Transcripts For CSPAN Hearing On Live Anthrax Shipments 2024

Cspans road to the white house is providing coverage on cspan, cspan radio and cspan. Org. The New Hampshire leader along with media organizations are sponsoring the forum. Following the forum, you can provide your input by calling our callin program. Road to the white house 2016, cspan, cspan radio and cspan. Org. On tuesday, officials from the defense department, cdc and health and Human Services testified on capitol hill in regard to shipments of live sports of anthrax. Received live anthrax. This is a live interview. It is just over two hours. Two hour hearing. Good morning, welcome to our hearing dealing with anthrax once again. The subcommittee examines continue concerns over the federal agent select program with the focus on shipments of live anthrax from the department of Defense Laboratory that occurred over a ten year period. As last year we held a similar hearing that proposed dozens of cdc researchers to live anthrax due to safety procedures not being followed. The cdc director testified quote we will take every step possible to prevent any future incident that will put our Laboratory Scientist and public at risk. Yet, here we are again. We examine the mistake of avian flew and the vials of small pox in the nih building months after the hearing and after the white house ordered safety stand down the cdc revealed there was a transfer of ebola from a cdc four lab to a cdc two lab. And despite the growing number of red flags these incidents keep happening. We learned an army lab in utah shipped anthrax to facilities across the globe. At least 192 labs have received shipments of the anthrax. The testing used to validate and insure the anthrax spores were not active failed to detect the live anthrax spores. What is most troubling is that doug way used this potentially deadly process for years. This is unacceptable. It is threatening the Nation Security and Public Health. The committee hopes to learn what is being done to prevent future safety lapses. The internal review of the circumstances surrounding the shipments of anthrax and according to the report the dod was unable to determine the root cause of how and why doug way labs shipped anthrax. It is said all of the labs operate outside of the experimental data. In other words, it seems the department of defense labs have been eradiating larger numbers of spores given. This revelation begs a lot of questions beginning with why. And why for so long . Who was responsible about making the decision on which ina inactivation process to use . And what is the cdcs role in developing the processes . According to a recent and all too familiar headline, cdc announced it will conducting another review of how it regulates safety and security at bio terror labs. I think it is important to improve current regulations for processes and procedures. But the past review is not bringing about change for safety and standardized policies and procedures. As i said a year ago, what we have is a pattern of reoccurring issues of complacency and a lax culture of safety. Cdc corrector Freedman States this is a wakeup call but it appears the Snooze Button has been hit again. None of us want to be here again a year from now discussing another set of safety laps and heaven forbid a loss of life. The u. S. Accountability office is conducting work on high Containment Labs and go has been issuing recommendations for years requiring the strategy for high Containment Labs and the need for designing, structuring, commissioning and maintaining such labs yet the recommendation is not implemented which is one of the reasons we are here discussing another safety lapse threatening National Security and the Public Health. Today i would like to thank our witnesses for testifying here. I look forward to hearing from you. Please be forward with us as we learn about the procedures. This subcommittee will not relent on the compliance with select agent regulations and explore the possibility of an independent agency to oversee the labs. I recognize the Ranking Member from colorado. Thank you, mr. Chairman. You say you dont want to be back here in a year like last year but we have been here in 2007, 2009, 2014 and now 2015. So might as well mark your calendar now. And part of that is because it is important for the government to identify risk. But the work contains risk and that is why we have to contain oversight. I talked about the high Containment Lab we have in fort collins where we identified terrible lapses years ago and i worked with former colleague bob sheriff to get the built and i am proud of that. But we have to continue to make sure similar facilities across the country provide no risk to workers or the broader community. The details of the doug way incident do not inspire confidence. We are talking about a longterm series of shipments of live anthrax from the ground in utah which is one of the most sophisticated facilities in the world. This only came to light in may because of a private company contacting the cdc after discovering what it thought was activated anthrax was live anthrax. We are learns that 86 laboratories and seven Foreign Countries have received anthrax from doug way over the last 12 years. They transferred the live spores to an additional 106 labs. We are talking about almost 200 labs in all 50 states accidently receiving live anthrax for over a decade. No body seems to have fallen ill from these instances but i am worried this activity was going on for so long. I am eager to hear answers from dod on how this happened in the first place and what they are doing to make sure it doesnt happen again. The report released last week found insufficient Science Literature to develop protocols for the inactivation of spores. The doug way lab was relying on procedures that didnt sterilize the spores. This seems troubling. How have we conducted research on this dangerous pathogen without thoroughly understanding how to inactivate it . We need to see if we use similar protocols for other agents, and if so i think we can agree we need to seize those operations to avoid putting the public at risk. Dod has issued a stop on shipping anthrax from the labs. This seems like an important first step. But i do want to know how that affects the research the lab was doing. Do we need to have to 200 labs working with anthrax . Can we limit the number of labs and limit the risk while still being able to do the important research. I want to hear if the breakdowns are indicative of broader problems at this site or across the higher containment. The incidents we have seen recently raise questions about whether we can trust high Containment Labs to handle select agents. In the last year, we have seen an anthrax exposure at cdc improper shipment of avian flu and even a potential ebola exposure at a cdc lab. I feel lucky we have not had anyone infected but it could happen. I hope you have answered on what we are doing to make serious changes and include the recommendations goa has made. With that i yield back. Anybody else on this side wish to make Opening Statements or comments . If not an article appeared in the usa today and i would like you to look at that and ask for consent to submit to the record . This is titled cdc key lab Incident Reporting policy despite scrutiny and promises. Now i will recognize mr. Palone. Thank you. I hope we can get to the bottom of this incident. Deputy of defense secretary described the lapses as a quote massive institutional failure and i hope it can be explained how this occurred. I am deeply relieved no one has fallen ill as a result of the lapses and i am hopeful this remains the case as dod and cdc continue to track the labs that receive the samples. But this incident raises questions about the safety of high Containment Laboratories across the country. Every day hundreds of labs in the federal government and academic institutions and private companies handle dangerous pathogens under the federal select Agent Program. The labs perform important work and conduct research to improve our defenses against biological atta attacks and strengthening Public Health situations. Laboratories are require to restrict and imelement safe guards. They must make sure laboratories are trained on Safety Measures. They are subject to registration and inspections by the division of select agents and toxins. They are penalties associated with lapses and safety protocol and unauthorized use of agents is subject to penalties. Incidents involving ebola, avian flu and other diseases raises the question of needing to stregthen the Safety Measures. Is the current Regulatory Framework sufficient . Do they are resources to insure oversight is robust . What is the cdc doing to prevent slab situations in the future. I look forward to hearing about the findings and recommendations from those reviews and how they can be used to enhance safety and security at all of the high laboratories. I look forward to hearing from goa about the recommendations to strengthen Safety Measures across high Containment Labs. I hope we can learn from this latest incident and take seriously the important recommendations made by recent and ongoing investigations by goa and others to make this program safer. We look forward to conductive discussion on how we can improve oversight and what this committee can do to facilitate that process. Again, i thank the chairman and Ranking Member as we proceed. I yield back. The gentlemen yields back and with no further comments we will go to our witnesses. So as you are aware. When the committee is holding an investigation hearing takes the testimony under oath. Do any of the witnesses have objection to testifying under oath . Under the rules of the house and committee, your entitled to be advised by council, do you any of desire to be advised by counsel . Rise and raise your right hand. Do you swear the testimony you are about to give is the truth, the whole truth and nothing but the truth . All of the our witnesses have answered in the affirmative. You may now each give a five minute summary of your written statement. Pay attention to the lights there. We will start with dr. Hassell. Thank you, chairman murphy and Ranking Member deget te. I appreciate being able to talk about the shipment of live anthrax. I am the Deputy Assistant secretary of defense for chemical and biological defense. The use of inactivated or dead anthrax is important to develop ways to protect war fighters and the public from known biological threats. Doing this with the development and Testing Systems and diagnostic and decontamination policies. We learned of this on may 22nd, 2015 when we were alerted by a private company reporting the growth of living anthrax in a sample at the doug way ground in utah. The cdc started working with dod officials and the laboratories and fbi. All known laboratories that received activated anthrax samples has been notified to stop working with the samples. And the laboratories that produced and operated anthrax were directed to stop producing, shipping and working with any activated anthrax other than purposes related to this current matter. Tested identified other batches containing live spores and on june 2nd the department of defense notified all known recipients of activated anthrax from doug way to stop working with material whether it was confirmed to contain live anthrax or not. 31 u. S. Citizens, eight nondod and 23dod were placed on postexposure treatment that was completed yesterday. Returning to the subject of the four dod laboratories that produced activated anthrax, on may 29 the deputy of defense ordered all of them test anthrax in their inventory to identify the presence of live spores. The results are in and since 2003, the four laboratories made 149 batches of live anthrax spores. Of the 96 samples available to test, 17 tested positive for the presence of live anthrax all coming from doug way. We know over the past 12 years, 86 laboratories in 20 states, washington, d. C. And countries received directly from doug way inactivated samples with live spores. An additional 106 labs received secondary transfers from some of the 186 direct recipient labs bringing the total to 192 labs in all 50 states. We completed the root causes of the incident resulting in key findings including the key issue is lack of standards to guide the development of protocols, processes, and Quality Assurance measures. The result recommendations are grouped into enhance quality programs, establish testing protocols based on relative Scientific Data and improve program management. The department is committed to insuring this doesnt happen again and we will implement the recommendations in the report and outlined by deputy work on the 23 rd of july. We remain committed to transparency as we go forward. Thank you for the opportunity to testify today and i welcome your questions. I want to note we have not had a chance to review a lot of your testimony because it wasnt in until 9 oclock and the Committee Rules are we ask for 48 hours. So when we get to the testimony at the last minute it is difficult for us to review it. I dont want to think that cdc is trying to frustrate our purposes here but i want to indicate to you if you could pass the word on to cdc that for future testimony we want the 48 hour limit adhered to. We would like to hear from you for five minutes at this point. Chairman murphy, and Ranking Member and distinguished members of the subcommittee, thank you for the opportunity to testify. I would like to share what the cdc has done with the release of live anthrax from doug way proving ground and provide information on the Selective Program cdc supports. Cdc works 24 7 to save lives and protect people. We activated the Operation Center in the face and uncertainty of this. We understand how concerning this incident has been and the primary focus continues to make sure people are safe and the anthrax materials are secured and ultimately disposed it. This incident raises serious and challenging issues. It is important to note however that Scientific Research in laboratories is a vital component of our Nations Defense against naturally occurring diseases and bioterrorism. This research is complex and sometimes dangerous. While it is not possible to eliminate all risk, those of us working in this field across the country and around the world must do what we can to minimize risk. Here is what we know about the doug way incident today. There has been no suspected or confirmed cases of anthrax infection associated with the samples. Some risk and people who have accepted treatment will have complet completed antibiotics yesterday and no complications were reported. The facilities that received the samples appropriately securied r destroyed them. Highlighting this positive news is not meant to downplay the seriousness of the situation. On multiple occasions, over more than a decade the production methods failed to inactivate the spores. The failure was evident was growth was being deducted on the runs. The runs were sent back for radiation and it should have been seen as the indication the margin of safety with the method was not sufficient. And testing at doug way to confirm the activation failed to detect live spores. We have looked and found no evidence of a similar problem at other facilities that inactivate anthrax spores. The existing rules and regulations on anthrax spore and regulations are under review. We dont know the federal select Agent Program relies on testing to assure its agent can no longer grow. We are unsure if there is a problem with the execution of the testing at doug way or the biology wasnt understood to make the procedure reliable. Here is what we are doing moving forward. We are maintaining the moratorium on the use and transfer of spores until we have an incredible approach to increasing asafety and security. We are developing an agenda on spore biology to answer questions about activation and help to conduct that research. At the doctors direction, we are initiating a review of the cdc select program and it will co compliment ongoing work. There is a thorough review of the program to make sure it is meeting mandets. The world benefits from discoveries made working with dangerous pathogens and science who work with the pathogens have a commitment to the Public Health and safety. We must achieve balance to protect the community and encourage and support advancement. But safety comes first. One characteristic of the cdc stewardship of the federal Celebrity Agency program is the commitment to improvement. The regulations have been refined with advice from many including review bodies and the public leading to revisions concerning personal reliability, Incident Reporting, coordination of inspections with federal partners, and tracking shipments of select agents. Although much work has been done to enhance the effectiveness of the cdc Regulatory Oversight more work needs to be done. Where improvements can be made, we will make them. Where there is disagreement on the best path forward we will contribute to the debate. We will work diligently and thoughtfully with anyone sharing the commitment to protect americans from biological threats. Thank you. Mr. Demske recognized for five minutes. Good morning, i am greg demske, chief counsel at the department of health and New Hampshire<\/a> leader along with media organizations are sponsoring the forum. Following the forum, you can provide your input by calling our callin program. Road to the white house 2016, cspan, cspan radio and cspan. Org. On tuesday, officials from the defense department, cdc and health and Human Services<\/a> testified on capitol hill in regard to shipments of live sports of anthrax. Received live anthrax. This is a live interview. It is just over two hours. Two hour hearing. Good morning, welcome to our hearing dealing with anthrax once again. The subcommittee examines continue concerns over the federal agent select program with the focus on shipments of live anthrax from the department of Defense Laboratory<\/a> that occurred over a ten year period. As last year we held a similar hearing that proposed dozens of cdc researchers to live anthrax due to safety procedures not being followed. The cdc director testified quote we will take every step possible to prevent any future incident that will put our Laboratory Scientist<\/a> and public at risk. Yet, here we are again. We examine the mistake of avian flew and the vials of small pox in the nih building months after the hearing and after the white house ordered safety stand down the cdc revealed there was a transfer of ebola from a cdc four lab to a cdc two lab. And despite the growing number of red flags these incidents keep happening. We learned an army lab in utah shipped anthrax to facilities across the globe. At least 192 labs have received shipments of the anthrax. The testing used to validate and insure the anthrax spores were not active failed to detect the live anthrax spores. What is most troubling is that doug way used this potentially deadly process for years. This is unacceptable. It is threatening the Nation Security<\/a> and Public Health<\/a>. The committee hopes to learn what is being done to prevent future safety lapses. The internal review of the circumstances surrounding the shipments of anthrax and according to the report the dod was unable to determine the root cause of how and why doug way labs shipped anthrax. It is said all of the labs operate outside of the experimental data. In other words, it seems the department of defense labs have been eradiating larger numbers of spores given. This revelation begs a lot of questions beginning with why. And why for so long . Who was responsible about making the decision on which ina inactivation process to use . And what is the cdcs role in developing the processes . According to a recent and all too familiar headline, cdc announced it will conducting another review of how it regulates safety and security at bio terror labs. I think it is important to improve current regulations for processes and procedures. But the past review is not bringing about change for safety and standardized policies and procedures. As i said a year ago, what we have is a pattern of reoccurring issues of complacency and a lax culture of safety. Cdc corrector Freedman States<\/a> this is a wakeup call but it appears the Snooze Button<\/a> has been hit again. None of us want to be here again a year from now discussing another set of safety laps and heaven forbid a loss of life. The u. S. Accountability office is conducting work on high Containment Lab<\/a>s and go has been issuing recommendations for years requiring the strategy for high Containment Lab<\/a>s and the need for designing, structuring, commissioning and maintaining such labs yet the recommendation is not implemented which is one of the reasons we are here discussing another safety lapse threatening National Security<\/a> and the Public Health<\/a>. Today i would like to thank our witnesses for testifying here. I look forward to hearing from you. Please be forward with us as we learn about the procedures. This subcommittee will not relent on the compliance with select agent regulations and explore the possibility of an independent agency to oversee the labs. I recognize the Ranking Member<\/a> from colorado. Thank you, mr. Chairman. You say you dont want to be back here in a year like last year but we have been here in 2007, 2009, 2014 and now 2015. So might as well mark your calendar now. And part of that is because it is important for the government to identify risk. But the work contains risk and that is why we have to contain oversight. I talked about the high Containment Lab<\/a> we have in fort collins where we identified terrible lapses years ago and i worked with former colleague bob sheriff to get the built and i am proud of that. But we have to continue to make sure similar facilities across the country provide no risk to workers or the broader community. The details of the doug way incident do not inspire confidence. We are talking about a longterm series of shipments of live anthrax from the ground in utah which is one of the most sophisticated facilities in the world. This only came to light in may because of a private company contacting the cdc after discovering what it thought was activated anthrax was live anthrax. We are learns that 86 laboratories and seven Foreign Countries<\/a> have received anthrax from doug way over the last 12 years. They transferred the live spores to an additional 106 labs. We are talking about almost 200 labs in all 50 states accidently receiving live anthrax for over a decade. No body seems to have fallen ill from these instances but i am worried this activity was going on for so long. I am eager to hear answers from dod on how this happened in the first place and what they are doing to make sure it doesnt happen again. The report released last week found insufficient Science Literature<\/a> to develop protocols for the inactivation of spores. The doug way lab was relying on procedures that didnt sterilize the spores. This seems troubling. How have we conducted research on this dangerous pathogen without thoroughly understanding how to inactivate it . We need to see if we use similar protocols for other agents, and if so i think we can agree we need to seize those operations to avoid putting the public at risk. Dod has issued a stop on shipping anthrax from the labs. This seems like an important first step. But i do want to know how that affects the research the lab was doing. Do we need to have to 200 labs working with anthrax . Can we limit the number of labs and limit the risk while still being able to do the important research. I want to hear if the breakdowns are indicative of broader problems at this site or across the higher containment. The incidents we have seen recently raise questions about whether we can trust high Containment Lab<\/a>s to handle select agents. In the last year, we have seen an anthrax exposure at cdc improper shipment of avian flu and even a potential ebola exposure at a cdc lab. I feel lucky we have not had anyone infected but it could happen. I hope you have answered on what we are doing to make serious changes and include the recommendations goa has made. With that i yield back. Anybody else on this side wish to make Opening Statements<\/a> or comments . If not an article appeared in the usa today and i would like you to look at that and ask for consent to submit to the record . This is titled cdc key lab Incident Reporting<\/a> policy despite scrutiny and promises. Now i will recognize mr. Palone. Thank you. I hope we can get to the bottom of this incident. Deputy of defense secretary described the lapses as a quote massive institutional failure and i hope it can be explained how this occurred. I am deeply relieved no one has fallen ill as a result of the lapses and i am hopeful this remains the case as dod and cdc continue to track the labs that receive the samples. But this incident raises questions about the safety of high Containment Lab<\/a>oratories across the country. Every day hundreds of labs in the federal government and academic institutions and private companies handle dangerous pathogens under the federal select Agent Program<\/a>. The labs perform important work and conduct research to improve our defenses against biological atta attacks and strengthening Public Health<\/a> situations. Laboratories are require to restrict and imelement safe guards. They must make sure laboratories are trained on Safety Measures<\/a>. They are subject to registration and inspections by the division of select agents and toxins. They are penalties associated with lapses and safety protocol and unauthorized use of agents is subject to penalties. Incidents involving ebola, avian flu and other diseases raises the question of needing to stregthen the Safety Measures<\/a>. Is the current Regulatory Framework<\/a> sufficient . Do they are resources to insure oversight is robust . What is the cdc doing to prevent slab situations in the future. I look forward to hearing about the findings and recommendations from those reviews and how they can be used to enhance safety and security at all of the high laboratories. I look forward to hearing from goa about the recommendations to strengthen Safety Measures<\/a> across high Containment Lab<\/a>s. I hope we can learn from this latest incident and take seriously the important recommendations made by recent and ongoing investigations by goa and others to make this program safer. We look forward to conductive discussion on how we can improve oversight and what this committee can do to facilitate that process. Again, i thank the chairman and Ranking Member<\/a> as we proceed. I yield back. The gentlemen yields back and with no further comments we will go to our witnesses. So as you are aware. When the committee is holding an investigation hearing takes the testimony under oath. Do any of the witnesses have objection to testifying under oath . Under the rules of the house and committee, your entitled to be advised by council, do you any of desire to be advised by counsel . Rise and raise your right hand. Do you swear the testimony you are about to give is the truth, the whole truth and nothing but the truth . All of the our witnesses have answered in the affirmative. You may now each give a five minute summary of your written statement. Pay attention to the lights there. We will start with dr. Hassell. Thank you, chairman murphy and Ranking Member<\/a> deget te. I appreciate being able to talk about the shipment of live anthrax. I am the Deputy Assistant<\/a> secretary of defense for chemical and biological defense. The use of inactivated or dead anthrax is important to develop ways to protect war fighters and the public from known biological threats. Doing this with the development and Testing Systems<\/a> and diagnostic and decontamination policies. We learned of this on may 22nd, 2015 when we were alerted by a private company reporting the growth of living anthrax in a sample at the doug way ground in utah. The cdc started working with dod officials and the laboratories and fbi. All known laboratories that received activated anthrax samples has been notified to stop working with the samples. And the laboratories that produced and operated anthrax were directed to stop producing, shipping and working with any activated anthrax other than purposes related to this current matter. Tested identified other batches containing live spores and on june 2nd the department of defense notified all known recipients of activated anthrax from doug way to stop working with material whether it was confirmed to contain live anthrax or not. 31 u. S. Citizens, eight nondod and 23dod were placed on postexposure treatment that was completed yesterday. Returning to the subject of the four dod laboratories that produced activated anthrax, on may 29 the deputy of defense ordered all of them test anthrax in their inventory to identify the presence of live spores. The results are in and since 2003, the four laboratories made 149 batches of live anthrax spores. Of the 96 samples available to test, 17 tested positive for the presence of live anthrax all coming from doug way. We know over the past 12 years, 86 laboratories in 20 states, washington, d. C. And countries received directly from doug way inactivated samples with live spores. An additional 106 labs received secondary transfers from some of the 186 direct recipient labs bringing the total to 192 labs in all 50 states. We completed the root causes of the incident resulting in key findings including the key issue is lack of standards to guide the development of protocols, processes, and Quality Assurance<\/a> measures. The result recommendations are grouped into enhance quality programs, establish testing protocols based on relative Scientific Data<\/a> and improve program management. The department is committed to insuring this doesnt happen again and we will implement the recommendations in the report and outlined by deputy work on the 23 rd of july. We remain committed to transparency as we go forward. Thank you for the opportunity to testify today and i welcome your questions. I want to note we have not had a chance to review a lot of your testimony because it wasnt in until 9 oclock and the Committee Rules<\/a> are we ask for 48 hours. So when we get to the testimony at the last minute it is difficult for us to review it. I dont want to think that cdc is trying to frustrate our purposes here but i want to indicate to you if you could pass the word on to cdc that for future testimony we want the 48 hour limit adhered to. We would like to hear from you for five minutes at this point. Chairman murphy, and Ranking Member<\/a> and distinguished members of the subcommittee, thank you for the opportunity to testify. I would like to share what the cdc has done with the release of live anthrax from doug way proving ground and provide information on the Selective Program<\/a> cdc supports. Cdc works 24 7 to save lives and protect people. We activated the Operation Center<\/a> in the face and uncertainty of this. We understand how concerning this incident has been and the primary focus continues to make sure people are safe and the anthrax materials are secured and ultimately disposed it. This incident raises serious and challenging issues. It is important to note however that Scientific Research<\/a> in laboratories is a vital component of our Nations Defense<\/a> against naturally occurring diseases and bioterrorism. This research is complex and sometimes dangerous. While it is not possible to eliminate all risk, those of us working in this field across the country and around the world must do what we can to minimize risk. Here is what we know about the doug way incident today. There has been no suspected or confirmed cases of anthrax infection associated with the samples. Some risk and people who have accepted treatment will have complet completed antibiotics yesterday and no complications were reported. The facilities that received the samples appropriately securied r destroyed them. Highlighting this positive news is not meant to downplay the seriousness of the situation. On multiple occasions, over more than a decade the production methods failed to inactivate the spores. The failure was evident was growth was being deducted on the runs. The runs were sent back for radiation and it should have been seen as the indication the margin of safety with the method was not sufficient. And testing at doug way to confirm the activation failed to detect live spores. We have looked and found no evidence of a similar problem at other facilities that inactivate anthrax spores. The existing rules and regulations on anthrax spore and regulations are under review. We dont know the federal select Agent Program<\/a> relies on testing to assure its agent can no longer grow. We are unsure if there is a problem with the execution of the testing at doug way or the biology wasnt understood to make the procedure reliable. Here is what we are doing moving forward. We are maintaining the moratorium on the use and transfer of spores until we have an incredible approach to increasing asafety and security. We are developing an agenda on spore biology to answer questions about activation and help to conduct that research. At the doctors direction, we are initiating a review of the cdc select program and it will co compliment ongoing work. There is a thorough review of the program to make sure it is meeting mandets. The world benefits from discoveries made working with dangerous pathogens and science who work with the pathogens have a commitment to the Public Health<\/a> and safety. We must achieve balance to protect the community and encourage and support advancement. But safety comes first. One characteristic of the cdc stewardship of the federal Celebrity Agency<\/a> program is the commitment to improvement. The regulations have been refined with advice from many including review bodies and the public leading to revisions concerning personal reliability, Incident Reporting<\/a>, coordination of inspections with federal partners, and tracking shipments of select agents. Although much work has been done to enhance the effectiveness of the cdc Regulatory Oversight<\/a> more work needs to be done. Where improvements can be made, we will make them. Where there is disagreement on the best path forward we will contribute to the debate. We will work diligently and thoughtfully with anyone sharing the commitment to protect americans from biological threats. Thank you. Mr. Demske recognized for five minutes. Good morning, i am greg demske, chief counsel at the department of health and Human Services<\/a> and appreciate the opportunity to discuss the federal select Agent Program<\/a>. Oig is authorized to impose penalties for violations of the regulations, and we audit and offer suggestions for improvement. Cdc reviews all matters and refers criminal matters to the fbi. In other matters, they determine whether to exercise to suspend or revoke registration or require action. If cdc concludes a civil violation occurred, it refers to the case to oig for potential enforcement. Oig calculates over referral and deci decides to percue the case and what penalties to seek in light of the particular case. Violations of the regulations pose bearing risks to Public Health<\/a> and safety. To date, oig has imposed violations totaling 2. 4 million with two cases involving doug way. In april 2007, doug way shipped anthrax to a reResearch Facility<\/a> with certification the anthrax was nonviable. The Research Facility<\/a> tested and found a low concentration of anthrax and we found doug way ignored the test showing viable anthrax was present. Later in november 2010, a Government Laboratory<\/a> received a shipment with a vile of bot botchlism. The slip said it contained an x exempt amount but it was wrong. Doug way presents an enforcement challenge for oig. Any cpt would shift money within the government at a net cost to taxpayers and may not promote better compliance. Oig issues notice of violation letters to doug way for both cases. Both letters stated that oig determined doug way violated the regulations and should examine current policies and take corrective action and monitor safeguards. Oig received another referral on doug way and we are reviewing that now. They audited Government Agencies<\/a> for compliance and provided six results to the heads of the relevant federal agencies putting them on notice of deficiencies. Oig is expanding the audit of select management and we will focus on cdcs oversight of the program and on the operation of hss laboratories that handle select agents. Through our enforcement work, oig identified several opportunities to improve compliance, oversight and enforcement. As reflected in the written testimony, the opportunities focus on enhance documentation requirements and increased authority for cdc inspectors. We stand ready to work with cdc and others in hss to improve the select Agent Program<\/a>, use enforcement tools to promote compliance with regulations that protect the American People<\/a>. Thank you for inviting me to speak. Dr. Crosse, you are recognized for five minutes. Chairman, Ranking Member<\/a>, and members of the subcommittee i am pleased to be here to discuss the work on high Containment Lab<\/a>oratories. The bio safety and security practices are intended to prevent exposure and their loss, theft or misuse. The recent shipment of live anthrax from dod to International Laboratories<\/a> similar to last years potential exposure of cdc personal to live anthrax bacteria shows multiple breakdowns in compliance with established policy and inadequate oversight of federal Containment Lab<\/a>oratories. This is another example in the ongoing series of safety lapses that continue to occur with the same root cause for prior incidents. We have been lucky so far. Researchers in these labs work with high risk biological agents that may result in serious or lethal infections and have the potential to be used in biological weapons. The laps develop vaccines and Counter Measures<\/a> and understand emerging Infectious Diseases<\/a>. However the pathogens have the potential for high consequence accidents. If the types of mistakes we have seen were to occur with a particularly transmissible pathogen like strains of influenza not only would have the Laboratory People<\/a> be at risk but an epidemic could be triggered with consequences far beyond what we have seen. Goa is conducting work to examine the issues and the preliminary work is showing dod and cdc has begun to address the we weaknesss but not fully implemented them. They are indended to address flaws in the over sight structure, reporting and tracking after the incidents occurred. Dod officials said the doug way incident is the first incident dod has tracked at the Senior Department<\/a> level. Since 2012, dod has been revi revisevising revising policy requirements and expects to finalize them by the fall but they only contain a subset of the dod laboratories. Our ongoing work will examine if dod is implementing steps intending to improve the culture of safety at the laboratories so future events are reduced or prevented. Similarly, cdc began taking steps to address weaknesses identified in assessments of the june 24th anthrax incident and other Safety Incidents<\/a> in their own laboratories. But the agency has not yet completed recommendations intended to improve the laboratory oversight. For example, an internal work Group Recommended<\/a> that cdc develop agency wide policies to develop clear requirements for bio safety for all laboratories. In response, cdc developed a specimen transport policy but not other requirements such as requirements for Laboratory Documentation<\/a> and emergency protocols. As i stated at the outset, the incidents you are examining today are part of a long sears of safety lapses. Goa has reported on the issues since 2007 making multiple rem recommendations. The federal departments agreed with our recommendations and have conducted some activities to respond but not implemented our key recommendation of establishing a key oversight of all laboratories. We recommended the establishment of a single federal enti temperatuentity to conduct planning for containment of the laboratories including assessments of their risk and two develop National Standards<\/a> for designing, commissioning, operating and maintaining such laboratories. We continue to believe that such an entity or another mechanisms to insure higher level oversight is needed into the face of the continuing proliferation of high Containment Lab<\/a>oratories and the ongoing failures by the agencies to fix their problems on their own. In closing, the lapses are indicative of failures in the system that is supposed to have multiple levels of control including cross checks, inspections, training, procedures and validated protocols that should prevent such accidents from occurring and should certainly prevent such incidents from reoccurring. This completes remarks and i would be happy to answer questions you or other members may have. Thank you. I recognize myself for five minutes of questions for the witnesses. Dr. Sosin, you said you would work to prevent everyone from threats. Please let the cdc know i dont believe them anymore. The usa today article i referenced earlier today said the cdc refused to produce a policy to usa today regarding the lab reports and the lab safety office. When was that report written actually . Do you have any idea . Thank you, chairman. I was asked to appear and apologize for the lateness of testimony do you know anything about the report they are referring to in usa today . I know the article came out last night. I do not know about the report. I would be map happy to provide answers after the hearing. This committee would like that report and to know when it was written. That would be valuable to have. Thank you. If i put a cup of coffee in a microwave it gets hot in a certain amount of time. If i put a dozen in a microwave and heat it at the same time it will not all be heated. We know that about radiation and mass. I believe this is on the report and on the graph here as well on the screen. The very upper left dot where it says the doug way levels are operating way out of the realm of the acceptable processes here and the report states that dod routinely operates from the data. Based on the finding, it sounds like experimental data does exist and all of the labs involve the activation of anthrax were operating outside of that. Is that correct . Yes, sir. Who is responsible for setting the number of spores and dozes of radiation . Are the protocols reevaluated to determine that routinely . This original review was focused on compliance to make sure people were following the protocols they had and show there was a willful disregard. You said it was willful . It wasnt willful or nefarious but they are working outside of the box showing it should have been the foundation for the work. The next step is looking at the very accountability issue. How is that decision made to move outside of the realm . As you noted, it doesnt just doug way. All of the labs were outside of that area. That is something we need to know. We like to think there is a scientific rule setup that they are following and all of the labs are following that, too. So let me ask, doctor hassell and sosin, have any of your agencies made personal changes or referred anyone for criminal prosecution for these actions . Have any one of our agencies done that . For dod, that is the second part of the investigation that would kick off now looking at the accountable issue to determine that. 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 gradually get outside of the experimental box. The accountability is taken seriously by all seniors in the department. Dr. Sosin . We understand your concern and take it seriously. No disciplinary action has been taken with respect to the dod sample. Cdc staff responded to make sure all of the samples were destroyed and the people might have been exposed were protected. Regarding the select Agent Program<\/a>, we consider to take advice and input on changing the nation of the program. Does the cdc work with other labs setting and reviewing standards on any regular bases or at all . The cdc works with dod in a variety of ways with regard to this . The reason is when we had our hearings with General Motors<\/a> and someone made the decision of making the spring this big or this big and cost the number of supplies and they refer to it as the gms incident. We are not looking for something deliberate here, i agree, but letting things slip by over time is a problem. As pointed out, luckily no one died from this. But we really have dodged a bullet for a long time. I recognize ms. Degette for five minutes. You talked about people being infected and even an epidemic could be started if you got a particular agent released, correct . Correct. We have national stuart issues relating to the mishandling of the agents. Is that also correct . That is also a concern. That is if these active agents got into the the wrong hands, right . That is recognize. You have a lot of recommendations that have not been fully implemented, right . Many of the recommendations they have taken action but the primary one with no movement is more centralized oversight. Having a single federal entity setting starboandards fol of the agencies, right . That is right. Doctor hassell what is your agencies opinion on a federal entity in i will say within the department we will do that internally. If it makes sense in many ways why havent you guys implemented that in cooperation with your fellow agencies . Like i said, we are going to do that internally. We are in discussions now on these issues. But you dont disagree with the idea . No, maam. What about you, dr. Sosin . What is your agency view of this . The cdc works with usda as if we are one program. We work very closely doing joint inspections on overlap agents whenever a change is considered in one program it is discussed with the other program. That is nice. But what about dod . So the oversight function of the lab i will trying to understand your question. I believe that is oversight function. What dr. Crosses agencies is recommending one single Oversight Agency<\/a> that would set forth the protocols for the dispensing of these agents. And so i am asking each of your agencies if you would object to that kind of it would make sense to get one protocol no matter which lab is dispensing it. What is your view on that . Thank you. My view is that it is a complex decision. There are constraints to having one standard for all procedures. What would those be . For example, with anthrax, there are many different uses of the product. Dna for developing vaccines if you are sending it around you dont want it to be live. That is not something to subject to debate. If you could have one agency coming up with protocols about oversight on how you will make it not be life and dispense it you would not object to that . I would not object and believe the select Agent Program<\/a> would be the appropriate body to do that. Could that have oversight over the dod, too . Absolutely. Do you think you might cooperate to make that happen . We will cooperate in any way. Let us know what we can do help you. It seems that is an excellent recommendation. I stated in the statement we definitely are working together. Now, here is Something Else<\/a> having been on this committee for a long time i have noticed this at all of the federal labs. Not just the one dealing with federal agents but the nuclear labs have it same culture of safety. We struggle 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 make a culture of safety . That is a question i have myself. I spent ten years at the Dupont Company<\/a> making gun powder and that Safety Culture<\/a> is there. I plan to go out and see if there is industry best practices how long have you been there . At dod. Just at a year today. And dr. Sosin, do you have ideas of increasing a Safety Culture<\/a> . I personal dont. I know the director developed a series of questions that the evolve. We need you to supplement your testimony about this. I would like a written answer tr this. I would like to know why all of the problems in this particular incident seem to have come out of this one lab. Was it a problem with how they were handling the anthrax, trying to treat it, or is it a problem with the procedure itself. This subject is foreign to me. I look forward to trying to learn on your questions. I am trying to go back it the fundamentals. Why would see ship an inactive cell to laboratories . What would you gain by shipping something that is dead . One of the asspects of this inactivated anthrax is it maintains the shells around the live spore, the physical structure is there. That is important because that is the bases for the detection systems and the diagnostic systems developed. The closer to that the better we are. Lets go back to something that was mentioned. We are doing this in 200 laboratories across the country . We have live anthrax in 200 laboratories . The statement is 192 labs received this. There are that many registered to poses user transfer. I struggle to understand we we have to have 200 looking at this. I really especially given the circumstances of this. How would you grade the dod handling of this . Would you give an a . An f . Since the incident was reported they have moved quickly to identify where the samples were sent. How would you grade it . Passing . Acceptable . A b or c . I think the response since discovered probably a b. I think leading up to this and the fact it went on so long is a failure. You said it has been going on ten years . Yes, that is a failure and the fact they have four laboratories activating anthrax with four different methods and four different chains of commands that dont talk to one another. Going back to dr. Hassell, since anthrax is the most dangerous agent we can handle. I suppose more dangerous than ebola. Getting that is probably the biggest threat. In this case, has anyone tried to grow the anthrax after receiving the products with 200 laboratories . Have they tried to reactivate it . It was grown to show the presence of the life spores. Is this the same type of anthrax used in 2001 . It is absolutely not the same type of anthrax used in 2001. This was in a liquid formation with small numbers of spores and one ml sample. Very different situation. None the less taken serious. This is different. Do you feel our National Security<\/a> is more at risk because of the process we have been handling this . I dont believe that these samples created such a risk. I believe they were secured quickly and destroyed and very small numbers of spores n this material and it is naturally occurring type of anthrax. It is often said that my thought process initially why were we shipping this to seven foreign nations . Was there is someone having a written authorization . Is there a proverbial emails someone was requesting this and who authorizes the shipment of that . Under what process do they explain how they want to get it . Why would we ship to seven foreign nations . In several cases, they were dod facilities located in those foreign nations. In other cases, they were allies. We dont have enough dod facilities in america we have to i am running out of time. I recognize mr. Greene for five minutes. Thank you, mr. Chairman. Unfortunately the incident that led to todays hearing is not the first instance of handling and shipment of agents at doug way grounds. Cdc and the office of Inspector General<\/a> examine safety lapses at doug way in 2007 and the result was the same kind of problems we are hearing about today failing to properly inactivate specimens. Is that correct . Yes. Based on the previous problem, should doug way have made a better effort to double check the procedure to see if it worked . That is my initial impression and we will look up on that more and report back. The cdc announced they transferred live anthrax the dod direct the lab to check their prone process to insure anthrax was inactivated properly . No, sir. Why not . What is dod doing to look at its policies and procedures . Look ate undertaking a the chain of command. It is desperate right now. We are trying to tighten that up. We are looking at the standards. We are looking to see that it is standardized across all of the laboratories. All four of those facilities do different activities. We have a production facility, the others are research facilities. There are lessons we can learn from this. Wherever possible we will standardize. Thatw is dod ensuring these concerns will be communicated to the Senior Leadership<\/a> . Some of the recommendations that were made previously. We will be more vigorous about these. Instruction that was mentioned earlier. Include aspects that will bring all of the reporting forward to a higher level. The 2007 incident, that will not if that happened today, it would come all the way up to the Central Office<\/a> in the department. We are in the process now of pulling and all of the Inspector General<\/a> reports in cdc reports from all of the laboratories to my office and we are reviewing all of them to see if there are indicators and lessons to be learned. Far, we have been extremely fortunate that these incidents have not led to broader Public Health<\/a> or security problems. I hope that this ongoing oversight of these issues will be a called action to tighten up these procedures. Not just for anthrax but other select agents and at all facilities. We do not want to have someone here again. Mr. Chairman, i yield back my time. I recognize dr. Burgess for five minutes. Thanks to our witnesses for being here today. Basically, i have questions about how we are hardening our Public Health<\/a> infrastructure where these agents may be under study. We have heard a recurring theme. I have been on this committee for a number of years. It seems like there is a recurring thing. We want everything to be perfect but there are human beings involved and sometimes they are not perfect. I was areading regular guy in private practice when the anthrax attack occurred. What happened when those five individuals were infected and subsequently died. I remember reading about their emergency room doctors experience. Here was a guy that did not look that sick. As we found out with anthrax, you can be a lot sigrid than what you look and by the time clinical studies can occur, it is almost too late to rescue them. Unlike ebola, anthrax is treatable with relatively common antibiotics. Bearing in mind that ebola experience from not quite a year us last was telling july that we had everyone up to speed about ebola. The president made a statement that we did not have to worry about ebola coming to this country because cdc has done everything it needs to do to be prepared. It did not happen. This is not quite the same thing but you know your sites where this is under study. You know that unfortunately lapses can occur. The you have a 35 or 50 mile radius around the site where you are notifying the people on the front lines, the Emergency Rooms<\/a> and doctors, that this is something we are working on in the community . Thank you for that question. First, with respect to hardening infrastructure. Yes. Atre are support programs the state and local level to address anthrax and other bioterrorism threats. As you pointed out. There are not only routine treatments but advanced countermeasures such as antitoxin to treat later stages of anthrax. They were brought to bear. Bioticsine and anna were brought to bear. Antibiotics were brought to bear. The state authorities are informed about the institutions and their jurisdictions and the agents that are there as part of their Public Health<\/a> preparedness program. There is no active outreach to the medical community. We are quick to respond as we did in this instance with information about how to diagnose, watch for, monitor, and treat. Not sent to the Emergency Departments<\/a> than we did consider that they were monitoring of a lot of tories closely into the materials were sent to the laboratories and state health department. Thats the point. They thought that they were getting activated strains and they werent active so somebody leaves work for the weekend and has a lowgrade temperature and doesnt feel right. They were isolated and working directly with the Laboratory Workers<\/a> in Health Departments<\/a> to monitor that. If the problem was you didnt know at that point and certainly the people in the community that they have been the doctors in curses and caregivers wouldnt have known that this is what they were up against. My concern is how do they get that information out there and make people aware once you know that anthrax is in the consideration, fair enough but before you know they look like the last 1500 patients with a firehose and drum. I do have a question that i want to ask and if 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 the federalists to cdc, nih presided states Army Medical Research<\/a> institute of Infectious Diseases<\/a> seem to be the top three so you have in enforcement policy but you dont find federal agencies is that correct . To date we have not the correct. But you rob banks because thats where the money is. Right now the violators seem to be coming from those three groups, who can you get back to writing and discuss what you are doing to consider providing the same as any other lab in the country would have to face. Hispanic to be cleared most of the referrals have been referred to us did not involve federal entities but thereve been repeated instances and we would be happy to provide you an answer. The multiple offenders. You are recognized for five minutes. Weve heard about the importance of keeping them safe and secure how the labs both private and public have failed to meet the critical Safety Standards<\/a> and regulations and how they are held accountable. Both the cdc and the hhs through the office of Inspector General<\/a> had roles in enforcement. The division of the select agents and can refer entities to the office of Inspector General<\/a> for the Civil Penalties<\/a> or the notice of violation. The cdc could read denied registration or require them to enter the Performance Improvement<\/a> plan. Criminal charges could also be made in the cases of misuse or unauthorized transfer. Can you walk us through the different options and how you determine the appropriate response for any given violation . You have correctly pointed out the administrative options to suspend, deny or revoke. The registration process is intended to screen and assure that there is Good Laboratory<\/a> practice into the appropriate use for the select agents material so that process and other steps in the program are intended to assure a. Is one taking. It is one taking very seriously the importance of balance for the nature that you are talking about here these are important bio defense facilities to work collaboratively on the specific problems to address them, but those are options of the referral to the fbi and the suspicious activity or the referral. Thank you. When we receive a referral, one of our attorneys will review the allegations and findings and will often consult with scientists and experts. It is the subject of the matter and it gives them the opportunity to provide us information or arguments about why the penalty would be appropriate. We take that into account in consultation to decide whether to go forward with the case and we look at the cases we have to make had to make a judgment about what we think the case should be valued at. Do your officers routinely Work Together<\/a> to take action against those that are in violation . We certainly communicate and Work Together<\/a> from our perspective to make sure that we understand the science matters to go forward. What types of violations would result in a lab losing its registration . I can tell you that process of revoking the registration is one that is undertaken through careful efforts to help the laboratory address the concerns and then prove the revocation would come only after the inability of the facility to make those changes to no longer be interested in doing that work. I can get a further clarification of the specific measures if you would like. In your opinion how often has that happened . Spirit i believe that its happened two times. I can get you the same number. I would like to get a sense of the frequency and actions to address them. Are you seeing any trends that at the cdc in terms of the Enforcement Actions<\/a> can any trends in the referral to the office of the Inspector General<\/a> or improvement plans quick the federal select Agent Program<\/a> is evil thing and its approaches and tools such as the corrective action process is relatively new and evolving so the trend is our hard to evaluate and another request of the Enforcement Actions<\/a> have been laid out in the response and should have the kind of information that you would be looking for. If you could perhaps feed a the panel with the same trend that you any trends that you cite that would be helpful. We now recognize ms. Blackburn for five minutes. I want to come to you if i may. I got a copy of the testimony from back in the last year, and he was testifying about the june june 2014 anthrax incident. He said, and im going to read from the testimony it should never have happened it was totally unacceptable. We will explore the broad implication and incorporate the Lessons Learned<\/a> to proactively prevent future incidents as at laboratorys that work with pathogens. So, i want to know can you explain why we didnt seem to learn the lessons and can you talk about why there is another comprehensive review of safety and security. Why is another review necessary or the problems at the cdc are not corrected. If i need refreshing pardon me. I would be happy to refresh. Its important to recognize it as an ac dc isnt a cdc laboratory itself. It functioned separately. Nonetheless in hindsight there has been a reason to look more closely at anthrax activation. If that is necessary and before the moratorium on the use and transfer of the materials will be lifted we will have a policy about how to validate wait a minute. That was supposed to be done. Why was it not done . Who is responsible but it they didnt get it tended to last you a the work of a complex laboratory, Microbiological Laboratory<\/a> has thousands of procedures and but no one person is in charge and its done by the committee. The current nature of the federal select Agent Program<\/a> is one of setting broad standards to achieve high Laboratory Performance<\/a> but does not review each individual specific procedure at each entity. Do they call for notifying the congress . Im sorry quick do they call on congress if you need to do a review and if you have another incident so thats not a part of business process click i apologize if congress wasnt notified reviewing. We take effect of the program at the cdc. That isnt a review of the labs and procedures, it is of what opportunities with me ask this way going back to the testimony where he says it never should have happened, lack of adequate procedures, unacceptable, going to the process in place and incorporate the Lessons Learned<\/a> how why was this not done lest you . Many things were done but this was not addressed. So it was not addressed. That is the answer i wanted, yes or no. Either it was done or it was not done and that is what we want to know. Part of why it is so frustrating to the taxpayers that are footing the bill for that because you will feel like you have any entity if he will any entity if you will and you dont do the job until it is convenient. So if you mess up twice you visit 86 times and its no skin off your back because nobodys responsible because you operate by the committee because we ask you to do something and report back to us what you do consider them did say we will get to it later maybe we need to get around to it and get the job done. The fact that we are having another hearing and look at this is something that is frustrating you should realize that there was a mistake and shut the correct procedures and policies and then should change the way that things are done and i know im running out of time and i will yield back. It is important to clarify the cdc is was addressed and it was a different situation. What i did acknowledge is that as the program with inactivation we should have and will address before that is used again. In the protocol the dod review concluded that one of the problems of the incident was scientific uncertainty about the process of inactivating anthrax. The review stated this instance only released questions about the inadequacy of the procedures and the department knew of this for quite a while. If the department was aware of the potential inadequacy of the inactivation process using radiation, why didnt the department have the better verification procedures to ensure they were properly inactivated before shipping. There were two issues involved one must be activation and the other was to validate the viability testing that they didnt catch that the first was not 100 effective. The review journals in the scientific richer have shown different what we call the debt curbs for revealing anthrax and what we need to do now is to try to pull this together to get a consensus view and work with a body of subject Matter Experts<\/a> and the cdc to try to figure out which why didnt you do that before if you knew that uncertainty for a while click it appears it was somewhat localized. It wasnt universally acknowledged. Each one set its own standards so this wasnt raised up and those standards were not acceptable . Going forward it will have to be done in concert. Are again reviewing all the protocols and procedures to ensure that there are not similar gaps in the scientific literature for the other dangerous toxins into pathogens . We will be doing that. How confident are you people will take that seriously the gaps in science and discrepancy how do you come to reconcile . Taking what is going to have been specifically in that review in the activation. In the difference of opinion whos been to be the responsible party we can go back and say we have this hearing and other agencies said we would address these gaps but if and when we have to have another hearing who is it that we will identify if we can provide to the committee because there is a problem with no personal accountability. Why is there such variation as to how they can activate anthrax quick thank you for the question. As mentioned earlier theres a number of needs for the material that come from that at anthrax and the proficiency testing have different purposes as well so the cdc historically required a validated procedure either published and followed or validated within the laboratory and has proven that testing. I think to the earlier question about accountability, the exemption of a select agent anthrax becoming now exempt is the requirement of the federal select Agent Program<\/a> and until we have a procedure that increases confidence that we can safely do that but you can see that we are very concerned we do accept the various activation protocols and how do we address the . As it was pointed out the nature of the spore being difficult to kill us in this instance the department was trying to kill the organism without disrupting the organism creates a challenge and safety into the attempt now is to set that margin and as you go back if you go back to the attorneys figured that he showed the gap and there were production runs that should have highlighted that the procedure wasnt adequate and Going Forward<\/a> we will make sure that there is a safety margin and a consensus in the inputs to have the opportunity to get to assure that we are taking their marching. If you could, you answer the previous question related to the foreign nation and some of those were dod facilities. And if not they were completely controlled by the United States<\/a> government, yes or no . Before they told us eyve been sizing we are told that you hunted it down and you killed the required browser to note that can we be because it doesnt sound like we can be very certain that something is taking some of the anthrax and all of a sudden came in for use in other ways. So the facilities that you referred to are the most trusted allies and we do many things with these allies across the board. Of it if they want to do the research on biological weapons, this would have given them an opportunity to acquire that at least the base material to start the culture with isnt that true, yes or no . Its true but they were already doing most of the work we were trying to use a common material across the board so everyone was testing on the same materials so that we can compare the results that we had. How comfortable are you that those facilities that are protocols that have better protocols that we do and that we dont have some worker that was supposed to be dead cells generating and gone out in the sample he or she may have given to the foreign agent. Its been in some of those cases they already have the material now. Like i said this was assumed to be dead material. You said that it was tracking down. It was discovered you didnt get notified until yesterday to investigate the problem that was discovered in may isnt that correct . That is correct, yes. We have at least 60 days since the problem was discovered before you were notified as the true . I dont consider that acting reasonably do you . We are not at the front lines that would have to go to the fda for the scientists, so it is normal for the cbc to do investigative work on its own before they would refer the matter. So you think that 60 days is reasonable and as a part of that they are doing their investigations and so forth, but dont you think its kind of interesting that you got notified today, do you think that the hearing of his that his breadth of time a little bit . I have no information about that. That when you filed your testimony he said today they havent received a referral from the recent potential violations involving the wave in the reference to the 2008 and 2010 incident. For the energy prevention and control and noticed in the report referred to by pitcher men earlier the acting director of his department. Why is everybody over there acting . Im sorry that information that you have about my acting, director, is previously for nine months acting director i have been for nearly a decade were over a decade the Deputy Director<\/a> for the office of Public Health<\/a> preparedness and response. Doctor munro i think that you are referring to as the acting associate director for science and safety as an outstanding Laboratory Scientist<\/a>. I do want to understand if it is necessary to have somebody lapse involved. On the numbernion of laps working with anthrax . I dont think we know the number of laps. That is one of the issues. We have information. You talking about the anthrax we do know. We do know the number of high Containment Lab<\/a>oratories that exist will stop they are other highly infectious pathogens that require certain laboratories. They do not all have to be registered. We do know for anthrax. He establishment of a single federal entity which would include developing National Standards<\/a> for designing, constructing, operating, and maintaining such labs. Can you elaborate . We think it is important theyre be a more comprehensive set of plans for how many labs are needed there have been a great increase in the number of labs over the last decade since the anthrax attacks. A number of different federal agencies have expanded the number of labs that they have. Academic institutions about labs. Some states have built labs, and private entities have built labs. We do not really know what is needed. They are developing there and there is not an. While expecting whilebcs problems have only typically been going to a level above, not the top of departments organizations. We are concerned theyre has not been a consistent it is not clear where that organization should be implemented. Different Companies Want<\/a> to be able to compete for contracts from the federal government. So, going back and retrofitting that kind of control is complicated. Gotten traction on the concept of moving forward to centralize this control. Do you believe that the establishment my address some of recents that led to the incidents at dod and cdc, and how can Congress Help<\/a> in establishing uniform standards . More consistent lines of authority maybe helpful. The different laboratories handling anthrax were indifferent chains of command, but they never came together, that there wasnt a sharing of information. They did on have toplevel procedures on the way these things were being conducted to conducted. We would like to work with you and members of the committee to develop some kind of proposal. Thank you mr. Chairman. Bushon now recognize dr. This hearing is astounding. In the 4. 5 years i have been here this is not the only Government Agencies<\/a> that we are hearing testifying saying they are establishing new policies. Sorry, we messed up. There is no accountability. There is no accountability across the federal government in my view. No one is responsible. People are in their jobs for a short area of time. Dr. Haskell, you have only been in your job for a year. If we really pressed you you would say i dont know because i dont know what the person did before me. Im tired of hearing how we are establishing new policies. We have had this for decades. It is ridiculous. That is the problem. Every hearing i go to. Almost people walking out of the room. They did not get a they did not get is this time. This is just ridiculous. How can theyre not be standardized protocols for this in the federal government after decades and decades . How can that not happen . That is just the question i have. You made the statement, we are standardizing how we deal with this. How can it not be standardized . I can answer for dod. The different chains of command had been one of the fundamental problems because each Laboratory Reports<\/a> to a different chain. I have been in place for a year, but i take this personally. I am not criticizing you. You have only been theyre a year. You are right. I agree with you. I own it now. I take personal responsibility to make sure these are standardized and will not recommend that we lift the moratorium until i am cop confident we have the proper operations and achieve the right level of standardization. I appreciate that. People are losing theyre jobs. This we will be standardized. How do you solve this problem. I dont know essentially is what you said. I no how to solve it. How many people across the government have been fired over this problem connect who has lost their job at cdc, dod, doing the same thing even though they sent a National Security<\/a> risk, anthrax around the world. As mr. Griffith found out, non dod properties, that doesnt matter. Not to mention the fact, how many people are protected from being fired because they are part of the federal Government Union<\/a> that does not allow them to be held accountable . I want answers. I would love to have you visit cdc and see how accountable the scientists and professional staff are. We take this incredibly seriously. Who lost their job . There are regulations around the use and transfer of live anthrax. This particular incident was about an exempted material, which was not considered a select agent, and knew action we will be taken to address it. You will put in more policies . What do you mean . For example what it means is the people responsible for doing this lose their job. For example, before material can be considered killed we need a validated procedure within the lab. My question, how come you have not had that . In hindsight we should have. Decades. I have acknowledged in hindsight with this organism in the vulnerability we should have done this before the federal government has not known what constitutes dead anthrax until this came up . I just dont the reliance [inaudible conversations] testing the material in the lab to see if there is growth, and that process in this instance failed. I yield back. Five minutes. Thank you, mr. Chairman. It is unfortunate we have to have another oversight hearing. Continue along the vein that doctor bouchard raised. There was a quote in usa today that says,says, the root cause of all of this is the lack of accountability. Incidents dont get reported and consequences dont occur. I think that many of us have expressed that frustration, not only in the agencies represented here, the two agencies that are subject to the problems, but across the government and va, for instance that have allowed a coverup of waiting lists and only three people have been fired. It gets back to one of the root causes. It is too hard to fire a federal union employee. Of the individuals at the proving ground, what are the percentage of uniform versus civilian at that facility . I do not have that information. I can get it to you. It is mostly civilian. Of the civilian, what percentage are unionized . Im not sure. I would appreciate responses for both of those. Have you taken action against any of those employees . Any civilian or uniformed employee . To date, no. There is an investigation. If weif we take action we want to make sure it is taken at the right place, to make sure the person who is truly accountable is held accountable. That is nice, but how many mistakes are happening right now because there is no accountability . Do you no today we are not shipping other live agents around right now . Do you no that . How can you no . As we pointed out, because of the anthrax being so hard to kill and being such a challenge, that has been stopped. Anything else . What is the next one, though . Where are the other vulnerabilities . Ebola last year from the cdc how can you be sure that we do not have any other incidents going on today . Certainty is hard to provide. As we understand the organism in the process of assuring sterilityc, there is no evidence these materials are not in activated. We have seen no evidence of a signal event, growth or disease or injury. That does not mean we dont take it seriously and consider whether additional procedures need to be implemented. This is going on now with respect anthrax. We will consider it in a broader complex. For the committees sake, walk through the ownership of the different elements of the federal select process, as respects your two agencies. Who owns what part . Give me the highlights. What parts to you on . Where do you handoff . And oversight program. The main activities, the improvements that have been made through the execution of this program include screening and assessing facilities and staff for their suitability. That means the facility, as an appropriate facility has Good Laboratory<\/a> practice and appropriate rules. It includes the fbi review of personnel reliability on all of those who we will be using it, includes a set of requirements elevate biosafety and security, inventory management, access control, and it includes a process and ability to detect and respond, including the notification of jurisdictions that have these facilities, including but we did with the anthrax response, being able to go in, investigate, identify whether people are at risk, and whether they are and this involves private sector as well as Public Sector<\/a> institutions; is that correct . Thats correct. Where you find the best practices going from . Doctor hassell was talking about going to the private sector. Where are we finding the best practices today . Private or Public Sector<\/a> . It is a combination of both. We will look at the private sector. That often does not happen as a 1st reaction. The department of defense my centers for disease control, nih are outstanding facilities doing cuttingedge work which have risks, places where best practices and not best practices will occur because of the broad range. I have additional questions that i was a bit for the record later. The gentleman is recognized for five minutes. Thank you, mr. Chairman. Appreciate you being here. I am sure you are having a blast. It is frustrating for me to see what is taking place. To here you guys say you have protocols. It is hard for me to follow this. Is it the practice of the dod to send out a death certificate with select agents when they leave. It has been. It has been . How long has that been going on . I apologize. One similar to this. I am not sure. We can look at that back 12 years. I will find out. This dates back. We know it has been going on for at least five years. Why is it the private lab, lab why did it not have a death certificate . Originally tested they did not see growth. If it shipped out, the practice, the dod with any shipment to have a death certificate. Why was theyre not one ship to a private lab. That particular operation, sending out blind tests. To see if people could protect the present. We knowingly shipped live anthrax . Say again . Shipping it to them to see if they could find it. He knowingly shipped live anthrax to this lab. Did not provide the certificate. We did not knowingly shipped live agent. To the shipment and have as your place or some other place a death certificate . Yes. Who produced the death certificate . The originator. The difference between the test private lab showed. Very similar. One showed in life. One of the key differentiators. Who is responsible for showing the procedure. Who is responsible for it at the time . Who was it . It was dugway. Who do they fall . Hassle, so some . Who oversees dugway . Army. Narrowing down for me. Help me. Help me figure out who is responsible, the chain of command responsible for the death certificate for the procedures that show the agents leaving is truly dead the. The chain of command of the laboratory. The chain of command to find out. This is not a hard question. Finding out for sure the procedures defined that the agent is dead. It would be you dont no. Can you answer that question . I cannot. Can you answer that question . Not specifically. As i was going through the Background Information<\/a> i cannot figure it out either. There is no clear line of chain of command. You have to have someone responsible for something. Thissomething. This goes back to line of questions that was already asked. No one takes responsibility. We assume everyone is doing there job in here we are shipping out live anthrax . No one takes responsibility for. Going to leave it like down where they could not be shipped until you declared a line of command and procedures. A minimal six months. If you could find out all the players in. The scientific studiesok. Live anthrax was shipped out and no one takes responsibility. No one can answer it. We have identified the problem. Thank you and i yield back. Thank you. Collins from new york. Thank you. The bacteria ground agent such as anthrax completely different than a virus. Easy to kill a virus. Part of the concern i have heard, the last question is all we know theres a lot of biological agents, a lot of potential weapon issues going on and i think the concern of the committee, if we had this with anthrax might we have it was Something Else<\/a> like smallpox , whatever . That is where not to give you suggestions you might want to help the committee differentiate bacteria from virus to give them the confidence level, different bargaining going on. He is radiation because your trying to penetrate this poor. You want to penetrate the spore which was hard. The way that you prove its death, the death certificate is take a sample and put it in culture and try to grow it. You make that clear. I am guessing the problem is they put it in culture for a month command it should have been in culture for six months. Is that safe to assume that they did not run the culture just long enough . We cannot identify for certain, but it is a possibility. Anthrax grows in culture within two days generally. No. It can last six months. This is where you take Something Like<\/a> anthrax which is a spore which can pop up at five months time if its arriving in the spore five months and someone is creating a death certificate after two months they are saying it is dead. It germinates and grows. That happens within 48 hours i can beg to differ. It doesnt grow in a month, two months and then in five months it shows up. I would suggest respectfully that i believe the big issue here was it was not radiated with enough intensity, but to validate that it was dead they put it in culture to see if it would have. If it was in culture 48 hours and did not drop did not grow i can tell you your problem right now. You did not put it in culture long enough. Best practice and industry you will see that batch sit in the refrigerator or in the freezer for six months and have that culture, spore for six months, not 48 hours. I think you would have to agree, if it is in that culture for six months it is dead in a doornail. Again, this is different than a virus. I think some of that confusion is going on. You doyou do the best certificate at the lab after it has been radiated and held in isolation until the culture test is run and then say i did not see anything. Now the entire batches good to go. That is what happens. Shipped out exempt because it had the death certificate the issue would be, that is up to the lab to decide. At this. In time the sterility testing is a laboratory procedure. There we will be additional requirements as a result of this incident. And that is what i encourage you to do my think that it falls apart. You trust these labs to be at the top of there game. I can assurei can assure you best practice and private industry on anthrax and on see death is six months. Six months of testing. Fortyeight hours. That is best practice. I yield back. Thank you. Thank you, and we now recognize the congresswoman from indiana for five minutes. Thank you, mr. Chairman, for holding this important hearing. I have to say in my prior role i was chair of the subcommittee on Emergency Preparedness<\/a> response communication for homeland security, and it opened my eyes to the vital need to protect the American People<\/a> and our country from bio attacks and bio defense incidents. I will say that at that time i learned this administration did away with a position that have been in place under the clinton administration, the Bush Administration<\/a> called the special assistant to the president for bio defense. I think we learned about that position being eliminated when the ebola attack, when people if this country. I think it goes to the. Of what doctor crosses talking about, as a government we are not theyre is no central line of authority, no central entity, no person who all of these issues bubble up to that as a government we have a massive enterprise with so many different wellintentioned hardworking scientists and government workers but yet theyre is when it comes to bio defense for this country no organization and we are not doing a good enough job. Later this week we will be introducing legislation that addresses the need to strengthen and streamline the existing bio defense initiative. I have a question. If lab workers or other medical professionals have been exposed to live anthrax apples, are you confident as to whether or not we would have had proper vaccines and therapeutics in place to save lives . Am confident that we do. Are you confident, doctor hassell . Okay. Are you confident that we have enough proper vaccines and therapeutics in place to save lives . I do not have sufficient information to answer that question. Nor do i. Would that be for the workers that are being exposed, or how about with respect to the committee, building on the congressmans questions about one of these individuals if you have been exposed to presented to any our . Can you explain to me what your view is, if you have one . Thank you for that question. The Strategic National<\/a> stockpile did provide vaccine for the states that have workers while receiving prophylaxis. I am confident we have the ability to do it, the vast supply of countermeasures for anthrax,anthrax, the nature of the events you might be trying to prepare for always determines whether you have enough, but theyre have been a variety of processes and procedures to review the requirements set by the federal government for this threat, and we meet those cant requirements. How we can ensure that we have the medical countermeasures in place. That is my colleagues purview. What i think this event going back to what this shows us, while we are trying to respond to the managerial level, are you familiar with the private sector involvement with the medical Countermeasure Development<\/a> of procurement . I have done some past work looking at how the federal government has built flexible manufacturing facilities to be able to respond. I have nothing to add. Okay. I would like to go back to with respect to the death certificate, is it building on congressman mullins question, could both of you please explain with more detail how that congress how that process works and how that process works, what is required to be placed on the death certificate, and if you are sending these spores to another lab, what is it that the one lab should have that the other lab what is common in looking at the death certificate . Is the organism required to be listed on not listed when doing the sample blind test . Can you please go into more detail . I am sorry that my time is up. If we might have a couple more minutes. One more minute, and if you could submit any further explanation writing. If i may we could submit our explanation. We are considering not using death certificates and current operation. At least we are reevaluating that. That is of concern. The laboratory itself makes the determination about death certificates. That is not a select agent regulation requirement. Thank you and i yield back. Chairman. Last words. The chair now recognizes the congressman from north carolina. Thank you for bearing with us. Would you like to expand on my colleagues question . I need to get more detail on that and get a better answer. Okay. I noi know the cdc does issue a death certificate with materials on the occasions it needs to my do not no the particular details. I would appreciate it if you would follow up. Common practice to send a death certificate when you are doing online sample. We would love to see a more thorough answer. Overall if anyone on the panel trying to grasp the mission of the federal select Agent Program<\/a>, your understanding, and if you think it is being fulfilled, open to anybody. Clearly the incidence you have seen a serious, the kinds of indicators that we need to do more. An Important Message<\/a> from us as forhistory for the regulation and authorization in 2,002, this program has continued to receive input and advice from bond broadspectrum improving the prm which has changed and improved over time. Thisthis incident and these incidents have elevated the importance of some procedures requiring more direct oversight and review which we will address if there is a broad question about how many labs. Important andimpt critical policy questions. The federal enter agency has an important role. Cdc will contribute. When consensus is achieved what direction is given we will follow the instructions the mission is worthy and salvageable . Absolutely. Dugway has had problems in the past. It has been referenced body of times. In summation how does this continue to keep happening and how do you see us getting out of the cycle . This falls under the army the army takes this seriously at the highest level which sounds easy to say,say, but my interactions with them, this is taken personally and seriously. The secretary of the army on down is taking action. They will look at issues specific to dugway but not limiting it to that. It is not just that this can be a better reporting chain. Theyre may be opportunities that arise. The laboratory that you sent rid. Many have capabilities. Perhaps it was preventing the free flow of information i am not sure that is the case. Getting all the laboratory is working better together, standardizing where appropriate and moving forward. I guess i would offer this to the gal or oig, what existing tools would allow it to better oversee and take corrective actions . We have a concern that the reporting is just one level up from the lab and more Senior Management<\/a> is not necessarily informed. Focused within the laboratory but not necessarily ensuring the accountability of the chain of command is occurring. We are just undertaking work at the request of this committee. The scientific questions how the methods validated. I appreciate that. I appreciate your testimony. I want to thank the witnesses for coming and really a conversation i had. I am urging him to have a hearing later this fall for the end of the year after you ive figured out what your improvements in the standardization and oversight are going to be what i have found is what we have some crisis like this witnesses come in and say we need to do better. Oig and gal command. I have urged the chairman command i think he is an agreement to hold your feet to the fire to make sure these improvements, gaps you have identified are felt, the standards and coordination plans are completed. I believe he will have the hearing. On both sides of the aisle we agree that needs to be done. I would ask you that we have some accountability. Several questions have been about how many people would lose their job. That is something we will be looking for, to see how many people have lost their jobs. With that in conclusion i would like to thank the witnesses and members who have participated. Membersmembers have ten Business Days<\/a> to submit questions for the record, and i ask witnesses agree to respond promptly. With that the meeting is adjourned. 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