Margin Of Safety Approach Research Articles

Risk Assessment of Glyphosate Exposures from Pilot Study with Simulated Heavy Residential Consumer Application of Roundup® using a Margin of Safety (MOS) Approach.

Due to the widespread application of glyphosate, a nonselective herbicide, to a variety of resistant food crops, the general population is exposed to glyphosate through dietary intake. Despite this, dietary exposures to glyphosate are considered low in comparison to application-related exposures. Although previous studies have evaluated exposure to horticultural and agricultural workers, to date only one study, which we recently conducted, has characterized exposure to glyphosate in consumers following heavy residential application of a glyphosate-containing herbicide in a residential yard and garden setting. In this previous study, we demonstrated that urinary glyphosate concentrations in these applicators were similar to or in some circumstances greater than those in occupational applicators, likely due to the nature of the simulation study, which ensured a heavy application protocol. However, it is unknown whether these urinary glyphosate concentrations in consumer applicators correspond to internal doses that may be of concern. Therefore, the purpose of this study is to provide a comprehensive risk assessment of glyphosate exposure in consumer applicators using a margin of safety approach. Here, we incorporated data collected from multiple spot urine samples across time from our previous study that assessed consumer exposure to glyphosate from Roundup® application. Estimated internal doses, even with the use of conservative assumptions across unique approaches, were below internal doses estimated from established health-based guidance values. Overall, this study demonstrates that glyphosate exposure from even heavy consumer application of a commercially available glyphosate-containing herbicide does not appear to be a health concern.

Re-evaluation of natural food colours—State of the art

Having started the re-evaluation of food additives in accordance with the Commission Regulation (EU) No 257/2010 of 25 March 2010 the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) of the European Food Safety Authority (EFSA) identified several complicating issues regarding the re-evaluation of natural food colours, including: (1) the extracts are often made from different natural sources, (2) the extracts can be made using a range of extraction solvents/methods, (3) chemical characterisation of different extracts is usually missing, (4) detailed specifications of the materials tested in the toxicity assays is generally unknown. Given this situation the ANS Panel considered that adequate chemical specifications for each extract are needed. Extracts derived from different sources or obtained by the use of different extraction solvents/methods can only be evaluated provided the chemical specifications allow a read across, or if there are toxicological data on each separate extract. If read across is not possible and if chemical specifications are limited, the safety evaluation of an extract has to be based on an adequate toxicological dataset on exactly that extract. When the shortcomings in the toxicological database do not allow to define a health based guidance value in form of an acceptable daily intake (ADI) it has to be decided on a case-by-case basis whether a margin of safety approach or a comparison of the intake resulting from the proposed uses and use levels as food additive to exposure resulting from the regular diet can be applied.