Off-label 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 Section 25A permit (Application for Off-label use of restricted chemical product permit) has been issued for that use by the DPI.
• The chemical is used at a rate higher than the maximum application rate for that use, as stated on the label, unless an Australian Pesticides and Veterinary Chemicals Authority (APVMA) Off-label Permit has been issued.
• The chemical is used at intervals more frequent than the intervals for that use, as stated on the label, unless an APVMA Off-label Permit has been issued.
• 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 an APVMA Off-label Permit has been issued.
• 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.

Provided the constraints listed above are complied with, no permit is required to use chemicals off-label.

DPI and APVMA off-label permits

DPI and the APVMA both issue off-label use permits to legalise the use of a chemical product in a manner not stipulated on the product label.

DPI issues a Section 25A permit to authorise the use of a ‘restricted use’ chemical product off-label. An example request is to authorise the use of a ‘restricted use’ product on a different crop or pest.

To apply for a permit, an Application for Off-label use of restricted chemical product permit must be submitted to DPI which includes field and laboratory data that supports the use on efficacy, safety and trade grounds.

In Victoria, an APVMA off-label permit is required to use an unregistered chemical or registered chemical at a rate or frequency greater than that stated on the product label or contrary to specific label prohibition statement.

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.

The APVMA website has a searchable database for all currently registered pesticides, off-label permits and lists of all maximum residue limits (MRLs).

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 DPI 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. DPI recommends that growers confirm the residue status of their produce through pre-harvest residue testing.

Further information

APVMA agricultural and veterinary permits
Chemical labels
Chemical residues and maximum residue limits
Giving chemical use advice
Off-label use of registered veterinary chemical products
Prohibitions on sale and use of veterinary chemicals