Environmental Project, 982 – Quantification and Identification of Active Microorganisms in Microbial Plant Protection Products – 6 Postscript by the Danish Environmental Protection Agency

Quantification and Identification of Active Microorganisms in Microbial Plant Protection Products

6 Postscript by the Danish Environmental Protection Agency

By Anita Fjelsted, Danish EPA.

The Danish EPA acknowledges that the microbial plant protection products contain living micro-organisms, and hence the content of viable micro-organisms may decrease during the period from the date of production until expiry. However, it is the producers' responsibility to make sure that the level and the efficacy that can be expected when the grower applies the product in the field are relatively constant during the period until the expiry. And of course, batch number, expiry date and information regarding storage condition always need to be included on the label of all these products. If the products need to be stored under certain conditions in order to keep viability and reduce the growth of contaminating bacteria (e.g. low temperature) it is the producers' and distributors' responsibility that this information is communicated to the end users.

When evaluating and authorizing chemical pesticides in the EU a certain level of maximum deviation of content of the active ingredient is allowed. However, such fixed deviations are not established for microbial plant protection products. As mentioned already, this item has briefly been discussed among a few EU regulatory authorities. It was suggested by a couple of member states that a margin of maximum five-fold deviation should be accepted. As a follow up on this report, the Danish EPA would like to initiate a discussion at the EU level, in order to establish an agreement on an acceptable level of deviation in the amount of CFU in the microbial plant protection products.

The Danish EPA will contact the producers who did not seem to have a constant and satisfactory level of active micro-organisms in their products. We will ask for explanation and for data proving that this large deviation is unlikely to occur in the future. The Agency will also look further into the question regarding what level of contaminating bacteria seems acceptable in microbial plant protection products. The relevant producers will be contacted by the Agency in order to require further information with the aim of assessing the potential risks connected with the presence of high levels of contaminating bacteria in these products.

The Danish EPA will in this way make sure to follow up on the outcome of this project. It will be the producers' responsibility to follow up by informing the Danish EPA on improved production methods and storage facilities as well as fulfillment of label requirements.

The producer of the product Mycostop containing the active micro-organism Streptomyces griseoviridis which has now been determined as S. umbrinus has been asked to investigate the taxonomic affiliation of the organisms further. The new affiliation of Verticillium lecanii is not expected to have an effect on the evaluation of products based on this species.

The Danish EPA does not foresee the project presented in this report as resulting in a need for continuous and regular control of the microbial plant protection products on the Danish market. However, the products that have shown large deviations compared with the expected content may be collected and checked again in the near future.