This consultation closed on 30 June 2022
We invite submissions from 29 March 2022 to 30 June 2022 on our proposed amendments to how the efficacy of certain pool and spa chemicals is assessed.
Currently, guidance on how to demonstrate the efficacy of pool and spa sanitisers is available on the Australian Pesticides and Veterinary Medicines Authority (APVMA) website.
Section 5B of the Agricultural and Veterinary Chemicals Code scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Agvet Code) provides a definition of how a product ‘meets the efficacy criteria’. Under this definition, the product, when used in accordance with instructions approved, or to be approved for the product, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.
The APVMA has made a legislative instrument in relation to efficacy. This includes criteria based on demonstrated effectiveness. Under these criteria, a product is taken to be effective if it would, to a reasonable degree, achieve one of the effects listed in paragraphs 4(2)(a) to (e) of the Agvet Code and this is evidenced or demonstrated by:
- results from efficacy trials or experiments; or
- valid scientific argument; or
- demonstrated history of sale and effective use in equivalent uses; or
- full results from overseas efficacy trials or experiments and the associated assessment reports by an overseas regulator that are relevant to the proposed product and use; or
- a combination of 2 or more of the above.
The current Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Determination 2014 (Efficacy Criteria Determination 2014) does not include specific performance-based criteria against which the efficacy of products, including pool and spa sanitisers, are compared.
The APVMA, therefore, proposes to amend the Efficacy Criteria Determination 2014. The amendments will include a change to clause 3, for agricultural chemical products, to refer to specific performance standards established for certain types of products. A schedule, containing the performance standards referred to in this clause, would also be added to the determination.
The APVMA’s current guidance on how to demonstrate efficacy of pool and spa sanitisers draws on international best practice, as set out in the Organisation for Economic Co-operation and Development (OECD) guidance document for demonstrating efficacy of pool and spa disinfectants1. In maintaining the commitment to follow international best practice, the APVMA will continue to rely on the OECD guidance. It will be a requirement for pool and spa sanitisers covered by the OECD guidance document to meet the following performance standards when tested in accordance with the procedures set out in the OECD guidance. These performance standards will be included in this schedule as follows:
|
Test organisms for both swimming and spa pools |
Number of log10 reductions to be achieved |
Time of exposure to test sanitiser at normal concentration during which reduction is to be achieved |
|---|---|---|
|
Bacteria |
|
|
|
Escherichia coli |
4 |
30 seconds |
|
Enterococcus faecium |
4 |
2 minutes |
|
Pseudomonas aeruginosa |
4 |
30 seconds |
|
Legionella pneumophila |
4 |
30 seconds |
|
Staphylococcus aureus |
4 |
30 seconds |
|
Virusesa |
|
|
|
Adenovirus (disaggregated) a |
3 |
10 minutes |
|
Rotavirus (disaggregated) a |
3 |
2 minutes |
|
Protozoa |
|
|
|
Naegleria fowleri (cysts) |
4 |
30 minutes |
|
Giardia intestinalis b or Giardia muris c (cysts) |
3 |
45 minutes |
a Prior to the test exposure, virus suspensions need to be treated to disassociate aggregated clusters of virus particles.
b Giardia intestinalis is the human pathogen – other terms sometimes used in the literature for this species are Gardia lamblia and the more general mammal parasite Giardia duodenalis.
c The rodent pathogen Giardia muris can be used as a surrogate for the human pathogen.
|
Test organisms |
Test method |
Maximum count allowable |
|---|---|---|
|
Bacteria |
|
|
|
Culturable micro-organisms colony count (also called 'aerobic colony count' or 'heterotrophic colony count' |
ISO 6222:1999: Enumeration of culturable micro-organisms – Colony count by inoculation in a nutrient agar culture medium |
100 Colony Forming Units (CFU) per mL |
|
Thermotolerant coliforms |
ISO 9308-1: Detection and enumeration of E. Coli and coliforms – Part 2: Membrane filtration method |
Not detectable in 100 mL |
|
Pseudomonas aeruginosa |
ISO 16266: Detection and enumeration of Pseudomonas aeruginosa – Method by membrane filtration |
Not detectable in 100 mL |
Along with the inclusion of the above performance criteria in a Schedule to the Efficacy Determination 2014, the APVMA website will be updated to accurately reflect the guidance document published by the OECD.
How to make a submission
Submissions from interested stakeholders on the proposed approach to the assessment of pool and spa chemicals are welcomed. It should be noted the proposal is to use the OECD guidance document as published, and the OECD guidance document itself is not released for consultation.
Please note: Submissions will be published on the APVMA’s website unless you have asked for the submission to remain confidential (see public submission coversheet).
Please lodge your submission with a public submission coversheet, which provides options for how your submission will be published.
Note that all APVMA documents are subject to the access provisions of the Freedom of Information Act 1982 and may be required to be released under that Act should a request for access be made.
Please send your written submission and coversheet by email or post to:
Email: Sheila.Logan@apvma.gov.au
Post:
Executive Director
Risk Assessment Capability
Australian Pesticides and Veterinary Medicines Authority
GPO Box 3262
Sydney NSW 2001
1 Guidance Document for Demonstrating Efficacy of Pool and Spa Disinfectants in Laboratory and Field Testing. Series on Testing and Assessment No. 170. Series on Biocides no. 4.
Submissions received
The APVMA sought comments from interested stakeholders on its proposed amendments to how the efficacy of certain pool and spa chemicals is assessed, in a consultation that closed on 30 June 2022. Two submissions were received from industry groups. A copy of the published submissions is available on our website.
Consultation feedback
The APVMA is currently considering the submission as part of this consultation.