A Data Based Perspective on the Environmental Risk Assessment of Human Pharmaceuticals II — Aquatic Risk Characterisation

  • S. F. Webb


Environmental risk assessment (ERA) evaluates the likelihood that adverse ecological effects result from exposure to a substance. It therefore requires a consideration of both exposure and effects in relevant environmental compartments. The exposure assessment considers the fate of a substance released to the environment and predicts the environmental concentration or PEC (“predicted environmental concentration”). The effects assessment considers data relating to the effects of the substance upon representative biota and uses such data to predict the no-effect concentration or PNEC (“predicted no-effect concentration”) for the various environmental compartments (i.e. surface waters, sediment, soil, etc.). The PEC and PNEC are combined in order to characterise the risk, i.e. calculation of the PEC/PNEC ratio (see Fig. 16.1). Decisions regarding the safety of the substance depend upon the value of this quotient.


Environmental Risk Assessment Assessment Factor Clofibric Acid Etidronic Acid Risk Characterisation 
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  1. Aherne GW, Briggs R (1989) The relevance of the presence of certain synthetic steroids in the aquatic environment. J Pharm Pharmacol 41:735–736CrossRefGoogle Scholar
  2. Aherne GW, English J, Marks V (1985) The role of immunoassay in the analysis of micro-contaminants in water samples. Ecotoxicol Environ Safety 9:79–83CrossRefGoogle Scholar
  3. Boethling RS, Howard PH, Meylan W, Stitler W, Beuman, J, Tirado N (1994) Group contribution method for predicting probability and rate of aerobic biodegradation. Environ Sci Technol 28:459–465CrossRefGoogle Scholar
  4. Bowman WC, Rand MJ (1980) Textbook of Pharmacology, 2nd edn. Blackwell Scientific Publications, OxfordGoogle Scholar
  5. Buser H-R, Poiger T, Müller D (1998) Occurrence and fate of the pharmaceutical drug diclofenac in surface waters: rapid photodegradation in a lake. Environ Sci Technol 32:3449–3456CrossRefGoogle Scholar
  6. CEC (1996) Technical guidance document in support of the Commission Directive 93/67/EEC on risk assessment for new notified substances and Commission Regulation (EEC) No. 1488/94 on risk assessment for existing substances. Commission of the European Communities, European Chemicals Bureau, Ispra, ItalyGoogle Scholar
  7. Cowan CE,Versteeg DJ, Larson RJ, Kloepper-Sams PJ (1995) Integrated approach for environmental assessment of new and existing substances. Reg Toxicol Pharmacol 21: 3–31CrossRefGoogle Scholar
  8. Desbrow C, Routledge E, Sheahan D, Waldock M, Sumpter JP (1996) The identification of oestrogenic substances in sewage treatment effluents. Environment Agency, Bristol, UKGoogle Scholar
  9. Dollery CT (ed) (1991) Therapeutic drugs, vol I and II. Churchill Livingstone, EdinburghGoogle Scholar
  10. ECETOC (1995) The role of bioaccumulation in environmental risk assessment: the aquatic environment and related food webs. European Centre for Ecotoxicology and Toxicity of Chemicals, Brussels (Technical Report 67 )Google Scholar
  11. Eckerman I, Martineus JC (1997) Medicines and the environment: what do we know today? Swedish Association of Physicians for the Environment ( SLFM ), StockholmGoogle Scholar
  12. FDA (1995) Streamlining food and drug administration - environmental assessments. FDA Backgrounder BG95–9 (March 16, 1995 )Google Scholar
  13. FDA (1996) 21 CFR Part 25 - National Environmental Policy Act: proposed revision of policies and procedures; proposed rule. Federal Register 61(65):14922–14942Google Scholar
  14. FDA-CDER (1996) Retrospective review of ecotoxicity data submitted in environmental assessments. FDA Center for Drug Evaluation and Research, Rockville ( MD ), USA (Docket No. 96N - 0057 )Google Scholar
  15. FDA-CDER (1998) Guidance for industry - environmental assessment of human drugs and biologics applications. FDA Center for Drug Evaluation and Research, Rockville MD, USA (CMC6 Revision 1, http://www.fda.govcder/guidance/index.htm)
  16. FWR (1995) Effects of trace organics on fish - Phase 2. Foundation for Water Research, Marlow ( Bucks. ), UK (FR/D 0022 )Google Scholar
  17. Hailing-Sorensen B, Nielsen SN, Lanzky PF, Ingerslev F, Holten Lützhoft HC, Jorgensen SE (5998) Occurrence, fate and effects of pharmaceutical substances in the environment - a review. Chemosphere 36(2):357–393Google Scholar
  18. Hansch C, Leo A, Hoekman D (1995) Exploring QSAR - hydrophobic, electronic and steric constants. American Chemical Society, Washington DC, USA (ACS Professional Reference Book )Google Scholar
  19. Heide EF Van Der, Hueck Van Der Plas EH (1984) Genessmiddelen en milieu. Pharmaceutisch Weekblad 119:936–947Google Scholar
  20. Henschel KP, Wenzel A, Diederich M, Fliedner A (1997) Environmental hazard assessment of pharmaceuticals. Reg Toxicol Pharmacol 25: 220–225CrossRefGoogle Scholar
  21. Hirsch R, Ternes T, Haberer K, Kratz KL (1999) Occurrence of antibiotics in the aquatic environment. Sci Total Environ 225: 109–158CrossRefGoogle Scholar
  22. Hoekman D (1997) (Internet site)
  23. Holten Lützhoft HC, Halling-Sorensen B, Jorgensen SE (1998) Algal testing of antibiotics applied in Danish fish farming. SETAC-Europe 8th Annual Meeting 14–18th April 1998, Bordeaux (Abstract 4I/004)Google Scholar
  24. Hussain Z, Hennessy T (1995) EC environmental risk assessment (1). The Regulatory Affairs Journal 6 (8): 634–640Google Scholar
  25. Kalbfus W (1995) Belastung bayerischer Gewässer durch synthetische Östrogene. Vortag bei der 5o. Fachtagung des Bayerischen Landesamtes für Wasserwirtschaft “Stoffe mit endokriner Wirkung im Wasser” (Abstract). (Effects in Bavarian watercourses through synthetic oestrogens. Presentation at the 5oth Seminar of the Bavarian Association for Waters Supply “Substances with endocrine effects in water”)Google Scholar
  26. Köpf W (1995) Wirkung endokriner Stoffe in Biotests mit Wasserorganismen. Vortag bei der 5o. Fachtagung des Bayerisches Landesamt für Wasserwirtschaft “Stoffe mit endokriner Wirkung im Wasser” (Abstract). (Effects of endocrine substances in bioassays with aquatic organisms. Presentation at the 5oth Seminar of the Bavarian Association for Waters Supply “Substances with endocrine effects in water”)Google Scholar
  27. Kühn R, Pattard M, Pernak KD, Winter A (1989) Results of the harmful effects of selected water pollutants (anilines, phenols, aliphatic compounds) to Daphnia magna. Wat Res 23(4):495–499Google Scholar
  28. Kämmerer K, Al-Ahmad A, Betram B, Wießler M (2000) Biodegradability of antineoplastic compounds in screening tests: influence of glucosidation and of stereochemistry. Chemosphere 4o: 767–773Google Scholar
  29. Länge R, Schweinfurth H, Croudace C, Panther G (1997) Growth and reproduction of fathead minnow (Pimephales promelas) exposed to the synthetic steroid hormone ethinylestradiol in a life cycle test (Abstract). 7th Annual Meeting of SETAC-Europe April 6-so,1997, Amsterdam, the NetherlandsGoogle Scholar
  30. Mackay D (1982) Correlation of bioconcentration factors. Environ Sci Technol 16: 274–276CrossRefGoogle Scholar
  31. Newton DW, Kluza RB (1978) pKa values of medicinal compounds in pharmacy practice. Drug Intell Clin Pharm 12:546–554Google Scholar
  32. Olejniczak K (1995) Environmental risk assessment for medicinal products in the EU, Phase I. In: Wolf PU (ed) Environmental risk assessment for pharmaceuticals and veterinary medicines. RCC Group, Itingen, CH (Proceedings of the International RCC Workshop held in Basel, Switzerland, February 1, 1995, pp 58–66)Google Scholar
  33. Panter GH, Thompson RS, Beresford N, Sumpter JP (1999) Transformation of a non-oestrogenic steroid metabolite to an oestrogenically active substance by minimal bacterial activity. Chemosphere 38(15):3579–3596Google Scholar
  34. Peterson SM, Batley GE, Scammell MS (1993) Tetracycline in antifouling paints. Mar Pollut Bull 26 (2): 96–100CrossRefGoogle Scholar
  35. Purdom CE, Hardiman PA, Bye VJ, Eno NC, Tyler CR, Sumpter JP (1994) Estrogenic effects of effluents from sewage treatment works. Chem Ecol 8: 275–285CrossRefGoogle Scholar
  36. Raymond GG, Born JL (1986) An updated pKa listing of medicinal compounds. Drug Intell Clin Pharm 20: 683–686Google Scholar
  37. Reynolds JEF (ed) (1996) Martindale - the extra pharmacopoeia (electronic version). The Royal Pharmaceutical Society of Great Britain. Micromedex Inc., Engelwood, CO, USAGoogle Scholar
  38. Richardson ML, Bowron JM (1985) The fate of pharmaceutical chemicals in the aquatic environment. J Pharm Pharmacol 37: 1–12CrossRefGoogle Scholar
  39. Schweinfurth H, Länge R, Günzel P (1996) Environmental fate and ecological effects of steroidal estrogens. Presentation at the Oestrogenic Chemicals in the Environment conference organised by IBC Technical Services Ltd in London on the 9th and loth May, 1996Google Scholar
  40. Ternes TA (1998) Occurrence of drugs in German sewage treatment plants and rivers. Chemosphere 32 (11): 3245–3260Google Scholar
  41. Ternes TA, Stumpf M, Mueller J, Haberer K, Wilken R-D, Servos M (1999) Behaviour and occurrence of estrogens in municipal sewage treatment plants - I. Investigations in Germany, Canada and Brazil. Sci Total Environ 225: 81–90Google Scholar
  42. Veith GD, Kosian P (1983) Estimating bioconcentration potential from octanol/water partition coefficients. In: Mackay D, Paterson R, Eisenreich S, Simmons M (eds) PCBs in the Great Lakes. Ann Arbor Science, Ann Arbor, MI, USA (Chap 15 )Google Scholar
  43. Watts CD, Crathorne B, Fielding M, Steel CP (1983) Identification of non-volatile organics in water using field desorption mass spectrometry and high performance liquid chromatography. In: Angeletti G, Bjorseth A (eds) Analysis of organic micropollutants in water. D.D. Reidel Publishing Company, Dordrecht, pp 120–131Google Scholar
  44. Webb SF (1995) Current status of the European guidelines on environmental risk assessment. ESRA Rapporteur 2 (3): 27Google Scholar
  45. Webb SF (1998) A data-based perspective on the environmental risk assessment (ERA) of human pharmaceuticals (Abstract). SETAC-Europe 8th Annual Meeting Interfaces in Environmental Chemistry and Toxicology: from the global to the molecular level (April 14–18, 1998 ), Bordeaux, FranceGoogle Scholar
  46. WSA (1994) Waterfacts ‘84. Water Services Association, LondonGoogle Scholar

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