24 hours to ask the White House to support DIY Bio

[Antony Evans]

Hello,

The White House is reviewing the Coordinated Framework which is the US regulations around biotechnology. There are 24 hours left to submit comments to them, the comment period ends at midnight Eastern Time on Friday Nov 13th (ie tomorrow). Comments are really easy to submit, you just go to this link:

http://www.regulations.gov/#!submitComment;D=FDA-2015-N-3403-0001

There are lots of ways the Government could make life easier for DIY Bio. There are also lots of ways they could make it more difficult, and as you can probably imagine most of the comments they have received so far are anti-biotech so there's a risk that we get more difficult regulations unless people engage. Please consider adding a comment with your thoughts.

There are several ways they could make things easier for DIY Bio:

1. Get the EPA to recognize DIY Bio participants as 'Technically Qualified Individuals' (TQI). The conversations I've had with them indicate that unless you have a masters degree in biology you don't meet this threshold and therefore do not qualify for the Research Use Exemption. My lawyers think it's less black and white than this as you can 'borrow' someone elses TQI qualifications (eg if working in a community lab and following safety rules set by a TQI) but it would be helpful to have clarity and broader use.

2. Deregulate DNA: at the moment you need EPA approval to sell DNA in kits. I know lots and lots of people sell DNA kits (including Amazon) but this is a violation of TSCA unless you can claim the Research Use Exemption. That means selling to a TQI and for research purposes (educational kits apparently don't count). We should get them to exempt non-pathogenic DNA from these regulations

3. It could spur entrepreneurship if there were more MCAN exemptions that meant iGem teams or people working in community labs could make products they can sell without needing EPA approval.

I posted the comments I submitted here for the curious, you are welcome to plagairise and modify to your hearts content: http://blog.glowingplant.com/post/133102353962/please-tell-the-white-house-how-important

Antony

[William Heath]

Comment Trackin Number: 1jz-8m8m-m058

I did my part.

-Tim BCSE, MSCS, MBA

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