This content is current only at the time of printing. This document was printed on 27 April 2017. A current copy is located at http://apvma.gov.au/node/128
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Our powers to manage risk and enforce compliance
The APVMA has specific powers to manage risk and enforce compliance.
Coercive powers to enable monitoring and information gathering
The APVMA conducts most of its enquiries and investigations without resorting to coercive powers. However, where needed, we may use powers and functions held by APVMA inspectors, which includes powers to issue notices to produce or attend or substantiate claims and representations, and the execution of monitoring and investigation warrants. We have developed regulatory guidelines to explain how we may use those powers. We have an Enforcement Committee to ensure the sound governance and oversight of investigations, especially where coercive powers may be exercised.
Monitoring and investigation warrants
Our monitoring and investigation powers may be exercised with consent or under a warrant issued by a magistrate.
An Inspector can apply to a magistrate for a monitoring warrant (section 69EH of the Admin Act; section 143 of the Code Act) or an investigation warrant (section 69EHA of the Admin Act; section 143A of the Code Act), which must contain specified information. The magistrate may issue a warrant if they are satisfied, based on information given under oath or affirmation (including further information sought by the magistrate), that access to the premises is necessary for the purposes of either monitoring compliance or investigating alleged noncompliance with agvet legislation.
APVMA Inspectors who enter premises with warrants have specific powers of what they are do and require from the occupants of the premises. Inspectors can copy documents, take photographs, measurements and samples and require the occupants to answer questions. They may also operate any electronic equipment on the premises and have other people assisting in undertaking various tasks. Further information on inspectors’ powers and responsibilities is available in the Monitoring—rights and responsibilities factsheet.
Notices to produce or attend
The agvet legislation enables the APVMA to require certain information by written notice.
Written notices provide time for the person to locate the information requested and to provide written context for the item or items. These notices may also require a person to attend a specific location and answer the questions of an inspector.
We send a formal notice to explain if information or records are being sought under a legislated power to request information. The notice refers to and explains the relevant provision of the legislation and outlines the consequences of noncompliance, if any.
There are penalties for noncompliance with notices requiring information or attendance, including fines and imprisonment. We have developed a regulatory guideline (Compliance and enforcement—notices to attend, give information or produce documents or things) to explain how we may use these powers.
Substantiation notices are notices issued by the APVMA that require the provision of information to justify or support claims or representations made in the promotion and the supply of agvet chemical products or active constituents. The notice specifies the claims we are seeking information about and indicates the types of information or documents that must be provided.
Section 145G of the Code Act and section 69EN of the Admin Act enable us to seek evidence with substantiation notices to support claims made about a product. The use of these notices is limited to information, including documents, about the supply, possible supply, manufacture, safety, efficacy, import, possible import or export of a chemical product. These notices do not apply to a person who publishes claims made by another person where there is no commercial relationship between the two, other than the role of publishing the claims (for example, by advertising agencies that merely publish claims on behalf of others).
The authority to issue substantiation notices is intended as a preliminary investigative tool where the APVMA suspects that a representation might not be able to be substantiated and subsequently is in breach of the Admin Act, Code Act or Collection Act. Their use means that we do not have to attempt to establish the veracity of the claims, but can seek information and documents about them.
We have developed a regulatory guideline (Compliance and enforcement—substantiation notices) to explain how we may use this power.
Seizure of evidence
An APVMA Inspector can seize any item that they believe on reasonable grounds to be evidence of an offence or contravention. The Inspector does not need to return the seized item if possession of the item would be an offence. We can also organise the disposal of seized items if that is appropriate; however, we will take steps to return an item for subsequent disposal by the owner if necessary. Further information about APVMA seizure powers is available in the Seizures factsheet.
Monitoring to prevent imminent harm
The APVMA is able to act swiftly to secure material if the material poses a potential health or safety risk to people, animals, the environment or international trade. Additional powers provided under section 131AA of the Code Act enable APVMA inspectors to exercise monitoring powers without warrant or consent if there is imminent risk to people of death, serious injury or serious illness. We have developed a regulatory guideline (Compliance and enforcement—monitoring to prevent imminent harm) to provide further detail about this power and the circumstances under which it may be exercised.
Seizures to manage risk
Similarly, APVMA inspectors have powers to seize items where it is reasonably necessary to do so to control products that may represent risk, either with the consent of the owner or person in possession of the item or during the execution of a monitoring or investigation warrant. Alternatively, the inspector can seize items without consent or warrant under section 131AA of the Code Act where they consider that there is a risk of imminent harm.
The APVMA may issue an enforceable direction relating to conduct when reasonable grounds exist to suspect that the conduct breaches the Code and the direction is necessary to protect people, animals, the environment and international trade. The direction requires a person or company to take action (to do something or cease doing something) to achieve compliance.
Noncompliance with an enforceable direction is taken very seriously and will be followed up with court action.
The APVMA has developed a regulatory guideline (Compliance and enforcement—enforceable directions) to provide further detail about enforceable directions and how we may issue and enforce them to ensure compliance.
Section 69EM of the Admin Act and section 145F of the Code Act authorises any person (including the APVMA) to apply to the court for an injunction in circumstances where a person has engaged or is proposing to engage in conduct that contravenes the Admin Act, Code Act or Collection Act. Injunctions may be restraining or performance injunctions. The terms of an injunction are determined by the court but may include an order to take particular actions.