Advanced Gene Editing: CRISPR-Cas9 (CRS Report for Congress)
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| Release Date |
Revised Dec. 7, 2018 |
| Report Number |
R44824 |
| Report Type |
Report |
| Authors |
Marcy E. Gallo; John F. Sargent Jr.; Amanda K. Sarata; Tadlock Cowan |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
Scientists have long sought the ability to control and modify DNAâthe code of life. A gene editing technology known as CRISPR-Cas9 offers the potential for substantial improvement over other gene editing 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, a Chinese researcher recently claimed that he had created the first genetically engineered human babies. According to the researcher, he used CRISPR-Cas9 to disable a gene that will make it harder for the twin girls, who were born in November 2018, to contract human immunodeficiency virus (HIV). The as yet unsubstantiated claim has sparked outrage and ethical debates by the international scientific community and others. Prior use of CRISPR-Cas9 gene editing in human embryos was generally limited to non-viable embryos, in part, to address ethical concerns such as the fact that the genetic change would affect not only the immediate patient, but also future generations who would inherit the change.
Additionally, CRISPR-related approaches (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 and environmental groups 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 productsâthe Coordinated Framework for the Regulation of Biotechnologyâmay 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 116th Congress, 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-Cas9 gene editing and future biotechnology products.
