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News Release
2 August 2004
NIAID Biodefense Program Funds in Violation of Federal Biosafety Rules
Mandatory Lab Biosafety Rules Needed(Austin and Hamburg, 3 August 2004) - The biodefense program of the National Institutes of Health (NIH) is not following the Institutes' own biosafety guidelines in grants made to research biological weapons agents.
According to Sunshine Project research, some three dozen laboratories that do not have a registered biosafety committee - as required by NIH guidelines - are currently receiving federal biodefense grants. The Bush administration recently decided to assign biosecurity oversight to the ailing biosafety committee system.
The Sunshine Project has lodged a complaint with the NIH Office of Biotechnology Activities demanding that it immediately suspend the noncompliant programs, some of which involve work with the world's most dangerous diseases. NIH's disregard for its own biosafety rules demonstrates the profound weakness of the United States' laboratory biosafety system and, according to the Sunshine Project, the need for international rules for high containment facilities and lab safety.
Under old federal rules called the NIH Guidelines on Research Involving Recombinant DNA Molecules (NIH Guidelines), all NIH-funded biotechnology research is supposed to be at labs that have a registered Institutional Biosafety Committee (IBC). The IBCs are in charge of protecting human health and the environment from accidental exposures in biotechnology experiments. While the NIH Guidelines are weak and legally voluntary, NIH policy theoretically makes compliance with them compulsory for grant recipients.
But with billions of biodefense dollars to disburse, and despite the Bush administration's insistence that IBCs can handle biosecurity, the National Institute of Allergy and Infectious Disease (NIAID) has thrown NIH's biosafety rulebook out the window. Since 2002, NIAID has made biodefense grants to about three dozen facilities that do not have a registered Institutional Biosafety Committee (IBC). For example:
Diversa Corporation of San Diego, California has NIAID-funded projects to develop genetically engineered antibodies for use against plague, anthrax, and SARS (as well as other NIH-funded non-biodefense biotechnology projects). Diversa does not have an NIH-registered IBC.
A University of Pennsylvania researcher is studying Ebola virus, which requires maximum biosafety level four (BSL-4) containment. The University has a registered IBC, but it does not have a BSL-4 lab, so the work is being conducted at the US Army Medical Research Institute for Infectious Disease (USAMRIID) at Ft. Detrick, Maryland. This makes USAMRIID responsible for biosafety in the NIAID grant. USAMRIID does not have an NIH-registered IBC.
NIAID has made grants for work at the Canadian BSL-4 facility in Winnipeg, Manitoba, including studies with five different types of arenavirus that cause hemorrhagic fever. A separate NIAID-funded project in Winnipeg involves Crimean Congo hemorrhagic fever virus. The facility does not have a registered IBC.
In total, based on a review of NIAID grants, the Sunshine Project estimates that three dozen laboratories that do not have a registered IBC are currently receiving NIAID biodefense grants that involve work with recombinant DNA. These include many private sector biotechnology companies. In addition, NIAID has made biodefense grants to the Universities of Maryland and Wisconsin for projects that appear to require BSL-4 containment, which these universities do not have. Neither Maryland nor Wisconsin has responded to repeated queries asking where these projects will be reviewed by an NIH-registered IBC.
Other examples include Biodefense Technologies Inc (Blacksburg, VA), which is trying to produce plague vaccine in genetically modified tobacco. Planet Biotechnology (Hayward, CA) has another NIAID-funded "pharming" project which aims to grow botulinum toxin antibodies in transgenic tobacco. Neither have NIH registered IBCs. Other NIAID biodefense grant recipients without NIH-registered IBCs are working on anthrax antibiotics, immunoregulators, biosensors, and transgenic animals. Most of the unregistered grant recipients are biotechnology companies.
The Bush administration insists that no mandatory laboratory safety and disclosure laws are necessary, because an alleged "culture of responsibility" at IBCs will protect Americans and the world from accidents and abuse in US biodefense research. According to the Sunshine Project, the administration is dead wrong.
"The voluntary US biosafety committee system has been battered and broken by decades of neglect and destructive lobbying by the biotech industry," says Edward Hammond, US Director, "The system is not up to the task of ensuring biodefense safety and security. That NIH's own biodefense program doesn't bother to ensure that its grantees comply with the NIH Guidelines is a scalding indictment of the US laboratory biosafety system."
According to Jan van Aken, Director of the Sunshine Project Germany, "The current flow of money into uncontrolled, unregulated biodefense research creates more and more risks of abuse and accidents. What is needed is an internationally harmonized, all-inclusive and mandatory system to ensure safety and security of biological research."
The Sunshine Project began calling for enhanced international lab biosafety rules in October 2003 (see Sunshine Project Backgrounder #11, online). Recent Sunshine Project publications, also available on our website, have drawn attention to lab biosafety problems in the United States, such as those related to projects involving reconstructed 1918 "Spanish" influenza.