Environmental effects, substantial risk

If this value is much smaller than unity, the risk is low. If it is unity or above, there is a substantial risk. These calculations only provide rough estimates of risk, and thus the environmental exposure must be considered as well. Such considerations strengthen the case for developing new strategies using biomarkers for risk assessment. Biomarker assays can provide measures of exposure (and sometimes of toxic effects) under actual field conditions. 

So, regarding the ecosystem acidification effect assessment, risk management is the evaluation of alternative emission reduction measures and implementation of those that appear cost-effective. Management concerns that arise because of substantial uncertainties about major environmental consequences determine the scope... 

The discovery that chemicals that are known to have adverse effects are widespread in environmental media is reportable under 8(e). There must be more to a study than simply finding a substance associated with a substantial risk in the environment before the study becomes reportable. The distribution in the environment must have been not only imknown but also unsuspected and previously considered unlikely, and there must also be a... 

The type of action requested in a petition determines the legal standard for review. If the petition sought to initiate a proceeding for the issuance of a rule under 4 or an order under 5(e), the petitioner has to demonstrate, in a de novo proceeding, by a preponderance of the evidence, that (a) the information available to the EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance and (b) in the absence of such information, (i) the substance may present an unreasonable risk to health or the environment, or (ii) the substance will be produced in substantial quantities and it enters or may reasonably enter the environment in substantial quantities, or (iii) there is or may be significant human exposure. 

As discussed in Chapter 7, Reporting and Recordkeeping, 8(e) of the Toxic Substances Control Act (TSCA) requires that any person who imports, manufactures, processes, or distributes chemical substances or mixtures in the United States and who obtains information generated in the United States or in another country that reasonably supports a conclusion that a chemical substance or mixture may present a substantial risk of injury to human health or the environment must immediately report such information to the United States Environmental Protection Agency (EPA), unless the person knows that EPA has already been adequately informed. The information must be submitted to the Agency within thirty calendar days of the individual or business obtaining the information. For information to be reportable under 8(e), it does not need to establish conclusively that a risk exists and does not need to provide evidence that the substance is hazardous to human health or the environment under actual conditions of use and exposure. The information may relate to actual instances of serious human health or environmental injury caused by the chemical or mixture or to observations that are early indications of such effects. Incidents of environmental contamination may also be report-able under TSCA 8(e) and should be reviewed under this procedure in order to determine its immediate reportability as soon as the Company has knowledge of the incident. 

Section 8 The US EPA can request data on the properties, manufacture, exposure, and health and environmental effects of existing chemicals. Companies must keep records of adverse effects from their chemicals on health or the environment. Notably, under Section 8(e), responsible parties must report information that reasonably supports the conclusion that a substance or mixture presents a substantial risk of injury to health or the environment. 

Uncertainty on tlie other hand, represents lack of knowledge about factors such as adverse effects or contaminant levels which may be reduced with additional study. Generally, risk assessments carry several categories of uncertainly, and each merits consideration. Measurement micertainty refers to tlie usual eiTor tliat accompanies scientific measurements—standard statistical teclmiques can often be used to express measurement micertainty. A substantial aniomit of uncertainty is often inlierent in enviromiiental sampling, and assessments should address tliese micertainties. There are likewise uncertainties associated with tlie use of scientific models, e.g., dose-response models, and models of environmental fate and transport. Evaluation of model uncertainty would consider tlie scientific basis for the model and available empirical validation. 

The new antimicrobial is an order of magnitude less toxic, several orders of magnitude less volatile, easier to handle, more compatible with other water treatment chemicals, more effective against biofilms, and it generates less than half the disinfection by-products compared to chlorine or other alternatives. One hundred fifty billion gallons of industrial water have by now been successfully treated globally. Use of this new antimicrobial has substantially reduced environmental and human health risks from industrial water treatment by replacing nearly thirty million pounds of chlorine. The new product is proven to comparatively perform better, more safely, and it is substantially easier to apply than chlorine. 

Significant opportunities exist for industry to reduce or prevent pollution through cost-effective changes in production, operation, and raw materials use. In addition, such changes may offer industry substantial savings in reduced raw materials, pollution control, and liability costs, as well as protect the environment and reduce health and safety risks to workers. Where pollution prevention practices can be both environmentally beneficial and economically feasible, one would consider their implementation to be prudent. 

The gains for society of improved chemicals control may be substantial, though not easy to quantify in monetary terms. They include, for example, reduced costs for health care as a result of fewer accidents with chemicals, fewer acute health effects caused by poisonings, skin corrosion or bums, reduced risk for chronic effects such as allergies, cancer, etc. Furthermore, improved chemicals control will lead to a reduction of costs for remediation of environmental damage and of other costs following from emissions, e.g. water and soil pollution due to accidents or misuse of chemicals. 

Heat waves result in adverse health effects in cities more than in rural areas. During periods of sustained environmental heat—particularly during the summer— the numbers of deaths classified as heat related (e.g., heatstroke) and attributed to other causes (e.g., cardiovascular, cerebrovascular, and respiratory disease) increase substantially. Those at an increased risk for heat-related mortality are elderly persons, infants, persons with chronic conditions (including obesity), patients taking medications that predispose them to heatstroke (e.g., neuroleptics or anticholinergics), and persons confined to bed or who otherwise are unable to care for themselves. 

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