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Billions for biodefense: federal agency biodefense funding, FY2001-FY2005.

Over the past several years, the United States government has spent substantial resources on preparing the nation against a bioterrorist attack. This article analyzes the civilian biodefense funding by the federal government from fiscal years 2001 through 2005, specifically analyzing the budgets and allocations for biodefense at the Department of Health and Human Services, the Department of Homeland Security, the Department of Defense, the Department of Agriculture, the Environmental Protection Agency, the National Science Foundation, and the Department of State. In total, approximately $14.5 billion has been funded for civilian biodefense through FY2004, with an additional $7.6 billion in the President's budget request for FY2005.

Bioterrorism↗

Lawmakers order EPA to clean up work environment.

Washington, Oct 6--On Wednesday, members of Congress ordered the Environmental Protection Agency (EPA) to do a "Superfund" cleanup of its own work environment. For 3 hours, lawmakers and the public listened as witnesses testified to patterns of intolerance, discrimination, and retaliation within the EPA--"This agency is run like a 21st century plantation and this has to stop," said witness and EPA policy analyst Marsha Coleman-Adebayo.

Environmental Health↗

Risk assessments of polychlorinated dibenzo- p-dioxins, polychlorinated dibenzofurans, and dioxin-like polychlorinated biphenyls in food.

The polychlorinated dibenzo-p-dioxins (PCDD), polychlorinated dibenzofurans (PCDF), and dioxin-like polychlorinated biphenyls (dioxin-like PCB) are ubiquitous in food of animal origin and accumulate in fatty tissues of animals and humans. The most toxic congener is 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD). The toxic responses include dermal toxicity, immunotoxicity, carcinogenicity, and reproductive and developmental toxicity. Toxic equivalency factors have been established for the other PCDD, PCDF and dioxin-like PCB relative to TCDD, and the combined toxicity of a sample can be expressed as toxic equivalent (WHO-TEQ). The EC Scientific Committee for Food evaluated these compounds in 2001. The assessment used the most sensitive adverse toxicological end-points of TCDD in experimental animals. These were developmental and reproductive effects in the male offspring of rats administered TCDD during pregnancy. Because of the large difference between rats and humans in the biological half-life of TCDD, the assessment used a body burden approach to compare across species and derived a tolerable weekly intake of 14 pg TCDD/kg of body weight (bw), which was extended to include all the 2,3,7,8-substituted PCDD and PCDF, and the dioxin-like PCB, and expressed as a group tolerable weekly intake of 14 pg WHO-TEQ/kg bw. The FAO/WHO Joint Expert Committee on Food Additives (JECFA) performed a similar assessment whereas the US Environmental Protection Agency (US EPA) has paid more attention to human data on carcinogenicity.

Adipose Tissue↗

Acute health reference values: overview, perspective, and current forecast of needs.

A number of organizations have developed acute inhalation health reference values, each with (1) a specific purpose, (2) populations to protect, (3) exposure scenarios (accidental releases, workplace, routine excursions of ambient levels), and (4) severity of adverse health effects considered in their development. The first section of this article reviews the existing values from different organizations and describes their purposes and method of development. The second part of the article provides a comparative review of how the values were derived, the critical endpoints considered for each value, the populations being protected by each value, and the potential for use outside of their intended purpose (e.g., Homeland Security, regulatory analysis, etc.). Additionally, an analysis of the acute inhalation reference values that was developed in support of the Office of Air and Radiation's residual risk assessment for hazardous air pollutants is presented and reviewed. The third and final part of the article focuses on the efforts of the U.S. Environmental Protection Agency (EPA) to develop a set of less-than-lifetime reference values, along with a discussion of how that effort fits with the existing sets of values described in the prior sections.

Air Pollutants↗

Sea urchin fertilization assay: an evaluation of assumptions related to sample salinity adjustment and use of natural and synthetic marine waters for testing.

Most industrial effluents discharged into the marine coastal environment are freshwater in nature and therefore require manipulation prior to testing with marine organisms. The sea urchin fertilization test is a common marine bioassay used for routine environmental monitoring, investigative evaluations, and/or regulatory testing of effluents and sediment pore waters. The existing Canadian and U.S. Environmental Protection Agencies test procedures using sea urchin (and sand dollar) gametes allow for sample salinity adjustment using either brine or dry salts. Moreover, these procedures also allow for the use of either natural or synthetic marine water for culturing/holding test organisms and for full-scale testing. At present, it is unclear to what extent these variables affect test results for whole effluents. The test methods simply state that there are no data available and that the use of artificial dry sea salts should be considered provisional. We conducted a series of concurrent experiments aimed at comparing the two different treatments of sample salinity adjustment and the use of natural versus synthetic seawater in order to test these assumptions and evaluate effects on the estimated end points generated by the sea urchin fertilization sublethal toxicity test. Results from these experiments indicated that there is no significant difference in test end points when dry salts or brine are used for sample salinity adjustment. Similarly, results obtained from parallel (split-sample) industrial effluent tests with natural and artificial seawater suggest that both dilution waters produce similar test results. However, data obtained from concurrent tests with the reference toxicant, copper sulfate, showed higher variability and greater sensitivity when using natural seawater as control/dilution water.

Animals↗

Guidelines for environmental infection control in health-care facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC).

The health-care facility environment is rarely implicated in disease transmission, except among patients who are immunocompromised. Nonetheless, inadvertent exposures to environmental pathogens (e.g., Aspergillus spp. and Legionella spp.) or airborne pathogens (e.g., Mycobacterium tuberculosis and varicella-zoster virus) can result in adverse patient outcomes and cause illness among health-care workers. Environmental infection-control strategies and engineering controls can effectively prevent these infections. The incidence of health-care--associated infections and pseudo-outbreaks can be minimized by 1) appropriate use of cleaners and disinfectants; 2) appropriate maintenance of medical equipment (e.g., automated endoscope reprocessors or hydrotherapy equipment); 3) adherence to water-quality standards for hemodialysis, and to ventilation standards for specialized care environments (e.g., airborne infection isolation rooms, protective environments, or operating rooms); and 4) prompt management of water intrusion into the facility. Routine environmental sampling is not usually advised, except for water quality determinations in hemodialysis settings and other situations where sampling is directed by epidemiologic principles, and results can be applied directly to infection-control decisions. This report reviews previous guidelines and strategies for preventing environment-associated infections in health-care facilities and offers recommendations. These include 1) evidence-based recommendations supported by studies; 2) requirements of federal agencies (e.g., Food and Drug Administration, U.S. Environmental Protection Agency, U.S. Department of Labor, Occupational Safety and Health Administration, and U.S. Department of Justice); 3) guidelines and standards from building and equipment professional organizations (e.g., American Institute of Architects, Association for the Advancement of Medical Instrumentation, and American Society of Heating, Refrigeration, and Air-Conditioning Engineers); 4) recommendations derived from scientific theory or rationale; and 5) experienced opinions based upon infection-control and engineering practices. The report also suggests a series of performance measurements as a means to evaluate infection-control efforts.

Air Microbiology↗

The role of the medical profession in the environmental arena.

Environmental agencies at both federal and state levels have enormous powers to control economic activities, yet these agencies must use these powers knowing very little about the actual effects of pollutants on human health or the environment. The author describes how this situation came about by reviewing (1) the history of the 19th-century sanitarians and how their traditions (especially of taking preventive action in the absence of definitive data, in order to ensure a margin of safety) later influenced the policies of the U.S. Public Health Service and, more recently, those of the Environmental Protection Agency (EPA); (2) the tradition of recovering damages from someone who harms your property or person; (3) the tradition of engineers to eliminate pollutants without concern for their effects; and (4) the value system of conservationists and ecologists. He then outlines four difficulties that these sometimes-conflicting traditions and values create for the EPA and other similar bodies. After reviewing the progress that has been made despite these difficulties, the author states the global nature of the environmental challenge that is upon us and how the public health tradition of prudent action will compel us to gather more data about global problems, which in turn will lead to more fine-tuned and appropriate actions. Finally, he states how important it is for health professionals to use their technical and scientific knowledge--especially their "habits of mind"--to help develop more intelligent and prudent environmental policies, and describes the crucial role of "citizen-health professionals" in the environmental arena of the future.

Allied Health Personnel↗

Evaluation of the SunWise School Program.

Melanoma, the most fatal form of skin cancer, is rising at rates faster than all other preventable cancers in the United States. Childhood exposure to ultraviolet (UV) light increases the risk for skin cancer as an adult, therefore, starting positive sun protection habits early may be key to reducing the incidence of this disease. The Environmental Protection Agency's SunWise School Program, a national environmental and health education program for sun safety of children in primary and secondary schools (Grades K-8), was evaluated. Pretests (n = 4,559) and posttests (n = 4,016) were completed by students from 85 schools in 35 states. Significant increases were noted for the three knowledge variables. Intentions to play in the shade increased from 70% to 76% (p < 0.001) with more modest changes in intentions to use sunscreen. Attitudes regarding the healthiness of a tan also decreased significantly. Brief, standardized sun protection education can be efficiently interwoven into existing school curricula and result in increases in knowledge and positive intentions for sun protection.

Adolescent↗

Water quality and poultry production.

Mineral and microbial content of water affects the performance of poultry. Because poultry production can adversely affect water quality, the Environmental Protection Agency monitors and regulates its impact. Management of nonpoint source water contamination is especially important. If properly managed, litter, a valuable secondary commodity associated with poultry production, can be used as fertilizer, food, or energy.

Animal Husbandry↗

Detection of human enteric viruses in stream water with RT-PCR and cell culture.

A multiplex RT-PCR method was used to measure virus occurrence at five stream water sites that span a range of hydroclimatic, water-quality, and land-use characteristics. The performance of the molecular method was evaluated in comparison with traditional cell culture and Escherichia coli membrane filtration assays. The study incorporated multiple quality controls and included a control for virus recovery during the sampling procedure as well as controls to detect potentially false-negative and false-positive data. Poliovirus recovery ranged from 16 to 65% and was variable, even in samples collected within the same stream. All five sites were positive for viruses by both molecular and cell culture-based virus assays. Enteroviruses, reoviruses, rotaviruses, and hepatitis A viruses were detected, but the use of the quality controls proved critical for interpretation of the molecular data. All sites showed evidence of faecal contamination, and culturable viruses were detected in four samples that would have met the US Environmental Protection Agency's recommended E. coli guideline for safe recreational water.

Base Sequence↗

[Reference values for indoor air: dearomatized hydrocarbon solvents (C(9)-C(14))].

To protect public health the German Joint Working Group on Indoor Guidelines of the Federal Environmental Protection Agency and the States' Departments of Health is issuing indoor air guideline values based on a fixed procedure published in 1996. Regarding dearomatized hydrocarbon solvents/white spirits (DAWS--CAS-No. 64742-47-8, 64742-48-9, 64742-88-7, 64741- 65-7) no human data are available. From animal studies, neurotoxicity, developmental toxicity and reproductive toxicity were identified as critical endpoints. For risk evaluation the Hass et al. (2001) study was used as the pivotal study. Based on effects at 4680 mg DAWS/m(3) for the endpoint developmental toxicity, the lowest adverse effect level for chronic exposure is assessed as 400 mg DAWS/m(3). By applying an interspecies factor of 10, an intraspecies factor of 10 and an additional factor 2 referring to the special physiology of children (higher breath rate compared to adults) a so-called health hazard value of 2 mg DAWS/m(3) indoor air and a so-called health prevention value of 0.2 mg DAWS/m(3) are obtained.

Air Pollutants↗

The development and use of respirator response functions as part of a workplace exposure monitoring program for control of potential respiratory hazards.

The traditional hierarchy of measures for control of potential respiratory hazards in the workplace includes (in order of preference) engineering controls, workplace practices, and use of respiratory protection. Although third in this hierarchy, respirators can be an important component of the control mix-particularly for difficult-to-control jobs, as an interim measure (pending implementation of other controls), and in cases where exposure is intermittent. One of the problems associated with the use of respirators as a control measure is that valid and adequate data on respirator usage are often not available. Absent these data it is difficult to determine the practical effectiveness of respirators and exposure calculations which include the protective effect of respirators are speculative. This paper presents models (and appropriate statistical fitting techniques) suitable for quantification of respirator usage and defines three potentially useful measures of effectiveness for a respirator program. These models are illustrated with monitoring data on refractory ceramic fiber (RCF) developed as part of a Consent Agreement between the RCF industry and the U.S. Environmental Protection Agency. For this substance there are extensive and comprehensive monitoring data available. The models and methods of analysis may prove applicable for other potential respiratory hazards in the workplace.

Ceramics↗

Ethical review of regulatory toxicology guidelines involving experiments on animals: the example of endocrine disrupters.

The safety assessment of new chemicals (including medicines, pesticides, food additives, and industrial chemicals) relies on the results of animal experiments. Because the safety of those exposed to these products and the welfare of the experimental animals used are considered critically important, both testing requirements and the welfare of experimental animals are controlled by law. In the U.K., projects that propose to use animals for experimental purposes, including for the testing of chemicals, have been controlled by law for over a century, with the most recent legislation (Animals [Scientific Procedures] Act of 1986) requiring a cost/benefit assessment before it may proceed. New regulations introduced in 1998 will require an ethical review process for all projects from April 1999. Such ethical review will have to take account of the toxicity testing methods and schemes that are required by the legislation aimed at protecting human health. Neither national nor international proposals for toxicity testing methods and schemes are generally subjected to ethical review from the point of protecting animal welfare. The international nature of the chemical and pharmaceutical industry means that testing requirements from one of the major national regulatory agencies (USA, EU, or Japan) or the international organizations (Organization for Economic Co-operation and Development [OECD]or the International Conference on Harmonization [ICH]) have an impact on the testing carried out by industrial organizations in all countries. The recent proposals for screening and testing chemicals to identify endocrine disrupters (ED) from the Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC) of the U.S. Environmental Protection Agency (EPA) are used as an example of the interaction between regulatory proposals and animal welfare issues. The current proposals are the most extravagant in the use of animals. Between 0.6 and 1.2 million animals would be required for each 1000 chemicals tested. The EPA, before incorporating them into regulation, is subjecting the recommendations to further review. This will undoubtedly moderate the number of animals actually used from the worst-case calculation. The variables that have the greatest impact on the number of animals required for testing are the prevalence of ED chemicals in the chemicals to be tested, and the sensitivity and specificity of the testing methods. The modeling demonstrates, for example, that increasing the prevalence from 10 to 50% reduces the number of animals used to detect one ED from 10,000 to 2700. Knowledge of the prevalence of EDs in the chemicals to be tested would allow rational selection of tier one screening based on the sensitivity and specificity of the screening tests. The EDSTAC proposals are difficult to justify from an ethical perspective, as equally effective detection rates may be achieved with fewer animals. National and international regulatory testing proposals should be subjected to formal independent ethical review before they are finalized, with a view to improving animal welfare.

Animal Rights↗

Ethylene oxide sterilization: how hospitals can adapt to the changes.

Ethylene oxide (EtO) gas sterilizers have been used by hospitals for over 40 years to sterilize surgical equipment and supplies that are heat sensitive or that cannot tolerate excessive moisture. However, in recent decades, EtO has been recognized as a potential mutagenic, reproductive, neurologic, and fire and explosion hazard to workers, and one agency has reportedly voted to classify EtO as carcinogenic to humans. Strict regulations concerning EtO exposure have been imposed by the Occupational Safety and Health Administration (OSHA), and the use of EtO, along with other toxic pollutants, is also being monitored by the Environmental Protection Agency (EPA) under the Clean Air Act. In addition, the use of chlorofluorocarbons (CFCs) as EtO diluents has focused attention on the EtO-CFC mixtures used in many sterilizers because CFCs have been linked to destruction of the ozone layer. Concerns about restrictive regulations related to these issues have prompted many hospitals to examine their use of EtO sterilization and propagated the misinformation that EtO sterilization is being phased out. In this article, we address some commonly asked questions regarding the use and regulation of EtO mixtures, as well as alternative sterilization agents and methods; provide two case studies illustrating how hospitals can evaluate various sterilization options; and summarize our conclusions and recommendations for hospitals facing decisions about sterilization techniques. For related topics, also see our Evaluation Update on endoscope reprocessors and our Hazard Report on improperly connected EtO-CFC cylinders to EtO sterilizers in this issue.

Air Pollution↗

U.S. EPA challenges and review--highlights of the Fiscal Year 1994 Inspection Program and EPA's laboratory accreditation considerations.

The reorganization and consolidation of the United States Environmental Protection Agency's (EPA's) Headquarters Enforcement and Compliance programs into a new Office of Enforcement and Compliance Assurance (OECA) is now complete. The Good Laboratory Practice (GLP) inspection program is now part of the Office of Compliance, one of the principal offices in this new organization. The role of the Office of Compliance and the implications of these changes for the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) GLP programs are addressed. Highlights of the fiscal year 1994 inspection program are reviewed. The status of the Agency's consideration of laboratory accreditation is discussed.

Accreditation↗

Approaches to reducing mercury in North America.

This article provides a summary of the Environmental Protection Agency's role in reducing anthropogenic sources of mercury. These efforts are expected to substantially reduce both mercury releases and exposure. EPA is aware that mercury in the environment is complex and that it must work with programs in other federal agencies, state and local governments that address the mercury problem as well as partner with nongovernmental organizations and industry to reach these goals.

Environment↗

Hispanic environmental health: ambient and indoor air pollution.

Air pollution has serious deleterious effects on health and is a public health matter of the utmost importance. The National Coalition of Hispanic Health and Human Services Organizations (COSSMHO) believes that reducing exposure to air pollution is a priority issue for the Hispanic community because 80% of Hispanics (compared with 65% of non-Hispanic blacks and 57% of non-Hispanic whites) live in nonattainment areas--areas that fail to meet the Environmental Protection Agency ambient air quality standard. Although Hispanics in general live as long as or longer than non-Hispanic whites, what morbidity data are available reveal that the quality of that life is severely impaired by a variety of chronic conditions, such as asthma. This makes environmental health a pressing matter for Hispanic communities, particularly in the area of air pollution. Action items are included.

Adolescent↗

Methods for reducing lead exposure in young children and other risk groups: an integrated summary of a report to the U.S. Congress on childhood lead poisoning.

As part of a Congressionally mandated report on U.S. childhood lead poisoning prepared by the Federal government (U.S. Agency for Toxic Substances and Disease Registry [ATSDR]), the authors have analyzed the relative effectiveness of measures to reduce source-specific lead exposure of U.S. children. An integrated overview of this analysis is presented in this article. Two national actions, the Federally mandated phasedown of lead in gasoline by the U.S. Environmental Protection Agency and the voluntary phasedown of lead use in domestic food can production, are examples of centrally directed initiatives that have been relatively successful in limiting childhood lead exposure in the U.S. Efforts to abate lead-based paint exposure of children have largely failed. This is especially true for the nation's 21 million residential units with the highest lead content paint. Similarly, abatement of lead exposure from contaminated dusts and soils has generally been unsuccessful. Comprehensive measures to reduce lead exposure from drinking water in residences and public facilities, e.g., elementary schools, are only now being promulgated or implemented. The full extent of their effectiveness remains to be demonstrated. There are many miscellaneous but potentially severe exposure sources that are difficult to control but require attention, such as poorly glazed foodware and ethno-specific preparations.

Air Pollution↗