Evaluation of EU risk assessments existing chemicals (EC Regulation 793/93)

An evaluation was performed on the first group (41) of completed risk assessments for chemicals of the EU priority lists (Existing Chemicals; EC Regulation 793/93). The evaluation focussed on the conclusions of the risk assessments. The EU risk assessment process detected a high number of substances of concern. Furthermore priority chemicals may pose potential risks to the whole range of protection goals of the risk assessment. The predictability of the risk assessments for priority chemicals was investigated. Our a priori knowledge on possible risks of priority chemicals is found to be poor, especially for consumers. Both for environment and human health the potential risks were linked with a broad spectrum of use patterns. It is concluded that no industry category can in advance be excluded from performing risk assessments. For a great number of chemicals, additional testing was found to be needed to finalize the risk assessment. This evokes questions about the completeness of the current base-set, but also about the suitability of some of the submitted human health tests that should initially fulfil the base-set needs. The results of this evaluation are useful for ongoing discussions on risk assessment processes for chemicals.     

Ecological risk assessment of pollutant chemicals: extinction risk based on population-level effects

The extinction probability is one of the most useful endpoints that are utilized in conservation biology. A parallel approach is advocated for the ecological risk assessment of chemical pollutants. The presented framework estimates extinction probability induced by pollutant chemicals in order to evaluate ecological hazards of pollution, and is applicable to any biological community (aquatic or terrestrial). The analytical framework, which is based on stochastic population dynamics theory, is briefly explained. The extinction risk estimation is feasible if ecotoxicological data concerning pollutant effects on population growth rate of organisms (the intrinsic rate of natural increase), and if environmental exposure concentration is provided. Tentative risk estimation was made for some agrochemicals and surfactants on zooplankton populations (Daphnia) as target organisms.     

Evaluation of an ecosystem model in ecological risk assessment of chemicals

We used a Lake Suwa version of Comprehensive Aquatic Systems Model (CASM_SUWA) to demonstrate the risk estimation of 10 different chemicals and examined the applicability and reliability of the model in ecological risk assessment by qualitatively and quantitatively comparing with the results of studies on multiple species using mesocosm tests. The qualitative comparison of the model results with those of the reported mesocosm tests indicated that some evidence observed in mesocosm studies supported the indirect effects predicted from simulation using the model. The comparison of the concentration levels at which 20% biomass reduction (BR20) in the most sensitive population estimated from the model with the no-observed effect concentration values derived from multiple species mesocosm tests (MS-NOEC) suggested that both data were related to each other and the model can be used to help in the determination of an ecological acceptable level of chemicals in aquatic environments. The analysis of the potential of indirect effects of a chemical for fish population indicated that the magnitude of the potential of indirect effects was quantified based on the ratio of BR50 to LC50 for fish population.     

Environmental risks of chemicals and genetically modified organisms: a comparison. Part II: Sustainability and precaution in risk assessment and risk management

The principles of precaution and sustainability require more consideration in the assessment of environmental risks posed by chemicals and genetically modified organisms. Instead of applying risk reduction measures when there are serious indications for damage, full scientific certainty is often waited for before taking action. The precautionary principle particularly should be applied in those cases in which the extent and probability of damage are uncertain, e.g. in the case of persistent chemicals which are additionally bioaccumulative or highly mobile. Based on these principles, environmental action targets for risks associated with GMOs and chemicals can be developed. Risk management not only includes statutory measures but also instruments designed to influence behaviour indirectly are important to achieve the goals. Particularly for risks of GMOs which provoke fear, risk communication is important. Some rules to which attention should be paid in communication with the public are presented.     

Some Danish approaches to selection of existing chemicals

A number of Danish projects based on the OECD principles fon selection of existing chemicals are described. Methods of using SAR to predict lacking biological data are proposed, starting from homologous chemical groups. Exposure data is however usually obtained from information related to chemicals from very diverse chemical groups and this presents difficulties in combining exposure and effects data at an early stage in the selection process.     

Opportunities for a probabilistic risk assessment of chemicals in the European Union

In risk assessment of new and existing substances, it is current practice to characterise risk using a deterministic quotient of the exposure concentration, or the dose, and a no-effect level. A sense of uncertainty is tackled by introducing worst-case assumptions in the methodology. Since this procedure leads to an assessment with an unknown degree of conservatism, it is advisable to deal quantitatively with uncertainties. This paper discusses the advantages and possibilities of a probabilistic risk assessment framework, illustrated with an example calculation. Furthermore, representatives of EU Member States and the chemical industry were interviewed to find out their views on applying uncertainty analysis to risk assessment of industrial chemicals.     

A screening method for preliminary assessment of risk to groundwater from land-applied chemicals

A simple mathematical model for initial screening is presented that can aid in evaluating the relative risk to groundwater from applying nonpolar synthetic organic chemicals to soil. The basic premise is that the magnitude of the quotient of the chemical concentration of the water entering the aquifer and the maximum allowable concentration (as established by EPA or Health Departments) represents the health risk of a chemical. The chemical concentration of the soil water is estimated based on conservative, simplifying assumptions and requires only readily available data such as: basic soil properties (organic matter and saturated hydraulic conductivity), organic chemical properties (octanol-water partition coefficient and degradation rate) and environmental factors (recharge rate and depth to groundwater).The methodology was applied to assess the relative risk of organic chemicals in municipal sewage sludge and pesticides applied to agricultural land. The results are realistic.     

Risk assessment of environmental chemicals

This article is a summary from eleven important symposia. In these meetings, critical facts were discussed which are the necessary basis for the important legislation about toxic substances in Europe, in the U.S.A. and in Japan. This review article should also be of some help to the readers of “Chemosphere” for direct contacts with the experts mentioned. It is therefore an informative and coordinative survey, in which chemical and ecotoxicological details are largely omited.     

典型氯碱污染场地环境风险评价

以广东某氯碱化工污染场地为研究区域,采集了场地22个土壤及地下水样品,分析了25项污染物在不同区域的分布特征及其来源。监测结果表明,煤炭堆场与锅炉房区土壤受重金属铅、镍污染。六六六、四氯化碳、三氯甲烷、六氯苯、苯是场地的特征污染物,主要分布在危险品仓库、漂洗车间与四氯化碳车间。根据监测结果开展了不同暴露途径致癌风险值及非致癌危害商的计算。结果表明,部分样品表层土壤中上述有机污染物的基于人体健康致癌风险指数均超过10-6,最高达到1.65×10-2,表明风险水平高;非致癌危害在各暴露途径下也超过可接受值1,最高达5.59×104,表明风险水平高。说明对于存在高风险的区域必须进行采取合适的措施进行修复,减缓场地再利用后对人群健康的影响。     

浅谈风险评价在有毒化学品管理中的作用

本文简单介绍了有毒化学品风险评价和风险管理的基本过程和方法以及它们之间的关系。作为实例 ,对某市某主要河道的污染物进行了监测、分析和计算 ,确定了主要有害污染物。取得的数据为环境管理部门采取控制措施提供了科学依据     

Specific issues in health risk assessment of endocrine disrupting chemicals and international activities.

Specific issues in health risk assessment of EDCs and correlated international activities thereof are discussed. Risk characterization is a synthesis of all information including hazard assessment, dose-response relationship, and exposure information to identify clearly the strengths and weaknesses of the database, the criteria applied to evaluation and validation of all aspects of methodology, and the conclusions reached from the review of scientific information. In the case of EDCs, new models need to be developed taking into account possible new kinds of information, e.g., effects of EDCs on gene activation in response to hormonal challenge or effects on receptor expression. Such models should also account for homeostatic adaptive responses and consider the possibility of having windows of exposure for given effects. Work to compile and harmonize the definitions and terms appropriate to endocrine disruption will be conducted within the joint IPCS/OECD project on harmonization of risk/hazard assessment terminology reviews. The ICPS is the process of preparing a "State of the Science" report, and is implementing a global inventory of ongoing research on ECDs.     

Environmental Hazard- Assessment of chemicals and products

Part II: Persistence and Degradability of Organic Chemicals The criteria “Persistence” and “Degradability” are defined and explained, starting from the “functional” definition of the environment. In this definition, theenvironment is the counterpart of thetechnosphere, which consists of all processes controlled by man. A substance is persistent if there are no sinks (degradation processes). It is shown that persistence is the central and most important critérium of environmental hazard assessment of organic chemicals. It follows that all substances released into the environment should be degradable, preferentially into small inorganic molecules (mineralization). As examples for persistent substances, the polychlorinated biphenyls (PCB), the chlorofluorohydrocarbons (CFC), bis (2-ethylhexyl) phthalate (DEHP), and 2,3,7,8-tetrachloro-dibenzo-dioxin (TCDD) are discussed. Finally, an attempt to quantify persistence is made.     

Hazard assessment of chemicals in soil

Based on a stepwise (tiered) approach, degradation, adsorption and leaching tests as well as various effect tests (using plants, microorganisms and animals) are recommended for the testing of environmental chemicals. If, after the tests of tiers 1 and 2, the results of a monospecies-effect-test (including a safety factor) are within the range of the predicted exposure, the ecotoxicological hazard should be determined using a terrestrial model ecosystem. Some of the tests for the proposed strategy were selected from practical experience in testing environmental chemicals in the laboratory, and some on the basis of a comprehensive literature review.     

有毒化学品销毁设施的环境保护

销毁有毒化学品时最重要的是确保人员安全与健康，以及生态环境安全。因此，其销毁活动必须遵守严格的安全与环保规定。介绍了有毒化学品销毁设施的安全与环境设计标准、控制工艺废弃物，尤其是有毒废气的具体做法，以及销毁设施内部、作业区附近的环境监测方案。这些环境保护措施同样也适用于其他有毒化学品销毁设施。     

Problems in testing and risk assessment of endocrine disrupting chemicals with regard to developmental toxicology.

Endocrine disrupting chemicals (EDCs) may affect mammalian development either indirectly (by impairing implantation, placental development, lactation, etc.) or directly, altering the maturation of target tissues. Current regulatory tests for reproductive/developmental toxicity should be carefully evaluated with regard to risk assessment of EDCs, considering hazard identification (are relevant endpoints being assessed?) and dose-response assessment (are sensitive NOEL/dose-response curves being provided?). Many in vitro and in vivo assays for sex steroid disruption are available; provided that the metabolic capacities of the assays are defined, they could be integrated in a sensitive battery for early detection of steroid-disrupting potentials. The screening battery should address further regulatory in vivo tests (e.g. what specific parameters have to be investigated). As regards dose-response, qualitative differences may be observed between lower and higher exposures, showing primary hormone-related effects and frank embryotoxicity, respectively. Other problems concern (a) the identification of critical developmental windows, according to hormone concentrations and/or receptor levels in the developing target tissues; (b) the potential for interactions between chemicals with common mechanism/target (e.g. xenoestrogens); (c) most important, besides sex steroids more attention should be given to other mechanisms of endocrine disruption, e.g., thyroid effects, which can be highly relevant to prenatal and postnatal development.     

基于区域环境风险敏感性分析的石油化工行业规划环境风险评价

石油化工行业规划涉及多个石油化工项目的选址和多个备选方案的比选,增大了环境风险评价的不确定性.基于区域环境风险敏感性分析,研究了环境风险评价方法.在传统的环境风险分析框架即事故的发生概率(风险度)与事故的环境后果的基础上,考虑区域环境风险敏感性对环境风险评价的影响,对规划布局涉及区域的环境风险进行评价,最后将该方法初步应用于实际案例中.研究表明,该方法可以有效地分析多个备选方案的规划的环境风险,分析结果直观、可行,且可以辅助决策者对产业布局的合理性作出准确的判断,通过对该方法在应用中存在问题的分析,展望了规划环境风险评价的进一步工作.     

Environmental risk assessment of human pharmaceuticals in Denmark after normal therapeutic use

An environmental risk assessment is presented for the 25 most used pharmaceuticals in the primary health sector in Denmark. Predicted environmental concentrations (PECs) for the aquatic environment were calculated using conservative assumptions and all PECs exceeded 1 ng/l. Measured concentrations were in general within a factor of 2-5 of PECs and ranged from approximately 0.5 ng/l to 3 micrograms/l for nine of the pharmaceuticals reported in literature. The calculation of predicted no-effect concentration (PNEC) based on aquatic ecotoxicity data was possible for six of the pharmaceuticals. PEC/PNEC ratio exceeded one for ibuprofen, acetylsalicylic acid, and paracetamol. For estrogens the PEC/PNEC ratio approached one when non-standard test was used. The ratio was below one for estrogens (standard test), diazepam and digoxin. For the terrestrial compartment, toxicity data were not available, and no assessment was carried out. Comparisons of predicted concentrations of furosemide, ibuprofen, oxytetracycline and ciprofloxacin in sludge based on either preliminary experimental sludge-water partition coefficients (Kd), octanol-water coefficients (Kow) or acid-base constants (pKa) revealed large variations.