BIOSAFETY BITES
ABOUT BIOSAFETY BITES
The Sunshine Project is in the midst of a survey of nearly 400 US institutional biosafety committees (IBCs). These committees, maintained at labs conducting federally-funded biotechnology research, are established to protect people and the environment from risks of biotechnology experiments. Now, following a 2003 study by the National Academies and the establishment of a federal biosecurity board, IBCs are assuming a new "biosecurity" role as the local committees responsible for review of risky dual-use research with biological weapons agents.
In the course of conducting the IBC survey, the Sunshine Project has encountered a number of biosafety problems in research involving potential biological weapons agents. These include physical issues at high containment laboratories, risky experiments approved with dubious safety precautions and/or inadequate IBC review, dysfunctional and otherwise noncompliant committees, and other types of biosafety problems.
"Biosafety Bites" is a series of short articles that briefly describe cases of problems that primarily relate to laboratory safety. Biosafety Bites will culminate in the publication of the final report of the IBC survey, which will focus on public accountability and the fitness of institutional biosafety committees to take primary responsibility for the conduct of dual-use research.
Biosafety Bites #1 (28 June 2004)
US Army Builds Biodefense Lab, Neglects to Inspect ItBiosafety Bites #2 (29 June 2004)
Tropical Disaster: The University of Hawaii Institutional Biosafety CommitteeBiosafety Bites #3 (6 July 2004)
Moribund: The Department of Homeland Security Plum Island Biosafety CommitteeBiosafety Bites #4 (12 July 2004)
Incautious University of Washington Bends Biosafety in 1918 "Spanish" Flu ExperimentsBiosafety Bites #5 (19 July 2004)
No Biosafety Meetings at Rockefeller UniversityBiosafety Bites #6 (27 July 2004)
TIGR: Genomics Powerhouse, Biosafety TragedyBiosafety Bites #7 (10 August 2004)
No Functional Biosafety Committee at BattelleBiosafety Bites #8 (12 August 2004)
No Biosafety Reviews at Emory UniversityBiosafety Bites #9 (13 August 2004)
"West St. Louis virus" and USDA BiosafetyBiosafety Bites #10 (18 August 2004)
Tulane University's Broken Biosafety CommitteeBiosafety Bites #11 (3 September 2004)
Asleep at the Wheel? The NIH Office of Biotechnology ActivitiesMore coming soon...
Biosafety Bites #1 (28 June 2004)
US Army Builds Biodefense Lab, Neglects to Inspect It
The US Army-funded BSL-3 facility at Oak Ridge National Laboratory in Tennessee holds biological (and chemical) weapons agents and is preparing to produce ricin. While the facility is physically a BSL-3 lab, it is said to operate at BSL-2 containment (obviating the need for NEPA evironmental review). The facility activities and agents held, however, suggest that BSL-3 containment is already needed for safe operation. In December 2003, the ORNL Institutional Biosafety Committee considered lab safety and resolved that it "remains comfortable of the review and inspections of the Chem/Bio Facility conducted by the CDC and the Army". In fact, the lab not been inspected by the Army for three years, and CDC hadn't visited for more than four.
A US Army-funded biosafety level three (BSL-3) lab in Tennessee that holds biological weapons agents and is used for biological and chemical weapons studies hasn't had an Army biosafety inspection in three years.
In late 1998, officials at Oak Ridge National Laboratory (ORNL) in Tennessee opened a new BSL-3 laboratory. Located beside ORNL's aerosol chamber, the lab opened new possibilities for ORNL research on biological (and chemical) weapons agents. Built to facilitate research links with the US Army's Dugway Proving Ground in Utah, the Army funded the lab's construction and signed a contract with ORNL that committed it to perform annual inspections to ensure lab safety. In late 1998 or early 1999, ORNL received its first biological agent, botulinum toxin, while work proceeded on chemical weapons agents.
But ORNL's biological expansion drew unflattering attention from the Department of Energy's Inspector General. In a 1999 report, the Inspector General determined that, in addition to financial mismanagement, ORNL had ignored NEPA, the National Environmental Policy Act. NEPA requires environmental review of new federal level 3 and level 4 labs. An embarrassed ORNL replied by saying that it would operate the lab at BSL-2 and that it would give up its "select agent" permit to handle live bioweapons.
At the time, the inspector general dryly - and presciently - noted that "the Chem-Bio facility was prefabricated to contain a fully functioning Biosafety Level 3 laboratory and that the future microbiological capabilities of the laboratory would not be affected by simply deregistering the facility for live biological weapons agents."
Indeed. ORNL's work at the facility with chemical weapons agents was never impaired. And by 2003 (at least), ORNL was back into biosafety level three territory. It is again registered to handle select agents. In fact, it may never have gotten rid of its bioweapons organisms. Earlier this year, a US government report stated that ORNL holds biological weapons agents; but that the precise organisms are classified "secret".(1) At least one of ORNL's bioweapons projects is known - the Chem/Bio Facility, as the BSL-3 is locally-known, is preparing to extract batches of ricin from castor beans.
In December 2003, the ORNL Institutional Biosafety Committee (IBC) reviewed safety at the entire lab, concluding that "the Chem/Bio Facility continues to operate properly and [the IBC] remains comfortable of the review and inspections of the Chem/Bio Facility conducted by the CDC and the Army." (CDC=Centers for Disease Control)
Oops.
In early 2004, the Inspector General returned. It turns out that CDC hadn't visited the lab since its commissioning in 1999, and that Army safety inspectors, who were supposed to come every year, hadn't been seen for three years. In effect, the IBC had declared its satisfaction with fictitious safety inspections. And the Army had neglected - for three years running - to ensure the safety of a bio (and chemical) defense lab that it built.
In summary, the Army-ORNL BSL-3 facility at Oak Ridge, Tennessee holds biological (and chemical) weapons agents and is preparing to produce ricin. It handles select agents, despite previously surrendering its permit to do so. While it is physically a BSL-3 lab, the facility is said to operate at BSL-2 (obviating the need for a public NEPA review). The facility activities and agents held, however, suggest that BSL-3 containment is already needed for safe operation. While, in December 2003, the ORNL IBC "remain[ed] comfortable of the review and inspections of the Chem/Bio Facility conducted by the CDC and the Army", in fact, the lab not been inspected by Army biosafety officials for three years, and CDC hadn't visited for more than four.
(1) In addition, the facility was described as a BSL-2 lab in this report, the US Confidence Building Measure A for 2004, submitted to the Biological Weapons Convention.
Sources:
DOE Office of the Inspector General, Inspection of Selected Issues of the Chem-Bio Facility at the Oak Ridge National Laboratory, November 1999.
Minutes of the ORNL IBC, meetings of 9 July 2003, 12 December 2003, and 23 February 2004.
ORNL Ridgelines (lab newsletter), "The real thing: At last, researchers can work with real chem-bio agents", 12 November 1998.
US Department of State, Confidence Building Measure A, submitted to the Biological Weapons Convention, April 2004.
Biosafety Bites #2 (29 June 2004)
Tropical Disaster: The University of Hawaii Institutional Biosafety Committee
Early this month, when Le'a Kanehe of the Native Hawaiian Legal Corporation took to a podium in San Francisco to tell a mainland US audience about biotechnology research in Hawaii, she didn't pull any punches. Kanehe said that Hawaii had become "a sacrifice zone" for sloppy (and culturally insensitive) experiments. Kanehe was impassioned; but as one in a lineup of stridently anti-biotech speakers, audience members who were skeptical might have wondered if her description was more rhetorical flourish than reality.
A close examination of the disaster known as the University of Hawaii Institutional Biosafety Committee (IBC) should convince any skeptics that Kanehe has good reason to be indignant.
The University of Hawaii (UH) may be 2500 miles (4000km) from the west coast; but its Pacific location hasn't hurt its biotechnology research programs, which are the islands' largest. Manoa, the main UH research campus, has 20,000 students and attracts major federal research funding. UH has large-scale biological programs at its medical school, college of agriculture, and in related centers. UH operates biosafety level three labs and works with potential biological weapons agents, as defined by the Centers for Disease Control ("select agents") and the US Department of Agriculture ("high consequence pathogens")
Among UH's many research projects is its NIH-funded Pacific Center for Emerging Infectious Disease Research. UH develops high-profile biotechnology: In 1999, it boasted of having produced the "first male clone" (a mouse). Its website offers licenses for a technology to produce an experimental recombinant vaccine in silkworms. One UH lab is dedicated to technologies for the large scale production of recombinant proteins in bioreactors.
The UH Institutional Biosafety Committee (IBC) is required under federal research rules and exists for the purpose of protecting health and the environment from biotechnology research accidents. IBCs review proposed research, ensure frequent inspection and certification of labs and lab equipment, receive reports of accidents and take steps to address and prevent them, try to anticipate safety problems, periodically examine and renew approval of ongoing projects, and perform other duties to ensure safety. As is the case with many institutions, at UH the IBC is responsible not only for biotech projects (i.e. those involving recombinant DNA); but all research projects utilizing biological materials posing significant risks, such as unmodified disease-causing agents.
With so much research activity at UH, one might expect its IBC to be busy with the business of biosafety. Think again. According to documents provided to the Sunshine Project by the University of Hawaii, the business that the UH IBC is occupied with is the Monsanto Corporation.
In the past eight months, the UH IBC has met twice. The record of the first meeting, in November 2003, is titled "Meeting with Monsanto". At the hour and half-long meeting, whose minutes consist of less than a half a page, Monsanto and Hawaii told each other that they enjoy working together and that they will each comply with applicable rules. There is no review of research, no review of lab conditions, and no real biosafety business recorded concerning the Monsanto arrangement, much less other research going on on anywhere else at UH. At its only meeting since, in March 2004 and titled "Pre-Commercialization/Commercialization", the UH Institutional Biosafety Committee discussed a researcher's need for IBC support for his commercialized recombinant papaya, a project that also involves a relationship with Monsanto. Supporting commercialized genetically-engineered crops is a curious choice of business for an IBC. IBCs deal with biological containment, not transgenics released for sale, which are, by definition, not contained. Again, no real biosafety business is recorded.
Federal rules require UH to release its IBC meeting minutes to the public, but it resisted doing so. When UH consented to provide records of its meetings, after several requests over the first half of 2004, it claimed that minutes of the November 2003 and March 2004 meetings are the only ones that exist. UH explained this by saying that its IBC didn't start taking meeting minutes until after the National Institutes of Health (NIH) issued guidance to IBCs on minute-taking. The problem with UH's response is that the NIH document was issued in May 2004, months after the IBC meetings took place.
Making its position even more dubious, the minutes UH provided state that its IBC reviewed and adopted additional minutes taken at meetings prior to November 2003. But UH's cover letter says that these minutes don't exist, because its IBC didn't take minutes before November 2003. In short, either UH's IBC minutes are a fabrication, or it knowingly responded falsely. Either way, UH's credibility is not high.
So it is with the University of Hawaii Institutional Biosafety Committee which, like its counterparts across the country, will now be given a new charge by the federal government: to review and assess the conduct of dual-use research with biological weapons agents. The leadership of the Departments of Homeland Security and Health and Human Services assure that there is a "culture of responsibility" in the IBC system that will enable IBCs like Hawaii's to rise to their serious new responsibilities; but the situation at UH strongly suggests otherwise.
In recent correspondence, the Assistant Vice President for Research of the University of Hawaii has promised to produce more information concerning the UH IBC. The NIH Office of Biotechnology Activities, which oversees the UH IBC, has been alerted to the information contained here; but has not, to the Sunshine Project's knowledge, taken any action. Further developments with the UH IBC will be discussed in future Biosafety Bites or the final report of the Sunshine Project IBC survey.
SOURCES:
Documents purported by the University of Hawaii to be the minutes of its Institutional Biosafety Committee meetings of 20 November 2003 and 27 March 2004.
E-mail from Frank O. Perkins, Assistant Vice President for Research of the University of Hawaii, 25 June 2004.
Letters from James T. Douglas, Chair, University of Hawaii Institutional Biosafety Committee, 4 February 2004 and 17 June 2004.
University of Hawaii Environmental Health and Safety Office, Forms BSP-1-5 (http://www.hawaii.edu/ehso/bio/)
Biosafety Bites #3 (6 July 2004)
Moribund: The Department of Homeland Security's Plum Island Biosafety Committee
According to the Bush administration’s senior science policy officials, the way to address the problems posed by ever more aggressive US research on biological weapons agents is not to regulate laboratories; but to turn the matter over to institutional biosafety committees, the local bodies that review research safety. These voluntary committees, the administration argues, have a culture of responsibility that will ensure that dual-use research with biological weapons agents doesn’t go awry. So it follows that at facilities such as those of the Department of Homeland Security (DHS), if anywhere, a robust and effective institutional biosafety committee system should be found. That is not the case.
Few, if any, biodefense research facilities have had as controversial a relationship with neighbors as the Plum Island Animal Disease Center, a large biosafety level three lab located on a small island in New York. In the Long Island Sound between New York and Connecticut shores, Plum Island was originally slated to be a US Army chemical weapons lab. In the 1950s, however, it passed to the US Department of Agriculture and became USDA’s primary research lab on exotic animal diseases, such as African swine fever and foot and mouth disease. In 1999 and again in 2002, USDA tried to upgrade Plum Island to biosafety level four. Each time, the USDA was stymied by local opposition that has been remarkably effective at mobilizing its elected officials' influence in Washington. (1)
Things are changing, however, and on June 1st, 2003, Plum Island got a new owner. Since assuming control, the US Department of Homeland Security (DHS) has been coy about its plans, saying that it does not plan a BSL-4; but that Plum Island has a significant role in DHS’ highly controversial biological weapons “threat characterization” agenda. (2) Recently, DHS revealed that Plum Island will be renovated and re-christened as the Department’s Agricultural Biodefense Center (ABC).
On the face of it, DHS says it is "committed to positive community relations"; but in a recently-published notice in the Federal Register, it proposed to grant itself authority to make secret the environmental assessments of government activities that are required by the National Environmental Policy Act (NEPA). The change would make it possible for DHS to conduct activities on Plum Island (and other facilities) without divulging risks, effects or even their existence under NEPA. Plum Island is poised on the bleeding edge of DHS’ research program on biological weapons, a program that includes activities that independent observers conclude are practically indistinguishable from offensive biological weapons research.
Which brings us back to Plum Island’s institutional biosafety committee (IBC), the local committee that, according to the Bush administration, forms the government’s major line of defense to review dual-use research projects and to ensure their safety and security. Thus, if there is a place where the government might demonstrate that IBCs can in fact be an effective mechanism to review the conduct of dual-use bioweapons research, it is at facilities like Plum Island, which are under direct government control and which have missions that are focused on biodefense.
What has DHS done with the Plum Island Institutional Biosafety Committee? Nothing. Since DHS took over the facility more than a year ago, the Plum Island IBC has not met. Not once. The committee whose responsibility it is to ensure that research is safe and secure appears to be moribund. Not only has there been no committee review of Plum Island’s new and ongoing research projects, the committee has not met to review safety conditions in laboratories nor to perform any of the other duties incumbent upon it.
Bush administration biodefense policy leaders claim that IBCs can take responsibility for the conduct of dual-use research with biological weapons agents; but the Department of Homeland Security itself does not maintain an effective institutional biosafety committee at Plum Island.
NOTES AND SOURCES:
(1) Although USDA never built a lab with full BSL-4 containment in Plum Island, it did develop a type of enhanced BSL-3 containment for large animals for the Plum Island facility. Called “BSL-3ag”, the Plum Island facility has some characteristics of BSL-4 labs not typically found at BSL-3 facilities.
(2) For a discussion, see Ruppe, David “Proposed U.S. Biological Research Could Challenge Treaty Restrictions, Experts Charge”, Global Security Newswire, 30 June 2004 (http://www.nti.org/d_newswire/issues/2004_6_30.html)
DHS. Fact Sheet: Plum Island Animal Disease Center Transition
http://www.dhs.gov/dhspublic/display?theme=27&content=937DHS. Response to Sunshine Project information request, FOIA case 04-459, 21 June 2004.
DHS Environmental Planning Program. Notice of proposed directive, request for comments. See:
http://www.dhs.gov/dhspublic/interweb/assetlibrary/MD5100-106-01-04.pdfAlso see the wesbite of the NSABB, http://www.biosecurityboard.gov
Biosafety Bites #4 (12 July 2004)
Incautious University of Washington Bends Biosafety in 1918 "Spanish" Flu Experiments
Summary: As more laboratories begin to handle genetically-recreated 1918 "Spanish" Flu and similar flu strains, the chances that a lab will be the source of the next global influenza pandemic increase. The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary, because an alleged "culture of responsibility" among institutional biosafety committees will protect Americans, and the world, from its biodefense research. But at the University of Washington in Seattle, whose scientists are eager to handle 1918 Spanish Flu, the IBC's judgment is unsound. It has approved experiments by summarily changing the containment level of a planned lab, using inappropriate safety benchmarks, and by unilaterally lowering the safety threshold required for work with the potentially pandemic virus.
It's back from the dead. It packs a lethal punch. It's the 1918 "Spanish" Flu virus. (1) In its heyday decades ago, 1918 influenza killed ten, perhaps twenty million people worldwide. The 1918 flu was recently brought back to life by scientists from the US Departments of Defense and Agriculture, and private institutions including the Mt. Sinai School of Medicine in New York. Digging through archives of medical samples and, literally, digging up the dead, the team's work resulted in the re-emergence - in the lab - of one of the most dreaded diseases in human history.
The 1918 flu was recreated at a lab at the University of Georgia. Now, flu strains with 1918 genes are cropping up in other labs across the country. There are reasons for scientists to study why the 1918 flu was so devastating. A similarly virulent strain could reappear naturally. But a need to understand why 1918 flu was so devastating doesn't necessarily justify recreating and widely distributing a very dangerous - and otherwise eradicated - bug.
Because influenza spreads so easily, as the "new" 1918 strain and its lab-created genetic cousins are sent to more facilities, the risk that the next major influenza pandemic will be man-made is on the rise. It wouldn't be the first time that an influenza lab accident made the whole world ill (2) And, of course, scientists in other countries may repeat the US 1918 experiments, resulting in even wider proliferation of very dangerous man-made bugs.
So then, it is logically the case that responsible labs that are handling 1918 influenza are taking extraordinary precautions through their institutional biosafety committees (IBCs), which are charged with ensuring safety of such experiments. Ideally, that is. But things got off to a bad start with the 1918 influenza. When it was recreated, neither the US Department of Agriculture nor the University of Georgia (the institutions in charge of the Georgia lab) bothered to have an IBC review the experiments. (3)
Still, according to science policymakers, USDA and Georgia's failure should be an anomaly. That is because while the National Academy of Sciences and the Bush administration have rejected regulation of labs, they say that the "culture of responsibility" of institutional biosafety committees will ensure safety in the brave new world of aggressive biodefense research.
But the rhetoric isn't matched by the realities of the IBC system. USDA and the University of Georgia aren't the only problems. In fact, they aren't even the only problem when it comes to 1918 influenza.
In Seattle, University of Washington (UW) researchers are gearing up for some of the most ambitious experiments yet undertaken with 1918 influenza. UW will work with the previously recreated 1918 flu and make more types by inserting the critical 1918 virulence-related genes into a similar (H1N1) but less dangerous type of flu that was isolated in Texas in 1991. UW researchers' plans include culturing 1918 viruses, infecting animal cell lines with them, isolating samples after such 'passages' and, in the course of research, shuffle through the lab with various biological materials and equipment containing live 1918 flu types.
The objective is to develop and research a non-human primate (Pigtail macaque) model for 1918 influenza infection. In other words, the experiments will culminate by UW spraying lab monkeys with genetically engineered 1918/Texas flu and recording the results. The macaques might rather be home in Southeast Asia; but the hope is that using them as models for human infection with 1918 flu will provide useful information for managing flu outbreaks, either natural or deliberate.
But the University of Washington doesn't have an appropriately facility for the studies and its IBC isn't at all clear or vigorous in implementing necessary safety protocols.
The UW IBC's approval of Spanish flu experiments is, however, critical for the projects to receive federal funding. So, in August 2003, the UW IBC took up the matter. The first problem it encountered was that the animal biosafety level three (ABSL-3) facility where the experiments were to take place hasn't been built. Secondly, USDA, which was providing the 1918 influenza, had classified it as requiring BSL-3ag containment.(4) BSL-3ag is a more stringent standard than that of existing UW labs and the planned ABSL-3 lab. BSL-3ag is just one step short of maximum containment BSL-4, the level that a cautious institution might have assigned the 1918 constructs in the first place. (Neither USDA nor Georgia, however, have a BSL-4 lab.)
Apparently unwilling to hold its researchers back over biosafety issues, and despite the lack of adequate facilities, the UW IBC approved 1918 flu projects. It has allowed some activities to go forward in an existing (non-animal) BSL-3 facility, despite USDA's BSL-3ag designation of the agent. Remarkably, the UW IBC also decided, on the spot, to change the biosafety level of the new UW lab. The IBC decided that the new lab, previously not intended to be BSL-3ag, would meet the more stringent designation "in principle". This dubious endorsement enabled grant applications to move forward and for UW researchers to proceed to acquire the 1918 flu from USDA, with the "in principle" UW BSL-3ag lab.
After "resolving" the problem of not having appropriate containment, the UW IBC then considered the operating procedures to be followed in the existing BSL-3 lab for 1918 flu experiments. Here, the "culture of responsibility" of the UW IBC again failed.
The benchmark that the UW IBC referred to for 1918 flu safety were procedures used to handle human immunodeficiency virus (HIV). But the virus that causes AIDS is relatively difficult to transmit, especially by aerosol, the main cause for concern with influenza. Moreover, the risk to the community posed by a lab-acquired HIV infection is trivial in comparison to the threat posed to the world by a case of potentially pandemic influenza.
The UW IBC only considered one of the many opportunities for influenza aerosolization in the studies, that if a tray were dropped. In such an event, the UW IBC decided that researchers "will be trained to stop breathing... just as they are taught to do when working with HIV". An independent microbiologist who the Sunshine Project provided a copy of the UW IBC minutes called the UW biosafety protocols in the 1918 project to be "inappropriate" and "risible".
The minutes of the UW IBC also suggest - but don't entirely clarify - that UW researchers, already working at a lower level of containment than that assigned by USDA, may plan to place cultures infected with 1918 influenza in an unshielded centrifuge. Because their spinning energy can rapidly aerosolize liquids, centrifuges are a notorious source of laboratory infections.
UW's irresponsible treatment of biosafety in the 1918 influenza project does not appear to bother the National Institute of Allergy and Infectious Disease (NIAID). NIAID recently funded the project. Its formal start date was the beginning of this month, July 1st, 2004.(5)
Notes and Sources
(1) The 1918 influenza strain is popularly called "Spanish" influenza, based on incorrect suspicions about its origin at the time of the outbreak. In fact, to this day, there is no scientific consensus on the origin of the strain.
(2) It is an unpublished; but open secret among influenza researchers that a global pandemic of H1N1-type influenza that began in 1977 was, in all likelihood, the result of an accidental release from a lab in China. Public references to the origin of this outbreak occasionally surface. See, for example, ProMedMail, 1 June 2004 (http://www.promedmail.org)
(3) USDA Agricultural Research Service reply, dated 2 October 2003, to Sunshine Project FOIA of 11 August 2003, for minutes of the IBC meeting that reviewed 1918 influenza experiments. Personal communication with Daryl Rowe, Institutional Biosafety Officer, University of Georgia, September 2003.
(4) How USDA and/or Georgia determined BSL-3ag containment, which is stated in the UW IBC minutes and NIH grant abstracts, is unclear. As indicated in note 3, under FOIA, USDA asserts that no IBC ever reviewed the project to re-create 1918 influenza.
(5) NIH Grant 1P01AI058113-01 to the Mt. Sinai School of Medicine includes the UW component for 1918 influenza studies.
Other sources:
Minutes of the University of Washington Institutional Biosafety Committee, meetings of 2 December 2002 and 22 August 2003.
Baskin CR et al. Gene Expression Control in Pigtail Macaques Infected with Influenza A/Texas/36/91: A PILOT STUDY. Innate Immune Response and Patterns of Immune Cell Migration in an Uncomplicated Influenza Infection, online poster submission for the Fifth Annual Northwest Gene Expression Conference, to be held at the University of Washington, 25-27 May 2005. URL: http://ra.microslu.washington.edu/Website/nwgec/posters/postersubmit.html
Biosafety Bites #5 (19 July 2004)No Biosafety Meetings at Rockefeller University
Summary: The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this and the increasingly evident chronic, institutionalized problems with IBCs across the country, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary. It says that an alleged "culture of responsibility" among institutional biosafety committees will protect Americans, and the world, from its biodefense research.
Since 1998, the Institutional Biosafety Committee (IBC) of one of the world's most prestigious biomedical research institutions, The Rockefeller University in New York City, has met exactly twice. Violating the NIH Guidelines, the University did not respond to requests for its IBC minutes and refuses to produce committee records. The University is a major biomedical research center. Its professors advise the government on biodefense and conduct anthrax and plague studies in the NIH biodefense program. Yet, over a period of more than six years, its IBC only met one time.
The IBC system lacks legal teeth and can't adequately handle the jobs it presently has. How, then, can it possibly rise to the greater charge of ensuring health, safety, and good judgment in the conduct of dual-use biological weapons research?
The Rockefeller University isn't your average college named after a rich guy. Located in New York City, it is wealthy, elite, and focused solely on biomedical research. Rockefeller has reason to be proud. It has been associated with no less than 32 Nobel laureates, and boasts of having achieved major research advances, including discovering that DNA is the basic material of heredity, determining that cancer can be caused by a virus, confirming the connection between cholesterol and heart disease, and developing "cocktail" drug therapy for AIDS.
Rockefeller researchers are also leaders in biodefense. They have political clout and advised the top levels of the US government on biological weapons issues for decades. In the lab, the University is currently leading studies on anthrax and plague as part of NIH's crash program to develop responses for the newfound US fear of biological terrorism.
Back in March 1998, it was a more optimistic time than now. The skyrocketing Dow Jones industrial average was poised to crack 9000. CEO Bernie Ebbers of Worldcom was crowing about shareholder's approval of a merger with MCI. And the Pentagon willingly agreed that a storage tank left by Iraqi troops in Kuwait did not contain chemical weapons, as had been reported. It was actually a fuel additive. 1998 was Monsanto's heyday, Wall Street's "irrational exuberance" was inflating biotech pipe dreams, and the NIH Guidelines were in the midst of series of revisions, continuing their general slide toward laxity. Jessie Gelsinger was an unknown teenager in Arizona.
Biosafety was out of vogue and out of mind. Even at one of the world's most prestigious biomedical research centers, worries were uncommon.
On March 26th, 1998, the Rockefeller University Institutional Biosafety Committee (IBC) held what appears to have been its last-ever regular meeting. There was no outstanding business to discuss and only one new project that the committee felt merited review. According to the meeting's minutes, exactly three committee members were present – the rest signed off without a meeting and didn’t bother to attend. A single committee member, an expert in circadian rhythms, was reluctant to approve the project that had been tabled. It was a gene therapy experiment involving injecting genetically modified adenoviruses into human volunteers. The possible dangers were unclear. The dissenter stood his ground; but the final fate of the experiment isn’t clear, because the committee never met to consider it again.
The Rockefeller IBC didn't meet again until September 23rd, 2003. But that was even less of a proper meeting than the last one - five and a half years before. In 2003, it examined a single project, involving injection of DNA into cancer patients, and determined that the project did not involve gene transfer, as defined by the National Institutes of Health. So there was nothing to discuss. End of story. The committee hasn't met since.
The Sunshine Project had a very difficult time getting to the bottom of the Rockefeller IBC's dysfunction. The University did not reply to the first request for minutes of its IBC meetings. After a second request, Rockefeller still did not provide any minutes, instead it peremptorily insisted that the Sunshine Project declare it had "cooperated fully" with the Project's survey of IBCs – in the absence of any substantive response. A third request was ignored. A fourth request resulted in a hostile letter from Rockefeller's former biological safety officer.
Finally, after additional haggling by electronic mail involving copies sent to NIH regulators and senior Rockefeller professors, after five and half months of delay, Rockefeller produced the minutes of the two most recent meetings of it Institutional Biosafety Committee – those of September 2003, and... March 1998.
In its defense, Rockefeller says that its IBC usually "conducts its business electronically", meaning that it says handles biosafety by e-mail and doesn't take any minutes of its proceedings. But it refuses to provide any of the e-mails. It is thus not only impossible to verify Rockefeller's claim; but frankly difficult to fathom how, over more than six years, the Rockefeller IBC has only once encountered a biosafety issue that merited a face to face discussion by the committee that has ultimate responsibility over the safety of its biotechnology research. (And the one meeting, as mentioned above, was perfunctory.)
Rockefeller University isn't the only embarrassed owner of a dysfunctional IBC, although the failure of its committee to even meet – for years - is particularly glaring considering the prestige of the institution. The Biosafety Bites series and the final report of the IBC survey will reveal many more IBCs with major problems. These same IBCs are, according to the Bush administration, to be placed in charge of reviewing the conduct of dual-use research with biological weapons agents. Senior administration officials say that, in lieu of regulation, IBCs can adequately manage the conduct of biodefense research. But the IBC system lacks legal teeth and can't adequately handle the jobs it presently has. How, then, can it possibly rise to the greater charge of ensuring health, safety, and good judgment in the conduct of dual-use biological weapons research?
Sources:
Minutes of the Rockefeller University IBC, 23 September 2003 and 26 March 1998.
Sunshine Project Correspondence with Rockefeller University officials, 30 January 2003 through 15 July 2004.
Biosafety Bites #6 (27 July 2004)
The Institute for Genomic Research: Genomic Powerhouse, Biosafety Tragedy
Summary: The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this and the increasingly evident chronic, institutionalized problems with IBCs across the country, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary. It says that an alleged "culture of responsibility" among institutional biosafety committees will protect Americans, and the world, from its biodefense research.
The Institute for Genomic Research (TIGR) is a genomics powerhouse located in Rockville, Maryland. TIGR is expanding its biodefense programs, which involve work with a variety of biological weapons agents, and include the creation of novel strains of disease with altered virulence genes. In its entire history, the TIGR Institutional Biosafety Committee (IBC) has met exactly twice. Averaged over the twelve years that TIGR has existed, this amounts to ten minutes of meeting time per year. The TIGR IBC plainly does not meet to review research projects and does not fullfil any other biosafety responsibilities.
The Institute for Genomic Research (TIGR), based on Maryland's "biotech corridor" northwest of Washington, DC, is a non-profit powerhouse of genomics. TIGR has led in the sequencing of microbial genomes, particularly of human and animal diseases.
While TIGR continues to devote research to important tropical diseases that are understudied, such as Chagas disease and sleeping sickness, its biodefense portfolio is expanding. Active in biodefense for many years, in late 2001, it jumped in with both feet. It performed genetic analysis of spores from the anthrax letters, fingering a US biodefense lab as the likely source of the strain. TIGR biodefense projects include work with valley fever (Coccidiodes immitis), Q fever (Coxiella burnetti), and brucella (B. suis).
Much of TIGR's genetic sequencing work with potential bioweapons agents involves handling the agents broken into small genetic subunits that are not dangerous. However, TIGR's work is not limited to such studies. In one National Institutes of Health-funded project begun in mid-2003, a TIGR scientist is tweaking the virulence genes Burkholderia mallei, the bacteria that causes glanders, a disease that naturally primarily affects horses; but which is a potent biological weapons agent that can infect humans and has been weaponized in the past. The genetically-engineered bacteria with altered virulence are then introduced into mice and hamsters, which serve as scientific surrogates for humans, in order to observe the changes in the GM types.
With assets of nearly US $200 million and annual revenues over US $40 million, the well-funded and well-connected TIGR scientific team operates without many of the financial and market pressures acutely felt in other academic and commercial labs. While its privileged situation would seem to mitigate for increased attention to its institutional biosafety committee (IBC), the tragic reality is that since TIGR was founded in 1992, the TIGR IBC has only met twice, once in 2002 and once in 2004. Each meeting lasted one hour, for a total of two hours face time in twelve years - or, on average, ten minutes per year that the TIGR IBC meets to perform its duties.
During its entire existence, the TIGR IBC has examined exactly two projects, both in 2002, quickly deciding that each was exempt from full committee review under the NIH Guidelines, and thereupon halting its discussion. When the committee met in 2004, it only came together to review the format of its paperwork. It did not review any research projects, much less any other aspect of biosafety at TIGR.
Despite the requirements of the NIH Guidelines, it was only after the Sunshine Project began sending copies of its correspondence to the National Institutes of Health that TIGR decided to reply at all to the Sunshine Project's requests. The committee meeting of 2004, on April 23rd, at which no real biosafety business transpired, took place almost three months after the Sunshine Project began to request TIGR's IBC minutes; but before TIGR replied to the Sunshine Project's requests.
In correspondence with the TIGR IBC Chair, the Sunshine Project directly raised the question of TIGR research with biological weapons agents that has not been reviewed at an IBC meeting. TIGR's IBC Chair initially said that he could not reply promptly because he needed to file grant applications. He then sent a letter ignoring the question; but which, after six months of Sunshine Project queries, finally clarified that the TIGR IBC has only met twice in its history.
As with other institutions, such as Rockefeller University, the Department of Homeland Security's Plum Island, and the Department of Energy's Oak Ridge Lab, if the institutional biosafety committee system is effective anywhere, it should be at these kinds of labs. Again and again, as discussed in previous editions of Biosafety Bites, the IBCs of these institutions are nonfunctional or, at best, dysfunctional. At far too many institutions, including institutions deeply involved in biodefense, IBCs do not meet to review projects, nor to review the myriad of other biosafety issues that should be their responsibility. The deep failures of the IBC system, touted by the Bush administration and the National Academies of Science as the primarily solution for the dangers posed by the mushrooming US biodefense program, are becoming more and more apparent.
Sources:
Correspondence with Najib M. El-Sayed, Chair TIGR IBC, January - July 2004.
Minutes of the TIGR IBC, meetings of 6 March 2002 and 23 April 2004.
TIGR Internal Revenue Service Form 990 (non-profit tax return), fiscal year 2002.
NIH CRISP database, grant abstracts for TIGR.
Biosafety Bites #7 (10 August 2004)No Functional Biosafety Committee at Battelle Memorial Institute
The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this and the increasingly evident chronic, institutionalized problems with IBCs across the country, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary. It says that an alleged "culture of responsibility" among institutional biosafety committees will protect Americans, and the world, from its biodefense research.
Battelle Memorial Institute, headquartered in Columbus, Ohio, is a gigantic science contractor with an emphasis on defense research, including classified programs. Battelle has offices across the US - often near Department of Defense facilities - as well as business in at least six foreign countries. Battelle operates four US Department of Energy-owned laboratories,(1) each of which conducts biotechnology research. Battelle also has its own in-house BSL-3 facility, at West Jefferson, Ohio, which is reported to conduct classified biodefense research for the US government.
Battelle is overwhelmingly funded by the US government, which provides it with US $1.3 billion per year in grants, plus hundreds of millions in payments for services. Technically a non-profit organization, Battelle is an unusual ‘charity’. It pays a seven-figure salary to its director, controls more than two dozen for-profit spin-off companies, and dispenses grants to nonprofit organizations near its facilities, such as the Columbus Zoo, in a manner similar to corporate sponsorship.
While Battelle is a colossal enterprise, its institutional biosafety committee (IBC) is not. In fact, for a period covering four and a half years (since 1 January 2000), Battelle cannot produce a single page of minutes of IBC meetings.
In the same time period, Battelle has only once reported to the NIH Office of Biotechnology Activities, which oversees IBCs. The late 2001 report was made shortly after the New York Times ran a story saying that Battelle would be the site of a project to genetically engineer a vaccine-resistant strain of anthrax. The “report” merely consists of a single page listing IBC members, and attaching their resumes, and informs NIH that Battelle "has established” an IBC. The “report” strongly suggests that the Battelle IBC did not exist until after the institute's involvement in classified biodefense studies was widely reported.
Battelle did not answer the Sunshine Project's January request for its IBC minutes. Battelle replied to a follow-up letter, sent by certified mail in May, by saying its IBC hasn’t met since June 1st, 2003. Battelle replied to a third request - this time for all IBC minutes and all reports to NIH since January 1, 2000 - by providing a single, heavily redacted page of paper - the late 2001 letter it submitted to NIH, informing the Office of Biotechnology Activities that it "has established" an IBC. (2)
Battelle's final reply to the Sunshine Project, however, curiously states that "Battelle's IBC has been inactive [since January 1, 2000], except for review of one project, for which no IBC documents are available for release to the public." It is possible that this project, documentation of which Battelle refuses to provide, is the anthrax genetic engineering effort, although that project is only one of many involving recombinant DNA that Battelle conducts.
In sum, Battelle's institutional biosafety committee does not meet, does not report to the NIH Office of Biotechnology Activities, does not review projects, and does not take responsibility for lab safety. Rather, its IBC is decorative – a slight, cynical gesture in the direction of the NIH Guidelines.
The situation reveals some of the deep failings of the US' guidelines-based laboratory biosafety system. So far, Biosafety Bites has profiled a few IBCs that are failing to live up to their responsibilities. There are many more to come.
Despite the realities of IBCs, the Bush administration and the National Academies of Science argue that the weak and neglected system, heavily littered with failed and dysfunctional committees such as Battelle's, has a "culture of responsibility" that will enable it to take on the very serious task of ensuring safety, security, and good judgment in biodefense research. The administration and the academies are simply wrong.
NOTES
(1) The labs operated by Battelle are Brookhaven, Oak Ridge, and Pacific Northwest National Labs, as well as the National Renewable Energy Lab (NREL). These labs have NIH-registered IBCs, although one (Pacific Northwest) is brand new and another (NREL) refuses to comply with the NIH Guidelines public access provisions. Oak Ridge's IBC was the subject of Biosafety Bites #1.
(2) Battelle did not maintain a copy of this "report" to NIH. The redacted cover letter received by the Sunshine Project bears a NIH received stamp, indicating that Battelle had to ask NIH for a copy of its own "report" in order to provide it to the Sunshine Project.
SOURCES
Battelle Annual Report 2003
Correspondence with Adam Wagenbach and Donald Cagle of Battelle, January – August, 2004.
Battelle Internal Revenue Service Form 990 (non-profit tax return), fiscal year 2002.
Biosafety Bites #8 (12 August 2004)
No Biosafety Reviews at Emory University
No Biosafety Reviews at Emory University
----------------------------------------The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this and the increasingly evident chronic, institutionalized problems with IBCs across the country, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary. It says that an alleged "culture of responsibility" among institutional biosafety committees will protect Americans, and the world, from its biodefense research.
Emory University in Atlanta, Georgia, is a biomedical research powerhouse. It has approximately 1.3 million square feet (120,000 square meters) of research laboratory space, 600 biological safety cabinets, a primate research center, and several BSL-3 labs scattered across its suburban campus. Many of those labs are occupied with biodefense research. In NIH-funded studies, Emory scientists are researching vaccines for smallpox, Ebola, Rift Valley Fever and Lassa viruses, and studying anthrax. Emory scientists are genetically-engineering measles, Yellow Fever, and other viruses in attempts to produce a vaccine against AIDS. Some Emory projects are closely linked to research at the US Centers for Disease Control, also in Atlanta.
Emory University's Institutional Biosafety Committee has not reviewed any projects in at least four years. Not a single protocol from Emory's large portfolio of biodefense and genetic engineering research has received a moment's consideration at a biosafety committee meeting. In fact, since 2001, the Emory IBC has only met three times, less than once per year. The last Emory IBC meeting occurred in July 2003, when one third of the committee's members played hooky, leaving only 11 of 16 members in attendance.(1)
In addition to being charged with biosafety responsibility, Emory's IBC (locally called the "Health and Biosafety Committee") also handles chemical and radiological issues. Thus, even when the committee has actually met, its attention has been divided. At none of its meetings since 2001 has the Emory IBC reviewed biosafety of any project. Instead, Emory's IBC hears general presentations from staff about biological, chemical, and radiological safety. The minutes of Emory's meetings indicate that, after hearing the presentations, members of the IBC have only rarely had any questions or comments to make, for example, this passge from the minutes of the committee's 2001 meeting: "Comments and Questions from the Committee: There were not any comments and/or questions. [The Chair] thanked everyone for attending the meeting." (2)
As with other institutions with IBCs that do not review proposed biotechnology research, the Sunshine Project had difficulty obtaining Emory's IBC minutes, despite the NIH Guidelines, which state that IBC minutes "shall be made available to the public upon request". Emory did not respond to the Project's initial inquiry. It was only after a full six months, and correspondence that involved copies sent to NIH staff and by certified mail, that Emory finally produced a full set of its IBC minutes.
Prior to this Biosafety Bites, the Sunshine Project offered Emory's Associate Vice President the opportunity to explain why the Emory IBC does not review any proposed research, a particularly disturbing situation in view of Emory's huge biomedical research portfolio. Emory's defense, which was presented in a letter consisting of two sentences, is essentially to admit that its IBC is derelict in its duties. According to the University, "Designated IBC committee members review all protocols requiring IBC review."
Emory produced no record of any these alleged reviews and none of the research protocols or reviews are even mentioned, much less discussed, at its actual IBC meetings. Nor did the Associate Vice President even attempt to explain how the Emory IBC's total abdication of responsibility for project review can be squared with the NIH Guidelines.
Despite the realities of IBCs, the Bush administration and the National Academies of Science argue that the weak and neglected system, heavily littered with failed and dysfunctional committees such as Emory's, has a "culture of responsibility" that will enable it to take on the very serious task of ensuring safety, security, and good judgment in biodefense research. The administration and the academies are simply wrong.
NOTES
(1) Minutes prior to those of 22 July 2003 list only those members present and do not list members who were absent.
(2) Emory University IBC Minutes of 12 April 2001.
SOURCES
Correspondence with Kristin West, Associate Vice President, and Robin Lutrell, Biological Safety Officer, Emory University, January - July 2004.
Minutes of the Emory University Institutional Biosafety Committee, 12 April 2002, 20 June 2002, and 22 July 2003.
Biosafety Bites #9 (13 August 2004)
'West St. Louis Virus' and USDA Biosafety Issues
The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this and the increasingly evident chronic, institutionalized problems with institutional biosafety committees (IBCs) across the country, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary. It says that an alleged "culture of responsibility" among IBCs will protect Americans, and the world, from its biodefense research.
This summer, fear of the West Nile Virus (WNV) epidemic grips much of the northern hemisphere. This week WNV was confirmed in Portugal. The virus has recently been confirmed in Siberia, and it continues to establish itself in many areas of the United States.
A team of US Department of Agriculture (USDA) scientists is taking a dubious approach to combating the problem. At the University of Wyoming, USDA researchers are trying to create new, pathogenic types of WNV that could prove to be worse than the naturally occurring virus. USDA is doing this by crossing West Nile with St. Louis Encephalitis (SLE), a related flavivirus that is endemic to the US but that presently infects far fewer people each year. (1)
The two viruses are not known to naturally cross, and a prior study done elsewhere suggested that the possibility is not high. Rationalizing that it still might happen, however, the USDA researchers are forcing the issue by forcing WNV and SLE to recombine. The researchers will isolate lab-created WNV-SLE hybrids ("West St. Louis Virus") and then plan to infect mosquitoes, birds, and lab mice with the engineered viruses. They then plan to study the results, characterizing the pathogenicity and host range of the novel viruses. They will also develop a diagnostic test to detect the bugs which, insofar has been established by research, will only exist in the lab in Wyoming.
USDA is performing this research at the University of Wyoming because BSL-3 animal facilities at its own lab in Laramie, the Arthropod-Borne Animal Diseases Research Laboratory (ABADRL), were closed for emergency repairs in 2003.
USDA is thus deliberately making novel, lethal viruses with epidemic potential for humans (and animals). Its specific intent is to create, isolate, culture, characterize, and study transmission of a new and deadly disease. USDA is doing this at a university lab because its own facilities are broken. Not only will a containment failure in these experiments pose a serious public health threat; but also there is limited scientific justification for experiments, and they raise questions about the US biodefense program and the Biological Weapons Convention. What if other countries start government programs to create designer disease citing similar rationales?
When weighed against the risks that the experiments generate, there is ample room to question whether 'West St. Louis Virus' should be created at all. Certainly, this USDA project, like a number of other biodefense experiments to deliberates create disease, such as reconstituted 1918 "Spanish" influenza, present public, policy, arms control, and scientific issues that deserve extremely careful review before the project is conducted (or discarded as unnecessary, unsafe, unwise, or unlawful).
But USDA's ABADRL does not have a registered Institutional Biosafety Committee. Thus, it was only because the condition of USDA's labs forced it to move the experiments onto the Wyoming campus that they were reviewed by a registered IBC at all.
When it comes to Institutional Biosafety Committees and the NIH Guidelines, the US Department of Agriculture is an unmitigated disaster. According to its regulations, USDA-funded biotechnology research must comply with the NIH Guidelines. Yet ABADRL has no registered IBC. Experiments to recreate 1918 influenza, conducted at a USDA lab in Athens, Georgia, were not reviewed by a biosafety committee.(2) The IBC of the Plum Island Animal Disease Center in New York, where the USDA conducts research, hasn't met for more than a year.(3)
In January, the Sunshine Project requested IBC meeting minutes from five USDA labs that have registered IBCs (others, like ABADRL, don't). Not a single USDA facility has produced a single page of meeting minutes. One hasn't replied at all, while another, the National Veterinary Services Lab in Ames, Iowa, explicitly refuses to comply with the guidelines. (4)
Perhaps most tellingly, despite USDA's own regulations (5) at least one of its major agencies has stopped asking labs to assure that the NIH Guidelines are followed. When the Sunshine Project filed a Freedom of Information Act request with the USDA's Agricultural Research Service (ARS) for forms that certify compliance (called a "research assurance statement", or ARS Form 411), USDA replied that ARS "discontinued the collection of this information in February 2001. The ARS-411 is no longer in use and we do not maintain this information." (6)
So are biosafety committees and compliance with the NIH Guidelines at the US Department of Agriculture. Despite the realities of IBCs, the Bush administration and the National Academies of Science argue that the weak and neglected system, heavily littered with failed and dysfunctional committees, has a "culture of responsibility" that will enable it to take on the very serious task of ensuring safety, security, and good judgment in biodefense research. As the situation at USDA demonstrates, the administration and the academies are simply wrong.
NOTES
(1) According to the Centers for Disease control, the US averages 128 human cases of St. Louis Encephalitis each year. The virus can cause paralysis and is fatal in 3-30% of cases. (See http://www.cdc.gov/ncidod/dvbid/arbor/sle_qa.htm)
(2) USDA reply to Sunshine Project FOIA request of 11 August 2003.
(3) See Biosafety Bites #3.
(4) Alerted to this fact, the NIH Office of Biotechnology Activities did not reply to the Sunshine Project and, to the Project's knowledge, has not taken any action.
(5) 7 CFR 3015.205 (b)(3) - General provisions for grants and cooperative agreements with institutions of higher education, other nonprofit organizations, and hospitals - (b) assurances and compliance - (3) It will assume primary responsibility for implementing proper conduct or recombinant DNA research and it will comply with the national Institute of Health Guidelines for Recombinant DNA Research, as revised. [sic]
(6) USDA reply to Sunshine Project FOIA request of 1 July 2004. Unlike ARS, the USDA Cooperative State Research, Education, and Economic Service continues to use research assurance statements for research involving recombinant DNA, although USDA estimates that statements are on file for less than 50% of such projects (about 800 of 1659 grants since 1 September 2001).
SOURCES
Minutes of the University of Wyoming Institutional Biosafety Committee, 17 April 2003.
Correspondence with Paul J. Hauer, Chair, USDA NVSL/CVB IBC, Ames, Iowa, January - June, 2004.
USDA reply to Sunshine Project FOIA request of 1 July 2004, for USDA research assurance statements.
USDA reply to Sunshine Project FOIA request of 11 August 2003, for minutes of the IBC meetings at which 1918 influenza experiments were reviewed.
Biosafety Bites #10 (18 August 2004)
Tulane University's Broken Biosafety Committee
The skyrocketing biodefense budget, now exceeding that of the Manhattan Project (adjusted for inflation), is rapidly increasing research on biological weapons agents, including risky genetic engineering projects. Despite this and the increasingly evident chronic, institutionalized problems with institutional biosafety committees (IBCs) across the country, the Bush administration maintains that comprehensive laboratory safety and disclosure law is unnecessary. It says that an alleged "culture of responsibility" among IBCs will protect Americans, and the world, from its biodefense research.
Tulane University in New Orleans, Louisiana is a major biomedical research center. Tulane operates BSL-3 facilities in New Orleans and is a partner in both the Western Regional "Center of Excellence" in Biodefense (led by the University of Texas Medical Branch in Galveston), and the Southeast Regional "Center of Excellence" (led by Duke University in Durham, NC). Both centers are funded by the National Institutes of Allergy and Infectious Disease (NIAID).
Several Tulane scientists have leapt into biodefense studies. These include one whose grant application states as a matter of fact that China, Syria, and other countries have offensive biological 'weapons of mass destruction' programs. NIAID funded it. Tulane scientists are working with anthrax, plague, and other biological weapons agents.
The Tulane National Primate Research Center (TNPRC), located in Covington, LA, is a research facility housing 5,000 monkeys for biomedical studies. In 2003, TNPRC received a regional biocontainment laboratory grant from NIAID, enabling it to build a large new BSL-3 biodefense facility. Three BSL-3 laboratories are already in operation at TNPRC, and new primate aerosol facilities are being developed. One of the first projects planned for the aerosol facility are pathogenesis studies involving spraying macaques with the biological weapons agent brucella.
So if the Bush administration and the National Academies of Science are right when they say that the alleged 'culture of responsibility' of Institutional Biosafety Committees is sufficient to ensure safety, security, and good judgment in biodefense research, then Tulane University is clearly a place where a healthy and robust IBC should be found. After all, NIAID is heavily funding Tulane to work with biological weapons agents and, particularly, to develop its capacity to run biological weapons aerosol challenge studies on large primates.
But when asked for all minutes of all meetings of its IBC since January 1st, 2002, Tulane replied that it has no responsive documents. That is, Tulane University cannot produce a single page of minutes of any Institutional Biosafety Committee meeting for the past two and half years. Tulane was most unforthcoming about its IBC's inactivity. Tulane did not reply to a faxed request and ignored a request sent by certified mail. It was not until the Sunshine Project contacted several people at Tulane and sent copies of the correspondence to the National Institutes of Health that the University confessed to its IBC's inactivity. It did so in a letter consisting of three terse sentences.
Remarkably, and perhaps most indicative of Tulane's attitude about its IBC, is that the University didn't even schedule an IBC meeting a produce a perfunctory set of minutes after the Sunshine Project's initial, smaller request in January. That is, Tulane had more than four months to activate its IBC after it became aware that the Sunshine Project insisted on copies of the committee's minutes. Instead, it simply ignored requests until July, when pressure finally forced it to admit that it had no minutes.
Such is the Institutional Biosafety Committee of Tulane University. Despite the realities of IBCs, the Bush administration and the National Academies of Science argue that the weak and neglected system, heavily littered with failed and dysfunctional committees such as Tulane's, has a "culture of responsibility" that will enable it to take on the very serious task of ensuring safety, security, and good judgment in biodefense research.
The administration and the academies are simply wrong.
SOURCES
Letter to the Sunshine Project from James J. Balsamo, Director, Tulane Office of Environmental Health and Safety, 8 July 2004.
Region VI Center for Biodefense and Emerging Infections (grant application to NIAID), University of Texas Medical Branch, January 2003. (Obtained under the Texas Public Information Act.)
NIH CRISP database, abstracts for NIAID awards to Tulane University. (See 1R21AI055013 re China and Syria.)
Biosafety Bites #11 (3 September 2004)
Asleep at the Wheel? The NIH Office of Biotechnology Activities
As the Biosafety Bites series nears its close, the Sunshine Project has filed ten new complaints against US research institutions that do not maintain institutional biosafety committees as required under the National Institutes of Health Guidelines on Research Involving Recombinant DNA Molecules (the NIH Guidelines). The causes for the complaints range from an IBC that approved dozens of projects without actually meeting (ever), to IBCs that, despite explicit instructions from NIH, continue to resist release of records that "shall be made available" to the public.
It remains to be seen if NIH's Office of Biotechnology Activities (OBA), which is in charge of the NIH Guidelines, will take action in the new cases. OBA has remained stoically silent over 2004, a tumultuous year to date. Complaints have been filed against dozens of the IBCs it oversees concerning serious problems; but OBA refuses to communicate about its investigations, if the complaints have actually stirred OBA from its slumber and prompted a serious attempt at federal oversight.
Meanwhile, arms control advocates are increasingly disconcerted with OBA's imperceptibly slow movement to get the National Science Advisory Board on Biosecurity (NSABB) up and running - NSABB is the Bush administration's alleged answer to ensuring safety and good judgment in dual-use research with biological weapons. Senior administration officials announced NSABB with much fanfare in early March. But since Secretary Tommy Thompson's announcement generated a wave of publicity that gave the impression that the federal government is doing something about dual-use dangers, NSABB has remained theoretical - a paper kitten. Even its members remain unappointed.
While OBA officials fiddle with job descriptions and extend application deadlines, hundreds of millions of dollars for research on biological weapons agents continue to flow out of the National Institute of Allergy and Infectious Disease (NIAID) and other federal agencies. NIAID is an NIH agency that does not hold OBA and the NIH Guidelines in high regard, having repeatedly funded institutions whose biosafety committees either simply do not exist or which violate federal biosafety rules in other ways.
The following paragraphs provide a brief overview of each of the ten new complaints that the Sunshine Project has filed with the NIH Office of Biotechnology Activities. Collectively, these complaints and those previously submitted demonstrate profound problems with federal oversight of biotechnology and biodefense research that will require major actions to correct.
Utah State University (Logan, UT)
Utah State says that its IBC somehow managed to "approve" at least 48 research protocols before the committee was ever organized. Utah State could not produce any minutes of meetings of its IBC, except those of an emergency meeting - its first meeting ever - called after the Sunshine Project requested its IBC minutes. At its first meeting, Utah State's IBC leaders thoughtfully provided the committee members with a list of the projects that the committee had approved over a period of six and half years - before it actually existed. Utah State University thought that it was a good candidate to receive a BSL-4 National Biocontainment Laboratory grant from NIAID and has a virology institute that actively advertizes its large collection of biological weapons agents and its knowledge of how to manipulate them.The State University of New York at Stony Brook (SUNY-SB)
SUNY-SB conducts a large amount of NIH and DOD-funded biological weapons research, yet its IBC maintains atrocious records that it holds for up to a year and a half before release to the public. To top it off, SUNY-SB has decided to consider its IBC records 'informal' and 'intra-agency', allowing it to invoke New York State open records law to gut the content of its already poor IBC minutes. In addition to maintaining inadequate records, SUNY-SB's stance on records access is in direct conflict with the NIH Guidelines, which require that the documents be promptly released, that they be formal records, and that they be public (as opposed to "intra-agency").The Salk Institute (La Jolla, CA)
The renowned Salk Institute, a major recipient of federal research money, cannot produce a single page of minutes from any meeting of its institutional biosafety committee. Salk claims that none of its work on items such as anthrax toxins, genetically-engineered viruses, and gene therapy techniques requires review by an institutional biosafety committee. Salk's moribund IBC is an interesting example of what the Bush administration calls the 'culture of responsibility' among institutional biosafety committees.The Donald Danforth Plant Science Center (St. Louis, MO)
Like Salk, the Danforth Center is an interesting example of just how strong the biosafety "culture of responsibility" is among prestigious institutions. On its Board of Trustees, the Danforth Center counts the President of the National Academies of Science, the current or former CEOs of the Monsanto, Merck, and McDonnell Douglas Corporations, and a fistful of university presidents. The Danforth Center receives funding from NIH and USDA; but it does not have an IBC that works. It can produce minutes of only one meeting, a meeting that was called two weeks after the Sunshine Project requested Danforth's IBC minutes. At the meeting, IBC members were introduced to concepts such as what an IBC is, and what its responsibilities are - suggesting that the meeting was, in fact, the only IBC meeting that has ever taken place. Danforth's IBC membership does not comply with the NIH Guidelines and its IBC does not meet to review the safety of biotechnology research at the institute.Carnegie Mellon University (Pittsburgh, PA)
Carnegie Mellon's IBC has, for at least two and a half years, been in an ongoing state of sporadically trying to organize itself and to first identify all of the biotechnology research on campus that it needs to oversee. In 2002, the nascent Carnegie Mellon IBC deferred approval for a whopping 11 research projects, saying that they needed to be addressed at the IBC's next meeting. The 11 projects were never heard from again. At the next meeting, which occurred more than a year later, there is no mention of them. The Sunshine Project asked Carnegie Mellon what happened to these projects. The University said it would respond; but in the end it didn't. It appears that at least some of the projects were "approved" without actually being reviewed.Medical College of Wisconsin (Milwaukee, WI)
The Medical College of Wisconsin (MCW) has more than 4,000 employees, 1200 students, and receives almost $120 million in annual research grants, many of which come from NIH. Its research includes a wide variety of biotechnology studies and work with the biological weapons agents plague and botulinum toxin. MCW cannot produce any meeting minutes because it says its Institutional Biosafety Committee has never met.Medical College of Georgia (Augusta, GA)
With 750 faculty, over 2000 students, and $169 million in external funding, the Medical College of Georgia (MCG) also dips into NIH's coffers for biotechnology research grants. Unlike MCW, MCG can produce some IBC minutes; but the problem is that its IBC doesn't do its job of reviewing research projects to ensure safety - not even for BSL-3 projects. MCG says, "Our IBC does not meet as a committee to review protocols". In violation of the NIH Guidelines, the MCG IBC has effectively abdicated responsibility for biosafety and instead devotes its meetings to discussion of how biosafety paperwork can be made "very user-friendly", expedited and simplified.Washington University (St. Louis, MO)
The Sunshine Project first complained to OBA about Washington's refusal to properly release its IBC records in March of this year. In one of its very few public actions related to the Sunshine Project's complaints, OBA did direct Washington University and other IBCs to provide copies of their IBC minutes. But Washington University, which has hundreds of ongoing NIH-funded projects, is effectively refusing to obey an explicit order from OBA. (Other institutions, most notably Iowa State University, are also reluctant to comply.) While Washington University openly defies OBA and the NIH Guidelines, NIH research grants continue to flow into its coffers, thus revealing how extraordinarily weak US government oversight is of laboratory biosafety.University of Kansas Medical Center (Kansas City, KS)
The University of Kansas Medical Center (UKMC) refuses to release its IBC records unless requesters explicitly agree to a set of terms and conditions that are posted on its website. UKMC's position violates the NIH Guidelines, which require release of IBC records to the public upon request.University of Nebraska Medical Center (Omaha, NB)
The University of Nebraska Medical Center (UNMC), which entertains notions of building a biosafety level four laboratory, cannot produce a single page of minutes from a meeting of its institutional biosafety committee. After six months of playing e-mail footsie, Nebraska finally decided that it could come up with documents from alleged "electronic meetings" of its IBC. Curiously, the records of these "electronic meetings" are not available in electronic format. Having ignored the requirements of the NIH Guidelines and delayed its response, Nebraska has now invoked its state open records law and says that it can only release the paper version of its electronic records in return for nearly $100, a prohibitively high cost for almost all public requesters.