CDC and APHIS were delegated authority by their respective department Secretaries to  regulate the use, possession, and transfer of select agents. Preliminary Observations on DOD’s and CDC’s Efforts to Address Weaknesses in the Management of Their High-Containment Laboratories

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. 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. 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. 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. 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. 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. In addition, CDC is taking other steps  intended to improve the management of high-containment laboratories  but has not yet completed these activities. Increased Federal Oversight of High- Containment Laboratories Continues to Be Needed

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. 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.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.