Table of Contents Introduction I. Background A. CRISPR's Predecessors B. Combining CRISPR With Gene Drives C. Benefits D. Concerns II. Legal Protections for Wildlife Edits A. International Law 1. Convention on Biological Diversity 2. Cartagena Biosafety Protocol 3. Nagoya Protocol B. Federal Law 1. Coordinated Framework for Regulation of Biotechnology 2. National Environmental Protection Act 3. Endangered Species Act C. State Law D. Professional Self-Regulation III. Recommendations A. Federal Level Solutions B. State Level Solutions C. Scientific Community Solutions D. Additional Issues Conclusion Introduction
Scientists have discovered a revolutionary molecular tool that can rewrite the code of life and spread genome changes through wild species at an accelerated pace. CRISPR-Cas9, commonly referred to as CRISPR, (1) represents a paradigm shift in genetic modification. CRISPR-Cas9 is just one of many combinations of CRISPR that exist and that will continue to be discovered. (2) In this Article, the CRISPR toolkit is used to refer to existing combinations such as CRISPR-Cas9, and also future combinations of CRISPR systems. Researchers have discovered that CRISPR-Cas9 can be combined with gene drives to disrupt the traditional norms of evolutionary biology. This Article uses "wildlife editing" to refer to the combination of gene drives with CRISPR-Cas9, or any subsequent mechanism within the CRISPR toolkit which will be applied to wildlife animals. This process allows scientists to deliberately edit an animal's genome to spread changes through generations of a species.
Today, CRISPR largely escapes regulation under rules that cover traditional genome editing technology, raising the concern that there are no legal constraints to protect against unreasonable risks posed by this new tool. The potential benefits of this technology outweigh calls for a moratorium, but the risks involved demand regulation that strikes a delicate balance between supporting both wildlife protection and scientific innovation. Regulatory protections need to be scientifically based, subjected to interdisciplinary review, and defined broadly enough to cover future applications of the CRISPR toolkit. By officially joining the Convention on Biological Diversity, the United States will have an opportunity to craft a cohesive approach to regulating the CRISPR toolkit in its application to nonhumans by drafting the treaty's implementing legislation. This legislation should incorporate the same precautionary principle that is implicit in the treaty and establish a system that addresses risk management and liability, and incorporates transparency. Further, the legislation should incorporate effective language, define the role of relevant agencies, and facilitate the inclusion of the scientific and local communities and cultures. The states--along with the public and private scientific industries--can also protect wildlife against the consequences of this new technology. If the federal government fails to take action, states can create their own guidelines modeled after the principles and ideals set out in the Convention on Biological Diversity. Additionally, the scientific realm can voluntarily assent to self-imposed limitations, continue identifying benefits and risks of the technology, and help raise public awareness of the potential benefits of this new technology.
Outside the scientific community, most commentary surrounding the CRISPR toolkit ignores consequences to wildlife animals. (3) This Article analyzes the CRISPR toolkit's application to wildlife while considering potential legal and regulatory shortcomings. In Part I, this Article provides a summary of the science behind CRISPR and gene drives. (4) Next, Part II explores which existing legal frameworks are the most applicable to the CRISPR toolkit in its use with wild animals. In Part III, this Article suggests new policies for the federal government, state governments, and the scientific community to adopt in relation to wildlife editing and the CRISPR toolkit.
The discovery of CRISPR-Cas9 started a revolution in genome editing technology. CRISPR-Cas9 was first introduced by scientists in 2012. (5) Its introduction was followed by patent litigation and further innovation. (6) The CRISPR-Cas9 technique falls within the umbrella of synthetic biology, which is a subset of biotechnology. (7) It uniquely creates multiple edits along the genome using natural processes, with precision, in a cost-effective manner. (8) CRISPR represents chunks of regularly recurring space sequences that naturally arise as an ancient bacterial defense system against viral invasions. (9) In CRISPR-Cas9, a guide RNA (gRNA) directs and assists an enzyme (Cas9, a nuclease) to specific locations along the genome. (10) A genome is an organism's complete set of DNA, including all of its genes. (11) After reaching a specific location, the enzyme, Cas9, acts as molecular scissors by cutting and pasting along the genome. (12) This process allows scientists to program gRNA to seek out precise DNA sequences in the genome to be edited through the insertion, replacement, or deletion of the desired gene sequences, and can be used in many different species. (13) Additionally, scientists can use gRNA to target genes along the genome to apply epigenetics, which regulates the expression of genes without modifying the underlying DNA. (14) Although Cas9 is the most commonly used enzyme combination, it is not the only one available with CRISPR. (15) Researchers are constantly searching for other implementations and variations of CRISPR to expand the CRISPR toolkit. The law has been criticized for its slow pace in responding to rapid scientific developments. (16) To avoid such criticism in the future, it is important to consider the development of future CRISPR combinations when designing regulations that will anticipate and address any potential issues.
Not long after the discovery of CRISPR-Cas9, mammalian genes were edited using this tool. (17) CRISPR-Cas9 can genetically modify animal and human cells and shows promise as an in vivo method for mammalian genetic modification. (18) As will be discussed below, CRISPR-Cas9 combined with gene drives can disrupt traditional norms of evolution and spread edits rapidly throughout populations. In turn, wildlife editing could be used to help solve climate change problems, promote public health, prevent diseases, improve conservation efforts, as well as solve problems related to invasive species. Yet, the novelty and unique characteristics of the CRISPR toolkit raises various legal, ethical, moral, and cultural questions. For example, wildlife editing has the potential to wipe out entire species considered harmful to humans--or other animals that are simply disliked by the public. However, these risks can be controlled for, and gene drives can be used to deliver significant benefits to wildlife and humans so long as adequate safety measures are put in place to protect the environment and human health. One way to ensure such protections are brought about is to adopt the precautionary principle, as is ingrained within the Convention of Biological Diversity, which is discussed later in this Article.
The CRISPR toolkit is unique when compared to predecessor technologies and techniques that edited the genetic code of animals. One professor compared the impact of the CRISPR revolution to that of the creation of the Model-T Ford because it was far from the first technology of its kind to be created, but one whose simplicity of production, dependability, and affordability transformed society. (19) Smaller public and private laboratories can be involved in this innovation due to the CRISPR toolkit's flexibility and availability. (20) To those outside of the scientific realm, the intricacies and distinctions between the CRISPR toolkit and predecessor technologies are not always clear, but at their core, they differ both in their goals and the processes they use to manipulate genetic codes.
Prior to the CRISPR revolution, gene editing techniques allowed scientists to manipulate DNA sequences and create gene-editing varieties within individual animals. (21) These techniques were time-intensive, costly, and constrained to single edits of genes within the genome. (22) In contrast, the CRISPR toolkit can target multiple genes simultaneously, known as genomic editing, with speed and precision while maintaining cost-effectiveness and wide accessibility. (23)
Conventional genetically modified organisms (GMOs), cloning, and other predecessor biotechnology advances are also distinguishable from CRISPR. Mammalian cloning involves the manipulation of an animal or human cell to grow a virtual copy of the animal or human with identical nucleic DNA. (24) Thus, cloning creates identical genes, whereas the CRISPR toolkit transforms the genes. (25) Also, in contrast to human cloning, nonhuman mammalian cloning has not been banned in the United States. (26)
Conventional GMOs arose in the 1970s and 1980s and immediately attracted controversy. These forms of genetic engineering were widely criticized by the public for violating the natural order. (27) Conventional GMOs are created by transgenic editing, a process in which the genes of one organism are deliberately introduced and incorporated within another. (28) "Genetically modified" is used to refer to different concepts but is used most often to refer to plants and animals that have been altered in a way that would not have arisen naturally. (29) Many laws drafted in response to GMOs explicitly emphasize that unnatural process, specifically how these transgenic procedures leave behind foreign DNA. (30) Similar to other states, California defines transgenic as "[a]n animal whose genome has been deliberately altered, modified, or engineered, through means not possible under natural conditions, by insertion of a...