The government is making decisions about genome-edited food that prevent consumers from identifying it, exposing us to potential risks.
Did you know that meat from a genome-edited (GE) cow could soon be in grocery stores, and it wouldn’t be distinguishable from other meat? That’s because it will likely not need to be labeled as being GE (or “bioengineered” to use the USDA’s term). Worse, the FDA has cleared this product with only cursory oversight because it believes the GE cows to be “low-risk.”
This is a betrayal of consumers’ right to know about the contents and origins of their food and a failure to adequately protect public health. If you’re like us, you’d want an abundance of evidence showing that the safety profile of GE and non-GE meat were equivalent before they were freely sold to the public without any labeling to separate them. We’d also want plenty of studies verifying long-term safety. Unfortunately this is not the approach taken by the federal government.
The only thing that we know can stop the FDA continuing on its mistaken path which assumes bioequivalence of GE and non-GE food is “us.” The great us: the American public. We have to fight back and call for more stringent oversight of GE food.
Speeding up approvals for industry’s sake
Last year, the FDA cleared meat from GE cattle to enter the marketplace. It was the fourth approval of a GE animal in the past three years, a significant uptick compared to three approvals in the prior 11 years.
This accelerated pace looks, to us, like a clear signal that the FDA wants to serve the interests of Big Ag and Big Biotech, not the public. Last year, these special interests complained in a letter to USDA Secretary Tom Vilsack that the FDA was taking too long to approve GE animals, arguing for the USDA to take over their regulation. You can see why: the USDA approved dozens of GE plants for cultivation since the mid-1990s; in 2020, the agency even released a rule that exempted many GE crops from review.
Race to the bottom
The FDA apparently doesn’t want to be outdone by the USDA in its willingness to kowtow to industry. By categorizing GE cattle as “low-risk,” the agency has made it easier for food and other products from those cattle to come to market.
The FDA views intentional changes to an animal’s DNA as an animal drug falling under the FDA’s jurisdiction. As such, companies producing GE animals are generally subject to premarket requirements like an approved new animal drug application (NADA). Except, as explained in an FDA guidance document, if the agency decides to skip these requirements because it believes the GE animal in question to be “low-risk.”
The first approved NADA for a food-producing animal was in 2015 with the AquaAdvantage Salmon. In 2020, the agency approved a GE pig both as a food and a drug (the pigs are GE so they do not produce alpha-gal sugars which is responsible for a rare allergy). Before then, GE goats, chickens, and rabbits had also been approved, but not for food; these animals are engineered to produce drugs. For example, the GE goats produce a protein in their milk intended to be used for anticlotting treatment in humans.
In 2022, the FDA cleared cattle that are modified to have short, slick hair coats so they can better withstand hot weather. This was the first time the FDA decided to exempt a GE animal from premarket requirements because it was deemed “low-risk.” Why? Because, the agency explains, the genetic change is “equivalent to naturally occurring mutations that have arisen in several breeds of cattle as an adaptation” to tropical weather. In its press release, the agency boasts that the decision:
…demonstrates our ability to identify low-risk [genetic alterations] that don’t raise concerns about safety, when used for food production. We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk [genetic alterations] to more efficiently reach the marketplace [emphasis added].
That’s right: the FDA is bragging to industry about its lax enforcement of GE animals so these products can more quickly reach a store near you. It’s a signal to industry to prepare to bring more GE food animals before the FDA so they can be rubber-stamped through the process.
Consumers left in the dark
The approval of GE cattle also highlights how the GMO labeling law passed by Congress in 2016 completely sold out on consumers. It’s very likely that meat from the GE cattle will not have to be labeled. Among the many problems with the law that we laid out in our coverage was the very definition of a “bioengineered” food, which excludes many foods developed through genome-editing techniques like CRISPR. The government has taken the position that genome-editing largely produces results that could have been obtained through conventional breeding, so we need not worry about the process used to arrive at that genetic alteration. It’s the final product, rather than the process, that matters to the government.
For example, the USDA decided that a CRISPR-created non-browning mushroom did not have to be regulated nor, by extension, labeled as genetically modified. For the same reason, the GE cattle recently cleared by the FDA will likely not have to be labeled because the modification could in theory be obtained through conventional cattle breeding. As a result, such GE foods aren’t even considered to be GE foods for the purposes of the federal labeling law. Work that one out!
The point is that the government passed a labeling law that does not apply to a huge swath of GE foods. CRISPR and other biotech, nano-science techniques are widely regarded as the future for agriculture, medicine and science more generally, with some observers noting that “with new gene editing techniques, [GMOs] will no longer be necessary.” No wonder Big Biotech lobbyists didn’t work to successfully block the 2016 sham labeling bill – they knew exactly what was in the pipeline.
A broken system
All of this is illustrative of the larger problem that sits within the federal government’s approach to GE products. The entire federal framework for dealing with GE foods focuses on the final product rather than the process used to develop that product. This approach is fundamentally flawed because the processes themselves, like CRISPR gene editing, can produce unpredictable and unintended consequences. Natural genes can be deleted or permanently turned on or off, while hundreds of other genes may change their behavior because of the new insertions or deletions. Even the inserted gene can be damaged or rearranged, and may create proteins that can trigger allergies or promote disease. A recent study involving human embryos found that when CRISPR was used to repair a mutation that can cause hereditary blindness, it appeared to “wreak genetic havoc in about half the specimens that the researchers examined.”
Claiming that a specific intended gene alteration can be achieved through natural means as proof that a CRISPR technique targeting this same gene is scientific and legal nonsense. The government has largely absolved itself from looking closely at the potential disasters that are possible when developing and producing GE foods—benefitting the special interests behind GE foods, to the cost of consumers.
GE food dangers
We’ve articulated our opposition to GE foods for many years. Manipulating one or two genes does not just produce one or two desired traits—a single change at the level of DNA has the potential to alter the entire DNA blueprint and numerous other characteristics of the genome-edited organism. This may happen in unexpected and undesirable ways, and these traits can be passed down through generations. Despite the lack of research funding, a substantial body of scientific work has already shown a variety of negative health outcomes from consuming GE foods, such as impaired liver and kidney function, infertility, impaired embryonic development, allergic reactions, damage to the gastrointestinal tract, and more. An increasing abundance of GE animals in the marketplace, indistinguishable from those from animals with unedited genes, opens the floodgates to even more unintended consequences and potential public health disasters.
The bottom line is that we need proper transparency and oversight over GE foods so we know they’re safe, but the FDA appears to be moving in the opposite direction to appease Big Food and Big Biotech. We must push back to register consumer outrage at this cronyism.