The CPA/CRD Working Group
In answer to the House of Commons Agricultural Select Committee fifth report of 1994/95, the Government agreed to continue to review the scope and scale of efficacy data requirements and to ensure that these requirements are reasonable. To meet this objective the Pesticides Safety Directorate (PSD) (now CRD) and the British Agrochemical Association (BAA) (now the Crop Protection Association (CPA)) convened an Efficacy Working Group to critically examine these issues.
Minor uses were looked at by a separate group, the Horticultural Uses Working Group (HUWG), and was composed of representatives from PSD (now CRD), the BAA (now CPA), the Horticultural Development Council (HDC) and the National Farmers Union (NFU). Its efforts to encourage more uses to appear on pesticide labels are recorded in the report ‘Pesticides for Horticulture: A New Approach’.
The group were successful in delivering significant advances in rationalising efficacy data requirements and producing guidance documents to the industry.
To conclude the work of the Efficacy Working Group, a Forum was held in Peterborough in July 1997 where the results could be passed on to a wider audience. PSD (now CRD) Efficacy Branch presented the major outcomes of the Working Group as a series of talks, which summarised the main guidance documents that had been produced as a result of the Group’s work. Sixty-five representatives of BAA (now CPA) member companies attended the Forum and received copies of the Guidance produced, which was subsequently published on PSD’s website.
The Forum was a success and both parties agreed that the original need identified had been met, i.e. the scope and scale of efficacy data requirements were seen to be reasonable, and the Group did not need to meet again at that stage.
The CPA/PSD (now CRD) Efficacy Working Group (2000 onwards)
In the intervening years since the original Group, a number of developments took place in the efficacy area. The main development being European harmonised requirements making a greater impact on the UK’s National system and on the companies gathering of evidence. It was decided to reinstate regular discussions between those in PSD (now CRD) evaluating efficacy data and setting standards and those working on this area in industry. With the name change to the Crop Protection Association (CPA), the Group would be known as the CPA/PSD (now CRD) Efficacy Working Group. The first meeting was held in December 2000.
Since that time there has been an annual meeting of the CPA and efficacy evaluators in CRD.
Aims of the Working Group
The aim of the Group is to work together in the following areas to ensure that applicants can comply with data requirements laid down under the Directive when seeking approval in the UK and so that these approvals may be Mutually Recognised in other Member States.
- Clarification of data requirements in areas laid down for efficacy under European Directives – including those for Mutual Recognition and Re-registration.
- Discussion of the impact of the new regulation replacing 91/414, and particularly efficacy assessments for zonal authorisations
- Development of the registration report for applicants and Member State assessments
- Production and interpretation of UK and EPPO Guidelines.
- Clarification of UK efficacy data requirements, particularly in relation to product label claims, including production of new guidelines.
- Discussion of efficacy related regulatory matters e.g. pesticide resistance
Both parties are to use their influence on developments with the EU and European and Mediterranean Plant Protection Organisation (EPPO), directly by CRD and indirectly via European Crop Protection Organisation (ECPA) by the Crop Protection Association (CPA), to help to ensure that guidance is based on a sound, scientific rationale.
The terms of references and central aim being to:
Act as an expert interface between the CPA and CRD on efficacy related regulatory matters. Continue to review the scope and scale of efficacy data requirements and to ensure that these requirements are reasonable, particularly in an EU context.
The IBMA (UK)/CRD Working Group
In 2005 PSD formed an efficacy working group with representatives of the UK International Biocontrol Manufacturers Association (IBMA-UK). This was set up in response to various concerns expressed by this sector over the perceived barriers to approval of biopesticides in the UK. Part of these concerns were addressed through setting up the Biopesticides Scheme, which focuses on providing tailored support to potential applicants, and introduced a revised (reduced) fee structure.
The IBMA (UK)/CRD working group specifically considers how to address efficacy data requirements. This was an area where there was considerable confusion over the UK standards, for example numbers of trials, levels of control required, use of reasoned cases in lieu of data. Following on from an initial presentation at one of the IBMA meetings, and dissemination of information on efficacy data requirements, the group discusses development of appropriate guidelines and current issues of concern.
