The produce industry is in the midst of figuring out how best to comply with the Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, and administered by the U.S. Food and Drug Administration (FDA). Implementation deadlines have been rolling out since late 2016, with the entire industry readying for compliance with most regulations by the spring of 2018.
Contamination by foodborne E. coli, salmonella, listeria, and the like affect millions of people in the United States, resulting in as many as 3,000 deaths per year. The intent of FSMA, the first major food safety reform in more than seven decades, is to maintain the safety of the U.S. food supply by focusing proactively on prevention, rather than reacting to incidents after the fact. Reaching this goal involves striving for continuous improvement, implementing preventive measures that are backed by science, ensuring effective training, and documenting all safety activities on an ongoing basis.
Much of FSMA is based on existing best practices; complying with the law is, in many ways, more a matter of improving recordkeeping and paperwork and introducing a training regimen than about wholesale changes in core safety processes and procedures. Training and documentation are key to all of FSMA’s rules. “Training is essential for each member of an organization,” says John Lynch, national quality assurance manager for RPE, a Wisconsin-based grower and distributor of potatoes and onions. “Year over year, we’re refining and advancing our training content to communicate risks, controls, and solicit input for continuous improvement.”
Despite familiarity with food safety in general, there is still trepidation among many in the industry. “It’s not so much about the requirements as it is about the liability,” comments Jennifer McEntire, vice president of food safety and technology at United Fresh Produce Association. “No matter what regulations you follow, produce is a raw product and something could go wrong. It’s the threat of criminal prosecution that scares people.”
Following is an overview of the FSMA regulations, six of which are applicable to produce, with each targeting a different segment of the industry.
Rule #1 Preventive Controls for Human Food Primarily affects: Off-farm processors, warehouses, packers Final rule effective date: November 16, 2015 Compliance deadline rollout: general: September 19, 2016 through January 26, 2018; small businesses: September 18, 2017 through September 18, 2019; very small businesses: January 1, 2019 through September 19, 2020 Requirements: Requires facilities to implement a food safety plan for preventing and addressing contamination by chemical, biological, and physical means and to train employees in how to follow the procedures. Exemptions or modified requirements: Facilities with annual revenues of under $1 million.
The produce industry is in the midst of figuring out how best to comply with the Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, and administered by the U.S. Food and Drug Administration (FDA). Implementation deadlines have been rolling out since late 2016, with the entire industry readying for compliance with most regulations by the spring of 2018.
Contamination by foodborne E. coli, salmonella, listeria, and the like affect millions of people in the United States, resulting in as many as 3,000 deaths per year. The intent of FSMA, the first major food safety reform in more than seven decades, is to maintain the safety of the U.S. food supply by focusing proactively on prevention, rather than reacting to incidents after the fact. Reaching this goal involves striving for continuous improvement, implementing preventive measures that are backed by science, ensuring effective training, and documenting all safety activities on an ongoing basis.
Much of FSMA is based on existing best practices; complying with the law is, in many ways, more a matter of improving recordkeeping and paperwork and introducing a training regimen than about wholesale changes in core safety processes and procedures. Training and documentation are key to all of FSMA’s rules. “Training is essential for each member of an organization,” says John Lynch, national quality assurance manager for RPE, a Wisconsin-based grower and distributor of potatoes and onions. “Year over year, we’re refining and advancing our training content to communicate risks, controls, and solicit input for continuous improvement.”
Despite familiarity with food safety in general, there is still trepidation among many in the industry. “It’s not so much about the requirements as it is about the liability,” comments Jennifer McEntire, vice president of food safety and technology at United Fresh Produce Association. “No matter what regulations you follow, produce is a raw product and something could go wrong. It’s the threat of criminal prosecution that scares people.”
Following is an overview of the FSMA regulations, six of which are applicable to produce, with each targeting a different segment of the industry.
Rule #1 Preventive Controls for Human Food Primarily affects: Off-farm processors, warehouses, packers Final rule effective date: November 16, 2015 Compliance deadline rollout: general: September 19, 2016 through January 26, 2018; small businesses: September 18, 2017 through September 18, 2019; very small businesses: January 1, 2019 through September 19, 2020 Requirements: Requires facilities to implement a food safety plan for preventing and addressing contamination by chemical, biological, and physical means and to train employees in how to follow the procedures. Exemptions or modified requirements: Facilities with annual revenues of under $1 million.
Fresh-cut processing, packing, and warehousing facilities—if located off the grower’s farm—are among the industry segments that fall under this rule. The Preventive Controls regulation requires each location to write a food safety plan outlining the specific and scientifically endorsed procedures it will use to prevent and address biological, physical, and chemical threats, based on a risk analysis, and to ensure all employees are trained in these procedures.
There is some flexibility built into the law; rather than being government-prescribed, optimal safety measures and training needs are determined by industry best practices. Though FSMA sets forth a new safety regime, the Hazard Analysis and Risk-Based Preventive Controls (HARPC), it is built upon and replaces the traditional Hazard Analysis and Critical Control Points (HACCP) system.
“Companies my size doing business with retailers have a lot of food safety programs in place already,” comments Rod Bernard, director of food safety at Southern Specialties, Inc., a Florida grower and importer. “We’re considered a small company by the standards of the FDA, but we’re big enough to have a full-time director of food safety. For us, it’s mainly about understanding what is in the law and changing some verbiage.”
The situation is similar for California table grape grower Jasmine Vineyards, Inc. in Delano. “At Jasmine, we sell what we grow,” says Luis Katsurayama, food safety and quality assurance manager. “We’re not bringing in raw materials from anywhere else; it’s when you deal with outside growers that it becomes hard to trace.” Since the company’s existing HACCP plan matched very closely with the requirements under the Preventive Controls rule, only minor tweaks in wording were necessary to meet FSMA protocols. “The actions are the same.”
Bernard, like others in the industry, believes there is still much confusion about the rules, their reach, and implementation. “FSMA is still new and we’ll see how it’s going to play out, since it’s an interpretation of law,” he notes. “The uncertainty is probably the thing that’s most troubling to a lot of people right now.”
Rule #2 Preventative Controls for Animal Food Does not apply (generally) to the fresh produce industry.
Rule #3 Produce Safety Primarily affects: Growers Final rule effective date: January 26, 2016 Compliance deadline rollout: general: January 26, 2018 through January 28, 2019; small businesses: January 28, 2019 through January 26, 2021; very small businesses: January 27, 2020 through January 26, 2021. All growers have an additional two years to comply with some of the agricultural water requirements. Requirements: Dictates that farms implement science-based standards, processes, and training for food safety throughout the growing process, addressing risks in water, fertilization, sanitation, animal control, facilities and equipment, and human intervention. Exemptions or modified requirements: Farms with annual sales of $25,000 or less or only selling direct-to-end users, such as farmers’ markets, local grocers, or restaurants. Also exempt are “rarely eaten raw” commodities like asparagus, cranberries, eggplant, okra, potatoes, pumpkins, sweet corn, and water chestnuts. Conversely, problem-prone commodities such as sprouts are subject to specific and additional regulations and have earlier compliance dates.
The Produce Safety rule is complex and a whole new world for growers, which—unlike many processors—have not had to be FDA-registered in the past. The provisions of this rule encompass everything from water testing, use of manure and compost, and control of domestic and wild animals to training, cleanliness standards (for equipment, tools, and buildings), and sanitation practices and worker hygiene. The rule requires setting standards, implementing ongoing preventive and mitigation procedures, and training.
“The Produce Safety rule is the most important [part of FSMA for us], as it impacts supply chains beginning at the farm,” says Lynch. “The expectations necessary for a food-safe supply chain are a significant change in the produce industry,” he adds, noting that RPE has been working for years to upgrade procedures, verifications, and training to support food safety. Continuous evaluation, communication, and improvement are essential to accomplish a culture of zero tolerance of food safety incidents.”
Companies doing business abroad may already be compliant with some of the rule’s requirements. Katsurayama notes that Jasmine Vineyards has GlobalGAP certification, as required by its global customers, so “we’re already doing a great part of it.”
Some commodities are innately easier to monitor than others. Jasmine’s table grapes grow five feet off the ground. Irrigation water, a focus of the Produce Safety rule, never touches the fruit. “I do feel lucky about the structure of our business,” Katsurayama observes. “For other produce companies, all the monitoring in the field and across the supply chain is a big challenge.”
For Rast Produce, Inc. in Visalia, CA, which sells California-grown and imported produce to chain stores and foodservice companies on the East Coast, “there’s a lot more tracking and attention to detail,” contends John Rast, president of the eponymous grower and Sierra Agricultural Transportation, also based in Visalia. “It’s not that different from what we’ve been doing; it just needs to be more vigilant.”
Unfortunately, Rast has experienced pushback from growers about the increased paperwork. “Very rarely does a week go by that a new grower doesn’t contact us about selling a commodity, but they have to adhere to our standard operating procedures. Until I have the paperwork in order, [a grower] can have the most beautiful oranges in the world—but I can’t buy them.” Rast notes that even growers he’s worked with for years are balking at the new requirements, until they realize he won’t purchase from them until they comply.
Unresolved Issues McEntire points out that the Produce Safety rule contains a couple of points that have not yet been resolved, the first having to do with water testing protocols, including the use of antimicrobials in washwater. She explains that many facilities have been using antimicrobials, but questions remain about how much to use and how frequently. “You have to show historical practice works, with evidence from science. You may feel like you’re doing the right thing, but you have to prove it. So there’s been an uptick in research to understand what happens in different situations.”
The FDA is also working with industry groups to reconsider the rules for water testing on farms. The goal is to offer more flexibility on how the goal of clean water can be achieved, since a one-size-fits-all approach does not work for all commodities, environments, or growing conditions. The compliance dates for water testing have been extended due to these ongoing concerns and discussion.
The second unresolved issue has to do with the boundaries between the Produce Safety and Preventive Controls rules. If the packing is done on the farm, the activity falls under the Produce Safety rule; if it’s done by a separate packer, it’s governed by the Preventive Controls rule.
“Functionally, you’re doing the same thing and the risks and hazards are identical,” McEntire contends. “Both rules get you to the same end of food safety, but their approaches are very different.”
Compliance with the Preventive Controls rule allows for subjectivity and flexibility, while the Produce Safety procedures are more prescriptive. “We get the question from our members, ‘If we’re doing the same thing as the guy next door, why are the rules so different?’” McEntire says the industry is working with the FDA to resolve the discrepancy and is optimistic the issue can be resolved by the January 2018 compliance deadline.
Rule #4 Foreign Supplier Verification Program Primarily affects: Importers Final rule effective date: January 26, 2016 Compliance deadline rollout: general: May 30, 2017 through July 26, 2017; small businesses: March 19, 2018 through July 29, 2019; very small businesses: March 18, 2019 through July 27, 2020 (importers working with raw produce packing and holding facilities have an additional 16 months to match the Produce Safety deadlines). Requirements: Places liability on importers to ensure that foreign suppliers comply with either the Preventive Controls for Human Food or the Produce Safety rule. Exemptions or modified requirements: Importers with less than $1 million in annual food sales, or those working with very small growers with $25,000 or less in annual sales.
The Foreign Supplier Verification Program (FSVP) is the longest, most complex, and arguably most confusing of the seven rules. It places liability on importers for the safety of the food they purchase from foreign suppliers. “Life has changed for food importers, that’s for sure,” says McEntire. “It’s the most complicated, nuanced rule; it’s also pretty prescriptive.”
She notes that compliance will likely be easier for importers who are also grower-shippers and familiar with food safety protocols, as opposed to companies involved only in facilitating imports, which have never had legal responsibility for food safety until now.
Bernard agrees with McEntire. “The biggest impact will be on importers that don’t have farms, the one- or two-person operations with a minimum of food safety training,” he says. Importers must “now have a competent person, on site, review all food safety operations.” Some importers, he notes, “may have had food safety people outside of the country, but that doesn’t work under FSMA.”
Who Must Comply At its core, the regulation requires importers to verify all goods they bring into the U.S. market are safe and consistent with the provisions of the Preventive Controls or Produce Safety rules, with separate FSVPs for each supplier.
Importers must develop and maintain a process for verifying, throughout the whole growing, manufacturing, and transportation process, that the food is safe and correctly labeled, identifying any risks or hazards through experience, historical data, audits, scientific reports, sample testing, or other information. They must also have a plan for addressing any problems.
“You have to look at the companies’ history, examine their processes, or evaluate the food itself to make sure they’re doing everything properly,” McEntire stresses, and a further complication is that the growers and processors who must follow the rules may not even be direct suppliers of the importer.
One of the first steps in complying with FSVP is for each importer to provide the name, email address, and unique facility identifier to the FDA for each line entry of food product offered for importation in to the United States, according to Ana Ramos, licensed customs broker at The Perishable Specialist, Inc., a Miami-based company that clears cargo at all major U.S. ports.
The Data Universal Numbering System (DUNS), assigned and managed by Dun & Bradstreet, is FDA-recognized for use with FSVP. Getting a free DUNS number prior to a company’s compliance date is encouraged, since the number allows the FDA to accurately identify FSVP importers as it implements, monitors compliance with, and enforces FSVP. Importers must comply with this part of the rule even when handling commodities that are exempt under FSMA, such as the list of produce items that are rarely, if ever, consumed raw.
“We are currently clearing asparagus from Peru, which is a product that’s exempt from FSVP but not exempt from the transmission of their unique facility identifier,” Ramos says. She notes that her company has made sure all of its asparagus importers are compliant with this transmission, which occurs at the time-of-entry filing.
Rule #5 Third-Party Certification Primarily affects: Importers Final rule effective date: November 13, 2015 Compliance deadline rollout: N/A Requirements: Sets up a pay-for-play program, the Voluntary Qualified Importer Program to expedite FSVP compliance by submitting to third-party audits. Exemptions or modified requirements: n/a
This portion of FSMA sets up a voluntary accreditation process involving FDA-recognized third-party auditors that can certify foreign food-producing facilities are adhering to the Preventive Controls and Produce Safety rules. If suppliers have passed an audit, they are eligible for the Voluntary Qualified Importer Program and go to the head of the line at the border. The audits may also be used to determine if certain regions present an overall hazard; for example, if there has been a chemical accident in a food producing area, then all food from growers in this region would be at risk.
“Voluntary quality provider status is an add-on to FSVP,” McEntire says. It takes note of FSVP-compliant businesses and suppliers that have gone above and beyond food safety protocols, and are rewarded with what McEntire calls “a fast pass for imports.” Because the program is “pay-to-play,” she adds, “we don’t know yet how to quantify the benefits, as each importer has to decide if the cost is worth it.”
Rule #6 Sanitary Transportation Primarily affects: Shippers, distributors, receivers, truck brokers, and carriers Final rule effective date: June 6, 2016 Compliance deadline rollout: general: April 6, 2017; small businesses: April 6, 2018; very small businesses: April 6, 2019 Requirements: Holds shippers responsible for conveying proper food safety procedures during transit, and for carriers to follow these instructions. Exemptions or modified requirements: Carriers engaged in food transportation operations with less than $500,000 in average annual revenue.
The Sanitary Transportation rule is considered the shortest and simplest of the seven rules, yet can still be challenging. “I’ve been surprised at the reaction of the industry,” observes McEntire. “It’s caused so much confusion and so many questions.” One reason may be that the FDA has not, at press time, released its guidance on training.
The rule focuses on vehicle and equipment characteristics and operations, as well as training and recordkeeping. Shippers are given leeway to dictate their own safety protocols and training requirements, which generally follow industry best practices already in place.
John Husk, a partner at the law firm of Seaton & Husk, which represents clients including property brokers and carriers involved in produce and other industries, notes that the FDA and the transportation industry worked together, holding listening sessions and soliciting input from shippers, carriers, rail companies, brokers, and other stakeholders to ensure the rule worked. “The industry has been policing itself,” he says. “The new rule means you need a contract or special instructions so brokers and shippers can comply.”
Foreign Suppliers and FSMA Produce growers, shippers, packers, and fresh-cut processors outside the United States must all comply with FSMA if they want to sell into the U.S. market. While the legal liability is with the importer, under the Foreign Supplier Verification Program (FSVP) compliance to either the Preventive Control or Produce Safety rule is a must if foreign produce suppliers want their product to cross the border and for retailers to accept it.
There is a process under FSVP for reducing the burden when the FDA views a country’s food safety program as comparable to FSMA. Importers must still comply with FSMA regulations, but the recordkeeping burden can be substantially reduced—but only if the imported food will be used as is. For produce undergoing further processing, the modified procedure does not apply and the product must be in full compliance with FSMA.
To date, only Canada, Australia, and New Zealand fall into the preferred category, although the FDA is working with other countries to add them to the list. Since food safety systems vary significantly from one country to another, it can be difficult for a nation to have its program deemed comparable. After FSMA became law in 2011, Canada passed the Safe Food for Canadians Act (SFCA) the following year, which keeps the two nations’ programs operating in parallel, although not identically. Implementation of SFCA will occur in 2018.
Jeff Hall, food safety specialist for the Canadian Produce Marketing Association, says there are a few minor points that differ between the Canadian and U.S. regimes, but “otherwise, if you’re compliant with one, you’re compliant with the other.” Documentation, for example, differs slightly: FSMA requires Canadian growers or processors to be recognized by the Canadian Food Inspec-tion Agency (CFIA) to do business in the United States.
Because the SFCA will not be final until 2018, there is a transition period when the two systems are not quite comparable. “This issue has come up, and CFIA and FDA are in discussions about it,” Hall relates. “They have a great relationship and have been fairly responsive to the industry, so we don’t expect any huge issues.” He notes that the delay in full implementation of FSMA’s Produce Safety rule to 2018 will help alleviate some of the issues caused by the lag.
Kenny Lund, vice president of support operations at the Allen Lund Company, a transportation broker headquartered in La Canada, CA, says many growers seem to think that simply transferring all liability to the transportation company is enough to comply with the rules. The point of the rule, he stresses, is to put the best practices already in place in writing, so everyone knows what to expect. “If you had best practices in place, there’s very little change,” he explains. “You just need more documentation and it’s all at the loading dock.”
Lund recommends adding two other forms to the standard transfer documentation, which traditionally consists of a bill of lading outlining the products, destination, and temperature. The first is a trailer inspection sheet. “FSMA says the loader and the driver—and the communication between them—is the key,” he says. The loader and driver can go through the checklist together, examining the chutes, drains, cleanliness, precooling, and any other factors that need to be recorded.
The second is a basic handling sheet, outlining and following best practices—which are not stipulated by FSMA. “The best practices for bananas differ from the best practices for watermelon,” Lund says. “You just need to put the best practices in writing and communicate them, and the best place to do that is at the dock.” The sheet, he says, should include information such as temperature, how many checks should be performed per day, how to identify problematic color changes, and other information, with full details clearly spelled out.
Recent fixes The reliance on industry best practices has alleviated some of the challenges expected to arise as the rule was originally written. The initial version suggested that if produce arrived at a consignee with temperature variations but still perfectly safe, it would be rejected, putting the burden on the carrier to mitigate, according to Husk. The industry and FDA worked together on this challenge, so the parties involved can now get an inspector to see if there is danger or if the goods can be sold, rather than requiring destruction out of hand.
Lund cites another example: if a load needs to be unsealed en route for multiple drops, the handling sheet can note this information so the load won’t be rejected at subsequent stops. Originally, there was a fear that an unsealed container would require rejection and destruction, no matter the circumstances.
Rule #7 Intentional Adulteration Primarily affects: Large produce-processing companies Final rule effective date: July 26, 2016 Compliance deadline rollout: July 26, 2019 Requirements: Directs companies to have a prevention and mitigation strategy in place to combat breaches in the food safety system due to terrorism or other bad operators. Exemptions or modified requirements: Businesses with less than $10 million in annual food sales and farms.
The Intentional Adulteration or “food defense” rule guards against acts meant to purposefully cause widespread harm through the U.S. food supply, with acts of sabotage, terrorism, counterfeiting, and the like. It is directed only at food companies with revenue over $10 million per year excluding growers (except dairy). Like other regulations in FSMA, it requires a plan, training, and adequate recordkeeping. The FDA plans to provide training and more guidance for this portion of the law, which has a longer lead time until the compliance date than other rules.
Moving Forward It will take human and financial resources to comply with FSMA’s rules. But for the most part, the industry views the new regulations as common sense and worthy of the time and effort required to comply.
Lynch believes the FSMA rules “will provide protection for both consumers and the entire supply chain. Consumers must be able to purchase and enjoy products without the fear of debilitating illness. Members of the supply chain must protect themselves from lost sales, service interruptions, and lost trust brought about by foodborne illness outbreaks.”
“I haven’t heard too many complaints from our members about the cost,” shares McEntire. “They’re willing to make investments, if those investments really do improve food safety.”
Lynch concurs and is convinced the cost of FSMA will always be less than the cost of not implementing food safety procedures. That said, the path to compliance may not be smooth. Noting that the industry is less than a year into the process, McEntire says, “I predict a bumpy road. We’ll learn a lot, both on the industry side and on the regulatory side, [which will likely prompt more] change as rules are interpreted.”
