For the past thirty years, innovations in crop biotechnology have allowed farmers to reduce synthetic inputs and environmental impact while increasing crop yields and even crop quality. But the regulatory review process hasn’t kept pace with innovations. A new report from USDA’s Economic Research Service (ERS) analyzed how the agency operated under its streamlined biotechnology framework, the vacated 2020 SECURE rule. While far from perfect, the updated process showed that modernizing regulatory frameworks significantly sped up product approval, and USDA should ensure future reforms incorporate a tiered, risk-based approach where crops are regulated based on the actual risks they pose.
Beyond the environmental upside of crop innovations, biotech has also delivered economic benefits. Since 2013, more than 90 percent of U.S. corn, soybean, and cotton acres have been planted with genetically engineered (GE) seed. Most of those crops carry one or both of two traits: tolerance to herbicides or resistance to insects. Because herbicide-tolerant crops can be sprayed with weed-killing chemicals like glyphosate without being harmed, they’ve made it easier for farmers to reduce or eliminate tillage, which farmers traditionally used to control weeds by turning over the soil. Leaving the soil undisturbed improves soil health and helps protect soil carbon. Similarly, the use of insect-resistant crops has reduced insecticide application and crop loss. According to ERS, these traits generated up to $5.2 billion in total economic value to U.S. farmers, seed companies, and consumers between 2007 and 2011 alone. Looking specifically at farmers, additional data from Breakthrough Institute show that GE crops added $30 to $111 per hectare to average net farm income over two decades.
Farmers desperately need new solutions as they face additional stressors like new diseases, invasive pests, a changing climate, and insects and weeds growing resistance to current varieties. Seventeen weed species in the U.S. are now resistant to glyphosate– the most widely used herbicide, and in parts of the Corn Belt, rootworms (plant eating insects) have developed resistance to nearly every variety of Bt corn, which is engineered to produce its own insect-killing protein.
Newer gene-editing tools like CRISPR let scientists change the genes a plant already has, like turning off a gene that makes it vulnerable to disease. With this newer technology, scientists can improve a crop without years of crossbreeding or the longer process of developing and testing a gene from another species. ERS notes that gene editing could cut development costs by at least 40 percent and shorten the time to market by a quarter or more.
Lower development costs could also make it economically feasible to develop biotech traits for specialty crops like fruits and vegetables, many of which are slow or difficult to improve through conventional breeding and have largely been left out of earlier genetic engineering.
Federal biotechnology regulation, however, relies on outdated rules that have shifted from their original intent, overemphasizing how a crop is developed and getting in the way of safe, useful products reaching farmers. Rather than create a new statute when biotechnology innovation was ramping up, the federal government established a Coordinated Framework in 1986 that used existing laws and divided responsibility among federal agencies based on the type and intended use of a product. Simply put, USDA analyzes whether a new plant could harm other crops or the environment, EPA reviews plant-incorporated protectants–plants that produce their own pesticides– and FDA makes sure those crops are safe to eat. The framework intended these reviews to be product-based, focused on the risks and characteristics of the product rather than the process used to make it. However, because the framework relied on existing laws, agencies had to fit reviews into rules that weren’t designed for the type of new products emerging, and reviews became focused on how the product was made. According to the National Security Commission on Emerging Biotechnology (NSCEB), this caused lengthy reviews for products similar to those that had already been approved, and uncertain reviews for new products.
The Breakthrough Institute found that petition reviews to approve crops engineered with DNA from a plant pest took an average of 600 days, and only one of 30 came close to the 180-day timeline set in the regulations between 2015 and 2025. Because these crops are “regulated articles,” developers must obtain a permit from the Animal and Plant Health Inspection Service (APHIS) for field trials or transportation and file a petition for nonregulated status before commercial sale. After this, APHIS completes a plant pest risk assessment and opens a 60-day public comment period before issuing a final decision.
Regulatory approval is also expensive and inadvertently decides who gets to participate in innovation. Developing and approving a new trait across multiple countries costs about $115 million, with 29 percent going to regulatory science and another 9 percent to registration and regulatory affairs. Large companies can absorb costs like that, but they price out small companies and academic researchers. Reflecting this hurdle, another Breakthrough analysis found that about 77 percent of recent petitions for transgenic crops came from large companies.
Prompted by a 2019 executive order directing agencies to regulate based on risk, USDA finalized the SECURE rule in 2020. USDA said the rule would focus on a plant’s properties instead of how it was made. Gene edits that could have happened through conventional breeding were exempt, and crops that still needed review went through a shorter Regulatory Status Review instead of a full petition. Yet because it exempted crops that could have been edited through conventional breeding, it was still using process-based regulation. According to the ERS report, the median review dropped from 526 days to 222 days. In about four and a half years, USDA cleared 42 plant species, compared with just 53 in the previous 28 and a half years. A federal court vacated SECURE in December 2024, finding that USDA hadn’t adequately explained key changes in the rule, and the agency returned to the old process.
In May, USDA opened a public comment on what an updated system should look like. To be effective, any new process must evaluate products based on actual risk, not the engineering method used. As proposed by the NSCEB report, a tiered, risk-based system where crops are regulated based on the actual risks they pose is a welcome step. This would allow regulators to spend more time on products with genuinely novel risks, such as plants engineered to produce pharmaceuticals, while accepting products with familiar traits already proven safe.
Those reforms are long overdue, but there must be better interagency coordination as well. More than 15 federal offices and programs have some role in biotechnology oversight, with the EPA, FDA, and USDA APHIS primarily regulating agricultural products. To address overlaps and give developers clearer guidance, NSCEB has recommended creating a National Biotechnology Coordination Office. This office should actively monitor emerging biotechnology and ensure the current framework can regulate emerging products rather than waiting for regulatory frameworks to fall behind again. This, coupled with adequate resources and expertise at agencies, would go a long way in speeding up review.
Incorporating these reforms into USDA’s next framework is critical for American farmers. The economic and environmental record of crop biotechnology is well established. By building a streamlined, risk-based system that keeps up with modern science, regulators can ensure American farmers have the tools they need to meet today’s growing challenges.
