Human Practices

Monsanto and Pfizer

Thanks to Washington University in St. Louis's excellent relationship with Monsanto and Pfizer we were lucky enough to visit with them multiple times throughout the summer. The first visit was on July 10th when we got a tour of both facilities and then gave a presentation about our idea and the work we had done so far. They spent about 30 minutes with us asking questions and giving feedback, and then another 30 minutes offering advice on where we could go next. Specifically, they suggested that our initial plan of using GFP as a reporter could interfere with our results because GFP's absorption spectrum overlapped with UV-B

IGNORE THIS PART FOR A SEC MARK BUT FINISH THE THING ABOVE impractical, and suggested we used another gene that we not use GFP as a reporter Additionally, Dr. Larry Gilbertson (a molecular biologist at Monsanto and iGEM enthusiast) offered to come to WashU to talk with us about protocols for transforming genes into plants, which was an application we were thinking about at the time.

We were invited back to Monsanto on July 20th to talk with local high school teachers and administrators about iGEM and why we chose to become STEM majors when going to college. More information on that can be found on the Public Engagement page.

Dr. Gilbertson visited our team on July 26th to talk about how to transform genes into plants

In addition to actually visiting the Monsanto campus, we were put in touch with Austin Burns, who works in Regulatory Affairs at Monsanto. We had a phone interview with him early in the summer to ask him about what the next steps could be if we were able to successfully transform our genes into cyanobacteria. Specifically, we were wondering what channels we would have to go through to safely start testing UV-B radiation in the wild. Our main question for Mr. Burns was: who could we give our research to who would be able to eventually get our product into the environment? Mr. Burns did not have a specific answer for us, and he explained that that was because there is no precedent for releasing genetically modified organisms into the environment on such a large scale like the ocean. One of the problems is that no one country controls the whole ocean, so in theory, every country would need to agree in some way in order to release the genetically modified organism.

Even though Mr. Burns did not think the organism could be released into the wild, even if we did get a working construct, he walked us through how we might be able to go about testing in controlled environments. First, we would have to answer questions about the organism itself. Where did it come from and how did we obtain it? This is important because of trade agreements and international treaties. The next step would be to go to the USDA, which is the agency that would give permission to test microbes in controlled environments. The USDA can regulate what they want in the environment and will bar certain organisms if they think there is a risk to endangered species or agriculture. Mr. Burns also suggested that we build failsafes into our constructs so that if something were to go wrong, there is a way for the organism to shut itself down. He also said that the USDA would be more willing to work with the organism if they knew there was a backup if something went wrong. In addition, we might need to get permission from the USEPA because of the clean air and clean water act which overlaps with the endangered species act of the USDA.

Mr. Burns continued to talk about how we would go about testing in the environment, but his main point that he repeated was that there is no specific avenue to achieve what we wanted to with our genes. He walked us through the process of hypothetically getting a meeting with the USDA or EPA, and things we would need in order to prepare; the main thing being a huge amount of data, specifically data showing the positive effects of the organism, a benefits document, and data that specifically shows that it would do little to no harm in the ecological environment it is in. Mr. Burns also gave us sample questions we would have to answer before moving forward with environmental testing and meeting with a governmental agency. Some of the questions are listed below:

If our organisms die, could the DNA get taken up by other organisms?

Could our DNA help other organisms that are harmful to fish or people or the ocean itself?

Are we going to try and profit or is this free?

Mr. Burns also briefly walked us though the process of possibly putting our DNA into plants (which involves the FDA and USDA) and he spent a few minutes talking about biofuels and regulations. Mostly he told us to keep asking ourselves questions about what would happen if things went wrong and how we would respond. It was a very informative conversation, and after talking to him we reached out to contacts at the USDA and EPA to talk to them about staring the testing process from their perspective, but we never got a response.