President’s Budget Jeopardizes American Biotech Leadership

Trump administration will struggle to achieve needed deregulation amid downsizing at USDA, EPA, and FDA

By Emily Bass

Imagine a world where crops thrive with less water and fewer pesticides, where livestock resist disease without antibiotics, and where we continue to grow more food for a growing population despite climate shocks. This isn't a distant dream; it's the tangible promise of agricultural biotechnology. From vibrant purple tomatoes engineered for enhanced nutrition and citrus armed against devastating diseases to the landmark approval of gene-edited pigs resistant to respiratory infection, biotechnology-enabled innovations hold immense potential to dramatically reduce agricultural emissions, significantly boost yields, and fortify global food security. However, realizing this future hinges on the complex, shared regulatory authority wielded by the U.S. Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA), agencies charged with unlocking biotechnology’s potential while safeguarding our farms, environment, and dinner tables.

The current U.S. regulatory framework stifles innovation with overly burdensome hurdles limiting the advancement of new genetically engineered crops, animals, and microbes. Regulatory reform is needed to enable new innovations to more quickly reach the market, generating powerful returns for agricultural productivity and the environment while also accelerating American leadership in agricultural biotechnology. The Trump administration has expressed real interest in both maintaining U.S. agricultural competitiveness and rolling back regulations that unnecessarily limit the growth of American industries. In March, the White House revoked a previous Executive Order guiding the growth of the U.S. bioeconomy. This leaves the current administration with significant runway to establish their own goals for advancing innovation in biotechnology centered around deregulation. The administration could finally level the playing field for biotechnology products with conventional products, a goal that presidential administrations have tried and failed to achieve since 1992.

But, any goals to improve regulatory oversight of agricultural products produced with biotechnology are put at risk by ongoing federal workforce reductions. Since a series of probationary staff firings in President Trump’s first weeks in office, the federal workforce remains under threat. Federal agencies continue to enact deferred resignation ‘buyouts’ and the administration is pushing for pending layoffs outlined in reduction in force plans. Federal agencies recently sent their budget request to Congress, the first comprehensive summary of the new administration’s priorities for each federal office and program, as well as a look into their preferred size of government. At a high level, the President’s budget proposes a 22% cut to USDA, a 4% cut to FDA, and a 54% decrease to EPA below fiscal year 2025 levels. Sweeping reductions in staff across these agencies will stretch already resource constrained regulatory efforts that include completing technical reviews, issuing industry guidance, and developing new rules. Sacrificing deregulatory goals in favor of short-term “wins” for downsizing the federal government is a mistake.

USDA Needs Staff to Overhaul Plant Biotech Regulations

Genetically modified crops have significantly improved U.S. agricultural productivity and reduced the need for inputs like pesticides. For example, farmer adoption of genetically modified corn in the U.S. raised yields by 17% from 1996 to 2020, while also boosting net farm income. Insect resistant genetically modified crops used with integrated pest management practices can reduce the use of broad-spectrum pesticides without compromising yields. However, despite the clear benefits of genetically modified crops, outdated regulatory frameworks fail to keep up with the pace of technology and continue to hinder innovation.

Due to the result of a years-long lawsuit over how USDA regulates plant biotechnology, the administration has a window of opportunity to relieve regulatory bottlenecks. At the close of 2024, the U.S. District Court for the Northern District of California vacated the SECURE rule, which had been in place at USDA since 2020. Accordingly, USDA’s Biotechnology Regulatory Service, the office tasked with regulating the introduction of plants developed using genetic engineering, threw out the SECURE rule and reverted back to using a decades-old regulatory review process. The old framework relies on an outdated understanding of genetic engineering that limits innovation in agriculture. Rather than continuing to operate under this outdated framework, USDA should prioritize developing new product- and risk-based regulations immediately.

Rewriting USDA’s regulatory framework will be resource-intensive and can take several years. Doing so while also managing an existing pipeline of applications, will likely require more, rather than less staff. But, the Trump administration’s pursuit of workforce reduction has already impacted the agency.

Over the course of two deferred resignation program iterations since President Trump took office, more than 15,000 USDA employees have left the agency. This includes over 1,200 staff at the Animal and Plant Health Inspection Service, which houses BRS—a loss of almost 20% of the workforce. Court ordered delays on the agency’s release of its forthcoming reorganization and reduction in force plans are likely holding back the flood gates on another round of layoffs.

Before President Trump came to office for his second term, BRS was a prime example of how regulatory efficiency can be steadily improved without the need for additional staff. For example, at the end of 2023, BRS completed less than 20% of regulatory status reviews (which are required for plants developed using genetic engineering that have not previously been evaluated to determine whether the modified plant can be safely grown and bred in the U.S.) on time, leaving 80% of applications delayed. A year later, BRS had reduced the average response time for an initial review of a regulatory status request by 145 days. Over the two year period, BRS full time staff stayed relatively constant.

The President’s budget asks Congress to keep funding for BRS flat at existing levels, but indicates the BRS team is down about 25% of staff from the start of the year. It will be crucial for Congress to maintain current resources for BRS to ensure the office can be fully staffed to continue timely review of products in the existing application pipeline in addition to developing new regulations.

FDA Workforce Reduction Risks Slower Regulatory Review Times

Increasing animal health and productivity through disease resistance can reduce both antibiotic use and greenhouse gas emissions associated with livestock production. Most recently, FDA approved pigs with a heritable intentional genomic alteration that makes them resistant to porcine reproductive and respiratory syndrome (PRRS), which causes losses costing $1.2 billion each year in the U.S. The pigs have been genetically modified using CRISPR genome editing to remove a DNA sequence essential for the PRRS virus to cause infection. Gene editing and genetic engineering are also being used to increase cattle resistance to diseases like bovine respiratory disease, mastitis, and bovine viral diarrhea virus. According to Breakthrough's analysis, if half of the U.S. beef herd were resistant to bovine respiratory disease, about 309,000 fewer cattle would be needed to produce today’s level of beef, reducing emissions by 2.3 MMT CO2e per year. But achieving this kind of progress will require an experienced and capable workforce at FDA to review new breakthroughs before they can reach the market.

The Human Foods Program under FDA is responsible for overseeing the safety of gene-edited foods intended for human consumption. FDA’s Center for Veterinary Medicine (CVM) is tasked with evaluating the safety and effectiveness, including potential environmental impacts, of novel technologies, like intentional genomic alterations in animals. The Human Foods Program also oversees the voluntary consultation process for developers of foods made with biotechnology-derived new plant varieties (NPV) to engage with the agency ahead of commercialization. The new administration has an opportunity to improve this consultation process. In 2024, FDA released new guidance that unjustifiably increased oversight of gene-edited NPVs relative to conventionally bred NPVs. FDA should course correct and ensure its regulatory processes related to NPVs are based on the risks of the end product, rather than being process-based.

According to a recent report from the National Security Commission on Emerging Biotechnology, staff at FDA’s regulatory offices were already spread thin at the start of the year. Amid a staff of nearly 20,000, the Commission estimates that FDA had less than 10 employees working on premarket oversight of plants and microorganisms produced with biotechnology. Despite this, the budget request for the Department of Health and Human Services sent to Congress includes plans to cut 534 staff from FDA’s Human Foods Program. In April, about 140 staff from CVM were fired as part of a reduction in force, adding to the earlier layoffs of probationary staff at FDA that were in their first two years of service. Several dozen were temporarily reinstated in the days that followed, including those working on bird flu response activities. The president’s budget request reflected a reduction of 124 staff compared to fiscal year 2025. In addition to layoffs of staff that directly conduct IGA animal reviews or lead NPV consultation processes, cuts to management and administrative teams could also jeopardize ongoing reviews.

Staffing Changes at EPA Could Help Address Regulatory Backlogs

Regulatory streamlining can help new pesticides that are better for biodiversity, farmers, human health, or the environment reach the market faster. Many conventional pesticides in EPA’s review pipeline are intended to be applied to new herbicide-tolerant genetically engineered crops. EPA is also charged with overseeing biopesticides, including biochemical pesticides, microbial pesticides, and plant incorporated protectants.

EPA is touting their reductions in force and restructuring as a way to improve regulatory processes, specifically for the review and registration of new pesticides, new uses for existing pesticides, and reauthorizations. EPA’s decision to move 130 staff to its Office of Chemical Safety and Pollution Prevention, which houses the Office of Pesticide Programs (OPP), to address the backlog of 12,000 delayed pesticide registrations is a welcome step in the right direction. Of course, moving staff from one program to another doesn’t happen in a vacuum. There are well warranted concerns that prioritizing reviews will come at the cost of the agency’s independent health and environmental research initiatives. But, in a vacuum, increasing the staff capacity at OPP is especially positive given that other corners of the administration seem diametrically opposed to putting more pesticides on the market. While a federal report recently released by the Making America Healthy Again Commission acknowledged that past EPA reviews did not establish a direct link between pesticides and bad health outcomes, it alleges there is still cause for concern around specific products like glyphosate and indicates a need for more, not less, scrutiny of pesticides.

Efforts at the EPA to streamline reviews of new pesticides and to maintain science-based pesticide residue limits have the potential to enable farmers to leverage the benefits of crop protection tools with lower toxicity and environmental impacts. However, as EPA reallocates staff for OCSPP and evaluates opportunities for regulatory improvements, it must dedicate sufficient resources to adequately train staff and prioritize efforts to retain existing staff with deep regulatory expertise. Without this, the EPA risks inconsistent and unpredictable regulatory decision making.

Prioritizing Smart Deregulation and Strategic Staffing

So far under the second Trump term, Agriculture Secretary Brooke Rollins has put forward various agriculture agendas to lower egg prices and support small and family farms. Health Secretary Kennedy has acknowledged the power of biotechnology for life sciences. But, the administration has not yet put forward a comprehensive strategy to accelerate biotechnology innovation in agriculture. The Trump administration should put deregulation at the center of their strategy, prioritizing efforts across USDA, FDA, and EPA to streamline and improve reviews of products of biotechnology that pose real risks.

To ensure efforts to cut red tape are successful, the administration needs to be forward thinking about staffing. When considering plans for future workforce reduction, the leaders of USDA, FDA, and EPA must not allow indiscriminate staffing cuts that jeopardize the government’s ability to efficiently complete regulatory reviews and pursue beneficial deregulatory efforts. This includes retaining and attracting regulators with sufficient scientific expertise. Crucially, Congress must appropriate sufficient funding for these activities in FY26 and beyond. And the Trump administration must put that funding to use under a coherent and cross-agency national biotechnology strategy.