Biological monitoring and standard setting in the USA: a critical appraisal

Occupational exposure limits (OELs) issued in the US by the Occupational Safety and Health Administration (OSHA) require measurements of toxic substances in air rather than in biological samples. Most of OSHA's limits were adopted from the 1968 list of the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs). Although there are no formal requirements to monitor exposures to these substances, it is implicit in the standards that air sampling will be performed. Of the 13 OELs which OSHA has set de novo, 2 (i.e., those for lead and cadmium) require biomonitoring after air sampling has identified the heavily exposed workers. OSHA appears to value biomonitoring in some circumstances but has apparently not found a consistent rationale for using biomarkers to set and enforce its standards. This paper discusses 2 valuable features of biomarkers which should be exploited by OSHA to further its regulatory agenda. The first relates to controversies associated with dose rate which have come into play in setting short-term exposure limits (STELs) when acute effects do not provide the necessary justification. OSHA has not provided evidence that its STELs are needed to reduce the risks of disease (as in the cases of benzene and ethylene oxide). By investigating the exposure-biomarker relationship, it is possible to determine whether the rate of exposure has any influence on the uptake and elimination of toxic substances and, therefore, whether STELs is needed. This is illustrated with data from 2 studies on styrene exposure. The second feature concerns biomonitoring as the primary means of exposure assessment in situations where the biomarker is accumulated over months or years (as in the cases of lead and cadmium). Using data from the lead-battery industry, it is shown that 'correct' compliance decisions are more likely to arise from evaluation of blood lead measurements than from traditional air monitoring.