In terms of organisational requirements on the side of the regulator, a division solely dedicated to BCA should be established within a pesticide registration department to ensure that BCA would be treated appropriately and proportionally. Specific time periods for completion of registration are normally prescribed by registration authorities, provided that all relevant data have been submitted by the registrant. To promote use of BCA, special fast-track services should be offered (probably involving a BCA specialist regulator and an online system), reducing registration time significantly. The regulatory authority will issue a validity period of a registration for each type of registration (see above). Once the validity period ends, re-registration should be granted to the original registrant after review of the previous data as well as any new data generated after a previous registration, provided that the registrant has complied with the regulatory provisions, in particular, with regard to consistency of the specifications of the product or active ingredient (registration standard) and that any changes in, such as production method and formulation are addressed. In order to promote mutual, cross-border acceptance of products, the ASEAN BCA experts on regulation indicated that data such as field test evaluations could be accepted if these were appropriate for local situations in terms of crop, climate, and pest or disease. With regard to toxicological/infectivity data, it was proposed that companies should be encouraged to share dossiers. 46 Box 3: What might regulatory harmonisation mean? One of the goals of these Guidelines is to stimulate discussion among ASEAN Member States (AMS) on regulatory harmonisation of BCA. It is important to consider what ‘harmonisation’ would actually mean. Common guidelines might enable AMS to ‘speak a common language’ when it comes to registering BCA (data requirements, policies, etc.), but national registrations remain unique processes of neighbouring Member States. Such an approach would certainly be beneficial to the cause of BCA. However, could ‘harmonisation’ go even further and mean closer integration of processes among AMS? Taking the EU as an example of a regional regulatory framework: regulation in the EU is still complicated for BCA and cannot be recommended to be adopted as a whole, but the most valuable harmonisation aspects might be considered: Regulation of BCA in the EU makes use of positive lists. Active ingredients of BCA are registered EU-wide, and if approved (usually by one ‘rapporteur’ country that consults with the other Member States), the BCA is included in a positive list, called Annex 1. In practice, it means that all data that have been generated for inclusion in Annex 1 and basic data (toxicity studies, environmental risk assessments, etc.) will be accepted by all EU Member States. The registrant has then to proceed with national registrations (in those countries with a suitable market), but data requirements are reduced substantially to only additional, country specific points (e.g. local efficacy, etc.) Therefore, development and mutual acceptance of positive lists could effectively bring about ‘harmonisation’.
Implementing Biological Control Agents in the ASEAN Region
To see the actual publication please follow the link above