Posted: May 6, 2016

For the first time, the Food and Drug Administration (FDA) is enforcing food safety activities through its new Food Safety Modernization Act (FSMA).

Rice Fruit Company
Rice Fruit Company

One invisibly small bacterium--smaller than a red blood cell, smaller even than a particle of smoke--is all it takes to end lives. The damage begins with a cozy home--a curd of Ricotta, a smear of peanut butter, a divot in the husk of a cantaloupe. There, one individual bacterium rapidly becomes two, then four, then eight, then sixteen, then thirty-two, then sixty-four, and so on. Before long, the numbers reach deadly heights.

In 1993, 732 people were infected and four children died from E. coli O157:H7 infections associated with Jack in the Box hamburgers. In 2011, 147 people were sickened and 30 people died from Listeria-tainted cantaloupes. In 2014, 35 people fell ill and at least three were killed by caramel apples contaminated with Listeria monocytogenes. And just this winter, produce contaminated with a pathogenic strain of E. coli that was used by Chipotle Mexican Grill was the likely source of an outbreak that sickened more than 50 people.

These are just a handful of the food poisoning outbreaks that have seen widespread media coverage in recent years. The Centers for Disease Control and Prevention estimate that some 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die of foodborne illnesses each year.

But consumers aren't the only ones to suffer. Farmers, harvesters, packers, processors, and company owners also are affected.

For example, within two years of its hamburger outbreak, Jack in the Box restaurants lost $160 million and faced hundreds of lawsuits from ill customers. The brother- owners of the cantaloupe farm were sentenced to five years of probation and six months of in-home detention. The caramel apple incident resulted in a significant loss of sales to all apple growers in the United States, as customers shied away from the fruit in all its forms. And Chipotle Mexican Grill is still in the throes of a federal criminal investigation. Indeed, outbreaks and recalls often result in lawsuits that can last years, financial ruin for company owners, job losses for workers, and sometimes even prison for those responsible.

On top of all that, food companies now have even more to worry about. For the first time, the Food and Drug Administration (FDA) is enforcing food safety activities through its new Food Safety Modernization Act (FSMA), a law passed by Congress in 2011 with final enforcing regulations just starting to emerge last year. FSMA establishes mandatory practices that farmers must adopt to prevent microbial contamination of fresh produce and processed food and feed.

"This is a huge change in how safety of foods is regulated," says Luke LaBorde, Lester Earl and Veronica Casida Development Professor for Food Safety and associate professor of food science. "The meat and dairy industry has always been regulated, but now, for the first time, even produce farms will be under the watchful eye of the FDA. From what I've heard, people are scared. They know that just a few pathogenic bacteria in their facilities or on their foods have the potential to devastate their livelihoods."

According to LaBorde, helping industry navigate the new FSMA regulations is a priority of Penn State Extension, whose primary goal is to protect consumers, but also to assist Pennsylvania's businesses, which are essential to the state's economy. Specifically, extension conducts food safety research, develops science-based strategies for the prevention of microbial contamination, assists companies in implementing food safety procedures, provides formal training on federal and state requirements, and offers advice on how to navigate through the new FSMA regulations.

What Is FSMA?

At its core, FSMA establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rules cover only commercially sold, fresh produce--fruits, vegetables, nuts, herbs, mushrooms, and sprouts that typically are eaten raw--rather than foods that generally are cooked or further processed.

Sounds simple, but in practice, FSMA is quite complicated. "The new regulations are extremely complex," says LaBorde. "At Penn State, our biggest issue right now is just trying to help people figure out if they are affected, because many will be exempt."

According to LaBorde, produce growers who earn less than $25,000 in sales are not covered under the law. However, those who earn more than $25,000 but less than $500,000 in food sales are eligible for exemptions based on how they market their product; for example, whether they sell directly to consumers or through indirect routes such as distributors. Additionally, those who sell their produce locally may be exempt.

LaBorde and his colleagues have created a flow chart that will help people to determine if they are covered by the law. Once companies know where they stand, they can receive training and assistance from Penn State in figuring out what to do.

The FSMA includes seven regulations, three of which are of particular importance to Pennsylvania's produce growers, packers, and processors: (1) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Standards for Produce Safety, for short); (2) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food, for short); and (3) Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Feed, for short).

Each of these regulations contains a number of requirements. For example, the Preventive Controls for Human Food and the Preventive Controls for Animal Feed require the execution of a food safety plan. And all three regulations require the use of uncontaminated agricultural water and soil amendments, and the implementation of a regular workforce-training program focused on maintaining best practices regarding health and hygiene. Depending on the size of their operations, companies will be given a certain amount of time to implement the rules.

How Is Extension Helping?

Since 2009, Penn State Extension educators have trained more than 2,000 growers, packers, and processors in the prevention of produce contamination. Their courses and workshops focus on, among other things, where pathogens live and how they spread, best practices for avoiding pathogens, and how to create food safety plans. Now, with the new FSMA regulations, extension is revamping its offerings to include detailed information to help companies navigate the rules. The new courses and workshops are based on a mandated curriculum created by the FDA.

According to LaBorde, extension anticipates receiving many more requests for training, especially from smaller companies. "The large companies, those who sell wholesale, have been voluntarily meeting most of these requirements for some time," he says. "They had to for liability reasons. Many of the distributors, like grocery chains, wouldn't buy their products otherwise."

This expected boom in business is the reason that extension hopes to hire three new educators and a research associate, says Catherine Cutter, assistant director of food safety and quality programs. One position, says Cutter, will work in Lancaster County to train fresh produce growers that are important in the state. Another will be based in the Chester County-Berks County area and focus on food safety, integrated pest management, and water quality for all horticulture industries. For this position, Cutter says, extension hopes to find someone who is bilingual, given the large number of Spanish-speaking individuals working in the mushroom industry. The third educator position will focus on animal feed safety.

The research associate will be located at University Park and conduct research related to FSMA. "This person could, for example, study apples, inoculating them with pathogenic Listeria monocytogenes cells in the laboratory and testing whether particular chemical antimicrobials work to eradicate them," says Cutter. "The associate could then publish those results, and share them with the apple industry through workshops."

According to Cutter, such a research position focusing on FSMA-related topics will complement the Department of Food Science's overall research program. For example, the new researcher may collaborate with LaBorde and Stephen Knabel, professor of food science, who are investigating, among other things, why certain strains of pathogen are persistent in certain processing plants.

Indeed, research forms the basis of extension's entire food safety program. "We conduct research in all areas of food safety," says Cutter. "Our findings provide scientific documentation to support decision making for why a certain pathogen should be controlled in a certain way. This is where the true integration of research and extension comes to fruition because we are taking what we're doing in the lab, talking about it in our extension workshops, and making recommendations. This is where real-world applied science happens."

LaBorde notes that no one really knows if the FSMA will make a difference. "It's certainly going to cost people a lot of money and time," he says. "In my opinion, one of the most important things to come from the FSMA is the requirement to use science-based evidence to demonstrate the safety of agricultural activities. People will have to know for sure that what they're doing is making their product as safe as possible."

The educational component also is key, he adds. "It raises awareness. People will be much more aware of safety issues and more thoughtful about what they are doing. That's definitely a good thing."

Learn more at the Penn State Extension Food Safety website.

Giorgi Mushroom Co.

Location: Blandon, PA

Primary Activity: Grower, packer, and shipper of mushrooms

Giorgi Mushroom Co. produces close to 2.5 million pounds of mushrooms per week.


"When I came into the mushroom industry, I realized right away how important food safety was. My job was to implement programs to protect us, and I did that by attending several of the Penn State short courses specific to our food safety program requirements. We need to continue to make sure that every step in our process does not pose a threat to our finished product. We utilize the Penn State short courses to guide us in the direction we need to be going in." --Bill Green, Quality Assurance Manager

B&R Farms

Location: Ringtown, PA

Primary Activity: Grower of hay, grain, strawberries, and wholesale fresh vegetables

B&R Farms ships 10,000 packages of farm-raised produce every year.


"We are a little confused and scared. My kids are the seventh consecutive generation to live in our farmhouse. My family has been in fresh vegetable production since 1825, starting as sharecroppers on our farm and finally purchasing the farm in 1842. I am concerned that FSMA will force us out of the wholesale fresh vegetable business." -Barron "Boots" Hetherington, Owner

Dawson's Orchards, Inc.

Location: Enon Valley, PA

Primary Activity: Grower and packer of apples, pears, cherries, peaches, plums, watermelons, and berries

Dawson's Orchards, Inc., has 20 acres of dwarf apples, two of pears, five of peaches, and assorted berries.


"Having Penn State come alongside to navigate the waters with FSMA regulations will go a long way to encourage farmers. Many times over the last several years of complying with food safety regulations, which our customers required, I had come to the point of wanting to give up. But each family farm that folds has larger implications than simply a few people needing to find another job. Farmers are the backbone of communities, and once farms go out of business it creates a void that is not easily filled." -Carolyn McQuiston, Owner

Rice Fruit Company

Location: Gardners, PA

Primary Activity: Grower and packer of apples, peaches, and nectarines

Rice Fruit Company is the largest apple-packing facility in the eastern United States.

"Food safety continues to be one of the most difficult and potentially devastating challenges facing our industry at present, so it's very comforting to know that we have allies in addressing this challenge. We feel a true sense of urgency to move as quickly as we can in the right direction but are often stymied by an incomplete understanding of where we should focus our efforts. Food safety is too important and a farming budget is too tight for us to throw expensive darts at a target we can't see clearly, hoping that something hits the mark. We need science-based guidance to develop practices and processes that fit the level of risk of our product, and there's just no way we're going to be able to do that on our own." --Ben Rice, Vice President of Operations

Overview of Regulations

Standards for Produce Safety

  • Standards are set for the maximum allowable E. coli to be present in agricultural water.
  • Testing is required for untreated agricultural surface water that comes into contact with the crop.
  • Standards are set for the use of raw manure and compost.
  • Standards are set for the safe growing and handling of sprouts.
  • Companies are required to avoid harvesting produce that is likely to be contaminated by domesticated or wild animals.
  • Companies must train workers in proper hygiene to avoid contamination of produce.
  • Standards are set to prevent equipment, tools, and buildings from contaminating produce.

Preventive Controls for Human Food

  • Companies must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan.
  • For each significant hazard, companies must identify preventive controls, such as a sanitation process or supply-chain control, and write a recall plan.

Preventive Controls for Animal Feed

  • Standards are set for producing safe animal food that take into consideration the unique aspects of the animal food industry and provide flexibility for the wide diversity in types of animal food facilities.
  • Companies must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan.
  • For each significant hazard, companies must identify preventive controls, such as a sanitation process or supply-chain control, and write a recall plan.

--Sara LaJeunesse