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Saturday, June 04, 2016

FDA Mandates ‘Food Defense Plans’ Against ‘Intentional Adulteration Related to Terrorism’

( -- The Food and Drug Administration (FDA) released a final rule last week mandating that food-related facilities implement “food defense plans” to prevent “intentional adulteration of food” with the intent to cause “wide scale public health harm,” including “intentional adulteration related to terrorism.”

The regulation, which is the seventh and final rule of the 2011 Food Safety Modernization Act (FSMA), requires an “owner, operator, or agent in charge of a facility” that manufactures, processes, or stores food to “prepare and implement a written food defense plan.”

“Very small businesses” - defined as averaging less than $10 million in revenue per year - are exempt from the rule.

“Our interactions with the intelligence community, as well as the conclusions reached during vulnerability assessments conducted in collaboration with industry, have identified the inside attacker as the highest threat,” FDA stated.

The food defense plan must “identify any significant vulnerabilities” in the food manufacturing process that would allow an attacker to introduce foreign substances into the food, and then “implement mitigation strategies” that significantly minimize these vulnerabilities.

The FDA identified “four key activity types” – “bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities” – that leaves food “at high risk of intentional adulteration caused by acts of terrorism.”

Suggested mitigation strategies include adding locks and barriers to restrict physical access to food supplies, use of a “buddy system” to prevent employees from adding anything to the food undetected, and “food defense awareness” training for employees present at vulnerable steps in the process.


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