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?".