In the United States, synthetic biology products are overseen by a patchwork of federal agencies, often guided by outdated and difficult-to-interpret regulations. Consequently, many innovators struggle to navigate this confusing landscape. SynBioBeta recently spoke with three biotech regulation experts, gathering their insights and practical advice to help innovators steer clear of regulatory roadblocks.
As Anastasia Bodnar, PhD, plant geneticist and biotechnology policy expert at the National Security Commission on Emerging Biotechnology (NSCEB), explains, biotechnology products in the United States are regulated by three primary agencies: the FDA, the EPA, and the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA).
Additionally, members of the NSCEB will present their latest findings at SynBioBeta: The Global Synthetic Biology Conference, taking place next week in San Jose, California, from May 6 to 8.
These three agencies operate under a national policy known as the Coordinated Framework (also referred to as the Coordinated Framework for the Regulation of Biotechnology). In 1986, the White House Office of Science and Technology Policy published the first Coordinated Framework, establishing a comprehensive federal regulatory policy for biotechnology products. The framework was last updated in 2017.
In the United States, Bodnar emphasizes that products created with biotechnology—including synthetic biology—are regulated based on the product, not the process by which they are made. In other words, a drug is regulated as a drug, a food additive is regulated as a food additive, and so on.
“However, especially when we are talking about living organisms, a product may fall under the regulatory authority of multiple agencies,” she notes. “This leads to overlaps and gaps in regulation.”
Nazish Jeffery, PhD, bioeconomy policy manager for the Federation of American Scientists and Chair of the Bioeconomy & Policy Track at SynBioBeta 2025, argues that regulatory hurdles often pose a double-edged sword for synthetic biology. “On the one hand, they promote a better understanding of the effects of a given technology on society, the environment, and agriculture before they become widely available,” she says.
However, she points out that regulations can slow down the potential for new innovations, make products more expensive, and prevent new and innovative technologies from ever coming to the market.
She notes that regulatory hurdles are especially burdensome for smaller start-up companies with one or two products. In contrast, they are less problematic for larger companies—which typically have the necessary resources to advance through the regulatory process.
“This can sometimes give larger corporations an advantage, which doesn't always align with the most innovative solutions,” says Jeffery.
Becky Mackelprang, PhD, Director of Security Programs at the Engineering Biology Research Consortium and Chair of the Biosecurity & Bioethics Track at SynBioBeta 2025, voices her concerns about the antiquated nature of the laws governing the regulation of biotechnology products. She notes that many of these laws were passed decades ago, before the current capabilities of synthetic biology were unimaginable. “Regulatory agencies are left to squint at those old statutes until they can find ways to interpret them in a modern technical landscape,” she says.
In the case of synthetic biology, Mackelprang notes that because many products are often the first of their kind, they often lack clear regulatory pathways. Even when a product is not the first of its kind, small differences in product design and development can result in entirely different regulatory processes.
Bodnar advises that regulation should be considered early in development. “This can help innovators make sound design choices that reduce unnecessary risks and ensure a product is eligible for a less challenging regulatory pathway,” she notes.
She also recommends that innovators identify similar products that have already been through the regulatory process. This may involve reviewing any public regulatory documents for those products. “Ideally, they can reach out to that company or person to ask if they used a consultant, which agencies they had to work with, and what processes they had to follow,” she advises.
Furthermore, early interactions with regulators can allow innovators to anticipate what data they need to collect during product development. “Some companies make the mistake of having to collect regulatory data after the product is mostly complete,” she warns.
Meanwhile, Mackelprang notes that regulatory agencies have worked hard to clarify their processes for developers of biotechnology products. Among other resources, Mackelprang recommends a website from the USDA called the Unified Website for Biotechnology Regulation. She also highlights an online interactive tool for researchers working on genetically modified microorganisms. Finally, the USDA has published a plain language summary that explains the Coordinated Framework in an easy-to-follow manner.
How will the current Trump Administration’s policies affect the regulatory landscape? Jeffery says that circumstances are largely unknown. “Right now, they are in the process of eliminating and removing certain regulations, but that could change at any point,” she notes.
Can we expect regulations to become laxer under a Trump Administration? “It is hard to say,” speculates Jeffery. “Some regulations may become more lenient while others, like stem cell technologies, may be tightened,” she predicts.
Mackelprang warns that the USDA may also be clamping down on some older forms of transgenic technology. She explains that several years ago, the USDA sped up the approval process for certain bioengineered crops, saving plant biotechnology companies millions of dollars in effort.
However, at the end of 2024, a judge blocked this rule (called USDA SECURE). This latest reversal of the original decision has been described as a catastrophic hurdle for researchers working on engineered crops.
Mackelprang also highlights the landmark Loper Bright Enterprises v. Raimondo decision by the U.S. Supreme Court in 2024, which gives agencies less power to interpret ambiguous statutes. “It's possible that we'll see court challenges to the ways that agencies interpret statutes and apply them to synthetic biology. There are ways in which that could be good, and ways in which, in my opinion, that would be bad,” she says.
Jeffery suggests how U.S. regulatory pathways might find a better balance in the future. For instance, the EU has benefited from regulatory sandboxes. She explains that regulatory sandboxes are supervisory frameworks established by regulators that allow firms to test innovative products and services under temporarily relaxed regulatory oversight.
Ultimately, she argues that regulatory sandboxes in the United States could facilitate better dialogue between innovators and regulators, helping products come to market faster and enabling a better regulatory understanding for the future.
Jeffery also suggests that U.S. government intervention may be necessary to reduce the perceived regulatory risks faced by the private sector when investing in emerging or highly regulated sectors. “This might involve streamlined regulatory processes or pre-certification pathways that offer greater clarity and predictability around compliance obligations,” she says. “Ultimately, this could minimize the regulatory risk and increase private sector investment in emerging technologies.”
Finally, Bodnar argues that U.S. biotechnology regulation must be streamlined to address modern products. “The need for better coordination across the agencies – including removing duplication and filling gaps—has been raised since the very beginning of the Coordinated Framework 40 years ago,” she stresses.
Lorem ipsum dolor sit amet, consectetur adip elit. Donec posuere dolor massa, pellentesque aliquam nisl facilisis sed.
In the United States, synthetic biology products are overseen by a patchwork of federal agencies, often guided by outdated and difficult-to-interpret regulations. Consequently, many innovators struggle to navigate this confusing landscape. SynBioBeta recently spoke with three biotech regulation experts, gathering their insights and practical advice to help innovators steer clear of regulatory roadblocks.
As Anastasia Bodnar, PhD, plant geneticist and biotechnology policy expert at the National Security Commission on Emerging Biotechnology (NSCEB), explains, biotechnology products in the United States are regulated by three primary agencies: the FDA, the EPA, and the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA).
Additionally, members of the NSCEB will present their latest findings at SynBioBeta: The Global Synthetic Biology Conference, taking place next week in San Jose, California, from May 6 to 8.
These three agencies operate under a national policy known as the Coordinated Framework (also referred to as the Coordinated Framework for the Regulation of Biotechnology). In 1986, the White House Office of Science and Technology Policy published the first Coordinated Framework, establishing a comprehensive federal regulatory policy for biotechnology products. The framework was last updated in 2017.
In the United States, Bodnar emphasizes that products created with biotechnology—including synthetic biology—are regulated based on the product, not the process by which they are made. In other words, a drug is regulated as a drug, a food additive is regulated as a food additive, and so on.
“However, especially when we are talking about living organisms, a product may fall under the regulatory authority of multiple agencies,” she notes. “This leads to overlaps and gaps in regulation.”
Nazish Jeffery, PhD, bioeconomy policy manager for the Federation of American Scientists and Chair of the Bioeconomy & Policy Track at SynBioBeta 2025, argues that regulatory hurdles often pose a double-edged sword for synthetic biology. “On the one hand, they promote a better understanding of the effects of a given technology on society, the environment, and agriculture before they become widely available,” she says.
However, she points out that regulations can slow down the potential for new innovations, make products more expensive, and prevent new and innovative technologies from ever coming to the market.
She notes that regulatory hurdles are especially burdensome for smaller start-up companies with one or two products. In contrast, they are less problematic for larger companies—which typically have the necessary resources to advance through the regulatory process.
“This can sometimes give larger corporations an advantage, which doesn't always align with the most innovative solutions,” says Jeffery.
Becky Mackelprang, PhD, Director of Security Programs at the Engineering Biology Research Consortium and Chair of the Biosecurity & Bioethics Track at SynBioBeta 2025, voices her concerns about the antiquated nature of the laws governing the regulation of biotechnology products. She notes that many of these laws were passed decades ago, before the current capabilities of synthetic biology were unimaginable. “Regulatory agencies are left to squint at those old statutes until they can find ways to interpret them in a modern technical landscape,” she says.
In the case of synthetic biology, Mackelprang notes that because many products are often the first of their kind, they often lack clear regulatory pathways. Even when a product is not the first of its kind, small differences in product design and development can result in entirely different regulatory processes.
Bodnar advises that regulation should be considered early in development. “This can help innovators make sound design choices that reduce unnecessary risks and ensure a product is eligible for a less challenging regulatory pathway,” she notes.
She also recommends that innovators identify similar products that have already been through the regulatory process. This may involve reviewing any public regulatory documents for those products. “Ideally, they can reach out to that company or person to ask if they used a consultant, which agencies they had to work with, and what processes they had to follow,” she advises.
Furthermore, early interactions with regulators can allow innovators to anticipate what data they need to collect during product development. “Some companies make the mistake of having to collect regulatory data after the product is mostly complete,” she warns.
Meanwhile, Mackelprang notes that regulatory agencies have worked hard to clarify their processes for developers of biotechnology products. Among other resources, Mackelprang recommends a website from the USDA called the Unified Website for Biotechnology Regulation. She also highlights an online interactive tool for researchers working on genetically modified microorganisms. Finally, the USDA has published a plain language summary that explains the Coordinated Framework in an easy-to-follow manner.
How will the current Trump Administration’s policies affect the regulatory landscape? Jeffery says that circumstances are largely unknown. “Right now, they are in the process of eliminating and removing certain regulations, but that could change at any point,” she notes.
Can we expect regulations to become laxer under a Trump Administration? “It is hard to say,” speculates Jeffery. “Some regulations may become more lenient while others, like stem cell technologies, may be tightened,” she predicts.
Mackelprang warns that the USDA may also be clamping down on some older forms of transgenic technology. She explains that several years ago, the USDA sped up the approval process for certain bioengineered crops, saving plant biotechnology companies millions of dollars in effort.
However, at the end of 2024, a judge blocked this rule (called USDA SECURE). This latest reversal of the original decision has been described as a catastrophic hurdle for researchers working on engineered crops.
Mackelprang also highlights the landmark Loper Bright Enterprises v. Raimondo decision by the U.S. Supreme Court in 2024, which gives agencies less power to interpret ambiguous statutes. “It's possible that we'll see court challenges to the ways that agencies interpret statutes and apply them to synthetic biology. There are ways in which that could be good, and ways in which, in my opinion, that would be bad,” she says.
Jeffery suggests how U.S. regulatory pathways might find a better balance in the future. For instance, the EU has benefited from regulatory sandboxes. She explains that regulatory sandboxes are supervisory frameworks established by regulators that allow firms to test innovative products and services under temporarily relaxed regulatory oversight.
Ultimately, she argues that regulatory sandboxes in the United States could facilitate better dialogue between innovators and regulators, helping products come to market faster and enabling a better regulatory understanding for the future.
Jeffery also suggests that U.S. government intervention may be necessary to reduce the perceived regulatory risks faced by the private sector when investing in emerging or highly regulated sectors. “This might involve streamlined regulatory processes or pre-certification pathways that offer greater clarity and predictability around compliance obligations,” she says. “Ultimately, this could minimize the regulatory risk and increase private sector investment in emerging technologies.”
Finally, Bodnar argues that U.S. biotechnology regulation must be streamlined to address modern products. “The need for better coordination across the agencies – including removing duplication and filling gaps—has been raised since the very beginning of the Coordinated Framework 40 years ago,” she stresses.
Lorem ipsum dolor sit amet, consectetur adip elit. Donec posuere dolor massa, pellentesque aliquam nisl facilisis sed.
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