USDA Regulations Stifle Innovation

Over the past few decades, American consumers have witnessed an explosion of new produce in their grocery stores. From asian apple pears to sumo oranges, seedless watermelon, avocados, heirloom tomatoes, year-round fresh berries and stone fruit, ripe mangos, kiwis, and papaya, there are dozens of fruits and vegetables lining grocery store shelves across the country that could either only be found seasonally in 1990, or only in specialty markets. This abundance of sweet and tangy pleasure is the result of years of impressive advances in cold-storage shipping, free trade agreements, and agricultural innovation.

But this is just the tip of the iceberg when it comes to the kinds of produce that are possible.

Despite decades of availability of the technological capacity to produce genetically modified fruits and vegetables, there are only seven kinds of genetically modified produce currently available to U.S. consumers in grocery stores—and most of them are not widely available. Increased anti-oxidant purple tomatoes, non-browning Arctic apples, disease-resistant papaya and summer squash, bruise-resistant Innate potatoes, pink pineapple, and insect-resistant and herbicide-tolerant sweet corn make up the entirety of the genetically modified crops available in U.S. marketplaces. All the while, genetically modified crops are extremely common for large-scale commodity production of corn, soy, alfalfa, canola, sugarbeet, and cotton, for inputs into animal agriculture, food oils and sugars, or textiles. There are no gene edited fruits or vegetables currently available in U.S. grocery stores—though less bitter mustard greens were briefly sold—but the reasons for this are somewhat different.

American consumers are left without many novel and improved genetically modified products, not because the technology is unavailable or growing them would be too expensive. But, rather, because the American regulatory system is so time consuming and costly that there is no incentive for scientists or smaller biotechnology companies to try to bring products to market.

In some cases, developers have adapted, and found ways to work through the regulatory morass, but, for many, the barrier is too great to even try.

The Petition Process Limits Novel Genetically Modified Produce

USDA reviews genetically modified crops through a process called Petition for Determination of Nonregulated Status (Petition, for short). Under this process, the average review time between 2015 and 2025 was 600 days. USDA completed 30 Petition reviews over that ten-year period and only one of the reviews was (almost) completed within the 180-day timeframe set in the regulations.

Not only is this process long, it is also unpredictable—ten of the 30 Petitions took under one year to review, but seven took over two years. There is no data available for the cost of navigating the Petition process specifically, but based on data from 2017 to 2022 from the four largest biotech companies, the average cost of developing and authorizing a plant with a new genetically modified trait across multiple countries was $115 million total, with 29% devoted to regulatory science and 9% to registration and regulatory affairs.

This time-consuming and expensive process for genetically modified crops limits the variety of products that are developed and who can develop them. The long regulatory process, high data submission requirements, and high cost selects for big companies that are developing multiple products and can afford to wait years for products to be approved, limiting participation from small companies and academic developers. Further, even though bigger companies can more easily shoulder this burden, the high cost of regulation incentivizes them to develop genetically modified varieties of mainly staple commodity crops like corn and soy that can be commercialized and grown on many millions of acres to recoup the cost of product development.

For the few successful developers of genetically modified produce that has actually reached the market, navigating the regulatory process required sacrifice, patience, and funds.

Anti-Oxidant Rich Tomatoes, Once Forced into Greenhouses, Moved to Fields

In the early 2000s, Cathie Martin, a plant scientist at the John Innes Centre in Norfolk, UK, started trying to make a purple genetically modified tomato. The goal was to increase the concentration of particular antioxidants called anthocyanins—the pigments that give other fruits like blueberries and blackberries their color—which may provide health benefits like lowering blood pressure and reducing the risk of heart disease.

In 2008, Martin and other researchers published a paper showing increased lifespan in tumor-prone mice that were fed the tomatoes. Public interest was high, and Martin started a spinout company called Norfolk Plant Sciences to commercialize the tomatoes.

Because of the high cost associated with USDA’s Petition process to receive deregulated status for a product—the status necessary to allow cultivation outdoors without extensive containment measures—Norfolk decided to forgo the process and cultivate the tomatoes only in contained greenhouses, which would not require the same type of regulatory approval from USDA. But, while growing the tomatoes only in contained greenhouses would avoid the Petition process, it also increases the cost of production and constrains production volume compared to outdoor cultivation.

Thinking they would bypass the USDA Petition process altogether, Norfolk Plant Sciences focused on getting FDA approval for the safety of the tomatoes for human consumption. But during this process, USDA revised its biotechnology regulations in May 2020 to create the SECURE rule, which included a more streamlined pathway to deregulation for genetically modified crops—the Regulatory Status Review (RSR) process. This change prompted the company to reconsider their initial plan to grow their product only in greenhouses and expand their business to involve cultivating tomatoes under normal field conditions.

Ultimately, Norfolk Plant Sciences applied for deregulation under the new RSR process at USDA. Subsequent USDA approval in 2022, along with FDA approval in 2023, allowed Norfolk Plant Sciences to start selling the purple tomato seeds directly to home gardeners in 2024, as well as selling the fresh tomatoes in U.S. grocery stores.

Norfolk Plant Sciences’ decisions about product direction and pathway to commercialization illustrate the power of regulations to shape the types of products that ultimately reach U.S. consumers. In 2025, a lawsuit forced USDA to revert to the pre-2020 “legacy” regulations, reinstating the extensive approval process that originally dissuaded Norfolk Plant Sciences from growing fresh purple tomatoes outside of greenhouses and from selling seeds directly to consumers.

The purple tomatoes are here to stay, as are the other genetically modified products that went through the improved RSR process from 2020 to 2024—the changing regulations don't have a retroactive effect on previously-approved products. But the reversion to pre-2020 processes like Petition will assuredly stifle further innovation in genetically modified product traits and crop species from small and academic developers.

Non-Browning Arctic Apples Left in the Cold By Regulatory Changes

Around the same time Cathie Martin and Norfolk pioneered the purple tomato, Okanagan Specialty Fruits (OSF), a Canadian company, developed non-browning apples using the apple’s own genes to silence the enzyme responsible for oxidative browning. These apples stay fresh longer and do not change appearance after being cut, or damaged when being transported, thereby reducing food wasted.

OSF originally submitted a Petition for two genetically modified non-browning apple varieties—Arctic Golden Delicious and Arctic Granny Smith—in 2010 and received deregulated status in 2014. The company first started selling the apples in November 2017 after over 20 years of scientific development and regulatory review.

In 2016 and 2020, OSF approached USDA to approve additional varieties of non-browning apples. All four apple varieties were created using the same transformation method and the same new genes, and have the same non-browning phenotype—the only difference is which pre-existing apple variety (Fuji, Gala, etc.) the company added the non-browning trait to. Since they were developed the same way as the previously-approved variety, they were eligible for USDA's expedited review under the Petition process, called an Extension of Nonregulated Status. Despite the expedited extension process, these approvals still took over eight and 13 months, respectively.

Later, under the SECURE rule in 2021 and 2023, OSF submitted Confirmation requests for two more varieties, which were also transformed using the same method and new genes and have the same non-browning phenotype as the previous four. These exemptions through the Confirmation process were much faster than previous extensions under the Petition process—they took 35 and 56 days, respectively.

Altogether, approval of these additional four non-browning apple varieties through the Petition and Confirmation processes took over two years. If all four varieties after the initial application had been processed through the more efficient Confirmation pathway under the SECURE rule, this total could theoretically have been reduced by more than a year and a half.

The Way Forward

Fortunately, USDA is aware that the lengthy Petition process creates problems for developers, and the agency is planning to implement some efficiency improvements this spring. The only proposed change so far that impacts the Petition process is to exempt products that are similar to others that have previously been reviewed by USDA. This would exempt some products from the Petition process—like the new varieties of Arctic apples—but would not speed up reviews for products that are still subject to it.

In a future round of changes to its biotechnology regulations, USDA must revise the definition of the types of products it regulates to better align with risk factors, which could exempt lower-risk products from the Petition process altogether—both the initial Arctic apple and the purple tomato could qualify for exemption under these criteria. USDA should also make Petition review a two-step process, mirroring the successfully streamlined RSR review process for genetically modified products under the SECURE rule, which would reduce review time and burden on developers.

Matching the regulatory burden with the risk profile of genetically modified crops would enable increased innovation in crop biotechnology and shift incentives for smaller developers to bring novel products to market.