FDA Sets Out to Fight Food Terrorism with New Rule: 3 Takeaways for Food Facilities

“[T]he rules would provide an uncertain level of protection from an admittedly very unlikely occurrence, at a significant cost to industry.” (John Moore of Venable)

Late last year, the Food and Drug Administration announced that it was joining the fight against terrorism with a new rule aimed at protected food from intentional contamination. The background, from attorney Marc Sanchez:

“The FDA has identified four key activities within the food system that are most vulnerable to such forms of adulteration. They include:

  • bulk liquid receiving and loading;
  • liquid storage and handling;
  • secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and
  • mixing and similar activities.”

Three takeaways for food facilities:

1. Implementation likely to be complicated:

“FDA does a decent job of mapping out the specifics and exclusions, but long-term implementation is likely to be complicated. Ensuring that food defense plans mesh successfully with existing business needs and production controls will no doubt be challenging. FDA has deemed a variety of specific production steps and facility locations ‘significant vulnerabilities.’ This list and its administration are likely to be the subject of debate and disagreement, and could lead to many future meetings between individual producers and FDA over the adequacy of ‘mitigation strategies’ and their execution.” (Cary Greene of Davis Wright Tremaine)

2. Potentially high cost of compliance:

“Once the actionable process steps at a facility are identified and documented, the next step is to develop focused mitigation strategies to reduce the vulnerability at each such step. […] Additional requirements under the proposed rule would include: (1) development of a written monitoring plan to check that the focused mitigation strategies are being properly implemented; (2) development of a corrective action plan describing steps to be taken in case monitoring reveals that implementation has not been effective; (3) verification of corrective action, implementation, and effectiveness; and periodic reanalysis of the food defense plan; (4) employee training on food defense awareness and responsibilities; and (5) recordkeeping, retention, and disclosure to the FDA upon request.” (John Moore of Venable)

3. Staggered rollout based on size of business:

  • “Very Small Businesses: A business that has less than $10 million in total annual sales of food would have to comply within three years after the publication of the Rule.
  • Small Businesses: A business employing fewer than 500 persons would have to comply two years after the publication of the Rule.
  • Other Businesses: A business that is not small or very small and does not qualify for exemptions would have to comply one year after the publication of the Rule.” (Jonathan Havens, Robert Hibbert, and Tony Pavel of Morgan Lewis)

The updates:

Read more on Food Safety at JD Supra Business Advisor>>