High-Containment Laboratories: Preliminary Observations on Federal Efforts to Address Weaknesses Exposed by Recent Safety Lapses
Published: 2015-07-28T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Recent safety lapses at high-containment laboratories raise questions about how federal departments and agencies manage high-risk biological agents. DOD and CDC both conduct research on high-risk biological agents at their respective laboratories. Biosafety and biosecurity practices in these laboratories are intended to reduce exposure to, and prevent loss, theft, or misuse of, biological agents. CDC regulates the possession, use, and transfer of certain biological agents that pose potentially severe threats to public health under the select agent program.
This statement summarizes (1) preliminary observations from ongoing GAO work on federal laboratories' biosafety and biosecurity policies and practices and (2) GAO's past work on oversight of high-containment laboratories. To conduct ongoing and past work, GAO reviewed documentation and interviewed federal agency officials, including those from DOD and CDC, about policies and procedures for high-containment laboratories; efforts to monitor compliance and evaluate effectiveness of biosafety and biosecurity policies and practices; and the status of federal oversight activities.
section_title: What GAO Found
paragraphs: Recent safety lapses—including shipments of live anthrax bacteria from the Department of Defense (DOD) to U.S. and international laboratories and potential exposures of Centers for Disease Control and Prevention (CDC) laboratory personnel to live anthrax bacteria—have illustrated multiple breakdowns in compliance with established policies and inadequate oversight of high-containment laboratories. In these laboratories, researchers work with potentially high-risk biological agents that may result in serious or lethal infection in humans. Preliminary observations from GAO's ongoing work show that DOD and CDC have begun to address weaknesses in the management of their high-containment laboratories, but their activities have not yet been fully implemented. GAO's ongoing work will include further examination of the status of DOD's and CDC's activities to improve management of high-containment laboratories.
DOD began taking steps to address weaknesses in its management of high-containment laboratories in 2012 by reviewing and revising biosecurity policies and procedures. According to officials, the revised biosecurity policies will require all DOD laboratories that conduct research with certain high-risk biological agents to submit all inspection reports to senior DOD management, which was not previously required. DOD plans to finalize these policies by September 2015. DOD also plans to make further changes to these policies as a result of its assessment of the May 2015 anthrax incident, after the first set of revisions is finalized. DOD has also begun to track biosafety and biosecurity incidents at the senior department level, such as potential exposures to or misuse of biological agents, which it had not done prior to the May 2015 anthrax incident. DOD officials said the May 2015 incident is the first incident that DOD has tracked at the senior department level.
CDC also began taking steps to address weaknesses identified in internal and external working group assessments of the June 2014 anthrax incident and other safety incidents but has not yet completed implementing some recommendations intended to improve its laboratory oversight. For example, an internal workgroup recommended that CDC develop agency-wide policies to provide clear and consistent requirements for biosafety for all agency laboratories. In response, CDC developed a specimen transport policy but has not developed other agency-wide policies, such as requirements for laboratory documentation and emergency protocols.
Since 2007, GAO has reported on issues associated with high-containment laboratories and recommended improvements for federal oversight. GAO's prior work recommended the establishment of a single federal entity to (1) conduct government-wide strategic planning for requirements for high-containment laboratories, including assessment of their risks, and (2) develop national standards for designing, constructing, commissioning, operating, and maintaining such laboratories. Federal departments to which GAO's recommendations were addressed agreed with them and have conducted some activities to respond but have not implemented the recommendation to establish a single federal entity with responsibility for oversight of high-containment laboratories.
section_title: What GAO Recommends
paragraphs: GAO has previously made recommendations to agencies to enhance biosafety and biosecurity. Because this work is preliminary, GAO is making no new recommendations at this time. GAO shared preliminary observations from this statement with DOD and CDC and incorporated comments as appropriate.

section_title: Letter
paragraphs: We are pleased to be here today as you examine issues related to the  management of biological agents in high-containment laboratories and  the federal select agent program. High-containment laboratories are  those laboratories in which researchers work with potentially high-risk  biological agents, such as Bacillus anthracis, the bacterium that causes  anthrax, which may result in serious or lethal infection in humans. High- containment laboratories also house agents that have the potential to  seriously threaten animal health and disrupt the U.S. economy, such as  highly pathogenic influenza viruses in birds. As recently as May 2015, the  Department of Defense (DOD) announced that it had inadvertently  shipped samples containing live anthrax bacteria to U.S. and international  laboratories prior to discovering that procedures to inactivate the anthrax  were incomplete. The Centers for Disease Control and Prevention  (CDC), within the Department of Health and Human Services (HHS), also  reported several recent safety lapses, one of which, in June 2014, was  also a result of inadequate inactivation procedures that potentially   (See app. I for a timeline of  exposed personnel to live anthrax bacteria.the CDC safety lapses and the agency’s assessments of these lapses.)  These safety lapses have raised questions about how federal  departments and agencies manage high-risk biological agents at their  high-containment laboratories. We have previously examined federal  oversight of high-containment laboratories and recommended  improvements to this oversight.
Each level of containment describes the laboratory practices, safety equipment, and  facility safeguards for the level of risk associated with handling particular biological agents.  Laboratories are to be designed, constructed, and operated to (1) prevent accidental  release of infectious or hazardous agents within the laboratory and (2) protect laboratory  workers and the external environment, including the community, from exposure to the  agents.
Inspection Service (APHIS), within the U. S. Department of Agriculture  (USDA), are responsible for overseeing the select agent program.
Our testimony today will draw from our ongoing work examining the  management of biological agents in federal high-containment  laboratories, as well as our prior reports and testimonies on high- containment laboratories. In particular, this statement reflects our  (1) preliminary observations from our ongoing work on biosafety and  biosecurity of federal laboratories and (2) prior work examining federal  oversight of high-containment laboratories from 2007 through 2014. In  addition, we have begun work for the House Energy and Commerce  Committee to examine inactivation methods and protocols for biological  agents. relative strengths and weaknesses of the various types of inactivation  methods and any current scientific issues involving inactivation protocols.
This work will also examine attenuation procedures, which are methods of weakening  biological agents such as viruses so that they no longer cause disease. recommendations intended to improve or enhance monitoring and  evaluation activities and controls, and available agency documentation of  plans and time frames for addressing these recommendations. We  interviewed DOD and CDC officials to (1) obtain information on their  efforts to monitor compliance with and evaluate the effectiveness of their  policies and procedures and (2) discuss agency plans and time frames for  implementing improvements and tracking their progress. We will use  federal internal control standards, as well as department and agency  policies and procedures and information obtained from interviews, to  determine whether departments and agencies have appropriate protocols  in place for monitoring and evaluation and are conducting these activities  in accordance with written protocols.
For our prior work on federal oversight of high-containment laboratories,  we have summarized our findings from our 2007, 2009, 2013, and 2014  reports and testimonies. documents such as those identifying any national needs assessments for  high-containment laboratories, conducted literature reviews, and  interviewed federal officials, including those from CDC and other federal  agencies. Each of these reports provides more detailed information on its  objectives, scope, and methodology.
GAO-14-785T, GAO-13-466R, GAO-09-574, and GAO-08-108T. the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
We shared our preliminary observations with DOD and CDC. DOD and  CDC provided us with technical comments, which we have incorporated  as appropriate.
subsections: section_title: Background
paragraphs: CDC partners with the National Institutes of Health to publish Biosafety in  Microbiological and Biomedical Laboratories, which provides guidance on  biosafety principles and practices for protecting laboratory personnel, the  public, and the environment from exposure to biological agents for each  biosafety level. BSL-3 laboratories work with indigenous or exotic  agents with known potential for aerosol transmission or those agents that  may cause serious and potentially lethal infections. BSL-4 laboratories  work with exotic agents that pose a high individual risk of life-threatening  disease by aerosol transmission and for which treatment may not be  available.
CDC and APHIS were delegated authority by their respective department Secretaries to  regulate the use, possession, and transfer of select agents. a new certificate of registration or renewing an existing registration.CDC and APHIS may also conduct interim inspections, such as annual  inspections, to assess compliance with select agent regulations. High- containment laboratories may also conduct work with biological agents  that have not been designated as select agents and are therefore not  registered with the select agent program.
Many federal departments and agencies own and operate high- containment laboratories in the United States and abroad. For example,  DOD conducts and supports research on detection, identification, and  characterization of biological threats and the development of medical  countermeasures against those threats at its high-containment  laboratories in the United States and located overseas. As part of its  bioterrorism preparedness and response program, and in addition to its  responsibilities for overseeing other entities’ laboratories under the select  agent regulations, CDC also conducts research on potentially high-risk  biological agents at its own high-containment laboratories.
section_title: Preliminary Observations on DOD’s and CDC’s Efforts to Address Weaknesses in the Management of Their High-Containment Laboratories
paragraphs: DOD and CDC had existing policies and procedures that addressed  biosafety and biosecurity within their high-containment labs at the time  the safety lapses occurred in 2014 and 2015. However, as a result of  these lapses—which illustrated multiple breakdowns in compliance with  established policies and procedures and inadequate oversight—both  DOD and CDC have identified weaknesses in the management of their  high-containment laboratories and have begun to take some steps to  review and revise policies and procedures and improve monitoring and  evaluation activities.
DOD Steps to Address Weaknesses in Laboratory Management  Our ongoing work shows that DOD has begun to take some steps to  address weaknesses in the management of its high-containment  laboratories but had not yet implemented them prior to the May 2015  anthrax safety lapse. After an internal reorganization in 2012, DOD began  revising its policies and procedures for safeguarding select agents,  including security standards for these agents, to streamline policies and  improve monitoring and evaluation activities. DOD officials told us that the  changes will include new requirements for all service laboratories (within  Air Force, Army, and Navy) registered with the select agent program to  submit all inspection reports, such as those from CDC’s select agent  office, to DOD senior management regardless of inspection findings.  Officials stated that, prior to this new requirement, the laboratories were  required to report only what they determined to be significant findings to  DOD senior management, which officials stated was no longer  acceptable. DOD expects to finalize the new policy by September 2015;  Air Force, Army, and Navy will have 6 months to become compliant with  the updated policy once it is finalized. In addition, DOD officials told us  that they identified further changes that they plan to make to this policy as  a result of the May 2015 anthrax safety lapse, which they will make after  the current changes are finalized.
DOD plans to collect inspection reports from its select agent-registered  laboratories; however, it does not plan to collect and monitor the results of  any reports of inspections conducted at high-containment laboratories  that are not registered with the select agent program but nonetheless  conduct research on potentially high-risk biological agents. According to  officials, DOD does not conduct department-level inspections of its high- containment laboratories, including those high-containment laboratories  that do not conduct research with select agents and are not registered  with the select agent program. Instead, DOD delegates responsibility for  inspections to the services, where management responsibility for  conducting or monitoring the results of laboratory inspections varies and  may not lie with senior-level offices, depending upon the service. For  example, DOD officials stated that high-containment Air Force  laboratories are inspected by an office one level higher than the office in  which the laboratory is located. Air Force officials told us that inspectors  general at various levels of the service inspect Air Force laboratories.  However, in our initial conversations, officials we spoke with did not tell us  whether senior Air Force offices monitor the results of laboratory  inspections. Our ongoing work will examine service-level responsibilities  for conducting and monitoring the results of inspections and the extent to  which DOD, CDC’s and APHIS’s select agent offices, the services, and  the laboratories communicate and coordinate to address significant  findings and resolve deficiencies identified during inspections.
DOD has also begun to address weaknesses in its incident reporting  requirements. DOD requires its laboratories to report potential exposures  to and possible theft, loss, or misuse of select agents to CDC’s or  APHIS’s select agent office, but, according to officials, DOD does not  currently track these incidents or laboratories’ responses to them at the  department level. DOD officials told us that the May 2015 anthrax safety  lapse is the first incident that DOD has tracked at the department level;  the updated biosecurity policy will include requirements for tracking  exposures and other biosafety and biosecurity incidents. Our ongoing  work will include an examination of the nature of DOD’s tracking and what  the department might require from the laboratories or the services as a  result of this tracking, such as identifying corrective actions or requiring  another type of response.
CDC Steps to Address Weaknesses in Laboratory Management  Our ongoing work shows that CDC has begun to take a number of steps  as a result of the recent safety lapses but has not yet completed  implementing some agency recommendations intended to address  weaknesses in its laboratory management. In October 2014, an internal  workgroup established by CDC issued a report from its review of the 2014  safety lapses, which included recommendations to improve agency  management of its laboratories and improve biosafety. Among its  findings, the workgroup discovered considerable variation across CDC in  the level of understanding, implementation, and enforcement of laboratory  safety policies and quality systems. Their recommendations addressed  weaknesses identified in six functional areas. Recommendations  addressed weaknesses in areas of particular relevance to our ongoing  work: (1) policy, authority, and enforcement; (2) training and education;  and (3) communications and staff feedback.
Policy, authority, and enforcement. The workgroup noted that CDC  lacked overarching biosafety policies, which limits accountability and  enforcement. The workgroup also noted that CDC needed clear  policies and effective training for leaders and managers to help them  implement accountability measures, assure competency, and enforce  biosafety adherence throughout agency laboratories. To address  these gaps, the workgroup recommended that CDC (1) develop  agency-wide policies to communicate biosafety requirements clearly  and consistently to all of its laboratories and (2) enforce existing  laboratory safety policies by clarifying the positive and negative  consequences of adhering or not adhering to them.
Training and education. The workgroup noted that CDC’s training  systems, competency and proficiency testing, and time-in-laboratory  requirements varied greatly across the agency’s laboratories. The  workgroup recommended a comprehensive review and unification of  training and education best practices across all CDC laboratories to  improve laboratory science and safety.
Communications and staff feedback. The workgroup noted CDC’s  need for comprehensive communication improvements to provide a  transparent flow of information across the laboratory community  regarding laboratory science and safety. The workgroup  recommended that CDC should include clearer communication flow  diagrams, point-of-decision signs, and improved notification systems  to distribute information to neighboring laboratories when an event  such as a potential exposure occurs.
In addition, in January 2015, an external advisory group completed its  review of laboratory safety at CDC and identified recommendations that  reinforced the internal workgroup’s findings and recommendations. For  example, this advisory group found that CDC lacked a clearly articulated  safety mission, vision, or direction and recommended the creation of a  biomedical scientist position in the CDC Director’s office.
As we conduct our ongoing review of federal management of high- containment laboratories, we are assessing CDC’s progress in  implementing the recommendations from its internal and external  workgroups. Our preliminary observations show that CDC has taken  some steps to implement workgroup recommendations and address  weaknesses in laboratory oversight but has not addressed some  recommendations or fully implemented other activities. For example, CDC  reported that, in response to the recommendation to develop overarching  biosafety policies, it is developing policies for specimen transport and  laboratory training. In addition, CDC developed a new procedure for  scientists leaving the agency to account for any biological specimens they  may have been researching, which the agency rolled out in February  2015. This procedure was among those policies the workgroup  recommended to be included in overarching agency policies. However, as  of July 2015, CDC has not developed other agency-wide policies that  include comprehensive requirements for laboratory biosafety, such as  policies that outline requirements for appropriate laboratory  documentation and for laboratories to maintain site-specific operational  and emergency protocols, to fully address the workgroup  recommendation. To address the recommendation made by the external  advisory group to create a senior-level biomedical scientist position, CDC  created a new Laboratory Science and Safety Office within the office of  the CDC Director and established the position of Associate Director for  Laboratory Science and Safety to lead the new office. The primary  responsibility of the associate director is to establish additional agency- level policies for laboratory safety and communicate CDC’s safety efforts  to agency staff. As of July 2015, CDC had not yet filled this position with a  permanent staff member. In addition, CDC is taking other steps  intended to improve the management of high-containment laboratories  but has not yet completed these activities. For example, in its 2013 policy  for sample and specimen management, CDC included a directive for the  agency to implement an electronic inventory management system.  According to officials, CDC rolled out its electronic specimen  management system for inventorying biological agents to all of its  infectious disease laboratories on March 30, 2015. However, CDC has  not made the new system available to all agency laboratories; it expects  to do so within the next 2 years.
section_title: Increased Federal Oversight of High- Containment Laboratories Continues to Be Needed
paragraphs: Since 2007, we have reported on several issues associated with high- containment laboratories and the risks posed by past biosafety incidents  and recommended improvements for increased federal oversight. Our  prior work included recommendations that address (1) the need for  government-wide strategic planning for requirements for high- containment laboratories, including assessment of their risks; (2) the need  for national standards for designing, constructing, commissioning,  operating, and maintaining such laboratories; and (3) the need for federal  oversight of biosafety and biosecurity at high-containment laboratories.  HHS and other agencies to which the recommendations were directed  have conducted some activities to respond but have not fully  implemented most of the recommendations. For example,  In our 2007 and 2009 reports, we found that the number of BSL-3 and  BSL-4 laboratories in the United States had increased across federal,  state, academic, and private sectors since the 2001 anthrax attacks  but no federal agency was responsible for tracking this expansion.   In addition, in our 2009 report we identified potential biosafety and  biosecurity risks associated with an increasing number of these  laboratories. We recommended that the National Security Advisor,   in consultation with HHS, the Department of Homeland Security,  DOD, USDA, and other appropriate federal departments, identify a  single entity charged with periodic government-wide strategic  evaluation of high-containment laboratories to (1) determine, among  other things, the needed number, location, and mission of high- containment laboratories to meet national biodefense goals, as well  as the type of federal oversight needed for these laboratories, and   (2) develop national standards for the design, construction,  commission, and operation of high-containment laboratories, including  provisions for long-term maintenance, in consultation with the  scientific community. We also recommended that HHS and USDA  develop a clear definition of what constitutes exposure to select  agents. The administration, HHS, and USDA have addressed some  of our recommendations. For example, in 2013, the administration’s  Office of Science and Technology Policy reported that it had begun to  support periodic, government-wide assessments of national  biodefense research and development needs and has taken some  steps to examine the need for national standards for designing,  constructing, commissioning, maintaining, and operating high- containment laboratories. CDC and USDA have developed scenarios  to more clearly define what exposures to select agents they consider  to be reportable.
In our 2013 report and 2014 testimony, we found that no  comprehensive assessment of the nation’s need for high-containment  laboratories, including research priorities and capacity, had yet been  conducted. We also found that no national standards for designing,  constructing, commissioning, and operating high-containment  laboratories, including provisions for long-term maintenance, had yet  been developed.assigned responsibility for oversight of high-containment laboratories.
In addition, no single federal entity has been  In summary, the safety lapses of 2014 and 2015 continue to raise  questions about the adequacy of (1) federal biosafety and biosecurity  policies and procedures and (2) department and agency monitoring and  evaluation activities, including appropriate levels of senior management  involvement. Preliminary observations on DOD’s and CDC’s steps to  address weaknesses in managing potentially high-risk biological agents in  high-containment laboratories—as well as findings and recommendations  from our previous work on high-containment laboratories—continue to  highlight the need to consider how best the federal government as a  whole and individual departments and agencies can strengthen laboratory  oversight to help ensure the safety of laboratory personnel; prevent the  loss, theft, or misuse of high-risk biological agents; and help recognize  when individual safety lapses that appear to be isolated incidents point to  systemic weaknesses, in order to help prevent safety lapses from  continuing to happen.
Chairman Murphy, Ranking Member DeGette, and Members of the  Subcommittee, this completes our prepared statement. We would be  pleased to respond to any questions that you may have at this time.
section_title: GAO Contact and Staff Acknowledgments
paragraphs: If you or your staff have any questions about this statement,   please contact Marcia Crosse, Director, Health Care at (202) 512-7114   or crossem@gao.gov; John Neumann, Director, Natural Resources   and Environment at (202) 512-3841 or neumannj@gao.gov; or   Timothy M. Persons, Chief Scientist at (202) 512-6412 or  personst@gao.gov. Contact points for our Offices of Congressional  Relations and Public Affairs may be found on the last page of this  statement. GAO staff who made key contributions to this testimony   are Mary Denigan-Macauley, Assistant Director; Karen Doran,   Assistant Director; Sushil Sharma, Assistant Director; Cheryl Arvidson;  Nick Bartine; Colleen Corcoran; Shana R. Deitch; Melissa Duong;  Terrance Horner, Jr.; Dan Royer; Elaine Vaurio; and Jennifer Whitworth.
section_title: Appendix I: Timeline of Recent Centers for Disease Control and Prevention (CDC) Safety Lapses and Related Assessments
paragraphs: Appendix I: Timeline of Recent Centers for  Disease Control and Prevention (CDC) Safety  Lapses and Related Assessments This is a work of the U.S. government and is not subject to copyright protection in the  United States. The published product may be reproduced and distributed in its entirety  without further permission from GAO. However, because this work may contain  copyrighted images or other material, permission from the copyright holder may be  necessary if you wish to reproduce this material separately.