Environmental risk guidelines analysis

VICH has representatives of industry and regulatory authorities from Japan, the USA and the EU with observers from a number of other countries and organisations. It has developed a number of guidelines including those for areas of toxicity testing, residues analysis and pharmacovigilance which VICH-associated countries are meant to adopt.VICH has developed two guidelines for environmental risk assessment, which have many... 

FSTRAC. 1995. Summary of state and federal drinking water standards and guidelines. U S. Environmental Protection Agency. Contaminant Policy and Communications Subcommittee. Federal-State Toxicology and Risk Analysis Committee (FSTRAC). September 12, 1995. 

Risk is defined as a measure of human injury, environmental damage, or economic loss in terms of both the incident likelihood (probability) and the magnitude of the loss or injury (consequence) (AICHE/CCPS, Guidelines for Chemical Process Quantitative Risk Analysis, 2d ed., American Institute of Chemical Engineers, New York, 2000, pp. 5-6). It is important that both likelihood and consequence be included in risk. For instance, seat belt use is based on a reduction in the consequences of an accident. However, many people argue against seat belts based on probabilities, which is an incorrect application of the risk concept. 

Blair A, Burg J, Foran J, Gibb H, Greenland S, Morris R, Raabe G, Savitz D, Teta J, Wartenberg D (1995) Guidelines for application of meta-analysis in environmental epidemiology. ILSI Risk Science Institute. Regul Toxicol Pharmacol, 22 189-197. 

OEHHA (2000) A ir Toxics Hot Spots Program risk assessment guidelines. Part IV. Technical support document for exposure assessment and stochastic analysis. Oakland, CA, California Environmental Protection Agency, Office of Environmental Health Hazard Assessment (http //www.oehha.ca.gov/air/hot spots/pdf/Stoch4f.pdf). 

Ecotoxicity can only be measured by the application of biological methods, whereas chemical analysis determines concentrations of defined chemicals that may be used to deduce toxic effects. All concentration levels such as screening values, guideline values, threshold concentrations, benchmark concentrations and trigger values used for the assessment of contaminated media (water, soil, sediments, etc.) should ideally be derived from the observation of biological effects. Comparing pollutant concentrations with these usually conservative standard values is a common practice in the preliminary assessment of contaminated sites. The integration of further information, such as ecotoxicity data from the site, can improve the risk assessment process and enable a more reliable prediction of environmental threats. 

The annex V of Directive 67/548/EEC, in the EU document, OECD guidelines for testing method for chemicals, addressing three areas of concern (i) determination of physical-chemical properties (ii) methods for determining effects on human health and (iii) methods for environmental effects. Annex lA of Directive 93/67/EEC is involved with the risk assessment of potential toxic effects concerning human health. The technical guidance document on risk assessment published by the European Commission [4], is involved with human health assessment. Analysis of hazard identification and dose-response assessment is based on the following key points ... 

---