We could easily live in a world of less expensive, more humane, and environmentally friendly meat production. However, we have chosen to keep the door to that world closed.
Why not decide to open it?
Highlights:
“There is a clear path towards success for genetically modified livestock: relieving the regulatory burden so companies are free to innovate and utilize their resources unrestrained by unnecessary government oversight.”
“The trend – especially in the United States – towards using genetically modified crops has been aided by a regulatory framework that is increasingly aware of its tremendous benefits and lack of almost any downside. It is unfortunate that the same cannot be said regarding genetic modifications to livestock.”
“The research has been done; the technology already exists. The only obstacle that blocks our path to a better world are paper regulations.”
Key Recommendations:
FDA and USDA should create a clearly defined, common sense regulatory framework for genetically modified livestock so firms and researchers can operate instead of stagnate.
USDA should engage with livestock farmers and meat processors about the changing world of meat production so that firms are (relatively) prepared for the eventual market expansion.
FDA has been publicly developing their regulatory capacity for lab-grown meat since at least 2018. However, it took the FDA a little under two years to approve cultivated chicken for sale after companies initially applied for approval. Being the first in an industry, there were likely collaboration quirks that needed to be worked out between FDA and USDA. Going forward, FDA should streamline the inspection of production facilities to meet consumer demand and allow for market growth. See: Lab Grown Meat: To Eat Or Not To Eat? A Response To The Cultivated Meat Panic By Patricia Patnode and Owen Yingling
What's Holding Up Genetically Modified Livestock?
By Owen Yingling
It has been 12,000 years since humans first domesticated plants and animals. These two innovations have been the bedrock of human civilization – permanent settlements are virtually impossible without one or the other. The enormity of that timespan makes it hard to grasp how radically agriculture has changed in the last 100 years.
During the vast majority of recorded history, agriculture was a virtually frozen part of human existence. The yields of wheat crops in the Neolithic Era, for example, are similar to the yields obtained in Medieval times and even comparable to yields during the Early Modern Era.
Yet, from 1945 to 1995 global wheat yields rose over 250% – an average 4 times higher than any yields previously reached in the last 12,000 years. In 1900, the average hen in the United States produced 83 eggs per year, but an average farm hen today produces almost 300 – a 360% increase.
Our exponential agricultural improvements are reflected at the consumer level: food prices are lower now than they ever have been, even though the current population makes up almost 10% of all the humans who have ever lived.
The dramatic increase in agricultural production and efficiency is almost entirely due to market forces: a beautiful feedback loop between increased demand from post-industrialization population growth and the subsequent profit incentive for better technology that unleashed the power of unfettered human ingenuity. Yet today, even as humanity dreams of unrestricted growth and a post-scarcity world of limitless abundance, government agencies restrict the technologies that hold the key to the next agricultural revolution.
While the technological springboard of the “Green Revolution” of the 1950s and 60s was selective crop breeding and the use of fertilizers and pesticides – today it is the agricultural use of genetically modified plants and animals, known colloquially as GMOs.
GMOs are created by altering the genetic material of an organism by altering, removing, or adding to its genes. The first modern genetically modified(GM) organisms were created in the 1970s when scientists managed to insert a single gene into a bacterium and incorporate it into its DNA but initially the processes used to induce changes were complicated and had high failure rates. The first genetically modified food: the Flavr Savr Tomato was approved for commercial use more than 20 years later in 1994, but it was only in production for three years.
It was not until the 2000s that ingredients from GM plants became ubiquitous in American food: by 2010 almost 80% of processed food sold in the US contained GMOs and today virtually all US corn, cotton, and soybeans – our most widely grown crops – are genetically modified.
GMO adoption is not unprecedented: we have been “genetically engineering” the organisms that we need for almost all of human history. Since the dawn of agriculture, mankind has selected for optimal phenotypes when breeding plants and animals – this is how the process of domestication works – modern day dogs, cows, horses and even apple trees are products of primitive genetic modification over innumerable generations.
As humans learned more about genetics, our techniques grew more sophisticated: for instance, in the 1950s and 60s, before the discovery of modern genetic engineering, plant breeders would use x-rays and gamma radiation to try and induce mutations in their plants. Perhaps the greatest irony of the controversy surrounding modern GMOs is that in comparison to these older methods, modern genetic engineering changes almost nothing in the DNA of the organism. For example, genome data from a sample of almost 3000 cattle – created through selective breeding – revealed more than 86.5 million variants between subject DNA including 2.5 million insertions and deletions and 84 million instances of a single nucleotide being changed. The modification of a gene or two by modern genetic engineering is miniscule by comparison. There is no evidence of ill effects caused by eating food produced through thousands of years of selective breeding, so it should not come as a surprise that scientists have found no evidence of harm caused by human consumption of food created using modern genetic engineering.
The benefits for both farmers and consumers are tremendous: a 2014 meta analysis of GM crop studies found that their usage increased farmer profits by 68%, reduced chemical pesticide use by 37% and increased yields by 22%. And while much of the yield increase is contingent on inserting or removing genes to give increased pest resistance and survivability, scientists have also used gene editing to create crops that have higher yields than conventional crop even in controlled environments, suggesting that there is ample room for further improvement of GMO crops – especially when factoring in the lowered cost of gene editing using recent technologies like CRISPR-Cas9. The use of GM crops also offers broad global benefits: by 2020 the use of GM crops reduced world-wide CO2 emissions by 23 billion kg – the equivalent to taking 15.6 million cars off the road. GM crop productivity has also preserved biodiversity by saving 231 million hectares of land from needing to be used for farming.
The trend – especially in the United States – towards using genetically modified crops has been aided by a regulatory framework that is increasingly aware of its tremendous benefits and lack of almost any downside. It is unfortunate that the same cannot be said regarding genetic modifications to livestock.
The first genetically modified livestock was created in 1990 by micro-injecting embryonic cells with the human gene coding for lactoferrin, since then, only three GM livestock products have gotten approval from the FDA to be sold as food: the AquaAdvantage salmon in 2015, Galsafe pork in 2020 and two slick-hair cattle variants in 2022. And consumer access to these products is virtually nonexistent: AquaAdvantage salmon are only available through a single distributor, the pigs are only produced by a regenerative medicine company for organ transplants and the slick-hair cattle breeds will not enter the market until at least 2024. The market penetration of GM livestock is jarring when considering that almost all of the most widely grown crops in the US are genetically modified and over 80% of processed foods contain GM plants.
Animals are more structurally complex than plants and their life cycles are often far longer – which makes both selective breeding and genetic engineering more difficult. But the reason genetically modified livestock have not made their way to consumers and reduced the prices of animal products is not due to scientific or breeding failures: researchers have created cows that grow without horns, dairy cows that produce allergy free milk and disease resistant swine variants. Instead, the failure of GM livestock is primarily due to unfair barriers erected by the FDA that were not present in the regulation of GM plants.
Initial government guidance on GMOs, published in 1992, right before the commercial introduction of genetically modified organisms, by the White House Office of Science and Technology Policy, suggested that “exercise of oversight in the scope of discretion afforded by statute should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique.” In essence, the OSTP argued that regulators should judge risks and safety based on the product rather than the genetic engineering techniques that went into creating the product – that logic continuously served as the philosophy behind regulation of GM plants: the USDA primarily focused on the risk of plant-pest material in genetically engineered plants and the FDA applied the same standards to food products with GM plants in them that they did with all other food.
With GM animals however, the FDA, beginning in 2009, began working under the philosophy that genetic modifications to animals were actually animal drugs – thus under their purview by way of the new animal drug section of the Food and Drug Act – and since they had jurisdiction they felt the need to regulate the genetic engineering process itself instead of just ensuring the safety of the final product that they also regulated – the food. Of course the USDA also regulates the living GM livestock but like with plants, they’ve generally been content with working to lower the risks of possible contamination events more than anything else. The FDA began by saying they would only regulate livestock modified by genetic engineering if it used recombinant DNA technology. Recombinant DNA is DNA created from multiple sources and in genetic engineering it is often incorporated into the organism for various purposes. The use of rDNA in much of genetic engineering was an easy loophole for the FDA to exploit: they claimed that they were not actually regulating the animals themselves or genetic engineering in general, just rDNA because in their view it was an animal drug which is legally defined as “ an article (other than food) intended to affect the structure or any function of the body of … animals.“ But while such an action might technically fit under the wording of the law, it certainly violated the earlier regulatory philosophy of focusing on the products of genetic engineering when regulating rather than the process itself. Indeed the 17 year old OSTP guidance specifically warned that “Triggering the exercise of oversight based on the use of a specific innovative technology, such as recombinant DNA, will tend to discourage the use of that technology by industry and researchers.”
The FDA struck again in 2017. After researchers spent decades developing genome editing, a genetic modification technique that was more precise than earlier genetic engineering processes and didn’t require the use of recombinant DNA, the FDA reused their earlier tactics and released a draft guidance that claimed mandatory pre-market oversight over any animal with “intentionally altered genomic DNA” because genome editing too was a drug according to their definition. They doubled down again in 2020, arguing that it was “necessary for there to be regulatory oversight…even when the intended modification seeks to replicate a naturally occurring mutation,” but also noting that for undisclosed reasons their comments did not apply to “alterations in plants or other organisms,” which – for at least plants – the USDA has chosen not to regulate if the changes were reproducible through selective breeding.
GM crop producers sometimes need to deal with the USDA regarding planting and transportation of their crops – if their products could not be created through traditional breeding – and the FDA regulates food products containing their GMOs like all other food products. These are virtually the only regulatory barriers they face – their genetic engineering techniques are not regulated pre-market like drugs and they do not have to fill out form after form to get every new product approved as a new drug like GMO livestock companies do. Thus it is no surprise that GM livestock companies have stagnated and have virtually no market penetration in the US or anywhere else in the world while GM crops are present in most of the food that we eat every day.
What needs to change so that genetically modified livestock can offer benefits comparable to the ones that have come from widespread use of GM crops around the world? The adoption of any new technology faces the dual fronts of regulation and public perception. While regulatory burdens were lighter, commercial integration of genetically modified crops was not an easy battle. It was unpopular to introduce new crops that initially depended on the use of herbicides and pesticides to increase crop yields at a time when the environmental damage they caused was becoming widely known. And it is impossible to quantify the hysteria surrounding the notion that people would unknowingly be eating “unnatural” products created by white lab coats with unknowable risks. Initially for GM crops, public perception posed a barrier of the same or perhaps an even greater magnitude than that of regulation. Yet winning the image battle – lowering global pesticide and herbicide demands, freeing land from being used as agriculture, and not causing a single adverse effect, also contributed tremendously to the (when compared to animals) hands-off regulatory framework adopted by the government.
Animals are, of course, a different ballgame. Some possible genetic changes are unlikely to face any sustained public backlash. Take, for example hornless cattle, which already exist and where genetic modification are just accelerating changes that are possible with selective breeding or genetic tweaks that make livestock more resistant to diseases. There are others, however, that could be tremendously beneficial to agricultural productivity, but might face more backlash. Breeding animals that only produce offspring of a certain sex is an oft raised possibility, or using genome editing to increase animal muscularity— just to name some examples.
But, at the moment, there is hardly any public knowledge, much less a public opinion, on genetically modified livestock because they barely even exist on a commercial level much less in the food of everyday people.
Still, unlike GM crops who dealt with an initially vague and unclear regulatory framework but did face strong public backlash, GM livestock face a uniquely crushing regulatory burden, yet they are dealing with a public audience that has grown increasingly used to GMOs in their food over the last several decades.
There is then a clear path towards success for genetically modified livestock: relieving the regulatory burden so companies are free to innovate and utilize their resources unrestrained by unnecessary government oversight.
We have locked away a technology that could revolutionize how we eat; now is the time for freedom and abundance. Indeed, the regulatory winds have finally begun to shift. In the last days of the Trump Administration the USDA and HHS signed a memorandum of understanding to shift some of the regulatory burden of genetically modified animals over to the USDA instead of the FDA. Under the new regulatory framework the “USDA would safeguard animal and human health by providing end-to-end oversight from pre-market reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering.” The change could transform the commercial landscape for GM livestock and stakeholders are well aware. Numerous industry leaders, including the National Pork Producers Council, the American Farm Bureau Association, and the National Cattlemen's Beef Association signed a letter encouraging the agreement because “the FDA’s current regulatory approach… only [stifles] U.S producer’s access to much-needed innovation.”
The industry was right to be optimistic. The commercial adoption of genetically modified crops, where the product is only regulated by the USDA before it’s introduced into food is a showcase of how different the USDA regulatory philosophy is from the FDA. They have generally followed the maxim of “regulate the product not the process,” by focusing primarily on ensuring that GM crops don’t pose an agricultural risk instead of on the techniques used to produce them. In March 2018, the USDA also affirmed their stance of not regulating any GM crops if they could have been produced through selective breeding. Such a regulation could be a tremendous boon if applied to GMO animals as well, but it was a step that the FDA would not take because they regulated the genetic changes as new animal drugs.
Understandably, the FDA was not particularly happy with the idea of losing some of their regulatory authority. In response to the announcement of the agreement between the USDA and HHS, then FDA commissioner Stephen Hahn said he would not sign the memorandum of understand and stated on Twitter that “FDA has no intention of abdicating our public health mandate,” and that they still sought to ensure that all agricultural biotech products would be reviewed by experts before commercial release.
So far, the FDA has gotten their wish. Since 2020 the USDA’s attempt to claim jurisdiction of GM livestock has stalled despite calls throughout the past several years from industry leaders for FDA agreement and for the USDA to follow through with their proposed reforms.
There is no good reason that the organisms being animals should trigger stricter regulatory scrutiny, especially when GM animal research is far more expensive and time consuming than plant research, making the extra requirements even more burdensome for researchers and companies. It is not hyperbole to suggest that genetically modified livestock will not provide us any social or economic benefits in the near future if regulatory authority is not given to the USDA, or if FDA does not cease regulating genetic modifications to animals as animal drugs, and brings their regulatory framework in harmony with the one that already exists for genetically modified plants.
We could, easily, live in a world of less expensive, more humane, environmentally friendly, meat production. But, we have rather chosen to keep the door to that world closed.
Why not choose to open it?
The research has been done; the technology already exists. The only obstacle that blocks our path to a better world are paper regulations.
Owen Yingling is a Mercatus intern and student at The University of Chicago (Class of 2027)
Further Reading:
Farming Abundance | Phony Demand and Underpopulation: Problems Plaguing American Farmers By Matthew Yglesias
Farming Abundance | Lab Grown Meat: To Eat Or Not To Eat? A Response To The Cultivated Meat Panic By Patricia Patnode and Owen Yingling
Farming Abundance | Nobody Is Poisoning Your Groceries By David Norcross and Patricia Patnode
Farming Abundance | Farmers, Cover Up With Cover Crops By David Norcross