RE: [DIYbio] Re: civil disobedience and diybio

> -----Original Message-----
> From: diybio@googlegroups.com [mailto:diybio@googlegroups.com] On
> Behalf Of matt harbowy
>
> The OP was not discussing any project in specific, just saying that any
> project that involves chemical synthesis would be illegal to perform at
> home.

Can be illegal. I believe it is illegal to do the chemistry you described in
your longer post without appropriate licenses and red tape in much of the
US, though it's hard to quantify what the attendant risk actually is in any
given case, and what can be done to mitigate it. The scenarios I'm more
concerned with are those that fall under FDA purview and are therefore
definitely illegal.

The rest of your comments appear to be arguing the cost side of the
cost-benefit equation, in that you think it's high enough to be an issue for
any work of significance, particularly around knowledge transfer.

A concrete example of the procedure that I was thinking of would be this
sort of thing: the SENS Research Foundation establishes a bacterial enzyme
derived small molecule that breaks down A2E usefully (or some other
lipofuscin constituent) and shows it's effective and non-toxic in vivo in
mice and in vitro for human cells. The protocols are all laid out in the
relevant papers, with the usual amount of domain knowledge required. The
enzyme-derived molecules are something that could be created with the right
toolkit, but certainly not something that's ever going to see the other side
of the FDA for anything other than treatment of advanced AMD, despite
general utility for all older people.

With collaboration, you could reliably reduce something like this down to an
established procedure, something that can be taught, videos made, ebooks
written, meetup classes held, etc, etc. But it's certainly illegal - or
retroactively illegal as soon as it is noticed - to sell a compound that the
FDA will class as a drug, and quite possibly illegal to even manufacture it
in small amounts for the sake of curiosity. Publishing on the topic may or
may not be legally risky, but given that the FDA isn't all that restrained
it may get you attacked and greatly inconvenienced by agents of the state.
And so on, with the risk rising the greater the attention you gather to your
operations: anything that looks like medical manufacture, becomes popular,
and winds up in the news will result in some form of attack, even the FDA
has to first declare what you are doing illegal. This sort of threat matrix
puts a big damper on generating the grassroots ecosystem you need to
recreate research results effectively in a diybio environment.

> I picked an example synthesis to show how a practical reaction
> which is fairly easy to do and is legal to do can have unintended
> consequences. I am certain of the outcome: but if you're not careful,
> the average DIY person reading and repeating published methods in
> reputable journals might be misled if they take what is written at face
> value.

So where you argue for the hardness of the work as a barrier, I'd argue for
the personal risk attendant to the regulatory threat as something that makes
it hard to build the necessary structures to make the work accessible.

Reason

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