This content is current only at the time of printing. This document was printed on 19 June 2018. A current copy is located at https://apvma.gov.au/node/604
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The APVMA expects the agvet chemical industry to demonstrate a high level of product stewardship and adhere to all relevant Commonwealth, state or territory legislation.
We value strong industry practices that augment government regulatory arrangements and support the Agvet Code. We also encourage the development of industry-wide codes of practice that help industry members comply with legislation and promote best-practice chemical manufacture, supply and use.
The importance of maintaining accurate records
Maintaining accurate records and adopting business practices that enable the verification of product and active-constituent compliance is key to effective product stewardship.
Products can only be lawfully supplied to the Australian marketplace if they comply with their particulars of active-constituent approval, product registration, label approval or relevant permit. Particulars are recorded at the time of approval or registration and relate directly to the compliance of a product or active constituent. They are recorded in the Record, the Register or the APVMA file and remain valid and until formally varied.
When we assess the compliance of an active constituent or chemical product, we will consider the substance in accordance with these recorded particulars. It is therefore very important to maintain the accuracy of these particulars, and to check that the active constituent or chemical product for which you are responsible continues to accord with the particulars on the record, register or file. Non-compliance with the particulars will result in compliance and enforcement action.
Section 161 of the Agricultural and Veterinary Chemicals Code Act 1994 obliges interested persons in relation to active constituents or chemical products and holders of permits to advise us in writing of any new and relevant information about the chemical substances. You must advise us in writing as soon as practicable. This is especially important if the changed information would or might adversely affect our understanding of the product or active constituent or activity under permit.
Relevant information is specified by Section 161 of the Agvet Code and includes information that:
- contradicts information previously given to us under the Agvet Code
- shows that use or dealing with the substance may be hazardous, harmful or have unintended effects
- shows that use of the substance may be ineffective
- would have led us to make a different decision about the substance, if we had known.
When you advise us of a change in details or adverse information, we will carefully consider the information using risk-assessment principles and may take action such as a chemical reconsideration, or seek your assistance to manage any risks identified. For example, new information about the action of a chemical product might mean that we will work with you to modify instructions for use.
In the rare case that something goes wrong with a product we expect you to have adequate business systems in place to quickly mitigate risks.
Responsibility for unapproved or unregistered agvet chemicals
Agvet chemicals (active constituents and products) not approved or registered by the APVMA have not been evaluated for the Australian marketplace and may represent a potential and unacceptable risk to people and animals, the environment and international trade.
We take a risk based approach and will carefully consider any actions that may need to be taken. If we assess risk to be high we may take action to control the substances and stop supply. Once it is confirmed that material is unapproved or unregistered, we will take action to ensure public safety. This may include:
- requiring destruction of existing materials or products (and potentially recalling previously supplied products)
- exporting materials or products to another jurisdiction, or
- requiring them to be stored and quarantined from use, pending registration.
In all cases, any costs associated with these actions will be borne by the party identified as primarily responsible for releasing the materials or product into the Australian marketplace. It should be noted that the costs of chemical disposal or export can be significant and may be calculated on a per-item basis. When little or no information about an active constituent or chemical product is known, the cost of disposal may be high.
When disposal, export or storage is required, we will provide details of the timeframe within which actions must occur, as well as the broad principles that must be complied with (such as the requirement to use a licensed chemical disposal operator). On rare circumstances, we may dispose of material and seek recovery of costs from responsible parties (and this may include legal proceedings).