FDA Tackles Terrorism and Adulteration

Focused mitigation strategies. For each actionable step, facilities are required to identify and implement strategies to insure the vulnerability will be significantly minimized or prevented and the food will not be adulterated. The Food Defense Plan must not only identify these strategies, but also explain how they sufficiently minimize or prevent the vulnerability and will be monitored. In the event of a breakdown, corrective procedures must be identified in the Food Defense Plan.

FDA also requires companies to verify and document what has been done and verify that corrective actions are made by qualified individuals. The agency specifically requires a regular review of the monitoring and corrective action records to insure that they are complete, the activities reflected in the records occurred in accordance with the Food Defense Plan, that mitigation strategies are being properly implemented, and that appropriate decisions were made. FDA also requires that the Food Defense Plan include a description of these verification activities, and that records be created documenting the verification procedures.

Are There Exemptions?

Yes, based on size of the business and type of food being processed. Larger businesses covered by the rule may develop a Food Defense Plan that covers only a portion of a facility or certain product lines. Those that average less than $10 million annually qualify as “very small businesses” and are generally exempt.

The rule does not apply to farms covered by FDA’s Produce Safety Rule. It also does not apply to 1) the packing, re-packing, labeling, or re-labeling of food where the existing container of the food remains intact; 2) the holding of food (except the holding of food in liquid storage tanks); 3) most alcoholic beverage manufacturing; 4) on-farm manufacturing, processing, packing, or holding of eggs or game meats by small or very small businesses that conduct only those activities; or 5) animal foods.

When Are the Deadlines?

The Food Defense Rule is currently in effect, however, FDA is deferring enforcement in order to give businesses time to adjust to the rule and implement the necessary changes. Large businesses must be in compliance within three years, small businesses (those with less than 500 employees) have four years, and very small businesses have five years.

What About Public Relations and Legal Liability?

Before a crisis. There is a truism in Crisis & Reputation Management: “The best time to do damage control is before damage happens.” By addressing matters up front, you limit or eliminate any legal liability. Do not do the bare minimum. When safety and security are at stake, err on the side of caution. Your actions will demonstrate that the public’s well-being is your top priority, and this earns you invaluable goodwill.

It is best to be proactive. Putting controls in place in advance is a relatively modest expense with a high return on investment. They are invaluable to limit liability, or avoid it altogether.

Too often, people and companies think bad things will not happen to them, make half-hearted attempts to be prepared, or procrastinate until the proverbial eleventh hour. These companies end up on the wrong side of the media and the law, playing defense while scrambling to clean up a mess they were not ready for.

With the Food Defense Rule, your legal risks are greatest if someone gets hurt and you’ve failed to take appropriate action. FDA discussed just such a case—a 2013 incident in Japan involving an employee who poisoned seafood, resulting in at least 2,843 people getting sick and the recall of 6.4 million packages of frozen seafood.

In addition to possible fines, criminal penalties, and the FDA’s ability to suspend your food registration and put you out of business, you could face class action or individual lawsuits where the plaintiffs’ lawyers will argue that you intentionally failed to follow the law to save money in support of higher damage awards.