'Genetically modified humans are among us'

An alum of my constitutional law class, Paul Enríquez, J.D., LL.M., Ph.D.—Structural and Molecular Biochemistry, is doing some stellar academic work at the cutting edge of genetic science and law and policy.  He privileged me with a sneak peak at his latest contribution to the legal literature, now available on SSRN, Editing Humanity: On the Precise Manipulation of DNA in Human Embryos, forthcoming in 97 N.C. L. Rev. Here is the abstract:

Genetically modified humans are among us. Emerging technologies for genome editing have launched humanity into the uncharted territory of modifying the human germline—namely, the reproductive cells and embryos that carry our genetic ancestry. Reports of the first live births of humans with edited genomes in China recently confirmed that the power to manipulate our genes at an embryonic stage is no longer theoretical. In the wake of enormous scientific progress, questions regarding how the law will treat this technological breakthrough abound.

This Article examines the legality of human genome editing, specifically germline genome editing (“GGE”), from administrative and constitutional law perspectives. It argues that the Food and Drug Administration’s (“FDA” or “Agency”) forbearance in claiming jurisdiction over GGE is creating a perilous void for an emerging field of law. At the same time, the contemporary de facto legislative ban on GGE clinical applications, which categorically prohibits the Agency from evaluating the safety and efficacy of any investigational new drug or biological product application derived from the technology, is unnecessary and creates more societal costs than benefits. On a broad scale, the ban embodies poor public policy because it prevents the FDA from exercising jurisdiction over matters that constitute extensions of the Agency’s traditional regulatory scope. An analysis of the law reveals salient regulatory gaps that could be viewed as rendering some types of GGE beyond the FDA’s regulatory reach. Notwithstanding those gaps, this Article argues that the FDA can work within the existing statutory framework to cure regulatory deficits and promulgate rules to regulate the technology and, thus, urges the FDA to exercise that jurisdiction. This Article ultimately demonstrates how law and policy converge into a proposed new regulatory paradigm for human GGE that flows from the D.C. Circuit’s ruling in United States v. Regenerative Sciences, LLC, which held that specific stem cell mixtures can be regulated as drugs or biological products within the meaning of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.

This Article further contends that efforts to ban GGE technologies cannot withstand constitutional scrutiny in the long run because they impinge on a cognizable fundamental right that protects select uses of GGE. This fundamental right flows from jurisprudence in the areas of procreative, parental, and—to some extent—privacy rights, but it is not absolute. The Article presents an interpretive model for this body of jurisprudence in the GGE context, which promotes extrapolation of applicable legal principles that can guide and promote coherent public policy. Launching from this jurisprudential departing point, this Article introduces a novel legal- and science-based normative framework to delineate primary limits for a right to perform GGE based upon four distinct categories: (1) therapeutic uses to remedy disease; (2) prophylactic purposes, which may or may not be therapeutic; (3) cosmetic or enhancement purposes; and (4) uses involving modification of traits that raise concerns of discrimination already prohibited by the law. This conceptual and structural approach outlines a legal blueprint for GGE clinical interventions, but more importantly it circumvents problems that dominate the existing literature, which arise from the conventional tendency to group GGE applications into therapeutic uses on one hand, and enhancements on the other.

Beyond anthropomorphism: Research posits post-humanist animal rights

Tomorrow the UMass Law Review will ceremoniously launch its volume 14.  Included therein is a deep, thought-provoking work on animal rights and welfare by Barnaby McLaughlin, '19, himself a teacher in the English Department at Rhode Island College.  The paper, "A Conspiracy of Life: A Posthumanist Critique of Appoaches to Animal Rights in the Law," is available online from the law review.  I'm proud to say I was a reader on this project, though it was decidedly one of those I-got-more-than-I-gave scenarios.  I'll take my Ph.D now, please.  Here is the abstract.

Near the end of his life, Jacques Derrida, one of the most influential philosophers of the twentieth century, turned his attention from the traditional focus of philosophy, humans and humanity, to an emerging field of philosophical concern, animals. Interestingly, Derrida claimed in an address entitled The Animal That Therefore I Am that, 

since I began writing, in fact, I believe I have dedicated [my work] to the question of the living and of the living animal. For me that will always have been the most important and decisive question. I have addressed it a thousand times, either directly or obliquely, by means of readings of all the philosophers I have taken an interest in. . . .

Derrida’s insistence that the question of the animal has always been the focus of his work reflects an interesting turn in philosophy at the end of the twentieth century, where the primacy of the human was rightfully being challenged, and the lives of animals were being considered on their own terms. Increasingly, the shift in focus from the primacy of the human to a more thoughtful consideration of animals has moved outside of just philosophy into other academic fields. These developments have been reflected in the emerging interdisciplinary field of posthumanism. Posthumanism, inclusive of all disciplines, seeks to shed the legacy of liberal humanism and the primacy of the human and instead consider all the interests of those that the human shares the world with (including animals, plants, technology, et cetera). Curiously however, while posthumanism has had an impact in most disciplines, outside of a few scholars, it is absent in the legal field (both in academia and in practice). Where the status of animals in the law has been challenged, it has largely been done through arguments derived from the legacy of liberal humanism. The two most significant challenges to the status of animals in the law have been mounted by the Nonhuman Rights Project in the United States, and the Great Ape Project, which has primarily been successful in New Zealand and Spain. Both projects have sought to expand legal rights to hominids, though each has adopted different strategies. The Nonhuman Rights Project has sought to use arguments within existing legal paradigms to force the courts to recognize chimpanzees as “persons,” whereas the Great Ape project has intentionally avoided court (for fear of setting unfavorable precedents) and favored pressing change through legislation. Ultimately however, both projects are thoroughly rooted in liberal humanism and advance their arguments through proximity claims—the idea that certain animals, in these cases, apes, deserve legal consideration because of their similarity to humans.

This paper is an interdisciplinary comparative analysis of the Nonhuman Rights Project’s failures in the United States and the Great Ape Project’s success in New Zealand. The success of the legislative approach of the Great Ape Project demonstrates the need to approach these arguments outside of the courtroom to avoid hostile judges, philosophical legacies, and archaic precedents. However, the Great Ape Project does not go far enough in expanding the rights of other beings as it relies on emphasizing similarities with humans as the sole reason for extending rights, leaving other beings, even higher order mammals like dolphins, without inclusion— and a real possibility that any such inclusion would forever be cut off. Therefore, this paper proposes the need for a posthumanist foundation for pursuing the rights of other beings through legislative means.

CFP: UMass Law Review calls for papers, presentations in law and media

The UMass Law Review has issued the following call for papers. Download the call in PDF here, and please share it with any interested scholarly communities.

UNIVERSITY OF MASSACHUSETTS LAW REVIEW
CALL FOR SYMPOSIUM PAPERS AND PRESENTATIONS

November 14, 2018

We are pleased to announce the 2019 UMass Law Review Roundtable Symposium, currently titled “Law and Media.” In the age where the 24/7 news cycle and social media have impacted current politics and where data protection, personal branding, and technology have affected entertainment and media as well as the rule of law, an investigation of the relationship between law and the media of our current times is timely and warranted. Accordingly, the UMass Law Review seeks thoughtful, insightful, and original presentations relating to the impact of the law on media as well as the impact of media on the law.

Interested participants should submit a 500-word abstract to cshannon@umassd.edu, with “Attn: Conference Editor – Symposium Submission” in the subject line by December 31st, 2018 for consideration. Selected participants will be notified by the end of January and invited to present their work at the 2019 UMass Law Review Symposium taking place in late March of 2019. Selected participants may also submit a scholarly work for potential publication in the 2019-2020 UMass Law Review Journal. If you have questions about submissions or the Symposium, please contact our Business/Conference Editor, Casey Shannon or Editor-In-Chief, Kayla Venckauskas (kvenckauskas@umassd.edu). We thank you in advance for your submission.

Sincerely,

Kayla Venckauskas
Editor-in-Chief

Casey Shannon
Business/Conference Editor