding general of medical research and Material Command and chief of the u. S. Army nurse corp. We thank the major hol come for being here and the Safety Program and at the department of defense. I want to thank all on the floor the witnesses for being here and appreciate that. Yall are aware that this committee is holding an Investigative Committee and when doing so, we take the testimony under oath. Do any of you have objections to taking the testimony under oath . I see no objections. Youre entitled to be advised by counsel. Do any of you advise to be advised by counsel. Can you rise and i will swear you in. Do you swear that the testimony youre about to give is the truth, the whole truth and nothing but the truth. Youre now all under oath and the penalties set forth in title 18 of the United States code. We will have you each give an Opening Statement and starting with dr. Pearsons and pull it close as possible and Pay Attention to the timing. Will do, sir. I am pleased to be here on the report of the issues last week. As you may know in activation is a process for the pathogens while retaining the characteristics for the research as in developing vaccines. This delicate balance of eliminating them affects for the study and may be achieved for the safety of the top priority. The federal agent over seas the high Containment Lab through the cdc and with the long term and the interest in the programs over site you asked us to begin the work before the may 2015 revolutions containing the shipment over the course of 12 years of bacteria that causes n anthrax and although regulating these labs is and will remain a complex endeavor, the nature and extent of this specific challenge had not been anticipated when you made the request. There are three findings from the report. As for the first we found that the total number of incidents with the in complete is unknown and unknowable. While the program recorded that ten incidents occurred from 2003 to 2015, gio identified an additional 11 that the program did not intentionally identify. Taken together, these 21 incidents involved labs and in activation methods as shone in the figure before you. Because the program cannot easily identify the incidents, it does not know how often they occur or why they occur. This makes it difficult for the mitigating the future ones. Lying behind this are first the fact that no clear of activation exists and the program of the nih have and second the programs forms are currently not structures to specifically identify this type of incident. As a result they cannot report the incidents and that means in turn that regulators cannot provide a number of them. The second key finding is the critical challenges that affect the in activation and the high labs. The challenges that we identify are the gaps subpoeand scientif knowledge and how to develop the protocols and three the in consistent use of safe guards. With respect to gaps and knowledge we found that resources are dedicated to the research and the methods. With respect to limited guida e guidance, we found that while theyre developed through the lab, sometimes they vary within the same department and increasing the bio safety and bio security risk. With respect to safe guards we found among other things a general lack of safety in several lab that is we visited. This increases the risk of human error. The third is that cdc neither referred the violations to the Inspector General nor enforced the regulations related to the incidents. For example we found that cdc did not use the same for further investigation and did not clearly document them for referring or not referring the violations. Why some were enforced and others not. The Program Required one private and two academic labs and never required on similar o occasions until the revelations in 2015. Without consistent criteria and the decisions for the referring violations and regulations, the program cannot ensure that its applied consistently. This with the work raised serious questions ton nature and extent and con sis ten si of the over site that they have provided. We have made recommendations concerning the issues and the lack of the understanding of the National Need for high Containment Labs and the fragment and selfplitsiolicing. We have recommended among other things that a single over sight entity be identified to determine one the number of location and mission of the labs needed to meet the goals and the biological threats and the risks associate with the proliferation. Although some of the recommendations have been implemented, the key recommendation on the need for the single entity has not been addressed while the safety and labs have continued increasing the risk of exposure to workers and the general public. In this era and the ongoing threats to national and Homeland Security and the time for getting both right across the Research Enterprise is now. This concludings my remarks and im happy to respond to anything. Thank you. Thank you. Chairman murphy. Is it working . Members of the subcommittee, thank you for the opportunity to testify before you today regarding the contributions of the center for Disease Control and prevention to the federal select Agent Program. I am Deputy Director and chief medical officers for the cdc. I have leds through significant change. Inspection report are more timely, clear and risk based and consistent. The regulated community is a stronger partner in achieving the standards of bio safety and pathogen security. Response planning is more proactive and pub plik awareness of the agent work and over site is improving. Our work is by no means done, and i am pleased to introduce dr. Sam edwin that joined three weeks ago and swho will continue the commitment for the federal program. I want to recognize the importance that they have made with the activation of the pathoge pathogens and proposing ways of the practice and over site. We concur with the recommendations relate today the program, and have already initiated efforts to address them. As recommended, theyre expecting to publish a final rule and thats gofing to be th over sight. Were developing the guidance to be released concurrently thats going assist the community with the new requirements. Were improving the Incident Reporting and Data Collection and also recommended in the report by updating the form used to report the threat loss and toxins. We say that complete and the case of the exposure to the agents will now be captured. Were working to improve the consistency and how we do the findings to focus attention where its needed most. Were using this process to better standardize the application of enforcement actions. Including referral to the Inspector General as was recommended by jao. These are the trans parn cipare the over site. This saves lives by supporting the vaccines and zpruthe drugs needed when they can be treated or prevented. We continually strive for the safety and security with the commitment to science. The scientific methods and objectives of the research are converse and complex, and we must be careful to not over prescribe and interview with the advances. Were increasing through the collaboration of the community and that shares a common interest of the bio safety and the security and also bares responsibility for accessing the risk of their work and applying the Program Safety measures. We also use the experience and judgment of our inspectors and over 60 percent that hold ph. Ds in microbiology and the rest are master degrees. When necessary, we set specific method requirements through the rule change as we are doing with the in activation of the agents. For 70 years the scientists and staff at cdc are on the frontlines of the Public Health and tackling the pandemics and the health to the American People. The division of the agents and toxins is responsive in making improvements and the gao in the recommendations. Work with agents saves lives, and we balance the needs for restraints and the benefits of scientific discovery. I assure you that we have worked and will protect americans from biological threats. We welcome to subcommittees in put as we continue on this path. Happy to take questions. Thank you. Youre recognized for five minutes. Good afternoon chairman murphy and members of the subcommittee. Thank you for the opportunity to testify before you today. I am dr. Steve monroe and the director for the Laboratory Science and safe tichlt i serve as the single point of accountability for the quality and safety and i report directly to the cdc director tom freedom. My office was created last year to provide over sight of the cdcs internal laboratories. This is the role of the division and the toxins. I exercise with the authority over the programs and regulations or their enforcement activities. My office does insure that those cdcs that work with the select agents comply with the select agents and regulations. The responsibility for the Laboratory Safety is the over sight of the chemical and the laboratories whether or not they work with the select agents. Cdcs laboratory is playing a role in protecting the publics health. Our Laboratory Screen newborns for rare illnesses and detect the outbreaks for the communities and then in vent new ways of the diseasinesdiseases. Its a critical part of this work. In activation destroys the ability to cause an ainfection and that allows the Laboratory Work to occur at lower level. This enhances the safety for workers at the cdc and expands the number of laboratories that would require higher levels of containment. It enables the vaccines and provides like pole lio and prots the safety of the Laboratory Staff and the public. However, its critical that when laboratories and the pathogens, they do so safety, completely and verify bli. The in complete activation in the cdc laboratory in 2014 was an event that lead to major reforms. I take very seriously the pathogens in the laboratories. This afternoon i want to briefly highlight ways that were strengthen the activation at cdc. The first is the creation of the Laboratory Safety review board. This group is charged with reviewing every protocol for the activation and transfer of biological materials out of the bsl 3 and 4 to lower the levels of containment. It reviews every Standard Operating Procedure and ensures that the scientists have appropriate skills and training. Its a safety reform and remits a change in the over site of the in activation of pathogens and cdcs laboratory. The second way that we aim at cdc and throughout the laboratories in general is through enhancements to the reference guide and bio safety and biological and laboratories or bmbl. That created with the partnership of health is a comprehensive guide on the bio Safety Practices and guides. With the influence of the community, the gao reported and recommended and they concurred that the upcoming revision to that include clear definitionings of in activation and clear and consistent guidance for the development and implementation of the protocols. Cdc and nih are working together to incorporate this definition and guidance in the next version of bmbo. Laboratory safety at cdc is not a single objective that can be accomplished and checked off but an ongoing commitment that demands the constant dedication. Its an important example to this culture. We have made strides and we will continue to monitor and improve the efforts in this area. Thank you for the opportunity to testify on this important matter, and i welcome any questions that you may have. Thank you. Dr. Davidson youre recognized for five minutes. Members of the subcommittee, i thank you for the opportunity to testify at todays important hearing. I am dr. Mark davidson and associate deputy for Veterinary Services within the Us Department of agricultures animal and plant health inspections. We jointly over sea the federal selection program. We insure that anyone processing, using or transferring biological select agents or toxins that have the protensional to pose a Severe Threat to the public, plant or animal health, does so safely and securely. This is a role that we take seriously. We understand the consequences that the agent as and toxins can have. We recognize the gravity of the resent incidents and i can assure that you that actions have the Agent Program and while we can not completely eliminate all risks, we have over lapping safe guards and processes in place as low as possible. In addition to the gao review the program has participate in a broad review and other studies of the program. We have implements a majority and addressing the remaining recommendations. This includes the five recommendations in todays gao report. Were are providing a rule that will provide clarify for the community and the select Agent Program about the roles and responsibilities for the in activation of the select agents. The rule will clarify what is required to achieve in activation and the related guidance will lay out standards to help resempers and others validate in activation protocols. Once these standards are in place, we will hold those that we regulate accountable for meeting the standards. To that end were finalizing revisions to the standard reporting forms that the program us uses. We will collect information on the in complete and activation and other causes so that we can monitor and track the issues that arise and assuring the accountability and the agents and the ability to analyze the trends to reduce the risks of the future incidents. Were also in the final stages of the developing a new enforcement system and the select alth program. The three tiered system assigns violations into the categories based on the severity and tan zard how the Agent Program is going to respond to those violations. With implementation of the system that will include consistent consequences related to o the activation guide, endorsement under the agent and the stakeholders have a clear unctioning of their responsible. Again, they take a release of a toxin very seriously. Were working closely with the federal partners and the regulated community to develop a strong culture of the safety and responsibility and policies and procedures that are science base and to the maximum extent possible and insuring the safety and security of these potentially dangerous selected agent as while allowing the valuable research to continue. This concludes my statement, and i would be happy to answer any questions that you or the members of the committee may have. Thank you dr. Davidson. Now mr. Pots for five minutes. Its on honor to be here today. Including those that work with taths and toxins. The go report released today is the analysis and the recommendations that have the policies and procedures moving forward. I am just committed to work being the federal partners. I am the barge manager and responsible for the over sight and guidance to the Research Community for matters with the high consequence pathogens. All the containments are held to the same operational standards and working with a team of the Safety Professionals we over sea the laboratories in maryland, frederick, maryland and montana. They have a Important Mission to conduct the research for treatments, diagnose nos stick and vaccines and medical measures for the ever evolving threat of diseases. Its a component of the research and in activation aallows for the removal of the high laboratory for the down stream use. And its developed by the collaboration and then the management staff and review by the Safety Officer and then review of the approval by the committee. These policies and procedures are applicable to all path jens and the Research Community looks to two publications when it comes to research. The comment or molecules referred to as the nh guidelines and the sebcenter for the disea criminal and referred as the bmbl. In addition to these documents theyre regulated by the cdc or sda. I will look to these two agencies to establish the activation. Its important that ever effort is made to insure a clear message as well as provide the guidance for the protocols. The ga report call for the consistency and involving the complete or failures. In order to provide the greater accuracy and retrieval with the failures, and to revise the template for the reporting ibs debit of the guidelines, and internally and thats the destination of the samples and thats shipped. In the upcoming revision of the bmbo, guidance is on the shipment of the in activated material. I am not just commit today the outreach and the broader Outreach Community and will spontaneous or safety this many october. Throughout the month, all Research Institutions are encouraged on the policy and practice and procedures. This year the outreach effort is going to encourage institutions to have the programs and collaborate with other professionals and commit resources to insure that they have a robust and government structure in place. In an effort to foster in the topic, they will host their third design workshop. The topic is going to be activation and lessons learn and a way forward. This will provide a venue for the scientific and safety percent knesonnel and successes failures and the sign and information gaps. In closing i want to assure that we remain commit today the public and the scientific to find ways to enhance health, lengthen life and reduce illness and disability. We remain in the Publics Trust through the Safety Practices and strong leadership. Thank you for the opportunity to stf. I am glad to answer any questions that you may have. Thank you. General holcomb. This is the safe hand oflg the toxins or b sap. I am the commanding general of the u. S. Army and medical general command and i am here in support of the Army Surgeon General thats with the bio Safety Program. The executive agent responsible official over seas the policy and technical review and guidelines across the dod. Today i will briefly describes the actions that the dod accomplished since the last hear asking the plans for the future validations procedure, over sight and implementations for the bio safety. The executive agent responsible official chartered the dod and b stat office in march of 2015 and now establishing processes and hiring staff. They advise the executive agent responsible on all matters on the lab and operations, risks and over sights. This office serves as the agency and insures the standardization and identifies the best practice across the full spectrum. The life size with the live anthrax were sent was reacquaint signed in the u. S. Army assigned under the research and army Material Command. We stablished a Safety Review Panel in february 2016. Since its establishment the panel has met facetoface and conducted multiple conferences. We review the Scientific Evidence and the concerns and provide recommendations for the acceptability for the con on i have the Army Directive 2016 and 204 and its the bio Safety Program. This directed e stlashs the policy and assigns several responsibility to applicable dod and service activities. This directive replaces the previous secretary of the army with additional safe guards regarding the production, handling and in active and also critical reAgent Program materials. However, the deputy secretary of the anthrax remains in affect for the production, handling and shipment. Were working on several initiatives that are intended to enhance the harm sags and standardization of practices and procedures across the dod network of laboratories. We initiated the studies to better define the conditions for the activation and viability testing and i rat yags study for anthrax is under way and scheduled for come pleex in october 2016. Its focused on monitoring the bio safety and in bsat operations and all laboratories. Others include development of a joint inspection team, bio safety and scientific review of all of the protocols and procedures and possible unified over sight for the bio safety and security to enhance the Risk Management for the operations. My written testimony provides a description of these and other initiatives. We value the analysis from vieded by the gao. Its going to in form the bio safety efforts and improve the over sight. The dod is adregs the bsat over sight and documentation and improving the guidance for the development and in activation of the protocols and developing investigation and referrals. We look forward to coordinating and cooperating with the department of health and Human Services and the department of ago harrah kul church as they respond. Thank you for the opportunity to testify today, and i am happy to answer your questions. Okay. Thank you panel. I will recognize myself for five minutes of questions. I want to start by saying we have been here before with the agencies and we have seen some of the problems occur and were hearing again you take it seriously and we hear about the number of scientists with the advances degrees and rules and this is pretty Severe Threat that we have had more case here of anthrax and pathogens released than by terrorist in the country. Now, at this level luckily we have not seen someone die from this, but its serious and you all recognize the seriousness of this. I want to start off with this important question. Dr. Monroe, should the cdc put out an announcement that anyone that fails to follow it is summit to personnel action . So wherch theres an issue that we recognize with in activation failures or other issues related to dangerous pathogens, we immediately my office is involved in. From the on set . Employees notified. This could have been a disregard, reckless or endangerme endangerment. Do they understand the seriousness of this and held accountable if they do not respond to the rules that theyre setting forth . Thats a part of the culture and the responsibility. The disciplinary action is a management decision outside dr. Davidson, how about within afis . All of the scientists have an Important Role to uphold the integrity and each case is investigated for the release and then if the Management Action is needed. Mr. Potts, is it clearly state today the employees there . Well, we stress the importance of following the standards and all protocol has been aapproved and like dr. Davidson if we find that theres a willful or a negligence involved, we pursue those actions. General hol come. Well, theyre enrolled in a program and failure to comply with the policies are grounds for disle cqualification and th privilege to work with the agent as. Thank you. Thats what we need to here. There can be no if and or buts. We do not want to hear anything else on this. Where theres a ton bit of leeway, theres a problem. We all know and understand that people make mistakes but when we have heard time and time ahear gain and we have heard of refrigerators left unlocked and people putting things through a zip lock bag and the mess is continuing and were not clear yet that things are taking place. Dr. Davidson, so youre agency is in agreement for the go recommendations and it comes down to help us understand why do we trust you . Why should we trust you now . Whats difference in the culture . Many aspects its on. Get close. I may have to eat this one. One of them have changed. I am happy to talk about how the inspections have change and the opportunities for best practice sharing and training has improve and the response and others have improved and all hof these calld in a broader report. I think that you can look at what has happened since the year that we have been here and see many clangs and each one of the recommendations that came out in the resent report. Dr. Davidson . As dr. Sosin said we Work Together through the changes and through the different reviews and the federal reviews and the gao, we have found gaps that we need to address. We have been active in the work that we have done with the inspectors and through the steps that were taking through the guidance and policies ask weve got to continue to always look for improvement. Let me ask one of the areas. So the gao report say that is they need to be reports, is this issue solved now dr. Sosin . I do not understand. The in activation cases. Is there a specific way that its concrete now . Yes. Okay. Do you have that set up now . Yes, weve worked together to i have a few seconds, do you have that concrete and set up now where theres an in activation and case of clear reporting set up . Yes, theyre daupdated in august. General holcomb . Yes, we do. Okay. Im out of time. Thanks. In reviewing the ga i guess the 2016 report, theres now six additional recommendations to improve over sight of these high Containment Laboratories and the select agents and we have seen a number of recommendations. I have been on this subcommittee for over 20 years and over the last ten years we have seen a number of recommendations that were always trying to improve on the program, and so having seen this overall of these years i have to ask does the existing structure with responsibilities spread across the different agencies and provide the over site that we despite the efforts . I want to ask you a couple of efforts with this dr. Piersons. Is it going to require considerable coordination across several agencies, is that correct . Thats correct. Do you believe that can be achieved and if so, how . I believe that its possible to do coordination. Of course gao does a good deal of work not just on this topic but in general. Its sometimes challenging to do and as the recommendations shows that we have key things that we found to try to make them essential to most if not all of them. In the earlier work you found that its fragmented and at times relies on south policing, is that correct . Thats correct. And given these ongoing efrtds, i guess that im wondering if you believe the current structure provides adequate over site with the adjustments that people are test identifying about here today or do we need a single entity for this program . Thank you for the question. I think its important to go back and answer this in context. The way that it evolved goes back to the post Oklahoma City bomb asking then layered in with the legislation and post 9 11 and so on. I think what is important and this was confirmed by several of of the experts but its the context of the security and the bio safety and over imposing against. So i think theres work to be done in the bio safety arena and once the in activation is a largely related issue and i think as one type of incident it exposes the challenges and the structure thats largely built around the agency and then those things that are a concern and in the National Security sense. So given those challenges that you just described and the time frame, do you think that it would be practical to have a new single over sight entity over site for the high Containment Labs . Well, right now for this committee were looking at a comparative structure and we will be able to say more and evaluate it since and what were doing mpth were looking with partners that do this. So you dont have a conclusion on if we need a single entity or not yet, but youre working on it, is that fair . Its a thing to consider given the need in term of the bio safety domain. Okay. Are there ways to better over sight of the select Agent Program and high Containment Labs . Im not able to comment on that other than working within the existing system on the recommendations to make it better and we do as the various witnesses that testified there. Thank you. I would like to ask the rest of the witnesses what they think of the con september of the centralized agency to over see this program. I was a Ranking Member and i believe there was a missunderstanding on what the federal program is authorizized to do. Its authorized to over see a set of toxins and not the lab tory laboratories. Right. But you could authorize some agency to over see it. Hi, im congress. Congress could authorize that, do you think thats a good idea, yes or no . I dont have enough information to know. Okay. Dr. Monroe . Theres not currently one agency that has the breathe of expertise thats needed. So we would have to set up dr. Davidson . I agree as we work as the single entity and the breathe that we bring from the scientists and the expertise, is the coordination. Mr. Potts . I think that its working and theyre providing their Expert Opinion and guidance. You think that we can coordinate enough . I think that we can coordinate. Holcomb . Within dod we have done that regardless of the service, so for us, thats what makes sense. Thank you. Thank you mr. Chairman. Okay. Now from new york. Okay. I know that we have met before and again with all full disclosure i was the founder and ceo of one that operating a lab with a select agent and license. I am familiar with what youre doing and we have been inspected by the cdc and i give everyone c kudos for the type of inspectors and we never had concerns on the type that i have seen over private labs. My concerns is in two airs. Its hard to in activate and its very straight forward if youre not trying to protect the rna. Youre killing it off. Hard to imagine that anyone is going to go through that and ship anything thats not in act vatded. If youre trying to protect the rna and dna, that gets trickier. Certainly when youre into anything like bacteria and you test it and its in activated and you have them and they pop and germinate, we have had some discussion before and we found that it could be months down the road. I know dr. Sosin you thought it could be days and our finding was that its months. With tuberculosis we did find that, so i guess one thing that i would urge and we have talked before is to have a very very rigged in activation procedure in particular and thats grown in the test that its in activated and then especially down the road it pops. So could you maybe speak to that and on the bacteria side . Sure. The viability testing of agents following in activation p procedures is critical. Were going to have requirement itself and specific to the since the doug way incident we have disallowed the treatment of or the in activation of the spurs to be used for the future use as the agents. Until we have the clarity of the science and how long that period of viability testing needs to be, we will not lift that prohibition on treating as far as in activated. I would just encourage you to really test that out and look months down the road and not days down the road. It cannot hurt and maybe not just anthrax but other things like tuberculosis. Now, the other thing that we have gotten into here and i suppose just for clarification the committee should know that we ship live virus all of the time including zika. Theres no prohibition against that. To some extent i feel that some think that it should be in activated and thats not the way that it is. Some researchers need live virus and we rely on that and i think that theyre very tight and by and large folks that work in the laboratory and the space suit realize how dangerous they are and what theyre working with. The one thing that i read here and then i worry a little and then when the federal government wants to complete and then the private sector is doing just fine and then today theyre technologies that i know of where you can treat the virus and totally protect the rna and dna and in activate it and it would beg the question on why the federal government is not going to look to license those technologies as opposed to trying to complete and look and establish new methods for Something Like zika and those methods are already available and covered by at that tipatent. Why would the government be looking to do something thats already available in the private sector . Thank you, sir. What youre referring to is a program that we stablished this fiscal year to do the research and look at the activation and other activities around the Science Behind the Laboratory Safety that were involved with. We do have a project that has looking at alternative ways to look at zika and other born viruss as apart of that work. Yeah, youre aware that the private sector can already do . Yes, sir, but its the use of the material thats going to be used down stream. For us its important to say method thats going to work for the activities. Okay. I would just encourage you make sure that you look at the private sector objects too. Thank you, fair enough. Okay. Youre recognized for five minutes. Okay. Thank you mr. Chairman and the witnesses for being here today. They made six recommendations in august 2016 report to reduce the risks of incidents of dangerous pathogens. I would like to hear from each of the agencies on your reaction to gaos recommendations and the length of time that you believe it will take you to implement them. First they suggested to testing the secretary of the health and Human Services and t this will help to close the gap in the science and high Containment Laboratories. I would like to ask cdc and nih and dod at this point what are the specific scientific gap that is need to be addressed . Ne in other words, what is still unknown and what is the significance of the lack of knowledge . What will be involved in closing the gaps . When do you believe the recommendation could be substantially achieved . Why dont we start on this side with the cdc. So as i just eluded to within cdc we did allocate funds within this fiscal year for some work to look at specific issues around in activation and other issues with the Laboratory Safety. Part of the problem here is again the notion that theres not one perfect way to in activate any pathogen because it depends on what youre going do with the pathogen in the drown stre drown stream uses. Theres some things and for instance major holcomb can describe to this if the everies at d o ood to look and because e aware that that work was going on at dod theres no work that comp to that going on at cdc. So usda as dr. Monroe talked about we each have individual areas that will work. One of the things that were doing with the in activation is training conferences to help people understand everything that has to go into an in activation protocol and the step that is have to be taken to volume da validate that. From there its the agent as that we work with within the high Containment Laboratories. So nih has active Research Projects and collaborations that we have addressed some apps. Nih were constantly looking at new science, new techniques, there are no pathogens discovered and the science is going to be following that. Were committed to constantly pursuing this at nih we have a process where every pathogen and every protocol is brought before the i bc and is looked at for testing to make sure that the protocol is affective. We have ongoing collaborations with other agencies within the government to bring align the guidance document and the verbiage for the definitions. The dod is currently conducting a series of experiments for the radiation of the spores and the study has identified a method for spore preparation and then a radiation dose thats going to produce assurance level of ten to the negative six. Thats the probability of one in a million. In a method to validate the red yags dose received by the sample and the activation of spores. The assurance was achieved and the upper range was 50 and the lower range use was 25. This is the measure of the confidence for the sterility thats used by the medical device industry. We must address the compounding verbals that can be used in various types of samples and until those are completed and reviewed and accepted by the Agent Program, we will continue to manage the radiated spores as set. The agencies must first increase is findings and close the gaps. Would you agree or are you hopeful that this is going to be done in a timely way. Will gao monitor the agencies for the process and in closing the scientific gap . Okay. So thank you for the yes. Yes, we believe that its possible. We do believe that extensionive coordination is necessary and it sounds from the witnesses statements today thats begun and yes, gao will keep an eye on this moving forward. Thank you very much. Thank you. Mrs. Brooks youre recognized for five minutes. Thank you. I am impressed over the past years and as the chairman knows i am focused along with my colleague across congresswoman and strengthening the enterprise with the bill 3299 and thats the problem of responsible precurement of treatments needed to combat an outbreak or attack. However, as we focused on in the past hearings on the subject, breeches under nine the whole interv enterprise and fortunately we have not had a lap like this and leading to wide spread contamination but im just curious and want to explore a little bit with the respect to the lab safety and enforcement and while i am focused on the federal government and the industry to medical Counter Measures and prostrej i can stockpile, i am curious and if we use anthrax as an example and one thats currently stockpiled, are the lab workers and other sicientists and staffer thats begin the vaccines before working around these dangerous pathogens, i ask Major General holcomb, are they given vaccines . Most are. The military are. The civilian and contractors, its not a requirement. Theyre offered the opportunity. They certainly have all the personal protective equipment needed to work. But we cannot force them to take a vaccine for something that they dont choose to do. How about dr. Monroe in cdc . Whats the status of vaccines for those working in this space . At cdc, likewise. Specifically for an tracks. Workers who work with live anthrax have a vaccine. And we keep supplies in our Occupational Health clinic, appropriate antibiotics in case there would be an exposure in the lab. And thats what i wanted to follow up. So are there sufficient antivirals and antitorquesins on site for everybody . There are for you know, the workers who are working in with the incident in 2014 where there was a potential where there were workers who were exposed in other parts of the agency who would not normally. We may not in all cases have a stockpile on site within cdc to treat, you know, essentially every employee at the agency. What is the process in place if that were to be necessary . We would have access through the Strategic National stockpile if there were truly an incident where there was widespread release of an agent, we would be able to, with the other resources available, bring in enough antibiotic to treat the appropriate population. Do you want to add thank you. The process that the jurisdiction, in this case cdc atlanta, would be the jurisdiction of the state of georgia. Would recognize a need for countermeasures, would make a request to the secretary of hhs and those materials would be provided to cdc through the state to ensure that the staff received the prophylaxis needed. That sounds like a lot of different government entities. Its very fast. Thats what i but then you and the response to the botulinum toxin. You mentioned the state of georgia as wellbeing involved in that. And so when you said it all goes very fast, how fast are you talking about, a process like that taking, if there were to be exposure . Within hours. Okay. That can be done. And it has been done. The state of georgia would defer to cdc to carry out the work that needed to be done, and that would increase the speed of it. Thank you. Major general holcomb with respect to dod, with respect to the antivirals and antitoxins . We have access to the same supplies of the national stockpile. And so we keep enough on hand to address potential initial exposure for those working in with the agent. But again, have the same access that the other federal agencies have to the stockpile. Thank you. Dr. Monroe, or dr. Soesen, there were equipment issues, malfunctions, or failures, would you briefly explain the Alert Systems built into these machines should an issue occur . Im not familiar with the specific equipment issues associated with the findings that you mentioned. But the process is, when the laboratory identifies a failure of an activation, or an exposure of a worker in general, because of a breach of personal protective equipment, or failure of equipment, notification goes through the responsible official at the facility directly to cdc to notify us of the event. We begin a process of investigating with that facility to make sure that all necessary protective measures are taken to protect the workers, as well as secure agents. And if necessary, if its a significant exposure, well bring in state authorities and local authorities to be involved in that process. Thank you. Dr. Monroe, are there Alert Systems in place . And i guess thats what im curious about with respect to the functioning of the Alert Systems. Right. So what i can say for the four incidents of the 21 that did occur at cdc facilities, three of those involved chemical inactivation. So the material was not fully activated by the chemical processing. The fourth one was a mixup of samples such that the noninactivated samples were brought out of the lab. In our experience, we have not had an issue that we would relate to an equipment failure. Thank you. I yield back. I recognize the gentleman from texas for five minutes. Thank you, mr. Chairman. In your 2016 report, it makes six recommendations to the cdc and nih, aphs, to address the inactivation issue. If these are implemented and should improve safety and help mitigate the risk involved in handling these dangerous pathogens, have the three age s agencies fully accepted the gaos recommendations . Yes, sir, thats correct. Could they be implemented in a timely fashion . Im not able to say about the timeliness of these. Im going on their witness statements and testimony. But i have no way to evaluate the amount of energy or time it might take to adopt all of them. Doctor, i would like to have you expand on the importance of gaos recommendations as they relate to safe handling of these pathogens. Dr. Persons, gao recommended these three agencies develop clear and consistent definitions of inactivation for use in their respective guidance documents. Why is that recommendation important, and what will it do to improve safety . Thank you, sir, for the question. It just boils down definitions are important, understanding what these things are in a very scientific pristine way, so you can manage these labs effectively, is central to this. So if you cant identify it or define it, you cant manage it. And mitigate risk against it. Thank you. Can you talk about how the lack of clear definition of inactivation contributes to the issues at both hhs and usda with a uniform definition of inactivation reduce future incidents . I think, sir, it wont guarantee. Theres never a way of reducing all of risk. But i do think that one of the things we found in the report that this would do, coming up with a clear definition is bringing sameness to the language, even within the same institution, much less when you Start Talking about this department or agency interconnecting with that department or agency. I think it will help indeed. You also recommend these three agencies should identify when incidents when incomplete activation occur and i violation reported to help identify the causes of the incompletion and activation to mitigate the risk of future incidents. Why is it important to do that and how does it improve the safety . The Safety Culture that weve seen in parts, we would like to see in the entire enterprise, is the idea of Lessons Learned sharing. So you work through scientifically all of the it depends. Youll hear, it depends on my lab. What you need to do to fundamentally inactivate, there should be some common understanding of that, and some general way of or tool in the toolbox to be able to approach that and achieve the desired outcome. Some of these recommendations, whether its one agency or another, its just a matter of safety from gaos opinion . Thats correct. Were encouraging an increase in improvement of the coordination, the activities toward safety, including a science basis. And greater validation, verification efforts, and more tracking, more documentation. Regarding the issue of increasing scientific information, or inactivation, and viability testing, you recommend that the secretary of the health and Human Services, agriculture, and i quote, coordinate Research Efforts and take actions to help close gaps in the science of inactivation and viable testing. What kinds of resources are required to implement that recommendation and close this knowledge gap . Sir, im not able to say in a quantifiable way what that would take. I believe that would be part of the coordination to identify what the gaps are, and then naturally, of those identify gaps, be able to estimate resources to that and go through the natural process for requesting appropriated authorization of appropriations, and so on. Im not able to speak to it other than that it does need to be done, and more needs to be done according to the agencies, and the Scientific Community itself. Okay. Do you have any sense of how long it might take these three agencies along with other scientists to close these gaps in the science of inactivation . No, sir, i dont have a specific time. Although im sure it will be worked on for years to come. It depends on appropriations, though . Yes, sir. Thank you, mr. Chairman. I thank all the panelists for being here. Especially the gao for working on this. I yield back my time. Gentleman yields back. I just want to make a we have members who will have questions afterwards, too. I also want to make sure we have unanimous consent to put two letters of the fda into the record. Without any objection, well have that. Mr. Collins brought this up briefly. Do you have protocol for the nonselect agents then . When you deactivate those . Whether its tuberculosis, zika, things like that, do you have protocols for deactivation . Does cdc have protocols then . Yes, the review board that i mentioned reviews all protocols for any bsl 3 or 4 agent regardless of whether or not its a select agent, including tuberculosis. The nonselect agents including tuberculosis and others. In dod, you have protocols now for nonselect