agents. after that, the house rules committee considers legislation that would allow a formal lawsuit to be filed against president obama. and later, house democrats lay out their agenda for helping the middle class. july 20 martz anniversary of the lunar landing. tonight at 10:00 eastern. >> this week dr. tom friedman called the mishandling of life anthrax "unacceptable" at a hearing. hearingne of witnesses after more than 80 staffers were potentially exposed. this portion is two hours.

and >> good morning. you the subcommittee today and him and him and the subcommittee today examines the center for disease control anthrax incident last month that potentially exposed dozens of from you potentially exposed dozens of researchers to live and you and anthrax because established cdc policies were

not followed. you last friday, the director and you and you announced corrective actions being taken. are you corrective actions being taken. the review identified a fundamental flaw -- the agency had no written plan to ensure the safety of workers and proper handling of live biological you agents. the department of agriculture agriculturetment of the disinfectant they used was expired. this is troubling, and completely unacceptable. the center for disease control is supposed to be the gold standard of the u.s. public health system, and it has been tarnished. we rely on cdc to protect us, but the recent anthrax event and incidents have raised serious questions about the cdc ability to safeguard agents in its own labs. the director called the exposure a wake up call. this is not the first wake-up

call. i am not even sure wake-up call is the proper term. it is a gross and dangerous understatement. it would be potentially very dangerous. a wake up call is catching something before the danger exists. once a person is exposed to the serious pathogen, the danger is of a much higher magnitude. in 2006 bioterrorism labs sent anthrax on the mistaken belief it was enacted. later, mistaken procedure led them to ship live agents to an outside lab. in 2009, they learned a strain that can cause a highly contagious infection has been shipped to outside labs since 2001 because researchers believe it was a last dangerous strain. one must question the scientific altercations of the scientists. these are not isolated

incidents. from 2008 to 2010 the inspector general issued three reports documenting concerns cdc labs were not ensuring physical safety of agents and ensuring personnel receive required training. an audit found a scientist discovered agents in a drawer in an unsecured lab, and another found agents in a freezer leftover from an outbreak investigation many years earlier. this is reminiscent of the recent discovery of smallpox files in storage on the nih campus. it was discovered by accident. in 2011, oig bound cdc did not monitor certain agents at federal laboratories. in addition to the inspector general audit, several gao reports have raised concerns

about oversight of high containment labs, including those at cdc. despite the red flags, these incidents keep happening. we learned last friday scientists delivered an influenza strain that was contaminated with a very deadly flu virus. the cross-contamination was discovered may 23, but it took six weeks for this to be reported to cdc leadership. what we have here is a pattern of reoccurring issues, of complacency, and a lack of a culture of safety. this is not sound science, and this will not be tolerated. these practices put the health of the american public address.

it is sloppy and inexcusable. dr. frieden, i thank you for testifying today. i question if the corrective measures you have announced will solve the problem, and i look forward to the testimony. taking personal actions will not address problems that appear to be systemic. cdc needs to ensure that procedures are followed. you said you were distressed by the delay in notification over shipment. i want to know if you have reason to believe workers may be afraid to report incidents. cdc will not solve human errors unless it gets as much information as possible. since 2007, there have been 17 reports indicating a worker was potentially exposed to an agent or toxin. as far as we are aware, no one at cdc has become sick from improper handling, but 'these near miss events will continue. sooner or later, someone will get very sick or die.

the risks require failsafe mechanisms and redundancy similar to those used in contexts such as handling weapons. the subcommittee will review the oversight of laboratories and explore the possibility of an independent agency. i thank all the witnesses testifying, and now recognize the ranking member. >> thank you very much, mr. chairman. last month the cdc laboratories in atlanta made a series of mistakes. they transferred anthrax to two other labs, potentially exposing dozens of individuals to anthrax. luckily, no one has yet fallen ill. i am deeply troubled by what we learned about this incident. how did it happen? cdc conducted its own internal investigation that identified numerous failures.

there was no standard operating procedure for the analysis conducted by the cdc scientist. there was no study plan. the scientists used a pathogenic strain of anthrax when a non-pathogenic strain could have been used. the scientists used unapproved sterilization techniques for pathogenic anthrax and then transported the material without confirming it was inactive. this was obviously an alarming series of failures, but there were other problems at cdc that made this incident worse. cdc has provided to the committee a disturbing report from the u.s. department of agriculture, animal and plant health inspection service. after the incident, they conducted their own investigation of the facility. inspectors identified serious problems in lab procedures and decontamination procedures. they reported the agency was

inadequately prepared to handle the cleanup or treat those potentially exposed. i think we can all agree that reports on this incident are bad, but what is even more troubling to me is that in context they reveal a broad problem with cdc safety culture. we received report after report from gao, hhs, aig, and aphis offering a multitude of warnings and recommendations on operations of high containment labs. the report identified four other cases in the last decade where cdc shipped dangerous pathogens off site. the democratic committee staff repaired a memo describing the results from six different inspections at the cdc facility in2013 and 2014. overall, in six inspections, aphis and invite dozens of concerns.

29 related to equipment, 27 related to security, and 39 related to recordkeeping. in some cases, the observations revealed that what appeared to be on the paperwork problems, but in other cases they found serious problems. reports of scientists using torn gloves and exhaust blowing fumes in the wrong direction. none of these inspections gave cdc a totally clean bill of health. i want to make this part of the record, mr. chairman. the record shows cdc had ample warnings and should have been focused on the problems in high containment labs long before the june anthrax release. i just don't understand why they did not heed those warnings. dr. frieden has indicated he was as surprised as anybody by the scope of the problem, and the fact he worked so surprise is a problem in and of itself. it shows there is a fundamental problem with the culture of identifying and reporting safety

problems up the chain of command. i'm sorry to say, these lab safety issues are not new to me or the committee. this is one of the detriments of having been on this committee for 18 years. we have had multiple hearings on this problem at the cdc over the years. in 2006 and 2007, we had terrible problems at the cdc facility in fort collins, colorado, just north of my district, where we had vectorborne diseases being very sloppily handled. fortunately, we build a new facility since then in fort collins. a beautiful facility. and we are able to handle these diseases.

but these issues are not resolving themselves, and so while you have a strong record at the cdc, i know you have answers and, we all appreciate it. but what we all need to know is we cannot legislate a culture change. it has to come from within the agency. i'm glad to have gao and aphis witnesses here, because you're warnings were prescient and should have been taken more seriously. i can assure you, the warnings are being taken very seriously. not just by the agency, but by the people here on this panel. >> i recognize mr. upton for five minutes. >> thank you. this is a very serious hearing, for sure. two years ago after allegations about problems in cdc building 18, home of the deadliest agents

and pathogens, investigations about compliance in the operation of its main lab facilities. in response to concerns, cdc director tom frieden sent the committee a letter. the letter outlined the agency's efforts to ensure better oversight in safe handling of select agents at cdc labs, including rigorous training, constant review of safety measures, and multiple layers of systems. the letter stated that a senior official who was not identified would be designated to report directly to the cdc director on safety at cdc labs. these measures sound very similar to the corrective actions dr. frieden outlined last week to address the current lab crisis. why should we believe this time that things are in fact going to be different?

we asked cdc two years ago to invite each biosafety issue that had taken place since 2005. cdc provided us with a list in 2012, but we now know from the internal investigation released last friday that the list was not complete. improper shipments of pathogens in 2006, including anthrax, were not included in the cdc list of safety incidents that in fact was provided to this committee. cdc staff has no knowledge that the incidents reported should have been included. we don't know why they weren't. this raises the question of whether cdc leadership is receiving all the information about its own biosafety systems. as to the possible anthrax exposure, the delayed notice provided to leadership about avian flu shipments and the discovery of smallpox vials in a cardboard box on the nih campus, these issues no wonder seem isolated.

a dangerous, very dangerous pattern is emerging, and there is a lot of unknowns out there, as well. when dealing with pathogens, unknowns are, frankly, unacceptable. what you do not know can hurt you. why do these events keep happening? cdc needs to solve this problem now as a team. the agency needs to get as much as possible from its workers about true safety, biosafety, the true state of biosafety at cdc and keep this committee and the american public fully informed. there is zero tolerance for unlocked refrigerators and

ziploc bags. those days have to be over. >> i thank the chairman for yielding. i want to thank the panel for being here. as you can hear on a bipartisan basis, we have plenty of questions for you. we are deeply concerned about the incidents that have occurred at the federal labs that are run by the department of health and human services. cdc, with the anthrax specimens, dr., we appreciate the time you spend with us last week, but i think we have plenty of questions about the safety and the turf create you know, we would think that the priority would be safety and caring and making certain that you are tending to that culture of safety within these labs. nih, with the vials of smallpox and the fact that this was in an unused portion of a storage room, who all would have access to that? and then, of course, the cross-contamination of the influenza sample. we have all talked about the three of these events, and the fact that they have occurred within this framework of time, the fact that there seemed to be a dismissiveness of the serious

nature of these occurrences, the fact that the cdc's own report pointed out some of the contribute in factors in this and the lack of a standard operating procedure and best practices, and the fact that this is not known among the employees at that agency, we know that there are some remediation measures that have been implemented, but the culture of safety or lack thereof continues to be a concern to us for public health.

i yield back my time. >> thank you, and we go to mr. waxman. >> the possible release of these on the campus in atlanta, and i was on the committee, and we held hearings after the 2001 anthrax attacks. we looked at the safety of postal workers and the public in handling the mail, it and the postal service with the cdc response to those attacks, and we had hearings again in 2003 and 2005, where we found there were still gaps in biological detection of anthrax and in communicating test results to the public. those hearings showed why cdc's work on identifying and containing public health risks on these types of biological elements is so important.

but this work could also pose risks, and that is why this oversight hearing is important. in 2009, when i was chairman of the full committee, we held a hearing on the proliferation of high containment bio labs and the lack of oversight over such facilities. mr. dingell also held a hearing in 2007, so this is not our first introduction to this subject. at our request, we also looked into lab safety. it was reported in a number of studies, recently as 2013, the problems were associated with the government's fragmented, piecemeal dealing with these labs. no single agency has oversight over all high containment bio labs. there are no national standards for operation, and we have no record of how many labs even exist. the health and human services inspector general also issued numerous reports on high

containment labs and their handling of select agents. the inspector general identified issues with the treatment of select agents and the safety of the individuals working with these dangerous pathogens. the ig recommended that the centers for disease control labs improve training for individuals handling select agents, improve record-keeping, and take appropriate measures to improve safety. the american people count on the centers for disease control to protect them, and we want to be able to assure them that the cdc is conducting its research in safe and secure ways.

doctors efforts at cdc. we have worked with him on numerous issues over the last five years, and he has shown himself to be an effective leader and a strong communicator, and i appreciate the quick actions that he has taken in response to this incident. i am encouraged to see that dr. frieden has appointed dr. michael bell to oversee safety protocols and procedures. this investigation has shown us the cdc needs to change its safety culture, and i hope that dr. bell can help instill a new mindset at the agency. still, i am concerned that it took exposure of dozens of cdc staff to anthrax to finally spur cdc to action, so we want actions from the cdc about how this incident was allowed to happen in the first place, and i look forward to hearing from gao and others about the problems they have identified in the past, how cdc should implement their recommendations moving forward, and what role congress should play in making sure that happens.

mr. chairman, this is not the first hearing on the subject. we have looked at it before. we've now need to be sure that all of the recommendations we have had are put in place so we can stop something like this from happening again. thank you, and we yield back my time. >> thank you. i would like to introduce the witnesses in the first hearing. first, dr. thomas frieden, accompanied by dr. joseph henderson, the deputy director for emergency preparedness at

the center of disease control. the doctor works with the plant inspection services, and dr. nancy kingsbury works at the accountability office, and, dr., did you want to introduce somebody else from your district? >> mr. chairman, thank you for the opportunity. i know this witness is on the second panel, and it will be a little while before we hear from the second panel, but it is an honor and a pleasure to introduce off of the second panel sean kaufman, part of a company called behavioral-based improvement solutions. his background is long-term employment with the cdc before forming his own company in my district, the 11th congressional district of georgia, in woodstock, georgia, and i would encourage all members on both sides of the isle, if you have not had the chance -- i know we try to read all of the testimony, but sometimes we skip one or two along the way, but i will guarantee you that the testimony from mr. kaufman really hits the nail right on the head in regards to the

overall issue, and i will commend it to you, and i am proud to introduce him to you in anticipation of the second panel. mr. chairman, thank you very much, and i yield back. >> to the panel, you are aware that there is an investigative hearing, and they are used to taking testimony under oath. you any of you have objections to adding testimony under oath? it indicates no. the chair advises you that you are under the rules of the house and committee, and you're entitled to be advised by counsel. do any of you wish to be advised by counsel during today's testimony? all of the witnesses indicate no. in that case, please rise and raise your right hand, and i will swear you in. do you swear the testimony you

are about to give is the whole truth and nothing but the truth? thank you. all of the witnesses answered in the affirmative. title 18, section 1001 of the united states code, and you may now give a five-minute written summary of your statement. dr. frieden. >> chairman murphy, ranking member degette. chairman murphy, ranking member degette, members of the subcommittee, thank you for letting us appear before you. with me -- i will review the problems that have come to light in the past month and tell you what we are doing now to address improving lab safety. the fact that it appears that no one was harmed and that there were no releases does not excuse what happened. what happened was completely unacceptable. it should never have happened. if i leave you with just one thought about today's hearing as it relates to c.d.c., it is this, with the recent incidents we recognize the pattern at c.d.c. where we need to greatly improve the culture of safety and i'm overseeing sweeping measures to improve that culture of safety.

c.d.c. works 24/7 and our scientists protect americans from threats like ebola and mers and manmade threats such as anthrax. but we must do that work more safely, and we will. there's a recap of the recent incidents that summarized in our report, which has been completed and we are just at the outset of our investigation of the influenza contamination. sterile. use of a pathogenic strain when a nondangerous form would have been appropriate. in the influenza cross-contamination, we are trying to understand how it occurred and investigating how there could have been such a long delay in notification. the risks to employees from the anthrax exposure was at most very small, and the risk of release to the public was

nonexistent but that does not change the fact that these were unacceptable events. they should have never happened. in the past as the committee has outlined, there were a number of specific incidents, and i do believe that c.d.c. staff worked hard to address the specific findings of past investigations but i think we missed a critical pattern. instead of just focusing on those when we issued the anthrax report, we provided not only these two incidents but the prior episodes of what has happened because what we are seeing is a pattern that we missed, and the pattern is an insufficient culture of safety. we're now implementing every step we can to make sure that the problems are addressed comprehensively in order to protect our own work force and to strengthen the culture of safety and continuing our work protecting americans. i have taken a number of specific steps.

i have a moratorium on the transfer of all biological materials out of all 3 and 4 laboratories at c.d.c. i have closed the two laboratories that were involved in this situation until we're sure they can be reopened safely. i have appointed dr. michael

bell, a senior scientist, to be director of laboratory safety reporting directly to me as a single point of accountability. he will review the moratorium and lift it lab by lab when we are confident and will facilitate expansion and use of that safety culture throughout c.d.c. scientists are world famous for their rigor in scientific investigation and we will apply that same rigor to improving the same safety in our own laboratories. i'm convening a high-level working group inside cdc, internally, to advise us on every step of the process and external working group to take a fresh look to see what we can do to do better. and we are looking at protocols and improve them as needed. we'll look at future incidents if they occur with a command structure which should have been used earlier in the anthrax exposure.

i will ensure that appropriate disciplinary action is taken as indicated by our investigations and will apply lessons learned from this experience to our function as a regulatory agency and our select agents' regulatory program. in hindsight, we realize we missed a pattern of incidents that reflected the need to improve the culture of safety at c.d.c. but as with many things, recognition is only the first step and we are taking a number of additional actions to establish and strengthen a culture that prioritizes the safety of our own staff, encourages reporting of actual and potential situations that may place staff and others at risk, openly assesses those risks and implements redundant systems to keep risks at the absolute minimum. part of that culture will be increased reporting of problems or potential problems.

one of the aspects of an effective culture of safety is rapid reporting of problems. so if we do uncover problems in the coming weeks and months, this may well be the result of strengthening our culture of safety rather than failing to address it. we have concrete actions under way to change processes that allow these incidents to happen, reduce the likelihood of an occurrence in the future. and apply the lessons broadly. we will do everything possibly to live up to the high standard that congress and the american public rightfully expect us to achieve. i look forward to your questions and thank you for inviting me to testify today and your interests in this important topic. >> thank you, doctor, you are next.

make sure your microphone is on a very close to your mouth. thank you. it is not on. green light. there you go. thank you. >> mr. chairman and members of the subcommittee, thank you for the opportunity to testify today about the animal and plant health inspection services inspection into the release of possibly live anthrax at the c.d.c.'s campus. i'm dr. jerry dick. associate administrator within usda. we conducted a thorough inspection of the incident to learn how it happened and determine appropriate remedial measures. we will continue to monitor the c.d.c.'s response to ensure all necessary corrective action is taken and that when work resumes at the laboratories, it will be done in full compliance with the health and safety of the employees and the public at the forefront. usda was designated as a partner with cdc in the oversight of select agents because of our expertise and experience safely working with select agents over the past entry through our efforts to prevent diseased agents from impacting u.s. agriculture safety environment. for decades, it has safely operated high containment

laboratories that handle select agents including those for concern for human health. our personnel are experts in the effective -- of high containment laboratories. to ensure objectivity, we signed a memorandum of understanding in october of 2012, which makes aphis the lead inspection agency for cdc entities. since the m.o.u. was finalized, aphis has carried out 11 inspections of the four c.d.c. laboratories. aphis takes any potential release of a select agent or toxin very seriously with a goal of quickly ensuring that the release is contained and determining what led to the

release to ensure no future incidents. on june 13, c.d.c. officials discovered a potential release of anthrax and notified us. c.d.c. voluntarily closed impacted labs on june 16. we made the inspection a priority and quickly began its work to make sure all agents were secured and no other breaches in biosafety or bio security. a specially trained inspection team of veterinarians and a plant pathologist spent nearly two weeks beginning on june 23, conducting a facility review of the laboratories and interviews with c.d.c. personnel. we briefed c.d.c. officials on july 2, outlining deficiencies so they could immediately begin taking corrective actions. aphis found that the laboratory did not use an adequate

activation protocol and did not even sure that the protocol was in fact validated. the initial response to this incident by the c.d.c. laboratories was inadequate. both in securing as well as disinfecting laboratories. for example, individuals without approval to handle select agents were able to access space containing or potentially contaminated with anthrax at least four days after the incident was discovered. we also found that employees did not have appropriate training in some instances. we found no clear management oversight of the incident at the labs and no clear single manager overseeing the overall c.d.c. incident response, which

resulted in employee confusion about how to respond. in addition, c.d.c.'s occupational health clinic was not prepared to respond to the potential exposure of a large number of workers. aphis currently have in place a cease and desist order with select agents and the toxins -- at the two impacted select agent laboratories. we will require that corrective actions be taken to ensure the integrity of these research programs. we have directed c.d.c. to provide aphis with its plan for coming into compliance by july 25. and before allowing c.d.c. to resume select agent work in the laboratories, we will conduct a re-inspection to ensure that all corrective actions have been taken.

mr. chairman, this concludes my testimony. i would be happy to answer any questions that you or members of the subcommittee have. >> thank you, dr. dick. dr. kingsbury, please point the microphone very close to your mouth. closer than that. >> pardon me? >> bring being mic really close. >> is that better? thank you very much for inviting us to come to talk to you about some of our past work on biosafety issues. as mr. waxman noted in his statement, we have been doing this work for quite a while. we started with the original anthrax attacks, and we have gone on to a number of other issues over the years. our past work has a couple of major themes. one of them is a lack of strategic planning and oversight of the whole picture of biosafety laboratories. aphis and cdc are only a part of that picture and since 2001, there have been an increasing number of biosafety laboratories both within that sector and also

across the whole government. there are six or seven different agencies involved and no one entity has been charged with developing a strategic plan. we became particularly concerned about that as budgets began to shrink recognizing that the management and operation of these laboratories is an expensive venture and if they are not properly maintained, other kinds of problems can arise. we have also observed that there is a continued lack of national standards for designing, constructing, commissioning and operating these laboratories. there is guidance.

the biosafety and microbiological and biomedical laboratories guidance is available, but it's not required and there is no process by which an entity needs to make sure that they are following that guidance. we have done some work since the most recent episode became public. we did take a team to atlanta. i want to thank dr. frieden and his staff. and 10 days notice is a bit of a challenge for us, but his staff was very good at providing everything we asked for. i'm not going to add very much to that debate. i think the two previous witnesses have covered the details pretty well. the one thing i would add, however, is while we agree there is a requirement to have standard operating procedures that are reviewed at appropriate levels for biosafety, we believe it's important that those procedures be validated, by that, we mean independently tested so we can be assured if these procedures are followed, there will be no further episodes. so i will add that one thought to the debate about the incident

itself. thank you very much, mr. chairman. that concludes my statement. >> i recognize myself for five minutes. dr. frieden, is anthrax a biological agent that could be used in warfare? >> yes. >> and the mishandling of it, if someone was sickened, what would the symptoms be? >> the most severe forms are respiratory anthrax, which can cause severe illness or death. >> i have an image of some workers handling testing for anthrax, et cetera. one sees that -- i don't know if this is a lab but some other workers investigating. but when i toured labs the number of levels there what's required for breathing, covering clothes before and after. pretty severe. i got to ask these questions, a

zip-locked bag and i have to think what would go through the minds thinking that a zip-locked bag is enough when you have other incidents of the clothing that someone has to wear. have you talked to these personnel about transporting anthrax and why? >> i have been directly involved in the investigation and i will be directly involved in the remediation of the problem that we find. many of the issues that are mentioned in the findings relate to what was done with the material that was believed to have been inactivated. so once the laboratory has said, here is killed anthrax, it was handled in the lower containment laboratories as if it were not infectious. our subsequent studies were that it is likely that it was not, but the core there was the failure -- >> this is like saying i didn't

know the gun was loaded but somebody got shot. but you should always assume that it is. for someone to say i didn't assume it was live. quite frankly, i wonder if you have the ability to not only reprimand such personnel, but to fire them, suspend them or quite frankly, do they understand the extent to this they could have been charged with criminal negligence or negligent homicide or reckless endangerment? do they understand the seriousness to the american public health? >> i think first your idea, mr. chairman, of a two-key system as is used in other circumstances

is quite appropriate here. both within the high containment laboratories and to verify this stuff coming out safe if it does come out because stuff has to come out of those laboratories to be tested or worked with elsewhere. in terms of disciplinary proceedings, what we want to do is strike the right balance. on the one hand, we recognize the need to make sweeping improvements in our culture of safety and part of that means staff need to feel comfortable any time saying hey, there may be a problem here, coming forward. at the same time if our investigation finds that there is negligence that people knowingly failed to report or took actions that were likely to or should have been known to endanger themselves or others, then we will take appropriate actions. >> dr. dick said people who were not approved were able to access space possibly contaminated at least through june 17 four days after the incident was discovered. now, my assumption these scientists are pretty smart people but it is extremely disturbing to think they are not thinking -- well, let me ask

this, it has been a week since you learned about the march, 2014 shipment of the influenza and six-week delay in notifying. did you find out why there was a six-week delay and was there a cover-up involved in that or the bureaucratic hurdles too high? what was the cause? >> i only got preliminary information on that but i will make a general point, however. when we look at emergencies in emergency departments or intensive care units in the health care sector, the biggest problem usually isn't a failure to respond to this activity when people recognize there is an emergency. but we haven't completed our investigation of that and we will look at all possibilities. >> is there any kind of notification offer alarm system that lets people know when there has been a release or a problem there? >> there are multiple alarm

systems. within cdc. in this case it was a cross-contamination of a culture and somehow, and we haven't figured out how yet, a avian one crossed with another one. >> i get more alarms when you walk out of wal-mart with a shirt that wasn't paid for. is there a cover-up not wanting employees know? >> no, we have not seen any evidence of a cover-up, but we do see the need to strengthen the culture of safety that encourages reporting, any time there is a problem or potential problem, so we can assess it and take rapid and prompt action. >> thank you. i recognize ms. degette for five minutes. >> you testified that there is an increasing number of labs that are handling these bioagents, correct? >> correct.

>> and you say there is no one agency in charge, is that correct? >> correct. >> now -- you said that today, but in 2007, the g.a.o. testified before this committee the same thing, no single government agency was responsible for tracking all of these labs. >> that is correct. >> that is correct too. dr. frieden, are you aware of this finding by the g.a.o. going back all the way to 2007? >> yes, i am. >> and do you agree with dr. kingsbury there are an increasing number of labs handling these bioagents? >> yes. if we look back over the last 10 years, there is a increasing number. >> do you agree with her there has never been one agency in charge despite the red flags going up all of these years? >> there is a clear division of responsibilities between cdc and aphis, inspection and enforcement. several years ago at my direction, we turned over some of the inspections to aphis, but the issue of lab safety touches many parts of both the public sector and nongovernmental

sector. >> so are you saying that aphis is in charge now since you put that into effect the last few years? >> in terms of the inspection of laboratories which are working with select agents, there is a clear addition of responsibilities between ourselves and aphis. >> does that mean that aphis is in charge? >> they are in charge of investigating c.d.c. select agent laboratories. they are not in charge of the overall enterprise. >> do we need to clarify who is in charge of the enterprise? >> we are looking at recommendations. >> would it be helpful to have one agency in charge of all of the inspections and making sure people are doing things in the right way? >> i am seen several suggestions of how we can improve oversight

and select agent oversight and my sense is that each of these ideas is certainly worth exploring. >> what do you think about that? dr. kingsbury, do you think it would be useful to have one agency in charge? >> we have said for a number of years that there needs to be some entity in charge of a national strategy, not necessarily in charge of every laboratory in the country. >> so you are saying and agency in charge of developing the protocols how you are go to go do this? >> ensuring biosafety and biosecurity. but the more important issue from a strategic point of view is how many of these laboratories do we really need for what purpose against what threat. one of the interesting things that i have become a little more sensitive to in the last few weeks is the whole structure that we have, that cdc and aphis are involved in, it is around the select agent agents and

there are a lot of other bugs out there in other laboratories that are not select agents that also need to be protected and there's very little visibility about that sector of this enterprise. >> and, dr. frieden, i'm going to assume that you agree with dr. kingsbury that it would be very useful to have national safety and security stands that would apply to everybody, is that correct? >> i'm not sure i understood the question. i am sorry. >> well, i mean what g.a.o. says is that we don't have one single agency developing national biosafety and security standards and as a result we have all these labs doing this type of research, a proliferating number of labs, but there's no one standard -- nobody developing standards across those agencies. >> i think there are many aspects of biosafety and biosecurity which merit careful investigation and if we can figure out a better way to do

them, we are certainly completely open. >> do you think the protocols should apply to everybody? >> the protocols may be specific for the different situations, but they should all adhere to the highest standards. >> dr. dick, what's your opinion of this? >> thank you, congresswoman. i think that there should be a single oversight body. right now for the select agent program, there is a single oversight body made up of the division of select agents and toxins at c.d.c. there is a single oversight body in agriculture that makes up the other half of that select agent program. together, we meet on a monthly basis. we have the directors and assistant directors of the

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

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

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

should inactivated select agents be added back to the select agent list? >> i think what we need to ensure that any inactivation is done completely because once something is inactivated, it may be able to be used, and may be necessary to use that to diagnose, and you wouldn't have to follow select agent requirements out diagnosing something out in the lab or in the field but the key is to have that two-key system to make sure that when inactivation is undertaken, it is validated and verified that the materials are inactive. >> the last question, you noted in your testimony you only learned of the march 13, 2014 shipment from the c.d.c. influenza lab a virus that was cross contaminated with h5n1 to a usda laboratory on july 9, and march 13 is when it actually occurred, to when you were informed of it july 9.

can you please describe how you are going to improve communications of these incidents up and down the chain of command? >> thank you. in fact it was the afternoon of our meeting, which was in the morning, when i learned about this. what your question gets to is the crux of the matter, which is how do we improve the culture of safety at cdc, and i think that's going to involve a number of steps that we think will succeed but will take time. we need to encourage reporting and encourage all staff to take responsibility in addition to having a single point of accountability for laboratory safety.

we need to have a clear vision of working safely. we are, after all, the prevention agency and we want to apply that same rigor that we apply to our work in the field and in disease control to preventing any incident from happening in our laboratories. we also want to build on many of the organizational strengths and identify the laboratories that are doing this very well within c.d.c. and identify the practices they are taking that will prevent these incidents. and finally, coming up with ways to monitor progress and track progress and identifying what are called the critical control points. what are the flash points, what are the areas where problems may occur. and then developing redundant, effective, validated, monitored

ways to address those critical control points whether it is inactivation or transfer of materials or making sure that transferred materials only contain those materials. we have terrific scientists at c.d.c. and they are focusing their creativity, their energy, their commitment on improving our culture of safety. >> dr.frieden, thank you very much, and, mr. chairman, i will yield back my 30 seconds. >> recognize mr. waxman for five minutes. >> thank you, mr. chairman. doctor, last friday when you released the c.d.c. report on the anthrax incident you announced you are imposing a moratorium on c.d.c. transferring any biological samples out of any b.s.l. 3 or 4 labs until they had conducted a lab by lab assessment and you additionally close to the bioterrorism and rapid response and advanced technology, or the brat lab, and announced it i will remain closed until it is approved to reopen under safer conditions.

this is so the cdc can undertake a comprehensive safety review and ensure that the proper procedures and protocols are in place moving forward. dr. frieden, how long you anticipate this moratorium lasting, and the brat lab being closed? >> the short answer is so they can open safely. the long answer is that some can resume. proficiency testing for those agents in the laboratory response network, and that is something we will look at very carefully, but i am committed we will not open them until we can open them safely. >> what steps are you taking to lift the moratorium, and when will you know, or how will you know when it is safe to do so? >> i have appointed dr. michael l, who is a top expert at cdc, not only in laboratory safety, but also in safety. he works in the control and safety unit of cdc him to oversee a high-level working

group reporting to me, and they will develop the next day or so, finalize criteria by which they will set each of the laboratories, and each laboratory will look at its own protocols and practices and determine whether they are validated, effective, and scientifically proven, and implemented in a way where we can be sure they will be applied, and then each laboratory will apply to a lifting of the moratorium. i will review his recommendations and ultimately approved laboratory by laboratory with the reopening during this process. i will mention that this is not a small thing, because many of our laboratories have adjacent laboratories, and much of their work has to be done in the bsl2. so they inactivate in the bsl3, and then they move it to the bsl3, and that work has to be stopped until we can assure that it can be done safely. this is one of the things we need to do to improve the culture of safety at cdc. >> one of the disturbing

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

cdc serves a critical role for studying dangerous pathogens to finding cures and vaccines for deadly diseases. these labs are critical to our nation's response to bioterrorism threats, so i am interested in learning about how this moratorium and the lab closures are affecting critical research that these labs were conducting. dr. frieden, how did the moratorium and lab closures limit the cdc capabilities, what happens to the studies, some of which i am guessing were operating on detailed schedules, while they were being conducted in the labs? >> we are looking at the labs in detail and identifying any laboratories which need to resume transfers for individual patient care or for public health response with highest priority, and we expect that those laboratories we will be able to get reopened for transfer very soon, but we have already heard from, for example,

the laboratory that deals with drug-resistant tuberculosis, the laboratory that deals with ebola, and the laboratory that deals with avian influenza, but they have deadlines coming up for either patient care or public health response, and we will address that very quickly, but we will always put safety first. >> how did the closures and moratorium affect research occurring in other labs outside? >> we provide proficiency testing and other materials to laboratories, and so there may be impacts on some of our partners, but the one that we are most aware of now, and we are working with them before the deadline, the provision of 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 and the moratorium and the lab closures appear to be the appropriate response.

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

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

scope of cdc and aphis, and until there can be some kind of strategic look, they may be changing due to things like the ebola outbreak, but somebody should be thinking about this a little bit more broadly than a single agency, and that is basically our point. >> i will ask a question. why are there 435 members of congress? what is magic about 435? and the answer is that is as many seats that they could put on the house floor. when they got to 435, they could not put any more, and so it was an odd number, and they just stopped, so there was nothing magic about it. the same thing with a laboratory situation. i think there should be a strategic review, and the sooner, the better. >> staff has asked me to ask this question. it concerns the fact that beginning in 2012, the united

states department of agriculture and the center for disease control and turned into a memorandum of understanding that allows the usda animal and plant health inspection service to inspect the cdc laboratories for compliance with the select agent program. since the select agent program was authorized in two thousand two, the cdc had been inspecting its own laboratory. why did the cdc decide to turn its inspection process over to the department of agriculture? was that because cdc did not think it could do the job itself? i will ask dr. frieden that. >> we have made improvements both in our own laboratories and in our regulatory function, and i looked at this issue. i was concerned that there was at least the appearance that we could not be objective in inspecting our own laboratories. i did not believe that was the case.

i believe that one part of cdc, which has no organizational affiliation with another, could do it objectively, but i did not think the appearance was a good idea, so i requested aphis, and they graciously agreed to take over the inspections of our own campus so there would not be the appearance of that. >> if you had to do it over again, would you? was it a good idea to let usda do those inspections? >> i believe that decision was appropriate. if i had it to do over again, i wish i recognized the pattern, which is why we put this into our july 11 report. >> with that, mr. chairman, i yield back. >> or i can tell a aggie joke. >> i yield back. >> recognized for five minutes. >> thank you very much, mr. chairman, and ranking member, for calling this meeting. 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, avian flu issue that was not reported in a timely manner, and, you know, we have very high expectations for everyone at the cdc. i am impressed with everything that is happening there, but for the high-containment biological laboratories, to have these lapses is not acceptable, so it is really troubling that although numerous government agencies over the past few years have warned cdc about problems with the containment labs, it appears cdc has not heeded those warnings. we know of at least 14 separate reports and letters and investigations from gao, u.s. animal plant and health inspection services, hhs, the inspector general, to talk about the lack of oversight at the cdc

high containment lab. dr., your testimony is invaluable here. can you tell us more about the concerns gao had identified with regard to safety at the high containment lab? you said now someone has got to look at the number of labs across the country, as well. who is that? what entity is that? what are your recommendations? >> i wish i was in the position to say i know the answer to that. one of the difficulties we faced in making that suggestion is that when you look around the government, because they are being built and managed across multiple agencies, and each agency has its own mission and its own focus, it is difficult to think about who would be the single agency. we have discussed the issue with the office of science and technology policy at the white house, but they, while they have some overarching responsibilities, they do not have staff and management

officials that would permit actually doing it that way, so we don't really have a good answer to that question, but we think it is worth just keeping the issue on the table, particularly in tight budget times. >> you mentioned in your opening statement that you have heightened concerns because of budget cuts. talk little bit about that. is there a particular area we should be focused on? >> well, it is as i said in my statement. the management and the building and management and these kinds of laboratories is relatively expensive, compared to building just ordinary buildings, and if we are going to have x number of laboratories, i would like to see the strategy that will allow us, even in tight budget times, to continue to fund them and upgrade them when necessary and to manage the biosafety and programs to keep them safe, so that total picture just isn't

available now, and that worries us. >> 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 have been able to accomplish our mission in support of the select agent program over the recent years and provide the funding that is necessary. >> ok, and before the june anthrax investigation, aphis conducted investigations at the campus facilities in 2013 and 2014. can you summarize those? >> yes. i think there were a number of findings, some of which were found in the recent finding, some of which were not. simple things that would be simple, like unlocked refrigerators. those kinds of things, up to and including more serious incidents, if you will, around

invalidation protocols not being up-to-date. >> and, dr. frieden, it is troubling. this has gone on for years now. gao, aphis, outside experts have been calling attention to these issues, and i am encouraged because you have been forthcoming in your statements. you have not been defensive, but what is your current action plan now going forward in detail? is there a culture among researchers. what is it? get specific for us. from this day forward, what are you going to do in the timeframe? >> well, first, i think for past incidents, the staff at cdc, the scientists did take the reports seriously and did respond to those individual reports. what we missed was a pattern, and you're absolutely right that that pattern was an in adequate culture of safety, and so the

overarching challenge now is to ensure that we establish and strengthen a culture of safety at all of our laboratories throughout all of cdc, and there are a number of steps that we are beginning to do that. the first is the moratorium, so that we can stop and think about that particular procedure of inactivation and make sure it is done right. the appointment of a single point of accountability for laboratory safety throughout cdc, the establishment of a working group that that person, mr. henderson, will lead. 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 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 identify ways to improve safety and security. we also need to verify that that is happening. >> ok, thank you. the gentlelady's time has expired, and we recognize the gentlelady from tennessee for five minutes. >> thank you, mr. chairman. dr. frieden, if you go back to the usda-aphis investigation, let's look at that. this started 10 days after the event. there was 18 days after possible exposure. you had a lot of really awful, basic errors. even you admit there is not a culture of safety. there is 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 c.d.c. guarantee that the new policies are followed immediately -- effective immediately. you know, our hospitals and organizations get all sorts of new rules from h.h.s. on friday afternoons at 4:00. they're effective immediately. so i want you to detail for us how you implemented that and what the new policies are. >> so effective immediately, all transfers, not just from these two laboratories but from every single bsl-3 and bsl-4 laboratory at c.d.c. have been stopped. effective immediately, these two laboratories, the bsl-3, part of

the influenza laboratory, and the brrat lab for the bioterror response, have been closed. those two laboratories will not be reopened until both aphis and i are confident that they can be reopened safely. we've also appointed a single point of accountability to look at this and to review before we reopen, before we begin any more transfers, procedures that are in place to ensure they can 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 see whether the onsite clinic was thorough and consistent in examining the staff potentially exposed to the anthrax? >> in the first week after the anthrax potential exposure was identified, we did not respond in the way that we would respond to an outside emergency and that's one of our after-action

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

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

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

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

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

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

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

aware of -- it's possible that in the coming weeks and months we'll hear of other things in the past that occur and that may be a reflection that we've strengthened that culture of safety rather than we failed to address it. >> well, if it's an issue of culture, and, again, like you said, you have some great labs and i'm familiar with some of them, is it just because they teal with these -- deal with these dangerous substances so often that they get lacked and they're not dealing with the safety they're dealing with it? >> i think that's a significant part of it. if you work with something, even if it's a dangerous -- deadly microbe day in and day out year after year, you get to a familiarity of doing things you normally shouldn't do. we should have protocols, training and a culture of safety with a vision that we will work to minimize risks such that no worker and the public are never exposed to the -- a risk that could have been prevented in our laboratories.

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

give this committee details on what that would be? >> i don't actually have -- [inaudible] >> microphone. >> i don't actually have a basis on which to be specific about what might need to be done. i think we probably need to continue to work with your staff to talk through what some of the options might be going forward. >> thank you. now, mr. harper is recognized for five minutes. >> thank you, mr. chairman. and thank you for holding this hearing on a very important issue. certainly some agencies can be dysfunctional and there's no concern or no real harm in that, but the c.d.c. is one that cannot be dysfunctional. so we're very concerned about safety within the labs and obviously the workers there and certainly for the public on how we can address that. if i could, dr. frieden, refer you to tab 7. that's a letter that you sent in september, 2012, to the committee responding to concerns about c.d.c. lab safety.

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

so there were concerns about some airflow issues. there were concerns about some of the security issues in our laboratories. and while i would never say that we're 100% resolved on those things, we really focused on those particular problems. what we missed was the broader pattern. that's what dr. bell is overseeing now. >> so does this mean that dr. bell will now continue until -- that there will always be a point person, is that your plan? >> yes. dr. bell is the person now. we'll transition that to a single point of accountability for lab safety. one of the things that dr. bell and his group will do is to recommend where that entity should sit within c.d.c. to be most effective. >> dr. dick, the c.d.c. reported that since 2007 there have been two surprise inspections of c.d.c. both performed by c.d.c.'s select agents and toxins before aphis took over of inspections of c.d.c. labs. since 2012, i'm showing that

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

>> we intend to follow-up -- >> that's a great tool to have. >> absolutely. and certainly first and foremost, we're going to be following up on the current incident with them in making a revisit when c.d.c. indicates that they are ready for us to revisit. and then we will be doing surprise inspections after that point. >> let's say that -- and this is for you, dr. frieden, or for you, dr. dick, if it's determined that a dangerous biological agent has been stolen, who do you report that to? >> sir, we have a protocol for dealing with theft. there has been no theft of biological agent reported from either c.d.c. or any of the regulated facilities in the 10 years of the program, to my knowledge.

when there are concerns for potential theft or misplacement, we work with law enforcement, including the f.b.i., to do a joint investigation. i would just mention that our expansion of surprise inspections was something that we had erected over the last few years at c.d.c. because we felt it was important to do. >> so you say there have been no reports of stolen agents? >> that's my understanding. >> what about missing biological agents? >> there have been losses at certain facilities and in those circumstances we also coordinate with the f.b.i. usually it's an issue of inventory control. so earlier we were talking about critical control points, such as inactivation of virulent pathogens. certainly inventory is a critical point. >> i yield back. >> i do want to ask clarification of mr. harper's question. when he asked about theft of an item. your inventory control is not so tight so that someone could not walk -- someone could take something, replicate it and walk out for something, am i correct on that? >> inventory control is one of

the critical controls to prevent loss or theft. but there have been, to my knowledge, no thefts reported from any of the select agent regulated labs, including c.d.c.'s, over the past decade. >> well, there was one at the army one in texas i believe a few years ago. >> i'm not familiar with that. >> mr. tonko, you're recognized for five minutes. >> thank you, mr. chair. welcome to our panelists. the c.d.c. is responsible for registration and oversight of all laboratories that possess, use or transfer select agents that could pose a threat to human health. while aphis is responsible for those select agents that pose a threat to animal or plant health. select agents that pose a threat to both human and animal health, like anthrax, are regulated by both c.d.c. and aphis.

so that being said, dr. kingsbury, can you tell us what g.a.o. has found with regard to the increase in the number of high containment biolabs? >> i'm not sure i understand your question. i think within the select agent program, i think there is information about how many laboratories there are, and they are regularly inspected, as these gentlemen have just been saying. our concern about the national strategy is that there are a lot of other laboratories that deal with highly infectious pathogens that are not considered select agents and nobody knows how many of those laboratories there are. >> but with the high containment biolabs, is there in that given category, is there an increase that's been measured by your review? >> i didn't hear the word. >> is there an increase in the number of -- >> there has been an increase

since the anthrax attacks in 2001. the last time we actually tried to count them was two or three years ago and i think at that point it looked like there were slightly fewer than there were the year before, which we sort of think is maybe just a budget problem. but that, again, is the only ones that people are actually aware of. i think there are private entities and perhaps state government entities that have bsl-3 and bsl-4 laboratories that are not overseen in the same way and that is of little concern to us. >> is -- what accounts for the growing numbers of these labs that you suggested are out there? >> well, following the anthrax attacks in 2001, there are a number of agencies whose missions touched on the issue of biological weapons and whether

those pathogens could be used to attack our country. and so each within their own sphere developed a program to counter those possible threats. and each got funded by the congress to build additional laboratories and so forth. 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 to addressing -- >> well, we made recommendations there should be a single entity that has responsibility for developing a national strategic plan and national standards for the operations of high containment laboratories.

the delay is figuring out how to do that in the current environment with competing interests among the agencies involved and so forth. it's quite -- there's even a competing interest issue in the congress since different committees of the congress have different jurisdictions over these different agencies. so it's a tough problem to solve, but we think it would be worth spending some time even at a theoretical strategic level to begin to address this issue and think through how we would go about doing it in the future. >> and dr. frieden, what are your view here in terms of the growing numbers of these labs and just what -- how to move forward with the activity here in the u.s.? >> i do think this is a complicated topic for which there's probably not a quick and simple solution, but just logically, the more places work with dangerous pathogens goes

on, the more possibility there is of accidents or -- accidental releases. so ensuring that the work that happens is happening in a safe environment is critical, and 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 ensure that the benefit is something that's reasonably likely to occur. >> thank you. thank you very much. with that i yield back, mr. chair. >> thank you. i now recognize mr. griffith for five minutes. >> thank you, mr. chairman. i appreciate that. appreciate you all being here today to testify to us. dr. frieden, if i could get you to turn to tab 5 in the booklet. as you look at that tab 5, that is the h.h.s. inspector general

report regarding the c.d.c. roybal facility which says it was sent to you. have you seen this before at some point? front page says it was sent to you. ok. if i could direct you to page 5 and on page 5 it says that the inspector general's office could not verify that 10 out of 30 samples approved individuals for select agents had received the required training. and do you see that on that page? >> yes. >> and likewise, it says that the -- that select agent inventory records are incomplete and you also acknowledge that that's on that page? >> yes. >> and then if you go over to page 6, the report says that agents stored in areas -- that there were agents stored in areas not listed in the registration. you see that on the top page, page 6? >> yes. >> thank you. and one example given is a scientist found a vile of -- vial of select agent in a drawer and another found 16 in an unsecured freezer.

do you see that in that paragraph? >> yes. >> and the report on page 6 also states that there were unauthorized transfers and packages received by unapproved individuals. now, my concern is this. this is at the roybal facility. weren't these the same kind of violations that then popped up and were found in subsequent inspections by the usda in 2013 and 2014 and then revealed again in the matter that brings us here today in the anthrax influenza incident of 2014, aren't they the same types of problems? >> the answer is yes and no. the specific problems that were found led to a specific response. for example, on security we implemented layers of security. we strengthened the systems. we locked and improved personal background checks and security so in each of these we felt --

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

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

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

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

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

in those first few days we were really focused on the employees who may have been exposed and making sure ha they got into care and into treatment. >> but it took a while to even identify who those people were. >> yes, in an effort to do that we identified that we didn't have the kind of systems that were needed or the systems we had in place weren't used promptly. for example, viewing security camera coverage who left 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 was not activating our incident command system. >> can you elaborate on the finding? about response? >> our findings were very similar. we had an independent team that came in. they were interviewing

employees and workers. we found very similar findings to those that he just indicated. >> i wanted to follow-up on what the chairman was saying about the possibility of even stealing something. in the smallpox incident, it turned out the vials were discovered at nih. they could have been somewhere else. nobody seemed to know. that is disturbing. who knows. somebody could have taken them out. i'm not sure when you say that nothing has been stolen, it also

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

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

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

protect the public? >> i'm confident that the incident we saw did not cause the release of agents into the community or exposure to city staff. they are a tipping point and a recognition of the need to improve our laboratory safety. we are fully functional in terms of responding to an event. it is the step i have issued a moratorium on. we will lifted as soon as we are confident we can do it safely. >> what i intend to do is to bring an advisor and have them tell us every way -- >> what about the national science advisory board?

>> that is not the current plan. they purged half their members from the board. i was inquisitive whether you knew about this. why the administration took this action. whether an ih consultant -- nih consulted. >> you will have to do for to them. >> that eliminates one question. in light of the anthrax incident, they recently completed -- you think inspections were sufficient?

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

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

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

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

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

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

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

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

has stated what they are any refrigerated walk-in storage or otherwise, when the nih ran across their most recent problem, they put in place with a colace -- what they call a clean sweep. you said there was a transition between nih and fda. were they already in the process? is that what the queen -- clean sleep is? are doing this.