By: William Correll and Douglas Stearn
We have made dramatic changes in our response to complex, potentially high-risk food safety situations that may be difficult to address quickly.
Almost a year ago, we heard concerns that FDA was not doing enough to ensure that companies promptly and effectively initiate recalls of potentially dangerous food products in those rare instances in which a firm is not responding appropriately. FDA has always been committed to protecting the U.S. food supply, which is among the safest in the world, but we recognized 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.
And so, we took to heart issues raised by the Office of the Inspector General at the Department of Health and Human Services and have used them as a catalyst for change.
Not just change, but a culture change. At the heart of this change was the creation of SCORE, which stands for Strategic Coordinated Oversight of Recall Execution. We are the co-chairs of this group of senior leaders that gets involved in the most challenging food safety situations, working with field staff and district offices to evaluate the range of available options and deciding quickly what action to take. For example, SCORE can drive agency action if the company is not acting aggressively enough to recall their products, and can push for use of administrative or judicial remedies.
We now have FDA compliance, enforcement, and field leaders at the table, reviewing cases every week or more often, as needed. Science and medical officers are engaged in the conversation, as are field investigators, and lawyers.
What is the right action? What should FDA be doing? What should the company be doing? These are real time, high-level decisions, with the result being that field investigators are now empowered to immediately engage senior leaders in overcoming obstacles to the rapid removal from the marketplace of foods that are, or could be, contaminated. The process of raising a food safety issue up within the agency has thus been streamlined to put FDA leaders and field staff on the same page right away.
Among the thousands of product recalls that FDA oversees each year, SCORE has played a critical role in addressing the most significant risks to the public. SCORE’s involvement has ensured that multiple recalls involving high-risk products have been initiated, has improved tactical planning, and sped the use of enforcement tools when necessary.
In the past year, SCORE has been involved in cases that included lead contamination of dietary supplements, Salmonella contamination of powdered milk, E.coli O157:H7 in soy nut butter, and Listeria monocytogenes in hummus, soft cheese and smoked fish. In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or expedited the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food.
The creation of SCORE is not the only change we’ve made. There is a new recall audit plan to assess the adequacy of a company’s recall efforts and more than two dozen procedural and policy changes that have either happened or are in the works. These include an expansion of public notification of recalls that may affect the most vulnerable consumers, including the very young and elderly.
Most companies readily initiate a voluntary recall when faced with evidence that their product is unsafe. But when there is an obstacle, we are determined to overcome it, using all of the tools we have available. We’ve always taken our job seriously and we’ve shown over the past year that we will use every opportunity to do it better.
William Correll is the director of the Office of Compliance in FDA’s Center for Food Safety and Applied Nutrition
Douglas Stearn is the director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs