tv Key Capitol Hill Hearings CSPAN July 22, 2014 8:00am-10:01am EDT
investigation finds that there is negligence, that people knowingly failed to report or took actions that were likely two or should've been known to endanger themselves or others, then we will take appropriate action. >> dr. dick said that people who were not approved were able to handle select agents, were able to access space containing potential anthrax, four days after the incident was discovered. my assumption is the scientist and the it's a pretty smart people but it's actually distributed think they are not thinking of this -- well, let me ask this. it's been weeks since you learned about the march 2014 cd shipment of h. five in one influence the. ..
>> that lets people know when thers been a problem there? >> there are multiple alarm systems within cdc. in this case, it was a cross-contamination of a culture. so somehow, and we haven't figured out how yet, a relatively low virulence avian influenza was cross-contaminated with the highly pathogenic h5n1. >> is there any evidence of cover up here from employees not wanting to let someone else know that -- >> no.
we've seen at this point no evidence of a cover up, but we do see the need to strengthen the culture of safety that encourages reporting. anytime there's a problem or potential problem so we can assess it and take rapid and prompt action. >> thank you. i now recognize ms. degette for five minutes. >> thank you, mr. chairman. 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 bioagents, correct? >> correct. >> and you said there's really no one agency in charge. is that correct? >> correct. >> now, in -- you said that today, but in 2007 the gao testified before the 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 or so, it is my understanding there is an increasing number. >> and do you agree with her 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 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 lab to haves to afis which has conducted them since that point, but lab safety does touch many parts of -- >> so are you saying afis is in charge now since you put that a into effect the last few years? >> in terms of laboratories working with select agents, there's a clear division possibility between ourselves
and afis. >> does that mean that afis is in charge? yes or no. >> afis is not in charge of the overall enterprise. >> so do you think we need to clarify who's going to be in charge of the overall enterprise? >> we're certainly willing to look at every suggestion to improve laboratory safety and biosecurity. >> do you think it would be useful if we had one agency in charge of all of the inspections and making sure people were doing things in the right way? >> i've seen several suggestions for i how we could improve the process of select agent oversight, and my sense is 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? >> well, we've said for a number of years, as you know, 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 insuring 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 i've become a little more sensitive to in the last few weeks is the whole infrastructure we have 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. >> right. >> and there's very little visibility about thatting to have of this enterprise. >> dr. frieden, i'm going to assume you're going to agree with dr. kingsbury, it would be useful to have standards that would alie to everybody, is that correct? >> i'm not sure i understood the question, i'm sorry. >> okay. well, i mean, 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 and, if we can figure out better ways to do them, we're certainly completely open to -- >> do you think the protocols should apply to everybody? >> the 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 -- >> but 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 biobe safety and biosecurity -- biosafety and biosecurity regulations that are followed by both sides. >> but we don't have that now, is that what your saying? >> no. what i'm saying is that i think we currently do have that. i do agree with dr. frieden that eventually after we get done with this investigation we should take a very close look at all of the issues and see if
there are updates that need to be made to biosafety and biosecurity. >> thank you. now be recognize dr. gingrey for five minutes for questions. >> mr. chairman, thank you. and i'm going to address my questions to this panel to dr. frieden. dr. frieden, thank you very much for being here and providing the subcommittee with your testimony. i actually have a number of questions for you, in fact, four, and i'll get right to those since time is of the essence. firstly, can you leads describe the -- please describe the oils and procedures cdc has in place to handle biosafety issues that may arise from human error like what happened in the bioterrorrism 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 bsl3 and bsl4 laboratories while we review each lab
laboratory's policy and procedure to insure there's an appropriate activation before any materials are transferred out. >> and i appreciate that answer, and you explained that to us, i think, last week in an informal setting, and i think that's a good thing. that leads to my second question, what is the impact on the cost of the brrat laboratory shutdowns? if you shut down those two laboratories for x number of days, do you have a cost estimate in regard to them being offline for a period of time? >> i don't have a cost estimate for that. the impact of the moratorium is potentially significant, and so we're working rapidly to rigorously assess protocols and where there are situations such as the diagnosis of drug-resistant tuberculosis or helping to control the ebola outbreak or beginning work on next year's flu vaccine. we will work to make sure we can
do that safely this time, but there are real challenges with this hour to have yum. one of the things the brrat lab does, the lab associate with the the anthrax incident, is to provide to the laboratory response network -- a network of over 150 laboratories -- proficiency testing to make sure they can identify dangerous pathogens safely. so we'll figure out a way to do that safely in time. >> well, i would think time is of the essence in regard to cost, but as you say, safety is the most important factor, you've got to get it right, and be i'd certainly agree with that. should inactivated select agents be added back to the select agent? >> um, i think that what we need to insure is that any inactivation is done completely, because once something is inactivated, it may be able to be used, it may be necessary to use that. for example, to diagnose it.
and you wouldn't want to have to follow select agent requirements out diagnosing something in a hospital lab or a clinical lab or even the field. but the key point here is to have that two-key system that the chairman mention inside the meeting, 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, dr. frieden. in your testimony you noted you only learned of the march 13, 2014, shipment from the cdc infliewns what lab -- influenza lab of a virus that was cross-contaminated with h5n1 to a usda laboratory on july the 9th. so that's from june 13th or -- march 13 to july 9. can you please describe how you are going to improve communication 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, if i remember correctly. what your question gets to is really 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, we need to encourage all staff to take responsibility in addition to having a single point of accountability for laboratory safety. we need to have a clear vision of working safely. we are, after all, the prevention agency, and we want to apply that same rigor that we alie to our work in the field -- apply to our work in the field and in disease control to prevent any incident from happening in our laboratory. we also want to build on many of the organizational strengths and identify the laboratories that are doing this very well within cdc and identify the practices that they're 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 flashpoints, 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 that materials transferred only contain those materials, we have terrific scientists at cdc, and they are now focusing their creativity, their energy, their commitment on improving our culture of safety. >> dr. frieden, thank you very much for that. mr. chairman, i'll yield back my 30 seconds. >> thank you. now recognize mr. waxman for five minutes. >> thank you, mr. chairman. dr. frieden, last friday when you released the the cdc report on the anthrax incident, you announced you were opposing, imposing a moratorium on cdc
transferring any biological samples out of any bsl3 or bsl4 labs until they had conducted a lab-by-lab assessment. additionally, you closed the bioterrorrism rapid response and advance technology or the brrat laboratory and announced it will remain closed until it is approved to reopen under safer conditions. these seem like appropriate interim steps until cdc can undertake a comprehensive safety review and insure that the proper proceed yours and protocols are in place moving forward. dr. frieden, how long do you anticipate this more to moratorm lasting and the brrat lab being closed? >> the short answer to your question is as long as it takes to insure that they can open safely. the longer answer is that there are some things that need to reasylum. for example -- resume. for example, proficiency testing for select agents in the
laboratory response network, and that's something that we will look at very carefully. but i i am committed that we will not open to them until we can open them safely. >> uh-huh. what steps are you taking to lift the moratorium and reopen the facilities, and when will you know or how will you know when it's safe to do so? >> >> i've appointed dr. michael bell who's 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 imelemented in a way that we can be sure they will be applied. and then each laboratory will apply to him for resumption and
lifting of the moratorium. i are review his recommendations -- i will review his relations 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 bsl3 laboratories have adjacent bsl2 laboratories, and much of their work has to be done in the bsl2. so inactivate the bsl3, move it to the bsl2, that work has all stopped at this point until we can insure that we're doing it safely. and this is one of the things that really is a tipping point for improving the culture of safety at cdc. >> one of the more disturbing findings of cdc's own report on this incident is that scientists use a pathogenic strain of anthrax when they could have used a nonpathogenic strain, isn't that correct? >> yes, it is. >> well, when the more to morats listed and the brrat lab is
opened, will you have clearer standards and protocols to make sure scientists are not unnecessarily using potentially dangerous strains of bacteria when it's not necessary? >> yes. >> gao and afis both conducted investigates of the brrat laboratory following the june anthrax exposure. dr. kingsbury and dr. dick, you belief the moratorium and lab closure an appropriate response of this incident, don't you? >> yes, i do. yes, i do. >> okay. we should not forget today that the reason cdc conducts the special agent research is to help chemoamericans -- keep americans, the american public safe. cdc serves a critical role for studying dangerous path pathogens -- pathogens and finding cures and vaccines for deadly diseases. these labs are critical to our nation's sons to bioterrorrism threats, so i'm interested in learning about how this moratorium and the lab closures
are affecting the critical research that these labs were conducting. dr. frieden, how do 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 now 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 laboratory that deals we bowl la the laboratory that deals with avian influenza that they have deadlines coming up for either patient care or public health response, and we will address that very quickly. but we will always put safety
first. >> how do the closures and moratorium affect research occurring at other labs outside of the campus? >> we provide proficiency testing and other materials to laboratories, and so there may be impact on some of our partners. the one that we're most aware of thousand and will work to address -- now and will 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 has expired, but it seems to me that protecting the safety and health of your scientists, the moratorium and the lab closures appear to be the appropriate response. thank you, mr. chairman. >> thank you. gentleman's time has expired. now recognize mr. barton for five minutes. >> thank you, mr. chairman. in answer to a previous question, dr. kingsbury raised the point about how many laboratories there are. the gao has indicated that there
are probably too many laboratories. my first question would be to you, dr. frieden. why do we have so many laboratories, and are they all necessary? >> i don't know that there's a right number of laboratories out there. our job within cdc is to make sure that we only work with dangerous pathogens where it's necessary to do that and that we do so safely, and 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 observe 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 large outbreak in history now in west africa. so the challenges we have are substantial. in terms of outside laboratories, our function in the division of select agents and toxins is to insure that the laboratories that are there are operating safely. >> well, it would seem that one way to increase security would be to have fewer locations and
fewer laboratories. i mean, if you're only using extreme cases, if you're trying to protect a hundred, that's going to to be more difficult than if you're just trying to protect one. i don't know what the magic number is, but i think especially since the gao has said there are probably too many, that would be worthy of a look see. dr. kingsbury, do you have an opinion on that? >> well, i'm not sure we've actually said there may be too many. i think what we've actually said is nobody knows how many there are, and nobody knows how many we need -- [laughter] and that goes beyond -- >> well, that's even worse this a way. >> yeah. that goes beyond the scope of cdc and afis, and until there can be some kind of strategic look at what our requirements actually are and they may be changing, but somebody ought to be thinking about this, i think, a little bit more broadly than a single agency at a time, and that's basically our point.
>> well, 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. [laughter] when they got to 435, they couldn't put anymore, so it's an odd number, and they just stopped. there's nothing magic about it -- >> that's correct. >> and same thing with the laboratory situation. i think there shoulda 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 and 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 it could do the job itself? i'll ask dr. frieden that. >> we've made a number of improvements both in our own laboratories and in our regulatory function through the division of select agents and toxins, and as i looked at this issue, i was concerned there was at least the appearance that we couldn't be objective in inspecting our own laboratories. i didn't believe that was the case, i believe that one part of cdc which has no organizational affiliation with another could do that objectively, but i didn't think the appearance was a good idea, so i requested and afis graciously agreed to take over inspections of our own campus so there wouldn't be that appearance of the problem. >> if you had to do it over again, would you do the same thing? would you let -- was it a good
decision to let usda do the inspection? >> yes, i believe that decision was appropriate. i wish i had recognized the pattern of incidents that we now recognize which is why we put those prior incidents into our july 11th report. >> okay. with that, mr. chairman, i yield back. be -- or i can tell an aggie joke, whatever. i yield back. >> yields back. recognize ms. castor for five minutes. >> thank you very much, mr. chairman and ranking member, for calling this hearing today. i had the opportunity to visit the cdc last spring, and on the surface they appear very serious about security, laboratory security, and yet every few years there are these lapses. and now an anthrax scare, an 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'm impressed with everything that is happening there, but for our, 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 has beens, it appears cdc has not heeded those warnings. we know of at least 14 separate reports, letters and lab investigations from gao, the u.s. animal and plant health inspection service and hhs inspector general that documented a series of safety lapses and lack of oversight at cdc high containment labs. dr. kingsbury, your testimony's invaluable here. can you tell us more about the concerns gao has identified with regard to safety lapses at the high containment lab? you've said now someone has got to look at the number of labs
across the country as well. who is that, what entity is that? wonder about your recommendations there. >> i wish i was in a position to say i know the answer to that. one of the difficulties that we've 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 your arching 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. >> right. 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, 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 security 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. >> okay. and before the june anthrax incident, afis conducted at least six separate investigations at cdc's campus facilities in 2013-2014. can you summarize your findings in those investigations? >> yeah. i think there were a number of findings that some of which were found in the recent finding, some of which were not. simple things that people would maybe think are simple like unlocked refrigerators, those kinds of things to -- up to and including more serious incidents, if you will, around invaluation protocols -- invalidation protocols not being up-to-date. >> and, dr. freezen, it's -- frieden, it's troubling. this has gone on for years now, outside experts have been calling attention to these
issues. i'm encouraged because you've been forthcoming in your statements, you haven't been defensive, but what is your current action plan now going forward in detail? is there a culture among researchers? what is it and what -- get specific for us from this day forward with these recommendations, what are you going to do in the time frame? thank you. >> well, first, i think for past incidents the staff at cdc and the scientists did take the report seriously and did respond to those individual reports. what we missed was a pattern, and you're absolutely right that that pattern was an inadequate culture of safety. so the overarching challenge now is to insure that we establish and strengthen a culture of safety in all of our laboratories throughout all of cdc. and there are a number of steps that we're doing to begin to dod that. the first is the moratorium so that we can stop and think about that particular procedure of inactivation, make sure it's done right. the appointment of a single
point of accountability for laboratory safety throughout cdc, the establishment of a working group that that person and mr. henderson will lead. the invitation to an external advisory group, and i intend to invite some of the leading independent experts of the country by the end of this week to serve on that advisory group for cdc. a hard look at all of the critical control points where there may be a problem with lab safety and reviewing to make sure that we have protocols in place that are validated and verified. it gets back to that trust but verify approach. we need to make sure that we are empowering our laboratory staff to report and to identify ways to improve safety and security. we also need to verify that that's happening. >> okay, thank you. gentlelady's time has expired, now recognize ms. blackburn of tennessee for five minutes. >> thank you, mr. chairman. dr. frieden, i want to come back to you, and if you go to tab 15,
the usda/afis investigation, and let's look at that. this started ten days after the event. there was 18 days after possible exposure. you had a lot of really awful basic errors. even you admit there's not a culture of safety, there's not that double check system. and it is something that when you look at worker safety, how it was compromised, and then the management lacking the basic information on what substances to use to have the contamination cleaned up, so looking at this tab and that investigation, i want you to detail for the committee what new policies have been designed as a result of this, and how did cdc guarantee
that the new policies are followed effective immediately? you know, our hospitals and organizations that get all sorts of new rules from hhs on friday afternoons at 4:00, they're effective immediately. so i want you to detail for us how you implemented that and what the new policies are. >> so effective immediately all transfers not just from these two laboratories, but from every single bsl3 and bsl4 laboratory at cdc have been stopped. effective immediately, these two laboratories -- the bsl3, 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 afis and i are confident that they can be reopened safely. we've also appointmented a single point -- appointed a single point of accountability to look at and review before we
reopen, before we begin any more transfers procedures that are in place to insure they can be done safely. >> how could it possibly have transpired that your management team couldn't even decide on the formula of bleach to use to clean up the contamination or to 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 that we would respond to an outside emergency, and that's one of our after-action findings. when we deal with emergencies whether it's ebola or fungal meningitis or another problem, we activate our emergency operations center -- or even if we don't activate it, we utilize the resources of that center to have a systematic, structured, intensive, immediate response. that wasn't done for the first
week after the anthrax potential exposure, and that's something that we will be sure to do in the event of any such internal event in the future. >> let me ask you this, did the management team get preferential treatment to the point that they were unaware that the staff was turned away? >> no, absolutely not. >> okay. and then why didn't the staff feel confident in expressing their worries to their managers so that they could get adequate treatment? >> i'm not certain of what that, what's behind that. i do know that part of encouraging and strengthening the culture of safety is making sure that people are encouraged and, in fact, 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 that was there at the cdc? >> i think, you know, at cdc scientists are so used to risk, they go out into dangerous places where they're not sure
what the risks are going to be that sometimes if you work year in and year out with pathogens that are scary, you can get inyou ared to that danger. -- inured to that danger. >> let me ask you another question. once the june incident was discovered, why, why did it take you so long to track down the anthrax, and why wasn't there a record of where this was stored? >> um, well, as soon as, in june 13th, as soon as we identified there was the potential that any of the plates that were sent out of the containment lab were notster lille, we immediately -- 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 in hallways? >> my understanding, and we'll have to confirm that in the coming days, is that those findings relate to primarily the
materials that were believed to have been sterile and sent out of the laboratory. it's not as if there was an anthrax culturing with kept in the lab, in an unlocked, unsecured place. i think the point there was once that initial error was made of thinking something has been inactivated when it had not been or may not have been inactivated, then that material was then out of the containment space. that's my understanding. >> thank you. mr. chairman, i yield back. >> all right. now recognize mr. green of texas for five minutes. >> thank you, mr. chairman. first, of all our panel there are a number of federal agencies that handle some of these substances, not just cdc. is there a general protocol that all the agencies look at and coordinate handling these substances, dr. frieden or -- >> when it comes to select at --
select agents, then both cdc and afis establish standards and inspect and enforce those standards. other than select agents, there are agency by agency or entity by entity approaches that may be specific to the type of research or to the type of agent. >> okay. so there is some umbrella type standard for all federal agencies. >> for select agents, there is. >> okay. dr. kingsbury, can you summarize your recommendations for us, and can you elaborate which would require congressional action? >> [inaudible] if you're talking about our recommendations, i think that resolving this issue of whether there is a national strategy probably can't be done without congressional alaska, and it'll take -- action, and it'll take some thought to get us there. >> okay. 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 cdc, we will do everything to implement these recommendations. the report that we released on july 11th has a number of steps that we are already beginning to implement. >> okay. any of them require congressional action, or is that something you control within your agency? >> at this point i'm not aware of anything that would require congressional action for us to take appropriate steps. >> dr. dick, do you have any recommendations for congress or cdc that congress needs to deal with? >> be at this point -- at this point in this investigation, we do not have anything that can't be controlled through the select agent program and our work with cdc. >> okay. dr. frieden, does cdc based on the findings in the report have any recommendation for congress? you have none for us? >> we're focused at this point on doing our jobs as well as
possible, insuring that we strengthen laboratory safety throughout cdc and use the findings from this experience to strengthen our regulatory funk through our division of agents and toxins which inspects and regulates hundreds of entities around the country that work with these materials. >> okay. let me ask you about the cdc budget. and, again, i've heard other questions from my colleagues that this was not a budget with issue as much. has cdc received adequate funding from are congress to conduct its safety mission, period? be obviously, you have other missions. >> i think the challenges for safety are more than just funding. there are a variety of issues in implementing safety policies and procedures, and i don't think the primary issue here is a lack of funding. >> okay. some of the witnesses we've been hearing from today have stated this, cdc employees need better training and there need to be better standard operating procedures but overall there's a
problem with the culture at cdc. dr. green, 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 their scientific experiments to improving safety. and that's why we're taking a number of steps to strengthen the culture of safety at cdc. and part of that is to encourage reporting of potential or actual problems. and because of that, it is possible -- though i don't know of anything at this point that i'm aware of, it is possible that in the coming weeks and months we'll hear of other things in the past or that occur, and that may be a reflection that we've strengthened that culture of safety rather than that we've failed to address it. >> well, if it's a, if it's an issue of culture and, like you said, you have some great labs and i'm familiar with some of them, is it just because they
deal with these dangerous substances so often they get lax in their -- they're more interested in what they're working with than maybe the safety of that they're dealing with? >> i think that's a significant part of it, that if you work with something even if it's a deadly microbe day in and day out year after year, you get a level of familiarity that may lead to doing things that you really shouldn't do. and that's why we have to have double checks in place, policies and protocols, training and a culture of safety with the vision that we will work to minimize risk such that no worker and the public are never exposed to a risk that could have been prevented in our laboratories. >> i guess that complacency, it needs to be hon to haved 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 for other agencies? >> absolutely. that's what we've done 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 lahr story needs to be -- a laboratory needs to be conscious of and think of ways to continuously improve. >> okay. mr. chairman, i would hope we'd have a follow up in a few hospitals to see the success and, again, 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. >> think that is a good idea to follow up, and i do want to also -- dr. kingsbury, when you were responding to mr. green's question about congressional authorization would be required, could you get with us, this committee, details on what that would be? >> [inaudible] >> mic? 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.
mr. harper's recognized for five minutes. >> thank you, mr. chairman, and thank you for holding this hearing on a very porn issue -- important issue, and certainly an agency, some agencies can be dysfunctional, and there's no concern or no real harm this that, but cdc is one that cannot be dysfunctional, so we're very 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. frieden, get you to refer to tab 7, that's a letter that you sent in september 2012 to the committee responding to concerns about cdc lab safety. in that you stated a senior official was designated to report directly to you about safety issues and those things. who was that senior official? >> i will have to get back to you about that to get you the name and the details of what was done pursuant to that letter. >> okay.
then, obviously, the question would be -- and i would hope you could have answered today -- was who was that senior official and what were the results of that action. and then the question that perhaps you can answer now is how is the appointment of dr. michael bell as the new cdc point person on lab safety when we don't 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 was we did address comprehensively the specific problems that were identified. so there were concerns about some air flow 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. >> so --
>> that's what dr. bell is overseeing now. >> so does this mean dr. bell will now continue to -- that there'll always be a point potential, is that your plan? >> yes. dr. bell is the person now, we will transition that to a single point of accountability for lab safety, and one of the things he will do is recommend where that entity should sit within cdc to be most effective. >> dr. dick, the cdc reported since 2007 there have been two surprise inspections of cdc both performed by cdc's division of select agents and fox sins before afis took over inspections of cdc labs. since 2012 i'm showing that afis has conducted 11 inspections, why haven't they done surprise inspections 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, we came on in late 2012 as the oversight entity for cdc at roible lab. we actually have been there six -- seven if you include this last incident time -- in that year and a half, so we have not had the 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 be 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 manned -- [laughter] but it -- is planned, but it does seem like lie that 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 and making a revisit when cdc indicates that they're ready for us to revisit.
and then we'll be doing surprise inspections after that point. there are. >> let's say, 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? >> so we have a protocol for dealing with theft. there has been no theft of a biological agent reported from either cdc or any of the regulated facilities in the ten years of the program to my knowledge. when there are concerns for potential theft or misplacement, we work with law enforcement including the fbi to do a joint investigation. i would just mention the increase, our expansion of surprise inspection, we felt that was very important to do. >> so you said there have been no reports of stolen agents. >> that's hi understanding. >> -- my understanding. >> but what about missing biological agents? >> there have been losses at
certain facilities, and in those circumstances we also coordinate with the fbi. usually it's an issue of inventory control, so as earlier we were talking about critical control points such as inactivation of virulent pathogens, similarly, inventory is a critical control point. >> 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 -- i mean, someone could take something, replicate it and walk out with 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 be thefts reported -- no thefts reported from any of the select agent regulated labs including cdc's over the past decade. >> well, there was one in the army one of texas a few years
ago. >> i'm not familiar with that. >> thank you. mr. conklin, you're recognized for five minutes. >> thank you, mr. chair. welcome to our panelists. the cdc is responsible for registration and oversight of all laboratories that possess, use or transfer select agents that could pose a threat to human health while afis is responsible to 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 cdc and afis. so that being said, dr. kingsbury, can you tell us what gao has found with regard to the increase in the number of high containment biolabs? >> i'm not, 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 to be select agents, and nobody knows how many of those laboratories there are. >> but with the high containment biolabs, is there -- in that given category is there an increase that has been measured by your review? >> i mean, is there -- i didn't hear the word. >> is there an increase in the number of -- >> can there has been an increase since the anthrax attacks in 2001, the last time we actually tried to to count them was two or three years ago, and i think at that point it looked like there were slightly fewer than there had been 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 bsl3 and bsl4 laboratories that are not overseen in the same way, and that is of little concern to us. >> well, is -- what accounts for the numbers, 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. 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 the number of labs in these various missions associated, what would your recommendations be be to addressing -- >> well, we've made recommendations that 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 a -- 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 given to address this issue and think through how we would go about doing it in the future. >> and dr. frieden, what are your views 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 with dangerous pathogens goes on, the more possibility there is of accidents or stental releases -- accidental releases. so insuring the 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 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 insure 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. now recognize mr. griffith for fife 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, and as you look at that there at tab 5, that is the hhs inspector general report regarding the cdc roible facility which says it was sent to you. have you seen this before at some point? front page says it was sent to you, okay. and then 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 sampled approved individuals for select agents had received the required training, and do you see that on that page? >> yes. >> and likewise, it says that select agent inventory records are incomplete, and you also acknowledge that's on that page? >> yes. >> and then if you go over to page 6, the report says that agents stored in areas -- there were agents stored in areas not listed in registration. you see that as well on page 6? >> yes. >> thank you. and one example given as a scientist find a vial of select agent in a drawer and another scientist found 16 stored in an unsecured freezer. do you see that in that paragraph? >> yes. >> there you go. and the report on page 6 also states there were unauthorized transfers and packages received by unapproved individuals. now, my concern is this, this is at the roible 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 and flu incidents of 2014? aren't they the same types of problems? >> the answer is yes and no. >> all right. >> there are specific problems that were found that led to a specific response. for example, on security we implemented layers of security, we strengthened the systems, we locked, we improved personal background checks and security. so in each of these, we -- >> let me ask you this question, did you all do a system-wide after these problems were discovered? because we've got 2010, then we've got 2013 and earlier in 2014. did you all ever do a system-wide recheck? >> not adequately. not adequately. >> okay. >> 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 do appreciate that, and i know you're having to answer a lot of tough questions, and i appreciate your demeanor today. i do think that's appropriate and appreciated. that being be said, let's look over 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 polled up on -- followed up on. >> well, i can shorten this by saying the key one was the fifth, and the fifth had to do with confirming that materials are inactive before transferring them, and that was specifically what was not done in the anthrax incident. so if we had applied this broadly, this incident would not have happened. the specific, to give you a sense of it, in 2006 the anthrax, the same laboratory, the blrat -- brrat lab, had a
pretty similar incident. 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. so 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 and improvement in our laboratory safety culture that we're now implementing. well, i appreciate that. what about the other four? number five may have been the host important, but could you look at the other four? >> the first has to do with physical security measures, and i believe we've taken a number of steps there. there are still steps we need to do better on in that area having to do with staff coming in and not swiping in every time --
>> and you've indicated you're going to have training which was number three. what about number two? >> yes. i think we've made a great deal of progress on insuring that only approved individuals are allow ared access to select agents and mr. henderson can speak more to that. >> i've got 20 seconds to do number four. >> inventory is an area where we have done a number of things, but given the recent incident at nih and the fact that inventory is a flashpoint, we will be reviewing all of our inventory work. it's a massive job to do it right, but we will do that as well. >> well, and i appreciate that. the safety of the 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, and i want to thank the witnesses. as you can see from the tone of this hearing, there's 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 cdc report described the identification of potentially exposed individuals and potentially affected lab rooms and communication of the possible release of anthrax to to all cdc 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. ..
we should have done that the moment we learned of the potential exposure. what that allows us to do is break down a big problem into smaller problems and address them one by one. communication, employee safety, clinical care, decontamination, scientific evaluation, investigation. and so instead of doing that in a systematic way, it was done i'm systematically and as well as it should've been done. in those first few days which i remember vividly, we were really focused on the employees who may have been exposed and making sure that they got into gear and got on treatment. >> but it took a while to even identify who those people were. >> yes. in the effort, to do that we
identified that we didn't have the kind of systems that were needed or the systems that we had in place weren't used promptly. for example, viewing security camera coverage to see that coming to an left the facilities on time. that wasn't done because one part of the agency didn't know or didn't use those resources. the root cause of the problem was not activating our incident command system. >> dr. dick, can you elaborate on the finding, about response? >> yes. i think our findings were very similar to dr. frieden's. we had an independent team that came in during, that was still ongoing investigation by cdc and their staff and our 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.
>> i wanted to follow up 42nd on what the chairman was saying -- for a second on what the chairman was saying about even stealing something, threats. in the smallpox incidents, it turned out that the vials were discovered at nih, but there could've been somewhere else. nobody seemed to know and the truly disturbing, too. you know, who knows? somebody could've taken them out. so i'm not sure when you say that nothing has been stolen, but it also says nothing could have been stolen. respond to that. >> we have taken a number of steps to strengthen the security aspect of select agent registration. those steps include suitability
assessment for all people who work with tier one agents. they include looking at cybersecurity issues and personal reliability, ongoing access of personnel who have access to tier one agents, increased physical security standards, incident response plans and ongoing training. so i do think that the concern for theft israel. some of these organisms still occur in nature, ensuring with our laboratories not just in this country but around the world that contest on them. >> let's worry about this country right now. smallpox of course would be a big concern. let me just and with this if i could, mr. chairman. whenever i hear the word coach or, a cultural problem, i know we have a real problem on our hands. handwashing change the face of medicine. it's not sexy and people don't
win nobel prizes over that kind of thing, but it really as part of the culture has made our medical system much more successful. a huge advance. and so these kinds of small things that deal with culture and attitude and awareness of these kinds of very simple things, we need to figure out, you need primarily to figure out how to make them part of the everyday thinking of your staff. we are willing participants year. i yield back. >> thank you. recognize mr. johnson for five minutes. >> thank you, mr. chairman. i want to thank our witnesses for joining us today. dr. frieden looks like you're the guy on the hot seat. you are getting peppered with all the questions and i've got a few for you as well. you know, the mission of cdc
laboratories as you will know includes carrying out work to protect the american public against bio terrorist activities. now critical lab activities are shut down pending the outcome of your remedial evaluation reform. so how will cdc be able to address any wild terrorism or other emergencies which might occur before they reopen? >> there is just one particular laboratory that is shot. there are multiple other laboratories that continue the operation, would be able to respond to bioterrorism, potential bioterrorism incident. >> so there's no concern on your part that because of the cdc errors that we may be limiting our ability to protect the public? >> no. i'm confident the incident that we saw did not cause any release of agents into the community. they most likely didn't cause any actual exposure to cdc
staff, but they really are a tipping point in our recognition for the need to improve our laboratory safety. but we are still fully functional in terms of being able to respond to an event. it's just that step of sending something out of a high containment space into lower containment space which i've issued a moratorium on come and we will list that laboratory while labrador as soon as we're confident we can do that safely. >> is the cdc planning to use the national science advisory board for biosecurity as the committee to advise cdc laboratory quality and safety? >> what i intend to do is to invite an external advisory group specific to look at cdc and specific to tell us everywhere they think we can do better. >> what about the national science advisory board for biosecurity? will you be using them? >> that is not our current plan to the best of my understanding the nih purged almost half of the members from that board, and
i was inquisitive about whether you knew about this, why the administration took this action and whether or not nih consulted. do use that advisory board for anything? >> i would have to get back to. it is primarily managed by in the eighth so i would have to defer to them for the management of that group. >> all right. that's good. that eliminates one question for you than. for dr. dick, in light of the anthrax incident investigation, aphis recently completed, do you think that prior inspections of cdc laboratories were sufficie sufficient? >> i do. >> well, given the fact that select agents were stored in an designated places, shouldn't such problems have come to light fully as a result of prior
inspections to? >> yeah, 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 this incident, and that was that this bacteria was not inactivated, 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. >> all right. that concludes my questions. mr. chairman, i yield back the balance of my time. >> now recognize mr. long for five minutes. >> thank you, mr. chairman. dr. frieden, are you familiar with this picture? >> i certainly am.
>> i'm going to turn 59 in less than one month, and this vile 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. >> so this while a smallpox that is older than i am have been on a cooler, am i can understand in one location. i can even imagine a cooler running for 61 years spent my understand was it was a walk in coulter that was used for storage. speaks of a walk in and discovered the smallpox? >> what happened was that laboratory as i understand it was transition from an age the fda many years ago. when the fda took over some of those functions. fda's move into its new facility. in the course of moving it was doing a complete inventory of everything in its facility, and
workers there discovered a large box that this and other senate. >> like working over? >> laboratory scientists. >> well, recently there was a case of someone that wanted to remove information from nsa and he got any position to do that. and with a $1500 thumb drive is able to take all kinds of severe government secrets with him out of his position. he had worked -- does it bother you at all that people, if they had cruelty, mean this in mind that they could not get into a cooler like this and take a 61 1 year old while a smallpox? >> we are certainly concerned that smallpox which should not have been there was there for many years. we want to ensure that on our campus and nih is looking at the campus and fda that there's,
there are not other examples of collections because this is a collection of organisms that are in place, in places where they shouldn't be. this particular box was created by scientists who was very experienced, a group of scientists. the materials were essentially freeze-dried, and then sealed in that and feel that you held up a picture of. and that was done before smallpox eradication was undertakeundertake n. it was not done with malicious intent. it was done just to record something for future spent either that which is the fact that this could lead around for 61 years but i can't even conceive of that font. but let me take you to a press conference last right now we move from 61 plus years ago at a press congress last right you indicated the cdc does research to figure out how better to treat people if they are exposed and prevent it if they're exposed in a predator to prevent
through vaccination. he also stated the fact that anthrax continues to occur in nature, that anthrax has been used as a weapon. my question is this. how many cdc laboratory workers receive the fda license anthrax vaccine prior to the anthrax incident last month as recommended by the cdc, it's advisory commit on immunization, practices committee for love workers since 2002? >> i would have to get back to you on the exact number but we offer anthrax vaccine to anyone for whom anthrax vaccine is indicated. we don't require people to get vaccinated but we offered to anyone who might be exposed to the laboratory work. >> so you think is a pretty active program to? >> yes. >> i know you say you have to get back to me and if you what i would appreciate it. >> i would have to get back to you. >> it's reported that you told reuters on june 30 the fact that anthrax is kosher was even a
concern or it might have happened was unacceptable. employees should never have to be concerned about the safety for preventable cures. as you note today, more than 12 million doses of the vaccine have been administered to more than 3 million individuals. so if you can get back to me with that i would appreciate it. >> i will. >> with that, mr. chairman, i will yield back spent 50. now recognize ms. ellmers of north carolina for five minutes. >> thank you, mr. chairman. and thank you to our panel. this is a very good discussion and i appreciate your candid responses. i think at this point the most important thing we all can do is get to the bottom of it and correct the issues at hand so that these things don't happen again. i did want 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? how to determine, if something is missing how do you determine that it absolutely was not stolen? and anyone else on the panel would like to comment on that i would appreciate it as well. >> so, to give you an example, there may have been a package that was sent from one location to another, had select agent in a. it did not arrive at the second location. the fbi was involved and an investigation and the fbi concluded in one particular case as an example that the package had been inadvertently destroyed. but it had not been stolen or lost. is anything you'd like to add to
that? >> just one thing i think is important. we take the notion of chain of custody very socially so we are always try to be mindful of where the select agents are stored and that there in transport, we have eyes on them or somebody trusted to be with them. occasionally dr. frieden is correct, there could be an accounting issue or something has been destroyed and they didn't complete the paperwork and went to go and try to understand what happened. there has been a couple of incidents like that. >> thank you for clarifying that. and then again getting back to some of the toxic substances that have been found, you know, inboxes that may not have, you know, stated what they were in a refrigerated walk in storage or otherwise, when the nih grant across their most recent probably put in place what they called a clean sweep. i know you have said that there
was a change, you know, there was a transition between nih and fda. were they already in the process? is that what the clean sweep is that you're talking about or did the institute for clean sweep afterwards? >> my understanding is that both nih and fda are doing complete inventory checks and follow-up to the discovery of a smallpox. >> psych test my question for you is is the cdc doing the same? >> yes, we will undertake a comprehensive inventory review at all of our facilities. that is my understanding. >> including the one shutdown now, obviously but all of them. >> yes. all of our lab facilities. >> thank you. i have time if anyone wants to use it. mr. chairman, 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 will just let you step away what we prepare the second bill but i'd also remind everybody that we will have some follow-up questions for you so please get back to us in quick time. >> mr. chairman, will yield for one second? >> yes. >> i would just 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's really important for us to know what they're doing and they know they're working hard on this. >> i agree and we would like to hear again so we will have them back. [inaudible conversations]
>> what we may do to get going, mr. kaufman, i mr. kaufman, i miss where you and so you can get started on adjustment and then we will swear in the doctor when he returns. you are aware of the committee into the gaza practice taking has been under oath. any objection to testifying under oath? advisor under the rules of the house you can be advised by counsel to do you have desired to be advised by counsel to the? i do not. >> thank you. spent please raise your right hand and i will swear you in. please were the test we about to give us the truth, the whole truth and nothing but the truth? >> i do. >> you are under oath subject to the penalties. you may not get a five minute written summary, five minute summary of your written statement. go ahead. >> fantastic. thank you, chairman murphy, ranking member degette, and members of the subcommittee. thank you for the opportunity to be to testify on the sims for disease control and prevention anthrax laboratory incidents. but he began like amending the
cdc, specifically the actions taken to protect the workforce inform the general public during this very serious issue. i stand by my belief that when someone does something wrong, we cannot forget what they have done right and in general we must not forget the cdc has an outstanding history of service. for over 10 years i have been providing biosafety training programs for individuals working in high containment laboratories. my background is in behavioral science, and i specialize in motivating individuals to behave and mitigate risk associate with infectious diseases. there are three main challenges we face when doing scientific research. the agent, the people working with the agent, and the organization where the work is being done. the first challenge of working safer with infectious agents has been for decades and can be a properly mitigated. effective engine controls, personal protection of equipment, standard operator
seekers are already in place. however, it is important to recognize that one person and one air, whether unintentional or intentional, can negate all these controls in an instant. this leads me to the second challenge we face when looking at safe sides and that is the people, working with the agent. human risk factors such as risk perception, attitudes, behavior, complacency, outrage, apathy and perceived mastery must be addressed to sustain optimal performance of the scientific workforce. we must accept and learn from and control for human error in a laboratory environment. in other words, we must stop focusing on the to and start focusing on the watch how and what went wrong passing a judgment other than we are all human which relate to solutions minimizing future human air. are final and greatest challenge is existing social norms that safety culture within an organization. let me repeat myself. the greatest challenge we face
is not the agent. it is not the worker. it is the culture of the organization. the culture permits norms to be developed and it is within these norms behavior is deemed acceptable or unacceptable. as a former private cdc employee, i am very, very disappointed by what i am hearing. it has been and remains very clear that this issue as a systemic one, or an organizational issue rather than an issue of the laboratory director and two scientists. i become irritated by the unnecessarunnecessary finger-pod statement threatening to split the action of scientists who work in parallel with the culture of the organization and made an unintentional error. the incident highlights the need for scientific protocols to be reviewed and verified, ensuring they work and they can be done by those working in the laboratory. this incident highlights the to ensure those protocols are followed, and if they are not,
consequences and that minimizing future failures are immediately applied. this incident calls for more evidence-based biosafety research to determine what specifically works and minimize risks associate with the challenges that 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 commonly which around the world. l. 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 my laboratory training. please consider this analogy. a laboratory is a home. the scientists working within the laboratory are a family. the scientific protocols are the house rules. if one member of the family breaks the house rules, it puts the whole family at risk. is breaking the rules is not addressed, the whole house is at risk and begins to affect other
houses in the neighborhood. let me clarify. the scientists don't follow their house rules, it impacts other laboratories within the organization. cdc is a neighborhood that houses hundreds of houses, or actually has hundreds of labs. if the neighbor does not establish a set of ground rules for all the houses, and each house begins to do their own thing and inevitably the neighborhood is at risk. building a culture of safety starts with establishing a commitment of residence, the sciences of the neighborhood or the organization. we don't banish family members for unintentional errors. we encourage homeowners our lab directors to come together and find solutions. we establish consequences for neighborhood members, scientist, 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 learns and grows from them. we recognize that together we are safer. this commitment is contagious and spreads to homes throughout the neighborhood, that includes laboratories throughout an organization. this is just the start of culture change, folks. deceived we planted is what we will reap five years from now. somewhere out there that may be a scientist or an organization that will find something unexpected in the freezer as as a him being makes an unintentional error. a choice has to be made. do i report this or not? i ask this committee to facilitate a process which encourages organizations to report incidents and accidents rather than punishing them for doing so. cdc remains a national treasure. the united states of america remains the land of opportunity for scientist and biological research. placing untested mandates as a result of this incident on scientists and institutions of
research may not only pushed science and innovation outside of infectious disease research, at worst, could shift it to other regions of the world. i asked this committee to continue to take leadership role at considering the implications of this hearing and future legislation. i look forward to your questio questions. >> thank you, mr. coffin. doctor, you are not available when i -- first ask you we were doing an investigative hearing, we take testament under oath. any objection to testifying under oath? and the chair will advise you under rules of the house and of the kind you're entitled to be advised by counsel. counsel. do you decide to devised by council today? in the case would you please rise and raise your right hand and i will swear you in. do you swear the test when you're about to give us the truth, the whole truth and nothing but the truth? i.t. you are now under oath and subject to penalties. you may now give a five minute verbal summary of your written statement. [inaudible]
>> mr. chairman, members of the committee, thank you for inviting me to discuss the 2014 cdc anthrax incident and its implications. i am board of governors professor of chemistry and chemical biology at rutgers university and laboratory director. i will discuss three topics. first, the 2014 cc anthrax incident. second, broader biosafety about security issues of assisi by secure weapons laboratory. also known as select agent laboratories. and three, broader biosafety about security issues at more than 1000 other governmengovernmen t academic and corporate select agent leveraged across the u.s. that are regulated by the cdc. might assessments are based on information and publish cities, oig, usda, oig and gao documents, published those are part of of biosafety about security standards for working with pathogen.
i will turn first to the 2014 cc anthrax incident. i note the 2014 cc anthrax incident did not involve one violation in one laboratory but instead involve an entire series of violations. the 2014 cc anthrax incident involve multiple violations of biosafety and biosecurity recommendations in each of three different cdc laboratories. there were at least seven distinct violations in total. had any of three violationviolation s in one cdc laboratory not occurred, the incident would not have occurred. had any up for violations into other cdc laboratories not occurred, the impact would've been mitigated. i note for the incident -- in the 2004 incident workers in frederick, maryland, using an approach procedure to inactivate a sample of anthrax bacteria, and interpreted to verify inactivation and viable anthrax
to children's hospital were a personal expose before learning that the anthrax bacteria were by with the sec -- invested at 2004 oakland anthrax incident at a 2005 issued a report on the incident. the 2005 cdc report included revised biosafety and biosecurity recommendations both were laboratories that prepare and provide inactivated anthrax by kerry and for laboratories that receive and use those. had a cdc admitted the recommendations in its own 2005 report, the 2014 cc anthrax incident could not have occurred. the cdc did not implement the recommendations in the 2005 report. the fact the cdc in 2014 made exactly the same errors that had been made in the 2004 oakland anthrax incident shows the cdc did not learn from that incident. i turn out to biosafety and
biosecurity and cdc select agent laboratories. i submit 2014 cc anthrax incident is not an isolate incident but is instead part of a pattern come a pattern that could recognize a half a decade ago, and should have been. last week a cdc report listed multiple other incidents, none preaches this goes to the public -- previously to the public. is previously undisclosed cdc select agent incidents are fundamentally similar to the 2014 incident, in particular to from 2006 involved anthrax and appeared to be identical to the current incident. all of these raise both safety and security concerns. i note for the hhs oig audits have document for the biosafety about security violations. hhs oig audits in 2008, 2009 and 2010 reported major violations.
these violations include failures to ensure physical security, to restrict access and failure to document inventories. they also for the failed to provide required training to workers with training being unverifiable for only one in three workers in the most recent available report. perhaps most egregiously the violations included unauthorized transfer of select agent labs to other laboratories or individuals. i note for the press reports from 2007 have document for the biosafety and biosecurity deficiencies in cdc select agent laboratories. to summarize include inadequate provision for emergency backup are, fatty to maintain negative pressure air flowing, nonfunctioning doors, non-function door seals, jerryrigged repairs with duct tape, failed to close entry doors, failure to latch entry doors, fitted to assign distinct key codes for select agent laboratories in at least one
case the discovery of an unescorted unauthorized person in a restricted area. taken together, the documents indicate that cdc is not adequately ensuring biosafety about security in its own labs and are consistent with pervasive and systematic violations of biosafety and biosecurity in its own laps. i turn out to biosecurity at sea -- >> could summarize the rest of your statement. >> the cdc and usda have regulatory responsibly for biosafety about security in the approximately 1000 other u.s. select agent labs. government, academic and corporate. there is no basis for confidence that biosafety of us agree standards are higher or that select agent inspections are more stringent fcc regulated not cdc select agent labs and in cdc select agent labs. there also is no basis for confidence that biosafety about security standards are higher on the select agent inspections are more stringent that usda select
agent laboratories than in cdc select agent laboratories. deficiencies in select agent standards at the cdc regulated and usda regulated other laboratories are amply document and hhs oig audit. >> we are way over time. we have to go on. >> one final point which is i note that the cdc and usda not only perform in select agent work but also regulate biosafety and biosecurity and select agent work. this represents a clear conflict of interest. this systematic and conflict of interest may at least partly account for the deficiencies that i've mentioned. >> thank you. i think the two witnesses. i were recognize muscle for five minutes. mr. kaufman, you specialize in the area of behavior and behavioral change along those lines. we've heard from you and other witnesses today that the culture of complacency is attention. congress has invested at length problems with the veterans administration. but we saw that there were caching system people to cover
things up, to shred them, to hide waiting list. we also had in this committee hearings of mary barra, the ceo of gm. americans are outraged about this and, describe a culture of complacency with the gm not. now we see this behavior probably get into an area of which you for a few words a veteran or if you didn't buy a chevy cars, but this, you release a pathogen it's pretty indiscriminate. so does this routine familiarity around pathogens 10 to lead people to cut some corners and just get complacent about this? >> i think that there's dust and i believe you know this, too. i think there's an inherent risk in behavior in general. you over behave, you run the risk of becoming complacent to you under the it, you run the risk of being unprepared. i think it's a balance, and that in essence is really what professional development and
training and assessments can be used for is to keep that healthy balance in check. in this case though if we are talking about anthrax incident in a laboratory, i don't believe that this was a complacency issue or even an incumbent is the 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 purposes are, and, unfortunately, there was a process to the that protocol. and so when it was adapted for one lavatory to another, the inactivation time it takes to kill one agent versus another is a lot more than it was with the brucella. >> what we heard, the way doors are have become weird about people being in an area that did not authorize to be there, that a key was left in the refrigerator. it seems to me there are several elements here were rules are in place and people are just
downright sloppy. >> chairman murphy, i think the things that you are saying of richard and they must be addressed, but i think they also have to be put in perspective. this key in a freezer is almost like come when you use a loaded gun or a gun earlier in the session. is almost like saying i have the house and inside the house i have a gun at my house has a door with locks. it also has a house alarm. and upstairs in the master bedroom is hidden us safe. and inside that save is a gun with a trigger lock that has a key in it -- >> but that's not the case here. if the key was left in the refrigerator and people can come into the area, if people are all piggybacking on each other's cards, those are violations of rules. >> chairman murphy, like i said i'm not going to argue the fact it's a problem because it is. i'm discussing the perspective and i'm telling i've seen those refrigerators. they are not common practice refrigeration that people go walking by. these refrigerators are in places where you actually have
to have access. i came in as a civilian. i'm not related to cdc. i've been to the laboratory. i've seen these freezers. they are not -- >> but the issue is how people behave. not the object you and that's a question i have for dr. frieden before is someone be required to use the actual card. so only certain persons can get in with authorization and record when they are into. in some cases the deadly pathogens require two keys, two sets of eyes. part of this, i mean, i'm not clear on what you're saying, mr. kaufman, i want to be clear. are you making excuses for the persons saying there wasn't enough protocol? >> no, sir. i'm not making any excuses. what i am saying is there's health respect for what truly is going on or anything but to look at the spectrum. we can't be arrogant and say this is just what happens in science. we also can't believe in an allusion where this is the end of the earth, we've got to stop
all research, we've got to minimize and cut things down to a certain number of laboratories as a result of what happened to. i think when to take a balanced approach and take a look at what really happened, and in the culture for which it happened. that's what i'm saying. >> i disagree. >> can you please explain? >> so these are problems of individuals by their problems and those acting in a context. that context is to compose. one is the laboratory culture. we've talked several times or personal times a day about a culture of blacks attitude toward safety. that is part of the problem. we've heard several times about research is becoming an art to working with dangerous or hazardous materials. that is part of the poem. hubris is fundamentally part of the problem here. a sense of the scientists that he or she should be able to proceed without restriction and without management.
these are all issues with the culture. but you have an institutional structure, and it's a crucial management and you have the oversight of that institution. i think these are even bigger problems that are even more significantly responsible for the issues that i described. i mentioned the fact that cdc and usda regulate their own biosafety and biosecurity. they perform the work if they funded the work. that's an inherent conflict of interest. until that regulatory responsibility as moved out of those two agencies and out of any agency that performs select agent research and unselect agent research, i believe you can predict with high confidence that same types of problems, the same patterns and the same cultures will remain in place in cdc labs, and usda labs and in the approximate 1000 other labs that regulate. >> thank you. i will not recognize
ms. griffin. >> mr. cotton, i've no doubt these individuals have no element. that will motivate the they are cut to do the research. dr. ebright, i think you would agree with that as well. >> i will. >> let me put this in context or i don't know if you hear when we gave our opening statements. i've been on this subcommittee since 1997, and i'd have to kill you that the reason why we are 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, they were six inspections. aphis identified 29 observations of concerns of facilities and equipment. 27 related to safety and security, and 39 on documentation and record keeping. and a lot of times what we are dealing with in this situation is very, very extreme violations
-- bio agents that could kill a number of people. your nodding your head so i assume you understand this, yes or no? >> yes, i do. >> so what we're trying to figure -- like i say, i think the people are trying to do their job. i think they are well motivated, but with all due respect we are not overreacting here. this has to be solved. what i want to ask you, since you were here, did you hear ms. kingsbury's testimony where she said that we need to have one agency a lease in charge of developing national standard? >> yes, i did. >> what did you think of that? she admitted it's going to be difficult to do that because of overlapping jurisdictions. but would you agree that it's worth an effort to try to do that? >> i know you like yes and no answers, and i'm trying to think.
i agree that we should explore what we're doing today and where we could go in the future, yes. >> dr. ebright come what you think about that suggestion? >> their catholic should be a single national agency that sets policy recommendation, policy standards, and advises on needs and how those needs should be met. there also should be a national entity that regulates and overseas the select agent. they need not be the same but they both need to be there. >> you know, let me just say that we've seen this in this subcommittee not just that cdc. we've also seen it in the labs. we sought at los alamos some years ago -- we saw it at los alamos some years ago were some nuclear data disappear because the researcher took it home to his house. it's the same kind of -- you call it hubris, or whatever. it's an assumption that there's important research going on, and
that nothing bad is going to happen. >> correct. >> and so what i think is that, in fairness, i think what dr. frieden thanks, too, is you need to put the systems in place so that it's not relying on somebody to have that kind of judgment where really you should have a system. would you agree with that? >> absolutely. >> mr. kaufman come which also agree with that? >> absolutely. >> mr. chairman, i don't have anything further. thank you for clarifying and i would you back. >> now recognize ms. blackburn of tennessee for five minutes. >> thank you, mr. chairman. i think we're all kind of on the same path here with our questions. dr. ebright, i want to come to you. let's go back to the cdc report from the 2004 anthrax incident, and he mentioned that, that incident stated enacted anthrax
should be culture both at the preparing five before shipment and at the research lab several days before use to ensure star really. so did cdc follow their own advice in this -- go ahead. >> no, they did not. i barely not in 2006, definitely not in 2014. so what we have a continued pattern of refusing to learn from their past mistakes. >> indeed, refusing to read their own report and follow their own recommendations. >> okay. you're the director for biomedical research lab, and you to some of his same work with dangerous pathogens. and how important is it to you that all personnel in your lab strictly follow your biosafety protocol, and that in order to
follow those biosafety protocols, they have an understanding that they have a culture of safety that is lacking at cbc? >> i think it's critically important, and for biosafety, working with biohazardous organisms at any level, one, two, three or four, that message of safety has to come first. that safety training has to come first. and before any experiment is even begun, there has to be a process of risk assessment, risk benefit assessment in which the investigator enumerates the risks, enumerates the benefits, ways the risks against the benefits, assesses that the risks are outweighed by the negative and that process has to be reviewed by another set of eyes. >> do you follow this as standard operating procedures to? yes, we do for our biohazard research. >> is it clearly understood from all other personnel? do they see this as written best
practices, and to the understanding that they are expected and required to follow? >> they understand that they are expected and required to follow these practices. they are monitored in these practices, and the message consistently is that these agents require respect. and they must be handled with respect. and before any experiment, that risk benefit assessment must occur. >> and if one of your personnel failed to follow those protocols, what would you do to them? >> depending on the nature of the failure, they would face consequences up to and including termination. >> okay. and we'll see that pattern taking place at the cdc. >> we haven't seen evidence for it. >> okay. do you think that cdc is in need
of a major correction? and do you have advice for cdc i want that correction would be? >> many of the things we are dr. frieden suggests will be undertaken at the cdc, are precisely the steps that are required at the cdc. 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 i think probably, according to what you said you would terminate the whole bunch? >> again, i'm not sure -- in this particular case, personnel action won't be sufficient to resolve the issue. this issue is institutional and organizational. they cannot have a regulatory authority to regulate themselves. it sadly doesn't work. it does work in many areas of human endeavor and it effort doesn't work in this area. >> mr. kaufman, anything to add to that? >> i continue to stand by my belief that any type of, and in
my conviction, because over the last 10 years i've traveled the world, including federal labs indiana state and i've asked scientists to please report laboratory accidents and incidents so we've a chance to learn from them. if we take this chance now and turn it into a punitive aspect against scientists that make unintentional injuries, it's well-known that punishment does three things. it builds resentment. it teaches no new behavior, and it hides true behavior. and so if were going to make decisions that are going to decrease risk inside, we better consider how we address incidents and accidents before doing so. punitive actions, in my opinion, are not the way to go. certainly not against a scientist that unintentionally makemakes a mistake if they scientists willingly, and there are scientists who do that, go against as obese, it's a completely different -- sops, secondly different job issue,
the cycl psycho outside of the p that is provided to them. >> thank you. mr. chairman, i yield back. >> i've got a comment to that can mr. kaufman. it builds resentment? you've got to be kidding me. you are telling me these people with ph.d's do not understand that anthrax is dangerous? are you kidding me? they need more training? you are making a statement that cdc anthrax lab was result of trading fairly? working with high content facilities consistent with -- blah, blah, blah. are you kidding me? are you making excuses for these scientists? if they don't understand that anthrax issues for a weapon, its force can kill people, they kill people and our people at the u.s. capital. then they shouldn't be working there. and 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.
look at this. "washington post." today's cartoon. to thank the employees of caci proud of this. ha ha hot. it's funny. know it's not. this is tragic. it could've been legal for people. i hear you telling ms. blackburn that we are going to build resentment. i'm sorry, i don't buy that at all. >> may i comment? thank you. thank you, chairman murphy. i again am not defending what's going on at the cdc. in fact, i said that an i disappointed even as a former cdc -- >> disappointed is not the right word. you should find this a board. any word other than yes or no come wasn't wrong or not wrong? we can make excuses -- mary barra center for gene she said this is wrong. there's a question about the dr. frieden said this was wrong. there's no gray zone in this. i don't get it. i'll let you respond.
>> i appreciate that. i know the individuals involved, and when i say training is needed and training is a solution, there are several phases of training. on the job since of the training would include sop verification is needed for scientists which have been mentioned in previous the aspects as well. i'm not making light of the situation. i'm not making light of the situation at all. i'm simply saying that if we choose to punish people who come forward when they make a mistake -- >> that's different but i'm not talking about -- >> that's what i'm saying. >> that's different but we want people to be willing to do that. >> thank you spent but what i thought you're saying here, i think it is your statement, they need more training. they don't need training to know this is bad. when you put anthrax in you put anthrax in his of walk back or any other pathogen, you don't need training to know that. so i've got over. >> that is subjective. >> well, and i guess my concern is that what we have here is a
series of reports that doctor e. bright has brought out thomas on the questioning i did and others did earlier. we've had a series of reports that dates back a good period of time, and yet the changes have not been made. it's a concern. a mistake is one thing. having a standard operating procedure which is so flawed that you repeated mistakes is something that i have to agree with the chairman on. that's our problem. i agree with you, mr. kaufman, you don't want to punish someone who merely makes a mistake. you want them to come forward as quickly as possible and let's fix it. but you've got to stop the same station happening over and over again. doctor e. bright, how do we make these are forms happened this time? how do we do that? while cdc is protect the american public from anthrax and other genes, our job is to make sure they're doing their job. how do we make it happen?
>> i think the two steps that congress and the administration could follow to reduce the probability that this happens again in cdc's own labs and in the labs that cdc and usda regulate outside those facilities, the two most important steps are first to reduce the number of select agent laboratories. the number of select agent personnel and the volume of select agent research increased by a factor of 20 to 40 over the last decade. that volume of registered individuals, that all of the activity needs to be rolled back to close to the level where it was at the beginning of that increase. that would represent taking the current 1000, more than 1000 select agent labs in years and reducing it to 50. >> let me ask a question real quick. high content of select agents, are those interchangeable terms
or are they different? >> they are very close to interchangeable. most select agent research, particularly most research consequences time at biosafety levels three and four are considered high level containment. >> your first recommendation down to 50 instead of 1000 of these select agents? >> roughly. the increase of the fact is 20 to 40. i would recommend we roll back a factor to a factor of 40. 1000 divided by 2050. a thousand divided by 40, 25. that i believe is the single, easiest single, fastest and certainly most economical approach. >> and another -- >> last one, independent entity that carries out the regulation and oversight of biosafety and biosecurity in those labs, not an agency that performs the work. not the agency that defines the work. >> you said we need to scale back but let me ask you. why has there been an expansion, and the phrasing i have is i containment laboratories, why
has there been such great expansion? >> so it was in large measure essentially in whole a response to the 2001 anthrax mailings. at the time of the 2001 anthrax mailings it was understandable because it was expected here and elsewhere in the u.s. was under attack with a biological weapon from a foreign source. it was expected that biology would be put on a mobilization voting to address this threat. we expanded by a factor 20 to 40. now more than a decade later, more than a decade after it has become clear that the 2000 anthrax mailings did not come from a foreign source. and after has become for the investigation believes they came from within the u.s. biodefense the establishment, we have the strength situation that we've expanded that establishment by factor of 20 to 40 without raising, or without reassessme reassessment. >> and the risks are self-evident speak was the risks
follow mathematically. when you increase the number of personal by factor of 20 to 40, particularly when you recruit people without prior experience, new to the field, you increased risk. the increase those risks by a factor of 20 to 40, or more. >> on those points, mr. kaufman, are you in agreement that we need to scale it back some? >> i am not. i agree with gao. i think that there's not enough information to make a decision to either back off over go up if we don't have a baseline. i also like to say that i containment laboratories are not fashion the capacity is not built for the threats we see today. they are built for the threats that we don't see coming around the corner tomorrow. >> let me switch gears and ask about the research applications, invitations from research of ranging pathogens such as the experience with university of wisconsin generating a virus summer to the 1918 influenza
outbreak that killed tens of thousand, maybe hundreds of thousands worldwide, and other ways to make h5n1 avian flu virus more contagious. is this part of expansion or is this speed this is work that is funded as biodefense research and this is a prime example of a culture of hubris. this is work that should not be performed, flat and black, should not be performed. in those cases were elements of his work are deemed essential 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, weighing at the national level. >> i appreciate that very much. i appreciate both witnesses a. mr. chairman, i appreciate the
anger i like the opportunity to learn and i've learned a great deal from the searing. thank you so much. >> i would encourage all members of the committee to go visit some of the labs around the country, particularly that cdc headquarters and see for the own eyes how this works. certainly for members of cdc, who made the listing, i hope they understand the seriousness of what congress views today on this. i ask unanimous consent that the members written opening 70 introduced in the record and without objection your documents and the record. i ask them in this consent of the document bind in the to reduction by staff. in conclusion, i want to thank the witnesses and members who participate in today's hearing. remind members of the 10 business days to submit questions for the record. i ask all witnesses agreed to respond probably to the questions. thank you very much and with that this hearing is adjourned. [inaudible conversations]
>> the head of the sensual disease control, dr. tom frieden, will give remarks and take questions at the national press club today. live coverage starts to 1 p.m. eastern here on c-span2. c-span to provide live coverage of the u.s. senate floor proceedings and key public policy defense. and every weekend booktv, now for 15 years the only television network devoted to nonfiction books and authors. c-span2 created by the cable tv industry and brought to you as a public service by your local cable or satellite provider. watch us in hd, like us on facebook and follow us on twitter. >> the senate starts its day in the few moments. leader time in speeches for the next 45 minutes, then votes to
advance three judicial nominations to district courts in california, florida and louisiana. members will recess for party lunches at 12:30 p.m. and when the return at 2:15 p.m. they will vote on any of the three nominations advanced this money. meanwhile, the house meets at noon for speeches at 2 p.m. for legislative business with 14 small bills on their schedule. live coverage of the house is over on c-span. now live to the senate floor here on c-span2. the president pro tempore: the senate will come to order. the chaplain dr. barry black will lead the senate in prayer. the chaplain: let us pray. eternal god, be attentive to our prayers. test our thoughts and examine our hearts, as we seek your wisdom to solve the problems