As biotechnology continues to advance, policies must catch up in order to properly regulate the safety and efficiency of technology. One of the popular and controversial advances in the scientific community is genome editing, which occurs when DNA is inserted, deleted or replaced in the genome of a living organism. While genome editing has mainly been used to modify foods, it has also been used on animals, and lately, on human embryos.
The new technology that is advancing gene editing is called clustered regularly interspaced short palindromic repeats (CRISPR). CRISPR allows scientists to alter DNA much more quickly than before, drastically impacting the health industry, since a parent can choose to decrease the risk of high cholesterol, or minimize the risk of getting cancer. According to Randall Lutter, a professor at University of Virginia, CRISPR is different from previous technologies because it can be used to affect heritable traits and thus create organisms with a variety of desired traits. The changes made in human cells could actually be passed down to future generations and would allow individuals to basically choose the traits they want for their children.
Despite some of the advantages of CRISPR, there are some concerns with how it can be used to engineer human embryos. This caused a dispute in the scientific community when the embryos used did not result in a live birth. Some scientists want to continue experimenting with the benefits and risks of genome editing, but others are fearful of the disruption it could cause in the ecosystem.
The 2017 updated version of the Coordinated Framework for the Regulation of Biotechnology describes the current statutory authority and regulatory programs, such as EPA, USDA, and FDA, as well as the safety and efficiency of biotechnology products. Under National Strategy for Modernizing the Regulatory System of Biotechnology Products, also known as The Strategy, the FDA will continue to update and clarify its policies in regards to gene editing, as well as finding new ways to improve coordination with federal research agencies.
Unlike previous technology, CRISPR doesn’t involve transgenics (which is when genes are inserted from foreign species into an animal or plant). Thus, the U.S. Department of Agriculture allowed it to be sold in the market place. However, this doesn’t mean the new device gets approval from the FDA. FDA’s process for approval of new products is somewhat slow. If the FDA does not approve this life changing technology, scientists will be forced in continuing to use older technologies that are not as efficient.
Even though genome editing can save lives, many are still skeptical on whether it should be used on human embryos. More research must be done in order to minimize the risks. While CRISPR has made modifying DNA much less costly, it continues to raise regulatory and ethical concerns.