Before the First Bite

In 2011, a listeriosis outbreak in cantaloupes sickened 147 people and killed 33 across the United States. That same year, the Food Safety Modernization Act was signed into law, marking the most sweeping reform of U.S. food safety laws in more than 70 years — a response to growing concerns about foodborne illnesses. This landmark legislation directs the U.S. Food and Drug Administration to shift the focus of food safety from responding to contamination events to preventing them.

Food safety regulations written under FSMA impact broadly the entire food system, including growers of fresh fruits and vegetables and producers of manufactured human and animal food.

Among FSMA's regulations, the Produce Safety Rule establishes science-based minimum food safety standards for growing, harvesting, packing and holding fruits, vegetables, mushrooms and sprouts that are likely to be eaten raw.

To guide farmers through FSMA compliance, Penn State Extension has formed a cross-disciplinary team of faculty, staff and statewide educators with expertise in the areas of feed and food safety. The team's goal is to deliver training and other educational resources, in both English and Spanish, to help Pennsylvania's food and agricultural industry comply, creating a safer food system in the commonwealth.

In addition to aiding produce growers with FSMA resources, training and expert guidance, extension educators help animal food producers meet the requirements of FSMA's Preventive Controls for Animal Food Rule by helping them understand how to develop and implement a food safety plan.

The stakes are high: Foodborne illnesses affect millions of Americans each year, posing serious risks to public health and the food industry alike.

Food Safety Starts in the Field

The FDA requires that all personnel handling fresh produce covered under its regulations receive food safety training. The Produce Safety Alliance, in partnership with the FDA, developed a seven-hour training program, which Penn State Extension offers regularly across Pennsylvania. Courses are available in a variety of delivery formats, such as in-person and online, to address the needs of all growers.

"We try not to scare them," said Jeff Stoltzfus, a Penn State Extension produce safety educator. "Regulations can be intimidating. Farmers worry about losing their business or being shut down. We focus on empowerment."

The Pennsylvania Department of Agriculture began inspections in 2019, and many farmers have navigated the process successfully. The biggest challenge? Record keeping. Logging cleaning and sanitation efforts is not overly complicated, but it requires diligence, Stoltzfus said. Any item that touches produce — harvest baskets, knives, clippers or packing lines — must be cleaned regularly, and each cleaning must be documented.

"Record keeping is often the hardest part," said Maria Gorgo-Simcox, a Penn State Extension horticulture educator. "That's why we've developed online resources to help growers keep accurate records."

Worker health and hygiene also play a critical role. Farmers must wash their hands before heading into the field. On small farms — especially among Pennsylvania's large Amish and Mennonite grower communities — this can be an adjustment. Many have livestock, and breaking the connection between animals and produce requires extra steps.

"You might be picking produce and suddenly remember it's time to feed the horses or cows," Stoltzfus explained. "Now, you must change your shoes and wash your hands before returning to the field."

The first part of the training, he said, is helping people understand why these steps matter: "If I ask a room of 50 people how many have gotten sick from something they ate, a lot of hands go up. We've all had that experience — at a restaurant or at home."

Foodborne outbreaks can have devastating consequences. "Today, we have a much more vulnerable population," Stoltzfus noted. "Thirty or 40 years ago, there were only a few thousand people living with organ transplants. Now, it's hundreds of thousands, plus those with autoimmune diseases or undergoing cancer treatments."

Advancements in technology have improved outbreak tracing. DNA analysis now can link bacteria from a hospital patient to a farm thousands of miles away.

"The whole point of FSMA is prevention," Stoltzfus said. "It's a lot easier to prevent contamination than to treat infections."

Beyond public health, compliance with FSMA opens doors for farmers. Rick Kralj, food safety and quality extension educator, highlighted the economic benefits.

"Without proper food safety training, growers might miss out on wholesale markets like Wegmans or Martin's, which require specific safety standards," he said.

And recalls can have a ripple effect, damaging entire industries.

"If there's a cucumber or strawberry recall, people avoid buying those items altogether," Kralj said. "Whether it's a small Amish farmer or a large company like Dole, the impact is widespread."

FSMA regulations are aimed at protecting consumers from biological, chemical and physical hazards, ensuring the safety of the food supply.

Reaching Crucial Farming Communities

Penn State Extension helps farming communities comply with FSMA. Stoltzfus estimates that more than 60% of Pennsylvania's vegetable farmers are Plain community growers, producing about half of the state's vegetables. To reach them, extension conducts trainings in community spaces such as fire halls, produce auctions and garages — places where Plain community members feel comfortable. An Amish farmer who completed FSMA's train-the-trainer program now helps spread the word, drawing large crowds to training sessions.

Luke LaBorde, professor of food science and extension food safety specialist, has developed training tailored to Amish growers, including a 44-page flip chart with culturally appropriate illustrations. In addition, he helped create bilingual training videos for apple packinghouse workers in English and Spanish.

Gorgo-Simcox, a lead FSMA instructor, also focuses on reaching Spanish-speaking farmers.

"Many growers and employees in Pennsylvania's mushroom and tree-fruit industries are Latino — they are key to agriculture's success in Pennsylvania and across the U.S.," she said.

Extension offers bilingual produce safety education and has developed materials in English and Spanish. Gorgo-Simcox noted that food safety starts on the farm, and employees are the first line of defense in preventing foodborne illnesses. She ensures that major agricultural events such as the Mid-Atlantic Fruit and Vegetable Convention include Spanish-language sessions. She also has conducted international trainings in Costa Rica.

"We meet growers where they are," she said. "On farms, through phone calls, emails — whatever they need, we try to help."

Uniquely Suited to Provide Guidance

Penn State Extension is uniquely positioned to guide farmers through FSMA compliance. Stoltzfus pointed to the On-Farm Readiness Review program as an example. This initiative pairs extension educators with U.S. Department of Agriculture inspectors to conduct nonpunitive mock inspections.

"The goal is to identify areas for improvement before an official FSMA inspection," he said. "We might discuss risks like a tomato field near a chicken pen or how to remodel a packing shed to meet FSMA standards."

Pennsylvania ranks around 15th nationwide in vegetable production, yet it ranks fourth in the number of growers trained, behind only California, Washington and Florida.

"That's a big deal," Stoltzfus said. "Our training efforts put us among the top states."

Beyond training, Extension keeps farmers informed about regulatory updates. "FSMA requires only a one-time training," Stoltzfus noted. "But regulations evolve, so we share updates through articles, grower meetings and conferences."

Pennsylvania's farms are mostly small — under 50 acres — and often rely on Extension for hands-on guidance.

"These are family-run operations with limited resources," Kralj said. "We help them develop food safety plans, review operations and make necessary changes."

Extension's strength lies in its network of educators and cross-disciplinary collaboration. "We work with horticulture, animal and dairy, and water quality teams to help farmers meet regulations," Kralj said.

"We didn't write the regulations," LaBorde added. "But we're here to guide people through them. That's our job."

The U.S. Centers for Disease Control and Prevention estimated that due to foodborne illness, every year in the United States:

• 48 million (one in six) people get sick
• 128,000 people are hospitalized
• 3,000 people die

Grower changes after attending a Penn State Extension FSMA workshop:

• Improved  water testing 
• Trained workers
• Updated safety protocols for field harvesting
• Safer handling and washing procedures
• Improved record keeping and sanitation logs
• 100% Safe food check before delivery

By Alexandra McLaughlin