Process for developing a standard for active constituents
In accordance with the statutory responsibilities under the Agricultural and Veterinary Chemicals (Administration) Act 1992, 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 through requests. The current practice is to be informed by domestic interested persons, organisations, government bodies, or international bodies or organisations.
New Standard
When the APVMA has become aware that a standard needs to be written, either through a formal application or review, the following procedure is implemented.
- A draft is written by either a member of the APVMA, or approved representative of the APVMA, or submitted to the APVMA. This 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, or international bodies or organisations or other interested parties.
- The drafted standard then goes to the appropriate industry group or appropriate input group from step 1 for consultation, if there is no industry group etc then this step is omitted.
- The standard is amended if required then published on the APVMA web site for a specific period of time, usually 2 months requesting public consultation.
- If the standard is for a new active constituent, then there is a 28-day period for response following a gazette notice. If it is an existing active, then it may be included as part of the chemical review consultation process and timeframe.
- Once the time period for public consultation has elapsed, the comments are collated and assessed on an individual basis in light of the standard.
- The standard is subjected to the final revision and published on the APVMA website. (At the moment there is no timeframe for this step in the process).
- A response is issued to the addressee for each public consultation received addressing each point raised addressing the reasons if necessary to why a specific point has not been used in the revised standard. (At the moment there is no timeframe for this step in the process).
- No other correspondence is entered into with any party after step 6
Note: An expert committee may be formed at any stage of the process to ensure the standard is robust and or appropriate for its intended use.
Revision of an existing standard
The same process occurs with a minor change to the 1st step. The existing standard is retrieved and assessed against the proposed changes for suitability. If it is assessed to have relevant changes then the process continues at dot point 2, above.