Posted: March 5, 2019

Penn State Extension is gearing up for on-farm readiness reviews that can help producers prepare for Food Safety Modernization Act inspections.

David Miller has a lot on his mind as he goes about his day on his family's 220-acre vegetable and plant farm in York, Pennsylvania. Changing weather conditions, managing employees, watching market trends, maintaining equipment, and monitoring crops for disease are just a handful of his concerns.

Lately, another matter has been frequenting his thoughts--an upcoming inspection for the federal Food Safety and Modernization Act (FSMA)--and it's a topic that doesn't put him, or most of his peers, in a celebratory mood.

After all, he points out, farmers across the country have undergone third-party audits and state food safety inspections for many years. "We work hard to make sure our operations are clean and that we are following safety regulations, so an added inspection is just one more thing that we have to contend with," says Miller.

That noted, he puts this on the table: he understands the reasons behind the act, and the need for everyone involved with food production--from growing to processing to packing to selling--to follow proper practices. "How can one argue against safe food? As a farmer, that's what I am supposed to do and want to do--grow safe and nutritious food for people," he says.

Miller is not unique in his trepidation about the first-ever inspections of farming operations under the Produce Safety Rule, according to Jeff Stoltzfus, produce safety educator with Penn State Extension, and Anita Maher, food inspection technician with the Pennsylvania Department of Agriculture (PDA). "Most of the farmers we deal with are apprehensive and have a lot of questions," Maher says. "We want them to know they don't have to be afraid of what is to come and that we are here to help every step of the way."

To aid produce growers in complying with the new requirements, Penn State Extension and PDA have teamed up on a new, voluntary program, called On-Farm Readiness Reviews, designed to put farmers' concerns to rest by help-ing them prepare.

The Food Safety Modernization Act


Each year in the United States, 48 million people get sick, 128,000 are hospitalized, and 3,000 die from food-borne diseases, according to the Centers for Disease Control and Prevention. Some of the more common foodborne illnesses include Salmonella, E. coli, Listeria, and norovirus. "Most cases of foodborne illness are not serious, perhaps causing an upset stomach or vomiting," says Luke LaBorde, professor of food science. "But, for the very young, elderly, or those with impaired immune systems, these illnesses can be serious and life-threatening."

Perhaps the most infamous outbreak case in U.S. history occurred in 1993 when 732 people became sick after eating hamburgers contaminated with E. coli at Jack in the Box restaurants in California, Idaho, Washington, and Nevada. Four children died; another 178 victims were left with permanent kidney and brain damage. In 2006, the FDA linked E. coli to uncooked baby spinach in 26 states. Three people died, 31 suffered kidney failure, and 205 more reported cases of diarrhea and dehydration. And just this past summer, more than 500 people in 16 states became ill after eating tainted lettuce found in salads from McDonald's. An investigation determined that the microscopic parasite Cyclospora cayetanensis was the culprit.

Preventing these types of outbreaks is the reason behind FSMA, according to Stephen Hughes, team leader for the Food and Drug Administration's Produce Safety Network. The federal act, signed into law in 2011, establishes regulatory practices that produce farmers, food processors, and feed manufacturers must adopt to prevent contamination of fresh produce, processed and manufactured human foods, and animal feeds. The requirements apply to both domestic and foreign food producers. "It creates a blueprint for the most sweeping changes to the nation's food protection system in FDA's history and, in fact, since Theodore Roosevelt was president," says Hughes. "The vision of FSMA is that the controls that food producers, in farm and factory, systematically put in place will protect foods from bacterial, chemical, and physical hazards."

A section of the legislation, called the Produce Safety Rule, focuses on farm food safety and minimizing the risk of bacterial contamination of fresh produce by using best practices covering hygiene, sanitary facilities, packing and storage methods, water use and testing, use of manure and compost on fields, and postharvest sanitation. These practices are especially important for produce that is often consumed raw, such as leafy greens, broccoli, onions, cauliflower, carrots, tomatoes, celery, tree fruit, and mushrooms, among others.

While farm food safety standards and inspections are not new to the produce industry, what is new is that federal and state inspectors will conduct on-site inspections. The first major compliance date was set for January 26, 2018, for large farms; large sprout operations were required to meet an earlier compliance date of January 26, 2017.

However, the FDA has announced that routine inspections associated with the Produce Safety Rule will not begin until spring of 2019 to allow time for more guidance, training, technical assistance, and planning. Those inspections will now commence with large farms (more than $500,000 in produce sales) in spring of 2019, small farms (more than $250,000 in produce sales) in spring of 2020, and very small farms (more than $25,000 in produce sales) in spring of 2021.

"As part of Penn State's land-grant mission, it's crucial for us to lead the way in educating and helping the state's produce growers navigate this unprecedented time of change in food safety regulations," says LaBorde. "The On-Farm Readiness Reviews are just one of the many ways we are doing that."

Maintaining Flourishing Farms


Much has changed since Miller's great-grandfather, Howard Miller, started the family farm in 1912. At that time, the property consisted of 35 acres and was a combination dairy and vegetable operation. Over the years and through five generations, the family has acquired neighboring properties, constructed 29 greenhouses, and built a large retail garden center bursting with colorful fruits and vegetables, seasonal flowers, freshly baked breads and pies, country crafts, and wares from local vendors.

The Millers not only grow their own vegetable and flower crops but also have a thriving vegetable transplant business that supports other farmers. Miller Plant Farm also participates in a 600-member community-supported agri-culture (CSA) program, an initiative that supports local agriculture while providing members with fresh produce. "As farmers, we love to see things grow--we witness a miracle every day," says Miller, a past president of the Pennsylvania Vegetable Growers Association. "To think that you put a small seed into several inches of soil and it be-comes a bountiful product is just amazing. All of mankind depends on agriculture, and I can't imagine myself or my family doing anything more rewarding."

To keep the family farm flourishing--and its produce safe--Miller always seeks to expand his knowledge, so when he received an email in May from Maher advising him of the On-Farm Readiness Reviews--an innovative program offered at no cost to farmers thanks to support from the FDA and the leadership of the National Association of State Departments of Agriculture (NASDA)--he didn't think twice. "This is one of the best allocations of funding by the FDA ever," says Miller. "I don't know why anyone would not want a comprehensive review of their operations, especially when it is purely informational. For me, it's much easier to follow regulations when I under-stand the changes and the reasons for them. That's why these reviews make a tremendous amount of sense."

Preparing for the Future


Penn State Extension and the Pennsylvania Department of Agriculture are helping farmers prepare for the first-ever inspections of farming operations under the Produce Safety Rule. Anita Maher and Jeff Stoltzfus, at left, speak with David Miller of Miller Plant Farm in York, Pennsylvania.

The On-Farm Readiness Reviews can help farmers address any areas in need of improvement before a regulatory inspection takes place in the future, Hughes explains. As part of the program, food safety professionals conduct voluntary, nonregulatory visits to farms and packinghouses. Their goal is to observe current practices and provide feed-back on how those practices can be strengthened to better align with regulatory expectations. Each on-site assessment takes approximately two to four hours.

Stoltzfus and Maher are two of the FSMA Produce Safety reviewers in Pennsylvania. Their territory--the south-central and southeastern parts of the state--is the heart of the state's agricultural community, so the reviewers are key players in the readiness program. A recent NASDA report indicated that 86 On-Farm Readiness Reviews were completed between April 27, 2018, and July 27, 2018, nationwide. Thirty percent of those completed reviews occurred in Pennsylvania.

Stoltzfus and Maher emphasized that reviewers are not there to conduct an audit or any type of regulatory assessment. Pennsylvania Department of Agriculture inspectors and Penn State Extension educators will simply go to the farms that request reviews and tell farmers what they need to do to achieve compliance. "We keep the reviews as conversational as possible," says Maher. "It's not a 'checklist' process, but rather a back-and-forth exchange with open discussion encouraged. And it's confidential--what happens on the farm, stays on the farm."

Miller said the unofficial nature of the visit, coupled with his confidence in Stoltzfus's and Maher's experience and knowledge, put him at ease during his recent review, which all parties deemed a success. "Jeff and Anita provided constructive feedback and were easy to work with," says Miller. "I knew we had the right mechanisms in place, but it was good to have that verified. They also helped us better understand the added recordkeeping that will be required for FSMA, which, for small growers like us, can be challenging, so I appreciated that information."

Understanding documentation requirements is one of the reasons Mike Nolan of Earth Spring Farm, a family-owned 42-acre organic farm in Carlisle, sought an On-Farm Readiness Review over the summer. "Some folks roll their eyes when they hear about extra recordkeeping, but I think it's good because it forces everyone to be better, especially when it comes to cleanliness," he says. "Plus, better recordkeeping ultimately leads to a stronger business."

He, too, was pleased with the guidance given by Stoltzfus and Maher, and he said that shortly after their visit, he put their suggestions into place. "They were fantastic and really helped me get my 'ducks in a row,'" he says. "I am better prepared for what's to come, and that gives me peace of mind. And, if I need more advice, I just have to ask."

Ongoing support is another benefit of the program, according to Stoltzfus, who says that Penn State Extension educators and PDA regulators are available for follow-up consultations. "We've been impressed by the cooperation we've seen from the state's agricultural community in preparing for these new regulations," he says. "They are committed to doing what needs to be done to provide safe food for the state, the country, and the world."

Maher agrees, adding, "Agriculture is always evolving and changing. Pennsylvania farmers have risen to challenges before, and this time will be no different."

By Amy Duke