SCORE co-chairs Douglas Stearn, top left, and William Correll, bottom left, at a recent team meeting.

FDA Streamlines, Strengthens its Role in Voluntary Food Recalls

A Conversation with William Correll and Douglas Stearn

In April 2016, the FDA moved to speed its response when there are foods on the market that present a real or potential danger to consumers’ health.

The agency created a team of key senior leaders to get involved with the most challenging recall situations, those complicated by such issues as the nature of the product, the scope of available evidence, and the company’s response. This team is called SCORE (Strategic Coordinated Oversight of Recall Execution).

This team was created, in part, to address concerns identified in the early stages of a study by the Office of the Inspector General (OIG) at the Department of Health and Human Services on FDA’s role in ensuring effective food recalls. Today, the OIG released its final report, addressing the same issues while detailing changes that FDA made in response to an early alert issued in June 2016.

So, what exactly has changed in terms of how FDA handles situations warranting a recall of food products?

William Correll, director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Stearn, director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA), are the SCORE co-chairs. They talk here about the changes that SCORE has implemented since the OIG’s alert was first issued and the progress it has made to help ensure that potentially dangerous foods are removed from the market as soon as possible.

Q: Would you summarize the OIG’s findings?

Correll: The OIG concludes that FDA did not always implement an effective food-recall process. The report cites deficiencies in our oversight of recall initiation, monitoring and information collection. The OIG bases its concerns on a selection of 30 voluntary recalls, including some very challenging ones, that occurred between October 1, 2012 and May 4, 2015. An early alert, issued in mid-2016, focused on two of the 30 recalls in which the companies did not initiate recalls of all affected products quickly. When a delay occurs, that situation is not acceptable. It bears noting, however, that in those three years from which the OIG selected the 30 recalls, FDA worked with companies to successfully bring about thousands of recalls, with an average initiation time of less than a week.

Q: What does FDA say in response?

Stearn: We take our jobs seriously and have always been committed to protecting the U.S. food supply, which is among the safest in the world. Have we done it perfectly? No. Even before the OIG released its early alert, we saw the need to strengthen certain compliance and enforcement strategies in cases made more complex by factors that include the nature of the product, the scope of available evidence, and the company’s response. We took the issues raised to heart and have used them as a catalyst for change in how we respond to difficult recall situations.

Correll: Some of the 30 recalls were outliers in terms of time and complexity. The two recalls with the longest initiation time involved a lengthy legal dispute in one case and a criminal investigation in another. So, while we agree that we need to act quickly to prevent the public’s exposure to potentially contaminated food, we do not believe that the recalls chosen can be used to characterize the whole recall system.

Q: What are the major changes that have taken place since the initial OIG report?

Stearn: There are three major areas we would like to highlight: the establishment of SCORE, the implementation of a recall audit plan, and more proactive communications to spread the word about potentially dangerous products. Additionally, we’ve made more than two dozen policy or procedural changes to improve how we handle cases that could present a danger to public health. And our enforcement strategy has been further strengthened by our use of whole genome sequencing in the laboratory to more rapidly identify foodborne contaminants and trace them to their source. This technique has proven to be a game-changer in outbreak response, and will be increasingly valuable in the future.

Q: So, let’s start with SCORE. How does this team work?

Correll: Doug and I are the co-chairs of SCORE in ORA and CFSAN. We are joined by colleagues who have operational and leadership roles in compliance, food law, field operations, outbreak response, enforcement and import operations, communications and policy. We also involve senior scientists and medical officers with expertise in specific disciplines to support individual cases. The participants bring their unique expertise to the table, whether it’s in compliance, our legal authorities, enforcement or science. Although we bring different skills and perspectives to the discussion, we must quickly decide, with one voice, what we’re going to do next. We discuss the full range of potential actions, come up with a tactical plan, and adjust as necessary based on new information. If we need to deploy additional resources in inspections, sampling and laboratory testing to gain additional information or make our case, we do. If we need to alert consumers to a possible danger, we do.

Stearn: The FDA’s field offices, located throughout the country, have direct dealings with the companies. They are the front line, the ones who work with companies to ensure the recalling company efficiently and effectively executes the voluntary recall. And sometimes they are the ones to raise the red flag when there’s a problem, such as a firm’s reluctance to appropriately respond to the fact that its food is, or could be, contaminated.

Once an issue is brought to us, we decide whether there’s sufficient evidence to act, or whether further investigation is needed. Sometimes we have enough evidence. Other times we have situations in which the path forward isn’t clear, and the team may decide to expand an investigation through additional inspections and sampling activities.

Q: What are the options that SCORE considers?

Stearn: When the situation warrants it, we make the company aware of our authorities and the actions the agency could potentially take if a firm chooses not to voluntarily recall. These actions include the enforcement tools provided by the FDA Food Safety Modernization Act (FSMA): suspension of a food facility’s registration, administrative detention, and mandatory recall. There are also the court-ordered actions, such as seizures and injunctions, and FDA-issued public notification. These conversations could include setting expectations of timelines for actions by food companies.

Q: Have you put in place specific timeframes for action?

Correll: We set timeframes for food companies to take certain actions on an individual basis. It is important to understand that when a firm is conducting a voluntary recall there is no set timeframe under the law to conduct recall activities. The agency expects a firm considering initiating voluntary recall to decide expeditiously. Timeframes are unique to the situation at hand. The timeframes may also cover voluntary recall initiation, public notification and cessation of manufacturing operations by the food facility. Timeframes may guide escalation of FDA action if the company fails to take adequate and effective action, such as a voluntary recall or issuing public notification. For instance, once the FDA makes the decision that recall action must be taken, we must ensure companies implement the recall swiftly and effectively and notify the public.

Stearn: We fully agree with the OIG that we must ensure that companies move as expeditiously as possible to conduct recall activities. In many situations, we agree that timeframes must be set, but they must be done on an individual basis rather than by setting one-size-fits-all deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations.

Q: Can you say more about the recall audit plan?

Stearn: In September 2016, ORA designed and implemented a plan to audit the recall program for all products regulated by FDA, including foods. This plan provides for both traditional auditing and continuous monitoring of the recall program. The plan focuses on the critical control steps of a recall that include initiation, recommendation, classification, effectiveness checks, and follow-up inspections. It also establishes timeframes for 14 of these critical control steps.

Q: And why has communications become a priority?

Correll: We are developing a guidance to urge more proactive communications around recalls.

For example, we have seen the need to provide recommendations for companies conducting some voluntary Class II regarding when to notify the public. Class II recalls are for situations in which a product may cause temporary or medically reversible health consequences or where the probability of serious harm is remote.

Q: Getting back to SCORE, what achievements can you point to since the OIG’s early alert was issued last year?

Stearn: In the cases brought to the team, SCORE has helped determine the right course of action and shorten recall timeframes, getting the products off the market faster. SCORE has helped improve tactical planning, leading to additional inspections and sampling assignments, and to getting the word out to more consumers about potentially dangerous products. In two cases, FDA suspended a food facility’s registration after a reinspection and additional sampling requested by SCORE showed continued contamination. Suspension of registration effectively shuts a facility down until FDA determines that adequate grounds no longer exist to continue the suspension. Additionally:

• SCORE members focus on identifying the appropriate tool or combination of tools, depending on the circumstances in each case. For example, based on information following one outbreak, SCORE issued an additional sampling assignment to obtain additional information related to the firm’s internal sampling process. This ultimately assisted a firm in identifying problems with a supplier, which resulted in safer food for consumers.
• During an active outbreak linked with illnesses, including two deaths, FDA worked closely with state officials to quickly conduct three inspections in two different states. This included joint finished product and environmental sampling, which led to the identification of the cause of the outbreak being linked to a firm not previously registered with FDA as a food facility. After a broad voluntary recall, the firm voluntarily ceased manufacturing.
• A very unusual situation occurred in which we had allergen contamination where we didn’t expect to find it – peanut protein in bulk flour. This finding involved many other large downstream companies and ultimately resulted in expansive voluntary recalls. We worked with each of the companies that had finished products made with this flour to accomplish recalls of their products as quickly as possible.
• Another case involved a facility that made sandwiches distributed in the U.S. Department of Agriculture’s Food and Nutrition Service’s school lunch program. The FDA found Listeria monocytogenes in the facility environment, including on surfaces where the food was made. The agency made it clear that it would consider notifying the public about the hazard unless a voluntary, public recall was initiated within 24 hours. There was a recall, an expanded recall, and public notification, and the firm ultimately decided to stop manufacturing its line of ready-to-eat foods.

Correll: You’ll notice that not all of these products were involved in an outbreak of foodborne illness. SCORE’s work involves potentially hazardous foods of all kinds, not just those that have made people sick, or worse.

Q: What are some of the complexities SCORE has faced?

Correll: When a firm has identified a specific lot of contaminated food, the need for an immediate recall with respect to that lot of food is clear-cut. It is rare that individuals and companies delay action in such situations. The complexity comes in trying to ascertain what more might be contaminated than a specific lot and over what range of time. It may take time to obtain the information necessary to determine what food is reasonably likely to be affected. It can be complicated when a potentially contaminated product has already been shipped and is not readily available at the facility for testing. Tracking down the product in the marketplace may also take time.

And time is what we don’t have if there is a possibility that people are, or will be, getting sick from eating this food. So, we focus on looking at conditions at the processing facility for the root causes and augment that with information from sampling and testing, as available. In some cases, we act based on the strength of evidence that the conditions in which the food was produced indicate a problem or that the contamination may be more widespread. In these situations, we are using a standard in the law that doesn’t require the government to demonstrate the food is contaminated, just that the food was prepared, packed or held under insanitary conditions and may have been contaminated.

Q: Will the enforcement of FSMA affect SCORE’s work?

Correll: Yes. For example, the system of preventive controls for human and animal food required by FSMA will result in more environmental monitoring by certain food processors to ensure that their preventive control measures are working. This testing will likely identify potential hazards before they result in contaminated food on the market. Over the coming years this will hopefully lead to fewer potential recall situations.

Stearn: The preventive controls rules for human and animal food require covered food facilities to identify potential hazards and take steps to minimize or eliminate risks. They are also required to have a recall plan. Compliance dates began for large firms in September 2016.

Q: What do you want consumers to know about how FDA handles recalls?

Correll: FDA’s public health mission includes a responsibility to help ensure the safety of our food supply. The reality is that most companies readily initiate a voluntary recall when faced with evidence that their product may be unsafe. But when there is an obstacle, we are determined to overcome it, using all the tools we have available.

Stearn: When the OIG’s early alert came out, we were already making changes and we will continue to strengthen our response to potentially dangerous foods. We’re consumers ourselves; we have families too. Everyone has a stake in the safety of the food supply.