Table of contents
This guideline outlines the minimum data required to support a proposal for a maximum residue limits (MRL) for registration. The report on the study must include sufficient data so that we can thoroughly understand how the study was conducted and how the results were derived, and thus determine whether the study was scientifically valid.
The report should state the purpose of the study and describe the methods and materials used and the results, including statistical analysis (where appropriate), in a suitable format. Discussion of the results should be given to permit the Australian Pesticides and Veterinary Medicines Authority to make a recommendation on the MRL and proposed withholding period relative to the label use pattern.
The components of the report should include, but not necessarily be limited to, the following.
1. Abstract
Summary of the application details and the results of the trial.
2. Introduction
Reason for and objectives of the trial.
3. Materials and methods
3.1. Site details
- Location of trial site(s)
- Type of application – for example, seed treatment; plants or soil sprayed to run-off, band spraying; animals – pour-on, oral, dermal
- Equipment used – for example, mist blower, knapsack, boom sprayer; animals – shower, jetting, dipping
- Test system details – for example, crop/variety, animal/breed, planting date, summer/winter, coat timing off-shears, growth stage, age, lactation period, soil type, dip capacity, plot dimensions, covered or open pens, number of replicates, number of animals, treatment, number of controls, cultivation, feed regime, other treatments applied
3.2. Application details
- Test substance(s) – including batch number, formulation number, formulation type, assay and/or stability data as applicable
- Product rate – for example, g/ha, mL/100 L, % solution, mL/kg bodyweight of animal
- Volume applied – for example, L/ha, litres of spray
- Timing between treatments – for example, days, weeks, months
- Date(s) of application(s)
3.3. Sampling
- Part of crop/animal sampled
- Soil depth of sampling if applicable
- Sample weight and number of units per replicate if applicable
- Date(s) of sampling – the sampling regime is dependent on the persistency of the pesticide residues and must include the time of any proposed withholding period (refer to the Withholding periods guideline for further information)
- Method of sampling – samples should be taken first from the control group and then from the lowest to the highest application. A specific description should be given of how the sample was taken and what was done to ensure the sample was representative
- Growth stage/animal weight at sampling (including normal harvest date if applicable)
- Method of storage and shipment of samples from field site to laboratory
- Storage conditions from time of collection/shipment/analysis – refer to the Stability of residues during storage guideline for further information
3.4. Preparation of sample
Details should be provided on how the samples were prepared for analysis, such as subsampling, chopping, mixing and grinding. Details should be provided on any pre-treatment carried out such as removal of fat, washing, peeling, soil removal.
A homogenised sample is essential if a meaningful result is to be obtained.
3.5. Analysis details
A summary of the method (uniquely numbered) should be given in the report. The entire method must be provided either as an appendix to the report or with the submission. Refer to the Residue analytical methods guideline for further information.
3.6. Conduct of trial
- Name(s) of people responsible for the trial and collection of samples
- Address of the facility carrying out the analysis and the name(s) of the analyst(s) responsible
- The period in which the analysis was carried out
4. Presentation of results
4.1. Residues
All results should be quoted including controls and recoveries. Results should be expressed as defined by Codex (for example, dry-weight basis or whole-fruit basis).
Representative recoveries should be determined at levels where residues are likely to occur. You will need to indicate whether results have been corrected for recoveries or not.
Results of individual analysis should be reported and not averaged.
5. Discussion and conclusions
The discussion should include any aspects of the report that require explanation, including any unexpected results. Conclusions should be made to permit a recommendation to be made on the MRL and proposed withholding period relative to the label use pattern. Where applicable, climatic effects should be discussed.
6. Appendixes
6.1. Weather
Where relevant (not required for internal animal treatment), weather details should be provided at or as close to the site(s) as possible. Include rainfall/irrigation and air temperature on day of application and daily for one week afterwards. Thereafter, data can be averaged on a weekly or monthly basis depending on the length of the trial.
6.2. Soil type
If the test material was applied directly to the soil, include data on soil classification (for example, soil type, pH and organic matter).