‘Biotech must be given room to innovate’

In biotechnology, safety regulations are much stricter than in chemistry, Britte Bouchaut noted as a PhD student and that stands in the way of becoming sustainable.

Britte Bouchaut: “Researchers get frustrated by the paperwork they have to submit.” (Photo: Jos Wassink)

“We need a new kind of chemistry that emits less CO2, uses biological raw materials and is less of a burden on the climate. This requires new processes and new chemicals, and a greening of chemistry. Biotechnology can contribute to this. But then it must be given room to innovate safely,” argues Dr Britte Bouchaut. She obtained her PhD cum laude in November on risk management and regulation of biotechnology at the faculties of Applied Sciences (AS) and Technology, Policy and Management (TPM). She advocates a new kind of regulation.

First some history, as the current strict regulations imposed on biotechnology did not come out of nowhere. In the 1970s, American biologists discovered that they could transfer hereditary material from one plant or animal to another. They found this such a shocking discovery that at a conference in 1975 they themselves imposed a moratorium: a pause until the risks associated with this so-called recombinant DNA technique became more clear.

Research was not at a complete standstill though. The promises of crop improvement were too tempting for that. And so, in the mid-1990s, the first genetically modified crops appeared on the market: soya, maize, tomatoes, potatoes and more. That advance led to public doubts and fear about ‘Frankenstein foods’ instigated by activists.

People took to the streets mistrusting genetically modified food crops. (Photo: Akshay Chauhan, Unsplash)

European politicians responded with strict regulations in all fields in biotechnology, including in the industrial sector that Britte Bouchaut focused on in her research as a PhD student. As a result, every genetic experiment in European laboratories involving living organisms still needs to be accompanied by a huge amount of paperwork to eliminate any risk. 


Britte Bouchaut began her studies with a bachelor’s degree in chemistry at the Hogeschool Zeeland. During her master’s in Innovation Sciences (TU Eindhoven), she studied the interaction between policy and technological innovation. In her PhD research, she compared policies for biotech and chemistry and discovered that safety regulations in biotechnology are much stricter than in the chemical industry.

As long as there is no evidence of toxicity, and that data must largely be provided by the producer, a chemical product is in principle allowed to enter the market. ‘No data, no problem’ is what this approach is called. And if a substance does turn out to be toxic, as was the case with the PFAS chemicals, the industry is free to come up with a variant (in this case shorter carbon chains) whose toxicity has not yet been established.

In her thesis, Bouchaut observes that strict regulations hamper innovation in biotechnology, while regulations lag behind in the chemical industry. These differences, she says, stand in the way of the emergence of safer and more sustainable chemistry. Its development can only succeed if chemistry and biotechnology are brought under the same regime, Bouchaut argues.

Do you think the legislation on biotechnology is too strict?

“From the researchers’ point of view, yes. There is a lot of emphasis on safety. For policymakers who want to ensure safety, the requirements are understandable. I just think we have lost the balance. On the one hand, it is good that safety is guaranteed, on the other hand strict regulations inhibit innovation. Here in the labs, you see that the GMO (genetically modified organism, Eds.) policy is pretty buttoned up. Researchers have to demonstrate that all risks have been sealed before they are allowed to conduct a new experiment.”

‘When you do something new, you don’t know everything in advance’

How does that hinder their work?

“Researchers get frustrated by the paperwork they have to submit to the GMO bureau, part of the RIVM (National Institute for Public Health and the Environment), and thus of the Ministry of Infrastructure and Water Management. All those forms need to prove that an experiment is safe. But when you do something new, you don’t know everything in advance.”

You note that things are less strict in the chemical industry. 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 chemical products on a daily basis.”

So in biotechnology, there are prohibitive regulations and in chemistry, monitoring lags behind industrial practice. Why do you want to bring these together?

“We need a new kind of chemistry that emits less CO2, uses biological raw materials and is less of a burden on the climate. This requires new processes and new chemicals, and a greening of chemistry. Biotechnology can contribute to this. But then it must be given room to innovate safely.”

You write that this can be done with the ‘safe by design’ method. What does that entail?

Safe by design comes from chemical engineering and nanotechnology. The process means involving many different people with diverse backgrounds in the innovation process: companies, knowledge institutes and policymakers. The innovation proceeds step by step. Unexpected things can always happen, but if you find that out at some point you can go back in the process and take it into account.”

Has it been tried before?

“The process has already been applied in nanotechnology. It showed that researchers can indeed develop new compounds through safe by design. But there is no guarantee that the outcome is always 100% safe. Even in nanotechnology, things have sometimes not gone quite right.”

What did not go right?

“There have been nanoparticles in sunscreen that afterwards turned out to be toxic if people ingest them. That was not foreseen. Safe by design emphasises responsible, inclusive and safe innovation. So the method may consider safety, but there are no guarantees.”

You wrote about that in Nature. Have you had any responses to your article?

“Not so far. That is a pity.”

What is your next step?

“Safe by design hinges on transparency and openness in 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 explore how to set up communication platforms. I want to apply for a Veni grant to do this in the near future.”

Science editor Jos Wassink

Do you have a question or comment about this article?

Comments are closed.