REACH Derived No Effect Levels (DNELs) vs OELs
In today’s environment our resources are dwindling (as everyone is already blogging). I am wondering how others are handling the new REACH registrations for products in commerce in Europe.
Each product has a lot of activity surrounding this registration, but one that strikes me as interesting is the registration criteria called “Derived No Effect Levels” (DNELs) from animal toxicity results. These are established for community members and then a separate set of values for each route of exposure for workers. These are not OELs by regulation, but are registration levels. But, they will be seen as very protective levels and could be misconstrued eventually as OELs.
As for workers, there would be both short-term and long-term values for inhalation (ppm or mg/m3), oral and dermal (mg/kg/day). Are there issues of comparing these worker DNELs back to the currently established OELs around the world? The DNELs are calculated using an algorithm with prescribed adjustment (uncertainty) factors and prescribed toxicology studies. The issue from my perspective is that the worker DNELs are 2-3 orders of magnitude lower than existing OELs.
My point of discussion here is to see if other OH&S professionals see these extremely low derived “no effect levels” as a potential litigation issue in other countries (e.g. USA) when using or comparing these to traditional OELs. It certainly would not be a regulatory issue. What are others’ experience and thoughts on the DNEL impacts beyond Europe?