The new rules are a requirement of the Food Safety Modernization Act, which President Barack Obama signed into law two years ago.
"These proposed regulations are a sign of progress," Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, who has been a critic of the FDA, told Reuters. "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."
About 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 bacteria contaminating everything from mangos to lettuce to onions to spinach, cantaloupe and peanut butter. And that's just in the last six months!
"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 Michael Taylor, FDA deputy commissioner for foods and veterinary medicine.
Under the new rules, makers of food to be sold in the United States, whether produced here or abroad, have to develop a formal plan for preventing their products from causing foodborne illness. The new standard also would require them to have plans for fixing 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, Taylor said.
The new rule sets requirements for "all firms across all commodities," Taylor added.
A second rule proposes safety standard requirements for farms that produce and harvest fruits and vegetables. Among other new regulations, farms would be required to meet national standards for the quality of water applied to their crops. (Water is commonly a pathway for pathogens.)
There will be 120 days for public comment before the proposals become set in stone.
The FSMA is the first food-safety overhaul in the United States in more than 70 years, although critics have charged the FDA with dragging its feet in implementing the requirements of the new law. Last August, the Center for Food Safety actually sued the FDA for missing several deadlines set under the law.
Next up: The FDA will issue a proposed rule on preventative controls for animal feed, as well as proposed regulations related to importer accountability for food safety.
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The agency also is working on setting requirements for the safe transport of food, and to set standards for trying to prevent intentional contamination of food.
Better late than never.
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