Establishment and maintenance of records under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule.
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The Food and Drug Administration (FDA) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals. The requirement to establish and maintain records is one of several tools that will help improve FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the information will improve FDA's ability to quickly notify the consumers and/or facilities that might be affected by the outbreak. (+info)
Select agent regulations.
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In recent years, there has been an increase in research with biological agents, particularly those that pose a potential for use by terrorists. In this environment, laws have been enacted and regulations developed to ensure the appropriate use of specified "select agents and toxins" for legitimate research. Within this regulatory environment, it has been necessary for institutions and investigators to adapt to an entirely new set of requirements to begin or continue to work with these pathogens. Registration and approval for use of select agents and toxins, security and safety requirements, and daunting record-keeping requirements are only some of the regulatory challenges that researchers face in working with these agents. A brief overview of recent regulations is presented, as well as where to obtain additional information on regulations, standards, and guidelines related to work with select agents and toxins. (+info)
Administrative issues related to infectious disease research in the age of bioterrorism.
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The recent unprecedented growth in infectious disease research funding and infrastructure has resulted in part from an outgrowth of concern about newly emerging and re-emerging diseases and the progressive development of antibiotic-resistant pathogens. However, the most compelling impetus is the suspected and demonstrated capability and will of unknown individuals, groups, or states to use biological agents and/or toxins as weapons. Although the actual number of known victims and fatalities from bioterrorism in the United States has been miniscule compared with many other daily hazards, biological agents have the potential to cause human mass casualties, severely damage segments of our economy or agricultural infrastructure, poison or compromise our food or water supply, and, perhaps most damaging, disrupt our society physically and psychologically. The significant institutional commitment necessary to participate in infectious disease research is described, with a focus on programs that involve research with pathogens thought to have potential for use by bioterrorists. Administrative considerations are described, and include obtaining necessary research funding to offset high operating costs; complying with "select agent" regulations, security screening of employees; building or renovating a biocontainment facility; finding skilled professional and technical manpower; providing adequate physical security in a threat environment; conducting targeted training; overcoming potential internal and external dissent; developing and/or providing sufficient occupational health and safety programs; achieving and maintaining compliance standards in a fluid regulatory environment; mitigating potentially hazardous working conditions; understanding personal and institutional liability; and reassuring and dealing with a concerned, skeptical, or even hostile public. (+info)
Veterinary medicine in the 21st century: the challenge of biosecurity.
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The veterinary profession is presently challenged with developing and maintaining on-farm biosecurity protocols to protect the nation's food supply from acts of bioterrorism, from the growing threat of foreign animal diseases, and from multidrug resistance among pathogenic organisms. This challenge comes at a time when the supply of food animal veterinarians in the United States is progressively in decline, and raises the possibility that the profession is not adequately prepared to fulfill its responsibilities to the health and productivity of the US livestock and poultry populations. Causes of the decline in demand for veterinary services are discussed. They include consolidation of the food animal industries and a trend toward transferring performance of tasks traditionally carried out by veterinarians to the province of lay staff. This development potentially reduces veterinary surveillance of food animal populations. It also runs the risk of delay in recognizing and controlling serious health problems when they arise. Several remedies are proposed, including profound changes in the curriculum for educating food animal veterinarians to serve the consolidated but vulnerable livestock and poultry industries suitably. Also advocated is the initiation of training programs for herdsmen on the symptoms of foreign animal diseases, together with advice on when to call a veterinarian. Significant investment of federal or state resources will be required if these changes are to become reality. (+info)
Mass transit infrastructure and urban health.
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Mass transit is a critical infrastructure of urban environments worldwide. The public uses it extensively, with roughly 9 billion mass transit trips occurring annually in the United States alone according to the U.S. Department of Transportation data. Its benefits per traveler include lower emissions of air pollutants and energy usage and high speeds and safety records relative to many other common modes of transportation that contribute to human health and safety. However, mass transit is vulnerable to intrusions that compromise its use and the realization of the important benefits it brings. These intrusions pertain to physical conditions, security, external environmental conditions, and equity. The state of the physical condition of transit facilities overall has been summarized in the low ratings the American Society of Civil Engineers gives to mass transit, and the large dollar estimates to maintain existing conditions as well as to bring on new improvements, which are, however, many times lower than investments estimated for roadways. Security has become a growing issue, and numerous incidents point to the potential for threats to security in the US. External environmental conditions, such as unexpected inundations of water and electric power outages also make transit vulnerable. Equity issues pose constraints on the use of transit by those who cannot access it. Transit has shown a remarkable ability to rebound after crises, most notably after the September 11, 2001 attacks on the World Trade Center, due to a combination of design and operational features of the system. These experiences provide important lessons that must be captured to provide proactive approaches to managing and reducing the consequences of external factors that impinge negatively on transit. (+info)
Possession, use, and transfer of select agents and toxins. Final rule.
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This document establishes a final rule regarding possession, use, and transfer of select agents and toxins. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture has established corresponding final rules designed to protect animal and plant health and animal and plant products. (+info)
Illegal alcohol sales and use of alcohol control policies at community festivals.
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OBJECTIVES: The primary goals of this study were to assess the propensity for alcohol sales to underage customers and obviously intoxicated customers at community festivals, and to assess the prevalence of alcohol control policies at these events. A secondary goal was to identify server and festival characteristics and festival policies related to the likelihood of illegal alcohol sales. METHODS: We conducted pseudo-underage purchase attempts at 43 festivals and pseudo-intoxicated purchase attempts at 50 festivals to assess the likelihood of illegal sales. Research staff made observations at festivals and contacted festival planners by telephone following each event to assess which alcohol policies were implemented. We conducted backwards stepwise multivariate analyses for each purchase attempt outcome to identify policies and characteristics related to likelihood of illegal alcohol sales. RESULTS: Pseudo-intoxicated buyers purchased beer in 89% of 95 attempts (standard deviation [SD]=0.31) and pseudo-underage buyers were able to purchase beer in 50% of 82 attempts (SD=0.50). All festival planners reported having at least two of the 10 alcohol policies we assessed, but no festival had implemented all 10 policies. Server characteristics were not related to either purchase attempt outcome. In the multivariate analyses, having more alcohol control policies was related to a greater likelihood of illegal sales to intoxicated customers; however, having more alcohol control policies was associated with a lesser likelihood of alcohol sales to underage customers. Restricting the number of servings per person was also associated with a lesser likelihood of alcohol sales to underage customers. CONCLUSIONS: Propensity for illegal alcohol sales at festivals is very high. Research is needed to identify interventions to prevent illegal alcohol sales at these events. (+info)
Destroying the life and career of a valued physician-scientist who tried to protect us from plague: was it really necessary?
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Thomas Campbell Butler, at 63 years of age, is completing the first year of a 2-year sentence in federal prison, following an investigation and trial that was initiated after he voluntarily reported that he believed vials containing Yersinia pestis were missing from his laboratory at Texas Tech University. We take this opportunity to remind the infectious diseases community of the plight of our esteemed colleague, whose career and family have, as a result of his efforts to protect us from infection by this organism, paid a price from which they will never recover. (+info)