Re: [DIYbio] Re: Help for thesis: american law regulating research

Okay, but still I don't really get it...;)
So, you say you can almost do anyhting you want ..you mean at home? One of the most important things is: is there, e. g., a special agency that really has control over your work?
And are all guidelines (NIH; CDC; BMBL;) only recommendet or required if you don't research at an institution?
So let's say you want to establish a community lab, can you open a BSL 1 - lab without any registration and expertise or is there an agency for the autorisation process?
Another question: you mentioned city laws, are there really special laws for each bigger city and if so, what are they mostly about?

Thanks again, it's not that easy to understand the American system, because in Austria, as already mentioned, you got really strict regulations. So here it's clear that you need to register somewhere if you want to organize community research...
Greetz, Eni

Am Samstag, 25. Januar 2014 22:01:12 UTC+1 schrieb Jacob:

In the US BS levels are guidelines not specific regulations. 

So generally you can do anything, provided you don't fall afoul of another agencies specific regulations: 

• OSHA(if you have employees)
• EPA(environmental release)
• CDC(when dealing with select agents)
• NIH/NSF(only when receiving funding from those sources)
• City Laws(Zoning issues if you don't live in Houston).
  
• FDA/HHS(if you are doing something that requires an IRB ie human studies)

I much prefer this method, because adding a restriction across the board would just add a cost to independents and school labs, while not actually increasing safety. Since everyone mostly follows the CDCs guidelines even if they don't have to. And it's not the creation of a GMO in a lab that's potentially harmful but releasing said GMO which is already regulated by the EPA and/or the FDA.

On Sat, Jan 25, 2014 at 1:45 PM, Mega [Andreas Stuermer] <masters...@gmail.com> wrote:

So, my question: Are there any regulations in America or do you have to abide by any law? 

I just know that S1 is unregulated. So it seems to be an absence of regulation in this particular case. Rüdiger from Berlin mentioned there even is a German law granting freedom of doing science, Recht auf freie Wissenschaft (or something like that). 

As you sure know, this right  stops with genetic modification here in Austria as well as in Germany. 

 suppose that it might be important if you want to establish a community lab or if you need materials for experiments. Or even if you tinker at home, isn't there any limiting rule??

AFAIK, you can do anything as long as it is not S2  regulated. 

The total American law system is totally diferent from ours. while we have the precautionary principle - everything is forbidden that is not allowed, in the US anything is allowed as long as not proven dangerous (evidence based) 

Greetings from Oberösterreich,

Andreas

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Cheers,
Jacob Shiach

founder: Brightwork CoResearch

program director: SynBio axlr8r