subject to the penalties set forth in section 1001 of the code. you may now give a five-minute written summary of your statement. >> chairman murphy, ranking member degette -- chairman murphy, ranking member degette, members of the subcommittee, thank you very much for this opportunity to appear before you. i'm dr. tom frieden. 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 savt. the fact that it appears that no one was harmed and that there were no releases do sd 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 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 the laboratory safety reporting directly to me as the single point of accountability. he will review the moratorium and lift it lab by lab 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 and scientific investigation and we will now apply that same wrrigor to imflg safety in our labs. 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 that 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 incidents to happen. reduced the likelihood of an occurinence 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. >> 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. >> 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 possible live anthrax at the cdc's campus. i'm dr. jere dick, associate administrator for afus within usda. they 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 cdc and the oversight of select agents because of our expertise and experience safely working with select agents over the past

century through our efforts to precent dangerous disease agents from affecting agriculture 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 diagnosticians and experts in though effective working of high containment laboratories to ensure objectivity, aphis and cdc signed a memorandum of understanding in october of 2012. which makes aphis the lead inspection 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. especially trained aphis inspection team of veterinar yaens and plant pathologist spent nearly two weeks beginning june 23rd conducting a facility review of the laboratoriey eies cdc personnel. aphis briefed cdc officials on july 2nd outlining the efficiencies so they could immediately begin taking

corrective actions. aphis found the laboratory did not use inadequate activation 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 his 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, please point that microphone very close to your mouth. a lot closer than that. bring it really -- bring it -- bring the mike 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 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, rerk inizing the management and operation of these labs is an expensive venture. if they aren't 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 follows, there will be no further episodes. so i'll just add that one thought to the debate about the incident itself. thank you, mr. chairman. >> i'll 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 thunderstorms 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, 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. this is a ziploc bag. i have to think what in heaven's name would go through the mind some of 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 deal with anthrax. have you talked to these individuals and asked them why? >> i have been directly involved in the investigation. i will be directly involved in the remediation of the problem 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 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 nejigence? do they understand the seriousness of this to the american public health? >> i think furst 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 any time saying, hey, there may be a problem 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 known to endarge themselves or others, then we will take appropriate action. >> the people who were not approved were able to handle select agents -- were able to access space through june 17th, four days after the incident was discovered. now my assumption is they are

pretty smart people but it's extremely disturbing to think they aren't thinking of this. but let me ask this. it's been a week since you learned about the march 2014 cdc shipment of h5n1 shipment. have you find out why there's a six-peek delay and is there a cover-up involved in this or is this bureaucratic hurdles are too high? what was the cause? >> i've only gotten some 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 the situation is an emergency or someone 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 whens 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 virlens avian influenza was cross-contaminated in our laboratory with the high pathogenic h5n1. i have to get more alarms going off when you try to walk out of walmart with the shirt that hasn't been paid for. is there any evidence of cover-up hiere from employees nt wanting others to know -- >> we've seen at this point no evidence of a cover-up but we see the need that to encourage reporting. any time there's a problem or potential problem so we can assess it and take rapid action. >> i now recognize ms. 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 these bio agents,

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 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 conducted them to this point. but the overarching issue of lab safety touches many parts of both the public sector and 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 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 security. >> would it 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 the 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? >> i think we currently do have that. 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 biosavt 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 foonl 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 of transferred out. >> i appreciate that answer. and you explained that to us last week. an informal setting. 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?

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 begin work on next year's flu vaccine. we'll work to ensure we can do that safely in time. but there are real challenges with this moratorium. one of the brings the brrat lab does, associated with the anthrax incident, is to provide to the laboratory response network, a network of over 1 fist laboratories, proficiency testing to make sure they can rapidly identify anthrax and other dangerous pathogens safely. so 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 we need to ensure 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:ical lab or even 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 whin an activation 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-contaminated with h5n1 to a usda laboratory on july 9th. so that's from march 13 tot wth when it actually occurred or when you learned of it on july 9th. can you advise how you'll approve of these incidents up and down the command? >> it was the afternoon of our meet chicago 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 all staff to take responsibility in

addition to having a single point of accountability for laboratory safety. we need a clear vision. we are the prevention agency and want to apply that same rigor we've applied to our work in the field and in disease control to prevent anything 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 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 under take a comprehensive safety review and ensure that the proper procedures are in place moving forward. 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 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 implement them the way we can be sure 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 bsl-2 labs and most of their work has to be done in the bsl-2. they activate in bsl-3 and move

to 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, 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 daurges 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 -- 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 lab 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 that 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 the 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 dont 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 africa. the challenges 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 one way to increase security would be to have fewer locations and fewer laboratories. you are only using the extreme case if you are trying to protect 100, that's going to be more difficult than if you are just trying to protect one. i don't know what the magic number is, but i think especially since the gao has sid 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 tragedy 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 a little more broadly than a single agency at a time. that's basingally 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 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 good so aphis agreed to take over inspection of our own campus so there wouldn't be that appearance of a problem. >> if you had to do it over again, would you do it again? was it a good decision to let them do the inspection? >> if i had to do it over again, i wish i had recognized a 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, mr. chairman and ranking member for calling this hearing today. i have 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 lapses and lack of oversight at cdc high containment laps. 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 have 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 the people would maybe think are simple like unlocked refrigerators. those kinds of things. up to and including more serious incidents if you will, of 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 and then 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? >> first, i think for past incidents, the staff at cdc and

the scientists did pick 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 safety in all of our laboratories throughout all of cdc. and there are a number of steps we're 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 acountcountability for safety. establishment of a working group that person and mr. henderson will lead. the invitation to an external advisory group and i intend to invite 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. gentle lady's time has expired. now ms. 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 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 are 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 laboratorielaboratories, buy single bsl 3 and bsl 4 laboratory at cdc have been stopped. effective immediately, these two laboratories, the part of the laboratory and the brat lab for the bioterrorist response have been closed. those two laboratories will not be reopened until both are confident they can be reopened safely. we appointed a single point of accountability to look at this and to review before we reopen and begin anymore transfares and procedures to ensure they can be done safely. >> how could it possibly transpired that your management team could not 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 in an outside emergency. that's one of our after action findings that when we deal with emergencies whether it's fun gal meningitis or another problem, we activate the center, and even if we don't activate if, we use the resources of the center to have a systematic, structured, intensive immediate response, and that was not done after the exposure, something we'll 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 they were unaware the staff was turned away? >> no, absolutely not. >> why didn't the staff feel confident in expressing worries

to their managers so that they could get treatment? >> i'm not certain what's behind that. i know that part of the encouraging and strengthening the culture of safety is making sure that people are are encouraged and awarded for bringing forth problems if they think there are problems and potential problems. >> do you think it had to do with the existing work culture there at the cdc? >> i think at cdc, scientists are so used to risk. they go out into dangerous places where they are not sure what the risks are going to be that sometimes you work year in and year out with pathogens that are scary, you can get immune to the 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?

>> as soon as we identified there was the potential that any of the plates sent out of the containment lab were not sterile, we immediately recovered the plates and put them back in the secure facilities. that's the best of my understanding. >> why wasn't there of record where it was stored and why was it stored in unlocked refrigerators in an unposted room or 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 laboratories. it's not as if there was an anthrax cultures kept in the unlocked, unsecure place. i think the point there was that once that initial error was made of thinking something had been inactivated when it was not -- may not have been inactivated, then that material was then out of the containment space.

that's my understanding. >> thank you. mr. chairman, i ye back. >> all right, i recognize mr. green of texas for five minutes. >> thank you, mr. chairman, and, first, of all our panel, there's a number of federal agencies that handle subsidies, not just cdc, is there a general protocol all agencies look at and coordinate handling these substances? >> when it comes to select agents both cdc and afis establish standards and effect and enforce standards. other than select agents, there are approaches that are proempt to the type of research or type of agent. >> okay, there's an umbrella-type agent for

agencies? >> for select agents there is. >> can you summarize recommendations for us and can you elaborate on which recommendations would require congressional action? >>. >> if you are talking about our recommendation and talking about a national strategy cannot be done without congressional action and will take thought to get us there. >> okay. >> dr. freiden, do you agree with the recommendations and implement them as you can within your control? >> in terms of laboratory safety regulations for cdc, we'll do everything to implement these recommendations with the report that we released on july 11 th 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 in our work with cdc. >> okay. dr. freiden, based on the report, you have no recommendations for us? >> we're focused, at this point, doing our jobs as well as possible ensuring we strengthen safety throughout cdc and use findings from this experience to strengthen our regulatory function in the division of select agents and toxins that inspects and regulates dozens of entities that work with these materials. >> let me ask you about the cdc budget, and, again, i heard other questions from colleagues this was not a budget issue as

much. have they received add quality funding from congress to conduct safety vision, 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 heard from today testified cdc employees need better training and better procedures, but overall, there's a problem with the culture at cdc. 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 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 the safety at cdc, and part of that is reporting partial or actual problems, and because of that, it is possible, although i don't know anything at this point i'm aware of, but it is possible 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 we failed to address it. >> well, if it's an issue of culture, and, again, like you said, you have great labs, and i'm familiar with some of them, is it just because they deal with dangerous sub substantiations so often they are lax and more interested in their -- what they are working with that maybe the safety of what they are 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, train, and a culture of safety with the vision that we will work to minimize risks such that no worker and public are never exposed to a risk that could have been prevented in our laboratories. >> well, and i guess that complacency needs monitoring literally every day 24/7 because of what you do. is that part of what you're trying to do at cdc and with the guidance of other agencies? >> absolutely. that's what we've done by establishing a single point of accountability for laboratory safety and empowered working group that work with that individual, but emphasizing that even with that individual, and even with that group, laboratory safety is something that everyone who touches a laboratory needs to be conscious of and think of ways to continuously improve. >> okay. well, mr. chairman, i hope that we have a follow-up in a few months to see the success, and, again, it's almost like retraining some of the smartest people in the country to be

certain of the substances they are dealing with. >> that is a good idea, but i do also -- when you were responding to question about authorization, can you give us details on what that would be? 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. holding this hearing on a very important issue. some agencies are dysfunctional and there's no concern or harm in that, but cdc is one that cannot be dysfunctional so we're concerned about safety within the labs for, obviously, the

workers there, and certainly 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 201 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 here. 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 rules of the 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 laborato laboratory, 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 that mean he'll continue until -- that there's always a point person 12? >> 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 taking 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 there been surprise inspection of inspections at cdc 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 and seven 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 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 for when one is planned, but it seems like we -- >> 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 determined a dangerous 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 regular 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, the fbi, and joint investigations. i will mention our expansion of surprise inspections was something that we directed over the last few years over cdc because we felt that was very important to do. >> so you said there've been no reports of stolen agents. >> that's my understanding. >> what about missing bilogical agents. there have been losses at certain facilities, and in those circumstances, we also coordinate with the fbi, usually an issue of inventory control. we talked about critical control points line inactivation of 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 dr someone could take something, rep kate 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 cdcs 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 pose a threat to human health. responsible for select agents

that pose a threat to animal or plants' health. agents that pose a threat to human and animal health like anthrax are regulated by the cdc and afis. can you tell me what gao found in the number of high containment bio labs? >> i'm not sure i understand the question. within the select agent program, there's select laboratories and regularly inspected as the gentleman have been saying. our concern about the national strategy is there's a lot of other laboratories that deal with highly infectious pathog s pathogens, not considered select agents, and nobody knows how many of those laboratories there are. >> but with the high containments, 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. in 2001, the last time we tried to count them, two or three years ago, and i think at that point, looked like there were slightly fewer than the year before, which we think is maybe just a bud problem, but that, again, is the only ones that people are 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 -- whatting th accor

the growing number of labs you suggest are out there? >> well, following the anthrax attacks in 2001, there are a number of agencies whose missions touched on the issue of bilogical 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 dr. >> 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. they are 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's a tough problem to solve, but worth spending some time even at a theoretical strategic level to address the issue and think through how we go about doing it in the future. >> what are your views here in terms of the growing numbers of of the labs and just what -- how to move forward?

with the activity here in the u.s. >> i do think this is a complicated topic for which there's probably not a quick and simple solution, but just logically, the more places with dangerous pathogens go on, the more possibility there is of accidents or accidental releases, so ensuring that the work that work that happens is happening in a safe environment is critical and the key concept i think we have to apply is risk-benefit. i don't think we can ever guarantee 0 risk for some of the things that are done that we can do everything humanly possible to get that risk as low as possible, but we have to ensure that the benefit is something that's reasonably likely to occur. >> thank you. thank you very much. with that, i yield back, mr. chair. >> thank you, i now recognize mr. griffeth for five minutes.

>> thank you, i appreciate, and i appreciate you here to testify to us. if i could get you to turn to tab 5 in the booklet. >> as you look at tab 5, that the inspector general report regarding the cdc for a minute which says it was sent to you. have you seen this before at some point? front page says it was acceptability to you. okay. if i could direct you to page 5. the inspector general's office could not verify approved individuals for select agents required the correct training. do you see that? >> yes. >> likewise, select agent inventory records are incomplete and you acknowledge that's on that page? >> yes. >> if you go over to page 6, the report sais that agents stored in areas not listed in the

registrati registration, page 6 -- >> yes. >> thank you. there was a vile of a select agent in the drawer and another found 16 viles store in an unsecured freezer. do you see that in that paragraph? >> yes. >> the report also states there were unauthorized transfers and packages received by unapproved individuals. now, my concern is this. with respect these the same kind of violations that then popped up and were found in subsequent inspections by the usda in 2013 and 2014 and revealed in the matter that brings us here today in the anthrax and flu situations? aren't they the same type of problems? >> the answer is yes and no. the specific problems that were

found led to a specific response. for example, on security, we implemented layers of security, lengthens the systems, locked, improved personal background checks and securities so in each of these, we -- >> let me -- >> we felt this question -- >> did you all do a system-wide after these were discovered? we have 2010, 20 13, and earlier in 2014, did y'all ever do a system-wide recheck? >> not adequately. >> noted a adequately. >> we addressed special problems with sincere effort to legislate my them, but we missed the broader pattern that we're now addressing by strengthening the culture of safety in our labs. >> all right. i do appreciate that, and i know you have to answer a lot of tough question, and i appreciate your demeanor today. i think that's appropriate and appreciated. that being said, look to page 7

and 8, five recommendations there. if you could read those out loud, that take place and let me though if they were followed up on. >> i can shorten it by saying the key one is the fifth which has to do with confirming materials are inactive before transferring them, and that was specifically what was not done in the anthrax incident. if we mied this broadly, this incident would not have hatched. the incident to give you saeps of it, in 2006, the same laboratory had a similar incident. that's why i direct it in the 2011 report. after that, they implemented a procedure for that particular type of bilogical material. when they had a different type of bilogical material, mooefing leaving the same laboratory, they did not mae that same procedure that would have end

acted it. it's the lack of administration pattern recognition that led us until the last few weeks not take the konsive sweeping kwhang and improvement in our safety culture we're now implementing. >> well, appreciate that. what about the other four? number five was important, but can you look at the other four? >> the first has to do with physical security measure, and i believe we've taken a number of steps there. there are still steps we have to do better on in that area. having to do with staff coming in and not swiping in every time, and -- >> you've indicated training, which is number three. what about number two? >> yes, i think we've made a great deal of process only approved individuals get access to select agents, and mr. henderson can speak more to that. >> number four? >> inventory is an area where we have done a number of things, but given the recent incident at

nih and it is a flash point we'll be reviewing all invenn to story work, a massive job to do it right, but we'll do that as well. >> well, i appreciate the safety of the american public rests in your hands, thank you, and i yield back. >> thank you. >> thank you. >> thank you, mr. chairman, and i want to thank the witnesses. as you can see from the tone of the hearing, there's complete bipartisan concern about what happened here. what i wanted to concentrate on is not the incidents themselves, but the response in particular to the anthrax release. the cdc report described delays in identification and potential of exposed individuals and potentially effective lab rooms and communication of the possible release of anthrax to all cdc staff that may have been

exposed, and that there was no clear lead for response to the incident in the first week. so, you know, the -- this -- i know you've discussed a number of these thing, but it's the management piece. once a problem was discovered and so i wanted to ask your doct doctor, what was your response to the finding? >> this was our finding, and we indicated that when we deal with outside events and currently dealing in west africa, we activate emergency operation center or sometimes we'll use facilities of the emergency operation center to manage a response more effectively. we should have dope thne that t moment we learned of the potential exposure. that allows us to break down

problems one by one, employee safety, clinical care, decontamination, scientific evaluation, investigation, and so instead of doing that in a systematic way, it was done unsystematically, and not as well as it should have been done. in the first few days, which i remember vividly, we were really know kused on the employees who may have been exposed in making sure they got into care and into treatment. >> but it took awhile to identify who those people were. ? yes, in effort to do that, we identified we didn't is the kind of systems needed or the system that we had in place were not used promptly, for example, security camera coverage to see who came into and left facilities on time. that was not done because one part of the agency didn't know or use those resources that the

root cause of the problem was not activating our incident command system. >> dr. dick, can you elaborate on that finding about response? >> yes. i think our findings were very similar to dr. frieden's. we had an independent team come in during and ongoing investigation by cdc and staff and select agent group was interviewing employees and workers from the various sections that were responding to this. we found very similar findings to those that he just indicated. >> okay. >> you know, i wanted to follow-up for a second on what the chairman was saying about the possibility of even stealing something that is a threat. you know, in the smallpox incident, it turned out that the viles were discovered at nih, but they could have been

somewhere else. nobody seemed to know. that's really disturbing too, that, you know, who knows, somebody could have taken them out. i mean so i'm not sure when you say nothing's been stolen, but it also says nothing could have been stolen. you want to respond to that? >> well, we have taken a number of steps to strengthen the security aspect of select agent registration. those steps include assessments for all people who work with tier 1 agents including looking at cybersecurity issues and personal reliability, ongoing access of personnel who have access to tier 1 agents, increase the physical security standards, incident response plan, and ongoing training. i do think that the concern for theft is real. some of these organisms still

occur in nature, and ensuring that where there are laboratories, not just in this country, but around the world that do tests on them -- >> well, let's worry about this country right now, and smallpox, of course, would be a big concern. let me just end with this, if i could, mr. chairman. whenever i hear the word "culture" and a culture problem, i know we have a real challenge on our hands. you know, hand washing changed the face of medicine. it's not sexy and people don't win nobel prizes over that thing, but it really, as part of the culture, made our medical system much more successful. huge advance. these kinds of small things that deal with culture and attitude and awareness of these kinds of

very simple thing, you need to primarily figure out how to make them part of the everyday thinking of your staff and, you know, we're willing participants here, and i yield back. >> thank you. i now recognize mr. johnson of ohio for five minutes. >> thank you, mr. chairman, and i, too, want to thank the witnesses for joining us today. dr. frieden, you're the guy on the hot seat, peppered with the questions, and i got a few for you as well. you know, the mission of cdc laboratories, as you well know, including carrying out work to protect the american public against bioterrorist activities. now, critical lab activities are shut down depending the outcome of the remedial evaluation and reform, so how will cdc address bioterrorism or other emergencies that might occur before they reopen? >> there's just one particular

laboratory shut. there are multiple other laboratories at c -- c that continue operation that would be able to respond to bioterrorist incidents. >> okay. there's no concern on your part because of the cdc errors we may limit our ability it protect the public? >> no, i'm confident that the incidents we saw did not cause any release of agents into the community. they most likely did not cause any exposure to cdc staff, but they really are a tipping point to improve our safety and functional to respond to an event. it's a step of sending something out of the high containment space that i issued a moratorium on and lift that laboratory as soon as we're confident we can do that safely. >> okay.

is the cdc planning on using the board as biosecurity to advise cdc on quality and safety? >> what i intend to do is to invite an external advisory group specific to look at cdc and special to tell us every way they think we can do better -- >> well, what about the national science board of national security, are you going to be using them? >> that's not my current plan to the best of my understanding. >> okay. purged almost half of the members from that board, and i was inquisitive about whether you knew about this, why the administration took action and whether or not nih consulted. do you use that advisory board for anything? >> i would have to get back to you -- primarily managed by nih, and i have 20 get back to you for the management of that group. >> all right, well, that's good. that eliminates one question for

you then. in light of the anthrax investigation completed, do you think that prior inspections of cdc laboratories were sufficient? >> i do. >> okay. well given the fact that select in undesignated places, shouldn't that come to light as a result of prior inspections? >> i think the important thing to recognize is that when we review their protocols, the protocols were in place, and because of the primary cause of the incident and that was that this bacteria was not enactivated, it was transferred to a laboratory that would not necessarily have to have a locked cabinet, and so therefore when we provide our report on

select agents as was indicated earlier, we also report on those laboratories where that select agent went, in this case, not deactivated. >> doctor, are you familiar with this picture? >> i certainly am. >> well, i'm going to turn 59 years old in less than a month, and this file is dated 17 months before i was born, and apparently, it was located in a cooler where? >> on the nih campus. >> last week. >> a little over that. >> and recent. >> yes. >> recently. >> yes. >> so this vile of smallpox older than i am have been in a

cooler, in one location? i can't imagine a cooler running for 61 years. >> my understanding was it was a walk-in cold room used for storage. >> and someone walked in and discovered this smallpox? >> what happened was that that laboratory, as india understand was transitioned when fda took over the functions, and fda is moving into the new facilities. in the course of moving, it was doing a complete inventory of everything in the facility, and the workers there discovered a large box that had this vile and others in it. >> workers like moving workers -- >> like laboratory scientists. >> lab work, okay. well, recently, there was a case of someone that wanted to remove information from nsa, and he got in a position to do that, and with a $1500 thumb drive, he was

able to take all kinds of severe government secrets with him out of his position. he worked into -- does that bother you at all that people could, if they had cruelty meanness in mind they could not get into a cooler like this and take a 61-year-old vile of smallpox? >> we're certainly concerned that smallpox, which should not have been there, was there for many years. and we want to ensure that on our campus and fda with theirs, there's not other examples of collections, because this was a collection of organisms in places where they should not be. this particular box was created by a scientist or a group of scientists, and materials were essentially freeze-dried, and then sealed in that what you

held up the picture of. that was done before smallpox eradication was undertaken. it was not done with malicious intent, but to preserve something for future -- >> no, i know that, but the fact this lays around for 61 years, i just can't conceive of that thought. a press conference from last friday now that we moved from 61-plus years ago. this indicated the cdc does research to figure ought how better to treat people if they are exposed to prevent it and how better to prevent it through vaccination and stated the fact that anthrax continues to occur in nature and use as a weapon. my question is there. how many cdc laboratory workers received the license anthrax vaccine prior to the anthrax incident last month as recommended by the cdc, advisory committee, and practiced for lab

workers since 2002? >> i have to get back to you on the exact number, but offer vaccine for anyone whom anthrax vaccine is indicated. we don't require vaccination, but offer it to those who may have been exposed through the lab work. >> active program? >> oh, yes. >> do you have any idea, and i know you have to get back to me, which is fine, i appreciate. >> i have to get back to you. >> okay. it's reported that you said on june 30th the fact that anthrax exposure was a concern or might have happened is unacceptable. employees should have -- should never have to be concerned about the safety of preventable exposures, and as you note to date, more than 12 million doses of the live anthrax vaccine have been administered to more than 3 million individuals. if you can get back to me with that, i appreciate it. >> i will. >> with that, mr. chairman, i

yield back. >> thank you, i now recognize ms. elmers of north carolina for five minutes. >> thank you, mr. chairman, and thank you for the panel. this is a very good discussion, and i appreciate your candida responses. at this point, the most important thing we can do is get to the bottom of it and correct issues at hand so these thing do not happen again. i wanted to clarify something. dr. frieden, there was a question posed to you about the number of missing possible toxic substances, and i know you had acknowledged that over time there has been an account of some missing, but not stolen, correct? if something is missing, how do you determine that it absolutely was not stolen? if anyone else on the panel would like to comment on that, i

would appreciate it as well. >> so in the -- to give you an example, there may have been a package that was sent from one location to another that had a select agent in it. it did not approve at the second location. the fbi was involved in that investigation, and the fbi commongrou concluded that the package had been inadvertently destroy, but it was not stolen or lost. >> is there anything you'd like to add? >> just one thing that's important is we take the notion of chain of custody seriously so we are trying to be mindful where the agents are stored and if they are in transport, we have eyes on them or someone trusted to be with them as much as possible. there could be a possibility of no paperwork, and i have to understand what happened, and there's been a couple instances like that.

>> okay. thank you for clarifying that for me, and then, again, getting back to just some of the toxic sub substantiations found in boxes, you know, not stated what they were, you know, in a refrigerated walk-in storage or otherwise, when the nih ran across their recent problem, they put in place a clean sweep, and i know you said that there was a change, you know, there was a transition between nih and fda. were they already in the process? i mean, is that what the clean sweep is that you talked about or institute the clean sweep afterwards? >> my understanding is that both nih and fbi do complete inventory checks and follow up the inventory of the smallpox

vile. >> is the cdc doing the same? >> yes, we'll do a comprehensive review at all facilities. >> all of the facilities, including the one shut down now, obviously, but all of them? >> yes. >> great. thank you. i have time, if anyone wants to use it, mr. chairman, but i yield back right now. if no one else wants my time. >> i believe that concludes our first panel, so i thank all the witnesses for coming today, and we'll just let you step away as we prepare the second panel. we'll have follow-up questions so we ask you get back to us in quick time. >> mr. chairman, can i ask a question -- i ask we have the panel back in the fall after they complete the investigation and puts controls in place.

i think it's really important for us to know what they are doing, and i know they are working hard on this. >> i agree with that, and we'll have you back. >> the witness is awol i guess. >> has he checked? >> i don't know. >> what we may do to get going, is i may swear you in so you can start your testimony and then swear in dr. bright when he returns. you're aware it's a practice of taking testimony under oath, any objections to testimony under oath and advise you under the rules of the house you can be advised by counsel.

do you have desire to be advised by counsel? >> i do not. >> you do? >> i do not. >> do you swear the testimony you're about to give will be the truth, the whole truthings and nothing but the truth? >> i do. >> you are now under oath, and you may now give a five-minute summary of your written statement. >> fantastic. thank you, chairman murphy, members of the subcommittee, thank you for the opportunity to be here to testify on the laboratory incident. let me begin by commending the cdc, specifically actions taken to protect the work force and inform the general public in this serious issue. i stand by my belief when someone does something wrong we cannot forget what they've done right, and in general, we can want forget the outstanding history of service. forev for over ten years, i've

provided programs for those works in laboratories, and my background is in behavioral science and motivate individuals to mitigate risk soergted with infectious diseases. there's three challenges we face in scientific research. the agent, the people working with the agent, and the organization where the work is being done. first challenge of working safely with infectious agents has been for decades and can be appropriately mitigated. effective engineering controls, effective equipment, and standard operating procedures are already in place. however, it is important to recognize that one person and one error, intentional or intentional can negate controls in an instant. this leads to the second challenge we face in safe science, and that is the people working with the agent. human risk factors like perceptions, attitudes, behavior, complacency, outrage, apathy, and mastery have to be

addressed to receive optimal performance from the scientific work force. we have to accept and control human error in laboratory environment. in other words, we have to stop focusing on the who and start focusing on the why, how, and what went wrong passing no judgment other than we're all human, which would lead to solutions minimizing further human error. our final and greatest challenge is the existing social norms of safety culture within the organization. let me repeat myself. the greatest challenge we face specific to safe science is not the agent. it is not the worker. it is the culture of the organization. the culture of the organization permits norms to be developed and within the norms behavior's deemed acceptable or unacceptable. as a former proud cdc employee, i'm disappointed by what i'm hearing. it's been and remains clear this

issue is a systemic one or organizational issue rather than an issue of a regulatory director and two scientists. i've become irritated by the unnecessary finger appointmenting and disciplinary action of scientists who worked in parallel with the culture of the organization and made an unintentional error. the intent highlights the need for scientific protocols to be review and verified ensuring they work and can be done by those working in the laboratory. this incident ensures the need that these protocols are followed, and if not, future failures are immediately applied. this incident calls for more evidence based research to determine what specifically works and minimize risks associates with the challenges we face, which, again, are the agent, the people, and the organization. in the years i've been doing training, i have been forced to speak a common language around the world. no matter where you are in the united states of america or

around the world, people can relate to the concept of neighborhood, house, and family. i have used a home sweet home approach for establishing a healthy culture in the laboratory trainings. please consider this analogy. a laboratory is a home. a scientist working within the laboratory or a family. the scientific protocols are the house rules. if one member of the family breaks the house rules and puts the whole family at risk. if breaking the rules is not addressed, the whole house is at risk and begins to affect other houses in the neighborhood. let me clarify. if scientists do not follow their house rules, that impacts other laboratories within the organization. cdc is a neighborhood that houses hundreds of houses or has hundreds of labs. if the neighborhood does not establish a set of ground rules for all the houses, then each house begins to do their own thing, and inevitably, the

neighborhood is at risk. this starts with building a commitment to the residents or the scientists of that neighborhood or that organization. we don't banish family members for unintentional errors and encourage lab directors to come together to find solutions. we blish consequences for neighborhood members, scientists who blatantly choose to break neighborhood rules. we support each other, especially when unintentional accidents occur. we talk about incidents, not hide them, so the whole neighborhood lemparns and grows from them and recognize together we are safer and this commitment is contagious and spreads to homes throughout the neighborhoods and laboratories throughout the organization. this just the change of culture change, folks. the seed we plant, we reap five

years from now. they could find something unexpected in a freezer or an unintentional error. a choice has to be made. do i report this or not? i ask this committee to facilitate a process encouraging organizations to report accidents rather than punishing them for doing so. cdc remains a national treasure, and the united states of america is the land of opportunity for science and bilogical research. placing untested mandates as a result of this incident on scientists and institutions of research may not only push science and innovation outside of infectious disease research, but worse, could shift to other regions of the world. i ask this committee to continue to take leadership roles while considering implications of the hearing and future legislation. i look forward to your questions. >> thank you. you were not available when i swore in, so i'll have to swear you in, but during the hearing, we take testimony under oath.

do you have objection to testifying under oath? the chair advises you under the rules of the house and committee, you are entitled by counsel, do you consider counsel today? do you swear the testimony you are about to give is the truth, the whole truth, and nothing about the truth? thank you. you are under oath and set forth to the penalties under title 18 of the united states code. you may give a five minute verbal summary of your written statement. >> thank you for inviting me to discuss the 2014 cdc anthrax incident and implications. i'm a professor at rutgers university and laboratory director at the waxman institute of microbiology. i'll discuss three topics. first, 2014 cdc anthrax accident, second, broader issues

and cdc bioweapons laboratories, also known as select agent laboratories, and, three, broader biosafety and biosecurity issues as well as more than 1,000 other government and corporate agencies across the u.s. regulated by the cdc. my assessments are based on information in established cdc, hhs, oig, usda, oig, gao documents, published press reports, and my knowledge of standard to work with bacterial pathogens. turning first to the cdc anthrax incident. i note the incident did not involve one violation in one laboratory, but instead involved an entire series of violations. the 2014 cdc anthrax incident involved multiple issues, and each of three cdc laboratories. there were at least seven

distinct violations in total. had any of three violations in one cdc laboratory not occur, the incident would not have occurred. had any of the four violations in two other cdc violations occurred, the impact of the incident would have been mitigated. i note further the incident reprized nearly exactly a 2004 incident. in the 2004 incident, workers in maryland used an inappropriate procedure to sample an anthrax bacter bacteria, and sent the viable anthrax bacteria to a children's hospital before eight persons were education posed before learning the material was viable. the cdc, as the agency with regulatory responsibility or select agent work relative to human health, investigated the 2004 oakland anthrax incident, a 2005 issued a report of the incident. the 2005 cdc report included revised biosecurity

recommendations for laboratories that prepare bacteria and for laboratories that receive and use inactivated anthrax bacter a bacteria. had they had the situation in the 2005 report, this incident could november have occurred, but the cdc did not implement recommendations from the 2005 report. the fact that the cdc in 20 14 made the exact same errors made in the oakland incident shows the cdc did not learn from the incident. i turn now to biosafety and security in cdc select agent laboratories. i submit the 2014 incident is not isolated, but part of the pattern and part tern that could have been recognized a half decade ago and should have been. last week, multiple other incidents, none previously disclosed to the public in which they activated viable select agents to other laboratories.

these undisclosed select agent incidents are similar to the 2014 incident, in particular, two previously undisclosed incidents from 2006 involved anthrax and identical. they raise safety and security concerns. i note further hhs and oig audits note the violations in select agent labs, and the cdc select agent labs in 2010 reported major violations including failures to ensure physical security, failure to restrict access, and failures to document inventories and failed required training to workers with training being unverifiable for one in three workers in the most available report. most e greersly was unauthorized transfers from labs to other

laboratories or individuals. i note further press reports from 2007 to the present documented further biosafety and security di forget sis in cdc select laboratories. examples are inadequate provisions for for emergency ba nour. none functioning doors and door seals. failure to close entry doors. failure to latch and treat doors. to the key cards for select agent laboratories and at least one case the discovery of an unauthorized person in a restricted area. taken together, the documents indicate that the cdc has not ensured biosafety and security in its own labs. i turn now to biosafety and bio-security -- >> could you summarize the rest of your statement? >> the cdc and the usda have responsibility for biosafety and

security in the approximately 1,000 other u.s. select agent labs. government, academic and corporate. there is no basis for confidence that biosafety and bio-security standards are hiring or that select inspections are stringent at cdc regulated noncdc select agent labs than in cdc select agent labs. there is no basis for service that biosafety and security standards are higher or that select agent inspections are more stringent at usda laboratories than in cdc laboratories. deficiencies at these cdc regulated and usda regulated laboratories are documented in hhs and usd and oig audits. >> i just give you 15 more seconds. >> not only performing and fund select agent work but also regulate biosafety and bio security select agent work. this represents a clear conflict

of interest. this systemic clear conflict of interest may at least partly account for the deficiencies i mentioned. >> i think the witnesses will recognize myself for five minutes. mr. kaufman, you specialize in the area of behavior change. we have heard from you and other witnesses today this culture as a concern. congress has investigated problems with the veterans ad n administration because of the care we have for our veterans and we saw cash incentives for people. we also had in this committee the ceo of the general motors. americans were outraged and described as the culture of come play sency. now we see this getting into an area which before if you weren't a veteran or didn't buy those chevy cars you were not a risk. but when you release a pathogen

it's around anybody exposed to it. does this review team familiarity around pathogens tend to lead people to cut some corners and just get complacent about this? >> i think that there's -- i believe you know this, too. i think there is an inherent risk in behavior in general. you overbehavior. offunder behave. i think it's a kind of a balance and that is in essence what professional development and training and assessments can be used for is to keep that balance in check. in this occasion, if we're talking about the anthrax incident in the laboratory, i don't believe that this was a come play sency issue or competency issue. i believe this was a scientist that implemented a protocol from another laboratory where it was used for good purposes and i would love to share what those are. unfortunately there was no process to vet that protocol.

and so when it was adapted from one lab to another, the inactivation time it takes to kill one agent versus another is a lot more with the spoer forming. >> we heard so many things that the doctor was saying, the way the doors were handled. we have heard of people being in an area that was not authorized to be there. that a key was left in a refrigerator. it seems to mean rules are in place but people are downright sloppy. >> i think the things you are saying is true and must be address addressed but must be put in perspective. the key in the freezer, it's almost like saying that i have a house and inside my house i have a gun and my house has a door with locks and it also has a house alarm and up stairs in the master bedroom is hidden a safe and inside that safe is a gun

with a trigger lock that has a key in it. >> but that's not the case here. if a key was left in the refrigerator and people come into that area, if people all pig gir backing on each other's cards here those are a violation of rules. >> i have seen the refrigerators. they are not common practice. these are in places where you actually have to have access. i came in as a civilian. i'm not related to cdc. i have been to the laboratory. i have seen these freezers. >> but the issue is how people behaved. that's the question i had for the doctor. should someone be required to use their actual card. it records when they're in there. in some cases with the deathly

pathogens. requiring two sets of eyes on that. part of this, too, i'm not clear on what you're saying. i want to be clear. in some cases are you making excuses for the persons in saying there wasn't enough protocol? i'm not sure what you're saying. >> no i'm not making excuses. there is a healthy respect for what is going on here. i think we have to look at the spectrum. we can't say this is just what happens in science but we can't live where this is the end of the earth, we have not to stop all research, we have got to minimize and cut things down to a certain number of laboratories. i think we have to take a look at really what happened and in the culture at which it happened. that's what i'm saying. >> doctor? >> i disagree. >> can you please explain? >> these are problems of individuals but they're problems of individuals acting in a

context. that context has two components, the laboratory culture. we have talked several times about a culture of lax attitude toward safety. that is part of the problem. we have also heard several times about researchers working with dangerous or hazardous materials. what hasn't been mentioned before is hubrouse. that is fundamentally part of the problem here. a sense of the scientist that he or she should be able to proceed without restriction and without management. so these are all issues with the culture. in addition to that culture, you have an institutional structure and the oversight. i think these are bigger problems more significantly responsible for the issues i described. i mentioned the fact that cdc and usda regulate their own biosafety and bio-security. they perform the work.

they fund the work. that's a conflict of interest. until that responsibility is moved out of those two agencies and out of any agency that performs select agent research and funds select agent research i believe you can predict the same types of problems, the same patterns and cultures will remain in place in cdc labs, in usda labs and in the approximately 1,000 other labs they regulate. >> i'll follow up on your questions. mr. kaufman, i have no doubt these individuals have no ill motives. they're trying to do their research. and i think you would agree with that as well? >> i would. >> but let me just put this in context. i don't know if you were here when we gave our opening statements. i have been on this subcommittee since 1997. i have to tell you that the reason why we're so concerned

here is because this kind of practice keeps happening over and over again. it's not just one isolated incident. as our memo that i put into the record said there were six inspections. identifying 29 observations of concern of facilities and equipment 28 related to safety and security. and 39 on document tags and record keeping and a lot of times what we're dealing with a very, very extreme bio agents that could kill a number of people and you're nodding your head so i assume you understand this. yes or no? >> yes i do. >> okay. what we're trying to -- like i say, i think the people are trying to do their job. i think they're well motivated. but with all due respect, we are not overreacting here. this has got to be solved. what i want to ask you since you

were here is did you hear ms. kingsbury's testimony where she said we need to have one agency at least in charge of developing national standards? >> yes, i did. >> what do you think of -- she admitted it's going to be difficult to do that because of overlapping jurisdictions. would you agree that it's worth an effort to try to do that? >> i know you like yes and no answers. i'm trying to think. i agree that we should explore what we're doing today and where we can go in the future, yes. >> dr. embright what do you think about that suggestion? >> there should be a single national agency that sets policy, recommendations policy standards and advises on needs and how those should be met. there should be a national entity that regulates and