Intensified food safety concern over melamine has prompted national authorities to assess its tolerable daily intake (TDI) for protection of general population including young children. TDI is calculated by dividing a no-observed-adverse-effect level (NOAEL) by a safety factor (SF). Based on appropriate choices of values, the US Food and Drug Administration determined two TDI values in the unit of mg per kg body weight per day as first 0.63 and then 0.063, while the World Health Organization, 0.5 and then 0.2, as a result of increasing the SF values in calculation. We used a similar procedure, with judicious selection of pertinent values, to obtain a TDI of 0.0081. Arguments in support of this lower TDI value were provided to alert the international community.
Date:
2009-10
Relation:
Regulatory Toxicology and Pharmacology. 2009 Oct;55(1):13-16.