Regulatory Caveat

Despite CDC s caveats, regulatory agencies within the United States have in many cases adopted the CDC s 1 ppb guideline as a generic standard for clean-up regardless of the circumstances at the site. For example, EPA has functionally Implemented a 1 ppb standard for clean-up at most of Its remediation sites within Missouri, regardless of the potential for human exposure (4.5). 

After the qualification of the DDCI biomarkers by regulatory agencies, a series of limitations were identified. These caveats focused mainly on the limited crossspecies reproducibility and applicability of the biomarkers, the need for a better characterization of the robustness of the biomarkers according to strain and gender of the preclinical models, the technical robustness of the assays used for biomarker measurement, as well as the applicability of these biomarkers in acute, subacute, and chronic studies. To this end, various studies have been conducted to address these caveats and have provided further understanding on the robustness, reproducibility, variation, and performance of these biomarkers in preclinical models (Pinches et al. 2012 John-Baptiste et al. 2012 Harpur et al. 2011 Guha et al. 2011). 

Regulatory Status. GRAS ( 182.10 and 182.20) also has been approved as a food color additive exempt from certification ( 73.500). Subject of a German therapeutic monograph, indicated as a sedative for spasms and asthma, with the caveat that claimed... 

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