This content is current only at the time of printing. This document was printed on 24 March 2017. A current copy is located at http://apvma.gov.au/node/216
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Stop supply or recall notices
The APVMA can issue recall notices under the Agvet Code requiring an entity to take any of a range of actions, depending on the status of a chemical product or active constituent, to manage risk, control the product and in some cases remove the product or constituent from the marketplace.
1. What is a recall?
A product recall occurs when the APVMA issues a formal notice under Part 6 of the Agvet Code. The term ‘recall’ does not refer just to the retrieval or return of products from the marketplace and consumers. Recalls can also include formal requirements pursuant to a notice ‘not to supply’ or to ‘stop supply’ and a range of actions in relation to product retrieval and disposal and notifications to consumers.
Recall activities that do not reach a threshold for the APVMA to issue a notice are referred to as ‘voluntary recalls’.
2. Overview of the legislative provisions
Sections 101, 102 and 103 of the Agvet Code give the APVMA powers to take action necessary to mitigate the risks posed by agricultural and veterinary (Agvet) chemical products in specific circumstances, such as if:
- a product is unregistered
- a product may or does not meet the safety, trade or efficacy criteria (if relevant)
- a registered product may or does differ by more than the prescribed extent from the constituents, composition or purity stated in the Register
- the label of a registered product differs from the approved label or the label otherwise required by an established standard.
The legislative provisions allows us to issue notices to the person who has (or has had) possession or custody of the relevant product or active constituent. The notices may contain additional instructions about the supply, recovery and disposal of products, and notification of the issue prompting the recall.
We have discretion to exercise the powers and to determine the requirements of the notice.
Section 106 of the Agvet Code refers to obligations that may also arise under the Competition and Consumer Act 2010.
The ability to recall defective or noncompliant products (including unregistered products) is fundamental to risk management and assuring the quality and safety of agvet chemicals in the Australian market. Recalls are risk management actions and are not intended to be punitive, although they may have financial and other consequences for an affected party.
4. When can we issue compulsory recalls?
The APVMA may decide to issue compulsory recalls when:
- a risk to the public or environmental health exists
- the product in question is unregistered
- a proposed voluntary recall activity is insufficient to mitigate risk or greater regulatory oversight is required.
In considering whether to exercise our recall powers, we consider a range of factors but focus mainly on risk.
If efficacy was not a relevant consideration during the registration of the product or if the product is of a type excluded from consideration for efficacy by the efficacy criteria, we do not take the effectiveness or lack of effectiveness of the product into account when considering a recall.
Before exercising a recall power, the APVMA will advise an affected party about the proposed product recall powers and allow reasonable time for them to respond.
5. What can the notice require?
A recall notice may list the actions a person or company must take, including:
- the level of application (wholesale, retail or end user)
- the future fate of the material (disposal, export etc.)
- the advertising or dissemination of the recall notice (local or national advertising, including newspapers or trade publications)
- the form and wording of any correspondence or advertisement informing affected parties
- the timeframe for actions.
The actions we take are proportionate to the risk. When deciding whether advertising of a product recall is required, we consider the ability of the responsible entity to contact all affected parties. For example, when a recall relates to an agvet chemical product with an identified lack of efficacy and the product is distributed by mail order directly to end users, we are likely to require direct correspondence from the supplier to each customer, rather than advertisements in national media. If the product is distributed through retail outlets to the general public, we may require notices at the point of sale and advertisements in print media to ensure an effective recall.
6. Can the notice be withdrawn?
The APVMA has discretion to withdraw a recall notice.
7. What happens if the notice is not complied with?
Noncompliance with a recall notice is an offence under the Agvet Code. The APVMA may respond to this form of noncompliance by issuing a formal warning or infringement notice or may pursue a civil penalty order.
8. Publication or disclosure
In accordance with the principle of transparency outlined in the APVMA’s Compliance and Enforcement Policy, every enforcement matter that is dealt with through litigation or formal resolution is made public. In accordance with this principle, the APVMA’s maintains a register on its website for publishing enforcement matters.
Recall notices are gazetted and published on the APVMA register on its website. The notice may also require the publication of information to mitigate risks associated with the recalled product. We also encourage the publication of voluntary recall information. There may also be requirements under consumer protection legislation that apply to voluntary recalls.
9. Additional considerations
Costs associated with any aspect of a recall (voluntary or compulsory) are the responsibility of the person or company responsible for the product. This includes the costs of any advertising required to mitigate risk as part of a compulsory recall.