Off-label chemical use permits: joining the dots
In Victoria, there are cases where the off-label use of an agvet chemical is illegal without a permit. What does a 'permit' to use chemicals off-label do?
A 'permit' issued by the responsible agency, makes an off-label chemical use legal in circumstances where the use would otherwise be illegal.
As part of most permit application processes, a risk assessment of the proposed off-label use is carried out to ensure negative impacts arising from the off-label use are avoided.
Not all off-label chemical use is illegal however, and this Agricultural Note provides information on when off-label use is illegal, when it is not, and what permit may be required to legalise the off-label use.
'Restricted use' chemicals
In Victoria, there are a number of agricultural chemicals that are restricted to on-label use by authorised persons. These are referred to as 'restricted use' chemicals and are agricultural chemical products that:
- are Schedule 7 Poisons (Dangerous Poisons)
- contain atrazine, metham sodium or ester formulations of 2,4-D, 2,4-DB, MCPA or triclopyr.
To be authorised to use these chemicals on your own property, you must hold a valid Agricultural Chemical User Permit (ACUP), with the appropriate chemical endorsement, or be working under the direct supervision (i.e. within sight and sound) of an ACUP holder.
'Restricted use' chemicals may also be used by Department of Environment and Primary Industries (DEPI) licensed spray contractors and chemical users operating within a recognised Quality Assurance program that requires chemicals to be used in accordance with label directions and is independently audited at regular intervals of less than two years.
DEPI permit v APVMA permit
'Restricted use' chemicals MUST be used in strict accordance with the label under Victorian law. The off-label use of these chemicals is illegal unless the user holds a valid Section 25A Permit issued for the use by DEPI. A Section 25A Permit is different from an ACUP (which only permits the on-label use of 'restricted use' chemicals), and is issued by DEPI, not the Australian Pesticides and Veterinary Medicines Authority (APVMA).
Many chemical users are under the belief that the APVMA issues all permits for off-label chemical use, but this is not the case. In Victoria, DEPI is the agency responsible for issuing permits to legalise the off-label use of 'restricted use' chemicals because DEPI has restricted the use.
If a person proposes to use a 'restricted use' chemical for a use that is not listed on the chemical product label, they must submit an application for a Section 25A Permit to DEPI. Application forms are available from the DEPI Chemical Use website. On receipt of an application, DEPI will conduct a risk assessment of the proposed use, and will decide whether or not to issue the permit depending on the results.
National restrictions on use
Some categories of off-label use are restricted nationally, such as when a chemical is used:
- at a higher rate than that listed on the label
- more frequently than the frequency listed on the label
- contrary to a specific label statement.
In these cases, a permit issued by APVMA is necessary to legalise the use.
In addition, the Control of Use laws governing chemical use are different between Victoria and other states. While a particular practice may not be illegal in Victoria, it may be illegal in other states, and vice-versa. It is therefore vital that chemical users who work across State borders are aware of the particular controls over chemical use that apply in the State where the chemical is to be used.
Permitted off-label use
For chemicals OTHER than the 'restricted use' chemicals, a permit from DEPI or APVMA is NOT required, and the off-label use is NOT illegal in Victoria provided that:
- the maximum label rate is not exceeded
- the label frequency of application is not exceeded
- any specific label statements prohibiting the use are complied with (e.g. DO NOT statements).
Provided the constraints listed above are complied with, no permit is required for the off-label use of these chemicals, which makes any APVMA Off-Label Permit issued for these chemicals in other States, invalid in Victoria. This is because the APVMA Permit is redundant in Victoria, hence the APVMA Permit would be attempting to legalise something that is already legal.
APVMA off-label permits
Off-label permits issued by the APVMA for non-restricted chemicals in States other than Victoria carry the wording 'Victoria is not included in this permit because their 'Control-of-Use' legislation means that a permit is not required to legalise this off-label use in VIC'.
Although an APVMA permit for off-label use may not be valid in Victoria, it may contain useful information, such as recommended rates of use and withholding periods (WHPs) that may be of assistance to Victorian chemical users.
Off-label use responsibilities
While the off-label use of chemicals other than 'restricted use' chemicals is permitted in Victoria under certain circumstances, any person who chooses to use such a chemical in an off-label manner does so accepting total responsibility for:
- Efficacy - whether the chemical achieves the desired result or not
- Residues in the environment
- Occupational health and safety issues
- Residues in produce.
For further information on chemical use, permits or Control of Use legislation contact:
- Australian Pesticides and Veterinary Medicines Authority website
- Department of Environment and Primary Industries Chemical Use website
Chemical Standards Officers
Fax: (03) 5430 4590
|Steve Field||(03) 5430 4463|
|Alex Perera||(03) 5430 4591|
|Felicity Collins||(03) 5833 5203|
|Neil Harrison||(03) 5336 6616|
|Craig Clutterbuck||(03) 5226 4719|
|South East and Metro|
|Jane Collin||(03) 5172 2198|
|Natalie Myring||(03) 5924 2609|
Enquiries from other regions should be directed to the nearest of the above-named regional officers.
Published and Authorised by:
Department of Environment and Primary Industries
1 Spring Street
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The advice provided in this publication is intended as a source of information only. Always read the label before using any of the products mentioned. The State of Victoria and its employees do not guarantee that the publication is without flaw of any kind or is wholly appropriate for your particular purposes and therefore disclaims all liability for any error, loss or other consequence which may arise from you relying on any information in this publication