Off-label chemical use
Off-label use refers to situations when a registered chemical is used in a manner that is not specified on the product label.
Examples of off-label use include when a chemical is used to control a different pest or to protect a different host (crop/animal), at a different rate, or in a different manner to that listed on the label.
Off-label use is intended to enable the use of agricultural chemicals in situations where extending label uses may be uneconomical for chemical companies (e.g. minor crops).
Off-label use is prohibited when:
The product is a 'restricted use' chemical unless a permit authorising that use has been issued by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
The chemical is used at a rate higher than the maximum application rate for that use, as stated on the label, unless a permit authorising that use has been issued by the APVMA.
The chemical is used at intervals more frequent than the intervals for that use, as stated on the label, unless a permit authorising that use has been issued by the APVMA.
The chemical is used in a way that the label specifically states must not be used in that way (e.g. 'DO NOT apply by air', unless a permit authorising that use has been issued by the APVMA.
The product is a veterinary chemical and is used in certain situations or on certain animals.
The product does not have label directions for use on stored grain or grain in transit but is used in those situations.
An agricultural chemical is applied to an animal without a permit for that use granted by the APVMA or the use is by, or in accordance with the written instructions from a veterinary practitioner and the use is not prohibited.
Pest animal baits containing PAPP or 1080 are used contrary to the Directions for the use of 1080 and PAPP pest animal bait products in Victoria, unless a section 25A permit has been issued by Agriculture Victoria authorising that use.
Provided the constraints listed above are complied with, no permit is required to use chemicals off-label.
To apply for a permit, an application must be submitted to the APVMA which includes field and laboratory data that supports the use on efficacy, safety and trade grounds.
Permits for off-label use of 1080 and PAPP
To use pest animal bait products containing PAPP or 1080 contrary to the Directions for the use of 1080 and PAPP pest animal bait products in Victoria, a section 25A permit from Agriculture Victoria is required.
For all other off-label uses of 1080 or PAPP, a permit from the APVMA is required.
Giving chemical use advice
Many chemical users rely on information and advice provided by others when selecting and using agricultural chemicals. If you provide chemical use advice, you have a duty to ensure that the information you provide is accurate and reliable.
If the advice you provide is different to the label directions (i.e. off-label advice), you may be held responsible for any adverse consequences resulting from the user following this advice.
Off-label user responsibilities
Off-label use of chemicals is not recommended by Agriculture Victoria and is not included within a manufacturer's warranty.
All aspects of off-label use are the user's responsibility, including residue control, environmental safeguards, occupational health and safety and animal welfare.
One of the main issue with using a chemical off-label relates to the ability to manage chemical residues in treated produce. When a chemical is used off-label, how it interacts with the crop being treated, and how long it will take before the residue reaches an acceptable level is unknown.
As there is a greater likelihood that produce treated off-label will contain unacceptable residues, care must be taken to manage residue risks. We recommend that growers confirm the residue status of their produce through pre-harvest residue testing.
Off-label use of agricultural chemicals – Requirements for legal off-label use of agricultural chemicals.
Off-label use of veterinary chemicals – Requirements for legal off-label use of prescription and over the counter veterinary chemical products.
Restricted use vs restricted supply chemicals – Understand the difference between these two important classifications and how this relates to off-label use.
Permits to legalise specific cases of off-label use-
- APVMA permits
- Section 25A permits (1080 and PAPP)
Residue management – Ensure you have a thorough understanding of residue management if you intend to use any chemical products off-label.