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FDA Authorizes the Marketing of Genomic-Altered Beef

Scientists are becoming the modern farmers of America. When one considers the “healthiest” form of commercial meat, some will seek the least amount of artificial manipulation. Naturally sourced food even function as marketing tactics, luring consumers and influencing the customer’s purchasing decision against heavily processed meat. Traditionally, it has been quality feed, sanitary conditioning, and generations of farming experience that led to the highest quality meat products. Now that Science has begun to change.

IGA’s, or intentionally genomic alteration, may become the modern quality control of the future for mass produced meats. With the ability to control the genome itself, scientists have the means to control how the animal develops. For this reason scientists could soon hold the power to control the future of the meat industry—from the consistency of the product, right down to the taste. What potential hazards exist in genomic altered meat? The FDA considers the marketing of such products as “low risk.” This means there isn’t yet enough data available to suggest negative health consequences.

Beyond the meat itself, companies like Select Sire, have begun offering the option to breed additional characteristics into their animals. Select Sires, breed Slick hair cattle which are genetically altered to produce a range of traits, and what the company describes as “additional desirable characteristics.”

How many genetic mutations are possible before the currently “low-risk” long-term health hazard is increased? What regulations are in store to ensure the amount of genomic alterations reside within the definition of “low-risk?”

“At Select Sires our mission is to provide slick genetics in the most advanced genetic merit package possible. Our current offering includes three sires that are heterozygous for the slick allele with a range of traits to provide solutions to various genetic needs. One of these sires, 9HO15357 SOLAR-P, also includes the Polled gene for additional desirable genetic characteristics.”

“The milk production advantages associated with the slick gene during the hot, humid months in the U.S. can be extrapolated to the entire year in tropical countries,” says Humberto Rivera, area director of marketing for Latin America. “Selecting for slick hair coat has the potential to become a tremendous advantage for producers working under tropical conditions worldwide.”

“Beat the heat with slick genetics.” states Select Sires1. Slick hair cattle have been specifically bred with “Slick genetics” to produce consistent milk through hot temperatures and humid months. While Select Sires Slick genetics have been used to produce consistent milk, now the genetically altered cattle have begun to serve an even larger consumer market, for the purpose of beef. According to the patent held by James West for Slick genetics, “The mutation is the A461VfsX1 mutation in the B. Taurus PRLR gene. The mutation results in a 120 amino acid deletion of the carboxy-terminal part of the PRLR protein2.”

“For the purpose of the current invention the term “cattle” refers to an animal belonging to B. taurus, B. mutus, and other members of the Bos genus. The subject invention is exemplified herein with respect to cattle; however, a person skilled in the art can practice this invention with other animals that could benefit from a short hair coat in order to improve heat tolerance, aesthetics, allergenicity, and/or cleanliness. Preferably, the animal is a non-human animal.

The patent states this genomic alteration could be used for other species, aside from cattle, suggesting “someone skilled in the art” can “practice this invention” on other animals which “could benefit” beyond the form in which they were created. Science can now offer the ability to adjust all forms of life to exist in a way determined best. This practice, for the time being, is still considered “low-risk,” and new and inventive mutations are sought after and encouraged.


FDA Approves Genome Edited Beef

On March 7th, 2022, the U.S. Food & Drug Administration (FDA) announced that they had completed their risk assessment for marketing Slick cattle genome edited beef3. The FDA concluded that consuming genetically modified animals posed a “low-risk” to human health.

“Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals.”

“It also demonstrates our ability to identify low-risk IGAs 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 IGAs to more efficiently reach the marketplace.”

Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine

Prior to this decision, the National Institutes of Health (NIH) released reports on the health risks associated with the Health Risks of genetically modified foods4. This isn’t the first time the FDA has announced genomic alterations would be allowed in consumer food. In December 2020, the FDA approved the “first-of its-kind” intentional genomic alteration in a line of pigs5. With these genetic alterations, scientists were able to create a new marketable product, “GalSafe pigs.”


Galsafe pigs

When natural swine is not enough, Galsafe pigs have been developed to ensure synthetic control straight down to the genome itself. The FDA stated in their approval of Galsafe pigs6, that the product “may be used for food or human therapeutics.” This means despite the fact that these genome-altered animals are not evaluated for use in organ transplants into human subject, they are clinically possible through the official approval of the FDA.

Xenotransplantation involves the transplant or organs from one species to another. Historically the practice of Xenotransplantation is an unsuccessful practice. However, more recent practices involve using genome-altered cells to remove sugars in the developing organs. This practice is less likely to be rejected by the human body. For this reason,

“It’s important to note that these pigs have not been evaluated for use as xenotransplantation products for transplantation or implantation into human subjects. Developers of any such human medical products must first submit an application to, and obtain approval from, the FDA before these products can be used in human medicine.”

The FDA noted that the developer of the genomic alteration, would “sell meat from GalSafe pigs by mail order, rather than in supermarkets.”


Pig Organs

The next man standing next you on the train may not be fully human. As organ transplant technology continues to develop, the next frontier of research is stem cells and synthetic organ growth. While these innovations are at least one generation away, current organ development has successfully allowed the growth of organs inside a living mammal, genetically modified to allow suitability for human harvesting.

On January 7th, 2022, a man received a breakthrough organ transplant, using a heart donor from a genetically modified one-year old two-hundred-pound pig. The transplant was a success, marking the beginning of human animal hybrids within society7. On March 8th, 2022, two months after receiving the pig-heart transplant, the patient David Bennett, died. However, the revolutionary medical experiment was seen as a monumental success for the medical community.

In order to allow long-term xenotransplantation for future generations, researchers must find ways to prevent organ rejection, allowing prolonged functionality. One method currently in the works, uses human stem cells with animal cells to form Chimeras, or animal-human hybrids. With this technology, scientists believe they may be able to literally “grow organs” inside of animals. While pigs are currently used to create genetically modified organs specifically used for harvesting, research may find it more economical to grow more than one human organ at a time within the animal hybrid. Ethical concerns exist to how far researchers can genetically modify pig DNA using human cells, without too many human cells ending up in the brain. What level of human cells defines a human being, and should products that use human stem cells be authorized for consumption?


Animal-Human Hybrids

While growing an organ using a living host allows for revolutionary medical possibility, growing multiple organs at one time inside of a living host provides greater financial profitability. Making those genomic altered animals edible, allows the yield of even more revenue. What makes an entity biologically human? Would the introduction of more human cells potentially effect the consciousness of the creature? What defines a “human being?”

Hiromitsu Nakauchi, of the University of Tokyo and Stanford University in California, planned to discover just that. Nakauchi and his team grew human cells inside both mouse and rat embryos, transplanting those embryos into animals as hosts. His process produced the first animals with organs made of human cells, which could [theoretically] be transplanted.

Human–animal hybrid embryos have since been made in countries, including America, however ethical laws are set in place which require the destruction of the embryos before the creatures reach a certain state.

Nakauchi stated human rights concerns have been taken into consideration.

“We are trying to do targeted organ generation, so the cells go only to the pancreas,” Nakauchi stated.

“By probing early embryogenesis and regeneration, interspecies chimeras provide a unique platform for discovery and clinical use. Although efficient generation of human:animal chimeric embryos remains elusive, recent advancements attempt to overcome incompatibilities in xenogeneic development and transplantation.”

Source: Suchy F, Nakauchi H. Interspecies chimeras. Curr Opin Genet Dev. 2018 Oct;52:36-41. doi: 10.1016/j.gde.2018.05.007. Epub 2018 May 30. PMID: 29859382.


FDA Warns Companies to be “Recall Ready”

These genomic alterations do not come without warnings, On March 3rd, the U.S. Food and Drug Administration (FDA) warned companies to be “recall ready.”

On March 3rd, the U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market8. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk. 

“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” said Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. “It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”

Could this one day also include genetically modified meats, and other synthetically altered entities?


Conclusion

While this announcement may not seem monumental, it comes as a first iteration of the FDA’s approval of the introduction of genetically modified meats into the mainstream consumer market. As the genome is continuously manipulated on demand, it opens the possibility for unpredictable mutations with unforeseeable consequences to future generations of consumers.

While high-profile meats, using cutting edge technology might appear glamorous on the surface, the truth is that we as a species have only just begun to understand the subtle reworking of human and animal genome, with no knowledge or experience of negative effects. As more companies view genomic-alteration as a patent-friendly mechanism to increase company revenue, the range of reconfiguration and modification of DNA is a far more concerning endeavor. At some point, specific limitations will need to be placed on genome modifications used consumer products to prevent ethical boundaries from being crossed.

While genetically modified cattle have begun to be sold for meat, what is the next step that the IGA industry will take? Should consumer limitations be set for the range of applicable use with IGA meat? Imagine eating what could be someone’s life saving organs, bred by science to function as both food and xenotransplant material. Beyond the long-term possibilities of consuming the same genome-altered material which doctors rely on in the operating room, the long-term effects by regularly eating artificially manipulated DNA are still greatly unknown. Despite a lack of existing research, the FDA still happily approved the marketing of these products. Eating genomic-altered meat may result in a “higher risk” diet than traditional animals, these synthetically manipulated mammals may function as a patient’s last resort when it comes to needing a vital organ. In the same way, the ability to “grow food” could solve sustainability issues worldwide. The animals altered to become organ donors not only offer the possibility for more transplants to occur but offer humanity a fairer world, reducing the demand for black market organ trafficking, a trade known well to the Chinese Communist Party. While there is still a long way to go, the prospect for future organ research and medical innovation allowing organ transplants seems promising. Should these DNA modified medical products be authorized for marketing as a consumer food?

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