FSMA's Recall Requirements: Are You Ready?

By Sam Lewis

With FSMA compliance looming just around the corner, many food manufacturers don’t know what the regulations are requiring if and when a recall happens to them. Here, Vickery Brewer, consumer safety officer at FDA/CFSAN, and Warren Stone, senior director of science policy at the Grocery Manufacturers Association (GMA), answer my questions about FSMA’s recall requirements and the biggest challenges food manufacturers are facing in becoming compliant with the regulations.

Food Online: How have FSMA’s requirements for product tracing evolved since 2011’s Product Tracing Pilots?

Stone: From the Preventive Controls For Human Food (PCHF) preamble, …”(Response 694) The supply-chain program that is being established in this rule is a preventive control for the ongoing production of safe food, not a “traceback” provision, established under the Bioterrorism Act, …”  Therefore traceback requirements remain the same as under the BioTerroism Act. Nevertheless, processors can expect greater FDA scrutiny and oversight in the post-FSMA world and we would advise them to review their procedures to ensure they are effective.

Brewer: I agree with Warren and confirm that firms can expect increased scrutiny of their trace-back efforts and added responsibility for reviewing the source of their raw materials.

Food Online: What are the biggest obstacles you’re seeing food manufacturers face in terms of implementing FSMA-ready traceability and recall practices?

Stone: In the case of human food, PCHF establishes recall requirements for processors in §117.137. FDA regulated processors are also subject to recall requirements set forth in § 7. 40., which have been established for quite some time. While the requirements are very similar, I would advise processors to make sure they have fully complied with both §117.137 and Part 7. Secondly, depending on the reason for the recall, the firm could have an obligation under the FDA’s Reportable Food Registry, which processors should review as part of the recall.

Brewer: The immediate obstacles manufacturers may face will likely be resources: time, training, legal, etc. While Recall requirements under 21 CFR, 7.40 have changed little in nearly 40 years, the additional steps of having a Recall Plan in advance of a recall, will require additional resources up front and for periodic reviews. The FDA has taken into consideration some of these resources constraints in developing the staggered time-line for compliance.

Aside from administrative issues, such as legal, administrative, regulatory or consultation needs, I see adequate training of personnel at the manufacturing sites and at corporate offices as an obstacle that firms will have to address.

Food Online: FSMA is requiring food companies to have a recall plan. What must it include and what recommendations do you have for building it?

Brewer: Every recall plan must include procedures that describe the steps to be taken and assign responsibility for taking those steps to perform the following actions as appropriate to the facility: 1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food; 2) notify the public about any hazard presented by the food when appropriate to protect the public health; 3) conduct effectiveness checks to verify that the recall is carried out; and 4) appropriately dispose of recalled food (e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food).

Stone: I advise our members to write the plan now, today. Don’t be searching for my business card during the recall. Recalls can be unnerving, highly-stressful situations and you want to develop your policies, procedures, protocols, etc. while you have a clear head and can document the contact info for all the potential entities that you may have to contact:  regulatory, legal, communications, accounting, logistics, testing laboratories, etc. Additionally, I advise firms review this info at least annually to make sure that it is all current.

Food Online: What resources are available for food manufacturers to learn more about becoming compliant with FSMA’s recall requirements?

Brewer: The FDA has guidance available on its website that can help food manufacturers better understand the requirements of a HARPC food safety plan. It can be found here: Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food

Stone: GMA has several publications available to GMA members and non-members at its Online Bookstore, available here. Additionally, together with the FDA and GMA, Food Online hoste a web chat on Monday, September 12, 2016 at 1 PM EDT. Both Vickery and I shared our knowledge, experience, and answered the food and beverage industry’s questions about recall requirements under the Food Safety Modernization Act. Check it out here.