Avoiding regulatory landmines in recall situations
Meat and poultry establishments often learn very hard lessons when going through a recall. Most recalls are high-pressure situations where the Food Safety and Inspection Service (FSIS) expects decisions to be made very quickly. Mistakes made in these pressure-cooker situations can be costly and often not reversible. Below are a few common examples of mistakes establishments make during a recall situation.
The first mistake many establishments make in recall situations is not consulting with outside regulatory experts in timely manner. Too often, companies wait until the very last moment — often right before the FSIS Recall Committee’s call with the company — to request the assistance of an outside regulatory expert. Even if the regulatory expert is able to get up to speed on the facts to adequately represent the company’s interests, it may be too late, as in most cases the FSIS Recall Committee has already made its decision regarding the need for a recall. If an establishment believes a recall is unnecessary or the scope should be limited, and it believes it needs assistance to make these arguments to the agency, it is imperative for the regulatory experts to be engaged as early as possible in the process. This ensures the regulatory expert has the maximum time to work with the establishment to develop the necessary arguments and present them to the committee for consideration before members decide on a recommendation.
A second common mistake is failing to appeal committee decisions that are not warranted. While most committee decisions are legally and factually supportable, there have been occasions in which it has overstepped its bounds. Unfortunately, many companies do not understand they have the right to challenge the committee’s decision by appealing to the Assistant Administrator of the Office of Field Operations, the Administrator and to the Under Secretary for Food Safety, in that order. Although the time given to exercise the appeal process may depend on the health hazard presented and could be necessarily very short, establishments should understand they have the right to appeal any agency decision as long as it is exercised in a timely manner. Note: Any appeal will be futile if the establishment has already agreed to conduct a recall with the recall committee, only to have second thoughts later about its decision. As I have told several clients, once an establishment has agreed to conduct a recall, the ship has sailed.
A third common mistake is rushing to notify the agency of a possible recall situation before the establishment has gathered all the facts. Admittedly, establishments are required under 9 C.F.R. § 418.2 to notify the agency within 24 hours of learning or having reason to believe that it has shipped or received adulterated or misbranded product in commerce. But many establishments rush to notify FSIS of a potential issue without utilizing the time period afforded by law to fully investigate the facts and determine the scope of the product implicated. The last thing an establishment would want is to agree to a recall only to learn later the recall was unnecessary or the scope of the recall was too small, thus making it necessary to expand the recall, which would include FSIS issuing another press release.
The final common mistake worth mentioning is the failure of companies to follow their recall plans once a recall is initiated. Often, this leads to problems such as inconsistent notifications to customers, the failure to conduct effectiveness checks with customers and the failure to request termination of recalls in a timely manner. Some of these problems can lead to FSIS asserting that an establishment had an ineffective recall. If the plan is not specific enough so that establishment employees know exactly what to do, the plan should be revised. At a minimum, the recall plan should provide detailed instruction on who is involved and how the recall decision is made, how the scope is determined, how the recall should be implemented and how to determine the effectiveness of a recall. Recall plans should also be reassessed after each recall and updated as necessary.
The above mistakes are just a few common mistakes establishments make when faced with high-pressure recall situations, but they are typically the ones that prove the most costly. Learn from the mistakes of others and make sure you do not repeat them. NP