Risk assessment framework

The APVMA has commenced a project to develop a risk assessment framework for determining the appropriate regulatory effort to be used in assessing applications for product registration or active approval.

The aim is to identify and implement practical improvements and incorporate more efficient processes in the way the APVMA manages applications.

Seeking the views of industry and the community is a key part of this project.

Background

Around 3 000 applications come into the APVMA each year and of these approximately 70 per cent are applications to produce a copy of an existing product. Depending on the nature of each application, there are up to eight different assessment components conducted as part of the registration process, including:

  • chemistry
  • toxicology
  • occupational health and safety
  • residues and trade
  • environmental safety
  • efficacy
  • antimicrobial resistance, and
  • gene technology.

The existing processes and information requirements already take into account that not all applications pose the same level of regulatory concern and therefore do not require the same level of regulatory intervention.

Using the more than 20 years of experience we already have in the regulation of agricultural and veterinary chemicals—we are seeking further opportunities to refine our approach.

There is scope to identify classes of products where the risks are well defined and suitable for reduced regulatory intervention, which can free up resources to focus on those submissions where a greater degree of assessment is needed. 

Project information

A revised framework for assessment of agricultural and veterinary chemicals will:

  • define different levels of regulatory effort required to assess applications for product registration or active approval
  • keep regulatory or administrative burden at the minimum required to satisfy our decision making obligations
  • ensure that decisions on the level of assessment and associated risk mitigation measures will be cost-effective, efficient, predictable, adaptive and responsive
  • ensure that the level of regulation is commensurate with the risks posed by particular products—‘acceptable risk’ not ‘nil risk’
  • ensure consistent and transparent application of regulation
  • be easy to understand, and
  • be well communicated.

Risk based assessment framework concept

 applications received are categorised with a regulatory risk of high, medium or low. Example treatment processes include full assessment for high risk applications, partial assessment for a medium risk application and self-registration or monitoring where the application is assessed as having a low regulatory risk. Example legislative tools used in treatment processes include modular assessment, conditional registrations, the notification scheme and the self-registration scheme, as relevant.

The APVMA has engaged Professor Mark Burgman from the Centre of Excellence for Biosecurity Risk Analysis (CEBRA) at the University of Melbourne to develop the principles and criteria to underpin a categorisation tool for the APVMA.

Key milestones

The framework will be developed in the first half of 2015, with consultation expected to occur later in 2015 (around October). Depending on progress, the aim is to begin implementation from 1 July 2016.

Consultation

The APVMA will be consulting with a wide range of stakeholders over the life of this project. 

Any formal consultation undertaken for this project will be published on the APVMA consultation page.

Feedback and comments

Comments and feedback on this project are welcome at any time, including on reports we make available as the project progresses.

You can send information by email, post or fax to:

Risk Framework Project Manager

Phone: +61 2 6210 4768

Fax: +61 2 6210 4776

Email: enquiries@apvma.gov.au

Resources

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