Recall Management Driven by Risks and Regulations

What does the globalization of the food supply, the increase in co-manufacturing and private label manufacturing, advances in technology, increasing consumer sophistication and demand for information, and new regulations all have in common? Each individually, and collectively, contribute to the risk of experiencing a product recall.

More than ever are we seeing lawmakers, regulators, consumers, and the media more focused on food safety. Several outbreaks of foodborne illness in recent years have identified new risks and have put food safety in the spotlight. The changing consumption patterns, global sourcing, evolving food-safety science, and the identification of new risks all contribute to the shifting food-safety landscape.

The science of food safety is continually evolving: New laboratory tests, improvements in genetic testing, and a greater fidelity of epidemiology have resulted in better capacity to detect and identify foodborne pathogens, and to link illnesses with specific food products. The vigilance of both mainstream and social media, along with consumer’s capacity to damage a brand has made it all the more important to maintain a robust food safety program. This includes a well-developed recall and crisis management plan that adapts to change whether it is regulatory, science, or consumer driven.

The signing of the Food Safety Modernization Act (FSMA) by the U.S. President in January 2011 is the most sweeping overhaul of the food-safety system in the U.S. since the Food, Drug, and Cosmetic Act of 1938. While FSMA has already delivered broad-sweeping changes through several proposed rules that have been released to date, this article will focus on the impact of FSMA on recall plans and the importance of effective recall management.

Regulatory Agencies and ­Applicable Recall Regulations

FDA and the FSMA. The FSMA specifically provides the FDA with mandatory recall authority, complete with the power to order a firm to cease distribution and recall a product “if the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food…is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.”

What does this mean exactly?

First, this new authority simply means that FDA has the power to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to do so by FDA. The reality of a company refusing this request is very unlikely thus we won’t see many truly “mandatory” recalls. However, if mandated, FDA can issue an order requiring the firm to immediately cease distribution of the affected product and immediately notify all persons who manufacture, process, pack, transport, distribute, receive, hold, or import and sell the affected product of the recall and to immediately cease distribution.

Second, there is one phrase in Section 417 that packs a big punch by way of impact on the scope of records FDA is entitled to review and copy in relation to a recall investigation. That is the “reasonable probability” standard. Prior to FSMA, FDA needed “credible evidence” of a situation that could cause serious adverse health consequence or death. Now this bar has been lowered—significantly—to only needing a “reasonable probability.” This expands FDA’s ability to seek and obtain records to ones previously off limits pre-FSMA. The bar may be lower, but the stakes are higher if you are not properly documenting and retaining required documents pursuant to the record retention requirements under FSMA’s new rules.

FDA provides an industry guidance document located on its website that outlines the major considerations and components of a recall. This document includes the key pieces of information needed and execution steps expected by the agency in the FDA Recall Industry.