They’re coming.

Not that there haven’t been plenty of warnings, not the least in the form of the 2011 Food Safety Modernization Act that calls for inspectors to visit produce farms and packing houses under the act’s Produce Safety Rule.

The rule opens the way for inspections, which began in July this year, for farms and orchards making more than $500,000 in annual gross product sales. Smaller farms will have another year to come into compliance with the rule.

As for packing houses, even though there have been some questions over whether a packing house is a farm or not, the FDA is developing an amendment to the rule that may have more to do with what happens in the packing house than who owns the packing house. In any case, the FDA wants all packing companies to follow the packing and holding requirements of the Produce Safety Rule or the good manufacturing practices portion of the Preventive Controls for Human Food Rule.

And while farms will, for the most part, be inspected during harvest, packing line inspections may happen any time that food is running over the lines.

This is the first time in history that produce farms will have to deal with regular inspections on their farms.

No, these inspections aren’t going to be heavy-fisted actions aimed at doling out penalties. Instead, according to what FDA and state inspectors have said, they’ll be educational and even collaborative.

“We won’t come down like a ton of bricks right out of the gate,” said Hector Castro, spokesman for the Washington State Department of Agriculture. “The goal is to help farms comply with the Produce Safety Rule to ensure that food is safe — not to hand out fines and penalties.”

But that doesn’t mean that farms and packing sheds that pose an immediate danger to public health won’t be subject to penalties. After all, these inspections are aimed at preventing conditions that could lead to foodborne diseases. That’s what the Food Safety Modernization Act is all about: preventing health problems, not just reacting to them, as was the case before the act was signed into law.

Whereas in most states, state Agriculture Departments will be conducting the inspections, six states — Oregon, Wyoming, North Dakota, South Dakota, Iowa, and Illinois — will let the FDA do the job.

According to the FDA, the Produce Safety Rule establishes mandatory science-based, minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

These standards are designed to work effectively for food safety across the wide diversity of produce farms.

In other words, they aren’t a hodge-podge of standards. Instead, farms covered by the rule will need to comply with certain standards that focus on making the nation’s food supply safer by reducing the presence of dangerous bacteria that can get people sick. This, in turn, will reduce the number of illnesses caused by contaminated produce.

CDC estimates that each year 48 million people get sick from a foodborne illness, 128,000 are hospitalized, and 3,000 die.

What are the priorities

Higher-risk farms will obviously be higher on the priority list than lower risk farms, which means it will be necessary to categorize farms by risk. Here are some of the known food-safety risks, according to a report, “A Model Produce Safety Implementation Framework, (” prepared last winter by the National Association of State Departments of Agriculture’s Food Safety Modernization Technical Working group.

  • Known food-safety risks: History of class 1 recalls and outbreaks;
  • Soil amendments: Type of amendments (manure and compost, for example) used by the farms;
  • Volume of produce that is covered under the Produce Safety Rule that the farm or packing shed is producing;
  • Compliance history (once the program is established);
  • Sample results;
  • Third Party audits;
  • Marketing agreements;
  • Geographical location of the farm;
  • End user of the farm’s produce;
  • Weather conditions (drought, flooding,etc);
  • Reportable food registry notices;
  • Recalls.
In addition to high-risk and low-risk categorization, the report points out that there’s also a need for an “Enhanced Regulatory Inspection Schedule.”
This schedule, says the report, should be used for some locations that may involve more or less frequent visits based on a farm’s compliance history.
The growing season will also figure into where a farm falls on the inspection priority list.
Some “common sense” tips
Don Stoeckel, the Midwest Regional Extension Associate for the Produce Safety Alliance, pointed to some food-safety practices farmers need to keep in mind when considering where their farms might fall on the list.
°Worker education. Considering that many crops we eat are touched by the workers, hygiene is crucial, he said. But along with that, the farmers need to cultivate a culture of food safety. Their managers need to know that while picking the crops quickly is important, food safety is also important. “Sometimes you need to take the time to keep the food safe,” he said.
And while wildlife, deer and elk, for example, as well as domestic animals that come into the fields, pose a risk, he said that the most dangerous animals are humans. “It’s humans that can carry every food pathogen that can infect other humans,” he said, underscoring the importance of farmworker education.
How a farmer handles waste from domestic animals is also to be considered.
And when it comes to packing houses, the food contact surfaces should be clean enough to eat off because many times the food “goes straight from there to the consumer.” Tools and equipment also need to be clean.
The cleanliness of the water used to clean the produce as well as to irrigate the crops is also important.
Getting ready
As part of its guiding principle, “educate before you regulate,” a team made up of the National Association of Agriculture Departments, FDA, state and Cooperative Extension food-safety leaders developed the “On-Farm Readiness Review.” This program, which is offered free to farms, is designed to foster a dialogue between the farmer and the regulator and/or educator about what it takes to comply with Produce Safety Rule.
While at the farm, the reviewer observes growing conditions, harvesting practices, packinghouse operations, water sources and discusses common food-safety “touchpoints.”
The visit is scheduled at the farmer’s convenience and generally takes only several hours.
At the end of the review, the assessor gives the farmer his or her top three suggestions for the farm to improve its food-safety practices.
After the review, the farmer is also connected with educational materials and resources to guide him or her toward becoming compliant with the Produce Safety Rule.
Go here ( to get a state-by-state rundown about scheduling an On the Farm Readiness Review.
What produce is covered by the rule
Produce that is usually eaten raw is covered under the Produce Safety Rule. This would include foods such as berries, tomatoes, almonds, lettuces, and melons.

But because cooking produce before it is eaten can reduce the risk of serious adverse health consequences or death, FDA has decided that it is not “reasonably necessary” to subject produce that is “rarely consumed raw” to the requirements under the Produce Safety Rule.

Go here ( to see which foods are and are not covered by the rule.

(To sign up for a free subscription to Food Safety News, click here.)