Off-label use and MRLs explained
Victorian producers must only use agricultural chemical products that are registered for use on a target crop or pest, permitted under the Department of Economic Development, Jobs, Transport, and Resources (DEDJTR) or Australian Pesticides and Veterinary Medicines Authority (APVMA) permit in accordance with Victoria's off-label use policy. This article describes off-label use and DEDJTR and APVMA permits and how they relate to maximum residue limits (MRLs).
Off-label use in Victoria
Off-label use refers to situations when a registered chemical product 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), or in a different manner to that listed on the label.
Off-label use is not illegal in Victoria providing the following restrictions are followed and residue limits are not exceeded:
- The product is registered with the APVMA
- The product is not a 'restricted use' chemical (i.e. all Schedule 7 Poisons (DANGEROUS POISONS), products containing atrazine, metham sodium or ester formulations of 2,4-D, 2,4-DB, MCPA or triclopyr)
- The use is not at a rate or frequency greater than that stated on the product label
- The product is not used in a way that the label specifically states it must not be used (e.g. 'DO NOT apply by air).
Off-label use of chemical products is not recommended by the department 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.
DEDJTR and APVMA permits
DEDJTR and APVMA both issue off-label use permits to legalise the use of a chemical product in a manner not stipulated on the product label.
DEDJTR 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 product on a different crop or pest.
To apply for a permit, an application must be submitted to DEDJTR which includes field and laboratory data that supports the use on efficacy, safety and trade grounds. Application forms are available from the Chemical use page, (search 'section 25A').
In Victoria, an APVMA 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 www.apvma.gov.au has a searchable database for all currently registered pesticides, off-label permits and lists of all MRLs.
Maximum residue limit (MRL)
Regardless of how a chemical product is used, the resulting chemical residues on the treated crop must not exceed the maximum residue limits (MRLs) set by the APVMA and Food Standards Australia New Zealand (FSANZ).
Every agricultural chemical use that is registered or permitted under an APVMA permit has a corresponding MRL. A MRL is the maximum concentration of a chemical residue legally permitted in or on a food, agricultural commodity or animal feed.
In cases where an MRL exists, residues equal to or less than the MRL are deemed safe for consumption. If there is no corresponding MRL for a chemical, a likely situation if a chemical product is used off-label on a non-approved crop, any detectable residue will be unacceptable.
MRLs are set for the use pattern, including application rate and frequency of application specified on the product label or permit. It is not likely that an MRL will be exceeded if the product is used according to label instructions.
Where food crops are involved in off-label chemical use, great care must be taken to ensure the risks of unacceptable chemical residues are effectively managed. To ensure produce does not contain excessive residues, DEDJTR recommends growers undertake residue testing to confirm the residue status of treated produce.