Post-registration monitoring

ASSESSMENT OF RISKS TO HUMANS EXPOSED TO PESTICIDES 2 The Four Steps in Risk Assessment 2 Hazard Identification 2 Dose-Response Assessment 3 Margin of Safety Approach 3 Quantitative Risk Assessment 3 Exposure Assessment 4 Risk Characterization 4 RISK MANAGEMENT 5 ADVANCES IN DATA INTERPRETATION 5 Probabilistic Approaches 5 Recognition of the Tier Approach 5 Aggregate Exposure 6 Cumulative Exposure 6 Impact of New Scientific Advances 7 Post-Registration Monitoring 7 HARMONIZATION OF REGULATORY APPROACHES SUMMARY 9... 

Some regulatory agencies also require the reporting of adverse effects. Such post-registration monitoring data can supplement and validate risk assessments for pesticides under re-evaluation and provide useful information for further risk mitigation and management. 

Commission Directive 96/46/EC of 16 July 1996, amending Annex II to the Directive 91/414/EEC, is the basis for the assessment of residue analytical methods for crops, food, feed, and environmental samples." Provisions of this Directive cover methods required for post-registration control and monitoring purposes but not data generation methods. Because it is necessary to provide applicants as precisely as possible with details on the required information, the guidance document S ANCO/825/00 rev. 6 dated 20 June 2000 (formerly 8064/VI/97 rev. 4, dated 5 December 1998)" was elaborated by the Commission Services in cooperation with the Member States. 

Requirements for post-registration and monitoring (enforcement) methods... 

The analytical methods for post-registration control and monitoring purposes submitted by industry to the authorization bodies help the enforcement laboratories. Data requirements from the authorization procedures are constantly compared with the needs of enforcement laboratories, in order to supply them with relevant data, and to avoid the generation of superfluous information. 

Validation of analytical methods for post-registration control and monitoring purposes in the European Union... 

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. 

Finally, to avoid the parallel use of similar but not identical method validation studies to fulfil the registration requirements, e.g., of the EU, US Environmental Protection Agency (EPA) or Japanese authorities, an adaptation of different data requirements for residue analytical methods for post-registration control and monitoring purposes would help to save resources. 

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