Week 1 HW: Principles and Practices

1. First, describe a biological engineering application or tool you want to develop and why. This could be inspired by an idea for your HTGAA class project and/or something for which you are already doing in your research, or something you are just curious about.

Synthetic Biology to develop climate-resilent crops

Climate change affects agricultural productivity and food security by altering temperature and precipitation patterns that are linked to crop pest and disease outbreaks. Also, increased temperatures can alter the growth and development of plants, causing a reduction in fruit yields. The change of one degree Celsius could decrease the yield of crops such as wheat, rice and corn between 3% and 7% [1]. Changes in precipitation patterns can cause droughts that affect crop yields. The impact of climate change on agriculture endangers the global food supply, particularly in vulnerable regions with limited response capacity [2].

Synthetic biology has enormous potential to create climate change-resistant plants by leveraging genetic engineering and other advanced techniques to develop crops with improved adaptive traits [3]. These plants resistant to climate change will be important to ensure food security. Among the main characteristics and challenges that these plants must face are: extreme environmental stress to heat, efficient use of water, resistance to frost. Among the most promising technologies, CRISPR-Cas9-based gene editing has become the most used tool for crop improvement due to its precision and versatility [4].

2. Next, describe one or more governance/policy goals related to ensuring that this application or tool contributes to an “ethical” future, like ensuring non-malfeasance (preventing harm). Break big goals down into two or more specific sub-goals. Below is one example framework (developed in the context of synthetic genomics) you can choose to use or adapt, or you can develop your own. The example was developed to consider policy goals of ensuring safety and security, alongside other goals, like promoting constructive uses, but you could propose other goals for example, those relating to equity or autonomy.

Goal #1: Environmental safety and biosecurity	a. Establish rigorous laboratory-based biosafety assessments to evaluate potential ecological impacts prior to commercial release b. Implement controlled field trials and post-release monitoring to track environmental consequences
Goal #2: Equitable access and benefit-sharing	a. Ensure equitable access to improved crop varieties for smallholder farmers, particularly in developing countries b. Develop frameworks for benefit-sharing arrangements that fairly compensate local and indigenous communities that contribute to research initiatives
Goal #3: Transparency and public participation	a. Promote open communication with stakeholders. Include farmers in developing countries, consumers and policy makers b. Require companies and research institutions to publish open access data. Also, encourage scientific communication to non-scientific audiences on the methodologies applied in biosecurity studies.

3. Next, describe at least three different potential governance “actions” by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”). Try to outline a mix of actions (e.g. a new requirement/rule, incentive, or technical strategy) pursued by different “actors” (e.g. academic researchers, companies, federal regulators, law enforcement, etc). Draw upon your existing knowledge and a little additional digging, and feel free to use analogies to other domains (e.g. 3D printing, drones, financial systems, etc.).

Governance Action #1: Biosafety Regulatory Framework

Goal: Strengthen regulatory pathways so they can be agile and adapt to the constant change of exponential technologies, especially those linked to new genetic engineering techniques

Design: Require environmental impact assessments in controlled environments, peer reviews, and regulatory mechanisms

Assumptions: Regulatory agencies have sufficient capacity and experience to conduct assessments.

Risks of failure and success: Delays in approvals could hinder innovation; excessive regulation could limit access for smaller developers.

Governance Action #2: Incentive-Based Licensing Model

Goal: Encourage private sector participation while ensuring equitable access.

Design: Implement a tiered licensing model where companies receive financial incentives for providing access to crops in low-income regions.

Assumptions: Companies will see value in voluntary participation.

Risks of failure and success: Market-driven disparities could persist if large corporations dominate distribution.

Governance Action #3: Public-Private Knowledge Consortium

Goal: Foster transparency and collective problem-solving.

Design: Establish a global, open-access database where research results, biosafety assessments, and performance metrics are shared.

Assumptions: Stakeholders will actively contribute data and maintain compliance.

Risks of failure and success: Potential intellectual property conflicts; challenges in maintaining data accuracy and trust.

4. Next, score (from 1-3 with, 1 as the best, or n/a) each of your governance actions against your rubric of policy goals. The following is one framework but feel free to make your own:

5. Last, drawing upon this scoring, describe which governance option, or combination of options, you would prioritize, and why. Outline any trade-offs you considered as well as assumptions and uncertainties. For this, you can choose one or more relevant audiences for your recommendation, which could range from the very local (e.g. to MIT leadership or Cambridge Mayoral Office) to the national (e.g. to President Biden or the head of a Federal Agency) to the international (e.g. to the United Nations Office of the Secretary-General, or the leadership of a multinational firm or industry consortia). These could also be one of the “actor” groups in your matrix.

It would be prioritized as the primary governance action Option 1: Biosafety Regulatory Framework as the main governance action, complemented by Option 2, an Incentive-Based Licensing Model, to ensure equitable access. Option 1 plays an important role in preventing and mitigating the risks associated with synthetic biology and genetic engineering. However, regulatory frameworks alone can be perceived as barriers to innovation ecosystems. Therefore, Option 2 can promote incentives that encourage greater participation from industry, universities, and entrepreneurs.

References:

[1] Zhao C, Liu B, Piao S, Wang X, Lobell DB, Huang Y, et al. Temperature increase reduces global yields of major crops in four independent estimates. Proc Natl Acad Sci U S A. 2017;114:9326–9331. pmid:28811375

[2] Montana A. Eck, Andrew R. Murray, Ashley R. Ward, Charles E. Konrad, Influence of growing season temperature and precipitation anomalies on crop yield in the southeastern United States, Agricultural and Forest Meteorology, Volume 291, 2020, 108053, ISSN 0168-1923, https://doi.org/10.1016/j.agrformet.2020.108053.

[3] Archibald BN, Zhong V, Brophy JAN (2023) Policy makers, genetic engineers, and an engaged public can work together to create climate-resilient plants. PLoS Biol 21(7): e3002208. https://doi.org/10.1371/journal.pbio.3002208

[4] Elena Fesenko, Robert Edwards, (2014) Plant synthetic biology: a new platform for industrial biotechnology, Journal of Experimental Botany, Volume 65, Pages 1927–1937, https://doi.org/10.1093/jxb/eru070

[5] Liu, Qier, Fan Yang, Jingjuan Zhang, Hang Liu, Shanjida Rahman, Shahidul Islam, Wujun Ma, and Maoyun She. (2021) Application of CRISPR/Cas9 in Crop Quality Improvement, International Journal of Molecular Sciences 22, no. 8: 4206. https://doi.org/10.3390/ijms22084206