No NBAF in Kansas

Real Biosecurity for the Heartland

Archive for December, 2010

The NAS Report on NBAF is a Game Changer

Posted by tmanney on December 4, 2010

When the the Department of Homeland Security (DHS) selected Manhattan as the site for the NBAF there was little this group could do until the funding process worked its way through Congress.  Because of the concerns raised by the Government Accountability Office (GAO) Congress instructed DHS to complete a “site-specific biosafety and biosecurity risk assessment (SSRA)”.  They also directed the National Research Council to conduct an independent evaluation of this SSRA to determine its adequacy and validity.  Congress would not release construction funds until these were completed and evaluated. We had to wait for the outcome of these even though the DHS/KSU/Kansas Bioscience Authority (KBA) started site preparation on the KSU campus using Kansas State and local funding.  These documents were released last month.  But Congress has not appropriated any funds for construction.  This can still be stopped.

The NRC evaluation found many serious faults in the DHS plans that call into question the decision to build the NBAF in Manhattan.  The composition of the NRC commission included leading experts in most, if not all, of the fields relevant to this incredibly complicated project.  Their 11 findings echoed the objections opponents to the NBAF (including us) had raised, which were based on the concerns raised by the GAO more than two years ago.  These findings reinforce our resolve that it is simply unacceptable for this facility to be built on the KSU campus in Manhattan. The findings concerning the risk of release of the Foot and Mouth Disease virus (FMDv) further reinforce our resolve that it is unacceptable to study this disease in large animals on the mainland of the United States.

To address these issues and work toward the goal of persuading Congress to refuse to fund this project, we have regrouped under a new name, but with the same objectives.  We will now identify our goal to be Biosecurity For the Heartland. We will soon move these efforts to a new web site under that name.  The only weapon we have at our disposal is information.  We can shine light on the facts that are a matter of public record and on the efforts by the proponents of this project to obscure those facts that challenge the project’s safety.

Because of the urgency of preventing the funding of this project, we will focus our efforts on the members of Congress who will be making this decision:  the members of the House and Senate Appropriation Committees, starting with the members of those committees who serve on their Homeland Security subcommittees.  To get our message to these members of Congress we will do our best to recruit those people who have the most to lose in the event of an FMD catastrophe:  the livestock growers and the organizations that represent them.  But Foot and Mouth Disease isn’t the only threat from this facility.  This germ lab is designed to study the most deadly diseases that infect both animals and people.  These are diseases that are deadly to people and for which there is no known vaccine or cure.  Every person who lives in the long shadow of this facility must understand  the risks.

Biosecurity For the Heartland is a coalition  of area residents who want to stop this madness by honest, rational information sharing and discourse.  None of us have anything to gain by the defeat of NBAF except a safer place to live and raise our families.

 

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NRC Report Adds to Doubts About NBAF Safety

Posted by tmanney on December 3, 2010

More than two years ago the Governmental Accountability Office (GAO) questioned the safety of doing Foot and Mouth Disease research on the U. S. mainland.  The motivated our opposition to the selection of Manhattan, or any other mainland location for the NBAF. It subsequently motivated Congress to require the Department of Homeland Security (DHS) to conduct a Site Specific Risk Assessment (SSRA) and to have an independent evaluation of that Assessment to determine its adequacy and validity. That Assessment was conducted by a Committee of the National Research Council, a subsidiary of the National Academy of Science.

NBAF Risk Assessment Report

The text of the 146 page report can be purchased or read online at http://nap.edu/catalog.php?record_id=13031

We have abstracted the major findings here:

OVERALL ASSESSMENT

The committee evaluated the SSRA’s methods, facility design plans, and mitigation strategies. The committee found that the models used in performing the SSRA appear to be appropriate and that many of the SSRA’s general conclusions are valid. The SSRA has considered the major release pathways (aerosols, fomites, liquid waste, and solid waste), as recommended in the committee’s preliminary letter report (see Appendix B), and has addressed mitigation strategies for each. DHS has also appropriately responded to GAO’s prior criticism that it had inappropriately dealt with a potential plume from an airborne release of foot-and- mouth disease virus (FMDv); the SSRA uses a state-of-the-art puff dispersion model to simulate the aerosol transport of pathogens, which turned out to be a less critical pathway of FMDv spread than the near-site exposure of cattle. However, as described in the findings below, the committee found that the SSRA had several major shortcomings with respect to potential risks and impact scenarios, and there are some critical limitations in the SSRA’s execution and analysis.

The committee found that the SSRA has many legitimate conclusions, but the SSRA is not entirely adequate or valid. The SSRA does not account for the overall risks associated with operating the NBAF and conducting FMDv work in Manhattan, Kansas. The inputs and assumptions for the models are inadequate because they do not fully account for how a biosafety level 3 agriculture (BSL-3Ag) and BSL-4 facility would operate, how pathogens might be released, and which animal populations might be exposed. The SSRA sometimes used arbitrary assumptions and did not account for uncertainties, some of which require experimental data that are currently not available but that could greatly alter the outputs. Consequently, the committee is concerned about the validity of the actual risk and impact levels determined by the SSRA’s outcomes from the models.

Given more time, the SSRA may have progressed further and may have better addressed some of the concerns expressed in this report. The committee thus views this as a notable first step in an iterative process aimed at identifying and minimizing risk and determining actions that will need to be taken.

FINDINGS

The SSRA shows that constructing the NBAF in Manhattan, Kansas, carries a number of risks and that the impact of an FMDv release could potentially have significant economic, health, and national security impacts. Some risks and impacts are generic to any high-containment large- animal facility, whereas others are specific to the Manhattan, Kansas, site. The risk of release is primarily a generic concern, whereas the risk of infection, spread, and impact is largely related to the site. The SSRA’s estimates indicate that the probability of an infection resulting from a laboratory release of FMDv from the NBAF in Manhattan, Kansas approaches 70% over 50 years (see Figure 3-1) with an economic impact of $9-50 billion. The committee finds that the risks and costs could well be significantly higher than that, and elaborates on those findings below.

Finding 1: The SSRA lacks evidence to support the conclusion that the risk of release that results in infection is very low relative to the risk of infection introduced from an external source.

Finding 2: The SSRA overlooks some critical issues, both site-specific and non-site-specific, that could significantly elevate the risk of accidental release and spread of pathogens.

Finding 3: The SSRA has several methodological flaws related to dispersion modeling, tornado assessment, and epidemiological modeling. Thus the committee believes that questions remain about the validity of the overall risk estimates. Finding 3: The SSRA has several methodological flaws related to dispersion modeling, tornado assessment, and epidemiological modeling. Thus the committee believes that questions remain about the validity of the overall risk estimates.

Finding 4: The committee agrees with the SSRA’s conclusion that for FMDv, long-distance plume transport will likely be less important than the near-site exposure of cattle.

Finding 5: Substantial gaps in knowledge make predicting the course of an FMD outbreak very difficult, which led to weaknesses in the SSRA.

Finding 6: Although the economic modeling was conducted with appropriate methods, the epidemiological estimates used as inputs to the SSRA were flawed.

Finding 7: The committee agrees with the SSRA’s conclusion that early detection and rapid response can limit the impact of an FMDv release from the NBAF, but is concerned that the SSRA does not describe how the NBAF could rapidly detect such a release.

Finding 8: The SSRA lacks a comprehensive mitigation strategy developed with stakeholder input for addressing major issues related to a pathogen release. The mitigation strategies that are provided do not realistically demonstrate current or foreseen capacity for how federal, state, and local authorities would effectively respond to and control a pathogen release.

Finding 9: The committee agrees with the SSRA’s conclusion that human error will be the most likely cause of an accidental pathogen release, and fomite carriage is the most likely way that a pathogen would escape the facility’s outer biocontainment and biosecurity envelope.

Finding 10: The committee agrees with the SSRA’s conclusion that investment in biosafety and biosecurity engineering and the training of personnel and responders can reduce the risks, but is concerned about current design plans that potentially compromise safety measures.

Finding 11: The SSRA’s qualitative risk assessment of work with BSL-4 pathogens in large animals was inadequate.

ADDITIONAL REMARKS

The SSRA team should be applauded for its effort in conducting an extensive risk assessment in such a short period of time. Although the committee’s findings express major concerns about the validity of some of the SSRA’s conclusions, the work that was completed constitutes a huge step forward compared with previous risk assessments of its kind and should be viewed as a solid starting point.

The nation clearly needs an institution to support comprehensive research programs for the study of foreign animal and zoonotic diseases, including detection, diagnosis, and means of mitigation (drugs, vaccines, and genomic forensics). Such activities require a capability to work with all known threat agents (not just the eight infectious agents listed in the SSRA), multiple pathogen introductions, and emerging and unknown disease threats. For these reasons, the committee agrees that there is a need for a facility like the NBAF to be constructed and operated in the United States.

Constructing a BSL-3Ag and BSL-4 facility of the magnitude planned for the NBAF, one that is capable of large animal work on a scale greater than other high-containment laboratories, undoubtedly presents new and unknown risks that could not be accounted for in the SSRA because of a lack of data and experience. Given the constraints of the design framework and the short timeframe available for data collection and analysis, the committee finds that the limitations of the data, facility design details, and operating practices may have limited the scope that the SSRA could adequately address at this time. As more data, facility designs, and operational plans emerge, updated analyses may be appropriate to better evaluate the risks posed by a BSL-3Ag and BSL-4 large animal facility in Manhattan, Kansas.

The SSRA and the committee identify some sources of risk that can be addressed as part of the design, preparation, and long-term operation of the NBAF to reduce risk wherever it is located. Though the SSRA and the committee offer several points for consideration to reduce the risk of a pathogen release and its consequences, further risk analysis is needed to determine the extent to which these measures would reduce risk. Ultimately, policymakers will need to decide whether the risks are acceptable related to constructing and operating the NBAF in Manhattan, Kansas, and DHS will need to determine steps to minimize risk and impact if construction and operation should proceed as planned.

CONCLUDING REMARKS

The SSRA team should be applauded for its effort in conducting an extensive risk assessment in such a short period of time. Although the committee’s findings express major concerns about the validity of some of the SSRA’s conclusions, the work that was completed constitutes a huge step forward compared with previous risk assessments of its kind and should be viewed as a solid starting point.

The nation clearly needs an institution to support comprehensive research programs for the study of foreign animal and zoonotic diseases, including detection, diagnosis, and means of mitigation (drugs, vaccines, and genomic forensics). Such activities require a capability to work with all known threat agents (not just the eight infectious agents listed in the SSRA), multiple pathogen introductions, and emerging and unknown disease threats. For these reasons, the committee agrees that there is a need for a facility like the NBAF to be constructed and operated in the United States.

Constructing a BSL-3Ag and BSL-4 facility of the magnitude planned for the NBAF, one that is capable of large animal work on a scale greater than other high-containment laboratories, undoubtedly presents new and unknown risks that could not be accounted for in the SSRA because of a lack of data and experience. Given the constraints of the design framework and the short timeframe available for data collection and analysis, the committee finds that the limitations of the data, facility design details, and operating practices may have limited the scope that the SSRA could adequately address at this time. As more data, facility designs, and operational plans emerge, updated analyses may be appropriate to better evaluate the risks posed by a BSL-3Ag and BSL-4 large animal facility in Manhattan, Kansas.

The SSRA and the committee identify some sources of risk that can be addressed as part of the design, preparation, and long-term operation of the NBAF to reduce risk wherever it is located. Though the SSRA and the committee offer several points for consideration to reduce the risk of a pathogen release and its consequences, further risk analysis is needed to determine the extent to which these measures would reduce risk. Ultimately, policymakers will need to decide whether the risks are acceptable related to constructing and operating the NBAF in Manhattan, Kansas, and DHS will need to determine steps to minimize risk and impact if construction and operation should proceed as planned.

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