Compliance Program Operating Principles

SCOPE

The purpose of this document is to identify for the benefit of the various stakeholders of the National Registration Scheme including the public and those within the regulated community, the operating principles of the Compliance Program operated by the APVMA. The document provides a framework for the operation of the Compliance Program and does not set out to detail operational procedures. It is not legally binding and may be subject to alteration without notice.

ABOUT THE APVMA AND THE NATIONAL REGISTRATION SCHEME

The Commonwealth and the States and Territories established the National Registration Scheme through adoptive complementary legislation with the aim of placing under one national umbrella the regulation of agricultural and veterinary chemicals in Australia. The States and Territories previously undertook this independently.

The APVMA administers the National Registration Scheme in cooperation with the States and Territories, according to the provisions of the Agricultural and Veterinary Chemical Codes (Agvet Codes), and associated legislation and regulations. The objectives of the National Registration Scheme are to:

enhance the well-being of Australian society by protecting the health and safety of human beings, animals and the environment;

support ecologically sustainable development by ensuring that agricultural and veterinary chemical products available in the marketplace will not impair the prospects of future generations; and

provide for nationally uniform regulation of agricultural and veterinary chemical products in a cost effective, efficient, predictable, adaptive and responsive manner so as to further Australia's trade and commerce and economic viability and competitiveness of primary industry and domestic industry for manufacturing and formulating such products.

OBJECTIVE OF THE APVMA COMPLIANCE PROGRAM

The objective of the APVMA Compliance Program is:

To support the integrity and objectives of the National Registration Scheme through cost efficient, targeted, regulatory and promotional mechanisms selected on a risk management basis.

This objective is an acknowledgement that not all non-compliances reported to the APVMA will necessarily be investigated and that not all non-compliances investigated will necessarily be prosecuted.

Consistent with the APVMA's overall authority, the APVMA's compliance actions relate to the supply of agricultural and veterinary chemicals to the point of retail sale. Matters relating to control of use of agricultural and veterinary chemicals are the responsibility of the States and Territories. The APVMA and the States and Territories work closely together, however, to help ensure that there is an effective interface of these responsibilities.

APVMA's APPROACH TO COMPLIANCE

The APVMA has a strong commitment to the development of both proactive and responsive compliance strategies to protect; the health and safety of humans, animals, plants and the environment; Australia's trade; and to maintain the integrity and public confidence in the National Registration Scheme.

The philosophy behind our compliance strategies is to:

enhance industry's awareness of obligations arising from the Agvet Codes and associated legislation,
adopt a combination of proactive and responsive compliance enforcement strategies using risk management principles,
adopt whenever possible a conciliatory approach to compliance issues; and
provide effective compliance enforcement using due processes and in observance of the principles of natural justice.

We aim to achieve this through three key strategies of:

prevention,
facilitation of quality, and
surveillance and enforcement.

Prevention
Our prevention strategy is based on the precept that education deters acts of non-compliance and provides assurance to those who do comply. To that end the prevention strategy includes a range of activities aimed at enhancing awareness and understanding of the National Registration Scheme and compliance obligations by the various stakeholders. Particular emphasis is given to:

industry liaison through general consultative and subject or program specific committees and groups;
publication and dissemination of targeted information and educational material for key stakeholder groups (chemicals industry, retailers, wholesalers, agricultural and livestock industry, the public);
provision of seminars and training sessions, some in partnership with other agencies, including industry;
working with industry to achieve desired outcomes through co-regulation and control of the promotion and advertising of agricultural and veterinary chemicals;
selected promotion of enforcement outcomes; and
improved barrier control of imports and management of interfaces with other regulatory authorities such as Australian Customs Service, Therapeutic Goods Administration (TGA), and Australian Quarantine and Inspection Services (AQIS).

Facilitation of Quality
The quality of agricultural and veterinary chemicals in the marketplace is facilitated through publication of various standards, codes and guidelines. In addition, programs such as the Manufacturers Licensing Scheme (MLS) and the Adverse Experiences Reporting Program (AERP) are operated by APVMA in respect of veterinary chemical products.

Chemical products must be manufactured consistently, by reproducible methods, under appropriate supervision and with effective quality control procedures. For veterinary chemical products the APVMA has prescribed Manufacturing Principles that include Codes of Good Manufacturing Practice (GMP). The Codes of GMP are the standards against which Australian-based manufacturers of veterinary chemical products are licensed under the APVMA's MLS. Overseas-based manufacturers of veterinary chemical products must, as a pre-requisite to product registration, demonstrate that their product is manufactured to a standard comparable to the relevant Australian Code of GMP.

The AERP is a post-registration quality assurance program for identifying corrective action necessary to assure continued safety, quality and effectiveness of registered veterinary chemical products in the Australian marketplace. Reporting under the Program includes a mandatory obligation on the Registrants under Section 161 of the Agvet Codes and voluntary reporting is encouraged for veterinarians, animal owners, farmers and other users of veterinary chemical products. Reports received are evaluated in consultation with the Registrant and the manufacturer to determine whether the adverse experience is related to the product formulation, manufacturing processes, use practices or product labelling. The Program also looks at whether any changes to the registration status of the product involved are necessary.

Surveillance and Enforcement
Routine surveillance is currently conducted by the APVMA only in respect of Hormonal Growth Promotants (HGPs) as part of the National Monitoring and Control Scheme managed by AQIS in support of Australia's beef exports to the European Union. This takes the form of audits of importer and retailer premises and records. The APVMA also conducts surveillance campaigns in respect of specific chemical products. These are generally undertaken in partnership with the relevant State/Territory control-of-use agencies.

Compliance enforcement action is targeted using intelligence gathered from reports of non-compliance submitted by industry, the general public, other agencies such as Australian Customs Service, AQIS, TGA and police, and APVMA and State field officers. Industry is by far the greatest source (constituting some 70%) of reports of non-compliance received by the APVMA. After acknowledging receipt of the report, the APVMA assesses the actual and potential risk posed by the non-compliance bearing in mind APVMA's legislative obligations for public health, the environment, trade and product efficacy, by examining the:

validity of the report's claims (status of registration/approval/permit/consent to import, conditions of registration and approved label details etc);

potential or actual severity of the consequences of the product's presence in the marketplace (for example, animal deaths, harm or pain and suffering, crop damage etc);

history of the matter (for example, previous non-compliances or responses to previous requests for compliance action); and

completeness of the information provided and the potential to obtain relevant evidence that is legally admissible.

Depending on the assessed risk and the resources available and required to pursue the matter, the APVMA may take one or in escalation a combination of the following actions in pursuit of compliance:

administrative action,

investigation with a view to prosecution, and/or

recall of the product in question.

The matter may also be referred for consideration of whether it would be appropriate to suspend or cancel the registration and/or approvals for the relevant product.

POSSIBLE COMPLIANCE ENFORCEMENT ACTIONS

Administrative Action
Administrative action may be taken if:

the particular non-compliance does not pose an immediate or high risk to public health, the environment, trade, primary production, animal welfare, or a significant threat to the integrity and public confidence in the National Registration Scheme;

there have not been previous reports of non-compliance relating to the product, individual or company in question that are unresolved; and

where a prosecution is unlikely to be in the public interest.

The administrative action usually involves a letter of advice or warning to the suspected offender explaining their obligations and warning them of the consequences of continuing to act in contravention of the relevant legislation.

In many cases, it is possible to resolve the particular non-compliance effectively through an administrative process. If a satisfactory response to a warning letter is received from the alleged offender, together with appropriate corrective action, the matter is regarded as being resolved.

Matters resolved to the satisfaction of the APVMA by way of administrative action will not be subject of later prosecution. However, should the offender commit a further offence, details of all previous actions taken by the APVMA will be considered in the determination of risk and subsequent compliance enforcement action.

Investigation With a View to Prosecution
The dominant factors considered in deciding whether to mount an investigation into an alleged non-compliance with a view to prosecution is whether:

in the APVMA's assessment the non-compliance poses an actual or potential high risk to public health and safety, the environment, trade, primary production, animal welfare, or a significant threat to the integrity and public confidence in the National Registration Scheme;

there have been previous attempts to address the non-compliance through administrative action;

the particular individual and/or company has repeatedly failed to comply with the relevant legislation;

the non-compliance involves a significant degree of criminality; and/or

whether a prosecution would be in the public interest.

In determining the appropriateness of commencing an investigation, the APVMA may also take into account:

the availability, or likely availability, of legally robust evidence to support a prosecution in relation to the alleged non-compliance;

the apparent culpability of the alleged offender;

the date on which the alleged non-compliance occurred and the timeframe within which the alleged non-compliance could reasonably be expected to be investigated, based on the probable availability of evidence (ie statue of limitations); and/or

the resources required and available to conduct an effective investigation.

The approach adopted by the APVMA in the investigation of alleged non-compliances with the legislation is objective and is as much concerned with the exculpation of the innocent as with the conviction of the guilty.

The Commonwealth Director of Public Prosecutions (DPP) in accordance with the Commonwealth's Prosecution Policy conducts all prosecutions for the APVMA.

While the APVMA may refer Briefs of Evidence to the DPP and make appropriate recommendations, it is the DPP who will make the final decision whether a prosecution should proceed and what charges are to be laid.

Recalls
In some situations, it may be necessary for non-complying product to be recalled from the marketplace, depending on the circumstances relating to and the risk posed by the particular non-compliance. In general terms, decisions as to whether products are to be recalled will be taken in light of consideration of the factors identified in respect of investigations with a view to prosecution.

Recalls can be either voluntary or compulsory. Voluntary recalls should generally be conducted in accordance with the Guidelines for the Recall of Agricultural and Veterinary Chemicals. The APVMA applies the term 'recall' to include any action to correct a non-compliant agricultural or veterinary chemical product (or batch(es)) and/or action to remove a product (or batch(es)) from supply.

Voluntary Recall
The APVMA will encourage suppliers of agricultural and veterinary chemical products to act voluntarily whenever a recall is indicated. The APVMA will monitor a recall to ensure that adequate information is received, the non-compliant product is brought back into compliance and that, within reason, all affected persons are notified of the non-compliance and the remedial action to be taken. The APVMA will provide assistance and advice to suppliers conducting the voluntary recall.

Compulsory Recall
The timeliness, scope and method of voluntary recall action may influence the APVMA in deciding whether or not to issue a compulsory recall notice. Where the APVMA is not convinced that the voluntary recall is being conducted satisfactorily or the non-compliance poses a high risk, a compulsory recall may be considered.

The APVMA may issue recall notices, under Part 6 of the Agvet Codes, requiring persons who have, or have had, stocks of chemical products in their possession or custody, to stop supplying the product and to take action in relation to the product as directed by the APVMA.

FEEDBACK AND CONFIDENTIALITY

The APVMA values the information provided to it about possible non-compliance of agricultural and veterinary chemical products. In many cases maintaining the integrity of the complianceactions being taken will limit the feedback that we can give. It is APVMA policy that we will maintain appropriate confidentiality in relation to the progress of any compliance action as disclosure of that information may:

be prejudicial to our compliance actions and possible prosecutions,

be in breach of confidence, or

unfairly damage the reputation of a company or individual subject to compliance action if the allegation is not subsequently proven.

The APVMA will, however, publicise the outcomes of compliance actions when it is legally possible and appropriate to do so, as a deterrent to other potential offenders.