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Briefing on Oversight of High-Containment Laboratories

On March 12 AAAS in partnership with the Center for Biosecurity of UPMC hosted a public briefing to discuss the current oversight of high-containment laboratories. The session was held to discuss the elements of H.R. 1225, the recently introduced Select Agent Program and Biosafety Improvement Act of 2009. This bill seeks 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.
Michael Ehret from the Midwest Research Institute, a private laboratory, Michael St. Clair, from Ohio State University an academic laboratory, and Michael Pentella from the University of Iowa, a public health laboratory discussed the regulatory procedures associated with the operation of each of their facilities. Each spoke about the different agencies and number of inspections or audits that they face each year, the costs of these audits and staff training as well as additional personnel reliability programs in place at their institutions.
All three speakers expressed concern about the number of agencies, each with a unique set of regulations, responsible for oversight of their facilities and suggested that a harmonized approach to regulation was necessary. Each of the represented laboratories also had internal oversight committees to ensure a high level of safety and security.

President Obama Overturns Bush Stem Cell Ban

During a ceremony at the White House today, President Obama signed an Executive Order to overturn President Bush’s 2001 restrictions on using federal funds for research on embryonic stem cells. The Executive Order is focused on stem cell research, but it signals a desire by the Obama Administration to return scientific integrity to its policy decisions. Accompanying the Executive Order will also be a Presidential Memorandum to ensure that the government’s scientific decisions are insulated from political influence. This is a welcome change after 8 years of the Bush Administration ignoring or distorting science to further its political agenda.

Over 30 Nations can deploy biological weapons

Yesterday Interfax news agency reported that experts estimate that over 30 nations have the capability to rapidly deploy biological weapons. The remarks were made by Natalya Kaverina of the Russian Academy of Sciences’ Institute of Global Economy and International Relations during a presentation for the Stockholm International Peace Research Institute on March 3. Kaverina suggested that the tempation to use such weapons had inreased due to global instability and economic uncertainty.

Plague Infected Mice Missing from UMDNJ Lab

This weekend it was reported that 2 mice infected with Yersinia pestis, the causitive agent of plague, were missing from a lab at the University of Medicine and Dentistry of New Jersey (UMDNJ). In September 2005 it was also reported that 3 live mice infected with Y. pestis were missing from UMDNJ a lab. In this case however, the “missing mice” are actually the carcasses of mice who died during an experiment, were bagged and placed in a freezer for storage until the experiment was completed and they could be incinerated. It is believed that the missing bag of mice was accidentally sterilized along with another bag.

In both cases the FBI investigated and determined that there was no public health risk.

USAMRIID Suspends Select Agent Research

ScienceInsider is reporting that the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has suspended their research on biological select agents and toxins. Officials froze research last Friday when they realized that there were problems with the system of accounting for high risk microbes and biological materials in the laboratories at Fort Detrick, MD and have begun an inventory of select agents and toxins at the facility. Not coincidentally, this is the same facility that has been under intense scrutiny after the FBI named researcher Bruce Ivins as their main suspect in the 2001 anthrax letter attacks.

“The decision was announced by institute commander, Col. John Skvorak, in a 4 February memo to employees. The memo, which ScienceInsider has obtained, says the standard of accountability that USAMRIID had been applying to its select agents and toxins was not in line with the standard required by the Army and the Department of Defense. USAMRIID officials believed that a satisfactory accounting involved finding all the items listed on its database, the Army and DOD wanted the converse; that is, all select agents and toxins needed to be matched to the database.”

The Army is clearly clamping down on their select agent research programs with very strict accounting of biological agents and, personnel in direct response to the Ivins case. Of note, on October 28, 2008 Army Regulation 50-1 came into effect. AR50-1, outlines a strict Biological Personnel Reliability Program for all DoD employees with access to BSAT. In order to be cleared to work with or have access to BSAT everyone must go through intense screening. This includes an interview, personnel security investigation, personnel records review, medical evaluation (includes mental evaluation and any medications) and drug testing.

NAS-AAAS Dual-Use Research Survey Results Released

Today the National Academies of Sciences (NAS) and the American Association for the Advancement of Science (AAAS), released their survey of Attitudes and Actions on Dual Use Research in the Life Sciences. The survey was sent to AAAS members whose primary area of research was in the life sciences in order to assess their awareness of and attitudes toward “dual-use” research-studies undertaken for beneficial purposes that could also have harmful applications. The survey also explored actions the scientists might support to reduce the risk of misuse of research, as well as steps that scientists may already be taking in response to these concerns.

David Franz of the Midwest Research Institute and Ronald M. Atlas of the University of Louisville, two of the members of the committee which reviewed the survey results and wrote the final report presented the main findings. David Franz began by defining dual-use research and its importance within the life sciences community and Ronald Atlas discussed the primary findings of the survey. Atlas noted that a low response rate and uncertainty about whether the sample is representative of the broader life sciences community limits the ability to draw definitive conclusions. Nonetheless, the survey results are useful and informative and Atlas went on to explain that the results indicate that some respondents have already been so concerned about dual-use issues that they have altered their research or experiments. Even in the absence of guidelines or government restrictions some scientists have already taken action to try to avert misuse of biomedical research.

Copies of A Survey of Attitudes and Actions on Dual Use Research in the Life Sciences: A Collaborative Effort of the National Research Council and the American Association for the Advancement of Science are available from the National Academies Press.

Today’s presentation can be heard via podcast from the National Academies website.

NBSB September Meeting – Disaster Medicine

On Sept 23, 2008 the National Biodefense Science Board (NBSB) held an afternoon meeting to review the report and recommendations for the National Disaster Medical System (NDMS) that had been prepared by the Disaster Medicine Working Group. The Working Group had assembled an assessment panel which evaluated previous reports done on the NDMS and put together their own report and specific recommendations which, with the approval of the NBSB, would be transmitted to the Assistant Secretary for Preparedness and Response.
Kevin Yeskey, Director of the Office of Preparedness and Response and Deputy Assistant Secretary for Preparedness and Response began the meeting by giving an overview of NDMS and its capabilities. He also highlighted the recent response to hurricanes Gustav and Ike and contrasted NDMS participation to what occurred in response to hurricane Katrina. For Gustav and Ike they had been able to mobilize fully equipped teams, totaling 1100 response personnel rather than the 37 in the wake of Katrina.
Next, Dr. Stephen Cantrill, the Chair of the Working Group presented the assessment panel’s key recommendations and the NBSB had the chance to go over each and comment. Below is an outline of the recommendations, as the panel chose to organize them.
Recommendation 1: Envisioning the Future
1.1 Develop a clear strategic plan for the NDMS and integration of all other disaster medicine response mechanisms.
1.2 Develop a civilian advisory group for NDMS.
Recommendation 2: Integrating the Past
2.1 Establish a formal mechanism to track the implementation of lessons learned and recommendations from after-action reports.
Recommendation 3: Strengthen the team
3.1 Ensure teams are fully staffed and well-equipped
3.2 Improve and streamline application process for all personnel – *This point was removed during the discussion because based on Director Yeskey’s opening presentation, the NBSB determined that this has been done. Yeskey reported that the application and hiring process has been reduced from 8-12 months to 42 days.
3.3 Implement a uniform training program across NDMS.
3.4 Put into place a system to register non-overlapping personnel so that response capability can be precisely accounted.
Recommendation 4: Serving the patient
4.1 Determine who the patient is, consider patients that have been displaced across state lines NDMS patients even if they were not receiving NDMS care.
4.2 Expand reimbursement so that it is not limited to NDMS hospitals. Ensure that it is timely.
4.3 Define a concept of operations for patient moving and tracking.
4.4 Expand Electronic Medical Records for field use.
4.5 Examine barriers to patient care in emergency response and define criteria for temporary suspension of HIPPA or other requirements during an emergency.
Recommendation 5: Engaging Partners
5.1 Partner with state and local organizations.
5.2 Seek out public/private sector partnerships for patient transport and care.
Recommendation 6: Secure Funding
6.1 Funding is inadequate for the program. Seek out new sources for sustained funding.
Recommendation 7: Future
7.1 Request feedback from ASPR for the NBSB Spring/Summer 2009 meeting on which of the recommendations are complete, in progress or will not be undertaken.
7.2 Recommend that a longer term follow-up study be conducted to focus on the NDMS and these recommendations – * This point was added by the NBSB during the discussion.

The next NBSB meeting will take place Nov 18-19, 2008 and the Board is expecting to hear a presentation from the Disaster Mental Health Subcommittee, a report from the Medical Countermeasure Processes Working Group, a report from the Personal Preparedness Working Group and receive a white paper from the Education and Training Working Group.

Job Posting: Project Manager for Biosecurity

The Federation of American Scientists Biosecurity Project has the following position available:

Job Title: Project Manager for Biosecurity

Location: Washington, D.C.

Salary: Commensurate with experience, generous benefits

Education: Ph.D. or Masters degree considered.

Description: FAS is looking for a smart, energetic individual to help direct a major web-based project using innovative video, multimedia and social networking tools to revolutionize the way biosecurity issues are communicated. The initial work will focus on building and development of an interactive and easy to use web portal. Unique content will be created and updated daily. This project is part of an ambitious FAS program to use web 2.0 principles and new technologies to provide comprehensive information on biological and chemical weapons. It will expand on current FAS work to provide high-quality education material on dual-use awareness by providing a hub for biosecurity information and training.

The individual will help design and build the web portal, create new and unique content to feature, keep it up to date and current, oversee efforts to evaluate its impact, plan and execute future work that expands the scope and utility of the site. The person will also participate in broader FAS work and further existing research programs on biological and chemical weapons.

Candidates should have taken graduate-level courses in biology or chemistry and have knowledge of html, web design, and image/video editing. Familiarity with Flash, MySQL database management, and WordPress blog software is highly desirable but not essential.

FAS professionals are expected to be highly motivated and able to work independently.  They are expected to be able to analyze complex issues and summarize findings; communicate clearly, both orally and in writing; have strong organizational skills; be capable of prioritizing work assignments in a heavy workload environment; and possess superior research and information technology skills.

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Anthrax scientist commits suicide

It was reported today in the Los Angeles Times that Bruce E. Ivins, a bioweapons scientist at Ft. Detrick MD has died of an apparent suicide. Ivins died on Tuesday, July 29, 2008 according to an obituary published in the Frederick News-Post. According to the LA Times, Ivins was under investigation in connection with the 2001 anthrax mail attacks and “criminal charges were looming.”

According to the Associated Press, “a U.S. official says federal prosecutors investigating the 2001 anthrax attacks had planned to seek indictment and the death penalty” against Ivins.

Click here for a related story in the Washington Post.