Creating a Science-Based Policy for Listeria
The Ask
AFFI and its members support appropriations language that requires the U.S. Food & Drug Administration (FDA) to develop a regulatory policy for Listeria monocytogenes (Lm) in low-risk Ready-To-Eat foods that is based on the latest available science including data from a pilot program evaluating novel approaches to Lm risk mitigation. Specifically:
None of the funds appropriated or otherwise made available by this Act may be used by the Food and Drug Administration (FDA) to issue or promote any new guidelines or regulations applicable to food manufacturers for Listeria monocytogenes (Lm) until the FDA considers the available new science and supports a stakeholder-developed pilot to investigate new sampling and testing procedures for low-risk RTE foods when updating the Compliance Policy Guide (CPG), Guidance for FDA Staff, Sec. 2 55.320 Listeria monocytogenes—regarding Lm in low-risk foods, meaning foods that do not support the growth of Lm.
Background
AFFI members’ number one goal is producing safe frozen foods. To enhance food safety, AFFI advocates for incorporating the latest science into FDA regulations concerning Lm. Current FDA approaches have led to unnecessary and costly regulatory burdens that fail to add any public health benefit.
Science demonstrates that frozen foods do not support the growth of Lm and thus the pathogen poses only a remote public health risk in such foods. If FDA formalizes a Compliance Policy Guide (CPG) that establishes a zero-tolerance enforcement action limit for all food categories, irrespective of risk to the public, the agency would fail to incorporate the latest available science on Lm, contradict the global scientific consensus, and fail to adopt a modern risk-based approach to food safety as mandated by Congress in the Food Safety Modernization Act (FSMA).
Furthermore, if zero tolerance on low-risk RTE foods continues, there will be significant negative impacts on business operations that include:
- Increased Regulatory Burden Without Public Health Benefit: Applying the same standard across all foods regardless of risk creates costly compliance requirements that do not improve public health outcomes.
- Difficulty Implementing Risk-Based Decision Making: Companies are obliged to focus on end-product testing, rather than directing their attention towards risk-based preventive controls, collecting vital data, and prioritizing food safety investments and tailored strategies.
- Unnecessary Food Waste: Finished products are destroyed based solely on the presence of Lm, treating all foods bearing equal risk, even where science demonstrates otherwise.
- Competitive Disadvantage Globally: U.S. manufacturers of low-risk RTE foods are held to a one-size fits all standard whereas international regulations apply a science-based threshold. (e.g., 100 CFU/g for low risk RTE foods that do not support Lm growth).
AFFI has proposed an industry pilot in partnership with global Listeria experts, food industry professionals, and consumer stakeholders. The proposed Listeria pilot would be undertaken by food facilities processing low-risk foods, with the objective of collecting critical data and information related to verification of Listeria control programs, i.e., environmental monitoring and finished product testing. This science-based approach is intended to allow facilities to apply aggressive ‘Seek and Destroy’ practices to address Listeria harborage.
The Impact
By supporting novel, risk- and prevention-based regulatory approaches, in alignment with FSMA, FDA will enhance public health outcomes and demonstrate global leadership in food safety