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FDA Publishes Proposed Rule for Intentional Contamination

The FDA proposes a new food defense rule under the Food Safety Modernization Act (FSMA) to address intentional adulteration of food.  The proposed rule was filed December 20 and posted online on December 24, 2013.


The FDA will hold a public meeting on the Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.  The meeting will be held in Colleg Park, MD on February 20, 2014.


As we anticipated, the rule would require written food defense plans.  It would include tiered compliance dates based on facility size.  It would apply to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act.


Businesses would have between one and three years following the publication of the final rule to comply.  This would depend on the size of the business.  There are certain excepted businesses including farms or other food facilities not required to register under section 415 of the FD&C Act.  Other types of facilities with exemptions or modified requirements:

  • Very small businesses (less than $10,000,000 in total annual sales of food).
  • The holding of food, except the holding of food in liquid storage tanks.
  • The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact.
  • Activities that fall within the definition of "farm."
  • Manufacturing, processing, packing or holding of food for animals.
  • Alcoholic beverages under certain conditions.


Interestingly, the proposed rule provides two methods to determine "actionable process steps," those process activities most vulnerable to large scale adulteration.  One method is to perform a facility-specific vulnerability assessment.  The FDA has previously provided two tools to perform a facility-specific vulnerability assessment, the CARVER + Shock methodology and a more simple vulnerability assessment bundled in the Food Defense Plan builder tool.

The second method is to identify if any of the facility processes are among four specific key activities within the food system that the FDA has identified among the most vulnerable to large-scale adulteration, including:

  • bulk liquid receiving and loading;
  • liquid storage and handling;
  • secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and
  • mixing and similar activities.


The FDA has emphasized in its previously released tools and workshops several components of the proposed rule including the creation of written food defense plans, training, facility specific vulnerability assessments and the use of focused mitigation strategies that target the vulnerable operations.  These will come as no surprise to our clients or others that have been following the FDAs voluntary guidance materials.

Finally there are some requirements that have not been heavily emphasized in the past, but are part and parcel of most compliance programs:

  • Monitoring
  • Corrective Actions
  • Verification
  • Recordkeeping


Stay tuned for our update after we have analyzed the fine print.

What is missing from the proposed rule for intenti...


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