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The contrast between risk assessment and rules of evidence in the context of international trade disputes: can the US experience inform the process?

Risk assessment provides a formalized process to evaluate human, animal, and ecological responses associated with exposure to environmental agents. The purpose of risk assessment is to answer two related questions: - How likely is an (adverse) event to occur? - If it does, how severe will the impact be? In the United States, the science of risk assessment has evolved out of the necessity to make public health decisions in the face of scientific uncertainty. Its basic propositions have been established over the past three decades and its applications have impacted virtually every aspect of public health and environmental protection in many countries, including the United States. More recently, the World Trade Organization's (WTO) dispute-settlement process has provided additional incentive for the reliance on risk assessments internationally through the requirement that member countries be able to provide scientific justification, based on a risk assessment, for public health and environmental regulatory measures that are challenged. The purpose of this article is to review the history of risk assessment in the United States, emphasizing the development of both its scientific and policy aspects, as one example of the development of institutional capacity for risk assessment. This article discusses the importance of the social, political, and economic contexts of risk assessment and risk management in shaping the approaches taken while highlighting the reality that the analytic or risk assessment part of the decision-making process, in the absence of scientific data, can be completed only by inserting inferences, or policy judgments, which may differ among countries. This article recognizes these differences, and the consequent difference between risk assessment that incorporates public health protective assumptions and the rules of evidence that seek to answer questions of causality, and discusses implications for the WTO dispute-settlement process. It further explores the value of country-specific risk assessment guidelines to facilitate consistency within a country along with the appropriateness and feasibility of international risk assessment guidelines.

Animals↗

Passive smoking as a cause of heart disease.

The effects of passive smoking on ischemic heart disease are reviewed. Short-term exposures of 20 min to 8 h result in increased platelet sensitivity and decreased ability of the heart to receive and process oxygen. Longer term exposure results in plaque buildup and adverse effects on blood cholesterol. The available epidemiology is reviewed, and it is concluded that passive smoking increases the coronary death rate among U.S. never smokers by 20% to 70%. The newest Environmental Protection Agency procedures for estimating deaths from passive smoking, when applied to the epidemiologic results on heart disease and passive smoking, indicate that in 1985 an estimated 62,000 ischemic heart disease deaths in the United States were associated with exposure to environmental tobacco smoke. Clinicians are advised to counsel their patients to avoid tobacco smoke at home, at work and in transportation settings.

Cardiovascular System↗

Winter air pollution and disease parameters in advanced chronic obstructive pulmonary disease panels residing in Denver, Colorado.

BACKGROUND: Ambient pollution might worsen chronic obstructive pulmonary disease (COPD). OBJECTIVE: We explored the associations of pollution to pulmonary function, rescue medication, and symptoms over 2 winters in 2 panels of subjects with advanced COPD in Denver, Colorado. METHODS: Subjects measured lung function and recorded symptoms and rescue medications. Daily ambient pollution concentrations for particulate matter (PM(10) and PM(2.5)), carbon monoxide (CO), and nitrogen dioxide (NO(2)) were obtained for Denver. Estimated effects of pollution on outcomes were derived for the same day and 1 and 2 days after pollution measurements (lags 0, 1, and 2, respectively). RESULTS: Sixteen (mean age, 65.8 years; mean FEV 1 , 42.3% of predicted value) and 18 (mean age, 67.4 years; mean FEV 1 , 39.4% of predicted value) subjects participated in the first and second winters, respectively. There were no differences in demographic or disease characteristics between the 2 panels. In the first winter no detrimental associations were found. In the second winter, however, there were significant detrimental associations of CO in the morning and PM(10), CO, and NO(2) in the evening, increasing medication use at lag 0. Total symptom score increased at lag 0 with NO(2). The concentrations of particulates were increased in the second winter compared with in the first winter, and this winter was colder and more humid. CONCLUSIONS: In the second winter, subjects with severe COPD had worse lung function at lags 0 and 1 and increased rescue medication at lag 0 with increases in ambient air pollution. The effects of pollution varied between the 2 winters, perhaps related to levels of pollution and weather patterns. Significant effects were seen despite ambient pollution levels that conformed to US Environmental Protection Agency standards.

Aged↗

Acute effects of volcanic ash from Mount Saint Helens on lung function in children.

To evaluate the acute effects of volcanic ash from Mt. St. Helens on the lung function of children, we studied 101 children 8 to 13 yr of age who were attending a 2-wk summer camp for children with diabetes mellitus in an area where about 1.2 cm of ash had fallen after the June 12, 1980, eruption. The outcome variables used were forced vital capacity, forced expiratory volume in one second, their ratio and mean transit time. Total and respirable dust levels were measured using personal sampling pumps. The children were tested on arrival and twice (early morning [A.M.] and late afternoon [P.M.]) every second or third day during the session. A within-day effect was measured by the P.M./A.M. ratio for the lung function variables; a between-day effect was measured by the change in the P.M. measurements over the 2 wk of camp. We found no strong evidence of either a within-day or a between-day effect on lung function, even in a subgroup of children who had preexisting lung disease or symptoms, despite daytime dust/ash levels that usually exceeded the Environmental Protection Agency's significant harm level for particulate matter.

Adolescent↗

Some public attitudes about health and the environment.

Public opinion is formed both by long-term developments and--at the other extreme--by single unanticipated events. This suggests that readers of opinion survey findings should note field interviewing dates and further determine what the news media have been reporting about relevant developments and events. Personal health and the cost of health care are high on the public's agenda; this is an important backdrop to a review of public attitudes and priorities related to health and the environment. What about the environment? Americans increasingly believe that we are not spending enough on environmental protection and improvement. The public thinks of environmentalists in a favorable light, and a very sizeable minority believe they have too little influence--the same number who feel it's "about right." Our surveys have shown that the more people perceive an environmental threat to their safety, well-being and health, the more they will want regulation or industry action to meet the threat. High on the public's anxiety list are hazardous wastes (especially their disposal) and the transport and use of toxic materials in manufacturing and processing, industrial accidents involving the release of pollutants, the leakage of chemical waste into the soil, and the pollution of water and air from industrial sources. Our data support the assumption that for the foreseeable future these and certain other ecological dangers will be seen as serious by large majorities of Americans. For example, even the safety of drinking water has slowly become more questionable in the public's mind.(ABSTRACT TRUNCATED AT 250 WORDS)

Acid Rain↗

Black-bellied whistling duck (Dendrocygna autumnalis) brain cholinesterase characterization and diagnosis of anticholinesterase pesticide exposure in wild populations from Mexico.

Rice is the main crop in the subbasin of the fluvial lagoon system of Palizada River (FLSPR) in the state of Campeche, Mexico. The pesticides used to control pests of this crop mainly are carbofuran, chlorpyrifos, and glyphosate. Black-bellied whistling duck (Dendrocygna autumnalis) is an ecologically and economically important species in the area. This duck is consumed by local inhabitants throughout the year, despite its potential exposure to pesticides. Due to its feeding habits, abundance, and nutritional value, D. autumnalis is a good indicator of environmental contamination and a potential route of human exposure to organophosphate and carbamate pesticides. In this study, the brain cholinesterase (ChE) in the frontal cerebral cortex of autochthonous ducks was characterized. In addition, the potential of the three locally used pesticides and mixtures to inhibit ChE activity was investigated and the exposure of the wild duck population during intensive pesticide applications in rice fields was evaluated. We found that acetylcholinesterase (AChE) seems to be the predominant ChE form in the biological fraction analyzed. Carbofuran was the most potent ChE inhibitor of D. autumnalis brain ChE activity from the three pesticides analyzed. Cholinesterase inhibition after exposure to pesticide mixtures predominantly was due to carbofuran. A decrease (p < 0.05) in AChE activity (>30%) was apparent in wild ducks compared to reference ducks, with recovery of ChE inhibition in wild ducks occurring months later when no pesticides were applied in the field. Dendrocygna autumnalis brain ChE is a suitable parameter for inclusion in biomonitoring programs for both environmental protection and human safety.

Acetylcholinesterase↗

Scientific trends in risk assessment research.

The use of risk assessment approaches to evaluate the effects of toxic chemicals had its primary origin in 1976 when the U.S. Environmental Protection Agency (EPA) adopted the first federal guidelines to commit a major regulatory agency to risk assessment approaches for the evaluation of suspect carcinogens. The accompanying policy statement also adopted a risk management policy, which acknowledged that the agency would accept risk in making public health policy decisions; in essence, this represented a primary departure from the zero-risk goal that had dominated the first half of the environmental movement of the 70s. The approach adopted in 1976 was based on the experience of risk assessment approaches used for assessing low-dose-radiation effects on human health. To be certain that no public health risk be underestimated, particularly in light of the prior zero-risk goal, the practice of risk assessment for the first decade relied heavily on extremely protective assumptions in all aspects of the assessment process. For example, these assumptions included ranking the weight-of-evidence according to results in all related studies without regard for distinctions of tumor end point relevance to humans and the possibility that low-dose effects at environmental exposures might not be the same as high-dose effects. For low-dose-response characterization, the practice has been to characterize a plausible upper bound on risk by the use of a low-dose linear non-threshold dose-response curve. Exposure assessment likewise relied on maximum plausible assumptions to characterize exposure. More recently, more attention is being paid to developing accurate scientific databases that advance almost every aspect of the risk assessment process in the direction of more accurate risk characterization. This paper will discuss the recent trends in weight-of-evidence characterization, dose-response modeling, and exposure assessment and will compare the outcomes of these refined assessments to those evaluations that have relied on the earlier, conservative approaches. In essence, if the practices of the first decade for establishing plausible upper bounds on the risk were accurate, improved scientific data by and large should be expected to lower the overall theoretical risk. Indeed, this is the case when recent risk assessment research is applied but there are examples to the contrary. This paper represents a survey of recent trends and applications.

Animals↗

Proposed framework for cleanup and site restoration following a terrorist incident involving radioactive material.

Cleanup following a terrorism incident involving a radiological dispersal device (RDD) or improvised nuclear device (IND) is likely to be technically challenging, costly, and politically charged. Lessons learned from the Top Officials 2 exercise and the increased threat of terrorist use of an RDD or IND have driven federal officials to push for an agreed-upon process for determining appropriate cleanup levels. State and local authorities generally have the ultimate responsibility for final public health decisions in their jurisdictions. In response to terrorist attacks, local authorities are likely to request federal assistance in assessing the risk and establishing appropriate cleanup levels. It is realistic to expect local and state requests for significant federal assistance in planning and implementing recovery operations. State and local authorities may desire "shared accountability" with the federal government in setting the appropriate cleanup levels. Government officials at all levels will face pressure to say how clean is clean enough and how quickly people can re-enter affected areas. Issues arising include (1) the nature of the relationship between the federal, state, and local leadership involved in the recovery efforts and (2) where the funding for recovery comes from. Many agencies, including the U.S. Environmental Protection Agency (EPA), the U.S. Nuclear Regulatory Commission (NRC), and the U.S. Department of Energy (DOE) have long been involved in cleanup activities involving radioactive materials. These agencies have recognized the need for a participatory process and realize the need to remain flexible when faced with possible unprecedented environmental challenges following a terrorist attack. Currently, the Department of Homeland Security has a committee process underway, with participation of the EPA, NRC, DOE, and other federal agencies, to try to resolve these issues and to begin engaging state, local, and tribal governments, and others as appropriate.

Decontamination↗

Integrated circuits protection with the Langmuir-Blodgett Films.

Integrated circuits (ICs) can be protected from the environment with the encapsulating polymer layer. Protection properties of such a polymer barrier-layer depend strongly from the structure of thin region where polymer stays in direct contact with the IC surface. One of the interesting questions is how thick should this interphase film be to assure good environmental protection to the IC conductor lines, preventing from their corrosion and failure. In order to answer this question a set of electronic testers with Al conductor lines were modified with 1, 20, 50 multilayers of stearic acid molecules deposited in the Langmuir-Blodgett (LB) transfer method. Next, the electronic testers were subjected to the highly accelerated aging conditions (100% relative humidity (RH), 100 degrees C) for a period of up to 800 h and conductor lines resistivity changes were monitored. Electronic testers modified with 20 multilayers of stearic acid were better protected from the accelerated aging conditions than the testers modified with 1 monolayer or 50 multilayers. Obtained results suggest that the thickness of the interphase region separating IC surface and polymeric film should be in the range of 10 nm.

Electric Impedance↗

Assessing drought-related ecological risk in the Florida Everglades.

In the winter-spring of 2001, South Florida experienced one of the worst droughts in its recorded history. Out of a myriad of ecological concerns identified during this time, the potential for catastrophic peat fire and negative impacts to wading bird reproduction emerged as critical issues. Water managers attempted to strike a balance between the environment and protection of water supplies for agriculture and urban interests. It became evident, however, that a broad-scale, integrated way to portray and prioritise ecological stress was lacking in the Florida Everglades, despite this being considered a necessary tool for addressing issues of environmental protection. In order to provide a framework for evaluating various water management operations using real-time information, we developed GIS-based indices of peat-fire risk and wading bird habitat suitability. These indices, based on real physical, chemical, and biological data, describe two ecological conditions that help define the physical and biological integrity of the Everglades. In addition to providing continuous, updated assessments throughout the drought period, we incorporated predictive models of water levels to evaluate how various water management alternatives might exacerbate or alleviate ecological stress during this time.

Animals↗

Particle mass emission rates from current-technology, light-duty gasoline vehicles.

Now that the U.S. Environmental Protection Agency has promulgated new National Ambient Air Quality Standards for PM2.5, work will begin on generating the data required to determine the sources of ambient PM2.5 and the magnitude of their contributions to air pollution. This paper summarizes the results of an Environmental Research Consortium program, carried out under the auspices of the U.S. Council for Automotive Research. The program focused on particulate matter (PM) emissions from representative, current-technology, light-duty gasoline vehicles produced by DaimlerChrysler Corp., Ford Motor Co., and General Motors Corp. The vehicles, for the most part taken from the manufacturer's certification and durability fleets, were dynamometer-tested using the three-phase Federal Test Procedure in the companies' laboratories. The test fleet was made up of a mixture of both low-mileage (2K-35K miles) and high-mileage (60K-150K miles) cars, vans, sport utility vehicles, and light trucks. For each vehicle tested, PM emissions were accumulated over 4 cold-start tests, which were run on successive days. PM emission rates from the entire fleet (22 vehicles total) averaged less than 2 mg/mile. All 18 vehicles tested using California Phase 2 reformulated gasoline had PM emission rates less than 2 mg/mile at both low and high mileages.

Air Pollution↗

Risk assessment for children exposed to decabromodiphenyl (oxide) ether (Deca) in the United States.

Decabromodiphenyl (oxide) ether (Deca) is a widely used brominated flame retardant in the United States predominantly in the hard-plastic housings of consumer electronics and in flame-retarded backing on textiles used in furniture. A child-specific exposure assessment of Deca was performed for the US Environmental Protection Agency's Voluntary Children's Chemical Evaluation Program (VCCEP). The VCCEP guidance for a tier 1 exposure assessment requires that a screening-level assessment be conducted using currently available data and conservative assumptions. For Deca, relevant exposure pathways considered were general environmental exposures (e.g., exposures to contaminated soil, dust, air, and food), breast milk exposures, inhalation of Deca-containing particulates in air, and mouthing Deca-containing consumer products. For each of these scenarios, a mid-range and upper estimate of age-appropriate intakes were calculated. The calculated intakes indicate that, despite the uncertainties, children appear to be exposed to Deca at levels at least 1 order of magnitude, with most being several orders of magnitude, below the National Academy of Sciences reference dose for Deca of 4 mg/kg/d. This analysis indicates that, using the available data, current levels of Deca in the United States are unlikely to represent an adverse health risk for children.

Child↗

The use of plants for environmental monitoring and assessment.

This paper presents a critical review on phytotoxicity tests for environmental monitoring and assessment. Vascular macrophytes used in the laboratory testing are emphasized; algae are mentioned only for comparison. Several issues are discussed, including the rationale for and misconceptions about phytotoxicity tests, relation to regulation, status of phytotoxicity test protocols, advantages and disadvantages of phytotoxicity tests, and possible research directions. Aquatic and terrestrial macrophytes, along with algae, are essential components of ecosystems. Macrophytes are becoming more important for the monitoring and assessment of herbicides, effluents, and industrial chemicals. In the United States, Canada, and international organizations, phytotoxicity tests can be required for environmental monitoring and assessment in statutes such as Federal Insecticide, Fungicide, and Rodenticide Act; Toxic Substances Control Act; Water Quality Act; Canadian Pest Control Products Act; and Canadian Environmental Protection Act. Possible research directions for phytotoxicity tests are discussed relative to the role in regulations of industrial chemicals, effluents, hazardous waste sites, and pesticides.

Environmental Monitoring↗

Screening 31 endocrine-disrupting pesticides in water and surface sediment samples from Beijing Guanting reservoir.

For screening 31 potential or suspected endocrine-disrupting pesticides in water and surface sediments, a multiresidue analysis method based on gas chromatography with electron capture detection (GC/ECD) was developed. Solid phase extraction (SPE) technology with Oasis HLB cartridge was also applied in sample extraction. The relevant mean recoveries were 70-103% and 71-103% for water and sediment, respectively. Relative standard deviations (RSD) are 2.0-7.0%, 4.0-8.0% for water and sediment, respectively. Thirty one pesticides (alpha-HCH, beta-HCH, gamma-HCH, delta-HCH, hexachlorobenzene (HCB), aldrin, heptachlor, endosulfan I & II, p,p'-DDD, o,p'-DDT, p,p'-DDT, p,p'-DDE, endrin aldehyde, endosulfan sulphate, methoxychlor, hepachlor epoxide, alpha-chlordane, gamma-chlordane, dieldrin, endrin, dicofol, acetochlor, alachlor, metolachlor, chlorpyriphos, nitrofen, trifluralin, cypermethrin, fenvalerate, deltamethrin) in water and surface sediment samples from Beijing Guanting reservoir were analyzed. Concentrations of pesticides ranged from 7.59 to 36.0 ng g(-1) on a dry wt. basis for sediment samples, from 279.3 to 2740 ng l(-1) for pore waters and from 48.8 to 890 ng l(-1) for water samples, respectively, with a mean concentration of 10.7 ng g(-1) in sediment, 735 ng l(-1) in pore water and 295 ng l(-1) in water, respectively. The data obtained provides information on the levels and sources of endocrine-disrupting pesticides in Guanting reservoir. These results underscore the need to improved environmental protection measures in order to reduce the exposure of the population and aquatic biota to these endocrine-disrupting compounds.

China↗

Benzene in Alaska.

Alaska Department of Environmental Conservation took indoor and ambient air samples during the winter of 1992-93 in Fairbanks. The samples showed a significant increase in the level of benzene in the air between December and February. The highest levels occurred in indoor air and exceeded workplace standards in garages. These findings were corroborated by NIOSH and OSHA personal monitoring studies done at the same time in Fairbanks and by blood samples taken by Centers for Disease Control and Prevention from workers exposed to gasoline in December and February. The blood samples showed a 300 percent increase in the amount of benzene in worker's blood after MTBE was taken out of gasoline. The most likely cause of this air pollution is gasoline evaporation and exhaust emissions. The benzene content of Alaska gasoline is 5 percent which is the highest in the nation. In view of these findings the Environmental Protection Agency is funding a new study of indoor air organic compounds including benzene in Anchorage, Alaska.

Air Pollution↗

Strategic environmental assessment in Hong Kong.

This review examines the development and application of strategic environmental assessment (SEA) process in the planning framework of Hong Kong. Two strategic planning case studies are evaluated within the context of SEA, namely the Territorial Development Strategy Review (TDS Review) and the Third Comprehensive Transport Study (CTS-3). Rapid population growth and urbanisation in Hong Kong, coupled with a historic lack of planning controls and inherent conflicts between government departments have been major obstacles to achieving sustainable development in the territory. Despite these challenges, Hong Kong was one of the first Asian countries to apply SEA to major development plans, where the implementation of the 'SUSDEV 21' study on sustainable development has demonstrated the government's commitment towards integrated environmental protection. The application of SEA has provided decision-makers with key information on potential environment impacts arising from proposed developments, resulting in greater accountability and transparency in the decision-making process. SEA in Hong Kong has also prompted an increased level of environmental awareness and co-operation between government departments and agencies responsible for the management of Hong Kong's natural and urban environments. However, the application of SEA in Hong Kong continues to have notable limitations. SEA needs to evolve beyond its current sectoral application to examine ways in which development decisions can not only pre-empt and prevent environmental damage, but also positively enhance and restore existing natural resources. Current land use plans and transportation strategies still largely determine the pattern of development in the near future without adequate longer-term environmental cost-benefit analysis. Sustainable development includes environmental, social and economic considerations, and these inter-related elements need be suitably balanced. SEA is not a means to obstruct development in Hong Kong, but should be recognised for its inherent socio-economic and ecological value, and fully integrated with the decision-making process. Whilst it is admirable that Hong Kong has taken positive steps in this direction, it is now an opportune moment for the government to have the foresight and tenacity to create a sustainable development framework for Hong Kong into the future.

Cities↗

Preliminary assessment of worker and ambient air exposures during soil remediation technology demonstration.

Hazardous waste site remediation workers or neighboring residents may be exposed to particulates during the remediation of lead-contaminated soil sites. Industrial hygiene surveys and air monitoring programs for both lead and dust were performed during initial soil sampling activities and during pilot scale technology demonstration activities at two lead-contaminated soil sites to assess whether worker protection or temporary resident relocation would be suggested during any subsequent remediation technology activities. The concentrations of lead and dust in the air during pilot scale technology demonstration studies were within applicable exposure guidelines, including Occupational Health and Safety Administration permissible exposure limits, National Institute for Occupational Safety and Health recommended exposure limits, American Conference of Governmental Industrial Hygiene threshold limit values, and the United States Environmental Protection Agency's National Ambient Air Quality Standards program limits.

Air Pollutants, Occupational↗

ATSDR evaluation of health effects of chemicals. IV. Polycyclic aromatic hydrocarbons (PAHs): understanding a complex problem.

Polycyclic Aromatic Hydrocarbons (PAHs) are a group of chemicals that are formed during the incomplete burning of coal, oil, gas, wood, garbage, or other organic substances, such as tobacco and charbroiled meat. There are more than 100 PAHs. PAHs generally occur as complex mixtures (for example, as part of products such as soot), not as single compounds. PAHs are found throughout the environment in the air, water, and soil. As part of its mandate, the Agency for Toxic Substances and Disease Registry (ATSDR) prepares toxicological profiles on hazardous chemicals, including PAHs (ATSDR, 1995), found at facilities on the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) National Priorities List (NPL) and which pose the most significant potential threat to human health, as determined by ATSDR and the Environmental Protection Agency (EPA). These profiles include information on health effects of chemicals from different routes and durations of exposure, their potential for exposure, regulations and advisories, and the adequacy of the existing database. Assessing the health effects of PAHs is a major challenge because environmental exposures to these chemicals are usually to complex mixtures of PAHs with other chemicals. The biological consequences of human exposure to mixtures of PAHs depend on the toxicity, carcinogenic and noncarcinogenic, of the individual components of the mixture, the types of interactions among them, and confounding factors that are not thoroughly understood. Also identified are components of exposure and health effects research needed on PAHs that will allow estimation of realistic human health risks posed by exposures to PAHs. The exposure assessment component of research should focus on (1) development of reliable analytical methods for the determination of bioavailable PAHs following ingestion, (2) estimation of bioavailable PAHs from environmental media, particularly the determination of particle-bound PAHs, (3) data on ambient levels of PAHs metabolites in tissues/fluids of control populations, and (4) the need for a critical evaluation of current levels of PAHs found in environmental media including data from hazardous waste sites. The health effects component should focus on obtaining information on (1) the health effects of mixtures of PAHs particularly their noncarcinogenic effects in humans, and (2) their toxicokinetics. This report provides excerpts from the toxicological profile of PAHs (ATSDR, 1995) that contains more detailed information.

Animals↗