Absence of adverse effects following the gavage administration of methyl propyl trisulfide to Sprague-Dawley rats for 90 days.

Methyl propyl trisulfide is a flavoring substance found in foods such as garlic and onions. At the request of the European Food Safety Authority (EFSA) for additional toxicological data on methyl propyl trisulfide, groups of Sprague-Dawley rats (10/sex/group) were gavaged with 0 (corn oil vehicle control), 0.5, 2, or 6 mg methyl propyl trisulfide/kg bw/day in a 90-day GLP-compliant study. No effects on clinical observations, hematology and clinical chemistry parameters, organ weights, or macroscopic and histopathological examinations were found attributable to ingestion of methyl propyl trisulfide. The oral no-observed-adverse-effect level (NOAEL) for rats of both sexes was the highest dose tested of 6 mg/kg bw/day.

Absence of renal adverse effects from ß-myrcene dietary administration in OECD guideline-compliant subchronic toxicity study.

ß-Myrcene is a flavoring substance that occurs naturally in a large variety of foods. At the request of the European Food Safety Authority (EFSA) for additional toxicological data on ß-myrcene, groups of Sprague Dawley rats (10/sex/group) were administered diets containing 0, 700, 2100, or 4200 ppm of ß-myrcene designed to provide nominal doses of 0, 50, 150, or 300 mg/kg bw/day in a 90-day GLP-compliant study. Based on body weights, feed consumption, and substance stability data, final estimated daily intakes of ß-myrcene were calculated to be 20.4, 58.8, and 115.2 mg/kg bw for males and 24.2, 70.0, and 135.9 mg/kg bw for females. No effects on clinical observations, hematology and clinical chemistry parameters, organ weights, or macroscopic and histopathological examinations were found attributable to ingestion of ß-myrcene. The oral no-observed-adverse-effect level (NOAEL) for rats of both sexes was the highest dose tested. Based on feed consumption and test substance stability in the diet, the NOAEL was calculated to be 115 and 136 mg/kg bw/day for males and females, respectively.

Absence of adverse effects following administration of piperine in the diet of Sprague-Dawley rats for 90 days.

Piperine (E,E-) is a naturally occurring pungent and spicy constituent of black pepperand is also used as an added flavoring ingredient to foods and beverages. Piperine has been determined safe under conditions of intended use as a flavoring substance by regulatory and scientific expert bodies. While concurring with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and Flavor and Extract Manufacturers Association (FEMA) Expert Panel on the safety of piperine, the European Food Safety Authority (EFSA) requested additional toxicological data. The results of a 90-day GLPcompliant dietary study, conducted in Sprague-Dawley rats at target doses of 0, 5, 15, or 50 mg/kg bw/day, to respond to this request are presented herein. No adverse effects were found attributable to ingestion of piperine. Statistically significant changes in food consumption, body weight gain, and plasma cholesterol levels were not considered adverse as discussed in this paper. Therefore, the oral no-observed-adverse-effect level (NOAEL) was determined to be the highest dose tested of 50 mg/kg bw/day. EFSA derived a lower NOAEL of 5 mg/kg bw/day based on increased plasma cholesterol levels which still affords an adequate margin of safety of over 48,000 and concluded that piperine is not of safety concern.

The Symbiotic Relationship Between Operational Military Medicine, Tactical Medicine, and Wilderness Medicine: A View Through a Personal Lens.

There are direct and indirect linkages and a form of symbiosis between operational military medicine from World War II and present wilderness medicine, from the beginnings to contemporary practice, and the more recently evolved field of tactical emergency medical support. Each of these relationships will be explored from the historical perspective of the Department of Military & Emergency Medicine, Uniformed Services University of the Health Sciences from 1982 to the present.

Integration of Tactical Emergency Casualty Care Into the National Tactical Emergency Medical Support Competency Domains.

Tactical emergency medical support (TEMS) is a critical component of the out-of-hospital response to domestic high-threat incidents such as hostage scenarios, warrant service, active shooter or violent incidents, terrorist attacks, and other intentional mass casualty-producing acts. From its grass-roots inception in the form of medical support of select law enforcement special weapons and tactics (SWAT) units in the 1980s, the TEMS subspecialty of prehospital care has rapidly grown and evolved over the past 40 years. The National TEMS Initiative and Council (NTIC) competencies and training objectives are the only published recommendations of their kind and offer the opportunity for national standardization of TEMS training programs and a future accreditation process. Building on the previous work of the NTIC and the creation of acknowledged competency domains for TEMS and the acknowledged civilian translation of TCCC by the Committee for Tactical Emergency Casualty Care (C-TECC), the Joint Review Committee (JRC) has created an opportunity to bring forward the work in a form that could be operationally useful in an all-hazards and whole of community format.

Development of a National Consensus for Tactical Emergency Medical Support (TEMS) Training Programs--Operators and Medical Providers.

INTRODUCTION: Tactical teams are at high risk of sustaining injuries. Caring for these casualties in the field involves unique requirements beyond what is provided by traditional civilian emergency medical services (EMS) systems. Despite this need, the training objectives and competencies are not uniformly agreed to or taught. METHODS: An expert panel was convened that included members from the Departments of Defense, Homeland Security, Justice, and Health and Human Services, as well as federal, state, and local law-enforcement officers who were recruited through requests to stakeholder agencies and open invitations to individuals involved in Tactical Emergency Medical Services (TEMS) or its oversight. Two face-to-face meetings took place. Using a modified Delphi technique, previously published TEMS competencies were reviewed and updated. RESULTS: The original 17 competency domains were modified and the most significant changes were the addition of Tactical Emergency Casualty Care (TECC), Tactical Familiarization, Legal Aspects of TEMS, and Mass Casualty Triage to the competency domains. Additionally, enabling and terminal learning objectives were developed for each competency domain. CONCLUSION: This project has developed a minimum set of medical competencies and learning objectives for both tactical medical providers and operators. This work should serve as a platform for ensuring minimum knowledge among providers, which will serve enhance team interoperability and improve the health and safety of tactical teams and the public.

Insights and perspectives on emerging inputs to weight of evidence determinations for food safety: workshop proceedings.

This workshop aimed to elucidate the contribution of computational and emerging in vitro methods to the weight of evidence used by risk assessors in food safety assessments. The following issues were discussed: using in silico and high-throughput screening (HTS) data to confirm the safety of approved food ingredients, applying in silico and HTS data in the process of assessing the safety of a new food ingredient, and utilizing in silico and HTS data in communicating the safety of food ingredients while enhancing the public's trust in the food supply. Perspectives on integrating computational modeling and HTS assays as well as recommendations for optimizing predictive methods for risk assessment were also provided. Given the need to act quickly or proceed cautiously as new data emerge, this workshop also focused on effectively identifying a path forward in communicating in silico and in vitro data.

Determining the applicability of threshold of toxicological concern approaches to substances found in foods.

Threshold of Toxicological Concern (TTC) decision-support methods present a pragmatic approach to using data from well-characterized chemicals and protective estimates of exposure in a stepwise fashion to inform decisions regarding low-level exposures to chemicals for which few data exist. It is based on structural and functional categorizations of chemicals derived from decades of animal testing with a wide variety of chemicals. Expertise is required to use the TTC methods, and there are situations in which its use is clearly inappropriate or not currently supported. To facilitate proper use of the TTC, this paper describes issues to be considered by risk managers when faced with the situation of an unexpected substance in food. Case studies are provided to illustrate the implementation of these considerations, demonstrating the steps taken in deciding whether it would be appropriate to apply the TTC approach in each case. By appropriately applying the methods, employing the appropriate scientific expertise, and combining use with the conservative assumptions embedded within the derivation of the thresholds, the TTC can realize its potential to protect public health and to contribute to efficient use of resources in food safety risk management.

Integrating the totality of food and nutrition evidence for public health decision making and communication.

The interpretation and integration of epidemiological studies detecting weak associations (RR <2) with data from other study designs (e.g., animal models and human intervention trials) is both challenging and vital for making science-based dietary recommendations in the nutrition and food safety communities. The 2008 ILSI North America "Decision-Making for Recommendations and Communication Based on Totality of Food-Related Research" workshop provided an overview of epidemiological methods, and case-study examples of how weak associations have been incorporated into decision making for nutritional recommendations. Based on the workshop presentations and dialogue among the participants, three clear strategies were provided for the use of weak associations in informing nutritional recommendations for optimal health. First, enable more effective integration of data from all sources through the use of genetic and nutritional biomarkers; second, minimize the risk of bias and confounding through the adoption of rigorous quality-control standards, greater emphasis on the replication of study results, and better integration of results from independent studies, perhaps using adaptive study designs and Bayesian meta-analysis methods; and third, emphasize more effective and truthful communication to the public about the evolving understanding of the often complex relationship between nutrition, lifestyle, and optimal health.

Global forum on telemedicine: connecting the world through partnerships.

The American Telemedicine Association (ATA) held the Global Forum on Telemedicine: Connecting the World Through Partnerships in September 2007 with sponsorship by the Telemedicine and Advanced Technology Research Center (TATRC), U.S. Army Medical Research and Materiel Command (USAMRMC). The goal was to bring together key stakeholders in global healthcare outreach to explore a flexible framework and sustainable business model that can leverage telemedicine and information technology (IT) to expand healthcare services internationally. Dr. Hon S. Pak, President of the ATA, opened the forum with a call for collaboration and partnership, and encouraged continued international dialogue to create a framework that leverages the telemedicine community to improve global disparity in healthcare. Keynote addresses included speakers from the World Health Organization (UN) and United Nations (UN) Global Alliance for Information and Communities Technologies and Development (GAID). Presentations from 15 government and nongovernment aid organizations (NGOs) and 12 international programs covered 5 key areas: (1) NGO perspective; (2) governmental/military programs; (3) financial sustainability; (4) disaster response; and (5) emerging opportunities. The forum resulted in an International Roadmap for Action that was developed by the authors based on the presentations and interactions from the 335 attendees and establishing a set of priorities and actions to improve healthcare using telemedicine and IT. Recommendations include: (1) continued dialogue in creating a telemedicine framework; (2) identification and leverage of resources; (3) provision of education to funding organization and expand training programs to build competency in the healthcare workforce; (4) alignment of international policy to support integration of telemedicine into country plans and support cross-country partnerships; (5) development of communications infrastructure; and (6) integration of telemedicine into disaster relief programs.

Tactical combat casualty care in the assault on Punta Paitilla Airfield.

Casualties incurred during the assault on Punta Paitilla Airfield during Operation Just Cause were evaluated through reviews of records and interviews with the participants. There were eight initial casualties. One-half of all subsequent casualties were wounded trying to move to these men while still under effective hostile fire. Consistent with other studies, the most common cause of death was internal hemorrhage; the second most common was catastrophic brain injury. Rapid control of external exsanguination was the technique most likely to prevent death. Tourniquets were applied to three lower extremities for two casualties, without sequelae.

Humanitarian service and recruitment and retention of uniformed services medical personnel.

A recent voluntary survey of 410 personnel from the U.S. Armed Forces Medical Departments and the Public Health Service indicated that humanitarian service experience has positive effects on recruitment and retention: 48% of respondents indicated that the opportunity to provide humanitarian service was a factor in their decision to join a uniformed service and 62% indicated that humanitarian service opportunities positively influenced their decision to remain in uniform. Humanitarian service requirements were a disincentive to remain in uniform for 25%. Pending further study, these preliminary implications can be applied to personnel policies and programs to recruit and retain uniformed health care professionals.

Toward more effective humanitarian assistance.

Although perspectives of military and civilian humanitarians may differ, they share common goals and parallel efforts for more effective humanitarian assistance. Effectiveness measures for military or civilian humanitarian assistance are discussed. Whereas examples cite military medicine, findings and recommendations are widely applicable to all forms of humanitarian assistance especially developmental relief. Humanitarian effectiveness is improved by a straightforward, standard approach to planning and evaluation, such as the logical framework process. Given successful application by a wide variety of private volunteer, nongovernmental, and international humanitarian organizations, the logical framework process is recommended for adaptation by the Department of Defense. More effective humanitarian assistance requires: developing specific, written purpose, criteria, and quantifiable measures, coordinating the purpose, criteria, and measures with all involved, including donor and host nation officials, all other providers (expatriates, private volunteers, nongovernmentals, international organizations), and beneficiaries, and documenting then analyzing results to compare outcomes with project purpose and international consensus standards for minimal performance in humanitarian assistance (i.e., Sphere project, see http://www.sphereproject.org/).

Military training and humanitarian and civic assistance.

Although the purpose of the Department of Defense humanitarian and civic assistance (HCA) projects is training, there is no system to evaluate HCA training or humanitarian effectiveness. Few after-action reports (AARs) document the number of personnel trained, skills taught, or proficiency before and after HCAs. Nevertheless, HCAs are positively viewed by participants and offer great potential for training service personnel as well as donors, expatriates, and host nation representatives. Linking unit training calendars with HCA projects and vice versa, would improve both projects and training. Mission essential tasks should be incorporated into HCAs, and conversely, HCAs into training. Training objectives should be clearly stated early in the planning and shared with all participants (subject to security). Proficiency to training standards and performance to international humanitarian standards should be documented in after-action reports. Mandatory after-action reporting (ideally, in a standardized, easily retrievable format that supports postproject analysis) should be implemented. Reported training benefits of medical HCAs include a large number of patients treated in a short amount of time, often under austere conditions, and the opportunity to treat diseases of military importance that are not endemic in the United States. The vast majority of medical HCAs have involved direct patient care, but this scope should be expanded to include public health-oriented developmental and infrastructure-building projects that would provide lasting humanitarian benefits and training for additional personnel and units.

Overview of overseas humanitarian, disaster, and civic aid programs.

The U.S. Department of Defense (DoD) conducts humanitarian assistance missions under the Overseas Humanitarian Disaster and Civic Aid program for the statutory purposes of training military personnel, serving the political interests of the host nation and United States, and providing humanitarian relief to foreign civilians. These purposes are undertaken via the humanitarian assistance (HA), humanitarian and civic assistance, and excess property donation programs. DoD conducts over 200 such projects annually at a direct cost of approximately 27 million dollars in fiscal year 2001. Although varying by year and command, as many as one-half of these projects involve aspects of health care. These range from short-term patient care to donation of medical supplies and equipment excess to the needs of the DoD. Despite the considerable resources invested and importance of international actions, there is presently no formal evaluation system for these HA projects. Current administrative staffing of these programs by military personnel is often by individuals with many other duties and responsibilities. As a result, humanitarian projects are often inadequately coordinated with nongovernmental organizations, private volunteer organizations, or host-nation officials. Nonmedical military personnel sometimes plan health-related projects with little or no coordination with medical experts, military or civilian. After action reports (AARs) on these humanitarian projects are often subjective, lack quantitative details, and are devoid of measures of effectiveness. AARs are sometimes inconsistently completed, and there is no central repository of information for analysis of lessons learned. (The approximate 100 AARs used in the conduct of these studies are available for official use in the Learning Resources Center, Uniformed Services University of Health Sciences.) Feedback from past humanitarian projects is rare and with few exceptions; DoD-centric projects of a similar design are often repeated. Critical reviews to determine whether other kinds of projects might be more effective are rarely conducted. Recommendations for improving the effectiveness of DoD HA under Overseas Humanitarian Disaster and Civic Aid programs include: ensuring adequate staffing to meet the complex, dynamic nature of humanitarian missions and measuring the effectiveness of each project in mandatory, standardized AARs. For medical HA projects, application of public health strategies would compliment the patient care approach of the majority of medical projects to date. This offers possibilities for enhancing host nation infrastructure, allowing improvements beyond the short period of most military humanitarian projects.

The role of telemedicine in disaster medicine

Telecommunications from telephone and radio to two-way audio, video, facsimile (fax), and digital imaging via satelite transmission have been used in reponses to disasters. Current and rapidly emerging communications technology offers the prospect of enormously expanded and more efficient application in predisaster, acute, and postdisaster rehabilitation activities. A survey of present and potential roles for telemedicine in disaster medicine will be presented with particular focus on initial on going medical needs assessment, prevention programs, and emergency assistance for provision of emergency care of victims, care for other survivors, and public health and sanitation services. Attention will also focus on telemedicine in education and training, disaster response exercises, development of comprehensive plans, and research. Finally, the essential relationship between the routine utilization of telemedicine in predisaster health care and effective employment in disaster situations will be discussed (AU)

Organization and development of a multidisciplinary research program in the TransAmazon area

Meeting of the Advisory Committe on Medical Research, 14. Pan American Health Organization; 7-10 Jul. 1975