By Carey Gillam
Jan 4 U.S. regulators proposed new food safety rules on Friday that aim to make food processors and farms more accountable for reducing foodborne illnesses that kill or sicken thousands of Americans annually.
The rules, required by the Food Safety Modernization Act (FSMA) that was signed into law two years ago, were announced by the U.S. Food and Drug Administration on Friday.
The agency has come under heavy criticism for failing to introduce new food safety rules faster, but many of those critics applauded FDA's announcement.
"These proposed regulations are a sign of progress," said Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, who has been a critic of the FDA. "The new law should transform the FDA from an agency that tracks down outbreaks after the fact to an agency focused on preventing food contamination in the first place."
Roughly one in six Americans suffers from a foodborne illness each year, and about 3,000 die, the FDA said. The United States has had numerous outbreaks from foodborne illnesses tied to salmonella, E. coli and listeria.
Food sickness has been linked to lettuce, cantaloupe, spinach, peppers and peanuts.
Under the new rules, facilities that manufacture, process, pack or hold human food to be sold in the United States, whether produced at a foreign or domestic facility, would have to develop a formal plan for preventing their products from causing foodborne illness.
The rule would also require them to have plans for correcting any problems that arise.
Companies will be required to document their plans and keep records to verify that they are preventing problems. Inspectors will be able to audit the program to enforce safety standards, which should "dramatically" improve the effectiveness of inspections, said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine.
"We're taking a big step for food safety by proposing the standards that will help us prevent food safety problems rather than just reacting to them," said Taylor. "Though many food processors already have documented food safety plans, the new rule sets requirements for "all firms across all commodities," he said.
A second rule proposes safety standard requirements for farms that produce and harvest fruits and vegetables. Among the requirements, farms would have to meet national standards for the quality of water applied to their crops, as water is often a pathway for pathogens.
Certain small farms would be exempt from most of the requirements.
The FDA will allow 120 days for public comment on the proposals.
Full implementation of the rules across food processors and farms will take several years, Taylor said.
Implementing the new rules will add costs for some food companies and farms, and the FDA will need additional financial resources for retraining inspectors and implementation, Taylor said.
The Food Safety Modernization Act was the first food safety overhaul in over 70 years in the United States and was signed into law in January 2011.
The proposals followed a series of meetings between FDA officials and consumer groups, corporate interests, researchers, and others.
Critics have charged FDA with dragging its feet in implementing the requirements of the new law. Last August, the Center for Food Safety, a nonprofit advocacy group, sued the FDA for missing several deadlines set under the law.
The standards for analyzing and documenting hazards were due last July, and the standards for safe production and harvesting of fruits and vegetables were due last January.
Within the next few months, FDA hopes to issue a proposed rule on preventative safety controls for animal feed as well as proposed regulations related to importer accountability for food safety.
The FDA is also setting requirements for the safe transport of food and hopes to have a proposal out later this year. It is also working to set standards to prevent intentional contamination of food.
"That is a very challenging area to figure out ... but we'll be working on that," Taylor said.
Congress also mandated FDA to improve the traceability of food and FDA is working with industry on a pilot study. FDA will issue a report on that work soon, Taylor said.
"There is plenty more in the pipeline," he said. "There will be more coming forward in 2013."
The Grocery Manufacturers Association, which represents more than 300 food, beverage and consumer product companies, said it was pleased to see FDA moving forward on implementing the two-year-old food safety law.
And the Consumers Union praised the new rules for going to the "heart of the problems" the United States has had with food safety.
But Center for Food Safety senior attorney George Kimbrell said it was disheartening that the agency did not issue these proposed rules until after the center filed suit to spur action.
"They are taking some action. But there are still several rules outstanding that they are behind schedule on," said Kimbrell. "This is a small part of a larger problem that is ongoing. There is a still a lot of work the agency has to do to comply with Congress' mandate."