APVMA clarifies the recalls process for agvet chemicals

The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates agvet chemicals used in the management of pests and diseases in plants and animals, up to and including the point of retail sale. For an agvet chemical product to be legally manufactured, imported, supplied, sold or used in Australia, it must be registered by the APVMA – unless exempt by the Agvet Code. Management after the point of sale, including use of agvet chemicals, is regulated by state and territory authorities.

Both the APVMA and the product holder (the individual or company who holds the registration for the product, also referred to as ‘the holder’ and defined under Part 1, section 3 of the Agvet Code) are responsible for different parts of the recall process.

When recalls are necessary

Australians expect that the agvet chemical products they buy are safe and effective and that product holders will take appropriate actions to protect the health and safety of consumers. Recalls of an agvet chemical product may be initiated to mitigate potential risks to safety (such as incorrect labelling or packaging failures), concerns that the product may not work as intended, or because of a potential risk to trade. This can be undertaken as a voluntary recall (where a supplier voluntarily recalls a product from the market). Alternatively, the APVMA can compel a supplier to recall the product (known as a compulsory recall).

Product holders are responsible for limiting the risk to public safety as quickly as possible by removing the product from sale, contacting consumers, and providing advice to anyone in possession of the recalled product. The holder of the product registration or active constituent approval is responsible for the recall, regardless of where the recalled product currently is in the supply chain – manufacturer, importer, distributor or retailer.

The APVMA’s role in the recall process

As the regulator responsible for the recall of agvet chemicals, the APVMA must publish the notice of voluntary recall on apvma.gov.au within 3 working days of notification by the product holder and in the APVMA Gazette within 14 days.

The APVMA also assess the risks around the recall and advises the product holder on their responsibilities in recalling a product.

If an agreement cannot be reached, the APVMA may start a compulsory recall. In this event, the APVMA will direct the way the recall is to occur and enforce compliance.

Product holders’ role in the recall process

If a product holder voluntarily recalls an agvet chemical product, that person must notify the APVMA within 2 days of action using the approved form. It is an offence not to do so.

The product holder is responsible for notifying consumers of the recall. An established recall process should already be in place so that in case of a recall, the holder can quickly communicate the recall to their supply chain. Other responsibilities may include, but are not limited to:

• stopping supply of a product (registered or unregistered)

• choosing a remedy such as finding, retrieving, correcting or destroying an agricultural or veterinary chemical product within a distribution network

• reporting on the details of the recall notice such as the product details, where it is sold, when it was sold, reasons for recall, hazard associated with the use of affected product, and what to do if someone has possession of the affected product

• reporting to the APVMA on the outcome of the returned product (such as destruction), investigation into the recall showing of the cause of the issue and, corrective actions taken to prevent the issue from happening again

• keeping a record of all the actions taken during the recall including how many units of the affected product were sold and how many returned. The APVMA may wish to audit the recall or exercise its monitoring powers to examine relevant records.

Consumers and users of agvet chemicals

Agvet chemicals must be used in accordance with the instructions on the APVMA–approved label. The APVMA does not monitor or enforce the correct use of agvet chemicals, as this is a responsibility of the state and territory authorities.

State and territory authorities

Control of use regulation is the responsibility of state and territory authorities. More information on the government agencies responsible for managing the use of pesticides and veterinary medicines in each state and territory is available on the APVMA website.

APVMA compliance and enforcement

The APVMA is responsible for compliance action in relation to unregistered or registered products, as well as those that are listed, exempt or reserved.

Our monitoring can include remotely assessing and visiting holders, manufacturers, wholesalers and retailers of agvet chemicals. Monitoring compliance helps us identify emerging issues so that corrective actions can be undertaken promptly.

More information on the APVMA’s role in the recalls process is available on apvma.gov.au.