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.

I want to develop an animal-free, bioengineered nacre-inspired cosmetic material that can replicate the most valued functions of traditional concha nácar (mother-of-pearl powder) without harvesting oyster shells. The core idea is to replace an animal-derived ingredient with a designed, renewable system that delivers comparable or improved benefits while reducing ecological impact and improving consistency. This application would combine (1) a biomimetic mineral structure designed to recreate nacre’s optical properties that contribute to visible “radiance,” and (2) microbially produced bioactive molecules, such as peptides or postbiotic compounds, intended to support skin recovery after irritation and help the skin return to baseline. I am interested in this because it sits at the intersection of biomaterials, synthetic biology, and ethical design, and it reframes “luxury skincare ingredients” as something that could be produced more sustainably and transparently through engineered biology rather than extraction.

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 A: Prevent harm to users (non-malfeasance) Sub-goal A1: Product safety and predictable behavior Ensure the material does not introduce unsafe contaminants, allergens, toxins, or unpredictable biological activity. Sub-goal A2: Clear boundaries for use Ensure labeling, instructions, and marketing do not encourage unsafe use (for example, applying to broken skin, mucosa, or using excessive frequency). Goal B: Prevent misuse and reduce biosecurity risk Sub-goal B1: Limit dual-use potential of biological components Ensure the microbial strains, genetic parts, and production methods are selected and managed to reduce the chance of misuse. Sub-goal B2: Strengthen traceability and accountability Enable the ability to audit supply chains, detect substitutions or tampering, and respond quickly if incidents occur. Goal C: Protect the environment and promote sustainability Sub-goal C1: Reduce ecological extraction pressure Decrease reliance on oyster shell harvesting and minimize impacts to marine ecosystems. Sub-goal C2: Manage environmental release risks Ensure that any biological components and waste streams are controlled so they do not unintentionally spread or disrupt ecosystems. Goal D: Promote constructive and equitable outcomes Sub-goal D1: Access and fairness Avoid turning “ethical” products into luxury-only offerings by encouraging affordability and responsible pricing strategies. Sub-goal D2: Honest communication Prevent misleading claims about what the ingredient can do biologically versus visually, so consumers can make informed choices.

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.). Purpose: What is done now and what changes are you proposing? Design: What is needed to make it “work”? (including the actor(s) involved - who must opt-in, fund, approve, or implement, etc) Assumptions: What could you have wrong (incorrect assumptions, uncertainties)? Risks of Failure & “Success”: How might this fail, including any unintended consequences of the “success” of your proposed actions?

Option 1 focuses on creating a safety and transparency standard for bioengineered cosmetic ingredients. Purpose: Currently, cosmetic labeling and quality practices vary, and consumers often cannot tell how ingredients are produced or what testing was performed. This option proposes a standard that includes minimum safety testing, standardized labeling, and documentation of biological components and manufacturing controls. Design: This would involve cosmetic companies, third-party certifiers, and regulators working together to require contaminant screening, allergen risk assessment, stability testing, and clear labeling of whether an ingredient is animal-derived, fermentation-derived, or bioengineered. Assumptions: This assumes regulators and industry can agree on standards that are not overly burdensome and that testing predicts real-world safety. Risks of failure and success: The standard could become vague or purely marketing-based, or costs could increase and limit participation by smaller innovators. If very successful, it could unintentionally favor large companies that can afford compliance.

Option 2 focuses on technical containment and safety-by-design requirements during research and manufacturing. Purpose: Biological engineering introduces risks if organisms or genetic materials are mishandled, so this option promotes safety considerations at the design stage. Design: Academic researchers, biosafety committees, companies, and manufacturing partners would select low-risk host organisms, avoid unnecessary harmful functions, design processes that minimize viable organisms in the final ingredient, and ensure waste is properly treated. Assumptions: This assumes organizations consistently follow procedures and that technical controls meaningfully reduce risk. Risks of failure and success: Controls could become paperwork rather than practice, or overly rigid rules could slow experimentation. If very successful, it could create a false sense of zero risk and reduce vigilance.

Option 3 focuses on incentives for animal-free biomaterials combined with shared reporting and monitoring. Purpose: Even if alternatives exist, companies may not adopt them without incentives. This option encourages adoption while requiring reporting to prevent greenwashing. Design: Industry groups, funders, certification organizations, and possibly public agencies could offer grants, prizes, procurement preferences, or certification benefits for animal-free ingredients that meet safety and environmental criteria, along with annual reporting on sourcing and waste handling. Assumptions: This assumes incentives are strong enough to change behavior and that reporting is accurate. Risks of failure and success: Companies may treat incentives as marketing, or reporting could become superficial. If very successful, demand could shift environmental pressure to other inputs unless broader metrics are included.

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.

Based on the scoring, I would prioritize a combined approach that emphasizes Option 2 and Option 1, with support from Option 3. Safety-by-design technical controls should be the primary priority because they reduce harm at the source by shaping organism selection, containment practices, and waste handling. Safety and transparency standards should be the second priority because they reduce consumer risk and improve accountability through clearer labeling and testing expectations. Incentives for animal-free materials should support adoption but must be paired with safeguards to prevent greenwashing. Trade-offs include the possibility that stronger standards increase costs or slow small innovators, so tiered requirements or support mechanisms may be necessary. Technical controls depend on compliance and culture, so documentation and training are important. Environmental impacts may shift rather than disappear, so animal-free should not automatically be considered impact-free. This recommendation could be directed to university leadership and institutional biosafety committees, as well as industry consortia or certification bodies that can implement transparency standards while broader regulation evolves.

Reflecting on what you learned and did in class this week, outline any ethical concerns that arose, especially any that were new to you. Then propose any governance actions you think might be appropriate to address those issues. This should be included on your class page for this week.

One ethical concern that emerged is how easily “bio-based” or “natural” language can blur the distinction between appearance-based effects and true biological intervention, leading to misleading claims. Another concern is that animal-free alternatives can still create environmental harm if manufacturing inputs or waste are not managed responsibly. To address these issues, a claims substantiation guideline could require companies to distinguish optical effects from biological effects, and an environmental impact checkpoint during scale-up could evaluate inputs, waste streams, and disposal so that harm is not shifted from one domain to another.