Correction to: Risk assessment for ecotoxicity of pharmaceuticals – an emerging issue
Kar S, Roy K. Risk assessment for ecotoxicity of pharmaceuticals – an emerging issue. Expert Opin. Drug Saf. 2012;11(2): 235-74.
Following publication of this article, some errors have been identified in text.
On p. 236, 2nd column, 2nd paragraph, the line “…when the expected concentration of the active pharmaceuticals in the aquatic environment is ≥1 μg/l…” should be “…when the expected introduction concentration (EIC) of the active pharmaceuticals at the point of entry into the aquatic environment is ≥1 μg/l…”. This is described in the FDA guidance document that is subsequently referenced (ref. 22, pgs. 2, 3, 4, and 13). Dilution in the receiving water is usually at least 10 fold. Regulating drugs based on an expected concentration of 1 ug/l in the aquatic environment would be much less stringent than what FDA actually uses.
On p. 237, Section 2.1.2, the line “These data showed approximately 90% of the results (dose effect concentrations) being 1 μg/l or greater, but only 10% being between 1 ng/l and 1 μg/l.” The article does not cite a reference for these data, but they come from an FDA report, “Retrospective Review of Ecotoxicity Data Submitted in Environmental Assessments,” referred to in this notice, http://www.gpo.gov/fdsys/pkg/FR-1996-10-22/html/96-27022.htm. The FDA report shows that the units in all three places should be higher by three orders of magnitude, i.e., “…being 1 mg/l or greater, but only 10% being between 1 ug/l and 1 mg/l”, which provides a more reasonable (and the correct) justification for the FDA EIC cutoff of 1 ug/l.
On the same page at the end of Section 2.1.2, the line “…at levels below 1 μg/l predicted environmental concentration (PECEFFLUENT)…” should read “…at levels below 1 μg/l expected introduction concentration (EIC)…”.