Residue Data Requirements

FDA Guidelines for Chemistry and Residue Data Requirements of Pesticide Petitions, Internal Document of the Bureau of Science, Food and Drug Administration, Department of Health, Education and Welfare, Washington, D.C. 20204, dated March, 1968. 

Guidelines of Safety Application of Pesticides, Good Agriculture Practices, Pre-Harvest Interval, ICAMA, Residue Data Requirements, Field Trials, Residue Analysis Method... 

Japan. In Japan, registration of dmgs for aquatic species requires the same data as those required for dmgs on other animals. The Ministry of Agriculture, Eorests, and Eisheries and the Ministry of Welfare control the use of chemicals in aquaculture in Japan (17). The preclinical data requirements include product chemistry, toxicity (acute, subacute, special) using rats and mice, safety to target animals, and metaboHsm. The requirements for clinical data include avadabiHty and residues. As of July 1990, more chemicals were registered for aquacultural use in Japan than in any other country (Table 4). 

The first step to define data requirements and criteria for decision making for residue analytical methods was attempted in Council Directive 94/43/EC, establishing... 

For analytical methods used for generating data required in the field of residue behavior, environmental fate, and other fields, the guidance document SANCO/3029/99 rev. 4 was developed."... 

Reliable residue data are generated during the development of an a.i. to support the assessment of the consumer risk (residue data and toxicological data) and the impact on the environment (fate and behavior, efficacy and ecotoxicological data). It is critical that these analytical methods are reliably validated. In the guidance document SANCO/3029/99 rev. 4 (11/07/00), harmonized requirements for the residue analytical method are described. Validated analytical methods are required for the following studies ... 

European Commission, Residues Guidance for Generating and Reporting Methods of Analysis in Support of Pre-registration Data Requirements for Annex II (Part A, Section 4) and Annex III (Part A, Section 5) of Directive 91/414, SANCO/3029/99 rev. 4, 11.07.00. European Commission, Bmssels (2000). 

Raw agriculture commodity requirements. Residues on all parts of crops that can be consumed are analyzed without preparation (e.g., washing and peeling, etc.) in the residue studies. There are no requirements on the residue data on processing foods. 

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. 

Field residue data, which are generated to meet requirements in the pesticide registration process, are used to regulate the use of agriculture products within the European Union (EU). This article examines the best practices to conduct crop field trials and to generate crop residue samples in Europe in order to provide part of the data that the agrochemical producers of the active ingredients must provide to the EU Commission. 

Cranberries Not likely to require foreign residue data. Cranberries account for an extremely low percentage of the US diet. In this case, ERA would probably not require submission of foreign residue data because dietary exposure to residues in imported cranberries is very low and ERA determines that US field trials would be representative of growing conditions in Canada. ... 

The registrant may submit residue data on any number of processed fractions. Table 1 of the 860 Series just defines what the EPA is required. A registrant may be wise to take a proactive approach and collect residue data on additional processed commodities for use in dietary exposure assessments. 

In the European Union, the medicinal products incorporated into feeding stuffs for prophylactic, coccidiostatic, and growth-promotion purposes are not subject to the above-mentioned authorization procedures for establishing MRLs. Being regulated under Directive 70/524/EEC (45) and its major amendments, especially 84/587/EEC (46) and 96/51/EEC (47), these products do follow, however, a centralized procedure through an EU system. Although no formal MRLs have been yet established for these products, the types of toxicity and residues data mentioned above are also required (48). 

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