Letters to Campus

March 2010

Dear K-State Faculty and Staff,

Greetings again this month from Anderson Hall! I hope you had a good spring break. Tim flew in from Starkville, Mississippi, to join the family as we followed the men's basketball team through the Big 12 Conference Tournament and through the first two rounds of the NCAA Tournament. While we were in Oklahoma City, I had the opportunity to visit with several K-State supporters about additional investment in our university. We do not have as big a presence in Oklahoma City as I would like us to have, so we will be working with our alumni association and KSU Foundation about maintaining a larger presence in this area of the country.

One of the most prestigious awards a young faculty member can receive is a National Science Foundation CAREER Development Award. These competitive grants are given to the best and brightest young faculty members in the country. Over the past year, K-State has landed more successful CAREER awards than any other time in our institution's history. I am pleased to announce that four of our faculty members have been selected to receive these five-year grants from NSF and a fifth award is pending. Recipients so far are Christine Aikens, Department of Chemistry, Jianhan Chen, Department of Biochemistry, Xinming (Simon) Ou, Department of Computing and Information Sciences, and Wenqiao Yuan, Department of Biological and Agricultural Engineering. Congratulations one and all! I hope to be able to announce the fifth recipient in my next campus letter.

During my visits around campus and in the community, one of the questions often raised involves the status of the Biosecurity Research Institute (BRI) in Pat Roberts Hall. Therefore, I thought I would spend part of this month's letter discussing this research facility, what is happening in the BRI, and what the future looks like for this facility.

First, a little history. Construction of the BRI began in 2004 and was completed in 2007. In 2008 the BRI was almost fully staffed to support research programs and biocontainment operations. Although no select agent work has yet been conducted in the facility, research has been ongoing in various portions of the facility since 2008, some as part of the facility "shake-down" to make it operational for select agent research. The BRI is configured into four defined areas or wings. These include the "P" or plant wing, the "A" or animal housing wing, "E" or enhanced basic microbiology lab wing and the "FS" or food safety wing.

Biocontainment facilities are classified by the Centers for Disease Control (CDC) and the National Institutes of Health into four distinct levels depending on the nature of the research and the biological agents that will be used in the laboratory. These levels are termed as Biosafety Level 1, 2, 3, or 4, and are normally designated as BSL-1, BSL-2, BSL-3, and BSL-4. Biosafety level 1 basically covers organisms that are not normally hazardous to healthy adults. Biosafety level 2 covers organisms and biological materials which pose moderate hazards to adults and personnel. These laboratories also have limited access and documented procedures for handling biological materials. Biosafety level 3 designates work with biological materials which could cause serious illness (including death) to humans if not handled properly. Biological materials which fall in this category include things like the West Nile virus. The highest level of biosafety is BSL-4, which involves work with biological materials where vaccines are not currently available and requires workers to wear full hazmat-like positive pressure suits with self-contained air supplies. For more information on the BSL designations, see the CDC manual (pages 35-37). Additionally, the University Research Compliance Office Web site has online training materials describing characteristics of the different CDC biosafety levels as well.

The BRI is a BSL-3 facility, and will not be working with any BSL-4 biological materials. In fact, the BRI is technically a BSL-3 and BSL-3Ag facility, the latter an enhanced and specialized form of BSL-3 for working with livestock. BSL-3Ag incorporates almost all the same construction features of a BSL-4 facility and must meet specific construction standards set by USDA for the rooms to be primary containment barriers. However, the self-contained "space suits" are not required.

At K-State, all laboratories are inspected by the Environmental Health and Safety Office. Those using biological materials must have their activities approved by the Institutional Biosafety Committee. These approvals follow a prescribed process and include site inspections by the Institutional Biosafety Committee and University Research Compliance Office for facility compliance as well as appropriate documentation for laboratory policies and procedures.

In order to work with more hazardous biological materials, additional external inspections must be made by organizations such as the CDC or the U.S. Department of Agriculture. This is the case with the most rigorously regulated biological materials, which are termed "select agents." In order to work with select agents, facility inspections are done for each specific project involving a select agent to ensure that the facility is configured appropriately, that the support staff are trained to safely handle the specific select agent, that the experimental plans and security measures for the select agents are appropriate and documented, and that the select agent can be used in a safe and secure manner for the facility personnel and surrounding community.

While all of this may be interesting, where does the BRI fit in to all of this? Taking into account previous experience and inputs from recently inspected peer institutions, we elected to apply for approval of the BRI wings one at a time for specific BSL-3 select agent work. Earlier this month, the CDC visited the "P wing" as an initial step to performing select agent work and we expect work on this specific project to begin in the not-too-distant future. We anticipate that we will have a similar visit by the USDA and CDC later this year to review the "A and E wings" for additional projects. Approval for select agent projects for the "FS wing" will occur last. As the BRI research programs grow, additional approvals will be required for addition of new personnel, additional select agents and different research projects.

So, has all of this taken longer than we would have liked? Certainly. However, you only get one chance to do this right and to do this well, and we want to be sure that when inspection teams leave Kansas State that they are impressed with our level of preparation and ability to conduct BSL-3 select agent research.

On a broader scale, facilities like the BRI are expensive to build and operate, difficult to obtain regulatory approvals for, and will require significant specialized staffing to maintain our operational readiness. However, it is also important that if K-State wants to be a major player in infectious disease research, that our faculty, staff, and students must have close access to these types of facilities. Thus, my priority is to work with the Office of Research and the BRI leadership team to ensure that we continue to move along a very deliberate path towards approvals for select agent use. So, are we making good progress towards doing select agent work in the BRI? Absolutely. Are we currently conducting research work in the BRI? Yes, we have several active projects. Plus, we have successfully met inspection requirements and received permits for two projects involving USDA-regulated infectious agents that are not technically "select agents" but require the BRI's BSL-3/BSL-3Ag infrastructure. Finally, will there be challenges as we continue to operate this facility? Certainly.

I hope this note has helped to clarify where we are with the BRI, and where we anticipate going in the future. This is a fantastic addition to the K-State research enterprise, and we are doing everything possible to move our research portfolio in infectious diseases to new heights.

If you have any questions or concerns, please do not hesitate to drop me a note. Good luck with the second half of the semester!

Go Cats!

Kirk