Fwd: Email from the OGTR

[Bryan Bishop]

From: Luke Weston <reindeer...@gmail.com>
Date: Wed, Dec 12, 2012 at 10:29 PM
Subject: Re: Email from the OGTR
To: bioha...@googlegroups.com

Interesting. It's kind of nice that their response is just "you must be compliant with the same rules as everybody else, but we're otherwise cool", as opposed to "it's absurd that you could do this stuff outside of a professional institution, do not do it".

Some quick thoughts:

- The attached PDF single-page "fact sheet" contains essentially nothing of value except the basic principle that certain activities involving any genetic engineering of an organism requires a permit from OGTR, but certain types of activities are exempt, in case the reader was unaware of that basic principle that you can't just do anything you want with novel GMOs in the environment without regulation.

- It is likely that most "DIY-bio" activities in Australia involving recombinant DNA, if any, are either exempt or NLRD. Dealings in a higher-risk category are likely to be rare to nonexistent. I would have a pretty good suspicion that nobody in the DIY-bio community would ever be likely to have any interest in any activity with GMOs or pathogens requiring a laboratory designed for (and regulated/approved for) PC2-or-greater containment.

- It is completely implausible that anybody in the DIYBio community or hackerspace or similar communities would have any interest in any dealings with any of the high-risk pathogens or biotoxins on the SSBA list, and in fact if anybody outside professional institutions did I would want them reported to the government anyway due to the high risk to the community. And all those sorts of nasty agents require you to have a PC3 (or 4) laboratory anyway, as well as the expertise in handling them safely, and it's just totally implausible that anybody is able to, should, or would be allowed to, or would want to, outside of a professional institution. I think it's just a moot point, with nothing to discuss.

- If the dealings are exempt, is accreditation of your organization with OGTR still required? Is an Institutional Biosafety Committee required?

- If the dealings fall into NLRD, accreditation of the organization, and the existence of the organization's IBC, is definitely required. How easy is this for an organization such as a hackerspace? What about an individual working in the DIY-bio space? Is it plausible at all?

But that's just what I think, quickly skimming over it.

Regards,
  Luke


On Tuesday, 11 December 2012 17:04:54 UTC+11, Meow wrote:
>
> If you got a letter from the OGTR, don't stress. I just spoke with the director of investigations and security and he just wanted to make ure that we were all aware of the relevant laws surrounding what we do. I invited him to come and give a talk in January. We will discuss more about this at the next meeting on thursday though.

[Patrik D'haeseleer]

On Wednesday, December 12, 2012 8:51:27 PM UTC-8, Bryan Bishop wrote:

From: Luke Weston <reindeer...@gmail.com>

- It is likely that most "DIY-bio" activities in Australia involving recombinant DNA, if any, are either exempt or NLRD. Dealings in a higher-risk category are likely to be rare to nonexistent. I would have a pretty good suspicion that nobody in the DIY-bio community would ever be likely to have any interest in any activity with GMOs or pathogens requiring a laboratory designed for (and regulated/approved for) PC2-or-greater containment.

If the PC categories are at all similar to the BioSafety Levels (BSL) here in the US, then yes, there are definitely DIYbio activities that strictly speaking would require a BSL-2 facility. That includes any time you isolate something from an environmental sample (e.g. isolating bioluminescent bacteria from fish!) or when you're working with human samples.

Again, strictly speaking, in a BSL-1 laboratory, you are only supposed to work with organisms that you know to be harmless. That would rule out any kind of environmental samples or microbiome analysis. I've definitely seen academic labs in the US play fast-and-loose with those rules as well though. But depending on how paranoid your local government is, it could be used as an excuse to crack down on certain DIYbio activities.
 

- It is completely implausible that anybody in the DIYBio community or hackerspace or similar communities would have any interest in any dealings with any of the high-risk pathogens or biotoxins on the SSBA list

How about, for example, synthesizing entirely harmless enzyme genes that just happen to be found in a pathogen? That tends to be a grey area where you normally need some review board to sign off on its safety in an academic setting.

[Cathal Garvey (Android)]

Such as, say, HindIII, a common restriction enzyme from H.influenzae.

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