After two years of delay, the Food and Drug Administration announced
today that rules putting the United States at the forefront of food
safety worldwide are finally moving forward.
signed the Food Safety Modernization Act on Jan. 4, 2010. Hailed as the
most sweeping overhaul of food safety in 70 years, it was held up in the
review process until Friday, possibly due to election-year jitters over
too much regulation. That logjam has now cleared and FDA is proposing
two significant rules that should greatly increase the safety of the
U.S. food system, experts say.
"The FDA Food Safety Modernization
Act is a common-sense law that shifts the food safety focus from
reactive to preventive," said Health and Human Services Secretary
Kathleen Sebelius in a statement.
The two new rules are part of a
suite of regulations in the 2010 legislation. They cover food
production-facility safety and fruit and vegetable safety on the farm
and in the packing shed. Three more rules are pending and should be
issued shortly, said Mike Taylor, officially FDA's deputy commissioner
for foods and veterinary medicine and unofficially the food safety czar.
He called their release the start of "a new era. We should have fewer
outbreaks, fewer illness and less disruption of the food supply."
Food safety advocates and the food industry, who have been waiting for the rules with mounting frustration, are thrilled.
legislation is "landmark" because it gives the FDA the ability to focus
on prevention of problems instead of waiting for outbreaks to occur and
then going in after the fact, said Caroline Smith DeWaal, food safety
director at the Center for Science in the Public Interest in Washington,
The new rules "will govern about 80% of the U.S. food
supply, pretty much everything but meat and poultry," said Erik Olson,
director of food programs at Pew Charitable Trusts' health group. It's a
significant step that is the first overhaul of "FDA's food safety laws
since the Great Depression."
Missing from the announcement are the
rules in the 2010 law that ensure safer imported food. They are
expected out in the coming months, Taylor said.
Those are critical because imported food is now over 15% of our food supply, and it's growing by about 10% a year, Olsen said.
nation's food industry has long called on government to level the
playing field in terms of food safety so that companies that do a good
job aren't at an economic disadvantage. Grocery Manufacturers
Association President and CEO Pamela Bailey applauded the move by the
FDA in a statement Friday. The new rules "can serve as a role model for
what can be achieved when the private and public sectors work together
to achieve a common goal," she said.
Two big food safety outbreaks
would have been significantly different had the rules been in place,
experts say. In last year's outbreak of salmonella that sickened at
least 42 people in 20 states from contaminated peanut butter, the rule
would have required producer Sunland Inc. in Portales, N.M., to report
the results of environmental sampling tests to officials, said DeWaal.
In that case, Sunland knew there was contamination in its plant, but
wasn't required to tell anyone about it "and FDA wasn't able to review
them," she said. "This new system will protect against incidents where
companies have tried to hide records that showed that their plants are
Another example Taylor gave was the listeria
outbreak from contaminated Rocky Ford cantaloupes that killed at least
29 people in 2011. When it happened, there was no requirement that the
water used to wash the cantaloupe in the packing shed must be free from
deadly microbes. Under the new rules, the company would be required to
test its wash water to ensure it was clean.
The two rules the FDA
will put forward for public comment cover fruit and vegetable safety and
food processing. The fruit and vegetable safety rule requires that:
- Farmers ensure irrigation water that touches fruits and vegetables isn't contaminated with dangerous organisms.
- The water used to wash fruits and vegetables in packing sheds must be clean.
- Farm workers must be provided with basic sanitation facilities that includes a place to wash their hands.
- Growers must implement controls for microbial hazards that are associated with animals that may enter growing fields.
- Manure and other material used as fertilizer must be sufficiently composted or treated to kill dangerous organisms.
- Packing sheds must be free from standing water and packing equipment must be easy to clean.
rules are based on common sense, Taylor said. For example, if a farmer
has a field of tomatoes, irrigation water that touches them must be
microbiologically safe. However, if farmers use drip irrigation, where
the water doesn't actually come into contact with the tomatoes, they're
not required to test the safety of their water.
The second rule
will apply to fruits and vegetables the same type of prevention controls
that have long been required for the nation's meat and seafood. These
require that food-processing facilities:
- Determine possible places where food could become contaminated.
- Figure out systems to keep that from happening.
- Check to make sure those systems work.
- Be able to prove to state or federal agricultural officials that those systems work through testing.
is the first time there have been enforceable food safety standards for
farms. "Congress has said that these modern techniques should be
applied to all foods across the board" and that's what these rules do,
Taylor said. He doesn't anticipate that FDA will be doing a lot of
judicial enforcement on farms, but will instead focus on education,
teaching and guidance.
It will take several years for the rules to take effect. First they will be published in the Federal Register, where
the public will have 120 days to comment. Then FDA makes adjustments to
the rules based on the comment. Finally, perhaps within a year, they
will be made final and go into effect, Taylor said.
The FDA is
proposing that larger farms be in compliance with most of the produce
safety requirements 26 months after the final rule is published in the Federal Register. Small
and very small farms would have additional time to comply. All farms
would have additional time to comply with some of the water quality
There's also an amendment to the rule which exempts food production facilities that:
- Have less than $500,000 in annual sales
over half their products going direct-to-consumer at farmers' markets
and through home delivery of fruits and vegetables or to retail
- Meet tests for being 'local.'
FDA will need extra funding to implement the rules but where it will
come from isn't yet clear. In its 2013 budget, the agency requested the
ability to implement fees that would have brought in $220 million in
funding, but Taylor said "we got a strong signal that we shouldn't
expect it" to come through.
Food-borne illness sickens an
estimated one in six Americans every year, with nearly 130,000
hospitalized, according to the Centers for Disease Control and
Prevention. It's estimated that about 3,000 die from their illness.