Navigating the Regulatory Frontiers of Emerging Products: From Cellular Meat to Biological Pest Controls
“Without a clear, predictable, and timely framework, this industry cannot succeed.” — Eric Schulze, Memphis Meats, on lab-grown meat technology regulatory gaps. 
Last week, two central food regulatory bodies in the United States, the U.S. Department of Agriculture and the U.S. Food and Drug Administration, jointly coordinated public outreach and stakeholder engagement sessions on the regulation of lab-grown meat, referred to by some as “clean meat,” by others as “in vitro meat” or “cultivated meat.” There is no single name for this emergent technology nor a formal definition recognized in our laws, so here we will call it “cellular meat.”
Stakeholders from the public sector, private sector, and civil society met in person and virtually to exchange ideas, offer concerns, and otherwise begin the process of forging consensus around a regulatory framework for cellular meat. Key questions emerged: What agency will have jurisdiction over various regulatory hurdles? Do existing standards reflect this new technology? What health and food safety concerns do this new technology implicate? Is lab-grown meat truly meat for purposes of existing regulations?
This case highlights the issues facing entrepreneurs around the globe who are pushing the envelope on new products and opportunities. Entrepreneurs exist all along commodity and food markets where opportunities to add value arise, whether that be through offering new services, product designs, or quality offerings to satisfy unmet demand. However, in realizing their business opportunity, these entrepreneurs can find themselves in new or unchartered territory when it comes to operating standards or regulations.
Regulators often — and appropriately — find themselves behind industry developments. Entrepreneurship and emergent technologies necessarily outpace the creation of regulatory frameworks. When new technologies shatter traditional models, paradigmatic shifts in regulation and compliance rarely coevolve. To keep up with the path and pace of change, a lean approach to regulation, frequently referred to as a “regulatory sandbox” may be most appropriate. A regulatory sandbox approach entails public sector and private sector co-creation of a regulatory framework through collaboration, shared learning, and adaptation, as emergent technologies evolve markets and nascent business models begin to form.
Recently, the Feed the Future Enabling Environment for Food Security project interviewed 25 small and medium-sized enterprises whose business models focus on delivery to smallholder farmers to hear about the challenges and issues these firms face in the enabling environment for their businesses. The companies generally expressed more concerns regarding the lack of regulations specific to their industry than an overabundance of existing policies and procedures. Companies expressed needs for new protocols regarding quality standards, biosecurity, and processing methods as well as greater protections for intellectual property. At the regional level, businesses are confronting the need for regulations to enable mobile money payments across borders and greater data sharing.
It takes time to establish regulations and protocols, often measured in years. For one business, working with the government to establish clear guidance on the ripening process for fresh produce took two years of joint experimentation and negotiation: “Getting the authorities involved to build a proper regulatory environment has taken two years. Boards, regulators don’t actually speak to each other very well and had no framework for that kind of process. It was hard to get them to negotiate with each other.”
Delays like these add risk and uncertainty to product development, impede the introduction of new technologies into the market, and slow the growth of new industries. Financial support from donors and governments is often very helpful to firms to expand and share the risks of breaking into new or difficult-to-reach markets, such as those serving smallholder farmers. However, supporting the proactive development of the legal and regulatory frameworks for new industries can be another important instrument and effective stimulator to cultivate business innovation and investment for the longer term.
For example, in Kenya policymakers passed new regulations governing the registration of live organisms for pest control use in 2006, as the market for biological pest control products was just beginning to shift away from traditional pesticides. The country now has four active biocontrol manufacturers with exports throughout East Africa as well as South Africa and Europe. In Bangladesh, policymakers recognized the need for disease-free shrimp stock to revitalize the aquaculture industry in the delta and funded a study tour for policymakers to learn from scientists in India, Thailand, Vietnam, and Hawaii, eventually overhauling biosecurity protocols to allow private sector investment in adapting imported breedstock to the conditions in the delta.
What might we learn? Here are a few key questions that emerge for donors, governments, and others looking to strengthen and ensure a regulatory climate that will work for shared private and public interests.
- What are the new risks created by this new technology, and how should the risks be apportioned? Who bears liability if harm occurs from this new technology?
- What agency can, or should, have the primary legal mandate to lead initial public sector collaboration?
- What does effective stakeholder engagement look like within the local context? What makes the process fair and open?
- How do you navigate entrenched interests to deliver reasonable new regulations that enable a virtuous public policy rather than simply creating higher regulatory compliance costs that increase entry costs for competitor firms?
To learn more about perspectives and learning from the private sector on this topic, check out the Feed the Future Enabling Environment for Food Security project’s report Private Sector Voices: Building an Enabling Environment for Investment.
 Politico, “Morning Agriculture.” 24 October 2018. https://www.politico.com/newsletters/morning-agriculture/2018/10/24/cell-based-meat-summit-day-2-387050.