FDA issues final guidance doc on intentional food adulteration

The FDA has issued the last of three promised guidance documents on the intentional adulteration of food, ahead of inspections that are due to start next month.

The Food Safety Modernization Act (FSMA) – signed into law by former US President Barack Obama in 2011 – called for the US regulator to help the food industry defend against intentional adulteration, including by acts of terrorism.

The three guidance documents are intended to help food facilities implement a food defence plan that identifies vulnerabilities in their in their plants and supply chains, sets out mitigation strategies to close them down, and the steps to make sure those strategies remain effective.

The latest draft guidance document has chapters covering “food defence corrective actions, food defence verification, reanalysis, and recordkeeping,” according to the FDA.

The first four chapters of the guidance were published in June 2018 and addressed how to set up a food defence plan and carry out vulnerability assessments, with preliminary guidance on mitigation.

A second document published last March extended the information on vulnerability assessment and other topics including staff training.

The latest instalment also includes appendices on FDA’s online Mitigation Strategies Database and how businesses can determine their status as a small or very small businesses under the rule.

Compliance requirements for large facilities began in July 2019, but the FDA opted to delay enforcement until this year at the request of industry.

Small business have a compliance deadline of four years after the publication of the final rule (July 26, 2016), while very small business have five years.

“Today we issued a supplemental guidance for industry to support compliance with this rule and took another meaningful step in ensuring that our food supply remains among the safest in the world,” said Frank Yiannas, the FDA’s deputy commissioner for food policy and response.

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