United States Environmental Protection Agency Office of Research and Development National Exposure Research Laboratory FY02 Research Abstract Government Performance Results Act (GPRA) Goal 8.3.1 APM257 Significant Research Findings: Develop Routine and Rapid Methods to Analyze Biological Agents In the fall of 2001 terrorist attacks with Bacillus anthracis spores overwhelmed the analytical laboratory capacity at the Centers for Disease Control and Prevention (CDC), at various state health laboratories, and at the U.S. Army Medical Research Institute of Infectious Diseases. Research On October 25, 2001, Administrator Whitman directed that the U.S. Approach Environmental Protection Agency's (EPA) biosafety level 3 microbiology laboratory located in the Andrew W. Briedenbach Environmental Research Center (AWBERC) in Cincinnati, Ohio, be upgraded in order to increase laboratory capacity at this time of national need. Results and In response to the Administrator's directive, numerous physical Implications improvements to the biosafety level 3 microbiology laboratory have occurred. The cast-iron waste-water line connecting the laboratory to the sanitary sewer was replaced with chemically resistant plastic pipe. Four new biosafety cabinets, which are 100% vented, replaced recirculating models. In order for these biosafety cabinets to work properly and be certified, four new exhaust fans were installed on the roof of the AWBERC to replace lower capacity models. Four incubators, four refrigerators, a centrifuge, a microfuge, and a freezer were purchased to meet the requirements for Bacillus anthracis analysis and spore production. Sensors that digitally monitor and record the temperatures of all incubators, refrigerators, and freezers were installed to alert the staff should the respective instrument exceed set upper and lower temperature points. Digital magnahelix devices were installed to monitor the pressure differential in each laboratory module to ensure that the laboratories maintain negative pressure with regard to the rest of the building. All walls, ceilings, and floors were resealed with epoxy to preclude penetration of pathogens into these porous surfaces. Eye wash stations were installed at each laboratory sink to meet current safety requirements. In addition, foot operated faucets were installed at each sink. Where there were insufficient ultraviolet bacteriocidal ceiling lamps, new lamps were installed to complete the coverage of the whole laboratory. Bulbs were replaced with new bulbs in existing ultraviolet bacteriocidal lamps, so that the ultraviolet Scientific Problem and Policy Issues National Exposure Research Laboratory — November 2002 ------- light output would be as effective as possible. Laptop computers were installed in various locations to facilitate digitally recording data to obviate the use of laboratory notebooks, which potentially could become contaminated. Furthermore, a digital camera was purchased to allow for the photography of all samples as they arrive. A specially secured area on the AWBERC local access network (LAN) was established. Only approved investigators and analysts have access to this secured area of the LAN. Of those with approved access, only two have the ability to edit the material. Some of the investigators have been granted top secret security clearance. All of the protocols required for analysis of anthrax spores were assembled, adjusted to the needs of the laboratory, and stored electronically on the LAN. In turn, these protocols were amended further with the addition of a quality assurance plan and a comprehensive program plan. All investigators scheduled to work with anthrax samples have been fit tested for respirators. Several positive air pressure respirators have been purchased and are on hand, if ultra-hazardous samples prone to aerosolization should need to be analyzed. The apparatus producing reagent grade water has been upgraded with a Milli-Q Synthesis, model A10. For additional safety, a new sample receiving building was positioned outside and to the side of the AWBERC loading dock. The intent is to repackage any sample shipments and decontaminate the exterior of the sealed repackaging in the chemical storage building before transporting the samples through the AWBERC to the biosafety level 3 microbiology laboratory. The laboratory was registered with the Laboratory Registration and Select Agent Transfer Program. The Agency's Registration is effective from 14 November 2001 until 14 November 2004. The registration gives the Agency access to reagents which are not commercially available but are prescribed by the CDC. Besides Bacillus anthracis, the Agency is registered to analyze samples for Burkholderia mallei, B. pseudomallei, and Clostridium botulinum. Because the Agency is registered with the Laboratory Response Network, investigators with potential exposure to B. anthracis are eligible to receive anthrax vaccinations consisting of a series of six inoculations administered over an eighteen-month period. Nine investigators have started the vaccination series. A vaccination declination form for investigators with potential exposure to anthrax, but refusing the vaccine, has been prepared and reviewed by the Office of General Council. Research None. Collaboration and Publications National Exposure Research Laboratory — November 2002 ------- Future Research To operate at the level of safety set by Agency officials, a number of tasks must be completed before actual research and sample analysis can begin. All of the investigators fitted for respirators must receive respirator training. Bacillus anthracis spore background levels must be determined both inside and outside the biosafety level 3 laboratory. The anthrax sample analytical capacity must be determined for the federal in-house staff. To support this capacity, an on-site support contract that would be used to assist in-house staff in the event of a surge of samples must be established. Based on these points, an acceptance criteria protocol must be prepared. Sterne strain B. anthracis spores must be produced for the various research projects awarded to AWBERC investigators as part of the Safe Building and Safe Water Initiatives. The Agency needs to obtain and install the laboratory information system and ancillary hardware currently being used by the CDC as part of the Laboratory Response Network. A memorandum of understanding between the U.S. Environmental Protection Agency and the U.S. Food and Drug Administration to maximize the potential of their respective biosafety level 3 laboratories and staffs during a time of national crisis is planned. Questions and inquiries can be directed to: Dr. Frank W. Schaefer, III US EPA, Office of Research and Development National Exposure Research Laboratory 26 West M.L. King Drive Cincinnati, Ohio 45268-1320 Phone: 513/569-7222 E-mail: schaefer.frank@epa.gov Contacts for Additional Information National Exposure Research Laboratory — November 2002 ------- |