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Describing it as the “future of how we need to feed people,” a group of scientists and researchers from Washington State University (WSU) enjoyed some “smoky, and mildly salty” pork sausage earlier this month — derived from gene-edited pigs.
The WSU research team recently received approval from the U.S. Food and Drug Administration (FDA) to allow pork meat from gene-edited pigs into the human food supply — resulting in the celebratory barbecue featuring sausage with “a good snap to the casings … just like regular pork.”
The FDA approval, which does not appear on the agency’s website, is investigational and limited to the specific pigs raised by the research team for this purpose. It is touted as evidence that “gene-editing livestock to quickly produce desirable traits for improved food production is a viable strategy for helping feed the planet’s growing population.”
However, some scientists and food safety advocates question the safety of the gene-editing technology — CRISPR (clustered regularly interspaced short palindromic repeats) — used by the WSU researchers and backed by investors like Bill Gates, and wonder if the products produced by the technology are really safe for human consumption.
‘Gene-edited meats could be mass produced for human consumption in 10 years’
CRISPR acts as a “precise pair of molecular scissors that can cut a target DNA sequence, directed by a customizable guide.”
Put differently, this technology allows scientists to edit sections of DNA by “snipping” specific portions of it and replacing them with new segments. Gene editing is not a new concept, but CRISPR technology is viewed as being cheaper and more accurate than other gene-editing technologies.
The WSU research team, led by Jon Oatley, Ph.D., associate dean for research for the College of Veterinary Medicine and tenured professor in the School of Molecular Biosciences, used CRISPR “to improve genetic traits in livestock.”
Must read! Bill Gates + WEF are among the biggest promoters of CRISPR, a recently developed gene-editing technology, but scientists interviewed by The Defender warned about the technology’s flaws and risks.https://t.co/bzdk1oRYkg
— Robert F. Kennedy Jr (@RobertKennedyJr) October 17, 2022
According to Nextgov, Oatley sought “to demonstrate that food made from the [gene-edited] animals is safe to eat and that it is possible for an academic institution to achieve this type of FDA authorization.”
“Gene-editing can make changes in an organism’s DNA that could occur in nature or through selective breeding but would take much longer without a tool like CRISPR,” Nextgov writes.
Oregon Public Broadcasting reported that WSU “is also studying CRISPR gene editing on cattle and sheep,” and wrapped up a goat study last year. “If all goes as planned … gene-edited meats could be mass produced for human consumption in 10 years.”
FDA’s investigational authorization is limited to five pigs. A WSU announcement described the work by Oatley and his team as “essentially a high-tech form of selective breeding,” adding that the pigs were originally gene-edited in a way that “would enable researchers to use them to sire offspring with traits from another male pig.”
According to WSU:
“Known as surrogate sires, this technology first gene-edits male animals to be sterile by knocking out a gene called NANOS2 that is specific to male fertility. These animals can then be implanted with another male’s stem cells that create sperm with that male’s desired traits to be passed on to the next generation.”
The research “has the potential to not just improve meat quality but the health and resilience of livestock in the face of changing environmental conditions, a critical goal for increasing protein sources in developing nations,” WSU said.
According to the university’s announcement, Oatley said:
“It’s important for a university to set the precedent by working with federal regulators to get these animals introduced into the food supply. … If we don’t go through that process, all of the research we’re doing is for naught because it will never make it out into the public.”
“The original intent in making these animals was to try to improve the way that we feed people,” Oatley said. “And we can’t do that unless we can work with the FDA system to get these animals actually into the food chain.”
WSU’s announcement did not mention Oatley’s membership on the Gene Editing in Agriculture Task Force, a collaboration of the American Association of Veterinary Medical Colleges and the Association of Public and Land-grant Universities created in June 2020.
According to the June 2021 report by the task force:
“The next frontier in devising strategies to effectively feed a growing global human population will be defined by genetic enhancement; gene editing technologies are a key component in this endeavor.”
The task force also suggested the same June 2021 report be distributed “to interested organizations,” including the Food and Agricultural Organization of the United Nations and the Bill & Melinda Gates Foundation.
According to WSU, “The surrogate sires’ progeny, which are themselves not gene-edited, have not yet been reviewed by the FDA for possible inclusion in the food chain.” However, the original pigs “were processed at the WSU Meat Lab, and the U.S. Department of Agriculture inspected the meat as it does with all meat products.”
The meat “will be used in catering services that raise travel funds for the student members of the WSU Meat Judging team,” WSU said.
CRISPR: ‘It’s not precise and it’s not breeding’
The public often holds “many misconceptions about gene-editing,” Oatley said, adding:
“There’s a trust that comes with university-based research. … At WSU, we’re all about the science. We just want to make sure the research is valid, and the animals we produce are healthy.”
However, other experts have previously raised questions about the potential safety risks of inserting gene-edited and lab-grown meat into the human food supply and using tools such as CRISPR for this purpose.
In October 2022 interviews with The Defender, Michael Antoniou, Ph.D., head of the Gene Expression and Therapy Group at King’s College London, and Claire Robinson, managing editor of GMWatch, explained why they believe the risks of developing gene-edited meats and using CRISPR in this process outweighs the benefits.
Though CRISPR is often described as a “precision” gene-editing technology, Antoniou told The Defender, “It is not precise and it’s not breeding.”
Robinson told The Defender:
“These were also risks with the old-style GMOs [genetically modified organisms], and they are still risks with these gene-edited GM plants and animals.
“The risks, if you’re gene editing them … are that there will be knock-on effects on the animals, welfare or health that we can’t anticipate, such as deformities or changes in the function of certain genes in the animal.”
Antoniou warned that there may be unintended or unforeseen effects arising from this process. He said:
“Innately, gene editing also can bring about unintended DNA damage … even at the site of your intended edit or elsewhere in the DNA of your target cells, with unknown downstream consequences.
“None of these products … have been tested properly.”
A report published in the Journal of Genetics and Genomics in 2020 found that CRISPR gene-editing in rice resulted in numerous unintended and undesirable on-target and off-target mutations.
However, major investors like Gates see significant potential in foods created via gene editing and CRISPR.
According to Business Insider, Gates has said, “Researchers are studying ways to modify the genes of livestock animals … to make them produce milk more like dairy cows” and “make dairy cattle more resilient in hot weather.”
Happy 10th birthday to CRISPR, one of the most important inventions in medicine, biology, and agriculture. https://t.co/t0B0ctWPos
— Bill Gates (@BillGates) July 7, 2022
Gates and other proponents of CRISPR also claim that such tools — and the development and production of gene-edited meats — can serve as a solution to increased food demand due to a growing global population.
Robinson, in her October 2022 remarks, disputed such claims. She said:
“There’s no shortage of food in the world. Even in those countries where there are terrible hunger problems, they are producing food and it is available for those to buy if you have money.
“But the problem with hunger is, of course, poverty. The failure of infrastructure, the fact that you cannot get food to the hungry people. But mostly it’s inequality, things like wars and conflicts that are going on in some countries that mean that supply chains are disrupted. So really, there is no shortage of food and there isn’t ever likely to be.”
Instead, Robinson said that major corporate interests lie behind the use of CRISPR for the development of gene-edited food products.
“What we want to avoid,” said Robinson, “is a situation where the food supply ends up entirely patented, owned by big corporations … The patents on CRISPR are mostly owned by Corteva. Another patent owner used to be Monsanto, now owned by Bayer.”
“The technology is patented; the products are patented. Therefore, it is all about increasing corporate control of the food supply.”
More FDA approvals of gene-edited meats likely coming soon
The FDA has approved only one other organization’s gene-edited animal for entering the food supply, according to WSU. The company, Acceligen, produces “slick-haired cattle,” which are gene-edited to grow coats that increase their resilience to higher temperatures.
The FDA’s March 7, 2022, announcement about the approval stated that “the intentional genomic alteration (IGA) does not raise any safety concerns” and that this was the agency’s “first low-risk determination for enforcement discretion for an IGA in an animal for food use.”
“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 IGAs to more efficiently reach the marketplace,” said Dr. Steven M. Solomon, director of the FDA’s Center for Veterinary Medicine.
In recent years, the FDA also approved — or is close to granting full approval to — other gene-edited meat products for human consumption.
On Dec. 14, 2020, the FDA approved “a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an animal that the FDA approved for both human food consumption and as a source for potential therapeutic uses.”
According to the FDA, the IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. “People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat,” the FDA said, adding that the potential environmental impact “is no greater than from conventional pigs.”
The FDA also said it noted “no animal safety concerns” for GalSafe pigs “beyond those that would be expected in well-managed, commercial swine operations,” and “the microbial food safety risk is low and is mitigated by the low number of GalSafe pigs entering the food supply and the ongoing surveillance for antimicrobial resistance, among other factors.”
And in November 2022, the FDA declared lab-grown chicken meat developed by Upside Foods, a California-based firm, safe for human consumption, as part of its completion of a pre-market consultation that will likely lead to full FDA approval.
The FDA’s Nov. 16, 2022, announcement described this development as “a food revolution” that enables “food developers to use animal cells obtained from livestock, poultry, and seafood in the production of food, with these products expected to be ready for the U.S. market in the near future.”
The lab-grown chicken appears to have been developed using a process involving CRISPR. In 2019, it was reported that Memphis Meats — the former name of Upside Foods prior to a 2021 rebrand — was employing CRISPR as part of its process for curating lab-grown meat, and even received a patent for this purpose.