The overturning of Chevron deference marks a pivotal shift in the regulatory landscape, particularly for biotechnology and agriculture technology. While the balance of power between federal agencies, Congress, and the courts could redefine innovation and safety standards in the next few years, it also presents an opportunity to encourage a more precise, evidence-based, and collaborative approach between the federal agencies, Congress, and the courts.

What Is Chevron?

The Chevron doctrine originated from the 1984 Supreme Court case Chevron USA v. Natural Resources Defense Council. The ruling established that when Congress’s laws are clear and unambiguous, both federal agencies and the courts must adhere to them. However, when the laws passed by Congress are ambiguous and allow for more than one reasonable interpretation, the courts must defer to the expert federal agencies designated by Congress to implement those laws.

The principles established by Chevron deference granted regulatory agencies considerable leeway to interpret the statutes they administer. This flexibility enabled the adaptation of regulations in response to rapid advancements in biotechnology, which enabled a more responsive regulatory framework for biotech innovations.

However, legal challenges and judicial scrutiny have called into question the applicability of Chevron deference. Opponents of the deference have argued that Chevron deference can lead to excessive agency power and can reduce accountability. This sentiment, in part, led to Chevron deference being overruled in the Loper Bright Enterprises v. Raimondo and the Relentless Inc. v. Department of Commerce cases (collectively called Loper Bright). In both these cases, the courts ruled against the National Marine Fisheries Service, citing that the agency’s interpretation of the law lacked a clear statutory basis. The Supreme Court reviewed and provided their opinion on both cases and ultimately, in a 6-3 vote, overturned Chevron. This decision highlights the need for agencies to have explicit authorization for their regulations and has led to a shift in how courts approach agency interpretations and the scope of Chevron deference. 

The overturning of Chevron will significantly reshape the authority of federal regulatory agencies in their areas of expertise, creating confusion and concern among biotechnology stakeholders. However, some see a glimmer of hope that this shift may lead to more streamlined or expedited biotechnology regulation. Fully understanding the implications of the Chevron decision on biotechnology regulation will take time, and in the interim, various stakeholders are adapting to this new landscape.

Federal Regulatory Agency Response

Federal regulatory agencies rely on their expertise in interpreting laws and regulations, aided by the Chevron Deference in the courts. However, with the recent overturning of the Chevron Doctrine and new directives limiting the authority and discretion of these agencies, they will need to adapt their operations. As the risk of increased scrutiny grows, agencies may shift towards offering guidance rather than engaging in formal rulemaking when it comes to new regulations on biotechnology products.

Unlike rulemaking, which is the official process for establishing regulations and setting standards, guidance documents provide agencies with more flexibility in outlining their views on a particular product. While guidance is not foolproof in court, it still allows agencies to offer direction to the industry based on evidence and facts.

That said, when agencies do propose formal rulemaking, the public comment period will be crucial. During this period, stakeholders can submit their feedback on the proposed rule, and agencies can use these comments to support their position in court if needed. For instance, if a significant number of stakeholders express support for the rule, these comments can be used in court to demonstrate that the agency is not overstepping its bounds, potentially helping the courts decide whether to defer to the agency's expertise in specific cases.

Ultimately, for regulatory agencies, both the guidance and rulemaking processes will become increasingly collaborative. However, it is expected that there will be some hesitation as the regulatory landscape evolves. Despite this, the shifting landscape presents an opportunity for greater collaboration, particularly among agencies involved in the Coordinated Framework for Biotechnology Regulation. The choice between issuing guidance or formal rules may facilitate better coordination, allowing agencies to work more effectively together in understanding and regulating various biotechnology products.

Public & Industry Response

As science has evolved and become increasingly complex and interdisciplinary, regulatory pathways have also become less straightforward and substantially more challenging. This has resulted in industry stakeholders not having clear insights into how new biotechnologies can and will be regulated, despite the best efforts of the Coordinated Framework for Biotechnology Regulation and the Unified Website for Biotechnology Regulation to simplify and clarify the regulatory process. Industry stakeholders have lamented about the difficulties in navigating the regulatory landscape, sometimes attributing the inability of technologies being approved due to the regulatory process. However, with the overturning of the Chevron deference, public and industry stakeholders now wonder if there is potential for the regulatory process to become much more simplified and that certain technologies could be brought to the market much faster. 

Though it’s tempting to expect rapid approval of breakthrough technologies, the regulatory process will likely proceed as usual. Established regulatory pathways, such as environmental reviews, safety assessments, and public consultations, will remain largely unchanged due to specific statutory mandates. The overturning of Chevron ultimately does not affect the core legal obligations that underlie these pathways. Ultimately, while these regulatory processes may seem cumbersome and slow, they are crucial for safeguarding both public health and the environment.

With the overturning of Chevron, judges may be more willing to challenge agency decisions, especially if there are concerns that the agencies have overstepped their legal authority or failed to properly follow statutory mandates. This shift could mean that, even after a technology has navigated the regulatory process, it may still face delays due to legal challenges that send it back for further review, potentially not only delaying its introduction to the market but also blocking it entirely.

Given this shift, it is increasingly important for both the public and industry stakeholders to actively engage in the regulatory process, particularly when responding to agencies' requests for public comment on proposed regulations, decisions, or rulemakings. By providing well-informed feedback, whether in support of or opposition to a regulatory agency’s plans or decisions, stakeholders can help ensure their views are considered during both the regulatory process and, if litigation arises, the judicial review process. When courts assess whether agencies are operating within their statutory authority, input from the public and industry can serve as evidence that agencies are following proper procedures. Public and industry perspectives are not only important for potentially shaping regulations but also for ensuring that the regulatory process is resilient to judicial review. As industries increasingly seek more transparent, adaptable, and forward-looking regulatory frameworks that can keep pace with technological innovation, they will likely press regulatory agencies to adopt approaches that align with both current scientific advancements and practical realities. Ultimately, this collaborative process will help facilitate the approval of innovative technologies that can address pressing societal and global challenges.

Legislative Branch Response

With the shifting judicial landscape, Congress may need to adopt a more prescriptive approach to legislative drafting. Chevron allowed for some ambiguity in statutes, granting regulatory agencies a degree of autonomy in interpretation. However, with the Supreme Court no longer deferring to agency interpretations, lawmakers may feel compelled to craft more detailed laws to reduce ambiguity. This could lead to clearer language, explicitly defining agency powers to minimize the risk of courts striking down agency actions or agencies exceeding their authority.

While this approach could reduce ambiguity, it may also limit flexibility. Modern regulatory issues often require flexible interpretation, and overly specific statutes could restrict agencies' ability to adapt. Congress could also increase oversight to ensure agencies adhere closely to legislative intent rather than exercising broad discretion. However, overly narrow statutes could reduce the flexibility needed to address complex, evolving challenges.

The legislative response to Chevron's overturn will also depend on the political composition of Congress. Ideological divides between Democrats and Republicans will influence how much authority is granted to agencies. For example, a more conservative Congress might limit agency powers, enacting laws that narrowly define regulatory authority. In contrast, a liberal Congress might seek to preserve agency discretion, particularly on complex issues like climate change or public health.

These political dynamics will shape how Congress approaches the specificity and prescriptiveness of future legislation. Frequent changes in the party controlling Congress could lead to inconsistency in lawmaking, with new majorities attempting to undo or reinterpret laws passed by the previous Congress. This could create political instability and uncertainty in the regulatory landscape, making it more difficult for agencies to operate effectively. As power shifts between the political branches, debates over agency autonomy and legislative authority will likely intensify, creating an unstable environment for both regulators and those subject to regulation.

Judicial Branch Response

The overturning of Chevron deference is expected to unfold through a lengthy and complex process involving significant participation from both the circuit courts and the Supreme Court. Given the political divisions within the U.S. judiciary, responses to this shift will likely vary across different circuits. Courts in more liberal-leaning regions may be more inclined to uphold broader agency discretion in interpreting ambiguous statutes, while courts in conservative-leaning regions may adopt a more restrictive approach, limiting agency authority. As a result, litigants may strategically choose where to file lawsuits, seeking out jurisdictions that align with their preferred interpretation of the law. This could create inconsistencies in how Chevron is applied across the country, leading to a fragmented legal landscape as different circuits respond to the shift in their own ways.

Ultimately, it will fall to the Supreme Court to resolve the ambiguity and inconsistency across the circuit courts. By hearing and ruling on several pivotal cases, the Supreme Court will be able to establish clear guidelines for how agencies can exercise their powers and how courts should review those actions. Until these cases are decided, however, the judicial system will face a period of legal uncertainty and potential conflict.

Overall, the overturning of Chevron represents a significant shift in how regulatory decisions are made and challenged, particularly in the realm of agricultural biotechnology and broader biotech regulation. What was once a system where courts deferred to agency expertise when statutes were ambiguous is now evolving into one where courts are more likely to intervene and provide their own interpretations. As a result, this change will likely lead to increased litigation against regulatory agencies, creating greater uncertainty in the regulatory process as agencies’ decisions are questioned more frequently. While the regulatory process is unlikely to become faster or easier, this shift offers an opportunity for public and industry stakeholders to engage more actively in the regulatory process by providing public comments as opportunities arise. The overturning of Chevron presents a unique opportunity for advocacy groups and non-profit organizations. With the increased scrutiny on regulatory agencies, these groups can advocate for the use of evidence-based, science-driven facts in the regulatory process and for increased resources to help agencies meet the growing complexity of biotechnology regulation.

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The author expresses deep gratitude for the insights provided by David Doniger and the team at H&K Law and Karen Carr at ArentFox Schiff.

‍Nazish Jeffery is the Bioeconomy Policy manager at the Federation of American Scientists and the Chair of the Bioeconomy and Policy Track at SynBioBeta 2025: The Global Synthetic Biology Conference, being held May 6-8 in San Jose, California.