A hearing slated for later today will examine the latest findings made by the Government Accountability Office (GAO) regarding the oversight and expansion of high-containment laboratories in the United States. In their report, the GAO focused on the Bio-Safety level 3 & 4 laboratories both operational and planned i.e. National Bio and Agro Defense facility (NBAF), for obvious reasons; these facilities conduct research on the deadliest most dangerous pathogens or select agents. Interesting enough, was GAO’s cited reason for the study; “public concern” regarding over-sight and accidental or intentional release of select agents. In short, opposition to these facilities nation-wide has turned those “living in the shadows” into activist, lobbyist and educators, all working to prevent or stop construction or expansion of the biolab slated for their area.
U.S. laboratories working with dangerous biological pathogens (commonly referred to as high containment laboratories) have proliferated in recent years. As a result, the public is concerned about the oversight of these laboratories. The deliberate or accidental release of biological pathogens can have disastrous consequences.
Ample evidence exist and experts agree that many incidents or accidents go “unreported and unrecorded”. Consider the Sunshine Project’s investigation into Texas A&M, Ed Hammond uncovered a serious incident that even the CDC; which regulates some of these facilities, missed. Texas A&M ended up paying a $1 million dollar fine for the incident but the findings by Hammond suggested that far more incidents are taking place than the public knows, which if left “as is” puts us all at risk. Consider the following from a report by the Congressional Research Office’s, Issues for Congress report released in June of this year.
The experts we spoke with also stated that it is highly probable that many incidents go unreported and unrecorded because of the lack of such serious consequences. Such underreporting represents lost opportunities to analyze and learn lessons that can provide a basis for continuing improvement and maintenance of laboratory safety.
We as a Nation cannot continue to ignore issues at hand with regard to the operation of high-containment laboratories and their dual -use research. It is, pardon the pun a double-edged sword for all concerned but Congress must act on the recommendation of the GAO once and for all before it is too late.
What the GAO found:
The recent expansion of high-containment laboratories in the United States began in response to the need to develop medical countermeasures after the anthrax attacks in 2001. Understandably, the expansion initially lacked a clear, governmentwide coordinated strategy. In that emergency situation, the expansion was based on individual agency perceptions of the capacity their highcontainment labs required as well as the availability of congressionally approved funding. Decisions to fund the construction of high-containment labs were made by multiple federal agencies in multiple budget cycles. Federal and state agencies, academia, and the private sector considered their individual requirements, but an assessment of national needs was lacking. Even now, after more than 7 years, GAO was unable to find any projections based on a governmentwide strategic evaluation of future capacity requirements set in light of existing capacity; the numbers, location, and mission of the laboratories needed to effectively counter biothreats; and national public health goals. Such information is needed to ensure that the United States will have facilities in the right place with the right specifications.
Furthermore, since no single agency is in charge of the expansion, no one is determining the aggregate risks associated with this expansion. As a consequence, no federal agency can determine whether high-containment laboratory capacity may now meet or exceed the national need or is at a level that can be operated safely. If an agency were tasked, or a mechanism were established, with the purpose of overseeing the expansion of high-containment laboratories, it could develop a strategic plan to (1) ensure that the numbers and capabilities of potentially dangerous high-containment laboratories are no greater than necessary, (2) balance the risks and benefits of expanding such laboratories, and (3) determine the type of oversight needed.
Four highly publicized incidents in high-containment laboratories, as well as evidence in scientific literature, demonstrate that (1) while laboratory accidents are rare, they do occur, primarily due to human error or systems (management and technical operations) failure, including the failure of safety equipment and procedures, (2) insiders can pose a risk, and (3) it is difficult to control inventories of biological agents with currently available technologies. Taken as a whole, these incidents demonstrate failures of systems and procedures meant to maintain biosafety and biosecurity in high-containment laboratories. For example, they revealed the failure to comply with regulatory requirements, safety measures that were not commensurate with the level of risk to public health posed by laboratory workers and pathogens in the laboratories, and the failure to fund ongoing facility maintenance and monitor the operational effectiveness of laboratory physical infrastructure.
Oversight plays a critical role in improving biosafety and ensuring that highcontainment laboratories comply with regulations. However, some aspects of the current oversight programs provided by the Departments of Health and Human Services and Agriculture are dependent upon entities monitoring themselves and reporting incidents to federal regulators. Since 2001, personnel reliability programs have been established to counter insider risks, but their cost, effectiveness, and impact has not been evaluated.
You can read the 103 page report here.