By: Heather Williams
Not all super heroes wear capes. Not saying that a group of people working behind the scenes to keep our food safe are actual super heroes, but to some of us it might seem so. As we speak, there is an organization tasked with responsibility of assessing threats involving the food we eat every day. This organization is known as SCORE. Among their everyday jobs in different parts of the industry is to gather and respond to issues that arise in food manufacturing that could result in people becoming ill, or worse.
What is SCORE?
Known as the Strategic Coordinated Oversight of Recall Execution (SCORE), SCORE was created in April 2016 in response to concern that the FDA (Food and Drug Administration) was not able to do enough to expedite cooperation and recalls when public health was a concern with food based companies. In this quest to advise the more serious situations, SCORE was born. Co-chairs William Correll and Douglas Stearn assembled senior leaders from Foods and Veterinary Medicine as well as Global Regulatory Operations and Policy with expertise covering inspections and investigations, compliance and enforcement, policy, legal, communications, outbreak response, and science backgrounds.
How Does SCORE Operate?
Essentially, these leaders evaluate current food safety issues as they arise and determine if their participation is needed. If a company has it under control, they step back and allow the FDA to monitor the situation and let the company make their own decisions. However, if the company seems reluctant to respond when their food is or could be contaminated, SCORE steps in to weigh in on the situation. According to Stern, “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.”
SCORE assists in providing resources to identify the contamination problem, whether that be deploying additional resources for inspections, conducting sampling and laboratory testing to confirm a problem, and if needed SCORE also alters customers to a possible danger in the event a voluntary recall is not implemented.
This organization is the silent super heroes behind the scenes ready to take action to keep our country safe. At lease where food manufacturing is concerned.
What Happens is the Company Does Not Cooperate?
If SCORE believes the criteria has been met and that serious consequences may occur if a recall is not implemented and it appears that the company is resistant to a voluntary recall, the key components of SCORE kick in. This agency was created to protect the public from harm and can invoke legal authority to make sure all measures are handled appropriately. These are enforcement tools already granted to the FDA and include suspension of a food facility’s registration, administrative detention to keep foods out of the marketplace, and mandatory recall. If the situation warrants it, SCORE can also take traditional court-ordered actions such as seizures and injunctions and can impose a timeline for actions. The FDA’s Food Safety Modernization Act (FMSA) already provides enforcement tools that the FDA and SCORE to take action as needed.
How Has SCORE Helped So Far?
SCORE has participated in several serious actions since the agency began. Many of the activities in which SCORE is involved do not relate to a foodborne outbreak. The organization handles contaminated foods of all kinds, not just foodborne illness related issues. In fact, the acronym SCORE originally stood for Strategic Coordinated Outbreak Response and Evaluation, but more focus on recalls prompted the acronym to change to Strategic Coordinated Oversight of Recall Execution, broadening the scope of the organization. Some of the cases SCORE has been involve in include allergen contamination in flour, listeria in sandwiches, and powdered infant formula that did not meet government compliance.
A company that processed bulk flour had allergen contamination with peanut protein. SCORE became involved because the flour made its way to large downstream companies that had already used this flour and finished products already served to the public. This created an extensive voluntary recall involving each of the companies that had used the tainted flour in their products.
The FDA identified Listeria monocytogenes in a manufacturing facility responsible for distributing sandwiches for the U.S. Department of Agriculture’s Food Nutrition Service’s school lunch program. Listeria was found in the facility environment and surfaces in which food was prepared. The company issued a recall, the extended recall, and eventually decided to cease ready-to-eat food manufacturing.
Another company that SCORE was involved in surrounded a powdered infant formula that was not in compliance with U.S. infant formula regulations. The company was not testing for the required nutrients and did not test for Cronobacter, a bacteria that is deadly for infants. The company initiated a recall after SCORE made it clear that enforcement actions would be pursued if a voluntary recall was not initiated within 24 hours.
Other cases include supplements containing lead contamination, powdered milk containing Salmonella contamination, and soy nut better contaminated with E. coli O157:H7. SCORE has also been involved in soft cheese, smoked fish, and hummus contaminated with Listeria monocytogenes.
Q and A With Doug Stern and William Correll
Doug Stern and William Correll are the Co-Chairs for this amazing organization. Stern is the Director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA). William Correll is the Director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). We had an opportunity to ask them some questions about how they got started, where they see SCORE in the future, and how they feel about what SCORE has done so far.
Q: How do you decide what cases to get involved in?
A: SCORE looks at the most challenging foodborne illness outbreaks, food safety issues, and food recalls; situations that are complicated by the nature of the product, the scope of available evidence, and the company’s response. When there is a potentially contaminated food product on the market, time is crucial to prevent people from getting sick, and in some cases it can be complicated to determine the most appropriate course of action. SCORE not only looks at recall scenarios in outbreak situations, but also cases in which recalls and other actions may be needed, even when there are no current reports of people who are sick. These cases can be elevated by any component or member of SCORE for consideration.
With these challenging cases, the team supports the FDA’s field staff and district offices across the country by evaluating a range of options for the use of the FDA’s compliance and enforcement authorities, and making quick decisions about the best course of action.
Q: Was there a specific event that made you decide that SCORE was needed?
A: There was no one specific event that prompted the creation of SCORE. SCORE was announced by FDA leadership to bolster FDA’s ability to ensure that companies initiate voluntary recalls in a prompt and effective manner. While FDA staff was already facilitating thousands of prompt and successful voluntary recalls, we recognized the need for a more urgent type of response for complex cases.
Q: How do you feel about the progress SCORE has made since implementation?
A: We believe that SCORE is making a difference in addressing difficult cases and streamlining processes to ensure consumer notification and get potentially harmful foods off the market as soon as possible to reduce consumer exposure. Among other things, SCORE has: 1) helped improve tactical planning, leading to additional inspections and sampling assignments; 2) shortened recall timeframes; and 3) and expedited our ability to communicate to consumers about potentially dangerous products. For instance, since implementation, SCORE has reviewed and directed recalls and related operations in cases that include flour contaminated with peanut protein, (a major food allergen), Hepatitis A found in imported frozen strawberries used in smoothies, Hepatitis A found in imported raw tuna, facilities contaminated with Listeria monocytogenes, soy nut butter contaminated with E. coli 0157, and pistachios in which Salmonella was detected.
Q: What do you see SCORE accomplishing in 5 years?
A: SCORE has achieved significant accomplishments in its first year, and we continue to streamline and to address challenging cases earlier in the process. We expect that SCORE will continue to streamline and empower an integrated approach to food recalls and swift response, particularly as whole genome sequencing is more widely used in linking pathogens and outbreaks. Additionally, with the arrival of the compliance dates for the FDA Food Safety Modernization Act rules, regulated industry will have new obligations to create systems to prevent food safety hazards and SCORE will continue to work toward implementing and improving the performance of an integrated food safety system.
SCORE’s goals include identifying and closing gaps that slow the process of determining whether a food is a threat to public health or interfere with identifying the right actions to take in response to potential contamination. Our ultimate goal is to continue to improve our ability to protect consumers from unsafe food.
Plans for the Future
The aim of SCORE is to act immediately when necessary, and create systems to automate action based on specific criteria. According to co-chair Correll “SCORE’s goals for the next year include identifying and closing gaps that slow the process of determining whether a food is a threat to public health or interfere with identifying the right actions to take in response to potential contamination. Our ultimate goal is to continue to improve our ability to protect consumers from contaminated food.”
Compliance dates of FSMA are beginning to occur, putting additional food safety controls in place and overseeing the safety of imported foods in addition to domestic companies. This will help reduce food contamination and help avoid food related outbreaks and contamination in the future.