The Preventive Controls Rule requires that food facilities establish a written recall plan for food that requires a preventive control. Although that provision has long been in effect, FDA just published draft guidance on writing the plan in early October. As Chapter 14 of the draft guidance for FSMA’s Preventive Controls Rule, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” provides recommendations for the plan focused on three key sections: the recall action steps you will take, your assigning of responsibilities for the recall actions, and your FDA notification process. Even if you are not subject to the Preventive Controls rule, the principles and recommendations can be helpful in preparing for a potential recall and managing the risk. 1. Recall Action Steps. Detailing the steps you will take to perform recall actions in the written recall plan will enable you to act promptly when you determine that a recall is warranted. It should include: a. Notifying Direct Consignees. How will you provide direct consignees with the information they need to conduct the recall and stay in contact with you. This could be through letters, email, fax, text, etc., as applicable. If you plan to contact them by phone, written documentation and follow-up confirmation of the call is recommended. The recall communication plan should include how you will: Identify the food. What information is to be provided to enable accurate and immediate identification of the food being recalled (e.g., product name, size, lot number(s), code(s), expiration dates, UPC codes, shipping dates, etc.). It is recommended that a product label be included as well. Explain the reason for the recall. Describe how you will concisely explain why the recall is needed and the health hazard(s) involved. Specify the depth of the recall. Detail how you will specify the depth to which the recall will extend (e.g., wholesale, retail, or consumer level). If your direct consignees may have further distributed the food, also specify how you will instruct them to notify their customers. Provide instructions for the recalled food. How will you instruct consignees who receive the recall communication on what they should do with the recalled food (e.g., remove it from sale, cease distribution, notify their customers, return food to specified location, destroy the food, etc.)? If your direct consignees are to notify their customers, FDA recommends you plan to send them a copy of the written recall communication, or you could provide a modified recall communication with all pertinent information. Make it easy for recipients to communicate with you. Explain what recipients of your recall communication will need to send you, how they will be informed of this and how to do so, (e.g., through a toll-free phone number, response form, etc.). How will you follow up with those who do not respond? Include model letters in your recall plan. Including model recall letters that you can customize to each situation will facilitate the rapid preparation of such letters when needed and can prompt you to include all needed information. b. Notify the Public. How will you notify the public, when appropriate, to protect public health? For example, for an urgent situation for which other means of preventing use appear inadequate, you could issue a public warning through the general or specialized news media to alert the public that a food being recalled presents a serious hazard to health. If less urgent, FDA’s public-access recall list may be enough. FDA also provides information from press releases and other public notices about certain recalls on its “Recalls, Market Withdrawals, & Safety Alerts” web page. Your recall plan should describe your criteria for determining whether a public warning is needed (based on FDA guidance) and the steps you will take when you determine it is. c. Conduct an Effectiveness Check. To verify that all consignees at the specified recall depth have been notified and taken appropriate action, describe how you will conduct an effectiveness check (e.g., through a letter, phone or in-person questionnaire, etc.). Including a model document will, again, facilitate rapid preparation of such documents when needed. d. Decide What to Do with the Recalled Food. Describe the options you will consider for disposal of recalled food (e.g., reprocessing, reworking, diversion, or destruction) and how you will determine the appropriate disposition. 2. Assigning Responsibility. Your recall plan must include who is responsible for each of the above steps, saving you time in a recall and helping you to communicate responsibilities to managers and staff so that they can act as soon as the decision to conduct a recall is made. (The draft guidance also includes a section on Resources [14.4], which FDA recommends be included in the recall plan for quick access by the recall team). As such, it is recommended that you: Identify members (and alternate members) of a recall management team, headed by a recall coordinator (e.g., those with responsibilities for distribution, production and quality assurance, consumer affairs, accounting, legal counsel, public relations, technical, marketing, and regional sales managers and staffs – See Table 14-2). Provide information about each member and alternate to include name, job position/title, business/cell phone number, email address, after-hours phone number (e.g., home or cell), and responsibilities. Specify who is responsible for the decision to conduct a recall. 3. Notifying FDA. The FD&C Act requires that food firms notify FDA electronically within 24 hours of determining that a food is a reportable food – that is, that there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. (FDA guidance on reportable food includes examples.) As such, the agency recommends that the recall plan either detail the procedures you have in place for compliance, or cross-reference these. It also is advisable to notify the appropriate FDA Recall Coordinator as soon as a decision is made for a recall – before issuing written notification to a customer or press. FDA guidance provides information on what to send. This article provides an abridged version of the steps included in FDA’s draft guidance, but even condensed, there’s a lot to include and consider. And, while the above is the minimum that FDA would expect there are many other aspects of managing a recall that should be part of your plan. This would include the process for escalation in your company, determining the level of risk such as by performing a Health Hazard Evaluation, how to undertake a root cause analysis to determine scope of impacted product, and, very important, how to undertake appropriate communication and manage your reputational risks. TAG has extensive experience in Recall and Crisis Management and can provide professional assistance in all of the above. Give us a call today. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
