FAS Strategic Security Blog

The National Research Council (NRC) just released a report that finds that “a National Institutes of Health draft assessment of the risks associated with a proposed biocontainment laboratory at Boston University is “not sound and credible.””

The NRC report came in response to a request by the Commonwealth of Massachusetts for technical input into the scientific adequacy of the NIH study. The NIH study, known as the Draft Supplemental Environmental Report (DSER), was to perform additional risk assessments and site analyses in response to environmental safety concerns raised in an earlier Federal court ruling.

From the NRC report cover letter:

The NRC committee was asked to address three specific questions:

1. Are the scientific analyses in the DSER sound and credible?
Overall, the Committee believes that the DSER as drafted is not sound and credible.

2. Has the NIH identified representative worst case scenarios?
The DSER as drafted has not adequately identified and thoroughly developed worst case scenarios.

3. Based on the comparison of risk associated with alternative locations, is there a greater risk to public health and safety from the location of the facility in one or another proposed location?
The DSER does not contain the appropriate level of information to compare the risks associated with alternative locations.

This latest report is unfortunate, but not unexpected in this case. The handling of the new BU lab has been mishandled on just about every conceivable level and has led to community distrust and has unfairly marked other biocontainment facilities with a scarlet letter. That the report was simply a draft is a poor excuse in this case because everyone involved was aware of the controversy surrounding the BU facility. This case is certainly cause for a serious re-evaluation of practices associated with the expansion of US biodefense capabilities and, at the very least, a system of checks and balances that prevent this brand of folly from ever happening again.

For the full NRC report click here.

To see the draft NIH study in question click here.

For a copy of the news release from the NRC, visit here.

Written with Nate Hafer.

written by ioelrich

The the Institute for Animal Health has confirmed a positive test for foot-and-mouth in Surrey, just outside London. The latest report that I could find indicated that they had ordered the slaughter of 300 animals in the area of the outbreak and that all cattle movement and exports had been halted. The site of the infection is very close to the location of an August outbreak. British authorities are apparently also investigating a possible case in Norfolk. If positive, that would be even more devastating than the reemergence of the disease in Surrey because it is over 100 miles away.

What I find remarkable is the British response to the reports, which are rapid collection, identification and diagnosis immediately followed by the establishment of a 6 mile control region and, perhaps most unusual, clear communication with the public. We do not have as sophisticated a system in the US right now, mainly due to the size and nature of our cattle industry, which dwarfs the UKs. While 80 to 90 percent of U.S. cattle production is concentrated in less than 5 percent of the nation’s feedlots, it is unclear that we could respond this quickly. Also, our herds are vastly larger than those kept in the UK and an outbreak in even a moderately sized herd of cattle could be devastating to our beef industry.

Senator Burr (R-NC) introduced the National Agriculture and Food Defense Act in July. The bill takes Homeland Security Presidential Directive 9 (HSPD-9) and turns it into law, expanding and detailing how the 28 sections of the Presidential directive will be implemented. The overall goal of HSPD-9 and the bill are simply to establish a national policy to defend our agriculture and food system against terrorist attacks, major disasters, and other emergencies. The bill has not been marked up in committee yet, and there are some contentious issues surrounding some of its provisions, but on the whole it is sorely needed so we can move forward with the Herculean task of establishing a system as advanced as the UK system, here. The thought of an FMV outbreak in any major US herd in the feed-belt makes me shutter.

written by ioelrich

Hey, we found the Iraqi WMD’s. They were being stored at the UN! I am sure it will be all over the news by tonight, but it is astonishing how fast the press was all over what really amounts to an act of stupidity, and most certainly not a large public hazard. Sure, one can’t even begin to fathom how disorganized the UN must be to actually lose track of vials that contain chemical weapons (even small amounts), but do a few handful of containers with dangerous chemicals that have been stored in a cabinet for over a decade deserve to be a headline story?

The details are not completely clear yet, but it appears as if there were only a few containers of which, at least one contained liquid phosgene. The UN staff learned of the vials on Friday while they were cleaning out storage cabinets, but it took them until Wednesday to figure out what they were, report them and get them out of the building. These containers have been around since 1996 and are not an imminent threat to public safety because of the small amount of agent reported to be in question.

So we are left with the bizarre fact that someone thought it would be OK to store them in a cabinet at the UN and then somehow they lost track of them. It’s embarrassing to the UN, for sure. Fodder for the Tonight Show monologue? Absolutely. The point should be made that chemicals far more dangerous than a few vials of phosgene (or whatever other chemical weapon they contained) are trucked in and out of cities and stored in large quantities every day. It is the aura of their previous purpose that the press finds sexy, not the true threat. Perhaps it is the culture of fear and panic that we have cultivated in the US that I abhor, but I would much rather spend my time avoiding stories about Lindsey and Paris than another over-hyped story about terrorism or media-perceived danger to the citizenry.

written by ioelrich

A very disturbing report in yesterday’s Guardian details how the Nuclear Regulatory Commission sealed records for two companies that manufacture and store highly enriched uranium in 2004. This was after some “protected information” regarding the Navy’s nuclear program were found on the Nuclear Regulatory Commission’s website. I am not sure what “protected information” is, but it apparently included “papers about the policy itself and more than 1,740 documents from the commission’s public archive.” This in effect hid from the public both information regarding their Navy work and records unrelated to the Navy’s work including the plant’s safety records.

YIKES! One incident hidden from the public was a rather disturbing spill of 9 gallons of uranium in 2006 at privately owned Nuclear Fuel Services Inc located in Erwin, Tennessee. While it is unclear how concentrated the liquid was, it is unlikely that it was enough to spontaneously detonate at the kiloton level, but certainly could have caused a nuclear chain reaction and explosion. It really depends upon how much uranium was in the liquid. To the NRC’s credit they later decided that this was a significant enough of an incident that they overrode the policy to make sure that Congress was made aware of it in their annual report, which included reference to three “abnormal occurrences.” In total there were nine violations or test failures that were hidden from the public since 2005 at the company, which has been supplying nuclear fuel to the Navy since the 1960’s.
From the Guardian:

“While reviewing the commission’s public Web page in 2004, the Department of Energy’s Office of Naval Reactors found what it considered protected information about Nuclear Fuel Service’s work for the Navy. The commission responded by sealing every document related to Nuclear Fuel Services and BWX Technologies in Lynchburg, Va., the only two companies licensed by the agency to manufacture, possess and store highly enriched uranium.”

Not really an open book: What I find astonishing is that even after the cat was out of the bag, neither the NRC nor the Department of Energy posted information relating to the incident or the policy on their websites. I certainly understand the principle of not making bad news a bigger story than it already is, but if history tells us anything we know that it is much better to come clean about these things before you get embarrassed by the press.

History of violations: Nuclear Fuel Services seems to have a history of problems that go back some time. On July 30 of this year a “confirmatory order” was published in the Federal Register that details some of this history and the fact that the Nuclear Regulatory Commission had to go into arbitration with the company over the issues.
From the Federal Register:

“Given the number and repetitive nature of some of the apparent violations, the parties acknowledged that: (1) Past disposition of violations via the enforcement policy had not resulted in NFS’s development of corrective actions capable of preventing recurrence of violations; (2) a deficient safety culture at NFS appeared to be a contributor to the recurrence of violations; and (3) a comprehensive, third party review and assessment of the safety culture at NFS represented the best approach for the identification and development of focused, relevant and lasting corrective actions.”

The order was originally issued in February of this year, but was not released because of the NRC policy. For what it is worth, the company issued a public response to the order on their web page.

written by ioelrich

Department of Homeland Security’s Inspector General released a stinging new report that details serious issues facing the National Bio-Surveillance Integration System (NBIS). NBIS was launched in 2004 with the goal of integrating all of the biosurveillance programs across the US into a single system to enhance our capability to detect agents and disease trends and respond rapidly. For example, the Centers for Disease Control and Prevention operates their BioSense program, to collect data on human health, but the data from that system is not integrated with data from the Department of Homeland Security’s BioWatch program, which is designed to detect the release of airborne biological agents. There are other surveillance systems in place and in development as well, and although you would be hard pressed to find anyone that thinks any of the systems are working optimally it is still important to try to integrate the programs into a single system (in case they ever do become robust and efficient).

The US has spent an estimated $32 billion on electronic surveillance systems and various other IT initiatives to address biodefense since 2001.

The report tells of inconsistent leadership and staffing, which has hampered NBIS delivery. In some cases many months were wasted with unnecessary administrative hurdles delaying the program. The few contracts that have been awarded under the program seem of questionable value, sometimes because the contractor was not given sufficient guidance to complete the work.

Most shocking to me was the fact that they have yet to finish a plan for implementation. The report stated plainly that, “As a result of the repeated transitions and staffing shortfalls, planning documents needed to guide information technology (IT) development have yet to be finalized. Program management has not effectively communicated and coordinated with stakeholders to secure the data, personnel, and information sharing agreements needed to support system development. Additionally, program management did not provide the contractor with adequate guidance, requirements input, or data sources to deliver a fully functional system. As such, the contractor may not fulfill NBIS capability and schedule requirements, which potentially could result in cost increases to the program.”

Assistant Secretary for Health Affairs and Chief Medical Officer, Jeffrey Runge MD, agreed with all of the findings and recommendations in the report and provided very constructive comments that indicate a sincere willingness to improve the program and stated that many of the IG’s recommendations were already being addressed. That is the nugget of good news here.

written by ioelrich

Most Strategic Security Blog readers are probably already aware of the recent outbreak of Foot and Mouth Disease (FMD) in the UK, but I thought it might be useful to post summary information on what we know to date. In short, it appears as if the virus was found on two farms, that the likely source of the virus was a research and vaccine production facility located nearby, and that there will be hell to pay if it is determined that someone at that facility is responsible for the outbreak and subsequent shut down of beef exports from the UK. The good news is that the response to this outbreak was vastly improved from a 2001 outbreak, which resulted in close to 7 million animals being destroyed. The bad news is that it was probably released from a laboratory and will no doubt spark new concerns about animal disease research.

Details:
An out break of FMD was confirmed on August 3rd on a farm in Surrey, according to the British Department for Environment Food and Rural Affairs (DEFRA). A second case was found at a nearby farm, but tests at two other farms were negative. The owner of the Woolford Farm, where the first disease outbreak was found, reported symptoms to his veterinarian and then DEFRA on the 2nd. DEFRA said in a statement that the strain is a 01 BFS67-like virus, isolated in the 1967 FMD outbreak in the UK. That strain was being used this past July for vaccine production at a nearby facility run by Merial Animal Health, which is jointly owned by Merck and French pharmaceutical company Sanofi-Aventis.
Continue reading »

written by ioelrich

The Federation of American Scientists has added a fifth Case Study to our Dual-Use Research education series. This new case study focuses on the work of Dr. Stuart Levy of Tufts University School of Medicine in antibiotic resistance. Dr. Levy is also a member of the National Science Advisory Board for Biosecurity (NSABB).

Dr. Levy’s lab identified a gene in Yersinia pestis, the causative agent of plague, that was similar to an E. coli multiple antibiotic resistance gene. A non-virulent strain of Y. pestis overexpressing the gene was resistant to several common antibiotics, including those typically used to treat plague infection. The case study includes a history of antibiotics and resistance, a description of the experiments as well as an in-depth interview with Dr. Levy discussing the work, its implications, and his perspectives on dual-use research. Dr. Levy is also one of the members of the NSABB, which is involved in developing strategies for oversight of dual-use research.

FAS is has also launched a survey for the case studies. To thank participants for completing the survey, we will enter them into a drawing for an 8GB iPod nano. Click here to go to the case studies or here to go directly to the survey. The survey is open through May 31, 2007.

The first four case studies include an introduction to biosecurity, the poliovirus synthesis experiments conducted in Eckard Wimmer’s laboratory at the State University of New York at Stony Brook; the porous particle development work of David Edwards at Harvard University; and the mousepox experiments conducted by two Australian researchers, Ron Jackson and Ian Ramshaw.

written by ioelrich

The Federation of American Scientists Biosecurity Project has prepared a brief online survey to collect feedback on our “Case Studies in Dual-use Biological Research.” To thank participants for completing the survey, we will enter them into a drawing for an 8GB iPod nano. Click here to go to the case studies or here to go directly to the survey. The survey is open now through May 31, 2007.

If you have any colleagues, students or friends involved in biological research or biosecurity, please let them know about the Case Studies and the survey. Thank you for your feedback!

The first four case studies include an introduction to biosecurity, the poliovirus synthesis experiments conducted in Eckard Wimmer’s laboratory at the State University of New York at Stony Brook; the porous particle development work of David Edwards at Harvard University; and the mousepox experiments conducted by two Australian researchers, Ron Jackson and Ian Ramshaw.

We include in-depth interviews with the researchers to document their personal experiences and present the details of their experiments, the implications for biosecurity, and the aftermath of publication. We also include commentary and analysis, accounts of the public reaction, and a discussion of scientist’s roles and responsibilities. The ultimate purpose of the case studies is to vividly illustrate the challenge and ethical complexities of conducting biology research in “an era of bioterrorism,” and to illustrate how government, the public, the scientific community, and law enforcement have interacted in the past and need to cooperate in the future.

written by ioelrich

Last month, there were three significant congressional committee hearings dealing with the Department of Homeland Security biodefense budget for FY’08. The Science and Technology Directorate’s budget request reached $799.1 million including $142.6 million for Administration and $656.5 million for research, development, testing and evaluation. A big chunk of that budget, $228.9 million was requested for Chemical and Biological security. The Department as well as the directorate has been significantly restructured in the past year after a, shall we say, rocky couple of years. It will be interesting to see what happens with the budget and how the reorganization of the biosecurity programs will play out. On the whole, they appear to be taking steps in the right direction to clean up their act.

Jerry Epstein from the Center for Strategic and International Studies testified before the Committee on Science and Technology regarding the FY’08 Biodefense budget at the Department of Homeland Security. Notably, Epstein comments on the transfer of the Biowatch program to the Office of Health Affairs, the creation of the Biomedical Advanced Research and Development Authority within the Department of Health and Human Services, and comments on classified biodefense research.

Undersecretary for Science and Technology Hon. Jay Cohen testified before the House Appropriations Committee, Subcommittee on Homeland Security. Admiral Cohen discussed the restructuring of the S+T directorate, fiscal responsibility within the agency, and their focus on etting products out of their research and development programs.

Dr. Jeffrey Runge, Chief Medical Officer for the Departments Office of Health Affairs also testified before the House appropriations Committee Subcommittee on Homeland Security where he discussed the new role of the Office of Health Affairs in BioWatch and how they will be cooperating with the S+T directorate. Dr. Runge was the Chief Medical Officer for the Department and in January of this year, the CMO office was renamed the Office of Health Affairs and given a larger role in directing the Departments Biosecurity Programs.

written by ioelrich

Representatives Lowey (D-NY) and Emanuel (D-IL) are circulating a Dear Colleague letter to be delivered to the President asking him to update the Congress on the National Strategy on Pandemic Influenza. Released 8 months ago, the strategy includes over 300 activities designed to prepare the nation for a potential influenza pandemic. However, many of the activities will also prepare the nation for other public health emergencies including bioterrorism events. Since the activities are tied to benchmarks, Congress is looking to ensure that plans are moving forward.

Dear Colleague:
Please join us in sending the attached letter to President Bush requesting an update on the progress made in federal efforts to prepare for a possible pandemic flu outbreak.

Public health experts tell us it is a question of when, not if, an influenza pandemic will strike. The World Health Organization (WHO) has reported that the avian flu has infected 258 people worldwide, killing 154 of them, with the most recent deaths occurring in Egypt just last month.

On May 3, 2006, President Bush released the federal government’s National Strategy for Pandemic Influenza Plan (NSPI) to coordinate federal efforts to prepare for a potential outbreak. The plan contains more than 300 activities to be performed by various federal agencies that are tied to specific accountability measures and timelines.

In our judgment, the eight months since the release of the NSPI are sufficient for the federal government to have made significant progress in executing at least a portion of its directives. While the status of many of the NSPI recommendations are listed on the federal pandemic flu website, not all of the relevant information has been made public.

Congress has a responsibility to carefully monitor the progress of the Administration in achieving the goals of its own plan. If you would like to sign this letter or have any questions, please contact Jean Doyle in Rep. Lowey’s office at jean.doyle@mail.house.gov, or Lauren Aronson in Rep. Emanuel’s office at lauren.aronson@mail.house.gov.

written by ioelrich