Food Safety Analysis, LLC



Food product recalls seem to occur with depressing frequency. Each such recall is not just a threat to public health but it also represents a serious financial hit to the food manufacturer involved. The direct costs (loss of inventory, time lost from production to prove that regulatory requirements have been met, plant downtime to allow careful inspection and operational review of all plant systems) may be easier to see than some of the indirect costs involved (loss of reputation among customers, loss of market share due to adverse publicity and higher operating costs resulting from the much increased attention from regulators).

The FDA Food Safety Modernization Act (FSMA) signed into law in January of 2011 will be implemented slowly, but surely. This new law does place new burdens upon food manufacturers regulated by FDA. For example, whereas before food manufacturers could rely upon the Certificates of Analysis provided by their suppliers, FSMA demands that food manufacturers independently verify their suppliers and any documentation they supply for the ingredients they sell to a food manufacturer.

The globalization of food production and trading has also complicated matters for food manufacturers. For example, a fertilizer or pesticide one may openly use in one corner of the globe may be viewed as a source of dire contamination elsewhere on the planet. Yet, how many food manufacturers know the provenance of their ingredients in enough depth to tell you what fertilizers and pesticides were used (let alone their application schedules) to produce each of the ingredients they use to make their products? On the other hand, it is not a trivial question to ask how much testing a food manufacturer may be expected to do and still produce a product his/her customers can afford to buy.

Food Safety Analysis is a consulting company both US and foreign food manufacturers may utilize to find their own best path through the regulatory matrix. FDA FSMA is a new law. Case law for it is sparse as yet. Nevertheless, given the many recent food outbreaks both here in the US and abroad, there is every reason to believe that the the legal community will soon redress this deficiency. Anyone who thinks that regulatory affairs compliance and laboratory testing are expensive should consider the alternative costs of litigation.

Copyright © 2012 by M. Mychajlonka, Ph. D.