What happens when I have no evidence for a regulator?
In our last post I wrote about evidence needed for regulatory decisions. But what happens when you don’t have that information? Can you still get approvals?
The answer is yes ― but you need to think about a range of pathways to achieve your goal.
Sometimes evidence is scarce for a number of reasons. This may be because the idea or technology is novel and the knowledge you need is not yet developed. It may be because of proprietary information; the knowledge is there but is someone else’s property. Or it may simply be because the evidence is hard to access, and presented in ways that are difficult to understand. In any case, a lack of evidence can make getting approvals from regulatory authorities tricky, but not impossible.
Not having data or information can be easily resolved through a range of options:
Collate the evidence you do have ― work out where the gaps are and the best way to fill them
Undertake research, development and demonstration ― design a research program to demonstrate that you can meet regulatory requirements
Undertake options analysis and literature review ― work out if there are other approaches or options for your business, and if there is sufficient evidence available to meet regulatory requirements.
Use a hazard-based analysis ― where there is insufficient information to undertake a risk assessment, a hazard analysis may be a viable alternative option.
We have been undertaking one or a combination of these options where further evidence is needed. Gap analysis is always a favourite; there is no point in reinventing the wheel when you already have everything you need! We have provided options for research programs in the waste management space, to ensure there is sufficient information to get a full approval for their new waste processing technology. We have recently been doing quite a few options analyses for waste management under the waste hierarchy of different regulators. This means we can use research already undertaken to determine alternative waste pathways and opportunities, whilst also understanding evidence gaps and limitations for regulator decision making. Hazard based analysis is a new option we have been trailing in the regulatory decision space, but which we have a lot of experience in using for environmental chemistry. It focuses on using limited information in evidence and risk-based way, but where a full risk assessment is not achievable.
What evidence is needed, and valid options for obtaining the evidence, will be different for each jurisdiction. As the knowledge may be in disparate places or not yet readily available, we need to compile the evidence together for a specific problem and this can take a bit of time. The good news is that even if a technology is completely new, we as scientists are well equipped to find pathways forward that ensure innovations are environmentally appropriate and acceptable to regulators.