On FDA’s Proposed Rule on Intentional Adulteration

FDA released its proposed rule on intentional adulteration of food in a December 24 Federal Register notice. The proposed rule, Focused Mitigation Strategies To Protect Food Against Intentional AdulterationFocused Mitigation Strategies To Protect Food Against Intentional Adulteration, would apply to both domestic and foreign facilities that are required to register with the agency and would require those companies to develop and implement a food defense plan.

The proposal introduces some terminology that may initially cause confusion among stakeholders. For example, the term ‘‘actionable process step,’’ is the food defense counterpart of the familiar term ‘‘critical control point’’ (CCP) used in Hazard Analysis and Critical Control Point (HACCP) plans. HACCP per se does not appear in the language of FSMA, which instead allows hazard analysis and preventive controls to be achieved by any means that can be shown to be effective. For the purposes of food defense, we will need to become familiar with the term ‘‘actionable process step,’’ which is a step identified during a vulnerability assessment. A vulnerability assessment, meanwhile, is similar to the hazard analysis conducted in developing a HACCP plan.

Yet another key term, “significant vulnerability,” is the food defense version of the term “reasonably likely to occur” which is used in the preventive controls proposed rules.

In many situations it may be difficult to say what constitutes a significant vulnerability. This is also an issue in the preventive controls rules, where what may or may not be “reasonably likely to occur” is a challenge for the regulators to sharply define. The agency defines a “significant vulnerability” as a vulnerability for which “a prudent person knowledgeable about food defense would employ food defense measures because of the potential for serious adverse health consequences or death and the degree of accessibility to that point in the food process.”

The agency has identified four key activity types as being especially vulnerable to intentional adulteration: bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities. But the agency is open to ideas about what other types of products and facilities may be vulnerable. Judging by the number of questions asked in the proposal, it is clear that even some fundamental elements of the proposal may be open to change before a final rule takes shape.

As proposed, the rule includes numerous exemptions. For example, it would apply to food in liquid storage tanks, but not to the holding of food in general. It would not apply to the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact, the agency says. It would not apply to activities of a facility that are subject to produce safety standards. With some exceptions, it would not apply to alcoholic beverages at a facility that meets certain conditions. And it would not apply to the manufacturing, processing, packing, or holding of food for animals.

The proposed rule would not apply to a “qualified” facility. Qualified facilities would include very small businesses, with less than $10 million in annual sales of food. But some companies could be deemed “qualified” if during the preceding 3-year period the average annual value of the food manufactured, processed, packed or held at the facility sold directly to qualified end-users exceeded the average annual monetary value of the food sold by such facility to all other purchasers, and if the average annual monetary value of all food sold during the preceding 3-year period was less than $500,000.

The agency is seeking comments by March 31, 2014 on the proposed exclusions – and, of course, on all other elements of the proposed rule.

Posted in 2014, 2014 January, FSMA Perspective.