Meeting the Requirements of FSMA in 2016

The food industry and government regulators alike will face significant challenges in meeting requirements of the Food Safety Modernization Act (FSMA), which begin taking effect in 2016. In 2015, FDA published final regulations for five of the seven major FSMA rules, establishing deadlines for food companies to embrace new manufacturing processes and requirements for testing, monitoring, recordkeeping, and reporting—all designed to ensure that safety is built into every link of the food chain, from raw materials, to transportation, to storage.

“Most companies want to do the right thing; many are doing it now,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine, following the multi-state outbreak of Listeria monocytogenes tied to Blue Bell Creameries ice cream in early 2015. “Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination.”

Missing court-imposed deadlines by several days, the FDA in 2015 published long-awaited final regulations for the preventive controls for human food, preventive controls for animal food, the produce safety rule, the Foreign Supplier Verification Program, and third-party certification of auditors for foreign suppliers. FDA must publish final rules for the sanitary transportation of food and for countering intentional adulteration in the first half of 2016.

“Will food companies understand what they need to do to be in compliance with all these rules, and will FDA inspectors be properly trained on how to enforce them?” asks David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods. “I am hearing these questions a lot. For FDA, doing so will require money and resources, and we know the agency doesn’t have what’s needed,” he tells Food Quality & Safety magazine.

Plan for Preventive Controls

Things will not be easy for industry, either. The first FSMA deadline comes September 2016, when large companies (having 500 or more full-time equivalent employees) must comply with the preventive controls rules for human food. Small companies (fewer than 500 employees) will have until September 2017, and very small businesses (less than $1 million in average annual sales), until September 2018. Large companies dealing with animal food also have until September 2016 to implement the current Good Manufacturing Practices (cGMP) requirements of that rule. In addition, FDA intends to implement “as soon as possible” the third-party auditor certification program for U.S. importing companies, regardless of size. That final rule was published in November 2015. The other FSMA rules have staggered deadlines, but companies will generally have between one and three years following publication to comply, depending on their number of employees or average annual sales volume.

Among the five published regulations, the two preventive controls and the produce safety rules will impact most food companies most directly. Generally speaking, FDA-registered food facilities must establish and maintain food safety systems that include a Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan, similar in many ways to Hazard Analysis and Critical Control Points, or HACCP, plans for juice and seafood. To verify the controls are effective, companies must monitor, test, take corrective actions, verify, and document the outcomes. Manufacturing and processing facilities must also maintain risk-based supply chain programs for raw materials and ingredients and provide cGMP education and training to their relevant employees.

FDA plans to work with public and private partners to develop and deliver training curricula. These will become standardized yet remain flexible. FDA will rely on existing alliances to develop training programs for domestic and foreign businesses. USDA is also providing grants to establish regional centers for food safety and training for small- and medium-sized farms and for fresh fruit and vegetable wholesalers. “One size doesn’t fit all. The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements,” the agency says.

The produce safety rule impacts growers of fruit and vegetables intended for raw consumption. Here, growers will be required to adopt science-based microbial testing of and standards for water used for irrigation. The rule also elaborates on standards for manure application and for composting. (The preventive controls rule clarifies when a farm is covered by produce safety rule and when its activities may place it under preventive controls jurisdiction.)

FSMA grants FDA access to company records during routine inspections. Should problems arise, FDA will first seek voluntary corrections at the facility level. If that fails, the agency will use its enhanced administrative powers, such as detention and mandatory recalls, and only afterwards seek court-ordered injunctions, seizures, or criminal prosecutions. Overall, FDA hopes to encourage industry compliance through education and technical assistance by partnering with other federal, state, and local agencies.

Filling Science and Technology Gaps

To successfully implement FSMA, FDA needs to fill “critical knowledge gaps” to support its regulatory decision-making. According to a strategic plan for 2015-2018 prepared by the agency’s Center for Food Safety and Applied Nutrition (CFSAN), which is tasked with implementing FSMA, the knowledge gaps span several areas, including intervention and preventive control strategies for microbial and chemical hazards; development of improved field laboratory screening methods for contaminant detection; and advancing bioinformatics. CFSAN “is focused on setting science-based preventive control standards for the way industry produces, distributes, and markets food in order to strengthen the nation’s food safety system,” the CFSAN report states.

For several years FDA, CDC, and other agencies have been successfully utilizing full-genome sequencing and other genomic tools to identify pathogens implicated in foodborne outbreaks, including the recent Blue Bell Listeria situation. “We will see more of this in 2016,” Dr. Acheson predicts, as FDA inspectors collect environmental swabs during routine inspections and the genomic sequences are stored in online databases. “It’s almost like a criminal DNA database for later cross-referencing,” Dr. Acheson says. “And should inspectors find a positive sample, there may be short-term consequences for the plant including the issuance of a Form 483 for objectionable conditions,” he says.

Budget Shortfall

A major ongoing problem is the lack of funds to implement FSMA rules. “FDA funding is the leading challenge in 2016,” notes Craig W. Henry, PhD, vice president for global business development, Americas, Decernis LLC. “Funding is well below what was projected and required to move forward with FSMA regulations.” FDA has requested $109.5 million in additional FSMA funding from Congress for fiscal 2016, which began Oct. 1, 2015. But the House allocated only $41.5 million and the Senate granted $45 million. And for the fourth consecutive year, both chambers rejected the agency’s requests for industry user fees, this year totaling $191.8 million in food facility registration and inspection fees. FDA’s proposed fiscal 2017 budget request will be presented to Congress in February 2016.

“If we receive [the requested] funding, we can move forward to implement this new, modern system in an effective and timely way,” said Taylor. “If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.” The ongoing budget challenge is confronting not only FDA, but also USDA, CDC, and state and local agencies responsible for food inspections and public health surveillance. “If states are expected to implement the regulations and have their enforcement plans executed, they will have to be funded and everyone will have to be in lockstep with the training that is required for all inspectors,” Dr. Henry explains.

This funding shortfall may also slow FDA’s issuance of guidance documents, which industry relies on to adopt the new regulations. Agency officials expect to release guidance documents for the preventive control rules by the end of the first quarter of 2016, which would give large companies only nine months to prepare. But these may also be delayed by politics. “In my experience in Washington, once you hit May in an election year you start walking through quicksand and you grind to a halt by July and August,” says Dr. Acheson.

The bottom line is that “industry has to be ready in 2016,” Dr. Henry tells Food Quality & Safety. “Things will become clearer once we see how the agency undertakes inspections after Sept. 30, 2016.”

Criminal Prosecutions

Building on successful criminal prosecutions of Peanut Corporation of America (PCA) and ConAgra Foods Inc., the Department of Justice in 2016 will likely pursue additional high-profile cases against company officials when food safety problems arise. In September 2015, former PCA CEO Stewart Parnell was sentenced to 28 years in prison for his role in the 2008-2009 Salmonella outbreak that killed nine people and sickened more than 700 others nationwide. It was the stiffest punishment ever handed down in a foodborne illness case. His brother, Michael Parnell, was sentenced to 20 years, and the plant’s former quality control manager, Mary Wilkerson, was sentenced to five years.

These sentences “demonstrate the consequences for those whose criminal actions threaten that trust by introducing contaminated food into the marketplace,” said Stuart F. Delery, acting associate U.S. attorney general, at the time of sentencing. “Americans expect and deserve the highest standards of food safety and integrity,” added Stephen Ostroff, MD, acting FDA commissioner. “Those who choose profits over the health and safety of U.S. consumers are now on notice that the FDA, working with the Department of Justice, will strive to use the full force of our justice system against them.”

Speaking at the American Food Manufacturing Safety Summit in Dallas in June 2015, Delery explained that the Justice Department will generally pursue felony charges against food company executives when it believes they acted intentionally. “A common thread in many of the cases we have pursued is that multiple people within an organization saw red flags of unsafe practices and chose not to act,” he explained. “Even a single decision to cut corners can have deadly consequences.” But when intent is not a factor, such as with Jensen Farms cantaloupes contaminated with Listeria monocytogenes, the government will generally pursue misdemeanor charges, he explained. (Eric and Ryan Jensen each received five years probation and were ordered to pay $150,000 in restitution.

In May 2015, ConAgra Grocery Products LLC agreed to pay $11.2 million in a misdemeanor plea agreement to resolve allegations that it shipped Salmonella-tainted peanut butter under its Peter Pan brand and Wal-Mart Stores, Inc.’s Great Value label. More than 700 people were sickened in 44 states, with about 20 percent of them requiring hospitalization; none died.

Social Media

Traditional disease surveillance systems capture only about 20 percent of the estimated 48 million annual U.S. foodborne illness cases because only a small proportion of sickened people will seek medical care or report their conditions to authorities. Researchers have found that social media, such as Twitter and online review sites such as Yelp, can help local public health departments identify and track foodborne illness outbreaks more effectively.

Biostatistician Elaine Nsoesie, a research fellow in pediatrics at Boston Children’s Hospital, and colleagues compared reports of foodborne illness posted on social media to those confirmed by the CDC. They found “significant correlations” for illnesses associated with poultry, leafy lettuce, and mollusks. “Online reviews of food service businesses offer a unique resource for disease surveillance,” Nsoesie said in a presentation at an American Statistical Association’s conference in August 2015.

Social media may even become a tool to help consumers learn more about their food. “We live in a highly connected world today where the consumer is more aware and empowered to learn about the origins of their food, recall alerts, and ingredients that they believe may cause them harm,” says Angela Fernandez, vice president of retail grocery and food service at GS1 US. “In 2016, I believe we’ll see fewer barriers between supply chain partners as they work to enhance traceability processes that make the recall process and entire supply chain more interoperable and collaborative,” Fernandez tells Food Quality & Safety. “This proactive approach puts consumer concerns at the forefront.”

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Agres is a freelance writer based in Laurel, Md. Reach him at [email protected].