FDA Commissioner Margaret Hamburg said the new rules could help prevent outbreaks like 153 recent Hepatitis A illnesses that were linked to a frozen berry mix sold at Costco. That outbreak, which hit nine states, was linked to frozen pomegranate seeds from Turkey.
Hamburg said Friday that the berry outbreak "illustrated the growing complexity of the food supply." FDA investigators had to look at berries from several different countries in the mix before they zeroed in on the Turkish seeds as the probable source of the illnesses.
The proposed guidelines would require U.S. food importers to verify that the foreign companies they are importing from are achieving the same levels of food safety required in this country. The rules, which would also improve audits of food facilities abroad, could cost the food industry up to $472 million annually.
Since Congress passed the food safety law in December 2010 and President Barack Obama signed it in early 2011, there have been several outbreaks caused by imported foods, including an occurrence of listeria in imported Italian cheese last year that killed four people. Other illnesses were linked to tainted papayas, mangoes and nuts and spices used as ingredients.
Michael Taylor, FDA deputy commissioner for foods, says the rules show a major shift in thinking in the way the government works to keep food safe.
Like rules for domestic farmers and food companies released earlier this year, the idea is to make businesses more responsible for the food they are selling or importing by proving that they are using good food safety practices. They might do that by documenting basic information about their suppliers' cleanliness, testing foods or acquiring food safety audits.
Currently, the government does little to ensure that companies are trying to prevent food safety problems but generally waits and responds to outbreaks after they happen.
"The onus is on us to detect the problem that has already occurred," Taylor said.
Requiring better prevention was the intent when Congress passed the bill. But since then, the law has run into several obstacles, including FDA delays in issuing the rules, a lack of congressional funding and increasing opposition from some rural members of Congress who represent worried farmers.
A farm bill passed in the House this month included an amendment sponsored by Rep. Dan Benishek, R-Mich., that would delay all of the food safety rules. Farmers and importers have expressed concern that the rules will require too much time, cost and paperwork.
FDA regulators say the new rules are necessary as the food system becomes more complex and more global. Food often stops in several locations and passes through many different hands in a matter of days before it hits grocery shelves.
And a lack of funding has given the FDA little oversight over what is being produced. The agency inspects most food companies in the United States only every five to 10 years, and it does even fewer inspections abroad. The food safety law requires the agency to step up those inspections, and Taylor said the FDA inspected as many as 1,300 facilities in foreign countries last year, up from 300 in 2010. That is still a just a fraction of the companies that import to the United States.
Many food companies and importers already follow the steps that the FDA is proposing. But officials say the new requirements for domestic and imported foods could have saved lives and prevented illnesses in several of the large-scale outbreaks that have hit the country in recent years.
The domestic food safety rules proposed in January would require U.S. farms and food processors to take new precautions against contamination such as making sure workers' hands are washed, irrigation water is clean and livestock 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 will take comments on both the domestic and foreign food safety proposals for the next several months and then move to issue final rules.