Responsive compliance and enforcement

When an investigation is completed, the APVMA has discretion to respond using a graduated range of compliance and enforcement tools. We choose a response or combination of responses that will deliver the best outcome to achieve operational and legislative objectives. This can include choosing to:

  • not pursue the matter further
  • support and encourage voluntary compliance (by providing advice, raising awareness and engaging stakeholder groups)
  • take administrative action to control risk
  • implement a mid-range compliance response, such as a formal warning or compulsory recall
  • pursue a sanction such as an infringement notice, civil penalty order, cancellation of authorisation or prosecution.
Where allegations about agvet chemicals include issues relating to use of the products, we can refer the matter to or investigate it jointly with state or territory agencies. Where noncompliance involves the responsibilities of other agencies, such as health or consumer protection, we can refer the matter for consideration. In certain circumstances, we can refer suspected contraventions of agvet legislation to the Australian Federal Police or other enforcement agencies for investigation.

Responding to noncompliance

Once the examination of an allegation has established whether noncompliance is evident, we take a range of factors into consideration, consistent with the APVMA compliance and enforcement policy, to determine the best response.

Factors that inform our decision-making include the following:

  • the nature and severity of harm—the seriousness of the risk the noncompliance poses to people, animals, the environment or international trade; whether the Australian Government or community has incurred cost (or loss) due to the contravention; and whether Australia’s obligations under international agreements have been affected detrimentally
  • the law—whether APVMA-administered legislation provides specific provisions for dealing with the type of contravention and, if so, the scale of the applicable penalty provision; any legal precedent; the required deterrent value of the APVMA response; the likely standard of evidence that can be collected; the availability and willingness of witnesses to support litigation; and the time elapsed since the contravention, including the time available for a response within the statute
  • the integrity of the regulatory system—including whether there are legislative policy issues that have contributed to the noncompliance; the frequency of the type of contravention; likely public concern about the contravention; and whether the proposed response will deliver effective compliance
  • culpability and mitigating circumstances—whether the contravention was deliberate, reckless, negligent or a mistake; the actual or potential benefit to the offender, including levy evasion; any history of similar behaviour; whether the matter was self-reported; and the degree of cooperation afforded by the offender.

Noncompliance can be categorised based on risk and seriousness. Incidents that require only minor corrective action may be considered low level (or low regulatory risk). Where noncompliance requires significant corrective action or has resulted in harm, the incident may be considered mid to high level (or mid to high regulatory risk).

Low-level or low regulatory risk noncompliance

Examples of low-level noncompliance include a self-reported minor incident, a one-off incident that is readily rectified and for which direct benefit is negligible, an isolated incident in a high-volume business, or an incident involving a reasonable misinterpretation of a definition, condition or requirement.

Low-level noncompliance responses include (but are not limited to) taking no further action; letters of advice; increased monitoring; increased awareness raising or campaign activity; formal warnings; compliance audits; suspension of authorisations; and amendments of conditions.

All APVMA responses to noncompliance, including decisions to take no further action, are defensible and are recorded.

Compliance campaigns

We proactively undertake compliance campaigns on specific issues or in specific regions to promote and ensure voluntary compliance. These campaigns may include compliance information and education sessions, mail outs or visits. For example, inspectors may visit a number of pool and spa chemical retailers to provide information and check the registration status of chemical products being offered for supply.

We also track allegations of noncompliance to determine where low-level campaign responses may be appropriate. The allegation frequency relates to the number of complaints received about a particular product type or activity, and research into the number of noncompliant entities likely to also be engaged in that behaviour (although not individually the subjects of complaints). Our monitoring of the market (the physical market and internet trade) assists by providing supporting data to guide these activities.

In a hypothetical example, the APVMA Compliance section might receive 15 complaints about products of Type X during a quarter. Three complaints about products of Type Y are also received. As the allegations are risk assessed and prioritised, they are identified as of low regulatory risk. However, research during the screening and validation stage reveals that there are a further 85 noncompliant Type X products in the marketplace. None of the 85 products is yet the subject of a complaint. Research identifies that the complaints about Type Y products can be traced to one supplier.

This scenario may lead us to consider that there is an issue in the marketplace involving Type X products and that a potentially large market sector is affected, but that there is just one ‘unaware’ supplier of Type Y products.

The most efficient way to resolve these noncompliances is to encourage voluntary compliance through direct contact with the Type Y supplier and to pursue the matter until it is resolved. Simultaneously, we would undertake a low-level campaign to provide information on how suppliers can comply with agvet legislation if they are supplying Type X products. We would monitor the effectiveness of the campaign and apply different measures to sustained noncompliance by any individuals.

Mid to high-level or medium to high regulatory risk noncompliance

Examples of mid to high-level noncompliance include repeated contraventions or failure to respond to low-level interventions; incidents that have significant impact on matters protected by agvet legislation; incidents that entail significant potential for direct benefit to the offender or loss to others; frequent incidents in a high-volume business; deliberate, reckless or criminal non-adherence to definitions, conditions or requirements; the submission of false and misleading information to us; and levy evasion.

Mid-level noncompliance responses include (but are not limited to) formal warnings; enforceable directions; enforceable undertakings; infringement notices; substantiation notices; notices to produce or attend; suspensions or cancellations of authorisations; monitoring under warrant; and amendments of conditions.

High-level responses to noncompliance include enforceable directions; infringement notices; suspensions or cancellations of authorisations; seizures leading to forfeiture if you are convicted of an offence; enforceable directions; civil penalty orders; injunctions; investigations under warrant; and referrals for prosecution.

Mid to high-level responses are undertaken with oversight of the APVMA Enforcement Committee because they may involve investigation, the deployment of APVMA resources and the exercise of coercive powers by APVMA inspectors. Our preferred response may vary in the course of investigation as more becomes known about the noncompliance, and the investigation may result in any type of response, including a decision to take no further action.

In all aspects of civil and criminal proceedings, the APVMA endeavours to act as a ‘model litigant’.

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