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Public Consultation Meeting of the NSABB

On Tuesday, July 15, 2008 the National Science Advisory Board for Biosecurity (NSABB) hosted a meeting to solicit public comment on the June 2007 report, “Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information”.

The meeting was broken into three panels that examined different aspects of the framework document, and each panel included several members of the public who shared their perspective on these issues. Continue Reading →

Select Agent Program Regulations and High-Containment Laboratories

On June 12, 2008 Senators Richard Burr (R- North Carolina) and Edward Kennedy (D- Massachusetts) introduced S.3127, a bill to reauthorize the Select Agent Program by amending the Public Health Service Act and the Agricultural Bioterrorism Protection Act of 2002 and to improve oversight of high containment laboratories. To provide a context for the content of the bill, the AAAS Center for Science, Technology and Security Policy hosted a briefing featuring Gigi Kwik Gronvall from the UPMC Center for Biosecurity, Nancy Connell from the University of Medicine and Dentistry of New Jersey and David Relman from Stanford University.

Gronvall gave a brief background of the Select Agent Program which is run jointly by the Center for Disease Control and Prevention and Animal and Plant Health Inspection Service at the US Department of Agriculture. She also made the point that the SA program is focused on security, but high containment laboratories and protocols are designed primarily to provide safety, not security.

Connell, a research scientist who works with select agents, contrasted the week or two it took to plan an experiment before the SA program was put in place to the 6-12 months it takes now. Experiments are also much more expensive, cumbersome, and according to Connell “what is missing now is an environment of transparency and collaboration.”

Relman, who is also a member of the National Science Advisory Board for Biosecurity (NSABB) underscored the fact that there are risks associated with expanding biotechnology, but there are also enormous benefits. For example, he highlighted the new NIH Human Microbiome Project “basically the human genome project on steroids”, an initiative to map the genomes of all the microorganisms that live on the human body – providing a tremendous amount of information. Relman also expressed concerns about overusing and over-relying on the SA program because regulates access to agents that are found naturally and provides a very specific list that could be circumvented with synthetic or engineered agents.

The bill has now been referred to the Committee on Health, Education, Labor, and Pensions.

National Biodefense Science Board Meeting

On June 18, 2008 the National Biodefense Science Board held their second meeting. The NBSB was created under the 2006 Pandemic and All-Hazards Preparedness Act and was established to provide expert advice and guidance to the Secretary of the U.S. Department of Health and Human Services (HHS) on scientific, technical, and other matters of special interest to HHS regarding activities to prevent, prepare for, and respond to adverse health effects of public health emergencies resulting from chemical, biological, nuclear, and radiological (CBRN) events, whether naturally occurring, accidental, or deliberate. During the inaugural meeting of the NBSB on Dec 17-18, 2007 members were sworn in and working groups were formed to consider the issues members felt were important.

The meeting began with a presentation from Robin Robinson, the newly named the Director of the Biomedical Advanced Research and Development Authority (BARDA), on “Old & New Perspectives at BARDA”. Whereas in the past initiatives for CBRN threats and Pandemic Flu were independent projects within BARDA, and BioShield was used for high risk acquisition tasks, these have all been integrated under the new BARDA strategy. During both this and a later presentation, Robinson described BARDA’s interest in the possibilities of personal preparedness. He described the progress made on small medical kits (MedKits) containing doxycline to treat anthrax that could be stored by individuals in their homes in case of an emergency. He also discussed the plans for influenza-focused antiviral MedKits. On what became the hot topic of the day, Robinson solicited input from the board on the issues surrounding home stockpiling, whether it is safe, effective, and worthwhile. He also asked for input on what should be the  right balance of government and personal strategies for preparedness.

Later in the day Robinson continued the discussion of personal preparedness and invited comments from Richard Besser of the CDC and Boris Lushniak of the FDA. Besser and Lushniak discussed public safety issues with personal stockpiling as well as some of the underlying problems with antibiotic resistance, drug expiration, product labeling and other regulatory issues.

In their December meeting, the NBSB had expressed an interest in biosurveillance. To address this, Capt. Daniel Sosin of the CDC briefed the board on the draft National Biosurveillance Strategic Plan. The NBSB has also indicated a concern for vulnerable populations in the event of pandemic of other major public health emergency, and therefore invited Susan Cooper from the Tennessee Department of Health to come and talk about this issue. Cooper gave an overview of the Association of State and Territorial Health Officials (ASTHO) Guidance document on “At-Risk Populations and Pandemic Influenza: Planning Guidelines for State, Territorial, and Local Health Departments”.

The NBSB also heard from C. Norman Coleman from the Radiation Research Program at HHS and Richard J. Hatchett from the Radiation Countermeasures Research and Preparedness program at NIAID. Coleman presented some of the strategies within the Radiation Management System and Hatchett discussed providing support services for radiation countermeasures product development.

Amy Patterson, executive director of the National Science Advisory Board for Biosecurity (NSABB) provided an overview of NSABB efforts to the NBSB. The NSABB has a similar mandate as the NBSB, and has been working since 2005 on issues of dual-use research of concern. Patterson focused on the NSABB’s recent recommendations on synthetic genomics and their draft oversight framework for dual-use research.

Throughout the day the Chairs of the working groups which were formed in December (Pandemic Influenza, U.S. Government Medical Countermeasures Processes for CBRN Agents, Markets and Sustainability, and Disaster Medicine) gave progress reports. In addition, a new subcommittee on Disaster Mental Health was introduced.

Finally, the NBSB discussed their recommendations and future activities. The members expressed interest in looking more carefully at the issue of personal preparedness. To this end it was decided that a working group be formed to deal specifically with the issue. It was also decided that no formal recommendations be made to Secretary Leavitt at this time, however, they would ask the Secretary to review the comments made by individual members on the topics of personal preparedness and home stockpiling during the meeting.

The next NBSB meeting will be held in November 2008.

Promoting Mutual Security and Development through Bioscience Cooperation

Yesterday the CUBRC Center for International Science and Technology Advancement held a symposium entitled “Promoting Mutual Security and Development through Bioscience Cooperation”. The meeting focused on ways to promote cooperation and networking across organizations to create a more prosperous and secure world.

Dr. Leonard Marcus of the Department of Health Policy and Management at Harvard University began the day by discussing the qualities of leaders that successfully link disparate groups and organizations.His remarks were especially relevant considering the diverse background and expertise of individuals and organizations involved in cooperative bioscience projects.

Continue Reading →

Understanding President Bush’s FY2009 Biodefense Budget Request

Today the American Association for Advancement in Science (AAAS) Center for Science, Technology and Security Policy sponsored a briefing on Capitol Hill entitled “Understanding President Bush’s FY2009 Biodefense Budget Request.” Dr. Alan Pearson of the Center for Arms Control and Nonproliferation was the featured speaker at the event and his presentation was followed up by comments from distinguished roundtable panelists.

Dr. Pearson has done an in-depth analysis of federal biodefense funding and his full report “Federal Funding for Biological Weapons and Defense, Fiscal Years 2001 to 2009″ is available online. Today Dr. Pearson presented data from this report and highlighted some trends. On the whole, since FY02, federal biodefense funding has remained relatively consistent between 5 and 7 billion dollars each year. In addition to this, Project BioShield received 3.3 billion dollars in FY04 and FY05 and is slated to receive an additional 2.175 billion in FY09 (which will bump total FY09 spending to nearly 9 billion). Overall, the bulk of funding is received by the Department of Defense, the National Institutes of Health, and the Center for Disease Control and Prevention. More than half of the funding goes towards research, development, testing and evaluation (RDT&E) as well as medical countermeasures procurement and stockpiling. In general, funding for these activities as well as surveillance and food and agriculture needs has been increasing since FY03, but money provided for state and local hospital preparedness is actually declining.

Dr. Pearson also pointed out that funding for prevention projects as compared to RDT&E projects decreased to about 3% of total biodefense spending immediately following September 11, 2001. For FY08 and FY09, funding has returned to 7%, which is approximately equal to the pre-9/11 levels. Other trends Pearson mentioned were the increased focus on global engagement as opposed to focusing on the former Soviet Union, and an increased emphasis on infectious disease surveillance, biosafety and biosecurity.

Immediately following Dr. Pearson’s presentation the roundtable panelists each added a few comments of their own. Dr. Brad Smith of the UPMC Center for Biosecurity said a few words about medical countermeasures. Specifically he noted that this really isn’t a large amount of money in defense terms, and likely isn’t adequate for the long term nature of drug development and testing to protect the entire nation.

Dr. Gerald Epstein from the Center for Strategic and International Studies continued by pointing out that this really isn’t a problem that can be addressed using an export control model as has been done in the past for nuclear material. In this case the spread of biotechnology is necessary to promote long-term capacity building worldwide, and the dual-use nature of it presents the security problem.

Dr. Eric Toner of the UPMC Center for Biosecurity briefly brought up the lessons learned from the 2001 anthrax attacks. He noted that hospitals are better prepared today to handle an event and have greatly improved the communications networks within their region and with first responders.

Dr. James Roth from Iowa State University discussed agriculture and food defense. He argued that this sector is underfunded because the U.S., since the end of World War II, has always had plenty of (cheap) food available. This has dramatically changed, and now the lack of agriculture and food security present huge vulnerabilities.

Finally, Dr. Georges Benjamin from the American Public Health Association talked about infectious disease surveillance and public health preparedness. He highlighted the fact that within the U.S. there is no culture of civilian preparedness; that most people have not recognized this issue as part of their daily lives and have not made family disaster plans.

The “What if?” of Dual-Use Research Awareness

By Michael Stebbins, originally at Science Progress.

The principle is simple. The products, information and techniques of some life sciences research could be misused for nefarious purposes, such as bioterrorism, and the scientific community should do everything it can to prevent such misuse without impeding research progress. What is unclear is what steps scientists should take when they have concerns about such “dual-use” research.

The problem is that we (myself included) have not taken the long-view on this issue.

Dual-use research has been the subject of much discussion in the biosecurity community since the 2003 release of the National Research Council report, Biotechnology Research in the Age of Terrorism, which suggested that, “Adequately addressing the potential risks that research in advanced biotechnology could be misused by hostile parties will require educating the community of life scientists, both about the nature of these risks and about the responsibilities of scientists to address and manage them.” But convincing scientists that they should add dual-use research awareness and evaluations to their already long list of idiosyncratic worries turned out to be far harder than anyone imagined.

Enter the National Science Advisory Board for Biosecurity. In June of last year, the NSABB released their Proposed Framework for the Oversight of Dual Use Life Sciences Research, in which the board recommend that life scientists receive “mandatory education about dual-use research issues and policies,” with the goal of “ensure(ing) that all individuals engaged in life sciences research are aware of the concerns and issues regarding dual use research and their roles and responsibilities in the oversight of such research.”

In addition to mandatory training, both the National Research Council and the NSABB have advocated for the creation of codes of conduct for life sciences researchers that includes dual-use awareness. Now, research societies are preparing and implementing their codes of conduct, infusing another layer of awareness into the research community.

Indeed, it will not be long before it is mandatory that all federal grantees in the life sciences receive such training, and that all biologists sign codes of conduct. Awareness will spread like happy little dandelions. That is until someone points out that they are weeds.

Don’t get me wrong. I am an advocate of mandatory training and think codes of conduct are a good tool for increasing awareness. Not least of the reasons for my support being that the Federation of American Scientists arguably has the most extensive dual-use training materials available to date in the form of our multimedia Case Studies in Dual-Use Research. Wide distribution of these case studies and materials created by other groups has been a goal of ours from the time we started the project.

The problem is that we (myself included) have not taken the long-view on this issue. If we dramatically increase awareness, then we also increase the chances that scientists will have concerns about dual-use research or worse—suspicions that a colleague is up to no good. What the NSABB, National Research Council and the biosecurity community on the whole have failed to fully address is how those researchers should attend to their concerns. Government-issued guidelines for researchers will only get them so far.

Since part of the duty of a responsible researcher will certainly be reporting unsafe experiments or suspicious behavior, instituting codes of conduct and training all scientists makes potential whistleblowers out of every working biologist. This creates an immediate need for protocols and methods for scientists to get advice and report their concerns.

There is currently no reliable independent system in place for these researchers to report or receive advice on how to handle their concerns.

It is well recognized that a major barrier to reporting such incidents to law enforcement, supervisors, biosafety officers, or institutional review boards, is the fear of reprisal. This might also be compounded by some members of the scientific community not trusting government officials and law enforcement in particular. This extends from laboratory technicians and support staff to primary investigators. Even if there is no indication of foul play, scientists may feel that there are experiments being conducted at their institution that have serious dual-use implications, or that are dangerous to those conducting them and their colleagues.

There is currently no reliable independent system in place for these researchers to report or receive advice on how to handle their concerns. Such a system would be a valuable contribution to strengthening biosecurity awareness and participation within the biological research community. It should be pointed out that such a system is a good way to get across the idea that official whistle-blowing is not the first and only resort.

I and others have suggested that we need to build a secure Internet-based system where scientists will be able to report their concerns and receive advice and recommendations on the steps that they should or should not take. Concerns will naturally run the range of how to fill out dual-use reporting forms on grants to reporting potentially illegal situations in the lab. It is important that the government not operate the system to ensure buy in. Rather, an ombudsman network should be run by a non-government organization that will allow partial anonymity.

In the event that a clear cause of action is required, such as when a law is being broken, a non-government organization would be well-placed to help facilitate conversations with law enforcement, make queries on the behalf of the scientist to government, or alleviate concerns without endangering their status at the institute.

The system will have to be backed by a large group of advisors, including experts from multiple science disciplines, ethicists, legal and law enforcement representatives to ensure that users are receiving timely and accurate advice. The system administrator will have to be available at all times and have constant access to advisors in the case of a serious problem.

One major concern of scientists will be the preservation of anonymity. This issue can be simply handled by having staff farm out the query to advisors without revealing the identity of the scientist. Total anonymity, however, cannot be completely preserved in such a system.

In principle, users will turn to this system when they feel uncomfortable reporting concerns within their institution or when they are unsure of who to turn to. Responses will either ask for further information, clarification, or report back advice on the appropriate course of action.

Users must also feel comfortable that the information they divulge will not be released to anyone unless they approve it. This can be accomplished by making users agree to simple terms before sending their query. Those terms will detail operation standards and will inform users under which conditions the managers have a legal responsibility to inform appropriate authorities, and that they may be contacted by such authorities directly in the event that a law has been or is about to be broken.

Detailed records of responses and customizable electronic form letters will allow us to provide useful assistance and inform users of their rights and the laws that might apply to them in a timely manner. It should be stressed that in the event a user reports an imminent threat, they will automatically receive instructions on who they should contact. There are several important issues that will have to be addressed while developing a biosecurity reporting system, among them:

Whistleblower Laws. The United States has a well-established set of “whistleblower” laws that protect people from reprisals for reporting. There are several excellent non-profit groups that specialize in this area and it will be important to bring them in for legal advice and possibly to present a series of Frequently Asked Questions on the site for scientists to learn about their options.

Legal Advice. We will need legal advice on a broad range of issues, including the liability associated with giving advice, maintaining anonymity, the situations under which those with knowledge of possible crimes are legally obligated to contact law enforcement, and applicable laws for users.

Advisory Boards. An advisory board consisting of scientists, ethicists, biosecurity experts, and legal advisors will have to be brought in for the design and implementation. A second advisory board will have to be available for advice on individual cases. It will be important to have a wide array of expertise and knowledge on hand to address any reports that come in.

Law Enforcement Guidelines. A clear relationship with law enforcement will need to be established so that in the event that there is a user who is uncomfortable going to law enforcement themselves, we would be able to report an incident on their behalf.

Testing. It will be necessary to test the system through a series of table-top scenarios that provide challenges to our response times and content.

It is a virtual certainty that this type of system would eventually be abused maliciously against other scientists trying to slow down a competitor, or exact revenge. In that sense, the system itself would have dual-use potential and like science, safeguards and awareness will reduce, but might not eliminate, unfortunate incidences.

It is also hard to predict how often such a system would be used and what percentage of the time it would receive cranks. But it is equally unclear to what degree dual-use research is a threat to national security. If we are going to require scientists to learn about the potential for misuse, then it is essential that they have a place to turn if they recognize potential misuse or have questions about complying with legal and ethical requirements.

Michael Stebbins is the Director of Biology Policy for the Federation of American Scientists, President of the SEA Action Fund and author of Sex, Drugs and DNA: Science’s Taboos Confronted.

Public Meeting of the NSABB July 15th

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.

Survey of Pox Virus Research

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.

Homeland Security used wrong study for Foot and Mouth research plan

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

NBACC director says they will not create threats at lab

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.