Transcripts For CSPAN3 Key Capitol Hill Hearings 20240622 :

Group recommended that cdc develop agencywide policies to provide clear and consistent requirements for biosafety for all agency laboratories. In response, cdc developed a specimen transport policy but has not developed other agencywide policies such as requirements for Laboratory Documentation and emergency protocols. As i stated at the outset the incidents you are examining today are part of a long series of safety lapses. Since 2007 gao has reported on these issues and has made multiple recommendations to improve federal oversight of highcontainment laboratories. The federal departments agreed with our recommendations and have conducted some activities to respond but have not implemented our key recommendation, to establish a single federal entity with responsibility for oversight of all highcontainment laboratories. We recommended the establishment of a single federal entity to, one, conduct governmentwide Strategic Planning for requirements for highcontainment lab rotorys, including assessments of their risks. And two develop National Standards for designing constructing, commissioning, operating and maintaining such laboratories. We continue to believe that such an entity or some other mechanism to ensure higher level oversight is needed in the face of the continuing proliferation of highcontainment laboratories and the ongoing failures by agencies to fiction their problem fix their problems on their own. In closing, they are supposed to have multiple levels of control, including crosschecks inspections, training, procedures and validated protocols that should prevent such accidents from occurring and certainly should prevent such incidents from recurring. This completes my remarks. I would be happy to answer questions you or other members of the Sub Committee may have. Thank you, doctor. I now recognize myself for five minutes of questioning of the witnesses. And dr. Sosin, you said we will work diligently with our partners and anyone sharing our commitment to protect americans from biological threats. Please let the cdc know i dont believe them any mofrmt the usa today article i referenced earlier said that the cdc actually refused to the provide a policy to usa today regarding the lab reports in the newly recorded lab safety office. When was that report written do you have any idea . Thank you chairman. I was asked to appear here today, and i apologize for the lateness of the testimony. I apologize that but do you know anything about this report that theyre referring to in usa today . I know an article came out last night. I do not know about that report. Id be happy to assure ha after this hearing we provide you answers to this committee would like to know when that was written. If we could have that that would be valuable. Thank you. Doctor, im trying to dumb this down. If i put a cup of coffee in a microwave oven and turn it on it gets hot in a certain amount of time. If i put a dozen cups of coffee in the microwave at the same amount of time theyre not going to all be heated. We know that because of mass and principles. This is on the graph here as well is that on the screen, that on the very upper left dot where it says the dougway irradiation levels here is saying its operating way out of the realm of the acceptable process here. And it, the report states that dod routinely operates outside of data for kill curves. Based upon that finding it sounds like validated extrim nal data does exist for those operating outside of it, is that correct . . Yes, sir. Are the protocols reevaluated review fine routinely . Thats something we looking at. To make sure people were following the protocols they had, to show that there was no willful disregard. It was not willful. But what the graph shows that they were working outside of that gray box that kind of shows the experimental parameters that should are been the should have been the foundation for this work. How is that decision made to move outside of that realm. And if you noted it wasnt just dougway, all of the labs were outside of that area. Somebody did make the decision. And we need to know because we like to think that theres a scientific rule set up that theyre pollfollowing and that all the labs are following that too. Let me ask, in response to these most recent shipments of live anthrax, have any of your agencies made any personnel changes or referred anyone for prosecutions for these actions . Have either one of your agencies done that . So like for dod, that is the second part of the investigation that will kick off now, looking at the accountability issue to determine that. And if i may, one of the issues is not only the individual that made that decision, if that was an individual that made that decision but what was the process . Was there an overall systemic process that led people to perhaps gradually get out of that experimental box. The accountability is taken very seriously. Id like to ak knowledge that we understand your concern and take it seriously. No disciplinary actions have been taken at cdc with respect to the sample incident. In fact, staff responded in a remarkable way to ensure that all these samples were secured and destroyed and that the people that might have been exposed were protected. Regarding the select Agent Program, we continue to consider and take advice and input on how to change the mature of the program do you work with dod . Does cdc work with other labs in setting and reviewing standards on any regular basis or at all . Cdc works with dod in a variety of ways. The reason is this, when we had our hearings for general motors, and somebody made the decision of making a spring this big or a spring this big and it cost a number of lives and they referred to it as the gm shrug. I have the highest respect for them. When things begin to slip out, i agree, were not looking at something nefarious or deliberate here. But as mr. Plum pointed out. Luckily no one has died from this. But we really have dodged the bullet for a long time. Now dr. Crosse you testified in your testimony about how people could be infected and even some kind of epidemic could be started if you got a particularly vir length agent that got released correct . Correct. In addition we have National Security implications relating to the mishandling of these agents, is that right . Thats also a concern. And thats if these active agents got into the wrong hands, thats right . Thats right. You have a lot of recommendations that have not been fully implemented yet, right . Many of the recommendations they have taken an at least some actions the primary one where there has been no movement is to have some type of more centralized oversight. To have a single federal entity that could set the standards for all of the labs or for all the agencies, is that right . Thats right. Now dr. Hassell, whats your agencys opinion about that idea of a single Government Entity . It makes sense in many ways. Were going to do that in the department itself. If it makes sense in many ways, why havent we done that . Why havent you guys implemented that in cooperation with your fellow agencies. We are going to do that internally, and were in discussions now on these issues. But you dont disagree with the idea . No, maam. What about you, dr. Sosin . Whats your agencys view of this . The cdc works with afis as if we are one program. We work very closely. We do joint inspections on overlap agents whenever a change is considered or proposed its discussed with the other program. Thats nice, but what about dod . So the oversight function of the lab im trying to understand your question i believe its about the oversight function, correct correct . What dr. Crosses agency is recommending is one single Oversight Agency that would set forth the protocols for the dispensing of these agents. And so im asking each of your agencies if you would object to that kind of it would make sense to me to get one protocol no matter which lab is dispensing it or whatever. Whats your view on that . Thank you. My view is that its a complex decision, that there are constraints to having one standard for all procedures. What constraints would those be in. For example with anthrax there are many different uses of the products. Dna, preps, for developing vaccine. In any case if youre sending it around you dont want it to be live. Thats absolutely. Thats not something thats subject to debate. So if you could have one agency that could come up with the protocols about oversight on how youre going to make that not, not be live and how youre going to dispense it you wouldnt object to that, would you. Wouldnt object and we believe that the select Agent Program would be the appropriate body to do that. Okay, could that have oversight over the dod too . Absolutely. So do you think that you might cooperate to make that happen . We will cooperate in any way. Let us know what we can do to help you. Because it seems to me thats an excellent recommendation. And youre nodding dr. Hassell. Can you work request dr. Sosin and his colleagues . Yes. We stated in our statement we would Work Together. Heres something else, having been on this committee for a long time, ive noticed is that all the federal labs, not just the ones dealing with anthrax and other select agents but also our nuclear labs have the same problem of a culture of safety. And we we really have struggled in this committee to get people to understand how important it is to have a culture of safety. So dr. Hassell, can you think of anything we can do to systemize some kind of culture of safety . Thats a question i have myself. Maam. I spent ten years at the Dupont Company which goes back 200 years making gunpowder for Thomas Jefferson and that Safety Culture is there. So one of the things i plan to do is to go out and see those industry best practices for doing this. How long have you been there . At the at dod. Just at a year today. And dr. Sosin do you have some ideas about how we could increase the culture of safety at these labs . I personally do not. I know that the cd c c dcs director takes this very seriously. I think we need you guys to supplement your testimony about this. I have one other question. I dont have time, but id like a written answer for this. Id like to know why all of the problems in this particular incident seem to have come out of this one lab. With how they were handling this anthrax, how they were trying to treat it or is it a problem with the procedure itself . Maybe its what youre investigating now, but that seems to be the krufx the problem. Thank you, mr. Chairman. The chair would recognize mr. Mckinley for five minutes. Thank you, mr. Chairman. This is a subject i acknowledge is foreign to me. So i was delighted to try to hear and learn from some of your testimony on this, but im just curious before i get a list of six questions. Im trying to go back to the fundamental. Why would we ship an inactive cells to laboratories . What would you gain by shipping something thats dead . Maybe so one of the aspects of this inactivated anthrax is that it maintains the shell that is around the original live spore the physical structure is still there. Thats important, because thats the basis for the detection systems and the diagnostic systems that are developed. So the closer we can get to that, the better we are. That helps a little bit. Lets go back to something that the gentle lady from colorado mentioned earlier that i didnt pick up in the reading that were doing this in 200 laboratories around the country . Is that an accurate statement . Were studying that in 200 laboratoryies laboratories . We have live anthrax in 200 laboratories . The statement was there were 192 labs that received this material were not intended to receive live anthrax. There are 181 registered entities within the federal select Agent Program registered to possess, use, or transfer. Apparently theres some i really struggle with that to understand why we have to have 300 or2 200 especially looking at the circumstances of this. Dr. Crosse, how would you grade the dods handling of this matter . Would you give them an a . An f . Give me. Since the incident was reported, they have moved pretty quickly to identify where the samples were sent, although that was still developing over the last few days. And, and how would you grade it . Would you grade it passing . Acceptable . A b . A c . I think their response, once it was discovered, has been probably a b. I think they, the activities leading up to it and the fact that this went on for so long is definitely a failure. Its been going on for ten years . Yes. Thats a failure and the fact that they have four different laboratories inactivating anthrax with four different methods and four different chains of command that dont talk to one another. To go back to dr. Hassell. Since anthrax is probably the most dangerous agent that we could handle, i suppose its more dangerous than ebola but is getting it, getting that is probably the biggest threat that we have in National Security, that someone doesnt get this agent. So in this case, is anyone tried, has anyone tried to grow this live anthrax after theyve received these products . With 200 laboratories . Have they tried to reactivate it . It was grown to show the presence of the live spores. I may not understand your question, i apologize. I only have one minute left, so is this the same type of anthrax that was used in 2001 . Its, this is absolutely not the same type of anthrax used in 2001. This is a wild type anthrax. It was in a liquid formulation with extremely small numbers of spores in a 1 ml sample. Very different situation. Nonetheless, taken very seriously. So this is different. Do you feel that our National Security is more at risk because of the process that weve been handling this for the past ten years . The cdc its a yes or no. Follow up. I dont believe that these samples created such a risk. I believe that they were secured quickly and destroyed. That theyre very small numbers in this material and its a naturally occurring anthrax. Let me ask, my thought process initially when why were we shipping this to seven foreign nations . Was there a, does someone have a written authorization . Is there one of those proverbial emails . And who authorizes the shipment of that in and under what process . Do they explain why they want to get . Why would we ship to seven foreign nations . In several instances those were dod locations. In other cases they were allies. We dont have enough dod facilities here that we have to go overseas . Im running out of time. I recognize mr. Green for seven minutes. Unfortunately the incident that led to todays hearing is not the first about handling and shimming of bioagents at dougway. Cdc and the office of the Inspector General investigated safety lapses in 2007. Is that correct . Dr. Hassell . Yes, sir. Based on the previous problem, should dougway have made a better evident of effortver effort to check its procedures . We can report back. Similarly, when cdc announced last year that it had inadd ver tently transferred live anthrax, did dod direct its lab to check their own processes to ensure that anthrax was inactivated properly . No, sir. Why not . Im not sure. Thats a good question. Were going back and trying to figure out what were the steps leading to this. Again i think the reason for the hearing is it seems kind of strange that, you know, cdc made a mistake, and we had a problem with the dod facility, and somebody in Management Authority didnt say lets check to make sure dod is doing it right because what happened at cdc, technically because particularly because of the problem at dougway. Nobody decided to do that . It doesnt appear so, sir. Yobts r beyondbeyond the particulars it raises serious questions of select agent handling. Based on the continued problems at dougway, what assurance can you give the Sub Committee that theres no longstanding safety problems at dougway or other dod facilities that handle highrisk biological agents . Thats a good question. Were trying to look and see if there are general lessons we can learn from this and ask the questions such as your previous question, are there indicators here that indicate we need to be asking questions about other operations across the whole complex. What is dod doing to look across all of its facilities and check their biosafety and biosecurity procedures and policies are adequate. Were taking an effort now to look at the chain of command. Were trying to tighten that up. We want to make sure that the standards for the inactivated anthrax, we will ensure that thats standardized across all of the laboratories and use that as a basis and see if there are other place we need to take actions on. Dougways largely a production facility. The others are more research facilities. So one size may not fit all. But theres definite lessonsque we can learn from this. And whenever possible we will standardize. How about concerns about miscommunication to from the laboratories to the Senior Leadership . Some recommendations have been made, were going to be more vigorous. The dod instruction that was mentioned earlier that will include aspects that will bring all of the reporting forward to a higher level. For example the 2007 incident, if that were to happen today, that wouldnt just remain at dougway or the immediate command. It would come all the way up to a Central Office within the department. Were in the process now of pulling in all of the Inspector General reports cdc reports from all of the laboratories up to my office and reviewing all of those to see if theres indicators and lessons to be learned. Following my colleague from west virginia. So far weve been extremely fortunate, these incidents at dougway have not led to broader Public Health or security problems, and i hope todays hearing and other ongoing incident of this serves as a call to action to tighten up these processes, not just for anthrax and at dougway but other select agents and all facilities. We dont want to have to have somebody here again, or i hope the Armed Service committee is also looking at it and seeing that the issues are being corrected. Mr. Chairman, i yield back my time. Ill recognize dr. Burgess for five minutes. Thanks mr. Chairman. Thanks to our witnesses for being here today. Dr. Sosin, let heme ask you a few questions about what were doing to harden our infrastructure in these locations where it may be under study. Appreciate what Laboratory Documentation<\/a> and emergency protocols. As i stated at the outset the incidents you are examining today are part of a long series of safety lapses. Since 2007 gao has reported on these issues and has made multiple recommendations to improve federal oversight of highcontainment laboratories. The federal departments agreed with our recommendations and have conducted some activities to respond but have not implemented our key recommendation, to establish a single federal entity with responsibility for oversight of all highcontainment laboratories. We recommended the establishment of a single federal entity to, one, conduct governmentwide Strategic Planning<\/a> for requirements for highcontainment lab rotorys, including assessments of their risks. And two develop National Standards<\/a> for designing constructing, commissioning, operating and maintaining such laboratories. We continue to believe that such an entity or some other mechanism to ensure higher level oversight is needed in the face of the continuing proliferation of highcontainment laboratories and the ongoing failures by agencies to fiction their problem fix their problems on their own. In closing, they are supposed to have multiple levels of control, including crosschecks inspections, training, procedures and validated protocols that should prevent such accidents from occurring and certainly should prevent such incidents from recurring. This completes my remarks. I would be happy to answer questions you or other members of the Sub Committee<\/a> may have. Thank you, doctor. I now recognize myself for five minutes of questioning of the witnesses. And dr. Sosin, you said we will work diligently with our partners and anyone sharing our commitment to protect americans from biological threats. Please let the cdc know i dont believe them any mofrmt the usa today article i referenced earlier said that the cdc actually refused to the provide a policy to usa today regarding the lab reports in the newly recorded lab safety office. When was that report written do you have any idea . Thank you chairman. I was asked to appear here today, and i apologize for the lateness of the testimony. I apologize that but do you know anything about this report that theyre referring to in usa today . I know an article came out last night. I do not know about that report. Id be happy to assure ha after this hearing we provide you answers to this committee would like to know when that was written. If we could have that that would be valuable. Thank you. Doctor, im trying to dumb this down. If i put a cup of coffee in a microwave oven and turn it on it gets hot in a certain amount of time. If i put a dozen cups of coffee in the microwave at the same amount of time theyre not going to all be heated. We know that because of mass and principles. This is on the graph here as well is that on the screen, that on the very upper left dot where it says the dougway irradiation levels here is saying its operating way out of the realm of the acceptable process here. And it, the report states that dod routinely operates outside of data for kill curves. Based upon that finding it sounds like validated extrim nal data does exist for those operating outside of it, is that correct . . Yes, sir. Are the protocols reevaluated review fine routinely . Thats something we looking at. To make sure people were following the protocols they had, to show that there was no willful disregard. It was not willful. But what the graph shows that they were working outside of that gray box that kind of shows the experimental parameters that should are been the should have been the foundation for this work. How is that decision made to move outside of that realm. And if you noted it wasnt just dougway, all of the labs were outside of that area. Somebody did make the decision. And we need to know because we like to think that theres a scientific rule set up that theyre pollfollowing and that all the labs are following that too. Let me ask, in response to these most recent shipments of live anthrax, have any of your agencies made any personnel changes or referred anyone for prosecutions for these actions . Have either one of your agencies done that . So like for dod, that is the second part of the investigation that will kick off now, looking at the accountability issue to determine that. And if i may, one of the issues is not only the individual that made that decision, if that was an individual that made that decision but what was the process . Was there an overall systemic process that led people to perhaps gradually get out of that experimental box. The accountability is taken very seriously. Id like to ak knowledge that we understand your concern and take it seriously. No disciplinary actions have been taken at cdc with respect to the sample incident. In fact, staff responded in a remarkable way to ensure that all these samples were secured and destroyed and that the people that might have been exposed were protected. Regarding the select Agent Program<\/a>, we continue to consider and take advice and input on how to change the mature of the program do you work with dod . Does cdc work with other labs in setting and reviewing standards on any regular basis or at all . Cdc works with dod in a variety of ways. The reason is this, when we had our hearings for general motors, and somebody made the decision of making a spring this big or a spring this big and it cost a number of lives and they referred to it as the gm shrug. I have the highest respect for them. When things begin to slip out, i agree, were not looking at something nefarious or deliberate here. But as mr. Plum pointed out. Luckily no one has died from this. But we really have dodged the bullet for a long time. Now dr. Crosse you testified in your testimony about how people could be infected and even some kind of epidemic could be started if you got a particularly vir length agent that got released correct . Correct. In addition we have National Security<\/a> implications relating to the mishandling of these agents, is that right . Thats also a concern. And thats if these active agents got into the wrong hands, thats right . Thats right. You have a lot of recommendations that have not been fully implemented yet, right . Many of the recommendations they have taken an at least some actions the primary one where there has been no movement is to have some type of more centralized oversight. To have a single federal entity that could set the standards for all of the labs or for all the agencies, is that right . Thats right. Now dr. Hassell, whats your agencys opinion about that idea of a single Government Entity<\/a> . It makes sense in many ways. Were going to do that in the department itself. If it makes sense in many ways, why havent we done that . Why havent you guys implemented that in cooperation with your fellow agencies. We are going to do that internally, and were in discussions now on these issues. But you dont disagree with the idea . No, maam. What about you, dr. Sosin . Whats your agencys view of this . The cdc works with afis as if we are one program. We work very closely. We do joint inspections on overlap agents whenever a change is considered or proposed its discussed with the other program. Thats nice, but what about dod . So the oversight function of the lab im trying to understand your question i believe its about the oversight function, correct correct . What dr. Crosses agency is recommending is one single Oversight Agency<\/a> that would set forth the protocols for the dispensing of these agents. And so im asking each of your agencies if you would object to that kind of it would make sense to me to get one protocol no matter which lab is dispensing it or whatever. Whats your view on that . Thank you. My view is that its a complex decision, that there are constraints to having one standard for all procedures. What constraints would those be in. For example with anthrax there are many different uses of the products. Dna, preps, for developing vaccine. In any case if youre sending it around you dont want it to be live. Thats absolutely. Thats not something thats subject to debate. So if you could have one agency that could come up with the protocols about oversight on how youre going to make that not, not be live and how youre going to dispense it you wouldnt object to that, would you. Wouldnt object and we believe that the select Agent Program<\/a> would be the appropriate body to do that. Okay, could that have oversight over the dod too . Absolutely. So do you think that you might cooperate to make that happen . We will cooperate in any way. Let us know what we can do to help you. Because it seems to me thats an excellent recommendation. And youre nodding dr. Hassell. Can you work request dr. Sosin and his colleagues . Yes. We stated in our statement we would Work Together<\/a>. Heres something else, having been on this committee for a long time, ive noticed is that all the federal labs, not just the ones dealing with anthrax and other select agents but also our nuclear labs have the same problem of a culture of safety. And we we really have struggled in this committee to get people to understand how important it is to have a culture of safety. So dr. Hassell, can you think of anything we can do to systemize some kind of culture of safety . Thats a question i have myself. Maam. I spent ten years at the Dupont Company<\/a> which goes back 200 years making gunpowder for Thomas Jefferson<\/a> and that Safety Culture<\/a> is there. So one of the things i plan to do is to go out and see those industry best practices for doing this. How long have you been there . At the at dod. Just at a year today. And dr. Sosin do you have some ideas about how we could increase the culture of safety at these labs . I personally do not. I know that the cd c c dcs director takes this very seriously. I think we need you guys to supplement your testimony about this. I have one other question. I dont have time, but id like a written answer for this. Id like to know why all of the problems in this particular incident seem to have come out of this one lab. With how they were handling this anthrax, how they were trying to treat it or is it a problem with the procedure itself . Maybe its what youre investigating now, but that seems to be the krufx the problem. Thank you, mr. Chairman. The chair would recognize mr. Mckinley for five minutes. Thank you, mr. Chairman. This is a subject i acknowledge is foreign to me. So i was delighted to try to hear and learn from some of your testimony on this, but im just curious before i get a list of six questions. Im trying to go back to the fundamental. Why would we ship an inactive cells to laboratories . What would you gain by shipping something thats dead . Maybe so one of the aspects of this inactivated anthrax is that it maintains the shell that is around the original live spore the physical structure is still there. Thats important, because thats the basis for the detection systems and the diagnostic systems that are developed. So the closer we can get to that, the better we are. That helps a little bit. Lets go back to something that the gentle lady from colorado mentioned earlier that i didnt pick up in the reading that were doing this in 200 laboratories around the country . Is that an accurate statement . Were studying that in 200 laboratoryies laboratories . We have live anthrax in 200 laboratories . The statement was there were 192 labs that received this material were not intended to receive live anthrax. There are 181 registered entities within the federal select Agent Program<\/a> registered to possess, use, or transfer. Apparently theres some i really struggle with that to understand why we have to have 300 or2 200 especially looking at the circumstances of this. Dr. Crosse, how would you grade the dods handling of this matter . Would you give them an a . An f . Give me. Since the incident was reported, they have moved pretty quickly to identify where the samples were sent, although that was still developing over the last few days. And, and how would you grade it . Would you grade it passing . Acceptable . A b . A c . I think their response, once it was discovered, has been probably a b. I think they, the activities leading up to it and the fact that this went on for so long is definitely a failure. Its been going on for ten years . Yes. Thats a failure and the fact that they have four different laboratories inactivating anthrax with four different methods and four different chains of command that dont talk to one another. To go back to dr. Hassell. Since anthrax is probably the most dangerous agent that we could handle, i suppose its more dangerous than ebola but is getting it, getting that is probably the biggest threat that we have in National Security<\/a>, that someone doesnt get this agent. So in this case, is anyone tried, has anyone tried to grow this live anthrax after theyve received these products . With 200 laboratories . Have they tried to reactivate it . It was grown to show the presence of the live spores. I may not understand your question, i apologize. I only have one minute left, so is this the same type of anthrax that was used in 2001 . Its, this is absolutely not the same type of anthrax used in 2001. This is a wild type anthrax. It was in a liquid formulation with extremely small numbers of spores in a 1 ml sample. Very different situation. Nonetheless, taken very seriously. So this is different. Do you feel that our National Security<\/a> is more at risk because of the process that weve been handling this for the past ten years . The cdc its a yes or no. Follow up. I dont believe that these samples created such a risk. I believe that they were secured quickly and destroyed. That theyre very small numbers in this material and its a naturally occurring anthrax. Let me ask, my thought process initially when why were we shipping this to seven foreign nations . Was there a, does someone have a written authorization . Is there one of those proverbial emails . And who authorizes the shipment of that in and under what process . Do they explain why they want to get . Why would we ship to seven foreign nations . In several instances those were dod locations. In other cases they were allies. We dont have enough dod facilities here that we have to go overseas . Im running out of time. I recognize mr. Green for seven minutes. Unfortunately the incident that led to todays hearing is not the first about handling and shimming of bioagents at dougway. Cdc and the office of the Inspector General<\/a> investigated safety lapses in 2007. Is that correct . Dr. Hassell . Yes, sir. Based on the previous problem, should dougway have made a better evident of effortver effort to check its procedures . We can report back. Similarly, when cdc announced last year that it had inadd ver tently transferred live anthrax, did dod direct its lab to check their own processes to ensure that anthrax was inactivated properly . No, sir. Why not . Im not sure. Thats a good question. Were going back and trying to figure out what were the steps leading to this. Again i think the reason for the hearing is it seems kind of strange that, you know, cdc made a mistake, and we had a problem with the dod facility, and somebody in Management Authority<\/a> didnt say lets check to make sure dod is doing it right because what happened at cdc, technically because particularly because of the problem at dougway. Nobody decided to do that . It doesnt appear so, sir. Yobts r beyondbeyond the particulars it raises serious questions of select agent handling. Based on the continued problems at dougway, what assurance can you give the Sub Committee<\/a> that theres no longstanding safety problems at dougway or other dod facilities that handle highrisk biological agents . Thats a good question. Were trying to look and see if there are general lessons we can learn from this and ask the questions such as your previous question, are there indicators here that indicate we need to be asking questions about other operations across the whole complex. What is dod doing to look across all of its facilities and check their biosafety and biosecurity procedures and policies are adequate. Were taking an effort now to look at the chain of command. Were trying to tighten that up. We want to make sure that the standards for the inactivated anthrax, we will ensure that thats standardized across all of the laboratories and use that as a basis and see if there are other place we need to take actions on. Dougways largely a production facility. The others are more research facilities. So one size may not fit all. But theres definite lessonsque we can learn from this. And whenever possible we will standardize. How about concerns about miscommunication to from the laboratories to the Senior Leadership<\/a> . Some recommendations have been made, were going to be more vigorous. The dod instruction that was mentioned earlier that will include aspects that will bring all of the reporting forward to a higher level. For example the 2007 incident, if that were to happen today, that wouldnt just remain at dougway or the immediate command. It would come all the way up to a Central Office<\/a> within the department. Were in the process now of pulling in all of the Inspector General<\/a> reports cdc reports from all of the laboratories up to my office and reviewing all of those to see if theres indicators and lessons to be learned. Following my colleague from west virginia. So far weve been extremely fortunate, these incidents at dougway have not led to broader Public Health<\/a> or security problems, and i hope todays hearing and other ongoing incident of this serves as a call to action to tighten up these processes, not just for anthrax and at dougway but other select agents and all facilities. We dont want to have to have somebody here again, or i hope the Armed Service<\/a> committee is also looking at it and seeing that the issues are being corrected. Mr. Chairman, i yield back my time. Ill recognize dr. Burgess for five minutes. Thanks mr. Chairman. Thanks to our witnesses for being here today. Dr. Sosin, let heme ask you a few questions about what were doing to harden our infrastructure in these locations where it may be under study. Appreciate what Ranking Member<\/a> degette has stated earlier. Ive been on this committee for years and it seems like theres recurrent theme here. We want everything to be perfect. But there are human beings involved and sometimes they arent perfect. I was a regular guy when the anthrax attacks happened in 2001. I remember reading in horror what happened when those individuals were infected and died reading about the emergency room doctors experience, here was a guy who didnt look that sick. And as we found out you can be a lot sicker than what you look and by the time clinical deterioration begins youre almost too late on the curve to rescue someone although rescue is possible if you start early. Because unlike ebola, anthrax is treatable with relatively common antibiotics. So bearing in mind that ebola experience from not quite a year ago, cdc was telling us last july, august, september, we got everybody up to speed on ebola. We dont have to worry about ebola coming to this country. The president made a statement, we dont have to worry about ebola getting to this country because cdcs done everything to get everybody prepared. And then it didnt happen. This is not quite the same thing. But you know you have sites where this is under study. You know lapses can occur. So do you have like a 35 or 50 mile radius around these sites where you are at least notifying the people on the front lines, the Emergency Rooms<\/a>, the emergency room doctors that this is something were working on in your community . Thank you. Thank you for that question. First, with respect to hardening infrastructure yes, there are support programs at the state and local level to address anthrax and other bioterrorism threats, as you pointed out there are not only the routine treatments. There are some advanced counter medical measures that have been developed such as antitoxin to help treat later stages of anthrax and vaccine. Those were brought to bear the anthrax and vaccine brought to bear in ibuprofen laxis in this incident. The local, the state authorities are informed of the institutions and their jurisdiction and the agents that are there as part of their Public Health<\/a> preparedness programs. There is no active outreache reach into the medical community. But we are quick so respond as we did in this instance with information about how to diagnose, how to watch for monitor and how to treat. Let me just interrunts you, could you provide the committee those materials that you provided . Absolutely. To the Emergency Rooms<\/a> and what radius around where the breach occurred, what the geographic radius was in. I will say that these materials were not sent to emergency departments, although we did consider it. We monitoring the workers in the laboratories. Thats point. If these people thought they were getting inactivated rains, strains and they were active. Somebodys got a lowgrade fever and they dont feel now. And they go down to the care now facility. Again, theyll look well until they get deathly ill. Thats the problem. Thats why these were isolated to laboratories, and we working with the laboratories and Health Departments<\/a> to monitor them. Forgive me if im unmollified. But the problem is you didnt know what you didnt know at that point. And certainly the people in the community who may have been the doctors and nurses and caregivers who were seeing patients wouldnt have known that this was what they were up against. I guess my concern is how do we get that information out there, how do we make people aware. Once you know that anthrax is a consideration, okay. Fair enough. But before you know it, it looked like the last 1500 patients that have come through the door with a viral syndrome. I do have a question i need to ask mr. Demske, and we dont have time to get through all of it. Maybe you can provide me an answer in writing. But when you look at the referrals for valuations of the federal select Agent Program<\/a>, United States<\/a> Army Institute<\/a> of Infectious Diseases<\/a> seemed to be in the top three. So you have an enforcement policy where you can actually find but you dont fine federal agencies, is that correct . To date we have not fined any of agencies. Thats what Willie Sutton<\/a> says, you rob banks, because thats where the money is. For now, the viesolateors seem to be coming from those three groups. Can you get back to me and discuss what you are doing to providing the penalties that any other lab in the country would have to face if they had a breach of these agents . Yes to be clear most of the referrals and most of the labs or incidents that have been referred to us have not involved federal entities, but certainly there have been repeat instances and we would be happy to provide you the multiple offenders, thats problem. And its the Civil Penalties<\/a> and other penalties we need to know about from there. Thank you. Mr. Tonko, youre recognized for five minutes. Thank you mr. Chair. Weve heard about the importance of keeping labs safe and secure, thus, id like to explore how labs both private and public that fail to meet critical Safety Standards<\/a> and regulations are held accountable. Both cdc and hhs through their offices of Inspector General<\/a> have roles and enforcement. Cdcs division of select agents and toxins can refer entities to the office of Inspector General<\/a> for civil money penalties or certainly notices of violation. Cdc could deny, revoke or suspend a labs registration or require a lab to enter into a Performance Improvement<\/a> plan. Criminal charges can also be made in cases of misuse, unauthorized possession or unauthorized transfer. So dr. Sosin could you walk us through the different options and how you determine the appropriate response for a given violation . Thank you for your question. Youve correctly pointed out the options, the administrative options. The registration process itself is intended to screen and assure that theres Good Laboratory<\/a> practice, Good Laboratory<\/a> leadership, an appropriate use for the select its materialagent materials. So that process are intended to assure that the entity itself is taking the appropriate steps that it needs to take. The decision to suspend or revoke is one taken very seriously. The importance of balance particularly for facility of the nature that you all are talking about here, these are important biodefense facilities doing important work. And the history of the program has been to work collaboratively to identify the specific problems and address them. But those are options and the referral to fbi if theres concern about suspicious activity or referral to oig. Thank you. Mr. Demske . Yes when we receive a riefrl from the cdc, one of our attorneys or multiple attorneys will review the findings and allegations and the cdc will often consult with the expert to make sure we understand those facts. If we brief that theres been a violation, its our policy to then contact the entity that is the subject of the matter and give them the opportunity to provide us with information or arguments about why a penalty would not be appropriate. We take that into account. Often, again in consultation with cdc and decide whether to go forward with the case. And we use our looking across the experience of the cases that weve had, make a judgment about what we think the case should be valued at if we do seek a civil money penalty. Now do your offices routinely Work Together<\/a> to take action against those who are in violation . We certainly communicate and Work Together<\/a> from our perspective to make sure that we understand the facts and the science in these matters for us to determine whether to go forward. And dr. Sosin, what types of violations would result in a lab losing its registration . Sbr i can tell you that the process of revoking registration is one that is undertaken through careful efforts to help the laboratory address the concerns and improve its practices, and that revocation would come only after the inability of that facility to make those changes or their decision to no longer be interested in doing that work. I can get further clarification of the specific measures if youd like. And in your opinion how often has that happened . I believe that its happened two times. I can get you the exact number. Okay. Id also like to get a sense of the frequency of violations and the actions to address them. Dr. Sosin, are you seeing any trends at the cdc in terms of Enforcement Actions<\/a> any trends in referrals to the Office Inspector<\/a> general for instance or Performance Improvement<\/a> plans or Lab Registration<\/a> actions . The federal select Agent Program<\/a> is constantly evolving, and its approaches and tools uch is as the corrective action plan process, are relatively new and evolving. So trends are hard to evaluate in that context. I know that if requested the Sub Committee<\/a>, smifk Enforcement Actions<\/a> have been laid out in a response and should have the kind of information you would be looking for. Okay. And im out of time, but if mr. Demske if you could, perhaps, feed the panel with that same trend that you cite, any trends that you cite that would be helpful. Thank you. I now recognize ms. Blackburn for five minutes. Thank you, mr. Chairman and thank you to our witnesses for your patience. We appreciate this as you know, weve got another hearing going on this morning. Dr. Sosin i want to come to you, if i may. Ive got a copy of dr. Freedens testimony from this Committee Last<\/a> year. And he was testifying about the june 2014 anthrax incident. He said and im going to read from the testimony. And im quoting. These incidents should never have happened. The lack of adequate procedures and oversight that allowed them to happen was totally unacceptable. We will explore the broader implications of these incidents and incorporate the Lessons Learned<\/a> from them to proactively prevent future incidence at laboratories across the nation that work with pathogens. So i want to know. Can you explain why we didnt seem to learn the lessons . Can you talk about why there is another comprehensive review of safety and security of the bioterror labs . Why was not congress notified . Why is another review necessary . Were the problems at the cdc not corrected . And then who is going to conduct the new review. And ultimately. Who do we hold responsible for this . Thank you for your questions. Pardon me if i need refreshing on some of them. Ill be happy to refresh. Im sure you will. I think its important to recognize that the Oversight Program<\/a> is not a cdc laboratory itself. It functions separately. Nonetheless, in hindsight there has been reason to look more closely at anthrax inactivation. Theres no question that that is necessary and before a moratorium on the use and transfer of these materials will be lifted, we will have a policy about how to validate. Whoa whoa whoa. Wait a minute. That was supposed to be done. So why was it not done . Whos responsible that it did not get tended to last year . The work of a complex lort micro biological lort has thousands of procedures. So youre saying no one person is in charge that its done by chitommittee . No. Im saying that the current nature is one of setting broad standards to achieve high Laboratory Performance<\/a> but does not review each individual specific procedure at each entity. There will need to be procedures call for notifying congress . Im sorry . Do the procedures call for notifying congress if you need to do a review . If you have another incident . So thats not a part of thats not a part of your best, your business processes. I apologize if congress was not notified regarding the review that dr. Freeden requested we take internally of the federal select Agent Program<\/a> at cdc, that review is not a review of cdc labs and procedures. That is a review of what opportunities we have to improve the Oversight Program<\/a>. Okay. Let me ask it this way. Going back to his testimony where he says that it never should have happened lack of adequate procedures totally unacceptable. Going to put the processes in place and incorporate the Lessons Learned<\/a>. Was this not done last year . Many things were done. This was not addressed. This, okay so it was not addressed. Thats answer i wanted a yes or no. Either it was done or it was not done. And that is what we want to know. And, see, this is part of what is so frustrating to the taxpayers who are footing the bill for this. Because you all feel like you have immunity, if you will, and you dont have to move forward and do the job because you have a continuing appropriation. You just dont do the job until its convenient. Congressman you mess up once, you mess up twice. You mess up 86 times and its no skin off your back. Because nobodys responsible. Because you operate by committee. Because we ask you to do something and report back to us. What do you do . Sit around and go oh well, well get around to it later . Maybe we need to give you a round tuit and have you get the job done. The fact that we are having to have another hearing and look at this is something that is frustrating. You should be realize once that there was a mistake. And immediately move forward to correct the procedures and the policies. And then should change the way that things are done. And i know im running out of time. I will yield back the balance of my i do think its important to clarify that the cdc error with anthrax was addressed. If was a different situation. What i did acknowledge is that as the federal select Agent Program<\/a> with anthrax with inact administration, in hindsight, we should have, and we will enact inactivation procedures before that is used again. Im sure you can understand weve heard that before. Ms. Castor, youre recognized for five minutes. Thank you. Mr. Chairman. Regarding the dod review of the dougway incident and the science surrounding inact administration protocols. The dod reported that one of the root causes of the dougway incident was scientific uncertainty about the process of inact vatsing anthrax spores. The review spated that this uncertainty led to the protocols that do not permanently deactivate anthrax spores and although this incident only recently raised questions about the inadequacy of these procedures, the department knew of this uncertainty for quite a while. So dr. Hassell, if the department was aware of the potential inadequacy of the inactivation process using gamma irradiation, why didnt the department have better verification procedures to ensure the spores were properly inactivated before shipping them . So thats a good question because it really separates, there are two issues involved. One was the inactivation was infective. And the other was that the vieblts testing didnt catch the fact that the first was not 100 effective. Regarding the inactivation there is several scientific publications and peer review journals in the scientific literature that have shown different what we call death curves for killing anthrax. What we need to do now is to try to pull all those together, get a consensus view of those. Work with the body of subject matter experts. Work in consensus with cdc and figure out why didnt you do that before if the department knew of this uncertainty for a while . It appears that that was somewhat localized. It wasnt universally acknowledged. Each individual Laboratory Set<\/a> its own standards and so this wasnt raised up to a central body. And that was not acceptable. Those standards were not acceptable. Was not acceptable. And going forward, it will have to be done in concert, so the so, is the dod reviewing all of its protocols and procedures to ensure that there are not similar gaps in the scientific literature for the inact administration of other dangerous toxins and pathogens . We will be doing that. You are doing that for anthrax and for other toxins. Right. Well see if theres any Lessons Learned<\/a> from that that we can apply across the board. How confident are you that people are going to take that seriously. There are gaps in science and discrepancyies discrepancies. How are you going to reconcile . Certainly you would err on the side of safety. Certainly. Anthrax is technicallyparticularly hard to kill. That should give us our biggest challenges, boast in the activase and on the viability testing afterwards. Things that we learned from both of those we will then take forward. When theres a ditch offference of opinion, who is going to be the responsible party that we can go back and say, wow, we had this hearing and another agency said we will address thesen gaps if and when we have to have another hearing. Who is it that we will identify or if you could provide that to the committee because there is this problem with no personal accountability. Dont you agree . Yes, maam. And the second part of this investigation will be looking at the accountability. We will have some of those people identified. And well certainly provide that to the committee. Thank you. Id like to turn to dr. Sosin to ask some questions about the cdcs role in overseeing the direct Agent Program<\/a>. Why is there such variation across labs as to how they inactivate anthrax . Thank you for your question. As mentioned earlier there are a variety of needs for materials that come from dead anthrax. And the laboratories, some research, some production for proficiency testing of labs, et cetera, have different roles and purposes as well. So cdc historically has required a ral dated procedure either published and followed or val dated within that laboratory and proof of sterility testing. I this to your question about accountability exemption of a select its, anthrax now becoming exempt because its dead is a requirement of the federal select Agent Program<\/a>. And until we have a procedure that increases confidence that we can safely do that, we will not lift that moratorium. You can see that were very concerned. Absolutely. Are we to expect similar variation in inact administration protocols for other select agents and toxins and how do we address that . As dr. Hassell pointed out, the nature of a spore being extremely hardy and difficult to kill, plus the fact that in this instance we were or the department of defense was trying to kill the organism without disrupting the organism creates a challenge in safety. The attempt, now, is to set that, an appropriate wide margin. It if you go back to the chairmans figure that he showed, the dod shows a dosing and a gap between the kill curve and the dosing. That gap wasnt happening here. Clearly there were production runs that were growing anthrax and should have highlighted that procedure was not adequate. Going forward, we will make sure that there is a safety margin and achieve consensus with the broad input that we have opportunity to get to assure that were taking the right margin. Im out of time. I will now recognize mr. Griffen for five minutes. Thank you very much mr. Chairman. Dr. Hassell, if you could, weve got folks out there receiving this. You answered a previous question related to the foreign nations and said some of those were dod facilities facilities. Were they all dod facilities, and if not dod facilities, were they facilities controlled by the United States<\/a> government . Yes or no . No. So some of these would have gone to facilities not controlled by the United States<\/a> government. How certain can we be that these folks who were receiving live samples, and i believe it was over the course we now know of ten years, didnt discover this before they necessarily told us and have been out there growing some of their own samples and siphoning off some . So when were told that you all hunted it down and you killed or acquired all of the live anthrax, how certain of that can we be . Because it doesnt sound like it me that we can be very certain if somebody was taking some of that anthrax and skimming off some of the live for use in other ways. So the nondod facilities that you refer to, those are some of our most trusted allies. We do many things with these allies. Like across the board not just for bio. Theyre trusted, but if they wanted to do research on biological weapons, this would have given them an opportunity it acquire that or at least to acquire the base material to start the cultures with, isnt that true . Yes or no . Its true, but they were already doing most of that work. We were trying to use a common material across the board so everyone was testing on the same material, so that we can compare the results that we had. And how but they do have those programs already. How comfortable are you with those facilities had better protocols than we do and that we dont have some worker who might have taken what was supposed to be some dead cells, generated the live cells and gone out with a sample that he then might have, he or she may have given to a Foreign Agent<\/a> . In some of those cases they already have the material now. Like i say, this was a soon to be dead material and we do have records of it, it has all been deemployed. What you found has all been destroyed destroyed. Since there was live, yes or no. The answers yes. Lets move on. Dr. Sosin, you said that the cdc act the reasonably in tracking down the live anthrax and then securing or killing it. Dr. Crosse you indicated that you would give them a b once it was discovered. But mr. Demske you didnt get notified until yesterday to investigate the problem that was discovered in may isnt that correct . Thats correct. Yes. So weve got at least 60 days since the problem was discovered before you were notified. Isnt that true . I dont yes. I dont consider that a b or acting reasonably, do you . Well were not the front lines of an emergent situation. That would have to go do the fda and the scientists with the cdc, so it is normal for cdc to do investigative work on its own before it would refer a matter to us. And that actually helps us, because the evidence is more so you think 60 days is reasonable before youre notified to do your investigation . Yes. Okay. And as a part of that theyre doing their investigations and so forth, but dont you think its kind interesting that you got notified yesterday . Do you think that our hearing might have sped ha time up a little bit . I have no information about that. But when you filed your testimony, you said to date. Oig has not received a referral for any more recent potential violation involving dougway which was in the reference to 2008 and 2010 incidents. Thats correct. We submitted the testimony on friday. At that time we had not received it. My opinion is that oversight by this commit see a very effective way at spurring attention to this matter within the government. Just wish we didnt have to do it so often. Dr. Sosin, youre the acting director for National Center<\/a> for injury, prevention and control. I noticed in the report referred to by the chairman earlier that Stephen Moore<\/a> is the acting director of his department. What is the relationship between your two areas and why is everybody over there acting and nobodys permanent . Im sorry. The information you have about my acting director role is old. I was previously for nine months acting director there. I have been for nearly a decade, or over a decade actually, the Deputy Director<\/a> for the office of Public Health<\/a> preparedness and response. Dr. Monroe i think youre referring to was the acting associate director for Laboratory Science<\/a> and safety is an Outstanding Laboratory<\/a> scientist who comes from the center of emerging infections. And hes in an acting role because we are trying to hire a topnotch Laboratory Scientist<\/a> to lead the Laboratory Safety<\/a> and science effort. Do you work with him or just report to him. I work with him. I yield back, mr. Chairman. Thank you. As the investigation into the dougway incident continues, were learning that more and more labs received these live anthrax shipments. In addition to the 86 labs to which dod directly sent shipments there have been an additional 106 labs that received secondary transfers so were now talking about nearly 200 labs, and as more labs are involved the opportunities for error only increase. So i do want to understand why its necessary to have so many labs involved with dangerous biological agents. I know ms. Degette mentioned this in her opening statement. Do you have an opinion on the number of labs that are working with anthrax . I dont think we know the number of labs that are working with anthrax. I think thats one of the issues. Well, we have information of where are you talking about the the select agent. Thats right. Anthrax, we do know. We do not know all of the highcontainment lack ra torys that exist. We have controls for a subset of dangerous pathogens. There are other highly infectious path gins that require a level three laboratory. We do know for anthrax. My apologies. So it has been recommended for a single entity for oversight for highcontainment labs. This would include standards. Can you elaborate even this on this recommendation . Yes we think its important that there be a more comprehensive set of plans for how many labs are needed. You know, there have been theres been a great increase in the number of labs over the last decade, since the anthrax attacks in 2001. A number of different federal agencies have expanded the number of labs that they have. Academic institutions have built labs. Some states have built labs. And a lot of private entities have built labs. And theyre very expensive. We dont know what, really, is needed. They, as weve heard today, they are developing their own validation procedures. And theres not, necessarily an assurance of consistency. And, so while inspections can be performed of these laboratories the kinds of reportings of problems have been only typically been going to a level above the laboratory, so theyre not going to the top of departments or organizations. And so i think that were concerned that there hasnt been kind of a consistent set of standards in place. A consistent understanding of what the needs are. A consistent plan developed for where these laboratories are to be built and maintained and what the costs are going to be over the long term for maintaining this kind of infrastructure and whether it is in line with the needs. Well have you gotten feedback from the federal Government Agencies<\/a> that operate these highcontainment labs with regard to this recommendation to establish the single federal entity . I know you mentioned some obstacles to that but what other obstacles would there be to implement it . Well, you know, i think that its not clear where that organization should be located. As weve heard today, its difficult to retrofit this kind of control on top of existing enterprise, different departments want to have control over what their own needs are, Different Companies<\/a> want to be able to compete for contracts from the federal government. And so going back and retro fitting that kind of control is complicated. We have not gotten traction on the concept of moving forward to try to centralize this control. Let he just say then, ask again, do you believe that the establishment of these National Stan<\/a> darsd and oversight might address some of the gaps that led to the recent incidents at dod and cdc and how can Congress Help<\/a> in establishing uniform policies and procedures . We do believe that having more consistent lines of authority would be helpful. Dod in its report on the dougway incidents has pointed out that the different laboratories handling anthrax were in different chains of command and never came together. That there wasnt a sharing of information, and they didnt have toplevel knowledge of what was going on in these laboratories and how the procedures were being conducted. Thats the type of thing we think would be helpful. And wed be happy to work with you and members of the committee to try to develop some kind of proposals. Thank you thank you mr. Chairman. Well now recognize dr. Due shon. This is not the only Government Agencies<\/a> that were hearing testifying in front of congress saying theyre establishing new policies. Sorry, we messed up. Sorry we did this, sorry we did that. You know why . Theres no accountability. Theres no accountability across the federal government in my view. No ones responsible. People are in their jobs for short periods of time. Dr. Hassell, youve been on your job for a year. If we really pressed you, youd say, i dont know, ive only been on my job a year. So i dont know what they did before me. This is a decadelong process. Anget tired of hearing how were establishing new policies. This is anthrax. We should have had policies for decades. Its ridiculous. Thats the problem. And theres almost contempt for, against congressional oversight. Every hearing i go to. Its, almost people walk out of the room and they go, well, they didnt get us this time, and they cant get us. Theres nothing they can do to us. Thats what people, i mean, this is just ridiculous. So dr. Hassell, how can there not be standardized protocols for this in the federal government, after decades and decades of this . How can that not happen . I mean thats just the question i have. Dr. Hassell how could, you made the statement, you know, theres, were standardizing how we deal with this. How can it not be standardized . I can answer for dod. It was noted earlier that the different chains of command has been one of the fundamental problems here, because each Laboratory Reports<\/a> to a different chain. They meet too high up in the organization. So yes ive been in place for a year, i take this very personally. Im not criticizing you. In fairness youve only been there a year, youre right. You cant be accountable for what happened ten years ago. I agree with you. But i own it now. So i take personal responsibility to work with other people in the department to make sure these things are sdardized. And i will not recommend to the undersecretary to lift the moratorium until im confident that we have the proper basis for our operations and ha we achieve the right level of standardization. I prefectureappreciate that. If people were losing their jobs this would be standardized. Doctor","publisher":{"@type":"Organization","name":"archive.org","logo":{"@type":"ImageObject","width":"800","height":"600","url":"\/\/ia801304.us.archive.org\/7\/items\/CSPAN3_20150731_030000_Key_Capitol_Hill_Hearings\/CSPAN3_20150731_030000_Key_Capitol_Hill_Hearings.thumbs\/CSPAN3_20150731_030000_Key_Capitol_Hill_Hearings_000001.jpg"}},"autauthor":{"@type":"Organization"},"author":{"sameAs":"archive.org","name":"archive.org"}}],"coverageEndTime":"20240629T12:35:10+00:00"}