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Fda And Food Safety

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According to the FDA Web site, the U.S. food supply remains among the safest in the world. However, it also warns that threats to food safety related to importation from multiple foreign sources, the mislabeling of products, and even bio-terrorism have added to the set of existing “natural” occurrences of food contamination.



While the FDA does not have the authority to actually order food distributors to issue a recall, they frequently issue recall requests. These requests, if not heeded, can result in lawsuits which force distributors to comply. Still, the August 2004 issue of Consumer Reports states that a large percentage of products subject to recall remain in use. The reports sites one of the major reasons for this is that “companies are unable - or unwilling - to track down and notify customers” once a problem is recognized.

The consequences of your organization continuing to distribute a contaminated or mislabeled food item instead of issuing a product recall can potentially include expensive settlements (the average settlement for recall-related litigation is over $200,000), damaged customer relationships, and even loss of life. Smart companies prepare themselves in advance of a potential recall situation.

Here is a summary of a 9-step food recall plan created by a research group led by the University of Florida and sponsored by a U.S. Army Grant. By following these steps in the face of a recall situation you will be preparing yourself to act quickly and effectively:

Step #1: Make assignments from emergency checklists: “The Food Recall Manual” includes 11 checklists designed help your company organize itself properly when facing a recall situation. These steps include selecting a recall coordinator, training a spokesperson, and prioritizing risks.

Step #2: Gather evidence as to the cause: Now and in the near future, your company will be asked how it identified the need for a food recall campaign and what steps you took to enact the recall and remedy the situation. You need to think like a lawyer and gather evidence, ultimately showing that your company is being thorough and careful in its treatment of the situation. Sources of information can include external sources (e.g., brokers and distributors) and your own company records (e.g., complaint histories, accounting, consumer affairs, and distribution departments).

Step #3: Analyze the evidence and work with FDA on classification: Next, your team needs to make a determination as to the severity of the threat posed by your contaminated or mislabeled food product. The FDA has a three-level classification system, from Class I (most severe) to Class III (least severe).

Step #4: Get the word out: Good crisis communication on behalf of your company can make the difference between a small business disruption and going out of business. Key points to consider: determine the right audience, decide the best way to get your message out, and give enough detail. Be sure to limit the information you provide only to that which you know to be true.

Step #5: Monitor the recall: You may be asked in the future by both the regulatory agency overseeing your recall effort and by lawyers representing various affected parties to show adequate documentation of your food recall effort. Be sure to keep detailed records of information such as the number of consignees contacted, the dates and methods used to contact them, and the total quantity of product that has been accounted for so far.

Step #6: Dispose of the product: Before disposing of the recalled product, be sure to notify the FDA or other overseeing agency about your plans. It can also be wise to have a member of that agency witness the disposal effort to show them that your effort is thorough and being executed properly.

Step #7: Apply for termination of recall: At the appropriate time, your company may request that the recall effort be terminated. In order to do this, you will need to get permission from the FDA or other agency involved in your case.

Step #8: Assemble recall team and debrief: Once the recall effort has ended, be sure to assemble your team to review what happened and determine how to avoid future problems. In particular, you should rate yourselves on the effectiveness and efficiency of the recall effort in order to be better prepared for future recall situations.

Step #9: Prepare for legal eventualities: A variety of civil or criminal charges may arise as the result of a food product contamination situation. Customers can make a range of claims, including strict liability (in which case there is no burden of proof placed upon the client), punitive damages, and class action lawsuits.

Once you have set a recall effort into motion, your company can potentially minimize the legal, financial, and health-related impacts of the problem by preparing yourselves ahead of time to identify the threat, notify customers, and document your efforts meticulously.

Source: “The Food Recall Manual,” University of Florida IFAS Extension
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