Some Biotechnology Product Reviews Have Gotten Faster, Despite Changing Regulations

In December 2024, a U.S. District Court struck down the U.S. Department of Agriculture’s (USDA) SECURE rule, which structured how the agency regulated agricultural biotechnology. When the SECURE rule was initially adopted in 2020 it was USDA’s first major biotechnology regulation update in 33 years. While the SECURE rule had its flaws, it instated a dramatically more efficient process for review of transgenic aka genetically modified crops.

After the District Court ruling, USDA simply reinstated its pre-SECURE “legacy” regulations. Many biotechnology experts warned that this reversal would slow down USDA’s review of new biotechnology crops and hinder progress. But in many ways the opposite has happened. The agency has managed to cut its review time for most applications for biotechnology crops by more than 50%, while still processing almost as many applications as it did in 2024.

But the legacy system also has a serious shortcoming: it imposes extremely long processing times for some transgenic products (commonly referred to as genetically modified or GMO). Transgenic products contain DNA from other species and include insect-resistant and herbicide-tolerant crops, non-browning apples, and disease-resistant potatoes with low acrylamide potential. These traits can help increase crop yields, decrease pesticide use, support no-till farming, and reduce food waste. The legacy system’s time-consuming and expensive process for certain transgenic products limits the variety of products that are developed and disadvantages smaller developers such as startups and academics.

USDA Biotech Regulations Have Improved in Key Ways

USDA’s biotechnology regulations, codified in 7 CFR Part 340, govern genetically engineered organisms that USDA believes could pose a plant pest risk. USDA has discretion to determine which products are regulated, but their decision-making and review processes are different under the legacy framework than they were under the SECURE rule.

Under the legacy regulations, USDA regulates organisms including plants and microbes if (1) the organism is a plant pest, (2) any genetic material added to it is from a plant pest, (3) the organism used to add new genetic material is a plant pest, or (4) USDA has any other reason to believe the organism is a plant pest.

Regulated organisms are subject to Part 340 and must go through a process to determine whether they pose plant pest risk before they can be grown outside confined field trials. Under the legacy regulations, developers of regulated organisms must submit a Petition for Nonregulated Status, which involves presenting a large amount of detailed data including from field trials that is expensive to collect. Under SECURE, USDA instead required developers to go through the Regulatory Status Review (RSR) process, which was significantly more streamlined. RSR began with a first stage in which USDA reviewed straightforward information about the identity and characteristics of the genetically engineered organism, and a second more involved stage for the subset of applications that raised concerns during the first stage.

Many gene edited crops, like most of those made using CRISPR, are not considered regulated under Part 340. For these products, USDA offers a separate pathway through which developers can get official documentation that their product isn't regulated, which helps build confidence among trade partners and consumers. Under SECURE, developers went through the Confirmation process; under the legacy framework, it is the Am I Regulated (AIR) process.

Since many biotech crops are not considered regulated articles, it is critical that USDA be able to process large numbers of applications for confirmation of regulatory status quickly. This was part of the rationale behind the SECURE rule—under it, USDA was able to issue confirmations quicker than they previously had. Yet after the reversion to the legacy framework, USDA has managed to accelerate the process even further, processing a large number of AIR applications even faster than they had processed similar Confirmation applications under SECURE.

USDA Must Still Improve Treatment of Genetically Modified Crops

Although USDA has dramatically decreased AIR response times, agency response times for Petitions have not improved and are still extremely slow. Out of the 30 Petition reviews completed between 2015 and 2025, none were completed on time and only 8 were completed within 360 days—double the timeframe set in the regulations. For two insect-resistant and/or herbicide-tolerant corn applications submitted in 2020, USDA did not issue a decision until 2023 and 2025. Slow reviews and high requirements for data submission make the Petition process expensive, and mean it receives very few applications, with the vast majority from large companies. Based on data from 2017 to 2022 from the four largest biotech companies, the average cost of developing and authorizing a new plant biotech trait across multiple countries was $115 million total, with 29% devoted to regulatory science and 9% to registration and regulatory affairs.

Until USDA created AIR in 2011, the only regulatory avenue for biotech crops at USDA was the Petition process, which—along with the high cost and time required to develop a product—contributed to establishment of just a few companies that dominate the market, with subsequent mergers leading to just four main biotech companies today: Bayer, BASF, Corteva, and Syngenta. The high cost of developing a product also contributed to a very narrow set of crop species and types of traits—mainly insect resistance and herbicide tolerance in row crops like corn and soy.

Overall, review of transgenic products is also slower than review of non-transgenic products because they are perceived to carry greater risks. However, USDA has shown that it can review transgenic products much faster. Under the SECURE rule, USDA reviewed transgenic products about twice as quickly as it does under the Petition process. USDA claims they regulate biotech products based on the traits of the actual product—which includes the type and size of genetic change and whether there is foreign DNA—and not based on the method used to produce it, whether that’s gene editing, genetic modification, or breeding. However, a more product- and risk-based approach would regulate based on the traits of the product that contribute more directly to risk. For example, herbicide-tolerant crops can contribute to the development of herbicide-resistant weeds by influencing which herbicides farmers use. Yet USDA quickly green-lights many herbicide-tolerant traits simply because they are gene edited, while carefully scrutinizing those that are transgenic.

USDA’s slow and expensive Petition review process deters many smaller organizations from developing or commercializing transgenic crops that would be considered regulated articles. The highest percentage of big companies have submitted products to the Petition process largely because the review time and amount of data needed to apply makes it expensive for developers. In contrast, many fewer big company developers submitted transgenic products to the RSR process.

Overall, even with the disruptive reversion to legacy regulations in late 2024, USDA has done an impressive job of quickly reinstating legacy systems and decreasing review times. Now, the main problem is still very long review times for Petitions, which restricts the types of developers that end up submitting products in this category and the variety of products submitted. As the agency contemplates changes to regulations at 7 CFR Part 340, streamlining review of Petitions while maintaining safety should be a high priority.