Food manufacturers must be more vigilant about keeping their operations clean under new government safety rules released Thursday in the wake of deadly foodborne illness outbreaks linked to ice cream, caramel apples, cantaloupes and peanuts.
The rules, once promoted as an Obama administration priority and in the works for several years, ran into delays and came out under a court-ordered deadline after advocacy groups had sued. Even then, the Food and Drug Administration allowed the Aug. 30 deadline to pass without releasing the rules to the public.
When the rules go into effect later this year, food manufacturers will have to prepare food safety plans for the government that detail how they are keeping their operations clean and show that they understand the hazards specific to their product. The plans will lay out how they handle and process food and how they monitor and clean up dangerous bacteria like listeria, E. coli or salmonella that may be present, among other safety measures.
The idea is to put more focus on prevention in a system that for decades has been primarily reactive to outbreaks after they sicken or even kill people. The majority of farmers and food manufacturers already follow good food safety practices, and the law would aim to ensure that all do.
“The food safety problems we face have one thing in common — they are largely preventable,” said Michael Taylor, the FDA’s deputy commissioner for foods.
The Centers for Disease Control and Prevention estimate that 48 million people — or 1 in 6 Americans — get sick annually from foodborne diseases. An estimated 3,000 people die.
FDA investigators have often found dirty equipment in food processing facilities after deadly outbreaks. In the Blue Bell ice cream outbreak this year, FDA inspectors found many violations at a company plant, including dirty equipment, inadequate food storage, food held at improper temperatures and employees not washing hands appropriately. Three listeria deaths were linked to ice cream produced by the company.
A 2011 listeria outbreak linked to Colorado cantaloupe killed 30 people. The FDA said old, hard to clean equipment and improper cooling were partly to blame for the illnesses.
The outbreak of salmonella linked to a Georgia peanut company in 2009 killed nine and sickened more than 700 people in 46 states. It was that outbreak, early in President Barack Obama’s first term, that prompted the government and Congress to move forward on strengthening the food safety system.
Mindful of the high cost of outbreaks and recalls, food companies generally have supported the rules.
The rule “ensures that prevention is the cornerstone of our nation’s food safety strategy, places new responsibilities on food and beverage manufacturers, and provides the FDA with the authorities it needs to further strengthen our nation’s food safety net,” said Pamela Bailey, head of the Grocery Manufacturers Association, which represents the largest food companies.
FDA’s Taylor said that the rules will create a “level playing field” and ensure that all companies are following the rules.
“Facilities with a strong food safety culture, they want to fix the problem,” he said.
Congress first passed the rules in 2010, and it took the FDA two years to write the specific requirements. The agency revised that proposal after some opposition to the first version from farmers and the food industry but agreed to deadlines in a lawsuit filed by food safety advocates who said the agency was moving too slowly. The FDA waited until the Aug 30 deadline to submit the rules to the Federal Register, a process that kept the agency in compliance with the courts. But they did not make the rules available to the public until Thursday.
The food manufacturing rule is one of seven that the FDA is issuing to improve food safety, as per the law. The agency also issued rules Thursday to ensure safer manufacturing of pet food.
The most controversial rules are regulations due in October that would set new standards for farmers growing produce. The rules would require farmers to take new precautions against contamination, making sure workers’ hands are washed, irrigation water is clean and that animals stay out of fields, among other things. The FDA has worked with the agricultural sector to set reasonable standards, but some in the industry and in Congress say the standards will be burdensome for business.
In addition to regulating farms and food manufacturing facilities, the food safety law authorized more inspections by the FDA and gave the agency additional powers to shut down facilities. The law also required stricter standards on imported foods.
