one crossed with another one. >> i get more alarms when you walk out of wal-mart with a shirt that wasn't paid for. is there a cover-up not wanting employees know? >> no, we have not seen any evidence of a cover-up, but we do see the need to strengthen the culture of safety that encourages reporting, any time there is a problem or potential problem, so we can assess it and take rapid and prompt action. >> thank you. i recognize ms. degette for five minutes. >> you testified that there is an increasing number of labs that are handling these bioagents, correct? correct, and you say there is no one agency in charge, is that correct? >> correct. >> now -- you said that today, but in 2007, the g.a.o.

testified before this committee the same thing, no single government agency was responsible for tracking all of these labs. >> that is correct. >> that is correct too. frieden, are you aware of this finding by the g.a.o. going back all the way to 2007? >> yes, i am. >> and do you agree with dr. kingsbury there are an increasing number of labs handling these bioagents? >> yes. if we look back over the last 10 years, there is a increasing number. >> do you agree with her there has 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 inspection and , enforcement. several years ago at my direction, we turned over some buthe inspections to aphis,

the issue of lab safety touches many parts of both the public sector and nongovernmental sector. >> so are you saying that 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 is a clear addition of responsibilities between ourselves and aphis. isdoes that mean that aphis in charge? >> they are in charge of investigating c.d.c. select agent laboratories. they are not in charge of the overall enterprise. >> do we need to clarify who is in charge of the enterprise? >> we are looking at recommendations. >> would it be helpful to have one agency in charge of all of the inspections and making sure people are doing things in the right way? >> i am seen several suggestions of how we can improve oversight and select agent oversight and my sense is that each of these

ideas is certainly worth exploring. >> what do you think about that? think itbury, do you would be useful to have one agency in charge? >> we have said for a number of years that there needs to be some entity in charge of a national strategy, not necessarily in charge of every laboratory in the country. >> so you are saying and agency in charge of developing the protocols how you are go to go do this? >> ensuring biosafety and biosecurity. but the more important issue from a strategic point of view is how many of these laboratories do we really need for what purpose against what threat. one of the interesting things that i have become a little more sensitive to in the last few weeks is the whole structure that we have, that cdc and aphis is arounded in, it 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. i'm going. frieden, to assume that you agree with that it would be very useful to have national safety and security stands that would apply to everybody, is that correct? >> i'm not sure i understood the question. i am sorry. >> well, i mean what g.a.o. 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 nobody standard -- nobody developing standards across those agencies. >> i think there are many aspects of biosafety and biosecurity which merit careful investigation and if we can figure out a better way to do them, we are certainly completely open. >> do you think the protocols should apply to everybody? >> the protocols may be specific for the different situations, but they should all adhere to the highest standards.

>> dr. dick, what's your opinion of this? >> thank you, congresswoman. 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 c.d.c. 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 -- >> so if that's the case, why are we having all these problems then? >> what we need -- what we have is a single set of biosafety and biosecurity regulations that are followed by both sides.

>> but we don't have that now? is that what you are saying? >> no, what i am saying is i think we currently do have that. i do agree with dr. frieden eventually after we get done with this investigation we should take a very close look at all of the issues and see if there are updates that need to be made to biosafety and bio security. >> thank you. >> we now recognize the doctor for five minutes. questions. >> mr. chairman, thank you, and i am going to address my questions to dr. frieden. dr., thank you very much for being here and for providing the subcommittee with your testimony. i actually have a number of questions for you, in fact, four and i will get right to those. firstly, can you please describe the policies and procedures cdc has in place to handle i/o safety issues that may arise from human error, like what

happened in the bioterror rapid response in the biotechnology laboratory in atlanta on june 5? >> we have extensive policies and procedures, but what we are doing now is implementing a moratorium on all transfers out of three and four laboratories while we review each laboratory's policies and procedures to ensure there is appropriate inactivation before any materials are transferred out. >> and i appreciate that answer, and i think and you explained that to us last week in an informal setting and that's a good thing and that leads to my second question. what is the impact and cost of this laboratory shutdown? you shut down those laboratories for x number of days. do you have a cost estimate to them being offline for a period of time?

>> i don't have a cost estimate for that, the impact is potentially significant and we are working rapidly to assess protocols and where there are situations such as the diagnosis of drug resistant t.b. or helping to control the ebola outbreak, or beginning work on next year's flu vaccine and will work to ensure we do that in time safely, but there are real challenges with this moratorium. one of the things that the lab that was associated with the anthrax incident is to provide to the laboratory response network, a network of over 150 laboratories proficiency testing so they can identify anthrax and other dangerous pathogens safely. so we will figure out a way to do that safely in time. >> well, i would think time is tothe essence in regard cost, but, as you say, safety is the most important factor, and i certainly agree with that. should inactivated select agents

be added back to the select agent list? >> i think what we need to ensure that any inactivation is done completely because once something is inactivated, it may be able to be used, and may be necessary to use that to diagnose, and you wouldn't have to follow select agent requirements out diagnosing something out in the lab or in the field but the key is to have that two-key system to make sure that when inactivation is undertaken, it is validated and verified that the materials are inactive. >> the last question, you noted in your testimony you only learned of the march 13, 2014 shipment from the c.d.c. influenza lab a virus that was toss contaminated with h5n1

a usda laboratory on july 9, and march 13 is when it actually occurred, to when you were informed of it july 9. can you please describe how you are going to improve communications of these incidents up and down the chain of command? >> thank you. in fact it was the afternoon of our meeting, which was in the morning when i learned about , this. what your question gets to is the crux of the matter, which is how do we improve the culture of safety at cdc, and i think that's going to involve a number of steps that we think will succeed but will take time. we need to encourage reporting and encourage all staff to take responsibility in addition to having a single point of accountability for laboratory safety. we need to have a clear vision. of working safely. we are, after all, the prevention agency and we want to apply that same rigor that we apply to our work in the field and in disease control.

to preventing any incident from happening in our laboratories. we also want to build on many of the organizational strengths and identify the laboratories that are doing this very well within c.d.c. and identify the practices they are taking that will prevent these incidents. and finally, 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 is inactivation or transfer of materials or making sure that transferred materials only contain those materials. we have terrific scientists at c.d.c. and they are focusing their creativity, their energy, their commitment on improving our culture of safety. thank you very

much, and, mr. chairman, i will yield back my 30 seconds. >> recognize mr. waxman for five minutes. >> thank you, mr. chairman. doctor, last friday when you released the c.d.c. report on the anthrax incident you announced you are imposing a moratorium on c.d.c. transferring any biological samples out of any b.s.l. 3 or 4 labs until they had conducted a lab by lab assessment and you additionally close to the bioterrorism and rapid response and advanced technology, or the announced it i will remain closed until it is approved to reopen under safer conditions. this is so the cdc can undertake a comprehensive safety review and ensure that the proper procedures and protocols are in place moving forward.

how long you anticipate this moratorium lab beingnd the brat closed? >> the short answer is so they can open safely. the long answer is that some can resume. proficiency testing for those agents in the laboratory response network, and that is 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 when will you know, or how will you know when it is safe to do so? >> i have appointed dr. michael l, who is a top expert at cdc, not only in laboratory safety, but also in safety. he works in the control and safety unit of cdc him to oversee a high-level working me, and theyng to will develop the next day or so, finalize criteria by which they will set each of the

laboratories, and each laboratory will look at its own protocols and practices and determine whether they are validated, effective, and scientifically proven, and implemented in a way where we can be sure they will be applied, and then each laboratory will apply to a lifting of the moratorium. i will review his recommendations and ultimately approved laboratory by laboratory with the reopening during this process. i will mention that this is not a small thing, because many of have adjacentes laboratories, and much of their work has to be done in the bsl2. ,o they inactivate in the bsl3 and then they move it to the be3, and that work has to stopped until we can assure that it can be done safely. this is one of the things we need to do to improve the

culture of safety at cdc. >> one of the disturbing findings of cdc's own report is that scientists use a pathogenic strain of anthrax when they could have used a nonpathogenic strain, isn't that correct? >> yes, it is. >> well, when the moratorium is lab is and being brat reopened, will you make sure that scientists are not unnecessarily using potentially dangerous strains of bacteria when it is not necessary aphis? >> yes. >> gao and aphis both examinations. dr, yousbury and believe this was an appropriate response to this incident, don't you? >> yes, i do. >> yes, i do. >> we should not forget that the way the cdc conducts this is to help keep the american public

safe. cdc serves a critical role for studying dangerous pathogens to 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 critical research that these labs were conducting. den, how did the moratorium and lab closures limit the cdc capabilities, what happens to the studies, some of which i am guessing were operating on detailed schedules, while they were being conducted in the labs? >> we are looking at the labs 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 have

already heard from, for example, the laboratory that deals with drug-resistant tuberculosis, the laboratory that deals with ebola, and the laboratory that deals with avian influenza, but 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 did the closures and moratorium affect research occurring in other labs outside? >> we provide proficiency testing and other materials to laboratories, and so there may be impacts on some of our partners, but the one that we are most aware of now, and we are working with them before the deadline, the provision of toerials that companies need make next year's flu vaccine, and we anticipate being able to do that on time. >> my time has expired, but it seems to me that protecting the safety and health of your scientists and the moratorium and the lab closures appear to

be the appropriate response. thank you, mr. chairman. >> thank you. the gentleman's time is expired. we now recognize another for five minutes. >> thank you, mr. chairman. question to a previous raised thebury question about how many laboratories there are, and the gao said there are probably too many laboratories, and my question would be to you, dr. fr ieden. so manye have laboratories, and are they all necessary? >> i do not know why. our job would cdc is to make sure we only work with dangerous pathogens where it is necessary and that we do so safely. we will take a fresh look at every where we work with these pathogens internally at cdc to make sure it is kept to the minimum necessary to serve the function of responding to infectious disease outbreaks. we still have anthrax in nature,

and respond to that. we have ebola, with the largest outbreak in history now in west africa, though the challenges we have our substantial. in terms of outside laboratories, our function with the division of toxins is to assure that the light -- laboratories there are operating safely. it would seem one way to increase security would be to have fewer locations and fewer laboratories. to use an extreme case, if you're going to try to protect 100, that is going to be more difficult than if you are just trying to protect one. i do not know what the magic number is, but i think especially since the gao has said there are probably too many, that would be worthy of a look see. dr. kingsbury, do you have an opinion on that? >> well, i am not sure we have actually said there may be too many. i think will be set is nobody knows how many there are, and nobody knows how many we need. >> well, that is even worse in a

way. >> yes, that goes beyond the scope of cdc and aphis, and until there can be some kind of strategic look, they may be changing due to things like the ebola outbreak, but somebody should be thinking about this a little bit more broadly than a single agency, and that is basically our point. ask a question. why are there 435 members of congress? what is magic about 435? as the answer is that is many seats that they could put on the house floor. when they got to 435, they could not put any more, and so it was an odd number, and they just stopped, so there was nothing magic about it. the same thing with a laboratory situation. i think there should be a strategic review, and the sooner, the better. >> 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 and turned into a memorandum of understanding that plant the usda animal and health inspection service to inspect the cdc laboratories for compliance with the select agent program. since the select agent program was authorized in two thousand two, the cdc had been inspecting its own laboratory. cdc decide to turn its inspection process over to the department of agriculture? was that because cdc did not think it could do the job itself? i will ask dr. frieden that. >> we have made improvements both in our own laboratories and in our regulatory function, and i looked at this issue. i was concerned that there was at least the appearance that we could not be objective in inspecting our own laboratories. i did not believe that was the

case. i believe that one part of cdc, which has no organizational affiliation with another, could do it objectively, but i did not think the appearance was a good and, so i requested aphis, they graciously agreed to take over the inspections of our own campus so there would not be the appearance of that. >> if you had to do it over again, would you? was it a good idea to let usda do those inspections? >> i believe that decision was appropriate. if i had it to do over again, i wish i recognized the pattern, which is why we put this into our july 11 report. >> with that, mr. chairman, i yield back. >> or i can tell a agy jok. >> i yield back. >> recognized for five minutes. mr.hank you very much, chairman, and ranking member, for calling this meeting.

on the surface, they appear very about security, laboratory security, and yet every few years, there are these lapses, and now an anthrax scare, avian flu issue that was not reported in a timely manner, and, you know, we have very high expectations for everyone at the cdc. i am impressed with everything but forhappening there, the high-containment biological laboratories, to have these lapses is not acceptable, so it is really troubling that although numerous government agencies over the past few years have warned cdc about problems ith the containment labs, appears cdc has not heeded those warnings. we know of at least 14 separate reports and letters and investigations from gao, u.s. and healtht inspection services, hhs, the inspector general, to talk about

the lack of oversight at the cdc hi containment lab. dr., your testimony is invaluable here. about thell us more concerns gao had identified with regard to safety at the hi containment lab? you 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 the 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 is difficult be thek about who would single agency. we have discussed the issue with the office of science and technology policy at the white they, while they have

some overarching responsibilities, they do not 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 is worth just keeping the issue on the table, particularly in tight budget times. >> you mentioned in your opening that you have heightened concerns because of budget cuts. about that.bit is there a particular area we should be focused on? >> well, it is as i said in my statement. the management and the building kindsnagement and these of laboratories is relatively expensive, compared to building just ordinary buildings, and if numbergoing to have x of laboratories, i would like to see the strategy that will allow us, even in tight budget times, to continue to fund them and

upgrade them when necessary and to manage the biosafety and programs to keep them safe, so that total picture just isn't available now, and that worries us. 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 have been able to accomplish our mission in support of the select agent program over the recent years and provide the funding that is necessary. >> ok, and before the june anthrax investigation, aphis conducted investigations at the campus facilities in 2013 and 2014. can you summarize those? >> yes. i think there were a number of findings, some of which were found in the recent finding, some of which were not. that would be

simple, like unlocked refrigerators. those kinds of things, up to and including more serious incidents, if you will, around invalidation protocols not being up-to-date. n, it isdr. friede troubling. this has gone on for years now. gao, aphis, outside experts have been calling attention to these issues, and i am encouraged because you have been forthcoming in your statements. you have not been defensive, but what is your current action plan now going forward in detail? is there a culture among researchers. what is it? . from thisc for us day forward, what are you going to do in the timeframe? >> well, first, i think for past incidents, the staff at cdc, the scientists did take the reports seriously and did respond to those individual reports. what we missed was a pattern,

and you're absolutely right that that pattern was an in adequate culture of safety, and so the overarching challenge now is to ensure that we establish and strengthen a culture of safety at all of our laboratories throughout all of cdc, and there are a number of steps that we are beginning to do that. the first is the moratorium, so that we can stop and think about that particular procedure of inactivation and make sure it is done right. singleointment of a point of accountability for laboratory safety throughout cdc, the establishment of a working group that that person, mr. henderson, will lead. and external advisory group, and i intend to invite some of the leading independent experts of the country by the end of this week to serve on that advisory group for cdc. the points at all of 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 ways tot and identify improve safety and security. we also need to verify that that is happening. you., thank the gentlelady's time has expired, and we recognize the gentlelady from tennessee for five minutes. >> thank you, mr. chairman. dr. frieden, if you go back to investigation, let's look at that. 10 days after the event. there was 18 days after possible exposure. awful, a lot of really basic errors. even you admit there is not a culture of safety. there is not that double check and it is something that when you look at worker safety,

how it was and then the management, lacking the basic information on what substances to use to have the contamination cleaned up. so looking at this tab and that investigation, i want you to detail for the committee what new policies have been designed as a result of this and how did c.d.c. guarantee that the new policies are followed immediately -- effective immediately. you know, our hospitals and organizations get all sorts of new rules from h.h.s. on friday afternoons at 4:00. they're effective immediately. so i want you to detail for us how you implemented that and what the new policies are. >> so effective immediately, all transfers, not just from hese two laboratories but from every single bsl-3 and bsl-4 laboratory at c.d.c. have been stopped. effective immediately, these two laboratories, the bsl-3, part of the influenza

laboratory, and the brrat lab for the bioterror response, have been closed. those two laboratories will not be reopened until both aphis and i are confident that they can be reopened safely. we've also appointed a single point of accountability to look at this and to review before we reopen, before we begin any more transfers, procedures that are in place to ensure they can e done safely. >> how could it possibly have transpired that your management team couldn't even decide on the formula of bleach to use to clean up the contamination or see whether the onsite 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 that we would respond to an outside emergency and that's one of our

after-action findings, that when we deal with ebola or fungal meningitis or another problem, we activate our emergency center or if we do not activate it, we use the resources to have a systematic, structured, intensive immediate response. that wasn't done for the first week after the anthrax potential exposure and that's something that we'll be sure to do in the event of such internal event in the future. >> let me ask you this -- did the management team get preferential treatment to the point that they were unaware? -- unaware that the staff was turned away? >> no, absolutely not. >> ok, why didn't the staff feel confident in expressing their worries to their managers so that they could get adequate treatment? >> i'm not sure what's behind that. i do know part of encouraging and strengthening the culture of safety is making sure that people are encouraged and in

fact reinforced and rewarded 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 c.d.c.? there at the >> at c.d.c., scientists are so used to risk. they go out into dangerous places that they're not sure where the risk will be, if you work year in and year out with pathogens that are scary, you get used to that danger. >> ok. let me ask you another question. once the june incident was discovered, why, why did it take you so long to track down the anthrax? and why wasn't there a record of where this was stored? >> well, as soon as -- june 13, as soon as we identified there was the potential that any of the plates that were sent out of the containment lab were not sterile, we immediately recovered those plates and put them back in the secure facilities. that's the best of my

understanding. >> why wasn't there a record of where it was stored and why was it stored in unlocked refrigerators stuck in an unposted room and hallways? >> my understanding -- and we'll have to confirm that in the coming days -- is that those findings relate to primarily the materials that were believed to have been sterile and sent out of the lab tournament it's not as if there was an -- anthrax cultures being left in an unlocked, unsecured place. i think the point there, once that initial error was made of hinking something had been inact vate when it -- or may not have been inactivated, then that material was then out of the containment space. that's my understanding. >> thank you. mr. chairman, i yield back. >> all right. i now recognize mr. green of texas for five minutes. > thank you, mr. chairman.

first, of all our panel, there are a number of federal agencies that handle some of these substances, not just c.d.c. is there a general protocol that all the agencies look at and coordinate handling these substances, dr. frieden? >> when it comes to select agents, then both c.d.c. and aphis establish standards and then inspect and enforce those standards. other than select agents, there are agency-by-agency or entity-by-entity approaches that may be specific to the type of research or to the type of agent. >> so there is an umbrella type of standard for all federal agencies? >> for select agents there is. >> ok. dr. kingsbury, can you summarize your recommendations for you us and can you elaborate which of these recommendations would require congressional action?

>> [inaudible] if you're talk about our recommendations, i think resolving this issue of whether there is a national strategy probably can't be done without congressional action and it will take some thought to get us there. >> ok. dr. frieden, do you agree with these recommendations? will you be implementing them that you can within your control? >> in terms of laboratory safety recommendations for c.d.c., we will do everything to implement these recommendations. the report that we released on july 11 has a number of steps that we are already beginning to implement. >> ok. any of them require congressional action or is that something you control within your agency? >> at this point i am 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 c.d.c. that congress needs to deal with? >> at this point in this

investigation, we don't have anything that can't be controlled through the select agent program and our work with c.d.c. >> ok. r. frieden, does c.d.c. base -- based on the findings in their report have any recommendations to congress? you have none for us? >> we're focused at this point on doing our jobs as well as possible, ensugar that we strengthen laboratory safety throughout c.d.c. and use the findings from this experience to strengthen our regulatory function through our division of select agents and toxins which inspects and regulates hundreds of entities around the country that works with these materials. >> let me ask you about the c.d.c. budget and, again, i have heard questions from my other colleagues that this wasn't a c.d.c. much as received adequate funding from congress to conduct its safety mission? period. obviously you have other

missions. >> i think the challenges for safety are more than just funding. there are a variety of issues in implementing safety policies and procedures, and i don't think the primary issue here is a lack of funding. >> ok. some of the witnesses we've been hearing from today have stated c.d.c. employees need better training and there needs to be better standard operating procedures but that overall there is a problem with the culture at c.d.c. dr. frieden, how do you -- do you agree with these assertions? >> i do agree with them. i think that while we have scientists who are the best in the world at what they do, they have not always applied that same rigor that they do to heir scientific experiments to improving safety, and that's why we're taking a number of steps to strengthen the culture of safety at c.d.c. part of that is to encourage reporting of potential or actual problems. and because of that, it is possible -- though i don't know

anything at this point that i'm aware of -- it's possible that in the coming weeks and months we'll hear of other things in the past 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 some great labs and i'm familiar with some of them, is it just because they teal with these -- deal with these dangerous substances so often that they get lacked and they're not dealing with the safety they're dealing with it? >> i think that's a significant part of it. if you work with something, even if it's a dangerous -- deadly microbe day in and day out year after year, you get to a familiarity of doing things you normally shouldn't do. we should have protocols, training and a culture of safety with a vision that we will work to minimize risks such that no worker and the public are never exposed to the -- a risk that could have been

prevented in our laboratories. >> and i guess that complacency, it needs to be monitored every day 24/7 because of what you do. is that part of what you're trying to do at c.d.c.? and with the guidance for other agencies. >> absolutely. that's what we've done of -- by establishing a single point of accountability for laboratory safety and empowered working group that will work with that individual but emphasizing even with that individual and even with that group, laboratory safety is really something that everyone who touches a laboratory needs to be conscious of and think of ways to continuously improve. >> mr. chairman, i'd hope we would have a follow-up in a few minutes to see the success and, again, it's almost like retraining some of the smartest people in the country to be, you know, certain what they're doing with the substance they're dealing with. and i yield back my time. >> i think that's a good idea to follow up. i do want to also -- dr. kingsbury, when you were responding to mr. green's question about other congressional authorization

could be required, could you give this committee details on what that would be? >> i don't actually have -- [inaudible] >> microphone. >> i don't actually have a basis on which to be specific about what might need to be done. i think we probably need to continue to work with your staff to talk through what some of the options might be going forward. >> thank you. now, mr. harper is recognized for five minutes. >> thank you, mr. chairman. and thank you for holding this hearing on a very important issue. certainly some agencies can be dysfunctional and there's no concern or no real harm in that, but the c.d.c. is one that cannot be dysfunctional. so we're very concerned about safety within the labs and obviously the workers there and ertainly for the public on how we can address that. if i could, dr. frieden, refer you to tab 7.

that's a letter that you sent in september, 2012, to the committee responding to concerns about c.d.c. lab safety. in that you stated, a senior official was designated to report directly to you about safety issues and those things there. who was that senior official? >> i'll have to get back to you about that to get you the name and details and what was done pursuant to that letter. >> ok. obviously the question would be, and i would have hoped you could have answered today was who was that senior official and what were the results of that action? and then the question that perhaps you could answer now, how is the appointment of dr. michael bell as the new c.d.c. point person over lab safety, when we don't even know who the old point person was, how is that going to be 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 is we did address comprehensively the specific problems that were identified. so there were concerns about some airflow issues.

there were concerns about some of the security issues in our laboratories. and while i would never say that we're 100% resolved on those things, we really focused on those particular problems. what we missed was the broader pattern. that's what dr. bell is overseeing now. >> so does this mean that dr. bell will now continue until -- that there will always be a int person, is that your plan? >> yes. dr. bell is the person now. we'll transition that to a single point of accountability for lab safety. one of the things that dr. bell and his group will do is to recommend where that entity should sit within c.d.c. to be most effective. >> dr. dick, the c.d.c. reported that since 2007 there have been two surprise inspections of c.d.c. both performed by c.d.c.'s select agents and toxins before aphis took over of inspections of c.d.c. labs.

since 2012, i'm showing that aphis has conducted 11 inspections of c.d.c. labs. i'd like to know why hasn't aphis conducted any surprise inspections of c.d.c. labs, or have they done that? >> we conduct surprise inspections to enforce compliance between renewal inspections which is every three years. we, as we stated, we came on in late 2012 as the oversight entity for c.d.r. at roybal lab, we've actually been there six, seven, if you include this last incident in time, in that year and a half, so we have not had an opportunity to do a surprise inspection since we're there regularly. >> so the last time a surprise inspection was done was when? >> we have not done a surprise inspection prior to taking over in 2012. i'm not familiar with before that. >> and obviously i won't ruin the surprise by asking when one

is planned but it does seem like we -- >> we intend to follow-up -- >> that's a great tool to have. >> absolutely. and certainly first and foremost, we're going to be following up on the current incident with them in making a revisit when c.d.c. indicates that they are ready for us to revisit. and then we will be doing surprise inspections after that point. >> let's say that -- and this is for you, dr. frieden, or for you, dr. dick, if it's determined that a dangerous biological agent has been stolen, who do you report that to? >> sir, we have a protocol for dealing with theft. there has been no theft of biological agent reported from ither c.d.c. or any of the regulated facilities in the 10 years of the program, to my knowledge. when there are concerns for potential theft or misplacement, we work with law enforcement, including the f.b.i., to do a joint investigation. i would just mention that our expansion of surprise

inspections was something that we had erected over the last few years at c.d.c. because we felt it was important to do. >> so you say there have been no reports of stolen agents? >> that's my understanding. >> what about missing biological agents? >> there have been losses at certain facilities and in those circumstances we also coordinate with the f.b.i. usually it's an issue of inventory control. so earlier we were talking about critical control points, such as inactivation of virulent pathogens. certainly inventory is a critical point. >> i yield back. >> i do want to ask clarification of mr. harper's question. when he asked about theft of an item. your inventory control is not so tight so that someone could not walk -- someone could take something, replicate it and walk out for something, 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 c.d.c.'s, over the past ecade. >> well, there was one at the army one in texas i believe a few years ago. >> i'm not familiar with that. >> mr. tonko, you're recognized for five minutes. >> thank you, mr. chair. welcome to our panelists. the c.d.c. is responsible for registration and oversight of all laboratories that possess, use or transfer select agents that could pose a threat to human health. while aphis is responsible for those select agents that pose a threat to animal or plant health. select agents that pose a threat to both human and animal health, like anthrax, are regulated by both c.d.c. and aphis. so that being said, dr. kingsbury, can you tell us what

g.a.o. has found with regard to the increase in the number of high containment biolabs? >> i'm not sure i understand your question. i think within the select agent program, i think there is information about how many laboratories there are, and they are regularly inspected, as these gentlemen have just been saying. our concern about the national strategy is that there are a lot of other laboratories that deal with highly infectious pathogens that are not considered select agents and nobody knows how many of those laboratories there are. >> but with the high ontainment biolabs, is there in that given category, is there an increase that's been

measured by your review? >> i didn't hear the word. >> is there an increase in the number of -- >> there has been an increase since the anthrax attacks in 2001. the last time we actually tried to count them was two or three years ago and i think at that point it looked like there were slightly fewer than there were the year before, which we sort of think is maybe just a budget problem. but that, again, is the only ones that people are actually aware of. i think there are private entities and perhaps 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. >> is -- what accounts for the growing numbers of these labs that you suggested are out there? >> well, following the anthrax attacks in 2001, there are a number of agencies whose missions touched on the issue

of biological weapons and whether those pathogens could be used to attack our country. and so each within their own sphere developed a program to counter those possible threats. and each got funded by the congress to build additional laboratories and so forth. o 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 the number of labs in these various missions your ated, what would recommendations be to addressing -- >> well, we made recommendations there should be a single entity that has responsibility for developing a national strategic plan and national standards for the

operations of high containment laboratories. the delay is figuring out how to do that in the current environment with competing interests among the agencies involved and so forth. it's quite -- there's even a competing interest issue in the congress since different committees of the congress have different jurisdictions over these different agencies. so it's a tough problem to solve, but we think it would be worth spending some time even at a theoretical strategic level to begin to address this issue and think through how we would go about doing it in the future. >> and dr. frieden, what are your view here in terms of the growing numbers of these 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 work with dangerous pathogens goes

on, the more possibility there is of accidents or -- accidental releases. so ensuring that the work that happens is happening in a safe environment is critical, and and the key concept i think we have to apply is risk benefit. i don't think we can ever uarantee zero 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. griffith for five minutes. >> thank you, mr. chairman. i appreciate that. appreciate you all being here today to testify to us. dr. frieden, if i could get you to turn to tab 5 in the booklet. as you look at that tab 5,

that is the h.h.s. inspector general report regarding the c.d.c. roybal facility which says it was sent to you. have you seen this before at some point? front page says it was sent to you. ok. if i could direct you to page 5 and on page 5 it says that the inspector general's office could not verify that 10 out of 30 samples approved individuals for select agents had received the required training. and do you see that on that page? >> yes. >> and likewise, it says that the -- that select agent inventory records are incomplete and you also acknowledge that that's on that page? >> yes. >> and then if you go over to page 6, the report says that agents stored in areas -- that there were agents stored in areas not listed in the registration. you see that on the top page, page 6? >> yes. >> thank you. and one example given is a -- ntist found a vile of

vial of select agent in a drawer and another found 16 in an unsecured freezer. do you see that in that paragraph? >> yes. >> and the report on page 6 also states that there were unauthorized transfers and packages received by unapproved individuals. now, my concern is this. this is at the roybal facility. weren't these the same kind of violations that then popped up and were found in subsequent inspections by the usda in 2013 and 2014 and then revealed again in the matter that brings us here today in the anthrax influenza incident of 2014, aren't they the same types 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. we strengthened the systems. we locked and improved personal background checks and security

so in each of these we felt -- >> let me ask you this question. did you all do a systemwide after these problems were discovered -- because we have 2010 and 2013 and earlier in 2014 -- did you all ever do a systemwide recheck? >> not adequately. not adequately. we addressed the specific problems, i believe, with a sincere effort to rectify them. but what we missed was the broader pattern that we are now addressing by strengthening our culture of safety in our labs. > all right. i i do appreciate that and know you are having to answer a lot of tough questions and i do thank your demeanor here and i do think that's appropriate and i appreciate it. let's look at page 7 and on top of page 8 there are five recommendations there. if you could read those out loud that take place and then let me know if they were followed up on. >> i can shorten this by saying the key one is the fifth and the fifth has to deal with

confirming that materials are inactive before transfering them and that was specifically what was not done in the nthrax incident. to give you a specific, in 2006, the same laboratory, the brrat lab, had a pretty similar incident. that's why i directed that it be put into our july 11 report. and after that incident, they implemented a standard operating procedure for that particular type of biological material leaving the laboratory. but when they had a different type of biological laboratory -- excuse me -- biological material leaving the same laboratory, they didn't apply that standard operating procedure that would have inactivated it. i do think it's the lack of adequate pattern recognition that has led us until these last few weeks not to undertake the kind of comprehensive sweeping change in our -- and improvement in our laboratory safety culture that we're now implementing.

>> well, i preerblet appreciate that. now, what about the other four? number five may have been the most important but what about the other four. >> the first has to do with physical security measures and i believe we have taken a number of steps there. there are steps we need to do better on in that area having to do with staff coming in and not swiping in every time. >> you indicated you'll do training, which is number three. what about number two? >> yes. i think we've made a great deal of progress in ensuring that only approved individuals are able to do select agents. >> i've got 20 seconds. number four. >> inventory is an area where we have done a number of things, but given the recent incident at anyway and the fact that -- that n.i.h. and the fact that inventory is a flashpoint, we are working on inventory. it's a massive job to do it right but we'll do that as

well. >> well, i appreciate that and the safety american public rests in your hands. thank you and i yield back. >> thank you. >> thank you. now recognize ms. schakowsky for five minutes. >> thank you, mr. chairman. i want to thank the witnesses. as you can see from the tone of this hearing, there is complete bipartisan concern about what happened here. and what i wanted to concentrate on is not the incidents themselves but then the response, in particular, to the anthrax release. the c.d.c. report described delays in identification of otential exposed individuals affected lab rooms and the possible release of anthrax to all c.d.c. staff that may have been exposed and that there was no clear lead for response to this incident in the first -- in the first week. so, you know, i know you

have discussed a number of these things. but it's the management piece. once a problem was discovered and so i wanted to ask you, dr. frieden, what was your esponse to this finding? >> this was our finding and when we're dealing with outside events, we activate our emergency operation center or sometimes we'll use the facilities to manage our response more effectively. we should have done that the moment we learned of the potential exposure. that allows to us break down a big problem into smaller problems and address them one by one. employee safety, clinical care. decontamination. investigation. so instead of doing that in a systematic way it was done

unsystematically. in those first few days we were really focused on the employees it took a while to identify who those people were. that, we effort to do identified we did not have the kind of systems that were needed. the systems were not used properly. camerample, security coverage to see who had come into and let the facilities at time. that was not done because one part of the agency did not use those resources. the root cause was not activating our incident command system. >> can you elaborate on the finding? about response? >> our findings were very similar. we had an independent team that came they were interviewing

employees and workers. findingsvery similar to those that he just indicated. follow-up on what the chairman was saying about the possibility of even stealing something. incident, itox turned out the vials were discovered at nih. they could have been somewhere else. nobody seemed to know. that is disturbing. who knows. somebody could have taken them out. i'm not sure when you say that

nothing has been stolen, it also says nothing could have been stolen. want to respond to that? >> we have taken a number of steps to strengthen the security of select agent registration. those steps include suitability assessment for people who work with their one agents. one agentst. tier one agents. incident response plans. ongoing agents. the concern for theft israel. -- is real. some of these organizations -- organisms occur in nature. . >> let's worry about this country right now. smallpox is a big concern.

let me end with this if i could. the wordi hear culture, a cultural problem, i know we have a real challenge on our hands. and washing changed the face of medicine. -- handwashing change the face of medicine. it is not sexy. it has made our medical system much more successful. a huge advance. these kinds of small things that deal with culture and attitude and awareness of these cards is -- kinds of things, we need to figure out, you need to figure out how to make them part of the everyday thinking of your staff. we are willing participants here. i yield back. mr. johnson for

five minutes. >> i want to thank our witnesses for joining us. dr. friedman, it looks like you are the guy on the hot seat. i have a few for you as well. the mission of cdc laboratories, as you well know, includes carrying out work to protect the american public. labical like it -- activities are shutting down pending the outcome of your reform. how will cdc be able to a dress any bioterrorism or other emergencies that might occur before they reopen? >> there is one particular laboratory that is shut. there are multiple other laboratories that continue their operation and would be able to respond to bioterrorism incidents. >> or not because of the errors -- there is no concern that we

may be limiting our ability to protect become -- the public? >> i'm confident that the incident we did not -- we saw did not cause the release of agents into the community or exposure to city staff. they are a tipping point and a recognition of the need to improve our laboratory safety. we are fully functional in terms of responding to an event. -- i havestep of issued a moratorium on. we will lifted as soon as we are .onfident we can do it safely >> what i intend to do is to

bring an advisor and have them tell us every way -- >> what about the national science advisory board? >> that is not the current planned. that is not the current plan. they purged half their members from the board. inquisitive whether you knew about this. why the administration took this action. nihher an ih consultant -- consulted. to do for toave them. >> that eliminates one question. in light of the anthrax incident, they recently -- you think

inspections were sufficient? >> i do. the protocols were in place because of the primary cause of the incident, which was the the inactivated, it was transferred to a laboratory that would not this is early have to have a locked cabinet. when we provide a report on select agents, as indicated earlier, we report on those laboratories where the select agent went. in this case, not deactivated. >> that concludes my questions.

i yield back the balance of my time. >> the speaker week -- recognizes mr. long. >> thank you. docrtor, are you familiar with this question -- picture? monthsal is dated 17 before i was born. -- i can't even imagine a cooler running for 60 years. my understanding it was a walk-in cold room used for storage. >> someone walked in and discovered the smallpox?

washat laboratory transitioned from nih to fda many years ago. in the course of moving, it was doing a complete inventory. box.rs discovered a large i'm sorry, laboratory scientist 's. >> recently, there was a case of remove who wanted to information from the nsa. they got in a position to do that. with a 1500 dollars drive, he was able to take all kinds of severe secrets from the government. does it bother that it -- you that if people had cruelty and meanness in mind, they could get

into a cooler and take a vial of smallpox? >> we are concerned that small smallpox, which should not have been there, was there for years. we want to ensure on our campus -- and nih is looking at their campus -- there are not other examples of collections. this is a collection of organisms that are in places they should not be. this particular box was clearly created by a scientist who is very experienced. the materials were essentially freeze-dried. sealed in that object you held up the picture off. that was done before smallpox eradication was taken. it was not done with malicious intent. >> i understand. but the fact that this could lay around -- i cannot even conceive.

let me take you to a press conference now that we have moved from 61 years ago -- a press conference, you indicated the cdc does research to figure out how better to treat people if they are exposed and prevented if they are exposed. thatlso stated the fact anthrax continues to occur in nature, it has been used as a weapon. my question is this. how many cdc laboratory workers received to the fda licensed vaccine prior to the incident last month? >> i would have to get back to you on the exact number. we offer anthrax vaccine to anyone for whom it is indicated. we don't require people to it vaccinated, but we offer it to anyone who might be exposed. >> you think that is an active

around -- program? do you have any idea? >> i would have to get back to you. >> it is reported you told the fact thate anthrax exposure was even a concern is unacceptable. should never have to be concerned about the safety of preventable exposures. doses of 12 million the vaccine have been administered to more than 3 million individuals. if you can get back to me, i would appreciate it. >> i will. >> a yield back. >> thank you. we recognize -- >> thank you mr. chairman. this is a good discussion. i appreciate your candid responses.

this point, the most important thing we can all do is get to the bottom of it. so these things do not happen again. i did want to clarify something. posed aboutquestion possibler of missing toxic substances. i know you it knowledge to overtime -- i know you ain't how doged overtime -- you determine it was not stolen? if anyone on the panel would like to comment i would appreciate it. example, there may have been a package sent from one location to the other. with a select agent in it. it not that she did not arrive

at the second location. the fbi concluded in one particular case the package had been inadvertently destroyed. it had not been stolen or lost. is there anything you would like to add? >> one thing i think is important. chain ofhe notion of custody seriously. we are trying to be mindful of where the agents are stored. we have eyes on them. somebody trusted to be with them. isasionally the doctor correct. there could be an accounting issue where something has been destroyed and they did not complete the paperwork. we have to understand what happened. i have been a couple of incidences like that. >> thank you for clarifying that. some of the to toxic substances that have been found in boxes that may not --

has stated what they are any refrigerated walk-in storage or ranrwise, when the nih across their most recent problem, they put in place with a colace -- what they call a clean sweep. you said there was a transition between nih and fda. were they already in the process? is that what the queen -- clean sleep is? >> my understanding is both nih and fda are doing complete inventory checks and follow-up. >> i guess my question for you is is the cdc doing the same? >> we will do a comer hence of inventory review -- a comprehensive inventory review at all our facilities. >> including the one that shut

down? >> yes. >> thank you. i have time if anyone wants to use it. i yield back. if no one else wants my time. >> i believe that concludes our first panel. i think all the witnesses for coming today. i will let you step away well he prepare the second panel. we will have some follow-up questions so please get back to us in quicktime. >> will you yield for one second. i would hope that we would have this panel back in the fall after dr. frieden completes his investigation and puts his controls in place. i think it is important for us to know what they are doing. i know they are working hard. >> i agree. back.l bring them

>> has he checked andin? >> i don't know. sleeping -- i may swear you in so you can get started on your testimony. committee is the holding a hearing. do you have any objections to the testimony under oath. a desire to be advised by counsel? raise your right hand. do you swear the testimony is nothing but the truth? >> i do. ofsubject to the penalties

the u.s. code, you can now give a five-minute written summary -- summary of your written statement. let me begin by commending the cdc. during this very serious issue. belief thaty someone does something wrong, you cannot forget what they had done right. cdc has an outstanding history. for over 10 years, i have been writing -- been providing biosafety. mowed -- therei are three main challenges we face when doing scientific research.

the agent, the people working with the agent, and the people where the work is being done. the first chart -- challenge has ben, for decades and can appropriately mitigated three -- mitigates. recognizertant to that no person can negate -- one person can negate all the controls in an incident -- risk factors such as risk behavior,, attitudes, complacency, and perceived mastery must be addressed. we must accept and learn from human error. in other words, we must stop focusing on the who.

passing no judgment other than that we are all human. challengeand greatest is the safety culture. let me repeat myself. the greatest challenge we face is not the agent or worker. is the culture of the organization. the culture from its norms to be created and the area there deemed except the bolt or unacceptable. by what i amted hearing. it sounds like this is a systematic problem rather than of a laboratory director. disappointed with the people

who made an unintentional error. it calls on the need for scientific protocols to be reviewed to make sure they work. not, consequences are immediately applied. this incident calls for more evidence-based research to in minimizeat works risks associated with the challenges we face. which again are the agent, the people, and the organization. in the years i have been doing training, i have been forced to speak a common language around the world. no matter where you are in the u.s., or around the world, people can relate to the concept of neighborhood, house, and family. homee used a home sweet approach for establishing a healthy culture and my laboratory training. these consider this analogy.

is a home.y the scientists are a family. the scientific recalls or the house rules. familymember of the breaks the house rules, it puts the whole family at risk. if breaking the rules is not addressed, the whole house is at risk. it begins to affect other houses in the neighborhood. let me clarify. the scientists do not follow their house rules, which impacts houses in the neighborhood. cdc has hundreds of labs. if the neighborhood does not establish a set of ground rules for all the houses, each couch -- house begins to do their own thing and the neighborhood is at risk. building a culture of safety begins with a commitment to the residence or scientists. familyt banish scion --

members for unintentional errors. we encourage them to come together to find solutions. we established consequences for those who choose to break neighborhood pools -- rules. we support each other when accidents occur. we talk about incidences so the neighborhood grows and learns. we recognize together, we are safer. this commitment is contagious and spreads to homes throughout the neighborhood. this includes laboratory throughout the organization. this is just the start of culture change. the seed we plan today is what we will reap five years from now. is anere out there organization or scientist to find something unexpected or makes an unintentional error. a choice has to me made. do i report this or not. this committee to facilitate a process that

encourages organizations to report rather than punishing them for doing so. cdc remains a national treasure. remains a land of opportunity for research. placing untested mandates on scientists and research institutions may never only push scientists out of this research, but could shifted to other regions of the world. i asked this committee to take a leadership role while cousins -- wellhe application considering the invocations. >> thank you. you are not a available so i will have to swear you. we take testimony under oath. you have an objection to testifying under oath? the chair will advise you. we will -- you are advice -- please raise your right hand.

the testimony is true and nothing but the truth. andare now under oath subject to the penalties under title 18 he. -- title 18. you may now give a verbal summary of your statement. members of the, committee, thank you for inviting me to discuss the 2014 anthrax incident. i am board of governors for fetzer of chemistry at rutgers. laboratory director. i will discuss three topics. first, 2014 cdc anthrax incident. second, broader while safety and bio security implications. also known as select agent laboratories. three, broader issues at more than 1000 other government academic and corporate select bynt laboratories regulated

the cdc. my assessments are based on andrmation in published cdc other agency documents. published press reports. and my knowledge he -- of standards. i turn first to the 2014 incident. incidentcdc anthrax did not involve one violation in one laboratory. it involved a series of violations. it involved multiple violations of biosafety and bio security in threeations laboratories. there were seven distinct violations total. in any of three violations one laboratory not occurred, the incident would not have occurred. of four violations into other laboratories not occurred, the impact would have been mitigated.

nearlyident reprised exactly a 2004 incident where workers in frederick, maryland, used an inappropriate procedure to -- to verify an activation. and sent it to oakland transit -- oakland children's hospital where eight persons were exposed. as the agency with regulatory responsibility investigated the 2004 oakland anthrax incident and issued a report. included revised biosafety and security recommendations for laboratories that prepare and provide the bacteria and laboratories that receive and use those. had the cdc implemented the recommendations in its own 2005 report, the 2014 incident could

not have occurred. but they did not implement the recommendations in the 2005 report. effect of the cdc in 2014 made exactly the same errors that have been made in the oakland they did nots learn from that incident. i turn now to iowa safety and bio security. submit is not an isolated incident but a pattern. report listed multiple incidents. undisclosedusly incidents are similar to the 2014 incident, in particularly to previouslyar undisclosed incident.

they raise safety and security concerns. documented -- in 2008, 2009, and 2010 reported major violations. violations included failure to ensure is a goal safety. to -- to ensure physical safety. providere -- to training to workers. with training being unverifiable and one in three workers. unauthorized transfers to other individuals. 2000ress reports from seven have documented further biosafety and bio security deficiencies. include inadequate

provisions for backup power. failure to maintain pressure areas. nonfunctioning door seals. failure to close entry doors. to latch entry doors. to do -- assign key codes. in one case, the discovery of taken together, the documents indicate that the cdc is not adequately ensuring biosafety in its own labs and are resistant with systematic violations of bio security in its own labs. i turn now to via security at cdc. >> can you summarize the rest of your statement? havee cdc and usda responsibility in the approximately 1000 other u.s. .elect agent labs government, academic, and corporate. there's no basis for confidence that bio security standards are higher or more stringent

.t cdc-regulated non-cdc labs there is no basis for confidence that bio security standards are higher or select agent inspections are more stringent than at cdc agent laboratories. deficiencies in standards at these other laboratories are amply documented in the oig audit. one final point. i know that the cdc and usda funds the work but also regulates biosafety and bio security for select agent work. this represents a clear conflict of interest. the systematic clear conflict of interest may at least partially account for the deficiencies mentioned. think the two witnesses and i recognize myself for five minutes. in kaufman, you specialize

behavior and behavioral change along those lines. we have heard from you that the culture of complacency is a concern. we have investigated problems administrationns but we saw that there were cash incentives for people to cover things up, shred them, hide waiting lists. gm ceo also heard from mary barra. americans were outraged that it was discussed as a culture of complacency and now we see this in an area, if you're not a veteran or did not by the city -- chevy cars, you are not at risk. a pathogen is pretty indiscriminate. does this routine familiarity around pathogens tend to lead people to cut corners and just get complacent? i believe you know this.

i believe that there is an inherent risk in behavior in general. you over-behave and you run the risk of being complacent. if you under-behave you are not prepared. this is what, in essence, professional training and assessments can be used for to keep the balance in check. anthraxlking about the incident in a laboratory. i do not believe this was a complacency issue or an incompetency issue. this is a time to that implemented a protocol from another laboratory where it was used for good purposes and i would love to share with those purposes are. there was no process to that that protocol. when it was adapted from one isoratory to another, it a lot more with b.a. doors werethe

handled and we heard about people being in an area and they were not authorized to be there and a key was left in a refrigerator. it seems to me there are several elements where rules are in place and they are just downright sloppy. >> chairman murphy, the things you are saying are downright true and they must be addressed and concerned but they need to the put in perspective. er, i have a freez a house and inside my house i have a gun and it has a door with locks and it also has a house alarm. upstairs inside that safe is a gun with a trigger lock that has a key in it. >> that's not the case here. if people can come into that achywhere they are all

backing on each other's cards, those are violations of rules. >> i will not argue the fact that it's a problem, because it is. i'm telling you i've seen those refrigerators. these refrigerators are places where you actually have to have access. i came in as a civilian. i've been to the laboratory. i've seen these freezers. is how people behaved. that's the question i had before. there required to use the actual card. only certain persons can get and with the authorization and it records when they are in there. some cases the deadly pathogens require two keys, two sets of eyes. i'm not clear on what you are saying and i want to be. making excuses for the persons saying there were is not

enough protocol? sir. i'm saying there is a healthy respect for what is truly going on here. we need to look at the spec from. and sayt be arrogant this is just what happens in science. say we need to stop all research, minimize, cut certain numbera of laboratories as a result of what happens here. we need to take a balanced approach at what happened in the culture for which it happened. >> i disagree. >> can you please explain? >> these are problems of individuals acting in a context and the context has two components. one is the laboratory culture. we have heard several times about a culture of lax attitude toward safety and that's part of the problem. we have heard several times today about them becoming in

nerd to working with this. hubris is fundamentally part of the problem here. the sense of the scientist that he or she should be able to proceed without restriction and without management. these are all issues with the culture. you have an institutional structure, institutional management and then these are even bigger problems that are even more significantly responsible for the issues that i described. i mention the fact that cdc and usda regulate around biosafety and bio security. they perform the work and they fund the work, an inherent conflict of interest. until the responsibility is moved out of those two agencies and out of any that performs select agent research, i believe you can predict with high

confidence the same types of problems, the same patterns, the same cultures will remain in cdc labs, usda labs, and the approximately 1000 other labs they regulate. you, mr. chairman. mr. kaufman, i have no doubt that these individuals have no ill motive. they are motivated to do their research. let me put this in context. i don't know if you were here when we gave opening statement. i've been on this committee since 1997. the reason why we are so is because this kind of practice keeps happening over and over again. it is not just one isolated incident. the memo that i put into the were sixid there

inspections. avis identified 29 observations of concern the facilities and equipment. 27 related to safety and security and 39 on documentation and record keeping. what we'remes, dealing with in this situation is very, very extreme bio agents that could kill a number of people. you are nodding your head so i .ssume you agree like i say, i think the people are trying to do the job and they are motivated. with all due respect, we are not overreacting here. this has to be solved. , did you hearhere ms. kingsbury's testimony where she said that we need to have one agency at least in charge of developing national standards? >> yes, i did.

that?t did you think of she admitted it would be difficult because of overlapping jurisdictions. agree that is worth an effort to try to do that? >> i know you like yes and no answers. i agree we should explore what we are doing today and what we should do in the future. >>d dr. ebright? >> there should be a single agency that sets policy regulations, policies standards, advises on needs and how they should be met. there should also be a national entity that regulates and oversees the select agent. they need not be the same. that we'veust say seen this in this subcommittee not just at cdc. we've also seen it in the lab. alamosa -- losss

some sensitive data disappeared because a researcher took it home to his house. .ou call it hubris or whatever it's an assumption that there is important researcher going on and nothing bad will happen. >> correct. so what i think -- in fairness, i think what dr. you needhinks, too, is to put systems in place so it's not relying on somebody to have that kind of judgment where you should have a system. would you agree with that? >> absolutely. >> mr. kaufman? >> absolutely. >> mr. chairman, i don't have anything further. >> i now recognize ms. blackburn of tennessee. >> thank you.

i think we are now on the same path here with our questions. i want to come to you. let's go back to the cdc report .rom 2004 anthrax incident it stated it should be cultured both at the preparing lab before shipment and at the research lab several days before use to ensure sterility. advice?follow their own go ahead. >> they did not. definitely not in 2006. definitely not and 2014. >> we have a continued pattern of refusing to learn. their owng to read report and follow their own recommendations. >> you are the director of a biomedical research lab.

>> yes. >> you do some of the same work with dangerous pathogens. how important is it to you that all personnel in your lab strictly follow your biosafety protocol? in order to follow those of biosafety protocol, they have an understanding, that culture of safety that is lacking at cdc. >> it's critically important. for biosafety working with while hazardous organisms that any thel, 1, 2, 3, or 4, message of safety has to come first. the safety training has to come first. before any experiment has even begun, there has to be a process of risk assessment, risk-benefit y weighent, in which the the risk against the benefits, assesses that the risks are

outweighed and that cost needs to be reviewed by another set of eyes. >> do you follow this is standard operating procedure? >> we do for biohazard research. >> is a clearly understood from all of your personnel? do they see this as written best practices? that they aretand expected and required to follow? they arenderstand expected and required to follow these practices. they are monitored. the message consistently is these agents require respect and they must be handled with anyect and before experiment, the risk-benefit assessment must occur. >> and if one of your personnel failed to follow the protocols, what would you do to them? >> depending on the nature of

the failure, they would face consequences up to and including termination. >> we don't see that pattern taking place at cdc. >> we haven't seen evidence of it. in n you think cdc is eed of a major correction? do you have advice on what that would be? >> many of the things we heard our exactlysuggests the steps required. the question is whether this time will be different from the previous time and the time before that, and the time before that. >> and if they did not do that, according to what you said, you would terminate the whole bunch? [laughter] >> in this particular case, personnel action won't be sufficient to resolve the issue. this issue is institutional and organizational.

the regulatorye authority to regulate themselves. it simply does not work. it does not work in many areas of human endeavor. >> mr. kaufman, anything to add? >> i continue to stand by my belief that -- and my conviction -- because over the last 10 years i have traveled several labs and i have asked scientists laboratoryeport accidents and incidents so we can learn from them. if we take this chance now and turn this into a punitive action against scientists that make intended injuries, it builds resentment, teaches no new behavior, and it hides true behavior. if we're going to make decisions to decrease risk in science, we better consider how we address incidents and accidents before doing so. a punitive actions, in my

opinion, are not the way to go. scientistagainst a makes a mistake. if they go against standard operating procedure, that's a completely different job issue than a scientist doing their job within a culture and does not go outside of the s.o.p. provided to them. >> thank you. mr. chair, i yield back. >> it builds resentment? you've got to be kidding me. you are telling me these people with phd's don't understand that anthrax is dangerous? are you kidding me? they need more training? you are making your statement that it was a result of a training failure. blah, blah, blah. are you making excuses for these scientists? if they don't understand that anthrax is used for select --

used for a weapon and it can harm and kill people then they should not be working there. it sounds like you are saying they need more training. boo hoo. this is a bad situation and i don't think you understand the seriousness of this and it sounds like you're making excuses. post," today'sn cartoon. you think the employees of the cdc are proud of this? this is not funny. this could have been lethal for people. i hear you tell ms. blackburn that we are going to build resentment? i'm sorry. i don't buy that at all. >> may i comment? not defending what's going on at the cdc. i've said i'm disappointed even as a former -- >> "disappointed" is not the right word.

should find it abhorrent. we can make excuses -- mary barra from gm said it was wrong. wrong.edaen said it was there is no gray zone in this. i don't get it. i will let you respond. i appreciate that. i know the individual involved and when i say training is needed and it's a solution, there are several phases. on the job specific training which includes s.o.p. verification is needed, which has been mentioned in previous panels. i'm not making light of the situation at all. i'm saying if we choose to punish people who come forward when they make a mistake-- >> that's different. >> that's what i'm saying. we want people to be willing to do that. i thought you were saying that they need more training.

when you put anthrax in a ziploc bag, you don't need training to know that. >> that is subjective. concern is what we have here is a series of reports has brought out some of the questioning we've done earlier and we have a series of reports that dates time toood period of get the changes have not been made. is one thing. having a standard operating procedure, which is so flawed that you have repeated mistakes, is something that i have to agree with the chairman on. that's the problem. i agree with you, mr. kaufman. you don't want to punish someone for making a mistake. but you have to stop them same

mistake from happening over and over again. dr. ebright, had we make the reforms happen this time? how do we do that? the cdc has to protect the american public and our job is to do oversight to make sure they are doing their job. how do we make it happen? the two steps that congress and the administration could follow to reduce the probability that this happens again in cdc toss on labs and the labs that cdc and usda regulate, the two important steps are to reduce the number of select agent laboratories. the number of select agent personnel, the volume of select agent research increase by a over the lasto 40 decade. that volume of activity needs to be rolled back" where it was at

the beginning of that increase. that would represent taking the current more than 1000 select agent labs in the u.s. and reducing it to 50. >> high containment select agents, are those interchangeable? >> they're very close. most select agent research, particularly much of consequence, is done at level 3. >> so you want 50 instead of 1000? >> i would recommend we roll back. 50. divided by 20 is easiest,he single single fastest, and most economical approach. independent entity that carries out the regulation and oversight

of biosafety and bio security, not an agency that performs the work, not an agency that funds it. you said we need to scale back. why has there been an expansion and the phrasing that i have is high containment laboratories, why has there been a great expansion? >> in large measure it was a response to the 2001 anthrax mailings. time, it was understandable because it was expected here, and elsewhere, that the u.s. was under attack with a biological weapon from a foreign source. it was expected biology would be put on a mobilization footing to address the threat. 20 toanded by a factor of 40. more than a decade later when it was made clear that the anthrax mailings was not a foreign source and after it was cleared

the investigation believes it came from within the u.s. bio defense establishment, we have the strength situation that we have expanded the establishment withouttor of 20 to 40 reason or without reassessment. >> and the risks are self-evident? mathematically. when you increase the number personnel by a factor of 20 to yound you incurred -- and recruit people without experience new to the field, you increase risk. you increase those risks by a factor of 20 to 40 or more. >> are you in agreement we need to scale back? >> i am not. i agree with the gao. there's not enough information to make a decision to back off or go up. high containment laboratories, the capacity, is not built for the threats we see today. threats built for the

we don't see coming around the corner tomorrow. >> let me switch gears and ask about the research implications of reengineering pathogens such as the university of wisconsin generating a virus similar to the 1918 influenza outbreak that killed tens of thousands, maybe hundreds of thousands, worldwide, and other ways to h5n1 more contagious. is that part of the expansion? defense funded as i/o research and it's a prime example of the culture of hubris . it is work that should not be performed -- flat out should not be performed. when the research information could be obtained in no other way, then this work should only be performed in a very limited

number of institutions, perhaps one or two nationally, and only after extensive review of risk-benefit and only under the most stringent safety and security measures. >> i appreciate both of you being here. i would like the opportunity to learn and i have learned a great deal from this hearing. thank the gentleman and i would encourage some of the members of the committee to go visit the labs around the country, particularly the cdc headquarters, to see how this works. for members of the cdc, i hope you understand the seriousness today onongress views this. i ask unanimous consent that the opening statement he introduced to the record. i also asked animus consent to put the document binder in the record subject to redact meant by staff. in conclusion, i want to thank all who have participated in today's meeting. you have 10 business days to

submit for the record and i ask that all witnesses respond promptly to the questions. with that, as hearing is adjourned. [captions copyright national cable satellite corp. 2014] [captioning performed by national captioning institute] >> federal reserve chairman janet yellen was on capitol hill today to talk about the economy and fed policy. that hearing is available at c-span.org. here is part of her testimony where she discusses the housing market. i wanted to ask what forces

are contributing to this lackluster housing recovery. housing did seem to be recovering through most of the recovery and it looked like it was on a reasonably solid course recovering from a very low level and then we essentially saw a cessation of progress were more or good traits rose significantly last year. i think my expectation was that it would be a temporary setback for housing and with mortgage rates higher but still at very period of and with a very weak household formation, i expected that we would see a rebound by now, a pick up in the housing sector. frankly, it continues to be sluggish.

i cannot give you a precise why that has occurred. we are certainly aware of the fact that mortgage credit remains very tight. as i've said several times this morning, for a wide range of borrowers. that may be part of it. we also hear about some supply that builders face that perhaps is contributing, but i have to say that i'm somewhat surprised. >> what more do you think the fed can do to help stimulate recovery in the housing sector both for those homeowners who are upside down in values as well as to help new entrants be able to qualify for homes? >> housing prices are continuing to increase and they have increased substantially. i think particularly on the markets that saw the worst booms and busts, particularly in re are a large

fraction of homeowners underwater. i think if you look at the aggregate numbers, just the increase in house prices we have seen, and i think that is in part reflecting accommodative fewerry policy, many borrowers are underwater. the numbers have diminished substantially. i know the las vegas area particularly as one of the most the hit and still has about highest numbers on this, but i really think that's helping and eventually we will see greater progress in the housing market. many impediments that servicers face in the aftermath of the problems, the foreclosure problems we've had during the crisis. things have not yet settled out there. >>