This article is from the source 'nytimes' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at http://www.nytimes.com/2013/07/27/health/fda-proposes-rules-to-ensure-safety-of-imported-food.html

The article has changed 4 times. There is an RSS feed of changes available.

Version 1 Version 2
F.D.A. Proposes Rules to Enforce U.S. Standards for Imported Food F.D.A. Proposes Rules to Enforce U.S. Standards for Imported Food
(about 7 hours later)
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. WASHINGTON — More than two years after Congress passed a landmark law meant to prevent the importation of contaminated food that sickens Americans, the Food and Drug Administration proposed rules on Friday that for the first time put the main onus on companies to police the food they import.
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. Major food importers and consumer advocates generally praised the new rules, but the advocates also said they worried the rules may give the companies too much discretion about whether to conduct on-site inspections of the places where the food is grown and processed. They said such inspections must be mandated.
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. The law itself was grappling, in part, with problems that have grown out of an increasingly globalized food supply. About 15 percent of food that Americans eat comes from abroad, more than double what it was just 10 years ago, including nearly two-thirds of fresh fruits and vegetables. And the safety of the food supply — foreign and domestic — is a critical public health issue. One in every six Americans becomes ill from eating contaminated food each year, Dr. Margaret Hamburg, F.D.A. commissioner, estimated. About 130,000 are hospitalized and 3,000 die.
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. The F.D.A. has tried to keep tabs on imports, but, in reality, only manages to inspect one to two percent of all imports at American ports and borders.
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 new rules would subject imported foods to the same safety standards as food produced domestically and require companies importing the food to make sure it meets those standards. American companies would have to prove that their foreign suppliers had controls in place with audits of the foreign facilities, food tests, and reviews of records, among other methods. The companies would also have to keep records on foreign suppliers. They would be allowed to hire outside auditors to make on-site inspections — if such inspections are ultimately required. The auditors would be vetted in a process approved by the F.D.A.
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. Consumer advocates said that the test will be whether importers are required to conduct such on-site audits, or whether that is left to the companies’ discretion, as one option proposed in the draft rules would allow. If that option becomes final it would effectively allow the industry to police itself, advocates said.
“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.” “Without more clarity, this could end up as a paper exercise,” said Erik Olson, head of food programs at The Pew Charitable Trusts. He added, however, that the rules are “an important improvement over the weak current import system.”
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. Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the F.D.A., said the different options simply reflected an effort to be flexible in a very complex food supply.
“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.” “We envision circumstances in which it would be required to have an on-site audit,” he said. “We are trying to – with these two different options – flesh out different ways of getting there.”
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. These are the last major rules needed to implement the Food Safety Modernization Act, a 2010 law that was the first significant update of the agency’s food safety authority in 70 years. The Obama administration has been criticized for taking over two years to propose the rules, with some complaining that the White House delayed acting to avoid Republican attacks at the cost of public safety.
“What we’re really looking for is a level playing field here,” said Michael Robach, vice president for food safety at Cargill. Some of the biggest importers, such as Walmart and Cargill, praised the proposed rules and said they already do much of what they would require to avoid food outbreaks that could damage their global brands.
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. “What we’re really looking for is a level playing field here,” said Michael Robach, vice president for food safety at Cargill. He said the company was still studying the rules to determine what changes, if any, it would have to make.
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. Consumer groups said that outbreaks have persisted under the current system, and noted that a significant share of imports are brought to the United States by smaller companies.
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. The cost to industry of the new rules on imports would be $400 million to $500 million, Mr. Taylor said. . The money reflects new costs, because, in the past, no one was legally accountable for ensuring safe food production before the food arrived in the United States.
Mr. Taylor said the goal of the changes is to build a system that prevents food contamination rather than reacting to it. The F.D.A. is responsible for the safety of about 80 percent of food that Americans consume. The rest falls to the Agriculture Department, which is responsible for meat, poultry and some eggs.
“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.” Daniel Carpenter, a Harvard political scientist who studies the F.D.A., said it is not possible – or desirable – to send armies of F.D.A. inspectors fanning out across the globe to make sure food is safe for Americans. Supply chains are now highly decentralized and mobile, and the most efficient way to keep food safe is to require companies doing business with foreign sellers to impose checks at critical points in the chain before the product arrives in the United States.
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. The current system “relies on the F.D.A. detecting and reacting to problems at the border,” Mr. Taylor said. “The big paradigm shift is toward prevention and industry being being responsible for documenting what they have done to prevent problems.”
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. The agency is also asking for more resources for itself since staff will be responsible for auditing the new company records, though some observers say Republican opposition in Congress may make additional money to carry out the regulations difficult to obtain. The F.D.A. has about 1,600 investigators handling imports of everything from food to drugs and medical devices, a spokeswoman said. President Obama has requested about $260 million more in his 2014 budget, much of which would go to build the system to regulate imports.
“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.” “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 now with Leavitt Partners, a food safety and health care consulting firm in Washington whose clients include food companies. The current system, he said, “doesn’t work anymore. So let’s leverage the private sector.”
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. The rules proposed Friday will be open to public comment for 120 days. They exempt seafood and fruit juices, which are subject to different rules.
Mr. Olson of Pew Charitable Trusts said 8 multistate outbreaks of illness linked to imported food products the F.D.A. regulates have occurred since January 2011, when the bill was signed into law.
Caroline Smith DeWaal, the food safety director for the Center for Science in the Public Interest, a consumer health advocacy group, said the fact that there were two different options in the rule for on-site inspections indicated that there was disagreement within government – possibly between the F.D.A. and the White House – over which policy to adopt.
Without on-site visits, she said, “importers could just rely on paperwork and promises that may or may not reflect conditions on the ground in these facilities.”
Mr. Taylor said the new rules would be unlikely to prompt objections from foreign trading partners and described them as being “well within those obligations,” an assertion that Mr. Olson of Pew echoed. Part of the delay in the rules, a source close to the negotiations said, was the Obama administration making sure they did not interfere with any foreign trade obligations.