By Carey Gillam
Jan 4 U.S. regulators proposed new food safety
rules on Friday that aim to make food processors and farms more
accountable for reducing foodborne illnesses that kill or
sicken thousands of Americans annually.
The rules, required by the Food Safety Modernization Act
(FSMA) that was signed into law two years ago, were announced by
the U.S. Food and Drug Administration on Friday.
The agency has come under heavy criticism for failing to
introduce new food safety rules faster, but many of those
critics applauded FDA's announcement.
"These proposed regulations are a sign of progress," said
Caroline Smith DeWaal, food safety director at the Center for
Science in the Public Interest, who has been a critic of the
FDA. "The new law should transform the FDA from an agency that
tracks down outbreaks after the fact to an agency focused on
preventing food contamination in the first place."
Roughly one in six Americans suffers from a foodborne
illness each year, and about 3,000 die, the FDA said. The United
States has had numerous outbreaks from foodborne illnesses tied
to salmonella, E. coli and listeria.
Food sickness has been linked to lettuce, cantaloupe,
spinach, peppers and peanuts.
Under the new rules, facilities that manufacture, process,
pack or hold human food to be sold in the United States, whether
produced at a foreign or domestic facility, would have to
develop a formal plan for preventing their products from causing
The rule would also require them to have plans for
correcting any problems that arise.
Companies will be required to document their plans and keep
records to verify that they are preventing problems. Inspectors
will be able to audit the program to enforce safety standards,
which should "dramatically" improve the effectiveness of
inspections, said Michael Taylor, FDA deputy commissioner for
foods and veterinary medicine.
"We're taking a big step for food safety by proposing the
standards that will help us prevent food safety problems rather
than just reacting to them," said Taylor. "Though many food
processors already have documented food safety plans, the new
rule sets requirements for "all firms across all commodities,"
A second rule proposes safety standard requirements for
farms that produce and harvest fruits and vegetables. Among the
requirements, farms would have to meet national standards for
the quality of water applied to their crops, as water is often a
pathway for pathogens.
Certain small farms would be exempt from most of the
The FDA will allow 120 days for public comment on the
Full implementation of the rules across food processors and
farms will take several years, Taylor said.
Implementing the new rules will add costs for some food
companies and farms, and the FDA will need additional financial
resources for retraining inspectors and implementation, Taylor
The Food Safety Modernization Act was the first food safety
overhaul in over 70 years in the United States and was signed
into law in January 2011.
The proposals followed a series of meetings between FDA
officials and consumer groups, corporate interests, researchers,
Critics have charged FDA with dragging its feet in
implementing the requirements of the new law. Last August, the
Center for Food Safety, a nonprofit advocacy group, sued the FDA
for missing several deadlines set under the law.
The standards for analyzing and documenting hazards were due
last July, and the standards for safe production and harvesting
of fruits and vegetables were due last January.
Within the next few months, FDA hopes to issue a proposed
rule on preventative safety controls for animal feed as well as
proposed regulations related to importer accountability for food
The FDA is also setting requirements for the safe transport
of food and hopes to have a proposal out later this year. It is
also working to set standards to prevent intentional
contamination of food.
"That is a very challenging area to figure out ... but we'll
be working on that," Taylor said.
Congress also mandated FDA to improve the traceability of
food and FDA is working with industry on a pilot study. FDA will
issue a report on that work soon, Taylor said.
"There is plenty more in the pipeline," he said. "There will
be more coming forward in 2013."
The Grocery Manufacturers Association, which represents more
than 300 food, beverage and consumer product companies, said it
was pleased to see FDA moving forward on implementing the
two-year-old food safety law.
And the Consumers Union praised the new rules for going to
the "heart of the problems" the United States has had with food
But Center for Food Safety senior attorney George Kimbrell
said it was disheartening that the agency did not issue these
proposed rules until after the center filed suit to spur action.
"They are taking some action. But there are still several
rules outstanding that they are behind schedule on," said
Kimbrell. "This is a small part of a larger problem that is
ongoing. There is a still a lot of work the agency has to do to
comply with Congress' mandate."