The Food and Drug Administration on Friday proposed two sweeping rules aimed at preventing the contamination of produce and processed foods, taking a long-awaited step toward codifying the food safety law that Congress passed two years ago.
The proposed rules represent a sea change in the way the agency polices food, a process that currently involves swinging into action after food contamination has been identified, rather than preventing it.
The rules range from requirements for better record-keeping and contingency plans for handling outbreaks to measures that would prevent the spread of contaminants in the first place, by requiring farmers to ensure that water used in irrigation is clean, for example, or that food processors prevent fresh food that may contain bacteria from coming into contact with food that has been cooked. New safety measures could be as simple as requiring farmworkers to wash their hands or installing portable toilets in fields.
Whether consumers will ultimately bear some of the new rules' cost was unclear. But FDA Commissioner Margaret Hamburg said a big question remaining to be resolved is whether Congress will approve the money to support the oversight needed to ensure compliance and enforcement of the new rules. The president requested $220 million, to be financed largely by fees, in his 2013 budget, but Dr. Hamburg conceded that "resources remain an ongoing concern."
Nonetheless, FDA officials were optimistic that the new rules would better protect consumers. "These new rules really set the basic framework for a modern, science-based approach to food safety and shifts us from a strategy of reacting to problems to a strategy for preventing problems," Michael R. Taylor, the agency's deputy commissioner for foods and veterinary medicine, said in an interview.
The FDA is responsible for the safety of about 80 percent of the food that the nation consumes. The remainder of the burden falls to the Department of Agriculture, which is responsible for meat, poultry and some eggs. One in 6 Americans becomes ill from eating contaminated food each year, the government estimates; of those, roughly 130,000 are hospitalized, and 3,000 die.
Congress passed the groundbreaking Food Safety Modernization Act, or FSMA, in 2010 after a wave of incidents involving tainted eggs, peanut butter and spinach sickened thousands of people and led major food makers to join consumer advocates in demanding stronger government oversight.
But it took the Obama administration two years to move the rules through the FDA, prompting accusations by advocates that the White House was more concerned about protecting itself from Republican criticism than about public safety. Mr. Taylor said, however, that the delay was a function of the wide variety of foods that the rules had to encompass and the complexity of the food system. "Anything that is important and complicated will always take longer than you would like," he said.
The first rule would require manufacturers of processed foods sold in the United States to identify, adopt and carry out measures to reduce the risk of contamination. Food companies also would be required to have a plan for correcting any problems that might arise and for keeping records that FDA inspectors could use for audit purposes.
One such preventive measure might be roasting raw peanuts at a temperature guaranteed to kill salmonella bacteria, which has been a problem in nut butters in recent years. Roasted nuts might then be sequestered from incoming raw nuts to further reduce the risk of contamination, said Sandra B. Eskin, director of the Pew Charitable Trusts' safe food campaign. "This is very good news for consumers," she said. "We applaud the administration's action, which demonstrates its strong commitment to making our food safer."
The second rule would apply to harvesting and production of fruits and vegetables in an effort to combat bacterial contamination that has arisen over the last decade, particularly from E. coli, a bacterium that is transmitted through feces. It would address what advocates refer to as the "four W's" -- water, waste, workers and wildlife.
Farmers would establish separate standards for ensuring the purity of water that touches, say, lettuce leaves and the water used to saturate soil, which will only nourish plants through their roots. A farm or plant where vegetables are packaged might, for example, add lavatories to ensure that workers do not urinate in fields and post signs similar to those in restaurants that remind employees to wash their hands.
The food industry cautiously applauded arrival of the proposed rules, with most companies and industry groups noting that they would be poring over them and making comments as necessary in coming weeks.
After a 120-day period for public comment, the FDA will finalize the rules. Food manufacturers will have a year to comply, and large farms, 26 months. Smaller farms and businesses will have additional time.
"Consumers expect industry and government to work together to provide Americans and consumers around the world with the safest possible products," the Grocery Manufacturers Association said in a statement. "FSMA and its implementation effort can serve as a role model for what can be achieved when the private and public sectors work together to achieve a common goal." The association noted that the FDA will have to issue more than 50 regulations to fully carry out the new law.
The businesses that must comply with the new proposals may face new costs as they implement steps to comply, but how much remains to be seen. The FDA's Dr. Hamburg noted that the measures they take may actually save them money in the long run, and that, in many cases, they already take such precautions voluntarily.
"The produce industry and the food industry in general has implemented food safety programs in the past, so it will depend on what the FDA has come up with as far as new requirements," said David Gombas, senior vice president for food safety and technology at the United Fresh Produce Association, who had not yet read the new rules. "It may or may not add costs."
During a conference call with reporters, the FDA's Mr. Taylor said some foods would require more attention than others. Fruits and vegetables destined for canning operations, for instance, might be subject to a less stringent set of handling guidelines because they are processed using heat that would kill bacteria, while the same produce intended for consumption fresh would be subject to different processes. Vegetables such as potatoes and artichokes, which are much more likely to be consumed cooked, he said, would be exempt from the rules altogether.