F.D.A. Proposes Rules to Enforce U.S. Standards for Imported Food

WASHINGTON — The Food and Drug Administration proposed new draft rules on Friday that would require food importers like Walmart and Cargill to make sure that their foreign growers and processors were following American food safety standards to prevent contamination in an increasingly globalized food supply.

About 15 percent of food that Americans eat now comes from abroad, more than double what it was 10 years ago, including nearly two-thirds of fresh fruits and vegetables.

The rules, if made final, would shift much of the burden for tracking food safety to companies. Currently, the F.D.A. inspects less than 2 percent of food imports at the border.

American companies would have to prove that their foreign suppliers had controls in place through actions like auditing the foreign facilities, testing food, and reviewing records. American importers would have to keep their own records on foreign suppliers. They would be allowed to hire outside auditors to make on-site inspections.

These are the last major rules needed to implement the Food Safety and Modernization Act, a landmark law passed by Congress in 2010 that was the first significant update of the agency’s food safety authority in 70 years. The administration has been criticized for not moving more quickly to carry out the law. The first set of rules, which applied to domestic producers, was proposed in January. The rules proposed Friday exempt importers of seafood and fruit juices.

The cost to industry of the new rules on imports would be $400 million to $500 million, said Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the F.D.A.

“If you look at the cost of doing it all by the feds, what you end up with is inadequate dollars,” said Dr. David Acheson, a former F.D.A. official who is currently with Leavitt Partners, a food safety and health care consulting firm in Washington. The current system, he said, “doesn’t work anymore. So let’s leverage the private sector.”

The new rules would represent a shift in the way the United States handles food safety by subjecting imported foods to the same safety standards as food produced domestically. Under the current system, the F.D.A. has very limited authority to ensure the safety of food produced abroad. It inspects less than 2 percent of all imported food.

“We don’t live in local land anymore,” said Dr. Acheson. “Though many people want to buy local, the reality is most Americans are buying things in big stores and relying on imported products.”

But major importers like Walmart and Cargill said they already do much of what is proposed under the new rules and that the change would have a bigger effect for smaller producers.

“What we’re really looking for is a level playing field here,” said Michael Robach, vice president for food safety at Cargill.

Consumer advocates said that it remained to be seen whether the new rules would have a real effect and that the test would be whether importers would be required to make sure their foreign sellers were adhering to new standards, or whether it would be voluntary. The Obama administration has also been criticized for taking two years to complete the rules, with some complaining that the White House was more concerned about protecting itself from Republican criticism than about public safety.

The draft rules will be open to comment from the public for 120 days, the agency said. The comment period will end in the late fall for Friday’s rules as well as the ones proposed in January.

The Food and Drug Administration is responsible for the safety of about 80 percent of the food that Americans consume. The rest falls to the Agriculture Department, which is responsible for meat, poultry and some eggs.

Mr. Taylor said the goal of the changes is to build a system that prevents food contamination rather than reacting to it.

“Less than 2 percent of import shipments are physically examined, and we’re up to around 10 million food products annually,” he said. “We all realize we need to do more.”

The agency, which has about 1,600 investigators handling imports of everything from food to drugs and medical devices, has also asked for more funds. President Obama’s 2014 budget reflects that, Mr. Taylor said, requesting about $260 million in additional resources, much of which would go to build the system to regulate imports.

Erik Olson, head of food programs at The Pew Charitable Trusts, which advocated for passage of the law, said the new rules “are a significant step forward,” but need to require on-site audits for risk foods, and that it was not clear that they did.

“Without more claritiy, this could end up as a paper exercise,” he said. “We view on-site verification as absolutely critical to a successful program.”

Mr. Olson said that 8 of the 19 multistate food outbreaks linked to F.D.A. regulated products that have occurred since January 2011 when the bill was signed into law have been linked to imports. Most recently, pomegranate seeds from Turkey sickened more than 140 people across the country with hepatitis A.

U.S. Standards for School Snacks Move Beyond Cafeteria to Fight Obesity

“Parents and schools work hard to give our youngsters the opportunity to grow up healthy and strong, and providing healthy options through school cafeterias, vending machines and snack bars will support their great efforts,” Tom Vilsack, the agriculture secretary, said in a statement.

The new rules were required under the Healthy, Hunger-Free Kids Act, which was passed by Congress in 2010 with broad bipartisan support. The law, supported by Michelle Obama and drafted with an unusual level of cooperation between nutrition advocates and the food industry, required the Agriculture Department to set nutritional standards for all foods sold in schools.

The department had previously set the standards for fats, sugars and sodium in meals prepared in schools, and the new rules bring other foods under similar standards. When schools open in the fall of 2014, vending machines will have to be stocked with things like whole wheat crackers, granola bars and dried fruits, instead of M&Ms, Cheese Nips and gummy bears.

“By teaching and modeling healthy eating habits to children in school, these rules will encourage better eating habits over a lifetime,” said Margo Wootan, director of nutrition policy at the Center for Science in the Public Interest, which worked on the legislation. “They mean we aren’t teaching nutrition in the classroom and then undercutting what we’re teaching when kids eat in the cafeteria or buy food from the school vending machines.”

Health advocates are taking the same approach to curb the consumption of fatty, sugary and salty foods that they did to reduce smoking: educating children in the hopes that they will grow up healthier and perhaps pass along healthy eating behavior to their parents.

Ms. Wootan said she was pleased that the rules would prevent the sale of sugary sports drinks like Gatorade in high schools. The drinks have already been withdrawn from elementary and middle schools, but Ms. Wootan said teenagers mistakenly think such drinks are healthier than sodas. “All they are is a sugary drink with added salt,” she said.

Some Republicans were critical of the new rules. Representative Lee Terry, a Republican from Nebraska, tweeted his opposition using the hashtag “nannystate” and writing “RIP tater tots.” Schools could probably sell Tater Tots, a hash-brown potato nugget made by Ore-Ida, if they were baked instead of fried.

Schools and big food and beverage companies have been trying to improve the nutritional quality of food sold in educational institutions for some time. The American Beverage Association, which lobbies on behalf of the beverage makers, noted that its members had already reduced the calories in drinks that are shipped to schools by 90 percent.

The Grocery Manufacturers Association, which represents big food companies, applauded the new rules, though it said it would continue to encourage the Agriculture Department to phase them in gradually.

This article has been revised to reflect the following correction:

Correction: June 28, 2013

An earlier version of this article misspelled the surname of the agriculture secretary. He is Tom Vilsack, not Vilsak.

U.S. Agencies to Develop Standards for Bed Rails

“Considering the number of deaths and injuries, we strongly believe all reasonable and timely efforts should be undertaken to address this hazard and protect the safety of the public,” the agencies wrote.

The standards were developed by ASTM International, which is an organization that develops and publishes voluntary technical standards for a wide range of products and which will oversee the committee.

A spokesman for Representative Edward J. Markey, Democrat of Massachusetts, who had called on the agencies to address bed rail deaths, said the congressman was disappointed.

“It’s a really tepid response,” said the spokesman, Eben Burnham-Snyder. “They issued voluntary standards for bed-rail manufacturers the last time and people still died. We’re not sure how this is going to be different.”

Gloria Black, who has campaigned for safer bed rails after her mother was killed in a 2006 accident, said the agencies’ action was a positive first step. “But they are still not addressing the serious problem of deaths and injuries that occur in hospital beds, only portable rails,” she said.

Bed rails are metal or plastic bars used on hospital beds and in home care to assist patients in pulling themselves up or helping them out of bed. They can also prevent people from rolling out of bed. But sometimes patients, particularly those with Alzheimer’s, can get confused and trapped between a bed rail and a mattress, which can lead to serious injury or even death.

After first being warned of the deaths in 1995, the F.D.A. in 1999 formed a working group made up of medical device makers, researchers and patient advocates. The agency considered requiring bed rail makers to add warning labels, but decided against it after they resisted. The agency said the added cost to small manufacturers and the difficulties of getting regulations through layers of government approval worked against tougher standards.

In 2006, the F.D.A. issued voluntary guidelines, instructing hospitals and nursing homes on the use of bed rails.

Last year, The New York Times reported that about 550 bed-rail-related deaths had occurred since 1995. In a review, the safety commission found 155 such deaths from January 2003 to last September. Most of those who died were 60 or older. Almost 37,000 people were injured in bed rail accidents and treated at hospital emergency rooms from 2003 to 2011, the agency said.