Phased development of a pesticide registration scheme
Countries developing or strengthening their pesticide registration scheme should not only consider the establishment of an appropriate regulatory framework but also the available resources, both financial and human (professional and scientific capacity), necessary for operating such a scheme.
Depending on the resources available, a country can choose the degree of complexity of the registration procedures that suits it best. Countries with limited resources may initially choose a registration scheme requiring less staff or funding. As experience is gained over time with the evaluation of pesticide registration dossiers, expertise and infrastructure will be built up and the scheme can progressively be strengthened and tailored to the specific conditions of use in the country.
Two stages of the pesticide registration process are particularly resource-intensive. First, the generation of data for the registration dossier, which is carried out mainly by the applicant but which may also involve public research institutions. Second, the evaluation of the dossier, which is primarily done by the pesticide registration body. Phased development of a registration scheme, when resources are limited, therefore tends to focus on optimizing the use of funds and personnel during these two stages.
There are various ways to introduce or strengthen a pesticide registration scheme in a gradual manner, which all have their particular advantages and disadvantages. They include:
- Registration by analogy. This involves the acceptance of registrations in other countries. If a pesticide has been authorized in a reference country, with a reputable registration system, the registration authority may decide to register that same pesticide for the same uses based on only a limited evaluation of the dossier. Registration by analogy is discussed in more detail elsewhere.
- Acceptance of data from other countries. If relevant data of good quality have been generated in other countries, the registration authority may waive the requirement for local data generation. This is particularly relevant for efficacy trials, residue data and environmental field studies, all of which likely require the involvement of national (public) research institutions.
Resource gains: data generation & submission by the applicant - Extrapolation among crops and/or pests. Extrapolation of data from other crops or pests may reduce the need for specific studies in newly to be registered (minor) uses. This is often applied for biological efficacy and residue studies.
Resource gains: data generation & submission by the applicant - Prioritization of specific groups of pesticides. In the early stages of development of the registration scheme, the registration authority may focus on more in-depth evaluation of pesticides which are either likely to be used in high volumes, or by many different groups of users, or are likely to pose moderate to high risk to human health or the environment.
Resource gains: Evaluation by the registration authority; data generation & submission by the applicant. - Registration by equivalence. In case a supposedly equivalent product has already been registered in the country, Registration by equivalence may be used. Only a reduced set of data requirements is generally needed, and the assessment of the product does not have to be as extensive as in a complete evaluation.
Resource gains: Data generation & submission by the applicant; evaluation by the registration authority. - Setting up fast-track registration channels. For certain groups of pesticides, (temporary) fast-track registration channels may be set up, which either limit the data requirements or simplify and shorten the dossier evaluation process. The responsible authority may, for instance, allow fast-track registration for pesticides that have been used on a large scale in the country, and for a long time, without adverse effects or insufficient efficacy having been reported; for pesticides expected to pose very low risk; for minor use products; or for active ingredients or products that already have been authorized in the country on another crop or for another use.
Resource gains: Data generation & submission by the applicant; evaluation by the registration authority.
These options for phased development of a registration scheme are not mutually exclusive, and in practice several of the above approaches are generally implemented at the same time. As expertise is built up over time, or as more resources become available, the registration procedures can be further strengthened, data requirements better tailored to local conditions, efficacy and risk evaluations improved and the coverage of the scheme made more comprehensive.
It is generally better to operate a pesticide registration scheme effectively with recognized, but politically accepted, limitations, than to set up a complex system intended to cover all eventualities, which cannot be implemented with the available resources.