Experts Have Identified Several Capability Needs for Bioforensics

In addition to DHS and the FBI, other organizations, such as the NRC of  the NAS and the NSTC of the Office of Science and Technology Policy  (OSTP), have been involved in identifying bioforensics capability needs. With the assistance of the NAS, we convened our own  meeting of experts in April 2016 to review and update capability needs  that the NRC and OSTP identified and to identify additional needs that  might be useful for DHS and the FBI to consider when they identify their  capability needs as part of a bioforensics capability gap analysis. However, we believe that this information could  help inform the DHS’s and FBI’s efforts to identify capability needs and  prioritize gaps. Some of the needs the  experts confirmed as still relevant were similar to those identified by the  DHS and the FBI, and some were different. For example, like DHS and  the FBI the experts agreed that an ability to characterize genetically  engineered agents was needed, but they also suggested that evaluating  existing protocols, such as those for DNA sequencing, to determine  whether they were validated, was needed. The identified needs in table 1  can generally be grouped into three broad areas: (1) science,   (2) technology and methods, and (3) bioinformatics and data. These  agencies could consider this information as part of any capability gap  analysis. DHS and the FBI are Focusing on Methods- Based Capabilities to Provide a Broader Bioforensics Capability

DHS has taken several actions to enhance some of NBFAC’s  bioforensics capabilities for use on FBI casework. It also reflects DHS’s shift toward  methods-based approaches, such as genomics and proteomics. DHS is developing a capability  that will allow NBFAC to characterize unique, novel agents, “unknowns”  (emerging or synthetic organisms) and “unknown, unknowns” (de novo  synthetic organisms). However, it is not clear to what extent or when DHS will be  able address key challenges related to enhancing its bioforensics  capabilities that include interpreting results from metagenomics and  proteomic analyses, with a defined statistical confidence, according to  both DHS and the FBI officials. Conclusions

DHS has identified some bioforensics capability gaps since 2010 using an  informal, undocumented process but has not systematically identified the  gaps or performed a bioforensics capability gap analysis. Therefore, without a capability gap analysis and  documentation of the results of its process for identifying gaps, the  rationale for DHS’s resource allocations and its plans for future  enhancements to its existing capabilities are not clear. Recommendation for Executive Action

We recommend that the Secretary of Homeland Security—in consultation  with the Federal Bureau of Investigation—conduct a formal bioforensics  capability gap analysis to identify scientific and technical gaps and needs  in bioforensics capabilities to help guide current and future bioforensics  investments and update its analysis periodically. DHS concurred with our recommendation. Key  contributors the report are listed in appendix V.

Appendix I: Objectives, Scope, and Methodology

For this report, we evaluated (1) the extent to which DHS and the FBI  have identified gaps in their bioforensics capabilities since 2010,   (2) bioforensics needs experts have identified, and (3) any actions DHS  and the FBI have taken to enhance their bioforensics capabilities,  including those for characterizing a novel synthetic biological weapon,  and any challenges they have experienced in enhancing bioforensics  capabilities. To determine the extent to which DHS and the FBI have identified gaps in  their bioforensics capabilities, we reviewed agency documents and  interviewed relevant agency officials about their efforts to identify such  gaps since 2010, which is when the Department of Justice closed the  FBI’s investigation into the 2010 anthrax case. We also  examined DHS’s actions to enhance NBFAC’s capabilities for the long  term as well as for the FBI’s casework. Appendix II: DHS R&D to Enhance Bioforensics Capabilities, 2008 – 2016

	Bacterial and viral bioforensics research and development

Sequence-based  approach to  bioforensics analysis  Whole genome  approach to microbial  forensics  Bioforensics research  R&D: Whole genome  approach to microbial  forensics  and the identification of adaptive mutations that can have forensic utility  Establishing match criteria for discriminating “difference” or “sameness” in sample  comparisons  Developing statistically rigorous sampling strategies to acquire spatially referenced  genetic information on reservoirs of these pathogens  Developing bioinformatics-based analytical tools for supporting hypotheses testing  regarding pathogen origin that go beyond current phylogeny-based inferential methods  and can meet forensic (legal) admissibility  Develop novel techniques to culture threat agents from complex environmental  samples  Improve dry collection and extraction strategies for forensic samples  Develop detection methods for rare variant detection in a bacterial sample using ultra- high throughput next generation sequencing technology  Understand dynamics of mobile elements in select agent bacteria  Develop forensic genotyping methods for select agent viruses   Develop novel applications of orthogonal methods to genetic characterization of  biological threat agent signatures and their sample matrices   Develop biased primer set design to amplify biological threat agents from complex  backgrounds  Production methods for ultraclean reagents  Sequence data error model for next-generation and single molecule sequencing  platforms  Taxonomic classification of metagenomic sequences  Develop and apply mathematical models for statistical confidence measurements in  metagenomic analysis  Develop a procedure to transport agents from BSL-3 to BSL-2 laboratories  Produce whole-genome sequencing to capture the global biodiversity of human, plant,  and animal pathogens (bacterial, viral, and fungal) in support of microbial forensics  analysis  Development and population of comparative genomic database with pathogen  sequence data at the National Center for Biotechnology Information Center  Products to identify select agents including C. botulinum toxins, with high confidence  Next generation and novel technologies to characterize biological threat agents (the  organism, the agent, or the sample matrix) for source attribution  Research on the bacterial populations of select agents with critical knowledge gaps,  including C. botulinum and B. anthracis (North Africa,  Middle East)

	Year 2016

Appendix III: List of Experts

The names and affiliations of the experts who participated in the group  meeting held April 20-21, 2016, in Washington, D.C. are as follows:
Christopher Bidwell, J.D., Senior Fellow for Nonproliferation  Law and  Policy at the Federation of American Scientists.
Why GAO Did This Study

The ability to attribute the source of an intentionally released biological threat agent and quickly apprehend and prosecute the perpetrator is essential to our nation's safety. However, questions remain about whether DHS's and the FBI's capabilities have improved since the 2001 anthrax attack. GAO was asked to report on DHS's and the FBI's bioforensics capabilities.
This report examines the (1) extent to which DHS and the FBI have identified gaps in their bioforensics capabilities since 2010, (2) bioforensics needs experts have identified, and (3) actions, if any, DHS and the FBI have taken to enhance their ability to attribute the source of a biological attack, and to identify any challenges to enhancing bioforensics capabilities. GAO's review focused on the agencies' efforts since 2010, when the FBI's investigation of the 2001 anthrax attack was closed. GAO analyzed relevant agency documents and interviewed agency officials and scientists on issues related to bioforensics. GAO also convened a meeting of experts with NAS's assistance to discuss potential bioforensics needs.

What GAO Found

The Department of Homeland Security (DHS) and the Federal Bureau of Investigation (FBI) have identified some gaps in their bioforensics capabilities, but DHS has not performed a formal bioforensics capability gap analysis. It is therefore not clear whether DHS and the FBI have identified all of their capability gaps. A capability gap analysis can help identify deficiencies in capabilities and can help support the validation and prioritization of how to address the gaps. DHS and the FBI have identified capability gaps using an informal undocumented process. For example, DHS held informal meetings to seek FBI input on capability gaps associated with recent casework. Gaps identified through this informal process include the inability to (1) characterize unique, novel, and engineered agents and “unknowns” (emerging or synthetic organisms) and (2) understand and communicate uncertainty associated with analyzing complex biological samples, among other things. In the absence of a well-documented bioforensics capability gap analysis, the rationale for DHS's resource allocations, or its plans for future enhancements to existing capabilities are not clear and thus cannot ensure that resources are being targeted to the highest priority gaps.
In addition to DHS and the FBI, other organizations, such as the National Research Council (NRC) of the National Academy of Sciences (NAS), and the National Science and Technology Council (NSTC) of the Office of Science and Technology Policy (OSTP), have identified potential bioforensics capability needs. These needs can generally be grouped into three areas: science, technology and methods, and bioinformatics and data. GAO also convened a meeting of experts, with the help of NAS, and these experts updated a list of potential bioforensics capability needs that NAS and OSTP had previously identified within each of these areas. Some of the needs these experts confirmed as still relevant were similar to those DHS and FBI officials have identified, while others were different. For example, like DHS and the FBI, the experts agreed that an ability to characterize genetically engineered agents was needed, but they also suggested that evaluating existing protocols, such as those for DNA sequencing, to determine whether they were validated, was needed. GAO believes that this information may be helpful to DHS and the FBI as part of any future bioforensics capability gap analysis they undertake.
Since 2010, DHS has enhanced some of its bioforensics capabilities, with FBI input, by focusing on developing methods-based capabilities while maintaining agent-based capabilities. DHS has funded research and development projects addressing areas such as genome sequencing approaches, which underpin many methods-based bioforensics capabilities. DHS is also developing an in-house reference collection for use in investigations. In addition, DHS is developing the ability to characterize unique, novel agents as well as “unknowns,” such as synthetic organisms. DHS projects that some enhanced capabilities will be complete in about 2025. However, in pursuing enhancements, DHS faces several challenges, including establishing a statistical framework for interpreting bioforensics analyses and associated inferences and communicating them in a court setting, as well as obtaining suitable biological agents and DNA sequences to ensure quality references for use in investigations.

What GAO Recommends

GAO recommends that DHS—in consultation with the FBI—conduct a formal bioforensics capability gap analysis and update it periodically. DHS concurred with GAO's recommendation.