The Sunshine Project
Biosafety Bites #19 (v.2) - 1 December 2006
IBC EnFARCEment: OBA "Investigates" the Venter Institute
Key points:
- Venter IBC in a long-term state of noncompliance undetected by NIH
- No IBC reporting requirements, so government didn't find violations
- Venter IBC failed to meet, failed to identify and review research
- Several noncompliant rDNA projects utilized biological weapons agent DNA
- Systemic violations: Senior Venter scientists conducted offending projects
- Admitted noncompliance went unpunished by NIH
- Leader of a noncompliant plague project rewarded with NSABB appointment
- Venter IBC may remain noncompliant as of July 2006, after NIH "investigation"
- Proposed IBC synthetic biology "self-governance" cannot be taken seriously
Introduction
When it comes to US Institutional Biosafety Committees (IBCs), a genetically engineered disaster might be the only thing that would prompt the Bush administration to fix the corrupt IBC approach to scientific "self-regulation". Widespread noncompliance with the rules won't. The National Institutes of Health (NIH) does not penalize IBCs that ignore their responsibilities. Rather, NIH has perversely thanked IBC violators and even rewarded them with important roles in shaping policy. It's no wonder then that synthetic biologists - averse to regulation but hooked on federal money - are proposing that IBCs be a "governance" safety net to oversee their research.With newly released Freedom of Information Act (FOIA) information, this Biosafety Bites reveals what happened when the Sunshine Project denounced nearly a decade of dereliction by the IBC of The Institute for Genomic Research (TIGR) in Rockville, Maryland. The story shows why IBCs cannot be relied upon to oversee biosecurity without dramatic, legislated, change.
TIGR Noncompliance Denounced
In July 2004, Biosafety Bites #7 told the sordid tale of the TIGR IBC. TIGR has since become known as the Venter Institute.(1) Although its 400 research employees typically have about 150 projects active,(2) over nearly a decade the Venter IBC only bothered to review two of them. And of the exactly two meetings held in its history (up to July 2004), one of them didn't assess biosafety. It was dedicated to discussing the format of the committee's paperwork.(3)It was difficult to discover what a mess the Venter IBC was. IBCs aren't required to report anything of the substance about their activities, so the government won't discover dysfunctional committees. IBCs must release meeting minutes to the public upon request,(4) but it took many requests to the Venter Institute before an answer came. When it arrived, the IBC Chairman said that he was too busy with grant applications and holidays to comply with the NIH Guidelines.(5) Eventually it became apparent that the Chairman's reluctance to reply probably also had to do with the fact that he didn't have any real meeting minutes because his IBC didn't really meet.
In July 2004, the Sunshine Project lodged a complaint with the NIH Office of Biotechnology Activities (OBA). An IBC that is not meeting and not reviewing projects is obviously not exercising its responsibilities and is not complying with the NIH Guidelines that OBA is charged with enforcing.
NIH OBA "Investigates"
About three months later, on 25 October 2004, NIH OBA got around to acting on the complaint. It sent a letter to the Venter IBC Chair, NIH OBA asked Venter Institute (then TIGR) a number of questions, most important among them, if its IBC was reviewing and overseeing research. (6)On 13 December 2004, Venter Institute replied. It stated that the Institute "received its NIH funded project involving recombinant DNA in early 1996," meaning that the IBC should have been overseeing research for nine years at that point. But the Institute admitted, "During its first years, the TIGR IBC did not formally meet".(7) In other words, the committee did not function, not bothering to even meet once until 2002.
Then came the following: "we have identified nine [9] projects that were not properly registered or reviewed by the TIGR IBC". This was an admission that the IBC was failing to identify and review research. In addition the Institute stated that there were 116 more genetic engineering projects active in its labs that, it claimed, did not require IBC oversight. Venter Institute said that it was gathering information about the unreviewed projects and would have the IBC review them ex-post-facto in January 2005. (8)
The minutes of the January 2005 Venter IBC meeting, which likely would never have been held absent the Sunshine Project's complaint, reveal that the unreviewed projects included work on biological weapons agents. The projects included work with the entire genome of strains of plague (Yersinia pestis), as well as glanders (Burkholderia mallei), melioidosis (B. pseudomallei), and valley fever (Coccidioides immitis), all of which are defined as biological weapons agents ("select agents") in US law. In addition, there were two NIH-funded biodefense "pathogen genomics" projects for which the minutes do not reveal what the specific pathogens are in use.(9, 10)
Seven Venter Institute investigators were responsible for the (at least) five projects involving both recombinant DNA and biological weapons agents that were not reviewed by the IBC. These include senior investigators in the Venter pathogen, parasite, and microbial genomics groups as well as Claire Fraser, the President of TIGR (now President of the TIGR division of Venter Institute). Dr. Fraser's unsupervised work involved the whole genome of four stains of plague.
An Alarming Situation of Noncompliance
NIH OBA was thus presented with an alarming situation that demanded a response. A major recipient of NIH recombinant DNA and biodefense funding had failed to maintain an Institutional Biosafety Committee that functioned and did not properly identify, review, or oversee research. While none of the projects that Venter Institute admitted to have blown involved large quantities of pathogens, the simple fact of the matter was that Venter's noncompliance was obviously systemic, penetrating to the leadership of the organization and ongoing for many years. In addition, it should have been apparent to NIH OBA that the problems would not have been detected by the government, because Venter (and other IBCs) have no effective reporting requirements to the federal government.What did NIH OBA do? The penalty is loss of NIH research funding. Instead, NIH OBA quickly moved to reward Venter's noncompliance. An OBA staff member called Venter to confirm that the IBC performed the after-the-fact review of the nine offending projects.(11) There is no evidence from the correspondence between OBA and Venter that OBA made any effort to independently verify Venter's claims about the 116 other projects, nor to identify and assess other past projects funded by NIH, other government agencies, or otherwise that were not properly overseen. (12) There was discussion of NIH OBA training the Venter IBC (13), but it is unclear if it ever happened. If so, it may have been ineffective (see below).
Thanking and Rewarding Venter for Ignoring the Rules
On 13 May 2005, NIH OBA sent Venter Institute a letter thanking it for providing "its helpful response and attention to compliance" and declared that Venter's reply "satisfactorily addresses the issues".(14) Case closed. No enforcement. No penalty. No sanctions. No increased oversight. No further discussion. In 2005 and 2006, Venter continued to receive NIH genetic engineering funding, including handouts for projects led by some of the same principal investigators whose previous projects were not overseen by an IBC.(15) Other federal agencies also continue their funding.Then, a few weeks later in late June 2005, NIH OBA announced Dr. Fraser's appointment to the National Science Advisory Board on Biosecurity (NSABB).(16) Thus, NIH OBA did not merely shrink away from sanctioning Dr. Fraser and/or Venter Institute for blatant IBC noncompliance, it actually rewarded the behavior with an important policy advisory position. There is no detectable sense of irony in NIH OBA's press release announcing the appointment, even though only months before her institute's IBC chair was forced to admit to NIH that it had ignored NIH rules for years on end. On the NSABB, Dr. Fraser sits on the subpanel developing recommendations for governance of synthetic biology.
The Sunshine Project never received a reply from NIH OBA regarding its complaint (until filing a Freedom of Information Act request to obtain OBA's file on the matter).
Is the Venter IBC Still Broken?
Remarkably, the most recent documentation available suggests that little has changed at the Venter IBC. In July 2006, it responded to another Sunshine Project request for its minutes. Although NIH OBA says it requires IBCs to meet at least once a year, the Venter IBC had no meeting minutes subsequent to the January 2005, a meeting that it only held because it was forced to as a result of the Sunshine Project's complaint. One has to wonder what message Venter took away from NIH OBA's farcical "investigation". Apparently, it was not that compliance matters. More likely, it was the opposite.
A Cynical Suggestion
And now the Venter Institute proposes that US Institutional Biosafety Committees are an appropriate mechanism for "self regulation" of synthetic biology. With the facts about Venter's IBC and NIH OBA's investigatory prowess now available, can Venter Institute's proposal possibly be taken seriously by anyone with a genuine interest in good governance of this emerging and potentially dangerous science? It is difficult to conclude that the suggestion is anything but a cynical gesture intended to evade effective oversight. After all, a cynical and evasive gesture is all that Venter's IBC has been since its inception.
NOTES
(1) In October 2006, TIGR merged with two related entities into an organization now called the Venter Institute (VI). See URL: http://www.venterinstitute.org/press/news/news_2006_10_16.php
(2) Letter from Najib M. El-Sayed, TIGR IBC Chair to Amy Patterson, Director, NIH OBA, 13 December 2004. (Obtained by the Sunshine Project in NIH FOIA Case #30635.)
(3) TIGR IBC Meeting Minutes of 23 April 2004 and 6 March 2002. (Obtained - grudgingly - from TIGR after several requests pursuant to the Public Access Provisions of the NIH Guidelines.) These are the only minutes TIGR could provide and the only recorded TIGR IBC meetings that ever occurred prior to the Sunshine Project's complaint. This despite the fact that, according to TIGR management, the IBC became responsible for oversight of federally funded recombinant DNA research in early 1996 (see note #2).
(4) A right that was very rarely invoked until 2003, when the Sunshine Project began exercising it across the country. Since 2003, the Sunshine Project has filed over 1,000 requests for IBC minutes.
(5) Letter to the Sunshine Project from Najib M. El-Sayed, TIGR IBC Chair, 12 July 2004.
(6) Letter from Amy Patterson, Director, NIH OBA to Najib M. El-Sayed, TIGR IBC Chair, 25 October 2004. (Obtained by the Sunshine Project in NIH FOIA Case #30635.)
(7) As stated elsewhere, the first meeting took place in 2002, when only 2 projects were reviewed. At the second meeting, in 2004, no projects were reviewed. Instead, paperwork formats were discussed.
(8) Letter from Najib M. El-Sayed, TIGR IBC Chair to Amy Patterson, Director, NIH OBA, 13 December 2004. (Obtained by the Sunshine Project in NIH FOIA Case #30635.)
(9) The 24 January 2005 Venter IBC minutes are written in the present and future tense, thus they do not reveal that the reviews, according to Venter's statements to NIH OBA, are in fact after the fact "oversight" of the projects. In other words, it cannot be detected from the minutes alone that at this meeting, the Venter IBC was scrambling to review past research that it had been forced to admit was not being properly overseen. The unusual and dubious after the fact nature of these protocol reviews is only apparent if the minutes are read beside Venter's correspondence with NIH OBA.
(10) There are only 6 projects reviewed in the minutes. It is unclear what happened to the other 3 protocols that Venter told NIH OBA that its IBC had failed to identify and review. There are no redactions apparent in the minutes. These might be related to Venter work for the Federal Bureau of Investigation; but if so, that is not stated.
(11) Although only 6 are noted in the minutes (see note #10).
(12) Because Venter Institute receives NIH funding, under the NIH Guidelines all genetic engineering work at the institution must be overseen by the IBC, not only that funded by NIH.
(13) TIGR IBC Meeting Minutes of 24 January 2005.
(14) Letter from Amy Patterson, Director, NIH OBA to Najib M. El-Sayed, TIGR IBC Chair, 13 May 2005. (Obtained by the Sunshine Project in NIH FOIA Case #30635.)
(15) Search NIH grant data at: http://www.sunshine-project.org/crisper/
(16) HHS Press Release "HHS Appoints Members to National Science Advisory Board for Biosecurity", 29 June 2005.