February 14, 2011
The comparative assessment of products is a contentious element of the new EU Plant Protection Product (Authorization) Regulation (EC1107/2009). This process is meant to drive the substitution of existing products with “safer” alternatives if available. BCPC has previously expressed concerns about this, amongst a number of other aspects of the legislation. These include the much-opposed move from risk-based to hazard-based cut-off criteria. BCPC takes the view that if an active ingredient or product has passed the stringent, science-based risk assessments in the current (UK) registration process, it should continue to be available to growers.
From the scientific perspective, BCPC’s particular concerns about any comparative assessment process have been:
- the difficulty of making valid comparisons for every crop/pests/weed/disease situation;
- the risk that non-chemical options are considered “safe” in the absence of data;
- the difficulty of comparing products with different risks e.g. impact of a pesticide in the aquatic environment, or on biodiversity, compared with any risk to human health.
The Chemicals Regulation Directorate (CRD) is now completing a consultation on the adoption of proposals from EPPO for a tiered system for Comparative Assessment. BCPC is pleased to see that this takes into account factors such as: cost, efficacy, safety on a range of pest problems, sustainability of Integrated Pest Management (IPM) systems, resistance risk and availability for minor uses. The assessment requires the availability of good information on all of these factors, which must be provided for both chemical and non-chemical alternatives. If this is not forthcoming, EPPO proposes that the assessment is stopped, i.e. there is no further action to substitute the product(s) involved.
The proposed process goes a long way to meet BCPC’s concerns, although more detail is required in some areas; for example guidelines are needed on products to be used in comparisons, and on how registrants can access relevant comparative data. Another concern is the dwindling number of independent experts in the UK available to assist in making the scientific and agronomic judgements needed.
Despite these provisos, BCPC welcomes the proposals, and encourages CRD to adopt them – this is one area of the legislation where a Member State can apply their own risk/benefit judgement within a science-based regulatory process. This opportunity should be exploited in order to retain our dwindling armoury of safe and effective products – including those for the minor/speciality crop sectors. These are increasingly vital for sustainable intensification of UK agricultural production, as the recent Foresight The Future of Food and Farming (2011) Final Project report clearly demonstrates.