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PubMed1989

Immune reactions in a changing environment. USA initiatives.

Environmental hazards occurring as an undesirable consequence of economic progress, urbanization and pollution have become a worldwide concern. In the US, this is evident from the campaign against smoking which has focused attention on the lung in part because the lung as a target organ is constantly exposed to many visible environmental hazards. On the other hand, environmental hazards which are not lethal, but cause their effects in an insidious fashion, may be difficult to study and identify. Among the disciplines available to assess adverse health consequences of xenobiotics ('strange' substances in our environment), application of modern immunological methods in concert with traditional toxicologic studies have to date demonstrated significant progress in drug allergy, food allergy, environmentally induced lung diseases and autoimmunity. These successes have come from the collaboration of immunologists, allergologists, pulmonologists, pharmacologists and toxicologists. In fact, a newer discipline of immunotoxicology has emerged in order to deal with these complex issues. The National Institutes of Health, through a series of workshops and research initiatives, and in collaboration with other US government agencies, including the Environmental Protection Agency, the National Institute of Environmental Health Sciences, and the National Academy of Sciences, is attempting to foster research aimed at enhancing progress in the field of immunotoxicology. The overall aim is to encourage the use of modern immunologic approaches to the study of the alleged harmful effects of xenobiotics on the immune system. Success will permit the development of improved diagnostic tools followed by initiatives concerned with prevention. Apart from their scientific implications the results are expected to have an impact on social, legal and economic issues within society.

Environment↗

PubMed1990

Worksite behavioral research. Results, sensitive methods, test batteries and the transition from laboratory data to human health.

Ample evidence demonstrates that many chemicals, at some concentration, affect the nervous system. Disastrous incidents resulting from food adulteration, medical experiments and pharmaceutical errors, and industrial and environmental exposures warn of the serious potential for neurotoxicants to affect human health. This article identifies the approximately 185 epidemiological behavioral neurotoxicology studies published through 1989 of extended workplace exposures to chemicals. Approximately 250 different tests have been administered to exposed workers in primarily cross sectional studies, and statistically significant decrements were reported in 43% of the approximately 1100 test/population administrations (virtually all 185 studies employed several of the 250 tests). In this research, 28 different chemicals as well as multiple chemical exposures have been studied. The most extensive findings are seen in research on carbon disulfide, lead, mercury, and multiple solvent exposures, although three or more independent studies also have been reported on workers exposed to styrene and organophosphates. Analyzing the consistent findings in these studies, they reveal a broad spectrum of cognitive, motor, and affective or personality changes. The most frequently reported functional deficits are in tests of intelligence, memory, spatial relations, coordination, and speed plus coordination. Individual behavioral measurement methods and significant test batteries that have been employed to assess changes in human nervous system functions to determine the degree of risk posed by new and established chemicals are described; two of those human behavioral test batteries are predicted to dominate research at the onset of the 1990's. There is a lack of parallelism between the human test methods found in these batteries and the US Environmental Protection Protection Agency (EPA) and Food and Drug Agency (FDA) guideline methods for pre-production screening of chemicals and food additives in animals, and it appears unlikely that the widely employed human and animal behavioral test batteries, as currently evaluated, could identify disease complexes newly suspected of having a chemical etiology.

Animals↗

PubMedDate not supplied

Chemical testing strategies for predicting health hazards to children.

The United States Environmental Protection Agency has proposed the development of a Children's Health Test Program under the Toxic Substances Control Act. The Environmental Protection Agency's proposal for the children's health test battery has 12 different assays including general toxicity, genotoxicity, carcinogenicity, neurotoxicity, and developmental and reproductive toxicity. The current Environmental Protection Agency testing proposal is an "all or nothing" test battery. An alternative and preferable approach would be to use a science-based, tiered testing scheme. It is proposed that the Screening Information Dataset program, currently used by the Organization for Economic Co-operation and Development (OECD) for the Screening Information Dataset-High Production Volume test battery, or equivalent, be considered for the first step. Step 1 would include acute and repeat dose toxicity testing, developmental toxicity testing (first species OECD 414 or OECD 422), reproductive toxicity screening (OECD 415 or 422), and genetic toxicity testing. For this step, the rat would be the initial and only species tested unless the mouse was used for in vivo genetic toxicity. Step 2 of the proposed children's health test battery would include developmental testing (second species OECD 414) or special mode of action studies performed for those chemicals that proved to be developmental toxicants in Step 1. Those chemicals that tested positive as reproductive toxicants in Step 1 would be tested in a two-generation reproduction study (OECD 416) or a special mode of action study. Steps 1 and 2 provide information on whether oncogenicity or developmental neurotoxicity testing is useful. Step 3 would include chronic toxicity/oncogenicity testing for those chemicals that tested positive for genetic toxicity in Step 1, and positive for developmental concerns in Step 2. In this step, chemicals would also be tested for developmental neurotoxicity if they showed evidence of neuropathy, behavioral effects, or neurotoxic potential in earlier studies. This stepwise approach would conserve resources and answer scientific questions in a logical, orderly, timely, and cost-effective manner.

Animals↗

PubMed2006

Environmental justice in Indian country: dumpsite remediation on the Swinomish Indian reservation.

The U.S. Environmental Protection Agency (EPA) defines environmental justice as the "fair treatment for people of all races, cultures, and incomes, regarding the development of environmental laws, regulations, and policies." The last decade has focused considerable national attention on the environmental pollution inequity that persists among the nation's poorest communities. Despite these environmental justice efforts, poor communities continue to face adverse environmental conditions. For the more than 550 Native American communities, the struggle to attain environmental justice is more than a matter of enforcing national laws equitably; it is also a matter of a federal trust duty for the protection of Indian lands and natural resources, honoring a promise that Native American homelands would forever be sustainable. Equally important is the federal promise to assist tribes in managing their reservation environments under their reserved powers of self-government, an attribute that most distinguishes tribes from other communities. The PM Northwest, Inc. (PMNW) dumpsite is located within the boundaries of the Swinomish Indian Reservation in Washington State. Between approximately 1958 and 1970, PMNW contracted with local oil refineries to dispose of hazardous wastes from their operations at the reservation dumpsite. Almost two decades would pass before the Swinomish tribe was able to persuade EPA that a cleanup action under Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) was warranted. This article reviews the enduring struggle to achieve Indian environmental justice in the Swinomish homeland, a process that was dependent upon the development of the tribe's political and environmental management capacity as well as EPA's eventual acknowledgement that Indian environmental justice is integrally linked to its federal trust responsibility.

Environment↗

PubMed1996

Comparison of the recoveries of Escherichia coli and total coliforms from drinking water by the MI agar method and the U.S. Environmental Protection Agency-approved membrane filter method.

Drinking water regulations under the Final Coliform Rule require that total coliform-positive drinking water samples be examined for the presence of Escherichia coli or fecal coliforms. The current U.S. Environmental Protection Agency-approved membrane filter (MF) method for E. coli requires two media, an MF transfer, and a total incubation time of 28 h. A newly developed MF method, the MI agar method, containing indoxyl-beta-D-glucuronide and 4-methylumbelliferyl-beta-D-galactopyranoside for the simultaneous detection of E. coli and total coliforms, respectively, by means of their specific enzyme reactions, was compared with the approved method by the use of wastewater-spiked tap water samples. Overall, weighted analysis of variance (significance level, 0.05) showed that the new medium recoveries of total coliforms and E. coli were significantly higher than those of mEndo agar and nutrient agar plus MUG (4-methylumbelliferyl-beta-D-glucuronide), respectively, and the background counts were significantly lower than those of mEndo agar (< 5%). Generally, the tap water source, overall chlorine level, wastewater source, granular activated carbon treatment of the tap water, and method of grouping data by E. coli count for statistical analysis did not affect the performance of the new medium.

Agar↗

PubMed1996

Evaluation of the NESHAP radiological risk assessment.

The Environmental Protection Agency performed a risk assessment as a basis for the National Emission Standards for Hazardous Air Pollutants. This paper compares the Environmental Protection Agency's risk assessment with the models used by the National Research Council's fifth Committee on the Biological Effects of Ionizing Radiations, the United Nations Scientific Committee on the Effects of Atomic Radiation, and the International Commission on Radiological Protection. Comparison of the parameters used by each organization suggests that the Environmental Protection Agency could improve its own risk assessment by adopting one of the assessments done by the BEIR V Committee, the United Nations Scientific Committee on the Effects of Atomic Radiation, and the International Commission on Radiological Protection.

Air Pollutants, Radioactive↗

PubMed2006

Using relative risk to compare the effects of aquatic stressors at a regional scale.

The regional-scale importance of an aquatic stressor depends both on its regional extent (i.e., how widespread it is) and on the severity of its effects in ecosystems where it is found. Sample surveys, such as those developed by the U.S. Environmental Protection Agency's Environmental Monitoring and Assessment Program (EMAP), are designed to estimate and compare the extents, throughout a large region, of elevated conditions for various aquatic stressors. In this article, we propose relative risk as a complementary measure of the severity of each stressor's effect on a response variable that characterizes aquatic ecological condition. Specifically, relative risk measures the strength of association between stressor and response variables that can be classified as either "good" (i.e., reference) or "poor" (i.e., different from reference). We present formulae for estimating relative risk and its confidence interval, adapted for the unequal sample inclusion probabilities employed in EMAP surveys. For a recent EMAP survey of streams in five Mid-Atlantic states, we estimated the relative extents of eight stressors as well as their relative risks to aquatic macroinvertebrate assemblages, with assemblage condition measured by an index of biotic integrity (IBI). For example, a measure of excess sedimentation had a relative risk of 1.60 for macroinvertebrate IBI, with the meaning that poor IBI conditions were 1.6 times more likely to be found in streams having poor conditions of sedimentation than in streams having good sedimentation conditions. We show how stressor extent and relative risk estimates, viewed together, offer a compact and comprehensive assessment of the relative importances of multiple stressors.

Animals↗

PubMed2005

Environmental monitoring and assessment of a Great River ecosystem: the Upper Missouri River pilot.

Most Great River ecosystems (GREs) are extensively modified and are not receiving adequate protection to prevent further habitat degradation and loss of biotic integrity. In the United States, ecological monitoring and assessment of GREs has lagged behind streams and estuaries, and the management of GREs is hampered by the lack of unbiased data at appropriate spatial scales. Properties of GREs that make them challenging to monitor and assess include difficult sample logistics and high habitat diversity. The U.S. Environmental Protection Agency's Environmental Monitoring and Assessment Program (EMAP) has developed a comprehensive, regional-scale, survey-based monitoring approach to assessment of streams and estuaries, but has not yet conducted research on applying these tools to GRE monitoring. In this paper we present an overview of an EMAP research project on the Upper Missouri River (UMR). We summarize the assessment objectives for the study, the design for selecting sample locations, the indicators measured at these sites and the tools used to analyze data. We present an example of the type of statements that can be made with EMAP monitoring data. With modification, the set of methodologies developed by EMAP may be well suited for assessment of GREs in general.

Conservation of Natural Resources↗

PubMed2006

A more cost-effective EMAP benthic macrofaunal sampling protocol.

Benthic macrofaunal sampling protocols in the U.S. Environmental Protection Agency's Environmental Monitoring and Assessment Program (EMAP) are to collect 30 to 50 random benthic macrofauna [defined as animals retained on a 0.5 mm (East and Gulf Coasts, USA) or a 1.0 mm mesh sieve (West Coast, USA)] samples per reporting unit using a 0.044 m(2) (East and Gulf Coasts) or 0.1 m(2) (West Coast) grab. Benthic macrofaunal community conditions in the reporting unit are characterized by cumulative distribution functions (CDFs) on end points of interest, such as number of species (S), abundance (A), and Shannon-Wiener diversity (H'). An EMAP and a companion field study were conducted concurrently in Tillamook Bay (Oregon, USA) to compare the cost effectiveness of benthic macrofauna samples collected using the EMAP West Coast (0.1 m(2) x >or=7 cm deep, 1.0 mm mesh), a 0.01 m(2) x 5 cm deep, 1.0 mm mesh, and a 0.01 m(2) x 5 cm deep, 0.5 mm mesh sampling protocol. Cost was estimated in relative laboratory sample-processing time. Sampling protocols were judged equally effective for EMAP purposes if, after linear transformation to adjust for scale changes in end point distributions, their S, A, and H' CDFs were not significantly different. The 0.01 m(2) x 5 cm deep, 1.0 mm mesh sampling protocol was the most cost effective.

Animals↗

PubMed2004

The structure of variation and its influence on the estimation of status: indicators of condition of lakes in the Northeast, U.S.A.

One goal of regional-scale sample surveys is to estimate the status of a resource of interest from a statistically drawn representative sample of that resource. An expression of status is the frequency distribution of indicator scores capturing variability of attributes of interest. However, extraneous variability interferes with the status description by introducing bias into the frequency distributions. To examine this issue, we used data from a regional survey of lakes in the Northeast U.S. collected by the U.S. Environmental Protection Agency's Environmental Monitoring and Assessment Program (EMAP). We employ a components of variance model to identify sources of extraneous variance pertinent to status descriptions of physical, chemical, and biological attributes of the population of lakes in the NE. We summarize the relative magnitude of four components of variance (lake-to-lake, year, interaction, and residual) for each indicator and illustrate how extraneous variance biases the status descriptions. We describe a procedure that removes this bias from the status descriptions to produce unbiased estimates and introduce a novel method for estimating the 'cost' of removing the bias (expressed as either increased sampling uncertainty or additional samples needed to achieve the target precision in the absence of bias). We compare the relative magnitude of the four variance components across the array of indicators, finding in general that conservative chemical indicators are least affected by extraneous variance, followed by some nonconservative indicators, with nutrient indicators most affected by extraneous variance. Intermediate were trophic condition indicators (including sediment diatoms), fish species richness and individuals indicators, and zooplankton taxa richness and individuals indicators. We found no clear patterns in the relative magnitude of variance components as a function of several methods of aggregating fish and zooplankton indicators (e.g., level of taxonomy, or species richness vs. numbers of individuals).

Analysis of Variance↗

PubMed1988

Estimates of radiation dose and health risks to the United States population following the Chernobyl nuclear plant accident.

Estimates of both individual and collective doses received by the United States population following the Chernobyl accident have been made by using the data obtained from the U.S. Environmental Protection Agency's Environmental Radiation Ambient Monitoring System. Radionuclides associated with the debris first were measured in precipitation and surface air particulates at Portland, OR and Olympia, WA on 5 May 1986. Iodine-131 was the most consistently measured nuclide in all media, although several Cs and Ru isotopes also were observed. Strontium and any actinides notably were absent from the samples at the lower level of detection. The highest calculated individual-organ dose due to intake during May and June 1986 was 0.52 mSv to the infant thyroid in the state of Washington. This was predominantly (98%) from the ingestion of milk. The maximum U.S. collective dose equivalent to any organ was calculated to be 3,300 person-Sv to the thyroid. Risk estimates project three excess lung cancer deaths and an additional four deaths due to cancers of thyroid, breast and leukemia in the U.S. population over the next 45 y from exposure during the May-June 1986 interval. The only long-lived radionuclide measured in milk samples following the accident was 137Cs. We estimate 20 excess fatalities from the ingestion of 137Cs in milk during all subsequent years, with six of these due to lung cancer and the majority of the remainder distributed approximately equally among cancers of the thyroid, breast, liver and leukemia. A total of 100 excess fatalities from all dietary components was estimated. Because of the uncertainty of risk estimates from data such as those available for this study, all calculated values carry a range of uncertainty from a minimum of one-half the calculated value to a maximum of two times the calculated value. The estimated excess fatalities given above may be compared with corresponding projected cancer mortality from all other causes: 41,000 fatalities from thyroid cancer and 3,800,000 fatalities from lung cancer are estimated to occur within the U.S. population during the next 45 y.

Accidents↗

PubMed2005

Health-related benefits of attaining the 8-hr ozone standard.

During the 2000-2002 time period, between 36 and 56% of ozone monitors each year in the United States failed to meet the current ozone standard of 80 ppb for the fourth highest maximum 8-hr ozone concentration. We estimated the health benefits of attaining the ozone standard at these monitors using the U.S. Environmental Protection Agency's Environmental Benefits Mapping and Analysis Program. We used health impact functions based on published epidemiologic studies, and valuation functions derived from the economics literature. The estimated health benefits for 2000 and 2001 are similar in magnitude, whereas the results for 2002 are roughly twice that of each of the prior 2 years. The simple average of health impacts across the 3 years includes reductions of 800 premature deaths, 4,500 hospital and emergency department admissions, 900,000 school absences, and > 1 million minor restricted activity days. The simple average of benefits (including premature mortality) across the 3 years is 5.7 billion dollars [90% confidence interval (CI), 0.6-15.0] for the quadratic rollback simulation method and 4.9 billion dollars (90% CI, 0.5-14.0) for the proportional rollback simulation method. Results are sensitive to the form of the standard and to assumptions about background ozone levels. If the form of the standard is based on the first highest maximum 8-hr concentration, impacts are increased by a factor of 2-3. Increasing the assumed hourly background from zero to 40 ppb reduced impacts by 30 and 60% for the proportional and quadratic attainment simulation methods, respectively.

Adolescent↗

PubMedDate not supplied

[Meta-analysis of the Italian studies on short-term effects of air pollution--MISA 1996-2002].

INTRODUCTION: the Italian Meta-analysis of short-term effects of air pollution for the period 1996-2002 (MISA-2) is a planned study on 15 Italian cities, among the larger country towns summing up 9 millions and one hundred thousand inhabitants at 2001 census. HEALTH OUTCOMES DATA: mortality for all natural causes (362254 deaths), for respiratory causes (22317) and cardiovascular causes (146830), and hospital admissions for acute conditions, respiratory (278028 admissions), cardiac (455540) and cerebrovascular (60960), have been considered. Mortality data came from Regional or Local Health Unit Registries, while hospital admissions data have been selected from Regional or Hospital Archives (exclusion percentages range for all admissions between 45% and 82%). For each participating city daily series averaged about 4.3 years, with a minimum of three consecutive years. AIR POLLUTANTS DATA: daily pollutants concentration series (SO2, NO2, CO, PM10, O3) came from air quality monitoring networks of Regional Environmental Protection Agencies, of Environmental Offices of Provinces or Municipalities. Monitors' selection has been done by a working group composed by representatives of monitoring network Agencies. The selection criteria are the representativeness of general population exposure for each specific pollutant, avoiding as possible monitors close to high traffic roads; and the number, quality and location of monitors, selecting around 3-4 monitors with continuous data flow in the period (at least 75% of valid hourly data). The final series has been created averaging over monitors and imputing missing values under proportionality assumptions. Median of Pearson correlation coefficients between pairs of monitors of the each city was 0.62, interquartile range 0.42-0.77. STATISTICAL METHODS: A generalized linear model on daily counts of health events has been fitted for each city. Linear pollutant effect has been specified and bi-pollutant models have been fitted for PM10+NO2 and PMO+O3. Temperature has been modelled parametrically using a change point at 21 degrees C and lagged effects. Humidity, day of the week, national holidays and influenza epidemics (using data from the National Surveillance Programs from 1999) are the other considered confounders. An age-specific natural cubic spline on season has been specified with 5 degree of freedom (on average) per year for mortality and 7 degree of freedom per year for hospital admission data. The base model is age-stratified (0-64, 65-74, 75+ years). Gender, age, season specific models have been fitted, too. Five sensitivity analyses have been done, varying the degree of freedom for the seasonality spline and specifying non parametric functions on temperature. Constrained distributed lag models have been fitted on mortality data to study potential harvesting effects. City-specific results have been meta-analyzed by random effects hierarchical Bayesian model. Four different models have been fitted in the sensitivity analyses, assuming different priors on heterogeneity variance and outlier-resistant prior on city-specific effects. Bayesian meta-regressions have been fitted on base model, bi-pollutant and season-specific city-specific results. Attributable deaths have been estimated by Monte Carlo methods using effect, pollutant, baseline rate distributions. Fourteen different scenarios have been considered for PM10 and ten for NO2 and CO, using meta-analitic and posterior city-specific effect estimates RESULTS: Pollutants effects are reported as percent increase on mortality or hospital admissions for an increase of 10 microg/m3 of SO2, NO2 and PM10, and 1 mg/m3 of CO. We found an increase on mortality for all natural causes associated to increase of air pollutants concentration (for NO2 0.6% 95%CrI 0.3,0.9; CO 1.2% 0.6,1.7; PM10 0.31% -0.2,0.7). Similar findings were found for cardiorespiratory mortality and hospital admissions for respiratory and cardiac diseases. We found no difference by gender. There was a weak evidence of greater effect size in extreme age groups (0-24 months and over 85 years where we found a percent increase in mortality for all natural causes for PM10 of 0.39% CrI95% 0.0,0.8). There was a strong evidence for each pollutant of greater effects in the warm season (1st May-30th September) on mortality and hospital admissions (we found a percent increase in mortality for all natural causes for PM10 in the warm season of 1.95% CrI95% 0.6,3.3). The associations between pollutants concentration and health events were present at different time lags, depending on outcome and exposure. For mortality, the excess risk peaked within few days from the exposure increase (two days for PM10, up to four days for NO2 and CO). Mortality displacement was minor and ended within two weeks. Cumulative effects at fifteen days showed higher risks for respiratory diseases (PM10 1.65% CI95% 0.3,3.0). The results of meta-regressions showed associations between PM10 effects on mortality and hospital admissions, and mortality for all causes (SMR) and PM10/NO2 ratio. The effect modification of temperature was very consistent, and also using bi-pollutant models. Such effect modification was greater during the cold season. We found and overall impact on mortality for all natural causes in the period 1996-2002 between 1.4% and 4.1% of all deaths for gaseous pollutants (NO2 and CO). The estimates were more imprecise for PM10, due to the variability among cities of the effect estimates (0.1%; 3.3%). The limits stated in the European Union directives for 2010 would have been saved about 900 deaths (1.4%) for PM10 or 1400 deaths for NO2 (1.7%) among all the MISA cities, applying posterior city-specific effect estimates.

Adolescent↗

PubMed1995

A comparison of results for the University of Missouri Research Reactor radiological airborne release assessments obtained from PC-based computer programs.

The United States Environmental Protection Agency has published three computer programs, COMPLY, AIRDOS-PC, and CAP88-PC, to assist the regulated community in determining compliance with the Environmental Protection Agency radionuclide air emission standards. The programs calculate radiation doses from routine airborne release to the general public residing outside a nuclear facility site. They consider doses from inhalation, ingestion of contaminated food, air immersion, and ground deposition. A PC-based computer code, XOQDOQ-82, developed for the Nuclear Regulatory Commission, was also chosen to compare and evaluate dispersion results from the Environmental Protection Agency codes for the University of Missouri Research Reactor Center. Effects of building parameters, terrain conditions, and downwind distances on dispersion factors were calculated. The results of this study indicated that dispersion factors calculated using AIRDOS-PC and CAP88-PC were several times lower than those calculated using XOQDOQ-82 at all distances, and those dispersion factors calculated using COMPLY were several times lower than the XOQDOQ-82 values at distances greater than 600 m.

Air Pollutants, Radioactive↗

PubMed1991

How sick a patient? Report of a workshop on cancer risk assessment.

A report by the U.S. Government Office of Management and Budget (OMB) criticized the way health, safety, and environmental regulation of potential cancer causing substances is conducted by federal agencies, especially the Environmental Protection Agency. Cancer risk assessment--this report indicates--is governed by arbitrary policy assumptions and procedures improperly disguised as scientific and is designed to overestimate risk. Unwarranted economic burdens of ensuing regulation may then adversely affect standards of living and ultimately the very health and longevity that regulation is presumed to safeguard. An interdisciplinary workshop generally agreed with the OMB position and sharpened criticism of the procedures and scientific pretensions in the regulation of potential carcinogens. Various options for change were discussed, although it was felt that the success of detailed remedies would require a wider political, administrative, and scientific discourse.

Carcinogens↗

PubMed2003

Review of procedures for protecting human subjects in recent clinical studies of pesticides.

Arguments have been made for and against the regulatory use of data from human subjects on both scientific and ethical grounds. One argument against the use of data from human clinical studies involving pesticides asserts that such data are obtained from studies that do not follow the Common Rule (40 CFR 26), which provides procedures for protecting human subjects in studies funded by federal agencies, including the U.S. Environmental Protection Agency (U.S. EPA). Although privately conducted studies using human subjects are not legally subject to or required to comply with the Common Rule, the protections of the Declaration of Helsinki and the International Conference on Harmonisation (ICH) Good Clinical Practice are commonly followed. We sought to answer the question of whether recent human clinical studies with insecticides performed according to Good Clinical Practice provided volunteers with the same protections as the Common Rule. All three sets of guidance have in common the intent to protect volunteer human subjects by providing standards for the conduct of studies in which they participate. This analysis compares the elements of the Common Rule with comparable elements from the Declaration of Helsinki and Good Clinical Practice to evaluate similarities and differences in procedural requirements. It then evaluates the documentation from 15 recent human studies of twelve insecticides conducted at four clinical laboratories in order to determine whether the conduct of those studies is consistent with the protections of the Common Rule. There were some cases for which we could not verify compliance with certain Common Rule elements; however, based on our evaluation it is apparent that the studies we reviewed were conducted in a manner substantially consistent with the fundamental protections of the Common Rule-voluntary participation, informed consent, and review by an ethical committee or institutional review board.

Clinical Trials as Topic↗

PubMed1996

Evaluation of the hazard quotient method for risk assessment of selenium.

Environmental contamination with selenium from industrial and agricultural sources has poisoned fish and wildlife at several locations in the United States. Monitoring and risk assessment activities are currently being conducted by many state and Federal agencies. The U.S. Environmental Protection Agency (EPA) recommends a hazard quotient (HQ) method (waterborne concentration divided by the national water quality criterion) to assess the toxic threat of individual waterborne elements, including selenium. An evaluation of the EPA HQ method was conducted by comparing it to a recently published protocol (Protocol) for selenium assessment. Hazard estimates obtained using HQ were found to be invalid because the EPA water quality criterion is outdated, and the procedure uses mean rather than maximum waterborne concentrations. The HQ method seriously underestimates hazard and could lead to risk management decisions that would not protect fish and wildlife from selenium toxicity. The Protocol method provides an accurate assessment because it evaluates hazard by examining multiple exposure pathways on a site-specific basis. Until a revised (lowered) national water quality criterion is available, the EPA HQ method should not be used for selenium. Even then, with the availability of the Protocol, HQ analysis should be restricted to data sets where water is the primary or sole source of information on environmental concentrations of selenium.

Environmental Monitoring↗

PubMed2002

Starlink corn: a risk analysis.

Modern biotechnology has dramatically increased our ability to alter the agronomic traits of plants. Among the novel traits that biotechnology has made available, an important group includes Bacillus thuringiensis-derived insect resistance. This technology has been applied to potatoes, cotton, and corn. Benefits of Bt crops, and biotechnology generally, can be realized only if risks are assessed and managed properly. The case of Starlink corn, a plant modified with a gene that encodes the Bt protein Cry9c, was a severe test of U.S. regulatory agencies. The U.S. Environmental Protection Agency had restricted its use to animal feed due to concern about the potential for allergenicity. However, Starlink corn was later found throughout the human food supply, resulting in food recalls by the Food and Drug Administration and significant disruption of the food supply. Here we examine the regulatory history of Starlink, the assessment framework employed by the U.S. government, assumptions and information gaps, and the key elements of government efforts to manage the product. We explore the impacts on regulations, science, and society and conclude that only significant advances in our understanding of food allergies and improvements in monitoring and enforcement will avoid similar events in the future. Specifically, we need to develop a stronger fundamental basis for predicting allergic sensitization and reactions if novel proteins are to be introduced in this fashion. Mechanisms are needed to assure that worker and community aeroallergen risks are considered. Requirements are needed for the development of valid assays so that enforcement and post market surveillance activities can be conducted.

Bacillus thuringiensis↗