How to innovate safely and responsibly

Caution by microbiologists has helped create the strict regulations on their own profession, says Dr Britte Bouchaut. She obtained her PhD with honours last month on risk management and regulation on biotechnology at the Faculties of Applied Sciences and Technology, Policy & Management.

In the 1970s, American biologists discovered that they could transfer hereditary material from one plant or animal species to another. This was such a shocking discovery that at a conference in Asilomar in 1975 they imposed a moratorium on their own field: a research stop until there was more clarity about the risks of the newly discovered ‘recombinant DNA’ technology. They feared the creation, intentionally or unintentionally, of things like superbugs against which there was no defence.

Afterwards, it would turn out that the most dangerous bacteria and viruses are not created in the lab but in nature. But the tone was set, and biotechnology was long and widely distrusted. Fear and discontent were expressed in several ways, including through demonstrations against genetically modified crops (GMOs) and ‘Frankenstein foods‘.

Bouchaut began her studies with a bachelor’s degree in chemical engineering. She later saw that safety regulations in chemistry are much less stringent than in biotechnology. As long as there is no evidence of toxicity, and that data has to be provided by the producer, a chemical product is in principle allowed to appear on the market. ‘No data, no problem’ is what this approach is cheerfully called. And if a substance does turn out to be toxic, as was the case with PFAS, the industry is free to come up with a variant (in this case with shorter carbon chains) whose toxicity has not yet been established.

In her PhD thesis, Bouchaut observes that regulations in biotechnology stand in the way of innovation, while in the chemical industry, regulations lag behind. The rise of green chemistry makes it inevitable to bring chemistry and biotech under the same regime, she argues.

Do you think biotechnology is too tightly restricted?
“From the researchers’ point of view, yes. A lot of weight is put on safety. On the part of policymakers who want to ensure safety, the requirements are understandable. But I think we have lost the balance. On the one hand, it is good that safety is guaranteed, but on the other hand it also inhibits innovation. Here in the labs, you see that the GMO (genetically modified organism) policy is pretty buttoned up. Researchers have to demonstrate that all the risks have been sealed before conducting a new experiment.”

How does that get in the way of researchers?
“Researchers get frustrated by the paperwork they need to submit to the GMO bureau, which is part of the RIVM and thus of the Ministry of Infrastructure and Water Management. In that paperwork researchers have to prove that an experiment is safe. But when you do something new, you don’t know everything beforehand.”

You note that things are different in chemistry. How can that be?
“The chemical industry has been around much longer than the biotech industry. There is a strong lobby behind it, and we need many of their products in our daily lives.”

So in biotechnology, there are innovation-hindering regulations, and in chemistry, monitoring lags behind industrial practice. Why do you want to lump these together in one category?
“Biotechnology has the potential to find solutions for CO2 emissions and climate change. For that, we need new types of chemistry, new processes, and new chemicals. You want these to be safe, now and in the future. So safety and innovation have to go hand in hand. In biotech, you see a lot of emphasis on safety, and less on innovation. In the chemical industry, you see a lot of innovation, but safety could often be better. We must find a middle ground.”

And you call that middle ground Safe by Design. What does that entail?
“Safe by Design comes from chemical engineering and nanotechnology. It involves many different people with diverse backgrounds in an innovation process. You can make that a step-by-step process. Unexpected things can always happen. But if you find that out halfway through, you can go back in the process and take it into account. Safe by Design can set up a learning process that encourages new techniques or applications for biotech or chemistry.”

That sounds plausible. Has it ever been tried?
“Safe by Design has already been applied in nanotechnology. This showed that it can be done. But there is no guarantee that it is always 100% safe. Things haven’t gone quite right in nanotechnology either.”

What then?
“There were nanoparticles in sunscreen that later turned out to be toxic if ingested. That was not foreseen. So Safe by Design emphasises responsible, inclusive, and safe innovation. The method focuses attention on safety but cannot guarantee it.”

You wrote about this in Nature Communications with Professor of Biocatalysis Frank Hollmann (AS) and Lotte Asveld who researches the societal impacts of biotechnology at TPM. Did you get any reactions to your article?
“Not so far, so that’s a bit of a bummer.”

What is your next step?
“Safe by Design hinges on transparency and openness from companies and knowledge institutes so that there is an open communication platform between chemical companies, technology developers and policymakers. In the next few years, I want to examine how we can set up these communication platforms and channels. We need to look at what is needed to do this in terms of policy as well as of industry? How can we change this? Do we need to enforce it, or can it be voluntary? I want to apply for a Veni grant to do this one year.”