Simplify Regulation for American Biotechnology Companies

Challenges of the U.S. Biotechnology Regulatory System

Innovators have identified four key challenges within the U.S. biotechnology regulatory system. First, they face uncertainty about which agencies are responsible for regulating their products. Second, they must navigate overlapping processes across multiple agencies. Third, they frequently encounter unnecessary regulatory burdens for products that have already been deemed safe. Fourth, even when they overcome these hurdles, the regulatory agencies’ limited capacities result in significant delays.

Because each agency acts independently and there is no coordinated way to enter the regulatory system, innovators can struggle to determine who is responsible for regulating their products. It is often unclear how regulatory agencies work together to review products, and innovators can face lengthy delays as products are bounced between agencies. Engineered insects, for example, may fall under the FDA’s animal drug authority, EPA’s pesticide authority, and APHIS’s plant and animal health authority. Developers of gene-drive mosquitoes, which are engineered to reduce pathogen transmission or fertility in their offspring, were passed off from agency to agency for nearly 10 years.¹²⁶ In contrast, similar mosquitoes that are modified without biotechnology are regulated by the EPA and gained approval in just five years.

Even after identifying the appropriate starting point, innovators must navigate a convoluted maze of overlapping processes across multiple agencies. Each agency has its own requirements, timelines, and procedures, resulting in duplicative and asynchronous review. Innovators must contact each regulatory agency separately, and each product must follow a unique path to obtain multiple approvals at different times. Innovators have to repeat themselves, double back, and change course with little predictability, all of which is remarkably inefficient.

These obstacles pose a particular challenge for biotechnology products that are similar to products made with conventional methods or to products that have been repeatedly reviewed. For example, non-browning apples and potatoes have both been approved in the United States, but regulatory agencies are unable to take prior approvals into account to expedite reviews of similar products. As of today, a non-browning avocado, peach, or pear would likely face the same lengthy approval process, even when the non-browning traits are the same.¹²⁷

Finally, after navigating this regulatory maze, innovators must wait their turn in an ever-lengthening queue. Regulatory agencies face persistent understaffing despite a growing backlog of applications. Timelines vary from product to product, but some innovations have been held by agencies for a decade or more.¹²⁸ If agencies do not shift their focus onto the most novel and complex products, the backlog will only grow, and more innovations will remain uncommercialized.

Focus Review on Novel Products

Biotechnology is a powerful tool for producing safe and beneficial products. The potential risks stem not from the technology itself but from the novel products it enables.¹²⁹ For decades, biotechnology has been safely used to produce life-saving medicines like insulin. But it can also be used to create novel products that have characteristics not found in nature. Some biotechnology products are themselves living organisms, which live on and replicate when introduced into the environment. These products may have effects that require a closer look.

Several other countries are simplifying or have already simplified regulations for certain biotechnology products. Not surprisingly, innovators are increasingly seeking approval in those countries first or even moving their operations there. Without efforts to simplify and clarify U.S. biotechnology regulation, this offshoring trend is likely to continue, and the United States will lose its hard-won leadership in biotechnology development and commercialization.

The recommendations in this section aim to simplify America’s biotechnology regulatory system. If taken together, they would result in more straightforward and risk-proportionate regulation that would encourage innovators to bring biotechnology products to market efficiently and transparently, while still protecting human health and the environment.

Food Security is National Security

The American agricultural sector encompasses over a third of all U.S. land and almost 3.5 million farmers, ranchers, fishers, and other producers, and faces many potential vulnerabilities.ᵛⁱ These vulnerabilities are especially concerning in light of a rapidly evolving threat landscape with profound consequences for our national and economic security.ᵛⁱⁱ

Threats to agriculture come in many forms. Diseases and pests cost farmers an estimated $590 billion globally each year.ᵛⁱⁱⁱ Moreover, geopolitical conflicts increasingly threaten global supply chains: after Russia’s 2022 invasion of Ukraine, global fertilizer prices tripled due to Western sanctions on Russian exports.ⁱˣ

Biotechnology and biomanufacturing offer exciting new opportunities to protect American agriculture from these threats. For instance, advances in these biotechnologies could improve the nutritional quality of foods, boost plant and animal resistance to disease, and reduce the need for fertilizer.ˣ Domestically produced bioproducts could support robust supply chains for everything from feedstocks to chemicals, creating new jobs and growing our economy.ˣⁱ

Realizing the full potential of agricultural biotechnology requires addressing the challenges it faces. Total U.S. spending on agricultural research has fallen by a third since peaking in 2002.ˣⁱⁱ By contrast, China is now the largest global funder of agricultural research and development (R&D), and China-based companies are acquiring and consolidating global agricultural companies to bolster their technology portfolio.ˣⁱⁱⁱ For all of these reasons, it is critical that the United States leverage the opportunities of biotechnology today to build an agricultural sector that is up to the challenges of tomorrow.

Congress must direct federal regulatory agencies to create simple pathways to market and exempt familiar products from unnecessary regulation.

The U.S. biotechnology regulatory system was intended to regulate products based on their characteristics and risks, rather than the processes used to create them.¹³⁰ Unfortunately, this distinction has eroded over time, resulting in unnecessary and burdensome regulation. The current approach is not just unwise; it is also unsustainable, given the growing number of truly novel biotechnology products entering the development pipeline. The default government policy should be that if a biotechnology product is generally understood to be safe and can be made through conventional means, it should be regulated no differently than conventional products. If a biotechnology product is similar to previously reviewed products that are well-understood by regulators, it should be exempt from further review. Regulators should spend their time and energy on understanding the effects of truly novel products made with biotechnology.

To achieve these goals, the National Biotechnology Coordination Office (NBCO) (see recommendation 1.1a) should be empowered to drive simplified biotechnology product regulation. Congress should direct the NBCO to:

• lead and coordinate biotechnology regulation efforts across the interagency through a deputy director for regulation (though regulatory authorities would remain with existing agencies);
• work with regulators to resolve overlaps, gaps, and ambiguities;
• work with regulators to map clear regulatory pathways, including to simplify and ease regulation for familiar products and conduct regulatory trials;
• build and maintain digital infrastructure; and
• communicate clearly and consistently about biotechnology regulation.

To accomplish these goals, the NBCO should be staffed with full-time biotechnology science and regulatory policy experts, as well as experts in human-centered design, software engineering, and science communication. Staffing needs may decrease over time as clear regulatory pathways are successfully established. Additionally, Congress should grant the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) the authority to determine and enforce clear regulatory pathways when the regulators cannot reach consensus.

Create Simple Pathways and Exemptions

To create simple pathways to market, regulators should identify biotechnology products that could have arisen naturally or through conventional methods, as these generally pose no additional risk, and exempt or expedite their regulatory review.¹³¹

Currently, regulatory agencies lack the statutory authority to apply their expertise to reduce regulation for well-understood products. Instead, they are required to evaluate each product independently, even when similar products have already been reviewed and found to be safe.

Recent judicial actions, such as the Supreme Court decision in Loper Bright Enterprises v. Raimondo and a ruling against the USDA in the Northern District of California, have raised uncertainty about agencies’ ability to interpret their authorizing statutes.¹³² Regulatory agencies may now face additional legal challenges when using authorities that are not explicitly intended for biotechnology, and it may be harder for agencies to nimbly address novel products. As a result of the decision reversing USDA’s policy, developers of biotechnology products are again subject to potentially lengthy and cost-intensive permitting processes.¹³³ 

To address these challenges, Congress should authorize regulators to reduce or remove regulatory hurdles for familiar products based on accumulated evidence, enabling agencies to reallocate resources toward supporting emerging biotechnologies.

Specifically, Congress should amend relevant statutes that give agencies authority to regulate biotechnology products, such as the Plant Protection Act, the Federal Food, Drug, and Cosmetics Act, and the Toxic Substances Control Act. Amendments should clearly delineate which agencies are responsible for each type of product and authorize the NBCO and the OIRA to resolve any remaining overlaps, gaps, and ambiguities.

Map Clear Regulatory Pathways that Resolve Regulatory Overlaps, Gaps, and Ambiguities

Congress should instruct the NBCO to guide regulatory agencies in creating interagency agreements that map clear regulatory pathways. The NBCO would work with agencies to ensure that such agreements describe expected timelines, data requirements, and decision points for each product type. Each map would show how a developer could advance to each step, with clear handoffs between agencies. Agreements would also facilitate information sharing across agencies, with appropriate safeguards for confidential business information. High-quality maps that delineate all applicable regulatory processes during research and development (R&D) would allow innovators and investors to accurately estimate what it takes to get to market.

Conduct Regulatory Trials to Inform Clear Regulatory Pathways

For products that lack a clear regulatory pathway, Congress should authorize the NBCO to work with regulators to create a regulatory “sandbox,” an environment featuring short-term trials of proposed tests so that they can evaluate new regulatory pathways and potential improvements to existing pathways.

Sandboxes can help facilitate dialogue between developers and regulators, informing the development of regulatory processes that facilitate innovation while mitigating risks.¹³⁴ Governments are increasingly creating regulatory sandboxes for emerging technologies, as the United Arab Emirates and Spain have done.¹³⁵ In 2024, the United Kingdom created the Engineering Biology Sandbox Fund to support regulator-led sandbox projects that accelerate regulatory reforms. ¹³⁶

The NBCO-led sandbox would allow innovators to propose new or updated regulatory pathways. For example, an innovator could propose a new testing method to replace a more expensive, older method. Working together, the NBCO, the innovator, and regulators would develop and conduct a short-term trial for the new method, with metrics to determine success. If the proposed method meets established guidelines for safety and efficacy, the NBCO would then work with regulators to update regulatory pathways accordingly.

The NBCO could also use the regulatory sandbox to identify ways to accelerate the approval of crucial products. The FDA provides “emergency use authorization” for medical countermeasures and expedited processes for certain therapies and devices that meet a serious medical need.¹³⁷ But there are few expedited processes for agricultural or industrial products, leaving innovations such as disease-resistant citrus trees languishing in review while American farmers are forced to expend resources removing diseased trees. ¹³⁸

Verify Voluntary Standards for Biotechnology

Alongside the regulatory process, voluntary standards can boost confidence in new products—for example, helping farmers weigh the value of new agricultural inputs, food manufacturers evaluate the benefits of new ingredients, and insurers consider the risks of introducing new products into existing supply chains.

The USDA’s Process Verified Program (PVP) allows companies, trade groups, and others to create custom standards through a fee-for-service model, with audits to ensure that the standards are being followed.¹³⁹ The USDA is already authorized to use audits for products in food and agriculture, but is not currently using this authority for biotechnology.¹⁴⁰ Congress should encourage the USDA to advertise the PVP as an option for biotechnology products, thereby helping innovators to determine if the program could provide value for them and their customers.

Build Digital Infrastructure to Simplify Biotechnology Regulation

Each regulatory agency currently has its own submission portal, forms, processes, and data requirements. Even though regulators have taken some steps to coordinate, biotechnology product developers must submit the same information multiple times in different formats, a frustration that has led them to call for a “single door” approach that would streamline submissions, data requirements, and timelines.¹⁴¹ Moreover, each regulatory agency keeps its own repositories of regulatory decisions, in some cases providing limited or no public information. This lack of transparency presents a challenge for innovators, consumers, and others seeking to identify what paths products have taken through the regulatory system and which products have previously been approved.

Congress should authorize the NBCO to build and maintain a single point of entry for biotechnology innovators at biotech.gov (see recommendation 1.1a). The NBCO could create easy-to-find repositories of interagency agreements and regulatory decisions, driving toward a “single door” application process for biotechnology products that would minimize the administrative burden on both industry and government.

Communicate Clearly and Consistently about Biotechnology Regulation

It should be easier for industry and the public to find useful information about biotechnology regulations. Researchers and startups need to understand regulatory requirements so that they can gather the necessary data and make sound decisions early in product development, and investors need a better grasp of regulatory pathways to assess market readiness. Consumers should also have easy access to information about biotechnology products and the processes used to ensure their safety.

The NBCO could work across the agencies on:

• regulatory guides: Providing guidance for innovators as they enter and progress through the regulatory system for the first time (the NBCO would build on lessons learned from the FDA’s Veterinary Innovation Program (VIP), which gives developers of animal drugs feedback and other assistance during the regulatory process);¹⁴²
• developer outreach: Delivering plain-language information about biotechnology regulation for the developer community, including academia and industry;
• public outreach: Exploring outreach methods to identify concerns and improve public understanding of biotechnology (including collaboration with community leaders such as Master Gardeners, who help provide science-based information to the public);¹⁴³
• regulatory diplomacy: Working toward international alignment of biotechnology product regulations. This could include reviewing applications collaboratively, aligning data requirements, and sharing risk assessments, all of which could shorten regulatory timelines and reduce burden for both developers and regulators. (See Section 6.1 for more detail on regulatory diplomacy.)

Rainbow Papaya: A Regulatory Success Story

The historic story of the Rainbow papaya shows the importance of both agricultural biotechnology and streamlined regulation. The papaya ringspot virus devastated the U.S. papaya industry in the 1990s. Scientists detected the virus on commercial papaya farms in 1992, and by 1995, Hawaiian farmers could no longer grow papayas.ˣⁱᵛ

With support from the Department of Agriculture (USDA), Dr. Dennis Gonsalves led a team of scientists at Cornell University in developing a virus-resistant papaya using a gene from the virus itself, effectively vaccinating the plant.ˣᵛ The team crossbred the resistant plants with commercial varieties, resulting in the Rainbow papaya.ˣᵛⁱ

The scientists grew Rainbow papayas on a farm that had gone out of business due to the destructive virus, demonstrating that the new papaya was resistant and still had the familiar qualities that had existed for generations.ˣᵛⁱⁱ Next, the Rainbow papaya underwent a thorough but expedited review by the USDA, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) to ensure it was safe for consumption and the environment. In 1997, the Rainbow papaya was officially approved and made available for widespread cultivation.ˣᵛⁱⁱⁱ

Biotechnology saved the Hawaiian papaya industry. Less than two years after their livelihoods were wiped out, farmers returned to growing papaya and the threat of the virus waned.ˣⁱˣ This example shows that biotechnology can promote food security and economic security if regulatory frameworks balance safety reviews with timely access for farmers. Today, U.S. crops and livestock are under constant threat from pests and diseases, including citrus greening, wheat rust, avian influenza, and African swine fever.ˣˣ Biotechnology can help combat these hazards and ensure continued prosperity of American farmers.

Congress should direct federal regulatory agencies to prepare for novel products to come to market.

Even if biotechnology product regulation is simplified and coordinated, the U.S. government’s low regulatory capacity will continue to delay the commercialization of biotechnology products in the United States. Regulatory agencies cannot keep up with the exponential increase in applications for regulatory review.¹⁴⁴ The APHIS, for example, received and completed an average of 4.5 requests for review each year between 1992 and 2022. In 2023 alone, it received 43 requests.¹⁴⁵ This increase in applications is expected to continue and will quickly overwhelm regulatory agencies.

Congress should prepare regulatory agencies for the products of the future in three ways. First, it should ensure that agencies have the necessary capacity and expertise to review these products. Second, Congress should give regulators access to public-private partnerships through a regulatory foundation. Finally, Congress should establish a regulatory research program that provides the scientific underpinning needed to simplify biotechnology regulation.

Bolster Regulatory Agency Capacity

Staffing at regulatory agencies has remained constant even as applications have more than doubled in recent years. Experts shared with the Commission that the Food and Drug Administration (FDA) has only nine employees working on food safety for plants and microorganisms produced with biotechnology, despite the importance of pre-market oversight for such foods, and the Environmental Protection Agency (EPA) has only six staff reviewing applications for the commercial use of certain microorganisms produced with biotechnology. Senior scientists are stretched particularly thin since they must provide technical reviews, meet with innovators, develop rules, coordinate with domestic and international regulators, and train junior staff, among other responsibilities.

Appropriators should provide small funding increases for all biotechnology regulatory agencies, with additional targeted increases for a subset of these agencies. After years of flat budgets and growing workloads, a modest boost in regulatory capacity would benefit American biotechnology companies and unlock major economic growth by enabling more products to safely enter the market. The NBCO could work with regulatory agencies to quantify staffing and expertise needs, particularly as those needs shift to address novel products.

In addition, the NBCO could coordinate a biotechnology regulatory fellowship program for federal government employees. Such a program would improve the regulatory workforce, help provide continuing education for current federal employees, and encourage cross-functional understanding of biotechnology research and regulation. While the primary participants would be current regulators, the program could also be open to other federal government employees, such as lawyers who work in regulatory agencies, policy advisors in trade agencies, and program officers in research agencies. Fellowships could include a capstone project on regulatory topics, such as clear regulatory pathways, digital infrastructure, or communication strategies.

Establish a Foundation to Enable Biotechnology Innovation

Regulatory agencies need access to external experts in order to improve regulatory processes, scan the horizon for emerging technologies, and engage with the public, among other activities. Government-affiliated foundations provide a flexible and efficient way to supplement federal activities. Examples include the Reagan-Udall Foundation for the FDA and the Foundation for Energy Security and Innovation (affiliated with the Department of Energy (DOE) and established by the CHIPS and Science Act of 2022). A more recent example is the Foundation for Standards and Metrology, which was proposed in Congress in 2024 and would be affiliated with the National Institute of Standards and Technology (NIST).¹⁴⁶ Some government-affiliated foundations focus on R&D and others make policy recommendations, but none focus on biotechnology.

To fill the gap, Congress should establish an independent, non-profit foundation to support U.S. biotechnology product regulation. This foundation could work with the NBCO and across biotechnology regulatory agencies. Industry stakeholders have expressed interest in partnering with regulatory agencies through a foundation, including by financially supporting it. To protect against potential conflicts of interest, the foundation would have strict accountability requirements in its authorizing language.

While creating a foundation is no substitute for sufficiently funding regulatory agencies, it would significantly increase their capacity by allowing regulators to focus on regulation. A foundation would bring together experts from academia, industry, and government to share information about regulatory challenges, and suggest ways of solving them. It could also make recommendations about how regulation might incentivize innovation—for example, proposing simplified regulations for certain platforms to encourage companies to modernize their manufacturing practices.

The foundation could also help the NBCO and federal agencies with communication and outreach. For example, the foundation could offer a regulatory fellowship for innovators and others involved in biotechnology product development, including a short course on biotechnology regulation. Shadowing experiences and other interactions between developers and regulators would help developers better understand regulatory processes and help regulators understand those processes from the vantage point of developers. External fellows would not handle potentially sensitive developer data, and safeguards would address potential conflicts of interest and protect confidential business information. Eventually, programs could place federal employees in academia, industry, or trade groups for additional learning experiences.

Establish a Federal Biotechnology Regulatory Research Program

U.S. regulatory agencies need scientific information to justify simplifying regulatory pathways. In 1992, Congress established the U.S. Department of Agriculture (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program to fund research that supports biotechnology regulation, but its success has been limited. Funded by withholding two percent of the budget of USDA biotechnology research projects, the program receives only $5-6 million annually.¹⁴⁷ This amount is inadequate to meet regulatory research needs, and BRAG does not support the multi-season, multi-location studies necessary to evaluate the potential environmental impacts of biotechnology products. Furthermore, researchers who study biotechnology products outside of agriculture may not even be aware of the USDA’s programs.

Congress should establish a biotechnology regulatory research program at the National Science Foundation (NSF). To make certain that the research is targeted to regulators’ needs, the NSF should collaborate with the NBCO and regulatory agencies in designing requests for proposals. In implementing this program, the NSF should use a variety of funding mechanisms, including research grants, cooperative agreements, and temporary research consortia to ensure that researchers produce the information that regulators need to allow others to unlock innovation. If the NSF program is established, Congress should consider rolling BRAG’s responsibilities into it.

In addition, Congress should instruct the NSF to contract with the National Academies of Science, Engineering, and Medicine (NASEM) to study the safety and benefits of biotechnology tools and products relative to conventional manufacturing methods and other human activities. NASEM has conducted multiple studies related to biotechnology, but none have provided a consensus on the safety of biotechnology tools.¹⁴⁸ Such a study would yield a public source of high-quality information needed to update regulations for U.S. biotechnology products and identify any gaps in scientific information needed for regulation.