Remove DNA from TSCA review process so companies can ship DNA kits to these groups c. Remove regulatory barriers which inhibit sale of ‘kits’ to non-institutional scientists, eg: a.Ěllow them to self-certify as a Technically Qualified Individual and thereby gain access to the research use exemption b. The federal government should publish a document online clearly, in English not legalese, articulating which products are regulated by which agenciesĢ.Ĝompanies should not be allowed to claim confidential business information in regulatory reviews as it reduces public trust in the process and makes it harder for small companies to predict how likely their products are to get approvedģ. ![]() Here’s a summary of my recommendations, with detailed explanations contained within the text to follow:ġ. Our products are regulated by EPA and APHIS, and based on my experience with those agencies I have several recommendations for the coordinated framework review. I’m willing and available to discuss any of the points raised in these comments at your convenience. I ran the Glowing Plant Kickstarter campaign which launched the company and was the first ever crowdfunding application for a genetically engineered organism. ![]() As CEO my role is to focus on the non-technical aspects of the business including business development, marketing, fundraising, external communication and regulation. I’m the founder and CEO of TAXA, an early stage synthetic biology company with five employees focused on making consumer products with genetic engineering techniques. It’s time to try a less burdensome regulatory approach aligned with the actual scientific consensus on the risks. The current regulatory system has failed to build trust in biotech products amongst consumers, while imposing significant burdens on innovators and in so reducing the economic potential of the industry. As you can see we need particular support around kit’s and DIY Bio as there’s an opportunity to lift restrictions in that space. To support you with ideas for comments I’m sharing my own comments in the section below, my responses to questions 4 and 5 in bold (scroll down!) are likely the most relevant to you as that’s where we highlight this project and crowdfunding’s impact. Comments are open until Midnight eastern time tomorrow (Friday) and can be submitted at this link:įeel free to say whatever you like, support for genetic engineering is the main thing, sharing why you backed this project might be interesting. I should emphasis that none of this is going to affect delivery of any rewards as any changes will take time to move into action.Īs you can probably imagine most of the comments are currently from anti-GMO, anti-Science types so it would be great to counter-balance with pro-science comments. ![]() Regulation is the unglamorous side of what we do but it’s critical to our and future projects freedom to operation. ![]() Please tell the White House how important Synthetic Biology isĪs we mentioned in our last backer update the White House has asked for comments on their updates to the Coordinated Framework for Biotechnology.
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