Recall Survival Guide

Recall Survival Guide: The most important information you'll (hopefully) never have to use

It's never going to happen to you, right? You have a clean plant, produce a wholesome product, and take precautions. That's what the 44 meat and poultry processors who had a recall in 1998 thought. You may not want to think about it, but way back in the corner of your mind you know that it could happen to you. Despite sound GMP, SSOP, and HACCP programs, micro testing, and conscientious employees, the risk is still there. For several reasons, every processor should have a recall plan in place:

  1. Safety and efficiency: So you are able to track and recall all potentially harmful products. To get as much harmful product as possible out of commerce to minimize health risk. Plus, a well thought out plan will save money; if you plan ahead you can consider cost-effective logistics, instead of reacting to a situation under pressure.
  2. Public relations: Let the public know that your company is concerned and is taking appropriate action. Accurately explain risks to public.
  3. Damage control: Protecting brand and company image.

I've put together some background on recall policy and provide guidelines for forming a recall plan. Think of it as an insurance policy. You'll probably never have to use it, but don't be caught without it.

Recall refers to any actions to remove product from trade or consumer channels. Most of us think of recalls as something the processor "had to do," something regulators mandated. Recall is a voluntary action undertaken by an establishment; FSIS, ODA and FDA (except in the case of baby food) do not have the authority under current regulations to demand a recall. However, if these regulatory agencies recommend a recall and the establishment ignores the recommendation, these agencies can issue press releases making the public aware of potential health risks of products. If this doesn't light a fire under management, more drastic steps follow. The USDA can withdraw inspectors from a plant, which prohibits the plant's products from being sold in commerce. Ultimately, USDA can order a shutdown and/or pursue criminal action against the plant. FDA can go through civil court to obtain authority to seize the product--technically, this is considered action against the product, not the company, but of course the end result resembles a "voluntary" recall.

Another important point--FSIS or ODA must oversee recall activities. Establishments must notify ODA within 24 hours of ordering a recall. If the recall is initiated by the processing establishment, ODA must review establishment's recall strategy. If ODA recommends a recall, it will confirm in writing ODA's determination of need for recall and include the specific violation, recall classification and recommended recall strategy.

Recall classifications

USDA (includes ODA) and FDA classify recalls into three categories:

    Class I - reasonable probability that product will cause death or serious health problems

    Class II - remote probability that product will cause serious health problems; or products that could cause temporary, reversible health problems

    Class III - Product is not likely to cause serious health problems

ODA Position on Product Recall

The Ohio Department of Agriculture's Division of Meat Inspection has announced that they will request a Public Notification/Recall where food-borne pathogens are found in product that has been placed in distribution or offered for sale. They are particularly concerned with pathogens, such as Listeria monocytogenes, which is more of a concern in Ready-to-Eat (RTE) meat products.

Inspection Oversight of Recalls

Your inspection division (either FSIS or ODA) oversees all recalls. Even the Center for Disease Control (CDC) can get involved, if they find a link between your product and sick or dead consumers, as they did in the BilMar case this past winter. Though no government agency can mandate a recall yet, they can take action that forces a processor to enact a "voluntary" recall. If your company doesn't publicly announce its recall voluntarily, FSIS and ODA will do it for you by informing media of the recall. It always looks better in the consumers' eyes, if you announce the recall, and not a government agency. Recall monitoring by inspection divisions involves review of recall status reports, conducting of effectiveness reviews, and a final review at the completion of the process.

Recalls are also classified by "depth", meaning who is in possession of the questionable product. The three depth levels are: consumer or user level; retail level; and wholesale level. This means that notification of a recall is limited to the extent that the product in question has been distributed at the time that the recall is needed. For this reason, it is highly recommended that companies hold or retain all products from lots, in which your inspector has pulled a sample for pathogen screening. Where possible, some plants stop processing and do a full cleanup and sanitation, after their inspector has pulled a sample, in order to start a new lot (according to FSIS's lot definition, this reduces that amount of product that needs to be either retained or recalled later).

A lot identification system is crucial for an efficient, thorough recall. A detailed lot identification system is necessary to remove all potentially harmful units from commerce as quickly as possible. By pinpointing date, time and batch, your recall will be more precise and you will be able to track and recover questionable product and leave safe product on the shelf. The article on lot identification in this issue will give the specifics on assigning lot numbers. Once you have an identification system in place for your products, the next step is to devise a system that ties lot information from raw materials (ingredients) you receive, with lot information on your products. This enables you to trace specific ingredients down to product lot in order to find the common thread among contaminated product and determine the cause of the problem. For your major customers, keep a record of your product lot numbers and dates shipped to each, in order to reduce the time needed to trace product as possible.

Finally, do mock recalls to test your system. Does your system run smoothly? How easily can you trace and recover your products? Can you look at your lot identification records and determine which ingredients recalled products have in common? You will likely find that you need to "fine-tune" your system until the mock recalls run smoothly.

Just as important as the technical information needed to get product off the shelf is having and emergency management communication strategy in place. Emergency management communication is advanced preparation for unexpected events, including a positive L. monocytogenes or Salmonella sample, a food-borne outbreak, a natural disaster, product tampering or a bomb threat. Form a crisis communications team and give each member specific tasks. Designate a leader who will be your media spokesperson. Another person will notify customers (via telephone, letter, and e-mail), another team member will focus on interacting with regulatory personnel. Someone must be carefully trained to answer the calls that come to the company, following a media announcement, who may or may not be legitimately reporting illnesses, or simply regular customers who become irate or overly concerned about the safety of their family. Spell out everyone's role in the emergency management plan, a comprehensive file that contains all the information you need to know in the event of a recall in one place. OSU will be conducting Recall Training at HACCP sessions this fall. In the mean time, contact Lynn Knipe (800-752-2751), at OSU, to request an Emergency Management Plan Example or other recall information.