Chevron Deference Decision: What It Means for FSMA 204 and Food and Beverage Manufacturers
Eric Edmunds, JD
The recent U.S. Supreme Court decision to overturn Chevron deference marks a pivotal shift in how federal regulations are interpreted and enforced. Historically, the Chevron doctrine provided regulatory agencies like the Food and Drug Administration (FDA) with leeway in interpreting ambiguous statutes. With this doctrine overturned, courts will now play a more active role in reviewing and interpreting regulations independently of the agencies. For food and beverage manufacturers, this change raises questions about how regulatory standards, particularly the Food Safety Modernization Act (FSMA) and FSMA 204, will be enforced in the future. This article breaks down what Chevron deference is, what has changed, and what this means for manufacturers—especially in relation to FSMA 204 compliance.
Understanding Chevron Deference
Chevron deference stems from the 1984 Supreme Court case Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which established a two-step test:
Is the statute ambiguous? If the law is clear, the court must apply it as written.
Is the agency's interpretation reasonable? If the law is ambiguous, the court will defer to the agency's interpretation, as long as it's a reasonable one.
This principle gave federal agencies significant authority to interpret laws, allowing them to create and enforce rules within the framework provided by Congress.
In the context of food safety, this meant that the FDA had broad authority to interpret and implement regulations under the FSMA, providing flexibility to adjust rules as new safety challenges emerged. This flexibility extended to the interpretation of FSMA 204, a key regulation focused on food traceability for high-risk foods.
What Changed with the Recent Supreme Court Decision?
The Supreme Court’s decision in Loper Bright Enterprises v. Raimondo overturned Chevron deference, which had allowed federal agencies like the FDA to interpret ambiguous laws based on their expertise. This change means that courts will now play a more active role in interpreting statutes themselves, rather than deferring to the interpretations of regulatory agencies.
The impact of this decision on FSMA, including FSMA 204, is not expected to be immediate or drastic. FSMA is a detailed law that already provides the FDA with clear authority to regulate food safety. Still, the removal of Chevron deference means that in the future, courts may apply stricter legal scrutiny to any ambiguous terms within FSMA. This could result in less flexibility for the FDA when issuing guidance or interpreting provisions like those related to high-risk foods and traceability requirements.
Implications for FSMA and FSMA 204
FSMA grants the FDA significant authority to enact and enforce its provisions, including FSMA 204, which focuses on enhanced traceability for high-risk foods. Given the strength of the statutory language, it would be challenging to legally undermine FSMA itself. In other words, the core framework of FSMA and FSMA 204 is likely to remain stable.
One critical consideration for manufacturers is weighing the cost of waiting to see how FSMA 204 enforcement plays out versus acting now to meet compliance requirements. The advice from experts at The Acheson Group (TAG), is clear:
now is not the time to wait. With the compliance deadline approaching and the significant amount of work required to meet the rule, delaying action could be costly.
FSMA 204 compliance involves complex components such as identifying and tracking CTEs and KDEs across the supply chain, which requires substantial preparation and coordination between internal teams and external partners.
What Should Food and Beverage Manufacturers Do Now?
Given the uncertainty introduced by the Chevron ruling, food and beverage manufacturers should take proactive steps to ensure compliance with FSMA 204. Here’s how manufacturers can stay ahead:
Stay the Course with Compliance: The FSMA traceability rule is robust, and while the Chevron decision may create some uncertainty, FSMA grants the FDA strong enforcement authority. Manufacturers should continue to follow the FDA’s guidance on traceability and maintain records in compliance with FSMA 204. The work required to meet compliance—particularly identifying and tracking CTEs and KDEs—must be addressed now, rather than waiting for further regulatory developments.
Internal and External Assessments: Begin by conducting an internal assessment to determine what traceability systems and processes you have in place. Identify gaps and areas that need improvement to meet FSMA 204 requirements. Additionally, evaluate external conditions by identifying key stakeholders in your supply chain who must participate in compliance efforts. FSMA 204 involves more than just the food safety team; it requires collaboration across supply chain management, IT, and other departments to ensure that traceability data can be effectively managed and shared.
Leverage Technology for Traceability: Implementing digital systems is essential for meeting FSMA 204’s traceability requirements. Electronic records are crucial for ensuring that data can be organized and shared quickly between departments and with external partners. While not an end-to-end traceability tool, SafetyChain’s digital plant management platform can help streamline compliance by providing real-time compliance verification on the plant floor and comprehensive records management. By digitizing processes, manufacturers can not only comply with current regulations but also stay prepared for any changes in enforcement that might arise from the Chevron ruling.
Prepare for Potential Legal Scrutiny: While FSMA and FSMA 204 are unlikely to face legal challenges that would overturn them entirely, specific provisions could be subject to stricter legal interpretation. To mitigate this risk, manufacturers should ensure that all traceability documentation is thorough and up to date. By maintaining comprehensive records and ensuring that all components of traceability data are properly documented, manufacturers can protect themselves against potential legal disputes regarding FSMA 204 compliance.
Looking Ahead: What Does This Mean for Food Safety Regulations?
The overturning of Chevron deference signals a new era in how courts will interpret regulations, with potentially less deference to agency discretion. For food safety regulations like FSMA 204, this could mean more precise legal interpretations but also a reduced ability for the FDA to adapt regulations based on evolving industry practices. Moving forward, manufacturers should expect clearer but possibly stricter enforcement of FSMA’s provisions.
Despite some uncertainty in the regulatory landscape, the key takeaway for food and beverage manufacturers is clear: compliance with FSMA 204 remains critical, and waiting to see how enforcement plays out could be costly. By leveraging digital tools and ensuring close collaboration across internal departments and external partners, manufacturers can ensure they remain compliant and well-prepared for any regulatory shifts.
