Week 1 HW: Principles and Practices

1. First, describe a biological engineering application or tool you want to develop and why.

I’m passionate about both food and biotechnology and seek to combine the two discipline together for my future career. A biological engineering application that I would love to work on is precision fermentation production for alternative sustainable protein sources, specifically β-Lactoglobulin (BLG) protein for recombinant milk production. I was inspired by a PhD student’s publication at Wageningen University & Research while I was searching for a university to earn my Master’s degree. Indonesia’s demand for milk and dairy products has been increasing over the years, and our climate isn’t suited for dairy cattle farming compared to other countries with a more appropriate climate and productive dairy cows. Not to mention the environmental impact of dairy farming, along with the scarcity of arable land, are also factors to be considered to supplement part of the industry with precision fermentation (Hoppenreijs, 2024).

According to our Ministry of Cooperation’s estimation, 80% of Indonesia’s milk is still imported from overseas. With precision fermentation of milk proteins, Indonesia could potentially reduce its reliance on imported milk and redirect that funding to other industries that require it. Precision fermentation is also an emergent technology that’s not widely taught and researched in Indonesia. I would one day like to learn everything about it, so I would be able to bring that knowledge and its application to my motherland.

There have been commercializations of recombinant milk made from non-animal-derived dairy proteins, especially in developed countries with a thriving dairy industry, such as Perfect Day in the USA, Remilk in Israel, Verley Food in France, All G in Australia, and several others. These companies have one thing in common: utilising genetically engineered microorganisms (most often yeast and fungi) as a “cell factory” to produce non-animal dairy proteins for their recombinant milk production. While my idea isn’t novel on a global scale, it is novel in Indonesia and tackles many issues faced by Indonesia’s dairy industries, such as Indonesia’s indigenous dairy cattle, the Balinese Cattle, being low milk producers despite their high fertility rate compared to other breeds of cattle (Suryani et. al., 2017).

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.

My Main Goal: Ensuring non-malfeasance in the production and commercialization of synthetically produced BLG and BLG-derived products such as recombinant milk and dairy products.

The Sub Goals:

• Food safety: Provide pre-market assessment for BLG synthesised through the precision fermentation of genetically modified microorganisms and their derived product to ensure that they are nutritionally identical and as safe and fit for consumption as their conventionally produced counterparts (FAO, 2008). These can be supported by strict monitoring and assessment by Indonesia’s Biosafety Commission of GMOs.

• Environmental safety: Evaluate the biosafety of the production process of synthesised BLG and the finished products along with their derivatives to assess the possible effects on the environment and biodiversity of Indonesia (FAO, 2008). Strict regulations and policies must be adhered to prevent harm to Indonesia’s environment.

• Knowledge sharing and dissemination: Share and disseminate the technical knowledge of the overview on precision fermentation to promote the application of this emergent technology in various industrial applications for Indonesia, such as for pharmaceutical purposes.

3. Next, describe at least three different potential governance “actions” by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”).

 Conducting food and environmental safety inspection along with pre-market assessment of BLG and its derivatives, creating standardised labelling, and establishing a clear legal category for precision-fermented proteins within Indonesia’s national food law framework.

1. Purpose: Due to synthetic proteins made through precision fermentation still being inside many regulatory and legal grey areas in Indonesia, a more rigorous safety and risk assessment should be conducted to ensure the health and safety of the manufacturers, the consumers, and the environment.
2. Design: Various government agencies and regulatory bodies, such as the National Agency for Drug and Food Control, the Biosafety Commission of GMO, and the National Standardization Agency of Indonesia. The assessment of alternative proteins is funded by the applicant company, while the regulatory system itself is paid for by the state budget of Indonesia.
3. Assumption: The applicant company would follow all the regulatory and safety assessments.
4. Risk of Failure and “Success”: Corruption and fraud that result in improper testing of a genetically modified product could lead to violations of health and safety standards, potentially jeopardising the health of consumers and the environment.

 Increasing the national budget for research grants and public funding for research into precision fermentation.

1. Purpose: To increase the amount of research into precision fermentation in Indonesia, enabling the country to compete with developed nations in the sphere of biotechnology advancement and incentivising prospective researchers.
2. Design: The Ministry of Finance would be responsible for allocating funds for the increase of research budget from the state budget of Indonesia, while the researchers are responsible for using the allocated budget responsibly within the scope of the research into precision fermentation.
3. Assumption: The Ministry of Finance deems precision fermentation important enough to increase the state funding for research, and for there to be no corruption and mismanagement of said funding by either the government or the applicant company/research institute developing the precision fermentation technology.
4. Risk of Failure and “Success”: Failure to secure the funding or the mismanagement of the fund could lead to the research into precision fermentation in Indonesia being stalled, and the further dissemination of the knowledge of precision fermentation in Indonesia being halted.

 Create public education guidelines for recombinant food proteins.

1. Purpose: Educating the public and managing public perception on precision-fermented proteins and GM products is crucial for building public trust in a product that many Indonesians might not be aware of. It is also an anticipatory act to prevent the spread of misinformation from either the uninformed public or malicious parties by providing scientific FAQ’s backed by influential neutral parties in Indonesia, such as government regulators, religious institutions (which is a big influence in Indonesia), such as the halal certification boards, and other scientific authorities.
2. Design: As said before, there are many neutral parties involved in creating public education guidelines for recombinant food proteins. Government institutions such as the National Agency for Drug and Food Control, the Biosafety Commission of GMO, the Ministry of Health, and the National Research Institute. Due to Indonesia’s major Islamic population, reassurance from halal certification bodies would also help immensely on alleviating public preconception notions towards GM products. Other scientific authorities, such as university researchers and food technologists, would also assist on educating the public due to being perceived as less biased than companies and the government.
3. Assumption: These institutions managed to convey the safety from the health, environmental, ethical, and religious angles of precision-fermented products and their derivatives.
4. Risk of Failure and “Success”: It’s possible that failure in educating the public would lead to rejection of future precision-fermented products, halting the advancement in the research of precision fermentation, not just for food application, but also other novel applications, such as pharmaceutical applications that can save and improve the lives of many others.

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.

While research into precision fermentation of alternative proteins is still in its infancy in Indonesia, I believe that implementing the food and environmental regulatory policies on the subject of precision-fermented products should be prioritised just as much as the research on precision-fermented products as a governance option. Based on the Government Regulation No. 21/2005 on Biosafety of Genetically Engineered Products, Indonesia takes a more cautionary approach towards genetically modified organisms and related products, which will be evaluated by the Biosafety Commission. Due to the novelty of BLG and other precision-fermented proteins in Indonesia, it would be prudent to lay out the legal groundworks first for future GM proteins.

Technically speaking, Indonesia already uses GM products for commercial purposes, such as imported GM soybeans for our tempeh and tofu industry and corn livestock feeds. However, these uses remained in the upstream, which remains fairly invisible to the public eye, rather than branded foods. Commercialization of precision-fermented protein would be a new territory, and thus, new laws and regulations should be enacted for these products first. This is not meant to discourage the proliferation of precision-fermented products, but the opposite. It is for incentivizing research and commercialization of these products. If the laws and regulations of the country are strict and uncertain, then potential investors of the research wouldn’t invest due to the uncertainty if the product could be sold in the first place. The Porter Hypothesis posits that strict, well-designed environmental regulations can trigger innovation, enhancing corporate productivity and competitiveness to outweigh compliance costs (Ambec et. al., 2011). It is better for Indonesia to make laws clear first on precision-fermented products for the interest in the research to increase to the point where the commercialization of this technology is economically viable.

However, this is all with the assumption that precision fermentation technology is already advanced in Indonesia to the point where commercialization becomes the next step. The fact of the matter is, Indonesia is not quite there yet. Indonesia is not scientifically incapable of producing precision-fermented milk proteins; there are plenty of research in Indonesia around industrial fermentation, though mostly on natural microbes. Rather, the absence of regulatory clarity, pilot-scale facilities, and commercialization frameworks prevents translation of existing microbiological research into an alternative protein industry. Because of this, increasing awareness of precision fermentation technology and its myriad of applications would not only increase the research interest among Indonesia’s scientific community, but also help the government realise its significance to justify increasing national research funding.

References:

Ambec, S., Cohen, M. A., Elgie, S., & Lanoie, P. (2011). The Porter hypothesis at 20: Can environmental regulation enhance innovation and competitiveness? Resources for the Future Discussion Paper No. 11-01. Social Science Research Network. https://ssrn.com/abstract=1754674

Food and Agriculture Organization of the United Nations. (2009). GM food safety assessment: Tools for trainers. FAO. https://www.fao.org/4/i0110e/i0110e.pdf

Hoppenreijs, L. (2024). β-lactoglobulin by precision fermentation: Application-driven design and processing (PhD’s thesis, Wageningen University & Research). Wageningen University Repository. https://groenkennisnet.nl/zoeken/resultaat/β-lactoglobulin-by-precision-fermentation-:-application-driven-design-and-processing?id=1413396

Republic of Indonesia. (2005). Government Regulation No. 21 of 2005 on Biosafety of Genetically Engineered Products. https://peraturan.bpk.go.id/Details/49379/pp-no-21-tahun-2005

Suryani, N. N., Suarna, I. W., Sarini, N. P., & Mahardika, I. G. (2017). Increasing energy ration of Bali cattle to improve digestible nutrient, milk yield and milk quality. International Research Journal of Engineering, IT and Scientific Research, 3(1), 8–17. https://sloap.org/journals/index.php/irjeis/article/view/526