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FDA to Begin “Intentional Adulteration” Inspections in March 2020

The U.S. Food and Drug Administration announced on 17 April that routine inspections to verify compliance with the Food Safety Modernization Act’s intentional adulteration rule will begin in March 2020. The FSMA was signed into law on 4 January 2011 and the FDA has been working to develop a final rule on intentional adulteration to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Food defence is defined as the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting or other illegal, intentionally harmful means. Food defence activities had been voluntary but they will now be required on a staggered basis beginning with large firms. The FDA acknowledges that “the IA rule represents new regulatory territory for all of us.”

Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment. Food defence differs from food safety, which seeks to prevent unintentional contamination of food products such as that occurring from exposure to E. coli, Salmonella or Listeria. The final intentional adulteration rule takes a HACCP-type approach as the most effective means of ensuring that mitigation strategies are consistently applied to areas of highest vulnerability in food production.

The rule requires covered facilities to prepare and implement a written food defence plan that includes:

  • a vulnerability assessment, including required explanations, to identify significant vulnerabilities and actionable process steps;
  • mitigation strategies including required explanations;
  • procedures for monitoring the implementation of the mitigation strategies;
  • procedures for food defence corrective actions; and
  • appropriate training and records maintenance for food defence monitoring, corrective actions and verification activities.

Larger businesses will be subject to the rule on 26 July 2019, with FDA enforcement efforts beginning in March 2020, while small businesses employing fewer than 500 people have until 27 July 2020 to comply. Very small businesses (roughly described as firms with less than US$10 million in annual sales) are exempt from most of the requirements but by 26 July 2021 they must document that they meet the exemption requirements. The rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic Act. Facilities outside the United States are subject to the same coverage criteria as U.S. firms if they export food to the United States. The rule does not apply to farms.

Ryan Newkirk, senior advisor for intentional adulteration at the FDA, said that companies have significant flexibility in choosing the most appropriate mitigation strategies as the FDA does not specify the preventive steps that must be pursued. According to Newkirk, there are instances where technology-based strategies may be the best way for a facility to reduce a significant vulnerability while, in other instances, a strategy based on personnel may be a more practical and cost-efficient strategy that still reduces the significant vulnerability.

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