Strategic Coordinated Oversight of Recall Execution (SCORE)

Image of Bill Correll and Doug Stearn

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

SCORE Hits the Ground Running
A Conversation with William Correll and Douglas Stearn

Six months ago, 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).

With these tough cases, the team supports the FDA’s field staff and district offices across the country by evaluating the whole range of options for the use of the FDA’s compliance and enforcement authorities, and making swift decisions about the best course of action to take.

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 what SCORE has achieved in its first six months, the challenges it has faced, and the road ahead.

Q: How did SCORE get off the ground?

Stearn: The FDA has successfully worked with companies to accomplish thousands of recalls in recent years, but as a public health agency we are always looking to improve. Our bosses, Stephen Ostroff, the deputy commissioner for Foods and Veterinary Medicine, and Howard Sklamberg, the deputy commissioner for Global Regulatory Operations and Policy, recognized that there are unusual and challenging situations that would benefit from the direct involvement of leaders who could support the field by expediting decisions.

Correll: Doug and I are the executive leaders of SCORE in ORA and CFSAN, the two FDA compliance and enforcement hubs that oversee food safety, including oversight of the food and cosmetic recall operations. We are joined by colleagues who have leadership roles on the legal team, in field operations, in communications, in outbreak response, in policy, and other offices. We also involve senior scientists and medical officers with expertise in specific disciplines. Bringing senior leaders together in this effort shows that effective recalls are a priority for the FDA. We have a set weekly SCORE meeting at our Maryland headquarters and we communicate with each other more often than that, as our routine duties intersect on a day-to-day basis. We don’t want potentially dangerous situations to drag out, so we also convene on short notice when necessary. The important thing is that we’re all at the table when the time is right to decide what must be done.

Q: So how does SCORE work?

Stearn: The FDA’s district offices have direct dealings with the companies. They are the first responders and the ones who work with companies to efficiently bring about many, many voluntary recalls. 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, but other times we have situations in which the path forward isn’t clear. The question for our scientists often is: Are you able to say that, in your expert opinion, we have evidence that meets the SAHCODA standard? (In other words, is this a hazard reasonably likely to cause “serious adverse health consequences or death to humans or animals”?) And if we do, we have certain options under the law, such as pursuing a mandatory recall. And if not, we need to consider other options.

Correll: Everyone brings their unique expertise to the table, whether it’s in compliance, litigation or science. We’re each in our own swim lane based on our role in the foods program – but we have to 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 for each case, and adjust as necessary based on new information. While these plans are strategic in nature, I use the word tactical because people often think of strategic as long term and SCORE’s goal is to catalyze immediate action when necessary. If we need to deploy additional resources in inspections, sampling and laboratory testing to make our case, we do. If we need to alert consumers to a possible danger, we do.

The bottom line is that there is an expectation that the company will be taking immediate steps to remove potentially harmful or implicated food from the market, and ensuring prevention of contamination. If their safeguards have failed, companies have the responsibility to act, not only to rectify their system for prevention but, more immediately, to do something about the food that they already delivered into the marketplace. Time matters in these kinds of situations.

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 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 the circumstantial evidence that the conditions in which the food was produced indicates 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: What are the options that SCORE considers?

Stearn: When the situation warrants it, we make the company aware of the authorities we have to act if a voluntary recall is not imminent. These actions include the enforcement tools provided by the FDA Food Safety Modernization Act (FSMA): suspension of a food facility’s registration, administrative detention to keep foods out of the marketplace, and mandatory recall.

There are also the traditional court-ordered actions, such as seizures and injunctions. They may also include the setting of timelines for actions by the FDA and by food companies.

Almost all companies choose a voluntary recall when faced with the prospect of an enforcement action. At the point we have reliable evidence that a product presents a hazard, we are prepared to pursue an action, and to decide what the right timeframe should be in dealing with the firm.

Q: Are there exceptions? Have you used one of those enforcement authorities?

Correll: Yes. In September the FDA suspended the facility registration of a company because the food produced there may have been contaminated with Listeria monocytogenes. SCORE requested a reinspection and additional sampling at the facility after Listeria was found there this summer. The company agreed to a recall and briefly ceased operations at the FDA’s request to improve its cleaning and sanitation procedures. SCORE was concerned that the facility didn’t satisfy our verification expectations and we directed an immediate follow-up inspection. When environmental sampling showed continued contamination, FDA Commissioner Robert Califf ordered the suspension of the firm’s food facility registration, meaning it could not sell or distribute any food from that facility until the FDA determined that food produced there no longer poses a hazard to consumers. This has yet to occur, and the facility remains closed. The FDA continues to monitor the situation closely.   

Q: What are other examples of cases in which SCORE has been involved?

Stearn: In the first six months, the SCORE team has been focused on individual cases in which there is a potential risk to public health and an obstacle to fast resolution. In addition to the case that resulted in a suspension of food facility registration, these cases – which all resulted in at least one recall -- include:

  • 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 a number of 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 and made it clear that our first step would be to publicize the potential contamination if the company did not implement a voluntary recall within 24 hours.
  • Another case involved a facility that made sandwiches distributed in the U.S. Department of Agriculture’s Food 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 clear that it would issue press if a voluntary, public recall was not 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.
  • Powdered infant formula was identified that was not manufactured in compliance with infant formula regulations. Most importantly, it was not tested for Cronobacter, bacteria that can be deadly for infants. All infant formulas marketed in the United States must meet federal manufacturing and nutrient standards. The company was not testing for the required nutrients. The agency again made clear that it would take enforcement actions and issue press if a voluntary recall was not initiated within 24 hours. Following discussions with the FDA, the company issued a recall.

Correll: You’ll notice that these products were not involved in an outbreak of foodborne illness. Because SCORE’s work involves contaminated foods of all kinds, not just those that have made people sick, or worse, we recently expanded its name (originally Strategic Coordinated Outbreak Response and Evaluation) to reflect how we’re looking at cases in which recalls and other actions may be needed, even when no illnesses have been reported.

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

Correll: Yes, we have. Timeframes are unique to the situation at hand and are decided on an individual basis. The timeframes cover voluntary recall and cessation of manufacturing operations action by the food facility. They also cover escalation of FDA action if the company fails to take adequate and effective action, such as a voluntary recall. For instance, once the FDA makes the decision that recall action must be taken, the agency sets short deadlines for the company to begin implementation. As discussed before, this rarely involves the contamination of individual lots, but instead involves much more complex situations in which informed judgments must be made to protect the health and safety of consumers and facilitate broader action.

Q: Beyond the individual cases, will SCORE’s involvement have a more long-term impact on food recalls?

Stearn: Yes, we are looking for developing trends that may require policy action or wider notification to drive more system-wide measures to reduce or prevent a food safety risk.

For example, we have seen the need for companies conducting some voluntary Class II recalls 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. A press release is currently only something the FDA seeks when a situation appears to meet the standard for a Class 1 recall (those in which there is a reasonable probability that the food will cause serious illness or death).

While the risk is not as great with Class II recalls, there may be significant public health concerns for a number of reasons, including illnesses or allergic reactions or the vulnerability of certain types of consumers, for instance the very young or elderly. Within FDA, we are looking at this issue to determine if there are ways we can regularly ensure that consumers can more quickly receive notice of such recalls.

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

Correll: Yes. The system of preventive controls required by FSMA will result in more environmental monitoring through specimen collection as a verification tool for food processors to ensure that their control measures are working. This testing will likely identify more potential hazards before they actually result in contaminated food on the market. Over the coming years this will hopefully lead to fewer potential recall situations.

Q: How has the field staff responded to SCORE’s involvement?

Stearn: Among other roles, the FDA district offices are the face of the agency, especially in emergency situations. Sometimes they are the ones bringing the problem to us; other times, they provide contextual information. SCORE is here to align the leadership and organization to better support them. There is a natural tendency to want to fix a problem yourself, but that’s not always possible. When staff members see a problem and raise an issue and the agency isn’t acting, it creates frustration. When the leaders at the FDA come together with field staff, everyone starts working on the same page. SCORE empowers staff in the district offices to investigate issues and to get the agency aligned to support them when necessary to protect public health.

Correll: I would echo Doug’s comments about the field, and add that CFSAN’s compliance staff, which is aligned to support recall and other compliance operations in the field and at headquarters, is also leaning into these challenging situations to support sound and effective outcomes for public health.

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Page Last Updated: 07/07/2017
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