The opening chapter introduces the reader to the ongoing genome-editing revolution, which is spearheaded by the discovery of CRISPR. To set the appropriate context for the book, the chapter discusses human ingenuity, its presence throughout the history of civilization, and the power it holds to transform the world. The chapter lays out a foundation on which to argue that transformative technologies—such as the printing press, the Internet, nuclear weapons, and other technological feats that induced massive cultural and social change—share a common modus operandi. This exposition aims to help the audience grasp the significance of having access to the specialized tools required to rationally manipulate the genetic composition of living organisms. The chapter provides a high-level overview of the book’s contributions to the literature and discusses the importance of interdisciplinary inquiry to bridge gaps between science, law, and policy.

The introduction’s core purpose is to emphasize to the reader that the potential impact of genome editing is likely to be on par with—if not greater than—the discovery of nuclear fission, which led to the development of nuclear weapons, or the advent of modern computing, which spawned the era of worldwide communications via the Internet.

Human genome editing has become a reality and is here to stay. A logical question that follows, therefore, is whether the government should regulate the technology and, if so, what precise measures should be adopted to promote or hinder technological development. This chapter focuses on those questions at the intersection of human genome editing—specifically, germline genome editing (GGE) —and administrative law. The chapter highlights the FDA’s role as the agency in charge of protecting the public health by ensuring the safety and efficacy of human drugs and biological products, as well as shepherding scientific discoveries into the clinical realm. By examining precedents in gene therapy and stem-cell interventions, which are likely relevant to GGE, the chapter identifies regulatory gaps and proposes a novel regulatory framework for future GGE interventions. The chapter further frames the regulatory discussion in the context of an existing de facto legislative GGE ban, which prohibits the FDA from reviewing investigational uses of GGE technology in human embryos. Lastly, the chapter argues that the current legislative ban creates more societal costs than benefits, and it increases the likelihood that GGE technologies will be forced to develop in jurisdictions where regulatory systems may be inadequate from social and ethical standpoints.

CRISPR systems are democratizing scientists’ access to new tools required for uncovering future significant scientific, medical, and technological advances. CRISPR–Cas9, however, is not the only tool being used to edit DNA sequences. Much like the use of different types of airplanes and vehicles for human transportation, so too can different tools be used for gene editing. This chapter examines the evolution and development of the different types of modern genome-editing tools that have enabled the targeted manipulation of genetic sequences. In so doing, it elucidates how genome editing is a logical extension of the genetic manipulation enabled by pioneer recombinant-DNA techniques. The chapter argues that genome editing exists today because recombinant-DNA technology and molecular cloning were developed, promoted, and refined to give rise to avant-garde molecular tools. As it progresses, the chapter allows the reader to rummage through the genome-editing toolbox and focuses on examining the advantages and disadvantages of four distinct categories of genome editing: (1) chemistry-based systems; (2) viral-based editing; (3) nucleases that rely on protein-DNA interactions for DNA targeting—such as meganucleases, zinc-finger nucleases, and TALE nucleases; and (4) RNA-guided, DNA-nuclease systems, which comprise CRISPR–Cas systems.

The constitutional structure that supports our democratic system recognizes certain fundamental rights involving human liberties. These rights are considered so important that any governmental action impinging on them warrants examination under strict scrutiny, a legal standard that imposes a high bar for the government. Under strict scrutiny, the government must articulate a compelling purpose for enforcing a law encroaching fundamental rights and prove there are no less restrictive means to accomplish the law’’s purpose. Some fundamental rights, such as the freedom of speech and the right to vote, are enumerated in the Constitution. Others, including the rights to procreate, marry, exercise parental autonomy, make medical-care decisions, and others, are unenumerated yet also recognized as fundamental under the Constitution. But where do these rights come from? What, if anything, do they have in common with genome-editing technologies? This chapter examines novel issues related to genome editing and constitutional law. It surveys modern-day due process and equal protection jurisprudence to evaluate whether existing precedents define a cognizable fundamental right to select uses of germline genome editing. The chapter further illustrates the dangers of ignoring or misinterpreting science in constitutional law and analyzes the involuntary sterilization of “mentally defective”individuals legalized under Buck v. Bell.

A new age began in November 2018, when the world learned shocking news about the birth of the first gene-edited babies in China. He Jiankui, an unseasoned researcher who performed haphazard and surreptitious experiments on viable human embryos using CRISPR–Cas9, confirmed he had manipulated the CCR5gene, which plays a role in HIV resistance in humans. Calls for bans on such uses of genome-editing technology surfaced immediately. Some critics claim that editing the human germline (a term that refers to sperm, eggs, zygotes, and embryos) is immoral, unethical, and will push society down a dangerous eugenic path. A common concern is that genome-editing technologies are inherently insidious because they will lead to “designer babies” with a panoply of artificial traits, including superior intelligence, athleticism, or even beauty. Uncertainty in this emerging field of law and science is further compounded by the lack of scientific knowledge among the general public and the dearth of international norms in an increasingly globalized world. This chapter dives into the myth of designer babies and explores the dissonance between public opinion and the science of complex human traits. In so doing, it grounds the conversations on scientific facts to elucidate whether intelligence and other complex traits can really be engineered in a test tube.

The advent of recombinant DNA technology in the 1970s led to general concerns about the use of novel biotechnologies and the potential effects on public health and the environment. To assuage those concerns, the Reagan Administration created the Coordinated Framework for the Regulation of Biotechnology. This 1986 policy document avowed that existing health and safety laws could provide adequate regulatory oversight for biotechnology products under a products-based, rather than a process-based, approach and assigned broad federal jurisdiction to the FDA, EPA, and USDA. This chapter examines how novel genome-editing technologies will test the limits of the Coordinated Framework, which is largely limited in scope by older genetic-engineering methods. The chapter analyzes the regulatory status of gene-edited crops and how, under specific circumstances, these crops can escape regulatory oversight due to the Coordinated Framework’s focus on the use of transgenic DNA to carry out the intended genetic manipulations. The chapter explores current regulatory gaps and argues that, in the near future, it will likely be increasingly cumbersome to distinguish between genome-edited crops and naturally occurring crops. The technology, therefore, is likely to challenge the very essence of what constitutes a GMO and extends opportunities to help allay controversies surrounding genetically modified crops.

This chapter introduces normative recommendations for developing legal and science-based policy frameworks to address some of the genome-editing issues discussed throughout the book. The chapter, for instance, builds upon discussions in chapters 8–10 to propose a system to demarcate foundational rights and uses of germline genome editing (GGE) on the basis of four 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 unlawful discrimination. In so doing, the chapter explores conceptual and structural approaches to GGE clinical interventions and promotes dialogues about the extent to which editing the genetic composition of the human germline should be permitted and, in some instances, protected. Furthermore, to expand on concepts introduced in chapters 6–7, this chapter focuses on strategies to promote research- and science-based policy development related to GMOs and genetically modified crops. Within that backdrop, the chapter elucidates policy development as an inherently complex process that depends not only on strict science-based evidence, but on a multitude of legal, economic, social, political, and other factors that ultimately shape law and policy.

Scientists have long recognized the value of developing methods to induce modifications in DNA sequences. Although the wave of recent breakthroughs concerning gene editing has propelled the field to the forefront of science, the concept itself is not new. This chapter explains how genome editing became a reality and argues that the concept of genetic manipulation is rooted in popular culture. The chapter begins by introducing readers to Gregor Mendel’s groundbreaking pea-plant experiments in the mid-1800s, which gave rise to modern genetics. The chapter then provides a concise overview of the origins of the concept of genetic manipulation, and how the discovery of two critical elements—restriction enzymes and DNA-repair mechanisms—in the second half of the twentieth century marked the genesis of modern molecular biology and biotechnology. Importantly, this chapter acquaints readers with fundamental concepts in molecular biology and genetics—including gene expression, DNA replication, RNA transcription, protein translation, DNA repair, the structure of DNA, the rise of genetic mutations, the flow of genetic information through the central dogma of molecular biology, and more—and explains important scientific terminology in a clear and accessible format with the aid of illustrations.

Socrates, the renowned philosopher, famously averred that “the beginning of wisdom is the definition of terms.” The veracity of that ageless quip is, of course, debatable from a rhetorical standpoint. The definition of terms may or may not mark the genesis of wisdom but, rest assured, conceptual reflection of term definitions indisputably constitutes a crucial early step in legal construction and interpretation. This chapter focuses on a simple, yet fundamental, question that remains unaddressed in modern literature: What exactly is genome editing? To that end, the chapter lays an interpretive and normative foundation that imports meaning into the term’s scope. It starts by highlighting how scientific literature has remarkably devoted substantial efforts to discuss ways to develop, use, improve, and expand the technology without actually attaching a particular meaning to the term. After exposing limitations associated with the use of dictionaries in legal analysis, the chapter argues that congruity and uniformity on genome-editing terminology is sorely needed now due to the increasing interdisciplinary reach of the technology. Accordingly, it advocates for the adoption of a unified definition of genome editing. The proposed definition undergoes rigorous analysis and, along the way, the chapter dispels the myth that law generally lags behind scientific progress.

Feeding the world and achieving food security has become a major goal of biotechnology. The United Nations estimates that the world population will rise to nearly ten billion people by 2050. To confront challenges in global agriculture, scientists have engineered crops with specific traits to improve crop nutritional content and yields, and minimize the impact of suboptimal environmental conditions. This strategy led to the development and global commercialization of genetically modified (GM) crops, which in turn ignited fervid opposition to genetically modified organisms (GMOs) by many groups worldwide. To elucidate the basis of GMO controversies, this chapter dives into the science of GMOs. It offers a detailed account of the numerous techniques that scientists use to make GMOs and examines the advantages, limitations, and potential risks associated with each technique. The chapter further undertakes a comprehensive examination of the current state of the primary scientific literature concerning perceived health and environmental risks commonly associated with GMOs. The chapter’s primary aim is to furnish a succinct resource that renders dense scientific information related to GMOs accessible to all readers.

As we meet at the end of this journey, and before you and I embark on separate paths, let us reflect on the overarching theme of this book. My sincere hope is that you have gained a deeper understanding and appreciation of genome editing. This technology holds the power to fundamentally change the world, perhaps in ways we cannot yet begin to comprehend. How exciting it is that you and I are both alive at this time, when we can attest to having witnessed the world before and after the advent of genome editing!

Widespread use of a biotechnology often does not occur for years after it is first introduced to the scientific community. Yet CRISPR–Cas systems, unlike their predecessor technologies, have been adopted by laboratories all around the world with unprecedented speed and used to edit the genomes of virtually every living organism. One substantial predicament about powerful technologies is that they are often prone to manipulation by speculative agents who—knowingly or not—extrapolate unfounded notions of, and spread misinformation that oversells, what is technologically feasible. This chapter provides a comprehensive, yet nonexhaustive, survey of the current and prospective applications of genome-editing technologies that faithfully tracks primary scientific sources and, thus, is firmly grounded in a jurisprudence of scientific empiricism. The chapter examines applications of genome editing in myriad fields ranging from stem-cell research, pest-population control, viral diagnostics, biofuel production, and agriculture to synthetic biology, animal research, human therapeutics, epigenome editing, digital-data recording in living organisms, and more. This exposition underscores two points. First, genome-editing technologies are not mere tools for basic research, but rather epitomize prolific mines for future significant scientific breakthroughs. Second, every technology endowed with awe-inspiring powers should be handled responsibly and with respect.