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What (else) is missing from the proposed rule for intentional contamination (Part 2)

Missing from the proposed FSMA (Food Safety Modernization Act) rule on intentional contamination is any requirement for "broad mitigation strategies."  In this article we will explore the implications that has on protecting our "actionable process steps."

In part 1 of "what's missing" we described that there is no requirement to focus on disgruntled employees or competitors in the proposed rule.  The focus instead is on terrorists or others with an intention to "cause massive public health harm." 

 

What is missing from the proposed rule for intentional contamination (Part 1)

The rationale appears to be the same in excluding any requirement for broad mitigation strategies, instead focusing only "targeted mitigation strategies" on those "actionable process steps" where there is the most risk of a contamination that could cause massive public health harm.

Broad mitigation strategies are those common and general measures that help to protect the entire operation.  They are not usually unique to one kind of food or to particular process steps.  They serve to reduce the overall accessibility or vulnerability of the operation.  Examples include an outer perimeter fence, locked doors, employee screening, visitor check-in procedures, and color-coded uniforms.

"Actionable process steps" and "focused mitigation strategies" are related to specific points in your operation that have a significant vulnerability.  They are discussed further in our two article on vulnerability assessments.

I think that not requiring broad mitigation measures is a mistake, putting our actionable process steps at even higher overall risk.  This can best be understood in the context of a military doctrine called "Defense in Depth: Layering Multiple Defenses."  An example from my Navy background might help:

An aircraft carrier task force's most critical asset is the aircraft carrier itself.  It is surrounded miles ahead by submarines and aircraft cover.  Closer in, there are destroyers and cruisers protecting the carrier.  The carrier itself has point defenses - guns and missiles it can use for its own defense.  An enemy must penetrate all these barriers to strike the carrier.

This Defense in Depth doctrine avoids the risk that a single point of failure could adversely affect the critical asset.  This can also be illustrated with the United States Bullion Depository (Fort Knox):

The vault is lined with granite, with vault doors 21 inches thick.  The vault sits below the fortress.  The fortress is ringed by fences and is patrolled by the United States Mint Police.  All of this sits within the military base of Fort Knox itself.  Not yet mentioned are the legions of cameras, alarms, and sensors (Wiki).

Put simply and graphically, if we focus only on the "focused mitigation measures" at the point of our "actionable process steps," it is like tearing down the fences and fortress and removing the guards around the vault at Fort Knox.  Relying only on the strength of the vault is a mistake.

Indeed, some of the broad mitigation strategies included in previous guidance documents and the Food Defense Plan Builder tool are not particularly effective against a disgruntled employee that already has access to the facility.  Fences, guards and locked doors are most effective against the very perpetrator the rule is focusing on, the terrorist that could cause massive public health harm.

At the least, I encourage the owner to continue to include broad mitigation strategies in their food defense plan.  The FDA makes this same point in their commentary, even while not requiring broad mitigation strategies.  If you must weaken your broad mitigation strategies, I hope you will do that only in marginal and sensible ways.  An example of this is to relax certain requirements like color coded uniforms, stronger background checks, or visitor control only in specific operations, like corporate offices, or remote utility systems, while keeping them in place throughout the main production environment.

 

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