5 us, or HEALTH AND HUMAN Public Hearth Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30333 August 22, 2014 The lt-lonorable Fred Upton Chairman, Committee on Energy and Commerce .8. House of Representatives Washington, DC 20515 Dear Chairman Upton: Thank you for your recent letter on behalf of the on Energy and Commerce regarding further clari?cation of issues that arose during the hearing on July 16, 2014. The Centers for Disease Control and Prevention (CDC) is pleased to provide you with additional information to clarify any remaining questions that concern our handling of select agents or other practices to improve laboratory safety. Please ?nd enclosed speci?c responses to the Committee?s questions. I appreciate hearing from you and welcome further conversation to ensure that our nation?s laboratories engaged in research to protect public health remain safe and secure. We are taking immediate steps to address our recent laboratory incidents and are committed to strengthening our culture of laboratory safety. If you have additional questions, do not hesitate to contact Ms. Karyn Kendall in the CDC Washington Of?ce at KKendall@cdc.gov or (202) 245-6000. Please note this response is also being sent to the cosigners of your" letter. - Thomas R. Friec en, MD, MPH Director, CDC Enclosures to the House Committee on Energy and Commerce Questions regarding further clari?cation of issues that arose during the hearing on July 16, 2014 involving Centers for Disease Control and Prevention (CDC). 1) Does the CDC leadership accept responsibility for the lax safety culture which exists within CDC leadership is responsible for what happens within the agency and is working at. all levels of the organization to implement the steps needed to instill a new culture of safety. As CDC Director Dr. Thomas Frieden stated at the July 16, 2014, hearing on these issues before your Committee, these recent incidents should never have happened and the lack of adequate procedures and oversight that allowed them to happen was totally unacceptable. Although it does not appear that these incidents resulted in any illness, and there was no release of pathogens as a result oi?either event, this does not excuse what happened. CDC will take the necessary steps to prevent any future incident that could put laboratory scientists, others in the CDC workforce and the broader community, or the public at risk. Dr. Frieden is personally overseeing a series of reforms designed to address these specific incidents. More broadly, he recognizes that challenge is larger than addressing these two specific incidents, and he will oversee the careful and deliberate review of existing safety practices and the development of new safety practices at all levels of our agency. Dr. Friction has emphasized to CDC staff that the overriding culture at our agency must prioritize workplace safety as a core institutional value and that CDC cannot continue to address safety on a case-by-case basis, as problems become apparent, without. implementing, an agency-wide comprehensive laboratory safety management program. instilling an overall culture of safety at CDC is imperative to protect our workforce and the public, and it is what we are determined to achieve with our current laboratory safety improvement strategy. In his initial steps to address immediate safety concerns, Dr. Frieden directed that all transfers of biological materials from all biosafety level 3 and 4 (ESL-4) laboratories at all CDC facilities cease until each laboratory could individually document its safety practices and applied to the Director of Laboratory Safety to resurne transfer of biological materials. As of mid- August, more than 10 laboratories have followed this procedure and have been approved to resume transfer for some or all of the pathogens approved for transfer, including chikungunya virus, Brucella spp., Ebola virus, influenza virus, poxviruses, and Mycobacrertum tuberculosis. in addition, Dr. Frieden appointed Dr. Michael Bell to serve as new Interim Director of Laboratory Safety and directed him to immediately convene the newly formed internal laboratory Safety improvement Workgroup has reviewed applications from laboratories and recommended resumption of transfers for Dr. Bell?s review. LSIW has also solicited input from across the agency, as well as from the newly established external laboratory safety workgroup of the Advisory Committee to the CDC Director, regarding development and implementation of recommendations to improve laboratory safety. 2) The corrective actions announced by CDC on July 11, 20.14, are largely similar to steps the agency pledged it would take in reslionse to previous safety lapses and/or mismanagement, including steps you outlined in a letter to us on September 4, 2012. CDC Response to House Committee on Energy and Commerce Were any of these steps implemented, in whole or in part, following your 2012 letter? If not, why not? Ifso, were these previous corrective actions ineffective Steps taken in 2012 were designed to address a number of specific physical plant issues, that are now part of the more comprehensive laboratory safety improvements we are currently undertaking. As Dr. Frieden stated at the July 16, 2014, hearing: ?While specific corrective actions were taken in response to individual incidents in past years, the broader pattern of inadequate laboratory safety was not addressed effectively. AddreSsing that broader pattern and our safety culture is what we are doing now.? The September 4, 2012, let er from Dr. Frieden to your Committee described speci?c steps CDC took to address biosafety concerns that were raised following an incident in Emerging infectious Diseases Laboratory (BID Laboratory) at its Roybal Campus earlier that year. These steps included entranced use of outside expertise in review and oversight of laboratoriesmthe Canadian and Department of Agriculture (U SDA) roles described establishing a point. of contact for CDC staff for concerns 0r complaints related to safety at CDC laboratories. The steps we are now undertaking comprise far more sweeping changes. Steps undertaken in 2012: In regard to outside expertise inspecting CDC laboratories, the animal biosafety level 3 (ABSLG) vivarium facility located in the BID Laboratory was inspected in September 2012 by a team of four Canadian biosafety experts from the Public Health Agency of Canada and two US. biosafety experts who were recommended by the American Biological Safety Association. You may access a copy of the team?s external review at In addition, Animal and Plant Health inspection Service (APHIS) agreed in 2012 to assume lead responsibility for inspecting laboratories that are regulated by the Federal Select Agent Program (F SAP). This agreement is still in effect, and led inspections of laboratories in response to the recent incidents involving Bacillus (mt/tracts and Highly Pathogenic Avian influenza virus. in regard to establishing a senior of?cial to address laboratory safety concerns, Mr. Joe Henderson was designated to report to the CDC Director regarding concerns and complaints related to safety at laboratories. Mr. Henderson was also responsible for coordinating internal investigation of incidents at certain high~containment laboratories in Ell) Laboratory that were of particular concern, at the time. In this role, Mr. Henderson completed a comprehensive review of the incidents and the corrective measures to address them. He and the laboratories? program leadership took additional steps to improve laboratory safety, including consolidating sources of safety and other information for laboratory staff, as well as establishing mechanisms for laboratory staff to notify leadership of laboratory safety issues and concerns. Steps we a re taking in 2014: The corrective actions that Dr. Friedcn announced in July 20l4 recognize that these previous efforts lacked the comprehensive approach that was necessary. To enhance external expert input regarding laboratory safety at CDC, the agency has formed an external laboratory safety workgroup of the Advisory Committee to the CDC Director, governed by the Federal Advisory Committee Act, to provide advice and guidance to the CDC Director and newly established Director of Laboratory Safety. This external wort-{group is made up of experts from academic and other organisations and convened its ?rst meeting via CDC Response to House Committee on Energy and Commerce teleconference on August 5, 2014. The external workgroup will review and make recommendations for corrective actions and prioritized implementation of additional safeguards across all CDC laboratories. in? addition, at the request of Secretary Burwell, CDC is incorporating an HHS?wide perspective into the external workgroup by examining HHS laboratory protocols and reporting their ?ndings to the Secretary. To review the roster and speci?c charges and functions of this workgroup, please visit its webpage at To address broader biosafety issues internally, CDC established the Director of Laboratory Satety position to serve as the CDanide single point of accountability for laboratory safety who has sweeping responsibilities for improving laboratory safety at the agency. Dr. Michael Bell has been appointed as interim Director for Laboratory Safety. This position reports to the CDC Director and its responsibilities include: - 9 Establishing and enforcing agency-Wide policies that require formal review and approval of new select agent research or pro gram protocols; 0 Creating and reinforcing effective and redundant systems and controls for protocols and procedures, including inactivation of biological material and access to laboratories; Ensuring adherence to laboratory quality and safety protocols; 9 Reviewing and monitoring the implementation of training policies and procedures for new and existing staff; and 0 Serving as the chair of the newly formed LSIW. with the leadership ol?Dr. Bell, will work to accelerate improvements in laboratory safety and monitor implementation of existing recommendations from the Government Accountability Of?ce, APHIS, and internal ?ndings related to the recent incidents. As mentioned above, the strategy that CDC is now implementing aims to develop an agency- wide culture of safety among CDC personnel and will build upon the improvements made in 2012. The strategy encompasses a variety of elements to address all issues that relate to laboratory safety, including stricter, more specific protocols; more thorough training, employee performance; and external expert review and counsel. 3) Do the results of the 2013 and 2014 APHIS inspections of CDC labs, especially those in Building 18 including the biotcrrorism lab, indicate that the CDC methods and systems to ensure biosai?ety are not adequate? CDC has submitted its responses to FSAP regarding its select agent entity certificate of registration inspections that were performed in August 2013, September 2013 (postponed due to furlough and resumed in January), January 20%, and March 2014, and they are currently under review. There is no indication from these inspections that CDC methods and systems to ensure biosafety are inadequate when properly adhered to. In regard to the investigative inspection of the Bioterrorism Rapid Response and Technology laboratory that was involved in the potential exposure to anthrax, a cease and desist order was issued. This investigative inspection took place from June 23, 2014 to July 3, 2014. In CDC Response to House Committee on Energy and Commerce regard to the APHlS?lcd investigative inspection of the laboratory involved in the inadvertent transfer of highly pathogenic avian in?uenza virus, a cease and desist order was not issued This investigative inspection took place from July l4-18, 2014. 4) In 2010, the Office ofInspector General made a regarding CDC confirmation of the inactivity ofmaterials in select agent transfers. The recommendation came in response to the 2006 transfers ofboth anthrax and hotalinum, two separate incidents. Does CDC that this recommendation was presented as a generalized biosafcty plan requirement? Since part of the epidemiolog I work is detecting or recognizing patterns of disease outbreaks, how could CDC not recognize the pattern ot?select agent incidents that was recognized by the GIG in 2010? CDC acknowledges that the US. Department of Health and Human Services {ill-l8) Office of Inspector General?s 2010 recommendation regarding CDC confirmation of the inactivity of materials in select agent transfers was presented as a generalized biosafety plan requirement. Since then, CDC has developed and is implementing laboratory quality management practices that will provide effective measures for biosafety and identify patterns in select agent-related biosafety incidents in the future. As mentioned in the response to No. l, CDC recognizes that its challenge is larger than addressing a discrete set of Specific incidents, which is why we are implementing broad improvements to our overall safety practices. 5) What will he the role of CDC Deputy Director Joseph Henderson with regard to implementation of the corrective actions? Will Mr. Henderson be reporting to Dr. Michael Bell, the CDC Director of Laboratory Safety? Mr. Henderson reports to Chief Operating Of?cer and is the Director of Office of Safety, Security, and Asset Management (OSSAM). OSSAM consolidates multiple business services offices that are involved with laboratory safety improvement efforts. services include several thematic areas that are directly relevant to these efforts: protection and safety ofthe CDC population, physical and personal security of CDC staff and contractors, operations and maintenance of CDC owned and leased property, health and wellness within the CDC community, transportation, and commitment to continuous quality improvement and sustainability. Mr. Henderson is serving as Vice Chair of LSIW. He and Dr. Bell both have leadership roles in the workgreup to ensure that their distinct work areas (business Operations and science) in addressing laboratory safety are well-coordinated. In addition, their reporting structure, in which Dr. Bell reports to the CDC Director and Mr. Henderson reports to the Chief Operating Officer, allows for checks and balances in laboratory safety improvement oversight. 6) In response to the President's Executive Order 13546 "Optimizing the Security of Biological Select Agents and Toxins in the United States,? what steps has CDC taken to improve CDC personnel reliability for select agents? he national regulatory oversight of entities that possess, use, and transfer select agents and toxins is carried out by Division of Select Agents and '"l?oxins in conjunction and CDC Response to House Committee on Energy and Commerce collaboration with APIES/Agricultural Select Agent collectively as FSAP. in response to Executive Order 13546, DSAT in collaboration with its FSAP partners amended the select agent regulations (42 CFR Part 73, 9 CFR Part 121, 7 CFR Part 331 effective April 3, 20 3) to require li?SAP?registered entities? security plans to include procedures for both conducting a suitability assessment and ongoing suitability assessment of personnel with access to Tier 1 agents or toxins?~21 subset of the select agent and toxins list that presents the greatest risk of deliberate misuse with the most signi?cant potential for mass casualties or devastating effects to the economy, crucial infrastructure, or public con?dence. Speci?cally, section ll of the select agent regulations was revised to include the following persormel reliability provisions for security plans at entities that possess, use, or transfer Tier agents. These entities? security plan must: a Describe procedures for conducting a pre~access suitability assessment of persons who will have access to a Tier 1 select agent or toxin; a Describe procedures for how an entity's Responsible Of?cial will coordinate their efforts with the entity's safety and security professionals to ensure security of Tier 1 select agents and toxins and to share relevant: information, as appropriate; and 9 Describe procedures for the ongoing assessment of the suitability of personnel with access to a Tier 1 select agent or toxin. The procedures must include: 0 Self- and peer-reporting of incidents or conditions that could affect an individual's ability to safely have access to or work with select agents and toxins or to safeguard select agents and toxins from theft, loss, or release; 0 Training of employees with access to Tier 1 select agents and toxins on entity policies and procedures for reporting, evaluation, and corrective actions concerning the assessment of personnel suitability; and Ongoing suitability monitoring of individuals with access to Tier 1 select agents and toxins. To assist regulated entities in complying with these requirements, DSAT in collaboration with its FSAP partners developed guidance and FAQ (frequently asked questions) documents that specifically relate to personnel reliability. You may access these documents at: Specific actions taken by CDC at its laboratories to inrproiIe CDC personnel reliability for select agents include the appointment of a Certifying Of?cial; development of the Guidance on Suitability Assessments for Access to Tier 1. Biological Select Agents and Toxins document; development of an advisory panel to review Tier 1 suitability issues with. participants from Human Capital and Resources Management Of?ce, the Environment, Safety, and Health Compliance Of?ce, and the Security Services Office of the Office of Security, Safety, and Asset Management; development of initial and ongoing self and supervisory suitability assessment tools; and establishment of a peeraeporting mechanism. 7) Prior to July 2014, did the CDC ever check with the NIH and/or the FDA to determine whether any vials oi?smallpox might still be in storage? If so, please provide details. Prior to July 2014, did CDC have any reason to believe that the NIH 5 CDC Response to House Committee on Energy and Commerce and/or the FDA had conducted inventory checks and that the labs in these agencies did not have smallpox vials? If so, please explain. CDC. was aware of the US. Food and Drug Administration?s (FDA) and the National institutes of Health?s (NIH) noti?cation ofpossession of select agent forms that were submitted to HHS in 2002 as a result of the Public Health Security and Bioterrorism Act. and noti?cation forms did not indicate that they were in possession of Vm?folo major. Speci?cally, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 was signed into law on'Iune 12, 2002, and section 202 ofPublic Law 1074 88 directed the HHS Secretary to provide written guidance within 30 days of enactment of the bill on how facilities in possession of select agents shall notify the Secretary of possession. On July 12, 2002, CDC published a notice stating that facilities should complete the noti?cation of possession form by September 10, 2002 based on an inventory of its facility and consulting with others principal investigators), as necessary, to obtain information required for the form. Variola major was listed on the form, and neither Nil-l nor FDA identi?ed the possession of Varioia major. In addition, the HHS federal select. agent regulations (42 CFR Part ?73) became effective on February 2.003, and required the registration of the possession, use, and transfer of select agents and toxins, including Varioia major and Vm'iola minor viruses. The registration application submitted to FSAP by NIH, as required under the select agent regulations, did not include Variola major or Vartola minor viruses. 8) Is CDC able to conduct surprise inspections of NIH anchor FDA labs? If not, why not? If so, have surprise inspections been conducted? Please provide copies of any such inspections Since 2002. DSArl?wworlring in its role with the statutory authority to conduct inspections of entities, including Nil-I and FDA, that are registered with FSAP to possess, use, or transfer select agents and toxins per the select agent regulations (42 USC 262a(l)). Section 73.18ta) of the regulations states that ?without prior notification, the HHS Secretary shall be allowed to inspect any site at which activities regulated by thislpart are conducted and shall be allowed to inspect and copy any records relating to the activities covered by this part.? DSAT has routinely conducted announced inspections of entities registered with FSAP. However, in 2010 DSAT began performing unannounced inspections as well, Since 2010, DSAT has performed four unamiounccd inspections of NIH laboratories and seven unannounced inspections of FDA laboratories, as shown below: Entity .Datets) of Insoection FDA, IL October 7-8, 2010 FDA, CA lr?ebruary 15, 20l1 FDA, CO - June 23, 2011 FDA, MD June 30-July 1,2011 FDA, AR November 29, 2011 NIH February 24, 2012 NIH May 1-4, 20l2 Nil-I June 25-29, 2012 CDC Response to House Committee on Energy and Commerce FDA, CA September 25, 2012 FDA, WA. September 25, 2012 NIH December 1 1~l4, 2012 We will deliver copies of inspection reports from these unannounced inspections to your subcommittee staff separately. Please note that the information contained in the inspection reports is considered ?Sensitive But l'lnelassit'ied 6913 U). The zmaathorized disclosure of this information could adversely impact the conduct of federal programs or otherprogrants or operations that are essential to national interest. While this triaterial is retained, it should be safeguarded in a manner that will prohibit its unauthorized disclosure. Review of this material should be limited to those persons whose ojfteial duties require it. 9) Provide copies of all CDC select-agent theft, loss, or release reports since 2002. Were any of these reports not resolved? DSAT has received reports Form 3) of incidents from CDC involving potential losses and releases. These are de?ned as: Loss: Failure to account for select agent or toxin. Release: Discharge of a select agent or toxin outside the primary containment barrier clue to a failure in the containment system, an accidental spill, occupational exposure, or a theft. Any incident that results in the activation ofa post-exposure medical sarreillancehjrophylaxis protocol should be reported as a release. We will deliver copies of all the reported incidents from CDC regarding a potential loss or release of a select agent or toxin to your subcommittee staff separately. DSAT has received no reports of a theft of a select agent or toxin. As a result of the follow-up investigations to these reports, conducted by FSAP, it was determined there was no loss the repmted loss was due to a recordkeeping error) and no releases that; resulted in an illness clue to the reported incident. Certain information on this matter has been publicly released, please see the article by chkel, ct 211., ?Monitoring Select Agent Theft, Loss and Release Reports in the United States--2004~ 20l0,? available online at Please note that the iry?ot'tricttiozt in these incident reports ls considered ?Sensitive Bat Unclassified (SB U). The unauthorized disclosure of this iryrornzation could adversely impact the conduct of federal programs or other programs or operations essential to national interest. While this material is retained, it should be safeguarded in a manner that will prohibit its unauthorized disclosure. Review of this material should be limited to those persons whose o?clal duties require it. 10) Please identify all instances of discovery of select agents in unregistered locations at CDC since 2002. Include the dates, the locations, identity of the select agents, and actions taken. CDC Response to House Committee on Energy and Commerce The table below lists all instances of discovery of select agents in unregistered locations at CDC since 2002. The actions taken in response to each case included notifying the appropriate of?cial, retrieving the identified material by authorized personnel, and relocating and securing the material in registered select agent spaces. Following the recent laboratory safety incidents, and as directed by Secretary Bur'wcli, CDC is conducting a comprehensive search of all laboratories?~including all possible storage areas? to ensure that there are no select agents, toxins, or hazardous biological materials improperly stored in any ofits facilities. Date of - . . Incidenqs) Agent Location type of Discovery 11/29/2004 Multiple agents Freezer unit 14 Offnatmllai unregistered space . Special Bacteriology Discovery of vials located in . . mil-?005 Mump 13 igemg Research Laboratory unregistered laboratories CDC reported the inventory I . I discrepancy of 20 vials of 9/2/2005 Costello bm'nen?i Few: Labmamly Coxiello bums-tit as a result of?prior poor bookkeeping.? (Form 3) Multiple agents (Bacillus CASPIR storage 5/24/2006 anthracts, Brucella Spp? facility at the Discovery of 40 vials located Spp., and. Lawrenceville, GA in unregistered laboratories Pl'aneis'elio tularensis) . location .1. . . . I I, Discovery ofa vial located it? 11/22/2006 tale; mars laboratory unregistered laberatories Multiple agents (Bacillus ftofge D. I 1 . 5/ 1/2007 anthracis Brucella spp. am my of? Iscoveiy ?a mated . Lawrencev?le, GA unregistered laboratories Bm'khoidez'm app.) . - location m# Multiple agents CASPIR storage 6/1 1/2007 (Bacillus anthroets, facility at the Discovery of vials located in Brucella spP-a Lawrenceville, GA unregistered laboratories B?holderio Spp.) location 5/9/08 Brnoella aborlus Speola] Discovery of vials located in Research Laboratory Bracella sm?s unregistered laboratories Fronet'sefia filial-casts 7/18/08 I'l'a?iC?Seik" ?dwells? Leglonell? discovered in unregistered Laboratory space 10/27/200811/7/2008 Rickettsra spp. lizcketma laboratory Inventory discrepancy Please note that the information provided above is considered ?Sensitive Bar Unclassi?ed (SB The zaznuthorr?zed disclosure ofthis information could adversely impact the conduct of CDC Res 02136 to House Committee on Enos and Commerce federal programs or other programs or operations essential {o national interest Iln?s material is retained, if should be sqfeguorded a manner that will prolw'bfl ifs unauthorized disclosure. Review maferlal should be llmz?led to those persons whose o?lefal (ladies require if. 9