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Introduction

Classes and uses of pesticides

Legal framework

Approval Levels

Scientific information in the regulatory process.

Risk Management Process

Constitution and function of the various organisations

Management of pesticides in the future.

 

Reviews of pesticides that are already approved....

The aim of the regulatory process is that nobody should be made seriously ill through the use of a pesticide in an approved manner and that any adverse affects on wildlife and the environment should be acceptably small. With this goal in mind, a precautionary approach is taken to the approval of pesticides. A wide range of potential adverse effects are considered and acceptable exposures and environmental concentrations are defined with a wide margin of safety. Inevitably however, a measure of uncertainty remains and science can never give a cast-iron guarantee of zero risk.

Therefore, once a pesticide has been approved, it is important to look for any unexpected adverse effects that were not predicted by the initial risk assessment. For example, there might be reports of skin sensitisation in those handling the product, even though this did not occur when it was tested on animals. Also, once a pesticide is used on a commercial scale, large numbers of people are exposed to it, and epidemiological studies of their health may be possible. Such studies can provide direct evidence of any risks in humans, without the need for extrapolation from observations in animals. New laboratory studies may also be carried out additional to those that were evaluated when approval was granted. Where information from one of these sources suggests a previously unsuspected hazard it may be necessary to review the risk assessment for the pesticide. More Reviews

Priorities

There are many older pesticides on the market, and each review is time-consuming. Therefore the programme for reviewing older pesticides must be spread over a number of years, and the order in which products are considered must be prioritised. This ordering is based on various criteria, including the level of scientific concern about possible risks and the extent to which the product is used. Sometimes, one aspect of the risk assessment, such as the potential toxicity to humans, is a special concern and is examined ahead of other elements.

The scientific data sought at reviews are similar to those used in the evaluation of new pesticides, but in addition epidemiological and other data on human health effects are assessed when available. Where the risk assessment fails to provide adequate reassurance that human exposures and risks to wildlife are acceptable, it may be necessary to restrict the use of the product in order to overcome the problem, or if this is not possible, to revoke its approval.

Support withdrawn

Sometimes the company that holds an approval for a product that requires review may make a commercial decision not to invest in generating the additional scientific data that would be needed by today’s standards to support continued use. Examples

Revocation

Where revocation of an approval occurs, the time-scale for removal of the product from the supply chain will depend on the reason that it is being withdrawn. Details

Additional data

Sometimes when new data are first generated to bring the scientific information about a product up to modern standards, they do not provide the level of reassurance about safety that is now required, but nor do they clearly indicate that use of the product is unacceptable. Example

Precautionary Principle in pesticide regulation......graphic: arrow click to next screen