Benefit-risk analysis for foods (BRAFO): Evaluation of exposure to dietary nitrates.

Dietary nitrate has been associated with health benefits as well as potential risks, thus presenting a paradox for consumers and health professionals. To address the issue, we applied the Benefit-Risk Analysis for Foods (BRAFO) framework to evaluate dietary exposure to nitrate by considering how the risks and benefits might vary under the reference scenario of the acceptable daily intake (ADI) set forth by JECFA (3.7 mg/kg-day), or under an alternative scenario of a higher ADI (independently developed herein). Results demonstrated that risk, as conservatively characterized by various toxicological benchmarks, was present at levels ranging from the current ADI value of 3.7 mg/kg-day (lowest end of the range) to >15 mg/kg-day. When these ADI values, both established by regulatory bodies as well as independently herein were compared to intakes associated with benefits (decreased blood pressure observed following repeated exposure to nitrates ∼4-18 mg/kg-day), along with considerations of current dietary exposures associated with healthy diets, the alternative scenario allowed for benefits without incurring additional risk. For consumers aged 12 weeks and older, ADI values ∼12-17 mg/kg-day-based on more reliable data than used to derive the current ADI-allow benefits to be realized while still protecting public health. The assessment serves as a case study in how benefits can be considered in a risk assessment paradigm for foods, thus providing useful information to decision makers.