As part of our series of multiple perspectives on gene editing, we asked Adam Gross and Diana Bowman in the Sandra Day O’Connor College of Law at Arizona State University to describe key questions arising from the development of new food products produced using CRISPR-based technology.
Estimates published by the United States (US) Department of Agriculture suggest that approximately $1.46 trillion is spent annually within the US on “food and beverages in grocery stores and other retailers and on away-from-home meals and snacks”. Fierce competition exists within this space, resulting in industry investing heavily in emerging technologies and the development of new products.
It is therefore not surprising that the use of a new genetic modification technology—Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)-Cas9 based genetic modification technology—is receiving significant attention from certain industry sectors.
In this short piece, we explore what some of the law and regulation-based questions arising from the use of CRISPR-based modification technology may look like. We do not seek to answer the questions, but rather illustrate what policy makers, regulators, industry, and consumers will have to grapple with in the short-to-medium term. We will focus on swine modified by CRISPR-based technology as a practical case study to discuss these questions.
Against the backdrop of an innovative and rapidly evolving agri-food landscape, there is a generally held belief within American consumers that these products, designed specifically for consumption, are safe. The deployment of emerging technologies and tools within the foods sector including, for example, food irradiation processes, genetically modified organisms (GMOs) and nanotechnologies, has—in certain jurisdictions and populations—challenged this assumption. Put simply, the use of new technologies raises questions over the ability of the regulator and the regulatory regime to adequately and effectively regulate the technology and its products.
Concerns may be further exacerbated when there are substantial scientific gaps and/or unanswered questions relating to the potential risks—if any—of the technology. The employment of gene editing tools such as CRISPR, including the CRISPR-Cas9 system, across the agri-food system promises to raise a myriad of social and ethical questions. At the core of a number of these will be issues relating to the adequacy of existing regulatory regimes to ensure the safety of CRISPR-based foods.
CRISPR-Cas9 and other CRISPR-based technologies are the fastest growing genetic modification technologies. Most of the concerns surrounding this new technology revolve around its possible use in modifying humans, developing biological weapons, and the accidental creation of a pandemic super virus. However, given that this technology makes genetic modification cheap and easy, the concern is shifting to more immediate uses, like food production.
CRISPR-based technologies differ from other genetic modification technologies in cost, complexity, and capability. They are cheaper, easier, and more effective. A full explanation of CRISPR-based genetic modification technology and its capabilities is outside the scope of this article, but the technology has been used to simultaneously modify as many as 20 genes in pigs. For a complete description of the CRISPR-Cas9 technology read A Programmable Dual-RNA–Guided DNA Endonuclease in Adaptive Bacterial Immunity.
One company, Genus plc, is using CRISPR-based technology to breed healthier pigs and other livestock through genetic modification. Genus’s and its partners’ focus is on editing the genes that make pigs susceptible to Porcine Reproductive and Respiratory Syndrome (PRRS)—originally known in the US as “mysterious swine disease.” There is no effective vaccine for the PRRS virus, making it the perfect target for genetic modification. While this disease doesn’t directly affect human health, PRRS costs the food industry “nearly $1.6 billion every year in Europe alone”. These costs are associated with, for example, reproductive failure of an infected sow, respiratory failure of infected pigs in the herd and premature morbidity in the animals.
The economics are hardly the primary interest of the consumer protection organizations expressing concern. Those concerned raise, instead, questions of safety and effectiveness of current regulatory instruments in relation to the new technology. The Food and Drug Administration (FDA) regulates both food and genetic modification technology. Thus, the FDA is responsible for the oversight of CRISPR-modified foods, such as pork livestock.
The following are a general list of regulatory and enforcement questions that arise from CRISPR-modified livestock (CML).
First, this technology is so new that its safety is still unclear as it has only been used to modify pig cells and not living livestock. Will there be unforeseen side-effects that are dangerous to humans who consume CML? Thus far, no evidence supports dangers of consuming genetically modified foods. CML differ from GMOs in that outside DNA is not necessarily introduced into the livestock to modify its genes. However, as discussed above, researchers are using CRISPR technology to edit swine genes. It is unclear how CRISPR-based modification might produce different risks than those arising from GMOs.
Second, even if regulations are in place, it is unclear that governments can implement effective enforcement. Whether CML can be identified by biomarkers or other testable identifiers is unclear. Thus far, the differentiation between traditionally-bred organisms and GMOs has included the introduction of foreign DNA. However, CML do not necessarily include the use of foreign DNA. Instead, researchers are removing or deactivating genes—referred to as gene editing. The regulatory definition of genetic modification does not necessarily include gene editing. CML DNA could appear nearly identical to that of conventionally bred livestock. Thus, a producer may be able to pass off CML as conventionally bred livestock because regulators would not be able to detect the difference.
Third, some believe that CML fundamentally differ from other GMOs. Does the public have a right-to-know that they are buying CML? Should there be a labeling requirement when CML are sold for consumption? The public should have a right to know what they are consuming. While the US is not likely to approve CML for human consumption until it is found to be safe, consumers are likely to want to know what they are buying once it is approved and on the market. The US has passed a GMO labeling requirement, though it mostly only applies to GMO foods in their unrefined—unprocessed—state. This is because many refined products do not contain genetic material. Whether CML will be considered GMOs by either the US or the EU has yet to be determined, though there is no doubt that CML are genetically edited. Considering the GMO labeling requirements, it would seem appropriate for the US and EU to develop labeling requirements for the genetically edited CML.
Answers to these questions shall be sometime in the coming. What is clear, though, is that anything to do with food is very personal in nature, and industry should not move forward with the commercialization of CML foods without engaging the public in the process. The consumer is, after all, the ultimate judge of what succeeds or fails in the market.
About the contributors
Adam J. Gross graduated from Arizona State University with a Bachelor of Science in Marketing. Following graduation Gross followed is fascination with marketing, media, and technology, working for DynaTek Media Corporation, a digital signage company with networks nationwide, becoming the Chief Marketing and Chief Technology Officer. After eight years in the digital signage industry, Adam pivoted to focus on his passion for social justice, graduating from the Sandra Day O’Connor College of Law at Arizona State University in May of 2017. While at Sandra Day O’Connor College of Law, Adam served as an Executive Editor for Jurimetrics: The Journal of Law, Science and Technology, as an Executive Moot Court Board Writing Committee member, as a Research Assistant to Professor Diana Bowman, focusing on emerging technology’s use in combatting insect-vector transmitted diseases, as the UMOM Shelter Director for the Homeless Legal Assistance Project, and worked as a Rule 38 Certified Limited Practice Student at the Maricopa County Office of the Public Defender. Adam plans to practice criminal defense in Phoenix, Arizona.
Diana Bowman is Associate Professor at Arizona State University with joint appointments in the Sandra Day O’Connor College of Law and the School for the Future of Innovation in Society. Diana’s research has primarily focused on the legal and policy issues associated with emerging technologies, and public health law. Diana has a BSc, a LLB and a PhD in Law from Monash University, Australia. In August 2011 she was admitted to practice as a Barrister and Solicitor of the Supreme Court of Victoria (Australia).
This article is the third in a series of multiple perspectives on the topic of gene editing. Once additional perspectives are published, we’ll list them here.