Risk Assessment of the Fungicide Luna Privilege with the Active Substance Fluopyram

Luna Privilege is a new fungicide for use in apples, pears, outdoor and indoor strawberries, lettuces, peas, beans tomatoes, contains the active substance fluopyram.
 VKM was requested by Norwegian Food Safety Authority to consider possible health risk operators related properties of fluopyram; particular evaluate potential bioaccumulation, reproductive neurotoxic effects, discuss mechanisms involved liver thyroid tumor formation observed rats, establishment NOAELs reference values.
 also asked fate behaviour fluopyram environment, ecotoxicological effects risks its use, groundwater contamination, safety margins on birds aquatic organisms.
 The assessment finalized meeting December 13. 2013 VKM’s Panel Plant Protection Products.
 conclusions are as follows:
 Health:
 It opinion that:
 
 ingredient has low data do not suggest sex-specific excretion.
 An vivo Comet Assay rat could help further elucidate genotoxic can be excluded that reported incidence “gall bladder absent” treatment related.
 NOAEL 90-day feeding study rats should set 3.06 mg/kg bw/day, resulting an AOEL 0.03 bw/day.
 “dumb-bell or incomplete ossification and/or bipartite/normal cartilage” considered malformation regarded time points used measurements optimal detect from acute exposure, since window between first second too long.
 studies where phenobarbital compared exclude human relevance tumor-inducing effect female rats.
 results mechanistic insufficient support proposed mode action induction follicular cell tumors male mice, thus mice relevant humans.
 proposes:
 1.2 bw/day based 2 year ADI: 0.012 bw/day
 AOEL: ARfD: 0.25 Risk calculations field show minimal if personal protective equipment used. greenhouse exceeded, even without equipment. Re-entry bystander exposure calculated well below AOEL.
 Environment:
 Worst case degradation rates laboratory preferably calculate PECsoil values Both fluopyram-7-hydroxy have high contamination.
 efficacy buffer zones needs case-by-case basis, validation model simulation necessary.
 all refinements relevant. Since TER estimated crops except orchards trigger following refinements, it view indicate medium strawberries pulses, lettuce open field.
 LC50 with value 100 overly conservative, reduction both invertebrates fish 10 such suggested.
 toxicity exceeded any crops. For chronic toxicity, concludes there moderate when applied beans/strawberries vegetated mitigation buffer-strip.