Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption

Abstract

Biotechnology Law ReportVol. 41, No. 3 News BriefsFree AccessMoo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human ConsumptionBy Steven J. ZweigBy Steven J. ZweigSteven J. Zweig is the Managing Editor of Biotechnology Law Report.Search for more papers by this authorPublished Online:15 Jun 2022https://doi.org/10.1089/blr.2022.29269.sjzAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail United States regulators recently approved Recombinetics' genetically engineered cattle for human consumption, joining gene-modified pigs and salmon as the third engineered animal approved in the United States. Recombinetics used CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) to modify the cattle to have short, slick coats better suited to hot weather. The idea is that cattle who are not (metaphorically) wilting in the heat will be able to bulk up more easily, improving meat production. The notion certainly seems to make sense to anyone who's sweated their way through a torpid summer: humans, at least, seem to pack on the pounds more easily during cool weather and it's logical that cattle would too.The review of Recombinetics' cattle was shorter (several months, rather than years) than the reviews of the modified pigs and salmon because their genetic make-up is very similar to that of other cattle, to the extent that the gene-edited trait is already found naturally in other breeds. Dr. Steven Solomon, director of Food and Drug Administration's (FDA) Center for Veterinary Medicine, opined that Recombinetics' approach—building on a trait already found naturally in the subject animals—“opens up a completely different pathway” for approval as opposed to adding a trait not present in the animals' population. As such, he offered that FDA's decision in this case may encourage smaller or start-up biotech companies to follow Recombinetics' example.Even with the shorter review, it's expected to be another two years, perhaps more, before Recombinetics' beef reaches the market.The previously approved genetically modified pigs are intended for medical purposes (e.g., organ transplant) rather than the breakfast or dinner table. The previously approved salmon are for human consumption and are sold to distributors in some regions (e.g., the Midwest and Northeast).New Technology, Same Old ScamInvestment scams—convincing people to invest in vapor while the scam's organizer pockets their investment—are undoubtedly as old as money: almost certainly, there were Mesopotamians who invested their hard-earned shekels in pottery-making or reed boat-building opportunities that never materialized. The advance of technology doesn't change human nature: there will always be fraudsters and scam artists and the desperate, gullible, and overly trusting on whom they prey; all new technology does is give the criminals new dreams to sell.Case in point: Ariel Quiros, former owner of Vermont ski resorts Jay Peak and Burke Mountain, was just sentenced to five years in prison for defrauding 170 investors out of at least US$500,000 each (some considerably more), raising a total of US$400 million through this and related schemes. Sentenced with him were two associates, William Stenger, former president of Jay Peak, and William Kelly, an advisor to Quiros, to 18 months in prison each. A fourth conspirator, a South Korean businessman, presently remains at large.The scam? Quiros and his conspirators convinced foreigners to invest in building the “claimed” AnC Bio biotechnology plant in an economically depressed part of Vermont near the Canadian border. The investors put in their money pursuant to a visa program under which foreigners invest in job-creating ventures in exchange for the opportunity to obtain permanent U.S. residency. Unfortunately, there was no job creation, just as there was no AnC Bio plant being built; as U.S District Judge Geoffrey Crawford said at the sentencing hearing,1 “[t]his project was a fiction from beginning to end.” Quiros pocketed over US$30 million from his victims but ended up coming out well behind: in addition to prison time, he also settled civil charges brought by the Securities Exchange Commission by surrendering US$80 million in assets, including his two ski resorts.Also in Biotech-Related Crime News … Dr. Ishtiaq Ali Saaem, the director of advanced research at Massachusetts biotechnology firm Gen9,2 was sentenced to six months home confinement and a further two-and-a-half year probation for obstruction of justice in conjunction with hindering an investigation with his efforts to obtain ricin, a deadly toxin made from castor beans. Ricin is perhaps most famously (or infamously) known for its use in the 1978 broad daylight assassination of Bulgarian dissident Georgi Markov, killed on a London street using a Bond-movie-worthy device: a contact “umbrella gun” which used compressed gas to shoot a tiny pellet containing ricin into his leg. A passer-by3 “accidently” poked Markov with an umbrella and a few days later, he was dead. Ricin has also been used in other attempted assassinations and terror attacks.Saaem, however, did not take his cue from real-life uses of ricin as a murder or terror weapon, but from the popular television series Breaking Bad, on which it was also used.4 He ordered 100 packets of castor beans, each packet containing eight seeds, and lied to federal law enforcement about it, claiming that he had meant to buy only one packet but “accidently” ordered 100. He claimed he wanted them for gardening—this despite his researching tasteless poisons that could be made at home. He also tried to deny or downplay his knowledge of ricin.It's not Always about Covid: Geovax LABS Receives U.S. Patent Relating to a Malaria VaccineMalaria, a mosquito-borne disease caused by a microscopic parasite, causes almost a quarter-billion infections and over 400,000 deaths per year. It also can cause debilitating complications, including cognitive and neurological deficits, and can reappear or recur in its victims months or years after the initial infection. Because the parasite (members of the Plasmodium group) has a complex, multi-stage lifecycle, it has been difficult to effectively vaccinate against it: historically, most vaccines only target one stage of the parasite's lifecycle.However, GeoVax's in-development malaria vaccine candidates use a Modified Vaccinia Ankara (MVA) virus which has been engineered to express antigens derived from multiple stages of the parasite's lifecycle. By using antigens from several lifecycle stages, it is hoped that the vaccine will induce broader protection than vaccines just targeting one or two stages. While GeoVax is also, in common with just about every pharma and biotech company out there it seems, working on a COVID-19 vaccine, its CEO and president, David Dodd, said that “developing vaccines against global public health threats is also part of our longer-term focus” and that the company's goals “include developing such vaccines that are affordable, highly effective, safe, and [which] can be distributed and administ[ered] across various regions of the world in a simple manner.”Malaria is most prevalent in some of the most impoverished countries in the world and is not merely thought to be a hazard of poverty (e.g., a lack of public sanitation and health resources) but also a cause of poverty. Some studies, for example, suggest that widespread malaria can reduce a nation's annual Gross Domestic Product (GDP) growth to only around a fifth of what it would be without malaria.5 An effective, affordable, easily administered malaria vaccine would be a huge boon.Mission: Impossible BurgerImpossible Foods is the creator of the Impossible Burger. The Impossible Burger and other Impossible Foods meat-substitute or meat-analogue products make it a huge presence in the plant-based protein and meat-substitute market.6 The “secret” to its meat analogues is the use of heme, a hemoglobin precursor, which plays an important role in meat's taste, smell, and texture. Impossible Foods developed a technology using genetically modified yeast to express soy leghemoglobin, which is identical or nearly so to the heme molecule in animals. Its patent on this technology is the crown jewel of the company's intellectual property portfolio.Along comes competitor Motif Foodworks, which uses bovine myoglobin as its heme source. While significantly smaller than Impossible Foods, Motif Foodworks is potentially a formidable competitor: as a 2021 Ginkgo Bioworks spinoff, it already has a valuation of over US$1 billion and has raised around $340 million from investors, including Bill Gates. Impossible Foods brought a patent infringement suit against Motif Foodowrks, claiming that its patent also covers certain beef-substitutes using a muscle replica or fat tissue replicas, such as Motif Foodworks technology uses. Motif Foodworks, in turn, filed a petition with the United States Patent and Trademark Office's (USPTO) Patent Trial and Appeal Board seeking to invalidate Impossible Foods' patent. If Motif Foodowork's challenge to Impossible Food's patent is successful, it will likely lead to increased competition in the meat substitute market.1 There was no trial: Quiros pled guilty in August 2020 to conspiracy to commit wire fraud, money laundering, and concealment of material information, in exchange for other charges being dropped and a favorable sentencing recommendation—Quiros could have received more than five years in prison if convicted at trial.2 Gen9 is now part of Ginkgo Bioworks.3 Believed to be a member of the Bulgarian secret police, though high-level Russian defectors later confirmed that it was the KGB—Vladimir Putin's former outfit—who supplied the ricin.4 Saaem was not the only one inspired by Breaking Bad: several people have been convicted over the years for unsuccessful attempts to commit murder using ricin after the toxin's use on Breaking Bad.5 See, e.g. Sachs J, Malaney P, ”The economic and social burden of malaria”, Nature, 415 (6872): 680–85. doi:10.1038/415680a. PMID 11832956 (2002).6 Impossible Foods and Beyond Meat are the two most-widely known players in this space.FiguresReferencesRelatedDetails Volume 41Issue 3Jun 2022 InformationCopyright 2022, Mary Ann Liebert, Inc., publishersTo cite this article:By Steven J. Zweig.Moo-re Gene-edited Animals Get Regulatory Clearance: U.S. FDA Approves Genetically Engineered Cattle for Human Consumption.Biotechnology Law Report.Jun 2022.119-121.http://doi.org/10.1089/blr.2022.29269.sjzPublished in Volume: 41 Issue 3: June 15, 2022Online Ahead of Print:June 6, 2022PDF download