Some Biotechnology Product Reviews Have Gotten Faster, Despite…

Some Biotechnology Product Reviews Have Gotten Faster, Despite Changing Regulations

USDA should address remaining delays

In December 2024, a U.S. District Court invalidated the U.S. Department of Agriculture’s (USDA) SECURE rule, which had established the framework for how the agency oversaw agricultural biotechnology. When the SECURE rule was first implemented in 2020, it represented the USDA’s first significant update to biotechnology regulations in 33 years. Although the SECURE rule was not without its flaws, it introduced a notably more efficient review process for transgenic, or genetically modified, crops.

Following the District Court’s decision, the USDA reverted to its pre-SECURE “legacy” regulations. Many experts in the biotechnology field cautioned that this shift would likely impede the agency’s review of new biotech crops and stall industry progress. Surprisingly, the opposite has largely occurred. The agency has successfully reduced its review timelines for most biotechnology crop applications by more than 50%, while continuing to process a volume of applications nearly equal to its 2024 figures.

However, the legacy system possesses a significant drawback: it mandates excessively long processing periods for certain transgenic products, commonly known as GMOs. These products, which incorporate DNA from other species, include insect-resistant and herbicide-tolerant crops, non-browning apples, and disease-resistant potatoes with low acrylamide potential. Such traits can improve crop yields, lower pesticide usage, facilitate no-till farming, and minimize food waste. The time-intensive and costly nature of the legacy system for these specific transgenic products limits the diversity of available innovations and creates barriers for smaller developers, including startups and academic institutions.

USDA’s biotechnology regulations, found in 7 CFR Part 340, oversee genetically engineered organisms that the agency determines could present a plant pest risk. While the USDA maintains discretion over which products are regulated, its decision-making and review procedures differ under the legacy framework compared to the SECURE rule.

Under the legacy regulations, the USDA monitors organisms—including plants and microbes—if the organism is a plant pest, if any added genetic material originates from a plant pest, if the organism used to introduce new genetic material is a plant pest, or if the USDA has any other reason to suspect the organism is a plant pest.

Regulated organisms fall under Part 340 and must undergo a risk assessment for plant pests before they can be cultivated outside of confined field trials. Under these legacy rules, developers are required to submit a Petition for Nonregulated Status, a process that necessitates the submission of extensive, costly data, including results from field trials. Conversely, the SECURE rule utilized the Regulatory Status Review (RSR) process, which was considerably more efficient. The RSR began with an initial stage where the USDA evaluated basic information regarding the identity and traits of the genetically engineered organism, followed by a more comprehensive second stage for applications that raised concerns during the first review.

Many gene-edited crops, such as most developedthese items, the USDA provides a separate pathway allowing developers to obtain official documentation confirming their product is not regulated, which helps foster confidence among consumers and trade partners. Under the SECURE rule, developers utilized the Confirmation process; under the current legacy framework, this is known as the Am I Regulated (AIR) process

Because many biotech crops are not considered regulated articles, it is vital that the USDA maintains the ability to quickly process large volumes of applications for regulatory status confirmation. This necessity was a primary driver behind the SECURE rule, which allowed the USDA to issue confirmations more rapidly than in the past. Even after reverting to the legacy framework, the USDA has managed to accelerate this process further, handling a high volume of AIR applications even faster than similar Confirmation applications were processed under SECURE.

Although the USDA has significantly reduced AIR response times, the agency’s turnaround for Petitions remains sluggish and has not improved. Of the 30 Petition reviews finalized between 2015 and 2025, none were completed on schedule, and only eight were finished within 360 days—which is double the timeframe established by the regulations. For two insect-resistant and/or herbicide-tolerant corn applications submitted in 2020, the USDA did not provide a decision until 2023 and 2025. The combination of slow reviews and rigorous data requirements makes the Petition process expensive, resulting in a low volume of applications, the vast majority of which come from large corporations. Data from 2017 to 2022 regarding the four largest biotech firms indicates that the average cost to develop and authorize a new plant biotech trait globally was $115 million, with 29% of that budget allocated to regulatory science and 9% to registration and regulatory affairs.

Until the USDA introduced the AIR process in 2011, the Petition process was the only regulatory path for biotech crops. This, combined with the high costs and time required for product development, helped solidify a market dominated by a few major players, eventually leading to the current landscape where four companies—Bayer, BASF, Corteva, and Syngenta—control the industry. These high development costs have also restricted the variety of crop species and traits, focusing primarily on insect resistance and herbicide tolerance in major row crops like soy and corn.

Generally, the review of transgenic products is slower than that of non-transgenic products due to perceived higher risks. Nevertheless, the USDA has demonstrated that it is capable of reviewing transgenic products much more quickly. Under the SECURE rule, the agency reviewed transgenic products roughly twice as fast as it does under the current Petition process. The USDA maintains that it regulates biotech products based on the traits of the final product—including the nature and scale of the genetic change and the presence of foreign DNA—rather than the production method, whether that involves gene editing, genetic modification, or traditional breeding. However, a more risk-based approach would focus on the specific traits that directly contribute to risk. For instance, herbicide-tolerant crops can influence the development of herbicide-resistant weeds by affecting farmers’ herbicide choices. Yet, the USDA often quickly approves many herbicide-tolerant traits if they are gene-edited, while subjecting transgenic versions to much stricter scrutiny.

The USDA’s slow and costly Petition review process discourages many smaller organizations from developing or commercializing transgenic crops that fall under regulated status. Large companies submit the highest percentage of products to the Petition process, largely because the lengthy review times and data requirements make it prohibitively expensive for smaller developers. In contrast, far fewer large-company developers submitted transgenic products to the RSR process.

Overall, despite the disruptive return to legacy regulations in late 2024, the USDA has performed impressively in quickly reinstating these systems and reducing review times. The primary remaining issue is the excessively long review period for Petitions, which limits the types of developers who submit products in this category and the variety of products being developed. As the agency considers updates to the regulations at 7 CFR Part 340, streamlining the Petition review process while ensuring safety should remain a top priority.