• Malaysia: Regulation of pesticides is under the Pesticide Act 1974 (amended in 2004). She follows a notification system and distinguishes between commodity and proprietary (new AI) registrations. Only full registrations are allowed, no other types. Registrations are valid for a 5- year period. A completeness check of the dossier is done by the registration office for content and composition of the product with regard to the 'claim' by the producer. The staff of the registration laboratory includes mostly "chemists". There are around 12 applications for BCA per year. • Myanmar: a law on pesticide registration was enacted in May 1990 (no BCA-specific regulation). A pesticide board exists since 1992 and constitutes the highest authority, which oversees various technical committees. Currently, there is only the import of pesticides, which requires different types of registrations: provisional (5 years), full (10 years), amended (5 years). The minimum data requirements include identity, efficacy, toxicology, human health, environmental fate, etc. • The Philippines: The FPA (Fertilizer and Pesticide Authority of DOA) issues full (3 years) and conditional (1 year) registrations. An experimental use permit is issued for experiments by standard protocols for efficacy testing. Biorational products include microbials (with reduced requirements) and biochemicals; for pheromones, only provision of specifications is required. Genetically modified products are also categorised under biorationals. A regulatory guidance is available. There exists an institutional dichotomy with regard to regulation of BCA: since the ‘Organic Act’, BCA used in organic agriculture are regulated by the Bureau of Agriculture and Fisheries Standards (BAFS) of the DOA. Testing is done outside of the agency; the assessment and validation of the tests is done in the Fertilizer and Pesticide Authority’s lab. There are around 50 applications per year. Requirements are quite complicated and demanding, but waivers are possible. • Singapore: The Agri-Food and Veterinary Authority of Singapore (AVA) regulates agricultural pesticides including BCA used in the commercial cultivation of plants in Singapore under the Control of Plants Act and the Control of Plants (Registration of Pesticides) Rules. Pesticide products meant for use in the agricultural farms are required to be registered with AVA. AVA has on average 10 applications for registration of pesticide products per year. So far, there was no application for registration of BCA products in the last 2 years. • Thailand: A new registration procedure for pesticides is in place since 2009. Major changes include the fact that toxicology has to be done by GLP labs (which do not exist in Thailand) with regard to synthetic pesticides (for BCA, by national laboratories). One formulation cannot be associated with more than 3 trade names (per applicant). There exist specific data requirements for microbials, botanicals, and pheromones. Exempted from toxicological evaluation are Bt, NPV, nematodes, Sarcocystis singaporensis, and saponin. The data requirements for BCA are aligned towards OECD and the EU since 2009. Amended rules can be expected by 2015. Pesticides are regulated under the Hazardous Substance Act, whereby the Hazardous Substance Committee includes a pesticide registration sub-committee and a biopesticide data evaluation working group. Registration includes the following steps: submission of dossier, quality and efficacy testing, general evaluation, presentation of results, and decision by sub-committee. She relies on external experts for the assessment of dossiers. There are around 13 BCA applications per year (2012), mostly for imported products. In comparison, there are around 3000 applications per year for synthetic pesticides and a very high number of current products (approximately 30,000). In order to control illegal trade, she has limited entry points into the country to five, conducts inspection of factories and shops including taking samples, reports violations to the police, and requires labels in Thai language. The private sector in Thailand dealing with 42
Implementing Biological Control Agents in the ASEAN Region
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