DIYBio and biotinkering - Laws and regulations in Germany

A few days ago, I was reading a book on working with cell cultures, which includes an overview of the legal requirements for working with GMOs in a lab. This was a bit of a smack on the head for me - I had never thought of that before. With all that talk and all the recent articles hyping garage biology (often meaning garage genetic engineering), I had never come across a discussion of the legal situation. How could I have missed that?

So I looked into the matter, talked to people on the DIYBio mailing list, and it turns out that opening up a biohacking space in Germany as an autodidact is somewhat tricky. The following is a summary of the legal situation in Germany (though bear in mind that I'm no legal expert).

Genetic engineering is regulated through the Gentechnikgesetz (GenTG) and the Gentechniksicherheitsverordnung (GenTSV). Any work that inserts synthetic DNA into an organism falls under this law. To do that kind of work, you have to register a lab. This lab has to fulfill certain requirements, depending on the kind of work you want do. There are four categories (or levels) of work, from Level 1 (no risk to humanity or the environment) to Level 4 (high risk to humanity and the environment). This categorization is done based on a risk assessment and is closely associated with the kinds of organisms you want to work with.
There's a number of organisms that have already had an assessment done (see this document) - for example, E. Coli K12 is Level 1; Hepatitis C virus is Level 3.

Building and equipping a Level 1 lab seems doable, as the requirements are straightforward - it has to be a sufficiently spacious room, with a door that opens to the outside, a sink, workspace surfaces that are suitable for the chemicals that are used in the work and during disinfection, with an autoclave somewhere on the premise, and a number of other smallish things. Once you've registered such a Level 1 lab, you don't need to register every single project you're doing, but you have to keep detailed records for all of them.

The real hurdle is that you have to name two separate people in the registration, a project lead and a biosafety commissioner, both of whom need to have a degree in biology or medicine or closely related field, plus three years of work experience in an established genetic engineering lab and completion of a government-approved biosafety training.
Apparently, the agency responsible is a bit flexible on the qualifications of the project lead and biosafety commissioner, but very likely not to the point where they'd accept complete autodidacts.

This essentially means that any kind of biohacking space in Germany will have to rely on finding established professionals who are willing to cooperate and assume liability for anything that happens in this space.

Oh, and the penalty for doing any kind of genetic engineering work without going through this process is three years in jail or a fine of around 100,000 Euros.

All of this is currently a bit of a problem for me, as I have neither the formal proof of qualification, nor do I have two people with such proof of qualification who would be willing to act as project lead and biosafety commissioner, respectively.

I'm wondering how well suited this law is to the current development of a DIYBio movement in Germany, and whether it may provoke the creation of a biohacking "underground", which would be impossible to control or even monitor. Maybe a change to this law would be better able to police and integrate the current diffusion of genetic engineering technology amongst enthusiastic and capable autodidacts.

Meanwhile, in the US, the Obama administration seems prepared to take a more open-minded approach to garage biotechnology, as reflected in this article on Slate: "Faking Organisms: How can we govern the garage biologists who are tinkering with life?".

Comments

  1. Yeah the legal issues can get tricky... Even in US things can be very different depending on what state and city you live in, since each local government have their own regulations on the issue.

    Getting the legal and safety framework ironed out was a big part of the reason why Genspace took 2 years to open to the public. And we're still not done yet.

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  2. Seems ideas are unlimited. Open up your own lab lets say level 1 and play like tinker toys with your experiments. I already heard this with friends who are in the field, what an opportunity to get started.

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  3. The legal issues are pretty simple actually - you just cannot do any genetic engineering (including bacterial transformation) in your garage. Simple as that. Sorry. It's about the same here in New Zealand. I'm actually really surprised that it would be allowed in the US.
    You can still do DIYbio without genetic engineering - DNA testing and sequencing alone would be useful and interesting. Or any other type of biological experiments.
    DIYbio is a bit of a misnomer - it should be DIY molecular biology I think.

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  4. @Benjamin:

    Hmyes, hat's what I gathered. Up until now, I'm only doing DNA analysis/sequencing stuff, so I'm good for now. But eventually, I would like to move into genetic engineering as well, so I'll have to figure out how to handle these legal requirements.

    And yes, agreed on the misnomer. "DIY molecular biology" is just so unwieldy, so I sometimes get lazy and use "DIYBio" instead. Or biotinkering, as a fluffy term to refer to the mess of biology, molecular biology, and electronics that this work includes, and to signify that so far, I'm mostly just messing around.

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  5. I stumble upon this post every one or two months while searching and reading topics about DIYbio (google diybio germany). ;) Im not a biologist, I would describe myself as a curious software developer. First I like to thank you for your post and second it would be great if you could share some insights of your research "DNA analysis/sequencing stuff".

    What books or background knowledge do you recommend for people who like to get more into "biotinkering".

    Which kind of lab equipment do you own and what would be some good experiments to start?

    Thanks,
    R.

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