Regulating in Uncertainty: Animating the Public Health Product Safety Net to Capture Consumer Products Regulated by the FDA that Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, and Lab Grown Meat
Katharine A. Van Tassel
University of Akron, School of Law
October 13, 2013
University of Chicago Legal Forum, 2013
U of Akron Legal Studies Research Paper No. 13-09
The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.
Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer products to meet the twin goals of protecting public health while fostering innovation. However the current litmus test that the FDA is using to trigger regulation to protect public health is focused on hazard. Linking public health protections to the degree of hazard when operating in scientific uncertainty is outcome determinative – it means no regulation at all.
This Article will use nanotechnology as the main example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health safety net for consumer products. The public health safety net is a powerful, interactive network that involves consumers as well as the healthcare system, the state and federal public health protection agencies and the tort system. Together, these private and public actors act to ensure consumer safety through consumer self-protection, appropriate injury treatment by correct identification of novel ingredients as causative agents, proper reporting of the injury causing agents to the state and federal public health protection agencies in charge of the early warning and product recall systems and the instrumental use of the tort system to encourage the proper investment in product safety and insulate against the overuse and overconsumption of relatively risky products.
While this system is far from perfect, it is likely to improve exponentially as this country moves into the era of big data. The public health safety net will use big data strategies grounded in informatics to link the information collected from electronic health records and social media to the data generated by the state and federal consumer product reporting systems to create a highly sensitive, state-of-the-art surveillance system. This system will identify early warnings of product safety problems to proactively mitigate their effects.
Finally, this Article will show how this focus will operate to achieve this balance with other novel technologies used as ingredients in consumer products such as cloned animals, genetically modified plants and animals used for food, cloned animals used for food and lab grown meat.
Number of Pages in PDF File: 57
Keywords: nanotechnology, genetically modified food, GM food, GMOs, lab grown meat, innovative technologies, regulating in uncertainty, FDA, Food & Drug Law, consumer products, product liability, post market surveillanceAccepted Paper Series
Date posted: March 30, 2013 ; Last revised: October 27, 2013
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