New FDA Rules Focus on Prevention, Not Remediation

In today’s world, it is an unfortunate reality that food products can be the subject of contamination, as well as subsequent recall and litigation. This issue poses a problem to all sectors of the food industry: produce (recent salmonella found in cucumbers), beverages (e. coli found in bottled water), fresh meats (e. coli found in ground beef), and frozen desserts (listeria in ice cream and frozen treats). As has been noted by commentators, the U.S. Food and Drug Administration’s (“FDA”) policies have been largely reactive on food contamination, rather than proactive. Last week, however, FDA implemented new rules to the Food Safety Modernization Act which hold companies to more stringent standards. What are these new standards, and how may they be used in litigation?

shutterstock_228226555The compliance date for the new regulations vary, generally depending on the size of the business, between one and three years after publication of the final rule. Thus, generally, businesses with more than 500 employees and more than one million dollars in annual sales per year will have one year to comply with FDA’s new regulations. While the new regulations are lengthy and should be reviewed by food manufacturers in connection with their counsel, this blog post is intended to address a few of the significant aspects of the regulations.

First, a food manufacturer must develop a “hazard analysis,” which should consider any “known or reasonable foreseeable hazards” (such as biological, chemical, or physical hazards), as well as any “known or reasonable foreseeable hazards” which may be in food products because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain. Manufacturers must create a hazard evaluation which assesses the “severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventative controls.”

Second, a food manufacturer must implement written preventive controls to ensure that potential hazards are minimized and prevented. The required preventive controls include, as appropriate: 1) “process controls” (such as heat processing, acidifying, irradiating, and refrigerating); 2) “food allergen controls” (such as protection from cross-contact and appropriate labeling); 3) “sanitation controls” (such as cleanliness and cross-contamination); 4) “supply-chain controls”; and 5) a “recall plan.”

Third, to ensure compliance with the preventive controls, a food manufacturer must establish written monitoring procedures.

Fourth, a food manufacturer must implement written “corrective action procedures” which must be taken if the preventive controls are not implemented properly.

Fifth, a food manufacturer must verify that the preventive controls are being implemented and “are effectively and significantly minimizing or preventing the hazards.”

The regulations which will go into effect not only impact how a company manages its business, but will also have a significant impact in the unfortunate event it faces litigation as a result of food contamination. The preventive controls, which are required to be written, as well as all other written documentation, such as whether the manufacturer complied with its own preventive controls, will likely prove to be discoverable in litigation. This discovery may be relied upon to argue that a company was negligent and failed to comply with federal regulations and/or its own policies. Equally, however, these documents may prove to be helpful in showing that all proper precautions were taken, and the manufacturer acted reasonably under the circumstances. It is therefore vital for food manufacturers to proactively ensure its internal policies and procedures are modified to the extent necessary to achieve compliance with the new regulations. We here at Cozen O’Connor stand ready to help your business navigate this shift in tide.

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Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
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