USDA Reopens Comment Period for Deregulation of Gene-Edited Plants

The deregulation of gene-edited plants is on the USDA agenda, and the public comment period has been extended by 21 days. The comment page has yet to be posted on the Federal Register. CRISPR is a new technology that is being used in agriculture to modify plants. “New Gene Technologies” or NGTs are how big agricultural companies like Bayer are modifying crops. They are attempting to deregulate this technology before any legitimate safety studies are performed. While GMO crops have their own regulations, the new gene-edited crops will not be regulated if this proposal passes.

The impact of this blanket deregulation is concerning and summed up by Dr. Michael Antoniou, a professor in Molecular Genetics at Kings College in London. He states, “The market will be flooded with untested and unlabeled gene-edited food products with unknown short-term, let alone long-term, health and environmental consequences. This is simply a horrifying prospect.”

The big agricultural and biotechnology corporations say that the plants they produce with NGTs can theoretically be produced through natural plant breeding technology. Still, Dr. Antoniou has some disagreements with that assessment.

Dr. Antoniou elaborated, “Even if a gene-edited plant could theoretically be obtained through natural breeding (and by the way, there is no evidence that any GM gene-edited plant could have been produced with natural breeding; I believe that if two such plants produced using these two different techniques were put forward, they would be very different at the genetic and molecular levels and could have very different biological effects), the two PROCESSES (gene editing and natural breeding) bear no resemblance to each other with the spectrum of unintended DNA mutations differing markedly between the two.”

The potential of unintended DNA mutations has many concerned. They argue that there should be much more testing before allowing these products on the market. While some plants are modified to withstand higher amounts of glyphosate, others are modified for cosmetic changes. One of those changes? Enhancing how some fruit ripens; for example, bananas that don’t turn brown. Some scientists worry that this could cause changes in the DNA of the fruit.

Dr. Antoniou further explains, “The gene editing process as a whole (plant tissue culture, plant cell transformation, gene editing tool action) will inevitably result in hundreds if not thousands of sites of random unintended DNA damage leading to large scale alterations in gene expression patterns. This, in turn, can result in altered biochemistry and composition that could include the production of novel toxins and allergens. This contrasts with the genetic variation that results from natural breeding, which, contrary to the narrative spread by advocates of gene editing deregulation, results in far fewer sites of DNA change in a non-random manner.”

Jeffrey Jaxen reported about the CRISPR gene editing technology and some of the studies. There are indications there are more safety concerns to consider before allowing the free market to modify the food supply without regulation. Dr. Antoniou provided his own literature review that goes against the claims of the biotechnology firms pushing strongly for this deregulation.

Dr. Antoniou said, “Reviews of the literature confirm that gene editing can produce changes that conventional breeding could not achieve, or could only achieve with difficulty, as gene editing opens areas of the genome to DNA damage (mutations) that are protected from mutations in conventional breeding and mutagenesis breeding using chemicals or radiation.”

Studies that support the safety of plants that are modified with this gene-editing technology are nonexistent. Dr. Antoniou says, “This is why claims of the safety of gene editing are on the basis of the absence of evidence of health risks, which does not mean evidence of absence of health risks based on empirical, experimental observation.”

That is precisely why there is a push from the mega biotechnology companies calling for deregulation by reclassifying this method to place it in the same category as plants that go through a natural breeding process. They are asking for a regulatory process where the corporation doesn’t need to prove a product is safe; the government agency must determine it is unsafe based on the information provided by the corporation. The aim of the biotech giants is merely to present a case that insertion or deletion of DNA that naturally occurs in similar plants doesn’t contain any of the safety risks that occur when using foreign DNA from plants that wouldn’t naturally crossbreed. Thus, it would be a process that occurs naturally. There hasn’t been any credible evidence to support this claim, however.

According to the 2016 edition of the Worldwide Threat Assessment authored by James Clapper, the former Director of National Intelligence, deregulating gene editing within our food supply is a national security risk. The document states, “Research in genome editing conducted by countries with different regulatory or ethical standards than those of Western countries probably increases the risk of the creation of potentially harmful biological agents or products. Given the broad distribution, low cost, and accelerated pace of development of this dual-use technology, its deliberate or unintentional misuse might lead to far-reaching economic and national security implications. Advances in genome editing in 2015 have compelled groups of high-profile US and European biologists to question unregulated editing of the human germline (cells that are relevant for reproduction), which might create inheritable genetic changes. Nevertheless, researchers will probably continue to encounter challenges to achieve the desired outcome of their genome modifications, in part because of the technical limitations that are inherent in available genome editing systems.”

The USDA is proposing to remove any such regulations when it comes to plants modified with CRISPR and similar technologies. The concern will also be that patented plants can crossbreed with other plants, which could lead to a wave of litigation from agricultural giants like Bayer. Bayer recently acquired Monsanto, a company responsible for several lawsuits against farmers for growing their patented GMO seeds – seeds that unknowingly blew into their fields. If the regulatory burden is removed, a flood of new untested plants with modified DNA could potentially take over the food supply. This proposed deregulation is certainly a national security concern, as expressed by James Clapper and “high-profile US and European biologists.”

There is a 21-day period to submit comments to oppose this: https://www.regulations.gov/commenton/APHIS-2023-0022-0001