Header graphic for print

Food Safety News

Breaking news for everyone's consumption

Food safety scientist unravels questions about food safety act

Are you in or are you out?

That was one of the first questions Don Stoeckel, a food-safety scientist with Cornell University, posed to the farmers and processors attending his presentation on the federal Food Safety Modernization Act  during the Ag Summit in Skagit County, WA, on March 3 and 4.

It was a question that many of the people in his audience had on their minds. Just how much were these new regulations going to affect their operations?


“It (the act) has a pretty serious set of regulations, especially for produce growers,” said Chad Kruger, director of Washington State University’s research center on the west side of the state, just before the start of Stoeckel’s presentation.

“It’s enormous,” said farmer Linda Neunzig, referring to the effects of the act on agriculture. “We have to be ready.”

Signed into law by President Obama on Jan. 4, 2011, the act is the most sweeping reform of the nation’s food safety laws in 70 years. Its goal is to protect the health of consumers by preventing food from being contaminated in the first place. And as Stoeckel told his audience, the act’s Produce Safety Rule is the “first ever mandatory federal standard for growing, harvesting, packing, and holding of fresh fruit.”

Which is why the question, “are you in or are you out?” is so important. Or another way of putting it: Are you covered? Are you going to have to comply with the act’s regulations or will you be exempt ? Covered or exempt? Under the act, farming operations can fall under the Produce Rule  or the Preventive Controls Rule, or both, depending on the type of farming operation it is.

Fresh produce

The Produce Rule covers produce that is grown to be eaten raw. Carrots, berries, cucumbers, grapes, green beans, cantaloupes and tomatoes are just some of the many examples of this. Putting the consumer into the picture, the rule covers raw produce that, if contaminated, could get people sick.

That’s important because contamination can be caused by sometimes fatal food pathogens such as E. coli, Salmonella, and Listeria. The rule’s definition of produce does not include food grains — the small, hard fruits or seeds of arable crops such as barley, dent-or flint-corn, sorghum, oats, rice, rye, wheat and oilseeds.

Exempt from this rule is produce that is rarely consumed raw. This list includes foods that are for the most part cooked before they’re eaten. Examples of these crops are asparagus, corn, pumpkins, cranberries, eggplants, okra, peanuts, winter squash, cashews, coffee beans, figs, peanuts and peppermint.

Produce that is grown to go through commercial processing (various types of listed kill steps) is also exempt from the Produce Rule. An example of this would be tomatoes grown to be processed into tomato paste or sauce. In other words, if the produce does have contamination on it, the kill step will take care of it, thus making it safe to eat as long as basic food-safety practices, such as keeping it from coming into contact with raw meat or chicken, are followed.

Chad Kruger

Chad Kruger

Size matters

The size of operations, as defined by money, also comes into the picture, when it comes to who’s in and who’s out. Under the Produce Rule, farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less are exempt from the rule. However, should an outbreak caused by produce from an exempt small farm occur, the farm will no longer be exempt.

Then there’s the reality of the legal system to consider. “It doesn’t matter if you’re a big farm or a small farm,” you can be sued,” said WSU’s Kruger. The rule also provides a qualified exemption and modified requirements for certain farms, although these farms must still meet certain requirements.

Some of those pertain to the value of their food sales during the previous three years and where the buyers are located in relationship to the farm. Under the Preventive Controls Rule, facilities covered by the rule must establish and put into place a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule also sets requirements for a written food safety plan.

Compliance deadlines for the preventive rule are staggered depending on the size of the operation. Businesses defined as “very small,” with less than $1 million in total human food sales have three years to comply and “small” businesses with less than 500 employees but more than $1 million in annual sales will have two years to comply.

More information about how the Produce Rule will affect sprouts is available here.

Don Stoeckel

Don Stoeckel

What is a farm?

“Whoever thought we’d need to have a regulatory definition for a farm,” Stoeckel told the group. But as people began sending in comments about the proposed rule, it became apparent that the Food and Drug Administration was going to have to consider what farms today are actually like.

With that in mind, a primary production farm has been defined as one that’s under one management in one general — but not necessarily contiguous — location. As such, it is devoted to the growing of crops, the harvesting of crops, the raising of animals or any combination of these activities. The definition was expanded to include farming operations that just grow crops and those that just harvest crops.

In addition to these activities, a primary production farm can pack or hold raw agricultural commodities, regardless of who grew or raised them. It can also manufacture/process, pack or hold processed foods as long as all of such food is consumed on that farm or on another farm under the same management.

Likewise, the manufacturing/processing includes limited categories such as drying and ripening of fruits. The act’s definition of a farm can also include secondary activities, such as an operation not located on a primary production farm but that is nonetheless devoted to harvesting, packing, and/or holding raw agricultural commodities.

However, a primary production farm, or farms, that grow harvest, and/or raise those raw agricultural products must own, or jointly own, a majority interest in the secondary activities’ farm.

Operations defined as farms are not subject to the Preventive Controls Rule. As for the easiest way for a farmer or processor to know what the definition of a “facility” is under the Food Safety Modernization Act, Stoeckel said that if it had to be registered as a facility under the 2002 Bioterorism Act, then it’s a facility.

The “big change”

Stoeckel said that although the act and its Produce Rule represent a big change in agriculture. one of the significant changes has do with water — namely, the quality and testing requirements for water used in farming operations.

For farmers who are already following Good Agricultural Practices and getting third party audits, the biggest difference between what they are doing and what the rule requires is the water standards, said Stoeckel.

Under the act, agricultural water is water that’s used in covered activities on covered produce where water is intended to, or is likely to, contact covered produce (food that will be eaten raw) or food-contact surfaces as could happen in a packing operation.

In the case of surface water, growers will need to take 20 samples over 2 to 4 years and then after that annually collect at least 5 samples for analysis, which will be added to the 3 prior years to create a rolling 4-year data set. So what does this mean? It comes down to numbers.

Stoeckel assured the group that there are calculators that can help farmers figure out if their agricultural water is clean enough. Even so, he said there are “magic numbers” for a reasonable starting point for this based on this simple principle: “Is this water safe enough or not safe enough for application.”


The criteria for pre-harvest water quality is 126 or less colony forming units of generic E. coli per 100 mL water geometric mean. And 410 or less CFU generic E. coli per 100 mL water statistical threshold value. Stoeckel also pointed out that a water quality profile is meant to be a long-term management tool, not a short-term operational decision-making tool.

“Bottomline,” he said, “water from a source coming into contact with any covered produce needs to be tested to see if it meets the criteria,” he said. If the water source or the quality of the water source (livestock grazing upstream, for example) changes, then you have to start over.

Growers can also wait for a certain amount of time before harvest for the contamination from the water to “die off. But this needs to be calculated to determine a credit and also documented. When it comes to harvest and post harvest, water quality is just as, if not more, important.

In this case, water used for these purposes must have no detectable generic E. coli per 100 mL sample. In other words, it has to be very clean. In addition to direct contact with covered produce, this also applies to water coming into contact with surfaces, water used to make ice, and water used for handwashing. Untreated surface water may not be used for any of these purposes.

As for ground water, Stoeckel said that because it generally doesn’t vary as much in quality as surface water, only four samples need to be taken in the first year. After that, only one sample per year will need to be taken. Compliance dates for water quality surveys and use criteria are Jan. 26, 2022, for very small farms (doing $25,000 to $250,000 in business); Jan. 26, 2021, for small farms (doing $250,000 to $500,000 in business); and Jan 26, 2020, for other farms (doing more than $500,000 in business).

Training is key to food safety

Although there are approximately 190,000 farms in the United States growing fresh produce, many of them are too small to be covered under the food safety act.

Even so, Stoeckel said that 35,000 of them will need to go through training. Under these requirements, at least one supervisor or responsible person for a farm must have successfully completed food-safety training at least equivalent to training recognized as adequate by the FDA.


All employees, including temporary, part time, seasonal and contracted personnel who handle covered produce or food-contact surfaces, or who are supervisors of these employees must receive adequate training as it relates to the employee’s duties, upon hiring and periodically thereafter at least once a year.

The employees must be able to easily understand the person training them. Field harvesters. Employees who harvest food must be trained so they can recognize when covered produce must not be harvested because of contamination risks, such as animal poop.

They must also be trained in how to inspect harvest containers and equipment to make sure they are clean and maintained and working properly so they don’t become a source of contamination. Along those same lines, the workers need to be trained to either correct any problems they see or report them to a supervisor.

“All of this is really key, because the FDA wants to prevent the harvesting of compromised produce in the first place,” said Stoeckel.

After Stoeckel’s presentation, Mauricio Soto of Viva Farms said that everyone working on a farm needs to know about food safety.

“It all starts with relationships,” he said, referring to the farmworkers and the managers and owners. “If a farm abuses those relationships, things won’t go well. It’s challenging but not impossible.”

Enrique Lopez

Enrique Lopez

It’s very important to involve the farmworkers in food-safety training so they know what to do,” said Enrique Lopez, outreach specialist with WorkSource. “It’s critical for them to be informed about the regulations.

It’s all about communicating with the workers. They’ll inform their supervisors about problems they see if they know about it.

Ignacio Marquez, community liaison with the Washington State Department of Agriculture, said that everything in agriculture is so interconnected.

“Water isn’t just about availability and quality but also about how safe it is. And that’s connected to food safety and worker training. Let’s educate as many people as possible on this. You really need to be on top of everything.”


Untreated manure is considered high risk because foodborne pathogens such as E. coli, Salmonella, Listeria, Norovirus and Cyclospora travel through the fecal-oral route.

“The key is preventing poop from getting on the produce,” Stoeckel said. Currently, because the FDA has not yet come up with an official time interval between applying manure and harvesting a crop, it is working on getting enough information to do this.

But the agency has said that it wouldn’t take exception to the what the National Organic Program considers appropriate time periods. In that case, crops that are unlikely to come into contact with manure in the field or the soil can be harvested 90 days after manure has been applied. But crops that will likely come into contact with manure cannot be harvested until 120 days after application.

When will training programs be ready?

Stoeckel, who is also an Extension associate for Produce Safety Alliance estimated that training will be ready by this fall at the earliest, and he reminded the growers that they’ll still have another year after that to come into compliance.

The Cornell-based alliance is working of a produce-safety curriculum that will offer 7 1/2 hours of instruction in one day. It will include an introduction to produce safety; worker health, hygiene, and training; soil amendments; wildlife, domestic animals and land use; water (production and postharvest); postharvest handling and sanitation; and how to develop a farm food-safety plan.

Completion of the course will earn a successful participant a certificate from the Association of Food and Drug Officials to meet the regulatory requirement for training.

Note on corrected content: The original version of this article included inaccurate information about the exemption clauses and compliance dates for very small and small businesses. “Very small” businesses with less than $1 million in annual sales have three years to comply and “small” businesses with fewer than 500 employees but sales of more than $1 million have two years.


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

© Food Safety News