Federal inspectors will soon venture onto Oregon farms to ensure compliance with the Food Safety Modernization Act for the first time since it became law in 2011.
For the past eight years, the U.S. Food and Drug Administration has been writing and revising regulations implementing the statute, which aims to prevent food-borne illness.
This spring, FDA inspectors are beginning routine on-farm inspections of large operations — those earning more than $500,000 in annual revenue — that grow produce meant to be consumed raw.
The agency’s goal is to “educate before and while we regulate” during this initial round of inspections, though officials would take action to stop an imminent threat to public health, said Kate Allen, an FDA investigator.
“It is still regulatory in nature but we want to make sure they are understanding the regulation and what’s being asked of them,” she said. “We’re not going in there looking for what’s wrong. We’re just looking to see what their system is, and if there are any vulnerabilities in their food safety programs.”
The FDA inspectors would discuss possible plans of action to correct shortcomings rather than issue citations on the spot, Allen said.
“Unless there’s an egregious condition, we’re not planning on coming out with a heavy hammer,” she said.
The possibility of having a farm’s reputation “dragged through the mud” due to a visit from the FDA remains worrisome, particularly in light of the agency’s past actions, said an Oregon grower facing an upcoming inspection who didn’t want to be named.
“Being put out of business is the main concern, and it should be for everybody,” the farmer said.
Last year, the detection of the cyclospora parasite on cilantro led to an extensive FDA recall of another Oregon farm’s vegetable crops, effectively shutting down the company.
Such an “embargo” on shipping crops is financially devastating and raises due process concerns, since it’s impossible to recover lost revenues from perishable vegetables, said the Oregon farmer facing an inspection. “Then, there’s no recourse if they make a mistake.”
The farmer said he’s already compliant with third-party “good agricultural practice” standards and ensures employee training of the highest level, but is still nervous about how these measures will square with FSMA.
The FDA should recognize that crops are grown differently based on farm size and location and that it’s not realistic to “put a bubble over” vegetables in an open field, the farmer said. “There’s got to be a reasonable balance.”
If a grower is accused of having a contaminated crop during an inspection, he’s then likely subject to formal FDA action and should seek the advice of a lawyer, said Neil Evans, an attorney with the Lane Powell law firm who’s handled food safety issues.
“Foremost, I would say don’t sign anything unless it’s an acknowledgment there was an inspection,” he said.
Farmers also should not commit to a course of action in writing or waive any of their rights, Evans said.
When notified of an upcoming FDA visit, farmers should ask about the extent of the inspection, such as how long it will last and what will be examined, he said. “Try to set some parameters or understand their parameters.”
If inspectors take samples of crops or water, growers should ask them to retain portions for future testing or collect their own specimens, Evans said.
Documentation of the inspection is critical to avoid misunderstandings, such as having the FDA later claim that officials provided instructions that weren’t followed by the grower, he said.
Farmers should ask the FDA to put their recommendations in writing and follow up in writing to confirm their understanding of what happened during the inspection, he said.
“There’s some record of interaction with the agency,” Evans said.
To help farmers prepare for an FDA inspection, the Oregon Department of Agriculture is offering “on-farm readiness reviews” lasting two to three hours to evaluate strengths and weaknesses, said Susanna Pearlstein, the agency’s produce safety program manager.
“The idea is we are experts in the produce safety and the farmer is the expert in the farm,” Pearlstein said. “The most helpful is for us to get out there before the FDA gets out there.”
The ODA is partnering with Oregon State University to provide food safety trainings on April 16 in Hermiston, April 18 in Aurora and April 29-30 in Eugene. The Aurora session will be conducted in Spanish.
If requested by a farmer, an ODA representative can also attend an FDA inspection to act as a liaison, helping to translate farm lingo for federal officials and vice versa, she said.
Growers may be more comfortable with this arrangement if they have a relationship with ODA, particularly if the agency has conducted an on-farm review, Pearlstein said. “We would be very familiar with their operation.”