Anthrax Detection: Agencies Need to Validate Sampling Activities in Order to Increase Confidence in Negative Results

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DIANE Publishing, 2005 - 113 pages
In Sept. & Oct. 2001, letters laced with Bacillus anthracis (anthrax) spores were sent through the mail to two U.S. Senators & to members of the media. These letters led to the first U.S. cases of anthrax disease related to bioterrorism. In all, 22 individuals, in 4 states & Wash., D.C., contracted anthrax disease; 5 died. This report describes & assesses federal agencies' activities to detect anthrax in postal facilities, assess the results of agencies' testing, & assess whether agencies' detection activities were valid. Also includes recommendations to the Dept. of Homeland Security (DHS). Graphs & tables.

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Page 72 - Security is the principal Federal official for domestic incident management. Pursuant to the Homeland Security Act of 2002, the Secretary is responsible for coordinating Federal operations within the United States to prepare for, respond to, and recover from terrorist attacks, major disasters, and other emergencies.
Page 72 - To prevent, prepare for, respond to, and recover from terrorist attacks, major disasters, and other emergencies, the United States Government shall establish a single, comprehensive approach to domestic incident management. The objective of the United States Government is to ensure that all levels of government across the Nation have the capability to work efficiently and effectively together, using a national approach to domestic incident management. In these efforts, with regard to domestic incidents,...
Page 90 - We will also make copies available to others upon request. In addition, the report will be available at no charge on GAO's Web site at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7215 or robertsonr@gao.gov.
Page 82 - ... increase confidence in negative test results generated by that process. This approach would include working with agencies to ensure that appropriate validation studies of the overall process of sampling activities, including the methods, are conducted. Specifically, we recommended that the Secretary 1. take a lead role in promoting and coordinating the activities of the various agencies that have the technical expertise related to environmental testing; 2. ensure that a definition of validation...
Page 67 - Validation and regulatory acceptance of toxicological test methods: a report of the ad hoc Interagency Coordinating Committee on the validation of alternative methods.
Page 7 - Validation is a formal, empirical process in which an authority determines and certifies the performance characteristics of a given method Therefore, investments are also needed to validate these methods, as well as the overall anthrax detection process. Validating the overall process is important because operational and health-related decisions are made on the basis of testing results that the process generates. CDC and USPS officials said that they used targeted sampling; that is, they collected...
Page 4 - Findings Sampling Strategy The federal agencies primarily used a targeted strategy — they collected samples from specific areas considered more likely to be contaminated, based on judgments. Such judgments can be effective in some situations — for example, in determining whether a facility is contaminated when information on the source of potential contamination is definitive. However, in the case of a negative finding, when the source of potential contamination is not definitive, the basic question...
Page 9 - The bacterium is commonly found in the soil and forms spores (like seeds) that can remain dormant for many years. Although anthrax can infect humans, it occurs most commonly in plant-eating animals. Human anthrax infections are rare in the United States and have normally resulted from occupational exposure to infected animals or contaminated animal products, such as wool, hides, or hair.
Page 32 - ... and all articles and compositions containing poison, and all poisonous animals, insects, reptiles, and all explosives, inflammable materials, infernal machines, and mechanical, chemical, or other devices or compositions which may ignite or explode, and all disease germs or scabs, and all other natural or artificial articles, compositions, or material which may kill or injure another, or injure the mails or other property...

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