In his 2019 article, Governing Extinction in the Era of Gene Editing, Prof. Jonas J. Monast of the University of North Carolina School of Law recommends using the Endangered Species Act (ESA) framework to regulate the growing use of gene-editing technology.
CRISPR, short for “clustered regularly interspaced short palindromic repeats,” is a family of DNA sequences found in the genomes of prokaryotic organisms such as bacteria. CRISPR-Cas9, which stands for “CRISPR-associated protein 9,” is an enzyme that uses CRISPR sequences as a guide to recognize and cleave specific strands of DNA that are complementary to the CRISPR sequence. Together, they form the basis of a technology known as CRISPR-Cas9, which can edit genes within organisms.
Among other benefits, this type of genome-editing technology has allowed scientists “to expand genetic diversity of endangered species, control invasive species, and enhance species’ resiliency to a changing climate.” Eventually, CRISPR-Cas9 could also allow for the recreation of extinct species, the creation of new species, and the ability to fight vector-borne infectious diseases through spreading genetic alterations in animal populations. Because of these current and future benefits, CRISPR-Cas9 technology could help fight the rise in animal extinctions around the world and assist with conservation efforts. But, this new technology poses a myriad of ethical and policy questions with respect to its acceptable uses. What is the level of appropriate risk when experimenting with new technology that could severely impact animal species and habitats? Should we step in to eradicate some species? Should we save other species from extinction?
Though the current statutory framework does not directly address the questions CRISPR-Case9 raises, Professor Monast argues that the ESA should be used as a regulatory model, allowing exemptions to achieve both public health and conservation goals through gene editing. Using the ESA as a guideline
strikes a balance between scientific research, societal benefits, and a precautionary approach for genetic techniques that are still in developmental stages. It also recognizes that questions about species viability do not start with a blank slate. Society has made important value choices regarding species conservation that provide the foundation of the ESA and other conservation statutes. Gene-editing governance should incorporate these value choices to ensure that any gene-editing efforts deliver societal benefits without undermining conservation goals.
To align the rise of CRISPR-Cas9 technology with conservation goals, Professor Monast recommends two applications of the ESA framework to the biotechnology field. First, federal agencies should establish a presumption against the release of gene-edited organisms that could threaten species viability. This could be implemented by revising NEPA procedures and agency funding guidelines. Second, federal agencies should allow and specify exemptions to this general ban. Exemptions could potentially be made to protect some species (like island birds) from an invasive species (like rodents) or to attempt to eliminate a vector-borne infection (like Zika).
Professor Monast also recommends updating the ESA regulations to achieve a closer fit with the needs of genetic modification, including clarifying the definition of “species” to include genetically modified organisms. Policymakers should also revisit a 1996 proposed rule on hybrid species (defined as those created by breeding protected and nonprotected species together) to provide “ESA protections to gene editing intended to support recovery efforts while excluding other [genetically engineered] organisms created in laboratories and those targeting species that are not listed as endangered or threatened.”
Professor Monast’s piece was selected as a top 20 article by the 2019 Environmental Law and Policy Annual Review—an ELI-Vanderbilt Law School project that identifies creative environmental law and policy proposals. The piece was originally published in the North Carolina Law Review in 2019. The article builds upon Professor Monast’s earlier piece, Editing Nature: Reconceptualizing Biotechnology Governance, which appeared in the Boston College Law Review in 2018.