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Bioremediation Agents
Prior to the importation and use of bioremediation and organic waste treatment agents, AQIS is required to obtain and assess technical information relating to these products. This technical information must be sufficient for AQIS to determine whether the product is likely to contain, or be cross-contaminated with, microbes that are potential pathogens or that may be harmful to the environment if released into Australian ground water or soil systems. It should be noted that the potential for products to cause environmental damage in Australia may differ from that in other countries.
The technical information outline below is required for all new applications as well as applications that are for a renewal of an existing permit.
1. List of Ingredients
This should include microorganisms and the presence or absence of a biological carrier (eg. grain carrier).
2. Flow chart outlining the production process
A flow chart should summarise all steps in the production process. This may include filtering, heating (please include temperatures and times), addition of chemicals, purification, fermentation (please include 100% ingredients of the fermentation broth).
3. Pathogenicity of micro-organisms
Details of each species of micro-organism contained in the final product, including evidence to support claims that the organisms are non pathogenic for humans, animals and plants.
4. Purity of raw materials and preparation of product
(a) Details of the primary production starter method, eg:
- pure culture propagation of each microbe from pure seed isolates, then mixing of the respective organisms to make the final product; or
- mixed culture propagation from a mixed seed starter; or
- alternatively seeding and propagation from a starter culture drawn directly from a previous production batch.
Provide details of pre-fermentation treatments applied to production culture substrates eg. heating temperatures and exposure times.
(b) Details of the fermentation substrate and process, including:
- animal, plant or synthetic material contained in the fermentation substrate;
- the species of origin and country of origin of this material; and
- sterilisation procedures prior to inoculation.
(c) The method of harvest of the final product, eg direct harvest from production vats or harvest with purification/concentration of the active ingredients.
(d) Post-production steps and/or treatments applied to prepare and store the product prior to export. Details of stabiliser substrates such as grain or bran based carriers, and information relating to treatments that have been applied to these substrates. Other information required includes the drying, packaging and storage facilities for the product.
5. Quality assurance / quality control procedures
Details of the production process, including identification of any treatments applied to raw materials (including culture substrate) and quality control checks applied during production. Special care should be taken to identify quality control checks that may be applied to demonstrate that production cultures are not cross-contaminated with foreign micro-organisms.
6. Prevention of cross-contamination prior and during production
Steps taken prior to and during production to maintain asepsis and minimise cross-contamination of production cultures, eg. pre-sterilisation of production and handling equipment, airflow and personnel controls, etc.
7. Testing and quality control checks for cross-contamination
A detailed account of micro-biological quality control checks and testing techniques/methods applied during production and to the final product, eg. checks for:
- purity of microbiological content
- extraneous microbial contaminants
- pathogens such as salmonellae, toxigenic E.coli, etc.
Please include a description of the test methods and the sampling regimes/criteria that are applied.