The USDA has approved a new experimental GMO pea with beef proteins developed by Moolec, a molecular farming operation. The HighWire previously reported about the approval of Piggy Sooy, Moolec’s soy product that is spliced with pig genes to provide a soy product that is rich with animal protein. These products are not yet approved for human consumption in the U.S., as they still await FDA evaluation.

The USDA’s APHIS (Animal and Plant Health Inspection Service) division only has jurisdiction to evaluate whether the beef-spliced peas are a pest risk. The approval letter states, “APHIS reviewed the modified garden pea to determine whether there is a plausible pathway by which the garden pea would pose an increased plant pest risk relative to the plant pest risk posed by an appropriate garden pea comparator.”

APHIS said they evaluated the new food based on information provided by Moolec, “publicly available resources, and APHIS’ familiarity with garden peas and knowledge of the trait, phenotype, and mechanism of action.”

It is expected to take years to run field tests, get FDA approval, and bring these products to market. The Piggy Sooy product is currently being field-tested in Ohio, Missouri, and Iowa.

Chief Technology Officer and Moolec Co-Founder Martín Salinas said “One acre of Piggy Sooy™ could potentially produce pork meat proteins equivalent to 10 pigs, reducing water footprint, land usage and CO2 emissions. This is a clear demonstration on how we promote environmental improvements throughout all our operations. Our aim is to heal the meat production system.”

Animal agriculture, specifically cows, has been connected with climate change concerns. There are many government initiatives to reduce meat consumption for this purpose, and The HighWire has reported the strain this causes for small farmers. Contributor Tracy Beanz described how regenerative farming utilizes animals to build the soil and sequester carbon.

There is a disagreement on whether GMOs are good for human and environmental health. GMO labeling laws and allowing freedom of choice to the consumers may not be enough because crop drift causes cross-breeding. A USDA report last month found that 25% of wild alfalfa is genetically modified as a result of crop drift.

Last year, The HighWire reported about the dangers of CRISPR gene-editing technology and the push to deregulate the new class of GMOs. Dr. Michael Antoniou, a professor in Molecular Genetics at Kings College in London, expressed concerns of unintended DNA changes that occur in GMO seeds and plants.

“The gene editing process as a whole (plant tissue culture, plant cell transformation, gene editing tool action) will inevitably result in hundreds if not thousands of sites of random unintended DNA damage leading to large scale alterations in gene expression patterns,” Dr. Antoniou said. “This, in turn, can result in altered biochemistry and composition that could include the production of novel toxins and allergens. This contrasts with the genetic variation that results from natural breeding, which, contrary to the narrative spread by advocates of gene editing deregulation, results in far fewer sites of DNA change in a non-random manner.”

Dr. Antoniou was only referring to GMO alterations that “theoretically” could occur through natural cross-breeding, which Moolec’s beef-spliced peas and Piggy Sooy can not. The concern of unintended DNA changes is still relevant for the vegetables expressing animal proteins when these seeds can contaminate other nearby farms.

Other concerns with increased use of GMO seeds is the dependence that farmers have on corporations to provide patented seeds. Monsanto filed 144 patent-infringement lawsuits against farmers between 1997 and 2010 and accused them of saving patented seeds. The organic farmers said they had no interest in growing GMO crops and Monsanto’s patented seeds unintentionally cross-pollinated with their crops.

USDA APHIS does not evaluate whether cross-pollination can occur, but they evaluate whether cross-pollination would cause pest issues to be worse for the crop family. GMO Free USA posted about Moolec’s beef-spliced peas on X. “Would you agree that this GMO is a non-pest without knowing what the frankenfood trade secrets are?”

Just as the EPA can protect proprietary trade secrets for the chemical formulations it approves for sale, the USDA provides the same protections to agricultural firms like Bayer and Moolec. Piggy Sooy was the first plant genetically modified with animal protein, so an evaluation based on prior knowledge and publicly available information may not be sufficient to determine the product’s risk profile. Aside from that, APHIS considered the information that was provided to the agency by Moolec.

Moolec CEO Gaston Paladini said in a 2022 interview that they want to combine foreign molecules with bulk plant protein. Paladini also discussed marketing phrases to help sell the product. He said the products contain animal proteins, so they can’t really say “animal-free.” Paladini said he would prefer “cruelty-free,” but also suggested “plant-based” and “plant-made.” He stressed the importance of being transparent with the consumer. Paladini also described his company as being “proudly GMO.”

The company hopes to market the products to vegans, vegetarians, and individuals concerned about climate change. Claire Insley, a New Zealand spokesperson for the Vegan Society, said this venture is for profit rather than an attempt to fulfill a “genuine need.”  

“This new soy plant has created an entirely new species, plants with animal genes can no longer be considered plants,” Insley said. “Many people from religious and ethical backgrounds would find this soy hard to swallow. Many cultures see deep problems in mixing genes between plants and animals, as it goes against the natural order of things. Selective breeding cannot put animal genes into plants. For vegans and vegetarians, it is deeply problematic for ethical reasons.”

It may take years for Moolec to bring the Piggy Sooy and beef-spliced peas to market. The approval by USDA APHIS is a regulatory hurdle that some are concerned about, specifically as it relates to potential cross-pollination from crop drift.