Difference between revisions of "Team:Cornell/Policies"

Synthetic biology can be controversial, and we know that. As scientists, we wanted to make sure that we explored the societal and humanitarian consequences of OxyPonics. We tasked ourselves with deeply analyzing food legislation laws, farming costs, environmental impact, and risk. Through industry interviews, research articles, consultations with legal experts, and intense analysis, we developed a 360 degree view of our project. From the ground up, society to scientist.

Hydroponics is the future. Because it is space and water efficient, as well as an easy to locally source, hydroponics is a rapidly growing industry projected to be worth nearly $400 million by 2020 [1]. However, despite its promise, many hydroponic growers struggle to break even. Overhead is high and profit margins are low due to disease and a lack of experienced labor.

OxyPonics addresses this issue. By optimizing growth using oxidative stress, a novel but reliable method of measuring health and the chemical balance, hydroponic growers can improve crop yield and thus their margins. OxyPonics provides comprehensive, remote, real-time monitoring that existing systems cannot provide. Furthermore, the optogenetic feedback loop we developed enables OxyPonics to respond in real-time, while remaining significantly cheaper than more limited existing solutions.

Before putting OxyPonics out to market, the product must abide by federal and state regulations for water quality, agriculture, and food safety. Despite the extensive legislation on the regulation of genetically modified organisms, there is no existing body of legislation regarding synthetic biology-assisted food production. Since our crops are not genetically modified themselves, we had to look past existing legislation for answers.

First, we contacted Barbara Lifton, New York State Legislature Assemblywoman and member of the Assembly agriculture committee. We felt that contacting our local state representative was a great baseline into synthetic biology policy. Assemblywoman Lifton was glad to talk to us, and told us that most genetic modification regulation is based on the federal level rather than the state level. She also emphasized the distinction between legislative and regulatory departments in government. Therefore, we looked into current policy by regulatory agencies such as the Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA) [2].

In 2010, shortly after the first “synthetic organism” was produced at the J. Craig Venter Institute, the Obama Administration released a report on emerging issues in bioethical research. One of its primary goals was to describe how oversight of synthetic biology projects would move going forward. The report posited that many cases should be regulated on a case-by-case basis with the FDA and USDA, while others should be generally monitored by the two agencies (as well as the EPA) [3]. Our project would specifically fall under APHIS, the USDA’s Animal and Plant Health Inspection service. Currently however, APHIS lacks a robust approach to regulating technologies that rely on engineered organisms to assist crop growth. There is ambiguity on how to proceed, as a rule that would allow for the USDA to assess risks and use existing policies to regulate such technology has been stalled for years with no signs to indicate a change in the near future [2].

The EPA and FDA are even less clear on policies regarding our project. It is unlikely OxyPonics would be subject to EPA regulations, given that the only chemicals produced are our enzymes, such as superoxide dismutase, which are commercially available and do not fall under the category of “new chemicals” that the EPA regulates [4]. The FDA’s general policy towards GM crops is that they are fine so long as they are “substantially equivalent” to non-GM crops [5]. Despite its jurisdiction, the FDA has unclear policies regarding products that utilize genetically engineered organisms to produce a separate end product, as is done in our project. Our unique approach, which doesn’t modify the crop itself, places OxyPonics in a grey area with the FDA regarding their GM-regulations.

However, we aim for OxyPonics to eventually be used in full scale hydroponic systems. This means we must guarantee our end products follow more the FDA regulations for growing crops. The FDA Food Safety Modernization Act (FSMA) Produce Safety Rule has established a minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. Of particular relevance to our project, the FDA maintains that the E. Coli levels in our system must be below detectable levels, or less than 126 CFU (Colony Forming Units) per 100 mL of agricultural water [6]. Our containment system - placing the bacteria in dialysis tubing - should prevent the levels of E. Coli from rising to levels deemed unsafe by the FDA. For additional safety, we will also ensure that all crops produced with aid from Oxyponics are sanitized after being in close proximity with the genetically modified E. coli contained in the dialysis tubing. Further still, E. coli used in our system are non-pathogenic, which means their potential danger is greatly minimized and theoretically should not be considered a threat to humans.

Overall, we believe that the FDA, EPA, and USDA have a clear need to design more versatile policies to truly assess the legal implications of OxyPonics.

To understand the intersections between our project and society, we consulted the work of Dr. Greg Kaebnick of the Hastings Institute. Founded in 1969, the Hastings Institute was the world’s first bioethics research think tank and has the mission to assess the ethics of health and biotechnology and their impact on communities and public policy. In his assessment of synthetic biology, he discussed the intrinsic characteristics of synthetic biology. According to Dr. Kaebnick, the prospect of creating synthetic organisms may go against what we believe is natural, but it is hard, or even impossible, to draw a line between what is natural and what is not [7]. A strain of yeast that produces an antimalarial may not be “natural”, but is it ethically wrong to use it to save lives? Dr. Kaebnick’s report was especially valuable to us because it raised questions about the role of government and policy about biotechnology moving forward. We had to ask ourselves and our legislators about the implications of our definition of “natural” being altered and the role of government as it relates to what is natural.

In terms of policy making, Dr. Kaebnick’s work allowed us to think about synthetic biology as a broad enabling technologically with many applications, rather than a technology for a particular purpose [8]. Thinking about synthetic biology as an emerging technology has many ramifications for public policy making. Due to the many possibilities with synthetic biology for innovation analogous to developments in other technologies such as self driving cars and the internet, the best approach to emerging technology policy making is with transparent group policy making with broad public input [7].

The questions and insights we gained from Dr. Kaebnick’s work are relevant to our project because it shows that we need to clearly articulate the values and viewpoints of hydroponic farmers, users, and consumers. While it may be difficult to reconcile these viewpoints, it is our obligation and our desire to facilitate discussion between people from all backgrounds. This is our impetus for much of our outreach, as well as our collaboration with Stony Brook to produce a survey assessing the underlying attitudes of synthetic biology in various locations in the U.S. Our ultimate aim is to understand perceptions and knowledge of synthetic biology. A true understanding of another’s opinion and basis results in deeper, more productive conversation.

We developed our design through the guidance of our end users. We received feedback from over 40 interviews with hydroponic growers, suppliers, plant biologists, and oxidative stress researchers. This information allowed us to develop a robust system that addressed the most pressing issues hydroponic growers had. See Practices for more information about our integrated feedback. As we spoke with them, we realized that a common theme was that growers had a common problem: they faced incredibly high operating costs with low profit margins. Furthermore, many were shuttering their doors due to crop underperformance or even total failure. We needed a way to address this issue - and OxyPonics does just that by boosting crop performance and yield while keeping capital costs to a minimum.

We recognize that there is public concern about the danger of introducing mutant bacteria to consumer produce. However, we assert that Oxyponics is a legitimate and safe additive to any deep water hydroponic farm hoping to increase crop size and yield.

Our team believes there is little to no risk to adding genetically engineered E. coli to the hydroponic setup for two reasons. First, the bacteria is enclosed in dialysis tubing that allows water and molecules to flow freely, but not the bacteria themselves. Thus, there is no danger of the bacteria leaving the hydroponic facility or being ingested by any consumer. Second, all produce is processed and sanitized before being sold at market and/or eaten. Any bacteria residing on the vegetables would be washed off or killed. Both of these factors provide little chance for the bacteria to ever enter or harm consumers of these hydroponic crops. The risk of foodborne illness is not significantly higher compared to conventionally grown crops.

Though there is no theoretical danger to adding our E. coli, we have not addressed all risks. We do not know how the oxidative state of the growth solution will affect the nutritional value and chemical composition of produce. It is also possible that the bacteria could cause the aeration system of a hydroponic setup to clog and/or fail. We plan on further testing these unknowns.

OxyPonics improves the practice of hydroponics, and hence it carries with it environmental impact that hydroponic farming has overall. Hydroponic farming has greater water efficiency and can be a solution for food production with limited supply of freshwater, especially in drier regions. Furthermore, since hydroponic setups are enclosed systems that can be situated nearly anywhere, it avoids the negative impacts associated with conventional farming , including a large land requirement, soil degradation and erosion, and runoff of pesticides and nutrients [9].

In some cases, hydroponic farming has been shown to require greater energy input than traditional farming [9]. However, it is largely still considered beneficial since areas that use hydroponics to reduce water usage typically have large amounts of renewable energy available. Furthermore, as our system is dependent on bacterial fluorescence, there is minimal energy input to OxyPonics. This will lower the energy needs of hydroponic systems, increasing their sustainability.

Another concern shared by many about hydroponics is that the nutrient solution in the water can cause environmental harm during disposal [10]. OxyPonics tackles this issue as well. With accurate, precise, and real-time monitoring, OxyPonics can ensure that the water quality of the hydroponic system is high enough that even upon disposal, there is no adverse impact on the environment. Moreover, we can reduce waste because better monitoring allows nutrient solutions to be utilized longer, meaning that there is a decreased need for growers to throw out and replace their nutrient solution.

As mentioned in the Safety & Risk section, the E. coli we utilize will be contained within dialysis tubing. They will be handled with care, and all produce leaving the system will be sanitized. The E. coli hence will not be released into the environment. Through preventative measures and risk assessment we can properly control any environmental impact that the components of OxyPonics have.

MarketsandMarkets. (2016, February). Hydroponics Market by Equipment (HVAC, LED Grow Light, Communication Technology, Irrigation Systems, Material Handling & Control Systems), Type (Aggregate & Liquid), Crop Type, & by Input Type - Global Trends & Forecasts to 2020..

Carter, S. R., Rodemeyer, M., Garfinkel, M. S., & Friedman, R. M. (2014).Synthetic Biology and the US Biotechnology Regulatory System: Challenges and Options (No. DOE-JCVI--SC0004872). J. Craig Venter Institute, Rockville, MD (United States). Retrieved from http://www.jcvi.org/cms/fileadmin/site/research/projects/synthetic-biology-and-the-us-regulatory-system/full-report.pdf.

United States. Presidential Commission for the Study of Bioethical Issues. (2010). New directions: the ethics of synthetic biology and emerging technologies. .Presidential Commission for the Study of Bioethical Issues. Retrieved from http://bioethics.gov/sites/default/files/PCSBI-Synthetic-Biology-Report-12.16.10_0.pdf.

Environmental Protection Agency. (2017). Reviewing New Chemicals Under the Toxic Substances Control Act. Retrieved from https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/basic-information-review-new.

Tucker, J. (2011). U.S. Regulation of Genetically Modified Crops. Retrieved from https://fas.org/biosecurity/education/dualuse-agriculture/2.-agricultural-biotechnology/us-regulation-of-genetically-engineered-crops.html.

Food and Drug Administration. (2017, Oct 03). Food Safety Modernization Act: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Retrieved from https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm#key.

Kaebnick, G. E., Gusmano, M. K. and Murray, T. H. (2014), The Ethics of Synthetic Biology: Next Steps and Prior Questions. Hastings Center Report, 44: S4–S26. doi:10.1002/hast.392. Retrieved from http://www.thehastingscenter.org/publications-resources/special-reports-2/synthetic-future-can-we-create-what-we-want-out-of-synthetic-biology/.

Gregory E. Kaebnick, Michael K. Gusmano, and Thomas H. Murray, “How Can We Best Think about an Emerging Technology?,” Synthetic Future: Can We Create What We Want Out of Synthetic Biology?, special report, Hastings Center Report 44, no. 6 (2014): S2-S3. DOI: 10.1002/hast.391. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/hast.391/full?isReportingDone=true.

Barbosa, G.L., Gadelha, F. D. A., Kublik, N., Proctor, A., Reichelm, L., Weissinger, E., Wohlleb, G. M., and Halden, R. (2015). Comparison of Land, Water, and Energy Requirements of Lettuce Grown Using Hydroponic vs. Conventional Agricultural Methods. International Journal of Environmental Research and Public Health. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4483736/.

Adams, P. (1993). Crop Nutrition in Hydroponics. Acta Hortic. 323, 289-306. Retrieved from https://doi.org/10.17660/ActaHortic.1993.323.26.