Applications for approval of new phytosanitary treatments for seeds for sowing should follow the following guidance. Applications can be sent to imports@aff.gov.au, attention Plant T2.
International standards
Applications should aim to address the requirements included in the International Standards for Phytosanitary Measures (ISPM 28) Phytosanitary treatments for regulated pests.
Information on the pests and commodity targets of the proposed treatment
The application should clearly indicate whether the proposed phytosanitary treatment is for a single pest or pathogen or for several pests or pathogens.
The application should clearly indicate whether the proposed phytosanitary treatment is for the seeds of a single plant species or for the seeds of several plant species.
Based on the above 2 points, the application should identify whether the proposed treatment is for:
- a single pathogen on the seeds of a single species
- a single pathogen on the seeds of several species
- several pathogens on the seeds of a single species
- several pathogens on the seeds of several species.
The application should provide accepted taxonomic identification of the target pathogen(s), to species level.
Information on the proposed treatment
The application should describe the treatment in sufficient detail for it to be assessed and performed by another skilled operator, and should include information on:
- the biological mode of action of the proposed phytosanitary treatment on the target pathogens
- the physical and biological effects of the treatment on the target seeds (e.g. potential visual changes to seeds, germination effects)
- the application method, i.e. how the proposed phytosanitary treatment should be applied to seeds
- the monitoring method, i.e. how the correct application of the treatment will be monitored and recorded, for example, placement of electronic gas sensors and/or temperature sensors in a seed lot
- the formulation or the mix of chemicals
- dosage
- duration of exposure
- temperature during treatment
- CT (Concentration x time) of treatment, if applicable
Information on the experimental methodology used in studies conducted for developing the proposed phytosanitary treatment.
Note: Generally, we would expect applications to have the same standard of literature review, experimental design, data recording, data analysis and confidence levels sufficient for a peer reviewed publication, including provision of the data used for the analyses. This information should include:
- how seeds and test organisms were exposed during experimentation (e.g., application method and the testing environment such as containers used)
- experimental design
- number of experimental units (e.g., number of infected seeds, numbers of pests)
- number of replicates and information on control treatments
- whether experiments consisted of laboratory trials and/or field trials
- data on dose-response mortality, including mortality curves
- information on other effects or side effects of the treatment, such as likely effects of the treatment on the seeds and germination
- published and unpublished references and data (information will be kept commercial in confidence)
Note: The number of experimental units for testing should target efficacy standards accepted by National Plant Protection Organisations (NPPOs) for phytosanitary measures. Assurance requirements will vary based on the likely impacts caused by the pests and the size of infestations that may be typically encountered. Phytosanitary treatment requirements typically require higher assurance levels than treatments applied to ‘control’ pests.
Other information required
Work, Health and Safety information related to the phytosanitary application of the treatment will also be required, as will information on the application methodology and training for applicators for the proposed treatment, if the treatment is to be applied onshore in Australia. This information is not required for initial efficacy assessment but is needed prior to the final approval by the department.
Disclaimers:
This information outlines information requirements for the efficacy assessment of new phytosanitary treatments for seeds. It is not intended to provide information on the department’s or treatment applicator’s operational readiness to apply new treatments, nor any other matters unrelated to the efficacy assessment that are required for other approval processes.
All chemical treatments must also be approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA) before they can be applied to commodities in Australia.
All chemical treatments must also have residue approval from Food Standards Australia New Zealand (FSANZ) before they can be used on food commodities to be sold in Australia.
We may change these conditions if circumstances require, such as in emergency situations or changes related to global issues.