FSMA Enforcement: Focus on Inspections ABA Food & Supplements Workshop Maile Gradison Hermida Hogan Lovells US LLP June 9, 2015

FSMA Inspection Impacts for Industry Phased Implementation Systems-Based Inspections Escalation and Appeals

Applying the Goldilocks Principle If inspections are too lax, companies will not be driven to improve their programs If inspections are too regulatory in nature (focusing on the trees instead of the forest), FDA will not incentivize companies to develop a prevention-focused food safety culture If FDA takes a systems-based approach and phases in implementation, inspections will be just right!

Phased Implementation FDA will educate before and while it regulates Inspections and enforcement on Day 1 will look very different than in 2, 5, and 10 years With time, FDA’s expectations will increase See, e.g., seafood HACCP Some companies may consider this when planning for implementation Should programs be “good enough” on Day 1, or do they need to be at 100%?

Systems-Based Inspections What does a systems-based inspection look like? A big picture assessment, looking at Whether the facility’s relevant food safety systems are working The impact on food safety and public health It means taking a step back and looking at the forest (total systems), not just the trees (non-conformities) Approach is driven by questions and analysis

Systems-Based Inspections What would inspections look like if a systems based approach is used? Seek to understand the company’s food safety programs (e.g., sanitation, allergen control, environmental monitoring) Ask questions to understand those programs and what the company is doing to implement them Look to see if the company is properly implementing the programs If there are non-conformances, consider their scope and significance Are they systemic or isolated? What is the food safety risk and public health impact?

Systems-Based Inspections What if FDA Doesn’t Take a Systems-Based Approach? Inspections will be inefficient and ineffective Agency resources will be focused on technical deviations, rather than protecting the public health Food safety could take a back seat to regulatory compliance Companies will not be incentivized to develop a strong food safety culture Food safety programs will be reactive, rather than proactive FDA will only have a snapshot view of a facility

Escalations and Appeals Recent trade association comments encourage FDA to develop a formal process for appealing inspection findings Will help ensure consistent decision-making, which is particularly important given the range of experience within FDA’s inspection cadre and large number of state inspectors Allows FDA to helps monitor inspector understanding and application of agency policy, as well as track-and-trend enforcement Reinforces training for systems-based inspections

Conclusion Considerable changes to inspections are coming under FSMA FDA’s approach to FSMA inspections will determine whether the law is a success A systems-based approach is essential Industry should develop a mechanism to share inspection insights as FSMA implementation progresses

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