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| Jay Sjerven |
KANSAS CITY, Mo. – In the past six months, a senior-level group within the Food and Drug Administration has directed the agency’s response to select high-profile and complex threats to food safety where voluntary food recalls were required. The group, Strategic Coordinated Oversight of Recall Execution, or SCORE, was established in April largely in response to concerns raised by the Department of Health and Human Services’ Office of the Inspector General about the ability of the FDA to ensure companies initiate voluntary food recalls in a prompt and effective manner. The FDA in October marked SCORE’s first six months of activity and touted the strides taken by the group toward addressing the OIG’s concerns.
The SCORE team comprises senior agency leaders, whose authority may be used to expedite decisions and assist field offices to resolve the most vexing issues related to food safety, including a company’s response when requested to issue a voluntary food recall. SCORE’s co-chairmen are 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 the FDA’s Office of Regulatory Affairs (ORA). In addition, SCORE’s membership includes agency experts in inspections and investigations, compliance and enforcement, policy and legal affairs, communications, outbreak response and science.
The SCORE team meets weekly at the FDA’s Maryland headquarters and may convene more often and on short notice if required.
The deputy commissioners noted since April, SCORE has reviewed and directed operations in cases that included flour contaminated with peanut protein, facilities contaminated with Listeria monocytogenes, pistachios in which Salmonella was detected, and baby food that was not manufactured in compliance with infant formula regulations. All of the cases resulted in recalls and announcements issued by the firms and the FDA.
“In the cases brought to the team, we believe that SCORE has helped determine the right course of action and shorten recall timeframes, getting the products off the market faster,” Dr. Ostroff and Sklamberg said, “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 one case, FDA suspended a food facility’s registration after a re-inspection and additional sampling requested by SCORE showed continued contamination.”
By ensuring a comprehensive and directed approach to food safety issues brought to its attention, SCORE has been able to set deadlines ensuring prompt results in instances requiring voluntary food recalls, Dr. Ostroff and Sklamberg said. SCORE also is well positioned to advise companies that may resist such timelines for addressing a food safety issue of the authorities vested in the FDA by the Food Safety Modernization Act, including mandatory recall.
Stearn in an FDA Voice Blog on Oct. 25 explained the relationship between SCORE and FDA’s district offices.
“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.”
Dr. Ostroff and Sklamberg looked to the future, saying, “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.”
Stearn added SCORE may weigh in on whether companies conducting some voluntary Class II recalls should be required 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,” he said. “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.”
David Acheson, president and CEO, The Acheson Group, advised, “So what does all this mean to the food industry? Primarily that FDA will have much less tolerance in the amount of time it gives facilities to figure out the bookends of a recall. The agency is planning to move faster on recall action, which means you will have to move faster — or be subject to FDA action.”
