Law Commons^™

United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of …

Feeding The World: How Changes In Biotech Regulation Can Jump-Start The Second Green Revolution And Diversify The Agricultural Industry, John A. Erwin, Robert Glennon

William & Mary Environmental Law and Policy Review

As the Earth’s population climbs from 7.7 billion in 2019 to almost 10 billion by mid-century, farmers will need to increase food production by 70 percent. This Article analyzes the tools available to achieve this demanding goal. We assess changes in agriculture related to both the organic industry and the high-tech sector that are enabling farmers to become more efficient. Critically, biotechnology offers great promise to hasten the pace of increased agricultural efficiency through genetic engineering. While genetic modification has been controversial, we cannot exclude any viable policy option, especially one with so much promise. Yet the current regulatory environment …

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps, the …

Re-Framing Biotechnology Regulation, Alison Peck

Law Faculty Scholarship

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health-but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly …

Expanding Horizons: Scientific Frontiers, Legal Regulation And Globalization, Belinda Bennett

Indiana Journal of Global Legal Studies

In the six decades since the discovery of the double helix structure of DNA by Watson and Crick in 1953, developments in genetic science have transformed our understanding of human health and disease. These developments, along with those in other areas such as computer science, biotechnology, and nanotechnology, have opened exciting new possibilities for the future. In addition, the increasing trend for technologies to converge and build upon each other potentially increases the pace of change, constantly expanding the boundaries of the scientific frontier. At the same time, however, scientific advances are often accompanied by public unease over the potential …

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Other Publications

It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …

Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

This Article describes and evaluates the existing federal regulatory regime for protecting public health from risks posed by foods derived from GM plants. Part I briefly describes the technology involved in genetically modifying plants and relates the ongoing debates over the risks and benefits of GM food plants. Part II examines in detail the regulatory regime that has evolved in the United States to regulate the safety of GM foods, focusing in particular upon the pervasive role that the substantial equivalence doctrine has played in that regime. Finally, Part III suggests a more precautionary approach toward regulating GM foods that …

Normalizing Novelty: Regulating Biotechnological Risk At The U.S. Epa, Les Levidow, Susan Carr

RISK: Health, Safety & Environment (1990-2002)

Drs. Levidow and Carr examine EPA's regulation of biotechnology in the field of genetically modified organisms.

Intellectual Property Issues In Genomics, Rebecca S. Eisenberg

Articles

Controversy over intellectual property rights in the results of large-scale cDNA sequencing raises intriguing questions about the roles of the public and private sectors in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information. While the US Patent and Trademark Office has rejected patent applications on cDNA fragments of unknown function from the National Institutes of Health, private firms have pursued three distinct strategies for exploiting unpatented cDNA sequence information: exclusive licensing, non-exclusive licensing and dedication to the public domain.

Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

Part I of this Article describes some of the risks and benefits of newly emerging agricultural biotechnologies. After discussing, in Part II, the role of federal agencies in regulating agricultural biotechnologies, Part III of the Article proposes elements for an adequate regulatory regime. Part IV then measures the existing legal authorities, as implemented by the USDA and the EPA, against the ideal elements. Part V examines the willingness of these agencies to regulate. Finally, Part VI suggests changes that can be made in the current regulatory regime to bring about more effective regulation and to enhance public trust in regulatory …