A review of the evidence to support interim reference level for dietary lead exposure in adults
Laurie C. Dolan, Brenna M. Flannery, Dana Hoffman‐Pennesi, Alexandra Gavelek, Olivia E. Jones, Richard Kanwal, Beverly J. Wolpert, Kathleen F. Gensheimer, Sherri Dennis, Suzanne Fitzpatrick
Abstract
FDA developed the interim reference level (IRL) for lead of 3 μg/day in children and 12.5 μg/day in women of childbearing age (WOCBA) to better protect the fetus from lead toxicity. These IRLs correspond to a blood lead level (BLL) of 0.5 μg/dL in both populations. The current investigation was performed to determine if the IRL for WOCBA should apply to the general population of adults. A literature review of epidemiological studies was conducted to determine whether a BLL of 0.5 μg/dL is associated with adverse effects in adults. Some studies reported adverse effects over a wide range of BLLs that included 0.5 μg/dL adding uncertainty to conclusions about effects at 0.5 μg/dL; however, no studies clearly identified this BLL as an adverse effect level. Results also showed that the previously developed PTTDI for adults of 75 μg/day lead may not be health protective, supporting use of a lower reference value for lead toxicity in this population group. Use of the 12.5 μg/day IRL as a benchmark for dietary lead intake is one way FDA will ensure that dietary lead intake in adults is reduced.