Week 1 HW: Principles and Practices

Goal 1: Enhance Biosecurity

1a) Prevent contamination incidents: Ensure fermentation cultures don’t become contaminated with pathogenic bacteria (Salmonella, E. coli, Clostridium), prevent spoilage that could waste precious food rations, and protect immunocompromised populations (malnutrition weakens immune systems)

1b) Enable rapid response to foodborne illness: Establish clear protocols for identifying and responding to contamination events, create traceability systems to identify sources of problems, and enable quick intervention if adverse events occur

Goal 2: Foster Lab Safety

2a) Prevent incidents during culture development: Ensure safe handling of bacterial cultures in research labs, prevent accidental release of modified or non-native strains, and maintain biosafety level appropriate to organisms used

2b) Enable safe field implementation: Train refugee camp personnel in safe fermentation practices, provide clear protocols for culture maintenance and storage, and establish monitoring systems for culture purity

Goal 3: Protect the Environment

3a) Prevent ecological incidents: Avoid introducing non-native bacterial strains to the Sahara ecosystem, ensure waste products can be safely disposed of in desert environment, and prevent unintended environmental consequences of scaled implementation

3b) Minimize environmental footprint: Use locally-available or easily-transported materials, design for minimal water consumption (critical in desert), and avoid creating new waste streams

Goal 4: Other Considerations

4a) Minimize costs: Keep implementation costs low enough for humanitarian budgets, minimize labor burden on already-strained refugee communities, and avoid creating dependency on external inputs

4b) Ensure feasibility: System must work in extreme heat (50°C+) without refrigeration, must be replicable by people with minimal education, and must fit within existing camp infrastructure and social structures

OPTION 1: Standardized safety protocol

Purpose: What is done now and what changes am I proposing?

Current state: Fermentation in humanitarian contexts is ad-hoc and unregulated. NGOs occasionally distribute fermented foods (like fortified yogurt), but there are no standardized protocols for refugee-led fermentation of staple foods. Food safety in camps focuses on distribution logistics, not on food processing by recipients.

Proposed change: Create a standardized “Humanitarian Fermentation Safety Protocol” (HFSP) that establishes: (1) approved starter culture strains tested for safety and efficacy, (2) step-by-step fermentation procedures with safety checkpoints, (3) simple quality control tests (pH testing, visual inspection, smell tests), (4) clear guidance on when to discard batches, and (5) training curriculum for camp-based “fermentation coordinators.” This protocol would be certified by major humanitarian organizations (WHO, WFP, UNHCR) and implemented through existing NGO networks, similar to how water purification protocols are standardized across humanitarian operations.

Design:

What is needed to make it work?

Actors involved:

Primary implementers: Local NGOs already operating in camps (e.g., Médecins du Monde, Red Cross/Crescent)

Protocol developers: Academic researchers + food safety experts + humanitarian nutrition specialists

Certifying bodies: WHO Food Safety Division, WFP nutrition program

Funders: Humanitarian aid donors (ECHO, USAID, bilateral donors)

Onground trainers: Refugee community members trained as “fermentation coordinators”

Requirements: Scientific validation through clinical trials showing safety and efficacy, protocol development translating research into simple, visual protocols,training materials created in multilanguage, pictorial guides suitable for lowliteracy populations, starter culture supply chain established for distributing and replenishing cultures, monitoring system with simple data collection on usage, outcomes, and adverse events

Assumptions:

Assumption 1: Fermented foods will be culturally acceptable and palatable

Could be wrong if: Taste preferences or religious/cultural beliefs create barriers

Assumption 2: Simple quality control tests (pH, visual) are sufficient to ensure safety

Could be wrong if: Pathogenic contamination can occur without obvious signs

Assumption 3: Starter cultures can be maintained indefinitely through serial propagation Could be wrong if: Cultures drift genetically or become contaminated over time

Risks of Failure and Success:

Risks of Failure: Foodborne illness outbreak from contaminated batch undermines trust in all fermentation, low adoption due to complexity, taste, or cultural barriers, resource diversion from other critical needs without sufficient benefit

Risks of Success Refugees become reliant on external starter culture supply rather than building true selfsufficiency, market distortion if fermentation becomes commercialized, resources invested here could have greater impact elsewhere (e.g., fresh food supply chains)

OPTION 2: Opensource research commons

Purpose:

What is done now and what changes am I proposing?

Current state: Research on fermentation for humanitarian nutrition is scattered across academic institutions. Findings are published in paywalled journals, protocols are not standardized, and there’s no central repository. Researchers face liability concerns that limit field testing. Humanitarian organizations lack access to cutting-edge research.

Proposed change: Create an “Open Fermentation for Humanitarian Health” research commons - a Wikipedia-like platform where: (1) researchers openly share protocols, strain data, and results, (2) humanitarian workers can access and adapt proven methods, (3) users can report outcomes and modifications, (4) contributors receive credit but waive liability for implementations, and (5) platform includes discussion forums for troubleshooting. Modeled after open-source software or open-hardware. Researchers/institutions sign a “humanitarian use waiver” acknowledging that field implementations are beyond their control, similar to how drone hobbyists share designs with liability disclaimers.

Design:

What is needed to make it work?

Actors involved:

Platform creators: Academic consortium + tech developers (could be MIT Media Lab, Johns Hopkins Humanitarian Health)

Content contributors: Researchers, nutritionists, fermentation experts globally

Content users: NGO field staff, camp health workers, refugee communities Legal framework designers: International humanitarian law experts + academic legal counsel

Funders: Research grants (NIH, NSF), humanitarian innovation funds, foundation support

Moderators: Communityelected experts who curate content quality

Requirements: Digital platform that is secure, accessible, with offline capability, legal framework with carefully crafted liability waiver that protects researchers while not absolving them of gross negligence, quality standards through peer review system or community verification for protocols, translation capacity for multilanguage content (Arabic, French, Spanish, etc.)

Assumptions:

What could I have wrong?

Assumption 1: Liability waivers will adequately protect researchers from lawsuits

Could be wrong if: Legal systems in various countries don’t recognize waivers, or families sue anyway

Assumption 2: Open sharing won’t compromise academic careers (researchers need publications)

Could be wrong if: Universities don’t value opensource contributions for tenure/promotion

Assumption 3: Field workers have internet access to use platform

Could be wrong if: Refugee camps have limited connectivity (though offline access could help)

Risks of Failure and Success:

Risks of Failure: Legal disasters researcher sued despite waiver, chilling all future participation, misinformation spread bad protocols go viral, causing harm, abandoned platform like many wellintentioned websites, it gets no traction and dies quietly

Risks of Success: No one feels accountable for safety when problems arise (“I just found it online”), companies or individuals commercialize freelyshared research without giving back, Western researchers “share” solutions without meaningful input from affected communities

OPTION 3: Regulatory approval for probiotic food processing kits

Purpose:

What is done now and what changes am I proposing?

Current state: Fermentation cultures and probiotics are regulated as either foods or pharmaceuticals depending on health claims made. For humanitarian use, there’s regulatory gray area - cultures aren’t formally approved for “treating malnutrition.” Companies hesitate to develop products for small humanitarian market,analogous to how pharmaceuticals neglect “orphan diseases” with small markets.

Proposed change: Create a new FDA/EMA fast-track regulatory category: “Humanitarian Nutritional Intervention Kits.” These would be: (1) pre-packaged starter culture kits designed for specific deficiency contexts, (2) approved through streamlined process (like FDA Emergency Use Authorization), (3) manufactured to pharmaceutical quality standards but distributed like food aid, (4) include simple instructions and quality control measures, and (5) protected from liability similar to vaccines under PREP Act. Would incentivize biotech companies by providing: regulatory clarity and faster approval, liability protection from field implementations, tax incentives or procurement guarantees from aid agencies, and patent exclusivity for humanitarian applications. Similar to how the Orphan Drug Act incentivized pharmaceutical development for rare diseases.

Design:

What is needed to make it work?

Actors involved:

Regulatory agencies: FDA (US), EMA (Europe), WHO (international standards).

Legislators: Congress/Parliament to pass enabling legislation and liability protections.

Manufacturers: Biotech/probiotic companies (Chr. Hansen, DuPont Nutrition, small biotech startups).

Humanitarian agencies: WFP, UNHCR (as major purchasers, setting specifications).

Clinical researchers: To conduct safety/efficacy trials for approval. Funders: Government development agencies (USAID, DFID), foundations (Gates, Wellcome)

Requirements: Legislation creating new regulatory category and liability protections, regulatory guidance with FDA/EMA developing approval standards for kits, economic incentives including tax credits, advance purchase commitments, or grant funding for R&D

Assumptions:

What could I have wrong?

Assumption 1: Companies will be interested in humanitarian market despite low profit margins

Could be wrong if: Even with incentives, market is too small and uncertain

Assumption 2: Regulatory approval ensures safety in diverse field conditions

Could be wrong if: Lab/clinical trial conditions don’t replicate extreme heat, water quality, user error in camps

Assumption 3: Refugees trust/accept “pharmaceuticallike” interventions

Could be wrong if: Medical appearance creates suspicion or resistance

Risks of Failure and Success:

Risks of Failure: Companies don’t participate, leaving regulatory pathway unused; Lots of money spent on R&D and trials for products that don’t work in field; large companies dominate, excluding innovative small startups or academic solutions

Risks of Success Private companies gain undue influence over public health decisions in vulnerable populations,kits cost too much for cashstrapped humanitarian budgets, companies have no incentive to improve; regulatory barriers prevent new entrants

My Recommendation: Hybrid Approach Start with Option 1 (Standardized Safety Protocol with NGO Certification) as the immediate intervention, while simultaneously developing Option 2 (OpenSource Research Commons) as the research and innovation infrastructure.

Here, we see a balance of safety and access: option 1 provides structured safety protocols without the high costs and delays of Option 3, while being more controlled than Option 2 alone. Key aspects of this combination are that it enables iterative learning, feeding into the research commons, builds toward self-sufficiency, and leverages existing infrastructure.

There is a long timeline that comes along with option 3 alone, and it also requires a lot of funding, which is contrained in this particular context. Standardized kits are also unable to adapt to local variation and create permanent reliance on external supply chains. However, Option 3 could play a supporting role.

Key Tradeoffs Considered:

1. Safety vs. Access Choice: Prioritized access with structured safety over maximum safety with limited access. Rationale: Current situation (65% anemia) is already a health crisis. Moderate risk from fermentation is justified if it significantly improves nutrition. Mitigation: Strong training, simple quality control tests, rapid response protocols.

2. Innovation vs. Standardization Choice: Standardized protocol for implementation, open commons for innovation. Rationale: Field workers need clear, proven protocols. Researchers need freedom to experiment. Mitigation: Build feedback loop where field experiences inform research priorities.

3. Cost vs. Quality Choice: Lowercost, “good enough” solution over expensive pharmaceuticalgrade. Rationale: Perfect is enemy of good. Better to help 10,000 people moderately than 100 people perfectly. Mitigation: Invest in monitoring to catch and address quality issues quickly.

Key Assumptions and Uncertainties:

Assumption 1: Fermentation will significantly reduce anemia prevalence

Uncertainty level: Medium, lab studies show phytate reduction, but field efficacy unknown

Mitigation: Pilot study with rigorous monitoring before scaling

Assumption 2: Cultural acceptance will be high

Uncertainty level: High, haven’t done ethnographic research in Sahrawi camps

Mitigation: Extensive community consultation; start with culturally familiar fermented foods (if any)

Assumption 3: NGOs have capacity to implement

Uncertainty level: Medium, NGOs are overstretched but nutrition is priority

Mitigation: Design for minimal additional burden; integrate with existing food distribution

Target Audience for Recommendation: Primary audience: Director of Nutrition Division, World Food Programme (WFP)

Why WFP: WFP has been supporting Sahrawi camps since 1986 and manages food distribution (so can integrate fermentation protocols)

Liang et al. (2017): “Phytate Degradation During Fermentation.” Journal of Agricultural and Food Chemistry. DOI: 10.1021/acs.jafc.7b00455

Hurrell & Egli (2010): “Iron bioavailability and dietary reference values.” American Journal of Clinical Nutrition. DOI: 10.3945/ajcn.2010.28674F DOI: 10.1021/acs.jafc.7b00455

Advances in Nutrition (2022): “Dietary Intake and Nutritional Status among Refugees in Host Countries: A Systematic Review.” Available: https://pmc.ncbi.nlm.nih.gov/articles/PMC9526844/

Leaning (2017): “Research Ethics in Refugee and Displaced Populations: A Challenge.” Conflict and Health. https://conflictandhealth.biomedcentral.com/articles/10.1186/s1303101701157

Ostrom (1990): “Governing the Commons: The Evolution of Institutions for Collective Action.”