The Food and Drug Administration on Thursday finalized long-awaited rules that will require U.S. food manufacturers to make detailed plans to identify and prevent possible contamination risks in their production facilities.
The new regulations, which will apply to the production of both human and animal foods, mark the first step in a broader effort to make the nation's food safety system more proactive, rather than merely reacting to outbreaks after they occur.
The rules released Thursday represent a cornerstone of a far-reaching law passed nearly five years ago by Congress, which aimed to overhaul the nation's food safety system for the first time in generations. The FDA said it expects to finalize additional rules regarding the growing and packaging of produce, as well as requirements that imported foods meet U.S. safety standards, in coming months.
Contaminated foods sicken an estimated 48 million Americans annually, leading to 128,000 hospitalizations and roughly 3,000 deaths, according to the Centers for Disease Control and Prevention. A wide range of tainted foods, from cookie dough to cheese to caramel apples, have caused outbreaks even in the years since the law's passage. In recent days, for instance, an ongoing outbreak of salmonella-tainted cucumbers has infected 341 people and caused two deaths across 30 states.
FDA officials said the new rules finalized Thursday are intended to make companies more accountable for preventing contamination of their products to begin with, and making sure that any tainted foods never reach consumers.
"The food safety problems we experience have one thing in common -- they are largely preventable," said Michael Taylor, the FDA's top food safety official, adding that the new regulations "are not one-size-fits-all requirements. They are risk-based, targeted and flexible."
Taylor said many food manufacturers already have in place strict protocols to prevent bacteria and allergens from contaminating their products, and that the new rules draw from widely accepted best practice in the industry, as well as from extensive conversations with large and small producers.
"Why it’s great is for the first time, food processors are going to be required to take steps to prevent contamination, especially the kind of contamination that makes people sick," said Sandra Eskin, director of food safety for The Pew Charitable Trusts. "We should see, hopefully, fewer recalls and fewer illnesses linked to processed foods. It will take awhile, but that was the goal of this law."
The Grocery Manufacturers Association, which represents a large swath of the nation's food and beverage industry and had at times clashed with the FDA's regulatory efforts, also praised Thursday's rules and the agency for the "deliberative and inclusive approach it took in developing these regulations."
The FDA said it will phase in the new requirements over time, beginning late next summer. Some businesses, such as those with fewer than 500 employees, will have longer to comply.
Advocates said Thursday that even as the key elements of the food safety law are put into place, Congress must give the FDA sufficient funding to oversee the new rules.
"We do need additional resources to enforce this law effectively," Taylor said.
Eskin noted that while President Obama had requested more than $109 million in his most recent budget for food safety initiatives, proposals in the House and Senate have included no more than $45 million.
"It's less than half of what the FDA needs," she said. "This is crunch time; it's a critical point."