APVMA Compliance—our risk-based approach

The APVMA aims to maintain the integrity of the regulatory system and focus its compliance and enforcement effort on activities that pose the greatest risk to human or animal health, the environment, primary and other industries and trade, or that are of major concern to the community.

Our approach is based on identifying regulatory risk, taking into account the likelihood and severity of the consequences of noncompliance. We prioritise our compliance and enforcement activities based on risk and allocate proportionally more resources to activities that address higher regulatory risk.

In establishing the risk and priority of noncompliant activity or behaviour, we consider:

  • the seriousness of the noncompliance, including the potential for harm
  • the character of the behaviour leading to the noncompliance
  • the degree to which humans, animals, the environment or the agvet chemical, agricultural and trade industries have been or could be exposed to risk or harm
  • whether agvet legislation has been contravened
  • whether the APVMA is best equipped to respond.

Validation, risk assessment and prioritisation

All reports about actual or potential breaches of agvet legislation are subject to an initial assessment that seeks to validate key information and establish the risk and priority for compliance and enforcement action.

Based on the initial assessment, we quickly determine a course of action, which may be to:

  • not pursue the matter further
  • seek more information
  • begin an investigation.

Accountability

The APVMA keeps records of all reports and their treatment. Even if we elect not to act on a particular matter at a particular time, that view may change if we receive further reports or additional information.

Any further enquiries and investigations are undertaken in a manner that is respectful, lawful and meets relevant Australian Government standards, and are also fully recorded. The aim of further enquiries or investigation is to:

  • determine whether any agvet law has been contravened
  • understand the circumstances leading to any noncompliance
  • gather evidence in a manner that ensures it will be admissible (if needed later)
  • identify issues or needs for improvement in regulatory control
  • support a return to compliance
  • achieve an appropriate outcome within a reasonable time and at a reasonable cost, according to the law and the nature of the investigation.

All enquiries and investigations are documented to a standard that demonstrates thorough consideration of the matter and the basis for our response and to permit escalation of the matter to court if needed.

We conduct our compliance activities to ensure that the presumption of innocence is supported, the reputations of people and companies are respected, and company operations are not unduly prejudiced.

We conduct compliance activities in a manner that is sufficiently robust to ensure that the evidence collected is relevant and admissible. In conjunction with the need for our actions to withstand review, this means that some formality is necessary and desirable.

There are specific reasons why formality and strict processes are required. The use of some forms of power or the application of a sanction based on legislation can generally be disputed in a relevant court or tribunal. For example:

  • decisions about the issue of recall notices can be disputed in the Administrative Appeals Tribunal
  • culpability for criminal sanctions sought through the CDPP can be resisted in court.

As well as legal review, people or companies may also complain about the conduct of the APVMA compliance investigation or the APVMA inspectors or other staff. This may be on the basis of perceived bias or belief that unfair or inappropriate behaviour has occurred. The APVMA takes any complaint about its officers very seriously and will carefully consider all aspects of the matter. A senior officer independent of the activity subject of complaint will undertake any review. If a dispute is unable to be resolved it may be taken to the Commonwealth Ombudsman. The Ombudsman is the independent authority that safeguards the community in its dealings with Australian Government agencies.

Our compliance investigations

All reports and detections of potential breaches of agvet legislation are subject to an initial assessment by the relevant APVMA section to ascertain their priority for further compliance and enforcement action. Priorities are set to ensure that we use our investigative resources most effectively.

Initial assessment typically includes a preliminary examination and analysis of the noncompliance report or allegation to determine the likelihood that a breach of the agvet legislation has occurred and to assess its seriousness and likely consequences. If possible, the APVMA acts to prevent noncompliance and encourage ongoing and future compliance.

Based on the outcome of the initial assessment and the legislation, we determine the appropriate level of intervention, if any. Depending on the results of the initial assessment, we may elect to:

  • not pursue the matter further (taking into account its jurisdiction, priorities, whether a breach of legislation has occurred, and how best to achieve the objects of the legislation or program)
  • seek more information from the person or company that reported the noncompliance, as well as the marketplace or the entity that the noncompliance report relates to
  • proceed with a detailed investigative action (reserved for noncompliance identified as high risk).

Our enquiries and investigations aim to:

  • determine whether the law has been broken
  • gather evidence that will be admissible in civil or criminal proceedings, or that may facilitate regulatory action
  • improve controls to prevent contraventions
  • deter further or similar action
  • improve public confidence in the integrity of the regulatory system
  • achieve an appropriate outcome within a reasonable time and at a reasonable cost, according to the law and the nature of the investigation.

In certain circumstances, the APVMA can refer suspected contraventions to the Australian Federal Police or other enforcement agencies for investigation. During those investigations, the APVMA supports the investigating agencies on matters relating to administration or enforcement of agvet laws.

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