Food Safety Modernization Act could impact growers exempt from the new federal rules

Food Safety Modernization Act

Although greenhouse and controlled environment agriculture growers may be exempt from implementing Food Safety Modernization Act rules, produce buyers may make compliance mandatory.

U.S. Centers for Disease Control and Prevention estimates 48 million people are sickened each year by foodborne pathogens. Of those people about 128,000 are hospitalized and 3,000 die each year.

On Nov. 13, 2015, U.S. Food and Drug Administration finalized three rules of the Food Safety Modernization Act. The purpose of FSMA, according to a FDA press release is to prevent foodborne illness “that, for the first time, establish enforceable safety standards for produce farms and makes importers accountable for verifying that imported food meets U.S. safety standards.” FDA said FSMA’s “final rules will help produce farmers and food importers take steps to prevent problems before they occur.”

“The recent multistate outbreak of Salmonella in imported cucumbers that has killed four Americans, hospitalized 157 and sickened hundreds more, is exactly the kind of outbreak these rules can help prevent,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. “The FDA is working with partners across the government and industry to prevent foodborne outbreaks. The rules will help better protect consumers from foodborne illness and strengthen their confidence that modern preventive practices are in place, no matter where in the world the food is produced.”

The three final rules released by FDA in November are the Produce Safety rule, the Foreign Supplier Verification Programs rule and the Accredited Third-Party Certification rule. FDA has finalized five of the seven major rules that implement the core of FSMA. In September 2015, FDA released the Preventive Controls for Human Food rule, which mandates preventive practices in food processing and storage facilities.

Produce Safety rule

The Produce Safety rule is the one rule that should have the biggest impact on outdoor farmers, greenhouse growers and controlled environment agriculture (CEA) growers. FDA used public comments and input collected during farm visits, meetings and listening sessions to develop a rule it says aims at reducing contamination risk while providing flexibility for farmers and growers.

This rule “establishes science-based standards for growing, harvesting, packing and holding produce that are designed to work effectively for food safety across the wide diversity of produce farms.” The rule’s standards include “requirements for water quality, employee health and hygiene, wild and domesticated animals, biological soil amendments of animal origin such as compost and manure, equipment, tools and buildings.” The rule’s standards have been designed to “help minimize the risk of serious illness or death from consumption of contaminated produce.”

The Food Safety Modernization Act’s Produce Safety rule includes standards for water quality, employee health and hygiene, equipment, tools and buildings.
The Food Safety Modernization Act’s Produce Safety rule includes standards for water quality, employee health and hygiene, equipment, tools and buildings.


One crop that the rule specifically addresses is the production of sprouts, which have been frequently associated with illness outbreaks. FDA reports that between 1996 and 2014, there were 43 outbreaks, 2,405 illnesses, 171 hospitalizations and three deaths associated with sprouts. Among the outbreaks was the first documented case of Listeria monocytogenes associated with sprouts in the United States. This crop is particularly vulnerable to microbial contamination because of the warm, moist conditions in which they are produced.

Exemptions to the Produce Safety rule

The earliest compliance date for the Produce Safety rule for some farms is two year after the effective date of the final rule. There are exemptions to the rule for some producers. These include farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less. Also to be eligible for a qualified exemption, the farm must meet two requirements:

1. The farm must have food sales averaging less than $500,000 per year during the previous three years.

2. The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.

Buyers driving food safety regulations

Dr. Elizabeth Bihn, director of the Produce Safety Alliance at Cornell University, said prior to FSMA, buyer demand has been the primary driver for implementation of food safety practices. “Consumers are buyers, but they are not protecting a name brand like Kroger or Wegmans or Wal-Mart,” Bihn said. “These companies are protecting their brands. They are going to have much higher stipulations for food safety then the consumers at farmers markets. There is some consumer demand for increased accountability for food safety, but it’s not as big a driver as the retail buyers’ demand. This includes most large food retailers.”

Food Safety Modernization Act
Even if greenhouse and controlled environment agriculture growers of food crops are exempt from the Food Safety Modernization Act, they may be pressured by buyers to adhere to the Act’s rules.

Bihn said greenhouse vegetable growers and CEA growers may receive added pressure from buyers to follow FSMA whether or not they are exempt from it.

“If a buyer tells a grower, “I’m not buying your produce unless you have a third party audit,” and the grower wants that company’s account, then the grower is going to do the audit,” Bihn said. “Legally a grower may be exempt from the regulation, but a buyer may say it doesn’t matter, the grower will still have to meet the regulation. There are still going to be markets that don’t require growers to meet the regulation if their operations are exempt from it. If you are a greenhouse grower who sells to a market that’s not requiring compliance with FSMA and you are exempt from the regulation, you may not have to do anything related to the regulation. Also, I can see third party audits, like the Harmonized GAPs audit, being updated to align with the rules to make sure that growers who have audits done meet the federal regulations as well.”

Increased interest in food safety

Even before the final rules were released, Bihn said she is receiving increased inquiries from greenhouse growers about food safety. “Greenhouse growers are trying to decide if they are subject to FSMA rules and how the required practices might fit with what they do with their greenhouses,” she said. “They are trying to figure out if they need to be concerned with meeting food safety regulations. They are going to be in the same situation as field farmers and asking the same questions. Are buyers asking the growers to meet the regulations? Greenhouse growers not subject to the regulations could easily get pushed into following the regulations if their buyers tell them in order to do business with them, the growers must follow the regulations.”

Bihn said her job is to help guide produce growers, whether they are field farmers, urban farmers, greenhouse growers or CEA growers, toward implementing food safety practices.

“Initially there may be frustration, hostility and denial,” she said. “All of those things will occur when growers first hear what they have to do. When they finally sit down and start to learn something about food safety and start to ask how can I fix this, then they start to make progress really fast.

“I love farmers who question everything. They don’t understand why doing something is a risk. They tell me I’ve never killed anyone so what’s the problem. That’s the engagement that I need to get them to think about it. They need to get to where they understand all farms can have produce safety risks and admit that they need to learn something about food safety so that they can make adjustments within their operations and put practices in place to reduce the risks.”

Industry job opportunities

Bihn said she has been encouraging Cornell students majoring in horticulture to get a minor in food science. She has also been encouraging students majoring in food science who are interested in produce safety to get a minor in horticultural production.

“There are food science students who have no idea how farms operate,” she said. “Unfortunately this sometimes results in food science professionals offering ideas for problem solving that may not be doable.”

Bihn said that food safety has traditionally been housed with the food science departments and crop production has been housed with the horticulture department.

“It’s time for there to be some cross pollination between these two departments,” she said. “It has been slow to happen. We now have a Masters of Professional Studies degree at Cornell that merges horticulture and food science. There are jobs out there, but they are difficult to fill because there are people who know production or there are people who know food pathogens, but there are very few people who know both.”

Bihn said she has received requests from her horticulture colleagues at Cornell to give guest lectures on food safety and to collaborate on publications about incorporating food safety guidelines into field publications.

“The fruit and vegetable industry as a whole is certainly saying food safety is something that we need to be incorporating,” she said.


For more: Dr. Elizabeth Bihn, Cornell University, Department of Food Science; (315) 787-2625;

Produce Safety Alliance,

National Good Agricultural Practices Program,

David Kuack is a freelance technical writer in Fort Worth, Texas;