Last week Dr. Margaret Hamburg announced that she was stepping down after six years as Commissioner of the Food and Drug Administration. As with almost every one of her predecessors over the last half-century, Hamburg did not have an academic or professional background in nutrition, food safety, or any other arena of food-related work. Rather, her background was in with health care. Even in the pharmaceutical realm, the commissioner was controversial. Praised by many in the pharmaceutical and biotechnology industry for promoting "fast tracking" of drug approvals, she was also appropriately critiqued by many watchdog groups as weak and ineffectual in assessing the safety of those corporation's products. As for food safety issues, as is unfortunately routine at the FDA, for Hamburg they always seemed to come last.
Take food-borne illnesses. These are a major food safety concern for our nation. Each year around 50 million Americans will get sick from pathogens, disease-causing agents, in our food supply. Of these, around 128,000 will require hospitalization, and approximately 3,000 will die. Among all age groups, children under five are most likely to become ill, most likely to be hospitalized, and most likely to die.
To stem the tide of this epidemic, Congress passed and President Obama signed the Food Safety Modernization Act (FSMA) in January 2011. FSMA was the first overhaul of our food safety laws in 70 years. President Obama called it "hallmark legislation" and "a major leap forward."
FSMA's new requirements underscored the urgency of the food-borne illness epidemic, and food safety concerns more generally, that spurred Congress to act. The new law mandated that FDA meet specific time deadlines for promulgating FSMA's implementing rules, new enforcement powers and food recalls, increased inspections, safer and more sanitary food transportation, and preventing potential terrorist actions in contaminating food. This is because Congress knew that, without implementing agency rules, a new statute is just an empty vessel.
Yet despite the fact that Americans, including our youngest, were becoming sick and dying every day from food-borne pathogens, weeks and months passed, and FDA failed to draft the needed new safety rules. The mandated statutory deadlines passed, and progress on food safety was at a standstill. This was fine for industry that could continue to increase profits by taking advantage of safety loopholes, but FDA is not supposed to be serving industry, but rather devoting itself to protecting public health. Consumer groups wrote urgent pleas to the president and FDA to get the safety rules drafted and finalized, to no avail.
Finally, in August of 2012, my organization, Center for Food Safety, on behalf of itself and the Center for Environmental Health sued the FDA for its unlawful delay. In court, the FDA made the remarkable claim that it had the discretion to ignore the congressionally-set deadlines, and could delay the new FSMA food safety rules indefinitely. Thankfully, for the health of our citizens, the court completely rejected the FDA's arguments, issued an injunction setting new appropriate and binding deadlines for getting the safety rules finished and in force. The agency remained recalcitrant, appealing the decision. Finally a court settlement was reached and firm deadlines put in place; now the new FSMA draft rules are out, and being finalized. The case was an important victory for protecting public health, but it should not take years of hard fought litigation to force the FDA to simply obey the law, and provide urgently needed improvements to food safety for the American people.
Unfortunately, the FDA putting food last is only one part of our broken food safety system. There is also a fundamental failure of coordination and responsibility for food regulation at the federal level. There are 15 different federal agencies implementing at least 30 different federal laws related to food safety. That means that responsibility for food safety is juggled between different agencies, with differing and sometimes competing priorities, budgets, and capacities. For example, eggs, meat, and poultry are supervised by the USDA, not the FDA. And the FDA, USDA, and EPA all have various jurisdictions over genetically engineered foods and crops, yet there is no mandatory pre-market testing, labeling or effective oversight of these foods.
While not a total panacea, a critical step toward securing the safety of our food supply is establishing a single independent food agency that would reorganize the inefficient and chaotic regulatory tangle that reigns today. Food is fundamental, and we should join many of the other countries around the world that have independent, stand-alone food agencies. A new food agency would increase consumer confidence and make much more efficient use of taxpayer dollars. A unified agency would make it easier to trace pathogens and stop outbreaks before they occur. It would also clarify responsibility for regulating new technologies such as nanotechnology and genetically engineered foods.
In his proposed federal budget President Obama, perhaps sensing a need for change, suggested combining parts of both the USDA and the FDA that deal with food safety under the Department of Health and Human Services (HHS). But this is a bad idea that would probably make the problem worse. Fifty or more years of neglect have shown that the HHS, the umbrella agency of the FDA, cannot and will not put food first. Instead, the right answer has been provided by Congresswoman Rosa DeLauro (D-CT) and Senator Dick Durbin (D-IL) who have introduced a bill to establish a stand-alone, single federal food authority. All of us who eat, who care about our children and our public health, and hopefully that means all of us, should give this bill our strong support.