June 30, 2014

Focused Mitigation Strategies to Protect Food against Intentional Adulteration

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Department of Health and Human Services
Regulatory Identification Number
Reportcard Final Score
13 / 30 (43.3%)
Rule Publication Date
Public Interest Comment Filed Date
Comment Period Closing Date

The proposed “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” rule is intended to supplement four previous bioterrorism rules to reduce the probability of a successful terrorist act involving processed food.1 Congress mandates an essentially redundant regulation while paying no attention to the identified threat of intentional contamination through the mechanism of foot and mouth disease, which could cost the US economy in excess of $10 billion.

Apparently extending the reasoning of other parts of the Food Safety Modernization Act, which uses Hazard Analysis Critical Control Point (HACCP) principles to address non-intentional contamination of food, Congress instructed the FDA to apply HACCP principles to terrorism. The FDA discusses four relevant points about this rule: 

  1. Between the FDA and the food industry, there have been massive efforts to address food terrorism in the recent past.2
  2. The FDA is “further challenged by the paucity of the data on the extent to which facilities have already implemented programs to mitigate this risk . . . ”3
  3. This type of rule is “without precedent.”4
  4. The FDA provides evidence that there have been previous cases of intentional contamination of food, but there have been no large, terrorist-inspired intentional contamination events that this rule would address.

Given the uncertainty of the underlying risks that remain after all these efforts, the uncertainty as to which preventive controls are already in place, and the uncertainty about whether this rule might be effective in any fashion, this seems to be a case where it makes more sense to find out what the industry is doing and to test the design requirements (if necessary) before going forward to a final rule. Otherwise, given the massive expenditures and completely uncertain benefits, this rule can at best be characterized as “speculative precaution.” At a minimum, the FDA should put forward the least burdensome, most targeted regulation possible until there is more information.

The options discussed below would call for a much more targeted regulation to high-value food industries, particularly larger facilities that make non-shelf-stable foods (so that much of them would be consumed before detection). 

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