The U.S. Food and Drug Administration kicked off a series of public meetings last Thursday to explain its proposed new rules for improving the safety of the nation’s food supply— and gain feedback on the potential regulations.
The rules offer a framework for implementing the Food Safety Modernization Act, which was signed into law in January 2011. The law represents the most sweeping reform of food safety laws in more than 70 years.
More than 3,000 people in the United States die each year from foodborne illnesses, according to federal data. One in six are sickened and 100,000 hospitalized from illness tied to such pathogens as salmonella, E. Coli and listeria.
The new law is designed to move the FDA into preventive mode from the reactive mode in which it has operated historically, swooping in only after an outbreak has occurred. It gives the agency increased powers to inspect facilities and enforce compliance with safety standards.
Yet it remains an open question whether the FDA will be able to invest in the staff, training or technology it needs to implement the rules it has spent two years crafting.
President Barack Obama’s 2013 budget included an increase in the FDA’s funding of $225 million to implement the new law, the FDA’s deputy commissioner for foods and veterinary medicine, Michael Taylor, said in an interview.
The funds were to come from fees charged to food facilities, importers and exporters. That budget has not been authorized by Congress.
Even if the funds were to be authorized, they would not be enough to fully implement the regulations, Taylor said.
He declined to give an exact cost estimate, saying that would be presented in an upcoming report to Congress, but he said it would likely be less than the $583 million figure projected by the Congressional Budget Office.
“We think we can implement the law, with caveats, for less than that,” he said, “but $225 million wouldn’t cover it.”
Under the new law, the FDA for the first time will be allowed to penalize U.S. companies that fail to monitor produce they import from abroad, an extra layer of food safety protection for inspectors whose resources are stretched thin.
“Right now at the border, we’re limited in the percentage of food and medical devices we can inspect,” said Michael Roberts, a consumer safety officer at the FDA, who spoke in an interview at a conference for the National Treasury Employees Union.
In January, the FDA released two of five proposed new rules. It discussed the first of those rules, governing agricultural produce, on Thursday, and a proposal for ensuring safety at human food facilities on Friday. Later this year, it will release three additional proposals.
The new regulations lay out a myriad of standards, some less stringent than others, depending on the assessed risk of a particular product or facility. For example, products that are eaten raw are considered to carry a greater risk of contamination than those destined for a food processor.
Recent outbreaks of foodborne illness have been linked to lettuce, spinach, cantaloupe and peanuts, among other foods.
(Additional reporting by Anna Yukhananov; Editing by Jan Paschal)