This content is current only at the time of printing. This document was printed on 24 June 2017. A current copy is located at https://apvma.gov.au/node/207
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Cancellation or suspension of a registration or permit to prevent imminent risk
- 1. Overview of the legislative provisions
- 2. What we consider when cancelling or suspending a registration or permit
- 3. How is the suspension or cancellation given effect?
- 4. Period of suspension
- 5. Can the suspension or cancellation be withdrawn?
- 6. What happens if the cancellation or suspension is not complied with?
- 7. Publication or disclosure
The APVMA may suspend or cancel a registration or permit for an agvet chemical product for reasons relating to imminent risk of death, serious illness or serious injury to people.
The Chief Executive Officer (CEO) of the APVMA may exercise this power, which is not delegated.
1. Overview of the legislative provisions
Section 35A and section 119A of the Agvet Code allow us to suspend or cancel a registration of a chemical product or a permit respectively if we consider it necessary to prevent imminent risk of death, serious injury or serious illness to people. We can exercise this authority whether or not:
- the chemical product that is the subject of the registration is being used in accordance with instructions for its use that the APVMA has approved
- the conditions of the permit have been, or are being, complied with.
2. What we consider when cancelling or suspending a registration or permit
In considering whether it is necessary to cancel or suspend a registration or permit, we take into account factors such as:
- whether there is evidence of persons’ exposure to an imminent risk that relates to use of the registered or permitted use of the agricultural and veterinary (Agvet) chemical product
- whether there is evidence that the imminent risk is to people in general, rather than individuals
- whether the suspension or cancellation is strictly necessary to protect people
- whether the imminent risk is able to be addressed (even in part) by cancelling or suspending the registration or permit
- whether the suspension or cancellation is necessary and the most appropriate action to take to address the imminent risk
- whether there are feasible and preferable alternative measures available to manage the imminent risk.
We consider this to be a power of last resort. Such imminent risk would be most likely to arise in a situation in which we need or are asked to take action as part of a whole-of-government response to an emergency or major public health incident, and in which other agencies are taking commensurate and parallel action.
3. How is the suspension or cancellation given effect?
The suspension or cancellation is given effect, generally speaking, by the issue of the relevant notice and the amendment of the APVMA record.
4. Period of suspension
Where the suspension or cancellation deals with a permit we must specify the period to which a suspension applies. We determine this on a case-by-case basis and may consider such factors as:
- the nature of the risk
- whether the risk can be effectively mitigated with additional or varied permit conditions.
5. Can the suspension or cancellation be withdrawn?
Where a permit has been cancelled or suspended, this cancellation or suspension can be revoked the APVMA.
Where registration of a chemical product has been cancelled or suspended, this cancellation or suspension can also be revoked the APVMA.
6. What happens if the cancellation or suspension is not complied with?
If the cancellation is not complied with, that noncompliance is deemed to have occurred in contravention of the relevant provisions of the Agvet Code. For example supply of an Agvet chemical product whose registration was cancelled would constitute supply of an unregistered chemical product. Similarly, cancellation of a permit means that there is no exemption from the offence provisions subject to the permit. For example, if the permit was for the purposes of use of the chemical product, then the noncompliance is an offence in the state or territory jurisdictions where use occurs.
Noncompliance with a cancellation or suspension is treated seriously. In the circumstances of an emergency, other statutes may also apply.
7. 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.
Notices issued for the purposes of section 35A or section 119A of the Agvet Code are public and will be published on the APVMA’s register. In situations of potential harm to people in general, we may also disseminate information about the issue as widely as is appropriate.