FDA Strengthening Our Food Safety Foundation
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For the Food and Drug Administration, prevention is at the heart of food safety.
“Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century,” says FDA Commissioner Margaret A.
Hamburg, M.D. “We cannot afford to wait until people become ill to realize there is a problem.”
Prevention is the core principle of the FDA Food Safety Modernization Act that President Obama signed into law in 2011, creating a blueprint for the most sweeping changes to the nation’s food protection system since Theodore Roosevelt held office.
In accordance with that law, FDA is promulgating five new rules to support and strengthen the nation’s food safety system for the 21st century. Together, the proposed rules will establish requirements for farmers, food companies and importers to prevent foodborne illness.
The first two have been proposed and published for public comment:
- Preventive Controls for Human Food: This rule sets safety requirements for facilities that process, package or store food for people. (There is a separate, upcoming rule for animal food.) The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness.
- Produce Safety: The food-safety law requires that science-based standards be set for the production and harvesting of fruits and vegetables, and FDA is proposing such standards for growing, harvesting, packing, and holding produce on farms.
Controls for Human Food
FDA has oversight of more than 166,000 registered domestic food facilities, including manufacturers, processors, warehouses, storage tanks and grain elevators. Under the new preventive control rules, most human food facilities would be required to have a written plan that
- evaluates hazards that are reasonably likely to occur in food, such as pathogens (disease-causing organisms) and allergens.
- specifies the steps that will be put in place to minimize or prevent those hazards.
- specifies how these controls will be monitored.
- maintains routine records of the monitoring.
- specifies what actions will be taken to correct problems that arise.
The plan would specify the steps that will be put in place to minimize or prevent those hazards, and the actions that will be taken when problems arise.
Food facilities “must think up front about what they have to do to keep the food safe,” says Michael Taylor, FDA deputy commissioner for foods.
“While the plan will come from the food companies, the planning and execution are done under the watchful eye of FDA,” notes Donald Kraemer, senior advisor at FDA’s Center for Food Safety and Applied Nutrition. “The agency will evaluate the plans and will continue to inspect the facilities,” he says.
These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:
- Irrigation and other agricultural water
- Farm worker hygiene
- Manure and other additions to the soil
- Intrusion of animals in the growing fields.
- Sanitation conditions affecting buildings, equipment and tools
The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.
FDA staff traveled to 13 states and numerous farms to get a first-hand understanding of the diversity of farms and farming practices. “We met with Amish growers in the Ohio valley, organic and sustainable farmers throughout the nation’s heartland, small farmer cooperative members who supply major metropolitan areas, and large commercial growers and shippers,” says Kraemer.
Kraemer explains that there are many variables to consider. With water, for example, the actions farmers would be required to take depend in part on the kind of irrigation system used and whether the water comes in direct contact with the fruit or vegetable. The bottom line, though, would be that “you can’t use water that would cause food to be contaminated,” he says.
The Other Three Rules
The rules still to come are:
- Foreign Supplier Verification for Importers: This program will require importers to verify that foreign suppliers are following procedures that provide the same level of health protection as that required of domestic food producers. About 15 percent of the food consumed in the U.S. is imported, including about 49 percent of fresh fruit and 21 percent of vegetables.
- Accredited Third Party Certification: The accreditation of third-party auditors would help ensure that food producers in other countries comply with U.S. food safety laws.
- Preventive Controls for Animal Food: This is the implementation of preventive controls at animal food facilities that are similar to those proposed for human food.
The proposed rules have been published in the Federal Register, with a 120-day public-comment period. The rules are filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
January 4, 2013