On July 15, 2008, the Federal government will be sponsoring a public consultation to engage the scientific community and research organizations in a discussion of a framework for the oversight of dual use research proposed by the National Science Advisory Board for Biosecurity (NSABB). The proposed framework, which has been formally submitted by the Board to the Federal government for its consideration, outlines key features of oversight of dual use research, including criterion for identifying dual use research of concern, local oversight, evaluation and risk assessment of research with dual use potential, responsible communication of research with dual use potential, considerations in developing codes of conduct, and the need for outreach and education. The proposed framework also outlines the roles and responsibilities of key individuals and institutions in managing dual use research, including researchers, research institutions, institutional review entities, the NSABB, and the Federal government.

The public consultation meeting will take place from 8:30 am – 4:00 pm at the Natcher Conference Center (Building 45) on the National Institutes of Health (NIH) Campus in Bethesda, Maryland (Natcher Center – NIH Visitor Information). The meeting will focus on a set of questions, included in Appendix 2 of the NSABB’s proposed oversight framework, on which the government would specifically like to solicit comment. These questions concern such matters as the clarity of the criterion proposed by the Board for identifying dual use research of concern; institutional oversight responsibilities, including how to balance appropriate controls with academic freedom and scientific exchange; and approaches to education to enhance awareness of the issue.

The meeting will be conducted as a series of panels where participants will be asked to discuss particular topics of interest to the government. Each panel will include ample time for in-depth discussion of the issues surrounding each topic.

The meeting is open to the public and free of charge. Due to limited space, pre-registration is encouraged. To register, please connect to: http://www.capconcorp.com/meeting/lifesciences2008/ . Notice of this meeting will also be published in the Federal Register. Any groups or individuals who cannot attend the meeting are encouraged to submit in advance of the meeting written comments on the questions found in Appendix 2 of the NSABB’s report to: nsabb@od.nih.gov . Please note that this meeting will not be Web cast.

More information about the NSABB is available at http://www.biosecurityboard.gov/. Questions about this meeting can be addressed to Allan C. Shipp, Director of Outreach, NIH Office of Biotechnology Activities, 301-435-2152 or shippa@od.nih.gov.

Steven Aftergood at Secrecy News, just released a report produced for the intelligence community on pox virus research around the world. The report was written by Dr Alfred D. Steinberg, working for MITRE Corporation and published last January. While not classified, the report was also not approved for public release. From the report “It is widely feared that samples of variola virus may have been retained in several countries after a WHO directive to allow storage of such samples only in Russia and the United States.” It details the published pox virus research from around the world and provides a snapshot of the breadth of pox virus research happening today.

From Secrecy News:

Dozens of countries are conducting research involving animal pox viruses, according to a descriptive survey performed for the U.S. intelligence community’s Open Source Center.

There are various potential public health and security concerns associated with pox viruses (such as smallpox), the OSC report says in a background discussion.

“Naturally occurring smallpox disease was eliminated worldwide in 1977. Routine vaccination of US civilians against smallpox was discontinued in 1971, but allowed for travelers to endemic regions until the late 1970s. In most other countries, vaccination of the general population ended by 1982. As a result of this halt in vaccination, most of the US population could now become ill with smallpox disease should it be reintroduced by accident or intentionally.”

“In addition, humans are susceptible to several naturally occurring viruses related to smallpox, one of which could become a serious disease risk through natural evolution. Routine smallpox vaccination previously protected against these viruses. Finally, there is concern about the potential creation of a genetically engineered poxvirus that might be markedly pathogenic for humans.”

Like most finished intelligence products from the Open Source Center, the report on animal pox viruses has not been approved for public release. But a copy was obtained independently by Secrecy News.

Today in a hearing of the House Committee on Energy and Commerce it was revealed by the Government Accountability Office (GAO) that the Department of Homeland Security’s plan to move foot and mouth disease research to the mainland United States is based on faulty assumptions.

Foot and mouth disease is caused by the most infectious virus known to man. Nearly 100% of exposed animals become infected. Currently, the only place where foot and mouth disease (FMD) research can be done in the US is the Plum Island animal disease research facility, located off the tip of Long Island.

DHS had been planning to move that research to the mainland for sometime now, but that seems doubtful. The testimony given today by Nancy Kingsbury, the managing director of Applied Research and Methods at GAO indicates that DHS based its decision to move FMD research on a 2002 USDA study that simply addressed whether it was technically feasible to do so, ignoring the potential for human error.

We found that DHS has neither conducted nor commissioned any study to determine whether FMD work can be done safely on the U.S. mainland. Instead, DHS relied on a study that USDA commissioned and a contractor conducted in May 2002 that examined a different question: whether it is technically feasible to conduct exotic disease research and diagnostics, including FMD and rinderpest, on the U.S. mainland with adequate biosafety and biosecurity to protect U.S. agriculture. This approach fails to recognize the distinction between what is technically feasible and what is possible, given the potential for human error. DHS told us that this study has allowed it to conclude that it is safe to conduct FMD work on the U.S. mainland.

In addition to a number of other methodological problems with the study, we found that it was selective in what it considered in order to reach its findings. In particular, the study

1. did not assess the history of releases of FMD virus or other dangerous pathogens,

2. did not address in detail the issues related to large animal work in BSL-3 Ag facilities, and

3. was inaccurate in comparing other countries’ FMD work experience with that of the United States.

Subcommittee chairman Rep. John Dingell (D-MI) was particularly critical of DHS in his opening statement, noting the trend to move infectious animal disease research to islands, not off them.

“Equally troubling, it appears that DHS is out of step with the rest of the world. GAO investigators visited major labs across Europe and found that in other developed countries, the trend is to do just the opposite of what DHS has proposed: Germany built its new lab on an island; Denmark built its new lab on an island; and the U.K. Parliament is debating the relocation of its lab to an island.” Dingle continued, “Why then would DHS propose to move live virus of foot-and-mouth from Plum Island to the American heartland? GAO was unable to find a scientific reason for the move. They found apparent agreement that the current Plum Island lab needs substantial renovation, but they found no justification for moving the lab to the mainland.”

You can read the highlights of the GAO testimony here and read more press coverage of the plan here

The laboratory director of the National Biodefense Analysis and Countermeasures Center (NBACC), Dr. Patrick Fitch, said yesterday that research at the laboratory will not “create threats in order to study them”. This statement is a welcome change from previous presentations about the lab’s mission.

The controversy about the research goals of the NBACC emerged after Lt. Colonel George Korch, Jr., PhD, gave a powerpoint presentation about the facility in February 2004. According to this talk (the slides are available here), part of the NBACC threat assessment mission would include acquiring, growing, modifying, storing, stabilizing, packaging, and dispersing biological threat agents to determine various properties and capabilities. The presentation also states that the facility will “characterize classical, emerging, and genetically engineered pathogens for their biological threat agent potential” through “computational modeling of feasibility, methods, and scale of production.” These statements, if true, meant that portions of the research planned for the facility could be interpreted to be in violation of Article I of the Biological Weapons Convention, which says that signatory states are not “to develop, produce, stockpile, or otherwise acquire or retain microbial or biological agents, or toxins, that have no justification for prophylactic, protective, or other peaceful purposes.” From Dr. Fitch’s statements today it appears that the research priorities of NBACC have changed since 2004 to minimize the perception that the U.S. will conduct illegal research at this facility.

Dr. Fitch also said that a majority of the research that will occur at the lab will be unclassified, and he is working to develop a policy that will publicly list all of the projects going on at the NBACC, even if some of the research results remain classified. We’ll have to wait and see if these statements actually come true, but for the time being this seems like a positive development.

Monday’s talk was sponsored by the Homeland Security Program at the Center for Strategic and International Studies (CSIS). The Federation of American Scientists has more information about the debate surrounding the NBACC on their website, available here.

FAS just launched an online compilation of more than 500 documents on the US ratification of the Chemical Weapons Convention (CWC). The Archive (/blog/cw) includes a timeline of CWC negotiations, a history of its signing and ratification, and current news and commentary on the CWC.

In addition to the documents, Cheryl Vos, FAS Biology Research Associate, will report daily from The Hague during the Second Review Conference, 7 – 18 April 2008, on the proceedings, plenary sessions and open forum.

The online archive’s “Document of the Day” feature will kick off with a letter submitted by former Secretary of Defense and current Vice President Dick Cheney to the Senate Foreign Relations Committee. The letter expresses Cheney’s deep opposition to U.S. ratification of the Chemical Weapons Convention and was read into the record by former Secretary of Defense James Schlesinger who, along with fellow former Secretaries of Defense Donald Rumsfeld and Caspar Weinberger, was present at the Committee hearing to provide testimony against the CWC. /cw/cwc_archive/cheneyletter_4-8-97.pdf

The CWC entered into force on April 29, 1997. The archive highlights accomplishments over the past 11 years, and arguments made for and against US ratification in Congress.

Many of the letters, petitions and reports have not been previously available online.

Visit the Chemical Weapons Convention Archive at /blog/cw/.

To begin the day the NBSB listened to presentations from each of the members of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The Enterprise is coordinated within HHS by the Assistant Secretary for Preparedness and Response and includes the NIH, CDC, FDA and BARDA. PHEMCE’s role in HHS is to coordinate the research, development, acquisition and deployment of medical countermeasures to chemical, biological, radiological or nuclear (CBRN) threats. Many of the topics the NBSB will consider and provide recommendations on will fall within the PHEMC Enterprise, so the board heard a representative from each of the agencies describe their efforts and role in PHEMCE. The morning session ended with presentations from Bruce Gellin giving an overview of the HHS pandemic flu program and Robin Robinson detailing BARDA’s pandemic preparedness and response activities.

During the afternoon session the board got down to business. After being presented with information on the possible topics that they were considering, the NBSB voted for 4 specific topics and formed subcommittees for each.

First the NBSB wanted to address the issue of pandemic influenza preparedness. The subcommittee will evaluate current research, identify the gaps, and then report to the whole board to begin making recommendations.

The second subcommittee will review the US government research portfolio to determine whether efforts are as integrated as they could be. They too will return their findings to the whole board with the goal of making recommendations to increase collaboration and avoid duplication of efforts.

The third subcommittee was commissioned to look at disaster medicine. They will take HSPD-21 as a framework for evaluation and further development of a national disaster medicine plan. It will include the possibility of promoting ‘disaster medicine’ as a new discipline and setting up dedicated training courses and programs.

Finally, it was agreed that a subcommittee be set up to look at the gaps in the medical countermeasures marketplace. This subcommittee will focus on the private sector and look at ways to engage their involvement in countermeasures development.

It was also agreed that the issue of special and at-risk populations and the issue of communications and data interoperability not be stand alone topics. They will be integrated into each of the four subcommittees and a decision to exclude them would need to be explicitly justified.

Finally the members of the NBSB volunteered their placement on subcommittees within their areas of expertise and subcommittee chairs were appointed. Andrew Pavia will chair the pandemic influenza subcommittee, Patrick Scannon; the government research evaluation subcommittee, Jim James; the disaster medicine subcommittee and John Parker; the gaps in countermeasure marketplace subcommittee. The NBSB will meet again in 6 months to hear reports from the subcommittees and make recommendations.

Written with Cheryl Vos

The National Biodefense Science Board (NBSB) began their inaugural meeting yesterday in Washington DC. The board, made up of 13 voting members and 21 non-voting ex officio representatives, was created as part of the 2006 Pandemic and All-Hazards Preparedness Act. The NBSB was chartered with the task of providing expert advice to the Department of Health and Human Services (HHS) Secretary on science, technology, and other matters of special interest on chemical, biological, radiological, and nuclear issues, including both naturally occurring and deliberate events.

The members include Patricia Quinlisk (Iowa Dept. of Public Health, chair), James J. James (American Medical Association), Steve Cantrell (Denver Health Medical Center), Eric Rose (SIGA Technologies), Albert Di Rienzo (Welch Allyn), Ken Dretchen (Georgetown University Biosecurity Institute), John Grabenstein (Merck Vaccine Division), Ruth Berkelman (Emory University , Thomas MacVittie (University of Maryland School of Medicine), John Parker (SAIC), Andrew Pavia (University of Utah Medical Center) Roberta Carlin (American Association on Health and Disability), and Patrick Scannon (XOMA).

After the morning introductory session, the group listened to several talks presented by executive branch officials that discussed current US Government policies on preparedness and response. After this, the group heard another series of talks that outlined possible topics and issues that the NBSB could focus on initially. The broadly defined proposed topics, developed by officials at HHS, are as follows- an evaluation of research and development components of the HHS influenza preparedness strategy, innovation and medical countermeasure development, how to address gaps in the medical countermeasures marketplace, modeling and metrics to inform medical consequence assessment, and considerations for special and at-risk populations.

Today the group will make decisions about how to go forward as a board. The group will try to prioritize topics and determine how to fulfill their charge. Since the mandate to the NBSB is so broad, many members agreed that it is important to determine the group’s focus in a way that considers issues based on their timeliness and achievability.

The agenda for the meeting is here

NBSB main page

Members list

Written by Nate Hafer

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.

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.

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.

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.

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.

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