Thread: FDA proposes new rules for safer imported foods

FDA proposes new rules for safer imported foods

Reuters staff Reuters

Long-awaited rules aimed at improving the safety of foods imported to the United States were proposed by the U.S. Food and Drug Administration on Friday.

The first-ever draft rules for safety oversight of imported food are part of a larger mandated food safety regulatory overhaul underway at the FDA, and part of a series of rules FDA is proposing that cover everything from vegetables and other produce to dog food.

Under the rules proposed Friday, importers would be accountable for verifying with their foreign suppliers that certain food safety standards are being met. Under current conditions, U.S. food safety inspectors examine food coming into the country but are able to inspect only a small percentage for potential problems.

Importers have a market interest in ensuring the safety of the food they bring in, but currently are not required to mandate that their suppliers meet certain standards.

Under the new rules, importers would be required to maintain records verifying that their foreign suppliers have met standards for the production of the food coming into the country. Importers would undergo audits of their records and performance. The change should significantly improve food safety, according to the FDA.

Michael Taylor, FDA's deputy commissioner for foods, said in an interview that the new rule is the "central foundation" for an overall new import safety system.

"It embodies this paradigm shift from relying solely on FDA to detect and respond to problems and instead defining the responsibility and the accountability of the importers to prevent the problems," Taylor said.

FDA will continue to check products at points of entry into the country, and will increase foreign inspections and work more closely with foreign governments, Taylor said.

Food-borne illness is a serious problem in the United States. Roughly one in six Americans suffers from a food borne illness each year, and about 3,000 die, according to the FDA.

The FDA said annually illnesses associated with imported foods that would be subject to the new regulations costs about $1.18 billion, which is more than one-fifth of the entire estimated burden of illness related to foods consumed in the United States.

This summer, at least 150 people in the United States were sickened with Hepatitis A linked to frozen pomegranate seeds imported from Turkey and used in a berry mix sold in U.S. stores.

And cucumbers grown in Mexico and imported to the United States were linked to an outbreak of Salmonella earlier this year that made 84 people in 18 states ill.

The agency has said it cannot estimate quantitatively the benefits of the proposed rule. But while the proposed rule would not itself establish safety requirements for imported food, it would significantly help reduce illness and death by providing additional assurance that imported food is produced in compliance with certain rigorous safety standards, the agency said.

"We are very confident that if we are able to implement this over time we certainly will reduce the burden of illness," said Taylor. "We don't think we'll get to zero. But we know that these conscientious preventive measures work."

Sandra Eskin, director for food safety at The Pew Charitable Trusts non-profit organization, applauded the move as providing important extra protection for consumers.

"We have an ever-growing percentage of the food supply that is imported," she said. "This is important and long overdue."

The new rules are required by the Food Safety Modernization Act (FSMA) that was signed into law in January 2011 and the FDA has come under heavy criticism for taking so long to implement the requirements of the new law. Last August, the Center for Food Safety sued the FDA for missing several deadlines set under the law.

In June, a federal court ordered FDA to finalize all the rules by June 30, 2015 and said all draft rule proposals must be presented to the public by November 30 of this year.

Center for Food Safety senior attorney George Kimbrell said the FDA's new proposed rules were a "good development."

"It's unfortunate it required a court order and litigation," he said.

More rule proposals are in the works. Within the next few months, FDA hopes to issue a proposed rule on preventative controls for animal feed and pet food, Taylor said. It is also working on proposed rules to better control intentional harmful tampering with food and rules for transportation of foods.

"Food safety is a global problem. We're all eager to get this done as expeditiously as possible," said Taylor. (Editing by Bob Burgdorfer)

http://www.nbcnews.com/health/fda-issues-new-proposals-safer-imported-foods-6C10761187

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F.D.A. Says Importers Should Audit Food Safety

By SABRINA TAVERNISE

Published: July 26, 2013

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.

Major food importers and consumer advocates generally praised the new rules, but the advocates also said they worried the rules might 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 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 the amount 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 A. Hamburg, F.D.A. commissioner, estimated. About 130,000 are hospitalized and 3,000 die.

The F.D.A. has tried to keep tabs on imports, but, in reality, manages to inspect only 1 to 2 percent of all imports at American ports and borders.

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 were ultimately required. The auditors would be vetted in a process approved by the F.D.A.

Consumer advocates said that the test would be whether importers were required to conduct such on-site audits, or whether that was 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.

“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 were “an important improvement over the weak current import system.”

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 regarding a very complex food supply. “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.”

These are the last major rules needed to put into effect the Food Safety Modernization Act, a law passed by Congress in 2010 that was the first significant update of the agency’s food safety authority in 70 years. The Obama administration has been criticized for taking more than two years to propose the rules; some complained that the White House delayed acting to avoid Republican attacks, at the cost of public safety.

Some of the biggest importers, like Walmart and Cargill, praised the proposed rules and said they already do much of what they would be required to do to avoid food outbreaks that could damage their global brands.

“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 if it needed to make any changes.

Consumer groups said that outbreaks had persisted under the current system, and noted that a significant share of imports were brought to the United States by smaller companies.

The new rules on imports would cost $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.
http://www.nytimes.com/2013/07/27/health/fda-proposes-rules-to-ensure-safety-of-imported-food.html?_r=0