Decision-making using a risk based framework

Fact Sheet No. 1

The existing basis for the APVMA’s decisions is not sufficiently clear. In addition, the current approach lacks flexibility with a ‘one size fits all’ approach being used for all applications. The Better Regulation of Agricultural and Veterinary Chemicals reforms would improve the efficiency and transparency of decision-making under agricultural and veterinary chemical legislation by implementing an overarching framework for risk based decision-making¹. Providing a comprehensive reference to the risk assessment process will improve the predictability of regulatory decisions. 

Risk based framework

The framework would be developed, maintained and published by the APVMA. The framework will improve transparency by consolidating all relevant guidelines, standards and methods which guide regulatory decisions.

As the framework would apply for all regulatory decisions, it will assist in communicating the acceptable level of risk and the APVMA’s regulatory posture in regulating agricultural and veterinary chemicals. 

The framework would describe how the APVMA and its regulatory partners determine the scale of an assessment appropriate to the nature of the application proposal, and therefore match regulatory effort to risk.

Improved efficiency and transparency

The reforms align the APVMA’s assessment to the relevant risks posed by active constituents or chemical products seeking access to the Australian marketplace. In certain circumstances, the APVMA may use discretion in determining whether consideration of a particular aspect is necessary, such as efficacy and potential impact on international trade. For example, the APVMA would not need to consider prejudice to international trade when considering registrations for companion animal products or approvals for active constituents. However, if a chemical product would be used on export exposed animals or plants, the APVMA would retain the discretion to consider this matter. 

The reforms clarify the matters the APVMA must consider (for example, poison classification) and detail those matters that the APVMA may consider (for example, product stability). The APVMA would continue to consider public health, occupational health and safety and environment in all circumstances when making regulatory decisions about agricultural and veterinary chemicals.

The framework applies to all applications (including permits), reconsiderations (chemical reviews), recalls, suspensions and cancellations. This will ensure a consistent and transparent approach to each type of regulatory decision about agricultural and veterinary chemicals. The framework is also intended to assist applicants in ensuring that their data packages consistently meet the APVMA’s requirements. 

¹ _{Schedule 1 of the DRAFT Agricultural and Veterinary Chemicals Legislation Amendment Bill 2011 includes amendments to implement an articulated framework for risk based decision-making.}