November 15, 2016  -  The greatest risk for the managers of an American food business may not be that FDA (or USDA, Meat & Poultry) will somehow intervene in the business and impose massive “regulatory costs” on the business. It is also not reasonable to excessively fear the possibility of criminal prosecution, always highly unlikely except under egregious circumstances.

Rather, the greatest risk is always civil liability resulting from a Food Safety Incident which could be “discovered” in a number of ways which I will rank below in increasing order of seriousness.

First Line of Defense

But first, we need to discuss the First Line of Defense Against Food Liability– that is the HACCP Plan now called the Risk-Based Preventative Controls Plan (RBPC). Unless your company employs (either directly or as a consultant) a Qualified Individual with graduate level Food Science and Food Engineering credentials, it is highly unlikely that HACCP/RBPC Plans will fully identify and address all of the complex production control issues, including but not limited to: microbiological risk; toxicology (anthropogenic and natural poisons); toxins including mycotoxins; allergenicity; packaging (Food Contact Materials); food additives; processing aids; and prevention of physical adulteration prior to and during the processing phase. Furthermore, the HACCP/RBPC Plan must detail Pathogen Environmental Monitoring (PEM) Protocols, Sanitization Protocols, and specify statistically valid methodologies for Quality Control (QC/QA) Sampling meeting ANSI/ASQ Statistical Standards.

Ranking of Food Safety Incidents

Fortunately, most production defects are discovered before products reach consumers. A statistically valid sampling methodology – designed by a credentialed Food Scientists will capture most hazards and defects. This is particularly true when the plant design and HACCP/RBPC procedures have been reviewed by a Food Scientist with “hands-on” Food Engineering and plant management experience.

SCENARIO ONE – Lowest Danger Level

Internal Discovery Before Product Reaches Consumers – These situations are dealt with by Stock Recovery of inventory in warehouse or in transit and under company control. If Product has reached your downstream Customers but has not yet been sold to Consumers then this process is characterized as a Market Withdrawal. Again, no Product has reached the Consumer. These concepts also apply to Products that have reached Consumers, but are applied, of course, only to those portions that remain in the control of the Company or its immediate downstream Customer.

SCENARIO TWO - Discovery of Adulteration or Mislabeling After Product Reaches Consumers

This is of course most serious when the Product may cause the Illness or Death of a Human Person.  Here the Major Risks to the Company are: failure to make the mandatory RFR Report (Reportable Food Registry); failure to promptly institute Recall procedures; failure to promptly inform insurance carriers; failure to properly manage contractual Supply-Chain Indemnification Agreements and Guarantees; and failure to protect, in advance, critical information and documents from discovery in litigation.

These serious mistakes, often made by executives, not only increase civil liability liability risk to the Company, but also may invalidate insurance coverage.

Risk Mitigation Procedures and Tools

A discussion of Food Liability Risk Management Tools is beyond the scope of this brief Comment. However executives must work with an attorney who fully understands Food Liability Risk (Food Science) and the “Tool Kit” (Liability Risk Management) which includes: Product Liability Insurance (CGL Policy); Contamination and Recall Insurance (C&R); and Supply-Chain Risk Management (Indemnification Agreements and Third-Party Liability Insurance).

The time to work with counsel is before - not after - the Food Safety Incident occurs. All too often, executives fail to appreciate that internal company documentation must be protected, with careful precautions taken in advance, from discovery during litigation.

Bottom Line – Caveat Emptor

Executives should seek out an attorney with graduate level academic credentials in Food Science and Insurance Litigation experience, and great expertise in drafting Supply-Chain Agreements. It is possible to contain and control many of the risks that face American food businesses – but only if executives make wise decisions on their internal hiring and their selection of legal counsel.


Please read our 2014 article – Woodhouse, Preparing for FSMA, SciTech Lawyer, Summer 2014.

Also see our article – Woodhouse, Sanitary Transportation of Food, Food Cosmetics & Nutraceuticals, Spring 2016.

Also see our June 30, 2016 Post on our Essays Page regarding training for Qualified Individuals.

Finally, we note that a dozen or more major American research universities offer graduate programs in Food Science - and that one, Michigan State,  also offers the LLM (the advanced degree beyond a basic law degree) in Food Regulation. The list of top schools for Food Science includes: University of California at Davis, Texas A&M, University of Kansas, Michigan State, Cornell, and University of Florida among others.

I note that my law partner, Bill Shanahan, is currently completing his LLM Food Regulation at Michigan State. I am also completing my second Food Science MS degree at Michigan State - this one in Food Packaging.