Adventures in Human Practices: Integration from Day 1
4/1- First Meeting! We began to consider the steps necessary to make a food dye, such as looking into GRAS (Generally Regarded As Safe by FDA) vectors for our machine and how we could classify the project as natural, even though it seemed processed. When considering making a food product, we also thought the foundational problem of whether the public would ever buy into bioengineered dye.
4/7- Team dinner, and going through basic literature. Read Luis Campos “Follow the BioBrick Road.”
5/2- Offer for Monsanto Sponsorship. This was very exciting—our team, like many others, was concerned about being able to finance the project. However, we were not comfortable immediately accepting as we pondered whether this association could have effects in terms of our project’s public acceptance later on.
5/10- FDA Request for Comments regarding “Natural” food labelling deadline. We discussed the call for comments as a group. On the one hand, we really wanted to participate, and felt strongly at the time that we wanted to make a dye that would be categorized as natural in order to be marketed to large food companies that were seeking a natural dye that could precisely fit aesthetic concerns. Here was the opportunity to at least try and sway national policy in our favor. However, we needed to take time to really consider whether it was ethical to try and alter the legal framework surrounding our potential product. In light of the offer for Monsanto sponsorship and growing concerns of whether this sort of action might be a conflict of interest, we determined it was too early in our research to really offer the kind of guidance to the FDA that would be morally sound, and in the best interest of the American people. We opted to obstain.
5/12- Meeting with Paul from Mars Advanced Research division. During this meeting we discussed the problem that would define our project: companies want to make the change to all natural dyes due to legitimate health risks associated with coal-tar dyes and vocal consumer concern. However, these companies do not have exact replacements for colors. Paul opened up a bag of M&M’s and poured them on the table. He lined them up: brown first, then red, then orange, then yellow, then green, and blue at the end. He explained that brown was the easiest to replicate with naturally occurring means, and that red has replacements that, while somewhat unsavory, were not devastating. However, they had yet to find a blue dye in nature that was quite what they were looking for. Recently approved Spirulina extract was not entirely off the table, but the color was too light. We asked about industry processes for coating the foods, and learned that the candy coating was around pH 2. We took this challenge into account as we looked into the kinds of bacteria that might produce blue, with a preference for those that may have proteins that would not denature with that level of acidity, and focused on extremeophiles.
5/13- First skype meeting with UCSC team! One of the UCSC students had grown up in Davis and spent some time in the lab with our teammate Jon Chen, so we set up a preliminary meeting to talk about collaboration possibilities and resolved to speak again at the UC Bioengineering Conference.
5/19- Choose to accept Monsanto Sponsorship. After some discussion, our group determined that a mindful approach was the right way to engage with Monsanto. We did not condone the entirety of their corporate practices, but kowtowing to blind assumptions that any involvement was somehow poisonous seemed incorrect as well. Instead, we would engage with the lunch group of hard scientists working in the genotyping and phenotyping projects to talk about what science and society could do to make progress.
6/13- iGEM Meetup at UC Bioengineering Symposium (UCSC HP collaboration initiated). We woke up at 5:30 am and (following a brief coffee stop) met up with other UC iGEM teams to present our project idea and consider collaboration. We began the process of collaborating with UC Santa Cruz and advised the UC San Diego team about how we could improve the UC iGEM network going forward.
7/14- SB 764 Passed both House and Senate, ready for President. This senate bill created the first labelling guidelines for Bioengineered foods in the United States. Many other countries had already passed regulation, but this bill impacted every stakeholder we met with and informed our observations on SynBio regulation in the United States.
7/19- Meeting with Don Gibson, re: Prop 37. Don Gibson is a Ph.D student in plant biology at UC Davis and he has very strong feelings about the levels of regulation within GMO fields. He was also a dedicated advocate against Proposition 37, and state-specific GMO labelling bill in California during the 2012 election. He shared his experiences with public acceptance of science from the perspective of an early career academic.
7/19- Collab with UCSC meeting—Bacillus sharing, protocol transfer, and Human Practices progress.
7/21- Interview with Dr. Bruce German, a scientist whose groundbreaking work on what really nourishes humans had informed a shift in seeing health care as requisite in situations where humans are unwell to a proactive heath care system that asks how we can be more well. His interest is in expanding understandings of health and human history. We discussed the benefits of healthy gut flora and the collaboration between human and bacterium that occurs in every body from birth. He challenged us to see that not only could our dye operate as a protein, but within a vector like bacillus subtilis we could create probiotic food in whatever colors we wished and really expand potential health effects of our project.
7/21- Monsanto Lunch Meeting on “Science and Social Conscience” with Heather, genotyping lead at the Woodland, CA offices. She discussed Ursula K. Le Guin’s short story “The Ones Who Walk Away from Omelas” and how the understandings of privilege and suffering we gain from that story can be applied to SynBio projects and advocacy surrounding golden rice.
7/21- Monsanto meeting with Dr. Jose on regulation expectations and discussion of how to make our project viable. We also received an excellent tour and free veggies! This center had a substantial garden, and bell peppers and cherry tomatoes were very ripe.
7/21- IRB Paperwork Submitted. In order to really interact with the public and follow best ethical practices for human intervention, we submitted paperwork before conducting our survey in order to be under the supervision of the university to protect the public.
7/22- Call with 5-Prime’s Dr. Jenny Rooke. Dr. Rooke is an investor in start-up synthetic biology companies, and we discussed what kinds of external and internal factors would be relevant in her decisions to invest in a company. We focused on different governmental regulations altering investment decisions in emerging technologies. Learn more about her here: http://fprimecapital.com/team-members/jenny-rooke-ph-d/
7/22- Arcadia Bioscience Meeting with Dr. Daniel Faccioti. We discussed his regulatory experience with a nature identical product and the different types of testing and thresholds that are required by the FDA. One interesting note was that a food additive for dog food required a higher level of safety testing than a dietary supplement. We also saw the perspective of career scientists on the issue of GMO mandatory labelling. Learn more about Arcadia Bioscience here: http://www.arcadiabio.com/.
7/25- Meeting with Dr. Megan Palmer and Amy from the Stanford-Brown team. We had a great meeting at Stanford where we discussed different notions of safety and different ways of looking at lab safety and human practices safety.
7/25- IRB Exemption Published! So exciting! Following our registered exemption we were authorized by the university to conduct our survey with as long as we operated along our submitted protocol. Learn more about the internal review board process and how to protect your research subkects here under the “Humane Practices.”
7/26- Meeting with Dr. Ron Shigenta, Chief Science Officer and Food Lead of IndieBio in San Francisco. We discussed the struggles involved in bringing emerging synthetic biology products to market and different strategies for navigating public relations and start-ups in a developing field.
7/27- Farmer’s Market Survey Work. Our team went around and, obeying internal review board exception policy, ethically interviewed patrons at the Davis farmer’s market in order to learn more about this critical public’s understandings and expectations with genetically altered labelling.
7/29- SB 764 Signed into Law by President Obama; First bioengineered food labeling standards adopted.
8/6- Conversation with Carla from Cupcake Alley about natural colorings and her experiences trying to avoid allergens and use natural products, balancing her commitment to “Nothing fake here.” And vibrant colors. Upon mentioning our work on nature-identical colorings she requested “Please make blue!”
8/11- UCSC Survey Collab Complete! After a lot of Human Subjects training at Davis and Santa Cruz and several tours of Farmer’s markets in the areas, we are happy to announce the completion of the surveys. With this data we have a new perception on the concerns of this skeptical group and can better understand what people who are food conscious expect from food labeling schemes.
8/12- Synenergene Call with Dr. Todd Kuiken! We are honored to have been selected for a SYNENERGENE collaboration and we got to share our ideas and learn more about our Synenergene collaboration. To see the fruits of this work, please check out the Synenergene tab. To learn more about Dr. Kuiken, check this link: https://www.wilsoncenter.org/person/todd-kuiken-phd.
9/21- Conversation with Professor Daniel A. Farber at UC Berkeley School of Law (Constitutional Law and Torts Law Scholar) about fraud litigation and GE food dye. He elects to bring up whether “natural” labels on genetically modified food products constitute a state claim for fraud during his course for first years on torts civil actions. Every year he encounters different results. More information on Professor Farber here: https://www.law.berkeley.edu/our-faculty/faculty-profiles/daniel-farber/.