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Will your soil risk assessments fail in the future?

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Will your soil risk assessments fail in the future?

Soil risk assessments for plant protection products (PPPs) in the EU are currently relatively straightforward in comparison to other areas of the environmental risk assessment. The relevant guidance document (SANCO/10329/2002) is now 20 years’ old, and comprises just a few pages on soil risk assessment for earthworms, other soil macro-organisms and soil micro-organisms.

In 2017, a scientific opinion was published by EFSA outlining the state of the science on soil risk assessment and areas where improvements to the way we do soil risk assessments for PPPs were highlighted. Also in 2017, a new EFSA guidance document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil was published.

One of the outcomes from these publications was  a new PECsoil calculator tool, PERSAM (PERsistence in Soil Analytical Model), and updated versions of the numerical models PEARL and PELMO. PERSAM is central to the new soil exposure assessment scheme, which comprises 3 tiers (Tier 1, Tier 2, and Tier 3A/3B), all of which appear to be more conservative than the current methodology for PECsoil calculation. This means that soil risk assessments that used to pass, for parent compound and metabolites, may fail without additional refinement in the future .

The new exposure assessment scheme for soil organisms has not yet been adopted in the EU and is awaiting a vote by Member States. It is expected that this will happen relatively soon, and it is not yet known what the lead-in time will be for it to come into force and be required for all new PPP submissions. It is currently unknown how much time will be available for generating new data, if required, to demonstrate low risks to soil organisms.

Given these uncertainties, and the prospect of soil risk assessments becoming more difficult to pass in the future, now may be a good time to do some preliminary risk assessments on your active substances and formulated products to determine where you may encounter issues in the future, and what your options might be for addressing them.

At Cambridge Environmental Assessments (CEA) we have extensive expertise in higher-tier environmental fate and behaviour, exposure modelling, and ecotoxicology. Our experts can perform soil risk assessments using PERSAM and existing efate and ecotoxicology data sets to determine whether further refinement may be required in future (including higher-tier modelling using current versions of PEARL and PELMO). We take a holistic view of the available efate and ecotoxicity data to determine where optimisation of input parameters may be possible, where additional data generation may be beneficial, and develop novel solutions where necessary.

This type of horizon scanning activity will allow you to start planning early for future submissions when the new exposure assessment scheme for soil organisms comes into force, and current datasets would be insufficient to demonstrate low risks to soil organisms.

If you would like to discuss how we can help you with your soil risk assessments, please get in touch.

 

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