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From: Food Quality & Safety magazine, December/January 2010

The FDA Shifts From Food Safety to Public Safety

The agency's new approach appears to be more proactive

by Eric Hargan

In recent years, food-related illnesses followed by highly publicized product recalls have created concerns that food product regulation in the United States is inadequate. The food industry has a complex regulatory structure, divided among many federal, state, and local authorities, with the U.S. Food and Drug Administration (FDA) handling almost all federal food inspections other than meat products.

If something goes wrong, though, the FDA has little mandatory recall authority—usually, recalls are producer-initiated actions, and the FDA has been seen as a primarily reactive agency. The FDA’s reactive role may be changing, however, as a new generation of political leadership, combined with new inspection standards, increasingly creates a proactive and preemptive regulatory approach.

Illustrating this approach was a March 2009 recall—or “pre-call”—of pistachios and pistachio products by a leading processor. The recall was not related to any reports of consumer illnesses. Instead, the FDA urged the processor to initiate a recall after government inspectors at the processing plant found that roasted pistachios were not being kept separate from raw nuts that can carry Salmonella and other pathogens. In its comments about the recall, the FDA’s leadership made it clear that it was trying to minimize the likelihood of consumer exposure to health problems. The agency’s goal was to warn consumers not to eat pistachios until the implications of any possible contamination were clear.

In effect, this is a new regulatory approach that could signal a change in the formerly collaborative approach to food safety that the food industry and regulators have taken, shifting toward a preemptive philosophy more often used by public health officials. Of course, almost any agency charged with protecting public health and safety has both regulatory and enforcement sides.

Some, like the FDA and the Environmental Protection Agency, for example, concentrate on both the slow work of promulgating policies and regulations and the immediate need of public health response. Others, such as the Centers for Disease Control and Prevention (CDC), focus on public health response and have a smaller regulatory role. The FDA’s new leaders seem to want to shift the FDA toward a public health response mode. Not surprisingly, the FDA’s new senior leaders, selected by the Obama Administration, both come from a public health background.

Public Health Philosophy

The new orientation of the FDA toward preemptive, swift, and aggressive enforcement with a public health agency perspective suggests that such steps will presage a more vigorous domestic inspection and regulation effort.

Margaret A. Hamburg, MD, confirmed by the Senate in May as the twenty-first Commissioner of Food and Drugs, served during the 1990s as commissioner of New York City’s Department of Health and Mental Hygiene, making her the top public health official in the nation’s largest city. Subsequently, she was assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services. The FDA’s principal deputy commissioner, Joshua M. Sharfstein, MD, served as acting commissioner before Dr. Hamburg’s appointment and oversaw the agency’s actions in the pistachio recall. Before that, he was the commissioner of health for Baltimore.

Drs. Hamburg and Sharfstein, shortly after assuming their new positions, co-authored an editorial in the New England Journal of Medicine titled “The FDA as a Public Health Agency.” In the editorial, they declared that their agency should define success in terms of its ability “to promote health, prevent illness, and prolong life” rather than “such intermediate measures as the number of facilities inspected.” In food safety, the two commissioners stated, the FDA should use its public health clout to “partner with . . . other authorities to establish a modern food-safety system focused on prevention of contamination . . . [and] strive to build safeguards into every step of the production and distribution process.”

The two leaders specifically singled out the 2008 Salmonella outbreak linked to contaminated peanut butter products, calling it “a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls.” Although there is no general indication that food safety has been declining in the U.S., the FDA now seems to be orienting itself toward building in more preventive controls and setting for itself a goal of preventing any possibility of contamination.

Response Strategies

The two new leaders inherit an agency that already has substantial regulatory clout in the realm of inspections. Domestic and imported food manufacturing facilities must conform to the FDA’s good manufacturing practices (GMP), which cover standards for worker sanitation, plant construction, and cleanliness. When the FDA conducts surveillance and investigation of a food processing facility for GMP compliance, it may review everything from production history and firm management to direct observation of “objectionable conditions” and “deficiencies.”

The new orientation of the FDA toward preemptive, swift, and aggressive enforcement with a public health agency perspective suggests that such steps will presage a more vigorous domestic inspection and regulation effort. The FDA has noted that the new senior officials promise “swift, aggressive, and effective enforcement” and that they are concerned that pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.”

Statements such as these, coupled with actions such as the removal of review of most warning letters by the FDA’s chief counsel’s office, raise the notion that the FDA’s new top officials are switching the orientation of the agency from that of a deliberate, regulatory agency to a swiftly responding public health and safety agency, similar to a CDC or Federal Emergency Management Agency model.

Food producers would be well advised to begin developing response strategies that prepare for a more active role by industry regulators in an increasingly sensitive public health atmosphere. And any response strategy must include identifying the source of an alleged food problem and assuring the public and regulators of an operational solution.

An initial period of disruption should also be expected. If the FDA’s new leaders expect to set such worthy but vague goals as “promote health” and “prolong life,” it will be unclear for some time what they expect industry to do to move toward these targets. These goals could remain vague and easy to reach, as long as the U.S. population continues to extend its longevity.

In that case, it will remain impossible to sort out the contribution made by the FDA or regulated industry. On the other hand, the breadth of the goals could lead the FDA to demand anything it wishes of industry without providing clear direction. It is to be hoped, and indeed expected, that these worthy goals will eventually become reified in clear regulations, guidance, and intermediate measures that allow reasonable direction—within FDA’s jurisdiction—for industry.

The FDA’s move toward using its new aggressive public health stance “to build a system with multiple levels of oversight” and to regulate the entire chain from production to processing to distribution to consumption is in its early stages, but the implications are clear. Food producers must exercise more collective responsibility throughout the supply chain. They must know where food commodities are from, verify production compliance with all applicable standards, and be prepared to supply all required documentation in the event of regulatory inquiry.

Once the expected new proactive standard is more firmly established, there will be no turning back from anything other than full compliance with an FDA that promises to move swiftly and aggressively and, as then-deputy commissioner Dr. Sharfstein showed in the pistachio pre-call, preemptively. ■

Hargan formerly served as deputy secretary for the U.S. Department of Health and Human Services and as a regulatory policy officer. He is currently a partner with McDermott Will & Emery; reach him at ehargan@mwe.com or (312) 984-0385.

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