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) or the product is used in a low-risk, off-label manner
• 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

APVMA permits

In Victoria, an APVMA off-label permit is required to use an unregistered chemical or a 'restricted use' chemical in an off-label manner.

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.

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

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.

Low-risk off-label use

In Victoria, an APVMA permit is not required when using ‘restricted use’ chemical products in low-risk circumstances. This only applies to registered agricultural chemical products. Low-risk off-label uses are limited to the follow circumstances:

• the use is to control a pest that is different from the pest stated on the approved label for that use
• the registered agricultural chemical product is mixed with another registered agricultural chemical product
• at a rate that is lower than the rate for that use as stated on the approved label
• at a concentration that is lower than the concentration for that use as stated on the approved label
• at an interval that is less frequent than the interval stated on the approved label for that use
• in accordance with a use provided on the approved label for two or more other states or territories.

Low-risk off-label use does not apply to pest animal control or agricultural chemical products that have an approved label with directions for the control of a pest animal.

A ‘restricted use’ chemical cannot be used in low-risk circumstances if the product label includes critical comments or restraints in relation to geographical location, timing or other restriction that would otherwise prohibit that use at any time or any place or any other specified circumstance in Victoria.

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.

Chemical users, particularly if using products at lower rates or frequencies, should refer to the relevant industry resistance management and industry stewardship strategies, which contain information on preventing pesticide resistance.

Follow the correct label instructions

Chemical users should always refer to the agricultural or veterinary chemical product label that is currently approved by the APVMA, except when using a product in accordance with written instructions provided by a veterinarian practitioner.

Agricultural and veterinary chemical product labels can become outdated after they have been purchased. They can also become lost, deteriorate or unattached from the container if they have been in storage for some time.

To obtain a copy of the current agricultural or veterinary chemical product label visit the manufacturer’s website or APVMA Public Chemical Registration Information System Search (PubCRIS) online database.

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.

Prohibitions on agricultural chemical use

A person must not use an agricultural chemical to control a vertebrate animal unless:

• the control of the species of vertebrate animal is stated on the label of the agricultural chemical product
• the person who uses the agricultural chemical product is acting under and in accordance with a permit issued under Part 7 of the Schedule to the Agvet Code of Victoria (from the Australian Pesticides and Veterinary Medicines Authority)
• the person who uses the agricultural chemical product is acting under and in accordance with a permit issued under section 25A(2)(b) of the Act and Schedule 1 to the Agricultural and Veterinary Chemicals (Control of Use) Act 1992, which is not an agricultural chemical user permit (from Agriculture Victoria)

A person must not use agricultural chemical products containing a constituent listed in column 1 of the Table 1 for the prohibited use specified in column 2 unless:

• the person who uses the agricultural chemical product is acting under and in accordance with a permit issued under Part 7 of the Schedule to the Agvet Code
• the person who uses the agricultural chemical product is acting under and in accordance with a permit issued under section 25A(2)(b) of the Act and Schedule 1 to the Act, which is not an agricultural chemical user permit

Table 1 – Chemical products containing a constituent and their prohibited use

Key pages

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.