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Task Order Project Officer U. Skodack Signature David W. Zachary Willenberg Dr.
Environmental Protection Agency U. The organization chart in Figure 1 shows the individuals from Battelle, the vendor, and EPA who will have responsibilities in the technology evaluation.
The responsibilities of these organizations and datings matrix x sabre reviews are summarized in the following subsections. He will have overall responsibility for ensuring that the technical, schedule, and cost goals established for testing and evaluation are met, and that the procedures employed for testing are consistent with TTEP guidelines.
Taylor will serve as the primary interface for the TOPO. Taylor in responding to any issues raised in assessment reports and audits. Notify the Task Order Leader if such an order is issued. Willenberg as necessary.
Taylor in planning and conducting the technology evaluation.
Upon withing at the Senate, all members of the most, except the Usher of the Black Rod, stop at the bar of the Ability. All bills, except appropriation bills, are then gave to the Governor General for assent. The request, orchestrated by the titles of the bills to be assented to, is made by a man clerk in both official languages. The Governor General then travels assent by a nod of the head, and meet is announced by the Clerk of the Parliaments3.
Taylor in responding to any issues raised in assessment reports and audits related to facility operation. The Columbus facilities to be used are chemical laboratories equipped for safe handling of a wide variety of chemicals. The MREF, located in West Jefferson, has chemical and biological surety agent laboratories certified for use of chemical and biological warfare agents.
Other test facilities could be used depending on the availability and capability of the facilities.
The NHSRC is conducting tests to evaluate the performance of commercially-available products, methods, and equipment for decontamination of porous and non-porous indoor surfaces contaminated dating matrix x sabre reviews biological or chemical agents. The purpose of this testing is to generate objective performance data that can be used by building and facility managers, first responders, groups responsible for building decontamination, and other technology buyers and users to make informed purchase and application decisions.
All potential users need unbiased, high-quality, objective third-party data and information in order to assess how well the available decontamination tools will meet their performance objectives while protecting human health and the environment. Decontamination of personnel or large equipment items e. One or more biological agents e.
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The highly persistent biological warfare agent, Bacillus anthracis Ames spores, was selected for this evaluation. The indoor surfaces selected include both porous and non-porous materials see Section B1. Evaluation of each technology will be accompanied by careful monitoring of dwell time, decontamination agent concentration, temperature, relative humidity and other parameters that may impact decontamination efficacy. This plan specifically focuses on building decontamination in the context of use by personnel responsible for decontamination after a terrorist attack.
This plan focuses on the evaluation of technologies that are potentially applicable for decontaminating indoor surfaces contaminated with biological warfare agents or toxins. For this evaluation, the performance of each of the decontamination technologies will be evaluated by comparing the amount of biological agent remaining on the indoor surface carpet, wallboard, etc. Testing may be conducted over ranges of temperature and relative humidity representing those that might be encountered in a decontamination situation in a building environment.
The evaluation to be conducted under this plan is limited to detection of biological warfare agents or surrogates or toxins in or on individual samples test coupons of indoor materials. Testing will be conducted in two phases. The initial phase will take place in a naive area not a biological safety laboratory and the second phase will take place in a biosafety level BSL 3 area.
In the initial phase, the decontamination technology will be coupled with the test chamber, associated monitoring devices will be installed in the test chamber and the vendor staff will train the MREF staff regarding use of the decontamination technology.
In addition, the MREF staff will verify that all sub-systems comprising the testing apparatus are in working order. It is anticipated that four weeks will be required to complete all testing for a single sporicidal technology. This schedule is predicated upon the vendor shipping the decontamination technology to Battelle and training Battelle personnel in the use of the equipment in accordance with the overall testing schedule.
CPUs in extracts of control test coupons are determined using standard plating techniques. The log kill value is also efficacy discussed in Section Bl.
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The log kill or efficacy value is used as an indication of the overall effectiveness of the decontamination technology. The closer the efficacy value is to the number of spores applied to the test coupon the more effective or efficacious the treatment. If the growth medium appears cloudy, then the conclusion is drawn that viable spores remained on the decontaminated samples following extraction.
Growth could arise from spores added to the test coupon or reflect growth of indigenous organisms. Spores or other organisms giving rise to growth in the nutrient medium will be identified by standard culture techniques. A small sample of each positive culture will be streak plated onto tryptic soy agar plates and cultured overnight. The streak plates will provide information as to whether the organisms present are the same as those inoculated on the coupons, or other distinct microorganisms Qualitative assessment of spore strips and biological indicators.
Following implementation of the decontamination technology the spore strips and indicators are placed in growth medium. The growth medium is examined at one and seven days post-decontamination for evidence of viable spores medium becomes cloudy. The biological indicators and spore strips have been used in large-scale sabres reviews to assess the completeness of decontamination.
However, the spores on the biological indicators and spore strips are not B. In addition, the spore strips and biological indicators are more amenable to decontamination biological indicators are a metal disc, spore strips are filter paper. The results for biological indicators and spore strips provide a means of comparing the effectiveness of the decontamination technology with other results obtained using the same or other decontamination technologies.
Changes in appearance of representative indoor surfaces.
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Each test coupon is visually examined before and after application of the decontamination technology to assess whether or not the test coupon material exhibits physical changes loss or change of color etc. This information provides a general indication of how "caustic" the decontamination technology is and whether or not the contents of, for example, a subway station would be damaged or destroyed during decontamination.
Rather, bacterial colonies will be enumerated manually and recorded. All other determinations will be qualitative. Specific information regarding the individual decontamination technologies is included in the Appendix.
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That facility is described below. The following section describes the MREF biofacility. The MREF specializes in research, development, testing, and evaluation of medical countermeasures against highly pathogenic biological and highly toxic chemical materials.
This facility is one of a very limited number of U. This facility maintains state-of- the-art equipment, and professional and technical staffing expertise to safely conduct testing and evaluation of hazardous biological materials under the Food and Drug Administration's FDA Good Laboratory Practices Guidelines 21 CFR Part Army regulations and is routinely inspected by personnel from the appropriate government agency.
Army Inspector General, U.
Army Regulations, and Federal Government and State of Ohio regulations to conduct and support research, development, testing and evaluation studies using highly toxic chemical and pathogenic biological materials. The containment area within the facility is designed to meet or exceed the BSL-3 facility guidelines published by the CDC and National Institute of Health entitled Biosafety in Microbiological andBiomedical Laboratories 4th edition, Army Regulations and the CDC.
Battelle's facilities are certified through inspection by personnel from the appropriate government agency. Battelle's MREF is certified to work with both live and surrogate agents including bacterial endospores e.
The Battelle Quality Assurance Manager, or a designee, must assure that documentation of such training is in place for all evaluation personnel before allowing evaluation to proceed.
All participants in this evaluation i. Vendor staff will train Battelle evaluation staff in the use of their decontamination technology, but will not be the technology users during the evaluation. Access to restricted areas of the test facility will be limited to staff who have met all the necessary training and security requirements. The existing sabre reviews restrictions of the test facility will be followed, i. All visiting staff at the test facility will be given a site-specific safety briefing prior to the start of any technology evaluation activities.
This briefing will include a description of emergency operating procedures and the identification, location, and operation of safety equipment e.
Evaluation procedures must follow all safety practices of the test facility at all times. Any report of unsafe practices in this evaluation, by those involved in the evaluation or by other observers, shall be grounds for stopping the evaluation until the Quality Assurance Manager and testing personnel are satisfied that unsafe practices have been corrected.
Battelle will document training by the vendor with a form signed by the dating matrix x sabre reviews. Evaluation of the efficacy of a particular sporicidal technology for decontaminating a particular material will be accomplished by determining the differential mean reduction of viable agent or surrogate under an experimental treatment compared to mean reduction in the absence of the treatment control.
Treatments will be defined in terms of viable agent or surrogate, decontamination technology or lack thereof and operational use of the technology e. Decontamination efficacy will be assessed by comparing the number of viable organisms remaining after decontamination with the number initially applied to the test surface.
Efficacy will be expressed as the log dating matrix x sabre reviews 10 of result of dividing the mean number of viable organisms found on the control by the number of viable organisms found on a treated sample.
After obtaining the experimental treatment and control data, a statistical comparison will be conducted. Throughout the evaluation, the test coupons will be randomly assigned to control and experimental groups.
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Each decontamination technology will be applied in a manner consistent with the manufacturer's recommendations. The technology vendor will provide the equipment and training regarding application of their technology. The statistical approaches for these analyses are discussed in Section B6.
This test chamber has dimensions of 71 cm w x 59 cm d x 74 cm h 28" x 23" x 29" and outer dimensions of cm w x 61 cm d x 79 cm h 43" x 24" x 31". The review chamber has a total volume of L Glove ports are available for working in the test chamber. The test chamber may need to be modified, in accordance with the vendor, to accommodate the decontamination technology. The decontaminant fumigant, foam, liquid, gel will be directed from the vendor's system into the test chamber under the conditions dwell time, decontaminant concentration, temperature, and humidity specified by the vendor.
The performance tests will use test coupons that are approximately 1.
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This evaluation methodology comprises a highly controlled, reproducible approach to assess decontamination efficacy, while simulating a realistic, small-scale application of the decontamination technology. The surface materials to be used include both non-porous and porous surfaces representing a variety of materials.
Test coupons typically measuring 1. The representativeness and uniformity of the test materials are critical attributes to assure reliable evaluation results. Representativeness means that the materials used are typical of such materials used in buildings in terms of quality, surface characteristics, structural integrity, etc.
Uniformity means that all test pieces are essentially equivalent for evaluation purposes.
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