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Updated Saturday, January 5, 2013 at 12:31 AM

FDA proposes new rules for policing food safety

By STEPHANIE STROM
The New York Times

The Food and Drug Administration (FDA) on Friday proposed new rules aimed at preventing the contamination of produce and processed foods, taking a long-awaited step toward codifying the food-safety law Congress passed two years ago.

The proposed rules represent a transformation 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.

Since last summer, outbreaks of listeria in cheese and salmonella in peanut butter, mangoes and cantaloupe were linked to more than 400 illnesses and up to seven deaths, according to the federal Centers for Disease Control and Prevention. The number of those sickened is likely much higher.

The FDA's proposed rules would require farmers to take new precautions against contamination, to include making sure workers' hands are washed, irrigation water is clean and that animals stay out of fields. Food manufacturers will have to submit food-safety plans to the government to show they are keeping their operations clean.

The FDA commissioner, Dr. Margaret Hamburg, said a big question 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 Hamburg conceded that "resources remain an ongoing concern."

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, about 130,000 are hospitalized and 3,000 die.

Congress passed the Food Safety Modernization Act 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. It was signed in 2011.

It took the Obama administration two years to move the rules through the FDA, prompting accusations by some that the administration was more concerned about protecting itself from Republican criticism than about public safety.

One 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 the roasting of 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 Eskin, director of the safe-food campaign at the Pew Charitable Trusts.

Another rule would apply to the harvesting and production of fruits and vegetables in an effort to combat the 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 facility 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 the 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 the coming weeks.

"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.

The association noted that the FDA will have to issue more than 50 regulations to fully carry out the new law.

The produce rule would mark the first time the FDA has had real authority to regulate food on farms. In an effort to stave off protests from farmers, the farm rules are tailored to apply only to certain fruits and vegetables that pose the greatest risk, such as berries, melons, leafy greens and other foods that are usually eaten raw. A farm that produces green beans that will be canned and cooked, for example, would not be regulated.

The new rules could cost large farms $30,000 a year, according to the FDA. The agency did not estimate costs for individual processing plants, but said the rules could cost manufacturers up to $475 million annually.

After a 120-day period for public comment, the FDA will finalize the rules. Manufacturers will have a year to comply and large farms 26 months. Smaller farms and businesses will have additional time.

Other rules are pending, including one that would cover importers' responsibilities to verify the safety of food products grown or made overseas. About 15 percent of food eaten by Americans is imported, although a higher percentage of produce comes from abroad.

Material from The Associated Press is included in this report.


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