The Food and Drug Administration released historic food safety regulations on Thursday that will force food manufacturers to implement major reforms to reduce the risk that their products will make people sick. The Centers for Disease Control and Prevention estimate that 48 million Americans contract a foodborne illness every year, 3,000 of whom end up dying.
The new regulations, which cover packaged and processed foods from applesauce to ziti, stem from the Food Safety Modernization Act that President Barack Obama signed into law in January 2011.
Food safety advocate Sandra Eskin of the Pew Charitable Trusts hailed the release as "a big step forward for food safety and public health."
"For the first time, we have rules that require food processors to take steps to identify risks and do something to reduce them," she said.
The rules, which go into effect in 2016, were notoriously overdue. The FSMA mandated that new standards be released by July 2012, but they were delayed time and time again. In the three years since that deadline, a number of high-profile outbreaks of foodborne illness have been linked to foods that would have been covered by the rules, most notably Blue Bell ice cream and Sunland peanut butter.
Officials from the FDA and the Obama administration's Office of Management and Budget said they needed the extra time to make sure that the rules were written correctly, with input from all stakeholders, given that they make up the biggest overhaul of food safety regulations in a generation. The Grocery Manufacturers Association, which represents many of the companies most affected by the new rules, praised the FDA for the "deliberative and inclusive approach it took in developing these regulations."
The fact that these regulations were released now, rather than even later, is due in part to a lawsuit by the Sacramento-based Center for Food Safety. A district judge in northern California ruled that the FDA had "unlawfully withheld" the rules for too long, ordering the agency to release the regulation on preventive controls for human food -- the one released this week -- by August 30. Technically, the FDA missed even this deadline, but the Center for Food Safety's attorney George Kimbrell said the group was "pleased" that the regulations came in when they did.
"Without our case and it's injunction, no doubt we would still be waiting," Kimbrell told The Huffington Post.
The key measure in the rules is a requirement that food manufacturers write up -- and follow -- detailed plans that identify possible sources of pathogens and establish ways to prevent those pathogens from making it into food. Such plans have been mandated for producers of packaged seafood since 1995, and for juice producers since 2001. The new regulations released this week will require the plans for almost every food found in the middle aisles -- but not the perimeter -- of the grocery store. Meat and dairy products are regulated by the United States Department of Agriculture, rather than the FDA, while fresh produce is governed by a separate FSMA regulation.
Food safety advocates were pleased to find that the final rules also require that most manufacturers test their facilities and finished products for pathogens. Eskin said that she sees this testing as "a fundamental piece of a prevention-based system," because without it, there's no way to know whether a company's food safety protocols are actually working.
In short, Eskin said, "There were some little things we wish had been included, but the bigger picture is that these are very strong rules."
Still, the enthusiasm of many food safety advocates has been tempered by their long-held belief that the FDA lacks the resources to ensure that manufacturers actually obey the regulations when they take effect a year from now. Though the FDA's food safety budget has increased since FSMA passed, many believe it hasn't increased enough to ramp up the frequency and rigor of inspections even to the relatively modest level required by the law.
"The real question is how do you enforce it," said famed food safety lawyer William Marler. "We’re asking companies to implement the rules with very little oversight. Is that ultimately going to be sufficient to make our food supply safer? The jury is still out."
Marler also noted that the FDA has become far more willing to harshly prosecute food safety violations since Obama came to office. This summer, executives of the Peanut Corporation of America were found guilty of knowingly selling salmonella-tainted peanut butter that sparked a food poisoning outbreak that killed at least nine people. The plant's former owner now faces life imprisonment, which is unprecedented in the history of American food safety. Marler speculated that the looming threat of personal punishment for infractions could spur executives to take the rules seriously, even if the chance of inspection is low.
The FDA also released its final versions of regulations for the production of animal food on Thursday. Further FSMA regulations on topics including produce and imported food are expected in the next few months.
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