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.
President Obama 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.
The 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, D.C.
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.
The 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 contaminated."
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.
The 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.
This 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 requirements.
There's also an amendment to the rule which exempts food production facilities that:
- Have less than $500,000 in annual sales
- Have over half their products going direct-to-consumer at farmers' markets and through home delivery of fruits and vegetables or to retail establishments
- Meet tests for being 'local.'
The 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.
By Elizabeth Weise, USA TODAY
USA Today / Gannett