03/08/2013 - The first major overhaul of the nation's food safety system since the Great Depression is moving forward, now that the Food and Drug Administration has proposed new rules aimed at halting the contamination of produce and processed foods.
The rules represent a sea change in the approach to food safety. They would give federal regulators the authority to require fruit and vegetable growers and food manufacturers to prevent outbreaks of foodborne illness from tainted foods such as peanut butter, leafy greens, and cantaloupes. Each year outbreaks sicken an estimated 48 million Americans and kill 3,000.
The proactive approach is a significant change in how the FDA works. Previously, federal authorities generally would shut down food companies only after contamination occurred and people got sick. Once the rules are finalized, manufacturers will be required to have detailed safety plans, and those that do not meet standards can be shut down—before contaminated food reaches the marketplace.
The new rules are a long-awaited step in implementing the landmark FDA Food Safety Modernization Act. "With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families," said Health and Human Services Secretary Kathleen Sebelius in announcing the draft rules.
Pew has been a leader in supporting those efforts, bringing together victims of foodborne illnesses, health advocates, and industry organizations to help win passage of the law and to continue to push for the rules and for more resources for the FDA. Congress passed the law in late 2010, and President Barack Obama signed it on Jan. 4, 2011. (See Trust, Summer 2011, "Putting Food Safety on the Menu.")
Passage of the act was a historic moment: The FDA's food safety authority had not been substantially updated since the administration of Franklin D. Roosevelt. But the world of food had changed dramatically over the decades, with consumers eating much more packaged and processed food with ingredients coming from around the globe.
"The law is a game changer," said Sandra Eskin, who directs Pew's food safety projects. "Rather than wait for people to get sick, FDA can step in and close a plant before a single person becomes ill. That's a huge step forward for the safety of the nation's food supply and consumers."
Erik Olson, who leads Pew's food programs, noted that not only does the law change the emphasis from reaction to prevention, it also has broad scope. "Eighty percent of the country's food supply is regulated by the FDA. It's nearly everything except meat and poultry," he said.
But as extensive and precedent-setting as the new law was, it still required new rules to enact its provisions, and for months nothing happened.
Pew worked with its partners to urge the administration to move on the rules and keep its promise to ensure the safety of the food supply. The efforts included public statements, op-eds, advertisements, polling that showed people widely favored the new regulations, and other public calls to follow through on the landmark law.
Calls for the rules grew louder as additional outbreaks of foodborne illnesses occurred after the president signed the law. By last December, there had been 15 outbreaks since the law had been signed, with 1,395 illnesses, 437 hospitalizations, and 40 deaths.
In 2011, a listeria outbreak traced to cantaloupes killed 33 people, the largest number of deaths from a single outbreak in more than 25 years. Last November, salmonella sickened 42 people and was traced to a peanut butter plant in New Mexico. Even without the rules, the FDA used its new power under the law for the first time to temporarily halt production at the facility.
The long wait caused consternation among industry representatives and health advocates. In December, Pew delivered an online petition to the White House with 35,000 signatures urging the president to issue the rules, emphasizing strong public support for the measures.
In January, the FDA announced the long-awaited rules, two years to the day that the president signed the food safety act.
Industry groups said they welcomed the proposals and noted that many growers and processors already maintain high standards in their production facilities. There will be a comment period through mid-May.
The new rules are an essential first step because they address "the heart and soul" of the law, Eskin said. "This was as big a win as the legislation itself. These rules put the law into place," she said.
The rules focus on two key areas. Processing plants would have to ensure and document efforts to minimize contamination. While many processors do this already, before the new law there was no legal obligation on them to do so. Farms also would need to make sure that unsanitary water and animal waste don't contaminate crops. They would need to have lavatory and hand-washing facilities for field workers and clean storage for fruits and vegetables after harvesting.
Pew's efforts to enact the law continue. Other proposals associated with the food safety law are still being considered by the White House and the FDA is drafting rules to implement other provisions of the act.
One addresses prevention-based requirements for pet food. The Centers for Disease Control and Prevention has found that in a number of recent outbreaks, contaminated pet food made people sick from handling it and from interacting with pets that had eaten it.
Another would for the first time hold companies responsible for making sure foods they import are produced in ways consistent with U.S. safety laws. About 15 percent of the nation's food comes from overseas, and imports are growing by approximately 10 percent each year. Many experts on the food industry see these import rules as crucial to "leveling the playing field" by ensuring that importers are living by the same high safety standards as U.S. producers with whom they compete.
Pew plans to advocate for those rules as well as to ensure the FDA has the resources necessary to enforce the law and ramp up facility inspections—which will increase threefold under the new law.
"We will continue to work with industry, consumer advocates, survivors of foodborne illness, their families, and the administration to ensure that the remaining proposed rules are soon released—and that all the regulations are as strong as possible, quickly finalized, and effectively enforced," Olson said.
Daniel LeDuc is the editor of Trust.