simply can't or won't invade or be involved in every country on the planet where these things are occurring but cap as tating the local partners and trying to get other allies immediately impacted by it interested in defeating them militarily is important and we can provide that assistance. we have the world's greatest intelligence. even though it has been diminished the ways i've just described but we can improve the capacity of the countries and we need to spend time in the counter-terrorism of the countries in the training and the right weaponry and strategy they need to effectively defeat these insurgencies/terrorist group and armies. >> pretty well documents, almost every time we buy energy overseas some portion goes to finance terrorism. how do you view energy as a national security issue and what would a rubio energy policy look

like? >> what i don't want people to believe is if we produce all of the oil the countries around the world now benefiting from it will produce less of it. the truth is every day hundreds of thousands of day people join the middle class they buy cars and use airplanes. it has a benefit to the united states. to have domestic energy resources at our disposal, it lowers the cost of doing business in america which will strengthen our economy and allow us to have a manufacturing renaissance but there will be oil and some will be siphoned and used by terrorist groups. isis themselves sell oil in the global market because they have seized refinery that assad has refused to destroy because he hopes to seize them and capture them again. geopolitically it will allow us to help break the strangle hold that putin has on europe.

europe today relies on natural gas that they get from russia and if the russians can threaten to cut that off, it makes them vulnerable to pressure from putin and the russian federation. so in that realm it helps as well. >> we're going to be taking questions from the audience. we have written questions that have come in. jonathan hoffman is on the side, get them to him. one question from the audience today, what is the senate's general opinion of israel's defense capable. what is the senate's general opinion of israel's defense capability. >> they have never asked us to fight a war for them or invad anyone or send ground troops but they've asked if they run out of bullets, to resupply them. that in global forums we stand firmly on thur side and deeply

connected to their security. i have a moral connection that justifies our relationship. israel was created in the aftermath of the holocaust to ensure never again would there not be a homeland for the jewish people to escape persecution and that is a deep moral commitment our country must honor but we must remind ourselves that israel is the only free enterprise proamerican democracy in the middle east. if month looks like israel this conversation would be shorter. so there is one country in the middle east that is proamerican and we should ensure not just that they survive but that they prosper and part of that is to continue to supply and resupply them if they come under assault after they under attack by hezbollah and they were without

supplies for weeks and not turning it over to iran to improve the guidance capabilities of the rockets held by hezbollah. they are aiming to hit anywhere in israel. they are in creasing the guidance capabilities to the rockets become tactical weapons to use to specifically targ places within israel. i think it is important to continue our commitment to the iron dome and david sling and to the other defense mechanisms. but if the world gets in a crisis, israel needs to know we'll help them with money and weapons and intelligence and do whatever it takes to help israel defend itself. >> what are the odds the new deal with iran gets over turned in congress. >> there is no doubt in my mind that the majority of the members of the house in senate will vote against it. the real question is whether we can get 67 senators to vote against it because that is what it will take to override a presidential veto. we need to get 13 or 14 democrats to switch and vote for

us and that is the battle right now. can we convince enough colleagues in the senate this is not good for the future of the country or the world and that is where pressure is important. and august is a critical time. tomorrow we'll have a hearing in the senate and take testimony from experts. but it is important to be engaged in public advocacy and we pressure our senators not to sign on to this deal. they need to know in a couple of years from now and israel comes under assault from hezbollah and the rockets hitting and killing israelis were funded by the money this deal loosened up and made available to the iranian government. they need to know that. >> it is true that the iran deal commits more money from iran than the united states than we have given to israel? >> well i don't know how you measure that other than to say it doesn't provide direct u.s.

aid. [ technical difficulties ] my microphone was hacked by the iranians apparently. but what it does do -- you have all of this iranian money frozen in bank accounts around the world. that money will now be released under the deal. so yes, it provides -- the administration said between $50 billion and $100 billion of cash and that is a significant percentage of the gdp of iran. this is a significant percentage of the over all economy. it is a massive infusion of money that they will use -- i know they will use to do things like sponsor terrorism which they have done. and the second thing we have to understand is it opens the way for businesses to do business in iran which will prop up their coffers. and so we have germans and italy and others chomping at the bit to make deals there and before

they couldn't do any work in the u.s. if you were a deutsche bank and you wanted to do financing to iran you would lose access to the u.s. market place. under this deal, you can't provide lines of credit and capital and the iranians will use that to rebuild their capabilities and the administration insists they will use this to rebuild the economy and take care of domestic concerns. i bet you that isn't what happens. i guarantee you that won't be what happens. i guarantee you it will be used to develop terrorism for proxies around the region. >> what are the three greatest national security threats facing the united states and the person who asked this question has a foot note and please don't say climate change. >> well there are more than three worthy of our attention but the first we are immediately confronting is the threat militarily posed by russia. and again as i said a few

minutes ago, it is a real threat because between the united states and russia we control 90% of the world's nuclear arsenal. and when you have a russian military openly changed their military doctrine since for the first time since the cold war openly contemplate the use of tactical military weapons to defeat a nato assault you've run into a dangerous situation. when you see them taking aggressive moves to test fato you run the risk of miscalculation. vladimir putin is convinced he will test article 5 and push the edge on it and the argument to nato is look if we decide to move on the baltic states, the u.s. isn't going to go to war with us over that. and if he can convince them of that nato becomes a piece of paper and the notion he can do that is a tremendous risk and threat of a hot war starting between russia and the united states and that is a major risk

when you have the two largest nuclear arsenals in the world facing off even in a conventional showdown that could rapidly escalate because we're dealing with a vladimir putin that is more unpredictable and dangerous in his activities than we used to see in the former soviet leaders 35 years ago. the second risk that we face which is very significant is the risk of radical islamic and it spread throughout the world and it poses a new world 21st century risk not totally unlike that of a nation state. it doesn't have a state. they say they have one. they don't have a target or a conventional military force. they pose threats that you understand, not just local fighting forces that take over territory and behead people but people that are inspiring around the world that don't carry an isis membership card but they go online and become inspired to launch attacks against us and

the risk of that continuing to spread around the world is extreme and real. and third, the longer picture the dominant -- 100 years from now and when people look back at the history of our time that shaped the world is the relationship between the united states and china. that will determine much of what the next century looks like. china is a rising power and expanding military capabilities and facing significant head winds but they will continue to grow as a country and the question is how does china's rise balance with america's standing in the world and if you look throughout history a rising power and a status quo power have gone to war and i don't think that will happen but it is posing ral risks already. china has begun to act on the claim that they own the south china sea and building artificial islands and they can claim territory rights that extend out 12 miles and if you put those circles together china

claims they own the most important shipping lane in the world. we cannot allow in the 21st century for any country to dominate an international shipping lane. we don't do that. and much of the success was the free navigation of the seas and i think partly sunny important to challenge the notion and make sure that the chinese understand the costs are higher than any benefits they will take from it. >> and we live in an age where technology is increasing so rapidly and our government is stovepiped and lacks the ability to adapt and respond quick enough so it is almost as if the technology and threats can increasing prebtsly. how does president rubio respond quicker to threats. >> first understanding what you've just outlined. most of the people running for president have no idea what you are talking about when you say that. they might know what happened 18

years ago. but this rattled off some facts that will blow your mind when you think about it. you remember the old economy. think about the new economy. in the new economy, the largest hospitality company air b and b, doesn't own a single hotel room. the largest ground transportation company uber doesn't own a car. amazon doesn't own a single store. that is how much the economy has changed. and let me tell you how fast. it took the telephone 75 years to reach 100 million and it took instagram a year and candy crush reached 100 million users in one year. and the world is changing and faster than it ever has. there is no way the orlando world could possibly deal with these changes not ma mention how fast the changes are moving and one of the most important issues of this election is whether or not we'll elect people to the highest office in the land and to government that understand

this, that understand you can't regulate uber like a taxi cab and treat isis like a threat from the 20thth century and we need to have a government that can rapidly respond to these challenges an think ahead and by the time you are done regulating something it doesn't exist any more. and if you try to overregulate it, you'll cost yourself. so when you talk about the need to turn the page on the past, this is what i'm talking about. we need to elect people that understand the 21st century or the future will leave us behind. >> what is your view of foreign aid. >> i support foreign aid if it is done appropriately. it is less than 1% of the budget so anyone that tells you that foreign aid is the driver of our debt is not telling you the truth. number two there is foreign aid successful and foreign aid that has not been. columbia was a failed state 20 years ago, dominated by narco terrorists and traffickers.

they still face significant challenges but a stable and increasingly prosperous country and the strongest american ally in south america. they are a capable military force that partner closely with us and if you look at special operations they wear the same uniforms and use the same weapons and train the same way as our special operations do. i was in columbia in december and watched them work and the americans that work with them tell you they'll go to war anywhere along same the columbians. they are offering to use the special operations in guatemala in hondureas and el salvador and often offered to help the mexicans and that is how you turn a country about to fail into a strong ally. and here is another one -- south korea. the economy was smaller than the north korean economy.

15 years ago, south korea was still a recipient of foreign aid. today south korea has a developed economy, one of the ten largest in the world and today south korea is a donor, not a recipient of foreign aid and a strong american alley in the asia-pacific region made possible. and we put millions of dollars into haiti and with all of the money we put in there enough progress hasn't been made. we still fund money there and some is still being siphoned off by corrupt officials. and i think foreign aid gives us leverage to change the world. about two weeks ago or a month ago i called the girls count act and here is what it says. if you receive foreign aid you must give little girls birth certificates. i'll tell you why that matters. if they don't have a birth certificate, it makes them a

target to being trafficked to being enslaved and not receiving education. young girls do not exist in the roles of government and therefore it is easy to kidnap them and sell them as a dommic laborer or sex slave. and now we are saying if you have going to receive foreign aid, girls count. i'm proud that we passed that bill and the president signed it and an example of how we are using existing spending to improve the world to enhance our prestige in the world in the eyes of millions of people. >> looking back on your life experiences, what do you believe best prepares you to be commander-in-chief? >> well, it begins, i think, with a clear understanding of what america's role in the world should be. we are not just another country. americans have never been comfortable with the idea we must be the most influential country in the world. most of us would like to focus on issues here at home. tart our businesses raise our

families, go to work retire with dignity. america has no desire to conquer any territory and we don't want to invade and turn anything into the 51st state. for reasons we don't understand, america has been charged with this task of being the most influential nation on earth. the world will always have a more influential country and that will help shape and determine what the world will look like and it is not a coincidence since the end of world war ii democracy and peace has broken out throughout the world. you know why? because the most powerful country in the world was a free enterprise and a peaceful people, that is why the world took that direction. and that is why we didn't have a third world war. so in the 21st century we have a choice. either we remain the most powerful country in the world or we'll be replaced by another country like china that does not respect human rights or rlgs liberties or unfettered access

to information and tells bishops who their bishops or cardinals are or pastors can be. is that who we want to be. a nation that doesn't respect the dignity and the rights of their own people and not to mention others. because if that is it, the world will change and every single one of us will feel the impact of it. so i'm guided by the belief that america isn't just indispensable, it is exception. yes, the world grumbles because america is telling them what to do. but here the truth. when they don't they complain even louder. when we don't lead, they say chaos breaks out because america is not leading. i'm qualified and i know for a fact because the last five years of being engaged on these issues i know what happens when america doesn't lead. what happens is chaos. what happens is violence. what happens is war. what happens is radical jihadists grow and prosper. that is not the world i want to

live in and leave our children. whether i like it or not, this nation is tasked with the role of the leader of the free world and it is not a role we should give up because the world will return to darkness and a world of age and lack of freedoms and that is not the world i want to leave for my children. >> and in the previous question you talked about north korea, south korea, the type of missile kim jong-un looks like the missile of iran's and he's increasing the distance of the -- the range of that. how do you deal with the north korean regime today. >> i don't know in people realize this, north korea possesses a rocket that could hit california. they're not good at aiming. we don't know what they will hit but they will hit something. and that is why japan is developing defense capabilities. probably the fifth best navy in the world. people don't realize. but for the first time in history they can provide

collective self-defense and that means that for years after world war ii japan can only get engaged in a conflict if they were directly attacked. if a missile was launched against the united states they couldn't do anything about it and now they can do something about it and that is a significant force multiplier for us. that will improve our capability to provide anti-missile defenses at the front lines of the conflict right there in asia before it crosses the pacific and not only to figure out a way to get japan and south korea to work closer on some of the issues we'll multiply the capabilities even further and that is the first line of defense to ensure any rocket launched by north korea will be shot down before it hits japan south korea or the united states. >> the president today and the current government of afghanistan and iraq how would you work with them and how would it differ from the current administration. >> first of all we would start this artificial time line of

getting out of afghanistan by a date certain. we need to -- eventually afghanistan needs to be turned over to the afghan people but if we leave too early we'll undo all of the gains made. and there are still significant challenges. in fact we don't know the full brunt of the challenges because if we tell the taliban we're leaving at a date certain they'll just wait. every time we leave a province, the taliban gains influence in that province. so we have to continue to be committed unless we want afghanistan to become the next iraq. iraq is a mess because this president artificially pulled out from an artificial timeline without working harder on a status of forces agreement that allowed us to have a presence there. had we done that there, the government would have been much more stable and the conditions less conducive to what happened. when we pulled out of afghanistan, malachi went after

the sunni. they felt the press by the central government. and so when isis came in they initially greeted isis as liberators from the shiao pressors. they don't feel that way any more but now it is too late they are already there. it is important to work with the alleys to -- allies to work with the christians, kurds shia and if we don't do that, iran will dominate iraq and soon they will have another muppet state. >> we're coming to the end. and i want to thank you on behalf of the peace of prosperity and american security. thank you for coming to south carolina and last question, is there anything that we didn't ask today that you want to tell the people of south carolina? >> um, well you asked a lot of questions so i think we covered -- >> you gave a lot of answers. >> i want to thank you for this. and the most important obligation of the federal government is to provide for our national security. we do a lot of things in the federal government that we like

to do or maybe should do but the one thing we must do is provide for our national security. if a nation is not secure it can not prosper economically and the american dream cannot grow and reach people if this is a nation under threat and duress and the next president of the united states and the leaders who you elect to congress in the senate need to be people that clearly understand this and clearly understand the world as it is not the way we wish it was and understand that american plays a role in the world, that when america fails to lead the world is less prosperous and less stable and peaceful and i hope this election will give us a chance to restore our prestige on the world stage to lead the free people of this planet. >> thank you sir. >> thank you. >> thank you for being here. >> senator rubio and mr. hipp, thank you so much for enlightening conversation on behalf of apps and furman university thank you very much and thank you and have a good

day. >> thank you very much. [ applause ] . c-span is partnering to bring you a forum with republican candidates for president. it takes place on monday evening at 7:00 eastern at st. ann's college in manchester, new hampshire. live coverage on c-span c-span radio and c-span.org. this weekend on the c-span networks politics books and american history. saturday night at 8:00 eastern on c-span, net roots nation hosts a discussion on illegal immigrants and the enforcement of the arizona immigration laws. and new jersey governor and candidate chris christie on national security. he speaks at the university of new hampshire at manchester. on c-span 2 saturday night at 10:00 eastern on book tv's afterwards, michael tanner talks about the growing national debt

and looks at entitlement as a solution. and on saturday, glenn beckon extremism. and on c-span 3 sunday morning at 10:00 a.m. eastern we commemorate the lyndon johnson signing of the 1965 voting rights act. it includes phone conversation between johnson and his aids and dr. martin luther king and strategy on how to enact and enforce the law. and lbj's 1965 speech at the capitol and the signing of the bill. also this weekend saturday night at 7:10 university of california at berkeley history professor brian delay looks at the history of gun production in europe and how arms traded contributed to an american victory during the revolution. get a complete schedule at c-span.org. the defense department recently admitted that a u.s. army lab accidentally shipped live anthrax to 192 facilities

in all 50 states and seven foreign countries. officials from the defense department testified at a house committee hearing. tim murphy chairs this two-hour hearing. >> good morning. welcome to our hearing once again dealing with anthrax. the sub-committee today examines continuing concerns over the forward select agent program. this time our focus is on shipment of live anthrax from a defense laboratory that occurred over a ten year period. and as yogi berra said, it is like deja vu all over again. last year we held a similar hearing on a cdc anthrax incident that potentially exposed searchers to live anthrax due to the fact that

established safety procedures were not followed. during the hearing, the director frieden testified we'll take every step possible to prevent any future incident that could put our laboratory scientists and the public at risk and yet here we are again today. and we mistaked the avian flu and the discovery of smallpox in the nih building months after a hearing and the white house ordered a safety stand down and sweep of all federal labs, the sds revealed there was a transfer of ebola from a level four lab to a level two lab. this is all deeply troubling. and despite the growing number of red flags the incidents keep happening. so now we are learned that the dogway proving grounds in utah has shipped anthrax to facilities across the globe. at last count 192 labs had received shipments of live anthrax. apparently the process toin activate anthrax spores was not

effective and the sterility testing to make sure they were inactivated failed to detect the live anthrax spores. what is more troubling is dougway used this potentially deadly process for years. as i said before this is completely unacceptable. this is threatening our nation security and public health. the committee hopes to learn what is being done this time to prevent future safety lapses and will this be any different. last week the department of defense released a report and according to the report the d.o.d. was unable to definitively determine the root causes for how and why dougway shipped live anthrax, yet in the report the department acknowledged that all of the labs routinely operate outside of the validated experimental data for kill curves, unquote.

so in other words it seems that at the department of defense there are larger numbers of spores than recommended an the labs could know they could not guarantee an activation at those numbers especially at the dosage of radiation given. the revelation begs questions beginning with why and why for so long. who was smonl for making the decisions about whichin activation process to use, including how many spores and what level of radiation and are the decisions ever valuations and re-evaluated and what is the sds role in developing these processes. and according to a recent and all too familiar headline sds has announced it is conducting another review of how it regulated safety and security at bio terror labs. i think it is important to improve processes and procedures but past reviews had not brought about the change necessary to truly improve safety and standardized processes and

procedures maybe, we hope this review will bring about different results. as i said a year ago what we have here is a pattern of recurring issues of complacency and a lax culture of lacency. last year director frieden stated this was a wake-up call but critical government agencies have hit the snooze put on again. none of us want to be here again to discuss another safety lapse and heaven for bid a loss of life. we have work on the labs and gee yo has been calling for strategy for high containment labs and the need for national safety standards for maintaining such labs yet the recommendations have not been implemented which is run of the reasons we're here again today discussing another safety lapse that threatens national security and the public

health. today i would like to thank the witnesses for testifying here today. i look forward to hearing your testimony and learning from you. please be candid and straightforward with us as we try to find ways to improve the safety and procedures in our bioterrorism laps. this sub-committee will not relent on the over site of federal laboratories compliance with select agent regulations and further explore the possibility of an in deposit agency to oversee these labs. i now recognize miss deget of colorado for five minutes. >> thank you mr. chairman. mr. chairman i saw you don't want to be back here in a year, but we've been here in 2007, 2009, 2014 and now 2014 and might as well mark your calendar now. and part of that is because it is really important that the federal government work on identifying and maintaining public health risks. but the work itself inherently contains risks and that is why we do have to continue our over

sight. at last year's hearing on the anthrax transfer, i talked about the high containment lab that we have in ft. collins which some years ago we identified terrible lapses and i was able to work with my former republican colleague bob schaefer from that district to get a new lab belt. i'm proud of that work. but we have to continue to be able to assure our constituents that similar facilities across the country provide no risk tor workers or to the broader community. now mr. chairman, as you said, frankly, the details of the dougway incident do not inspire confidence. we're talking about a long-term series of in add vertent shipments of live anthrax from the dougway proving ground in utah which is supposedly one of the most sophisticated facilities in the world. this only came to light in may because a private company

contacted cdc after discovering what it thought was an activated anthrax was actually live anthrax. since then, we've learned that 86 laboratories in 20 states and the district of columbia and seven foreign countries received live anthrax spores from dougway over the last 12 years. the labs then transferred the live spores to an additional 106 labs. so we're talking about almost 200 labs in all 50 states accidentally receiving live anthrax for over a decade. miraculously, nobody seems to have fallen ill as a result of this series of incidents. still, like you, mr. chairman, i'm concerned that this activity was going on for so long before one lab finally raised questions that spurred the department to action. i'm eager to hear answers from d.o.d. how this was allowed to happen in the first place, and what they are doing to ensure it never happens again. i understand that the

department's review of the dougway incident released last week found insufficient scientific literature for thein activation of anthrax spores. the dougway lab was relying on procedures that did not permanently or completely sterilize the anthrax spores. now this is not my area of expertise but it seems troubling on its face. how have we conducted research on this dangerous pathogen for the past decade without thoroughly understanding how to inactivate it? we need to conduct a serious examination of whether we use similarly questionable protocols for other select agencies and if so i think we can all agree we should immediately cease those operations to make sure we are not putting public health at risk. for now appropriately d.o.d. has issued a moratorium on issuing anthrax from its labs.

this seems like an important first step. but i do want to know how that effects the research the lab was doing. furthermore, i want clarification as to how do we have 200 separate labs all across the country working with anthrax? do we need to have 200 labs working with anthrax or is it possible that we could limit the number of labs and therefore limit the risk while still doing this important research. i also want to hear today about whether the breakdowns at dougway are indicative of broader problems at this site or across the high containment lab system. the labs that handle these pathogens must be held to the highest standards yet the incidents that we've seen recently raise questions about whether we can trust high containment labs to safely handle select agents. in the last year we've seen an anthrax exposure incident at cdc, this is what you said, improper shipments of avian flu

and even a potential ebola exposure at a cdc lab. i feel really lucky that we haven't had anybody infected. but it could happen. and i think we're just going on borrowed time here. so i hope all of you have answers today about what we're really doing to make serious changes to the system and include the recommendations that gao has made. i also want to hear from our witnesses about the role congress should play in making sure that the program operates safely and with that, mr. chairman, i yield back. thank you. >> thank you. does anybody else on this side wish to make an opening statement or comments? if not, i would ask -- and i don't know if you've seen this yet, the cdc -- an article appeared last night in usa today and i would like you to look at it and see if there is unanimous consent to the record. this is titled cdc lab reporting policy despite scrutiny and

reporting problems and i think it is relevant to today's hearing and i recognize mr. palone for five minutes. >> i help we can find out what happened today in dougway that resulted in live anthrax submitted to 192 labs in all 50 states and five foreign countries. robert work described these as a massive institutional failure. i hope dr. hassell can explain how the failures could have occurred as well as what d.o.d. is doing to strengthen and standardize protocols across all labs as we move forward. i'm deeply relieved no one has fallen ill as a result of the lapses and i hope this is the case as d.o.d. and cdc continue to track the labs that receive the samples an the personnel that handle them but this incident raises broader questions about the safety of high containment laboratories across the country. every day hundreds of labs in the federal government and

academy and institutions handle pathogens and toxins. make no mistake the labs perform important work. they conduct research to improve our defenses against biological attacks and strengthening our public health response capabilities. laboratories are required to follow a set of risks the agents pose. they are required to select individuals who have undergone a risk security agent by the fbi and implement lab safety measures and incident response plans. they must also ensure that laboratory workers are properly trained on bio safety and security measures. labs that participate are also subject to registration and inspections by the cdc division of select agents and toxins. there are civil penalties associated with lapses in safety

protocols, unauthorized use of agents is subject to severe criminal penalties however incidences involving anthrax and ebola and avian flu raise questions about whether we need to strengthen our over site of labs working with dangerous pathogens. is the current regulatory framework sufficient. do the enforcement agencies have sufficient resources to ensure that over site is robust. what is cdc doing to improve the federal select agent program and provent similar situations from occurring in the future? i understand that cdc and d.o.d. have conducted reviews of the incidents and promise efrl more. i look forward to hearing about the findings and recommendations from the reviews an how they can be used to enhance safety and security at all of the nation's high containment laboratories. and the gao has an important body of work that can inform this discussion. i look forward to hearing from

gao about the recommendations to strengthen safety measures across high containment labs. i'm glad nobody appears to have suffered any injuries because of the latest incident out of dougway, but next time the mishap may be something more dangerous such as a highly infectious pathogen so i hope we can learn from this latest incident and can take seriously the recommendations made by recent and ongoing incident by gao and others to make this program safer. obviously we look forward to a productive discussion on how we can improve over sight and what the committee can do to facilitate that process. and again thank our chairman and ranking member as we proceed. i yield back. >> the gentleman yields back. and then with no further comments from the -- then we'll go to our witnesses. so as you are aware the committee is holding an investigative hearing has the practice of taking testimony

under oath. do any of the witnesses have any objections of testifying under oath? seeing no objections the chair advises you under the rules of the house and the committee you are entitled to be advised by counsel. do you want to be advised by counsel today? in that case. please rise and i will swear you in. do you all swear the testimony you are about to give will be the truth the whole truth and nothing but the truth. all of the witnesses have answered in the affirmative and now you are under oath and subject to the penalties set forth in title 18 section 1001 of the united states code. you may now each give a five minute summary. please pay attention to the lights there. we'll start with you dr. hassell. five minutes. >> thank you, chairman murphy, ranking member -- thank you and distinguish members of the sub-committee, i appreciate the

opportunity to brief you on the department of defense inadvertent of samples containing live spores or anthrax. my name is david hassell i'm the deposit assistant deputy of defense for biological defense. this is an important standard to develop ways to protect war fighters an the public from known biological threats. doing this with a development of testing of detection and protection equipment diagnostics and decontamination capabilities. we first learned of the incidents under consideration today on may 22nd of 2015 when the centers for disease control and prevention was alerted by a private company regarding the live of anthrax in a sample activated at the dougway proving ground in utah. the cdc immediately began an investigation working with d.o.d. laboratories state officials and the fbi. by may 25th all known laboratories that received

anthrax samples from the same batch had been notified and instructed to stop working with the samples. also on may 25th the four d.o.d. laboratories that produced an activated anthrax were directed to stop producing and shipping and working with any activated anthrax other than for purposed related to this current matter. subsequent tests by dougway identified other batches of in activated anthrax as containing live spores and on june 2nd they noted all recipients to stop working with the material, whether it was confirmed to contain live anthrax or not. there is no known or suspected case of anthrax infection among workers at any of the laboratories that produced or received inactivated anthrax and no known risk to the general house and very little risk to the laboratory workers themselves however as a precaution # 31 u.s. citizen and

8 nond.o.d. were paced on treatment and this was completed yesterday. now returning to the subject of the four d.o.d. laboratories on may 29th the deputy secretary of defense directed those four d.o.d. laboratories test all previous anthrax in their inventory to identify the presence of any live spores. that testing is now complete and the results as are follows -- since 2003 the four laboratories had a total of 149 batches of live anthrax spores. of the 96 samples available to test 17 tested positive for the presence of live anthrax. all of these originated from dougway. we now know over the past 12 years 86 laboratories in 20 states, d.c. and seven foreign countries received directly from doug way inactivated samples that contained live spores. in addition the cdc informed us

an additional 106 labs received secondary transfers from some of the original 86 direct recipient labs. this brings the total to 192 laps in all 50 states, d.c. and the three trts of guam, puerto rico and the u.s. virgin islands. the root causes of the incident vulted -- resulted in key findings including that the systemic issue is the lack of validated standards to guide the development of protocols processes and quality assurance measures and the resulting recommendations are grouped in three broad categories being enhanced quality control programs, establish testing protocols based on relevant scientific data and improve program management. the department is committed to ensuring this doesn't happen again and we'll implement the recommendations in the report and further outlined by deputy

work in june. our top priority is the safety of all involve and we remain committed to complete transparency of information as we go forward. thank you for the opportunity to testify today and i'll welcome your questions. >> thank you dr. hassell. dr. sosin, before you speak, i want to note, we haven't had a chance to review your testimony because it wasn't in until 9:00 last night and the committee rules, we ask for 48 hours so we didn't have time to review that. so when we get testimony at the last minute it is difficult for us to review it and i don't want to think that the cdc is trying to fuft rate our purposes here but i do want to indicate to you and if you could pass the word on to cdc that for future testimony, we want that 48 hour limit adhered to. so at this point we'd like to hear from you for five minutes. thank you. >> thank you. chairman murphy, ranking member degget and distinguish members of the sub-committee, thank you for this opportunity to testify

before you today. would you like to share with you what cdc has done to respond to the inadvertent release of live anthrax spores from dougway proving ground and to provide perspective on the select agent program that cdc supports. cdc works 24/7 to save lives and protect people. we activated our emergency operation center in face of uncertainty about the scope and severity of this release. we understand how concerning this incident has been and our primary focus continues to be making certain people are safe and the anthrax materials are secured and ultimately disposed of. this incident raises serious and challenging issues. it is important to note however, that scientific research in laboratories is a vital component in the nation's defense against naturally occurring diseases and bioterrorism. this research is complex and sometimes dangerous. while it is not possible to eliminate all risk, those of us

working in this field across the country and around the world must do all we can to minimize risk. here is what we know today about the dougway incident. there have been no suspected or confirmed cases of anthrax infection associated with the samples. persons at cdc assessed some risk and accepted treatment will have completed abt biekt and prophylactics yesterday. the facilities have destroyed them and those needing decontamination have the procedures or are well under way. highlighting this positive not meant to down play the seriousness of the situation. on multiple occasions over more than a dpek aid, the production methods at dougway failed to inactivate anthrax spores. growth was being detected on

multiple production runs. these runs were sent back for multiple irradiation. this should have been seen for what it was. an indication that the measure of safety was not sufficient. he they they failed to detect live spores. we have looked and found no evidence of a similar problem at other facilities that inactivate anthrax spores. the existing rules are under review. here's what we don't know. the federal select agent program relies primarily on sterility testing. we remain unsure whether there was a problem with the execution of this testing at dougway or if the biology of spores was not sufficiently understood to make the procedure reliable. and here's what we are doing moving forward. we are maintaining a moratorium on the use and transfer of inactivated anthrax spores until

we have an acceptable and credible approach to increasing safety and security, and we are developing a research agenda on spore biology and we will help to conduct some of that research. at dr. freeden's direction we are directing a review. the review will compliment ongoing work to improve laboratory safety at cdc this past year. the time is ripe with new leadership over the cdc select agent program for a thorough review of our program to ensure it's meeting its mandates, especially in light of recent lab inch dechbtss. the world benefits from work with dangerous pathogens. and they also have a commitment to protecting health and safety. we must achieve a balance to protect workers while encouraging scientific advancement, but safety comes

first. one characteristic is a commitment to improvement. the regulation have been refined with vice advice from many. incident reporting, coordination of inspections with federal partners and tracking shipments of select agents are some suggestions. where improvements requestcan be made to better the program we will make them. whether there is disagreement on the best path forward we will contribute to the debate. we will work diligently and thoughtfully with anyone sharing or commitment to protect americans from biologyical

threats. >> good morning chairman murphy members of the sub committee. i'm greg demske. appreciate the opportunity to appear before you today to discuss the federal select agent program. while cdc administers the select agent program with the department of agriculture, oig is authorized to yes, ma'am pose civil money penalties for violations of the regulations. we also audit, evaluate and offer suggestions for program improvement. cdc reviews all potential violations and immediately refers urgent or criminal matters to the fbi. in other matters, cdc further investigates and determines whether to exercise its authority to suspend or revoke regge administration or require remedial actions. if cdc concludes a civil violation may have occurred it

refers the case to oig for potential enforcement. oig carefully evaluates every referral and carefully decides whether to pursue the case and what penalty to seek based on the facts and circumstances of the particular case. in our experience violations pose varying risks to public health and safety. to date, oig has imposed $2.4 million for select agent violations. two of our cases have involved dougway. in april 2007 dougway shipped anthank rrax to a research facility. the research facility tested the material and found the presence of a low concentration of viable anthrax. we found that dougway ignored the results of its post inact administration viability test, which showed viable anthrax was present of the later in november 2010, a government laboratory received a shipment from dougway

that included a vial of bot u lie number. dougway reported two shipments of this achlgt as a federal entity, dougway presents an enforcement challenge for oig. any cnp on a federal agency would shift money in the government at a met cost to taxpayers and may not provoke betster compliance. both letters to dougway said that oig determined that dougway violated the regulations and that it should evaluate its

actions and take safeguards. yesterday oig received another referral from cdc on dougway, we are reviewing the matter now. over the years, oig has audited agents for compliance. oig provided audit results to the heads of relevant agencies putting them on notice of deficiencies. oig is expanding our management. we will focus on cdc's oversight and on the operation of hhs laboratories that handle select agents. through our enforcement work, oig has also identified several tientss to improve program compliance, oversight and enforcement. as reflected in my written testimony, these opportunities focus on enhanced documentation requirements and increased authority for cdc inspectors. we stand ready to work with cdc and others in hhs to continue to

to improve the select agent program and use our enforcement tools to promote the compliance to protect the safety and health of the american people. thank you for the opportunity to speak. i'll be happy to answer questions. >> dr. crosse? >> i'm pleased to be here today to cuss gao's work. the biosafety and biosecurity practices in these laboratories are intended to reduce the exposure to biological agents and prevent their loss, theft, or misuse. the recent shipments of live anthrax bacteria from dod to u.s. and international laboratories, similar to last year's potential exposures of cdc personnel to live anthrax bacteria shows multiple brake downs in compliance with established policies and inadequate oversight of high

containment laboratories. this is another example in an ongoing series of safety lapses which continue to occur often with the same root cause as for prior incidents. we've been lucky so far. researchers in these labs work with high-risk biological agents that may result in serious or lethal infections, and in some instances have the potential to be used in biological weapons. these labs do important work with pathogens to develop vaccines and countermeasures and to understand emerging infectious diseases. however, the pathogens handled by these laboratories also have the potential for high-consequence accidents. if this were to have occurred with high contagious element, we

could have had consequences far beyond what we've seen today. gao is conducting work with this committee to examine these issues. and our preliminary findings show that dod and cdc have begun to address weaknesses in their laboratories but have not yet fully activated these activities. the steps they are taking are intended to address fundamental flaws in the oversight structure, reporting and tracking of biosafety and biosecurity incidents after they have kurdoccurred. for example, they said that the dougway accident is the first that they have tracked at the senior department level. since 2012 dod has been revising procedures and expects to finalize changes by this fall. but these changes will only cover a subset of dod's high containment laboratories.

our ongoing work will also examine if dod is implementing steps to improve the culture of state of at its laboratories so that future events are reduced or prevented. similarly, cdc began taking steps to address weaknesses identified in assessments of the june 2014 anthrax incident and other safety incidents in its own laboratories. but the agency has not yet completed implementing recommendations intended to improve its laboratory oversight. for example, an internal work group recommended that cdc develop agency-wide policies to provide clear and consistent requirements for biosafety for all agency laboratories. in response, cdc developed a specimen transport policy but has not developed other agency-wide policies such as requirements for laboratory documentation and emergency protocols. as i stated at the outset the incidents you are examining today are part of a long series of safety lapses.

since 2007 gao has reported on these issues and has made multiple recommendations to improve federal oversight of high-containment laboratories. the federal departments agreed with our recommendations and have conducted some activities to respond but have not implemented our key recommendation, to establish a single federal entity with responsibility for oversight of all high-containment laboratories. we recommended the establishment of a single federal entity to, one, conduct government-wide strategic planning for requirements for high-containment lab ro-torys, including assessments of their risks. and two develop national standards for designing constructing, commissioning, operating and maintaining such laboratories. we continue to believe that such an entity or some other mechanism to ensure higher level oversight is needed in the face of the continuing proliferation of high-containment laboratories

and the ongoing failures by agencies to fiction their problem -- fix their problems on their own. in closing, they are supposed to have multiple levels of control, including cross-checks inspections, training, procedures and validated protocols that should prevent such accidents from occurring and certainly should prevent such incidents from recurring. this completes my remarks. i would be happy to answer questions you or other members of the sub committee may have. >> thank you, doctor. i now recognize myself for five minutes of questioning of the witnesses. and dr. sosin, you said we will work diligently with our partners and anyone sharing our commitment to protect americans from biological threats. please let the cdc know i don't believe them any mofrmt the usa today article i referenced earlier said that the cdc

actually refused to the provide a policy to usa today regarding the lab reports in the newly recorded lab safety office. when was that report written do you have any idea? >> thank you chairman. i was asked to appear here today, and i apologize for the lateness of the testimony. i apologize that -- >> but do you know anything about this report that they're referring to in "usa today"? >> i know an article came out last night. i do not know about that report. i'd be happy to assure ha after this hearing we provide you answers to -- >> this committee would like to know when that was written. if we could have that that would be valuable. thank you. doctor, i'm trying to dumb this down. if i put a cup of coffee in a microwave oven and turn it on it gets hot in a certain amount of time. if i put a dozen cups of coffee in the microwave at the same

amount of time they're not going to all be heated. we know that because of mass and principles. this is on the graph here as well is that on the screen, that on the very upper left dot where it says the dougway irradiation levels here is saying it's operating way out of the realm of the acceptable process here. and it, the report states that dod routinely operates outside of data for kill curves. based upon that finding it sounds like validated ex-trim nal data does exist for those operating outside of it, is that correct? ? >> yes, sir. >> are the protocols reevaluated review fine-- routinely?

>> that's something we looking at. to make sure people were following the protocols they had, to show that there was no willful disregard. >> it was not willful. but what the graph shows that they were working outside of that gray box that kind of shows the experimental parameters that should are been the should have been the foundation for this work. how is that decision made to move outside of that realm. and if you noted it wasn't just dougway, all of the labs were outside of that area. >> somebody did make the decision. and we need to know because we like to think that there's a scientific rule set up that they're pollfollowing and that all the labs are following that too. let me ask, in response to these most recent shipments of live anthrax, have any of your

agencies made any personnel changes or referred anyone for prosecutions for these actions? have either one of your agencies done that? >> so like for dod, that is the second part of the investigation that will kick off now, looking at the accountability issue to determine that. and if i may, one of the issues is not only the individual that made that decision, if that was an individual that made that decision but what was the process? was there an overall systemic process that led people to perhaps gradually get out of that experimental box. the accountability is taken very seriously. >> i'd like to ak knowledge that we understand your concern and take it seriously. no disciplinary actions have been taken at cdc with respect to the sample incident. in fact, staff responded in a remarkable way to ensure that all these samples were secured and destroyed and that the people that might have been exposed were protected.

regarding the select agent program, we continue to consider and take advice and input on how to change the mature of the program -- >> do you work with dod? does cdc work with other labs in setting and reviewing standards on any regular basis or at all? >> cdc works with dod in a variety of ways. >> the reason is this, when we had our hearings for general motors, and somebody made the decision of making a spring this big or a spring this big and it cost a number of lives and they referred to it as the gm shrug. i have the highest respect for them. when things begin to slip out, i agree, we're not looking at something nefarious or deliberate here. but as mr. plum pointed out. luckily no one has died from this. but we really have dodged the

bullet for a long time. >> now dr. crosse you testified in your testimony about how people could be infected and even some kind of epidemic could be started if you got a particularly vir length agent that got released correct? >> correct. >> in addition we have national security implications relating to the mishandling of these agents, is that right? >> that's also a concern. >> and that's if these active agents got into the wrong hands, that's right? >> that's right. >> you have a lot of recommendations that have not been fully implemented yet, right? >> many of the recommendations they have taken an at least some actions the primary one where there has been no movement is to have some type of more centralized oversight. >> to have a single federal entity that could set the standards for all of the labs or

for all the agencies, is that right? >> that's right. >> now dr. hassell, what's your agency's opinion about that idea of a single government entity? >> it makes sense in many ways. we're going to do that in the department itself. >> if it makes sense in many ways, why haven't we done that? why haven't you guys implemented that in cooperation with your fellow agencies. >> we are going to do that internally, and we're in discussions now on these issues. >> but you don't disagree with the idea? >> no, ma'am. >> what about you, dr. sosin? what's your agency's view of this? >> the cdc works with afis as if we are one program. we work very closely. we do joint inspections on overlap agents whenever a change is considered or proposed it's discussed with the other program. >> that's nice, but what about dod?

>> so the oversight function of the lab i'm trying to understand your question i believe it's about the oversight function, correct correct? >> what dr. crosse's agency is recommending is one single oversight agency that would set forth the protocols for the dispensing of these agents. and so i'm asking each of your agencies if you would object to that kind of -- it would make sense to me to get one protocol no matter which lab is dispensing it or whatever. what's your view on that? >> thank you. my view is that it's a complex decision, that there are constraints to having one standard for all procedures. >> what constraints would those be in. >> for example with anthrax there are many different uses of the products. dna, preps, for developing vaccine. >> in any case if you're sending it around you don't want it to be live. >> that's absolutely. >> that's not something that's subject to debate. so if you could have one agency that could come up with the

protocols about oversight on how you're going to make that not, not be live and how you're going to dispense it you wouldn't object to that, would you. >> wouldn't object and we believe that the select agent program would be the appropriate body to do that. >> okay, could that have oversight over the dod too? >> absolutely. >> so do you think that you might cooperate to make that happen? >> we will cooperate in any way. >> let us know what we can do to help you. because it seems to me that's an excellent recommendation. and you're nodding dr. hassell. can you work request dr. sosin and his colleagues? >> yes. we stated in our statement we would work together. >> here's something else, having been on this committee for a long time, i've noticed is that all the federal labs, not just the ones dealing with anthrax and other select agents but also our nuclear labs have the same problem of a culture of

safety. and we we really have struggled in this committee to get people to understand how important it is to have a culture of safety. so dr. hassell, can you think of anything we can do to systemize some kind of culture of safety? >> that's a question i have myself. ma'am. i spent ten years at the dupont company which goes back 200 years making gunpowder for thomas jefferson and that safety culture is there. so one of the things i plan to do is to go out and see those industry best practices for doing this. >> how long have you been there? >> at the -- >> at dod. >> just at a year today. >> and dr. sosin do you have some ideas about how we could increase the culture of safety at these labs? >> i personally do not. i know that the cd c+c dc's director takes this very seriously. >> i think we need you guys to supplement your testimony about

this. i have one other question. i don't have time, but i'd like a written answer for this. i'd like to know why all of the problems in this particular incident seem to have come out of this one lab. was it a problem with how they were handling this anthrax, how they were trying to treat it or is it a problem with the procedure itself? maybe it's what you're investigating now, but that seems to be the krufx the problem. thank you, mr. chairman. >> the chair would recognize mr. mckinley for five minutes. >> thank you, mr. chairman. this is a subject i acknowledge is foreign to me. so i was delighted to try to hear and learn from some of your testimony on this, but i'm just curious before i get a list of six questions. i'm trying to go back to the fundamental. why would we ship an inactive

cells to laboratories? what would you gain by shipping something that's dead? >> maybe -- so one of the aspects of this inactivated anthrax is that it maintains the shell that is around the original live spore the physical structure is still there. that's important, because that's the basis for the detection systems and the diagnostic systems that are developed. so the closer we can get to that, the better we are. >> that helps a little bit. let's go back to something that the gentle lady from colorado mentioned earlier that i didn't pick up in the reading that we're doing this in 200 laboratories around the country? is that an accurate statement? we're studying that in 200 laboratoryies laboratories? we have live anthrax in 200

laboratories? >> the statement was there were 192 labs that received this material were not intended to receive live anthrax. there are 181 registered entities within the federal select agent program registered to possess, use, or transfer. >> apparently there's some -- i really struggle with that to understand why we have to have 300 or2 200 especially looking at the circumstances of this. dr. crosse, how would you grade the dod's handling of this matter? would you give them an a? an f? give me. >> since the incident was reported, they have moved pretty quickly to identify where the samples were sent, although that was still developing over the last few days. and, and -- >> how would you grade it? would you grade it passing?

acceptable? a b? a c? >> i think their response, once it was discovered, has been probably a b. i think they, the activities leading up to it and the fact that this went on for so long is definitely a failure. >> it's been going on for ten years? >> yes. that's a failure and the fact that they have four different laboratories inactivating anthrax with four different methods and four different chains of command that don't talk to one another. >> to go back to dr. hassell. since anthrax is probably the most dangerous agent that we could handle, i suppose it's more dangerous than ebola but is getting it, getting that is probably the biggest threat that we have in national security, that someone doesn't get this agent. so in this case, is anyone tried, has anyone tried to grow this live anthrax after they've

received these products? with 200 laboratories? have they tried to reactivate it? >> it was grown to show the presence of the live spores. i may not understand your question, i apologize. >> i only have one minute left, so is this the same type of anthrax that was used in 2001? >> it's, this is absolutely not the same type of anthrax used in 2001. this is a wild type anthrax. it was in a liquid formulation with extremely small numbers of spores in a 1 ml sample. very different situation. nonetheless, taken very seriously. >> so this is different. do you feel that our national security is more at risk because of the process that we've been handling this for the past ten years? >> the cdc -- >> it's a yes or no.

>> follow up. i don't believe that these samples created such a risk. i believe that they were secured quickly and destroyed. that they're very small numbers in this material and it's a naturally occurring anthrax. >> let me ask, my thought process initially when why were we shipping this to seven foreign nations? was there a, does someone have a written authorization? is there one of those proverbial e-mails? and who authorizes the shipment of that in and under what process? do they explain why they want to get? why would we ship to seven foreign nations? >> in several instances those were dod locations. in other cases they were allies. >> we don't have enough dod

facilities here that we have to go overseas? i'm running out of time. >> i recognize mr. green for seven minutes. >> unfortunately the incident that led to today's hearing is not the first about handling and shimming of bioagents at dougway. cdc and the office of the inspector general investigated safety lapses in 2007. is that correct? dr. hassell? >> yes, sir. >> based on the previous problem, should dougway have made a better evident of effortver -- effort to check its procedures? >> we can report back. >> similarly, when cdc announced last year that it had inadd ver tently transferred live anthrax, did dod direct its lab to check

their own processes to ensure that anthrax was inactivated properly? >> no, sir. >> why not? >> i'm not sure. that's a good question. we're going back and trying to figure out what were the steps leading to this. >> again i think the reason for the hearing is it seems kind of strange that, you know, cdc made a mistake, and we had a problem with the dod facility, and somebody in management authority didn't say let's check to make sure dod is doing it right because what happened at cdc, technically because particularly because of the problem at dougway. nobody decided to do that? >> it doesn't appear so, sir. >> yobts r beyondbeyond the particulars it raises serious questions of select agent handling. based on the continued problems at dougway, what assurance can

you give the sub committee that there's no longstanding safety problems at dougway or other dod facilities that handle high-risk biological agents? >> that's a good question. we're trying to look and see if there are general lessons we can learn from this and ask the questions such as your previous question, are there indicators here that indicate we need to be asking questions about other operations across the whole complex. >> what is dod doing to look across all of its facilities and check their biosafety and biosecurity procedures and policies are adequate. >> we're taking an effort now to look at the chain of command. we're trying to tighten that up. we want to make sure that the standards for the inactivated anthrax, we will ensure that that's standardized across all of the laboratories and use that as a basis and see if there are other place we need to take

actions on. dougway's largely a production facility. the others are more research facilities. so one size may not fit all. but there's definite lessonsque we can learn from this. and whenever possible we will standardize. >> how about concerns about miscommunication to from the laboratories to the senior leadership? >> some recommendations have been made, we're going to be more vigorous. the dod instruction that was mentioned earlier that will include aspects that will bring all of the reporting forward to a higher level. for example the 2007 incident, if that were to happen today, that wouldn't just remain at dougway or the immediate command. it would come all the way up to a central office within the department. we're in the process now of pulling in all of the inspector general reports cdc reports

from all of the laboratories up to my office and reviewing all of those to see if there's indicators and lessons to be learned. >> following my colleague from west virginia. so far we've been extremely fortunate, these incidents at dougway have not led to broader public health or security problems, and i hope today's hearing and other ongoing incident of this serves as a call to action to tighten up these processes, not just for anthrax and at dougway but other select agents and all facilities. we don't want to have to have somebody here again, or i hope the armed service committee is also looking at it and seeing that the issues are being corrected. mr. chairman, i yield back my time. >> i'll recognize dr. burgess for five minutes. >> thanks mr. chairman. thanks to our witnesses for being here today. dr. sosin, let heme ask you a few questions about what we're doing

to harden our infrastructure in these locations where it may be under study. appreciate what ranking member degette has stated earlier. i've been on this committee for years and it seems like there's recurrent theme here. we want everything to be perfect. but there are human beings involved and sometimes they aren't perfect. i was a regular guy when the anthrax attacks happened in 2001. i remember reading in horror what happened when those individuals were infected and died reading about the emergency room doctors' experience, here was a guy who didn't look that sick. and as we found out you can be a lot sicker than what you look and by the time clinical deterioration begins you're almost too late on the curve to rescue someone although rescue is possible if you start early. because unlike ebola, anthrax is

treatable with relatively common antibiotics. so bearing in mind that ebola experience from not quite a year ago, cdc was telling us last july, august, september, we got everybody up to speed on ebola. we don't have to worry about ebola coming to this country. the president made a statement, we don't have to worry about ebola getting to this country because cdc's done everything to get everybody prepared. and then it didn't happen. this is not quite the same thing. but you know you have sites where this is under study. you know lapses can occur. so do you have like a 35 or 50 mile radius around these sites where you are at least notifying the people on the front lines, the emergency rooms, the emergency room doctors that this is something we're working on in your community? >> thank you. thank you for that question. first, with respect to hardening infrastructure yes, there are

support programs at the state and local level to address anthrax and other bioterrorism threats, as you pointed out there are not only the routine treatments. there are some advanced counter medical measures that have been developed such as anti-toxin to help treat later stages of anthrax and vaccine. those were brought to bear the anthrax and vaccine brought to bear in ibuprofen laxis in this incident. the local, the state authorities are informed of the institutions and their jurisdiction and the agents that are there as part of their public health preparedness programs. there is no active outreache reach into the medical community. but we are quick so respond as we did in this instance with information about how to diagnose, how to watch for monitor and how to treat. >> let me just interrunts you, could you provide the committee

those materials that you provided? >> absolutely. >> to the emergency rooms and what radius around where the breach occurred, what the geographic radius was in. >> i will say that these materials were not sent to emergency departments, although we did consider it. we monitoring the workers in the laboratories. >> that's point. if these people thought they were getting inactivated rains, strains and they were active. somebody's got a low-grade fever and they don't feel now. and they go down to the care now facility. again, they'll look well until they get deathly ill. that's the problem. >> that's why these were isolated to laboratories, and we working with the laboratories and health departments to monitor them. >> forgive me if i'm unmollified. but the problem is you didn't know what you didn't know at that point. and certainly the people in the

community who may have been the doctors and nurses and caregivers who were seeing patients wouldn't have known that this was what they were up against. i guess my concern is how do we get that information out there, how do we make people aware. once you know that anthrax is a consideration, okay. fair enough. but before you know it, it looked like the last 1500 patients that have come through the door with a viral syndrome. i do have a question i need to ask mr. demske, and we don't have time to get through all of it. maybe you can provide me an answer in writing. but when you look at the referrals for valuations of the federal select agent program, united states army institute of infectious diseases seemed to be in the top three. so you have an enforcement policy where you can actually find but you don't fine federal agencies, is that correct?

>> to date we have not fined any of agencies. >> that's what willie sutton says, you rob banks, because that's where the money is. for now, the viesolateors seem to be coming from those three groups. can you get back to me and discuss what you are doing to providing the penalties that any other lab in the country would have to face if they had a breach of these agents? >> yes to be clear most of the referrals and most of the labs or incidents that have been referred to us have not involved federal entities, but certainly there have been repeat instances and we would be happy to provide you -- >> the multiple offenders, that's problem. >> and it's the civil penalties and other penalties we need to know about from there. thank you. mr. tonko, you're recognized for five minutes. >> thank you mr. chair. we've heard about the importance of keeping labs safe and secure, thus, i'd like to explore how

labs both private and public that fail to meet critical safety standards and regulations are held accountable. both cdc and hhs through their offices of inspector general have roles and enforcement. cdc's division of select agents and toxins can refer entities to the office of inspector general for civil money penalties or certainly notices of violation. cdc could deny, revoke or suspend a lab's registration or require a lab to enter into a performance improvement plan. criminal charges can also be made in cases of misuse, unauthorized possession or unauthorized transfer. so dr. sosin could you walk us through the different options and how you determine the appropriate response for a given violation? >> thank you for your question.

you've correctly pointed out the options, the administrative options. the registration process itself is intended to screen and assure that there's good laboratory practice, good laboratory leadership, an appropriate use for the select it's materialagent materials. so that process are intended to assure that the entity itself is taking the appropriate steps that it needs to take. the decision to suspend or revoke is one taken very seriously. the importance of balance particularly for facility of the nature that you all are talking about here, these are important biodefense facilities doing important work. and the history of the program has been to work collaboratively to identify the specific problems and address them.

but those are options and the referral to fbi if there's concern about suspicious activity or referral to oig. >> thank you. mr. demske? >> yes when we receive a riefrl from the cdc, one of our attorneys or multiple attorneys will review the findings and allegations and the cdc will often consult with the expert to make sure we understand those facts. if we brief that there's been a violation, it's our policy to then contact the entity that is the subject of the matter and give them the opportunity to provide us with information or arguments about why a penalty would not be appropriate. we take that into account. often, again in consultation with cdc and decide whether to go forward with the case. and we use our looking across the experience of the cases that we've had, make a judgment about what we think the case should be valued at if we do seek a civil money penalty. >> now do your offices routinely work together to take action

against those who are in violation? >> we certainly communicate and work together from our perspective to make sure that we understand the facts and the science in these matters for us to determine whether to go forward. >> and dr. sosin, what types of violations would result in a lab losing its registration? sbr >> i can tell you that the process of revoking registration is one that is undertaken through careful efforts to help the laboratory address the concerns and improve its practices, and that revocation would come only after the inability of that facility to make those changes or their decision to no longer be interested in doing that work. i can get further clarification of the specific measures if you'd like. >> and in your opinion how often has that happened? >> i believe that it's happened

two times. i can get you the exact number. >> okay. i'd also like to get a sense of the frequency of violations and the actions to address them. dr. sosin, are you seeing any trends at the cdc in terms of enforcement actions any trends in referrals to the office inspector general for instance or performance improvement plans or lab registration actions? >> the federal select agent program is constantly evolving, and its approaches and tools uch is as the corrective action plan process, are relatively new and evolving. so trends are hard to evaluate in that context. i know that if requested the sub committee, smifk enforcement actions have been laid out in a response and should have the kind of information you would be looking for. >> okay. and i'm out of time, but if mr. demske if you could, perhaps, feed the panel with that same trend that you cite, any trends

that you cite that would be helpful. thank you. >> i now recognize ms. blackburn for five minutes. >> thank you, mr. chairman and thank you to our witnesses for your patience. we appreciate this as you know, we've got another hearing going on this morning. dr. sosin i want to come to you, if i may. i've got a copy of dr. freeden's testimony from this committee last year. and he was testifying about the june 2014 anthrax incident. he said and i'm going to read from the testimony. and i'm quoting. these incidents should never have happened. the lack of adequate procedures and oversight that allowed them to happen was totally unacceptable. we will explore the broader implications of these incidents and incorporate the lessons learned from them to proactively

prevent future incidence at laboratories across the nation that work with pathogens. so i want to know. can you explain why we didn't seem to learn the lessons? can you talk about why there is another comprehensive review of safety and security of the bioterror labs? why was not congress notified? why is another review necessary? were the problems at the cdc not corrected? and then who is going to conduct the new review. and ultimately. who do we hold responsible for this? >> thank you for your questions. pardon me if i need refreshing on some of them. >> i'll be happy to refresh. >> i'm sure you will.

i think it's important to recognize that the oversight program is not a cdc laboratory itself. it functions separately. nonetheless, in hindsight there has been reason to look more closely at anthrax inactivation. there's no question that that is necessary and before a moratorium on the use and transfer of these materials will be lifted, we will have a policy about how to validate. >> whoa whoa whoa. wait a minute. that was supposed to be done. so why was it not done? who's responsible that it did not get tended to last year? >> the work of a complex lort micro biological lort has thousands of procedures. >> so you're saying no one person is in charge that it's

done by chitommittee? >> no. i'm saying that the current nature is one of setting broad standards to achieve high laboratory performance but does not review each individual specific procedure at each entity. there will need to be -- >> procedures call for notifying congress? >> i'm sorry? >> do the procedures call for notifying congress if you need to do a review? if you have another incident? so that's not a part of -- that's not a part of your best, your business processes. >> i apologize if congress was not notified regarding the review that dr. freeden requested we take internally of the federal select agent program at cdc, that review is not a review of cdc labs and procedures. that is a review of what opportunities we have to improve the oversight program. >> okay. let me ask it this way.

going back to his testimony where he says that it never should have happened lack of adequate procedures totally unacceptable. going to put the processes in place and incorporate the lessons learned. was this not done last year? >> many things were done. this was not addressed. >> this, okay so it was not addressed. that's answer i wanted a yes or no. either it was done or it was not done. and that is what we want to know. and, see, this is part of what is so frustrating to the taxpayers who are footing the bill for this. because you all feel like you have immunity, if you will, and you don't have to move forward and do the job because you have a continuing appropriation. you just don't do the job until it's convenient. >> congressman -- >> you mess up once, you mess up twice. you mess up 86 times and it's no skin off your back.

because nobody's responsible. because you operate by committee. because we ask you to do something and report back to us. what do you do? sit around and go oh well, we'll get around to it later? maybe we need to give you a round tuit and have you get the job done. the fact that we are having to have another hearing and look at this is something that is frustrating. you should be realize once that there was a mistake. and immediately move forward to correct the procedures and the policies. and then should change the way that things are done. and i know i'm running out of time. i will yield back the balance of my -- >> i do think it's important to clarify that the cdc error with anthrax was addressed. if was a different situation. what i did acknowledge is that as the federal select agent

program with anthrax with inact administration, in hindsight, we should have, and we will enact inactivation procedures before that is used again. >> i'm sure you can understand we've heard that before. >> ms. castor, you're recognized for five minutes. >> thank you. mr. chairman. regarding the dod review of the dougway incident and the science surrounding inact administration protocols. the dod reported that one of the root causes of the dougway incident was scientific uncertainty about the process of inact vatsing anthrax spores. the review spated that this uncertainty led to the protocols that do not permanently deactivate anthrax spores and although this incident only recently raised questions about the inadequacy of these procedures, the department knew of this uncertainty for quite a while. so dr. hassell, if the department was aware of the

potential inadequacy of the inactivation process using gamma irradiation, why didn't the department have better verification procedures to ensure the spores were properly inactivated before shipping them? >> so that's a good question because it really separates, there are two issues involved. one was the inactivation was infective. and the other was that the vieblts testing didn't catch the fact that the first was not 100% effective. regarding the inactivation there is several scientific publications and peer review journals in the scientific literature that have shown different what we call death curves for killing anthrax. what we need to do now is to try to pull all those together, get a consensus view of those. work with the body of subject matter experts. work in consensus with cdc and figure out -- >> why didn't you do that before

if the department knew of this uncertainty for a while? >> it appears that that was somewhat localized. it wasn't universally acknowledged. each individual laboratory set its own standards and so this wasn't raised up to a central body. >> and that was not acceptable. those standards were not acceptable. >> was not acceptable. and going forward, it will have to be done in concert, so the -- >> so, is the dod reviewing all of its protocols and procedures to ensure that there are not similar gaps in the scientific literature for the inact administration of other dangerous toxins and pathogens? >> we will be doing that. >> you are doing that for anthrax and for other toxins. >> right. we'll see if there's any lessons learned from that that we can apply across the board. >> how confident are you that people are going to take that seriously. there are gaps in science and discrepancyies

discrepancies. how are you going to reconcile? certainly you would err on the side of safety. >> certainly. anthrax is technicallyparticularly hard to kill. that should give us our biggest challenges, boast in the activase and on the viability testing afterwards. things that we learned from both of those we will then take forward. >> when there's a ditch offference of opinion, who is going to be the responsible party that we can go back and say, wow, we had this hearing and another agency said we will address thesen gaps if and when we have to have another hearing. who is it that we will identify or if you could provide that to the committee because there is this problem with no personal accountability. don't you agree? >> yes, ma'am. and the second part of this investigation will be looking at the accountability. we will have some of those people identified. and we'll certainly provide that to the committee. >> thank you. i'd like to turn to dr. sosin to ask some questions about the

cdc's role in overseeing the direct agent program. why is there such variation across labs as to how they inactivate anthrax? >> thank you for your question. as mentioned earlier there are a variety of needs for materials that come from dead anthrax. and the laboratories, some research, some production for proficiency testing of labs, et cetera, have different roles and purposes as well. so cdc historically has required a ral dated procedure either published and followed or val dated within that laboratory and proof of sterility testing. i this to your question about accountability exemption of a select it's, anthrax now becoming exempt because it's dead is a requirement of the federal select agent program. and until we have a procedure that increases confidence that we can safely do that, we will not lift that moratorium.

>> you can see that we're very concerned. >> absolutely. are we to expect similar variation in inact administration protocols for other select agents and toxins and how do we address that? >> as dr. hassell pointed out, the nature of a spore being extremely hardy and difficult to kill, plus the fact that in this instance we were or the department of defense was trying to kill the organism without disrupting the organism creates a challenge in safety. the attempt, now, is to set that, an appropriate wide margin. it if you go back to the chairman's figure that he showed, the dod shows a dosing and a gap between the kill curve and the dosing. that gap wasn't happening here. clearly there were production runs that were growing anthrax and should have highlighted that procedure was not adequate. going forward, we will make sure that there is a safety margin and achieve consensus with the

broad input that we have opportunity to get to assure that we're taking the right margin. >> i'm out of time. >> i will now recognize mr. griffen for five minutes. >> thank you very much mr. chairman. dr. hassell, if you could, we've got folks out there receiving this. you answered a previous question related to the foreign nations and said some of those were dod facilities facilities. were they all dod facilities, and if not dod facilities, were they facilities controlled by the united states government? yes or no? >> no. >> so some of these would have gone to facilities not controlled by the united states government. how certain can we be that these folks who were receiving live samples, and i believe it was over the course we now know of ten years, didn't discover this before they necessarily told us and have been out there growing some of their own samples and siphoning off some? so when we're told that you all

hunted it down and you killed or acquired all of the live anthrax, how certain of that can we be? because it doesn't sound like it me that we can be very certain if somebody was taking some of that anthrax and skimming off some of the live for use in other ways. >> so the non-dod facilities that you refer to, those are some of our most trusted allies. we do many things with these allies. like across the board not just for bio. >> they're trusted, but if they wanted to do research on biological weapons, this would have given them an opportunity it acquire that or at least to acquire the base material to start the cultures with, isn't that true? yes or no? >> it's true, but they were already doing most of that work. we were trying to use a common material across the board so everyone was testing on the same material, so that we can compare the results that we had. >> and how -- >> but they do have those programs already. >> how comfortable are you with

those facilities had better protocols than we do and that we don't have some worker who might have taken what was supposed to be some dead cells, generated the live cells and gone out with a sample that he then might have, he or she may have given to a foreign agent? >> in some of those cases they already have the material now. like i say, this was a soon to be dead material and we do have records of it, it has all been deemployed. >> what you found has all been destroyed destroyed. since there was live, yes or no. the answer's yes. let's move on. dr. sosin, you said that the cdc act the reasonably in tracking down the live anthrax and then securing or killing it. dr. crosse you indicated that you would give them a b once it was discovered. but mr. demske you didn't get notified until yesterday to investigate the problem that was discovered in may isn't that correct? >> that's correct.

yes. >> so we've got at least 60 days since the problem was discovered before you were notified. isn't that true? >> i don't >> yes. >> i don't consider that a b or acting reasonably, do you? >> well we're not the front lines of an emergent situation. that would have to go do the fda and the scientists with the cdc, so it is normal for cdc to do investigative work on its own before it would refer a matter to us. and that actually helps us, because the evidence is more developed when we receive it. >> so you think 60 days is reasonable before you're notified to do your investigation? >> yes. >> okay. and as a part of that they're doing their investigations and so forth, but don't you think it's kind interesting that you got notified yesterday? do you think that our hearing might have sped ha time up a little bit? >> i have no information about

that. >> but when you filed your testimony, you said to date. oig has not received a referral for any more recent potential violation involving dougway which was in the reference to 2008 and 2010 incidents. >> that's correct. we submitted the testimony on friday. at that time we had not received it. my opinion is that oversight by this commit see a very effective way at spurring attention to this matter within the government. >> just wish we didn't have to do it so often. dr. sosin, you're the acting director for national center for injury, prevention and control. i noticed in the report referred to by the chairman earlier that stephen moore is the acting director of his department. what is the relationship between your two areas and why is everybody over there acting and nobody's permanent? >> i'm sorry. the information you have about my acting director role is old. i was previously for nine months acting director there. i have been for nearly a decade,

or over a decade actually, the deputy director for the office of public health preparedness and response. dr. monroe i think you're referring to was the acting associate director for laboratory science and safety is an outstanding laboratory scientist who comes from the center of emerging infections. and he's in an acting role because we are trying to hire a top-notch laboratory scientist to lead the laboratory safety and science effort. >> do you work with him or just report to him. >> i work with him. >> i yield back, mr. chairman. >> thank you. as the investigation into the dougway incident continues, we're learning that more and more labs received these live anthrax shipments. in addition to the 86 labs to which dod directly sent shipments there have been an additional 106 labs that received secondary transfers so

we're now talking about nearly 200 labs, and as more labs are involved the opportunities for error only increase. so i do want to understand why it's necessary to have so many labs involved with dangerous biological agents. i know ms. degette mentioned this in her opening statement. do you have an opinion on the number of labs that are working with anthrax? >> i don't think we know the number of labs that are working with anthrax. i think that's one of the issues. well, we have information of where -- are you talking about the -- >> the select agent. >> that's right. anthrax, we do know. we do not know all of the high-containment lack ra torys that exist. we have controls for a subset of dangerous pathogens. there are other highly infectious path gins that require a level three laboratory. we do know for anthrax.

my apologies. >> so it has been recommended for a single entity for oversight for high-containment labs. this would include standards. can you elaborate even this -- on this recommendation? >> yes we think it's important that there be a more comprehensive set of plans for how many labs are needed. you know, there have been there's been a great increase in the number of labs over the last decade, since the anthrax attacks in 2001. a number of different federal agencies have expanded the number of labs that they have. academic institutions have built labs. some states have built labs. and a lot of private entities have built labs. and they're very expensive. we don't know what, really, is needed. they, as we've heard today, they

are developing their own validation procedures. and there's not, necessarily an assurance of consistency. and, so while inspections can be performed of these laboratories the kinds of reportings of problems have been only typically been going to a level above the laboratory, so they're not going to the top of departments or organizations. and so i think that we're concerned that there hasn't been kind of a consistent set of standards in place. a consistent understanding of what the needs are. a consistent plan developed for where these laboratories are to be built and maintained and what the costs are going to be over the long term for maintaining this kind of infrastructure and whether it is in line with the needs. >> well have you gotten feedback from the federal government agencies that operate these high-containment labs with

regard to this recommendation to establish the single federal entity? i know you mentioned some obstacles to that but what other obstacles would there be to implement it? >> well, you know, i think that it's not clear where that organization should be located. as we've heard today, it's difficult to retrofit this kind of control on top of existing enterprise, different departments want to have control over what their own needs are, different companies want to be able to compete for contracts from the federal government. and so going back and retro fitting that kind of control is complicated. we have not gotten traction on the concept of moving forward to try to centralize this control. >> let he just say then, ask again, do you believe that the establishment of these national stan darsd and oversight might address some of the gaps that led to the recent incidents at

dod and cdc and how can congress help in establishing uniform policies and procedures? >> we do believe that having more consistent lines of authority would be helpful. dod in its report on the dougway incidents has pointed out that the different laboratories handling anthrax were in different chains of command and never came together. that there wasn't a sharing of information, and they didn't have top-level knowledge of what was going on in these laboratories and how the procedures were being conducted. that's the type of thing we think would be helpful. and we'd be happy to work with you and members of the committee to try to develop some kind of proposals. >> thank you thank you mr. chairman. >> we'll now recognize dr. due shon. >> this is not the only government agencies that we're hearing testifying in front of

congress saying they're establishing new policies. messed up. sorry we did this, sorry we did that. you know why? there's no accountability. there's no accountability across the federal government in my view. no one's responsible. people are in their jobs for short periods of time. dr. hassell, you've been on your job for a year. if we really pressed you, you'd say, i don't know, i've only been on my job a year. so i don't know what they did before me. this is a decade-long process. anget tired of hearing how we're establishing new policies. this is anthrax. we should have had policies for decades. it's ridiculous. that's the problem. and there's almost contempt for, against congressional oversight. every hearing i go to. it's, almost people walk out of the room and they go, well, they didn't get us this time, and they can't get us. there's nothing they can do to us. that's what people, i mean, this

is just ridiculous. so dr. hassell, how can there not be standardized protocols for this in the federal government, after decades and decades of this? how can that not happen? i mean that's just the question i have. dr. hassell how could, you made the statement, you know, there's, we're standardizing how we deal with this. how can it not be standardized? >> i can answer for dod. it was noted earlier that the different chains of command has been one of the fundamental problems here, because each laboratory reports to a different chain. they meet too high up in the organization. so yes i've been in place for a year, i take this very personally. >> i'm not criticizing you. in fairness you've only been there a year, you're right. you can't be accountable for what happened ten years ago. i agree with you. >> but i own it now. so i take personal responsibility to work with other people in the department

to make sure these things are sdardized. and i will not recommend to the undersecretary to lift the moratorium until i'm confident that we have the proper basis for our operations and ha we achieve the right level of standardization. >> i prefectureappreciate that. if people were losing their jobs this would be standardized. doctor sosin, you said you were asked how do we solve the problem. lost their job that cdc or dod? where food is still doing the same thing even though they're literally have a national security risk of anthrax around the world and

as mr. griffith found out that does not matter. how many are protected because they are part of a federal the reunion that is not allow them to be held accountable. >> i would like you to see how accountable the staff are at cdc retake this incredibly seriously. there are regulations and rules for the transfer of live anthrax this particular incident was is exempted material that is not considered a select agent and then choose tried to put in more policies.