On March 11, the Food Safety and Inspection Service (FSIS or the agency) announced the availability of the guidance FSIS Guideline for Industry Response to Customer Complaints, 2019. The guidance was issued to provide best practices to the meat and poultry industry for responding to customer complaints alleging adulterated or misbranded meat and poultry products, particularly those complaints regarding foreign materials. Importantly, the guidance indicates it is “not regulatory,” and that establishments are free to adopt different procedures than those set forth in the Guidance.

Although the Agency considers the Guidance “in effect,” comments may be submitted on the Guidance until May 10, 2019.

Written customer complaint program

The guidance recommends establishments adopt a written program to receive and process customer complaints, although establishments aren’t required to have such plans in place. FSIS recommends the following components be included in a customer complaint program:

• Customer complaint reporting: FSIS recommends establishments should provide household and non-household consumers with methods for reporting complaints, such as a toll-free number or email addresses. The agency also recommends that consideration be given as to how co-packers should be notified of complaints received by brand-name owners listed on labels and that complaints addressed to corporate headquarters or third-party contractors be relayed to producing establishments.

FSIS recommends the written plan should be designed to triage complaints according to whether they involved quality issues, complaints for adulteration or misbranding, or those that involve compliance regarding FDA-regulated products.

• Substantiation of complaints: FSIS recommends establishments develop criteria and mechanisms for determining the validity of complaints. This may include verifying the product is FSIS-regulated, verifying where the product was produced, and determining no product tampering occurred after shipment, and whether there is evidence of adulteration, based on information collected, including photographs, video or samples of the product and labels.

FSIS regulations require official establishments to notify FSIS within 24 hours of learning adulterated or misbranded products are in commerce. Although the guidance recommends establishments notify the agency as soon as the establishment begins investigating a complaint, establishments should be wary of this recommendation because notifying the agency too soon before an investigation can be completed could lead to the agency requesting actions that are not warranted before the facts are obtained. A more prudent approach would be to notify FSIS as soon as leaders of an establishment have reason to believe, based on an investigation, it has distributed adulterated or misbranded product in commerce. As a precautionary measure, an establishment could request its customers place a hold on the product pending the results of the investigation.

The guidance recommends establishments document their reasoning if they conclude a customer complaint is not valid or does not apply to FSIS-inspected products. FSIS notes that if the investigation reveals the complaint involves FDA-inspected products, the establishment should follow up to determine whether any FSIS-inspected products would be affected because of common ingredients or production areas.

• Establishment response to customer complaint: If the establishment determines a customer complaint is valid, FSIS recommends the establishment further investigate the incident. The agency recommends having a written response plan that involves identifying affected product and distribution. This could include reviewing relevant records, performing a visual inspection of product and operations and a discussion with relevant employees. The affected product should be placed on hold and inspected prior to distribution. FSIS also recommends evaluating the design and implementation of the establishment’s HACCP system.

In responding to a valid complaint, an establishment must notify every instance where an adulterated or misbranded product entered commerce. The guidance reiterates the agency’s long -standing position that any product containing foreign matter is deemed adulterated regardless of whether the foreign matter poses a health hazard.

The guidance specifically addresses corrective actions for foreign material findings. For instance, if the foreign material is a food safety hazard, corrective actions should be implemented per the facility’s HACCP plan. However, even if the foreign material is not a food safety hazard, it is evidence that the establishment’s SSOPs failed to prevent direct product contamination or adulteration. The establishment would need to take corrective actions under their SSOPs.

• Documentation of customer complaints: FSIS recommends establishments document all customer complaints, regardless of whether they are substantiated. The agency recommends this documentation include the investigate steps taken and the methods for substantiating the claims. This documentation includes not only information gathering on the complaint, but also follow-up activities, including corrective action. The agency states establishments should make records relating to customer complaints available to FSIS, but that it is not a “regulatory requirement.”  NP