| July 26
July 26 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
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.
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
"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
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,"
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)