To ask the Scottish Executive when the advice from the Statutory Advisory Committees on the implications of the report on organophosphates by the Committee on Toxicity will be published.
The advice which we received from the Veterinary Products Committee (VPC), the Advisory Committee on Pesticides (ACP) and the Committee on Safety of Medicines (CSM) on the regulatory implications of the report on organophosphates (OPs) by the Committee on Toxicity (COT), will be published today.
Publication of this advice, and our conclusions on it, marks the end of a key stage in the process of a full and transparent scrutiny of OPs.
The regulatory committees all take note from the COT report that while ill-health effects from prolonged low-level exposure to OPs remain unproven, there remains a question over whether there may be a small group of individuals particularly susceptible to OPs. They endorse the need for further research on this and the other areas of uncertainty identified by COT.
On the basis of current scientific knowledge, the regulatory committees' advise against any general withdrawal of OPs from the market. However, the VPC has advised that all OP sheep dips should be withdrawn from the market pending the introduction of new containers which would minimise operator exposure to concentrated dip.
The committees' advice shall be implemented on the following basis.
First, immediate action is being taken on OP sheep dip concentrate containers. The Veterinary Medicines Directorate (VMD) are writing to all holders of marketing authorisations for OP sheep dips requiring the withdrawal of these products from the market until containers are introduced which will minimise operator exposure to OP concentrate. Product recall from distributors and farms will also be implemented. Additionally, the Pesticides Safety Directorate (PSD) is taking urgent action to confirm that all containers of OP pesticide concentrates comply with modern standards; and PSD will take regulatory action if they do not.
Second, there will be a targeted research programme to take forward the research recommendations from COT and the regulatory committees. This will involve expertise from the wider scientific community in this process, and there will be a seminar in the New Year to determine the scientific input and approaches required to meet these defined research needs. A proposal to investigate databases of putative OP sufferers is also under consideration.
Third, measures will be implemented, aimed at continuing to promote best practice, through a range of measures, including further improvements to labelling to highlight necessary precautions; a continuing programme of targeted inspections by HSE inspectors to reinforce advice on risk control and training and competence for sheep dippers; and supply of protective gloves with sheep dip. There will also be improved guidance and training on pesticide usage.Fourth, the specification for the data packages for OP compounds shall enable full evaluations in line with modern safety standards through the continuing reviews of OP veterinary medicines other than sheep dips and of pesticides. In this regard, ACP has recommended that regulatory action should be taken against approvals for products containing three OP compounds for which supporting data have not been submitted under the anticholinesterase review. Revocations of the approvals are being sent immediately to approval holders.