The congressional passage of the Food Safety Modernization Act last year set in motion a process that could take more than four years for new rules to reach your farm, depending on its size.
Since the passage of the food safety bill, Food and Drug Administration officials have been meeting with commodity and other agricultural groups to learn more about typical production practices.
The background was needed before the FDA could move forward with rule making, says Jim Gorny, FDA senior adviser for produce safety.
“The vast, vast majority of produce in the market place is safe,” Gorny told attendees of the Florida Fruit & Vegetable Association’s annual meeting recently in Palm Beach. “We’ll take the best practices that are out there right now and codify them.”
The FDA hopes to publish a proposed rule in the Federal Register between January and March 2012.
The rule will apply to fresh fruits and vegetables, sprouts and seed production, mushrooms, raw peanuts and tree nuts.
It will not apply to products, such as potatoes, sweet potatoes and artichokes, that are typically cooked before they’re consumed.
It also won’t apply to products that undergo what Gorny described as a kill-step process. These include commodities, such as tomatoes, processed under high heat.
Produce traceability and the produce traceability initiative will be addressed in a separate rule as will food safety requirements for imported produce.
The public will then have an opportunity to weigh in on the proposed produce safety rule during a comment period.
Once that period has closed, the FDA must review the comments and respond.
As part of the process, the agency must consider the proposal’s economic impact on agriculture and the public.
Expect the final rule to be published one year after the proposed rule is published, Gorny says.
Rule will be phased in
Implementation will occur in phases, with larger farms having one year to adopt the regulations.
Mid-sized farms will have two years, and small farms will have three.
How farm sizes will be broken down has yet to be determined.
Under the Tester Amendment, operations are exempt if they have sales of less than $500,000 and if the majority of the produce is sold directly to end-users within 275 miles of the farm.
But those small farms still must comply with the federal Food, Drug and Cosmetic Act, Gorny says. That law prohibits anyone from misbranding or adulterating food, drugs or cosmetics with substances that may be injurious to health, including pathogens.
In addition, the FDA can withdraw the Tester Amendment exemption for a particular farm if there are problems.
During the implementation phase, Gorny says the agency will also be conducting educational sessions to help growers understand what is expected.
A risk-based approach
The proposed rules will be risk-based, but Gorny admits that the FDA doesn’t have all the answers. In the meantime, agency officials will be developing research protocols so scientists and Extensionists can conduct regional trials into specific food safety practices.
For example, if Florida strawberry growers use overhead sprinklers for frost-protection, how long does it take pathogens that might be in the irrigation water to be reduced to safe levels on fruit?
“We don’t know,” Gorny says.
At one time, the FDA considered grouping commodities by risk. But after weighing all of the scenarios, Gorny says the agency most likely will discard that concept because it is unworkable.
Instead, it favors looking at production practices based on risk.
For example, applying raw manure to a field carries significantly higher risks of contamination by human pathogens than applying aged compost or chicken manure pellets that have undergone microbe-killing heat during processing.
The produce safety rule will probably require farms to register with the FDA, much like the Egg Safety Regulation requires of egg production facilities, Gorny says.
“How do we develop a work plan if we don’t know how many are in each state and what they are growing?” he asks.
The agency also is mulling how inspections will be conducted and by whom.
With 186,000 farms in the United States, Gorny says it would take all of the FDA’s inspectors 10 years to visit each operation once.
Instead, he says the FDA hopes to enlist the help of other federal agencies that may already be on a farm, such as the Agricultural Marketing Service. In addition, he says the FDA is looking to form partnerships with state and local agricultural regulators.