2.1.4. ANSES

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BEI®s* generally represent the levels of determinants that are most likely to be observed in specimens collected from healthy workers who have been exposed to chemicals to the same extent as workers with inhalation exposure at the TLV®* –Time-Weighted Average (TLV®* –TWA*). However, there are BEI®s* for chemicals for which the TLV®s* are based on protection against non-systemic effects (e.g., irritation or respiratory impairment) where biological monitoring is desirable because of the potential for significant absorption via an additional route of entry (usually the skin). There are also BEI®s* that better predict health effects than air levels and finally, BEI®s* that are based on the levels in the environmentally exposed population. The BEI®* generally indicates a concentration below which nearly all workers should not experience adverse health effects. The BEI®s* have notations that indicate certain limitations. Notation “B” is given when the determinant may be present in biological specimens collected from subjects who have not been occupationally exposed, at a concentration that could affect an interpretation of the results. It is assigned when the observed 95th percentile value of a random sample from national population studies is more than 20% of the BEI®*. “Pop” indices are assigned when there are insufficient data to establish numerical BEI®* but where there are sufficient data on background levels in the general population to guide the health care professionals in the exposure assessment. Information given in the BEI documentation includes analytical methods, possible potential for confounding exposures, specimen collection recommendations, limitations, as well as other essential information, specific for each compound and analyte.

2.1.4. ANSES*

The French Agency for Food, Environmental and Occupational Health & Safety (ANSES*) was created on 1 July 2010. It is an administrative public establishment accountable to the French Ministries of Health, Agriculture, the Environment, Labour and Consumer Affairs. One of the main missions of the French Agency is the derivation of reference values (toxicological reference/limit values, occupational reference/limit values, DNEL*, and other related values). For workers, in addition to OEL* or OELV*, ANSES* derives, when it is relevant (if routes other than inhalation contribute largely to absorption, for cumulative pollutant, to take into account interindividual factors), biological limit values (BLV*). Since 2010, ANSES* has given recommendations for biological limit values for about 19 different substances, which are available on ANSES* OEL*/BLV* website (ANSES, 2021). The Biological limit value (BLV*) is the limit value for the relevant biomarkers (parent or one of its metabolites in a biological media). Depending on the available data and on the mode of action of the substance, the BLV* is derived according to different approaches:

1- For substances with a threshold effect

The options are similar to those of the former SCOEL*:

 As the 1st option of the SCOEL*, data based on epidemiological or volunteer studies are analyzed in order to quantify a dose-response relationship between biomarkers concentrations and the critical effect.  As described by the SCOEL* above, if it is not possible to quantify the relationship between concentrations of biomarkers and health effects, the alternative approach is to quantify the relationship between concentrations of biomarkers and atmospheric concentrations, to establish a BLV* corresponding to exposure to the French 8h-OEL*(regulatory or recommended by ANSES*). In this case, however, extrapolations are based on strong correlation(s) between the internal concentrations and the atmospheric concentrations of the substance, giving regression equation(s) or kinetic modelling.

2- For substances without a threshold effect

 in some cases, BLVs* may be based on a risk assessment and expressed by a scale providing three individual excess risks: 10-4, 10-5 and 10-6 (i.e., an excess risk of contracting an additional cancer for respectively 10000, 100000 and 1000000 exposed people). These relationships may be derived from kinetic modelling, or correlations from exposure data

OCCUPATIONAL BIOMONITORING GUIDANCE DOCUMENT © OECD 2022