Improving our GMO regulations for laboratory and biomedical research

I would like to see lower regulatory burden on low risk GMOs that are only kept in containment. I would specifically like to see it become easier to create and culture GMO bacteria and plants in containment for the purpose of producing valuable products such as enzymes.

I agree in principle however, the devil is in the details - specifically what organisms and types of changes will be included in which risk tier. It seems that governing agencies trend towards being more and more risk-averse which results in increasing restrictions and rules about how to perform research. Some of these rules are now becoming ridiculous. For example, the movement of kiwifruit leaf tissue as a risk good (potentially carrying PSA-V) which is then used for destructive testing (DNA extraction) - we have really strict rules surrounding this but the risk is absolutely zero. We would have to be rubbing our samples onto kiwifruit vines for there to be any risk at all and yet there are all these requirements. At the same time, any random person could climb a fence and walk into a kiwifruit orchard, take infected live cuttings and move them anywhere in the country without anyone knowing about it or restricting it. The risk currently does not justify the regulations. So my appeal is to make the regulations actually proportional with the risk without being risk averse in the extreme.

I'm not really convinced that this will reduce bureaucracy. Having worked at a CRI, it is possible for these biosafety committees to become expensive (CRIs are so expensive with the massive overheads that they impose on their researchers) and arbitrarily restrictive depending on the personalities of the people involved. I can see how hey could be useful as well but I'm really not sure about this idea.

I generally agree but I also think that organisations should maintain central records of new organisms, perhaps with reduced details than are currently required.

This is impractical for small containers and something that should be accessible from a central record. It's doable but seems impractical.

Movement authorisations are unnecessarily time consuming and I don't think that they actually contribute to reducing any risks.

An important update to account for new technology.

I agree with the suggested criteria.

I think that we should reduce the regulation of organisms that cannot survive without supplementation of specific nutrients, such as E.coli that require such nutrients to survive. This would be helpful to make it easier to produce products such as enzymes while the risk to the environment would be very low to zero if the organism were to escape containment, simply due to the fragile nature of the organism itself. Such organisms should remain in containment and still be decontaminated by autoclaving or chemical treatment, for example, but require less permissions to create them.

This would be very helpful and have potentially great financial benefits.

While 10 litres is a good size for small to medium fermentations and is a size manageable by people (ie easy to carry), there is no real logic in restricting it to that size. I would say that something like 100 litres (or perhaps even 1000 litres) would be more appropriate. A spill of 100 litres is not much more difficult to manage than a spill of 10 litres.

Best of both worlds. A prescriptive approach is simple and that is useful in many situations, while it is useful to have an outcome-based approach for specific situations.

I expect a hybrid approach to be low or no cost.
A shift to a purely outcome-based approach would likely bring more cost with uncertain (or no) benefits.

My specific wish is to make it easier to create transgenic bacteria (E.coli) which can produce valuable enzymes used in molecular biology. This includes being able create these GMOs and culture them in medium scale fermentations. For a high throughput DNA testing laboratory, I estimate that the cost savings of this could approach $100000 per year so it has very substantial potential in reducing the costs of genetic testing. Current regulations which require specific approvals and PC2 laboratories to carry out this low risk activity are too restrictive and they absolutely make it difficult to impractical to do this and benefit from it.