Registration based on resource rationalization
Because the generation of data, as well as the assessment of product efficacy, quality and risks, is very time-consuming and expensive, the majority of registration authorities – even those with considerable resources – will rationalize their pesticide registration strategy. This can be done in many ways, but tends to focus either on sharing data among countries or on conducting joint reviews of parts or, or the entire, registration dossier. Some of the more common methods are listed below
- Mutual acceptance of data
This is standard practice for most of the chemistry, toxicological and environmental data which, as long as they have been generated according to international guidelines, are accepted world-wide. Increasingly, results from efficacy and residue trials are also exchanged regionally or even globally.
International guidelines for the generation of specific data requirements can be found in the Data requirements and testing guidelines module in the Toolkit.
- Extrapolation of data
Extrapolation of data between crops, pests, commodities or non-target species is often used to reduce the need for the local generation of efficacy, residue or toxicity data.
Extrapolation of efficacy and residue data is especially used for registration of minor uses, but increasingly also for major uses of a pesticide. Extrapolation of environmental (toxicity) data is commonly used.Guidance has been provided in the Assessment methods module in the Toolkit, for those efficacy and risk assessment methods that make frequent use of extrapolations.
- Bridging of efficacy or risk assessments
In the Toolkit, we refer to bridging when an efficacy or risk assessment conducted in one country is used and interpreted for the situation in another (reference) country.
Bridging is normally done for specific aspects of the registration dossier, such as efficacy, residues, human health risks or environmental risks. A good (summary of the) risk assessment in the reference country is required as a basis for bridging as well as a good description of the intended use(s) in the country where the product is submitted for registration.The more similar the use conditions between the two situations that are being compared, the more clear-cut a bridging exercise will be. However, bridging is often also possible when use patterns or environmental conditions are not very similar. Further Guidance on the principles of bridging risk assessments is provided.
Specific bridging methods for efficacy and risk assessment have been provided in the Assessment methods module in the Toolkit.
- Simplifying efficacy or risk assessments
In particular in countries with limited resources, the registration authority may choose to simplify the evaluation of certain parts of the dossier. For instance, using a hazard assessment instead of a risk assessment, conducting a qualitative instead of quantitative risk assessment, waiving efficacy or risk assessments (e.g. for minor uses or label extensions).
Which aspects of the pesticide evaluation will be simplified generally depend on national legislation, policy priorities and the use pattern of the pesticide. As an example, reducing operator and consumer risks may be of high priority in a given country and therefore these aspects are evaluated using more complex, locally specific, risk assessment methods; on the other hand, environmental risks may be evaluated using qualitative bridging methods.
In another country, strict drinking water legislation may apply and therefore a complex groundwater exposure model is used by the registrar; but biological pest control may not be a priority and therefore the risk of the pesticide to beneficial arthropods is not assessed.
- Product equivalence determination In case a very similar product has already been registered in the country, Registration by equivalence may be used. A reduced set of product data requirements is then needed, and the assessment of the product does not have to be as extensive as in a complete evaluation.
- Joint review Increasingly, groups of countries are conducting joint reviews of a pesticide submitted for registration. Joint reviews tend to reduce the burden on individual registration authorities to assess each pesticide individually (and likely duplicating large parts of the assessment). They may also lead to more robust assessments and registration decisions.
More information about options for Regional collaboration can be found elsewhere in this module.
In practice, registration authorities will pick and combine various ways to rationalize pesticide registration, in a “building block approach”.
View some examples of registration approaches, using different Building blocks for resource rationalization.