Foreign object contamination has become a huge issue for FSIS as evidenced by the increasing number of recalls related to this issue. A few weeks ago, the TAG newsletter discussed the increasing incidence of foreign object recalls, particularly in meat and poultry. That increase has not gone unnoticed by USDA which published the FSIS Draft Guideline for Industry Response to Customer Complaints in March – specifically developed to address foreign material customer complaints, though it does apply to other complaints as well. As the guidance shows – and FSIS states – the agency is placing an emphasis on industry response to customer complaints and reporting those incidents to the agency within 24 hours of determining that the product is adulterated, as required by Notification (9 CFR 418.2). It also is important to note that product containing foreign materials is considered to be adulterated even when a physical food safety hazard is not present. In the draft guidance, FSIS addresses best practices and recommendations on how to receive, investigate and process customer complaints as well as the regulatory requirements for facilities to identify the cause of the adulteration of a recalled product and take steps to prevent recurrence in a HACCP plan reviewed by federal inspectors. As with any guidance, the publication is non-binding on industry, however it is always wise to follow agency recommendations. As such, the guidance recommends that establishments develop a program to receive and process customer complaints – whether they originate from a consumer, other establishment, FSIS inspector, USDA’s Consumer Complaint Monitoring System (CCMS), or another regulatory agency – with each complaint evaluated as a possible report of adulterated or misbranded product. In brief, the program should include: Customer Complaint Reporting. This should include methods of reporting for both consumers (e.g. postal address, toll-free number, website and/or email on the product label or company webpage) and downstream customers (e.g., QA/management contact information and instructions in the bill of lading or contract). Substantiation. Criteria and a mechanism for determining the validity of a complaint should include, first, verifying the product itself – that it is what the consumer states it to be and was produced by that establishment. Next, evidence of adulteration/misbranding should be verified, such as through photo or video or a sample of the product, label, and foreign material. A product not matching the label could be evidence of misbranding and should be investigated as such. Substantiation should be conducted as soon as possible; to enable this a specific employee should be designated to receive complaints and perform and initial substantiation, with allowance for complaints received during non-business hours. Although the facility is not required to notify FSIS until adulteration/misbranding is substantiated, FSIS recommends that it be notified of its potential as soon as it begins its investigation. If the complaint is determined to be non-valid, documentation of this determination should be maintained as well. Establishment Response. – Plan and Investigation. Once a complaint is substantiated, the establishment should quickly identify any affected product (e.g., lot, date, line, etc.) and its distribution. If any has entered commerce, recall requirements must be followed; any not shipped should be held and inspected prior to shipping. The establishment should have a thorough response plan that includes this, a thorough investigation into the cause, and an evaluation and reassessment of the HACCP plan. – FSIS Notification. As required by 9 CFR 418.2, this must include product type, amount of implicated product, origin, destination. Thus the facility should have a plan on how it will gather and provide this information. – Corrective Actions. When adulterated or misbranded product has been produced, the establishment must determine what part of the HACCP system failed and take steps to correct it. The draft guidance includes a question/answer section on various areas of potential failure and required corrective actions. Documentation. Again, while not required, best practice is for an establishment to document all customer complaints (whether substantiated or not), including the investigative steps performed and evidence used to substantiate or nullify the claim. If substantiated for a product in commerce, records should include FSIS notification, corrective action, ant the HACCP reassessment and result. It also is recommended that these records (for which 14 specifics are included in the guidance) be made available to FSIS upon request. As FSIS notes in the draft guidance, and with which I heartily agree, a well-developed and implemented customer complaint program is where it all starts. A good program provides benefits to the establishment beyond that of substantiating and correcting an issue. That is, it can reduce the long-term financial costs of recalls, while protecting public health, by identifying adulterated or misbranded product earlier in the development of a recall. I cannot overemphasize the importance of creating and following a robust program for managing consumer complaints. I know that companies worry about telling FSIS about a consumer complaint because they feel it will inevitably lead to a recall. But times have changed, and FSIS is focusing on the foreign object issues more than ever. In my opinion, if FSIS finds out that you have not “done the right thing” with a consumer complaint, it could land you in a lot of hot water that goes way beyond a recall. As draft guidance, FSIS is accepting comments through May 10, but encourages the industry to begin following the recommendations now. 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.