Evaluation environmental risks

D. Kriebel, J. Tickner and C. Crumbley, Appropriate Science Evaluating Environmental Risks for a Sustainable World, presented at Education for Sustainable Development, Committee on Industrial Theory and Assessment, University of Massachusetts Lowell, Lowell, MA, October 23-24, 2003. 

The character of the potential contaminants is a key consideration in the environmental vulnerability to a release. Solubility, biodegradability, toxicity and physical state must be considered in evaluating environmental risk. 

The main objective of ecotoxicology is therefore to produce suitable tools for the setting up of Environmental Quality Objectives and for the evaluation and prediction of environmental concentrations, in order to assess the risk for natural populations (including human), potentially exposed to environmental contaminants. In this chapter the essential of ecotoxicological background needed to understand the procedures for effect and exposure assessment in order to evaluate environmental risk will be described briefly. 

In the context of environmental risk/safety, several guidance documents have been developed that focus on an approach to evaluating environmental risk/safety, such as the Safety Considerations for Biotechnology Scale-up of Crop Plants published by the OECD (1993). In addition, many other OECD documents, developed through consensus of the member countries, have provided the basis for... 

Roberts, S., Teat, C., and Bean, J., Hazardous Waste Incineration Evaluating the Human Health and Environmental Risks, CRC Press, Boca Raton, FL, 1999, p. 400. 

Apart from of investigating the concentration of priority pollutants to assess the temporal and geographic trends as it has been done in the Ebro river basin until nowadays, the SCARCE project pretends to evaluate the consequences of the climate change in the water quality as well as predicting new environmental risks derived from water scarcity. This will be done by determining the presence of new priority (i.e. perfluorinated compounds) and emerging toxicants in Mediterranean river ecosystems in the Iberian Peninsula. In a subsequent step, the effects of chemical and environmental stressors on the biota will be assessed by combining field and experimental studies. The effects of multiple stressors will be addressed from a multi-biomarker perspective [27]. 

Selection of target pharmaceuticals (see Table 1) was based on the following criteria (1) the sales and practices in Spain (according to National Health system), (2) compound pharmacokinetics (the percentage of excretion as nonmetabolized substance), (3) their occurrence in the aquatic media (data taken from other similar studies), and (4) on data provided by environmental risk assessment approaches, which link the calculation of predicted environmental concentrations (PEC) with toxicity data in order to evaluate which compounds are more liable to pose an environmental risk for aquatic organisms [20-22], In the current European... 

Hughes, K., M.E. Meek, P.K.L. Chan, J. Shedden, S. Bartlett, and L.J. Seed. 1994. Nickel and its compounds evaluation of risks to health from environmental exposure in Canada. Jour. Environ. Sci. Health. Part C, Environ. Carcinogen. Ecotoxicol. Rev. 12 417-433. 

EMEA (1998) Note for Guidance environmental risk assessment for veterinary medicinal products other than GM-containing and immunological products. EMEA/CVMP/ 055/96. European Agency for the Evaluation of Medicinal Products, London... 

Substances that are used only to formulate cosmetics or to manufacture food-packaging materials are dual regulated they still have to be registered under REACH, although they are subject to separate EU measures that involve an evaluation of their safety to humans. Hence, in order to avoid duplication of work, the REACH CSR only has to include an environmental risk assessment. 

Environmental risk assessment examines the potential adverse effects to ecosystems from exposure of the aquatic, terrestrial and air components. Initial assessment normally focuses on the aquatic compartment, including effects on microorganisms in waste water treatment plants. This first tier risk assessment can be extended to cover the sediment part of the aquatic compartment and the soil compartment. At higher tonnage levels, effects relevant to the food chain are evaluated, i.e., secondary poisoning. Diderich in Chapter 8 of (73) discusses the principles of EU environmental risk assessment. 

ASTER. 1995. ASTER (Assessment Tools for the Evaluation of Risk) ecotoxicity profile. U.S. Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory. Mid-Continent Ecology Division. 

Environmental risk assessment of substances is nowadays based on an evaluation of exposure pathways and concentrations on the one hand and identification and selection of sensitive endpoints on the other. The concept is operationalised by comparing real or estimated (predicted) exposure concentrations (PEC) with calculated no-effect concentrations (NEC or PNEC, predicted NEC). The comparison can be made by calculating the quotient of exposure and no-effect concentration. If the quotient is less than one, then the substance poses no significant risk to the environment. If the quotient is greater than one, the substance may pose a risk, and further action is required, e.g. a more thorough analysis of probability and magnitude of effects will be carried out. 

Waters EM, Gerstner HB, Huff JE. 1977a. Mirex A risk benefit evaluation. Environmental Chemicals Human and Animal Health 5 49-77. 

Ecosystem characterization Long-term monitoring should continue in order to enable estimation of natural variability, as well as to establish a baseline against which to evaluate the effects of disturbances. Standard environmental risk assessment approaches may not be useful if the components of the ecosystem in question have not been determined. Further research on... 

Liteplo RG, Meek ME. 1994. 3,3 -Dichlorobenzidine evaluation of risks to health from environmental exposure in Canada. Environ Carcino Ecotox Revs 12(2) 287-292. 

Fig. 2 Scheme of the tiered approach of the European Medicines Evaluation Agency (EMEA) for environmental risk assessment... 

ERAVMIS Environmental Risk Assessment of Veterinary Medicines in Slurry, 1999-2003), whose aim was to evaluate the impact of some veterinary antibiotics (mainly macrolides and sulphonamides)... 

One study that has tackled this issue, however, was recently published by de Souza et al. [104], who set up an environmental risk assessment of the 21 intravenous antibiotics most used in an intensive care unit of a hospital in Curitiba (Brazil). They evaluated the RQ, based on PEC, both in the raw effluent and after a dedicated conventional biological treatment. They found that, in the raw effluent from the ward, the environmental risk was high for 15 compounds, medium for 4 and low for 2 similarly, the treated effluent was labelled as high risk in terms of 14 compounds, medium for 5 and low for 2. 

In conclusion, the authors of the cited studies all agree that further research into environmental risk assessment of hospital effluents, incorporating different types of substances used in care and diagnostic activities, as well as cleaning operations (pharmaceuticals, detergents, disinfectants, heavy metals, macropollutants), is vital. Moreover, further studies need to be focussed on evaluating the risk posed by pollutant mixtures, and work is needed to validate the predictive models proposed thus far [19, 49], to evaluate chronic toxicity due to PhCs and then-mixtures and to provide experimental data pertaining to specific case studies. 

EMEA (2003) Note for guidance on environmental risk assessment of medicinal products for human use. DRAFT. CPMP/SWP/4447/00 draft corr. The European Agency for the Evaluation of Medical Products... 

Abstract Active pharmaceutical ingredients (APIs) represent a group of emerging environmental contaminants. Albeit in trace amounts, they are of great concern since given their continuous introduction into the environment, their impact on ecosystems and human health is of great importance. As a result, the environmental risk assessment (ERA) of medicinal products has to be evaluated and appropriate legislation has been issued in the European Union (EU). 

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