Off-label chemical use
Off-label use is when a registered chemical is used in a manner that is not specified on the product label, such as:
- to control a different pest
- to protect a different host (such as a crop or animal)
- at a different rate
- in a different manner
Off-label use is intended to enable the use of agricultural and veterinary chemicals in situations where extending label uses may be uneconomical for chemical companies (for example, minor crops).
Prohibited off-label use
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 (for example, '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 line 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.
Permits for off-label use
To apply for a permit, you must submit an application to the APVMA that 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, you must get a section 25A permit from Agriculture Victoria.
For all other off-label uses of 1080 or PAPP, you must get a permit from APVMA.
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
- animal welfare.
Giving off-label 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 off-label (different to the label directions), you can be held responsible for any adverse consequences resulting from the user following this advice.
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 and 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
- Permits for the off-label use of 1080 and PAPP
Residue management — Ensure you have a thorough understanding of residue management if you intend to use any chemical products off-label.
Responsible chemical use — Information on chemical registration, how to read chemical labels, and giving chemical use advice.