§ Dr. GibsonTo ask the Minister of Agriculture, Fisheries and Food if he will make a statement on the use of humans in trials involving organophosphates. [55029]
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§ Mr. RookerThe Government do not require data from trials carried out on human volunteers to be submitted by applicants for pesticides approvals or veterinary medicines licences.
Applications for marketing authorisations for human medicines require data from trials in human volunteers; however regulatory approval is not required prior to undertaking such studies.
Any trials that are carried out in the UK are subject to two levels of control. First, the Control of Substances Hazardous to Health Regulations 1988 (made under the Health and Safety at Work, etc. Act 1974) apply as they would to any workplace activity. Second, good practice in respect of ethical standards is set down by the Helsinki Declaration and guidance from the Royal College of Physicians. Under these guidelines, studies require the approval of an ethics committee which takes full account of the rights of the volunteers.
§ Mr. LivingstoneTo ask the Minister of Agriculture, Fisheries and Food what is his Department's current evaluation of the extent to which(a) short-term and (b) long-term exposure to organophosphorus compounds produces chronic illnesses. [55336]
§ Mr. RookerThe Government are advised by the Advisory Committee on Pesticides (ACP) in relation to pesticides, and by the Veterinary Products Committee (VPC) in relation to veterinary medicines. On current available evidence it seems very likely that exposure to high doses of organophosphorus compounds can result in long term ill health (in addition to acute toxic effects). The range of effects is described in paragraphs 2.4 to 2.6 of the Official Group on OPs Report to Ministers (copies of which are in the Library of the House). What is more open to question and now being reassessed by our advisory committees is the long term effect of low level exposure.
As part of this reassessment the Government have invited a specialist sub-group of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) to consider a range of issues surrounding short term and long term exposure to OP compounds in general, including what evidence exists that chronic illness arises from long term exposure to OPs. The sub-committee has already begun its task.
§ Mr. LivingstoneTo ask the Minister of Agriculture, Fisheries and Food if he will list the reviews and research into the effect of organophosphorus compounds on human health which his Department has initiated since 1 May 1997, indicating who is carrying out the research and when it is expected to be completed. [55337]
§ Mr. RookerSince 1 May 1997, we have commissioned a study at the Defence Evaluation and Research Agency on the dose effect profiles for OP sheep dips on brain electrical activity and cognitive performance in non-human primates. This is due to be completed in May 1999.
As part of the national arrangements for the review of existing approved pesticides, the regulatory Departments responsible for pesticides announced on 13 May 1998 the start of a review of those organophosphorus and 1058W carbamate pesticides approved for agricultural use. The first stage of this review is expected to be completed by January 1999.
The use of OP sheep dips was last reviewed by the Veterinary Products Committee (VPC) in February 1997. The VPC confirmed earlier advice that, provided they are used safely and in accordance with manufacturers' instructions, there is no scientific justification for withdrawing them from the market.