pesticides is supported by the Thai Crop Protection Association and the Thai Agricultural Business Association. • Vietnam: the first pesticide law was implemented in 2001, followed in 2010 by a law on pesticide management, which was due for renewal in 2012. The Pesticide Board of the Ministry of Agriculture and Rural Development (MARD) includes the Plant Protection Department (PPD; pesticide management), the National Pesticide Advisory Committee (9 members), and a Technical Committee on Bio-efficacy (7 members). The PPD is responsible for checking dossiers, for licensing import & manufacture of pesticides, and for inspection. She follows the general policy of ‘one manufacturer/one applicant; one pesticide/one trade name’. The types of registration include field trial, full (5 years), supplementary, and renewal. ‘Biopesticides’ require large-scale efficacy trials. BCA and chemicals have the same data requirements. Vietnam does not have a separate guideline for BCA yet. That shall be established following to the ASEAN Guidelines development process. Capacity development for expanding expertise on BCA is required. There are around 200-300 pesticide applications per year, of which <10% are BCA (including abamectin and related products, with very few microbials). How might ‘regulatory harmonisation’ work in the ASEAN region? As indicated above, • a common set of data requirements • a standardised regulatory procedure • agreed ways or mechanisms on how to achieve mutual agreements, and communicate and A relatively high degree of sophistication in harmonising regulatory efforts has been reached in the EU with a positive list of active ingredients (the so-called ‘Annex 1’; based on a joint risk assessment), which Members States then acknowledge and include in their national regulatory procedures (see Box 1). This example shall just highlight a possible direction of development: whether this is feasible and desirable for Southeast Asia may be a subject of discussion in the future. A common set of data requirements for microbials and botanicals (currently the dominating products in markets of the region) has been developed by the ASEAN BCA expert group on regulation and is a major backbone of these Guidelines. These ‘Minimum data requirements’ have been prepared for formulated products and list a data set for a full registration. They were structured on an FAO template. A tiered system is proposed, whereby tier 1 requirements constitute the ‘minimum’ or basic requirements, and the rest of the requirements would be requested under tier 2, if certain ‘triggers’ make that necessary. Tier 1 requirements include biological/chemical characteristics, toxicological evaluation, bio-efficacy, as well as packaging and labelling. Tier 2 requirements are on residue data, human health exposure, environmental fate and effects data, and additional data as required. In certain technical details, both data requirement lists stand out from common regulatory texts in that they emphasise BCA-specific information requirements that were developed and proposed by expert panels under OECD and others. The two most important points shall be named here: 43 4.3 Harmonisation harmonisation can encompass a variety of elements, which might include: advance regulatory issues across AMS
Implementing Biological Control Agents in the ASEAN Region
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