We remind readers that individual biological control agents are, by their very nature, limited to a relatively small number of target pests and cannot be compared with ‘block-buster’ chemicals. It is vital to provide a regulatory environment that encourages development by SME producers: this means measures to simplify, harmonise and minimise the cost of procedures rather than adding regulatory burdens. For example, the FAO guidelines on registration of biopesticides proposed that import and export could be subject to the legal provisions of the “Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade 1998”. However, BCA are evidently not among the hazardous or banned pesticides and other chemicals listed (and by their inherent environmentally friendly properties, they certainly do not belong there). It is therefore inexplicable why this suggestion was made, since even the most toxic plant-derived substances such as rotenone would not be regulated under PIC. 47 4.4 The need for simplification 4.5 Post-registration issues and quality control Once registration is complete and a certificate has been issued, processes must be put in place to monitor compliance of the registrant with the specifications stipulated by the registration documents and the product label. The methods and frequency of checks for compliance with product specifications is best determined in detail by specialists (for each class of BCA) in Member States. This is a crucial aspect of the regulatory process: quality issues that currently plague various countries in the region threaten the future viability of some BCA. However, it is not usually the purpose of registration to provide for, or even guarantee ‘product quality’. This is the responsibility of the manufacturer. The main purpose of regulatory monitoring is to make sure that a product adheres to the standards of safety and effectiveness documented by the specifications, which have been agreed upon between the registrant and the regulatory authority. In practice, monitoring parameters should be reduced to aspects that are really operationally relevant. Samples must be collected by random at sales points and during inspections of the manufacturing facilities. Examples of how specifications of BCA can be monitored, and which technical facilities, equipment and methodology are useful and necessary, are described in the FAO guidelines (49). 4.6 Trade of BCA products within ASEAN Lack of international harmonisation in enabling regulations is perhaps the most important barrier to the wider implementation of biological control; in some circumstances, ‘gatekeeper’ regulations place barriers in the way of efficient introduction and application of BCA.
Implementing Biological Control Agents in the ASEAN Region
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