Beyond case-by-case assessment

Any new system needs to be practical and enforceable, says Sue Popple, of the UK Pesticides Safety Directorate (PSD). But would a semi-regulatory approach go far enough? 

This paper outlines current UK thinking on some of the technical issues. The question of the introduction of comparative assessment for pesticides is being addressed in the revision of Directive 91/414, and as part of this, the topic was discussed at the Commission’s stakeholder conference on the future of 91/414 in Corfu in July this year. 
    Last year, Ministers invited the Advisory Committee on Pesticides (ACP) to explore the possible role of comparative assessment in the registration of pesticides. The Committee considered a number of ways in which it might be applied to agricultural pesticides. Comparisons can be made at different levels – the active substance, the product, or the use or the actual application in a specific field setting. Against this background, the ACP considered three broad approaches to the application of comparative assessment and substitution in a pesticides regime:

• Firstly take comparative assessment/ substitution on board directly in the registration process either at the active substance level or at the product level;
• Secondly adopt a semi-regulatory approach such as some form of grading scheme requiring farmers to select the lower risk products in most situations;
• Thirdly maintain the current arrangements, but encourage schemes that will ensure that more information is available to farmers to make an assessment at the point of selection for use.

The second approach considered by the ACP was to adopt a semi-regulatory model requiring farmers to select the lower risk products in most situations. This could, for example, be based around differential labelling of products that would enable farmers to make an assessment at the point of choosing a pesticide for a particular application. 
    It might operate similarly to the UK’s current COSHH (Control of Substances Hazardous to Health) Regulations. Under these Regulations, those who use hazardous substances are required to conduct an assessment of all risks to health before starting work. They are then required to record the assessment and review it regularly.
    At the ACP’s request, PSD carried out a comparative assessment of the environmental risk for the use of several products and four crop/pest combinations. This was based on determining toxicity:exposure ratios, or similar indicators, for birds, mammals, honeybees, non-target arthropods, aquatic life and earthworms and scores derived using the pesticide Environmental Management for Agriculture (pEMA) model. The products were graded as A, B or C depending on their overall score. From the assessment, seven products were classified in category A and five in category B. Two products were graded in the higher risk group C, and it is interesting to note that their active substances are both in the first stage of the 91/414 review programme. It must be emphasised that this is an initial look-see – much more work needs to be done to develop robust systems, however, since the PSD study, one of these substances, fentin hydroxide, has been withdrawn due to environmental concerns.
    There are some good scientific arguments for this semi-regulatory model. It would offer a risk-based approach, which could take into account product and use details and the intended site of application. Higher risk products need not be substituted entirely, but could be reserved for situations in which there was no alternative. 
    There are stronger practical arguments against the approach. In particular, the need for record keeping would make it potentially bureaucratic and it would be difficult to enforce. It would also be very difficult to apply it evenly across member states. Some might apply it vigorously and others less so. For these reasons, the ‘actual’ effect of the approach in terms of reducing environmental impact would probably be more limited than more direct regulation.
    The third ACP option was to encourage schemes that will make more information available to farmers. There is no reason why this approach should not operate in addition to rather than as an alternative to a regulatory scheme. As part of the ‘Voluntary Initiative’ an industry led UK initiative which aims to deliver environmental benefits over and above a pesticide tax, companies are developing ‘Environmental Information Sheets’ to provide a basis on which farmers can take locally based decisions on product choice. Crop protocols may also have a role here. More generally there are advisory software packages which allow farmers to compare their environmental performance in pesticide use with ‘best practice’. So, in summary, initiatives in this area provide useful support to what might be called the ‘comparative assessment approach’. But they are not seen, by UK Ministers at least, as a satisfactory alternative to regulation. 
    Returning to the regulatory model, a key question that needs to be addressed is whether comparative assessment is made on active substances or products. The two-tier nature of the EU system makes this a fundamental issue in the design of the future regulatory framework. 
    Sweden has operated comparison and substitution at the product level. This makes sense, particularly in the context of a national approvals programme. Products have a narrow range of uses and direct comparision may be made. On the other hand, looking at active substances, there are far fewer of them: in the UK we have around 350 actives compared to over 10 times that number of products. So it follows that an active substance will normally have uses on a much wider range of crops. This is likely to make comparisons difficult in many cases although there may be exceptions. 
    In addition to these difficulties, there is the hazard versus risk argument. When comparing active substances, the intrinsic properties of the substances can be compared. But if products are compared, application rate, formulation type and other properties which determine risk can be factored in. A more reliable comparison can be made. This is illustrated by the parameters used in a comparison of granular nematicides. Hence it appears that the technical arguments favour comparison at the product level. But this approach does not sit so comfortably within the EU two-tier authorisation system. The acceptability of active substances is decided at EU level and the acceptability of products by member states. Directive 91/414 is in part a harmonisation measure. It is designed to bring about something approaching a ‘common market’ in plant protection products. If comparative assessment is applied on products at member state level it might act against this objective. 
    There are difficulties in turning an apparently simple and sensible idea into a practical policy. However, comparative assessment offers the opportunity to develop the system beyond the current case-by-case approach. And such a development is necessary to help meet the expectation that the public has for the regulatory system.

Edited presentation to the Pesticide Challenge conference, November 2003, Dr Sue Popple, Director of Policy, Pesticides Safety Directorate, UK.

[This article first appeared in Pesticides News No. 58, December 2002, page 11]