Advanced Gene Editing: CRISPR-Cas9, Congressional Research Service, April 28, 2017. [via FAS]

“Scientists have long sought the ability to control and modify DNA—the code of life. A new gene editing technology known as CRISPR-Cas9 offers the potential for substantial improvement over previous technologies in that it is simple to use and inexpensive and has a relatively high degree of precision and efficiency. These characteristics have led many in the scientific and business communities to assert that CRISPR-Cas9 will lead to groundbreaking advances in many fields, including agriculture, energy, ecosystem conservation, and the investigation, prevention, and treatment of diseases.Over the next 5 to 10 years, the National Academy of Sciences projects a rapid increase in the scale, scope, complexity, and development rate of biotechnology products, many enabled by CRISPR-Cas9. Concomitant with the promise of potential benefits, such advances may pose new risks and raise ethical concerns. For example, recent experiments by Chinese scientists and others that modified human embryos using CRISPR-Cas9 gene editing have sparked ethical debates, raising such concerns as how the genetic change would affect not only the immediate patient, but also future generations who would inherit the change without choice. Additionally, CRISPR-related approaches (i.e., gene drives) are being considered to reduce or eliminate the mosquito that serves as the primary vector for the transmission of Zika or malaria, thereby improving public health. Some scientists have raised ethical questions and expressed concerns about the unintended ecological consequences of eliminating a species or introducing a genetically modified organism into an open environment. Some experts assert that the current system for regulating biotechnology products—the Coordinated Framework for the Regulation of Biotechnology—may be inadequate, with the potential to leave gaps in oversight. Regulatory gaps may lead to increased uncertainty that could affect the development of future biotechnology products or a loss of public confidence in the ability of regulators to ensure that such products are safe. In the 115thCongress, policymakers may want to examine the potential benefits and risks associated with the use of CRISPR-Cas9 gene editing, including the ethical, social, and legal implications of CRISPR-related biotechnology products. Congress also may have a role to play with respect to regulation, research and development, and economic competitiveness associated with CRISPR-Cas9gene editing and future biotechnology products.”