Why “GEC” is the New, Unregulated “GMO”

When people talk about GMOs (genetically modified organisms), they usually start from this viewpoint: GMOs are weird because they only exist when scientists take a piece of food and insert foreign genes into it. But what if scientists could just cut part of a food’s original DNA strand to disable a gene without adding any foreign genes? Should the altered DNA strand be considered a genetically modified organism? Technically, the food was modified, but not with foreign genes. Now scientists can tweak, replace, and disable genes without foreign DNA using gene editing techniques. This articles outlines the current regulatory framework surrounding GMOs and how gene-edited crops (GECs) fit in.

GMOs and the U.S. Coordinated Framework for Regulation of Biotechnology.

Since its commercial introduction in the 1990s, genetic modification (GM), also known as genetic engineering (GE), emerged as a critical tool for modern agriculture. The three primary plant transformation methods included: Agrobacterium-mediated transformation, biolistic (gene gun) transformation, or other types of bacteria-mediated transformation. All three methods required the insertion of non-host, foreign DNA, to modify the plant.

To ensure that GM crops did not pose a risk to humans, plants, animals, or the environment, theUnited States’ Coordinated Frameworkfor Regulation of Biotechnology was established in 1986. Currently, three federal agencies are authorized to regulate GMOs: theFood and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the USDA Animal and Plant Health Inspection Service, Biotechnology Regulated Service (USDA APHIS-BRS). However, not all of them may regulate GM crops. It depends on the type of organisms involved and the purpose of the GM product.

Most GMOs fall under APHIS regulations. Under the Plant Protection Act, APHIS has regulatory oversight over any products that could pose an agricultural plant pest or disease risk. Because Agrobacterium, the bacteria used for many GM transformations, is inherently a plant pest, any GM crop created with these bacteria are “regulated articles” and subject to thorough oversight to move, handle, release, or otherwise use these GM products with plant pest bases. To be classified as non-regulated or de-regulated, an entity could petition APHIS-BRS for the determination of non- regulated status through a letter of inquiry commonly known as an “Am I Regulated Letter?” If APHIS grants the petition, the GM product will no longer be considered a “regulated article” and will no longer be subject to oversight by USDA-APHIS.

As GM methods evolved, a loophole pattern developed. Companies seeking to commercialize GM crops and technologies learned the quicker path to the U.S. market was the petition process. By presenting scientific evidence in the letter of inquiry to APHIS that a GM product did not contain any regulated materials, the USDA would confirm they did not have authority to regulate the GM product and indirectly approve GM commercialization.

Thus, a large number of GM products actually fall outside the purview of any regulation because the regulations were drafted to handle only plant-pest based genetic engineering technologies. The current Framework has been heavily criticized for failing to oversee new GM product types, while overregulating proven GE crops and technologies with decades’ worth of safety solely because the regulations were drafted to handle organisms that use potential plant pests.

The Introduction of Gene-Edited Crops.

In the past four years, gene editing has emerged as a brand new technology. Scientists can disable, replace, or tweak genes by using the CRISPR-Cas9 technique. CRISPR is a bacterial immune system that uses the enzyme Cas9 to snip DNA at sites determined by the sequence of a ‘guide’ strand of RNA. It works by allowing scientists to cut DNA at a specific location in the genome and insert, remove, or tweak desired genes in that place. Compared with previous methods, it is much quicker and cheaper.
In June 2012, a University of California Berkeley team led by Jennifer Doudna and Emmanuelle Charpentier published their research first showing they could reprogram the CRISPR system using an RNA guide sequence to cut any selected target DNA. Then in January 2013, a research team led by Feng Zhang at the Broad Institute, a biomedical and genomic research collaboration between Harvard and MIT, published its work reporting mammalian gene editing in mouse and human cells.

While other scientists around the world have also contributed to advancements in CRISPR-Cas9’s technology, Doudna and Zhang are heavily cited with the initial discovery as both researchers’ universities are embroiled in a heavy patent dispute over who owns CRISPR. Many other researchers have already demonstrated its potential, such as: removing peanut allergens from plants and removing degenerative traits (diseases) from humans. Due to its powerful impact over multiple vertical markets, the licensing royalties are already projected to be in the billions of dollars.

The Current Non-regulation of Gene-Edited Crops.

From a legal perspective, APHIS already decided it does not have the authority to regulate at least two GECs. In April 2016, USDA-APHIS confirmed a CRISPR-edited white button mushroom was neither transgenic, nor a regulated article. Dr. Yinong Yang of Penn State University used CRISPR to keep white button mushrooms from browning by inactivating a gene. Five days later on April 18, 2016 the USDA published a second letter response to Dupont Pioneer’s “Regulated Article Letter of Inquiry,” stating that it does not consider next-generation waxy corn developed with CRISPR to be a regulated article.

In conclusion, there are literally no U.S. federal rules that regulate gene editing techniques or GECs in agricultural products. The scientific community is hopeful that this time around, regulations will be science-based and more flexible, so they can evolve with innovative technologies. For example, in June 2016, a National Institutes of Health advisory panel approved the first human use of CRISPR for a clinical trial to target three types of cancer with the University of Pennsylvania, funded by tech billionaire Sean Parker. The CRISPR trial is still pending FDA approval.

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Erica Riel-Carden
erielcarden@rroyselaw.com
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