NOTE: This is a behind the scenes look at the discussions in RevBio about the importance of regulatory compliance. There will be additional installments to this conversation. We are not doing any biological work at this time.
Revolution Bioengineering was accepted into a biotech business accelerator to create color changing flowers, or to at least demonstrate the technology that will bring that about. The accelerator program only lasts three months, which is a pretty short timeframe to get biological science done. We are now beginning our third week and we have a problem: we do not have regulatory approval to move forward .
A researcher must get their individual project approved by the Irish EPA. This requires detailing the specifics of the genes used and the organism to be transformed, i.e., putting yeast genes into bacteria to study a particular metabolic pathway. Even simple transformations of an empty pUC vector into a DH5a are not permitted unless approval is sought beforehand . The Irish EPA website states that the timeline for approval is 45 days, but the UCC biosafety chair told us that the process is rarely that long. Two or three weeks is typical for a thorough review and approval. This approval was filed last week.
To summarize our current situation: We have made significant sacrifices in our lives to be in Cork, Ireland for the summer. We have a lab space that suitable for everything we want to do, and we have all the genes and the plasmids and the enzymes and the materials we need to start working. However, we have no regulatory approval.
1. Wait around until EPA approval comes through before starting science work.
There is a lot of outreach and networking we can do in the next 2 to 3 weeks instead of biology. We can prepare videos and materials for our website to “build our profile” and generate interest in the project. This keeps us in line with the regulations, but prevents us from accomplishing our ambitious scientific goals.
2. Start doing work at UCC and not tell anybody.
We are in a foreign country and in this option we would be knowingly breaking their laws concerning GMOs. It’s unlikely to be reported to the EPA, per conversations with faculty and staff, and by choosing this we would be able to move our science project forward.
3. Start doing work at UCC and blog about it.
We started our company with the ambition to be very open about everything we do to demystify the scientific process and plant biotechnology in particular. Choosing this option would be keeping in line with our values, would allow us to get work done, but would be exposing ourselves, our accelerator program, and UCC to trouble.
4. Move our scientific operations to another country and clone there until UCC approval comes through.
Other countries don’t require individual project approval to do simple molecular cloning. We could move our operations there and do work until we get approval from Ireland, then move back to Ireland to do the plant work. This is the most expensive option.
Keira: Regulations are important to retain the public trust – they should be respected. No biological work until regulatory approval is granted.
Let me start by saying that we are experts in our field. We understand the risks, how to mitigate them, and are confident in the safety of both our approach and our end product. We know this project inside and out.
However, we understand that GMOs are a complicated topic with some frightening associations for the public. Having an open scientific process and sharing detailed descriptions of the science behind the plant isn’t enough to unseat the skepticism and fear that has overwhelmed public debate on GMOs. Instead, those of us working in this field have an obligation take on these projects within an eye towards rebuilding the public’s trust in science and scientists.
One simple, easy way to do that is to adhere to the established regulatory framework. Working on this technology without the official regulatory approval will taint our project with the same arrogance people despise in larger companies like Monsanto. Our goal is to engage the public, not alienate them, and I believe regulatory compliance is essential to establishing trust with the public.
This is not to say that the regulations cannot be changed. But that effort should be conducted through the proper political forum with public input and widespread discussion on the merits and safety of synthetic biology. It is less convenient to do this – the conversations will be frustrating and circular, the work will take longer. But it restores integrity to a process that many have given up on as controlled by special interests.
I will add to this that it’s not only our project we need to worry about. There is a growing DIYbio community in Ireland who has taken the time to follow the rules. We would be undermining not only our own position as a company dedicated to open science and public engagement, but the efforts of the DIYbio community as a whole, and quite possibly the larger field of synthetic biology.
We have already had to adjust our experimental plan due to delays in shipping and synthesis. Waiting at least another three weeks for regulatory approval will set us back further, but it is the right thing to do. Alternatively, we can shift operations to Germany until we have regulatory approval. In this scenario we can both get the science started and maintain our integrity – the work we plan to do is allowed under German regulation, and we can import DNA to Ireland without restriction. While neither option is ideal, they both make clear that we are committed to furthering our business in a responsible way.
Nikolai: If we don’t start working now, there are no ethics to fret over because there will be no business
Keira and I are at an accelerator program that takes idea-stage projects and gives them time and money to develop a prototype which they can then pitch to investors. We have made significant life sacrifices to get to Ireland to take advantage of this opportunity, and we are fully committed to it. Without this accelerator, all we have is an idea.
Everything we are doing is safe, and the project falls well within the Irish EPA guidelines of biosafety level 1 work. Our application will be approved once the EPA gets around to sitting on the documents for a sufficiently bureaucratic amount of time. We just have to wait for that to happen.
Right now if we are not doing science, we are wasting our time. We are here to start a business, and if we have to do it by bending the rules, we need to do that. Following the rules to the letter is fine, but with such a short timeframe and ambitious scientific goals, we can’t afford to wait around to do work. If we don’t start doing science now, at the end of this accelerator we will still be at the idea stage and have nothing to show for it except some more blogs.
Since we have already wasted so much time moving to Ireland and getting equipped in a laboratory starting from scratch, I think temporarily moving our operations to a different country will be a further waste of time. Even if we show up in a fully functional lab, there will be additional time spent re-setting up, re-ordering things, re-acquainting ourselves with how things are done at the new facility and where everything is, not to mention time wasted for things outside the realm of science like getting another apartment.
The only two options I see available to us is to start working and blog about it as we had promised ourselves we would do (and worry about the consequences later, if there even are any), or start working and not blog about it and sacrifice our corporate principles from the very beginning in order to even have a corporation.
The EPA approval will come through at some point. They don’t have a deadline to approve our work. We do have a deadline to get work done. We need to come through with some scientific results, or our whole summer is fantastic waste of time and money.