moments of capability that emerged from it, but that's what he pointed to very frequently when he was frustrated with the international community on capacity building. >> all right. thank you very much. thank you for the panel for the insight. i'm from voice of america. i have a question for the ambassador in regard to his remarks about karzai being the consensus builder while afghanistan two weeks ago or less than two weeks ago was on the brink of a civil war and establishment of a parallel government and it took the u.s. intervention and john kerry's personal visit to avert the election crisis. do you see -- do you think karzai had the ability and the skills and the power to avert that crisis? and i had another question. you said karzai thinks democracy and accepts democracy and

political participation as two of his principles while at the same time the president has kept afghanistan's first lady hidden from the eyes of the world for the most part. do you think he fears that it's going to ignite the same protests and reactions from the tribal leaders in the conservative sections of the society? >> i will answer in the following way. the best solution would have been if the afghans could have solved this themselves. clear in his immigration speech in 2009, karzai said i want to organize the process. that was after the interference trying to unseat him at the time.

now that didn't work. that didn't work and, therefore, i believe that the visit by john kerry. i admire and respect the fact that he went there, sat down and came to what for me is i'm going to say the only obvious solution when it comes to the counting. if you disagree on how much to count, count it all, huh? but kerry's hands-on diplomacy in this respect is admirable. i think it's admirable. in 2009 when he came and we had a problem with the second round, to have president karzai accept a second round, he played an extremely big role.

and karzai i remember saying john kerry is the american politician that i trust the most. and through that answer i have half answered your question but avoided part of it. >> i think the question of the first lady is kind of intrigued me for a long time also. her sort of absence in the public sphere. if we go back to 2002, 2003 there are some interviews of her with the local media, international media, which shows that at least back then president karzai wasn't against her speaking out or being publicly involved, and she had said that she wanted to be involved in sort of health care for women and education and those issues. what i know from her involvement

now is that she does meet people, but she is not publicly involved, which is unfortunate. i think she's a very well-educated woman. she's a medical doctor, and one thing that afghanistan has lacked has been female role models after sort of a long -- a long blackout on women in society. especially after 2002. so the morale was low for women to get involved in the public sphere. she could have been a great role model, the education with her involvement. it's unfortunate but it has not happened. i don't have a clear answer, but i agree with you that it probably is being sensitive to the tribal realities and being sensitive to history. in the early part of the 20th century we had rulers who

involved their wives in public politics. it didn't go so well. that was one of the reasons of sort of coos against them basically, social coos. i think he's sensitive and because he's a tribal person or he rules in a tribal manner, i think that is a factor that plays in her absence but at the same time what intrigues me is how she was first involved and now she's not. i don't have an answer for that. >> good morning. i'm assad from a consulting group. it's a pleasure to be here. i have a couple of questions for the master and also for the general. general, you are a real american hero. there's enormous respect in afghanistan for you. i am in afghanistan once a

week -- once a month, and even president karzai has a lot of respect for you. he told me personally that you were the one, you fixed the broken relations -- diplomatic relations between afghanistan and the united states and also the afghan give you credit for decreasing the civilian casualties in afghanistan. the question i would have for you is afghans are really bothered by daily shelling of pakistani forces on the eastern province in afghanistan. that's happening on the watch of nato more than 100,000 nato soldiers being there. i wanted to know your perspective, and i'm sure you've had meetings with your counterpart in pakistan what was their response. and also the flow of the terrorists, including al qaeda,

isa, pakistan, taliban, they've been shelling the american embassy. most of the time i was there when they were doing that. how come we were not as an american super power, we were not able to tell pakistanis to slow down? that's one question. the other one is for ambassador to afghanistan, people love you, it's a great book. president karzai told me in 2009 it was not -- it was not because of you, ambassador, he said he would have been insane because of your assistant, mr. peter albrecht and also holbrook. could you tell us a little bit about that? what was going on in the background? the karzai of today and not the karzai of 2008. it was just you, albrook and

also your assistant. of course you were the one, you were trying as a referee to just bring some peace. karzai was very well managed before 2008 by george bush administration. he was fine. we even call him a hero. the best president. the best this and that around the world. and then all of a sudden he became a zero. the reason he was told me, i asked him, what happened? he said, because i don't get respect from this administration. and that comes back to sovereignty. i took a group of google and youtube to karzai and he was so impressed. he said, my god, you americans are such nice people. why the american diplomat don't behave like google and youtube. >> go ahead, general.

>> the border with pakistan is a very, very difficult piece of terra terrain. some of the federally administered tribal areas or the provinces on the eastern side of that frontier are very diffic t difficult. i'm going to say something about the border shelling, and i want to be very, very clear about what i'm going to say because i do not want to appear to be diminishing the importance of dealing with it, and i know that my successor joe done ford has spent a great deal of time working between afghanistan and pakistan in an attempt to deal with this. there were reports of thousands of rockets and artillery rounds coming across the border. it was creating a real panic in

kabul. at one point one of my helicopters, the minister of defense, minister of interior, the national -- the general -- the director general of the mds and one of the leading members of the parliament, we got in the bird and we flew to kunar where we met with the border troops, border forces. then we flew over the villages that had been so badly shelled according to reporting and found that there was no shelling at all. there was no effect of shelling at all in these villages. there was no shell craters, no dead animals that we had been reported on and so on. but that didn't mean there had been no shelling. we had to understand the problem. that was my point back to kabul, back to the security forces and back to the legislature, the parliament, was to make sure we clearly understood the problem because what we were doing was creating a crisis for ourselves

in many respects. the first was that the border trace, in case you department know it, actually follows four different border traces. you have the durand line, which i never mentioned in public in the palace for fear of the response that would get. you had the border trace that afghanistan recognizes. you have the border trace that pakistan recognizes then you have the soviet era border trace. none of those are the same. they all go back and forth. consequently pakistan, no excuses being made for pakistan here. subsequently or consequently pakistan shelled areas that they believed was a border trace and the rounds were landing on afghans. afghans could prove that their border trace included them and pakistan was shelling sovereign afghan territory. we worked very hard with both sides to try to create measures

whereby if the pakistanis saw ttp elements across the border, we would have the right of first refusal, we being isaf working in close conjunction with afghan forces would go up and get after some of these forces. bad reporting. bad intelligence on both sides made it much more difficult in really tough terrain to be able to solve this problem, but i think in many respects while that was a major issue before and it's still an issue if a single round comes flying out of pakistan and lands on afghanistan. it is a single issue and much has been done to solve that. to the point of cross border movement of terrorists and insurgent elements, we worked very hard with pakistan to create an environment whereby if we could get pakistan to take action primarily in north waziristan against the hakanis, we could solve a lot of problems

in the eastern five provinces to include kabul of afghanistan. just a very sad moment was the 24th and 25th of november 2011. i had spent a better part of the day with general khaini alone in his office over maps working in a way we would cooperate. were isaf forces available. we worked with him across the border. i woke up the next morning and found out that 24 troops had been killed overnight on one of my special operations in salala. they broke an operation and they closed a ground line and they worked nine months, nine months of no communications in the meantime the force levels of the isaf were starting to come down. they were operating up along the border because they had bigger issues to deal with along the

taliban. in 2009, 2010 and to some extent in 2011 that partnership ended at the end of november of '11. didn't pick back up and it hasn't still picked back up. pakistan ultimately to attack the insurgent elements on the eastern side of the frontier that we needed for them to go after which was the hakanis, and i ran, as you may remember, it was in the media, i didn't spend a lot of time talking about it in the public. we ran a very concentrated effort talking about knife edge where where we submitted, we being in partnership, afghanistan and isaf committed large numbers of operations against the hakanis. they proved them to be quite good and it gave me a sense to accelerate the afghans moving into the league. the cross border concentration is a serious issue. it's a major security issue that

has to be resolved and that's my concern about the comment a little earlier about we have a zero option that is playing out here by the end of 2016. the new president i think is going to have to take a very real clear-eyed, realistic look at what the american policy is with respect to our advisors and will remain in the country and consider very seriously whether he needs to speak directly to the president of the united states about changing that policy given the operational realities in afghanistan. and i would certainly applaud that president, whoever he's going to be, to undertake that very measure. >> now in 30 seconds what happened in 2009? >> i think what started was president obama decided to discontinue the video conferences that president bush had regularly with president

karzai and bush writes in his book, i made it a point of keeping in touch with him and not teaching him but advising. the only way to make him a real leader was to treat him as a real leader. that was the right approach. that was something new. it was acrimonious between vice president joe biden before they took over in kabul. and then came hobert. we had a slightly troubled relationship before iraq. we met at the u.s. ambassador's resident. the first question holbrook asks me is when does your contract expire? >> i was actually sitting there. >> you were there? >> i was in that room, yeah. >> and then started a hunt for somebody to run against karzai.

when the day was over and they had holbrook, karzai called them and called me up to the palace and we talked about the meeting. i cannot remember who said, was it him or me, but one of us said, you know, holbrook is after both of us. that was -- that was the feeling already from the very beginning unfortunately and that suspicion became stronger and stronger and stronger throughout the election process unfortunately. i had established quite a good relationship with karzai already because -- some because of casualties. when he was going to choose his vice presidential candidate he came up to the office and said to the vice president, and then at first i pursued it.

. i said, let me think about this. he came back and we had six meetings. i didn't succeed. why did he want to bring that? in the provinces he needed alliances in order to win the elections. very simple. but at that time there was a turn in the direction, more reliance of that kind of forces and less on the reform orie ended in 2009. then the crunch towards the end of the election process, we worked very closely together. our attitude was let's not worry. we haven't hit the wall yet.

there is something called the constitution and they are institutions created by the constitution and we must allow them to do their work. in spite of all the criticism that came from it. then john kerry came and i remember during kerry's period, this is anecdotal. the second day kerry was there. can we go down to your office downstairs instead of sitting in a big office because we never know what's happening. so we went downstairs and i said to the president, we were sitting there, i was red in my face. it was a very emotional meeting.

the second round because if the president doesn't follow the constitution, there's a role for me who has insisted on following the rules. he didn't have any impact. i don't know. you can talk about these kind of things. kerry came back. there was a long discussion. he would go for a second round. the rest of you know about it. the president continued for a second term and here comes the question because you said he had all the opportunity during higgs second round. i think president karzai suffered throughout these five years for the fact that he never had -- he never hit that mark,

therefore, i think he doesn't quite have the legitimacy that the constitution required from a president. and he blamed that on the obama administration. >> i think the legitimacy question is really interesting. you and i had a discussion about this in kabul. i think in terms of public perception, one thing that i've noticed past five years that karzai was not challenged over legitimacy. the opposition, abdullah could have done it very easily or any of the opposition politicians could have challenged the legitimacy. i think we'll throw that out there also that publicly he didn't get challenged for the past five years. yes, it was a personal pain to him. >> i think that brings us to the end of our final.

we had two hours' allowance. for me the discussion, even though i've lived through some of this and seen others of it and studied others of it, it's still been fascinating and revealing so i want to thank our three panelists and i want to thank all of you for coming and for your questions. and maybe this won't be the last time we host this kind of discussion, but i think for the first draft it was extremely good. thank the three of you very much. thank you. [ applause ] and a look at the capitol where copying has departed for the five-week summer break. the house passed a resolution that if passed by the senate sets the return date as monday, september 8th. members are busy in their home states, especially ohio where a water ban that had hundreds of thousands of people in both that state and michigan scrambling

for drinking water. that's been lifted. toledo mayor d. michael collins lifted the ban in a news conference and said the city's drinking water is safe. senator sherrod brown said the drinking water ban may be lifted in toledo but our work to ensure safe drinking water may continue. others are saying thank you to those who generously distributed water. coming up live 40 minutes we'll have coverage of south african president jacob zuma. he's one of the many african leaders in washington, d.c., to focus on africa's economic potential. we'll have his remarks live at 2:00 eastern time on cspan. tonight on "the communicators" three members of congress talk about their technology legislation. >> i believe in an open

internet, a free internet without government intervention. when you look where the internet has come and where it's going into the future, this is all being done on the private sector. >> why would they not want their team exposed, their product, their brand exposed to tens of thousands of people? so we think that the blackout rule is not too late. the fcc took the next move. they will vote at the end of this year. we believe the nfl will follow suit. >> a bill that tries to have retransmission consent and giving people level footing when it comes to being able to negotiate with broadcasts and being able to negotiate with the providers and the people who are trying to deliver that media to the consumer. so it puts people on a level playing field when it comes to those kinds of negotiations. >> republican representative bon latta from ohio. new york representative brian

higgins and colorado representative cory gardner tonight at 8:00 eastern on "the communicators" on cspan 2. cdc chief called the mishandling of live anthrax by his agency unacceptable and that it showed a lax culture of safety. he recently testified before the house energy and commerce committee on capitol hill on the centers for disease control mishandling of biological agents that could have potentially exposed dozens of staff members to deadly viruses. this is 2:40.

good morning. the subcommittee of oversight and investigation today examines the centers for disease control anthrax incident last month. that potentially exposed cdc members to live anthrax because safety procedures were not followed. last friday the cdc director announced the findings of their own internal reviews. like anthrax, the department of agriculture's investigation revealed more disturbing details. during the inspection cdc workers could not locate some of their anthrax samples. it took more than a week for inspectors to track it down that are in cdc's custody.

the agriculture inspectors uncovered that they were transporting dangerous material from biological containment labs in ziplock bags. this is troubling and completely unacceptable. the centers for disease control is supposed to be the gold standard of the u.s. public health system and it has been tarnished. we rely on cdc to protect us and uphold the highest ends of safety but the recent anthrax events have raised very serious questions about cdc's ability to safeguard properly selected agents in its own labs. the cdc director has called the potential anthrax exposure a wake-up call. our investigation has uncovered this is not cdc's first wake-up call. i'm not sure wake-up call is a proper term. it's a gross and dangerous understatement. it was the potentially dangerous failure. wake-up call is catching something before the danger

exists. once a person is exposed, the serious pathogens, the danger is of a much higher magnitude. in 2006 cdc bioterrorism labs september live anthrax to a lab on the mistaken belief that it was activated. later that year inactive vags procedures led them to ship live botulinum to a lab. a strain of brew sell la which can cause a highly contagious infection had been shipped since 2001 because they believed it was a less dangerous strain. one must question the scientific qualifications of these skein 'tises. reports by government watchdogs demonstrates that these events are not isolated.

a cdc scientist discovered select agents in a drawer in an unsecured lab during a reorganization and another cdc scientist found 16 viles of a select agent stored in an unsecured freezer that was left over from an outbreak investigation many years earlier. this is reminisce september of small position found in a storage container on an n.i.h. campus. the small pox no one knew was there. cdc did not monitor and enforce certain regulations at federal laboratories including those at the cdc. in addition to the inspector general audits, several gao audits have raised concerns of high containment labs including those at cdc despite the number of red flags these incidents keep happening. we learned last friday that cdc

scientists in march shipped influenza strains to a department of agriculture lab that was contaminated with a very deadly flu virus. the cross contamination was discovered on may 23rd, 2014, but it took six weeks for this to be reported to cdc leadership. what we have here is a pattern of re-occurring issues, of complacency and a lax culture of safety. this is not sound science and this will not be tolerated. these practices put the health of the american public at risk. it is sloppy and it is inexcusable. dr. freeden, i thank you for testifying today. i have questions about whether the corrective actions you have announced will ultimately solve the problems. we'll be looking for your testimony. cdc has already assigned one person for the duties. reports over the years appear to be systemic. cdc needs to assure the proper policies are implemented. dr. frieden, you said you were

distressed about the delay. i wanted to know if you were concerned about why cdc workers are not reporting everything and whether you have reason to believe that they may be afraid to report the incidents. cdc is not going to solve this unless it gets as much information as possible from its own people. since 2007 there have been 17 reports at cdc indicating that a worker was potentially exposed to an agent or toxin. thankfully as far as we are aware no one has become sick from improper handling but cdc should not assume that its luck will continue. soon oar or later that luck will run out and someone will get very sick or die. cdc needs to strengthen its safety procedures. the risks from the deadly pathogens require fail safe methods similar to those used in other contexts such as handling weapons. the subcommittee will review the oversight of oversight laboratories and to explore the possibility of an independent

agency to oversee the cdc labs. i recognize the ranking member. >> thank you very much, mr. chairman. last month scientists at cdc's rat laboratory in atlanta made a series of mistakes that could have had deadly consequences. they transferred anthrax spores to two other labs potentially exposing dozens of individuals to anthrax. luckily, nobody has yet fallen ill. like all of us, i'm deeply troubled by what we've learned about this incident. how did it happen? cdc conducted its own internal investigation. there was no standard operating procedure for the analysis being conducted by the cdc scientist. there was no approved study plan. the scientists used a pathogenic strain of anthrax when another could have been used. the scientists used unapproved sterilization techniques for pathogenic anthrax and proceeded

to transfer the material without confirming that it was inactive. this is obviously an alarming series of failures. but there were other problems at cdc that made this incident worse. after the anthrax incident afis conducted its own inspection of the facility. inspectors identified serious problems in lab operations and decontamination procedures but also detailed major problems that the cdc's response to the incident reporting that the agency was inadequately prepared to handle the cleanup or to treat those who were potentially exposed. i think we can all agree the reports on this incident are bad but what's even more troubling to me is that in context they reveal a broad problem with the cdc safety culture. we received report after report

from gao, hhs, aig and afis offer a multitude of warnings and operations of high containment labs. cdc ease after action report identified four other cases in the last decade where cdc shipped dangerous pathogens off site. the staff -- the democratic committee staff prepared a memo describing the results from six different afis inspections at the cdc facility in 2013 and '14. overall in the six inspections, afis identified dozens of observations of concern. 29 related to facilities and equipment, 27 related to safety and security and 39 related to documentation and recordkeeping. in some cases the afis revealed paperwork problems but in other cases they found serious problems. they found reports of scientists

using torn gloves i don't understand why they don't heed those warnings. dr. frieden has indicated that he was as surprised as anybody by the scope of the problems and the fact, dr. frieden, that you were so surprised is a problem in and of itself because what it shows is that there's a fundamental problem with the culture of identifying and reporting safety problems up the chain of command. now i'm sorry to say, mr. chairman, these lab safety issues are not new to me or the committee. this is one of the detriments of having been on this committee for 18 years. we have had multiple hearings on this problem at the cdc over the

years. in 2006 and 2007 we had terrible problems at the cdc facility in fort collins, colorado, north of my district where we had vector borne diseases that were being very sloppily handled. fortunately we built a new facility since then up in fort collins. it's a beautiful facility, and we are able to handle these diseases but, you know, these issues are not resolving themselves. dr. frieden, while you have a strong record, you have answers and you're acting aggressively to make sure this doesn't happen again. i appreciate that. we all appreciate that, but what we all need to know is what the plan is to change the culture at the cdc. we can't legislate -- we can do a lot but we can't legislate a culture change. it has to come from within the agency.

i'm also glad to have gao and afis witnesses here because in retrospect your warnings were precious and should have been taken more seriously. these warnings are being taken very seriously right now, not just by the agency but by the people here on this panel. thank you very much. >> thank you, gentle lady. recognize the chairman of the full committee, mr. upton for five minutes. >> thank you, mr. chairman. this is a very serious hearing for sure. two years ago after allegations of problems in cdc's building 18, the home to the world's deadliette agents and pathogens, this committee investigated whether the cdc was complying with federal safety requirements in the operation of its main lab facilities. in response to our concerns, cdc director tom frieden sent the committee a letter in september of '12. the dc letter which i'd like to include in the record outlined the agency's efforts to better oversee select cdc labs.

these methods included rigorous training, review of safety efforts and rigorous layers. the letter stated that a senior official who was not identified would be designated to report directly to the cdc director on safety at cdc labs. these measures sound very similar to the corrective actions that dr. frieden outlined last week to address the current lab crisis. why should we believe this time that things are, in fact, going to be different? we asked cdc two years ago to identify each biosafety incident that had taken place at its main lab since january 1st of '05. cdc provided the committee with a list in 2012 but we now know from cdc's internal investigation released last friday that, in fact, a list was not complete. improper shipments of pathogens in '06, including anthrax, were not included in cdc's list of

safety incidents that, in fact, was provided to this committee. cdc staff has now acknowledged to committee staff that the '06 incidents which were reported to the hhig should have been included. we don't know why they weren't. this raises the question whether cdc leadership is receiving all the information about its own biosafety systems. add to the possible anthrax exposure that delayed notice provided to cdc leadership about avian flu shipments and the discovery of small pox viles in a cardboard box in an fda storage room on the n.i.h. campus, and these incidents no longer appear isolated. a dangerous, very dangerous pattern is emerging and there is a lot of unknowns out there as well. when dealing with pathogens such as the ones being discussed today, unknowns are frankly

unacceptable. what you don't know can hurt you. why do these events keep happening? what's going to be next? cdc needs to solve the safety problem now as a team. the agency needs to get as much info as possible from its workers about true safety of -- biosafety -- true state of biosafety at cdc and keep this committee and the american people fully informed. there is zero tolerance for unlocked refrigerators and ziplock bags. those days have to be over. yield to marsha blackburn. >> thank the chairman for yielding. i want to thank our panel for being here. and as you can hear, on a bipartisan basis we have plenty of questions for you. we are deeply concerned about the incidents that have occurred at the federal labs that are run by department of health and human services, cdc with the anthrax specimens. dr. frieden, we appreciate the time you spent with us last week, but i do think we have plenty of questions for you

about the safety and the carefulness. you know, we would think that the priority would be safety and caring and making certain that you are tending to that culture of safety within these labs. n.i.h. with the viles of small pox and the fact that this was in an unused portion of a storage room, who all would have access to that? and then, of course, the cross contamination of the influenza sample. we've all talked about the three of these events, and the fact that they have occurred within this framework of time, the fact that there seemed to be a dismissiveness of the serious nature of these occurrences. the fact that the cdc's own report pointed out some of the contributing factors in this and the lack of a standard operating

procedure and best practices and the fact that this is not known among the employees at that agency. we know that there are some remediation measures that have been implemented, but the culture of safety or lack thereof continues to be a concern to us for public health. i yield back my time. thank you. now recognize mr. waxman for five minutes. >> thank you very much, mr. chairman, for holding this hearing. i think it's important for us to investigate this incident involving the release of potentially viable anthrax on cdc's campus in atlanta. when i was chairman of the oversight committee, we held hearings after the 2001 anthrax attacks. we looked at the safety of postal workers and the public in handling mail and the postal

service and cdc's response to those attacks. we had hearings again in 2003 and 2005 where we found there were still gaps in biological detection of anthrax and in communicating test results and risks to the public. those hearings showed why cdc's work on identifying and containing public health risks from these types of biological agents is so important. but this work can also pose risks, and that's why this oversight hearing is important. in 2009 when i was chairman of the full committee we held a hearing on the proliferation of high containment biolabs and the lack of oversight over such facilities. mr. dingle also held a hearing in 2007, so this is not our first introduction to this subject. at our request gao, the

government accountability office, also looked into lab safety. gao reported in a number of studies, one as recently as 2013 on the problems associated with the government's fragmented piecemeal approach to these labs, no single agency has oversight over all high containment biolabs. there are no national standards for operation, and we have no record of how many labs even exist. the health and human services inspector general also issued numerous reports on high containment labs and their handling of select agents. the inspector general identified issues with the treatment of select agents and the safety of the individuals working with these dangerous pathogens. the i.g. recommended that the centers for disease control labs improved training for individuals handling select

agents improve recordkeeping and take appropriate measures to improve safety. the american people count on the centers for disease control to protect them, and we want to be able to assure that the cdc is conducting its research in safe and secure ways. i am supportive of dr. frieden's efforts at the cdc. we work with him on numerous efforts in the last five years and he has shown himself to be an effective leader and strong communicator and i appreciate the quick actions that he has taken in response to this incident. i am encouraged to see that dr. frieden has appointed dr. bell to oversee laboratory safety protocols and procedures. this investigation has shown us that cdc needs to change its safety culture. i hope that dr. bell can help instill a new mindset at the agency. still, i am concerned that it

took exposure of dozens of cdc staff to anthrax to finally spur cdc to action. so we want answers from the cdc about how this incident was allowed to happen in the first place, and i look forward to hearing from afis and gao about the problems they've identified in the past, how cdc should implement their recommendations moving forward, and what role congress should play in making sure that happens. mr. chairman, this is not the first hearing on the subject. we've looked at it before. we need now finally to be sure that all the recommendations that we've had are put in place so that we can stop something from -- like this from happening again. thank you and i yield back my time. >> thank you. i would now like to introduce the witnesses on the first panel for today's hearing. first dr. thomas frieden is a witness from the centers of disease control.

he's accompanied by mr. joseph henderson, deputy director of the office of security and emergency preparedness at the centers for disease control. dr. gierdick is the associate director. dr. nancy kingsbury is the managing director of applied research and methods at the u.s. government accounting office. did you want to introduce someone from your district? >> mr. chairman, thank you very much for giving me the opportunity. i know this witness is on the second panel and it will be a little while before we will be hearing from the second panel, but it is an honor and pleasure to introduce also the second panel, shawn kauffman. mr. kauffman is president and founding partner of a company called behavioral solutions. his background is long-term employment with the cdc before forming his own company in my

district, the 11th congressional district of georgia in woodstock, georgia. and i would encourage all of the members on both sides of the aisle, if you haven't had a chance, i know we try to read all of the testimony, but sometimes we skip one or two along the way, but i will assure you that the testimony -- written testimony from mr. kauffman really hits the nail right on the head in regard to this overall issue and i would commend it to you. i'm proud to introduce him to you in anticipation of the second panel. thank you very much and i yield back. >> to the panel, you are aware that the committee is holding investigative hearings and when doing so has the practice of taking testimony under oath. do any of you have objections to taking testimony under oath? well, the witnesses indicate no. the chair then advises you all that you are under the rules of the house and the rules of the committee. you are entitled to be advised by counsel. to any of you who desire to be

advised by counsel? all of the witnesses indicate no. in that case would you rise and raise your right hand. i'll swear you in. stand please. do you swear the testimony you're about to give is the truth, the whole truth and nothing but the truth? thank you. all the witnesses answered in the affirmative. you are now under oath and subject to penalties under title 18. we now give a five-minute written summary of your written statement. dr. frieden, you're recognized. >> chairman murphy, ranking member duquette -- chairman murphy, ranking member duquette, members of the subcommittee, thank you very much for this opportunity to appear before you. i'm dr. tom frieden, director of the cdc. with me is mr. joe henderson who heads our office of security, safety and asset management. i'll review the problems that have come to light in the past

month and tell you what we're doing now to address improving lab safety. the fact that it appeared that no one was harmed and that there were there were no releases does not excuse what happened. what happened was completely unacceptable. it should never have happened. if i leave you with just one thought about today's hearing as it relates to cdc, it is this. with the recent incidents, we recognize the pattern at cdc where we need to greatly improve the culture of safety, and i am overseeing sweeping measures to improve that culture of safety. cdc works 24/7 and our scientists protect americans from threats, including naturally occurring threats like ebola and mers and drug resistant bacteria and manmade threats such as anthrax.

but we must do that work more safely and we will. there's a recap of the recent incidents that summarized in our report which has been completed and we're just at the outset of our investigation of the influenza contamination. i'd be pleased to go through the two diagrams we've provided to the subcommittee which outlined what we know to date. but in brief, the anthrax incident shows deeply troubling problems. a lack of proper protocol, incorrect inactivation procedures. failure to ensure that we were transferring materials that were sterile when we thought they were sterile. use of a virulent strain when a nondangerous form would have been appropriate. in the influenza cross-contamination, we're still trying to understand how the cross-contamination occurred and investigating how there could have been such a long delay in notification.

the risk to employees from the anthrax exposure was at most very small and the risk of release to the public was nonexistent. but that does not change the fact that these were unacceptable events. they should never have happened. in the past, as the committee has outlined, there were a number of specific incidents, and i do believe that cdc staff worked hard to address the specific findings of past investigations. but i think we missed a critical pattern. instead of just focusing on those when we issued the anthrax report, we provided not only these two incidents but the prior episodes of what has happened because what we're seeing is a pattern that we missed. and the pattern is an insufficient culture of safety. we're now implementing every step we can to make sure the problems are addressed comprehensively in order to protect our own workforce and to

strengthen the culture of safety and to continue our work protecting americans. i have taken a number of specific steps. i've issued a moratorium on the transfer of all biological materials outside of all bsl 3 and 4 laboratories at cdc. i've closed the two labs that were involved in this situation until we're sure they can be reopened safely. i've appointed dr. michael bell, a senior scientist, to be director of laboratory safety reporting drem directly to me as the single point of accountability. he will review the moratorium and lift it lab by lab when we're confident that can be done safely. he'll also facilitate expansion and use of that safety culture throughout cdc. cdc scientists are world famous for their rigor in scientific investigation and we will now apply that same rigor to improving the safety in our own laboratories. i'm convening a high level

working group within cdc internally to advise us on every step of the process and an external advisory group of outside experts who are top in the world to take a fresh look and see what we can do to do better. we'll look at every activation and transfer protocol and other protocols that improve them as needed. we'll look at future incidents if they occur with a command structure which should have been used earlier in the anthrax exposure. i will ensure that appropriate disciplinary is taken as indicated by our investigations and will apply lessons learned from this experience to our function as a regulatory agency in our select agents regulatory program. in hindsight, we realize that we missed a crucial pattern, a pattern of incidents that reflected the need to improve the culture of safety at cdc. but as with many things, recognition is only the first step. we're taking a number of additional actions to establish

and strengthen a culture that prioritizes the safety of our own staff and encourages reporting of actual and potential situations that may place staff and others at risk, openly assesses those risks, and implements redundant systems to keep risks to the absolute minimum. part of that culture will be increased reporting of problems or potential problems. one of the aspects of an effective culture of safety is rapid reporting of problems. so if we do uncover problems in the coming weeks and months, this may well be the result of strengthening our culture of safety rather than failing to address it. we have concrete actions under way to change processes that allow these indents to happen, reduce the likelihood of an occurrence in the future, and apply lessons broadly. we'll do everything possible to live up to the high standards that congress and the american public rightfully expect us to achieve. i look forward to your questions and thank you for inviting me to

testify today and for your interest in this important topic. >> thank you, dr. dick. you're next. make sure your microphone is on. push it very close to your mouth. thank you. it's not on. green light. there you go. >> thank you. >> thank you. >> mr. chairman and members of the subcommittee, thank you for the opportunity to testify today about the animal and plant health inspection services inspection into the release of possibly live anthrax at the cdc's campus. i'm dr. jere dick, associate administrator for aphis within usda. afis conducted a thorough inspection of the incident to learn how it happened and to determine appropriate remedial measures. we will continue to monitor the cdc's response to ensure all necessary corrective action is taken and that when work resumes at the laboratories, it will be done in full compliance with the

health and safety of the employees and the public at the forefront. usda was designated by congress as the partner with cd c in the oversight of select agents because of our expertise and experience safely working with select agents over the past century through our efforts to prevent dangerous disease agents from impacting u.s. agricultural and the environment. for decades, aphis has safely operated high containment laboratories that handle select agents, including those of concern for human health. our personnel, our leading diing a nos titions, and experts in the effective working of high containment laboratories. to ensure objective, aphis and cdc signed a memorandum of

understanding in october of 2012 which makes aphis the lead inspection agency for cdc entities. since the mou was finalized, aphis has cared out 11 inspections of the four cdc labs. aphis takes any potential release of a select agent or toxin very seriously with a goal of quickly ensuring that the release is contained and determining what led to the release to ensure no future incidents. on june 13th, cdc officials discovered a potential release of anthrax and notified aphis. cdc voluntarily closed impacted labs on june 16th. aphis made its inspection a priority and quickly began its work to ensure that all select agents were secured and that there were no other breaches in biosafety or biosecurity. a specially trained aphis

inspection team of veterinarians and plant pathologist spent nearly two weeks beginning june 23rd conducting a facility review of the laboratories and interviews with cdc personnel. aphis briefed cdc officials on july 2nd outlining deficiencies so they could immediately begin taking corrective actions. aphis found the laboratory did not use an adequate inactivation protocol and did not ensure that the protocol was, in fact, validated. the initial response to this incident by the cdc laboratories was inadequate both in securing as well as disinfecting laboratories. for example, individuals without approval to handle select agents were able to access space containing or potentially contaminated with anthrax at least four days after the incident was discovered.

we also found that employees did not have appropriate training in some instances. we found no clear management oversight of the incident at the labs and no clear single manager overseeing the overall cdc incident response which resulted in employee confusion about how to respond. in addition, cdc's occupational health clinic was not prepared to respond to the potential exposure of a large number of workers. aphis currently has in place a cease and desist order with select agents and the toxins at the two impacted select agent laboratories. we will require that corrective actions be taken to ensure the integrity of these research programs. we have directed cdc to provide

aphis with its plan for coming into compliance by july 25th. and before allowing cdc to resume select agent work in the laboratories, aphis will conduct a reinspection to ensure that all corrective actions have been taken. mr. chairman, this concludes my testimony. i'd be happy to answer any questions that you or members of the subcommittee have. >> thank you, dr. dick. dr. kingsbury, you're recognized for five minutes. please point that microphone very close to your mouth. a lot closer than that. bring it really -- bring it -- bring the mic really close, please. >> really close. >> thank you. >> is that better? yeah. okay. thank you very much for inviting us to come to talk to you about some of our past work on biosafety issues. as mr. waxman noted in his statement, we've been doing this work for quite a while. we started with the original anthrax attacks, and we've gone on to a number of other issues over the years.

basically our past work has a couple of major themes. one of them is a lack of strategic planning and oversight of the whole picture of biosafety laboratories. aphis and cdc are only a part of that picture. and since 2001, there have been an increasing number of biosafety laboratories both within that sector but also across the whole government. there are six or seven different agencies involved, and no one entity has been charged with developing a strategic plan. we became particularly concerned about that as budgets began to shrink, recognizing the management and operation of these laboratories is an expensive venture, and if they're not properly maintained, other kinds of problems can arise. we've also observed that there's a continued lack of national standards for designing, constructing, commissioning and operating these laboratories. there is guidance.

the biosafety and microbiological and biomedical laboratories guidance is available, but it's not required. and there is no process by which an entity needs to make sure that they are following that guidance. we think this broader government perspective about both how many of these laboratories we need and for what purpose and also a better framework for oversight is still needed. we have done some work since this episode became -- since the most recent episode became public. we did take a team to atlanta. i want to thank dr. frieden for his staff's cooperation with us when we were there coming together with something i'm prepared to sit here and talk about on something like ten days notice is a bit of a challenge for us. but his staff was very good at providing everything we asked for. i'm not going to add very much to that debate.

i think the two previous witnesses have covered the details pretty well. the one thing i would add is while we agree there is a requirement to have standard operating procedures that are reviewed at appropriate levels for biosafety, we believe it's also important that those procedures be validated. and by that we mean independently tested so that we can be assured that if these procedures are followed, there will be no further episodes. so i'll just add that one thought to the debate about the incident itself. thank you very much, mr. chairman. that concludes my statement. >> thank you, dr. kingsbury. i will now recognize myself for five minutes. dr. frieden, is anthrax a biological agent that has been or could be used in warfare? >> yes. >> and the mishandling of anthrax can have some real consequences. if someone were sickened by anthrax, what would some of the symptoms be? >> anthrax can cause a variety of symptoms, but the most severe forms are respiratory anthrax,

which can cause severe illness or death. >> now i have an image of some lab -- of some workers handling testing for anthrax, et cetera. one sees -- i don't know -- this is not a lab but some other workers investigating. when i toured labs, there have been -- the number of levels there, what's required for breathing, for covering clothes, for before and after is pretty severe. i've got to ask this question. these aren't live, but this is a ziploc bag. i have to think what in heaven's name would go through the mind of some scientist thinking a ziploc bag is enough to protect someone from anthrax when you have other instances of all that paraphernalia someone has to wear when they're dealing with anthrax. have you talked to these personnel involved with transporting anthrax and asked them why? >> i have been directly involved in the investigation. i will be directly involved in the remediation of the problems

that we find. many of the issues that are mentioned in the aphis findings relate to what was done with the material that was believed to have been inactivated. so once the laboratory had said, here is killed anthrax, it was handled by the staff in those lower containment laboratories as if it were not infectious. our subsequent studies suggest that it's likely that it was not, but the core error there was the failure to -- >> dr. frieden, this is like saying, i didn't know the gun was loaded but somebody got shot. but you should always assume it is. for someone to say, i didn't think the anthrax was live isn't acceptable, and quite frankly, i wonder if you have the ability to not only reprimand such personnel but to fire them, to suspend them from working with pathogens that are deadly, or, quite frankly, do they understand that the extent to

which this went could have left them in a condition where they were charged with criminal negligence or negligent homicide or reckless endangerment? do they understand the seriousness of this for the american public health? >> i think first your idea, mr. chairman, of a two-key system as is used in other circumstances is quite appropriate here. both within the high containment laboratories and to verify this stuff coming out is safe if it does come out because stuff has to come out of the laboratories to be tested or worked with elsewhere. in terms of disciplinary proceedings, what we want to do is strike the right balance. on the one hand we recognize the need to make sweeping improvements in our culture of safety, and part of that means that staff need to feel comfortable anytime saying, hey, there may be a problem here, coming forward. at the same time, if our investigation finds that there is negligence, that people knowingly failed to report or

took actions that were likely to or should have been known to endanger themselves or others, then we will take appropriate action. >> i'm looking at dr. dick, it said the people who were not approved were able to handle select agents, were able to access space potentially contained anthrax four days after the incident was discovered. my assumption is these scientists and their aides are pretty smart people, but it's extremely disturbing to think they're not thinking of this -- let me ask this. it's been a week since you learned about the march 2014 cdc shipment of h5n1 influenza. there was a six-week delay in notifying? have you found out why and was there a cover-up involved in that or is this bureaucratic hurdles are too high or what was the cause? >> i have only gotten some very preliminary information on that. i will make a general point, however. when we look at emergencies in emergency departments or intensive care units in the health care sector, the biggest

problem isn't usually a failure to respond effectively when people recognize there's an emergency. it's a failure to recognize that the situation is an emergency or something that requires immediate attention. but we haven't completed our investigation of that. we'll look at all possibilities. >> is there any occasion or alarm system that lets people know when there's been a release or a problem there? >> there are multiple alarm systems within cdc. in this case it was a cross-contamination of a culture. somehow, and we haven't figured out how yet, a low virulence avian influenza was cross-contaminated in our laboratory with the high pathogenic h5n1. >> i get more alarms going off when you try to walk out of walmart with a shirt that meant been paid for. you see those happening all the time. is there any evidence of cover-up here from employees not wanting others to know -- >> we've seen at this point no evidence of a cover-up but we see the need to strengthen the

culture of safety that encourages reporting any time there's a problem or potential problem so we can assess it and take rapid and prompt action. >> thank you. i now recognize miss degette for five minutes. >> dr. kingsbury, let me just make sure i heard your testimony right. you testified that there's an increasing number of labs that are handling niece these bioagents, correct? >> correct. >> and you said there's really no one agency in charge. is that correct? >> correct. >> now you said that today but in 2007, the gao testified before this committee the same thing. no single government agency was responsible for tracking all of these labs. >> that's correct. >> that's correct, too. dr. frieden, are you aware of this finding by the gao going back all the way to 2007? >> yes, i am. >> and do you agree with dr. kingsbury that there are an increasing number of labs handling these bioagents?

>> if we look over the past ten years, it's my understanding there's an increasing number. >> do you agree with her that there's never been one agency in charge despite the red flags going up all of these years? >> there is a clear division of responsibilities between cdc and aphis in terms of select agent oversight, inspection and enforcement. several years ago at my direction, we turned over the inspection of cdc's laboratories, select agent laboratories to aphis which has conducted them since that point, but the overarching issue of laboratory safety is one that does touch many parts of both the public sector and the nongovernmental sector. >> are you saying aphis is in charge now since you put that into effect the last few years? >> in terms of the inspection of laboratories which are working with select agents, there's a clear division of responsibility between ourselves and aphis. >> does that mean aphis is in charge? yes or no. >> aphis is in charge of investigating cdc's select

lab agent laboratories. not in charge of the overall enterprise. >> do you think we need to clarify who is going to be in charge of the overall enterprise? >> we're certainly willing to look at every suggestion to improve laboratory safety and biosecurity. >> do you think it would be useful if we had one agency in charge of all of the inspections and making sure people were doing things in the right way? >> i've seen several suggestions for how we could improve the process of bsl 3 oversight and select agent oversight. and my sense is that each of those ideas, each of these ideas is certainly worth exploring. >> what do you think about that, dr. kingsbury? do you think it would be useful to have one agency in charge? >> we've said for a number of years there needs to be some entity in charge of a national strategy. not necessarily in charge of every laboratory in the country. the other thing -- >> so you're saying an agency in charge of developing the protocols and how you're going to do this?

>> and ensuring biosafety and biosecurity. but the more important issue is how many of these laboratories do we really need, for what purpose against what threat? one of the interesting things i've become a little more sensitive to in the last few weeks is that the whole structure we have that cdc and aphis are involved in is around the select agent agents and there are a lot of other bugs out there in other laboratories that are not select agents that also need to be protected and there's very little visibility about that sector of this enterprise. >> dr. frieden, i'm going to assume you're going to agree with dr. kingsbury that it would be very useful to have national safety and security standards that would apply to everybody. is that correct? >> i'm not sure i understood the question. i'm sorry. >> well, what gao says is that we don't have one single agency

developing national biosafety and security standards. and as a result, we have all these labs doing this type of research, a proliferating number of labs but there's no standard across -- there's nobody developing standards across all those agencies. >> i think there are many aspects of both biosafety and biosecurity which merit careful investigation. if we can figure out better ways to do them, we're certainly completely open to that. >> you think the protocol should apply to everybody? >> protocols may be very specific for the different situations but they should all adhere to the highest standard of safety. >> dr. dick, what's your opinion of this? >> i think that there should be a single oversight body. right now for the select agent program, there is a single

oversight body made up of the division of select agents and toxins at cdc. there is a single oversight body in agriculture that makes up the other half of that select agent program. together we meet on a monthly basis. we have the directors and assistant directors of the programs that are in the two programs and we have ogc and other counsel present. >> if that's the case, why are we having all these problems then? >> so what we need, what we have is a single set of biosafety and biosecurity regulations that are followed by both sides. >> but we don't have that now? is that what you're saying? >> i think we currently do have that. i do agree with dr. frieden that eventually after we get done with this investigation, we should take a very close look at all of the issues and see if there are updates that need to be made to biosafety and biosecurity.

>> thank you. i now recognize dr. gingrey for five minutes for questions. >> mr. chairman, thank you. i'm going to address my questions of this panel to dr. frieden. dr. frieden, thank you very much for being here and providing the subcommittee with your testimony. i actually have a number of questions for you. in fact, four. and i'll get right to those since time is of the essence. firstly, can you please describe the policies and procedures cdc has in place to handle biosafety issues that may arise from human error? like what happened in the bioterrorism rapid response and advance technology laboratory in atlanta on june the 5th. >> we have extensive policies and procedures but what we are doing now is implementing a moratorium on all transfers out of bsl 3 and bsl 4 laboratories while we review each laboratory's policies and procedures to ensure that there's appropriate inactivation

before any materials are transferred out. >> i appreciate that answer. and you explained that to us i think last week in an informal setting, and i think that's a good thing. that leads to my second question. what is the impact and the cost of the brrat laboratory shutdown? if you shut down those two laboratories for "x" number of days, do you have a cost estimate in regard to them being offline for a period of time? >> i don't have a cost estimate for that. the impact of the moratorium is potentially significant. so we're working rapidly to rigorously assess protocols and where there are situations such as the diagnosis of drug resistant tuberculosis or helping control the ebola outbreak or beginning work on next year's flu vaccine, we will work to ensure that we can do that safely in time. but there are real challenges with this moratorium.

one of the brings that the brrat lab does, the lab associated with the anthrax incident, is to provide to the laboratory response network, a network of over 150 laboratories, proficiency testing to make that she can rapidly identify anthrax and other dangerous pathogens safely. we'll figure out a way to do that safely in time. >> i would think time is of the essence in regard to cost. but as you say, safety is the most important factor. you have to get it right. i'd certainly agree with that. should inactivated select agents be added back to the select agent list? >> i think that what we need to ensure is that any inactivation is done completely because once something is inactivated, it may be able to be used. it may be necessary to use that, for example, to diagnose it. and you wouldn't want to have to follow select agent

requirements diagnosing something in a hospital lab or clinical lab or even in the field. but the key point here is to have that two-key system the chairman mentioned in that meeting. that two-key system to make sure when an inactivation is taken it is verified that the materials are inactive. >> the last question, dr. frieden, in your testimony you noted you only learned of the march 13th, 2014 shipment from the cdc influenza lab, a virus that was cross-con tame nated with h5n1 to a usda laboratory on july the 9th. so that's from march 13th to when it actually occurred or when you learned of it on july 9th. can you please describe how you are going to improve communications of these incidents up and down the chain of command? >> that was. in fact, it was the afternoon of

our meeting which was in the morning when i learned about this if i remember correctly. what your question gets to is the crux of the matter which is how do we improve the culture of safety at cdc. that's going to involve a number of steps that we think will succeed but will take time. we need to encourage reporting. we need to encourage all staff to take responsibility in addition to having a single point of accountability for laboratory safety. we need to have a clear vision of working safely. we are, after all, the prevention agency, and we want to apply that same rigor that we apply to our work in the field and in disease control to preventing any incident from happening in our laboratory. we also want to build on strengths and identify the laboratories that are doing this very well within cdc and identify the practices that they are taking that will prevent these incidents. and finally, i think coming up with ways to monitor progress and track progress and

identifying what are called the critical control points. what are the flash points? what are the areas where problems may occur. and then developing redundant, effective, validated, monitored ways to address those critical control points, whether it's inactivation or transfer of materials or making sure the materials transferred only contain those materials. we have terrific scientists at cdc, and they are now focusing their creativity, their energy, their commitment on improving our culture of safety. >> dr. frieden, thank you very much for that. mr. chairman, i'll yield back my 30 seconds. >> now recognize mr. waxman for five minutes. >> thank you, mr. chairman. dr. frieden, last friday when you released the cdc report on the anthrax incident, you announced you were imposing a moratorium on cdc transferring any biological samples out of

any bsl-3 or bsl-4 labs until they had conducted a lab-by-lab assessment. additionally, you closed the bioterrorism rapid response and advanced technology or the brrat laboratory and announced it will remain closed until it as approved to reopen under safer conditions. these seem like appropriate interim steps until cdc can undertake a comprehensive safety review and ensure that the proper procedures and protocols are in place moving forward. dr. frieden, how long do you anticipate this moratorium lasting and the brrat lab being closed? >> the short answer to your question is as long as it takes to ensure that they can open safely. the longer answer is that there some are things that need to resume. for example, proficiency testing for select agents in the laboratory response network. and that's something we will look at very carefully. but i am committed we will not

open them until we can open them safely. >> what steps are you taking to lift the moratorium and reopen the facilities and when will you know -- how will you know when it's safe to do so? >> i have appointed dr. michael bell who is a top expert at cdc not only in laboratory science but also in safety. he works within the hospital infection control and safety unit of cdc to oversee a high level working group reporting to me. and they will develop in the next day or so, finalize criteria by which they will assess each of the laboratories. then each laboratory will look at its own protocols and practices and determine whether they are validated, effective and scientifically proven and implemented in a way that we can be assured they will be applied. and then each laboratory will apply to him for resumption and lifting of the moratorium. i will review his recommendations and ultimately

approve laboratory by laboratory reopening of this process. i would just mention this is not a small thing because many of our laboratories that have bsl-3 laboratories have adjacent bs l-2 laboratories and much of their work has to be done in the bsl-2. they inactivate in the bsl-3 and move to the bsl-2. that work has all stopped at this point until we can ensure we're doing it safely. this is one of the things that really is a tipping point for improving the culture of safety at cdc. >> one of the more disturbing findings of cdc's own report on this incident is that scientists use a pathogenic strain of anthrax when they could have used a nonpathogenic strain, isn't that correct? >> yes, that is. >> when the moratorium is lifted and the brrat lab is opened, will you have clearer standards and protocols to make sure scientists are not unnecessarily

using potentially dangerous strains of bacteria when it's not necessary? >> yes. >> gao and aphis both conducted investigations of the brrat laboratory following the june anthrax exposure. dr. kingsbury and dr. dick, you believe the moratorium and lab closure an appropriate response to this incident, don't you? >> yes, i do. >> okay. we should not forget today that the reason cdc conducts their special agent research is to help keep americans -- the american public safe. cdc serves a critical role for studying dangerous pathogens and finding cures and vaccines for deadly diseases. these labs are critical to our nation's response to bioterrorism threats. so i am interested in learning about how this moratorium and the lab closures are affecting the critical research these labs were conducting. dr. frieden, how did the

moratorium and lab closures limit cdc's research capabilities? what happens to the studies, some of which i'm guessing were operating on detailed schedules that were being conducted in the labs. >> we're looking at the moratorium in detail and identifying any laboratories which need to resume transfers for individual patient care or for public health response with highest priority. and we expect that those laboratories we will be able to get reopened for transfer very soon. but we've already heard from, for example, the laboratory that deals with drug resistant tuberculosis, the lab that deals with ebola and the labortory that deals with avian influenza that they have deadlines coming up for either patient care or public health response, and we will address that very quickly, but we will always put safety first. >> how do the closures and

moratorium affect research occurring at other labs outside of the campus? >> we provide proficiency testing and other materials to laboratories and so there may be impacts on some of our partners. the one we're most aware of now and we'll work to address before the deadline is provision of materials that companies need to make next year's flu vaccine. and we anticipate being able to do that on time. >> my time is expired but it seems to me that protecting the safety and health of your scientists, the moratorium and the lab closures appear to be the appropriate response. thank you, mr. chairman. now recognize mr. barton for five minutes. >> thank you, mr. chairman. in answer to a previous question, dr. kingsbury raised the point about how many laboratories there are. the gao has indicated that there are probably too many laboratories. my first question would be to you, dr. frieden.

why do we have so many laboratories, and are they all necessary? >> i don't know that there's a right number of laboratories out there. our job within cdc is to make sure we only work with dangerous pathogens where it's necessary to do that and that we do so safely. we will be taking a fresh look at everywhere we work with these pathogens internally at cdc to make sure it's kept to the minimum necessary to serve the function of responding to infectious disease outbreaks. we still have anthrax in nature and respond to events like that. we still have ebola with the largest outbreak in history now in west africa. the challenges we have are substantial. in terms of outside laboratories, our function in the division of select agents and toxins is to ensure the laboratories that are there are operating safely. >> well, it would seem that one way to increase security would be to have fewer locations and fewer laboratories. if you are only using the

extreme case, if you're trying to protect 100, that's going to be more difficult than if you're just trying to protect one. i don't know what the magic number is, but i think especially since the gao has said there are probably too many, that would be worthy of a look-see. dr. kingsbury, do you have an opinion on that? >> i'm not sure we've actually said there may be too many. i think what we've said is nobody knows how many there are, and nobody knows how many we need. and that goes beyond the scope of -- >> that's even worse in a way. >> that goes beyond the scope of cdc and aphis. and until there can be some kind of strategic look at what our requirements actually are, and they may be changing because of things like the ebola outbreak and so forth, but somebody ought to be thinking about this i think a little more broadly than a single agency at a time and that's basically our point. >> i'm going to ask the question, why are there 435

members of congress? what's magic about 435? and the answer is, that's as many seats or desks at the time they could put on the house floor, when they got to 435, they couldn't put any more and so it's an odd number and they just stopped. but there's nothing magic about it. >> that's correct. >> same thing with the laboratory situation. i think there should be a strategic review, and the sooner the better. the staff has asked me to ask this question. it concerns the fact that beginning in 2012, the united states department of agriculture and the center for disease control entered into a memorandum of understanding that allows the usda animal and plant health inspection service to inspect the cdc laboratories for compliance with the federal select agent program. since the select agent program was authorized in 2002, the cdc had been inspecting its own laboratory.

why did cdc decide to turn its inspection process over to the department of agriculture? was that because cdc didn't think that it could do the job itself? i'll ask dr. frieden that. >> we've made a number of improvements both in our own laboratories and in our regulatory function through the division of select agents and toxins. as i looked at this issue, i was concerned there was at least the appearance that we couldn't be objective in inspecting our own laboratories. i didn't believe that was the case. i believe that one part of cdc which has no organizational affiliation with another could do that objectively, but i didn't think the appearance was a good idea so i requested and aphis graciously agreed to take over inspections of our own campus so that there wouldn't be that appearance of a problem. >> if you had to do it over again, would you do the same thing? was it a good decision to let usda do the inspection? >> i believe that decision was

appropriate. if i had it to do over again, i wish i had recognized the pattern of incidents that we now recognize, which is why we put those prior incidents into our july 11th report. >> with that, mr. chairman, i yield back. or i can tell an aggie joke. i yield back. >> okay. thank you. now recognize ms. castor for five minutes. >> thank you very much, mr. chairman, and ranking member for calling this hearing today. i had the opportunity to visit the cdc last spring, and on the surface, they appear very serious about security, laboratory security. and yet, every few years there are these lapses. now an anthrax scare and avian flu issue that was not reported in a timely manner. and we have very high expectations for everyone at the cdc. i am impressed with everything

that's happening there, but for the high containment biological laboratories to have these lapses is not acceptable. so it's really troubling that although numerous government agencies over the past few years have warned cdc about problems at the high containment labs, it appears cdc has not heeded those warnings. we know of at least 14 separate reports, letters and lab investigations from gao, the u.s. animal and plant health inspection service and hhs inspector general that documented a series of safety lapses and lack of oversight at cdc high containment labs. dr. kingsbury, your testimony is invaluable here. can you tell us more about the concerns gao has identified with regard to safety lapses at the high containment labs? you've said now someone has got to look at the number of labs across the country as well. who is that? what entity is that? what are your recommendations?

>> i wish i was in a position to say i know the answer to that. one of the difficulties we faced in making that suggestion is that when you look around the government, because they are being built and managed across multiple agencies and each agency has its own mission and its own focus, it's difficult to think about who would be the single agency. we have discussed the issue with the office of science and technology policy at the white house. but they, while they have some overarching responsibilities, they don't have staff and management officials that would permit actually doing it that way. so we don't really have a good answer to that question, but we think it's worth just keeping the issue on the table, particularly in tight budget times. >> and you mentioned in your opening statement that you have heightened concerns because of budget cuts. talk a little bit about that.

is there a particular area we should be focused on? >> well, it's just that as i said in my statement, the management and the building and management and upgrade of these kinds of laboratories is relatively expensive compared to just building ordinary buildings. and so if we're going to have "x" number of laboratories, i would like to see the strategy that was going to permit us even in tight budget times to continue to fund them, to continue to upgrade them when necessary, and to manage the biosafety and biosecurity programs that are necessary to keep them safe. so that total picture just isn't available now, and that worries us. >> okay. dr. dick, do you think this has anything to do with budget cuts? >> i don't believe that it has anything to do directly with budget cuts. we've been able to accomplish our mission in support of the select agent program over the recent years and provide the funding that's necessary.

>> and before the june anthrax incident, aphis conducted at least six separate investigations at the campus facilities in 2013 and 2014. can you summarize your findings in those investigations? >> i think there were a number of findings that -- some of which were found in the recent finding, some of which were not. simple things that people would maybe think are simple like unlocked refrigerators, those kinds of things, up to and including more serious incidents, if you will, around invalidation protocols not being up to date. >> and dr. frieden, it's troubling with -- i mean, this has gone on for years now with gao, aphis, the inspector general, outside experts have been calling attention to these issues. and i'm encouraged because you've been forthcoming in your statements.

you haven't been defensive, but what is your current action plan now going forward in detail? is there a culture among researchers? what is it and what -- get specific for us from this day forward with these recommendations, what are you going to do in the time frame? thank you. >> first, i think for past incidents, the staff at cdc and the scientists did take the reports seriously and did respond to those individual reports. what we missed was a pattern. and you are absolutely right that that pattern was an inadequate culture of safety. so the overarching challenge now is to ensure that we establish and strengthen a culture of safety in all of our laboratories throughout all of cdc, and there are a number of steps that we're going beginning to do that. the first is the moratorium so that we stop and think about that particular procedure of inactivation, make sure it's done right. the appointment of a single point of accountability for laboratory safety throughout

cdc. the establishment of a working group that that person and mr. henderson will lead. the invitation to an external advisory group and i intend to invite some of the leading independent experts of the country by the end of this week to serve on that advisory group for cdc. a hard look at all of the critical control points where there may be a problem with lab safety and reviewing to make sure that we have protocols in place that are validated and verified. it gets back to that trust but verify approach. we need to make sure that we are empowering our laboratory staff to report and to identify ways to improve safety and security. we also need to verify that's happening. >> thank you. >> the gentle lady's time is expired. now recognize miss blackman of tennessee for five minutes. >> dr. frieden, i want to come back to you. if you'll go to tab 15, the

usda/aphis investigation. and let's look at that. the -- this started ten days after the event. there was 18 days after possible exposure. you had a lot of really awful basic errors. even you admit there's not a culture of safety. there's not that double check system. and it is something that when you look at worker safety, how it was compromised and then the management lacking the basic information on what substances to use to have the contamination cleaned up, so looking at this tab and that investigation, i want you to detail for the committee what new policies have been designed as a result of this and how did cdc guarantee that the new policies are

followed immediately -- effective immediately? you know, our hospitals and organizations that get all sorts of new rules from hhs on friday afternoons at 4:00. they're effective immediately. so i want you to detail for us how you implemented that and what the new policies are. >> so effective immediately all transfers, not just from these two laboratories, but from every single bsl-3 and bsl-4 laboratory at cdc have been stopped. effective immediately, these two tab loaboratories, have been closed. those two laboratories will not be reopened until both aphis and i are confident they can be reopened safely. we've also appointed a single point of accountability to look at this and to review before we reopen, before we begin any more transfers procedures that are in place to ensure that they can be done safely.

>> how could it possibly have transpired that your management team couldn't even decide on the formula of bleach to use to clean up the contamination and see whether the on-site clinic was thorough and consistent in examining the staff potentially exposed to the anthrax? >> in the first week after the anthrax potential exposure was identified, we did not respond in the way we would respond to an outside emergency. that's one of our after action findings that when we deal with emergencies whether it's ebola or fungal meningitis or another problem, we activate our emergency center, or even if we don't activate it, we utilize the resources of that center to have a systematic, structured, intensive, immediate response. that wasn't done for the first week after the anthrax potential exposure, and that's something we will be sure to do in the

event of any such internal event in the future. >> let me ask you this. did the management team get preferential treatment to the point that they were unaware that the staff was turned away? >> no, absolutely not. >> okay. and then why didn't the staff feel confident in expressing their worries to their managers so that they could get adequate treatment? >> i'm not certain of what that -- what's behind that. i do know that part of encouraging and strengthening the culture of safety is making sure that people are encouraged and, in fact, reib forced and rewarded for bringing forth problems if they think are problems and potential problems. >> do you think it had to do with the existing work culture that was there at the cdc? >> i think, you know, at cdc, scientists are so used to risk, they go out into dangerous places where they're not sure what the risks are going to be, that sometimes if you work year in and year out with pathogens

that are scary, you can get inured to that danger. >> let me ask you another question. once the june incident was discovered, why, why did it take you so long to track down the anthrax and why wasn't there a record of where this was stored? >> well, as soon as -- on june 13th, as soon as we identified there was the potential that any of the plates that were sent out of the containment lab were not sterile, we immediately recovered those plates and put them back in the secure facilities. that's the best of my understanding. >> why wasn't there a record of where it was stored and why was it stored in unlocked refrigerators stuck in an unposted room and hallways? >> my understanding, and we'll have to confirm that in the coming days, is that those findings relate to primarily the materials that were believed to have been sterile and sent out

of the laboratory. it's not as if there was an anthrax cultures being kept in an unlocked, unsecured place. i think the point there was that once that initial error was made of thinking something had been inactivated when it had not been -- or may not have been inactivated, then that material was then out of the containment space. that's my understanding. >> thank you. mr. chairman, i yield back. >> all right. now recognize mr. green of texas for five minutes. >> thank you, mr. chairman. and, first, of all our panel, there are a number of federal agencies that handle some of these substances, not just cdc. is there a general protocol that all the agencies look at and coordinate handling these substances, dr. frieden? >> when it comes to select agents, then both cdc and aphis

establish standards and then inspect and enforce those standards. other than select agents, there are agency by agency or entity by entity approaches that may be specific to the type of research or to the type of agent. >> okay. so there is some umbrella type standard for all federal agencies. >> for select agents, there is. >> okay. dr. kingsbury, can you summarize your recommendations for us, and can you elaborate on which of these recommendations would require congressional action? >> [ inaudible ] -- sorry. if you're talking about our recommendations, i think that resolving this issue of whether there is a national strategy probably can't be done without congressional action, and it will take some thought to get us there. >> okay. dr. frieden, do you agree with these recommendations? will you be implementing those

that you can within your control? >> in terms of laboratory safety recommendations at cdc, we will do everything to implement the recommendations. the report we released on july 11th has a number of steps that we are already beginning to implement. >> okay. any of them require congressional action or is that something you control within your agency? >> at this point i'm not aware of anything that would require congressional action for us to take appropriate steps. >> dr. dick, do you have any recommendations for congress or cdc that congress needs to deal with? >> at this point in this investigation, we do not have anything that can't be controlled through the select agent program and our work with cdc. >> okay. dr. frieden, does cdc, based on the findings in the report, have any recommendations to congress? you have none for us? >> we're focused at this point on doing our jobs as well as possible ensuring that we

strengthen laboratory safety throughout cdc and use the findings from this experience to strengthen our regulatory function through our division of select agents and toxins which inspects and regulates hundreds of entities around the country that work with these materials. >> okay. let me ask you about the cdc budget, and, again, i have heard other questions from my colleagues that this was not a budget issue as much. has cdc received adequate funding from congress to conduct its safety mission, period. obviously you have other missions. >> i think the challenges for safety are more than just funding. there are a variety of issues in implementing safety policies and procedures, and i don't think the primary issue here is a lack of funding. >> okay. some of the witnesses we've been hearing from today have stated cdc employees need better training and there needs to be better standard operating procedures but that overall there is a problem with the culture at cdc. dr. frieden, do you agree with

these assertions? >> i do agree with them. i think that while we have scientists who are the best in the world at what they do, they have not always applied that same rigor that they do to their scientific experiments to improving safety, and that's why we're taking a number of steps to strengthen the culture of safety at cdc, and part of that is to encourage reporting of potential or actual problems. and because of that, it is possible, though i don't know of anything at this point that i'm aware of, it is possible that in the coming weeks and months we'll hear of other things in the past or that occur, and that may be a reflection that we've strengthened that culture of safety rather than that we failed to address it. >> well, if it's an issue of culture, and again like you said, you have some great labs and i'm familiar with some of them, is it just because they deal with these dangerous substance so often they get lax

and they're more interested in what they're working with than maybe the safety of what they're dealing with? >> i think that's a significant part of it. that if you work with something, even if it's a deadly microbe day in and day out, year after year, you get a level of familiarity that may lead to doing things that you really shouldn't do, and that's why we have to have double-checks in place, policies and protocols, training, and a culture of safety with the vision that we will work to minimize risk such that no worker and the public are never exposed to a risk that could have been prevented in our laboratories. >> well, and i guess that complacency, it needs to be monitored literally every day 24/7 because of what you do. is that part of what you're trying to do at cdc with the guidance for other agencies? >> absolutely. that's what we've done by establishing a single point of accountability for laboratory safety, an em pow you ared working group that will work

with that individual. even with that individual and with that group, laboratory safety is really something that everyone who touches a laboratory needs to be conscious of and think of ways to continuous pli improve. >> mr. months to see the success, and, again, it's almost like retraining some of the smartest people in the country to be certain what they are doing with the substances they are dealing with. >> that is a good idea, but i do also -- when you were responding to mr. green's question about other authorization that would be required, can you give this committee details on what that would be? do you have your mike? your microphone. >> i don't actually have a basis on which to be specific about what might need to be done. i think we probably need to continue to work with your staff to talk through what some of the options might be going forward. >> thank you. >> now mr. harper is recognized for five minutes. >> thank you, mr. chairman, and

thank you for holding this hearing on a very important issue. some agencies can be dysfunctional and there's no real concern or harm in that, but the cdc is not one that can be dysfunctional. so we're very concerned about safety within the labs for, obviously, the workers there and also for the public on how we're going to address that. and if i could, dr. freiden get you to refer to tab 7, a letter you sent in 2012 to the committee responding to concerns about cdc lab safety. in that, you stated a senior official was designated to report directly to you about safety issues and those things there. who was that senior official? >> i will have to get back to you about that to get you the name and details of what was done with the person in the letter. >> obviously, the question would be, and i would hope you could have answered today was, who was that senior official, and what

were the results of that action? and then the question that perhaps you can answer now is how is the appointment of dr. michael bell as the new cdc point person on lab safety when we don't know who the old point person was? how is that more effective other than we know his name? >> what i believe to be the case is that what we did in 2012, similar to what we did in other incidents, was we did address comprehensively the specific problems identified so there were concerns about air flow issues. there were concerns about some of the security issues in our laboratories. and while i would never say that we're a hundred percent resolved on those things, we really focused on those particular problems. what we missed was the broader pattern, and that's what dr. bell is overseeing now. >> does this mean dr. bell will now continue until -- that there

will always be a point person? is that your plan? >> yes. >> yes. dr. bell is the person now. we'll transition that to a single point of accountability for lab safety, and one of the things that dr. bell and his group will do is recommend where that entity should sit within cdc to be most effective. >> the cdc reported that since 2007, there's been two surprise inspections of cdc, both performed by cdc's division of select agents and toxins before aphis took over inspections of cdc labs. since 2012, i show there's been 11 inspections of cdc labs. i'd like to know why hasn't aphis conducted any surprise inspections of labs, or have they done that? >> thank you for the question. we conduct surprise inspections to enforce compliance between renewal inspections, which is every three years. we, as we stated, came on in

late 2012 as the oversight entity for cdc. we actually have been there six, seven if you include this last incident time in the last year and a half. we have not had to do a surprise inspection since we're there regularly. >> the last time a surprise inspection was done was when? >> we have not done a surprise inspection prior to taking over in 2012. i'm not familiar with before that. >> i will not ruin the surprise by asking when one is planned, but it does seem like -- >> we intend to follow up -- >> that's a great tool to have. >> absolutely. certainly, first and foremost, we're going to follow up on the current incident with them in making a revisit when cdc indicates they are ready for us to revisit, and then we'll do surprise inspections after that point.

>> let's say, and this, if it's determined that a dangerous biological agent has been stolen, who do you report that to? >> so we have a protocol dealing with theft. there's been no theft of bilogical agent reported by the cdc or regulated facilities in the ten years of the program, to my knowledge. when there are concerns for potential theft or misplacement, we work with law enforcement, including the fbi, to do a joint investigation. i will mention our expansion of surprise inspections was something that we directed over the last few years at cdc because we felt that was very important to do. >> so you said there have been no reports of stolen agents. >> that's my understanding. >> what about missing biological agents? >> there have been losses at certain facilities, and in those circumstances, we also

coordinate with the fbi, usually an issue of inventory control. so as earlier, we were talking about critical control points, such as inactivation of virledge pathogens, similarly, inventory is a critical control point. >> i yield back. >> thank you. i do want to ask clarification of mr. harper's question, though. when he asked about theft of an item, your inventory control is not so tight that someone could not walk -- someone could take something, replicate it, and walk out with some. am i correct on that? >> inventory control is one of the critical controls to prevent loss or theft, but there have been, to my knowledge, no thefts reported from any of the select agent regulated labs including cdc's over the past decade. >> there was the army one in texas a few years ago. >> i'm not familiar with that. >> okay. thank you.

>> thank you, mr. chairman. welcome to our panelists. the cdc is responsible for registration and oversight of all laboratories that possess, use, or transfer select agents that could pose a threat to human health. while aphis is responsible per those select agents that pose a threat to animal or plant health. select agents that pose a threat to both human and animal health, like anthrax, are regulated by the cdc and aphis. that being said, can you tell us what gao has found with regard to the increase in the number of high containment biolabs? >> i'm not sure i understand the question. within the select agent program, i think there is information about how many laboratories there are, and they are

regularly inspected, as these gentlemen have just been saying. our concern about the national strategy is there's a lot of other laboratories that deal with highly infectious pathogens, not considered select agents, and nobody knows how many of those laboratories there are. >> but with the high containment biolabs, is there -- in that given category, is there an increase that has been measured by your review? >> i didn't hear the word -- >> is there an increase -- >> there has been an increase. since the anthrax attacks in 2001, the last time we actually tried to count them was two or three years ago, and i think at that point, it looked like there we were slightly fewer than there were the year before, which we think is maybe just a budget problem. but that, agoain is the only ons that people are actually aware of.

i think there's private entities and state government entities that have bsl 3 and bsl 4 laboratories that are not overseen in the same way, and that is of little concern to us. >> well, is -- what accounts for the growing number of labs you suggested are out there? >> well, following the anthrax attacks in 2001, there are a number of agencies whose missions touched on the issue of biological weapons and whether those pathogens could be used to attack our country, and so each within their own sphere developed a program to counter those possible threats. each got funded by the congress to build additional laboratories and so forth, so it's just a fragmented program that had a

very strong rationale at the beginning, but right now i think there's perhaps a different rationale that might be articulated, but nobody is in charge of doing that. >> so are there -- with this increase in a number of labs in the various missions associated, what would your recommendations be to addressing -- >> well, we made recommendations there could be a single entity with responsibility for developing a national strategic plan and national standards for the operations of high containment laboratories. the dilemma is figuring out how to do that in the current environment with competing interests among the agencies and so forth. there's even a competing issue in the congress since committees of the congress have different jurisdictions over agencies. so it'