Seeds of Innovation: Insights for Startups
Cassie Edgar
By Cassie Edgar
In today's dynamic agricultural landscape, a proactive and well-defined regulatory and intellectual property (IP) strategy isn't just a compliance exercise – it's a core driver of business growth for agtech companies.
As the U.S. seed sector embraces innovations like CRISPR-based genome editing and advanced trait stacking, navigating the complexities of federal oversight is critical. This challenge is amplified by the fact that U.S. regulatory bodies, often short-staffed and grappling with rapidly evolving technologies, are challenged to timely respond and review these latest agricultural advancements.
For startups and established players alike, a deep understanding of the regulatory environment, coupled with a robust IP strategy, is essential to unlock opportunities, mitigate risks, and secure a competitive edge in the agtech market.
The Current Regulatory Framework: USDA, EPA, and Beyond
Although commodity crops require a global framework of regulatory approvals in order for growers to plant the seed in the United States, most companies start with seeking U.S. approvals.
One of the most notable updates to the U.S. regulatory framework for biotechnology crops came with the USDA’s SECURE Rule (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient). Phased in beginning in 2020, SECURE represents a shift in the way USDA’s Animal and Plant Health Inspection Service (APHIS) evaluates genetically engineered crops. Under this framework, certain gene-edited plants —particularly those that could otherwise be developed through conventional breeding — may be exempt from rigorous regulation if they meet specific criteria.
This relative regulatory relaxation for some gene-edited crops opens a door for startups seeking rapid field testing and commercialization. However, it also introduces a host of legal and strategic considerations. It’s essential to confirm whether a startup’s product qualifies under the exemptions. Not all gene edits are treated equally; modifications that involve the insertion of foreign genetic material could still trigger a regulatory review. In positive news, on March 3 the USDA just resumed accepting petitions for nonregulated status according to APHIS biotechnology regulations at 7 CFR part 340.
Often overlooked, the U.S. Environmental Protection Agency (EPA) also has put out guidelines related to gene edted plant-incorporated protectants (PIPs) — traits engineered into plants to combat pests or diseases. With the advent of novel RNA interference (RNAi) technologies and other innovative crop protection methods, the EPA will likely or clarify oversight in the coming years. Close monitoring of EPA guidelines during development is critical for companies developing pest-resistant crops, such as navigating potential pre-market approvals, labelling and usage restrictions is a complex but necessary step toward product launch.
In addition, the U.S. Food and Drug Administration (FDA) oversees food safety evaluations for biotech crops intended for human consumption. While the FDA’s review process can be relatively straightforward— sometimes guided by voluntary consultations — startups should not underestimate the need for robust safety data and traceability. A well-defined strategy from the outset can help avert bottlenecks down the road.
CRISPR-based gene editing is no longer a theoretical possibility; it’s a mainstay of research and development in agriculture. Anticipate that as new editing techniques emerge — like base editing or prime editing — regulatory agencies will refine rules around what qualifies for exemption under USDA and EPA rules, or what demands further scrutiny. Track these changes closely because it could mean the difference between a streamlined path to market and more rigorous data submission requirements.
With climate challenges mounting, there is increasing attention from policymakers on seeds that offer drought tolerance, heat resistance, or improved carbon sequestration. While the U.S. has yet to create dedicated regulatory incentives for these climate-smart traits, future updates could expedite approvals or offer distinct pathways for crops with clear environmental benefits. Stay up to date and engaged in Farm Bill discussions, USDA innovation grants, and potential tax incentives to maintain an edge in shaping and responding to emerging policies.
Given the evolving nature of U.S. oversight, it’s crucial for early-stage seed enterprises to build a framework that anticipates changes rather than merely reacts to them. However, regulatory green lights are one step in commercialization — but public acceptance is the final hurdle. While pesticide-resistant crops drew scrutiny due to concerns over chemical usage, there was high hopes that gene editing would eliminate any concern, based on the scientific logic that the changes made could be the same as would be accomplished with conventional breeding. However, this science-based messaging has not eliminated risk that once a product receives market authorization, consumers will choose not to buy it.
There is a patchwork of consumer opinions on gene-edited food products, often influenced by messaging around GMOs. As public awareness grows around the differences between transgenic and gene-edited approaches, expect more nuanced dialogue and labeling debates. Whether labels are required or not is not the driving factor, as “non-gene-edited” labeling could result in de facto labeling of gene edited products even if they meet regulatory exemption criteria. Startups should be prepared with transparent communication strategies and data-driven evidence of safety and benefits.
To thrive in this changing environment, agtech companies should consider the following strategies:
1. Map your regulatory path early: From day one, assess whether your product falls under USDA’s (and EPA’s if a PIP) exempt categories for gene editing. If not, familiarize yourself with the data collection, environmental risk assessment, and possible consultation routes. Engaging with regulators or seeking informal guidance can clarify gray areas — especially when your technology sits on the cutting edge.
2. Invest in R&D: With continued focus on seed diversity and competition, prioritize developing innovative, resilient seed varieties.
3. Develop evergreen launch plans: Although it’s easy to focus on the R&D side, consider how your seeds will be produced, distributed, and used. Will growers need special licensing or stewardship agreements? If your crop is for export, how do international regulations align with U.S. standards? Mapping out these downstream considerations helps build credibility with investors, regulators, and potential partners. Keep abreast of policy changes and participate in public comment periods when new regulations are proposed.
4. Collaborate: Startups often benefit from strategic partnerships with established companies or universities that hold IP assets (such as gene editing IP) crucial to the business. Consider partnerships with research institutions, seed companies and consumer groups to foster innovation and maintain competitiveness.
5. Strengthen IP Strategies: As the legal landscape shifts and regulatory data continues to be reviewed by the patent office, companies should review and adapt their intellectual property strategies to protect their innovations effectively.
The U.S. seed industry is entering a period of significant change, driven by policy initiatives aimed at increasing competition and transparency and propelled by the promise of gene editing and the urgency of agricultural innovation. For startups, understanding the nuances of USDA’s Farmer Seed Liaison and Competition Framework, SECURE Rule, EPA’s evolving stance on new pest-resistance traits, and FDA’s food safety oversight is paramount.
By staying informed, engaging with regulators, adapting to new frameworks, and proactively managing IP and regulatory strategies, agtech companies can navigate these changes successfully and continue to drive innovation in the sector. For commercial success, regulatory compliance is only one piece of a needed broader mosaic that includes IP protection, consumer engagement, and scalable business strategies.
About The Author
Cassie J. Edgar, partner at McKee, Voorhees & Sease, PLC Cassie Edgar is a scientist and a registered patent attorney who represents both startup and publicly traded companies around the world in IP, regulatory, licensing, and corporate law matters. Cassie has extensive experience securing regulatory authorizations for agricultural technologies, protecting IP, and enabling research collaborations. For 14 years, she served as IP Counsel, Sr. Regulatory Counsel, and Director at Pioneer DuPont (now Corteva).
Editor's Note: This article is part of an editorial series in partnership with AgTech PR.