What evidence do I need to provide for a regulatory decision?

I have been thinking a lot lately about evidence-based decision making, and what evidence is needed to demonstrate risk management and best practice. Specifically, I have been thinking about this in an environmental regulation context, where people and businesses need to demonstrate that their activities will minimise harm to human health and environment. This could be for a range of things including waste reuse, intensive animal agriculture or even the expansion of an industrial complex.

Commercial composting in Victoria (Photo: Jess Drake)

We provide advice to clients about what is needed for regulatory assessments, and I realised that it is difficult to know what is needed in the regulatory hierarchy soup. We like to step back and look at individual needs to make sure our regulatory assessments meet requirements. Generally, we use three high-level principles when it comes to providing evidence for regulatory decisions:

  1. Provide evidence of best practice ― explain what you want to do or what you are doing, and that you are doing it the best way you can. That may be using the regulators own guidelines or providing evidence of alternative best practice nationally or internationally.

  2. Provide evidence of risk minimisation ― not only undertake a risk assessment and provide risk management options, but present evidence that demonstrates how the risk management options will reduce the risk of harm to human health and environment.

  3. Follow the legislative hierarchy ― work out where you fit in the hierarchy and make sure your legislative obligations are met within points 1 and 2 above.

When following these three points, there can be a lot of evidence that needs to be gathered. The method for collecting this evidence could include desktop reviews, sampling and analysis, or even trials. It is always great when the practices which need regulatory approval or review have been done before. This hopefully means that there is scientific evidence publicly available that demonstrates best practice and risk minimisation. This isn’t always possible with new ideas and technology, and this is where we develop research and evidence strategies to get the information needed for regulatory decisions.

When the new Environment Protection Act comes into force in Victoria in mid-2021, the definition of best practice and risk minimisation will be clearer. Similar to other states and territories in Australia, best practice will be about what is the best available practice irrespective of jurisdiction or industry standard practice. This means best practice could actually be in a different state or country. For example, there is a lot of information about waste to energy in Europe, and less in Australia. In Victoria, this means the evidence in regulatory assessments could be compared to European or other states best practice, not Victorian best practice.

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