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Bioindustrial manufacturing is rapidly growing and is crucial for economic development. It’s urgent to ensure that its expansion benefits society. We’ve explored the ethical aspects of this growth, focusing on safety, security, social responsibility, and sustainability, suggesting policy actions to maximize societal benefits.
Biomanufacturing, which encompasses the production of goods through biological processes, is a vital component of the bioeconomy, connecting innovation with market-driven production of biological products. The U.S. bioeconomy, valued at over $950 billion and contributing over 5% to U.S. manufacturing, is rapidly expanding, impacting economic vitality. With its increasing influence, it becomes crucial to integrate ethical considerations into biomanufacturing. While initiatives like the NIH’s ELSI Research Program have addressed societal and medical impacts of biotechnology, global competition and climate change emphasize the need for broader considerations including sustainability and social responsibility. Bioindustrial manufacturing provides an avenue to incorporate these norms on a global scale. For instance, BioMADE, established by the U.S. DoD in 2020, prioritizes “4S principles” – safety, security, sustainability, and social responsibility – into biomanufacturing and all its funded projects. This paper explores biotechnologists’ perceptions of these principles, aiming to understand their views and identify actions to enhance societal benefits and shape biomanufacturing policy. While the focus was primarily on the U.S., promoting 4S principles in bioindustrial manufacturing should be a priority for all governments investing in this field’s growth.
From April to June 2023, researchers held virtual interviews with 31 industry leaders from BioMADE, covering various perspectives including academia, CEOs, founders, CSOs, and CTOs of biomanufacturing firms. The majority were from U.S.-based organizations, with some from international companies. An interview guide was developed based on informal discussions with BioMADE leaders and researchers’ expertise, allowing flexibility for interviewees to discuss their experiences and priorities. Interviews were conducted anonymously to encourage honesty. Notes were taken during interviews, and audio recordings were transcribed with interviewees’ consent to supplement notes.
Researchers used a qualitative approach, employing NVivo software to analyze interview content regarding BioMADE’s 4S principles. They initially focused on sustainability, safety, security, and social responsibility, but added themes as they emerged during interviews. The final coding framework included additional themes such as education, public risk perception, competition, regulatory space, and workforce. Using NVivo12 Pro and Excel, they generated semi-quantitative metrics to measure the frequency of discussion on each code, identifying topics of greater importance. They also conducted a detailed qualitative analysis to identify prevalent comments and recommendations across interviews.
In response to the growing global technology competition, countries like China, the UK, and the EU are rapidly expanding their biomanufacturing capabilities and workforce. China, in particular, is catching up with the U.S. through aggressive R&D investments, government directives like “Made in China 2025,” and a focus on attracting and retaining STEM talent. President Biden’s Executive Order 14081, issued in September 2022, launched the “National Biotechnology and Biomanufacturing Initiative,” aiming to advance biotechnology in various critical areas like health, climate change, and food security.
The study suggests integrating the 4S principles (Sustainability, Security, Society, and Strategy) into the industry, emphasizing the need for the U.S. to lead rather than follow global standards. Recommendations align with the National Academies’ emphasis on evaluating environmental and health benefits and strengthening intellectual property and cybersecurity measures.
Industry stakeholders highlight barriers like fragmented regulations, policies favoring petrochemicals, and workforce shortages. The U.S. needs a comprehensive strategy to transform its industrial complex and become a global bioeconomy leader.
Regulatory frameworks like the Coordinated Framework for Biotechnology Products lack clarity, causing inefficiencies. Stakeholders propose streamlining processes, expediting regulatory pathways, and using AI for efficiency.
Industry leaders agree that biomanufacturing could create millions of high-paying jobs, requiring a diverse, well-trained workforce. Investments in education and infrastructure, particularly in rural areas with biomass resources, are crucial for industry growth.
Biomanufacturing significantly impacts carbon emissions, economic opportunities, and national security. The study emphasizes integrating ethical principles, including sustainability, into policy discussions to shape future policymaking.
In summary, for the U.S. to lead in establishing global standards and norms, it must overcome barriers hindering its bioindustrial sector’s growth and integrate ethical principles into policy development, leveraging insights from industry practitioners.
While this study had a strong methodology, some limitations exist, including the inability to interview all BioMADE members. Though interviews were conducted with strict confidentiality, concerns about competitiveness might have affected participation. It’s important to note that interviewees’ views may not reflect their organization’s stance, and broader inferences shouldn’t be made. Additionally, while all governments investing in bioindustrial manufacturing should prioritize 4S principles, discussions mainly focused on U.S.-centric initiatives.
As biotechnology advances rapidly, there’s an urgent call to integrate BioMADE’s 4S principles into new technology development frameworks. The U.S. bioeconomy has a limited opportunity to influence global norms, enhancing public acceptance and industrial biotech success. Insights from this study will inform future U.S. policy and norm-setting, highlighting industry perspectives.
Source:
Attal-Juncqua, A., Getz, J., Morhard, R., & Gronvall, G. K. (2024). Integrating safety, security, sustainability, and social responsibility principles into the U.S. bioeconomy. mSphere, e0008424. Advance online publication. https://doi.org/10.1128/msphere.00084-24