This content is current only at the time of printing. This document was printed on 24 January 2017. A current copy is located at http://apvma.gov.au/node/10711
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Process for developing a standard for active constituents
In accordance with statutory responsibilities under the Agricultural and Veterinary Chemicals Code, the APVMA routinely establishes standards for new active constituents, which are normally the result of an assessment of a new chemical. In addition, the APVMA also revises existing standards—either as a result of a review of a chemical or in response to requests by domestic interested persons, organisations, government bodies, or international bodies or organisations.
When the APVMA becomes aware that a standard needs to be written, either through a formal application or a review, the following procedure is implemented:
- A draft is either written by a member of the APVMA or an approved representative of the APVMA, or submitted to the APVMA. The draft may also take into consideration information or data from a variety of sources such as the manufacturer; an organisation; a working group; an industry group; federal, state or territory regulatory body or agencies; international bodies or organisations; or other interested parties.
- The drafted standard is then provided for consultation to the appropriate industry group or the appropriate input group from step 1. If there is no industry group or the like this step is omitted.
- If valid scientifically-based argument or comment is provided from step 2, the standard is amended then published on the APVMA website for a specific period of time, usually one month, with a request for public consultation.
- If the standard is for a new active constituent, there is a 28-day period for response following an APVMA Gazette notice. If the standard is for an existing active constituent, it will be included as part of the chemical review consultation process and timeframe.
- Once the time period for public consultation has elapsed, the comments on the standard are collated and assessed on an individual basis.
- For each public consultation received, a response is issued that addresses each point raised and, if necessary, details the reasons why a specific point has not been used in the revised standard. Feedback is provided within two to three weeks of the closing date of the public consultation period. After the response is issued, no other correspondence can be entered into with any party.
- The standard is subjected to a final revision and published on the APVMA website with an updated version number and date of publication to differentiate it from any superseded version. It is published within one month after the closing date for public consultation.
Note: An expert committee may be formed at any stage of the process to ensure the standard is robust, appropriate for its intended use, or both.
Revision of an existing standard
The same process occurs with a minor change to step 1. The existing standard is retrieved and assessed against the proposed changes for suitability. If the standard is assessed as requiring relevant changes it is redrafted and the process continues at step 2, above.