Posts by Michael Stebbins

Ask your Congressman About Science

CapitolThe Federation of American Scientists has joined 16 prominent scientific and engineering groups to ask all Congressional candidates seven questions on the science and technology policies that affect all of our lives.

The November election will be a critical moment for science and technology policy in the United States. Voters must know where the candidates stand on issues such as climate change, the environment, and soaring energy prices.

Innovation 2008 is a voter education initiative from Scientists and Engineers for America (SEA) to make science and technology a prominent part of the 2008 elections. Ask your candidates today!

For more information please visit: http://sharp.sefora.org/innovation2008/.

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.

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

FAS Launches Online Chemical Weapons Convention Archive to Mark 2nd Review Conference

FAS just launched an online compilation of more than 500 documents on the US ratification of the Chemical Weapons Convention (CWC). The Archive (http://fas.org/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.

cheney letterThe 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. http://fas.org/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 http://fas.org/blog/cw/.

National Biodefense Science Board Meeting: Day 2

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

National Research Council Report slams NIH findings on Boston U containment lab

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.

Another Foot and Mouth Disease case in the UK

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.

Iraqi Chemical Weapons Found…at the UN? Don’t Panic!

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.

Uranium spill hidden from public because of NRC policy

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.