In as little as two years, Americans may be able to bite into their first genetically modified burger, thanks to US Food and Drug Administration regulatory clearance for cattle approved by the US Food and Drug Administration. gene editing.first The animals, created by bioengineering company Recombinetics, are genetically engineered to make their coats shorter and sleeker.
Genetic modification of their plumage to make them more resistant to heat stress, allowing them to gain more weight and increase meat production efficiency2 – But at what cost? While a lengthy approval process is often required for gene-edited animals to enter the food market, the FDA has streamlined the process for gene-edited cattle, allowing them to comply with the regulatory approval process. normal browsing.
FDA issues first ‘Low-Risk Identification’ for gene-edited cattle
The FDA announced in March 2022 that Recombinetics’ gene-edited cattle received a low-risk determination for the marketing of products, including food, made from their meat. “This is the FDA’s first low-risk decision to enforce an IGA [intentional genomic alteration] FDA reports.3
The agency states that the gene-edited beef cattle do not pose any safety concerns because the genetic changes that lead to the same results as the genetic makeup seen in so-called cows do not pose any safety concerns. “plain coat”, bred in the usual way. According to the FDA:4
“There are cattle that are conventionally bred with natural mutations that result in the same extremely short and silky coat. Reports in the scientific literature indicate that this ultra-short, silky-coated cattle is better able to withstand hot weather. Cattle that are comfortable in their environment are less likely to experience temperature-related stress and can improve food production.”
But are conventionally bred and genetically edited cattle, known as PRLR-SLICK cattle, really equivalent? Genome alterations in cattle are performed using gene editing technology CRISPR, or Clustered Regular Interspaced Short Palindromic Repeat, gene editing technology. CRISPR is associated with unintended mutations that may not be immediately apparent, a worrisome prospect because genetic changes are passed on to progeny.
However, the FDA still allowed the technology to proceed, stating that because it did not expect PRLR-SLICK cattle producers using conventional technology to register with them, Recombinetics would not do either. so. They added that feed from both conventionally bred and genetically edited cattle were “same,” based on data provided by Recombinetics:5
“FDA has reviewed the genomic data and other information submitted by the product developer that confirms that IGA in PRLR-SLICK cattle have been genome-edited to equate to naturally occurring mutations in some Breed cattle as an adaptation to be raised in tropical or subtropical environments.
The data also confirm that IGA leads to the same lustrous coat characteristics found in cattle as found in conventional agriculture. Furthermore, forage forage is the same as forage from conventionally bred cattle with the same silky coat characteristics.”
Problems with CRISPR
The gene-editing technology CRISPR has brought science fiction to life with the ability to cut and paste fragments of DNA, potentially eliminating serious genetic diseases. In particular, CRISPR-Cas9 has excited scientists because,6 By modifying an enzyme called Cas9, the ability to edit genes is greatly improved.
To date, gene editing has been used to produce soybeans with altered fatty acid profiles, potatoes taking longer to brown, and fresh potatoes longer and producing no harmful chemicals. fried cancer. Other uses for gene editing in foods include creating low-gluten wheat, mushrooms that don’t brown, and tomatoes that can be produced in regions with shorter growing seasons.
Gene-edited foods have entered the food supply, but their safety is largely unknown, as gene editing is not a perfect science. Unintentional off-target edits can cause changes to plant DNA, with possible consequences including growth disturbances, exposure to plant diseases, or introduction of allergens. or toxins.7
In animals, gene editing has resulted in undesirable side effects, including an enlarged tongue and extra vertebrates.8,9 Usually researchers don’t know the level of function of a gene until they try to regulate it, and something like an extra vertebrate reveals itself. Speaking with Yale Insights, Dr. Greg Licholai, a biotech entrepreneur, explained some of the very real risks of CRISPR and other gene editing technologies:ten
“One of the biggest risks of CRISPR is what is called a gene drive, or genetic drive. That means because you’re actually manipulating genes, and those genes are incorporated into the genome, essentially, into the encyclopedia, which is in the cell, it’s likely that those genes then can be transferred to other organisms.
And once they’re transferred to other organisms, once they become part of the cycle, those genes stay in the environment.
That is perhaps CRISPR’s greatest fear. Humans manipulate the genetic code, and those manipulations are passed on from generation to generation. We think we know what we’re doing, we think we’re measuring precisely what changes we’re making to genes, but there’s always the possibility that we’re missing something. or our technology may not be able to keep up with other changes that may be made without our guidance.
And the fear then is that those changes lead to antibiotic resistance or other mutations entering the population and will be very difficult to control. Essentially creating incurable diseases or other latent mutations that we can’t really control.”
Brazil’s Gene Editing Plan for Gene Edited Cattle
It’s worth noting that in 2019 Brazil halted plans to allow a herd of Recombinetics gene-edited cattle after unexpected changes to the DNA were discovered. As with the FDA, Brazilian regulators have determined that Recombinant can proceed without any special supervision, as their gene editing involves modifying cattle with natural features.
In this case, instead of changing the cattle’s coats, Recombinetics modified the cattle to have no horns – until something went wrong. Wired report in 2019:11
“Minnesota-based Recombinetics, began preparing sperm shipments from one of its two genetically modified Holstein bulls, Buri. With it, the breeders planned to make about 10 calves to demonstrate that the edit could be passed on and to study their health for several years while they lived in Brazil.
If all goes well, they’ll try tweaks in a more elite dairy breed (sorry, Buri) and hit the market. But now, as WIRED learns, those plans have been abruptly scrapped.
As it turns out, Buri isn’t just the hornless gene that has been incorporated into his genome. Part of the editing machinery, the fragment of bacterial DNA that transduced the desired gene into Buri’s cells, called a plasmid, was accidentally pasted into his genome. He is, in fact, a bacteriophage – a tiny organelle that has about 4,000 base pairs out of a total of about 3 billion. “
Recombinant researchers reportedly examined undesirable changes in this process, concluding that by 2016 no alterations had occurred. However, Tad Sonstegard, CEO of Recombinetics’ agricultural subsidiary, Acceligen, told Wired, “We’re not looking for plasmid integration. We should have.”twelfth Recombinetics also asked the FDA to grant gene-edited hornless cattle “generally recognized as safe” in 2016, but the agency refused.
In 2017, the FDA announced it would begin classifying animals whose DNA had been edited or engineered to make drugs, prompting a backlash from the biotech industry,13 does not want such foods to be labeled. Previously, in November 2015, the FDA approved the AquaBounty salmon, which contains the DNA of two other fish species, a growth-promoting gene from Chinook salmon and a “booster” gene from a marine eel.
This genetic modification results in the fish always having growth hormone, and since they grow much faster than other types of salmon, they also need less food. GE fish was first sold and eaten in Canada,14 but AquaBounty acquired a fish farm in Albany, Indiana, where the first GE salmon eggs intended for human consumption in the US arrived in May 2019.15
AquaBounty begins harvesting GE salmon in late 2020 and is in the process of building another facility in Pioneer, Ohio, that will have about eight times the capacity of the Indiana farm.16 They describe their next phase of growth as a transition to a commercial production business, even with the health and environmental consequences of consuming and producing these modified salmon. – or other genetically modified foods – remains unknown.
Gene-edited cattle arrive at the supermarket
The FDA’s decision to grant gene-edited cattle a low-risk determination marks the first time that FDA has used “enforcement discretion” over IGAs for food animals. However, this is unlikely to be the final path, paving the way for more gene-edited animals to quickly access the US food supply. In fact, Steven Solomon, director of the FDA’s Center for Veterinary Medicine, has made it clear that he expects more animals genetically engineered for food production to come to market soon:17
“[The] The decision underscores our commitment to using a risk-based and science-based data-driven process, with a focus on the safety of animals that purport to be genetically modified and safe for humans to eat. food produced by these animals. It also demonstrates our ability to identify low-risk IGAs that do not pose a safety concern when used in food production.
We hope that our decision will encourage other developers to move animal biotech products forward for FDA to identify risks in this rapidly growing area, paving the way for Animals containing low-risk IGAs have more efficient market access. ”
Recombinetics plans to offer gene-edited meat products to “select customers in the global market soon,” while general consumers will be able to purchase genetically modified meat in due time. as early as two years.18 However, the public may not be excited about the idea, especially as more and more people are looking for real, whole foods instead of GMOs. A survey found that only 32% of Americans are comfortable with GMOs in their food.19
It is important to note that long-term safety studies have not been performed. Jaydee Hanson of the Center for Food Safety is among those who have said the FDA should study genetically modified animals for generations to find problems.20
In an interview with GM Watch, Michael Antoniou, a molecular geneticist in London, also explained that significant changes can result from gene editing, in both agricultural and medical contexts, requires long-term safety and toxicity studies.21 Currently, the best way to avoid genetically modified foods, if you so choose, is to buy organic and even better, bioavailable.
