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.